U.S. patent application number 17/112421 was filed with the patent office on 2021-05-27 for closed loop electric breast pump.
The applicant listed for this patent is LANSINOH LABORATORIES, INC.. Invention is credited to Rush BARTLETT, Hasan KESER, Faik KOKLU, Koji MATSUTORI, Peter Lawrence VISCONTI, Frank Tinghwa WANG.
Application Number | 20210154382 17/112421 |
Document ID | / |
Family ID | 1000005374364 |
Filed Date | 2021-05-27 |
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United States Patent
Application |
20210154382 |
Kind Code |
A1 |
BARTLETT; Rush ; et
al. |
May 27, 2021 |
CLOSED LOOP ELECTRIC BREAST PUMP
Abstract
Examples disclosed herein are relevant to breast pumps.
Disclosed examples include breast pumps that automatically adjust
various pumping parameters based on data obtained from one or more
sensors. The one or more sensors can produce data regarding an
amount of milk expressed by a user. The adjusting of the pumping
parameters can be configured to, for example, help the user
efficiently express milk by utilizing a closed-feedback system that
monitors the flow rate of the expressed milk.
Inventors: |
BARTLETT; Rush; (Austin,
TX) ; KESER; Hasan; (Izmir, TR) ; KOKLU;
Faik; (Izmir, TR) ; MATSUTORI; Koji;
(Alexandria, VA) ; VISCONTI; Peter Lawrence;
(Gurnee, IL) ; WANG; Frank Tinghwa; (Taipei,
TW) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LANSINOH LABORATORIES, INC. |
Alexandria |
VA |
US |
|
|
Family ID: |
1000005374364 |
Appl. No.: |
17/112421 |
Filed: |
December 4, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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16563019 |
Sep 6, 2019 |
10857271 |
|
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17112421 |
|
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62727880 |
Sep 6, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2205/3337 20130101;
A61M 1/062 20140204; A61M 2205/3389 20130101; A61M 2205/3334
20130101; A61M 2205/3317 20130101; A61M 1/066 20140204; A61M
2205/50 20130101; A61M 2205/3393 20130101; A61M 2205/3375 20130101;
A61M 2205/3344 20130101; A61M 2205/3306 20130101 |
International
Class: |
A61M 1/06 20060101
A61M001/06 |
Claims
1. A breast pump system comprising: a milk collection apparatus
comprising a pump volume; a pump console comprising one or more
processors and a pump, wherein the pump is configured to induce
suction at the milk collection apparatus based on one or more
pumping parameters; and a pressure sensor configured to measure
negative pressure within the pump volume, wherein the one or more
processors are configured to: control the pump through one or more
milk expression cycles, wherein each of the one or more milk
expression cycles includes at least one period; detect, using the
pressure sensor, a change from a first negative pressure measured
during the at least one period of a first milk expression cycle of
the one or more milk expression cycles to a second negative
pressure measured during the at least one period of a second milk
expression cycle of the one or more milk expression cycles; and
modify at least one of the one or more pumping parameters, based at
least in part on the detected change from the first negative
pressure to the second measured pressure.
2. The breast pump system of claim 1, wherein the milk collection
apparatus further comprises a breast shield, and wherein the
pressure sensor is directly attached to the breast shield.
3. The breast pump system of claim 1, wherein the pump console
further comprises a current sensor, wherein the current sensor is
configured to measure current draw of the pump, and wherein the one
or more processors are configured to modify at least one of the one
or more pumping parameters, based at least in part on a measured
current draw.
4. The breast pump system of claim 1, wherein the one or more
pumping parameters are selected from the group consisting of a ramp
time, a hold time, a duty cycle, a release time, and a pumping
waveform.
5. The breast pump system of claim 1, wherein the one or more
processors are further configured to: determine a milk ejection
pattern for a user of the breast pump system based on a volume of
milk expressed; and modify at least one of the one or more pumping
parameters based on the determined milk ejection pattern.
6. The breast pump system of claim 5, wherein modifying the at
least one of the one or more pumping parameters based on the
determined milk ejection pattern comprises modifying a stimulation
parameter.
7. The breast pump system of claim 5, wherein determining the milk
ejection pattern comprises determining a flow rate of a volume of
milk expressed over time.
8. The breast pump system of claim 1, wherein the at least one
period for each of the one or more milk expression cycles comprises
a ramp period, a hold period, and a release period.
9. The breast pump system of claim 1, wherein the at least one
period comprises a hold period.
10. A breast pump system comprising: a milk collection apparatus; a
pump; a current sensor configured to measure a current draw of the
pump; a voltage sensor configured to measure a voltage draw of the
pump; and one or more processors configured to: control the pump to
induce suction at the milk collection apparatus based on one or
more pumping parameters; and modify at least one of the one or more
pumping parameters based on current draw and the voltage draw of
the pump.
11. The breast pump system of claim 10, wherein the one or more
processors are further configured to determine a reduction in an
amount of effort expended by the pump, and wherein determining the
estimated volume of milk accumulated within the milk collection
apparatus is determined based on the reduction in the amount of
effort, thereby being based on the current draw.
12. The breast pump system of claim 10, further comprising a pump
console comprising the pump, the current sensor, and the one or
more processors.
13. The breast pump system of claim 10, further comprising a
pressure sensor configured to measure a negative pressure within
the pump volume, wherein the one or more processors are further
configured to detect a change in the negative pressure within the
pump volume.
14. The breast pump system of claim 13, further comprising a pump
console including the pump, the pressure sensor, and the current
sensor.
15. The breast pump system of claim 13, wherein the change in the
negative pressure is selected from the group consisting of a change
within the cycle and a change between the cycle and another
cycle.
16. The breast pump system of claim 13, wherein the cycle is a milk
expression cycle.
17. The breast pump system of claim 13, wherein modifying at least
one of the one or more pumping parameters includes transitioning
from stimulation pumping parameters to expression pumping
parameters or transitioning from expression pumping parameters to
stimulation pumping parameters.
18. A breast pump system, comprising: a milk collection apparatus
comprising a pump volume; a pump console comprising one or more
processors and a pump, wherein the pump is configured to induce
suction at the milk collection apparatus based on one or more
pumping parameters; and a pressure sensor configured to measure
negative pressure within the pump volume, wherein the one or more
processors are configured to: control the pump through a milk
expression cycle that includes at least one of a hold period or a
release period; detect, using the pressure sensor, a change in
negative pressure measured during at least one of the hold period
or the release period; determine an estimated volume of milk within
the milk collection apparatus, based on the detected change in
negative pressure; and record the estimated volume of milk.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 16/563,019, filed Sep. 6, 2019, which claims priority to U.S.
Provisional Application No. 62/727,880, filed Sep. 6, 2018. The
disclosure of these priority applications are hereby incorporated
by reference in their entirety into the present application.
BACKGROUND
[0002] Capturing breast milk is beneficial for mothers who want to
provide their infants with natural breast milk. The term "milk" is
used herein to refer to liquid expressed by a human or animal
breast, which generally includes milk produced by mammary glands.
Milk can include colostrum, hindmilk, and foremilk. Breast pumps
can be essential tools for mothers to capture milk for later use,
which can be especially useful for mothers that are traveling,
working, or otherwise away from their infants. Pumping is also
useful to relieve engorgement and milk build up in the breast.
[0003] Breast pumps traditionally require the user to manually
adjust the operating parameters of the pump. A typical breast pump
has two distinct modes: the first mode is a stimulation mode to
mimic the suckling of the baby to cause the breast to release milk,
which is also known as "letdown". The second mode is an expression
mode, where the pump creates a vacuum to facilitate the expression
of milk into a container, such as a bottle. As used herein,
"vacuum" need not refer to a perfect vacuum and instead encompasses
a volume having a relatively low pressure (e.g., relative to an
environment outside of the volume). Switching between expression
and stimulation modes is currently typically performed either
through a set timeout or from user input. Other settings that may
be available for the user to manually change are vacuum pressure
and waveform speed. A primary difference between various breast
pumps on the market is the waveform used by the pump. Each mother
is unique and would prefer one waveform over the other (and hence
prefer one breast pump over the other). It can be difficult for
users to properly adjust these manual breast pump settings to
quickly and comfortably achieving milk expression.
SUMMARY
[0004] Technology disclosed herein relates to breast pumps.
Disclosed examples include breast pumps that automatically adjust
various parameters of the breast-pump waveform. The adjusting can
be configured to, for example, help the mother efficiently express
milk by utilizing a closed-feedback system that monitors the flow
rate of the expressed milk and total volume of milk expressed.
[0005] In an example, there is a breast pump system comprising: a
milk collection apparatus comprising a sensor configured to measure
fluid within the milk collection apparatus; and a pump console. The
pump console can include a pump configured to induce suction at the
milk collection apparatus based on one or more pumping parameters
and one or more processors. The one or more processors can be
configured to obtain fluid data from the sensor; and modify the one
or more pumping parameters based on the fluid data.
[0006] The milk collection apparatus can further include a breast
shield, and the sensor can be coupled to the breast shield. The
system can further include a ring disposed around a portion of the
breast shield of the milk collection apparatus, and the sensor can
be coupled to the ring. The milk collection apparatus can further
include a valve, and the sensor can be coupled to the valve. The
breast pump system can further include a light source, and the
sensor can include a light detector. The light source and the light
detector can be arranged so that light emitted from the light
source passes through the valve to reach the light detector. The
milk collection apparatus can include a container, and the light
source and the light detector can be arranged so that light emitted
from the light source passes through the container to reach the
light detector. The milk collection apparatus can further include a
reflector, and the light source and the light detector can be
arranged so that light emitted from the light source passes through
the container and is reflected by the reflector to reach the light
detector. The sensor can include an electrode. The parameters
include but not limited to target pressure, rate of pressure
increase, a ramp time, a hold time, a duty cycle, a release time,
rate of pressure release or a pumping waveform.
