U.S. patent application number 14/793606 was filed with the patent office on 2016-01-07 for pump apparatus and methods for expression of human breast milk.
The applicant listed for this patent is Naya Health, Inc.. Invention is credited to Janica B. Alvarez, Jeffery B. Alvarez.
Application Number | 20160000980 14/793606 |
Document ID | / |
Family ID | 55016265 |
Filed Date | 2016-01-07 |
United States Patent
Application |
20160000980 |
Kind Code |
A1 |
Alvarez; Jeffery B. ; et
al. |
January 7, 2016 |
PUMP APPARATUS AND METHODS FOR EXPRESSION OF HUMAN BREAST MILK
Abstract
Improved devices, systems and methods for the expression of milk
from a breast are disclosed herein. A device for expression of milk
may comprise a peristaltic pump configured to move a fluid to or
from a breast interface, so as to apply pressure at the breast
interface and thereby express milk from the breast. The peristaltic
pump can be removably coupled to a tube carrying the fluid, so as
to maintain a separation between the peristaltic pump and the
fluidly coupled components of the device. A device for expressing
breast milk may further comprise an adjustable breast interface
configured to engage and fluidly seal against the human breast. The
adjustable breast interface may be manually or automatically
adjustable to fluidly seal against a plurality of sizes or shapes
of human breasts.
Inventors: |
Alvarez; Jeffery B.;
(Redwood City, CA) ; Alvarez; Janica B.; (Redwood
City, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Naya Health, Inc. |
Redwood City |
CA |
US |
|
|
Family ID: |
55016265 |
Appl. No.: |
14/793606 |
Filed: |
July 7, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62021601 |
Jul 7, 2014 |
|
|
|
62028219 |
Jul 23, 2014 |
|
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Current U.S.
Class: |
604/514 ;
604/74 |
Current CPC
Class: |
A61M 1/064 20140204;
A61M 2205/3379 20130101; A61M 2205/502 20130101; A61M 1/06
20130101; A61M 2202/0014 20130101; A61M 2209/088 20130101; A61M
2205/42 20130101; A61M 2205/3592 20130101; A61M 2210/1007 20130101;
A61M 1/062 20140204; A61M 2205/3327 20130101 |
International
Class: |
A61M 1/06 20060101
A61M001/06; A61M 39/08 20060101 A61M039/08; A61M 1/10 20060101
A61M001/10 |
Claims
1. A device for expression and collection of breast milk, said
device comprising: a breast interface configured to engage a breast
and fluidly seal thereagainst, the breast interface having a
movable member disposed within at least a portion thereof; a tube
filled with fluid and fluidly coupled with the breast interface;
and a peristaltic pump coupled with the tube, wherein actuation of
the peristaltic pump moves the fluid in a first direction or a
second direction opposite the first direction, and wherein movement
of the fluid in the first direction moves the movable member in the
breast interface in the first direction and thereby causes the
breast interface to apply vacuum pressure at the breast to express
milk therefrom, and wherein movement of the fluid in the second
direction moves the movable member in the breast interface in the
second direction and thereby applies pressure at the breast
interface.
2. The device of claim 1, wherein the peristaltic pump is removably
coupled with the tube.
3. The device of claim 1, wherein the movable member of the breast
interface comprises one or more of a flexible membrane, a
deformable portion of a sealing element coupled to a flexible
membrane, or an expandable membrane, configured to move in response
to actuation of the peristaltic pump.
4. The device of claim 1, wherein movement of the movable member in
the second direction returns the breast interface to atmospheric
pressure, thereby allowing the expressed milk to drain into a
collection vessel coupled to the breast interface.
5. The device of claim 1, wherein the device further comprises a
collection vessel fluidly coupled to the breast interface, and
wherein movement of the movable member in the second direction
applies positive pressure at breast interface, thereby forcing the
expressed milk out of breast interface into the collection
vessel.
