U.S. patent application number 15/450958 was filed with the patent office on 2018-02-22 for quantification and inventory management of expressed human breast milk.
The applicant listed for this patent is Naya Health, Inc.. Invention is credited to Janica B. Alvarez, Jeffery B. Alvarez, Nathaniel Gaskin, Polina Segalova.
Application Number | 20180050138 15/450958 |
Document ID | / |
Family ID | 55524774 |
Filed Date | 2018-02-22 |
United States Patent
Application |
20180050138 |
Kind Code |
A1 |
Alvarez; Jeffery B. ; et
al. |
February 22, 2018 |
QUANTIFICATION AND INVENTORY MANAGEMENT OF EXPRESSED HUMAN BREAST
MILK
Abstract
Systems, methods, and devices for milk expression are provided.
In one aspect, a system includes an expression apparatus having an
interface configured to engage a breast and an actuation assembly
operably coupled to the interface. Actuation of the actuation
assembly causes the interface to apply vacuum pressure against the
breast to express milk from the breast. The system also includes
various sensors for quantifying characteristics of the expressed
milk, and a unique identifier allows inventory management of the
expressed milk.
Inventors: |
Alvarez; Jeffery B.;
(Redwood City, CA) ; Alvarez; Janica B.; (Redwood
City, CA) ; Gaskin; Nathaniel; (Palo Alto, CA)
; Segalova; Polina; (Redwood City, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Naya Health, Inc. |
Redwood City |
CA |
US |
|
|
Family ID: |
55524774 |
Appl. No.: |
15/450958 |
Filed: |
March 6, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14858924 |
Sep 18, 2015 |
9623160 |
|
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15450958 |
|
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62052941 |
Sep 19, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2205/3393 20130101;
A61M 1/062 20140204; A61M 2205/6072 20130101; A61M 2205/502
20130101; G06Q 10/087 20130101; A61M 1/06 20130101; A61M 2205/071
20130101 |
International
Class: |
A61M 1/06 20060101
A61M001/06; G06Q 10/08 20120101 G06Q010/08 |
Claims
1. A system for quantifying expressed milk from a human breast,
said system comprising: a breast milk expression device configured
to express milk from the breast; a reservoir fluidly coupled to the
breast milk expression device and configured to collect the
expressed breast milk, wherein the reservoir comprises a unique
identifier; a sensor unit configured to quantify one or more
attributes of the expressed breast milk; and a peripheral device in
communication with the sensor unit, wherein the peripheral device
is configured to associate the one or more attributes of the
expressed milk quantified by the sensor unit with the unique
identifier of the reservoir containing the expressed breast
milk.
2. A method for quantifying expression of breast milk from a human
breast, said method comprising: expressing breast milk from a human
breast using a breast milk expression device; collecting the
expressed breast milk into a reservoir fluidly coupled to the
breast milk expression device; quantifying one or more attributes
of the expressed breast milk with a sensor unit; generating pump
session data comprising a start time of expression of the breast
milk and an end time of the expression; digitally associating the
pump session data with the one or more attributes of the expressed
milk; and updating a pump session log with the pump session data,
wherein the pump session log is stored on a peripheral device in
communication with the breast milk expression device.
3. A system for managing an inventory of expressed breast milk,
said system comprising: a reservoir containing expressed breast
milk, wherein the reservoir comprises a unique identifier; an
inventory management database comprising one or more inventory
items, each inventory item associated with a unique identifier of a
reservoir; and a computing device configured with instructions to:
receive the unique identifier of the reservoir, receive one or more
attributes of the expressed breast milk digitally associated with
the unique identifier, and update the inventory management database
in response to receiving the unique identifier.
4. A method for managing an inventory of expressed breast milk,
said method comprising: identifying, from an inventory of expressed
breast milk, an inventory item associated with a unique identifier
of a reservoir containing expressed breast milk; and updating the
inventory of expressed breast milk with respect to the identified
inventory item; wherein the inventory is locally stored on a
computing device, the computing device configured with instructions
to provide an inventory management application.
Description
CROSS-REFERENCE
[0001] The present application is a continuation of U.S. patent
application Ser. No. 14/858,924, filed on Sep. 18, 2015 [attorney
docket no. 44936-709.201], which claims the benefit of U.S.
Provisional Patent Application No. 62/052,941, filed on Sep. 19,
2014 [attorney docket no. 44936-709.101], the entire contents of
which are incorporated herein by reference.
[0002] This application is related to the following co-pending
provisional and non-provisional patent applications: U.S. patent
application Ser. No. 14/221,113 [attorney docket no.
44936-703.201], U.S. patent application Ser. No. 14/616,557
[attorney docket no. 44936-704.201], U.S. patent application Ser.
No. 14/793,606 [attorney docket no. 44936-705.201], U.S. patent
application Ser. No. 14/793,613 [attorney docket no.
44936-706.201], and U.S. patent application Ser. No. 14/793,617
[attorney docket no. 44936-707.201], the entire contents of which
are incorporated herein by reference.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0003] The present invention generally relates to medical devices
and methods, and more particularly relates to devices and methods
for expression and collection of human breast milk. Such devices
and methods preferably facilitate quantification of properties of
the expressed milk as well as inventory control of the expressed
milk.
[0004] Breast pumps are commonly used to collect breast milk in
order to allow mothers to continue breastfeeding while apart from
their children. It would be desirable to provide breast pumps that
not only collect the milk, but that can provide additional
information about the expressed milk. Additional features such as
quantification of milk production and nutritional information as
well as inventory management are further desirable for enhanced
user convenience. Managing the inventory of expressed breast milk
can pose challenges for the user, because of the fluctuating supply
and demand for the milk over time and the limited shelf-life of
expressed breast milk. It would be desirable to provide a way for
users to automatically keep track of the expressed milk inventory,
to manage the inventory, and even forecast both future consumption
and production. It would also be desirable to provide quantitative
information that characterizes the nutritional information about
the expressed milk.
[0005] At least some of these objectives will be satisfied by the
devices and methods disclosed below.
2.Description of the Background Art
[0006] The following US patents are related to expression and
collection of human breast milk: U.S. Pat. Nos.: 6,673,036;
6,749,582; 6,840,918; 6,887,210; 7,875,000; 8,118,772; and
8,216,179.
SUMMARY OF THE INVENTION
[0007] The present invention generally relates to medical devices
and methods, and more particularly relates to devices and methods
for expression and collection of human breast milk.
[0008] In one aspect, a system for quantifying expressed milk from
a human breast comprises a breast milk expression device configured
to express milk from the breast and a reservoir fluidly coupled to
the breast milk expression device, configured to collect the
expressed breast milk. The reservoir comprises a unique identifier.
The system further comprises a sensor unit configured to quantify
one or more attributes of the expressed breast milk. The system
further comprises a peripheral device in communication with the
sensor unit, wherein the peripheral device is configured to
associate the one or more attributes of the expressed milk
quantified by the sensor unit with the unique identifier of the
reservoir containing the expressed breast milk.
[0009] In any embodiment of the system, the sensor unit may be
integrated with the reservoir and configured to quantify the one or
more attributes of the expressed breast milk as the expressed
breast milk is collected into the reservoir. Additionally or
alternatively, the sensor unit may be integrated with the breast
milk expression device and configured to quantify the one or more
attributes of the expressed breast milk as the expressed breast
milk is collected into the reservoir. Additionally or
alternatively, the sensor unit may comprise a separate sensor unit
in communication with the peripheral device, the separate sensor
unit configured to quantify one or more attributes of the expressed
breast milk after the expressed breast milk has been collected in
the reservoir.
[0010] The one or more attributes of the expressed breast milk
quantified by the sensor unit may comprise a volume of the
expressed breast milk collected in the reservoir. Additionally or
alternatively, the one or more attributes may comprise a
composition of the expressed milk, wherein the sensor unit is
configured to quantify the relative amount of one or more compounds
present in the expressed breast milk.
[0011] In any embodiment of the system, the breast milk expression
device may be configured to generate pump session data comprising a
start time of a pump session and an end time of the pump session.
The peripheral device may be further configured to associate the
pump session data with the unique identifier of the reservoir.
[0012] In any embodiment of the system, the peripheral device may
be further configured with instructions to update an inventory of
expressed breast milk in response to the association of the one or
more attributes of the expressed milk with the unique identifier of
the reservoir containing the expressed breast milk. The peripheral
device may be configured to generate an inventory item in the
inventory of expressed breast milk corresponding to the unique
identifier of the reservoir containing the expressed breast
milk.
[0013] The unique identifier may comprise one or more of a
human-readable code, a barcode, a Quick Response (QR) code, and a
radio-frequency identification (RFID) tag.
[0014] In any embodiment of the system, the system may further
comprise a label printer for generating a label for the reservoir
comprising the unique identifier. The label printer may be
configured to communicate with the peripheral device and provide
the unique identifier to the peripheral device when the label is
generated.
[0015] In another aspect, a method for quantifying expression of
breast milk from a human breast comprises expressing breast milk
from a human breast using a breast milk expression device, and
collecting the expressed breast milk into a reservoir fluidly
coupled to the breast milk expression device. The method further
comprises quantifying one or more attributes of the expressed
breast milk with a sensor unit and generating pump session data
comprising a start time of expression of the breast milk and an end
time of the expression. The method further comprises digitally
associating the pump session data with the one or more attributes
of the expressed milk. The method further comprises updating a pump
session log with the pump session data, wherein the pump session
log is stored on a peripheral device in communication with the
breast milk expression device.
[0016] The quantifying may comprise quantifying the one or more
attributes of the expressed breast milk as the expressed breast
milk is collected into the reservoir. Additionally or
alternatively, the quantifying may comprise quantifying the one or
more attributes of the expressed breast milk after the expressed
breast milk has been collected in the reservoir. The quantifying
may comprise quantifying a volume of the expressed breast milk
collected in the reservoir, a relative amount of one or more
compounds present in the expressed breast milk, or a combination
thereof.
[0017] The method may further comprise feeding the expressed breast
milk to a child, and determining a volume of expressed breast milk
consumed by the child. The method may further comprise updating a
feed log stored on the peripheral device to add feeding session
data, wherein the feeding session data comprises a time of the
feeding and the volume of consumed breast milk.
[0018] In any embodiment of the method, the reservoir may comprise
a unique identifier, and the method may further comprise providing
the unique identifier to the peripheral device. The method may
further comprise digitally associating the unique identifier with
the pump session data and the one or more attributes of the
expressed milk.
[0019] The unique identifier may comprise a human-readable code,
wherein providing the unique identifier to the peripheral device
may comprise prompting a user to input the human-readable code via
an application of the peripheral device. Additionally or
alternatively, the unique identifier may comprise a
machine-readable code, wherein providing the unique identifier to
the peripheral device may comprise reading the machine-readable
code with a machine configured to recognize the machine-readable
code. The machine-readable code may comprise a radio-frequency
identification (RFID) tag, and providing the unique identifier to a
peripheral device may comprise scanning the RFID tag with an RFID
reader in communication with the peripheral device.
[0020] The method may further comprise updating an inventory of
expressed breast milk to add a new inventory item corresponding to
the unique identifier of the reservoir containing the expressed
breast milk.
[0021] The method may further comprise transferring the expressed
milk from the reservoir to another storage reservoir comprising a
unique identifier.
[0022] In another aspect, a system for managing an inventory of
expressed breast milk comprises a reservoir containing expressed
breast milk, wherein the reservoir comprises a unique identifier.
The system further comprises an inventory management database
comprising one or more inventory items, each inventory item
associated with a unique identifier of a reservoir. The system
further comprises a computing device configured with instructions
to receive the unique identifier of the reservoir, receive one or
more attributes of the expressed breast milk digitally associated
with the unique identifier, and update the inventory management
database in response to receiving the unique identifier.
[0023] In any embodiment of the system, the one or more attributes
of the expressed breast milk may comprise a date and time of
expression of the expressed breast milk.
[0024] In any embodiment of the system, the computing device may be
further configured to sort the one or more inventory items in the
inventory management database in order of first-to-feed to
last-to-feed. The computing device may be further configured to
display the inventory management database to a user. The computing
device may be further configured to locally store the inventory
management database.
[0025] Any embodiment of the system may further comprise a server
in communication with the computing device, the server configured
to remotely store the inventory management database.
[0026] In any embodiment of the system, the unique identifier may
comprise a Quick Response (QR) code, and the computing device may
be further configured to recognize the QR code. Alternatively or
additionally, the unique identifier may comprise a radio-frequency
identification (RFID) tag, wherein the system may further comprisee
an RFID reader in communication with the computing device. The RFID
reader may be configured to recognize the RFID tag and provide
identifier information to the computing device.
