U.S. patent application number 15/450576 was filed with the patent office on 2017-06-22 for method, apparatus, and system for expression and quantification of human breast milk.
The applicant listed for this patent is Naya Health, Inc.. Invention is credited to Janica B. Alvarez, Jeffery B. Alvarez, Jan Rydfors.
Application Number | 20170173235 15/450576 |
Document ID | / |
Family ID | 51569653 |
Filed Date | 2017-06-22 |
United States Patent
Application |
20170173235 |
Kind Code |
A1 |
Alvarez; Jeffery B. ; et
al. |
June 22, 2017 |
METHOD, APPARATUS, AND SYSTEM FOR EXPRESSION AND QUANTIFICATION OF
HUMAN BREAST MILK
Abstract
Disclosed herein are devices, systems, and methods for the
expression and collection of breast milk. A device in accordance
with embodiments comprises an actuatable assembly and a breast
interface configured to engage a breast and fluidly seal
thereagainst. The breast interface comprises a movable member
disposed within at least a portion of the breast interface. The
device further comprises a tensile element operatively coupling the
actuatable assembly to the movable member. Actuation of the
actuatable assembly applies a tensile force to the tensile element,
and the tensile element transmits the tensile force to the movable
member to move the movable member away from the breast, thereby
applying negative pressure to the breast to express milk
therefrom.
Inventors: |
Alvarez; Jeffery B.;
(Redwood City, CA) ; Alvarez; Janica B.; (Redwood
City, CA) ; Rydfors; Jan; (San Mateo, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Naya Health, Inc. |
Redwood City |
CA |
US |
|
|
Family ID: |
51569653 |
Appl. No.: |
15/450576 |
Filed: |
March 6, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14221113 |
Mar 20, 2014 |
9616156 |
|
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15450576 |
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61804722 |
Mar 24, 2013 |
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61879055 |
Sep 17, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 1/0068 20140204;
A61M 1/066 20140204; A61M 1/064 20140204; A61M 1/06 20130101; A61M
1/062 20140204; A61M 2205/10 20130101; A61M 1/0025 20140204 |
International
Class: |
A61M 1/06 20060101
A61M001/06; A61M 1/00 20060101 A61M001/00 |
Claims
1. A device for expression and collection of breast milk, said
device comprising: an actuatable assembly; a breast interface
configured to engage a breast and fluidly seal thereagainst, the
breast interface comprising a movable member disposed within at
least a portion thereof; and a tensile element operatively coupling
the actuatable assembly to the movable member, wherein the tensile
element is disposed within an axial load absorbing member, wherein
actuation of the actuatable assembly applies a tensile force to the
tensile element, and wherein the tensile element transmits the
tensile force to the movable member to move the movable member away
from the breast, thereby applying negative pressure to the breast
to express milk therefrom, and wherein the axial load absorbing
member is axially stiff to absorb reactive forces of the tensile
element during application of the tensile force to the tensile
element.
2. The device of claim 1, wherein the tensile element extends
continuously between the movable member and the actuatable
assembly.
3. The device of claim 1, wherein the tensile element comprises a
cable, wire, or rope.
4. The device of claim 1, wherein the axial load absorbing member
comprises a tube or coil having an axially stiff geometry to absorb
the reactive forces of the tensile element.
5. The device of claim 1, wherein the device further comprises a
tube extending between the breast interface and the actuatable
assembly, and wherein the tensile element and the axial load
absorbing member are disposed within the tube.
6. The device of claim 5, wherein the tensile element is
concentrically disposed within the axial load absorbing member, and
wherein the axial load absorbing member is concentrically disposed
within the tube.
7. The device of claim 1, wherein the breast interface further
comprises an interface housing having the movable member disposed
therein, and the actuatable assembly further comprises a driving
element and an assembly housing having the driving element disposed
therein, wherein the tensile element comprises a first end coupled
to the movable member and a second end opposite the first end and
coupled to the driving element, and wherein the axial load
absorbing member comprises a first end coupled to the interface
housing and a second end opposite the first end and coupled to the
assembly housing.