6. The device of claim 1, wherein the device further comprises a
collection vessel fluidly coupled to the breast interface, and
wherein the breast interface comprises a first breast interface
configured to engage a first breast and a second breast interface
configured to engage a second breast, and wherein actuation of the
peristaltic pump simultaneously causes the first breast interface
to express milk from the first breast and the second breast
interface to collect expressed milk from the second breast into the
collection vessel.
7. The device of claim 1, wherein the tube comprises a central
compliant region configured to engage the peristaltic pump and a
less compliant region that is less compliant relative to the
central compliant region disposed adjacent to the central compliant
region, such that the central compliant region compresses in
response to actuation of the peristaltic pump, while the less
compliant region transmits pressure along the tube to the breast
interface.
8. A method for expressing milk from a breast, said method
comprising: engaging and fluidly sealing a breast interface with
the breast; actuating a peristaltic pump coupled with a tube filled
with a fluid and fluidly coupled to the breast interface, thereby
applying vacuum pressure at the breast; and expressing milk from
the breast.
9. The method of claim 8, wherein actuating a peristaltic pump
comprises actuating the peristaltic pump so as to move the fluid in
a first direction or in a second direction opposite the first
direction, wherein moving the fluid in the first direction causes a
movable member within the breast interface to move away from the
breast and thereby apply vacuum pressure at the breast to express
milk therefrom, and wherein moving the fluid in the second
direction causes the movable member to move toward the breast and
thereby causing the expressed milk to drain into a collection
vessel fluidly coupled to the breast interface.
10. The method of claim 9, wherein moving the fluid in the second
direction returns the breast interface to atmospheric pressure,
thereby allowing the expressed milk to drain into the collection
vessel.
11. The method of claim 9, wherein moving the fluid in the second
direction applies a positive pressure at breast interface, thereby
forcing the expressed milk out of the breast interface into the
collection vessel.
12. The method of claim 8, wherein the breast interface comprises a
first breast interface configured to engage a first breast and a
second breast interface configured to engage a second breast, and
wherein actuating a peristaltic pump comprises simultaneously
moving the fluid away from the first breast interface to express
milk from the first breast, and moving the fluid toward the second
breast interface to collect expressed milk from the second breast
into a collection vessel fluidly coupled to the second breast
interface.
13. A device for expressing breast milk from a breast, said device
comprising: a breast interface comprising a flange configured to
engage and fluidly seal against the breast, and an expression area
where milk is expressed from the breast; wherein the breast
interface is manually or automatically adjustable to fluidly seal
against a plurality of sizes or shapes of breasts.
14. The device of claim 13, wherein the flange comprises one or
more resilient materials conformable to the breast and adapted to
fluidly seal against the plurality of sizes or shapes of
breasts.
15. The device of claim 13, wherein the flange comprises a pocket
fillable with a filling material, and wherein addition of filling
material to, or removal of the filling material from the pocket
adjusts a size of the flange.
16. The device of claim 15, wherein the filling material comprises
a plurality of bead-like elements, and wherein application of a
vacuum to the pocket substantially locks the plurality of bead-like
elements and the flange into a fixed configuration for fluidly
sealing against a particular size or shape of human breast.
17. The device of claim 15, wherein the filling material comprises
a fluid.
18. The device of claim 17, wherein the breast interface further
comprises a fluid pump fluidly coupled to the pocket, the fluid
pump configured to add or remove the fluid from the pocket.
19. The device of claim 13, wherein the device further comprises an
actuatable assembly operatively coupled to the breast interface; an
expression reservoir disposed within the breast interface; and an
adjustable reservoir fluidly coupled to the expression reservoir
and operatively coupled to the actuatable assembly; wherein the
actuatable assembly is configured to deliver fluid from the
adjustable reservoir to the expression reservoir or remove fluid
from the expression reservoir and return the fluid to the
adjustable reservoir, and wherein the adjustable reservoir
comprises a mechanism to adjust a volume thereof, so as to adjust a
volume of the expression reservoir and thereby adjust a size of the
expression area to fluidly seal against a particular size or shape
of breast.