[0027] Any embodiment of the system may further comprise a
reservoir organizer configured to store a plurality of reservoirs
in a stacked configuration. The organizer may comprise a top
opening configured to receive the plurality of reservoirs one at a
time, and a bottom opening configured to allow withdrawal of a
reservoir disposed at the bottom of a stack of the plurality of
reservoirs, thereby facilitating a first-in, first-out system of
organization. Optionally, the reservoir organizer may further
comprise an integrated RFID reader configured to scan an RFID tag
disposed on a storage reservoir as the storage reservoir enters or
exits the reservoir organizer. The RFID reader may communicate
detected scans to the computing device. Optionally, the reservoir
organizer may further comprise an integrated weight sensor
configured to measure a weight of the stack of the plurality of
reservoirs. The weight sensor may communicate detected changes in
the weight of the stack to the computing device.
[0028] In another aspect, a method for managing an inventory of
expressed breast milk comprises identifying, from an inventory of
expressed breast milk, an inventory item associated with a unique
identifier of a reservoir containing expressed breast milk. The
method further comprises updating the inventory of expressed breast
milk with respect to the identified inventory item. The inventory
may be locally stored on a computing device, wherein the computing
device may be configured with instructions to provide an inventory
management application.
[0029] In any embodiment of the method, the unique identifier may
be digitally associated with pump session data for the expressed
breast milk contained in the reservoir. The pump session data may
comprise a date and time of expression of the expressed breast
milk. Additionally or alternatively, the unique identifier may be
digitally associated with one or more attributes of the expressed
breast milk contained in the reservoir.
[0030] Identifying an inventory item may comprise obtaining the
unique identifier of the reservoir selected and removed from
storage by a user. Identifying an inventory item may comprise
displaying, via the inventory management application of the
computing device, a list of inventory items in the inventory, and
prompting a user to select the inventory item from the list of
inventory items. The method may further comprise sorting the list
of inventory items in order of first-to-feed to last-to-feed.
Sorting in order of first-to-feed to last-to-feed may comprise
sorting in order of date of expression of the expressed breast
milk, wherein an inventory item corresponding to expressed breast
milk with an oldest date of expression is determined to be the
first-to-feed, and an inventory item corresponding to expressed
breast milk with a newest date of expression is determined to be
the last-to-feed. Optionally, the method may further comprisee
providing, via the inventory management application of the
computing device, a visual display of a plurality of reservoirs
corresponding to a plurality of inventory items in the inventory,
the visual display identifying the first-to-feed inventory item.
Optionally, the method may further comprise indicating an inventory
item as expired if a difference between a current date and a date
of expression of the expressed breast milk corresponding to the
inventory item exceeds a predetermined expiry threshold.
[0031] Updating the inventory may comprise removing the inventory
item from the inventory in response to a determination that there
is no remaining milk in the reservoir. Alternatively, updating the
inventory may comprise updating information associated with the
inventory item in response to a determination that there is
remaining milk in the reservoir. Updating information associated
with the inventory item may comprise updating a volume of the
expressed breast milk contained in the reservoir, a storage
location of the reservoir, or a combination thereof.
[0032] In any embodiment of the method, the inventory may be
locally stored on the computing device. Additionally or
alternatively, the inventory may be remotely stored on a server in
communication with the computing device.
[0033] In any embodiment of the method, the unique identifier may
comprise a radio-frequency identification (RFID) tag, and the
method may further comprise scanning the RFID tag with an RFID
reader in communication with the computing device.
[0034] These and other embodiments are described in further detail
in the following description related to the appended drawing
figures.
INCORPORATION BY REFERENCE
[0035] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0037] FIG. 1 is a perspective view of a pumping device, in
accordance with embodiments;
[0038] FIG. 2 is a perspective view of a hydraulic pumping device,
in accordance with embodiments;
[0039] FIG. 3 is a cross-section of a hydraulic pumping device, in
accordance with embodiments;
[0040] FIG. 4 illustrates an actuation assembly coupled to a
driving mechanism, in accordance with embodiments;
[0041] FIGS. 5A-5B illustrate an actuation assembly coupled to a
controller, in accordance with embodiments;
[0042] FIG. 6 is a cross-sectional view of a breast interface, in
accordance with embodiments;
[0043] FIG. 7 is a cross-sectional view of another a breast
interface, in accordance with embodiments;
[0044] FIG. 8A is a cross-sectional view of an integrated valve
within a flexible membrane in an open position, in accordance with
embodiments;
[0045] FIG. 8B is a cross-sectional view of an integrated valve
within a flexible membrane in a closed position, in accordance with
embodiments;
[0046] FIG. 9 is a cross-sectional view of a breast interface with
a mechanical deformable member, in accordance with embodiments;
[0047] FIG. 10 is a cross-sectional view of a mechanical driver for
a mechanical deformable member, in accordance with embodiments;
[0048] FIGS. 11A-11L illustrate exemplary embodiments of sensors
for detecting fluid;
[0049] FIG. 12 illustrates a controller and a mobile device, in
accordance with embodiments;
[0050] FIG. 13 illustrates short range communication between a
controller and a mobile device, in accordance with embodiments;
[0051] FIG. 14 is a schematic illustration of a pumping device in
communication with a computing device and a server, in accordance
with embodiments;
[0052] FIG. 15 is a graph illustrating the pump performance of an
exemplary pumping device compared to a commercial device, in
accordance with embodiments; and
[0053] FIG. 16 is a graph illustrating the pumping efficiency of an
exemplary pumping device compared to a commercial device, in
accordance with embodiments.
[0054] FIG. 17 illustrates a schematic diagram of a system for
expression of milk;
[0055] FIG. 18 illustrates another exemplary embodiment of a system
for expression of milk;
[0056] FIGS. 19A-19C illustrate exemplary displays on a computing
device;
[0057] FIGS. 20A-20B illustrate exemplary displays in a milk
expression system;
[0058] FIG. 21 illustrates the use of a feedback control loop to
control a milk expression device;
[0059] FIG. 22 illustrates a dual expression system;
[0060] FIGS. 23A and 23B illustrate exemplary embodiments of a
sensor unit for quantifying the composition of expressed milk using
an enzyme assay;
[0061] FIG. 24 illustrates an exemplary embodiment of a sensor unit
configured to quantify the composition of expressed milk using
spectroscopy;
[0062] FIG. 25 illustrates an exemplary embodiment of a milk
expression and inventory management system;
[0063] FIG. 26 illustrates an exemplary embodiment of a storage
configuration for expressed milk reservoirs having unique
identifiers;
[0064] FIG. 27 illustrates another exemplary embodiment of a milk
expression and inventory management system;
[0065] FIG. 28 illustrates an exemplary embodiment of a label
printer which may be optionally incorporated with an inventory
management system;
[0066] FIG. 29 shows an exemplary method of adding an item to a
breast milk inventory;
[0067] FIG. 30A is a perspective view and FIG. 30B is a side
cross-sectional view of an exemplary storage reservoir
organizer;
[0068] FIG. 31 shows an exemplary method of removing an item from a
breast milk inventory; and
[0069] FIG. 32 shows another exemplary method of removing an item
from a breast milk inventory.
DETAILED DESCRIPTION OF THE INVENTION
[0070] Specific embodiments of the disclosed systems, devices, and
methods will now be described with reference to the drawings.
Nothing in this detailed description is intended to imply that any
particular component, feature, or step is essential to the
invention. Although the present invention primarily relates to
breast milk, any description herein of expression and collection of
breast milk can also be applied to other types of fluids expressed
from other portions of the body including but not limited to
colostrum fluid from the breast. Furthermore, the disclosed
embodiments may be used in other applications, such as applications
wherein negative pressure is used to help collect a body fluid or
other specimen.
[0071] The systems, devices, and methods of the present invention
provide improved pumping devices for the expression and collection
of breast milk, such as human breast milk. Contrary to existing
devices, the mechanisms described herein enable the development of
smaller and more efficient pumping devices, thereby enhancing
convenience and ease of use. Additionally, any of the exemplary
embodiments disclosed herein may optionally incorporate sensors for
measuring characteristics of milk expression. The resultant data
can be used, for instance, as feedback for improving pumping
efficiency, as well as to provide information and/or analytics
relevant to milk expression to the user. Furthermore, in preferred
embodiments, the data can be transmitted to another device in
communication with the pumping device, thereby enabling control,
display, and/or analysis of milk expression to be performed
remotely.
[0072] FIG. 1 illustrates an exemplary embodiment of a milk
expression device. Pumping device 100 (also known as an "expression
apparatus" or "expression device") includes breast interfaces 105,
a tube 110, and a controller 115 (sometimes also referred to as a
"pendant unit") operatively coupled to breast interfaces 105
through tube 110. Breast interfaces 105 include resilient and
conformable flanges 120, for engaging and creating a fluid seal
against the breasts, and collection vessels 125. Controller 115
houses the power source and drive mechanism for pumping device 100,
and also contains hardware for various functions, such as
controlling pumping device 100, milk production quantification, and
communication with other devices, as described in further detail
below. Tube 110 transmits suitable energy inputs, such as
mechanical energy inputs, from controller 115 over a long distance
to breast interfaces 105. Breast interfaces 105 convert the energy
inputs into vacuum pressure against the breasts in a highly
efficient manner, resulting in the expression of milk into
collection vessels 125.
[0073] Hydraulic Pumping Device
[0074] Hydraulic systems can reduce pumping force requirements, and
therefore also reduce the size of the pumping device, while
maintaining high pumping efficiencies. In a preferred embodiment,
the pumping device can utilize a hydraulic system to generate a
pressure differential against the breast for the expression and
collection of milk.
[0075] Exemplary hydraulic pumping devices are depicted in FIGS. 2
and 3. FIG. 2 illustrates a pumping device 150 with a syringe 155
fluidly coupled to breast interface 160 by tube 165. Syringe 155 is
coupled to tube 165 through a three-way valve 170. Breast interface
160 contains an exit port 175. The syringe 155 drives a fluid 180
contained within tube 165 against a flexible member contained
within breast interface 160 to create the pressure differential
necessary for milk expression from the breast.
[0076] FIG. 3 illustrates another embodiment of a pumping device
200. The actuation assembly 205 includes an assembly housing 210, a
driving element 215, radial seals 220, and a shaft 222. Driving
element 215 is operatively coupled to a controller, such as
controller 115, through shaft 222. The tube 225 contains a fluid
230 and is fluidly coupled to the actuation assembly 205 and the
breast interface 235. The breast interface 235 consists of an
interface housing 240, a flexible membrane 245, a reservoir 250, a
sealing element 255, an expression area 260, and a drain port 265.
The sealing element 255 includes deformable portion 270. The drain
port 265 is coupled to a collection vessel 275 and includes a flap
valve 280.
[0077] Actuation assembly 205 displaces fluid 230 contained within
tube 225, which can be a flexible line. Fluid 230 occupies
reservoir 250 within breast interface 235 and is coupled with
flexible membrane 245. Preferably, the couplings between the
flexible membrane 245, sealing element 255, and interface housing
240 are fluid-tight couplings, such that the fluid 230 is contained
within the reservoir 250 and cannot infiltrate into the expression
area 260. Flexible membrane 245 transmits vacuum pressure from
fluid 230 to the deformable portion 270 of sealing element 255.
When a breast is engaged into and fluidly sealed with breast
interface 235 by sealing element 255, displacement of the actuation
element 215 produces substantial vacuum pressure against the breast
through flexible membrane 245 and deformable portion 270, resulting
in the expression of breast milk into expression area 260. The
expressed milk drains through drain port 265 into collection vessel
275. Drain port 265 is configured with a flap valve 280 to provide
passage of milk while maintaining vacuum pressure in expression
area 260. Collection vessel 275 can be any suitable container, such
as a bottle or a bag. In many embodiments, collection vessel 275 is
removably coupled to flexible membrane 245. Collection vessel 275
can be coupled directly or remotely via any suitable device such as
extension tubing. Preferably, the collection vessel can be quickly
decoupled from the other components of the pumping device 22 (e.g.,
for milk storage, cleaning, etc.).
[0078] The fluid for the hydraulic pumping device can be any
suitable fluid, such as an incompressible fluid. In many
embodiments, the incompressible fluid can be a liquid, such as
water or oil. Alternatively, the fluid can be any suitable gas,
such as air. Any liquid or gas suitable for use with hydraulic
systems can be used for the hydraulic pumping devices described
herein.
[0079] Actuation Mechanism
[0080] Many actuation mechanisms known to those of skill in the art
can be utilized for the actuation assembly 205. Actuation assembly
205 can be a piston assembly, a pump such as a diaphragm pump, or
any other suitable actuation mechanism. The optimal configuration
for actuation assembly 205 can depend on a number of factors, such
as: vacuum requirements; size, power, and other needs of the
pumping device 200; and the properties of the fluid 230, such as
viscosity, biocompatibility, and fluid life requirements.
[0081] FIG. 3 illustrates an exemplary embodiment in which
actuation assembly 205 is a piston assembly and driving element 215
is a piston. Actuation assembly 205 includes radial seals 220, such
as 0-rings, sealing against assembly housing 210 to prevent
undesired egress of fluid 230 and to enable driving of fluid
230.
