Breast pump systems and methods

Abstract

To provide portable, energy-efficient breast pump systems and methods for collecting mother milk from a breast of a nursing mother.SOLUTION: Mother milk is expressed from a breast under suction, and is discharged from a pumping mechanism to a collection container under positive pressure.SELECTED DRAWING: Figure 20

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to portable, energy efficient breast pump systems and methods for collecting breast milk from a nursing mother's breast. [Background technology]

[0002] As more women consider breastfeeding to be the optimal source of nutrition for infants and to provide health benefits to nursing mothers, there is an increasing need for a user-friendly, quiet, discrete, and versatile breast pump solution for use by nursing mothers in a variety of situations. This is especially true for working women who may be away from home for 8 to 10 hours or more and need to express breast milk for their infants, but it is also a requirement for many other situations where mothers are away from the personal affairs of their home for extended periods of time, such as while shopping, eating out, or engaging in other activities.

[0003] A wide variety of breast pumps are available, but most are cumbersome, complicated, require many parts and assemblies, and are difficult to transport. A variety of manually operated 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. Some systems are battery powered, but electric pumps run continuously to maintain suction during the milk extraction process, which drains batteries fairly quickly. Many of the breast pumps available are clearly visible to others when the mother is using them, and many also expose the mother's breasts when in use.

[0004] There is a continuing need for a small, portable, self-powered, energy-efficient wearable breast pump system that is easy to use and that is discrete by not exposing the user's breasts and being invisible or barely noticeable when worn.

[0005] To ensure that a nursing infant receives proper nutrition, it is useful to monitor the infant's intake. It is desirable to provide a breast pump system that easily and accurately monitors the amount of breast milk pumped by the system, making it convenient for a nursing mother to know how much breast milk has been extracted by pumping. It is also desirable to track the amount of breast milk pumped per session, so that the amount of breast milk contained within any particular breast milk collection container can be easily known.

[0006] Many existing breast pump systems can cause significant discomfort to users over time. One cause of such discomfort is chafing of the nipple against the nipple flange / housing as the nipple expands and contracts during pumping sessions. There is a continuing need for breast pump systems that are more comfortable for users, even over repeated pumping sessions. Summary of the Invention [Problem to be solved by the invention]

[0007] In brief and in general terms, the present disclosure is directed to a breast pump system or method. The system includes a breast contacting structure and a reservoir, and a structure for pumping breast milk from the breast to the reservoir. The method involves pumping breast milk from the breast and pumping the pumped breast milk into the reservoir. [Means for solving the problem]

[0008] According to one aspect of the disclosure, a system for expressing breast milk from a breast includes one or more of a skin contact member configured to form a seal with the breast; a conduit in fluid communication and coupled to the skin contact member; a drive mechanism configured to establish a vacuum profile within the conduit; an outer shell, the outer shell having a compartment facing a distal end of the outer shell, the outer shell further having a proximal end surface facing outward from the proximal end, the skin contact member, the conduit, and the drive mechanism are received within the compartment of the outer shell, the breast milk collection container is positionable above the distal end surface of the shell, and the system is shaped and configured to contour to a user's breast.

[0009] In various disclosed embodiments, the system defines a natural breast profile. The natural breast profile is intended to fit comfortably and conveniently into a user's bra and to look natural. Thus, the profile is characterized by having a non-circular base. Moreover, like a natural breast, the profile of the device or system is intended to define one or more asymmetrical curves and eccentric centers of inertia.

[0010] In at least one embodiment, the skin-contacting member, conduit, drive mechanism, outer shell and breast milk collection container are all contained within the cup of a brassiere.

[0011] In at least one embodiment, the system is battery powered, where the system includes a battery, where the battery is received within a compartment in the exterior shell.

[0012] In at least one embodiment, the proximal surface of the outer shell is shaped and configured to be contoured to fit the user's chest and thus provide a more natural appearance when underneath clothing worn by the user.

[0013] In at least one embodiment, the proximal surface of the outer shell comprises a polygonal, flat, irregular or discontinuously curved shape that does not resemble the curvature of the breast, and the breast milk collection container is configured to interface with the proximal surface and is shaped and configured to be contoured to fit the user's breast and thus provide a more natural appearance when underneath the user's clothing.

[0014] In at least one embodiment, the proximal surface comprises a flat surface forming a sloped outer surface.

[0015] In at least one embodiment, the proximal surface comprises a flat central portion and a convex portion extending radially from the flat central portion.

[0016] In at least one embodiment, the breast milk collection container is configured and dimensioned to have a variable volume when filled such that when the breast milk collection container is filled with breast milk, it conforms to the proximal surface of the exterior surface while providing an externally convex shape, thereby mimicking the natural shape of the breast.

[0017] In at least one embodiment, the breast milk collection receptacle is pre-shaped to follow the contours of the proximal surface of the outer shell and provide an externally convex shape, thereby mimicking the natural shape of the breast.

[0018] In at least one embodiment, the breast milk collection container comprises a rigid distal surface that mates with the contour of the proximal surface of the outer shell and a flexible proximal surface that moves as breast milk enters the breast milk collection container to provide a convex shape that mimics the natural shape of the breast.

[0019] In at least one embodiment, the breast milk collection container comprises a flexible distal surface that changes shape to match the contour of the proximal surface of the outer shell as breast milk enters the breast milk collection container, and the breast milk collection container further comprises a rigid proximal surface that provides a convex shape that mimics the natural shape of the breast.

[0020] In at least one embodiment, the breast milk collection container comprises a rigid distal surface that is pre-shaped to mate with the contour of the proximal surface of the outer shell as breast milk enters the breast milk collection container.

[0021] In at least one embodiment, the breast milk collection container comprises at least one structural element configured to limit the amount of expansion of the breast milk collection container or to provide a shape to the breast milk collection container even when empty.

[0022] In at least one embodiment, the at least one structural element is selected from the group consisting of a baffle, a heat seal, a strut, and a restriction.

[0023] In at least one embodiment, the breast milk collection container comprises a unique identifier configured to be read by a computer processor and which uniquely distinguishes the breast milk collection container from all other breast milk collection containers.

[0024] In at least one embodiment, the unique identifier includes a sensor.

[0025] In at least one embodiment, the sensor includes a passive sensor.

[0026] In at least one embodiment, the system further includes a controller positioned within the exterior shell and configured to control operation of the drive mechanism.

[0027] In at least one embodiment, the breast milk collection container comprises a unique identifier configured to be read by at least one of the controller and an external computer processor, and which uniquely distinguishes the breast milk collection container from all other breast milk collection containers.

[0028] In at least one embodiment, the unique identifier includes a sensor.

[0029] In at least one embodiment, the sensor includes a passive sensor.

[0030] In at least one embodiment, the sensor is selected from the group consisting of an RFID device, an NFC device, a Wi-Fi device, a BLUETOOTH device, and a BLUETOOTH Low Energy (BTLE) device.

[0031] In at least one embodiment, the sensor is selected from the group consisting of an RFID device and an NFC device.

[0032] In at least one embodiment, the breast milk collection container includes a one-way valve that allows breast milk to flow into the breast milk collection container but prevents breast milk from flowing back out of the breast milk collection container into the conduit.

[0033] In at least one embodiment, the conduit is integral with the breast milk collection container.

[0034] In at least one embodiment, the system further includes: a contour element; wherein the contour element extends distally from a distal periphery of the outer shell and extends proximally over a distal portion of the outer shell to provide a contoured extension of the outer shell that provides a visually more appealing appearance that more closely mimics the natural appearance of breasts supported by a bra.

[0035] In at least one embodiment, the profile element tapers distally to create a smooth transition with the chest when the system is worn on the chest.

[0036] In at least one embodiment, the profile element is removably attached to the exterior shell using at least one of snaps, hook-and-loop fasteners, buttons, magnetic adhesion, or a friction fit.

[0037] In at least one embodiment, the profile element comprises an outer portion extending distally from the distal periphery a first length and an inner portion extending distally from the distal periphery a second length, the first length being greater than the second length.

[0038] In at least one embodiment, the profile element is formed from a lightweight material including at least one of foam, plastic, or fabric.

[0039] In at least one embodiment, the profile element is formed from a single thin layer of plastic or fabric.

[0040] In at least one embodiment, the outer shell includes a key portion and the profile element includes a mating key portion that mates with the key portion when the profile element is attached to the outer shell, ensuring that the profile element is consistently positioned relative to the outer shell, thereby ensuring that the orientation of the profile element relative to the outer shell does not change rotationally, upwards, downwards, outward, or inward upon successive attachments.

[0041] In at least one embodiment, the contour elements are adjustable to accommodate a variety of breast sizes.

[0042] In at least one embodiment, the contour element includes a first edge and a second edge, the first edge overlapping the second edge and can be adjusted to reduce, increase, or maintain a circumference around the distal periphery of the contour element.

[0043] In at least one embodiment, the overlap of the first edge relative to the second edge can be adjusted to reduce, increase, or maintain the circumference of the proximal periphery of the profile element.

[0044] In at least one embodiment, the profile element includes a material that facilitates cutting a portion of its distal periphery to adjust the fit of the profile element against the chest.

[0045] In at least one embodiment, the contour element includes predetermined markings to assist in adjusting the contour element to various predetermined sizes.

[0046] In at least one embodiment, the exterior shell includes at least one key portion and the contour element includes a plurality of mating key portions each mating with a respective one of the at least one key portion to allow adjustment of the size of the contour element.

[0047] In at least one embodiment, the profile element is made from a resilient material that conforms to the shape of the object against which it is pressed.

[0048] In at least one embodiment, the profile element is configured to assume a generally flat shape in the unbiased configuration.

[0049] In at least one embodiment, the profile element is attachable to a proximal end portion of the exterior shell.

[0050] In at least one embodiment, the contouring element contours to the outer shell and the bra when supported by the bra.

[0051] In at least one embodiment, the system further includes a valve in the conduit adjacent to the skin contact member, where the valve is configured to open in a first direction when a vacuum is created in the conduit, close when a positive pressure up to a predetermined positive pressure is applied to the valve, and open in a second direction when a positive pressure exceeding the predetermined positive pressure is applied to the valve.

[0052] According to another aspect of the present disclosure, a system for expressing breast milk from a breast includes one or more of: an outer shell including a compartment facing a distal end of the outer shell, further having a proximal end surface facing outward from the proximal end, carrying a self-contained power source and a pump mechanism; a skin-contacting member supported by the outer shell; an outlet for draining breast milk received from the breast interfaced with the skin-contacting member; and a breast milk collection container in fluid communication with the outlet and positioned against the distal end surface of the outer shell; wherein the system is shaped and configured to contour to a user's breast.

[0053] In at least one embodiment, the system is contained within the cup of a brassiere.

[0054] In at least one embodiment, the skin-contacting element, the outer shell, and the breast milk collection container are sized and configured to be supported between the breast and the breast cup of the bra while the system actively pumps breast milk from the breast and drains the breast milk through the outlet into the breast milk collection container.

[0055] According to another aspect of the disclosure, a breast milk collection container for use with a breast pump system includes one or more of: a preformed surface shaped to mimic the natural appearance of a breast; and a flexible surface opposing the preformed convex surface, the flexible surface configured to expand when breast milk enters the breast milk collection container.

[0056] In at least one embodiment, the breast milk collection container is attached to an exterior surface of the outer shell of the breast milk pump, where after the breast milk enters the breast milk collection container, the flexible surface moves outward and conforms to the shape of the outer shell.

[0057] In at least one embodiment, the breast milk collection container comprises at least one structural element configured to limit the amount of expansion of the breast milk collection container or to provide a shape to the breast milk collection container even when empty.

[0058] In at least one embodiment, the at least one structural element is selected from the group consisting of a baffle, a heat seal, a strut, and a restriction.

[0059] According to another aspect of the disclosure, a system for expressing breast milk from a breast includes one or more of: a skin contact member configured to form a seal with the breast; a conduit in fluid communication with and coupled to the skin contact member; a drive mechanism configured to establish a vacuum profile within the conduit by cyclically compressing a portion of the conduit and allowing it to be decompressed; and an exterior shell containing the conduit and the drive mechanism and supporting the skin contact member.

[0060] In at least one embodiment, the system further includes a breast milk collection container, wherein the breast milk collection container is in fluid communication with the conduit.

[0061] In at least one embodiment, the breast milk collection container is positionable above a distal end surface of the shell, the system being shaped and configured to contour to a user's breast.

[0062] In at least one embodiment, the skin-contacting member includes a breast-contacting portion configured and dimensioned to engage in a sealing manner with a portion of the breast, and a nipple-receiving portion extending from the breast-contacting portion.

[0063] In at least one embodiment, the nipple-receiving portion includes a non-tapered portion attached to the breast contacting portion and a tapered portion extending from the non-tapered portion, the tapered portion configured and dimensioned to receive a nipple of the breast.

[0064] In at least one embodiment, the non-tapered portion is cylindrical and the tapered portion is conical.

[0065] In at least one embodiment, the non-tapered portion is oval or elliptical in cross-section.

[0066] In at least one embodiment, the tapered portion is oval or elliptical in cross section.

[0067] In at least one embodiment, both the non-tapered and tapered portions are oval or elliptical in cross-section.

[0068] In at least one embodiment, the breast-contacting portion includes a first central longitudinal axis and the nipple-receiving portion includes a second central longitudinal axis, the first and second central longitudinal axes being collinear.

[0069] In at least one embodiment, the breast-contacting portion includes a first central longitudinal axis and the nipple-receiving portion includes a second central longitudinal axis, the first and second central longitudinal axes being parallel.

[0070] In at least one embodiment, the breast-contacting portion includes a first central longitudinal axis and the nipple-receiving portion includes a second central longitudinal axis, and the first and second central longitudinal axes intersect.

[0071] In at least one embodiment, the top of the nipple receiving portion is configured to contact an upper surface of the nipple and the bottom of the nipple receiving portion is configured to contact a lower surface of the nipple, the top being formed from a material having a first hardness and the bottom being formed from a material having a second hardness, the first hardness being greater than the second hardness.

[0072] In at least one embodiment, the chest contacting portion includes at least one region on its inner surface that is configured to contact the chest and provide greater friction against the chest than friction provided by other portions of the inner surface of the chest contacting portion.

[0073] In at least one embodiment, the system further includes a resilient flap extending radially inward from a portion of the breast contacting member; where when the breast is inserted into the breast contacting member, the breast presses and folds the flap against an inner wall of the breast contacting member, and when the breast is removed from the breast contacting member, the flap resiliently returns to an unbiased position and extends radially inward, thereby retaining breast milk within the breast contacting member that would otherwise spill out of the breast contacting member.

[0074] In at least one embodiment, the flap comprises a sticky or roughened surface configured to increase friction against the breast when in contact with the breast.

[0075] In at least one embodiment, the system further includes a sensor mounted in or on the skin contact member or conduit, and a controller configured to control operation of the drive mechanism and receive signals from the sensor.

[0076] In at least one embodiment, the system further includes a first sensor mounted in or on the skin contact member or conduit, where a thickness of the skin contact member or conduit where the first sensor is mounted comprises a first thickness; and a second sensor mounted in or on the skin contact member or conduit, where a thickness of the skin contact member or conduit where the second sensor is mounted comprises a second thickness; where the second thickness is greater than the first thickness.

[0077] In at least one embodiment, the system further includes a controller configured to control operation of the drive mechanism, and one or more switches in electrical communication with the controller, the switches extending into the skin contact member or conduit a distance away from an inner wall of the skin contact member or conduit, i.e., a distance predetermined as the distance the inner wall will deflect when a predetermined vacuum pressure is achieved; where, when the predetermined vacuum pressure is achieved, the switch is activated by contact with the inner wall and sends a signal to the controller.

[0078] In at least one embodiment, the switch extends into the nipple-receiving portion of the skin-contacting member.

[0079] According to another aspect of the disclosure, a method of operating a system for expressing breast milk includes one or more of: providing a system comprising a skin contact member configured to form a seal with the breast, a conduit in fluid communication and coupled to the skin contact member, a drive mechanism including a compression member configured to compress the conduit and allow decompression of the conduit in response to inward and outward movement of the compression member, a sensor, and a controller configured to control operation of the drive mechanism; sealing the skin contact member against the breast; operating the drive mechanism to generate a predetermined pressure cycle in the conduit; monitoring by the controller at least one of a position and a speed of movement of the compression member relative to the conduit; measuring or calculating the pressure in the conduit; and maintaining or modifying operation of the compression member as necessary based on feedback from the calculated pressure and at least one of the position and speed of movement of the compression member to ensure that the predetermined pressure cycle continues to be generated.

[0080] In at least one embodiment, the predetermined pressure cycle includes an extraction mode pressure cycle, and the method further includes manually adjusting the maximum suction pressure to modify the predetermined pressure cycle.

[0081] In at least one embodiment, the predetermined pressure cycle includes an extraction mode pressure cycle, and the method further includes purging breast milk from the conduit when the controller determines that the compression member has reached a location that is a predetermined percentage of a predetermined outward motion limit of the compression member relative to the conduit.

[0082] In at least one embodiment, purging includes controlling the compression member by the control device to drive the compression member to a predetermined inward movement limit of the compression member, thereby forcing breast milk out of a portion of the conduit compressed by the compression member.

[0083] In at least one embodiment, the method further includes controlling the compression member to perform a compression mode cycle after performing the purge.

[0084] In at least one embodiment, the predetermined pressure cycle includes an extraction mode pressure cycle, and the controller increases the stroke distance of the compression member relative to the amount of breast milk entering the conduit to maintain the predetermined pressure during the extraction mode pressure cycle.

[0085] In at least one embodiment, the predetermined pressure cycle includes a latch mode cycle, and upon determining that breast milk has entered the conduit or after a predetermined time, the controller actuates the compression member to achieve a predetermined extraction mode pressure cycle, where the predetermined extraction mode cycle differs from the predetermined latch mode cycle in at least one of a maximum suction level or a cycle frequency.

[0086] In at least one embodiment, the predetermined pressure cycle includes an extraction mode pressure cycle, and the method further includes: monitoring, by the control device, pressure waves in at least one of the conduit and the skin contact member; monitoring, by the control device, at least one of a position and a velocity of the compression member relative to a pressure level monitored by the monitored pressure waves; and when a predetermined amount of change in the monitored pressure versus the monitored position or velocity of the compression member is identified, altering at least one of the velocity, stroke length, and position of the compression member, thereby maintaining execution of the predetermined pressure cycle.