8. The device of claim 1, further comprising a driving mechanism
releasably coupled with the actuatable assembly, wherein the
actuatable assembly comprises a driving element, and wherein
actuation of the driving mechanism displaces the driving element
from a rest position to move the movable member away from the
breast or replaces the driving element to the rest position to move
the movable member toward the breast.
9. The device of claim 1, wherein the movable member comprises a
deformable member configured to fluidly seal against the
breast.
10. The device of claim 9, wherein the movable member comprises a
flexible membrane.
11. The device of claim 10, wherein the flexible membrane comprises
a corrugated region configured to expand and collapse.
12. A device for expression and collection of breast milk, said
device comprising: an actuatable assembly; a breast interface
configured to engage a breast and fluidly seal thereagainst, the
breast interface comprising a movable member disposed within at
least a portion thereof; and a tensile element operatively coupling
the actuatable assembly to the movable member, the tensile element
extending continuously between the movable member and the
actuatable assembly, wherein actuation of the actuatable assembly
applies a tensile force to the tensile element, and wherein the
tensile element transmits the tensile force to the movable member
to move the movable member away from the breast, thereby applying
negative pressure to the breast to express milk therefrom.
13. The device of claim 12, wherein the tensile element comprises a
cable, wire, or rope.
14. The device of claim 12, wherein the device further comprises an
axial load absorbing member, and wherein the tensile element is
disposed within the axial load absorbing member that is axially
stiff to absorb reactive forces of the tensile element during
application of the tensile force to the tensile element.
15. The device of claim 14, wherein the axial load absorbing member
comprises a tube or coil having an axially stiff geometry to absorb
the reactive forces of the tensile element.
16. The device of claim 14, wherein the device further comprises a
tube extending between the breast interface and the actuatable
assembly, and wherein the tensile element and the axial load
absorbing member are disposed within the tube.
17. The device of claim 16, wherein the tensile element is
concentrically disposed within the axial load absorbing member, and
wherein the axial load absorbing member is concentrically disposed
within the tube.
18. The device of claim 14, wherein the breast interface further
comprises an interface housing having the movable member disposed
therein, and the actuatable assembly further comprises a driving
element and an assembly housing having the driving element disposed
therein, wherein the tensile element comprises a first end coupled
to the movable member and a second end opposite the first end and
coupled to the driving element, and wherein the axial load
absorbing member comprises a first end coupled to the interface
housing and a second end opposite the first end and coupled to the
assembly housing.
19. The device of claim 12, further comprising a driving mechanism
releasably coupled with the actuatable assembly, wherein the
actuatable assembly comprises a driving element, and wherein
actuation of the driving mechanism displaces the driving element
from a rest position to move the movable member away from the
breast or replaces the driving element to the rest position to move
the movable member toward the breast.
20. The device of claim 12, wherein the movable member comprises a
deformable member.
21. The device of claim 20, wherein the movable member comprises a
flexible membrane.
22. The device of claim 21, wherein the flexible membrane comprises
a corrugated region configured to expand and collapse.
Description
CROSS-REFERENCE
[0001] The present application is a continuation of U.S. patent
application Ser. No. 14/221,113, filed on Mar. 20, 2014 [Attorney
Docket No. 44936-703.201], which claims the benefit of U.S.
Provisional Patent Application No. 61/804,722, filed on Mar. 24,
2013 [Attorney Docket No. 44936-703.101] and U.S. Provisional
Patent Application No. 61/879,055, filed on Sep. 17, 2013 [Attorney
Docket No. 44936-703.102], the entire contents of which are
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention generally relates to medical devices
and methods, and more particularly relates to devices and methods
for expression and collection of human breast milk.
[0004] The exemplary embodiments disclosed herein are preferably
directed at expression of breast milk, but one of skill in the art
will appreciate that this is not intended to be limiting and that
the devices, systems and methods disclosed herein may be used for
other treatments requiring application of a differential
pressure.