[0082] FIG. 4 illustrates another exemplary embodiment of an
actuation assembly 300 including a pair of pistons 305.
[0083] In preferred embodiments, the actuation assembly includes a
driving element powered by a suitable driving mechanism, such as a
driving mechanism residing in controller 115. Many driving
mechanisms are known to those of skill in the art. For instance,
the driving element, such as driving element 215, may be actuated
electromechanically by a motor, or manually by a suitable
user-operated interface, such as a lever. Various drive modalities
known to those of skill in the art can be used. In particular,
implementation of the exemplary hydraulic pumping devices as
described herein enables the use of suitable drive modalities such
as direct drive and solenoids, owing to the reduced force
requirements of hydraulic systems.
[0084] Referring now to the exemplary embodiment of FIG. 4, the
pistons 305 include couplings 310 to a crankshaft 315. The
crankshaft 315 is operatively coupled to a motor 320 through a belt
drive 325. The crankshaft 315 drives the pair of pistons 305 with
the same stroke timing in order to apply vacuum pressure against
both breasts simultaneously, a feature desirable for increased milk
production. Alternatively, the crankshaft 315 can drive the pair of
pistons 305 with any suitable stroke timing, such as alternating or
offset stroke cycles.
[0085] The driving mechanism can be powered by any suitable power
source, such as a local battery or an AC adaptor. The driving
mechanism can be controlled by hardware, such as onboard
electronics located within controller 115.
[0086] FIG. 22 illustrates another embodiment of an alternating
pump system 2200. The system 2200 includes dual expression devices
with an interface 2212 sized and shaped to conform to the target
tissue, here a breast. A reservoir 2214 is threadably or otherwise
coupled to the expression device. A hydraulic line 2210 fluidly
couples each expression device to a hydraulic piston assembly 2204
which has an incompressible fluid such as oil in a piston chamber
and an actuatable piston 2206. One hydraulic line 2210 is coupled
to the high pressure side 2208 of the hydraulic piston, and the
other hydraulic line is coupled to the lower pressure side 2208 of
the piston. A motor 2202 actuates the piston 2206. Thus, in
operation, as the piston is actuated the high pressure side creates
a higher pressure in one of the expression devices and a lower
pressure in the other expression device. The lower pressure
expression device results in a vacuum which creates conditions
under which milk expression occurs, while the high pressure side
does not express milk. Then, as the piston reaches the end of its
stroke, and reciprocates in the opposite direction, the high and
low pressure sides are reversed, thereby causing expression of milk
on the opposite side and no expression on the original side. This
process allows milk to be collected in an alternating fashion. The
expression devices, reservoirs in this system may be any of the
components disclosed elsewhere in this disclosure.
[0087] In any pump system comprising a pair of breast interfaces as
described herein, each breast interface may be fluidly coupled to a
separate hydraulic line, and each separate hydraulic line may be
operably coupled to a separate actuation assembly (e.g., actuatable
piston).
[0088] FIGS. 5A-5B illustrate an exemplary embodiment of an
actuation assembly 350 that includes releasable coupling 355. FIG.
5A is a perspective view of the embodiment, and FIG. 5B is a
cross-sectional view of the embodiment. Preferably, actuation
assembly 350 is releasably coupled to a controller 360 and the
driving mechanism housed therein. The coupling can be a mechanical
coupling or any suitable quick release mechanism known to those of
skill in the art. The releasably coupled design allows for
flexibility in the configuration and use of the pumping device. For
instance, user comfort can be improved through the use of
differently sized breast interfaces for compatibility with various
breast sizes. Additionally, this feature enables a common pumping
device to be used with interchangeable breast interfaces, thus
reducing the risk of spreading pathogens. Furthermore, the
releasable coupling enables easy replacement of individual parts of
the pumping device.
[0089] Flexible Membrane
[0090] In any of the embodiments, such as the embodiment depicted
in FIG. 3, the flexible membrane 245 is optionally located within
breast interface 235 and disposed over at least portion thereof,
forming reservoir 250 between the interface housing 240 and the
flexible membrane 245. Preferably, the flexible membrane 245
deforms substantially when subject to the negative pressures
created when the fluid 230 is displaced from reservoir 250 by
actuation assembly 205. The amount of deformation of the flexible
membrane 245 can be controlled by many factors, (e.g., wall
thickness, durometer, surface area) and can be optimized based on
the pumping device (e.g., pump power, vacuum requirements).
[0091] FIG. 6 illustrates an exemplary flexible membrane 370 with a
specified thickness and durometer.
[0092] FIG. 7 illustrates another embodiment of flexible membrane
375 with corrugated features 380 for increased surface area.
[0093] Suitable materials for the flexible membrane are known to
those of skill in the art. In many embodiments, the flexible
membrane can be made of a material designed to expand and contract
when subject to pressures from the coupling fluid such as silicone,
polyether block amides such as PEBAX, and polychloroprenes such as
neoprene. Alternatively, the flexible membrane can be fabricated
from a substantially rigid material, such as stainless steel,
nitinol, high durometer polymer, or high durometer elastomer. In
these embodiments, the rigid material would be designed with stress
and/or strain distribution elements to enable the substantial
deformation of the flexible membrane without surpassing the yield
point of the material.
[0094] FIGS. 8A and 8B illustrate preferred embodiments of a breast
interface 400 in which an exit valve 405 is integrated into the
flexible membrane 410 to control the flow of expressed milk through
exit port 415. The exit valve 405 is opened to allow fluid flow
when the flexible membrane 410 is relaxed, as shown in FIG. 8A, and
is closed to prevent fluid flow when the flexible membrane 410 is
deformed, as shown in FIG. 8B. The exit valve 405 enables
substantial vacuum pressure to be present in expression area 420
during extraction, while allowing milk to drain during the rest
phase of the pump stroke. While many conventional breast pump
valves function on pressure differentials alone, the exit valve 405
can preferably be configured to also function on the mechanical
movement of flexible membrane 410. Incorporation of an integrated
exit valve 405 with mechanical functionality as described herein
can improve the sealing of the breast interface 400 during vacuum
creation. Furthermore, the implementation of an exit valve
integrally formed within the flexible membrane 410 such as exit
valve 405 reduces the number of parts to be cleaned.
[0095] Mechanical Pumping Device
[0096] FIG. 9 illustrates an alternative embodiment of a breast
interface 600 in which a mechanical deformable member 605 can be
used in place of a flexible membrane. The mechanical deformable
member 605 can be constructed from similar techniques as those used
for the flexible membrane as described herein. The mechanical
deformable member 605 is coupled to a tensile element 610. In some
instances, tensile element 610 is disposed within an axial load
absorbing member 615. The axial load absorbing member 615 is
disposed within tube 620. Preferably, tensile element 610 is
concentrically disposed within axial load absorbing member 615 and
axial load absorbing member 615 is concentrically disposed within
tube 620. Alternative arrangements of tensile element 610, axial
load absorbing member 615, and tube 620 can also be used.
[0097] FIG. 10 illustrates the tensile element 610 coupled to
driving element 625 of an actuation assembly 630 within an assembly
housing 635. Driving element 625 is operatively coupled to a
driving mechanism, such as a driving mechanism housed within a
controller, through shaft 640. Axial load absorbing member 615
within tube 620 is fixedly coupled to the assembly housing 635.
Displacement of the driving element 625 transmits tensile force
through tensile element 610 to the mechanical deforming member 605
to create vacuum pressure against the breast. The driving element
625 can be actuated by a suitable driving mechanism, such as the
embodiments previously described herein.
[0098] The tensile element 610 can be any suitable device, such as
a wire, coil, or rope, and can be made from any suitable material,
such as metals, polymers, or elastomers. Axial load absorbing
member 615 can be made from any suitable axially stiff materials,
such as metals or polymers, and can be configured into any suitable
axially stiff geometry, such as a tube or coil.
[0099] Fluid Collection and Quantification System
[0100] In many instances, it can be desirable to measure and track
various characteristics of the collected fluid such as milk
expression and collection, such as the amount of milk production
(e.g., volume, weight), expression frequency (e.g., time, date),
expression duration, and/or the composition of the expressed milk.
In existing approaches, the tracking of milk production is commonly
accomplished by manual measurements and record-keeping. Exemplary
embodiments of the devices described herein may provide
digital-based means to automatically measure and track milk
production for improved convenience, efficiency, and accuracy.
[0101] In order to facilitate milk inventory tracking and
management, a unique identifier may be assigned to the milk
expressed during a single pumping session and preferably for only a
single breast. Alternatively, a single unique identifier may be
assigned to milk expressed during multiple pumping sessions within
a pre-designated time window, from one or both breasts. The
pre-designated time window may comprise any length of time that is
appropriate or convenient for a user in managing the user's milk
inventory. For example, many users combine milk expressed during
multiple pumping sessions within the same calendar day or within 24
hours. Accordingly, the same unique identifier may be assigned to
milk expressed during all pumping sessions within the desired time
window.
[0102] The unique identifier may be disposed on the collection
vessel or on the reservoir coupled to the expression device,
wherein the reservoir may comprise a bottle and/or a bag. The
reservoir may be removably couplable to the expression device, such
that a new reservoir with a unique identifier may be used for each
pumping session. The collection reservoir, once removed from the
expression device, may be used as a storage reservoir for the
expressed milk. Alternatively or in combination, the unique
identifier may be disposed on a storage reservoir separate from the
collection vessel, such as a storage bottle or bag into which a
user may transfer the expressed milk collected in the collection
vessel.
[0103] The unique identifier may comprise a pre-labeled identifier
such as a barcode or a Quick Response (QR) code, or it may comprise
an identifier that is manually labeled by the user, such as a label
removably disposed in a label window, or an area that can be
written on with a pen or a marker. A pre-labeled serial number may
also be provided on the reservoir. The unique identifier may be
digitally coupled to the basic information pertaining to the
pumping session such as the date, start time, and end time of the
session, collected by either the controller of the pump or a sensor
integrated with the expression device. The unique identifier may
also be digitally coupled to the one or more attributes of the
expressed milk as quantified by the sensors as described herein.
The data associated with each unique identifier can be stored in a
data array either locally or remotely as described in further
detail herein, such that the data may be used to track and manage
the inventory of the expressed milk. A single unique identifier may
also be digitally coupled to information pertaining to multiple
pumping sessions, for example to all pumping sessions within the
same calendar day as described herein, or any other defined
collection period. The single unique identifier may additionally be
digitally coupled to the one or more attributes of the expressed
milk from the multiple pumping sessions. The attributes of the
expressed milk from each pumping session may be separately recorded
and each associated with the single unique identifier.
Alternatively, the attributes of the expressed milk from the
multiple pumping sessions may be combined. For example, the volume
of expressed milk from each of the multiple pumping sessions may be
added together to generate a total volume that is associated with
the single unique identifier, and/or the composition of the
expressed milk (e.g., fat content, calories, etc.) from the
multiple pumping sessions may be averaged to generate the average
composition of expressed milk that is associated with the single
unique identifier.
[0104] Alternatively to or in combination with the various types of
unique identifiers discussed above, the unique identifier may
comprise a radio-frequency identification (RFID) tag or near field
communication (NFC) tag. Preferably, the RFID tag comprises a
passive tag that may produce an authentication response to radio
energy transmitted by an RFID scanner or reader. Alternatively, the
RFID tag may comprise an active tag or a battery-assisted passive
tag configured to periodically transmit its ID signal. The RFID tag
may be read-only, wherein the tag comprises a pre-assigned ID, or
the tag may be read/write-enabled, wherein the tag may be
programmed by a user. The RFID tag may be read or scanned by an
RFID reader by placing the RFID tag near or in contact with the
RFID reader. The scanning of an RFID tag by an RFID reader can lead
to the addition or removal of the tagged milk to or from a user's
inventory, as described in further detail elsewhere herein.
[0105] In exemplary embodiments, the pumping devices described
herein can include one or more sensors for generating measurement
data indicative of one or more characteristics of milk expression,
such as the volume of expressed milk. In preferred embodiments, the
volume can be measured as volume per unit time, volume per pump
stroke (e.g., stroke of the actuation assembly), or volume per pump
power cycle (e.g., power cycle of the actuation assembly). Any
description herein pertaining to measurement of volume can also be
applied to measurements of other characteristics, and vice-versa.
Any suitable type of sensor can be used, such as accelerometers,
Hall effect sensors, photodiode/LED sensors, CCD sensors, cameras
and other imaging devices, capacitive sensors, strain gauges, etc.,
and such sensors can be used in any number and combination. The
sensors can be positioned at any location suitable for monitoring
fluid flow from the breast, such as on or near a breast interface
(e.g., the expression area 260, drain port 265, collection vessel
275). In embodiments where milk is concurrently expressed from a
pair of breasts via a pair of breast interfaces, sensors can be
located on or near both breast interfaces, or on or near only one
of the breast interfaces. The sensors may be integrally formed with
or permanently affixed to the pumping device, or they may be
provided separately and coupled to the pumping device prior to use.