[0007] In another example, there is a breast pump system
comprising: a milk collection apparatus; a pump console comprising:
one or more processors and a pump, wherein the pump is configured
to induce suction at the milk collection apparatus based on one or
more pumping parameters; and a sensor configured to directly or
indirectly obtain measurements regarding the milk collection
apparatus. The one or more processors can be configured to: obtain
data from the sensor; and modify the one or more pumping parameters
based on the data.
[0008] The milk collection apparatus can further include a breast
shield, and the sensor can be coupled to the breast shield. The
milk collection apparatus can further include a valve, and the
sensor can be coupled to the valve. The breast pump system can
further include a light source, and the sensor comprises a light
detector. The light source and the light detector can be arranged
so that light emitted from the light source passes through the
valve to reach the light detector. The milk collection apparatus
can include a container, and the light source and the light
detector can be arranged so that light emitted from the light
source passes through the container to reach the light detector.
The one or more processors can be configured to determine a change
in the data over time, and modifying the one or more pumping
parameters can be based on the change. The pump console can further
include the sensor. The sensor can be a pressure sensor. The one or
more processors can be configured to determine a volume of milk
within the milk collection apparatus based on a pressure measured
by the pressure sensor. The sensor can be a current sensor
configured to measure current draw of the pump, and the one or more
processors can be are configured to determine a volume of milk
within the milk collection apparatus based on the current draw. The
parameters can include a pressure, a ramp time, a hold time, a duty
cycle, release time, or a pumping waveform.
[0009] In another example, there is a method comprising: operating
a vacuum pump of a breast pump system using one or more parameters;
determining a volume of milk expressed as a result of the operation
of the vacuum pump; and automatically modifying the one or more
parameters based on the determined characteristic.
[0010] Determining the characteristic of the milk can include
measuring a pressure with a pressure sensor. Operating the vacuum
pump can include operating the vacuum pump through a cycle
comprising a ramp period, a hold period, a release period, and a
delay period. The release period can further include a first
release period, a plateau period, and a second release period and
so-forth. The method can include determining a milk ejection
pattern of a user of the breast pump system based on the volume of
milk expressed. Modifying the one or more parameters can be based
on the determined milk ejection pattern.
[0011] In yet another example, there is a milk collection apparatus
that includes a breast shield for placement on a breast, a
container configured to receive milk expressed by the breast, a
coupling conduit for coupling the milk collection apparatus to a
pump console, and a sensor configured to measure milk within the
milk collection apparatus and transmit data to the pump
console.
[0012] The milk collection apparatus can further include a light
source. The sensor can include a light detector. The light source
and the light detector can be arranged so that light emitted from
the light source passes through milk within the milk collection
apparatus to reach the light detector. The milk collection
apparatus can further include a ring disposed around a portion of
the breast shield. The sensor can be coupled to the ring. The milk
collection apparatus can further include a valve, wherein the
sensor is configured to measure motion of the valve. The sensor can
include an electrode.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] It is believed the present disclosure will be better
understood from the following description of certain examples taken
in conjunction with the accompanying drawings, in which like
reference numerals identify the same elements. The drawings are not
intended to be limiting in any way, and it is contemplated that
various embodiments can be carried out in a variety of other ways,
including those not necessarily depicted in the drawings. The
accompanying drawings incorporated in and forming a part of the
specification illustrate several aspects of the present disclosure,
and together with the description serve to explain the principles
of the disclosure; it being understood, however, that the scope of
this disclosure is not limited to the precise arrangements
shown.
[0014] FIG. 1 illustrates an example breast pump system.
[0015] FIG. 2, which is made up of FIGS. 2A and 2B, illustrates an
example implementation of a milk collection apparatus.
[0016] FIG. 3, which is made up of FIGS. 3A, 3B, and 3C,
illustrates an example operation of a breast pump system.
[0017] FIG. 4 illustrates an example milk collection apparatus
having one or more sensors configured as electrodes.
[0018] FIG. 5 illustrates an example milk collection apparatus
having one or more sensors configured as optical sensors.
[0019] FIG. 6 illustrates an example milk collection apparatus
having one or more sensors attached proximate the breast shield
[0020] FIG. 7 demonstrates an example valve having a sensor.
[0021] FIG. 8, which is made up of FIGS. 8A and 8B illustrates an
example milk collection apparatus having a sensor configured as a
magnetic sensor.
[0022] FIG. 9, which is made up of FIGS. 9A and 9B, illustrates an
example milk collection apparatus having a sensor configured as an
optical sensor.
[0023] FIG. 10 illustrates the use of a mobile device with a camera
as a sensor to capture an image of the container or another
component of the milk collection apparatus.
[0024] FIG. 11 illustrates the use of a weight sensor as a sensor
to determine an amount of milk in the container.
[0025] FIG. 12 illustrates an example milk collection apparatus
having a sleeve having one or more sensors disposed thereon or
therein to determine an amount of milk in the container.
[0026] FIG. 13 illustrates an example milk collection apparatus
having a holder for a container.
[0027] FIG. 14 illustrates an example milk collection apparatus
having a sensor configured to measure deflection of the
diaphragm.
[0028] FIG. 15 illustrates a waveform that can be used to control
the operation of the pump.
[0029] FIG. 16 illustrates example breast pump waveforms.
[0030] FIG. 17 illustrates an example waveform.
[0031] FIG. 18 illustrates an example breast pump vacuum waveform
with vibrational patterns added.
[0032] FIG. 19 illustrates four example categories of milk
expression patterns.
[0033] FIG. 20 illustrates example instructions implementing a
process.
DETAILED DESCRIPTION
[0034] Disclosed technology relates to breast pumps. Examples
disclosed herein can help breast pump users efficiently express
milk by automatically adjusting various parameters of the breast
pump. For example, the volume, rate, or other parameters of milk
expression can be directly or indirectly measured and pumping
parameters can be modified based thereon. Disclosed technologies
include technology providing the capability of a breast pump system
to directly or indirectly obtain measurements (e.g., milk flow
rate) via one or more sensors. Disclosed technologies further
include technology for using the measurements to form a closed-loop
system with the pump to optimize for desirable qualities (e.g.,
extraction time, comfort, and quietness). The closed-loop system
can include a feedback loop between one or more sensors, one or
more processors, and the pumping parameters.
[0035] Disclosed examples include various techniques for obtaining
measurements, including: measuring milk with a flow sensor (e.g.,
positioned proximate a breast shield of a milk-collection
apparatus), measuring accumulated milk proximate a valve of the
milk-collection apparatus, measuring back-pressure on a diaphragm
at the pump side as a surrogate of accumulated milk volume in the
valve, and measuring an effort of a vacuum pump (e.g., by measuring
current draw or a duty cycle). Other techniques are also possible,
including the use of sensors to measure an accumulation of milk in
a collection vessel and the use of a pressure sensor in line with
the vacuum pump.
[0036] Example sensors include one or more sensors associated with
a breast shield, anterior chamber, valve, or container of the milk
collection apparatus. For example, the one or more sensors can
include optical sensors, electrical sensors, mechanical sensors,
other kinds of sensors, or combinations thereof. An optical sensor
can include an optical emitter and an optical receiver. The amount
of light blocked or otherwise affected (e.g., by milk, a distended
nipple, or motion of a valve) can be used to directly or indirectly
obtain measurements regarding an amount of milk obtained or comfort
of the user (e.g., where the optical sensor is configured to detect
a distended nipple). In another example, the optical sensor can be
a camera to obtain one or more images that are analyzed to
determine measurements (e.g., an amount of milk in a container). A
mechanical sensor can be a flow meter that directly or indirectly
contacts the expressed milk to obtain flow measurements. An
electrical sensor can include one or more electrodes extending
along a nipple channel of a breast shield of the milk collection
apparatus. The one or more electrodes may be shielded to prevent or
reduce disturbance from the outside environment (e.g., a user's
hands). The one or more electrodes can measure a change in
capacitance to determine milk flow rate or other characteristics
(e.g., nipple distention, which is correlated to nipple pain). As
milk or a nipple move proximate the electrode, a dielectric
constant can be increased, which results in a measurable increase
in capacitance.
[0037] The one or more sensors used to obtain the data can be part
of a discrete component configured to couple with another component
of the breast pump system or the one or more sensors can be built
into (e.g., integral with) one or more components of the breast
pump system. The one or more sensors can be external to the
components of the system and can include, for example, a smart
bottle, an external scale, or a video camera.
[0038] The data from one or more of the sensors can be obtained and
used by one or more processors to apply some type of corrective
action, such as a change in parameters or an alert being provided
to a user. The processor can be within a pump console (e.g., a
component that houses the pump) or external to the pump console. In
some examples, a consumer device (e.g., a smartphone, tablet, or
laptop) can perform at least some of the processing and modify one
or more parameters of a pump. The processor can facilitate proper
pressure being presented at the breast. The processor can adjust
the various parameters of the waveform and can measure the
resulting effect on the milk flow rate. The system can take into
account potential user discomfort when modifying parameters (e.g.,
the parameters can be kept within safety or comfort tolerances).