[0087] In at least one embodiment, the controller monitors the position of the compression member and, when it detects that the compression member has reached a location that is a predetermined percentage of a predetermined outward movement limit of the compression member relative to the conduit, the controller controls the compression member to purge breast milk from the conduit.

[0088] According to another aspect of the disclosure, a system for expressing breast milk includes one or more of: a skin contact member configured to form a seal with the breast; a conduit in fluid communication and coupled to the skin contact member, a drive mechanism including a compression member, the compression member configured to compress the conduit and allow decompression of the conduit in response to inward and outward movement of the compression member; a sensor; and a controller configured to control operation of the drive mechanism; wherein, upon sealing of the skin contact member against the breast, the controller actuates the drive mechanism to generate a predetermined pressure cycle in the conduit, monitors at least one of a position and a speed of movement of the compression member relative to the conduit, measures or calculates the pressure in the conduit based on signals received from the sensor, and maintains or modifies operation of the compression member as necessary based on feedback from the calculated pressure and at least one of the position and speed of movement of the compression member to ensure that the predetermined pressure cycle continues to be generated.

[0089] In at least one embodiment, the predetermined pressure cycle includes an extraction mode pressure cycle, and the system is configured to allow manual adjustment of the maximum suction pressure to vary the predetermined pressure cycle.

[0090] In at least one embodiment, the predetermined pressure cycle includes an extraction mode pressure cycle, and the controller actuates the drive mechanism to purge breast milk from the conduit when the controller determines that the compression member has reached a location that is a predetermined percentage of a predetermined outward movement limit of the compression member relative to the conduit.

[0091] In at least one embodiment, purging includes controlling the compression member by the controller to drive the compression member to a predetermined inward movement limit of the compression member, thereby forcing breast milk out of a portion of the conduit compressed by the compression member.

[0092] In at least one embodiment, the controller is further configured to control the compression member to implement a compression mode cycle after performing the purge.

[0093] In at least one embodiment, the predetermined pressure cycle includes an extraction mode pressure cycle, and the controller increases the stroke distance of the compression member relative to the amount of breast milk entering the conduit to maintain the predetermined pressure during the extraction mode pressure cycle.

[0094] In at least one embodiment, the predetermined pressure cycle includes a latch mode cycle, and upon determining that breast milk has entered the conduit or after a predetermined time, the controller actuates the compression member to achieve a predetermined extraction mode pressure cycle, where the predetermined extraction mode cycle differs from the predetermined latch mode cycle in at least one of maximum suction level or cycle frequency.

[0095] In at least one embodiment, the predetermined pressure cycle includes an extraction mode pressure cycle, and the control device is further configured to: monitor pressure waves in at least one of the conduit and the skin contact member; monitor at least one of a position and a velocity of the compression member relative to a pressure level monitored by the monitored pressure waves; and modify at least one of the velocity, stroke length, and position of the compression member when a predetermined amount of change in the monitored pressure waves versus the monitored position or velocity of the compression member is identified, thereby maintaining execution of the predetermined pressure cycle.

[0096] In at least one embodiment, the controller monitors the position of the compression member and, when it detects that the compression member has reached a location that is a predetermined percentage of a predetermined outward movement limit of the compression member relative to the conduit, the controller controls the compression member to purge breast milk from the conduit.

[0097] According to another aspect of the disclosure, a method of purging breast milk from a breast milk pumping system after completion of a breast milk extraction process includes one or more of: providing a system comprising a skin contact member configured to form a seal with a breast, a conduit in fluid communication with and connected to the skin contact member, and a drive mechanism including a compression member configured to compress the conduit to pump the breast milk from the breast during the breast milk extraction process and to allow decompression of the conduit, wherein the skin contact member is sealed against the breast during the breast milk extraction process; reversing a direction of the drive mechanism upon completion of the breast milk extraction process to operate in a direction opposite to that in which the drive mechanism was operated to perform the breast milk extraction process to reduce suction in the conduit; breaking a seal of the skin contact member with the breast; and after breaking the seal, reversing a direction of the drive mechanism back to that in which the drive mechanism was operated to perform the breast milk extraction process, thereby forcing the breast milk out of the conduit.

[0098] In at least one embodiment, when the seal is broken, the reversal of direction of the drive mechanism is manually initiated by an operator.

[0099] In at least one embodiment, the system detects when the seal is broken and automatically reverses the direction of the drive mechanism upon detecting when the seal is broken.

[0100] In at least one embodiment, the method further includes terminating the pumping of breast milk from the conduit by ceasing actuation of the drive mechanism.

[0101] In at least one embodiment, the terminating is manually initiated by an operator.

[0102] In at least one embodiment, the system automatically initiates reversal of direction of the drive mechanism again and terminates after a predetermined period of time.

[0103] In at least one embodiment, the system initiates termination automatically by measuring the compliance of the conduit and initiating termination when the compliance reaches a predetermined compliance value.

[0104] In at least one embodiment reversing the direction of the drive mechanism to reduce the suction force in the conduit includes reducing the suction force to greater than -20 mmHg.

[0105] In at least one embodiment, reversing the direction of the drive mechanism to reduce the suction force in the conduit includes lowering the suction force and establishing a slight positive pressure force.

[0106] In at least one embodiment, reversing the direction of the drive mechanism to reduce the suction force in the conduit includes reducing the suction force to about 0 mmHg.

[0107] In at least one embodiment, reversing the direction of the drive mechanism to reduce suction within the conduit includes establishing pressure within the conduit at a value within the range of about -20 mmHg to about -50 mmHg.

[0108] According to another aspect of the disclosure, a system for expressing breast milk includes one or more of a pair of breast pumps, each pump comprising: a skin contact member configured to form a seal with a breast; a conduit in fluid communication with and coupled to the skin contact member; a drive mechanism configured to establish a vacuum profile within the conduit; a controller configured to control operation of the drive mechanism; and means for indicating whether the breast pump is attached to the left or right breast when both the breast pumps are attached to the left and right breasts.

[0109] In at least one embodiment, each drive mechanism includes a compression member configured to compress the conduit and enable decompression of the conduit in response to inward and outward movement of the compression member.

[0110] In at least one embodiment, the means for indicating is configured to receive a signal by one of the breast pumps from the other of the breast pumps to establish a relative position of the breast pumps.

[0111] In at least one embodiment, each breast pump further includes a magnetic coil, wherein a signal sent to one of the magnetic coils by a controller associated with the magnetic coil in one of the breast pumps induces a signal in the magnetic coil of the other breast pump, the signal being interpretable by the controller to determine the relative positioning of the breast pumps.

[0112] According to another aspect of the present disclosure, a system for expressing breast milk includes one or more of: a skin contact member configured to form a seal with the breast; a conduit in fluid communication with and coupled to the skin contact member; a drive mechanism configured to establish a vacuum in the conduit; and a means for indicating an amount of wear of at least one of the skin contact member and the conduit.

[0113] In at least one embodiment the means for displaying comprises a time-based indicator.

[0114] In at least one embodiment, the time-based indicator includes markings that disappear or appear over time.

[0115] In at least one embodiment, the time-based indicator comprises a clocking mechanism that provides at least one of a visual or audible indication upon the expiration of a predetermined time.

[0116] In at least one embodiment, the time-based indicator includes an indicator with multiple LCD bars that darken when the reset button is pressed and held, with the bars sequentially brightening over predetermined periods of time.

[0117] In at least one embodiment, the means for indicating the amount of wear comprises a wear indicator configured to appear or disappear with at least one of a color change or marking to indicate wear.

[0118] In at least one embodiment, the system further comprises a computer processor, wherein the means for indicating the amount of wear comprises a computer processor configured to track the cumulative time of use of at least one of the skin contact member and the conduit.

[0119] In at least one embodiment, the means for displaying the amount of wear comprises a processor, wherein the processor is configured to: track a position of the drive mechanism relative to the conduit; correlate pressure changes in the conduit to the position of the drive mechanism when the conduit was first used; continue to correlate pressure changes to the position during continued use of the conduit; compare correlation values ​​from the continued correlation with correlation values ​​from the correlation when the conduit was first used; and display the amount of wear in the conduit based on the comparison of the correlation values.

[0120] In at least one embodiment, the processor is included within the breast pump system.

[0121] In at least one embodiment, the processor resides in an external computer that is external to the breast pump system.

[0122] In at least one embodiment, the time-based indicator comprises a processor configured to track a time of use of at least one of the skin contact member and the conduit.

[0123] In at least one embodiment, at least one of the skin contact member and the conduit is provided with a passive sensor, and the processor is configured to track the passive sensor during use of the system.

[0124] According to another aspect of the disclosure, a method of operating a system for expressing breast milk includes one or more of: providing a system comprising a skin contact member configured to form a seal with the breast, a conduit in fluid communication and coupled to the skin contact member, a drive mechanism including a compression member configured to compress the conduit and allow decompression of the conduit in response to inward and outward movement of the compression member, a sensor, a controller configured to control operation of the drive mechanism and receive signals from the sensor, and a breast milk collection container in fluid communication with the conduit; sealing the skin contact member against the breast; operating the drive mechanism to extract breast milk from the breast and pump the breast milk into the breast milk collection container; and calculating an amount of breast milk pumped into the breast milk collection container based on dimensions of the conduit and position of the compression member.

[0125] In at least one embodiment, calculating the amount of pumped breast milk includes: calculating a total amount pumped based on dimensions of the conduit and the position of the compression member; and calculating the amount of pumped breast milk as a percentage of the total amount based on a compliance assessment of the conduit performed by comparing pressure changes in the conduit to the position of the compression member.

[0126] In at least one embodiment, the system further includes a one-way valve interconnecting the conduit and the breast milk collection container, and the method further includes: monitoring the one-way valve to determine when breast milk begins to flow into the breast milk collection container and stops flowing into the breast milk collection container; and wherein calculating the amount of breast milk pumped into the breast milk collection container is based on the dimensions of the conduit and the position of the compression member over time while the breast milk is flowing into the breast milk collection container.

[0127] According to another aspect of the disclosure, a nipple shield includes one or more of: a central region configured to cover a nipple of the breast and having a first thickness; and an attachment portion surrounding the central region, the attachment portion configured to be attached to the breast and having a second thickness; where the second thickness is greater than the first thickness, and the central region includes one or more openings to allow breast milk to pass therethrough.

[0128] In at least one embodiment, the first thickness is in the range of about 0.2 mm to about 1 mm and the second thickness is in the range of about 2 mm to about 5 mm.

[0129] In at least one embodiment, the first thickness is about 0.25 mm. According to another aspect of the disclosure, a method of automatic breast pumping includes providing a breast pump system including an outer shell, a conduit configured within the outer shell structure that contacts the breast, and a breast milk collection container; forming a seal between the breast pump system and the breast; and pumping breast milk expressed from the breast into the collection container, wherein the breast milk is pumped upwardly from the breast through the conduit and into the collection container, the outer shell, the breast contacting structure, and the collection container being sized and shaped to fit within the cup of a bra. According to another aspect of the disclosure, an automated system for controlling a cycle of expressing breast milk from a breast includes one or more of a breast contacting structure configured and dimensioned to form a seal with the breast, an outer shell, a collection container for storing breast milk expressed from the breast, and a tube configured within the outer shell, the tube in fluid communication with the collection container, the tube extending upwardly, breast milk extracted from the breast flows upwardly from the nipple, and the outer shell, the breast contacting structure, and the collection container are sized and shaped to fit within the cups of a bra. According to another aspect of the present disclosure, an automated breast pump system for controlling cycles of expressing breast milk from a breast includes one or more of a flange sized and shaped to receive and surround a user's nipple, a pump mechanism configured to provide suction pressure within the flange, and a controller associated with the pump mechanism and configured to control pump function, the controller providing automatic real-time adjustments to maintain a target pressure within the breast pump system.

[0130] These and other features of the present disclosure will become apparent to those skilled in the art upon reading the details of the systems and methods described more fully below. [Brief description of the drawings]

[0131] [Figure 1] FIG. 2 is a side view of a breast pump system (without a breast milk collection container) according to an embodiment of the present disclosure.

[0132] [Diagram 2] FIG. 2 is a distal perspective view of the system of FIG. 1 with the outer shell removed and made transparent to show components that would otherwise be covered.

[0133] [Diagram 3] 3 is a view similar to FIG. 2, but with the skin contact member removed to show the pumping area in greater detail.

[0134] [Figure 4] FIG. 1 illustrates components of a system according to an embodiment of the present disclosure.

[0135] [Diagram 5] FIG. 4 is a partial view of the system of FIGS. 2-3 showing the compression members and drivers in greater detail.

[0136] [Figure 6] FIG. 4 is a partial view of the system of FIGS. 2-3 showing an alternative compression member and driver in greater detail.

[0137] [Figure 7A] 1A-1C are schematic diagrams of one exemplary mode of operation of a compression member according to an embodiment of the present disclosure. [Figure 7B] 1A-1C are schematic diagrams of one exemplary mode of operation of a compression member according to an embodiment of the present disclosure. [Figure 7C] 1A-1C are schematic diagrams of one exemplary mode of operation of a compression member according to an embodiment of the present disclosure.

[0138] [Figure 8] 1 is a side view of a skin contact member according to an embodiment of the present disclosure.

[0139] [Figure 9] FIG. 1 is a side view of a prior art chest flange.

[0140] [Figure 10A] FIG. 9 is a cross-sectional view of the structure shown in FIG.

[0141] [Figure 10B] 13A-13C are cross-sectional views of alternative embodiments of nipple-receiving portions according to embodiments of the present disclosure.

[0142] [Figure 11A] FIG. 11C is a longitudinal cross-sectional view of the structure shown in FIG.

[0143] [Figure 11B] 13 is a distal end view of a skin contact member according to another embodiment of the present disclosure. FIG.

[0144] [Figure 12A] 2 is a side cross-sectional view of a skin contact member according to an embodiment of the present disclosure.

[0145] [Figure 12B] FIG. 12B is a transverse cross-sectional view of the skin interface member of FIG. 12A taken from the bottom of the system, showing the skin interface member and tubes along with the outer shell.

[0146] [Figure 12C] FIG. 12B is a proximal end view of the skin interface member of FIG. 12A showing the connected tubes.

[0147] [Figure 13] FIG. 1 is a schematic diagram illustrating components that define a total system volume according to an embodiment of the present disclosure.

[0148] [Figure 14] 13A-13C illustrate a compression member compressing a tubing section according to an embodiment of the present disclosure.

[0149] [Figure 15] 13 is a graph illustrating the relationship between tubing volume, tubing deflection, and load on a compression member according to an embodiment of the present disclosure.

[0150] [Figure 16] 13A-13D illustrate compression of a tubing section by a compression member according to an embodiment of the present disclosure.

[0151] [Figure 17] FIG. 2 illustrates power consumption data for a system according to an embodiment of the present disclosure.

[0152] [Figure 18] FIG. 1 is an end view of an exterior shell of a system according to an embodiment of the present disclosure.

[0153] [Figure 19] 13A-13D illustrate characteristics of systems using various tubing dimensions according to various embodiments of the present disclosure.

[0154] [Figure 20] FIG. 1 is a schematic diagram of working components of a system according to an embodiment of the present disclosure.

[0155] [Figure 21A] FIG. 2 is a proximal perspective view of a skin contact member according to an embodiment of the present disclosure. [Figure 21B] 1 is a side view of a skin contact member according to an embodiment of the present disclosure.

[0156] [Figure 21C] 21C is a cross-sectional view of FIG. 21C taken along line 21C-21C in FIG. 21A.

[0157] [Figure 21D] FIG. 1 illustrates a strain gauge mounted on or within a skin contact member according to an embodiment of the present disclosure.

[0158] [Figure 21E] FIG. 2 is a cross-sectional view of a nipple receiving portion in which a first non-contact sensor is attached to a relatively thin wall of the nipple receiving portion and a second non-contact sensor is attached to a relatively thicker wall of the nipple receiving portion. [Figure 21F] FIG. 1 illustrates a pressure sensor mounted on or within a skin contact member according to an embodiment of the present disclosure.

[0159] [Figure 22] 13A-13C show indicators attached to the inside of the chest contacting member for easy viewing by the user prior to placing the system on the chest, according to an embodiment of the present disclosure.

[0160] [Figure 23] 11A-11C show alternative locations where indicators may be placed according to embodiments of the present disclosure.

[0161] [Figure 24] FIG. 1 illustrates an example of a reusable, time-based indicator that may be used according to an embodiment of the present disclosure.

[0162] [Diagram 25] 13A-13C illustrate tracking of skin contact members and / or tubing by the system's controller and / or an external computer in accordance with an embodiment of the present disclosure.

[0163] [Figure 26] 1A-1C show wear indicators positioned on tubing sections according to an embodiment of the present disclosure.

[0164] [Figure 27] 13A-13C show wear indicators on skin contact members according to embodiments of the present disclosure.

[0165] [Figure 28] 1A-1C illustrate example arrangements for tracking compression member position according to embodiments of the present disclosure.

[0166] [Figure 29A] FIG. 13 illustrates one or more adhesive areas provided to facilitate breast restriction, according to an embodiment of the present disclosure. [Figure 29B] FIG. 13 illustrates one or more adhesive areas provided to facilitate breast restriction, according to an embodiment of the present disclosure.

[0167] [Figure 30A] FIG. 13 illustrates the difference between a skin contact member having a relatively large internal angle and a skin contact member having a relatively small internal angle. [Figure 30B] FIG. 13 illustrates the difference between a skin contact member having a relatively large internal angle and a skin contact member having a relatively small internal angle.

[0168] [Figure 30C] FIG. 13 illustrates a portion of the areola at the junction with the nipple that requires sufficient room to expand for optimal extraction of breast milk.

[0169] [Figure 31A] 1 is a schematic diagram of a breast pump system according to an alternative embodiment of the present disclosure. [Figure 31B] 1 is a schematic diagram of a breast pump system according to an alternative embodiment of the present disclosure.

[0170] [Figure 32A] FIG. 13 illustrates a breast milk collection container for use in a system according to another embodiment of the present disclosure. [Figure 32B] FIG. 13 illustrates a breast milk collection container for use in a system according to another embodiment of the present disclosure.

[0171] [Figure 32C] FIG. 2 illustrates a breast milk collection container according to an embodiment of the present disclosure, where the breast milk collection container is formed such that when filled with breast milk, the distal surface of the container has a shape that matches the proximal surface contour of the system's outer shell.

[0172] [Diagram 33] FIG. 1 illustrates a breast milk container having a baffle internally coupled to an inner wall of a portion of the container according to an embodiment of the present disclosure.