Alternatively, the sensors may be provided as a separate unit that
can measure the one or more characteristics of the expressed milk
after the milk has been expressed.
[0106] Sensors for quantifying the composition of the expressed
milk may also be provided with the pumping devices described
herein. For example, sensors may be provided for measuring the
relative amounts of certain carbohydrates, fats, proteins,
vitamins, and minerals known to be present in breast milk. Sensors
may also be configured to determine the estimated caloric value of
the expressed milk and/or the percentage of alcohol present in the
milk. Such sensors may include devices that can spectroscopically
measure the presence of certain compounds in a volume of breast
milk, or a multi-spectral imaging system that can image the
collected fluid under different wavelengths to estimate composition
and density, or devices that can measure the enzymatic activity
produced by certain compounds of breast milk that act as substrates
for specific enzymes. The sensors may comprise stand-alone units
with their own user interface, or they may be removably couplable
with a peripheral device such a mobile phone, tablet, or personal
computer, wherein the peripheral device can be provided with an
application programmed to control the sensor unit. The data may
also be stored in the cloud so that it may be accessed and used by
other computing devices and other users such as a physician or a
child caretaker. Other characteristics which may be sensed include
but are not limited to milk density, weight, percent fat content,
as well as other attributes.
[0107] FIGS. 11A and 11B illustrate exemplary embodiments of a
breast interface 450 with valve-integrated sensors 455. Sensors 455
are preferably located in a valve, such as the flap valve 460, but
may also be located in exit valve 465, or any other valve (e.g., on
or near the collection vessel) that is opened by fluid flow. In
exemplary embodiments, the sensor 455 includes an accelerometer
measuring the position and/or motion of the valve, such as a length
of time that the valve is opened, and the resultant measurement
data can be interrogated to quantify the fluid flow. Preferably,
the breast interface 450 is used in conjunction with a second,
identical breast interface to concurrently express milk from a pair
of breasts (e.g., simultaneously, alternatingly, or sequentially).
A pair of accelerometers can be used to detect the position and/or
motion of the corresponding valve in each interface. In some
instances, movements of the user may cause the accelerometers to
produce motion signals that are erroneously interpreted as valve
motion. Accordingly, in preferred embodiments, suitable approaches
are used to distinguish between signals resulting from motion of
the user and signals generated by motion of the valves. For
example, the pumping device can be configured to alternatingly
express milk from each breast, such that the corresponding valves
are also opened alternatingly. Consequently, motion detected
simultaneously from both accelerometers can be regarded as
resulting from user motion, rather than from valve motion. The user
motion can be subtracted from the total motion signal obtained by
the accelerometers in order to obtain the valve motion, and thereby
determine the position of each valve.
[0108] FIG. 11C illustrates an embodiment with an accelerometer 470
more clearly. The accelerometer 470 is coupled to a flap valve 476
on the output of the expression device 472 which has a breast
interface 474 (sometimes also referred to as a distal assembly in
this specification). The expression device and breast interface may
be any of the embodiments disclosed herein. As breast milk 468 is
expressed, it collects at the output of the device. When enough
fluid is collected, flap valve 470 opens, and the milk 468 drains
into reservoir 462 and collects in a layer 464 therein. The
reservoir 462 is preferably threadably connected to the expression
device 472 so that it may easily be attached and detached. Movement
of the flap valve 476 is tracked using accelerometer 470. Data from
the accelerometer is then processed, transmitted or displayed using
any of the methods or means disclosed herein.
[0109] In other exemplary embodiments, the pumping devices
described herein can utilize one or more beam-break sensors (e.g.,
infrared-based, laser-based, etc.) situated at a suitable location
in the pumping device (e.g., in or near a valve, an exit port, or
other component permitting fluid passage). The beam-break sensor
can include a plurality of sensor components and can be configured
to detect passage of fluid between or near one or more of the
components. Preferably, the sensor can be configured to generate a
signal when the expressed fluid breaks a beam by passing between a
beam emitter and a beam detector. The resultant signal can be used
to produce measurement data indicative of the volume of expressed
fluid. For example, the measurement data can be based on the length
of time the fluid passes between or near the sensor components.
[0110] FIG. 11D illustrates an exemplary embodiment of a milk
expression device that employs a beam break sensor 477. The
expression device 472 includes a breast interface 474 and a
reservoir 462. The reservoir is threadably or otherwise coupled 466
to the expression device. Any of the exemplary embodiments of
expression devices, interfaces, reservoirs, etc. disclosed in this
specification may be used in this exemplary system. A beam-break
sensor 477 is disposed adjacent the output of the expression
device, and thus as droplets 468 of milk drain from the expression
device outlet into reservoir 462, they break the light beam 477a,
allowing measurement of the fluid expressed. The fluid collects in
a layer 464 in reservoir 462. The data from the sensor can then be
processed, transmitted, or otherwise displayed using any of the
methods disclosed herein.
[0111] In another exemplary embodiment, the pumping devices
described herein can include one or more image sensors for
capturing images of the fluid in order to quantify the expression
volume, such as a charge-coupled device (CCD) or a camera. The
image sensors may be integrated with or coupled to a suitable
portion of the pumping device. Conversely, the image sensors can be
located on another device separate from the pumping device, such as
a smartphone or other mobile device. In exemplary embodiments, the
breast interface includes a valve permitting the passage of
expressed fluid, as previously described herein, and a suitable
image sensor is positioned on or near the valve in order to capture
images of fluid passing through the valve. Preferably, the image
sensor is operably coupled to a processing unit configured to
analyze the image data (e.g., using a suitable image analysis
algorithm) in order to determine the fluid volume. For example, the
image sensors can be used to capture images of drops of fluid, and
the images can be analyzed to count the number of drops. In some
instances, the image data can be transmitted to a computing device
(e.g., a smartphone) for analysis, as described in further detail
below.
[0112] FIG. 11E illustrates an exemplary embodiment having a CCD
device 479 adjacent an outlet of the expression device. The
expression device 472 includes interface 474 and reservoir 462,
either of which may be any of the embodiments disclosed herein. As
milk 468 is expressed, it passes through the outlet of the
expression device past CCD 479 which detects the fluid and allows
quantification thereof as previously described. The milk 468 then
accumulates in a layer 464 in reservoir 462. Data from the CCD may
then be processed, transmitted, or otherwise displayed using any of
the methods disclosed herein.
[0113] FIG. 11F illustrates an exemplary embodiment that uses an
image of the reservoir to characterized the expressed milk. Once
milk 468 has been collected in reservoir 462, the reservoir may
optionally be detached from the expression device. A mobile phone
or other device may then be used to take a photo 463a of the
reservoir which has a suitable application for analyzing the photo
and determining how much milk has been expressed, as well as
optionally providing other details about the expressed milk. The
data is processed, transmitted, or otherwise displayed using any of
the methods disclosed herein.
[0114] FIG. 11G illustrates an alternative embodiment of a photo
sensor system. After milk 468 has been expressed and collected in a
reservoir 462, a camera in the pump control unit 465 may be used to
obtain an image of the milk in the reservoir and analyze it for
quantity or other characteristics. The pump control 465 may be any
of the pump controls described elsewhere in this applications, and
the data may be processed, transmitted, or displayed using any of
the methods disclosed herein.
[0115] In some exemplary embodiments, the pumping devices described
herein can employ one or more capacitive sensors for measuring
fluid volume. The capacitive sensors can be configured to detect
the volume of fluid contained in any suitable portion of the
pumping device, such as fluid contained within a collection
reservoir and/or within a breast interface (e.g., expression area
260, a component permitting passage of fluid from the interface
such as a valve, exit port, or tube).
[0116] FIGS. 11H-11I illustrate exemplary embodiments of expression
devices that use capacitive sensors. The expression device 472 may
be any of the expression devices disclosed herein and they have an
interface 474 that also may be any of the interfaces disclosed in
this specification. A reservoir 462 is threadably 466 or otherwise
coupled to the expression device and the reservoir may be any of
the reservoirs described herein. As milk 468 is expressed and
collected at the outlet of the expression device, it passes through
the capacitive sensor 475 which is then able to measure fluid
volume. FIG. 11I is similar to the embodiment in FIG. 11H, with the
major difference being that the capacitive sensor 475a is disposed
in the reservoir 462 near the bottom, rather than in the outlet of
the expression device. The data from the sensor in either
embodiment may then be processed, transmitted, or displaying using
any of the techniques described herein.
[0117] In other exemplary embodiments, one or more strain gauges
can be used to measure the volume of expressed fluid. The strain
gauges can be situated at any suitable position in the pumping
device. For example, a strain gauge can be coupled to a flap valve
(or any other valve permitting passage of expressed fluid) and
configured to determine the volume based on the displacement of the
valve over time. Alternatively or in addition, a strain gauge can
be coupled to a collection reservoir and configured to measure the
volume of expressed fluid contained within the reservoir.
[0118] FIG. 11J illustrates an exemplary embodiment of a strain
gauge. The expression device 472 includes an interface 474 and
reservoir 462 threadably 466 or otherwise coupled thereto. Any
portion of this system may be any of the components described
elsewhere in this specification. As milk is expressed 468 it
accumulates in the outlet of the expression device. Eventually, the
weight of the accumulated milk is sufficient to actuate and open
flap valve 476. A strain gauge 481 is coupled to the flap valve and
this sensor is then used to collect data on movement of the valve
and therefore this correlates to the collected fluid. The fluid
accumulates in a layer 464 in reservoir 462. The data from the
sensor is then processed, transmitted, or displayed using any of
the methods disclosed herein.
[0119] FIG. 11K illustrates an alternative embodiment of a strain
gauge sensor. This embodiment generally takes the same form as the
previous embodiment with the major difference being that the
collected fluid layer 464 is disposed over a plate 483 which bears
the weight of the collected fluid. Thus, as the weight increases or
decreases, a strain gauge 481a disposed under the plate 483 detects
the weight change and this can be correlated to the collected fluid
volume. Data from the sensor is then processed, transmitted, or
displayed according to any of the methods disclosed herein.
[0120] FIG. 11L illustrates an exemplary embodiment that uses a
scale to quantify the weight of the expressed milk. The reservoir
462 containing the expressed milk 464 may be uncoupled from the
expression device and placed on a scale 490. The scale can measure
the weight of the reservoir containing the milk, and can be
configured to subtract the weight of an empty reservoir in order to
calculate the weight of the expressed milk. The scale may have a
stored calibration curve that can be used to convert the measured
weight to a corresponding fluid volume. Alternatively, the scale
may allow the user to enter in the fluid volume of the expressed
milk, and calculate the corresponding density of the expressed
milk. The scale may comprise a display screen 491, which may
display one or more of the weight, fluid volume, or density of the
milk. The scale may be configured to communicate with a peripheral
device such as a controller 500 of the breast milk expression
device or a computing device as described in further detail
herein.
[0121] In some embodiments, the composition of the milk expressed
by the pumping device may be quantified by a sensor unit provided
with the pumping device. The composition of breast milk can be
valuable information for understanding whether an infant is
obtaining the appropriate amount of nutrition via the milk. This
information can help mothers or clinicians identify whether
additional nutrition should be supplied to the infant. Components
of breast milk considered to be nutritionally important include
carbohydrates such as glucose and lactose, fats such as
triglycerides, proteins such as lactoferrin, organic acids such as
taurine, vitamins such as vitamin D, and minerals such as zinc,
copper, and iron.
[0122] FIG. 23A and 23B illustrate exemplary embodiments of a
sensor unit for quantifying the composition of expressed milk using
an enzyme assay. A test strip 2302 contains one or more enzymes
that can react with target components of the breast milk. For
example, the test strip may contain glucose oxidase to help detect
glucose and/or beta-galactosidase to help detect lactose. The test
strip may have a unique identifier that matches the unique
identifier of the reservoir. One or more drops of the breast milk,
expressed using the breast milk expression device as described
herein, can be placed on the test strip, and the test strip can
subsequently be inserted into the sensor unit. The user interface
of the sensor unit may prompt the user to enter or scan the unique
identifier of the reservoir or of the test strip, so that the data
from the analysis may be digitally coupled to the expressed milk
from a particular pumping session. Once the unique identifier is
entered or scanned into the system, the user may select an option
to run the test strip analysis from the user interface. The sensor
unit comprises electrodes that can detect an electrical current
produced by the enzymatic activity that results as the components
of the breast milk are hydrolyzed by the enzymes contained in the
test strip. The electrical current detected by the sensor unit can
be converted into a numerical value denoting the relative amount of
one or more components of the breast milk, using a calibration
curve stored on the sensing unit. The composition of the milk may
be presented as one or more of a concentration or percentage of the
one or more components being tested by the enzymes on the test
strip. The composition data can be digitally coupled to the unique
identifier of the expressed milk, and then stored on a local drive
of the sensor unit or of a peripheral device coupled to the sensor
unit, via wired communication such as via a USB cable.