20. The device of claim 19, wherein the mechanism is manually
adjustable.
21. The device of claim 19, wherein the mechanism is automatically
adjustable to adjust the volume of the adjustable reservoir in
response to a feedback from the actuatable assembly indicating a
degree of fluid seal between the breast interface and the
breast.
22. The device of claim 21, wherein the feedback comprises a
current produced by the actuatable assembly as the volume of the
adjustable reservoir is adjusted, wherein an increase in the
current indicates an increased degree of fluid seal between the
breast interface and the breast.
23. The device of claim 21, wherein the adjustable reservoir is
integrated with the actuatable assembly, such that the volume of
the adjustable reservoir may be adjusted by changing a setting of
the actuatable assembly.
24. The device of claim 23, wherein the actuatable assembly
comprises a piston assembly and wherein the adjustable reservoir
comprises a reservoir of the piston assembly, such that changing a
resting position of the piston assembly adjusts the volume of fluid
in the adjustable reservoir.
25. A method for expressing breast milk from a breast, said method
comprising: providing a device for expressing breast milk
comprising an adjustable breast interface having a flange and an
expression area; engaging the adjustable breast interface with the
breast; adjusting a size of the adjustable breast interface;
fluidly sealing the breast interface against the breast; and
expressing milk from the breast.
26. The method of claim 25, wherein adjusting the size of the
adjustable breast interface comprises adding a fluid to or removing
the fluid from a pocket disposed within the flange.
27. The method of claim 25, wherein adjusting the size of the
adjustable breast interface comprises: providing a plurality of
bead-like elements disposed in a pocket in the flange; molding the
plurality of bead-like elements against the human breast; applying
a vacuum to the pocket; and locking the flange into a particular
size or shape.
28. The method of claim 25, wherein the breast interface comprises
an expression reservoir fluidly coupled with an actuatable assembly
and an adjustable reservoir, and wherein adjusting the size of the
adjustable breast interface comprises: actuating the actuatable
assembly, thereby delivering a fluid from the adjustable reservoir
to the expression reservoir or removing the fluid from the
expression reservoir and returning the fluid to the adjustable
reservoir; and adjusting a volume of the adjustable reservoir so as
to adjust a volume of the expression reservoir, thereby adjusting a
size of the expression area.
29. The method of claim 28, wherein adjusting a volume of the
adjustable reservoir comprises manually adjusting the volume of the
adjustable reservoir.
30. The method of claim 28, wherein adjusting a volume of the
adjustable reservoir comprises automatically adjusting the volume
of the adjustable reservoir in response to a feedback from the
actuatable assembly indicating a degree of fluid seal between the
breast interface and the breast.
31. The method of claim 30, wherein the adjustable reservoir is
integrated with the actuatable assembly, and wherein automatically
adjusting the volume of the adjustable reservoir comprises changing
a setting of the actuatable assembly.
32. The method of claim 31, wherein the actuatable assembly
comprises a piston assembly and wherein the adjustable reservoir
comprises a reservoir of the piston assembly, and wherein
automatically adjusting the volume of the adjustable reservoir
comprises changing a resting position of the piston assembly.
Description
CROSS-REFERENCE
[0001] This application claims the benefit of U.S. Provisional
Application No. 62/021,601, filed Jul. 7, 2014 [Attorney Docket No.
44936-705.101] and U.S. Provisional Application No. 62/028,219,
filed Jul. 23, 2014 [Attorney Docket No. 44936-708.101], the full
disclosures of which are incorporated herein by reference.
[0002] This application is related to U.S. patent application Ser.
No. 14/221,113, filed on Mar. 20, 2014 [Attorney Docket No.
44936-703.201], U.S. patent application Ser. No. 14/616,557, filed
on Feb. 6, 2015 [Attorney Docket No. 44936-704.201], U.S.