The system can also take into account noise when modifying
parameters (e.g., to limit an amount of noise made by the system
when in operation). For example, the pump can be configured to
operate when vacuum is maintained. This can be helpful for users
that pump in the same room as their baby, as a breast pump pumping
while not attached to the breast can be very loud. Likewise, if the
breast shield is removed from the breast, the breast pump system
can detect the removal and can automatically stop the pumping
session. The technology herein can further facilitate determining
whether the system is functioning properly. For example, the system
can determine vacuum loss within the system. As a result of
detected vacuum loss, the pump can alert the user and potentially
indicate where the pump system is not assembled correctly or if any
components are not attaching well to each other within the
assembly. The processor can take into account an altitude at which
the pump is operating and whether the user is using single pump or
double pump system. While many examples herein are described in the
context of a single milk collection apparatus being used, disclosed
examples can be applied to breast pump systems having two milk
collection apparatuses. In examples with multiple milk collection
apparatuses, different sensor data can be collected and different
parameters can be determined for each milk collection apparatus, so
differences in milk expression on a breast-by-breast basis can be
determined and accounted for (e.g., by having a different pumping
waveform used by each breast). Alternatively, one or more sensors
can be used to generate data and pumping parameters shared by each
breast.
[0039] With the breast and breast pump acting as a closed-loop
system, the rate of milk expression measured by the sensors or via
another technique can be a feedback signal based on which
parameters can be changed to optimize for increasing an amount of
milk obtained during a session or decreasing an amount of time
taken to obtain a particular amount of milk (e.g., enough milk to
fully empty a user's breast). The optimization can include
optimizing for reduced hold time. To determine when the milk
extraction has completed for that cycle, the system can measure the
rate of change of pressure and when the rate is smaller than a
threshold the breast pump can then begin the release phase without
delay (or without substantial delay). Improvements to milk
extraction can be further based on a particular milk expression
pattern of the user. For example, research indicates that mothers
can be categorized into four different milk ejection patterns,
which are described in more detail in FIG. 20 herein. See Kuroishi
Sumiko, et al., "Study of Breast Pump Suction with Variable Rhythm
Temporal Change in Breast Milk Flow and Mothers' Feelings",
Japanese Journal of Maternal Health, 59(3), 247 (2018), which is
hereby incorporated by reference herein in its entirety for any and
all purposes. Further, some mothers express milk faster when the
pump waveform is variable and others express milk faster when the
waveform is constant. Disclosed examples can allow the breast pump
to automatically determine which kind of waveform can express milk
faster for a particular user. For example, the rate of milk
expression during use of a constant waveform can automatically be
compared against the rate of milk expression during use of a
variable waveform.
[0040] In one example optimization technique, a PID (Proportional
Integrative Derivative) loop is used that can include first and
higher order PID loops. To increase flow rate, the system can
modify pumping parameters, such as by modifying pressure, ramp
time, hold time, duty cycle, pumping waveform, other parameters, or
combinations thereof. The system can also use any of a variety of
machine-learning or artificial intelligence algorithms (e.g.,
simulated annealing or genetic algorithms) to facilitate processing
the data or selecting parameters. Through the use of such
techniques, parameters can be optimized for the particular user to
improve, for example, a rate of milk expression. Where a PID
controller is used, the system can first ensure that the tunable
parameters (e.g., rise time, hold time, pressure, and cycle time)
are in negative feedback (e.g., a detected decrease in milk flow
rate can result in a proportional increase in pressure to attempt
to increase the milk flow rate). The PID controller can attempt to
maintain a target milk flow rate. The PID controller can also be
set to maintain a target pressure on the breast. For example, when
the breast is emptied, the empty volume in the anterior chamber is
increased, thereby decreasing overall pressure to the breast.
[0041] The maximum rate at which pressure changes over a fixed time
can be set by a parameter or by the pump motor itself. By driving
the motor with a pulse-width modulation, the rate at which the
pressure rises over time can be controlled. Disclosed examples can
advantageously allow the system to determine whether a target
pressure is reached. Absent a closed feedback system, the target
pressure can be achieved by running the motor at a 100% duty cycle
for a fixed, pre-determined amount of time found by trial and
error, which can be difficult. With the closed feedback system, the
system can control the rise time and the target pressure
independently. The closed-feedback system can adjust the rise time
rate by controlling the pulse width modulation, and stop running
the motor once the target pressure is reached.
[0042] As described above, a breast pump system can include a
variety of components acting as sensors that can produce data to
control pumping parameters to improve the function of the system.
Breast pump systems can come in any of a variety of configurations.
An example breast pump system that can operate as a closed-loop
system is described in FIG. 1.
Breast Pump System
[0043] FIG. 1 illustrates an example breast pump system 100. The
pump system includes two primary components connected by a tube
102: a milk collection apparatus 110 and a pump console 120.
Although the figure illustrates the milk collection apparatus 110
and the pump console 120 being discrete components relatively
remote from each other, they need not be. In certain
implementations, the breast pump system 100 can have, for example,
the pump console 120 directly coupled to the milk collection
apparatus (e.g., the milk collection apparatus 110 and the pump
console 120 can be part of a same housing or structure).
[0044] The milk collection apparatus 110 is a component of the
breast pump system 100 configured to apply suction to a breast to
collect milk. An example implementation of the milk collection
apparatus 110 is described in more detail in FIG. 2. In the
illustrated configuration, the milk collection apparatus 110
includes one or more sensors 112. The sensors 112 are described in
more detail herein and can be configured to measure milk within a
flow path of the milk collection apparatus 110. The flow path can
include the path the milk takes from the breast to a container of
the milk collection apparatus 110. The data from the one or more
sensors 112 can be transmitted to the pump console 120 for
processing via a wired or wireless connection 104. In addition to
measuring milk within a flow channel, one or more of the sensors
112 can be configured to determine, for example, whether a nipple
has distended too far forward into the milk collection apparatus
110 (e.g., which may be an indicator of pain). The sensors 112 can
be configured to not impede a traditional pumping workflow (e.g.,
cleaning, assembly, and use of a breast pump). Further, the sensors
112 can be configured to not come in direct contact with fluids or,
if the sensors do come in contact with fluids, the sensors 112 can
be biocompatible and easy to sterilize and clean.
[0045] The pump console 120 is a component of the breast pump
system 100 configured to induce suction in the milk collection
apparatus 110. In the illustrated configuration, the pump console
120 includes a vacuum pump 122 coupled to the milk collection
apparatus 110 via the tube 102. While typically referred to herein
as a singular vacuum pump, the vacuum pump, the milk collection
apparatus 110 can include multiple pumps 122 and references herein
to a single pump can be replaced with multiple pumps. An example
implementation of the pump console 120 and its components
(including multiple pumps 122) is described in U.S. 62/727,897,
which is tilted "Multi-Pump Breast Pump", and which is hereby
incorporated by reference herein in its entirety for any and all
purposes. Other example implementations of the breast pump system
100 are described in U.S. Pat. No. 8,545,438, which is titled
"Breast Pump" and which is hereby incorporated by reference herein
in its entirety for any and all purposes. The pump 122 and other
components of the breast pump system 100 can be controlled by one
or more processors 124.
[0046] The one or more processors 124 are one or more electronic
components that control one or more other components of the pump
console 120. The one or more processors 124 can, for example,
control the function of the pump 122. The one or more processors
124 can be configured to obtain input (e.g., from the one or more
milk collection apparatus sensors 112 and from the one or more pump
console sensors 128), process the input, and take one or more
output actions based thereon. The output actions can include
modifying parameters that the one or more processors 124 use to
control components of the system 100. The one or more processors
124 can include one or more microprocessors, application-specific
integrated circuits, field programmable gate arrays, other
components, or combinations thereof. The one or more processors 124
can obtain input from the interface 130. The one or more processors
124 can be configured to execute instructions stored in the memory
132 to perform operations. The processor 124 can modify parameters
of the breast pump system 100 to facilitate the expression of milk
from the breast
[0047] The pump console 120 can further include a solenoid 126, one
or more sensors 128, an interface 130, and memory 132.
[0048] The solenoid 126 is a component of the vacuum pump console
120 (or the pump 122 itself) configured to actuate a release valve
to release some or all of the vacuum created by the vacuum pump
122. The solenoid 126 can be controlled by the processor 124 to
open, partially open, or close the release valve.
[0049] The one or more sensors 128 are components of the pump
console 120 configured to generate data. In an example, the one or
more sensors 128 can include a pressure sensor configured to
measure a pressure or amount of the vacuum created by the vacuum
pump 122. In addition to or instead of pressure sensors, the one or
more sensors 128 can include time sensors, location sensors (e.g.,
GPS-based location), temperature sensors, altitude sensors,
humidity sensors, accelerometers, impedance sensors, light sensors,
other sensors, or combinations thereof.
[0050] The interface 130 can include one or more components
configured to receive input or provide output. The interface 130
can include, one or more components to receive input from a user
(e.g., via one or more switches, buttons, touch interfaces, pointer
devices, other components, or combinations thereof), provide input
to a user (e.g., via one or more displays, lights, speakers, other
components, or combinations thereof), and one or more components
for communicating with other devices via a wired (e.g., via an
Ethernet connection, a serial interface connection, a parallel
interface connection, other connections, or combinations thereof)
or wireless (e.g., via a radiofrequency connection, such as WI-FI,
BLUETOOTH, other wireless radiofrequency connections, or
combinations thereof). Disclosed examples can further allow for new
user controls for the breast pump as part of the interface 130. For
instance, the processor 124 can be configured to detect a pressure
change caused by a user squeezing a component of the milk
collection apparatus 110 (e.g., a breast shield thereof) and, in
response, start or stop the pump 122.