[0005] Breast pumps are commonly used to collect breast milk in
order to allow mothers to continue breastfeeding while apart from
their children. Currently, there are two primary types of breast
pumps: manually-actuated devices, which are small, but inefficient
and tiring to use; and electrically-powered devices, which are
efficient, but large and bulky. Therefore, it would be desirable to
provide improved breast pumps that are small and highly efficient
for expression and collection of breast milk. Additional features
such as milk production quantification and communication with
mobile devices are further desirable for enhanced user convenience.
At least some of these objectives will be satisfied by the devices
and methods disclosed below.
[0006] 2. Description of the Background Art
[0007] The following US patents are related to expression and
collection of human breast milk: U.S. Pat. Nos.: 6,673,036;
6,749,582; 6,840,918; 6,887,210; 7,875,000; 8,118,772; and
8,216,179.
SUMMARY OF THE INVENTION
[0008] The present invention generally relates to medical devices
and methods, and more particularly relates to devices and methods
for expression and collection of human breast milk.
[0009] In one aspect, a device for expression and collection of
breast milk comprises an actuatable assembly and a breast interface
configured to engage a breast and fluidly seal thereagainst. The
breast interface comprises a movable member disposed within at
least a portion thereof. The de ice further comprises a tensile
element operatively coupling the actuatable assembly to the movable
member, wherein the tensile element is disposed within an axial
load absorbing member. Actuation of the actuatable assembly applies
a tensile force to the tensile element, wherein the tensile element
transmits the tensile force to the movable member to move the
movable member away from the breast, thereby applying negative
pressure to the breast to express milk therefrom. The axial load
absorbing member may be axially stiff to absorb reactive forces of
the tensile element during application of the tensile force to the
tensile element.
[0010] The tensile element may extend continuously between the
movable member and the actuatable assembly. The tensile element may
comprise a cable, wire, or rope.
[0011] The axial load absorbing member may comprise a tube or coil
having an axially stiff geometry to absorb the reactive forces of
the tensile element.
[0012] The device may further comprise a tube extending between the
breast interface and the actuatable assembly, wherein the tensile
element and the axial load absorbing member may be disposed within
the tube. The tensile element may be concentrically disposed within
the axial load absorbing member, and the axial load absorbing
member may be concentrically disposed within the tube.
[0013] The breast interface may further comprise an interface
housing having the movable member disposed therein, and the
actuatable assembly may further comprise a driving element and an
assembly housing having the driving element disposed therein. The
tensile element may comprise a first end coupled to the movable
member and a second end opposite the first end and coupled to the
driving element. The axial load absorbing member may comprise a
first end coupled to the interface housing and a second end
opposite the first end and coupled to the assembly housing.
[0014] The device may further comprise a driving mechanism
releasably coupled with the actuatable assembly, and the actuatable
assembly may comprise a driving element. Actuation of the driving
mechanism may displace the driving element from a rest position to
move the movable member away from the breast, or may replace the
driving element to the rest position to move the movable member
toward the breast.
[0015] The movable member may comprise a deformable member
configured to fluidly seal against the breast. The movable member
may comprise a flexible membrane. The flexible membrane may
comprise a corrugated region configured to expand and collapse.
[0016] In another aspect, a device for expression and collection of
breast milk comprises an actuatable assembly and a breast interface
configured to engage a breast and fluidly seal thereagainst. The
breast interface comprising a movable member disposed within at
least a portion thereof. The device further comprises a tensile
element operatively coupling the actuatable assembly to the movable
member, the tensile element extending continuously between the
movable member and the actuatable assembly. Actuation of the
actuatable assembly applies a tensile force to the tensile element,
and the tensile element transmits the tensile force to the movable
member to move the movable member away from the breast, thereby
applying negative pressure to the breast to express milk
therefrom.
[0017] The tensile element may comprise a cable, wire, or rope.