Alternatively or in combination, the composition data digitally
coupled to the unique identifier may be stored on a remote, or
cloud, server, wherein the data may be transmitted to the server
via wireless communication such as Bluetooth or WiFi.
[0123] FIG. 23A illustrates a stand-alone sensor unit 2300a having
its own user interface. The user interface may be presented to the
user through a display screen with an alphanumeric keyboard input,
or through a touch screen display 2304. The test strip 2302, having
one or more drops of breast milk placed thereon, may be inserted
into a port 2306 of the sensor unit 2300a. After entering or
scanning in the unique identifier of the reservoir or of the test
strip, the user may run the analysis, and the results of the
analysis may be displayed on the display of the sensor unit.
[0124] FIG. 23B illustrates a sensor unit 2300b that is configured
to be removably coupled to and controlled by a peripheral device
2310 such as a smart phone, tablet or other mobile device. The
sensor unit 2300b comprises a connector 2312 that inserts into a
port 2314 of the peripheral device, such as a headphone port. The
peripheral device may comprise a controller of the pumping device
or a computing device such as a mobile phone, tablet, or personal
computer. The peripheral device comprises an application programmed
to provide the user interface of the sensor unit. The user may
insert the test strip 2302 having the drops of breast milk placed
thereon into a port 2306 of the sensor unit 2300b. After entering
or scanning in the unique identifier of the reservoir or of the
test strip, the user may run the analysis of the test strip through
the user interface presented by the peripheral device.
[0125] FIG. 24 illustrates an exemplary embodiment of a sensor unit
configured to quantify the composition of expressed milk using
spectroscopy. The sensor unit 2400 comprises an emitter such as a
light-emitting diode, a sample holder 2406, and a detector such a
thermal detector or photonic detector. For example, the sensor unit
may comprise a mid-infrared transmission spectrometer. The emitter
emits light or energy through the sample, and the detector measures
the light or energy emissions from the sample and converts the
readout to concentrations and/or percentages of the compounds of
interest. After a pumping session, the user may transfer a small
volume of the expressed milk from the reservoir to a sample
container 2402, such as a tube or a cuvette, wherein the sample
container may comprise a unique identifier that matches the unique
identifier of the reservoir. The sample container with the milk can
then be inserted into the sample holder of the sensor unit, and
analyzed for the presence of certain compounds in the breast milk.
The sensor unit 2400 may be a stand-alone unit with its own user
interface, or it may be removably couplable to a peripheral device
2404 such as a mobile phone, table, or other device, having an
application programmed to provide the user interface. As described
herein, the sensor may digitally couple the obtained composition
data to the unique identifier, and store the coupled data either
locally or remotely.
[0126] Other exemplary embodiments of the breast milk composition
sensor may include devices that can detect the presence of various
components of breast milk via thin-layer chromatography,
colorimetry, electronic counting, chemiluminescence, nephelometry,
biuret reagent assays, and multispectral imaging. Specific
algorithms may be generated in order to increase the accuracy of
the readouts. These and other devices for the quantification of
breast milk composition may be integrated with the expression
device as described herein or may be provided as separate units
that can be stand-alone devices or devices configured to be
connected to a peripheral device for operation.
[0127] In exemplary embodiments, some or all of the measurement
data collected by the sensors can be fed back to the pumping device
in order to optimize fluid expression. Preferably, the feedback can
be transmitted to a processing unit and/or control unit of the
pumping device (e.g., suitable hardware located in the controller
115) configured to control one or more functionalities of the
actuation assembly. Based on the feedback, the processing unit can
determine changes to actuation parameters of the actuation assembly
in order to achieve and/or maintain optimal fluid expression. For
example, the feedback can be used to determine adjustments to a
vacuum stroke or stroke speed of a pump, piston assembly, or any
other suitable actuation assembly.
[0128] FIG. 21 illustrates an exemplary expression system with
feedback control. The system includes a pump unit 2100 preferably
including a controller and processor 2104 as well as a motor 2102
for actuating the device, and a distal assembly 2110 which is sized
and shaped to mate with the target anatomy, here a breast 2112. Any
of the elements in this exemplary system may be any of the
components disclosed elsewhere in other exemplary embodiments. In
this embodiment, feedback 2106 from the sensor which monitors
expressed milk in the expression device 2110 is transmitted from
the distal assembly (expression device with interface) to the
controller and processor 2104. The data is processed and this
information is used to provide instructions to motor 2102 which
increases or decreases actuation of the expression device which is
then transmitted by communication 2108 back to the expression
device or distal assembly 2110. Any of the embodiments in this
specification may include such a feedback loop.
[0129] FIG. 12 illustrates an exemplary embodiment of a controller
500 for a pumping device including a display screen 505. The
controller 500 can include suitable hardware for collecting,
processing, and storing the milk expression data described herein,
as well as analysis results obtained from processing the expression
data. In preferred embodiments, this information is displayed to a
user of the pumping device via the display screen 505. Furthermore,
information can also be transmitted from the controller 500 and
displayed on a separate computing device, such as a mobile device
510, as described in further detail below. The information can be
presented in any suitable format, including graphs, charts, tables,
images, or other visual elements, and may be static or dynamic
(e.g., updated in real time, etc.). The controller 500 can also
send information about the times of pump usage to the mobile phone
510 so that the mobile application can identify when pumping has
occurred and set reminders at desired pumping times. Such reminders
can help avoid missed pumping sessions, and thus reduce the
incidence of associated complications such as mastitis.
Additionally, the controller 500 can include input devices enabling
users to interact with the displayed information, such as the
button 515, as well as keyboards, joysticks, touchscreens,
switches, or knobs, or suitable combinations thereof.
[0130] In some embodiments, the results of the milk composition
analysis may provide feedback to the user. For example, if the
concentration of a critical nutritional component of the milk is
found to be present at levels lower than a specific threshold
value, the user interface of the sensor unit may display a warning
message to the user. The threshold values for the various
components of the milk may be calibrated by the sensor unit based
on the weight of the infant and the weight of the mother. The
feedback messages from the sensor unit may be shared by the user
with clinicians via e-mail or short messaging service (SMS), or may
be stored onto the data array for the corresponding unique
identifier, so that clinicians may access and review the
information remotely via a connection through a cloud server.
[0131] Communication with Computing Devices
[0132] In any of the embodiments disclosed herein, the pumping
devices described herein can be configured to communicate with
another entity, such as one or more computing devices and/or
servers. Exemplary computing devices include personal computers,
laptops, tablets, and mobile devices (e.g., smartphones, cellular
phones). The servers described herein can be implemented across
physical hardware, virtualized computing resources (e.g., virtual
machines), or any suitable combination thereof In preferred
embodiments, the servers are distributed computing servers (also
known as cloud servers) utilizing any suitable combination of
public and/or private distributed computing resources. The
computing devices and/or servers may be in close proximity to the
pumping device (short range communication), or may be situated
remotely from the pumping device (long range communication). Any
description herein relating to communication between a computing
device and a pumping device can also be applied to communication
between a server and a pumping device, and vice-versa.
[0133] FIG. 13 illustrates short range communication 515 between
the controller 500 of a pumping device and mobile device 510. The
communication 515 can utilize wireless communication methods, as
described below. In many embodiments, the controller 500 and mobile
device 510 are also capable of long range communication.
[0134] FIG. 14 is a schematic illustration of a pumping device 800
in communication with a computing device 805 and a server 810. The
pumping device 800 includes one or more breast interfaces 815, an
actuation assembly 820, a sensing unit 825, and a communication
module 835. Preferably, the communication module 830 is implemented
across suitable hardware within a controller of the pumping device
(e.g., controller 500). The pumping device 800 can communicate with
the computing device 805 and server 810 via the communication
module 830. In many embodiments, the communication module 830 is
communicably coupled to the computing device 805 and server 810 via
first and second data connections 835, 840. Furthermore, the server
810 can be communicably coupled to the computing device 805 via a
third data connection 845. Although the pumping device 800 is
depicted herein as communicating directly with the computing device
805 and the server 810, other configurations are also possible. For
example, the pumping device 800 may communicate with the server 810
indirectly via the computing device 805, or vice-versa. Conversely,
the server 810 may communicate with the pumping device 800
indirectly via the computing device 805, and the computing device
805 may communicate with the pumping device 800 via the server 810.
Any description herein related to communication between the pumping
device 800, the computing device 805, or server 810 can be applied
to direct communication as well as indirect communication between
these entities.
[0135] The data connections 835, 840, and 845 can utilize any
communication method suitable for transmitting data between the
pumping device 800, the computing device 805, and server 810. Such
communication methods can include wired communication (e.g., wires,
cables such as USB cables, fiber optics) and/or wireless
communication (Bluetooth.RTM., WiFi, near field communication). In
many embodiments, data can be transmitted over one or more
networks, such as local area networks (LANs), wide area networks
(WANs), telecommunications networks, the Internet, or suitable
combinations thereof
[0136] In exemplary embodiments, the pumping device 800 transmits
milk expression data to the computing device 805 or server 810
(directly or indirectly). The milk expression data can include
measurement data generated by the sensing unit 825 of the pumping
device 800, as previously described herein. In many embodiments,
the pumping device 800 analyzes the measurement data (e.g., using
suitable onboard hardware and/or software) and transmits the
analysis results to the computing device 805 or server 810.
Alternatively, the measurement data can be analyzed by the
computing device 805 or server 810, such as using one or more
applications. The computing device 805 or server 810 may be
associated with data stores for storage of the measurement data
and/or analysis results.
[0137] The applications (of the computing device 805 or server 810)
can also collect and aggregate the measurement data and/or analysis
results and display them in a suitable format to a user (e.g.,
charts, tables, graphs, images, etc.), as previously described
herein. Preferably, the application includes additional features
that allow the user to overlay information such as lifestyle
choices, diet, and strategies for increasing milk production, in
order to facilitate the comparison of such information with milk
production statistics. The mobile application can also include
features that allow the user to control aspects of the pump, such
as pump power and pump states (e.g., let-down and stimulate modes),
adjust expression pressure and speed, and adjust the size of a
breast interface, where the breast interface is automatically
adjustable. The application may also have resources for breast
feeding moms, such as advice or connection to advice, social
aspects such as peer comparisons, and an accessory store for
acquiring accessories for the pump. The analysis and display
functionalities described herein may be performed by a single
entity, or by any suitable combination of entities. For example, in
many embodiments, data analysis can be carried out by the server
810, and the analysis results transmitted to the pumping device 800
or computing device 805 for display to the user.
[0138] Additionally, the computing device 805 or server 810 can
include an application configured to control at least one
functionality of the pumping device 800 or a portion thereof (e.g.,
the actuation assembly 820), such as power, vacuum pressure applied
(via the interfaces 815), or speed. For example, the communication
module 830 can receive control signals from the computing device
805 and/or sever 810, and transmit the control signals to the
actuation assembly 820 to produce the desired actuation. In
preferred embodiments, the control signals can be generated using
feedback provided by the pumping device 800, such as feedback based
on measurement data provided by the sensing unit 825, as previously
described herein. Additionally, the computing device 805 or server
810 may implement machine learning techniques with regard to
control of the pumping device 800, in order to improve and optimize
pumping performance over time.
[0139] Furthermore, the pumping device 800, computing device 805,
and/or server 810 can be configured to provide notifications
reminding the user to express milk. Such notifications can help
avoid missed pumping sessions, and thus reduce the incidence of
associated complications such as mastitis. The notifications can be
generated based on previously collected milk expression data, such
as data relating to expression frequency and/or the timing of
previous pumping sessions, as well as based on user preferences.
Preferably, the notification functionality is included in a
suitable application running on the computing device 805 or server
810. For example, the pumping device 800 can send information about
the times of pump usage to the computing device 805 or server 810,
so that the application can identify when pumping has occurred and
set reminders at desired pumping times.
[0140] The notifications can be provided using any suitable method
and in any suitable format. For example, the notifications can be
generated by the computing device 805 or server 810, transmitted to
the pumping device 800 (e.g., to the communication module 830), and
displayed to the user (e.g., on a display of the pumping device
800, such as the display screen 505). Conversely, the notifications
can be generated by the pumping device 800 and transmitted to the
computing device 805 and/or server 810. In many embodiments, the
notifications are displayed to the user by the computing device
805. Alternatively, the pumping device 800, computing device 805
and/or sever 810 can provide the notifications to the user using
other methods. For example, the notifications can be sent to an
email address, via short message service (SMS) to a smartphone or
other mobile device associated with a cellular phone number, or to
a web page accessible by the user.