[0051] The memory 132 is a processor-readable storage media
operable to store information, such as data or instructions. The
information stored on the memory 132 can be accessed and processed
by the one or more processors 124. The memory 132 can include
random-access memory, read-only memory, programmable read-only
memory (e.g., electronically-erasable programming memory), volatile
memory, or non-volatile memory. The memory can use any of a variety
of technologies including, for example, optical, magnetic, spinning
disk, or solid-state, among other technologies. The memory 132 can
include transitory or non-transitory computer readable mediums.
[0052] The milk collection apparatus 110 and the pump console 120
can be implemented in any of a variety of forms. An example
implementation of the milk collection apparatus 110 is described in
FIG. 2.
[0053] FIG. 2, which is made up of FIGS. 2A and 2B, illustrates an
example implementation of a milk collection apparatus 110. As
illustrated, the milk collection apparatus 110 can include a
container 212 and a suction transfer assembly 216. The container
212 is a component for receiving milk. The container 212 can take
any of a variety of forms, such as a bottle, syringe, bag, or other
type of void space. The suction transfer assembly 216 includes a
breast shield 214 (which can also be referred to as a flange) for
placement on a breast, as well as an anterior chamber defined
within a suction housing 218, a vacuum housing 220, a diaphragm
222, and a valve 224. The diaphragm 222 can be a flexible membrane
or other component separating an anterior chamber of the milk
collection apparatus 110 from a pump volume while still allowing
pressure changes to be communicated across. Some implementations of
the breast pump system 100 can lack a diaphragm 222.
[0054] The valve 224 can be a component separating the anterior
chamber from the container 212. The valve 224 can be a one-way
valve, such as a duckbill valve. The valve 224 can take any of a
variety of forms, such as a flow restrictor valve, a spring driven
valve, a hydraulic piston, or other types of pressure regulating
valves. The suction transfer assembly 216 can transfer pressure
through the diaphragm 222. And the suction transfer assembly 216
can include a coupling conduit 226 for coupling the milk collection
apparatus 110 to a pump console 120 for modifying the pressure. In
some examples, the vacuum housing 220 can include or be configured
as a pressure regulation feature. The pressure regulation feature
can be adjustable by the user such that different dimensions of
pressure regulation features can be attached as the user desires to
provide for a higher or lower maximum vacuum dimension allowed by
the breast pump system 100. Additional details regarding an example
milk collection apparatus 110 are described in U.S. Pat. No.
8,444,596, which is titled "Breast Milk Collection Apparatus and
Components Thereof" and which is hereby incorporated by reference
herein in its entirety for any and all purposes.
[0055] The milk collection apparatus 110 can cooperate with the
pump console 120 to cause milk expression from a breast placed in
the breast shield 214. An example operation of the breast pump
system 100 is described in FIG. 3.
[0056] FIG. 3, which is made up of FIGS. 3A, 3B, and 3C,
illustrates example operation of the breast pump system 100. As
illustrated, the breast pump system 100 can define a pump volume
310, an anterior chamber 320, and a container volume 330. The
anterior chamber 320 can be a volume at least partially bounded by
a breast in which pressure is modified to stimulate the breast and
cause the expression of milk into the anterior chamber 320. The
anterior chamber 320 can be defined in part by the diaphragm 222,
which can separate the anterior chamber 320 from the pump volume
310. The diaphragm 222 can be flexible such that pressure changes
in the pump volume 310 affect the pressure of the anterior chamber
320. For example, the diaphragm 222 can contribute to a seal (e.g.,
a hermetic seal) that allows pressure changes in the pump volume
310 to be communicated to the anterior chamber 320. The pump volume
310 is the volume that the pump 122 directly affects in order to
cause pressure changes in the anterior chamber 320. The pump volume
310 can include a portion of the milk collection apparatus 110 that
is "above" the diaphragm 222 (e.g., where the anterior chamber 320
can be considered "below" the diaphragm 222) as well as the tube
102 and a portion within the pump console 120 that includes the
pump 122. The pump 122 can be activated to reduce pressure in the
pump volume, and a release valve (e.g., controlled by the solenoid
126) can be opened to allow pressure in the pump volume 310 to
begin to equalize with a surrounding environment. The illustrated
anterior chamber 320 is separated from the container volume 330 via
the valve 224. The valve 224 can be a one way valve (e.g., a
duckbill valve) that allows fluid (e.g., air and milk) to flow into
the container 212 but not to flow back into the anterior chamber
320. Beneficially, this separation can allow for the anterior
chamber 320 to be substantially smaller than the volume that would
typically be necessary for collecting expressed milk during a
pumping session. This smaller volume of the anterior chamber 320 is
more easily affected by the pressure changes in the pump volume
310.
[0057] FIG. 3A illustrates a breast and nipple received within the
breast shield 214. The pump 122 can receive a control signal from
the processor 124 that causes the pump 122 to activate to remove
air from the pump volume 310 or otherwise reduce the pressure in
the pump volume 310. As the pressure is reduced in the pump volume
310, the diaphragm 222 deforms and causes a reduction in pressure
in the anterior chamber 320, which induces suction at the
breast.
[0058] FIG. 3B illustrates the change in pressure causing milk to
be expressed in the anterior chamber 320 of the milk collection
apparatus. The change in pressure can further cause the valve 224
to close and seal off the anterior chamber 320 from the container
volume 330. As milk accumulates in the anterior chamber 320, the
milk displaces volume, which causes an increase in pressure in the
anterior chamber 320 and pushes the diaphragm 222 upwards. This
increase in pressure caused by the milk can be communicated to the
pump volume 310 via the diaphragm 222 and sensed by a sensor (e.g.,
one or more sensors 112 or one or more sensors 128 of the breast
pump system 100 as is described in more detail herein). For
example, the pump console 120 can detect the pressure change to
infer an amount of milk expressed, which can be used by the
processor 124 to help determine if letdown has occurred, if the
breast is out of milk, or if more stimulation is possible. By
integrating the accumulated milk in each cycle, the pump console
120 (e.g., the processor 124 thereof) can estimate the total amount
of milk pumped in the cycle and the session (which can include
multiple cycles). A sensor can measure or infer a change in
pressure as milk is expressed from the breast fills the anterior
chamber 320 (e.g., prior to release of the pressure and opening of
the valve 224 to allow the milk to flow into the container 212).
For example, depending on the variation in pressure relative to
power draw and or time, the breast pump system 100 can determine
how the volume in the anterior chamber changes and therefore
correlate to how much milk has been expressed into the anterior
chamber 320 as a surrogate method of determining milk flow.
[0059] FIG. 3C illustrates the release of pressure via the solenoid
126. For example, the processor 124 can send a control signal that
causes the solenoid 126 to at least partially open a release valve
to reduce the vacuum (e.g., allow the pressure to increase) in the
pump volume 310. The change in pressure in the pump volume 310
results in an increase in pressure in the anterior chamber 320,
which allows the valve 224 to open. The opening of the valve 224
allows the milk volume that was collected in that cycle to drop
into the container 212.
[0060] The operation cycle described in FIG. 3 can be repeated
several times until a desired amount of milk is expressed and
collected in the container 212. As described above, data obtained
from sensors 112, 128 or elsewhere can be used by the one or more
processors 124 of the pump console 120 to modify pumping parameters
that can affect the ability of the system 100 to cause milk
expression. For example, during the operation cycle, pressure
within the system 100 can be monitored and used to determine an
amount of milk expressed.
Determining Milk Expression Using Pressure
[0061] As described above, the breast pump system 100 can define
three primary volumes: the pump volume 310, the anterior chamber
320, and the container volume 330. A measured pressure in the pump
volume 310 correlates to the volume of the anterior chamber 320.
The resting pressure in the anterior chamber 320 can equal the
resting pressure on the pump volume 310. As the pump 122 is
activated (e.g., with the release valve closed and the valve
separating the anterior chamber 320 from the container volume 330
being closed), pressure decreases in the pump volume 310, which is
communicated to the anterior chamber 320 via the diaphragm 222,
which results in milk extraction from the breast into the anterior
chamber 320. The extracted milk is temporarily confined within the
anterior chamber 320 because the valve 224 is closed. The valve 224
can remain closed during a hold period of the pump waveform. During
the hold period, the hold pressure in the anterior chamber 320 is
equal to the hold pressure in the pump volume 310. Based on the
ideal gas law (i.e., PV=nRT, where P is the pressure, Vis the
volume, n is the number of moles, R is the ideal gas constant, and
Tis the temperature), it can be assumed that temperature change is
minimal and the displaced volume by the breast during the hold
period is constant. The extracted milk constitutes a decrease in
volume in the anterior chamber 320 by a .DELTA.y, which will result
in an increase in pressure by .DELTA.P in both the anterior chamber
320 and the pump volume 310. This increase in pressure can be
measured by an inline pressure sensor (e.g., sensor 128), which can
correspond to the milk during the hold phase. The pressure sensor
can take any of a variety of forms, such as a MEMS
(microelectromechanical systems) sensor, a deflection-based sensor,
a strain-based sensor, a magnetic sensor, other sensors, or
combinations thereof. Since the system 100 can determine a waveform
cycle period, the flow rate can be calculated. As the pump 122
transitions to vacuum-release, pressure in both the anterior
chamber 320 and the pump volume 310 is equalized, the valve 224
opens allowing the temporarily-confined milk to flow into the
container volume 330, thereby resetting the system 100 to be ready
to measure flow rate for a next waveform cycle.