Provisional Application No. 62/021,597, filed on Jul. 7, 2014
[Attorney Docket No. 44936-706.101], and U.S. Provisional
Application No. 62/021,604, filed Jul. 7, 2014 [Attorney Docket No.
44936-707.101], the full disclosures of which are incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0003] 1. Field of the Invention
[0004] 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.
[0005] 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.
The devices, systems and methods disclosed herein may be used for
treatments requiring application of a differential pressure to a
patient or work surface, with a device having an adjustable flange
that can accommodate varying patient anatomy or varying work
surfaces.
[0006] 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. Additionally, current
and proposed pump systems may only actuate a single breast pump,
and therefore it would be advantageous to provide a pump that can
actuate two breast pumps simultaneously.
[0007] Further, currently existing or proposed breast pumps may
only provide breast interfaces of limited, fixed sizes, which can
result in users having to purchase and return multiple parts as
well as contend with poor fit and inefficient pumping. Breast pump
users comprise a population with a wide range of size and shape
requirements, which may also change over the course of use of the
breast pump due to the effects of sustained use of the pump or due
to natural changes in user anatomies throughout the course of
breastfeeding. Therefore, it would be desirable for a breast pump
to provide a breast interface that is adjustable in size or shape.
At least some of these objectives will be satisfied by the devices
and methods disclosed below.
[0008] 2. Description of the Background Art
[0009] 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. U.S. Patent Publication No. 2014/0121593 also relates to
expression and collection of breast milk.
SUMMARY OF THE INVENTION
[0010] The present invention generally relates to medical devices,
systems and methods, and more particularly relates to devices,
systems and methods for expression and collection of human breast
milk.
[0011] Disclosed herein are small and highly efficient apparatuses
and methods of use for expression and collection of breast milk. An
apparatus for expression of milk as described herein may comprise a
hydraulic system, wherein movement of a fluid to or from a breast
interface can apply pressure at the breast interface and thereby
express milk from the breast engaged thereto. The apparatus may
comprise a peristaltic pump that is removably coupled to a tube
carrying the fluid, so as to move the fluid to or from the breast
interface while maintaining a separation between the peristaltic
pump and the fluidly coupled components of the apparatus.
[0012] Also disclosed herein are methods and apparatus for
providing an adjustable breast interface to accommodate a range of
size and shape requirements of the users. The adjustable breast
interface may comprise an adjustable flange configured to engage
and seal against the breast, wherein the adjustable flange may be
adjusted in one or both of the frustoconical portion and the inner
diameter of the tubular flange neck. Alternatively or in
combination, the adjustable breast interface may comprise an
adjustable expression area, whose size and/or shape may be adjusted
by adjusting a volume of an expression reservoir of the breast
interface. For example, the expression reservoir may be fluidly
coupled to an adjustable reservoir and an actuatable assembly,
wherein a volume of the adjustable reservoir may be manually or
automatically adjusted to adjust the volume of the expression
reservoir and hence the size of the expression area.
[0013] In a first aspect, a device for expression and collection of
breast milk comprises a breast interface configured to engage a
breast and fluidly seal thereagainst, the breast interface having a
movable member disposed within at least a portion thereof. The
device further comprises a tube filled with fluid and fluidly
coupled with the breast interface, and a peristaltic pump coupled
with the tube, wherein actuation of the peristaltic pump moves the
fluid in a first direction or a second direction opposite the first
direction. Movement of the fluid in the first direction moves the
movable member in the breast interface in the first direction and
thereby causes the breast interface to apply vacuum pressure at the
breast to express milk therefrom. Movement of the fluid in the
second direction moves the movable member in the breast interface
in the second direction and thereby applies pressure at the breast
interface. The peristaltic pump may be removably coupled with the
tube.