[0141] Other types of data can also be transmitted between the
pumping device 800, computing device 805, and/or server 810. For
example, in many embodiments, firmware updates for one or more
components of the pumping device 800 can be transmitted to the
pumping device 800 from the computing device 805 and/or server
810.
[0142] FIG. 17 illustrates another exemplary embodiment of a system
for expression of milk or for monitoring other fluids. The system
1700 includes a pump unit 1702, a distal assembly 1706 (sometimes
also referred to as an interface in this specification), wireless
communication transmitters and receivers 1709, 1712, a computing
device 1714 and a remote server 1718. The pump unit 1702 may be any
of the pump units described in this specification or known in the
art, and the distal assembly 1708 also may be any of those
described herein or known in the art. The distal assembly 1706 is
preferably sized and shaped to conform to the target anatomy, which
in this exemplary embodiment is a breast 1708. The pump unit 1702
actuates 1704 the distal assembly 1706 to cause expression of milk
from breast 1708 using any of the actuation mechanism disclosed
herein. A transmitter 1709 is preferably disposed on the pump unit
or adjacent thereto and is configured to transmit data 1710 (or any
other data generated, e.g. expressed milk data) from the pump unit
to a receiver 1712 on the computing device 1714. The data may be
transmitted wirelessly using methods known in the art such as those
disclosed in this specification. In alternative embodiments, a hard
connection such as with a USB cable may be used to operably couple
the pump 1702 and computing device 1714 together. The computing
device may be a smart phone, tablet, personal computer, or any
other electronic computing device that can display the data
transmitted from the pump unit 1702. The computing device may also
transmit information back to the pump unit to help control
operation of the distal assembly. The computing device 1714 may
also communicate 1716 with a remote server 1718 which may store or
display the data. Access to the remote service 1718 may be by the
Internet or by other means known in the art and thus the cloud
based data may be readily accessed from any other device with
Internet access.
[0143] FIG. 18 illustrates another exemplary embodiment of a system
1800 for expression of milk. In this embodiment, the system 1800
includes a pump unit 1802, a distal assembly 1806 and a cloud based
or remote server 1812. The pump unit 1802 may be any of the pumps
disclosed herein and it is operably coupled with the distal
assembly 1806 which is sized and shaped to conform to the target,
such as breast 1808. The distal assembly may be any of the distal
assemblies described herein. The pump unit 1802 actuates 1804 the
distal assembly using any of the mechanisms disclosed herein to
cause expression of milk from breast 1808. The pump unit 1802 also
includes a transmitter and receiver 1809 for transmitting pump data
1810 or any other data generated (e.g. expressed milk data) to a
remove server 1812, which in this embodiment is a cloud based
server. Thus, the data may be transmitted to the remote service via
the Internet, and accessed from the cloud based server by the pump
1802 or any other computing device via the Internet. Preferably
communication with the cloud based server is by wireless
communication.
[0144] FIGS. 19A-19C illustrate exemplary computing device displays
1904. For example, FIG. 19A illustrates an exemplary display on a
mobile phone 1902 and graphically illustrates milk production, the
time of the last pumping session, a graphic of goal attainment, and
a graphic illustrating the fluid consumption of the user.
Additionally, the display 1904 may also provide user encouragement
or user feedback based on the amount of milk production. FIG. 19B
is an enlarged view of the display 1904 in FIG. 19A. FIG. 19C
illustrates additional information that the display 1904 may show
when a touch screen is actuated (e.g. by swiping or touching the
screen). For example, the volume of the milk expressed is indicated
after the "Last Pumping Session" section of the display is
selected. Some or all items may be expanded, as also indicated in
FIG. 19C. Additional information, or in some situations, less
information may be displayed as desired.
[0145] FIGS. 20A-20B illustrate other exemplary displays which may
be used in a milk expression system. For example, FIG. 20A is an
exemplary display 2002 on any of the computing devices disclosed
herein and operably coupled with the pump unit. The display may
indicate an average volume of milk expressed over any time period,
along with an average duration of the expression session during
that same time period. Graphics may be used (e.g. bar chart, pie
chart, x-y plot, etc.) to show volume expressed during individual
sessions over the course of several days, here Monday through
Friday. The display may allow a user to annotate the display so
that missed sessions may be accounted for, for example if a session
is omitted due to traveling, the display may show travel during
that time period. Other annotations may also be made, such as when
certain foods or nutritional supplements are taken, here hops or
fenugreek. This allows the user to recall when expressed milk
samples were obtained relative to the consumption of the food or
nutritional supplements. The display may have other functional
buttons such as for obtaining tips, accessing the cloud, setting an
alarm, making notes, storing data, or establishing system
preferences. Communication between the computing device and the
pump unit in FIGS. 20A-20B is discussed more thoroughly above in
relation to FIG. 13.
[0146] FIG. 20B illustrates an exemplary display 2004 that may be
on a computing device in the system, or more preferably that is on
any of the pumps disclosed herein. The display 2004 is similar to a
dashboard style gauge and indicates the volume of fluid expressed
and collected and the time. Other information may also be displayed
including but not limited to that disclosed herein.
[0147] Inventory Tracking and Management
[0148] The relatively short shelf-life of expressed breast milk,
combined with the fluctuating supply and demand of the milk over
time, can pose challenges for the mother in building and
maintaining an inventory of milk. The breast milk expression device
described herein may be provided as a system having features that
facilitate the tracking and management of an inventory of expressed
milk.
[0149] FIG. 25 illustrates an exemplary embodiment of a milk
expression and inventory management system 2500. The system
comprises a breast milk expression device 2502 fluidly coupled to a
collection reservoir 2506 having a unique identifier 2508 as
described herein, where the unique identifier may be pre-labeled
onto the reservoir or may be manually labeled by the user. The
reservoir may comprise a bottle and/or a bag, and can be removably
coupled to the expression device to receive and collect the
expressed milk. The system may comprise an integrated sensor unit
2504 integrated with the expression device 2502 as described
herein, for example by being affixed to an exit valve or flap valve
of the expression device. The sensor unit may comprise one or more
of any of the sensors described herein. For example, the sensor
unit may measure the volume of milk expressed during the pump
session, or the concentration of one or more compounds of breast
milk. Alternatively or in combination with the integrated sensor
unit 2504, the system may comprise a separate sensor unit 2505,
which can be used to characterize the expressed milk after the milk
has been collected in the reservoir 2506. The system further
comprises a peripheral device 2510 connected to the expression
device, the peripheral device having suitable hardware for
collecting, processing, and storing the milk expression data as
described herein, as well as for analyzing the results obtained
from processing the expression data. The peripheral device may also
collect basic pump session data during expression, such as the time
and date of the pump session and the duration of pumping. The
peripheral device may be a controller of the expression device,
and/or a computing device such as a mobile phone, tablet, or
personal computer having an application programmed to control
and/or communicate with the expression device.
[0150] FIG. 27 illustrates another exemplary embodiment of a milk
expression and inventory management system 2700. The system
comprises an expression device 2702 such as any expression device
described herein, a collection reservoir 2706 fluidly coupled to
the expression device, and a peripheral device 2710 operably
coupled to the expression device and/or the collection reservoir.
The expression device may optionally comprise an integrated sensor
unit 2704a, such as any sensor unit as described herein, configured
to be integrated with the expression device. In addition, the
collection reservoir may optionally comprise an integrated sensor
unit 2704b, such as any sensor unit as described herein, configured
to be integrated with the collection reservoir. The integrated
sensor unit can be configured to measure one or more attributes of
the expressed milk during the pumping session, such as the volume
of expressed milk or the concentration of one or more components of
breast milk. If the collection reservoir is also used as the
storage reservoir, the integrated sensor unit can also be
configured to measure the volume of the milk during and/or after
feeding the milk to a child. In such embodiments, the integrated
sensor unit can not only measure the volume of milk expressed into
a collection reservoir, but also measure the volume of milk exiting
the collection/storage reservoir and therefore the volume of milk
remaining in the reservoir after a feeding session. The system may
optionally comprise a separate sensor unit 2705 as described
herein, the separate sensor unit configured to characterize the
expressed milk after the milk has been collected in the reservoir
2706. The expression device, the one or more integrated sensing
units, and the separate sensor unit may be in communication with
the peripheral device via wired or wireless connections. The system
may further comprise a server 2712 in communication with the
peripheral device and/or the expression device via a wireless
connection. The collection reservoir may comprise a unique
identifier 2708a as described herein, which may be pre-labeled onto
the reservoir and/or labeled onto the reservoir by the user. The
collection reservoir may be used as the storage reservoir for the
collected milk, wherein the opening the collection reservoir may be
securely sealed and the collection reservoir may be transferred to
a storage location (e.g., refrigerator or freezer). Optionally, the
system may comprise one or more storage reservoirs 2707 separate
from the collection reservoir, such that a user may transfer milk
collected in the collection reservoir to a storage reservoir after
expression of the milk. The separate storage reservoir 2707 may
comprise a unique identifier 2708b such as any unique identifier
described herein, which may be pre-labeled onto the storage
reservoir or manually labeled by the user.
[0151] During a pump session, an integrated sensor unit can collect
data by measuring one or more attributes of the breast milk as it
is expressed and collected in the collection reservoir. When the
pump session is complete, the sensor unit can send the collected
data to the peripheral device, where the data may be digitally
coupled to the basic pump session data. The peripheral device can
then prompt the user if she would like to add the milk expressed
during this session to her inventory. If the user selects the
option to add the milk to the inventory, the peripheral device can
prompt the user to provide the unique identifier of the reservoir,
for example by manually entering in a user-assigned code or by
scanning in a pre-printed label. For example, the reservoir may
comprise a bag having a pre-printed QR code, and providing the
unique identifier may comprise scanning the QR code with a mobile
phone running a QR code scanning application. When the peripheral
device obtains the unique identifier for the milk expressed during
the pump session, the unique identifier can be digitally coupled to
the data gathered for the pump session, including the time and date
of the pump session, duration of pumping, volume of expressed milk,
and/or compositional attributes of the expressed milk.
[0152] The expressed milk may also be analyzed after the pump
session has been completed, using the separate sensor unit. The
sensor unit may be a stand-alone unit with its own user interface,
or it may be a unit configured to be coupled to and operated by the
peripheral device. A small sample of the milk may be removed from
the reservoir and tested using the sensor unit as described in
further detail elsewhere in this specification. The sensor unit may
prompt the user to provide the unique identifier of the sample
(from the reservoir or from the test strip or sample container),
and the data generated by the sensor unit may then be digitally
coupled to the unique identifier. The digitally coupled data may be
transmitted to the peripheral device via a wired connection or
wireless connection. The peripheral device may further bundle the
data transmitted from the separate sensor unit with the data for
the unique identifier already stored on the peripheral device, such
as the basic pump session data and data generated from an
integrated sensor unit.
[0153] The complete array of the bundled data may be stored on a
local drive of the peripheral device, such as the local drive of
the controller or of a computing device in communication with the
controller. Alternatively or in combination, the bundled data may
be stored on a remote server, wherein the data may be transmitted
to the remote server from the peripheral device via a wireless
connection as described in detail elsewhere in this
specification.
[0154] For dual expression devices, i.e., devices comprising two
breast interfaces and two corresponding collection reservoirs, each
reservoir may have a distinct unique identifier, and fluid
collection, quantification, and inventory management may be
performed separately for milk expressed from each breast.
Alternatively, if the user combines the milk expressed from the two
breasts into a single reservoir (e.g., one of the collection
reservoirs or a separate storage reservoir), a single unique
identifier may be associated with the combined milk from both
breasts, stored in the single reservoir.
[0155] In embodiments wherein the unique identifier comprises an
RFID tag, the pump system may further comprise an RFID reader
configured to communicate with one or more of the peripheral device
and the server. The RFID reader may be a stand-alone device
disposed at a convenient location for tracking milk storage
reservoirs as they are added to and removed from storage locations
(e.g., attached to the door of the refrigerator/freezer, placed on
a kitchen counter, etc.). Alternatively, the RFID reader may be
integrated with one or more devices of the system, such as the
peripheral device or an organizer system for the milk storage
reservoirs, as described in further detail elsewhere herein. The
RFID reader may be configured to communicate with the peripheral
device and/or the server via a wired or wireless data connection.
When the RFID reader scans an RFID tag associated with a storage
reservoir, the reader may directly access the milk inventory stored
on the peripheral device and/or the server and make appropriate
updates to the inventory as described herein. Alternatively or in
combination, the RFID reader may send information regarding the
detected changes in inventory to the application of the peripheral
device. This information may be presented to the user via the
application in real time, or periodically at pre-determined times
of the day. The user may be prompted to acknowledge the updates to
the inventory, or confirm that the updates should be made.
Optionally, the RFID reader may comprise means for users to provide
inputs regarding the destination of a scanned storage reservoir.