[0173] [Diagram 34] 1 illustrates a breast milk collection container including a passive sensor according to an embodiment of the present disclosure.

[0174] [Diagram 35] 1 illustrates a breast milk collection container in which the connector includes a one-way valve according to an embodiment of the present disclosure.

[0175] [Diagram 36] FIG. 13 illustrates a breast milk collection container according to another embodiment of the present disclosure.

[0176] [Figure 37] 1 illustrates a breast milk container with easily identifiable markings according to an embodiment of the present disclosure.

[0177] [Figure 38] FIG. 2 illustrates events that may be performed to perform a purge, according to an embodiment of the present disclosure.

[0178] [Figure 39A]13A-13C illustrate various arrangements that may be provided on the system to help prevent loss of breast milk from the system when the system is removed from the breast, according to embodiments of the present disclosure. [Figure 39B] 13A-13C illustrate various arrangements that may be provided on the system to help prevent loss of breast milk from the system when the system is removed from the breast, according to embodiments of the present disclosure.

[0179] [Figure 40A] 1 is a cross-sectional view of a profile element provided in a breast pump system according to an embodiment of the present disclosure. [Figure 40B] 13 is another cross-sectional view of a profile element provided in a breast pump system according to an embodiment of the present disclosure.

[0180] [Figure 41A] FIG. 1 illustrates a single thin layer of plastic or fabric used as a profile element according to an embodiment of the present disclosure. [Figure 41B] FIG. 1 illustrates a single thin layer of plastic or fabric used as a profile element according to an embodiment of the present disclosure.

[0181] [Diagram 42] FIG. 1 illustrates a profile element fitted onto an outer shell according to an embodiment of the present disclosure, in which the outer shell is provided with a key portion that ensures that the profile element is properly oriented on the outer shell each time the two components are mated.

[0182] [Diagram 43] FIG. 13 illustrates a contour element according to an embodiment of the present disclosure, in which a first edge of the contour element overlaps a second edge and can be adjusted to reduce, increase, or maintain the circumference of the distal circumference while simultaneously reducing, increasing, or maintaining the proximal circumference.

[0183] [Diagram 44]FIG. 1 is a diagram of a contour element according to an embodiment of the present disclosure, the contour element being provided with predetermined markings that may be provided to assist the user in adjusting the contour element to better contour to the breast being used.

[0184] [Figure 45A] FIG. 1 illustrates an exterior shell provided with two keys according to an embodiment of the present disclosure.

[0185] [Figure 45B] FIG. 45B shows a profile element provided with mating keys configured to mate with keys of the outer shell of FIG. 45A.

[0186] [Figure 46A] FIG. 13 illustrates a contour element according to another embodiment of the present disclosure. [Figure 46B] FIG. 13 illustrates a contour element according to another embodiment of the present disclosure.

[0187] [Figure 47] FIG. 13 illustrates events that may be performed by the system during an extraction mode to pump breast milk from the breast, according to an embodiment of the present disclosure.

[0188] [Figure 48] 1 illustrates a nipple shield according to an embodiment of the present disclosure.

[0189] [Figure 49] FIG. 1 is a schematic diagram of the apparatus used to perform tests on light weight vinyl polysiloxane chest flanges.

[0190] [Figure 50] FIG. 50 shows results from the test setup used in the tests described with respect to FIG. 49.

[0191] [Figure 51]FIG. 1 is a schematic diagram of a modified apparatus used to test the dynamic force-pressure relationship of a system according to an embodiment of the present disclosure.

[0192] [Figure 52] FIG. 52 shows results from the test setup used in the tests described with respect to FIG. 51. [Diagram 53] FIG. 52 shows results from the test setup used in the tests described with respect to FIG. 51.

[0193] [Figure 54] 1 is a schematic diagram of an apparatus used to test the relationship between the position of a target location in the nipple receiving portion and the vacuum level within the nipple receiving portion, according to an embodiment of the present disclosure; FIG.

[0194] [Figure 55] 1 is a schematic diagram of an apparatus used to test the relationship between the position of a target location in the nipple receiving portion and the vacuum level within the nipple receiving portion, according to an embodiment of the present disclosure; FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0195] Before the present systems and methods are described, it is to be understood that this disclosure is not limited to particular embodiments described, which may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0196] Where a range of values ​​is provided, each intervening value between the upper and lower limits of that range, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, is also specifically disclosed. Smaller ranges between any stated or intervening value in a stated range and any other stated or intervening value in that stated range are encompassed in the disclosure. The upper and lower limits of these smaller ranges may be independently included or excluded within the range, and each range where either or both limits are included in the smaller range, or where neither limit is included in the smaller range, is also encompassed in the disclosure, provided that any specifically excluded limit is within the stated range. A stated range includes one or both of the limits, and ranges excluding either or both of these included limits are also included within the disclosure.

[0197] Unless otherwise defined, 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.Any method and material similar or equivalent to those described herein can be used in the practice or testing of this disclosure, but preferred method and material will be described below.All publications described herein are incorporated by reference to disclose and describe the method and / or material that they are cited in connection with.

[0198] It should be noted that, as used in this specification and the appended claims, "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, "a sensor" includes a plurality of such sensors, a reference to "the pump" includes a reference to one or more pumps and equivalents thereof known to those skilled in the art, and so forth.

[0199] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. The publication dates provided may be different from the actual exact publication dates, which may need to be independently confirmed. definition

[0200] The term "dead space" as described herein refers to the volume in the system that is not directly acted upon by the pump of the system. Dead space is calculated by subtracting the effective pump volume from the total volume. The total volume is the volume in the skin contact member 10 and the tubing 32 from the nipple receiving portion 112 to the one-way valve 50 when the system 100 is attached and sealed to the breast 2, so that the total volume is the space in the nipple receiving portion 112 not occupied by the nipple 3 / areola 4 and the remaining volume from there to the one-way valve 50. The effective pumped volume is the volume displaced by the compression member (e.g., compression member 38) as the compression member is moved from one limit of its full stroke to the other. The nipple also moves as the pressure changes, and the change in the total system volume is a combination of these two (and any small system compliance). The dead space is the unpumped volume of the system.

[0201] As used herein, "decline mode" refers to a mode in which the vacuum profile is characterized by higher frequency and shallower (smaller) amplitude changes in vacuum level. Decline mode may also be referred to as "non-nutritive suction mode" or "non-nutritive mode."

[0202] As used herein, "extraction mode" refers to a mode in which the vacuum profile is characterized by a lower frequency and deeper amplitude change in vacuum compared to the drop mode (non-nutrient mode). Extraction mode may also be referred to as "nutrient suction mode" or "nutrient mode."

[0203] "Purge" refers to the act of transferring breast milk from the active pumping area of ​​the pump tubing into a collection chamber or bag.

[0204] "Latching suction" or "latching vacuum" refers to the minimum vacuum level established when the pump is attached to the chest. It is set to the lowest level of vacuum, below atmospheric pressure, that will be effective for attaching the system to the chest. Detailed Description

[0205] FIG. 1 is a side view of a breast pump system 100 (without a breast milk collection container) according to an embodiment of the present disclosure. The outer shell 34 of the system 100 is shaped and configured to contour to the user's breast and thus provide a more natural appearance when under the user's clothing. As can be seen from the figure, the system can define a natural breast profile. The natural breast profile is intended to fit comfortably and conveniently into the user's bra and look natural. Thus, the profile is characterized by having a non-circular base as opposed to being embodied in a generally dome-shaped configuration. Extending from the base is a curved surface having an asymmetrical pattern. Moreover, much like a natural breast, the profile of the device or system is intended to define one or more asymmetrical curves and an off-center center of inertia. A variety of natural breast shapes may be provided to be selected from the user's preferences and needs. FIG. 2 is a distal perspective view of the system 100 of FIG. 1 with the outer shell 34 removed / transparent to show the otherwise covered components. System 100 includes a skin-contacting member 10 (such as a chest flange as shown in FIG. 2, or a member having a different shape but configured to seal against a wearer's chest and provide fluid communication with a pump), a pumping region 30, and a conduit 32. Figure 3 is the same view as Figure 2, but with the skin-contacting member 10 removed to show pumping region 30 in more detail.

[0206] FIG. 4 illustrates components of a system 100 according to an embodiment of the present disclosure. The conduit 32 includes a large conduit portion 32L that is of a relatively larger internal cross-sectional area than the internal cross-sectional area of ​​the small conduit portion 32S. Although both portions 32S and 32L are shown as tubular portions that are circular in cross-section, the disclosure is not so limited as either or both portions may be otherwise shaped. For example, the conduit region 32L in the embodiment of FIG. 3 is not cylindrical but is formed as a pump chamber having a generally elliptical surface 32F and a wall extending generally perpendicular thereto. Further details of this embodiment of the conduit region 32L can be found in U.S. Provisional Patent Application No. 62 / 052,476, filed September 19, 2014, and U.S. Provisional Patent Application No. 62 / 053,095, filed September 10, 2014, both of which are incorporated herein by reference in their entireties. Conduit region 32S2, which joins in fluid communication one-way valve 50 and larger conduit region 32L, may, but is not necessarily, of the same dimensions as smaller conduit region 32S. Like regions 32S and 32L, region 32S2 may, but is not required to, be cylindrical and circular in cross section. When tubular, its cross section may be oval, square, other polygonal, asymmetric, or non-geometric.

[0207] In the embodiment of Figures 2-3, the latching, pumping and extraction forces are established by two compression members 36, 38 that are actively driven by drivers 44 and 46, respectively. Although more than two compression members can be used and one or more than two drivers can be used, the presently preferred embodiment uses two compression members each driven by two drivers as shown. Figure 5 is a partial view of the system 100 of Figures 2-3 showing the compression member 36 and driver 44 in more detail. Figure 6 is a partial view of the system 100 of Figures 2-3 showing the compression member 38 and driver 46 in more detail.

[0208] 7A-7C illustrate generally one exemplary mode of operation of compression members 36, 38 according to an embodiment of the present disclosure. In FIG. 7A, tubing portions 32S and 32L are closed or nearly closed by compression members 36 and 38, respectively. When system 100 is powered on, compression member 36 opens as shown in FIG. 7B and compression member 38 begins to pull away from anvil surface 2232, thereby gradually increasing the suction level in tubing 32. When a predetermined maximum suction level is achieved (as confirmed by pressure readings taken from a pressure sensor, described below), compression member 38 stops its progression in the current direction and, if the operating mode of system 100 has a predetermined time to maintain maximum suction, either maintains its position for a predetermined time (or moves slightly in the same direction to compensate for the loss of suction as breast milk enters the system), or reverses direction to compress tubing 32L until a latching suction level is achieved. If the maximum suction level has not been achieved by the time the compression member is fully retracted away from the anvil surface 2232 on the first stroke, the compression member 36 compresses the tube 32S to seal the current vacuum level within the chest environment, and the compression member 38 fully compresses the tube portion 32L to pump more air out of the system (out through the one-way valve 50). The compression member 36 then reopens the tube portion 32S to fully open, and the compression member performs another stroke to again move away from the anvil surface 2232 to create a greater suction level. This cycling continues until the maximum suction level is achieved. It is noted that in some cases it is possible to achieve the maximum suction level on the first stroke, while in other cases multiple strokes may be required.

[0209] 7B shows that tubing portion 32S fully opens as compression member 36 is released and compression member 38 moves away from anvil surface 2232 increasing suction within tubing 32. When maximum suction is achieved, the system can be designed and programmed such that compression member 38 does not proceed in either direction to the maximum possible extent to achieve maximum and latching suction levels, thereby allowing some reverse suction and pressure generating capability. When maximum suction level is achieved and the pumping profile is programmed to return to latching pressure, compression member 38 proceeds toward anvil surface 2232 compressing tubing portion 32L, thereby increasing pressure within tubing 32. Upon achievement of latching suction pressure, compression member 36 recloses tubing 32S to ensure that latching pressure is maintained against the chest, thereby maintaining sufficient suction. At this stage, the compression member 38 again begins to move away from the anvil surface 2232, increasing the suction level back up to maximum suction, and the compression member 36 opens (moves away from the anvil surface 2230), allowing the tube 32S to open and expose the breast 2 to maximum suction. Alternatively, the system may be programmed such that the compression member 38 cycles between the maximum suction level and the latching suction level, with the compression member 36 not closing for a period of time within each cycle, and then closing when the latching pressure is exceeded.

[0210] Upon selection of the breast milk extraction mode, the compression members 36 and 38 function in the same manner as in the latch mode, but following an extraction waveform determined by the selected extraction mode. During the compression stroke of the compression member 38, the compression member 36 closes when the latch pressure / suction level is achieved. Continued compression by the compression member 38 (FIG. 7C) increases the pressure in the tubing 32 downstream of the compression member 36, establishing a positive pressure to push the contents (breast milk) of the tube section 32L out of the tube section 32L, through the smaller tubing section 32S2 downstream of 32L, and through the one-way valve 50. The positive pressure achieved is sufficient to open the one-way valve to transfer the breast milk from the tubing 32 into the breast milk collection container. In one embodiment, the positive pressure is in the range of 20 mmHg to 40 mmHg, and is typically about 25 mmHg. When the action of the compression member 38 is reversed, the compression member 36 opens, causing the suction level to return to the latching suction level, and the compression member 38 continues to open, increasing the suction level to the maximum suction level.

[0211] Prior art breast pump systems typically cycle between 0 mmHg (or close to 0) and peak vacuum, typically up to 250 mmHg vacuum. The flanges (i.e., the components that contact and seal against the breast) of prior art systems typically have a shaped distal portion and a large cylindrical section to accommodate the breast nipple as it is pulled forward into the cylinder by the application of vacuum. During pumping with these prior art pump systems, the nipple cycles back and forth approximately matching the cycling motion from 0 to the peak set vacuum. This motion is typically at least 1 cm of motion (the nipple expands and contracts at least 1 cm) and can be substantially greater than this. Studies have shown that the resulting nipple motion from a breastfeeding infant is not significant, for example, about 4-5 mm of motion in total (Elad paper, other Hartman group paper).

[0212] The present disclosure establishes a latching vacuum so that the skin-contacting member / breast flange 10 seals against the breast. The latching vacuum established by the system is currently about 60 mmHg, but can be any value within the range of about 20 mmHg to about 80 mmHg. After the system 100 is latched to the breast via the skin-contacting member 10, the system then cycles between the latching vacuum and a target (also referred to as "peak" or "maximum") suction level. Due to the fact that the system 100 does not drop to 0 mmHg, but maintains the suction applied to the breast at the minimum end of the suction cycle, which is the latching suction level (e.g., about 60 mmHg), the nipple does not retract as much as it would by using prior art breast pump systems. It has been observed that the nipple is drawn into the skin-attachment member 10 by the initial latch achievement in a manner similar to the formation of the nipple during breastfeeding. After the vacuum is cycled between the latching vacuum level and the target vacuum level, the back and forth movement of the nipple as the vacuum changes is significantly less than that which occurs using prior art systems. Nipple movement during use of the present system (the distance between fully extended and fully retracted) is typically less than about 2 mm, and in some cases less than about 1 mm.

[0213] This greatly reduced movement of the nipple during cycling results from the establishment of a latch at the latch vacuum level, and then limiting the range of the vacuum swing between the latch vacuum (suction force) and the peak vacuum (suction force). Typically, the vacuum difference between the latch vacuum and the peak vacuum is less than 200 mmHg, more typically 150 mmHg. In one example, the latch vacuum was 50 mmHg and the peak vacuum was 200 mmHg, resulting in a vacuum difference of 150 mmHg.

[0214] Limiting nipple movement as described in the use of the system of the present invention provides several advantages to the user. One advantage is that the friction on the side of the nipple against the flange wall is low, thereby greatly reducing the risk of irritation, skin damage, pain, swelling, etc. As a result, the system of the present invention is much more comfortable for use by nursing mothers, an advantage that becomes more and more noticeable with repeated use. By always maintaining at least the latch suction level, the system provides a more secure and lasting seal against the breast, greatly reducing the possibility of air and / or milk leakage. Because nipple movement is much less, this provides a more "natural" feeling to the user that more closely simulates the sensation of a nursing infant. Because nipple travel is less, this allows the skin attachment member / flange 10 to be designed as a smaller profile component, so that its length can be reduced, since it does not have to accommodate the greater length of nipple movement encountered by prior art systems. This allows the overall amount of projection of the system 100 from the breast to be smaller than that of the prior art, since the overall length of the system is reduced by the reduction in the length of the skin contact member / flange 10. Thus, the distance from the tip of the nipple to the exposed end of the system housing is reduced.

[0215] FIG. 8 shows a side view of a skin contact member 10 according to an embodiment of the present disclosure. As shown, the breast contact portion 122 is symmetrical about the nipple receiving portion 112, although alternatively, the nipple receiving portion 112 can be offset as described herein. The overall length 110 of the skin contact member 10 in this embodiment is approximately 63.75 mm. FIG. 9 shows a longitudinal cross-sectional view of a prior art breast flange 210. The overall length 212 of the flange 210 is approximately 60.6 mm. The skin contact member 10 is designed to reduce the internal volume of the nipple receiving portion 112 compared to the internal volume of the nipple receiving portion 214 of prior art devices, which is made possible by greatly reducing the amount of motion the nipple 3 encounters during the breast milk extraction process using a system 100 including the skin contact member 10 according to the present disclosure. The nipple receiving portion 112 of the skin contact member 10 is contoured to more closely match the natural shape of the nipple, thereby eliminating or greatly reducing the dead space present around the nipple in prior art systems. In the illustrated example, the nipple receiving portion 112 is cylindrical in a portion 112A adjacent the breast contact portion 122, and then tapers conically in a portion 112B extending from the portion 112A to the connector 134. This design allows for a portion of the areola 4 to be received within the nipple receiving portion 112A, while also limiting dead space by providing the conical portion 112B. The diameter of all cross sections of the nipple receiving portion 112 is large enough to allow for expansion of the nipple. The inner diameter of the conically tapering portion 112B tapers from an inner diameter equal to the inner diameter of the cylindrical portion to a smaller inner diameter. As noted, the length of the nipple receiving portion 112 is significantly less than that of the prior art. In the example shown in FIG. 8, the length 114 of the nipple receiving portion 112 is about 23 mm, compared to the 36.9 mm length 216 of the prior art nipple receiving portion 214, which may be in the range of about 350 mm to about 500 mm. The length 112 can vary within a range of about 22 mm to about 29 mm. The length 114 of the nipple receiving portion 112 is sufficient to allow expansion of the nipple 3 under vacuum without the distal tip of the nipple 3 contacting the proximal end of the nipple receiving portion 112.