[0062] Some implementations of a breast pump system 100 can lack a
diaphragm 222. In such examples, the pump 122 can directly affect
the pressure in the anterior chamber 320 without a diaphragm 222
communicating the pressure change. In such implementations, it can
still be helpful to distinguish between the pump volume 310 (e.g.,
a volume from the coupling conduit 226 to the pump 122) and the
anterior chamber (e.g., a volume between the valve 224 and the
coupling conduit 226), but rather than pressure changes being
communicated via the diaphragm 222, the pressure changes in the
pump volume 310 directly affect the pressure of the anterior
chamber 320.
[0063] In some examples, during a stimulation phase where no milk
is expressed, pressure in the pump volume can be measured using the
sensor 128 to serve as a base measurement of pressure without milk
present. The pressure can be measured at different points in a
waveform cycle and signal processing can be used to measure the
effects of the changed pressure (e.g., due to changes in volume in
the anterior chamber 320) from the expressed milk. As there can be
multiple letdowns within a pumping session, the system 100 can use
cycles within the first letdown as a baseline to optimize for
future letdowns within a current session or future sessions by
storing a pressure profile or tuned waveform parameters in memory
for use during future letdowns. Signal processing can include
averaging pressure waveforms within one or more cycles (e.g., to
create a running average) to increase a signal-to-noise ratio.
Other methods include creating a model (e.g., a mathematical or
statistical model) using historical data of milk expression for the
individual user, where a function takes a pressure as input and
produces a flow rate as output.
[0064] A more complicated signal processing method can use
sigma-delta modulation. The pump 122 can be driven using a
pulse-width modulation signal sent from the processor 124. A
pressure provided by the pump 122 can be affected by a duty cycle
of the signal. Sigma-delta modulation can be used to determine how
long the pump 122 needs to be active to maintain a set pressure
(e.g., the duty cycle needed to maintain a particular pressure in
the pump volume 310 during a hold period). Since the pump volume
310 likely has at least some leakage, the pump 122 can be active
even during a holding period to maintain a set pressure. As milk is
expressed into the anterior chamber 320, pressure increases, which
can reduce the amount of time needed to turn the vacuum on to
maintain the set pressure. The amount of time the pump 122 is in an
on state (e.g., a change in the duty cycle needed to maintain
pressure) can be correlated to the amount of accumulated milk
within the anterior chamber for each cycle. A sigma-delta count can
be used stand-alone measure or as an additional factor for an
algorithm to increase the accuracy of prediction for the milk flow
rate or the total accumulated volume.
[0065] In addition to or instead of the use of pressure or pump 122
characteristics, other sensors can be used to obtain data regarding
a pumping session. Example implementations of the sensors 112, 128
are described in FIGS. 4-14.
Sensors
[0066] Various sensors can be used by the breast pump system 100 to
obtain data usable to modify pumping parameters. An example sensor
is an acoustic sensor (e.g., disposed on the side of the container
212) that can indicate a change in the sound produced as milk
begins to flow and drip from the valve 224 into the collection
compartment. This change in sound can indicate that letdown
occurred and, in response thereto, the processor 124 can cause the
pump 122 to switch from a stimulation phase (e.g., having a
relatively rapid cycle) to an expression phase (e.g., having a
longer cycle time than the stimulation phase). A change in sound
can also indicate a reduction in flow rate. For example, the sensor
112 can take the form of a microphone configured to obtain sound
indicative of milk flowing from the anterior chamber 320 to the
container 212. The sound obtained from the sensor 112 can be
obtained and analyzed, such that if the sound obtained from the
sensor indicates that flow is relatively low or is decreasing at a
particular rate, then the processor 124 can cause the pump 122 can
begin a new stimulation phase.
[0067] Sensors can also be placed on or proximate the breast, which
can allow the pump system 100 to determine if the fluid retained in
the breast is indicative of there being a potential for a second
letdown with more expression of milk or if the breast is empty or
near empty with little additional reason to continue pumping. Such
sensors can also be configured to determine the amount of
engorgement in the breast and the amount of milk remaining in the
breast. An engorged breast tends to have less breast movement when
the vacuum is applied compared to a nearly-empty breast. This
breast movement can be detected by the pressure sensor and using an
algorithm determine the amount of milk remaining in the breast. In
some examples, an estimated amount of milk remaining in the breast
can be used to determine a milk ejection pattern of the user. In
addition or instead, such data can be used to modify pumping
parameters. Sensors can be, for example disposed at a portion of
the breast shield 214 that is likely to contact breast tissue. In
addition or instead, such sensors can detect if the user's skin is
dehydrated, stiff, or otherwise indicative of too much or too
little fluid within the body. Such data can be used as an
indication of dehydration or low milk supply. With the information,
the processor 124 can predict the remaining time to fully express
the milk from the breast. Further, the determination can facilitate
the user knowing if the breast is substantially empty, which can
reduce the incidence of mastitis.
[0068] Sensors can further include a location-determining sensors
(e.g., via GPS) for determining a likely altitude (and therefore a
likely atmospheric pressure). In addition or instead, systems can
include an external pressure sensor to determine the atmospheric
pressure directly. Examples can further include a clock or
time-input mechanism, which can be used to determine a current time
of day. The time of day can be used to recognize if a user is
pumping in the morning, midday, evening, night, or any other time.
The time of day can then be correlated to the pumping pattern for
that user based on prior daily patterns of pumping at those times.
In some instances, longer suction waveforms can be used to
facilitate the expression of milk at later times of the day as more
retained milk is held in the back parts of the breast.
Additionally, different times of the day can indicate different
cycles of stimulation phase and expression which can be helpful to
create more letdowns and produce more milk. Wavelengths can be
modulated in accordance with time or any other variables
incorporated into a processor to adjust the wavelengths of the
pumping curve within a single pumping session or even between
pumping sessions at different times of the day or year. In
addition, temperature sensors can be included in the system, such
as ambient air temperature sensors or skin temperature sensors as
an indicator of receptivity to letdown or provide another
parameter. Such data can also be used to determine which suction
pattern should be used by the breast pump system 100 given those
environmental parameters (e.g., to encourage fast and comfortable
pumping).
[0069] Other sensors for electrical impedance, capacitance,
resistance, ultrasonic wave measurement, and or electrical nerve
conduction or blood flow can help determine if there is letdown,
such that electrical signals are firing which can be measured.
Further, the opening of the milk ducts can be directly measured by
changes in features such as but not limited to diameter or
dielectric constants.
[0070] Among the kinds of sensors that can be used are
electrode-based sensors (see, e.g., FIG. 4, FIG. 7, and FIG. 14),
optical sensors (see, e.g., FIG. 5, FIG. 9, and FIG. 13), and
magnetic sensors (see, e.g., FIG. 7), among others. The sensors
112, 128 can be disposed in any of a variety of locations, such as
proximate the breast shield 214 (See, e.g., FIGS. 4-6), proximate
the valve 224 (See, e.g., FIGS. 7-9), proximate the container 212
(see, e.g., FIG. 12 and FIG. 13), proximate the diaphragm 222 (See,
e.g., FIG. 14), in other locations, or combinations thereof. In
addition sensors that are separate from the milk collection
apparatus 110 and the pump console 120 can be used, such as via a
consumer computing device (see, e.g., FIG. 10) or a separate
measuring device (see, e.g., FIG. 11). These examples
implementations are described in further detail in conjunction with
FIGS. 4-14, below.
[0071] FIG. 4 illustrates an example milk collection apparatus 110
having one or more sensors 112 configured as electrodes. In an
example, the electrodes can be configured as a capacitive flow
meter with impedance sensing (both real and imaginary) from direct
current to radiofrequency. In particular, the illustrated milk
collection apparatus 110 includes a sensor 112 that includes an
excitation electrode 402 and a sensing electrode 403. As
illustrated, the electrodes 402 403 are disposed across from each
other along a fluid flow path of the milk collection apparatus. In
particular, the illustrated configuration shows the electrodes 402,
403 disposed on or in the breast shield 214. In other examples, the
electrodes 402, 403 can be disposed elsewhere, such as proximate
the anterior chamber or the valve 224. The excitation electrode 402
and the sensing electrode 403 can cooperate to generate and sense
electric fields to measure fluid flow across a flow channel of the
milk collection apparatus 110. For example, the presence of milk
can affect the electric field. The effects of the milk on the
electric field can be sensed and used to modify operation of the
pump 122 or other components of the breast pump system 100. As
such, the electrodes 402, 403 can cause a signal to be sent to the
processor 124. The data can be used by the processor 124 to change
pumping parameters (e.g., different types of vacuum patterns,
actuation levels, time scales, or oscillation patterns).
[0072] In addition to or instead of the sensors 112 configured to
detect properties of milk flowing into the collection apparatus
110, the sensors 112 can also be configured to detect the presence
of nipple or breast tissue in the apparatus 110 and measure the
distance the tissue distends into the apparatus 110 when suction is
applied.