[0014] The movable member of the breast interface may comprise one
or more of a flexible membrane, a deformable portion of a sealing
element coupled to a flexible membrane, or an expandable membrane,
configured to move in response to actuation of the peristaltic
pump. Movement of the movable member in the second direction may
return the breast interface to atmospheric pressure, thereby
allowing the expressed milk to drain into a collection vessel
coupled to the breast interface. The device may further comprise a
collection vessel fluidly coupled to the breast interface, and
movement of the movable member in the second direction may apply
positive pressure at breast interface, thereby forcing the
expressed milk out of breast interface into the collection
vessel.
[0015] The device may further comprise a collection vessel fluidly
coupled to the breast interface, and the breast interface may
comprises a first breast interface configured to engage a first
breast and a second breast interface configured to engage a second
breast. Actuation of the peristaltic pump may simultaneously cause
the first breast interface to express milk from the first breast
and the second breast interface to collect expressed milk from the
second breast into the collection vessel.
[0016] The tube may comprise a central compliant region configured
to engage the peristaltic pump. The tube may further comprise a
less compliant region that is less compliant relative to the
central compliant region and disposed adjacent to the central
compliant region. The central compliant region may compress in
response to actuation of the peristaltic pump, while the less
compliant region may transmit pressure along the tube to the breast
interface.
[0017] In another aspect, a method for expressing milk from a
breast comprises engaging and fluidly sealing a breast interface
with the breast, actuating a peristaltic pump, and expressing milk
from the breast. The peristaltic pump may be coupled with a tube
filled with a fluid and fluidly coupled to the breast interface,
such that actuation of the peristaltic pump can apply vacuum
pressure at the breast to express milk from the breast.
[0018] Actuating a peristaltic pump may comprise actuating the
peristaltic pump so as to move the fluid in a first direction or in
a second direction opposite the first direction. Moving the fluid
in the first direction may cause a movable member within the breast
interface to move away from the breast and thereby apply vacuum
pressure at the breast to express milk therefrom. Moving the fluid
in the second direction may cause the movable member to move toward
the breast and thereby cause the expressed milk to drain into a
collection vessel fluidly coupled to the breast interface. Moving
the fluid in the second direction may return the breast interface
to atmospheric pressure, thereby allowing the expressed milk to
drain into the collection vessel. Alternatively or in combination,
moving the fluid in the second direction may apply a positive
pressure at breast interface, thereby forcing the expressed milk
out of the breast interface into the collection vessel.
[0019] The breast interface may comprise a first breast interface
configured to engage a first breast and a second breast interface
configured to engage a second breast. Actuating a peristaltic pump
may comprise simultaneously moving the fluid away from the first
breast interface to express milk from the first breast, and moving
the fluid toward the second breast interface to collect expressed
milk from the second breast into a collection vessel fluidly
coupled to the second breast interface.
[0020] In another aspect, a device for expressing breast milk from
a breast comprises a breast interface comprising a flange
configured to engage and fluidly seal against the breast, and an
expression area where milk is expressed from the breast. The breast
interface is manually or automatically adjustable to fluidly seal
against a plurality of sizes or shapes of breasts.
[0021] The flange may comprise one or more resilient materials
conformable to the breast and adapted to fluidly seal against the
plurality of sizes or shapes of breasts. The flange may further
comprise a pocket fillable with a filling material, wherein
addition of filling material to, or removal of the filling material
from the pocket adjusts a size of the flange. The filling material
may comprise a plurality of bead-like elements, wherein application
of a vacuum to the pocket substantially locks the plurality of
bead-like elements and the flange into a fixed configuration for
fluidly sealing against a particular size or shape of human breast.
Alternatively or in combination, the filling material may comprise
a fluid. The breast interface may further comprise a fluid pump
fluidly coupled to the pocket, the fluid pump configured to add or
remove the fluid from the pocket.