[0018] The device may further comprise an axial load absorbing
member, and the tensile element may be disposed within the axial
load absorbing member that is axially stiff to absorb reactive
forces of the tensile element during application of the tensile
force to the tensile element. The axial load absorbing member may
comprise a tube or coil having an axially stiff geometry to absorb
the reactive forces of the tensile element. The device may further
comprise a tube extending between the breast interface and the
actuatable assembly, wherein the tensile element and the axial load
absorbing member are disposed within the tube. The tensile element
may be concentrically disposed within the axial load absorbing
member, and the axial load absorbing member may be concentrically
disposed within the tube.
[0019] The breast interface may further comprise an interface
housing having the movable member disposed therein, and the
actuatable assembly may further comprise a driving element and an
assembly housing having the driving element disposed therein. The
tensile element may comprise a first end coupled to the movable
member and a second end opposite the first end and coupled to the
driving element. The axial load absorbing member may comprise a
first end coupled to the interface housing and a second end
opposite the first end and coupled to the assembly housing.
[0020] The device may further comprise a driving mechanism
releasably coupled with the actuatable assembly, wherein the
actuatable assembly may comprise a driving element. Actuation of
the driving mechanism may displace the driving element from a rest
position to move the movable member away from the breast, or
replace the driving element to the rest position to move the
movable member toward the breast.
[0021] The movable member may comprise a deformable member. The
movable member may comprise a flexible membrane. The flexible
membrane may comprise a corrugated region configured to expand and
collapse.
[0022] Other objects and features of the present invention will
become apparent by a review of the specification, claims, and
appended figures.
INCORPORATION BY REFERENCE
[0023] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0025] FIG. 1 is a perspective view of an exemplary embodiment of a
pumping device.
[0026] FIG. 2 is a perspective view of an exemplary embodiment of a
pumping device.
[0027] FIG. 3 is a cross-section of an exemplary embodiment of a
pumping device.
[0028] FIG. 4 illustrates an exemplary embodiment of an actuatable
assembly coupled to a driving mechanism.
[0029] FIGS. 5A-5B illustrate an exemplary embodiment of an
actuatable assembly coupled to a pendant unit.
[0030] FIG. 6 is a cross-sectional view of an exemplary embodiment
of a breast interface.
[0031] FIG. 7 is a cross-sectional view of another exemplary
embodiment of a breast interface.
[0032] FIG. 8A is a cross-sectional view of an exemplary embodiment
of an integrated valve in an open position.
[0033] FIG. 8B is a cross-sectional view of an exemplary embodiment
of an integrated valve in a closed position.
[0034] FIG. 9A is a cross-sectional view of an exemplary embodiment
of integrated sensors within a breast interface.
[0035] FIG. 9B is a cross-sectional view of another exemplary
embodiment of integrated sensors within a breast interface.
[0036] FIG. 10 illustrates an exemplary embodiment of a pendant
unit and a mobile device.
[0037] FIG. 11 illustrates an exemplary embodiment of a pendant
unit in communication with a mobile device.
[0038] FIG. 12 is a cross-sectional view of an exemplary embodiment
of a breast interface with a mechanical deformable member.
[0039] FIG. 13 is a cross-sectional view of an exemplary embodiment
of a mechanical driver for a mechanical deformable member.
[0040] FIG. 14 is a graph illustrating the pump performance of an
exemplary embodiment compared to a commercial device.
[0041] FIG. 15 is a graph illustrating the pumping efficiency of an
exemplary embodiment compared to a commercial device.
DETAILED DESCRIPTION OF THE INVENTION
[0042] Specific embodiments of the disclosed devices and methods
will now be described with reference to the drawings. Nothing in
this detailed description is intended to imply that any particular
component, feature, or step is essential to the invention. One of
skill in the art will appreciate that various features or steps may
be substituted or combined with one another.
[0043] The present invention will be described in relation to the
expression and collection of breast milk. However, one of skill in
the art will appreciate that this is not intended to be limiting,
and the devices and methods disclosed herein may be used in other
applications involving the creation and transmission of a pressure
differential, such as in the treatment of sleep apnea and/or other
remote pressure needs.