[0073] FIG. 5 illustrates an example milk collection apparatus 110
having one or more sensors 112 configured as optical sensors. In an
example, the optical sensors can be configured to provide an inline
flow meter. The one or more optical sensors 112 include one or more
light sources 502 and one or more photodetectors 503. The one or
more light sources 502 and one or more photodetectors 503 can
cooperate to measure whether and to what extent material passes
between the light sources 502 and the one or more photodetectors
503. For instance, the one or more light sources 502 can be
configured as one or more visible or non-visible spectrum light
emitting diodes positioned on the breast shield 214, and the one or
more photodetectors can be positioned such that milk flowing
through the collection apparatus 110 disrupts a signal measured by
the one or more photodetectors 503. The effect on the light
received by the photodetectors 503 can be measured to facilitate
the measurement of an amount of milk or a milk flow rate. While the
above example is described in the context of visible light,
non-visible wavelengths can be used in addition to or instead of
visible light.
[0074] FIG. 6 illustrates an example milk collection apparatus 110
having one or more sensors 112 attached proximate the breast shield
214. In particular, the illustrated milk collection apparatus 110
includes an outer ring 603 having one or more sensors or detectors
602 disposed on or within the ring 603. The ring 603 can be
disposed outside of a fluid flow path of the milk collection
apparatus 110. The one or more sensors and detectors 602 can be
configured to generate light, electrical fields, magnetic fields,
or other signals across a fluid flow path for detection and use in
detecting characteristics present in a fluid flow path. In an
example, the one or more sensors 112 can include magnetic sensors,
dielectric sensors, electrical field excitation sensors, photo
sensors, other non-contact external sensing mechanisms, or
combinations thereof. The sensors 112 can be used to sense the
movement of fluid magnitude and or timescale which would help the
pump system 100 determine how the system 100 is operating relative
to the production of milk. The ring 603 can be detachable from the
breast shield 614.
[0075] FIG. 7 demonstrates an example valve 224 having a sensor
112. As illustrated, the sensor 112 is configured as an excitation
electrode 702 on one side of a flap opening of the valve 224 and a
sensing electrode 704 on a second side of the flap opening. When
each these flaps are actuated or moved apart, milk can be detected
and measured as it moves through the valve 224. In an example, the
sensor 112 is configured to measure an amount of time or extent to
which the valve is open, which can be used to determine an estimate
of the volume or flow rate of fluid passing through the valve 224.
The sensor 112 can be configured as an impedance
(resistive/capacitive/inductive) sensor. A signal from the sensor
112 can be transmitted to the pump console 120 to provide input for
a software algorithm for use in determining operation of the breast
pump system 100.
[0076] FIG. 8, which is made up of FIGS. 8A and 8B illustrate an
example milk collection apparatus 110 having a sensor 112
configured as a magnetic sensor 811 disposed proximate a magnetic
component 808 of the valve 224 (e.g., the valve 224 can be a
duckbill valve having at least two flaps and one or more of the
flaps can have a magnetic component 808). The magnetic sensor 811
can be configured to detect movement of the magnetic component 808.
As the valve 224 actuates open and closed with flow of milk into
the container 212, the magnetic component 808 can move, and the
movement can be detected with the magnetic sensor 811 to produce
data. The produced data can be transmitted to the pump console 120
via the transmitter 803. The magnetic sensor 811 can be disposed on
or in a cuff or top of the container 212. The magnetic sensor 811
can be in communication with a transmitter 803 of the apparatus
110. The transmitter 803 is in wired or wireless communication with
the pump console 120. The magnetic component 808 can be magnetic,
ferromagnetic, or metallic component that can affect the current
and or voltage in an outer sensor ring such that as the valve 224
is manipulated to open or close, the sensor 811 can provide a
signal that (along with a timestamp) can be used to approximate the
amount or magnitude of fluid or fluid pulses that enter the
container 212.
[0077] FIG. 9, which is made up of FIGS. 9A and 9B, demonstrates an
example milk collection apparatus 110 having a sensor 112
configured as a light detector 906. The valve 224 has transparent
or semi-transparent sides 902. The apparatus 110 includes a light
source 904 configured to transmit a wavelength of energy or light
through the valve 224 to the light detector 906. The extent to
which the transmitted wavelength of energy is affected as it passes
from the light source 904 through the valve 224 to the detector can
be used to infer the presence of a milk in the valve as well as the
amount of milk therein. One or both of the light source 904 and
light detector 906 can be disposed proximate the valve 224 via a
ring 908. The ring 908 can be or attach to a cuff or top of the
container 212. The ring 908 can further include a transmitter 910.
The transmitter 910 can be in wired or wireless communication with
the pump console 120. The data generated by the light detector 906
can be provided to the transmitter 910 for sending the data to the
processor 124 via a wired or wireless connection for processing.
Depending on the power and wavelength emitted by the light source
904 and detected by the light detector 906, the molecular
composition, fat content, protein content, carbohydrate content,
water content, nutritional content, other content, or combinations
thereof of the milk in the valve 224 can be determined and recorded
in real time as the milk passes through the valve 224. This data
can help inform the pump console 120, for example, if the milk is
from the front of the breast (e.g., foremilk) or the back of the
breast (e.g., hindmilk) with a varied fat and other nutrient
content shift over time. In addition or instead, the data can
relate to movement of the valve 224, which can be used to infer an
amount of fluid passing through the valve.
[0078] FIG. 10 illustrates the use of a mobile device 1000 with a
camera as a sensor 112 to capture an image 1010 of the container
212 or another component of the milk collection apparatus 110.
Video or image data obtained from the camera can be analyzed to
determine the fullness of the container 212. The data can also be
used to determine a rate at which the container 212 is filling with
milk. In an example, the image 1010 can be analyzed using a
machine-vision algorithm. In an example, the container 212 can
include volume markings and a machine-vision algorithm can be
configured determine a volume marking most proximate to the milk
level in the container 212 to determine the amount of milk in the
container. In an example, the machine-vision algorithm is
programmed using the OPENCV library or another machine vision
library. In addition or instead, the visual qualities of the milk
can be analyzed to determine properties of the milk (e.g., whether
the milk is foremilk or hindmilk).
[0079] FIG. 11 illustrates the use of a weight sensor 1100 as a
sensor 112 to determine an amount of milk in the container 212. For
example, the container 212 can be placed on a scale or other weight
sensor 1100. The reading from the scale can automatically or
manually be provided to the one or more processors 124 for
modifying the pumping parameters.
[0080] FIG. 12 illustrates a milk collection apparatus 110 having a
sleeve 1200 having one or more sensors 112 disposed thereon or
therein to determine an amount of milk in the container 212. The
sensors 112 can include one or more sensors as described herein,
such as one or more electrical, magnetic, impedance, and or other
sensors to determine the level of fluid in the collection
container. The sleeve 1200 is sized and shaped to couple with or
fit around the container 212. In some examples, the sleeve 1200 can
be built into the container 212. Alternatively, the sleeve 1200 can
be discrete from the container.
[0081] FIG. 13 illustrates a milk collection apparatus 110 having a
holder 1300 for a container 212. The holder 1300 includes one or
more light sources 1310 and one or more light sensors 1320. The
light produced by the light sources 1310 can be transmitted through
the container 212, reflected off of one or more reflectors 1330 and
returns to be detected by the one or more light sensors 1320. The
light is modified as it passes through the container 212 and any
material contained therein. The properties of the received light
can be analyzed to determine properties of the milk in the
container 212. The reflectors 1330 can be discrete reflector
components disposed within a component of the apparatus 110.
Alternatively the reflector 1330 can be a component of the
apparatus 110 having natural reflectivity. Although light is
described, the source 1310, the sensors 1320, and the reflectors
1330 can be configured to operate using any of a variety of
wavelengths of energy and need not be limited to the visible
spectrum.
[0082] FIG. 14 illustrates an example milk collection apparatus 110
having a sensor 112 configured to measure deflection of the
diaphragm 222. In examples, an excitation electrode is disposed on
the diaphragm 222 and a detection electrode is disposed on or
within the vacuum housing 220 or vice versa. The rate and magnitude
of deflection can be used to determine the pressure relationship to
milk in the anterior chamber 320 of the apparatus 110 prior to the
milk flowing through the valve 224 into the container 212 when a
source of suction is applied. Displacement of the diaphragm 222 can
be measured using, for example, capacitance as surrogate to measure
expressed milk flow rate by measuring increase and decrease in
capacitance as the diaphragm moves closer to the sensing electrode
and farther away from it with changes in pressure.
[0083] The data from one or more of the above sensors can be used
to modify operation of the system 100. Further, the pump 122 or
other components of the system 100 can act as sensors themselves.
For example, the behavior of the pump 122 (e.g., current draw,
voltage, time needed to reach a target voltage, etc.) can act as a
sensor itself and the produced data can be used to infer
information regarding milk expression, pressure in the system, or
other events. An example pump waveform that indicates an amount of
milk expressed is shown in FIG. 15.
Determining Milk Expression Using Pumping Characteristics
[0084] FIG. 15 illustrates a waveform 1502 that can be produced by
the processor 124 and used to control the operation of the pump
122. The illustrated waveform 1502 a high signal corresponding to a
motor on condition and a low signal corresponding to a motor off
condition of a motor of the pump 122. The duty cycle of the
waveform 1502 can be expressed as a percentage representing the
relative amount time spent in a motor on condition compared to a
motor off condition in a single cycle. The waveform 1502 can be
produced by the processor 124 to control the operation of the pump
122. Although illustrated as a square waveform having binary motor
on and motor off states, the waveform 1502 can take other forms,
including sine, triangle, or saw tooth configurations.