[0216] Experiments with the present system 100 have shown that the majority of a woman's nipple extends into the nipple receiving portion 112 by a length of about 1.6 cm under a latch suction of about 50 mmHg (-50 mmHg pressure). The extra length provided by the nipple receiving portion 112 (beyond the length of the nipple under latch vacuum) is provided to allow for a small amount of stretching of the nipple under the target vacuum, typically about 1-2 mm under a maximum suction of about 150 mmHg, and to allow for a small amount of additional forward movement that the nipple may encounter when priming the pump. Thus, at least about 2 mm, and at most about 6 mm, of space is provided within the nipple receiving portion that extends longitudinally proximal to the tip of the nipple 3 when under latch pressure.

[0217] The nipple inlet diameter 116 of the nipple receiving portion 112 is large enough to accommodate most nipple sizes so that the nipple is not restrained from some expansion under vacuum. The nipple 3 expands in diameter more at the base (area where it joins with the areola 4) than at the tip, thereby allowing the nipple receiving portion 112B to be cone-shaped as shown. The inlet opening diameter 116 of the nipple receiving portion 112 is about 24 mm in the embodiment of FIG. 8, but can range from about 22 mm to about 29 mm. The inner diameter 118 at the proximal end of the nipple receiving portion 112B is about 13.16 mm in FIG. 8, but can range from about 9 mm to about 20 mm. In contrast, the inner diameter 218 of the portion 214 of the flange 210 is about 23.5 mm over the entire length of the portion 214.

[0218] A portion of the areola 4 may also be drawn into the nipple receiving portion 112, so that it is alternately compressed and at least partially relaxed by the pumping system 100 to simulate the way a baby naturally drinks. However, the skin-contacting member 10 is configured to restrict the areola 4 from completely entering the nipple receiving portion 112, and to restrict portions of the breast 2 other than the nipple 3 and areola 4 from entering the nipple receiving portion 112. This prevents the tip of the nipple 3 from contacting the proximal end of the nipple receiving portion 112, even under full vacuum.

[0219] In any of the embodiments of the skin contact member 10 disclosed herein, the top of the nipple receiving portion 112 is formed from a relatively hard and / or stiff material and the bottom of the nipple receiving portion 112 is formed from a relatively soft and / or more flexible material to better simulate a nursing infant in use, because the infant's tongue, which contacts the bottom of the nipple 3, is softer and more flexible than the infant's palate, which contacts the top of the nipple 3 during nursing.

[0220] To facilitate the restraint of the breast 2, the breast contacting portion 122 is provided with one or more adhesive portions 360, see Figs. 29A-29B. The adhesive area 360 is illustrated in Figs. 29A-29B as a continuous ring around the inner surface of the breast contacting portion 122, but may span one or more portions of this circumference and may be provided as one or more segments. The adhesive area(s) provide greater friction with the breast 2 than the remainder of the skin contacting member 10, thereby providing resistance to the portion of the breast 2 contacting it to prevent the breast from being drawn in towards the nipple receiving portion 112. The adhesive area 160 may be formed of a different material than the remainder of the skin contacting member 10 and / or may be a coated or roughened area that provides increased friction. For example, the adhesive portion may be silicone, while the remainder of the skin contacting member is formed of polyethylene or one of the other materials described herein for use in making skin contacting members. By preventing these parts of the breast from sliding into the nipple receiving portion 112, this reduces the occurrence of pain from compressing too much breast tissue and provides enough space within the nipple receiving portion 112 for the nipple 3 to naturally expand to express the amount of milk.

[0221] The internal angle 120 of the breast contacting portion 122 of the skin contacting member 10 is designed for use with the system 100 of the present invention and to maximize user comfort. This internal angle can also facilitate the ability to limit portions of the breast 2 from moving too far forward into the nipple receiving portion 112. In the embodiment of FIG. 8, the internal angle 120 is approximately 112°, which is wider than the internal angles of prior art flanges. For example, the internal angle 218 of the breast contacting portion 220 of the prior art flange 210 is 90°. The wider angle 120 helps prevent breast tissue from being forced into the nipple receiving portion 112, thereby allowing less breast tissue to be received within the nipple receiving portion 112, thereby making the use of this skin contacting member 10 more comfortable than prior art flanges and providing space for nipple expansion. By providing a wider angle 120, this also allows the overall system to be effectively shortened, allowing the system to lie flatter against the breast improving both comfort and appearance. 8, the length 124 of the chest contacting portion 122 is 15 mm, but can be in the range of about 12 mm to about 19 mm. In contrast, the length 222 of the chest contacting portion 220 is 25.8 mm, thereby causing a system using the flange 210 to extend farther from the chest than a system using the skin contacting member 10.

[0222] 30A-30B show the difference between a skin contacting member 122A having a relatively large internal angle 122A and a skin contacting member 122B having a relatively small internal angle 122B. The smaller angle 122B provides the ability to interact with relatively more breast tissue with more variation in breast size and shape. The chest contacting portion of the skin contacting member 122A shown in FIG. 30A has a larger internal angle 120A than the internal angle 120B of the chest contacting member 122B shown in FIG. 30B. As a result, when these skin contacting members 10 are worn on the chest 2, the initial contact of the chest tissue with the chest contacting member 122A at 362A is lower (or further in) on the chest contacting portion 122A than where the chest tissue initially contacts the chest contacting member 122B at 362B. The higher (more outer) initial contact location 362B of the breast 2 on the breast contacting portion 122B provides more contact surface of the breast 2 on the breast contacting portion 122 (compare length 364B to 364A) thereby providing better control over tissue movement within the nipple receiving portion 112 and increasing the available surface contact area creates more tension on the nipple as it forms. The nipple begins to form more quickly and the increased tension on the breast helps keep the distal portions of the breast tissue 2 and areola 4 from being sucked into the nipple receiving portion 112. The greater length 366B and area of ​​the areola 4 and nipple 3 that form the nipple is provided by the smaller angle 120B compared to length 366A and area of ​​the embodiment of FIG. 30A because 366B is greater than length 366A by an amount sufficient to cause the interior volume of the skin contacting member over length 366B to be greater than the interior volume of the skin contacting member over length 366A. Due to the larger angle 122A of the embodiment of Figure 30A, the areola contacts the side of the breast contacting portion 122A upon initial contact of portion 122A with the breast 2, so there is no room for the areola 4 to expand. For optimal results, it is necessary for the areola 4 to be long and wide during milk extraction, as this is what occurs when a baby is breastfed.The space provided between the areola 4 and the opening of the nipple receiving portion 112 upon initial contact of the breast 2 with the breast contact portion 122 allows the areola 4 to lengthen and expand (widen) as the nipple 3 is drawn into the nipple receiving portion 112. FIG. 30C shows a portion 4P of the areola 4 at the junction with the nipple 3 that requires sufficient room to expand for optimal extraction of breast milk because it contains milk ducts that would not drain milk efficiently or at all if they were not expanded. The skin contact member 10 of the present disclosure is preferably configured such that a maximum of about 0.25 inches (about 0.5 cm) of the areola 4 is drawn into the nipple receiving portion 112 and prevents further portions of the areola from entering the nipple receiving portion 112.

[0223] The thickness of the material forming the breast contacting portion 122 and nipple receiving portion 112 in the embodiment of FIG. 8B is about 1.5 mm, but the thickness can be within the range of about 1 mm to about 4 mm. Alternatively, the thickness of the breast contacting portion 122 and nipple receiving portion 112 can be different from each other. The breast contacting portion 122 and nipple receiving portion 112 and the tubing connector 134 can be made of silicone or other compliant biocompatible materials such as, but not limited to, polyurethane and / or polyether block amide (PEBAX) to provide a soft interface with the breast and a seal around the areola and nipple of the breast. The inner housing 126 of the breast contacting portion 122 can be rigid, semi-rigid, or compliant. Similarly, the nipple receiving portion 112 can be rigid, semi-rigid, or compliant. The portion of the breast contacting portion 122 adjacent to and serving as an inlet to the nipple receiving portion 112 is configured to contact at least a peripheral portion of the areola 4 and may be made from a less slippery material (compared to the slipperiness of the nipple receiving portion 112) to provide more frictional resistance on at least the periphery of the areola to help prevent the areola from being pulled into the nipple receiving portion 112 and to provide tension on the breast tissue away from the nipple 3 and areola 4 to control the amount of areola 4 that is allowed into the nipple receiving portion 112. Because the system 100 of the present invention significantly reduces nipple 3 movement during pumping, a surface that provides more friction and tension reduces the risk of tissue abrasion or blistering encountered with currently available nipple flanges when experiencing significant nipple 3 movement during pumping. The nipple receiving portion 112 and inner housing 126 may be made from materials of different materials and / or hardness and / or stiffness. For example, the inner housing 126 can be rigid and the nipple receiving portion 112 can be compliant, or any other combination of materials, hardness, and rigidity can be provided.Preferably, the breast contacting portion 122 and the nipple receiving portion 112 are compliant and made from silicone, although other materials and combinations of materials can be used, including but not limited to polyethylene terephthalate (PET), polyurethane, polyethylene, high density polyethylene (HDPE), low density polyethylene (LDPE), polyamide, polyethylene terephthalate (PET) and / or PEBAX. In embodiments where compliance is present, the nipple receiving portion 112 can be repeatedly opened and closed while the system 100 is used to extract breast milk from the breast, thereby simulating a feeding cycle similar to the sequence of the tongue against the nipple when the baby is suckling.

[0224] 8, the nipple-receiving portion 112 includes a portion 112A that is cylindrical and a cone-shaped portion 112B having an interior angle 130 of the cone-shaped portion 112B that is approximately 60 degrees. The interior angle of the cone can be within a range of approximately 55 degrees to approximately 65 degrees.

[0225] Both cylindrical portion 112A and cone-shaped portion 112B are circular in cross-section, as illustrated by the cross-sectional view of Figure 10A taken along line 10A-10A in Figure 8. Alternatively, one or both of portions 112A, 112B may be oval or elliptical in cross-section, as shown by 112A', 112B' in Figure 10B. This oval or elliptical cross-section more closely resembles the shape of a breastfeeding infant's mouth and therefore will provide a more similar pressure / force profile on the nipple as a baby drinks breast milk.

[0226] Further alternatively, the skin contacting member 10 can have an adjustable opening 132 to the nipple receiving portion 112 and the flange angle 120 can also be adjustable so that both the breast contacting portion 122 and the opening can be sized to optimize fit against the areola and nipple reception. In at least one embodiment, an insert is provided on the inside of the breast contacting portion 122. Additionally or alternatively, the insert can be provided at the rear of the breast contacting portion 122. In any of these arrangements, the insert changes the angle of the breast contacting portion 122 relative to the breast 2 when it is worn on the breast. Additionally, an insert can be provided to make the opening smaller. Different combinations of flange angle 120 and opening 132 diameters can be needed for different sizes and shapes of breasts. For example, a relatively small opening 132 and a relatively small angle 120 can be needed for a breast that is relatively more perky than average, while a relatively large angle 120 and a relatively large opening 132 can be better for a breast that is firmer than average. Further alternatively, pairs of skin contacting members 10 may be provided to provide a range of variations in angle 120 and opening 132. The wall thickness 128 may also be varied to accommodate changes in angle 120 of the chest contacting portion 122.

[0227] Portion 134 is a tubing connector used to connect skin contact member 10 in fluid communication with tubing 32. Diameter 136 of opening 138 that provides fluid communication with tube 32 is approximately 25 mm in FIG. 8 but can range from approximately 20 mm to approximately 28 mm. Length 142 of portion 134 is approximately 23.8 mm in FIG. 8 but can range from approximately 20 mm to approximately 28 mm.

[0228] 11A is a longitudinal cross-sectional view of the skin contacting member 10 taken along line 11A-11A in FIG. 11B, and FIG. 11B is a distal end view of the skin contacting member 10 according to another embodiment of the present disclosure. In this embodiment, the nipple receiving portion 112 is not centered relative to the chest contacting portion 122, in contrast to the embodiment of FIG. 8, in which the chest contacting portion 122 is concentric with the nipple receiving portion 112. Instead, in this embodiment, the central axis 146 of the nipple receiving portion 112 is positioned below the central axis 148 of the chest contacting portion 122 when the skin contacting member is placed in the orientation in which it is used for attachment to the chest, see FIG. 11B. In this embodiment, the opening 132 to the nipple receiving portion 112 is slightly larger in diameter than that of the embodiment of FIG. 8 (25 mm vs. 23 mm), thereby accommodating users with slightly larger nipples. The opening diameter 219 of the prior art flange 210 shown in FIG. 9 can be in the range of about 21 mm to about 32 mm. Of course, offset embodiments of the present disclosure can also use smaller opening 132 sizes. Similarly, the embodiment of FIG. 8 can be provided with larger opening 132 sizes. In this offset embodiment, the angle 120A of the breast contacting portion 122 above the nipple receiving portion 112 relative to the central axis 150 of the breast contacting portion 122 (and the central axis 164 of the nipple receiving portion 112 when the central axes 150 and 164 are parallel as in the embodiment of FIG. 11A ) is flatter than the angle 120B of the breast contacting portion 122 below the nipple receiving portion 112 relative to the central axes 150 and 164, see FIG. 11A . In other embodiments, the central axis 150 is not parallel to the central axis 164. In the example shown in FIG. 11A , the angle 120A is about 69 degrees and the angle 120B is about 52 degrees. However, angle 120A can be any angle within the range of about 32 degrees to about 85 degrees, and angle 120B can be any angle within the range of about 32 degrees to about 85 degrees. This configuration provides a better fit to the natural curvature of the breast that breast contacting portion 122 contacts, as compared to a design where both angles 120A and 120B are equal.In order to maintain a circumferential plane about the distal opening 152 of the chest contacting portion 122 approximately perpendicular to the central axis 150 as shown in FIG. 11A, a distance 154 from the top of the opening 132 to the top of the circumferential surface of the distal opening 152 is greater than a distance 156 from the bottom of the opening 132 to the bottom of the circumferential surface of the distal opening 152 due to the difference between angles 120A and 120B. In the example shown in FIG. 11A, the distance 154 is approximately 36.32 mm, but may be any value within the range of about 15 mm to about 62 mm, and the distance 156 is approximately 21.3 mm, but may be any value within the range of about 10 mm to about 58 mm. The outer diameter 158 of the chest contacting portion 122 at the distal opening (see FIG. 11B) is approximately 82.3 mm, but may be any value within the range of about 60 mm to about 150 mm. The distance 160 from the top of the perimeter of the distal opening 152 to the central axis 164 of the nipple receiving portion is about 49.8 mm in the embodiment of Figure 11A, but may be anywhere between about 30 mm and about 60 mm. The distance 162 from the bottom of the perimeter of the distal opening 152 to the central axis 164 of the nipple receiving portion in the embodiment of Figure 11A is about 33 mm, but may be anywhere between about 25 mm and about 40 mm. In contrast, the flange 210 of Figure 9 is symmetrical, where the distance 254 from the top of the perimeter of the distal opening to the central axis of the flange 210 is 28.2 mm, and the distance 256 from the bottom of the perimeter of the distal opening to the central axis of the flange 210 is 28.2 mm.

[0229] A number of holes or ports 140 are provided at the interface of the nipple receiving portion 112 and the tubing connector 134 to allow breast milk drawn from the nipple 3 to enter the tubing 32, which is connected to the tubing connector 134 and in fluid communication with the holes / ports 140. These holes / ports 140 allow breast milk to pass into the tubing connector 134 and tubing 32, and also prevent the nipple 3 from being drawn into the tubing connector 134 and tubing 32.

[0230] FIG. 12A is a side cross-sectional view of the skin contact member 10 and tube 32 with the outer shell 34. FIG. 12B is a transverse cross-sectional view from the bottom of the system 100, showing the skin contact member 10 and tube 32 with the outer shell 34. The tube 32 is shown generally as a single sized tube for simplicity, with the larger portion 32L in this embodiment having a larger inner diameter than the smaller tube portion 32S. FIG. 12C is a proximal end view of the skin contact member 10, showing the tube 32 connected thereto. In one embodiment, the inner diameter of the tube 32L is about 3 / 8" (9.53 mm). In another embodiment, the inner diameter of the tube 32L is about 7 / 16" (1.11 cm). In another embodiment, the inner diameter of the tube 32L is about 1 / 2" (1.27 cm). In another embodiment, the inner diameter of the tube portion 32L is about 5 / 16" (7.94 mm). In one embodiment, the inner diameter of tube portions 32S and 32S2 is about 1 / 4" (6.35 mm). In another embodiment, the inner diameter of tube portions 32S and 32S2 is about 3 / 32" (2.38 mm). In another embodiment, the inner diameter of tube portions 32S and 32S2 is about 1 / 8" (3.18 mm).

[0231] In one embodiment, the total system volume is about 24.0 cc. The total volume is calculated as the space (not occupied by nipple 3) in nipple receiving portion 112 and the portion of tube portions 32S, 32L, and 32S2 up to one-way valve 50, see schematic diagram in FIG. 13. Other embodiments may have a much smaller total system volume, preferably in the range of about 4.5 cc to about 12 cc, more preferably in the range of about 5 cc to about 8 cc, or in the range of about 8 cc to about 10 cc. In an embodiment having a total system volume of about 24.00 cc, the effective pump volume, i.e., the volumetric displacement achievable by compressing tube portion 32L by compression member 38 from a fully uncompressed state to the limit of compression, is about 3.4 cc. The compression member 38 in this embodiment has a compression member length 38L of approximately 2.5" (6.35 cm) (with the length 38L defined as shown in FIG. 14). When only air is present within the tubing 32 of the system 100, the pressure swing by moving the compression member 38 inwardly and outwardly away from the tubing section 32L is limited by the compressibility of air. In this embodiment, when the system is under a vacuum of -60 mmHg, a full stroke of the compression member (tube section 32L from compressed to completely uncompressed) increases the vacuum to -160 mmHg. The ratio of pumping volume to total system volume is important with respect to the power and size of the pumping system. In this embodiment, the tubing section 32L has an inner diameter of 0.375" (9.53 mm) and a wall thickness of 0.094" (2.39 mm), has a hardness of 50 Shore A, and is made of silicone (Dow The tube was made from Corning SILASTIC®. By using a 2.5″ (6.35 cm) long compression member, the force applied to tube segment 32L under full compression was 19.6 lbf.