[0022] The device may further comprise an actuatable assembly
operatively coupled to the breast interface, an expression
reservoir disposed within the breast interface, and an adjustable
reservoir fluidly coupled to the expression reservoir and
operatively coupled to the actuatable assembly. The actuatable
assembly may be configured to deliver fluid from the adjustable
reservoir to the expression reservoir or remove fluid from the
expression reservoir and return the fluid to the adjustable
reservoir. The adjustable reservoir may comprise a mechanism to
adjust a volume thereof, so as to adjust a volume of the expression
reservoir and thereby adjust a size of the expression area to
fluidly seal against a particular size or shape of breast.
[0023] The mechanism may be manually adjustable. Alternatively or
in combination, the mechanism may be automatically adjustable, to
adjust the volume of the adjustable reservoir in response to a
feedback from the actuatable assembly indicating a degree of fluid
seal between the breast interface and the breast. The feedback may
comprise a current produced by the actuatable assembly as the
volume of the adjustable reservoir is adjusted, wherein an increase
in the current indicates an increased degree of fluid seal between
the breast interface and the breast. The adjustable reservoir may
be integrated with the actuatable assembly, such that the volume of
the adjustable reservoir may be adjusted by changing a setting of
the actuatable assembly. For example, the actuatable assembly may
comprise a piston assembly, and the adjustable reservoir may
comprise a reservoir of the piston assembly, such that changing a
resting position of the piston assembly adjusts the volume of fluid
in the adjustable reservoir.
[0024] In another aspect, a method for expressing breast milk from
a breast comprises providing a device for expressing breast milk
comprising an adjustable breast interface having a flange and an
expression area. The method further comprises engaging the
adjustable breast interface with the breast, adjusting a size of
the adjustable breast interface, fluidly sealing the breast
interface against the breast, and expressing milk from the
breast.
[0025] Adjusting the size of the adjustable breast interface may
comprise adding a fluid to or removing the fluid from a pocket
disposed within the flange. Alternatively or in combination,
adjusting the size of the adjustable breast interface may comprise
providing a plurality of bead-like elements disposed in a pocket in
the flange. The method may further comprise molding the plurality
of bead-like elements against the human breast, applying a vacuum
to the pocket, and locking the flange into a particular size or
shape.
[0026] The breast interface may comprise an expression reservoir
fluidly coupled with an actuatable assembly and an adjustable
reservoir. Adjusting the size of the adjustable breast interface
may comprise actuating the actuatable assembly, thereby delivering
a fluid from the adjustable reservoir to the expression reservoir
or removing the fluid from the expression reservoir and returning
the fluid to the adjustable reservoir. The method may further
comprise adjusting a volume of the adjustable reservoir so as to
adjust a volume of the expression reservoir, thereby adjusting a
size of the expression area. Adjusting a volume of the adjustable
reservoir may comprise manually adjusting the volume of the
adjustable reservoir. Alternatively or in combination, adjusting a
volume of the adjustable reservoir may comprise automatically
adjusting the volume of the adjustable reservoir in response to a
feedback from the actuatable assembly indicating a degree of fluid
seal between the breast interface and the breast. The adjustable
reservoir may be integrated with the actuatable assembly, and
automatically adjusting the volume of the adjustable reservoir may
comprise changing a setting of the actuatable assembly. For
example, the actuatable assembly may comprise a piston assembly and
the adjustable reservoir may comprise a reservoir of the piston
assembly, wherein automatically adjusting the volume of the
adjustable reservoir comprises changing a resting position of the
piston assembly.
[0027] These and other embodiments are described in further detail
in the following description related to the appended drawing
figures.
INCORPORATION BY REFERENCE
[0028] 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
[0029] 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:
[0030] FIG. 1 is a perspective view of an exemplary embodiment of a
pumping device.
[0031] FIG. 2 is a perspective view of an exemplary embodiment of a
pumping device.
[0032] FIG. 3A is a cross-section of an exemplary embodiment of a
pumping device.
[0033] FIG. 3B is a cross-section of an exemplary embodiment of a
pumping device.
[0034] FIG. 4 illustrates an exemplary embodiment of an actuatable
assembly coupled to a driving mechanism.