[0085] The figure further illustrates how the properties of the
waveform 1502 can be analyzed to determine an amount of milk in the
system. For example, the processor 124 can be configured to
maintain a particular vacuum pressure, such as during a hold period
(see, e.g., FIG. 16). If there is expressed milk in the system
(e.g., in the anterior chamber above the valve 224), the free
volume is reduced, so the pump 122 does not need to work as hard to
maintain the pressure. This reduction in effort can be seen in a
relative amount of time spent in the motor on condition per cycle
compared to the amount of time spent in the motor off condition of
the cycle. As can be seen, less amount of time is needed in the
motor on condition to maintain the same pressure. As such, a
difference in the amount of time can allow the system to determine
the volume in the anterior chamber, which can correlate to an
amount of milk being present. In alternative examples, the relative
amount of time spent in a motor on condition can be used across
variable pressure examples as well, such that the time, power,
vacuum are measured and accounted for.
[0086] In addition or instead of the relative amount of time being
used, the amount of current consumed by the pump 122 or other pump
122 usage characteristics can be used as a measure to determine
various parameters, such as a milk flow rate, a volume of milk
expressed, or a pressure within the system. The pump can be driven
in a closed-feedback to maintain constant voltage across the pump,
while measuring the amount of current consumed by the pump. If
there is expressed milk in the valve system, the amount of current
consumed will at least temporarily decrease due milk occupying
space in the anterior chamber volume making the pump 122 need to
draw less current to cause a particular pressure change in the
anterior chamber. Thus the changes in the current draw of the pump
122 can be tracked and used to determine an amount of milk
expressed (e.g., by allowing the system to determine an amount of
milk in the anterior chamber of each cycle).
[0087] Another technique can include the use of a feedback loop to
drive the motor of the pump 122 at a constant voltage while
measuring the current consumed by the motor. As milk accumulates in
the anterior chamber, the motor does not need to work as hard to
maintain the pressure, so the current consumed during the waveform
can be used as a surrogate measure of the amount of milk
accumulated in the duckbill valve. This power or current
measurement can be used as stand-alone measure or as an additional
factor for the algorithm to increase the accuracy of prediction for
the milk flow rate and or the total accumulated volume.
Waveforms
[0088] FIG. 16 illustrates example breast pump waveforms
represented over a multitude of vacuum waveforms 1601. The
waveforms 1601 are shown in terms of pressure over time. A first
waveform 1602 is represented in a solid line and relates to a pump
having a 100% duty cycle and 100% vacuum. A second waveform 1604 is
represented with a long-dash line and relates to a pump having a
100% duty cycle and 75% vacuum. A third waveform 1606 is
represented with a short-dash line and relates to a pump having a
50% duty cycle and 75% vacuum. The pressure is relative pressure
within a portion of the breast pump system compared to a pressure
of the environment outside of the breast pump system. The figure
further shows a change in the waveforms 1601 over a cycle 1610. The
cycle 1610 can be a discrete sequence of pump activity, such as can
be controlled by the processor 124 via the production of a
waveform, such as the one shown in FIG. 15. The illustrated cycle
1610 includes different periods, including a ramp period 1612, a
hold period 1614, a release period 1616, and a delay period
1618.
[0089] The ramp period 1612 is a period of decreasing pressure,
such as caused by activating the vacuum pump 122. During the ramp
period 1612, the processor 124 can send a control signal to the
pump 122 to cause the pump to activate in such a way as to decrease
pressure in a portion of the system. In examples, the ramp period
1612 can be a fixed period of time or the ramp period 1612 can
depend on an amount of time that the system takes to reach a
particular pressure. A release valve (e.g., as controlled by the
solenoid 126) can remain closed during the ramp period 1612 to help
maintain the relatively low pressure. The length of the ramp period
1612 can relate to a relative vacuum level provided by the system,
with a long ramp period 1612 resulting in lower pressure than a
relatively shorter ramp period 1612. Thus, the ramp period 1612 can
depend on a vacuum level setting. For example, as shown, the first
waveform 1602 has a 100% vacuum (e.g., a maximum vacuum setting)
level and a relatively longer ramp period 1612 compared to the
second waveform 1604 and the third waveform 1606, which both have a
vacuum level of 75%. The ramp period 1612 of the pump can affect
the perceived comfort and perceived suction to the user. A very
fast ramp period 1612 can give the user the perception of a strong
suction, even though the end pressure may be the same as a
relatively longer ramp period 1612. A slow ramp period 1612 can
result in more comfort to the user.
[0090] The delay period 1618 is a period following the ramp period
1612 and prior to the release period 1616, during which the
pressure remains relatively low. The delay period 1618 can be a
period of time during which the pump 122 is inactive or during
which the pump 122 operates at a reduced rate compared to the ramp
period 1612. A release valve (e.g., as controlled by the solenoid
126) can remain closed during the ramp period 1612 to help maintain
the relatively low pressure. As shown in FIG. 16, an amount of milk
expressed during the hold period 1614 can cause a measurable change
in pressure from the beginning of the hold period 1614 to the end
of the hold period 1614. For example, the pressure in the anterior
chamber of the milk collection apparatus can change from nominal
pressure to a higher pressure as a result of milk flowing into the
chamber due to a reduction in the free air volume in the chamber.
This change in pressure can be detected and used to infer an amount
of milk expressed. In examples, the hold period 1614 can be fixed
or independently controllable (e.g., the hold period 1614 need not
vary based on vacuum level or duty cycle).
[0091] The ramp period 1612 and particularly the hold period 1614
are time periods during which a highest amount of milk is expected
to be expressed. Thus modifying the length of the ramp period 1612
(which can affect a vacuum level used to express milk) and the
length of the hold period 1614 can affect an amount of milk
produced. While a low pressure can cause more milk to be expressed,
it can also cause discomfort for the mother.
[0092] The release period 1616 is a period following the hold
period 1614 during which a vacuum in the system is allowed to be
released such that the pressure increases relative to the pressure
during the hold period 1614. During the release period 1616, the
pump 122 can be off and the processor 124 can send a signal to the
solenoid 126 to cause a release valve to be opened. In examples,
the release period 1616 can be fixed or independently controllable
(e.g., the release period 1616 need not vary based on vacuum level
or duty cycle).
[0093] The delay period 1618 can be a period after the release
period 1616 and prior to the end of the cycle 1610. During the
delay period 1618 the pump 122 can be off and the solenoid 126 can
cause the release valve to be closed or open.
[0094] Between cycles 1610 or during cycles 1610 (e.g., during the
delay period 1618), the processor 124 can analyzed data collected
regarding milk production during the periods and modify one or more
parameters to optimize milk production and comfort of the mother
during future cycles. The changes can include, for example
increasing the length of one or more of the periods. Relatively
shorter cycles can be selected for letdown stimulation and
relatively longer cycles can be selected for expression of milk.
For example, while the measured amount of milk is relatively low
(e.g., has not yet satisfied a threshold), the processor 124 can
control the pump 122 to provide letdown stimulation and milk
production satisfies a threshold, the processor 124 can modify
pumping parameters to provide expression stimulation. As described
elsewhere herein, various features or characteristics can be
imparted into waveforms by the pump 122 as the processor 124
detects and adapts to user preferences from input signals on other
measurement devices.
[0095] FIG. 17 illustrates an example waveform 1702. Like waveform
1602, the waveform 1702 includes a vacuum ramp period 1612, a hold
period 1614, and a delay period 1618. Unlike the release period
1616 of the waveform 1602, the waveform 1702 includes a release
period 1720 having a first release period 1722, a minor partial
vacuum plateau period 1724, and a second release period 1726. The
first and second release periods 1722, 1726 can have properties
similar to the release period 1616. The minor partial vacuum
plateau period 1724 can be a time period during which the pressure
does not substantially increase. For example, while a release valve
can be open during the first release period 1722, the release valve
can be closed at the start of the plateau period 1724. The plateau
period 1724 can be imparted into the waveform 1702 by an adaptive
process (e.g., a software algorithm) of the pump console that
adjusts the waveform 1702 in accordance with sensor feedback from
the pump 122 to extract milk. The waveform 1702 can be cycled again
or followed by other kinds of waveforms.
[0096] FIG. 18 illustrates an example breast pump vacuum waveform
1802 with vibrational patterns added. As with FIG. 17, this
waveform 1802 includes a cycle 1710 having a vacuum ramp period
1612, a first hold period 1614, a first release 1722, a minor
partial vacuum plateau period 1724, a second release period 1726,
and a delay period 1618. The vibrational pattern can be added by,
for example, the processor 124 causing the solenoid 126 to
repeatedly open and close the release valve. While the release
valve, the pump 122 can be deactivated to conserve energy. And as
illustrated, during the hold period 1614, plateau period 1724, and
delay period 1618, while the pump 122 may typically be disabled,
the pump 122 can be activated to return pressure to a relatively
steady state.
[0097] Additional example waveforms that can be used are described
in U.S. 62/727,909, which is tilted "Vibratory Waveform for Breast
Pump", and which is hereby incorporated by reference herein in its
entirety for any and all purposes. The configuration of the
waveforms and the cycles provided by the system 100 can be
configured to match particular milk expression patterns of the
users. Example milk expression patterns are described in more
detail in FIG. 19.