[0044] FIG. 1 illustrates an exemplary embodiment of the present
invention. Pumping device 100 includes breast interfaces 105, a
tube 110, and a controller or pendant unit 115 operatively coupled
to breast interfaces 105 through tube 110. Breast interfaces 105
include resilient and conformable flanges 120, for engaging and
creating a fluid seal against the breasts, and collection vessels
125. The device may optionally only have a single breast interface.
Pendant unit 115 houses the power source and drive mechanism for
pumping device 100, and also contains hardware for various
functions, such as controlling pumping device 100, milk production
quantification, and communication with other devices. Tube 110
transmits suitable energy inputs, such as mechanical energy inputs,
from pendant unit 115 over a long distance to breast interfaces
105. Breast interfaces 105 convert the energy inputs into vacuum
pressure against the breasts in a highly efficient manner,
resulting in the expression of milk into collection vessels
125.
[0045] One of skill in the art will appreciate that components and
features of this exemplary embodiment can be combined or
substituted with components and features of any of the embodiments
of the present invention as described below. Similarly, components
and features of other embodiments disclosed herein may be
substituted or combined with one another.
[0046] Hydraulic Pumping Device
[0047] Hydraulic systems can reduce pumping force requirements, and
therefore also reduce the size of the pumping device, while
maintaining high pumping efficiency. In a preferred embodiment, the
pumping device can utilize a hydraulic or pneumatic pumping device
to generate a pressure differential against the breast for the
expression and collection of milk.
[0048] Exemplary hydraulic pumping devices are depicted in FIGS. 2
and 3. FIG. 2 illustrates a pumping device 150 with a syringe 155
fluidly coupled to breast interface 160 by tube 165. Syringe 155 is
coupled to tube 165 through a three-way valve 170. Breast interface
160 contains an exit port 175. The syringe 155 drives a fluid 180
contained within tube 165 against or away from a flexible member
contained within breast interface 160 to create the pressure
differential necessary for milk expression from the breast.
[0049] FIG. 3 illustrates another embodiment of a pumping device
200. The actuatable assembly 205 includes an assembly housing 210,
a driving element 215, radial seals 220, and a shaft 222. Driving
element 215 is operatively coupled to a pendant unit, such as
pendant unit 115, through shaft 222. The tube 225 contains a fluid
230 and is fluidly coupled to the actuatable assembly 205 and the
breast interface 235. The breast interface 235 consists of an
interface housing 240, a flexible membrane 245, a reservoir 250, a
sealing element 255, an expression area 260, and a drain port 265.
The sealing element 255 includes deformable portion 270. The drain
port 265 is coupled to a collection vessel 275 and includes a flap
valve 280.
[0050] Actuatable assembly 205 displaces fluid 230 contained within
tube 225, which can be a flexible line. Fluid 230 occupies
reservoir 250 within breast interface 235 and is coupled with
flexible membrane 245. Flexible membrane 245 transmits vacuum
pressure from fluid 230 to the deformable portion 270 of sealing
element 255. When a breast is engaged into and fluidly sealed with
breast interface 235 by sealing element 255, displacement of the
actuatable element 215 produces substantial vacuum pressure against
the breast through flexible membrane 245 and deformable portion
270, resulting in the expression of breast milk into expression
area 260. The expressed milk drains through drain port 265 into
collection vessel 275. Drain port 265 is configured with a flap
valve 280 to provide passage of milk while maintaining vacuum
pressure in expression area 260.
[0051] The fluid for the hydraulic pumping device can be any
suitable fluid, such as an incompressible fluid. In many
embodiments, the incompressible fluid can be water or oil.
Alternatively, the fluid can be any suitable gas, such as air.
Suitable incompressible fluids and gases for hydraulic systems are
known to those of skill in the art.
[0052] One of skill in the art will appreciate that components and
features of any of the exemplary embodiments of the hydraulic
pumping device can be combined or substituted with components and
features of any of the embodiments of the present invention as
described herein.