[0232] In a preferred embodiment, it is also preferable to avoid fully compressing the tube section 32L and allowing full rebound of the tubing section 32L. Near full compression requires a sudden increase in compression force (see FIG. 15, #302), which is not efficient for the small amount of additional pressure change it provides, given the significant increase in motor power and the energy consumption this requires. Near full rebound of the tubing section results in a less efficient pressure change, given the amount of energy consumed by the driver 46 to fully withdraw the compression member 38, see FIG. 15, #305. During the drop mode operation of the system 100, the system 100 operates to effect a drop of breast milk in the breast 2, with a maximum suction force target of up to 120 mmHg (typically about 100 mmHg (-100 mmHg pressure)) to establish the drop, prior to extraction. The purpose of the drop mode (or non-nutritive suction mode) is to stimulate the breast 2 to express breast milk. The relatively shallow (small range of vacuum change) and relatively fast frequency of pumping during this phase is meant to mimic the initial breastfeeding of a child at the breast. In this mode, the first 10% of tubing compression (FIG. 15 #305) is not very productive. The reason is that during the drop phase, the suction pressure is not allowed to exceed the maximum drop suction of 110 mmHg or 120 mmHg, or whatever the maximum drop suction is set to, and the compression member 38 does not cycle to the first 10% range of tubing compression. Thus, as the compression member 38 is pulled away from the tube portion 32L, the system 100 is designed to reach 100 mmHg (100 mmHg suction pressure) (or -120 mmHg, or whatever the maximum drop suction is designed to be) by the time the compression member 38 reaches the uncompressed position where the tube 32L is 90%, see 307. Further movement of compression member 38 away from tube portion 32L (see region 305) from 90% to 100% compressed does not do much to create additional vacuum because tube portion 32L acts like a weak spring during this portion of the expansion.The graph in FIG. 15 tracks the generation of rebound pressure by the tube section 32L after compression to a particular level. For example, by compressing the tube section 32L 100% and then sealing the tube and allowing it to rebound, >300 mmHg is generated. Smaller deflections generating 10 mmHg are not "useful" for pumping purposes of the system 100. A 200 mmHg vacuum is established when the tubing 32L is compressed about 25% and then released, see 309. The compression member 38 only needs to operate within the range of vacuum generation that is useful for pumping purposes of the system 100. Activating the compression member 38 to compress the tube section 32L nearly 100% is inefficient due to ramping up of the compression load. Also, operating the paddles of the compression member 38 at nearly 0% compression of the tubing section 32L is only useful for controlling low vacuum peaks. When the tubing segment 32L rebounds, it reaches capacity for vacuum withdrawal, and further pulling of the compression member 38 away from the tubing segment 32L simply causes the paddle to lose contact with the tubing segment 32L.

[0233] During the drop (non-nutritive) mode, the system 100 may be configured to operate between -60 mmHg and -100 mmHg in one example. In this example, the compression member 38 may compress the tubing portion 32L nearly completely (e.g., about 97%) and then move away from the tubing portion 32L to create a vacuum. The maximum latch suction pressure of -100 mmHg is reached by a small amount of rebound of the tubing portion 32L, and the compression member 38 may cycle the tubing portion 32L between -100 mmHg and -60 mmHg within a narrow range or band close to full compression of the tubing portion 32L. As the milk flows, a shift in that narrow band (volume in situ → volume of paddle rise) of up to 100 is generated at about 10% (90% rebound), at which point the tube section 32L is purged by compressing it completely (to 100% or nearly 100% compressed) to push out the contents, thereby regaining more volume to pump again with the relatively small compressive force of the tube section 32L. In another embodiment, the compression member 38 operates in a range that compresses the tube 32L from about 10% > compressed to about 97% compressed. Additionally, the compression member 38 can move to a position where the tube 32L is 0% compressed to allow for installation, modification, etc. of the tubing 32. Typically, during purging, the vacuum level is reduced to a minimum vacuum (e.g., about -60mmHg) and the compression member 36 is used to close (seal) the tubing section 32 to maintain the 60mmHg vacuum against the breast 2. The compression member 38 then fully compresses the tubing section 32L to purge the contents of the tubing section 32L.

[0234] The contact surface of the compression member 38 may be shaped to improve pumping efficiency and reduce power requirements of the system 100. FIG. 16 shows an end view of the compression member 38 during compression of the tubing section 32L. The contact surface 38S of the compression member 38 is convex, such as by chamfering, in a direction transverse to the longitudinal axis of the compression member 38, thereby avoiding unproductive squeezing of the side walls of the tube section 32L. This minimizes peak loads on the driver 46. In FIG. 16, it can be seen that the central portion of the tube 32L is completely closed as the inner walls contact each other, while the portions near the sides of the annulus are not completely closed.

[0235] In an embodiment having a total system volume of 24.0 cc, a pumping force of 19.6 lbs was provided by the driver 46 and compression member 38. The estimated mechanism capacity was 44 lb. "Mechanism capacity" refers to the maximum compressive force that can be applied to the tubing section 32L by the driver 46 and compression member 38, and is a function of factors such as voltage, driver 46 stall torque, and other characteristics of the drivetrain, such as gear reduction. The system used a servo motor as the driver 46, which was coupled to the compression member 38 by a 0.188" (4.78 mm) lever arm 304 (see FIG. 14) to provide a 246:1 gear ratio and 5.9 ft-lb torque with a 500 mA current draw. The desired maximum speed of this pump system is 90 cycles per minute (CPM), with maximum compression travel limited to about 65 CPM. When compression travel (stroke) is reduced, such as in descending mode, the speed can be increased. The pump system has a "dry" 100 mmHg swing (i.e., the vacuum change is about 100 mmHg from one end of a full stroke to the other when there is no fluid in the tubing 32), so a full travel stroke may not be required in descending mode because the vacuum swing will be less than 100 mmHg, such as from about 60 mmHg latch suction to about 100 mmHg maximum suction. The force requirements of the pumping system can be greatly reduced by reducing the dead space in the total system volume, which in turn requires less volume to be pumped per cycle / stroke. By reducing the gear ratio, this increases the actuation of the compression member making it quicker and more responsive to pressure changes.

[0236] The driver 44 and compression member 36 were configured to apply approximately 1.0 lbf to a tube having an inner diameter of 3 / 8" (9.53 mm) to completely close (pinch) it. The driver 44 included an HS-85MG servo motor with dimensions of 0.51" (1.3 cm) x 1.14" (2.9 cm) x 1.2" (3.05 cm), 3.0 in-lb. stall torque and a 0.238" (6.05 mm) lever arm to provide approximately 12.8 lbf capacity.

[0237] FIG. 17 shows power consumption data for the system described above having a total system volume of 24.0 cc, a 0.375″ (9.53 mm) inner diameter tube 32, and a 2.5″ (6.35 cm) compression member 38. The drivers 44, 46 were powered by four alkaline C size batteries providing a voltage 330 of approximately 6V. Current was measured using a multimeter in series with the batteries connected to the drivers. The system was set up to drive the compression member 38 at a full stroke against the tube section 32L during operation. A single 15 minute pumping session required approximately 110 mAh of power, see 336. An estimate of the daily amount of pumping was set as 4 sessions, resulting in a daily power requirement 338 of approximately 440 mAh. The average current 332 was calculated to be approximately 440 mA and the maximum current 338 capacity was approximately 0.83 A.

[0238] In one embodiment, the outer shell 34, including the other components of the breast pump system (excluding the breast milk collection container, which may be mounted above the outer shell 34), is configured to have a diameter 340 of approximately 11 cm (4.3") (see FIG. 18) and a length 342 of approximately 4.1 cm (1.6") (see FIG. 1), although the diameter 340 may be anywhere within the range of about 10 cm to about 14 cm and the length 342 may be within the range of about 3.5 cm to about 6 cm. An outer shell 34 having a diameter 340 of approximately 11 cm and a length 342 of approximately 4.1 cm provides a component housing volume of approximately 151.2 cc. Assuming that the dead volume within the nipple receiving portion 112 is approximately 1.8 cc, a 1 cm length of tubing 32 is provided for compression by the compression member 36, and the nipple receiving portion 112 is offset from the center of the breast contacting portion 122 by approximately 1.5 cm, FIG. 19 illustrates the performance of the system 100 with various tubing dimensions. These properties are uniform throughout and therefore were measured using tubing 32 without the smaller tubing section 32S and the larger tubing section 32L, however the principles are still the same when using tubing 32 having both small 32S and large 32L sections. It can be seen that by reducing the dead volumes 350 and 352, the pumping efficiency 354 (pumped volume divided by total system volumes 352 and 356) is increased. This allows for a reduction in the length 38L of the compression member 38, resulting in smaller pump power and energy consumption requirements.

[0239] The system 100 responds to pressure changes in the tubing 32 caused by the breast milk entering the tubing 32. Figure 20 is a schematic diagram of the operating components of the system 100 according to an embodiment of the present disclosure. The compression elements 36 and 38 are driven by dedicated compression drivers 44, 46. Alternatively, the compression elements 36 and 38 can be driven by a single compression driver that is controlled by the controller 52 to drive each of the compression elements 36, 38 in the desired manner. As shown, the compression elements 36, 38 comprise pistons, however, alternative features such as lever arms, screw drives, clamps, cams, pliers, rollers, magnets, electromagnets, linear drives, solenoids, gears, stepper motors, or other features can each be used to achieve the same function. Further features of alternative embodiments of the compression member and its compression surface can be found in U.S. Provisional Patent Application No. 62 / 027,685, filed July 22, 2014, U.S. Provisional Patent Application No. 62 / 050,810, filed September 16, 2014, U.S. Provisional Patent Application No. 62 / 052,476, filed September 19, 2014, and U.S. Provisional Patent Application No. 62 / 053,095, filed September 19, 2014, each of which is incorporated by reference in its entirety herein.

[0240] Each compression element 36, 38 is operatively coupled to a driver 44, 46, respectively, for independent but coordinated drive and retraction of the compression elements 36, 38. When a powered driver is in use, a battery 48 is electrically connected to the drivers 44, 46 as well as the controller 52 and pressure sensor 54, and provides the power necessary to operate the drivers 44, 46 to drive the compression and retraction of the compression elements 36, 38.

[0241] A sensor 54 is used to provide feedback to the controller 52 for controlling the pumping cycle to achieve and / or maintain the desired vacuum level. The sensor 54 is preferably a pressure sensor, but can also be a flow, temperature, proximity, operation sensor or other sensor that can provide information usable to monitor the safety or function of the pump mechanism of the system 100. As shown, the sensor 54 is a non-contact sensor 54, meaning that it is not in fluid communication with the milk or vacuum space of the system 100. Preferably, the sensor 54 is positioned near where the tip of the nipple 3 of the breast 2 is positioned to determine the actual pressure exposed to the breast 2 / nipple 3, but other sensors 54 may be positioned within the system 100, for example near where the one-way valve 50 is positioned, and can be used to monitor other features such as the contents of the container 60 or the discharge pressure or flow rate. More generally, the sensor 54 can be positioned anywhere within the system, from within the collection container 60 between the breast 2 and the one-way valve 50. The sensor 54 can be positioned on the chest side of the compression member 36 or on the other side of the compression member 36. When positioned on the chest side (i.e., upstream side of the compression member 36), the sensor provides the pressure that the chest 2 encounters at all times and can therefore be used to monitor and determine the pressure environment of the chest 2 even when the compression member 36 is sealing the tubing portion 32S. When the sensor 54 is on the other side of the compression member 36 (i.e., downstream side of the compression member 36), the sensor 54 can provide the pressure at the chest 2 at all times except when the compression member 36 is sealing the tubing portion 32S. Thus, the sensor 54 can be placed anywhere in communication with the tube 32 and can be used to monitor and control the system by sensor reading feedback to the controller 52. With at least one sensor 54 present, by directly or indirectly monitoring the flow or pressure, and also taking into account the cycles and actual position of the compression elements 36, 38 over time, it is possible to derive / calculate the approximate amount of breast milk produced during a pumping session, as well as understand the flow rate at any particular time within the pumping session.The accuracy of this measurement is greatest when there is no air leakage around the chest 2 and when the air in the tube 32 is negligible after dissipation by several cycles of the pumping mechanism.

[0242] A one-way valve 50, such as a duckbill valve or other type of one-way valve, is provided at the end of the tube 32 that enters the breast milk collection / storage container 60, or alternatively may be coupled in fluid communication with the storage container by a separate tube. The valve 50 prevents backflow of breast milk into the tube 32 and prevents air from entering the proximal end of the tube 32, thereby maintaining a suction (vacuum) level within the tube 32. The valve 50 may further be designed to open in a reverse direction if a predetermined maximum vacuum level is exceeded within the tubing 32, for example, exceeding 250 mmHg vacuum (-250 mmHg pressure), for safety purposes. In at least one embodiment, the pressure at which the valve 50 opens to allow flow into the breast milk collection container 60 is approximately 25 mmHg. In an alternative embodiment, a pressure relief valve 150 may be optionally provided within the system 100, such as within the skin contact member 10 or elsewhere along the tubing 32. The pressure relief valve 150 may be configured to release at a vacuum above a predetermined amount (e.g., a vacuum above 250 mmHg (vacuum below -250 mmHg) or some other predetermined maximum vacuum level). The one-way valve 50 may be configured and designed to allow fluid to flow through it when the pressure in the tubing 32 is positive, e.g., about 25 mmHg, or some other pre-set "crack pressure". The action of the compression element cycles between increasing vacuum as the compression element moves away from the tube 32 and decreasing vacuum as the compression element compresses the tube 32, but typically should not increase pressure beyond a predetermined maximum vacuum. As the compression elements 36, 38 compress the tube 32, the pressure within the system 100 rises and reaches a minimum suction level (e.g., a latching suction level such as -60 mmHg, -30 mmHg, or some other predetermined latching suction level), at which point the compression member (pinch valve) 36 seals off portion 32S, thereby maintaining a minimum suction (latching suction) against the chest 2. Continued compression of portion 32L by the compression member 38 continues to increase the pressure downstream of the compression member 36 until it reaches a crack pressure (e.g., 25 mmHg, or some other predetermined, positive crack pressure) that opens the one-way valve 50.The compression elements 36, 38 continue to compress the tube 32 and pump the fluid (breast milk) through the one-way valve 50 and into the collection container 60 until it reaches the end of its travel (usually just before its lowest position against the anvil 2232). The end of the travel of the compression element 38 against the portion 32L may be predetermined or calculated on the fly by the controller 52 using feedback from the pressure sensor 54 and from the driver of the compression element 38 from which the controller 52 can calculate the relative position of the compression element 38 during its travel. The compression members 36 remain closed during this process as they are used to seal the tube 32 the entire time the compression element 38 is pumping the breast milk from the region 42 and into the collection container 60. When the compression elements 36, 38 reverse direction and are pulled away from the tube 32, they start the cycle again.

[0243] As milk enters the system, the suction level decreases (pressure increases). Feedback provided by pressure monitoring by pressure sensor 54 becomes the input to a feedback loop that adjusts the position of compression member 38 to maintain the desired vacuum (pressure) in tubing 32 by compensating for pressure changes that cause changes in the amount of milk in tubing 32. For example, if there is a relatively large amount of milk in the tubing, this will require a relatively short stroke of compression member 38 towards anvil surface 2232 to achieve the latching pressure. This change can be accommodated by slowing the movement of compression member 38 to achieve the same timing cycle as pumping, or by increasing the cycle frequency by taking less time for the short stroke of compression member 38.

[0244] A contact pressure sensor 54 is shown in Figure 4 where the pressure sensor 54 contacts the vacuum space (and possibly breast milk) within the system 100. In this embodiment, a T-connector 370 is coupled to the proximal end of the nipple receiving portion 112 such that both the tube 32S and the tube 32P can be joined in fluid communication with the interior of the nipple receiving portion 112. In this manner, the pressure sensor 54 is placed in line and in fluid communication with the tube 32 and the nipple receiving portion 112 such that pressure can be measured directly.

[0245] Alternatively or additionally, one or more non-contact pressure sensors may be used in the system 100. In the embodiment of FIG. 20, the non-contact pressure sensor is positioned on the exterior of the tubing portion 32S. A variety of different types of non-contact pressure sensors may be used, such as optical sensors, magnetic sensors, linear variable differential transformer (LVDT) sensors, etc. Further details on non-contact pressure sensors that may be used in the present disclosure may be found in U.S. Provisional Patent Application Nos. 62 / 053,095 and 62 / 027,685.

[0246] 21A-21B show proximal perspective and side views, respectively, of a skin contact member 10 according to an embodiment of the present disclosure having four different potential locations for placement of a non-contact sensor 54. At location 350A, a thicker wall is provided relative to the thickness of the nipple receiving portion 112. In this example, the thickness of location 350A was 4.12 mm and the thickness of the nipple receiving portion 112 was 2.38 mm. At location 350B, a thinner wall is provided relative to the nipple receiving portion 112. In this example, the thickness of location 350B was 1 mm and the thickness of the nipple receiving portion 112 was 2.38 mm. At location 350C, the thickness is the same as the rest of the nipple receiving portion but protrudes outwardly therefrom, see the cross-sectional view of FIG. 21C taken along line 21C-21C of FIG. 21A. The thickness at location 350D is the same as the thickness of the nipple receiving portion, which in this example is 2.38 mm. It has been found that all locations 350A-350D are displaced according to a linear relationship (with various scale factors that can be experimentally determined) to pressure changes in the system, see Example 1 below. Thus, non-contact sensors 54 can be used at any of locations 350A-350D to measure the displacement changes at those locations. Pressure change measurements can then be calculated from the displacement change measurements due to the linear relationship that exists between the force applied at locations 350A-350D and the pressure in the system that causes the force. More generally, pressure changes in system 100 can be measured by measuring the counterforce of any preloaded fluid contacting wall of system 100.

[0247] The displacement of a portion of the skin contact member 10, such as a portion of the nipple receiving portion 112, to the force also has a linear relationship. Thus, the displacement of a portion of the skin contact member 10 can be measured and the pressure change calculated therefrom. Furthermore, the strain measurements can be used to calculate the pressure change. Thus, attachment of a strain gauge 54 to the skin contact member 10, typically over the area of ​​the nipple receiving portion 112 (see FIG. 21D), can be used to measure the strain change in that area, which measurements can be used to calculate the pressure change in the nipple receiving portion 112.