Milk Expression Patterns
[0098] FIG. 19 illustrates four example categories of milk
expression patterns. Different users can express milk in different
patterns. The technology described herein can be used to identify
to which category the mom belongs and optimize the pumping waveform
based thereon. For example, the system can switch between
stimulation and expression mode to reduce the total breast pumping
time.
[0099] As illustrated, a category A user can typically experience a
first and only letdown after approximately 240 seconds of pumping.
Then the user will empty most of her breast within the next 60
seconds. So to optimize pumping for this kind of user, the system
can operate in a stimulation mode for approximately 240 seconds (or
until milk expression is detected). Then the system can switch to
an expression mode. Once the amount of milk expressed drops below a
threshold amount, then the pump can indicate pumping is
complete.
[0100] A category B user can typically experience a small letdown
within the first sixty seconds, and then have another letdown every
approximately two minutes thereafter, with the user's breast being
fully empty within approximately six minutes. To optimize pumping
for this user, the system 100 can operate in a stimulation mode for
approximately sixty seconds (or until milk expression is detected)
and then operate in an expression mode until the amount of milk
expressed drops below a threshold amount. Then the system can
switch back to the stimulation mode and repeat the process for a
certain amount of time (e.g., six minutes) or until the amount of
milk expressed while operating in an expression mode drops below a
threshold.
[0101] A category C user tends to have a relatively continuous
letdown and can require approximately ten minutes to empty her
breast. Thus, the system can optimize pumping for this user by
providing a stimulation mode, switching to an expression mode once
milk expression is detected and continue to operate in the
expression mode until the milk expression drops below a
threshold.
[0102] A category D user can have a relatively large letdown within
the first minute and have small letdowns every subsequent two
minutes and will require approximately ten minutes to empty most of
her breast. To optimize for a category D user, the system can start
in stimulation mode for the first minute and switch to expression
once the pump detects milk expression. Once the amount of milk
expressed drops below a threshold, the pump can will switch back to
stimulation mode. This process can be repeated for 5 times to
ensure that breast milk is emptied from the breast.
[0103] The system can detect to which category the user belongs
based on analyzing a cumulative amount of weight or flow rate of
the user over time and comparing the results to known categories
(e.g., by fitting a curve corresponding to a category to the flow
rate and/or weight). In other examples, the system can receive
input from the user indicating to which category the user belongs.
The system can then store category information and operate
according to the user's category.
[0104] An overall example process for operating the breast pump
system 100 is described in FIG. 20.
Example Process
[0105] FIG. 20 illustrates example instructions 2000 implementing a
process 2002. Although shown as being implemented with instructions
2000, the operations of the process 2002 can be performed using one
or more circuits configured to perform operations without needing
instructions 2000 to be executed. The process 2002 can begin with
operation 2010. In some examples, the process 2002 can begin
responsive to the pump console 120 being powered on or the system
detecting that a user pressed a start button.
[0106] Operation 2010 includes operating the breast pump system 100
using parameters. The parameters include the parameters described
herein and can correspond to values stored by the pump console 120
and used by the processor 124 to control operation of the pump
system 10.
[0107] In an example, the two primary components used to operate
the breast pump system are the pump 122, which creates a vacuum
within the system and the solenoid 126, which releases the vacuum.
Both the pump 122 and the solenoid 126 can be controlled via
signals from the processor 124. The processor 124 can generate such
signals based on a wide variety of parameters.
[0108] The parameters that can be changed include length of the
cycle 1710, length of the ramp period 1612, length of the hold
period 1614, length of the release period 1616, length of the delay
period 1618, maximum pressure level, maximum vacuum level, minimum
pressure level, minimum vacuum level, vibration patterns, presence
of plateaus during the cycle 1600 (see, e.g., FIG. 17), slope of
pressure changes over time during the ramp period 1612 or release
period 1616, other features or combinations thereof.
[0109] Parameters can exist at relatively high and relatively low
levels, with some parameters controlling the values of other
parameters. For example, the pump can have a parameter that
specifies a particular phase of pumping in which the breast pump
system 100 is operating. For instance, the breast pump system 100
selectively operate in a stimulation phase or an expression phase.
The stimulation phase can be a phase configured to stimulate a
breast to produce milk and the expression phase can be a phase
configured to facilitate the extraction of milk once milk begins to
be expressed in the stimulation phase. The phase in which the
breast pump system 100 operates can affect other parameters. For
example, a stimulation phase can have relatively shorter waveform
cycles and the expression phase can have relatively longer waveform
cycles as specified by one or more different parameters associated
with each type of phase. Following operation 2010, the flow of the
process 2002 can move to operation 2020.
[0110] Operation 2020 includes obtaining data from one or more
sensors. This operation 2020 can include the processor 124
receiving data from one or more sensors 112 of the milk collection
apparatus 110, one or more sensors of 128 the pump console 120,
other sensors, or combinations thereof. The data can include
measurements directly or indirectly obtained by the one or more
sensors regarding the milk collection apparatus. For example, a
sensor 128 within the pump console 120 can be used to measure a
power draw of the one or more pumps 122, which can be used to
measure an amount of milk in the milk collection apparatus 110. In
this example, while the sensor 128 directly measures power draw of
the one or more pumps 122, the obtained measurements themselves can
be used by the processor 124 to measure an amount of milk in the
anterior chamber 320 of the milk collection apparatus 110. Thus,
the sensor 128 can be considered to directly measure power draw and
indirectly measure the amount of milk because the amount of milk is
correlated to the power draw. In some examples, this operation 2020
includes receiving data pushed from the sensors, in other examples,
this operation 2020 can include sending requests for data from the
sensors. The operation 2020 can include determining characteristics
of expressed milk, such as milk flow rate or volume. The operation
2020 can include causing the sensors to obtain data. Following
operation 2020, the flow of the process 2002 can move to operation
2030.
[0111] Operation 2030 includes modifying the parameters based on
the obtained data. The operation 2030 can include modifying the
parameters directly based on the obtained data, or the operation
2030 can include processing (e.g., analyzing) the obtained data and
using the processor 124 and modifying the parameters based on the
processing.
[0112] In an example, the processing includes comparing at least
some of the data with a threshold and, responsive to the threshold
being satisfied, modifying one or more parameters. In many
examples, the modifying is performed based on whether and to what
extend the obtained data indicates the production of milk. This can
include data indicating a volume of milk collected or a rate at
which milk is being collected. As described above, the modifying of
the parameters can be configured to stimulating a breast to express
milk, obtain milk from the breast once milk is expressed, and then
stop pumping once a sufficient amount of milk has been expressed.
The modifying can be based on real-time data obtained from the
sensors. The modifying can be further based on comparisons of
current data with previous data stored in the system (e.g., stored
in the memory 132).
[0113] The processing can be based on, for example, statistical
analysis. In some examples, the processing is based on changes in
data over time, such as a rate of change in pressure, current draw,
estimated flow rate, or other data obtained by or inferred from the
sensors. In some examples, the processing can be performed with a
machine learning algorithm trained to produce output based on data
provided as input. For example, any of a variety of
machine-learning or artificial intelligence algorithms can be used,
such as simulated annealing or genetic algorithms. To use those
algorithms, each of the various parameters are randomly adjusted
simultaneously in each cycle, and the unique parameters to each
individual person that influence the rate of expression are found.
For example, the algorithms can be trained in real time on how the
change in parameters affect the volume of milk produced. Over time,
the algorithms become customized to the particular user.
[0114] In an example, a genetic algorithm can be used. Tuning of
parameters using a genetic algorithm can occurs over one or more
sessions. In an example implementation, various parameters are
initially randomly chosen and constitute the search space (which
can be constrained by comfort and safety) defined as Session S1. A
parameter from the search space for S1 can be chosen for each cycle
or for n-amount of cycles, and the flow rate is measured. For the
next Session S2, the top-n parameters that result in the highest
flow rates are selected for breeding the next generation of
parameters for Session S2. For the n settings, the system can
randomly generate nC2 pairs between the parameters. For each pair
(e.g., corresponding to a father and mother), i children will be
randomly generated with each child will having half of its
parameters from the father and half from the mother. Which
parameters from the mother and the father that gets passed down to
the children can be at least pseudorandom. These children
constitute the search space for Session S2. At the completion of
Session S2, the top-n parameters that resulted in the highest flow
rate for this session can be selected for breeding the next
generation of parameters for Session S3. As such, the system can
learn from the user over multiple sessions. The search space and
performance for each setting can be stored in memory the device or
at an external location (e.g., a removable memory device, a mobile
device, at a server, or another location) and can be unique to each
user. The system can also generate an aggregate model from many
users, to create a model that can work decently well for a subset
of users. For example, one hundred users can use different pumps
simultaneously, and the system can leverage the parallel users to
iterate through the search space much faster to generate a
generalizable model. This allows the system to search in a larger
search space, which can allow for not only rise time, pressure,
hold time, delay, but also unique waveforms as well. Models can be
shared between pumps to generate a generalizable model via a
network (e.g., the Internet, via BLUETOOTH, or another
communication medium).
[0115] Following operation 2030, the flow of the process 2002 can
return to operation 2010.
[0116] Although this detailed description has set forth certain
embodiments and examples, the present disclosure extends beyond the
specifically disclosed embodiments to other alternative embodiments
and/or uses of the embodiments and modifications and equivalents
thereof. Thus, it is intended that the scope of the present
disclosure should not be limited by the particular disclosed
embodiments described above.
* * * * *