[0053] Actuation Mechanism
[0054] Many actuation mechanisms known to those of skill in the art
can be utilized for the actuatable assembly 205. Actuatable
assembly 205 can be a piston assembly, a pump such as a diaphragm
pump, or any other suitable actuation mechanism. The optimal
configuration for actuatable assembly 205 can depend on a number of
factors, such as: vacuum requirements; size, power, and other needs
of the pumping device 200; and the properties of the fluid 230,
such as viscosity, biocompatibility, and fluid life
requirements.
[0055] FIG. 3 illustrates an exemplary embodiment in which
actuatable assembly 205 is a piston assembly and driving element
215 is a piston. Actuatable assembly 205 includes radial seals 220,
such as O-rings, sealing against assembly housing 210 to prevent
undesired egress of fluid 230 and to enable driving of fluid
230.
[0056] FIG. 4 illustrates another exemplary embodiment of an
actuatable assembly 300 including a pair of pistons 305.
[0057] In preferred embodiments, the actuatable assembly includes a
driving element powered by a suitable driving mechanism, such as a
driving mechanism residing in pendant unit 115. Many driving
mechanisms are known to those of skill in the art. For instance,
the driving element, such as driving element 215, may be actuated
electromechanically by a motor, or manually by a suitable
user-operated interface, such as a lever. Various drive modalities
known to those of skill in the art can be used. In particular,
implementation of the exemplary hydraulic pumping devices as
described herein enables the use of suitable drive modalities such
as direct drive and solenoids, owing to the reduced force
requirements of hydraulic systems.
[0058] Referring now to the exemplary embodiment of FIG. 4, the
pistons 305 include couplings 310 to a crankshaft 315. The
crankshaft 315 is operatively coupled to a motor 320 through a belt
drive 325. The crankshaft 315 drives the pair of pistons 305 with
the same stroke timing in order to apply vacuum pressure against
both breasts simultaneously, a feature desirable for increased milk
production. Alternatively, the crankshaft 315 can drive the pair of
pistons 305 with any suitable stroke timing, such as alternating or
offset stroke cycles.
[0059] The driving mechanism can be powered by any suitable power
source, such as a local battery or an AC adaptor. The driving
mechanism can be controlled by hardware, such as onboard
electronics located within pendant unit 115.
[0060] FIG. 5 illustrates an exemplary embodiment of an actuatable
assembly 350 that includes releasable coupling 355. Preferably,
actuatable assembly 350 is releasably coupled to a pendant unit 360
and the driving mechanism housed therein. The coupling can be a
mechanical coupling or any suitable quick release mechanism known
to those of skill in the art. The releasably coupled design allows
for flexibility in the configuration and use of the pumping device.
For instance, user comfort can be improved through the use of
differently sized breast interfaces for compatibility with various
breast sizes. Additionally, this feature enables a common pumping
device to be used with interchangeable breast interfaces, thus
reducing the risk of spreading pathogens. Furthermore, the
releasable coupling enables easy replacement of individual parts of
the pumping device.
[0061] One of skill in the art will appreciate that components and
features of any of the exemplary embodiments of the actuation
mechanism can be combined or substituted with components and
features of any of the embodiments of the present invention as
described herein.
[0062] Flexible Membrane
[0063] In many embodiments such as the embodiment depicted in FIG.
3, the flexible membrane 245 is located within breast interface 235
and disposed over at least portion thereof, forming reservoir 250
between the interface housing 240 and the flexible membrane 245.
Preferably, the flexible membrane 245 deforms substantially when
subject to the negative pressures created when the fluid 230 is
displaced from reservoir 250 by actuatable assembly 205. The amount
of deformation of the flexible membrane 245 can be controlled by
many factors, (e.g., wall thickness, durometer, surface area) and
can be optimized based on the pumping device (e.g., pump power,
vacuum requirements).
[0064] FIG. 6 illustrates an exemplary flexible membrane 370 with a
specified thickness and durometer.
[0065] FIG. 7 illustrates another embodiment of flexible membrane
375 with corrugated features 380 for increased surface area.