[0248] Use of the system 100 provided with a non-contact pressure sensor 54 involves loading the skin contact member 10 onto the main body / pump housing 34 (if it is not already preloaded) and then turning on the pump power. As the pump system 100 goes through a power-up routine, the controller 52 reads the force exerted by the pressure sensor 54, the position of the sensor 54 relative to the potentiometer if a displacement sensor 54 is used, or the strain on the strain gauge if a strain gauge is used as the pressure sensor 54. This is the preload force or position exerted by the sensor 54 against the nipple receiving portion 112 or the wall of the tube 32, or the strain measured by the strain gauge before the skin contact member is applied to the breast 2, which is therefore in a state where the pressure in the tube 32 is at atmospheric pressure. The controller 52 then calibrates the system so that the preload force or position or measured strain is equal to atmospheric pressure. Based on a look-up table or best fit equation, the controller 52 can now convert any changes in force, position or strain read by the pressure sensor 54 on the nipple receiving portion 112 or the wall of the tube 32 into a pressure reading within the breast pump system 100 during operation of the system 100 when attached to the breast 2.

[0249] Optionally, the system 100 may be provided with two or more non-contact sensors 54 to determine the pressure within the system 100. For example, by placing the sensors 54 on different areas of the nipple receiving portion 112 having different wall thicknesses, the linearity of the pressure change measured by the sensors 54 on the different wall thicknesses occurs within different pressure ranges (vacuum). FIG. 21E shows a cross-sectional view of the nipple receiving portion 112, where a first non-contact sensor 54 (see 54A) is attached to a relatively thin wall of the nipple receiving portion 112 and a second non-contact sensor 54 (see FIG. 54B) is attached to a relatively thick wall of the nipple receiving portion 112. The sensor 54B provides data for pressure change calculations at a higher range of vacuum pressures (low pressures) than those provided by the sensor 54A. The vacuum ranges over which the sensors 54A, 54B provide accurate data (linear relationship) can be designed to overlap, so that the effective range of linearity and therefore the range for accurately measuring changes in vacuum pressure can be extended. Furthermore, when the measured vacuum pressure is within the overlap region where reliable data is provided by both sensors 54A and 54B, this can be used as a check on the accuracy of each of the sensors 54A, 54B and / or can be used for calibration purposes. The present disclosure is not limited to the use of one or two sensors 54, and three or more sensors 54 can be used in this manner with or without overlapping pressure measurement ranges, although it is preferable to have overlap. FIG. 21F shows a pressure sensor 55 that can be used to activate or indicate when a predetermined vacuum pressure is achieved in the system. The pressure sensor 55 can be a switch in electrical communication with the controller 52. The pressure sensor 55 extends into the nipple receiving portion 112 (or alternatively into the tubing 32) a predetermined distance away from the inner wall of the nipple receiving portion 112 / tubing 32, which predetermined distance has been calculated or experimentally determined to be the distance the inner wall deflects when a predetermined vacuum pressure is achieved in the nipple receiving portion 112 / tubing 32.Thus, when the inner wall contacts the sensor 55 (as indicated by the dotted line in FIG. 21F), the sensor 55 sends a signal to the controller 52 which interprets the signal to indicate that a predetermined vacuum level has been reached. This type of sensor 55 may be used, for example, to indicate when maximum vacuum has been achieved. Alternatively or additionally, the sensor 55 may be provided to act as a safety mechanism, where if a signal is received from the sensor 55 indicating that an abnormally high level of vacuum has been reached, the controller 52 will shut down the system. For example, the system may be shut down when a 350 mmHg vacuum, or some other predetermined level of vacuum that is deemed to be too great for safe operation, is reached.

[0250] To account for possible degradation of the pump tubing 32 and / or the skin contacting member 10 over time, the system may optionally be provided with an indicator that alerts the user when it is time to replace the skin contacting member 10 and / or the tubing 32. FIG. 22 shows an indicator 352 mounted on the inside of the chest contacting member 352 for easy viewing by the user prior to placing the system 100 on the chest 2. The indicator 352 may measure the predetermined time / life to replace the tubing 32 and / or the skin contacting member 10 by a time-based indicator such as a marking that disappears or appears over time, other clocking mechanism that provides a visual and / or audible indication at the end of the measured time. If the skin contact member 10 and / or tubing deteriorate over time as a result of fatigue and / or oxidation, cleaning, etc., the indicator 352 can track the average expected life of the skin contact member 10 and / or tubing 32 and provide a visual and / or audible indication to the user when it is time to replace the current skin contact member 10 and / or tubing with new components. The average expected life of these components can be determined empirically by testing, whereby the average expected life can be empirically calculated and programmed into the indicator. Changes in the properties (e.g., elasticity, firmness, etc.) of the tubing 32 and / or skin contact member 10 can result in inaccurate pressure readings, insufficient sealing of the skin contact member against the breast 10 causing air and / or milk leakage, reduced pumping performance, etc. The indicator 352 can be a time-based indicator, such as a marking that disappears or appears over time.

[0251] 23 shows another location where indicators may be placed, in this case on the exterior shell 34 of the system 100. In situations where the time until the skin contact member is replaced differs from when the tubing 32 is replaced and an embodiment has a skin contact member 10 configured to be separable from the tubing (some embodiments provide the skin contact member 10 and tubing 32 as an integral unit), two indicators 352 may be provided, one set for the time until the skin contact member 10 is replaced and another set for the time until the tubing is replaced.

[0252] The indicator 352 can be disposable, such as the type used on the skin contact member 10 or tubing 32 as shown in FIG. 22, or can be reusable, such as that mounted on the external shell 34 as shown in FIG. 23, if desired (although the indicator 352 on the shell 34 can also be disposable and removable from the shell 34 and replaceable on the shell 34). FIG. 24 shows one example of a reusable time-based indicator 352 that can be used. In this embodiment, the indicator 352 is provided with multiple LCD bars 354 that darken when a reset button 356 is pressed and held. When a bar darkens, a timer is started, which is programmed for the time until replacement of the skin contact member 10 and / or tubing 32. As shown in FIG. 24, the indicator has four bars 354, but more or less can be provided. In the case of a four-bar embodiment, when a quarter of the time until replacement has elapsed after the bars are reset, the top bar becomes transparent or lightens, so that only three bars remain visible dark. Each bar successively becomes brighter or transparent once each quarter of the time until replacement has elapsed, until all bars are transparent and have expired. Thus, this type of indicator not only indicates when the full time until replacement has elapsed, but also provides the user with an approximate indication of how much time remains before replacement is required, i.e., three dark bars would indicate that 3 / 4 of the time of use is still remaining before replacement is required, etc.

[0253] Alternatively or additionally, other types of indicators 352 may be provided, including, but not limited to, indicators that change with friction, interaction with moving parts, etc. For example, wear indicator 352 can be located anywhere on tubing 32, such as where compression member 38 contacts tube 32L, where compression member 36 contacts tube 32S, or another location where tubing 32 is snapped into pump housing / area 30. FIG. 26 shows a wear indicator positioned on tubing portion 32L. Wear indicator 352 can be located anywhere on tubing 32 where wear is likely to occur. Wear due to friction, etc. resulting from interaction between tubing 32 and another component (compression member 36 or 38, pump housing 30, etc.) erases the color of indicator 352 as wear occurs. Thus, when the color fades or changes color, this indicates that it is time to replace tubing 32.

[0254] Similarly, wear indicators 352 may be used on components of the skin contact member 10 at locations that contact the pump housing 30 when it is snapped into place. Figure 27 shows a wear indicator 352 on the skin contact member 10. Wear occurs as the skin contact member is attached to and removed from the pump housing. A color change may be used to indicate that it is time to replace the skin contact member in the manner described above.

[0255] Further alternatively or additionally, the system 100 can detect wear of the tubing 32. The controller 52 can track the position of the compression member 38 relative to the tubing 32. FIG. 28 shows one example of an arrangement for tracking the position of the compression member 38, but the disclosure is not limited to this arrangement as alternative arrangements can be provided. In the embodiment of FIG. 28, the driver 46 includes a motor 46M, a gearbox 46G mounted on an opposite end of the motor 46M, and an encoder 46E. As the motor 46M rotates, the encoder 46E, which is fixed relative to the rotating motor, rotates with the motor. An optical monitor 1146, such as an infrared laser, emits a beam to the encoder 46E, so that the rotating blade of the encoder 46E intersects the optical beam emitted by the optical monitor 1146 as the motor rotates. When the blade intersects the beam, the beam is reflected back to the sensor 1148. By counting the reflections, the sensor 1148 and controller 52 can calculate the position of the motor 46M from a starting position, and hence the position of the compression member 38 it is driving, relative to its nominal position or the starting position of the compression member 38. A similar arrangement may be provided for the driver 44 of the compression member 36.

[0256] Thus, the controller 52 can keep track of the position of the motor 46 and the position of the compression member 38 relative to the tubing 32L. The controller 52 also tracks the pressure in the tubing 32 via a sensor 54 (e.g., as shown in FIG. 20 ), so that the controller 52 can correlate the pressure changes generated in the tubing 32 to the position (and / or, optionally, the speed) of the compression member 38. This correlation can be calculated when the tubing 32 is new, i.e., on first use. The correlation calculation can be performed continually by the controller 52 over subsequent uses of the system and compared to the correlation value from the first use. The correlation comparison shows trends over the useful life of the tubing 32 with subsequent uses. When the tubing 32 begins to wear, a smaller pressure change is produced by the same change in position / speed of the compression member 38 compared to when the tubing was new. This difference in pressure change can be tracked, and when a predetermined amount of difference occurs, the controller 52 can send a warning to the display 165 and / or the external computer 470 that it is time to replace the tubing 32. Also, by tracking trends over time in the use of system 100 and the resulting rate of change in variance in pressure changes, the controller can anticipate and predict when it will be time to replace tubing 32 and therefore send a warning to display 165 and / or external computer 470 a predetermined time before tubing 32 needs to be replaced. For example, such a warning could be sent a week, a month, or some other predetermined time before it is actually time to replace tubing 32.

[0257] Further, alternatively or additionally, the use of the skin contact member 10 and / or the tubing 32 can be tracked by the control device 52 and / or the external computer 470 using passive sensors 358 (see FIG. 25), for example via RFID or NFC. One or more sensors 358, each with a unique identifier (ID), can be attached or embedded in the skin contact member 10 and / or the tubing 32. With each use of the system, this / these unique ID(s) can be identified by the control device 52 and / or the external computer 470 to know that the skin contact member 10 and / or the tubing 32 is being used, thus tracking the number of uses, and / or tracking the time or use and / or cycle count (the number of cycles in use that the compression member 38 and / or 3 are performing). By tracking this data, the control device 52 and / or the external computer can then indicate when it is time to replace / change the skin contact member 10 and / or the tubing.

[0258] Further alternatively or additionally, the use of the skin contact member 10 and / or the tubing 32 can be tracked, such as by using radio frequency identification (RFID) or near field communication (NFC) tracking. This tracking can be performed, for example, by embedding a passive sensor / chip 358 configured for RFID or NFC tracking in one or both of the skin contact member 10 and the tubing 32, see FIG. 25. The one or more chips 358 can be identified by the control device 52 of the pumping system 100 (by wire and / or wirelessly, preferably wirelessly) by an external computer 470, i.e., an external computer that may be, but is not limited to, a smart phone, a tablet computer, a laptop computer, a notebook computer, or a server. The control device 52 and / or the external computer 470 communicate with the passive sensor(s) / chip(s) 358 that indicate when the system is in use. By tracking the time and / or number of uses, or even pump cycle count, the control device 52, or external computer, can alert the user when it is time to replace the skin contact member 10 and / or the tube 32. The alert can be audible and / or visual, such as a buzzer or voice message from the external computer 470 via the speaker 472 and / or a visual alert, such as text and / or graphics displayed on the display 478, or by the control device 52 via the optional display 165 and / or optional speaker 168. The tracking provided by the passive sensor 358 provides the ability to assign a unique identifier to each component to which the sensor 358 is attached or embedded. Thus, the control device 52 and / or external computer 470 can easily distinguish between the skin contact member 10 and the tube 32 being used.

[0259] This same technology can be provided to the breast milk collection containers 60 so that tracking of the date and time of extraction, amount extracted, etc. can be recorded and stored for each breast milk collection container used with the system 100 to extract breast milk. Thus, the system 100 can register each individual breast milk collection container 60 so that a user can easily identify when the breast milk in each container 60 was collected, the amount in each container 60, etc. The breast pump system can record the amount of breast milk in any given container 60 during a pumping session. The recorded data can be automatically or manually transmitted to the external computer 470 and / or via the internet.

[0260] There are multiple ways to link data to a particular breast milk collection container 60. The container 60 may be provided with easily identifiable markings 60M (see FIG. 37), such as alphanumeric markings (letters, numbers) among other markings that are easily identifiable and distinguishable from one another. Additionally or alternatively, the markings 60M on each container 60 may include a barcode, a QR code, an RFID, an NFC, other magnetic or electromagnetic identifiers, or the like pre-printed on the container 60. When initiating a breast milk pumping session using the system 100 with the breast milk collection container 60 attached, or at the end of the session, or any time in between, the user can scan the marking with a scanner on the external computer 470 (such as a smartphone), or the control device 52, or in an embodiment where a scanner 101 is provided on the system 100 as shown in FIG. 1, using the system 100 itself, or manually enter an identifier for the marking 60M if a barcode is not used, thus linking the particular breast milk collection container with the marking 60M in a database on the external computer. Upon termination of the breast milk extraction system, when the data is exported to an external computer 470 and / or an internet / cloud based computer, data such as amount, extraction date and time is exported along with an identifier of the mark 60M so that the data is linked and stored to the identifier of the particular breast milk collection container 60.

[0261] The marking 60M may automatically activate the system 100 for a pumping session when in range of the controller 52 and / or external computer 470, or may activate an activatable feature of the system, such as a power switch that may be activated by a user to begin a pumping session. If the container 60 includes a marking 60M that is not recognizable by the controller 52 and / or external computer 470, or does not include a marking 60M at all, the system 100 may be configured to be prevented from activating for a breast milk extraction session, since the unique ID is not recognized in this case. By ensuring that the breast milk collection container 60 used has a recognizable unique ID, this may provide additional assurance for the safety, sterility, and quality of the breast milk collection container 60 used. The presence of the unique identifier 60M allows the system 100 to track when the breast milk collection container 60 approaches the system 100 for use in an extraction session, when it leaves its proximity at the end of the session, as well as other data already described, such as the amount of breast milk extracted, the date and time of extraction, the length of the extraction session, etc. These information capabilities can be useful for managing personal use and consumption by the user's infant, as well as for breast milk donation services where breast milk extracted from one mother may be donated to a breast milk bank or to a different mother's infant. For breast milk donation services, the collection bank can use the same unique identifier provided by the mark 60M to scan the breast milk collection container 60 in its bank database and verify that it is a container 60 that is qualified for the program. In embodiments where the container 60 includes a one-way valve 50, this provides further assurance that breast milk has not been removed from the container 60 prior to arriving at the breast milk collection bank.

[0262] The controller 52 and / or the external computer 470 may be provided with a memory for storing a database of registered unique IDs, which may be periodically updated by communication with a central database over a network (wireless or wired) such as the Internet. Alternatively, the controller 52 and / or the external computer may be connected to the central database by a WiFi or other wireless connection to the Internet, or even by an Ethernet connection, etc.

[0263] As already mentioned, the breast milk collection container 60 may be provided with a passive sensor 358, such as an RFID or NFC chip (see also FIG. 34), which may be attached to or embedded in the breast milk collection container 60 and can be used to link the breast milk collection container 60 with all data recorded relating thereto.

[0264] As an alternative to pre-marked collection containers 60, a user can manually mark the containers 60 with unique identifiers and manually enter these identifiers into the external computer. Alternatively, the manual markings can be scanned into the external computer.

[0265] The system 100 can calculate the amount of breast milk pumped into the breast milk collection container 60. By knowing the dimension of the tubing 32 downstream of the compression member 36 when the compression member 36 seals the tubing section 32S, the total volume capacity of the system 100 downstream of the compression member 36 can be calculated. By tracking the position of the compression member 38 relative to the tube 32 (e.g., by constantly knowing the position of the driver 46), the volume change in the tubing 32 is read. When the pumping process is performed, the pumping / purging of breast milk into the breast milk collection container occurs when the compression member 36 seals the small tube section 32S at the place of compression. When the compression member 36 seals the tube section 32S, the change in position of the compression member 38 that occurs to purge breast milk from the tubing 32 and into the breast milk collection container 60 can be used to calculate the change in volume in the tubing 32 downstream of the compression member 36, which is equal to the amount of breast milk forced through the one-way valve 50 and into the breast milk collection container 60 bag.

[0266] Optionally, an estimate of the percentage of breast milk and air in the system tubing 32 can be calculated based on a compliance assessment of the tubing 32, such as at tubing section 32L. The more air in the tubing compared to breast milk, the more the tube section 32L will move for a given force or a given pressure change thereon by the compression member 38L. This relationship can be mapped, for example, to provide a look-up table to identify the percentage of air and the percentage of breast milk in the tubing 32 before purging. The amount of breast milk and the amount of air can then be calculated by knowing the amount purged by knowing the progress of the compression member 38 during purging.

[0267] Further optionally, the opening of the valve 50 can be monitored, or the movement of fluid past the valve 50 can be monitored. By knowing the crack pressure of the valve 50 and knowing the pressure in the tubing 32, this can identify when the purge is actually being forced through (i.e., when the pressure in the tube 32 reaches the crack pressure). This can increase the accuracy of the calculated purge volume by starting the calculation at the position of the compression member when the crack pressure is reached.

[0268] In addition to calculating the amount of milk purged by each purge cycle, the system (via the controller 52) can sum the amounts from all purge cycles to calculate the total amount of milk pushed into the milk collection container 60 during the milk extraction session. This amount can be stored along with a unique identifier on the milk container so that the system 100 keeps track of how much milk is stored in each milk collection container 60. This information can also be time-stamped so that the user knows the time and date the milk was collected for each milk collection container. Additional statistics can be calculated including, but not limited to, average amounts per extraction session, total amount extracted on any given day, average amount of milk extracted per day, etc. Any and all of this data can be manually exported to an external computer or it can be automatically uploaded to the computer 470 when the computer 470 is within range of the system 100 for wireless communication or if the computer 470 is wired to the system. Further optionally, any or all of this data can be uploaded manually or automatically to a cloud service via the internet, wirelessly or wired.