For example, after scanning a storage reservoir, the user may be
prompted to push a button disposed on the RFID reader to indicate
whether the scanned reservoir is to be placed in the
refrigerator/freezer (storage), in the garbage (dispose), or in the
baby's belly (fed). The RFID reader may accordingly update the
inventory with changes, if any, in the storage location of the
scanned inventory item.
[0156] FIG. 28 illustrates an exemplary embodiment of a label
printer 2800 which may be optionally incorporated to generate
labels for storage reservoirs. The label printer can be configured
to print labels 2805 comprising one or more unique identifiers that
are recognizable by human eye, such as alphanumeric text codes. For
example, the text codes may comprise a date code 2810 and/or an
inventory code 2815. Optionally, the labels may additionally
comprise a machine-readable identifier that is pre-printed or
otherwise provided on the labels, such as a bar code, QR code, or
RFID tag 2820. The label printer can be further configured to
communicate with a peripheral device, a server, or both, via a
wired or wireless data connection, to access and update the milk
inventory stored on either or both of the peripheral device and the
server. To generate a label for a new storage reservoir, a user may
simply press a button disposed on the printer. The one or more
unique identifiers of the reservoir on the newly printed label may
be provided to the application of the peripheral device via the
data connection, thereby generating a new inventory item in the
inventory corresponding to the storage reservoir. Optionally, the
label printer may comprise a plurality of buttons 2825 each
indicating a different storage location for the storage reservoir,
and the user may push a button corresponding to the desired storage
location to print the label. In such a configuration, the label
printer can automatically update the inventory item with the
storage location of the reservoir. The printed labels may be
configured to adhere to a storage reservoir, for example by way of
an adherent back side, such that the user can affix the printed
label to the storage reservoir containing the expressed milk. The
labeled reservoir can then be placed in the appropriate storage
location. The label printer can simplify the generation of unique
identifiers and automate the creation of new inventory items based
on the newly generated identifiers. Further, the human-readable
identifiers provided on the printed labels can assist a user in
selecting the desired storage reservoir, by facilitating visual
identification of desired reservoir.
[0157] FIG. 29 shows an exemplary method 2900 of adding an item to
a breast milk inventory. In step 2905, pump session data and/or
milk attribute data are collected during a pump session. The pump
session data may be collected by a peripheral device in
communication with the expression device, and may comprise the date
and time of pumping and the duration of pumping, for example. The
milk attribute data may be collected by an integrated sensor unit
disposed on one or both of the expression device and the collection
reservoir, and may comprise the volume of expressed milk and/or the
composition of the expressed milk.
[0158] In step 2910, following the completion of the pump session,
the pump session data and/or the milk attribute data are recorded
in a pump session log. The pump session log, which can maintain a
record of every pump session performed by the expression device,
may be stored on a local drive of the peripheral device and/or on a
remote server. In preferred embodiments, the peripheral device
provides an inventory management application, programmed to track
and manage the user's breast milk inventory. The application may
comprise the same application that is used to control and/or
communicate with the expression device, or the application may be a
separate application that can be incorporated with any breast milk
expression device, including commercially available systems. The
application can be programmed to display information, prompt user
action, and receive user input regarding milk inventory management.
The user may access and view pump session data, milk attribute
data, and/or the pump session log through the application.
[0159] In step 2915, the application determines whether the
expressed milk is to be fed, stored, or discarded. For example, the
application may prompt the user to select an action (feed, store,
or discard). Alternatively, the application may obtain the
information from another device in communication with the
peripheral device, such as an RFID reader comprising user inputs
for indicating the destination of a scanned storage reservoir as
described herein. Alternatively, the application may comprise
instructions to determine this information automatically. For
example, the application may be programmed to assume that the
expressed milk is to be stored if the child has been fed within a
certain time window (e.g., 1 hour) from the current pump session,
or the application may be programmed to assume that the expressed
milk is to be discarded if the milk attribute data indicates that
the expressed milk is unsuitable for feeding (e.g., alcohol level
exceeds a pre-set threshold).
[0160] In step 2920, wherein the expressed milk is fed to the
child, volume of milk consumed by the child is obtained, and a feed
log for the user is updated accordingly. The application may prompt
the user to input the volume of consumed or remaining milk, or the
volume of consumed or remaining milk may be automatically
determined via one or more methods as described herein, such as via
a reservoir comprising an integrated sensing unit. The feed log,
which can help a user maintain a record of her child's feeding
sessions, may then record information related to the feeding
session, such as the date and time of feeding, the volume of milk
consumed, the expression date of the milk consumed, etc. The feed
log may be stored on a local drive of the peripheral device and/or
of a remote server.
[0161] In step 2925, the application determines, based on step
2920, whether all of the expressed milk has been consumed. In step
2930, wherein all of the expressed milk has been consumed, no
updates are made to the milk inventory. If the expressed milk has
not been completely consumed and the volume of remaining expressed
milk is non-zero, the user may be directed back to step 2915,
wherein the user is prompted to select an action for the remaining
milk.
[0162] In step 2935, wherein the expressed milk is stored for later
feeding, a unique identifier of the storage reservoir for the
expressed milk is obtained from the user. For example, the user may
be prompted to manually provide a user-assigned, human-readable
code through the application, the user may generate an identifier
by printing a label using a label printer as described herein, or
the user may scan in a machine-readable code (e.g., scan a bar code
or a QR code with a mobile phone, or scan an RFID tag with an RFID
reader). The obtained unique identifier is then digitally coupled
with the pump session data and/or milk attribute data for the
expressed milk. If the expressed milk has been partially fed to the
child, the milk attribute data associated with the unique
identifier can comprise the remaining volume of expressed milk
after feeding. Optionally, the storage location of the milk may
also be obtained, for example by prompting the user to provide the
storage location through the application, or by obtaining the
information from another device configured to receive user input
(such as a label printer or milk organizer as described herein).
The obtained storage location may then be associated with the
unique identifier.
[0163] In step 2940, the milk inventory is updated with the milk
associated with the unique identifier in step 2935. The unique
identifier may or may not already exist in the inventory, depending
on whether the user has placed the freshly expressed milk in a new
storage reservoir with a new unique identifier, or has combined the
freshly expressed milk with previously expressed milk already
present in the inventory (e.g., milk expressed during previous
pumping sessions in the same calendar day). If the unique
identifier does not already exist in the inventory, a new inventory
item associated with the unique identifier can be created and added
to the inventory. If the unique identifier already exists in the
inventory, the inventory item associated with the unique identifier
can be updated to incorporate the information for the freshly
expressed milk. For example, the volume of milk for the inventory
item can be increased by the volume of the freshly expressed
milk.
[0164] In step 2945, wherein the expressed milk is discarded, no
updates are made to the feed log or the inventory, though the pump
session data and/or the milk attribute data may still be recorded
in the pump session log.
[0165] The steps of method 2900 are provided as an example of a
method of adding an item to a milk inventory in accordance with
embodiments. A person of ordinary skill in the art will recognize
many variations and modifications of method 2900 based on the
disclosure provided herein. For example, some steps may be added or
removed. One or more steps may be performed in a different order
than as illustrated in FIG. 29. Some of the steps may comprise
sub-steps. Many of the steps may be repeated as many times as
appropriate or necessary.
[0166] When the stored milk is ready to be fed to an infant, the
user may utilize the peripheral device to determine which batch of
expressed milk to select. Inventory management by the peripheral
device can follow a first-in, first-out rule, wherein the first
item to enter the inventory is the first item to leave. Under this
structure, the oldest expressed milk in the inventory may be
identified as the next to be fed. Exceptions may apply for milk in
the inventory whose storage duration has surpassed a pre-set limit
on the length of time the milk may be stored. For example, if the
inventory contains 10 batches of milk expressed on consecutive days
(day 1-day 10), but the storage duration limit is set to 8 days,
the batches expressed on days 1 and 2 may be identified as batches
to be discarded, and the batch expressed on day 3 may be identified
as the batch to be fed.
[0167] An application of the peripheral device may comprise an
algorithm to sort through the inventory of milk and identify milk
to be discarded and/or milk to be fed next. The algorithm can use
the unique identifier associated with each batch of expressed milk
in order to manage the inventory. For example, the algorithm may
compare the expression date for each batch with the current date,
calculate the difference in the number of days, sort the inventory
by this calculated difference, and identify the batch with the
largest difference (falling under the expiry threshold) as the
batch to be fed next.
[0168] For embodiments wherein the unique identifier comprises a
user-assigned, manually labeled identifier, the peripheral device
may simply present the selected unique identifier to the user via
its display, and the user may visually identify and select the bag
bearing the corresponding identifier from her inventory. The user
can then withdraw the recommended bag from inventory so that the
milk inventory is updated. This may be particularly helpful when
milk is entered into inventory at one location and withdrawn from a
second location. Also, the system can identify expired milk and
help ensure that it is discarded. For embodiments wherein the
unique identifier comprises a scannable code, such as a barcode or
QR code, the application of the peripheral device may comprise an
algorithm to help the user visually identify the bottle or bag
presenting the selected unique identifier. For example, the
algorithm may scan a bag of expressed milk using a camera coupled
to the peripheral device, identify the expression date of the bag
via its unique identifier, and determine whether or not the bag is
the next to be fed in the inventory. The algorithm can then overlay
a label on the display screen of the peripheral device to show the
status of the bag within the inventory. For example, if the bag
should be discarded, the overlaid label can be a red X. If the bag
is the next to be fed, the overlaid label can be a green O or
number 1. If the bag is the third in line to be fed, the overlaid
label can be a green number 3.
[0169] The reservoirs containing the expressed milk may be stored
in a configuration that facilitates the visualization of the
reservoirs by the user or by a peripheral device. FIG. 26
illustrates an exemplary embodiment of a storage configuration 2600
for expressed milk reservoirs 2602 having unique identifiers 2604.
The bags 2602 can be disposed in a configuration that allows their
unique identifiers to be visible from the top, as shown in the
figure. The peripheral device can then be used to visualize the
entire inventory at the same time, displaying over each unique
identifier the overlaid screen label showing its inventory status,
as described herein. The reservoirs may be bottles instead of bags,
and the unique identifiers may be disposed on the tops of the
bottles for easy visualization.
[0170] In still other embodiments, an augmented reality system may
facilitate inventory management. Once the expressed milk has been
collected in containers having a unique identifier, an operator may
quickly scan the entire inventory to capture all the unique
identifiers. An image of the inventory may be captured with a
camera phone, or wearable computing device and an indicator may be
generated by the system and overlaid on top of the image of the
inventory to indicate which container is to be used next, or which
containers should be discarded. For example, a green line may
highlight the next container to use, while a red line may indicate
which containers to throw away. Other display units may also be
used to help visualize the inventory management queues provided.
For example, Google Glass may be used and to provide visual
overlays or other visual cues to the user.
[0171] When the user confirms that the batch of milk bearing the
selected unique identifier has been fed to the infant and removed
from the inventory, the data array associated with the unique
identifier may be removed from the live or available inventory.
[0172] FIGS. 30A-30B illustrate another exemplary embodiment of a
storage configuration 3000 for storage reservoirs 3005 having one
or more unique identifiers 3010. FIG. 30A shows a perspective view
of a storage reservoir organizer 3015, and FIG. 30B shows a side
cross sectional view of the organizer 3015 of FIG. 30A. In this
configuration, a plurality of storage reservoirs can be stored
stacked on top of one another within the organizer, as shown in
FIG. 30B wherein the storage reservoirs comprise bags. The shape
and dimensions of the organizer may differ from the illustrated
embodiment, depending on the shape and dimensions of the storage
reservoirs. The organizer can be shaped and sized to have a
footprint that substantially matches the footprint of a single
storage reservoir in the storage configuration, such that a
plurality of storage reservoirs can be stacked one on top of
another. For example, if the storage reservoirs comprise bottles,
the organizer may have a narrower footprint and a greater height to
accommodate the bottles laid on their sides and stacked on top of
one another. The reservoir organizer may be configured to fit
within a compartment of a refrigerator or freezer, such as on a
shelf or in the door. A user may place a storage reservoir inside
the reservoir organizer through a top opening 3040 at the top of
the organizer, wherein the top opening may be sized to receive the
storage reservoirs one at a time. Accordingly, the first reservoir
to be placed in the organizer, containing the oldest milk, can end
up at the bottom of the stack of reservoirs, whereas the last
reservoir to be placed in the organizer, containing the newest
milk, can end up at the top of the stack. The organizer can
comprise a bottom opening 3020 at the bottom of the organizer,
through which the reservoir at the bottom of the stack may be
withdrawn. Thus, the stacked storage configuration can facilitate a
first-in, first-out system of organization for the expressed breast
milk, wherein the user first removes the reservoir containing the
oldest expressed milk.
[0173] Optionally, any of the milk storage configurations described
herein may incorporate features to automate one or more aspects of
inventory tracking and management. For example, as shown in FIG.