[0066] Suitable materials for the flexible membrane are known to
those of skill in the art. In many embodiments, the flexible
membrane can be made of a material designed to expand and contract
when subject to pressures from the coupling fluid such as silicone,
polyether block amides such as PEBAX, and polychloroprenes such as
neoprene. Alternatively, the flexible membrane can be fabricated
from a substantially rigid material, such as stainless steel,
nitinol, high durometer polymer, or high durometer elastomer. In
these embodiments, the rigid material would be designed with stress
and/or strain distribution elements to enable the substantial
deformation of the flexible membrane without surpassing the yield
point of the material.
[0067] FIGS. 8A and 8B illustrate preferred embodiments of a breast
interface 400 in which an exit valve 405 is integrated into the
flexible membrane 410 to control the flow of expressed milk through
exit port 415. The exit valve 405 is opened to allow fluid flow
when the flexible membrane 410 is relaxed, as shown in FIG. 8A, and
is closed to prevent fluid flow when the flexible membrane 410 is
deformed, as shown in FIG. 8B. The exit valve 405 enables
substantial vacuum pressure to be present in expression area 420
during extraction, while allowing milk to drain during the rest
phase of the pump stroke. While many conventional breast pump
valves function on pressure differentials alone, the exit valve 405
can preferably be configured to also function on the mechanical
movement of flexible membrane 410. Incorporation of an integrated
exit valve 405 with mechanical functionality as described herein
can improve the sealing of the breast interface 400 during vacuum
creation. Furthermore, the implementation of an exit valve
integrally formed within the flexible membrane 410 such as exit
valve 405 reduces the number of parts to be cleaned.
[0068] Milk Collection and Quantification System
[0069] With reference to FIG. 3, expressed milk drains through exit
port 265 in flexible membrane 245 into a collection vessel 275.
Collection vessel 275 can be any suitable container, such as a
bottle or a bag. In many embodiments, collection vessel 275 is
removably coupled to flexible membrane 245. Collection vessel 275
can be coupled directly or remotely via any suitable device such as
extension tubing.
[0070] In many instances, it can be desirable to track various data
related to milk expression and collection, such as the amount of
milk production. Currently, the tracking of milk production is
commonly accomplished by manual measurements and record-keeping.
Exemplary embodiments of the device described herein may provide
digital-based means to automatically measure and track milk
production for improved convenience, efficiency, and accuracy.
[0071] FIGS. 9A and 9B illustrates exemplary embodiments of a
breast interface 450 with one or more integrated sensors 455.
Sensors 455 are preferably located in flap valve 460, but may also
be located in exit valve 465, or any other suitable location for
monitoring fluid flow. In a preferred embodiment, at least one
sensor 455 is integrated into a valve that is opened by fluid flow
and detects the length of time that the valve is opened. The sensor
signal can be interrogated to quantify the fluid flow. Suitable
sensors are known to those of skill in the art, such as
accelerometers, Hall effect sensors, and photodiode/LED sensors.
The breast interface can include a single sensor or multiple
sensors to quantify milk production.
[0072] FIG. 10 illustrates an exemplary embodiment of pendant unit
500 in which milk expression data is shown on a display screen 505.
In many embodiments, the pendant unit 500 collects, processes,
stores, and displays data related to milk expression. Preferably,
the pendant unit 500 can transmit the data to a second device, such
as a mobile phone 510.
[0073] FIG. 11 illustrates data transmission 515 between pendant
unit 500 and a mobile phone 510. Suitable methods for communication
and data transmission between devices are known to those of skill
in the art, such as Bluetooth or near field communication.
[0074] In exemplary embodiments, the pendant unit 500 communicates
with a mobile phone 510 to transmit milk expression data, such as
expression volume, duration, and date. The mobile phone 510
includes a mobile application to collect and aggregate the
expression data and display it in an interactive format.