[0269] When calculating the amount of breast milk pumped from the system 100, it is necessary to distinguish between air pumped by the system versus breast milk pumped out of the system, and a pumped mixture of breast milk and air. When a breast milk pumping / extraction session is started, there is air in the tubing 32, and this initial amount of air must be pumped into the breast milk collection container 60 to prime the pumping system 100. The distinction between pumped air and pumped breast milk can be recognized by correlating the pressure change to the amount of movement of the compression member 38 required to establish this pressure change. For example, when air is in the tubing, a larger change in position, or more total travel of the compression member 38, is required to achieve the same pressure change than is required when the tubing 32 is filled with breast milk. Thus, a relatively large movement of the compression member with a relatively small pressure change indicates that there is air in the tubing 32. This pressure difference can also be detected when the compression member 36 is open (i.e., does not close the tube portion 32S) and the compression member 38 is retracted, which increases the vacuum pressure.

[0270] 31A-31B show schematic diagrams of a breast pump system 100 according to an alternative embodiment of the present disclosure, in which the exterior shell 34 of the system need not be continuously curved, but instead can have another shape, such as geometric (all or part not curved) or even amorphous or some other custom shape designed to conserve space. In the embodiment of FIG. 31A, the shell 34 has approximately flat surfaces forming a sloping exterior surface. These surfaces can contour the internal components of the system more closely than would be provided by a continuous convex exterior shell 34, thereby eliminating space that does not have components in a system having a continuous convex exterior shell 34. In the embodiment of FIG. 32B, the exterior shell has a flat central portion similar to the embodiment of FIG. 31A, but has convex portions extending radially from the flat central portion. It should be noted that these are two non-limiting shapes provided, as the shape of the exterior shell can take almost any shape that is well adapted to accommodate the internal components of the system 100 while minimizing empty space. The breast milk collection container 60 is mountable on the outer shell 34. The breast milk collection container 60 may be formed to provide an externally convex shape to mimic the shape of the breast 2, while having a variable volume to fit the outer surface of the outer shell when filled. As shown in FIG. 31A, the peripheral portion of the container 60, when filled, is narrower than the central portion of the container 60 when filled. In FIG. 31B, the container is pre-shaped to follow the contours of the outer shell 34, including a bulbous portion 34B that fits into the concave portion of the outer shell 34 when filled. These solutions result in a more compact overall system, while at the same time maintaining the appearance of the system 100 when worn similar to that of a natural breast. The outer surface 60E of the breast milk collection bag 60 may be formed to maintain a continuous convex appearance even when the breast milk collection bag is empty. The breast milk collection bag 60 can have a rigid inner surface that mates with the contours of the outer shell 34 and a soft, flexible outer surface that expands / moves as breast milk enters the bag 60 while maintaining a convex / naturally appearing breast shape.Alternatively, the exterior surface of the breast milk collection container 60 may be rigid to maintain a breast / convex shape and the interior surface may be soft and flexible to match the contours of the exterior shell 34 as the bag 60 expands while filling with breast milk. Another option is to make both surfaces rigid but allow some movement as a space / bladder during filling with breast milk, allowing the surfaces to part as needed to accommodate the volume of breast milk received.

[0271] 32A-32B show a breast milk collection container 60 for use in the system 100 according to another embodiment of the present disclosure. In this embodiment, the container 60 has a preformed convex surface 60C shaped to mimic the natural appearance of the breast 2. The surface 60C may be preformed, such as by molding, and maintains the illustrated convex shape when the container is empty as well as when it contains breast milk. When worn on the system housing 34, the convex shape 30 provides the appearance of a natural breast, whether or not contained by a bra. The opposing surface 60F of the container 60 is flexible and may include pleats or folds 60W when the container 60 is empty. When the container 60 fills with breast milk, the container 60 expands by moving the flexible surface outward. During the outward movement of the flexible surface 60W, the flexibility of this surface allows it to conform to the shape of the system housing / external shell 34, maximizing the space savings of the overall system 100. Figure 32A shows in dotted lines the shape of flexible surface 60W as it is moved to contour outer shell 34 of the embodiment of Figure 31 A. Figure 32B shows in dotted lines the shape of flexible surface 60W as it is moved to contour outer shell 34 of the embodiment of Figure 31B.

[0272] In addition to or as an alternative to providing a flexible surface 60F provided with a preformed surface 60C, the breast milk collection container may further be provided with one or more structural elements 76, such as baffles, heat seals, struts, or other restrictions that limit the amount of expansion of the flexible surface 60F relative to the contoured surface 60C and / or provide shape to the collection container 60 even when empty. FIG. 33 shows a container 60 having a baffle 76 that is internally connected to the interior walls of the portions 60F, 60C to limit the amount of expansion in the area where the baffle 76 is located compared to the amount of expansion that the remaining areas may experience. The baffles 76 may be provided in any desired pattern, thereby allowing the expanded contour of the flexible surface 60F to be customized to fit the particular contour of the exterior shell 34.

[0273] 32C shows a breast milk collection container 60 in which a distal surface 60D of the container is formed with a shape that, when filled with breast milk, matches the proximal surface contour of the outer shell 34. The proximal surface 60C may be flexible or may be preformed with a convex shape that mimics the appearance of the breast 2.

[0274] Even in embodiments of breast pump system 100 in which the exterior shell is convex, the breast milk collection container 60 used therewith will have variable levels of thickness from top to bottom and side to side when mounted on the system and breast milk is collected within the container 60. Thus, the container 60 may be pre-formed or pre-configured to assume a shape having a variable thickness between its rear and front walls when it contains breast milk.

[0275] FIG. 34 illustrates a breast milk collection container 60 including a passive sensor 358 that can be attached or embedded in the container 60. The sensor 358 can be an RFID or NFC device or the like that includes a unique identifier (ID) and is made recognizable to the controller 52 and / or external computer 470. The controller 52 and / or external computer is provided with a reading application that can wirelessly read the unique ID when the container 60 including the sensor 358 with the unique ID is brought in close proximity to the controller 52, such as by attaching the collection container 60 to the outer shell 34. Once read, this unique ID is then looked up by the controller 52 and / or external computer 470 in a database application that contains detailed information about what the sensor 358 is attached to. Upon identifying the unique collection container with the sensor 358 attached / embedded, the system 100 can then track the usage of the unique container including, but not limited to, the amount of breast milk collected, the date and time of collection, the duration of the extraction session, etc. Optionally, if a collection container 60 does not include a sensor 358 with a unique ID that is recognizable to the system 100, the system will not operate with that collection container.

[0276] FIG. 35 illustrates a breast milk collection container 60 in which the connector 62 includes a one-way valve 50 according to an embodiment of the present disclosure. In this embodiment, the outer shell 34 or tubing 32 is not provided with a one-way valve 50, but is provided with a mating connector that couples with the connector 62 that includes a one-way valve. Whether the one-way valve 50 is provided with the connector 62 / collection container 60 or the one-way valve 50 is provided at the end of the tubing 32, the mating connector for coupling with the connector 62 can otherwise be the same. Examples of mating connector arrangements can be found, for example, in U.S. Provisional Patent Application No. 62 / 027,685. Other examples of connector types that can be used for the connector 62 and mating connector include, but are not limited to, bayonet type, threaded connectors, compression fits, flare fittings, and the like.

[0277] 36 illustrates a breast milk collection container 60 according to another embodiment of the present disclosure. In this embodiment, the tubing 32 is integral with the breast milk collection container 60 and the one-way valve 50 as shown. The open end of the tubing 32 is provided with a connector 62 configured to mate with the connector 134 of the skin contact member 10.

[0278] When the user completes the pumping phase of pumping breast milk from the breast 2, it is useful and efficient to purge as much of the breast milk remaining in the tubing 32 from the tubing 32 into the breast milk collection container 60. FIG. 38 illustrates events that may be performed to perform a purge according to an embodiment of the present disclosure. At event 3802, the system 100 ends the pumping cycle that was performed during the extraction phase. The extraction phase may be terminated when a predetermined extraction phase time has elapsed, upon calculation of a predetermined amount of breast milk pumped, upon manual stopping of the extraction phase by the operator, or when some other predetermined value is reached after performing an extraction. At event 3804, the direction of the pumping stroke of the compression member 38 is reversed, and the compression member 38 proceeds in the reverse direction to reduce the suction force in the tubing 32, and optionally creates a small positive pressure in the tubing 32 to facilitate removal of the system 100 from the breast 2. Alternatively, the suction force may be reduced to a level where a slight suction remains such that the user still pulls on the system 100 from the breast 2 to remove it. Preferably, the vacuum is reduced to 0 mmHg or a slight positive pressure to automatically remove the system 100 from the chest 2. The final pressure value at which the pressure reduction by reverse pumping stops can be within a range of about -20 mmHg (weak vacuum) to positive 50 mmHg (e.g., crack pressure of the valve 50). The compression member 36 does not close the tubing portion 32S during this process, and the tubing portion 32S remains open. This initiation of reverse pumping may be automatic after performing event 3802, or may be initiated by a user activating a purge actuator on an optional control panel 166 provided on the system 100 (see FIG. 23). This process continues until the seal of the system 100 to the chest 2 is broken, which is detected by the controller 52 via the sensor 54 at event 3806. When exposure of the tubing 32 to atmospheric pressure is detected at event 3806, the pumping stroke direction is reversed again at event 3808, thereby pumping the milk in the tubing 32 under positive pressure and forcing the milk from the tubing 32 into the container 60. At event 3810, the purging process ends.Event 3810 may occur some predetermined time after the initiation of event 3808, or may be initiated by measuring the compliance of tubing portion 32L and executing event 3808 when the compliance of tubing portion 32L indicates that the contents within tubing 32L have at least a predetermined percentage (such as 90%, 95%, 97% or some other predetermined percentage) of air therein. If, accidentally, system 100 accidentally or otherwise reseals against chest 2 during purge pumping, system 100 may automatically shut off due to sensing the re-established vacuum pressure in the vicinity of chest 2 / skin contact member 10.

[0279] Figures 39A-39B show various arrangements that may be provided in the system 100 to help prevent loss of breast milk from the system upon removal of the system 100 from the breast 2. These arrangements may be provided in embodiments configured to perform a purging operation in the manner described with respect to Figure 38 above, but may also be provided in systems 100 that use different purging techniques other than those described with respect to Figure 38.

[0280] A frangible valve 390, such as a flap valve, may be provided in the small tube portion 32S near where it connects to the skin contact member 10, as shown in Figures 39A-39B. The valve 390 is very flexible so that it opens in a first direction (upward as shown in Figures 39A-39B) when a vacuum is generated in the tubing 32. A very small amount of vacuum (much less than the latching vacuum, e.g., about 5-15 mmHg) is sufficient to open the valve 390 upward, see Figure 390A. The valve 390 is of such stiffness that it remains closed under a positive pressure equal to the hydrostatic pressure generated when the tubing 32 is completely filled with breast milk. Positive pressure created above this hydrostatic pressure by a predetermined amount (e.g., 5-15 mmHg positive pressure above the positive pressure created by the entire water column of breast milk) will force the valve 390 open in the opposite direction (i.e., downward as shown in Figs. 39A-39B), see Fig. 390B. In this arrangement, the breast pump system 100 is not sealed and can be removed from the breast 2 after the breast milk has been extracted therefrom, with any milk remaining in the tubing 32 being prevented from escaping the skin-contacting member 10 by the closed valve 390. The system 100 can then be run in a forward stroking motion to create positive pressure using the compression member 38 to force the breast milk from the tubing 32 into the breast milk collection container 60.

[0281] Additionally or alternatively, a valve or flap may be provided extending radially inward from a bottom portion of the breast contacting member 122, as shown in FIG. 39A. When the breast 2 is inserted into the breast contacting member 122 to perform an extraction session, the breast 2 folds the flap / valve 522 and presses it against the inner wall of the breast contacting member 122, see 522-2. When the breast 2 is removed from the breast contacting member 122, the flap / valve 522 resiliently returns to its unbiased position (see 522-1), where it extends radially inward, thereby retaining breast milk within the breast contacting member 122 that would otherwise spill out of the system. By tilting the breast contacting member 122 at an angle, the user allows breast milk within the breast contacting member 122 to flow under gravity into the nipple receiving portion 112, where it can be pumped through the tubing 32 and purged into a breast milk collection container. Further alternatively, the flap 522 may be provided with an adhesive surface that contacts the breast 2 and thereby assists in creating tension on the breast 2 to control the amount of breast tissue that enters the nipple receiving portion 112, similar to the function of the adhesive region 360 described above. Further optionally or additionally, the stiffness or strength of the flap / flap 522 may be such that the chest contacting member 10 must be pressed against the breast 2 to deflect the flap / flap 522 and thereby establish tension. Furthermore, the flap 522 may be provided at both the top and bottom locations of the chest contacting member 122 (not just the bottom as shown in FIG. 39A ), or at other locations intermediate the top and bottom, or may be formed continuously around the entire circumference of the chest contacting member 122.

[0282] 40A-40B show two different cross-sectional views of a profile element 410 provided on the breast pump system 100. The profile element 410 extends distally from the distal perimeter 34D of the outer shell 34 and extends proximally across a distal portion of the outer shell 34 to provide a contoured extension of the outer shell that provides a more visually appealing appearance that more closely mimics the natural appearance of the breast 2 supported by a bra. The profile element 410 tapers distally to form a smooth transition with the breast 2 when the system 100 is placed on the breast 2, thereby making the system 100 less visible and unnoticed when worn by a user. The profile member 410 may be configured to snap around or, for example, form a friction fit therewith, the circumference of the main body 34 of the system 100.

[0283] FIG. 40A shows a cross-sectional view showing the upper and lower portions of the contour element 410. FIG. 40B shows the contour elements on the left and right sides of the outer shell 34. The embodiment shown in FIG. 40B is for the right breast. The contour element for the left breast will be a mirror image of that shown in FIG. 40B because in each case the contour element 410 has an outer portion 410A that extends further distally from the perimeter 34D than the inner portion 410B extends distally from the perimeter 34D. The outer portion of the system 100 is more contoured by the contour element 410 than the inner portion because that is where the cleavage will be formed and therefore deviations from the natural appearance are less visible on the medial side. Additionally, the inner extension will be smaller since there is less space to extend into. Additionally, the contour element 410 may extend over a portion of the proximal end portion of the exterior shell 34 to provide additional "flatness" to the proximal end of the system 100 to appear closer to a more natural breast 2 as opposed to a more pointy "ice cream scoop" shape. Although the sections of the components 410 in FIGS. 40A-40B are shown in FIGS. 40A-40B as being solid materials such as made from foam, plastic, or other lightweight materials, they may alternatively be made hollow or even made from a single layer of material to provide the same contouring shape. Thus, a single thin layer of plastic or fabric may alternatively be used as shown, for example, in FIGS. 41A-41B. The material of the contour element 410 may be elastic so that when it is pressed down or distorted, it naturally springs back to a natural looking contour.

[0284] Attachment members 412, such as snaps, hook-and-loop type, buttons, magnets, or other attachment members, may be provided at one, and preferably more, locations on the outer shell 34 and at other than the interior surface(s) of the profile element 410 to ensure fixation of the profile element 410 to the outer shell and to ensure that proper orientation of the profile element 410 relative to the outer shell 34 is achieved each time they are joined, thereby providing the desired appearance.

[0285] 42 shows an embodiment of a profile element 410 fitted onto an outer shell 34, where the outer shell 34 is provided with a key 34K that ensures that the profile element 410 is properly oriented on the outer shell 34 each time the two components are mated. The profile element 410 has a mating key 410K that mates with the key 34K to ensure that the position of the profile element 410 relative to the outer shell 34 does not change rotationally or change upward, downward, outward or inward, but is positioned substantially the exact same way relative to the outer shell 34 each time it is fitted thereon. As shown, the key 34K extends from a peripheral surface of the outer shell 34K, and the mating key 410K is an opening in the profile element 410 that mates with the mating key 34K. Alternatively, the key portion 34K can be formed as a recess in the exterior shell 34, and the mating key portion 410K can be a ridge (or an inwardly extending solid shape) that extends inwardly from the peripheral inner surface of the profile element 410 and is shaped to mate with the key portion 34K. It is further noted that the shape of the key portion 34K and the mating key portion 410 is not limited to that shown, but can be any shape that ensures that the profile element 410 can be attached to the exterior shell 34 in one orientation and position. Furthermore, the key portion 34K and the mating key portion 410K do not need to be centrally located, but can be anywhere on the exterior shell 34 (and corresponding location of the profile element 410). Also, multiple keys 34K and mating keys 410K can be provided in multiple locations.

[0286] The contour element can be adjustable so that it can be adjusted to fit optimally against the breast 2 and it can fit various sizes and shapes of the breast 2 while still providing a more natural appearance in each case. FIG. 43 shows an embodiment of a contour element in which a first edge 414 of the contour element 410 overlaps a second edge 416 and can be adjusted to reduce, increase or maintain the circumference of the distal circumference 410D while simultaneously reducing, increasing or maintaining the proximal circumference 410P. After adjustment, the first edge 414 can be secured to the surface underlying the contour element 410 that it overlaps, such as by using a hook-and-loop type, snap, adhesive, or the like. The contour element can further be adjusted, if needed, to fit better, however, by cutting all or a portion of the distal circumference 410D to a desired length to adjust the length that the contour element 410 extends from the distal circumference 34D at the top, bottom, and sides of the device. All of these distances can be adjusted as needed.

[0287] 44 shows an embodiment of a contour element 410 with predetermined markings that may be provided to assist a user in adjusting the contour element 410 to better contour to the breast 2 being used. For example, markings 418, 420, 422, and 424 may be provided as suggested starting locations for placement of overlapping edge 414 over edge 416 and placed at the appropriate markings for D-cup, C-cup, B-cup, and A-cup sizing, respectively. Markings 426, 428, and 430 are suggested locations for cutting distal edge 410D to fit breasts 2 of 36 (91 cm)", 34 (86 cm)", and 32 (81 cm)", respectively.

[0288] FIG. 45A shows an embodiment in which the outer shell 334 is provided with two key portions 34K1 and 34K2. The profile element of FIG. 45B is provided with mating key portions 410K1A and 410K2 configured to mate with key portions 34K1 and 34K2, respectively, when the profile element 410 is in a first size setting configuration. Additional mating key portions 410K1B and 410K1C are provided to mate with key portion 34K1 when the profile element 410 is adjusted in the manner described above to better contour to a smaller size breast 2. Although two additional mating key portions 410K1 and 410K2 are shown, more or fewer can be provided if more or less adjustability is required. Similarly, in addition to or as an alternative to providing multiple mating key portions 410K1, additional mating key portions can be provided for 410K2.