30A, a storage reservoir organizer may comprise an integrated RFID
reader 3025 configured to scan a storage reservoir as it enters
and/or exits the organizer. As described herein, the RFID reader
may be configured to communicate with one or more of a peripheral
device and a server having the milk inventory stored thereon, so as
to access and update the inventory when the reader scans a storage
reservoir comprising an RFID tag. When a user places a new storage
reservoir comprising an RFID tag 3030 into the organizer, the RFID
reader can read the RFID tag, and subsequently update the inventory
with the storage location of the inventory item and/or send an
alert to the application to notify the user of the detected change
in inventory. Likewise, when a user removes a storage reservoir
from the organizer, the scanning of the reservoir's RFID tag with
RFID reader can trigger the reader to update the inventory
accordingly.
[0174] Any milk storage configuration as described herein may also
optionally incorporate an integrated sensing unit to automatically
determine one or more attributes of the milk placed into the
organizer. For example, as shown in FIG. 30B, a storage reservoir
organizer may comprise an integrated weight sensor 3035, configured
to measure the weight of the stack of milk storage reservoirs
disposed on top of the weight sensor. When a storage reservoir is
added to or removed from the organizer, the weight sensor can
detect the corresponding change in weight, and communicate the
information to the inventory or to the application.
[0175] FIG. 31 shows an exemplary method 3100 of removing an item
from a breast milk inventory. In step 3105, a user selects an
inventory item to remove from storage from a list of available
inventory. For example, an application as described herein may
provide the user with the option of viewing the inventory of
available milk, and selecting an item to feed or discard. The
inventory may optionally present inventory items in order of
first-to-feed to last-to-feed, based on an algorithm as described
herein; for example, the oldest inventory item that has not
"expired" or surpassed a pre-set storage time limit may be
displayed at the top of the inventory list. In step 3110, the user
selects the milk storage reservoir or container corresponding to
the selected inventory item. The user may identify the appropriate
storage reservoir using any method described herein (e.g., visual
identification of a human-readable code, scanning and visualization
of a QR code, etc.).
[0176] In step 3115, the application determines whether milk in the
selected storage reservoir is to be discarded or fed. This
information may be obtained from the user, for example by prompting
the user to provide a selection through the application.
Alternatively, the application may obtain the information from
another device in communication with the peripheral device, such as
an RFID reader comprising means for users to provide inputs
regarding the destination of a scanned storage reservoir (e.g.,
buttons to select feed/store/discard). Alternatively, the
application may comprise instructions to determine this information
automatically. For example, if the selected inventory item has
exceeded an expiry threshold as described herein, the application
may assume that the item is to be discarded; conversely, if the
item has not exceeded the expiry threshold, the application may
assume that the item is to be fed.
[0177] In step 3120, wherein the inventory item is fed to a child,
the system determines whether all of the milk contained in the
storage reservoir is consumed. This information may be obtained
from the user, for example by prompting the user to provide the
volume of remaining milk, if any, through the application.
Alternatively, the information may be determined automatically, for
example by sensing the volume of the remaining milk with an
integrated sensor of the storage reservoir, or by sensing the
weight of the remaining milk with an integrated weight sensor of
the storage reservoir organizing system as described elsewhere
herein.
[0178] In step 3125, wherein there is milk remaining in the storage
reservoir after the feeding, the inventory is updated to show the
remaining volume of milk for the inventory item corresponding to
the selected reservoir. In step 3130, wherein all of the milk in
the reservoir has been fed, the inventory is updated to remove the
inventory item corresponding to the selected reservoir. In step
3135, the feed log as described herein is also updated with
information for the feeding session.
[0179] In step 3140, wherein the milk in the selected storage
reservoir is discarded, the inventory item corresponding to the
reservoir is removed from the inventory.
[0180] While method 3100 comprises selecting an inventory item from
a list provided through the application, the inventory management
system may also be configured to allow users to physically select a
storage reservoir without referring to the inventory list.
[0181] FIG. 32 shows another exemplary method 3200 of removing an
item from a breast milk inventory. In step 3205, a user selects and
removes a storage reservoir from storage. In step 3210, the user
provides the unique identifier of the selected storage reservoir to
the system, for example by manually inputting a user-assigned,
human-readable code through the application, printing a label with
an identifier using a label printer as described herein, scanning a
QR code with the peripheral device, and/or scanning an RFID tag
with an RFID reader.
[0182] In step 3215, the application determines whether the
selected storage reservoir is to be discarded or fed. This
information may be obtained from the user, for example by prompting
the user to provide a selection through the application.
Alternatively, the application may obtain the information from
another device in communication with the peripheral device, such as
an RFID reader comprising means for users to provide inputs
regarding the destination of a scanned storage reservoir (e.g.,
buttons to select feed/store/discard). Alternatively, the
application may comprise instructions to determine this information
automatically. For example, if the selected inventory item has
exceeded an expiry threshold as described herein, the application
may assume that the item is to be discarded; conversely, if the
item has not exceeded the expiry threshold, the application may
assume that the item is to be fed.
[0183] In step 3220, wherein the inventory item is fed to a child,
the system determines whether all of the milk contained in the
storage reservoir is consumed. This information may be obtained
from the user, for example by prompting the user to provide the
volume of remaining milk, if any. Alternatively, the information
may be determined automatically, for example by sensing the volume
of the remaining milk with a sensor of the storage reservoir, or by
sensing the weight of the remaining milk with an integrated weight
sensor of the storage reservoir organizing system as described
elsewhere herein.
[0184] In step 3225, wherein there is milk remaining in the storage
reservoir after the feeding, the inventory is updated to show the
remaining volume of milk for the inventory item corresponding to
the selected reservoir. In step 3230, wherein all of the milk in
the reservoir has been fed, the inventory is updated to remove the
inventory item corresponding to the selected reservoir. In step
3235, the feed log as described herein is also updated with
information for the feeding session.
[0185] In step 3240, wherein the milk in the selected storage
reservoir is discarded, the inventory item corresponding to the
reservoir is removed from the inventory.
[0186] Method 3200 can allow users to remove items from the milk
inventory without interacting with the application. The unique
identifier may comprise a machine-readable identifier as described
herein, and a machine capable of recognizing the identifier, such
as a barcode reader or an RFID reader, can be disposed in a
location near the refrigerator and/or freezer. The user can simply
remove a storage reservoir from its storage location and scan the
identifier of the reservoir with the machine to automatically
update the inventory. Such a configuration can allow persons who do
not have access to the application, such as caregivers, to update
the milk inventory automatically as they feed or discard stored
milk.
[0187] For example, wherein the unique identifier comprises an RFID
tag, an RFID reader as described herein may be disposed at a
convenient location for scanning the storage reservoirs (e.g.,
attached to the door of the refrigerator/freezer, placed on a
kitchen counter, etc.). A user can remove a storage reservoir from
storage and scan the reservoir with the RFID reader. The RFID
reader can be configured to communicate with the peripheral device
comprising the application for the pump system, for example via a
wireless connection. When the reader scans an RFID tag, the reader
can alert the application that the storage reservoir corresponding
to the recognized RFID tag has been removed from storage. As
described herein, the application may apply an algorithm to
automatically determine whether the identified milk is fed or
discarded, or the RFID reader may comprise a user input that allows
the user to indicate whether the milk is to be fed or discarded.
The inventory may be updated accordingly. Optionally, updates to
the inventory may be withheld until an authorized user of the pump
system approves the updates via the application. For example, when
a storage reservoir corresponding to an item in the inventory is
scanned, the application may alert the authorized user of the
system that a change to the inventory has been detected, and ask
the user to confirm that the inventory update is correct. Such
alerts may be presented to the user in real-time, or periodically
at set time-intervals (e.g., every day at 7:00 pm).
[0188] The steps of methods 3100 and 3200 are provided as examples
of methods of removing an item from a milk inventory in accordance
with embodiments. A person of ordinary skill in the art will
recognize many variations and modifications of methods 3100 and
3200 based on the disclosure provided herein. For example, some
steps may be added or removed. One or more steps may be performed
in a different order than as illustrated in FIGS. 31 and 32. Some
of the steps may comprise sub-steps. Many of the steps may be
repeated as many times as appropriate or necessary.
[0189] After a user has selected a storage reservoir as in step
3110 of method 3100 or step 3210 of method 3200, the user may
decide to take an action other than feeding or discarding the milk
contained in the reservoir. For example, the user may decide to
change the storage location of the reservoir. The application may
provide such an action as a user-selectable option when an
inventory item is selected by a user or identified via the unique
identifier. Alternatively, the application may obtain the
information from another device in communication with the
peripheral device, such as an RFID reader. For example, a user may
remove a storage reservoir from the freezer, select "refrigerator"
as the destination on the RFID reader and proceed to scan the
reservoir with the reader. The application may then recognize that
the reservoir is being moved from the freezer to the refrigerator,
and accordingly change the storage location associated with the
inventory item. The system may be further configured to allow and
keep track of other user actions (e.g., transfer of milk from a
selected reservoir to another).
[0190] An inventory management application for tracking and
managing breast milk inventory may be provided via the peripheral
device, and may be programmed with various features and
functionalities to facilitate inventory management by a user. As
described herein, the application may be programmed to prompt the
user to record additions to or removals from the inventory, or
record volumes of consumed milk. Optionally, the application may
provide additional features to further facilitate the user
workflow. The application may be programmed to provide a daily
reminder or trigger message to recommend one or more
inventory-related actions to the user. For example, the application
may be programmed to perform a check of the inventory every
evening, and recommend that the user move some inventory from the
freezer to the refrigerator if the inventory shows little or no
milk stored in the refrigerator. The application may be programmed
to periodically check the inventory for items expiring within a
short window of time (e.g., within 24 hours), and remind the user
to feed this milk within said window of time and/or move the
inventory item from the freezer to the refrigerator such that the
milk may be fed.
[0191] The expressed milk inventory may be stored onto a remote or
cloud server, so that the inventory may be accessed by users given
permission. For example, a child caregiver may update the inventory
appropriately as milk is fed to the infant. A pediatrician may also
be able to access the inventory to track milk production and
content, in order to determine whether the infant is receiving the
appropriate nutrition.
[0192] Experimental Data
[0193] FIGS. 15 and 16 illustrate experimental pumping data
obtained from a commercial breast pump device and an exemplary
embodiment of the present invention. The exemplary embodiment
utilized an incompressible fluid for pumping and had a maximum
hydraulic fluid volume of 4 cc, while the commercial device
utilized air for pumping and had a maximum volume of 114 cc.
[0194] FIG. 15 illustrates a graph of the pump performance as
quantified by vacuum pressure generated per run. For the exemplary
embodiment, pressure measurements were taken for 1 cc, 2 cc, 3 cc,
and 4 cc of fluid volume displaced by the pump, with the run number
corresponding to the volume in cc. For the commercial device,
measurements were taken with the pump set to one of seven equally
incremented positions along the vacuum adjustment gauge
representing 46 cc, 57 cc, 68 cc, 80 cc, 91 cc, 103 cc, and 114 cc
of fluid volume displaced by the pump, respectively, with the run
number corresponding to the position number. Curve 700 corresponds
to the exemplary embodiment and curve 705 corresponds to the
commercial device. The exemplary embodiment generated higher levels
of vacuum pressure per displacement volume compared to the
commercial device, with maximum vacuum pressures of -240.5 mmHg and
-177.9 mmHg, respectively.
[0195] FIG. 16 illustrates a graph of the pump efficiency as
measured by the maximum vacuum pressure per maximum volume of fluid
displaced, with bar 710 corresponding to the exemplary embodiment
and bar 715 corresponding to the commercial device. The exemplary
embodiment demonstrated a 42-fold increase in pumping efficiency
compared to the commercial device, with efficiencies of -71.1
mmHg/cc and -1.7 mmHg/cc, respectively.
[0196] The various techniques described herein may be partially or
fully implemented using code that is storable upon storage media
and computer readable media, and executable by one or more
processors of a computer system. Storage media and computer
readable media for containing code, or portions of code, can
include any appropriate media known or used in the art, including
storage media and communication media, such as but not limited to
volatile and non-volatile, removable and non-removable media
implemented in any method or technology for storage and/or
transmission of information such as computer readable instructions,
data structures, program modules, or other data, including RAM,
ROM, EEPROM, flash memory or other memory technology, CD-ROM,
digital versatile disk (DVD) or other optical storage, magnetic
cassettes, magnetic tape, magnetic disk storage or other magnetic
storage devices, solid state drives (SSD) or other solid state
storage devices, or any other medium which can be used to store the
desired information and which can be accessed by the a system
device. Based on the disclosure and teachings provided herein, a
person of ordinary skill in the art will appreciate other ways
and/or methods to implement the various embodiments.
[0197] It shall be understood that different aspects of the
invention can be appreciated individually, collectively, or in
combination with each other. Suitable elements or features of any
of the embodiments described herein can be combined or substituted
with elements or features of any other embodiment.
[0198] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
* * * * *