Preferably, the mobile application includes additional features
that allow the user to overlay information such as lifestyle
choices, diet, and strategies for increasing milk production, in
order to facilitate the comparison of such information with milk
production statistics. Additionally, the pendant unit 500 can send
information about the times of pump usage to the mobile phone 510
so that the mobile application can identify when pumping has
occurred and set reminders at desired pumping times. Such reminders
can help avoid missed pumping sessions, and thus reduce the
incidence of associated complications such as mastitis.
[0075] One of skill in the art will appreciate that components and
features of any of the exemplary embodiments of the milk collection
and quantification system can be combined or substituted with
components and features of any of the embodiments of the present
invention as described herein.
[0076] Mechanical Pumping Device
[0077] FIG. 12 illustrates an alternative embodiment of a breast
interface 600 in which a mechanical deformable member 605 can be
used in place of a flexible membrane. The mechanical deformable
member 605 can be constructed from similar techniques as those used
for the flexible membrane as described herein. The mechanical
deformable member 605 is coupled to a tensile element 610. In some
instances, tensile element 610 is disposed within an axial load
absorbing member 615. The axial load absorbing member 615 is
disposed within tube 620. Preferably, tensile element 610 is
concentrically disposed within axial load absorbing member 615 and
axial load absorbing member 615 is concentrically disposed within
tube 620. Alternative arrangements of tensile element 610, axial
load absorbing member 615, and tube 620 can also be used.
[0078] FIG. 13 illustrates the tensile element 610 coupled to
driving element 625 of an actuatable assembly 630 within an
assembly housing 635. Driving element 625 is operatively coupled to
a driving mechanism, such as a driving mechanism housed within a
pendant unit, through shaft 640. Axial load absorbing member 615
within tube 620 is fixedly coupled to the assembly housing 635.
Displacement of the driving element 625 transmits tensile force
through tensile element 610 to the mechanical deforming member 605
to create vacuum pressure against the breast.
[0079] The tensile element 610 can be any suitable device, such as
a wire, coil, or rope, and can be made from any suitable material,
such as metals, polymers, or elastomers. Axial load absorbing
member 615 can be made from any suitable axially stiff materials,
such as metals or polymers, and can be configured into any suitable
axially stiff geometry, such as a tube or coil.
[0080] One of skill in the art will appreciate that components and
features of any of the exemplary embodiments of the mechanical
pumping device can be combined or substituted with components and
features of any of the embodiments of the present invention as
described herein.
[0081] Experimental Data
[0082] FIGS. 14 and 15 illustrate experimental pumping data
obtained from a commercial breast pump device and an exemplary
embodiment of the present invention. The exemplary embodiment
utilized an incompressible fluid for pumping and had a maximum
hydraulic fluid volume of 4 cc, while the commercial device
utilized air for pumping and had a maximum volume of 114 cc.
[0083] FIG. 14 illustrates a graph of the pump performance as
quantified by vacuum pressure generated per run. For the exemplary
embodiment, pressure measurements were taken for 1 cc, 2 cc, 3 cc,
and 4 cc of fluid volume displaced by the pump, with the run number
corresponding to the volume in cc. For the commercial device,
measurements were taken with the pump set to one of seven equally
incremented positions along the vacuum adjustment gauge
representing 46 cc, 57 cc, 68 cc, 80 cc, 91 cc, 103 cc, and 114 cc
of fluid volume displaced by the pump, respectively, with the run
number corresponding to the position number. Curve 700 corresponds
to the exemplary embodiment and curve 705 corresponds to the
commercial device. The exemplary embodiment generated higher levels
of vacuum pressure per displacement volume compared to the
commercial device, with maximum vacuum pressures of -240.5 mmHg and
-177.9 mmHg, respectively.
[0084] FIG. 15 illustrates a graph of the pump efficiency as
measured by the maximum vacuum pressure per maximum volume of fluid
displaced, with bar 710 corresponding to the exemplary embodiment
and bar 715 corresponding to the commercial device. The exemplary
embodiment demonstrated a 42-fold increase in pumping efficiency
compared to the commercial device, with efficiencies of -71.1
mmHg/cc and -1.7 mmHg/cc, respectively.
[0085] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
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