[0289] 46A-46B show a contour element 410 according to another embodiment of the present disclosure. In this embodiment, the contour element 410 is made of an easily compressible material, such as a lightweight resilient foam, that easily conforms to the shape of the object against which it is pressed. In the illustrated embodiment, the contour element 410 is a generally straight plate-shaped element that tapers at the ends, although other shapes can be used. The central portion of the contour element 410 can be attached to the outer shell 34 using connectors, adhesives, or any of those previously described, as shown in FIG. 46A. When the system 100 is supported by the bra 440, as shown in FIG. 46B, the contour element 410 contours to the outer shell 34 of the system and also to the contours of the bra 440, thereby providing the appearance of a natural breast shape. Additionally, alternatively, the contour element 410 of FIG. 46A can be thinner and does not need to be contoured to the outer shell 34, as the bra 440 provides the contouring shape.

[0290] The system 100 may be configured to distinguish whether it is attached to the left or right breast 2 of the user. This may be useful for tracking the amount of milk extracted per breast, per session, total daily volume per breast, etc. When using two pumping systems, data tracking for each breast may still be accurately maintained even if one of the pumping systems 100 is attached to the left breast during a current pumping session after being attached to the right breast during a previous pumping session. In one embodiment, the pumping system 100 may establish its current location (i.e., left or right breast) by receiving a signal from the other pumping system attached to the other breast 2. This establishes the relative left-right location of the two pumping systems 100, so that each system 100 can accurately record whether milk is being extracted from the right or left breast 2. This identification is automatic without requiring any user input, which also relieves the user of the burden of otherwise keeping track of which pump system 100 is placed on each chest and maintaining this order with each successive pumping session.

[0291] Orientation signals such as Wi-Fi, BLUETOOTH, BLUETOOTH Low Energy (BTLE), RFID, NFC, etc., may be used to automatically determine which pump 100 is on which breast 2. Optionally, one or more magnetic coils 450 may be provided in each pump system 100 (see, for example, FIG. 23) so that the relative positions of the pump systems 100 may be determined by signals relative to one another in a manner similar to how surgical tracking is performed by coil magnetic sensors. By placing magnetic coils on the left and right sides of the pump systems 100 and passing a small amount of electrical current through the coil 450 in one of the pump systems 100, the current induces a signal in the coil 450 in the other pump system 100. The signal strength is small and is induced only when the breast pump systems are close to each other, such as when worn on adjacent breasts 2. This signal can be used to determine the relative locations of the pump systems 100, i.e., which system 100 is worn on the left breast 2 and which system 100 is worn on the right breast 2.

[0292] The system 100 can calculate pressure during operation of any of the methods described above. The suction (pressure) level can be altered as desired, and feedback provided to the controller 52 by the sensor(s) 54 by continuously or repeatedly measuring / calculating the pressure provides a control loop that can be used to adjust the position and / or velocity of the compression members 38 to alter the suction pressure to a desired level or to maintain a desired suction pressure. Thus, the controller 52 can control the position and velocity of the compression members 36, 38 to achieve any desired vacuum pressure pumping profile and make automatic real-time adjustments to maintain a desired vacuum pressure in the system.

[0293] The controller 52 tracks the position of the compression member 38 relative to the tubing 32L, such as by keeping track of the driver 46 position or shaft position (the interconnection between the driver 46 and the compression member 38), and calculates (or looks up) the pressure based on the data received from the sensor 54. Thus, changes in position and / or speed of the compression member 38 by the controller 52 can be controlled by the resulting changes in the calculated or looked up pressure relative to the pressure sought to be achieved. The controller 52 can control the compression member 36 in a similar manner, but control of the member 36 is more focused on position control, since the compression member 36 needs to fully close the tube portion 32S while maintaining a latch suction force on the breast 2 / nipple 3. However, the closure is timed and performed at a determined latch pressure, known from the data received from the sensor 54.

[0294] During extraction, the compression member 38 cycles between latch suction and maximum suction to extract breast milk from the breast 2. The suction level of maximum suction can optionally be adjusted anywhere between the latch suction pressure and a maximum possible suction pressure, such as 250 mmHg, or some other predetermined maximum possible suction pressure, for user comfort. As the tubing 32 receives more breast milk, the compression member moves further away from the tube portion 32L to achieve / maintain maximum suction. When the compression member 38 begins to approach its position limit away from the tube portion 32L (nearly completely uncompressed state of the tube portion 32L), the controller 52, by constantly knowing the position of the compression member 38, purges the breast milk currently held within the large tube portion 32L by controlling the driver 46 to drive the compression member 38 to its opposite position limit (where the compression member 38 most compresses the large tube portion 32L). This re-establishes or resets the compression member, allowing it to establish a maximum suction level without approaching its position limit. This process is repeated each time the compression member 38 comes within a predetermined distance of its position limit.

[0295] FIG. 47 illustrates events that may be performed by the system 100 during an extraction mode to pump breast milk from the breast. At event 4702, after latching and letting down of breast milk is achieved, the system begins operating in extraction mode. In extraction mode, the system cycles between a latching suction (e.g., about 55 mmHg, or a preselected value from the range of about 25 mmHg to about 80 mmHg suction) and a maximum suction (e.g., about 150 mmHg, or a preselected value from the range of about 130 mmHg to about 200 mmHg suction). The pumping cycles can be regular continuous cycles, or can be preprogrammed to provide some irregularity, such as occasional pauses in the pumping action to simulate when a breastfed infant takes a breath and then resumes drinking. The pumping cycles can be 60 cycles per minute, or some other predetermined frequency. The cycle rate of the pumping action, such as speed, is predetermined in this embodiment. Optionally, the operator may be able to set or adjust the cycle rate used when initiating the extraction mode and / or at any time during operation in the extraction mode. The controller 52 monitors the pressure waves and the operation of the compression member 38 in the system 100 at event 4704. In the absence of milk expression, the pressure wave profile and the operation of the compression member 38 are fairly consistent with little or no change in the end point of the compression member's progress. As milk enters the system, the controller needs to move the compression member further to achieve the same target maximum vacuum level, and this change in the relationship of the compression member 38 position to the pressure is identified by the controller as an indicator that milk has entered the tubing 32. If little change in the position of the compression member 38 to the pressure has occurred, pumping continues at the current pumping cycle parameters for the speed and movement of the compression member 38. When the position of the compression member 38 relative to the pressure changes, such as due to milk entering the system, the controller 52 identifies, at event 4704, via feedback from the sensor 54 and monitoring of the motor, gear train, and / or compression member position, a change in the relationship between the position of the compression member 38 and the vacuum pressure achieved, and adjusts the speed, travel range, and / or position of the compression member 38 in an attempt to maintain a desired pressure profile that cycles between latching vacuum and maximum vacuum levels, at event 4708. If no change in the pressure / position relationship (within predetermined minimum ranges) is sensed at 4704, the system continues pumping with the current cycle control parameters, at event 4706.

[0296] At event 4710, the controller checks to determine whether the outward position limit of the compression member 38 has been reached while attempting to maintain system operation according to the predefined pressure profile. If the position limit has been reached, the controller 52 controls the system at event 4712 to reduce the pressure to the latch pressure, seal the tubing section 32S by compressing it with the compression member 36, and executes a purge procedure by actuating the driver 46 to drive the compression member 38 inwardly relative to the tube section 32L to the other position limit to purge the breast milk from the tube section 32L, and then processing proceeds to 4714. If the position limit has not been reached at 4710, processing proceeds directly to event 4714. At event 4714, the pressure is checked again to see if the predefined pressure parameters have been achieved. If the pressure profile has returned to the target (predefined pressure profile), the controller checks to see if processing should continue at event 4716. Optionally, event 4716 can be omitted and the extraction mode can be manually terminated by the operator. Even when event 4716 is employed, the user may manually stop the extraction mode at any time by activating a manual switch on the control panel 166. Extraction mode pumping may be automatically terminated after a predetermined period of time or when some other event is achieved. For example, the flow of breast milk may be calculated based on a pressure change calculation made by the controller, and the total amount of breast milk extracted may also be calculated. Thus, extraction mode pumping may be terminated, for example, after a predetermined amount of breast milk has been pumped or when the controller 52 infers that the flow of breast milk has decreased below a predetermined rate for a determined time. Further alternatively, the system 100 may be automatically shut off after the controller 52 determines that a predetermined time (e.g., one minute, or some other predetermined time) has passed after the flow of breast milk has gone to zero.Further alternatively, the system may automatically shut off after the controller 52 determines that a certain combination of events has occurred, for example, after 5 minutes if the flow has been zero for at least 1 minute, or some other predetermined combined logic.

[0297] If the extraction mode should continue at event 4716, processing proceeds to event 4704. If the extraction mode should end, the process ends at event 4718. If the predetermined pressure profile was not achieved at event 4714, processing proceeds to event 4708.

[0298] A build-feed mode can be programmed into the system and can be used by the user to help increase milk production. When in the build-feed mode, with a milk extraction volume goal set, the system 100 will run the pumping session including the extraction mode as normal, but once the volume has been achieved, the system 100 will continue pumping by using pumping characteristics that simulate a hungry, growing baby, such as increasing the maximum suction and keeping that level slightly longer during the pumping cycle to simulate a baby trying to draw more milk from the breast 2, before shutting off the system.

[0299] In another embodiment, the predetermined pumping cycle speed of the system 100 in the extraction mode can be automatically increased according to the age of the user's infant. It has been found that the suction frequency of a newborn is slower than that of a 6-month-old infant, for example. By tracking the age of the user's infant, the controller 52 can automatically scale the predetermined pumping cycle speed to the age of the user's infant. Thus, for example, when using the system 100 when the user's infant is a newborn, the cycle speed can be 60 CPM (cycles per minute), 65 CPM when the infant is 2 months old, and 70 CPM when the infant is 6 months old. These figures are exemplary only and the present disclosure is not limited thereto, as the more general concept of automatically increasing the predetermined cycle operation frequency based on the infant's age is the subject of the disclosure.

[0300] The total volume of the tubing 32 and skin contact member 10 (minus the volume occupied by the breast 2 and nipple 3) is represented as T, and the volume displaceable by the compression member is represented as P, where P should be greater than 16.2% of T for purposes of this disclosure, i.e., P / T>0.162.

[0301] FIG. 48 illustrates a nipple shield 480 according to an embodiment of the present disclosure. The nipple shield 480 can be attached (by suction, reattachable adhesive, etc.) to the breast 2 as shown in FIG. 48 to cover the nipple 3 when the mother is breastfeeding the baby. One or more openings 482 are provided in a tip region of the nipple shield 480 to allow the baby to draw breast milk through the nipple shield 480. The tip portion 484, which overlaps at least a portion of the nipple 3 and areola 4, is made significantly thinner than the attachment portion 486, which surrounds the tip portion 484. For example, the nipple shield 480 can be made from a single material, such as silicone or other biocompatible elastomer having similar elastic properties, where the tip section is about 0.25 mm thick (or in the range of about 0.1 mm to about 1 mm), while the attachment portion 486 can have a thickness in the range of about 2 mm to about 5 mm. This gives the attachment portion 486 greater structural support and better holding ability against the breast 2, while the thinner tip portion 484 can expand easily, thereby minimizing resistance to the expansion of the nipple 3 and areola 4 so as not to restrict the flow of milk from the breast. Working Example

[0302] The following examples are set forth to provide those skilled in the art with a complete disclosure and description of how to make and use the present disclosure, and are not intended to limit the scope of what the inventors regard as their disclosure, or to represent that the experiments below are all or the only ones performed. Efforts have been made to ensure accuracy with respect to numbers used (e.g., amounts, forces, pressures, etc.), but some experimental error and deviation should be accounted for. Example 1

[0303] Tests were performed on a light weight vinyl polysiloxane chest flange (Danville Star VPS#80011-01 manufactured by Danville Materials, Ramon, Calif.) to determine the relationship between the force applied to the nipple receiving portion 494 and the pressure (vacuum) within the nipple receiving portion 494. The nipple receiving portion 494 was secured by a support 496 and a predetermined force was applied by a load cell 490 (see FIG. 49 ) to the side of the nipple receiving portion 494 opposite the side of the nipple receiving portion 494 that was supported. A stopper 498 was used to allow the establishment of a vacuum within the nipple receiving portion 494 and a tube 502 was used to connect a syringe 504 and a pressure gauge 506 in fluid communication with the interior space of the nipple receiving portion 494. Various runs were performed with different pre-forces applied by load cell 490 on nipple receiving portion 494 ranging from 1.5N to 4N, which correspond to pre-force displacements (at atmospheric pressure) of the nipple receiving portion walls ranging from -1.41mm to -11.60mm, see Figure 50. The pressure change in nipple receiving portion 494 produced by withdrawing the plunger of syringe 504 was measured by pressure gauge 506, recorded and plotted against the force on the nipple receiving portion measured by load cell 490.

[0304] Figure 50 shows the plotted results, where the recorded data points are interconnected by a best-fit line indicating that the data exhibits an approximately linear relationship between pressure (vacuum) 510 within the nipple receiving portion 494 and force 512 measurements on the exterior surface of the nipple receiving portion 494. As the vacuum increased (pressure decreased), the force exerted by the nipple receiving portion against the load cell sensor 490 decreased according to a linear force-pressure relationship. Example 2

[0305] The configuration of Example 1 was modified to test the dynamic force-pressure relationship of the system. An oscilloscope 508 (see FIG. 51) was electrically connected to receive output pressure and force readings from the pressure gauge 506 and the load cell / sensor 490, respectively. As in Example 1, the preload displacement at atmospheric pressure was varied from -11.60 mm to -1.41 mm for various runs of the test. For each run, the vacuum was cycled between high and low vacuum three times. For each run, it was observed that the force exerted by the nipple-receiving portion on the sensor of the load cell 490 decreased as the vacuum increased, following an approximately linear force-pressure relationship. FIG. 52 shows a plot of vacuum 512 and force 514 plotted as time against the voltage received by the oscilloscope 508 for a run with a preload displacement of -11.60 mm. It can also be observed that the force 514 decreased linearly proportionally with the increase in vacuum 512 and vice versa. The same can be observed in FIG. 53, which plots vacuum 512 and force 514 as time against voltage received by oscilloscope 508 for a run with a preload displacement of -1.41 mm. Similar results were observed for additional runs with initial displacements of -10.47 mm, -8.50 mm, -7.47 mm, -6.22 mm, -5.65 mm, -3.54 mm, -4.69, and -2.44 mm, respectively. Example 3

[0306] The arrangement of Example 1 was modified to test the relationship between the position of the target location of the nipple receiving portion 494 and the vacuum level within the nipple receiving portion 494, see Figure 54. In this example, the load cell 490 of Example 1 was replaced by a marker block 516 that was preloaded against the nipple receiving portion 494 by a spring 518 at atmospheric pressure. When a vacuum was drawn in the system by withdrawing the plunger of the syringe 504, the marker block 516 moved along with the walls of the nipple receiving portion 494 as they flexed inward with the reduction in pressure. Example 4

[0307] The arrangement of Example 1 was modified to test the relationship between the position of the target location of the nipple receiving portion 494 and the vacuum level within the nipple receiving portion 494, see FIG. 55. In this example, the load cell 490 of Example 1 was replaced by a first and a second marker block 522, 524 connected by an arm to a potentiometer 520, where the first marker block 522 is fixed at a fixed reference location and the second marker block 524 is fixed to the nipple receiving portion 494 and is therefore directly movable with the movement of the nipple receiving portion. The second marker 524 was preloaded against the nipple receiving portion 494 at atmospheric pressure. When a vacuum was drawn in the system by withdrawing the plunger of the syringe 504, the nipple receiving portion 494 is bent inwardly due to the reduction in pressure, so that the marker block 524 moves with the walls of the nipple receiving portion 494 relative to the fixed marker block 522. Movement of marker 524 caused arm 526 to move at an angle relative to arm 528, which was registered by a potentiometer and transmitted to an oscilloscope. The change in angle 530 was measured by the potentiometer, and the linear change in distance 532 between the positions of marker 524 and marker 522 was calculated by the difference between the original distance 532 and the distance corresponding to the angle calculated from the measured change in angle relative to the original angle.

[0308] Although the present disclosure has been described with reference to specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents 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.

Claims

1. 1. A wearable, portable, self-powered breast pump system for expressing breast milk from a breast, comprising: A pump mechanism; a fluid reservoir adapted to directly engage and fit within the bra and connected to the aspiration fluid line; a flange configured to receive the breast, the flange including a nipple receiving portion and a base; the base is configured to underlie the nipple receiving portion during use, the nipple receiving portion including a proximal end defining an opening; A breast pump system, comprising: a pump mechanism associated with a nipple receiving portion, the pump mechanism being fixed over the nipple receiving portion, the pump mechanism including a motor for generating suction and a suction flow path from the nipple receiving portion, both of which are disposed over a bottom of the flange.

2. The breast pump system generally defines a breast shape profile. The breast pump system of claim 1 .

3. The fluid reservoir generally forms part of a breast-shaped profile. The breast pump system of claim 2 .

4. Further comprising a controller; The breast pump system of claim 1 .

5. further comprising a sensor in communication with the controller; providing a control loop used to regulate the suction pressure; The breast pump system of claim 4.

6. the pump mechanism includes a tube that is compressed to generate suction pressure; A control loop is used to adjust the rate of compression of the tube to vary or maintain the suction pressure. The breast pump system of claim 5.

7. the pump mechanism includes a tube that is compressed to generate suction pressure; A control loop is used to adjust the position of the compression element to vary or maintain the suction pressure. The breast pump system of claim 5.

8. The volume of expressed breast milk is calculated by assessing the position of the compression element. The breast pump system of claim 7.

9. The pressure change is evaluated by comparison at multiple positions of the compression element; The breast pump system of claim 8.

10. the pump mechanism includes a second tube portion; The control loop is used to adjust the position at which one of the compression elements changes or maintains the suction pressure. The breast pump system of claim 7.

11. the pump mechanism includes a second tube portion; The control loop is used to adjust the rate at which one of the compression elements changes or maintains the suction pressure. The breast pump system of claim 7.

12. further comprising a tube and a compression member; The volume of milk expressed is calculated by comparing the pressure change in the tube with the position of the compression member. The breast pump system of claim 1 .

Images