[0035] FIGS. 5A-5B illustrate an exemplary embodiment of an
actuatable assembly coupled to a pendant unit.
[0036] FIG. 6 is a cross-sectional view of an exemplary embodiment
of a breast interface.
[0037] FIG. 7 is a cross-sectional view of another exemplary
embodiment of a breast interface.
[0038] FIG. 8A is a cross-sectional view of an exemplary embodiment
of an integrated valve in an open position.
[0039] FIG. 8B is a cross-sectional view of an exemplary embodiment
of an integrated valve in a closed position.
[0040] FIG. 9A is a cross-sectional view of an exemplary embodiment
of integrated sensors within a breast interface.
[0041] FIG. 9B is a cross-sectional view of another exemplary
embodiment of integrated sensors within a breast interface.
[0042] FIG. 10 illustrates an exemplary embodiment of a pendant
unit and a mobile device.
[0043] FIG. 11 illustrates an exemplary embodiment of a pendant
unit in communication with a mobile device.
[0044] FIG. 12 is a cross-sectional view of an exemplary embodiment
of a breast interface with a mechanical deformable member.
[0045] FIG. 13 is a cross-sectional view of an exemplary embodiment
of a mechanical driver for a mechanical deformable member.
[0046] FIG. 14 is a graph illustrating the pump performance of an
exemplary embodiment compared to a commercial device.
[0047] FIG. 15 is a graph illustrating the pumping efficiency of an
exemplary embodiment compared to a commercial device.
[0048] FIG. 16 illustrates an exemplary pump.
[0049] FIG. 17 illustrates a cross-section of the pump in FIG.
16.
[0050] FIG. 18 illustrates an alternative embodiment of a pump
system.
[0051] FIG. 19A is a cross-sectional view of an exemplary
embodiment of an adjustable flange 1600.
[0052] FIGS. 19B and 19C illustrate exemplary embodiments of
adjustable flanges of different sizes.
[0053] FIGS. 20A and 20B are perspective views of an exemplary
embodiment of an adjustable flange with a sizing element.
[0054] FIGS. 21A, 21B, and 21C are cross-sectional views of an
exemplary embodiment of an adjustable flange with a sizing
element.
[0055] FIGS. 22A, 22B, and 22C illustrate exemplary embodiments of
an adjustable flange that comprises a fillable pocket.
[0056] FIG. 22D is a cross-sectional view of an exemplary
embodiment of an adjustable flange with a pocket filled with a
fluid.
[0057] FIG. 22E is a cross-sectional view of an exemplary
embodiment of an adjustable flange with a pocket filled with a
plurality of bead-like elements.
[0058] FIGS. 23A and 23B illustrate an exemplary embodiment of an
adjustable flange that comprises a fillable pocket.
[0059] FIGS. 24A and 24B illustrate an exemplary embodiment of a
device for expressing breast milk comprising an adjustable
expression area.
[0060] FIG. 25 illustrates an exemplary embodiment of an
automatically adjustable system for adjusting the size of the
expression area.
DETAILED DESCRIPTION OF THE INVENTION
[0061] 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.
[0062] 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, wound
compression, and/or other remote pressure needs, and where it would
be desirable to provide an adjustable flange that can fluidly seal
against a variety of anatomical shapes and sizes or any other
varying work surface.
[0063] FIG. 1 illustrates an exemplary embodiment of a breast pump.
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 content analysis, 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.
[0064] 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.
Hydraulic Pumping Device
[0065] 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 pumping device to generate a
pressure differential against the breast for the expression and
collection of milk.
[0066] 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 an expandable member
contained within breast interface 160 to create the pressure
differential necessary for milk expression from the breast.
[0067] FIG. 3A 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
one-way valve 280 which may be a flap, duckbill, or ball valve.
[0068] 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. The flexible membrane 245 and deformable portion 270
are movable so as to move toward and away from the breast as the
actuatable element 215 is actuated. When a breast is engaged into
and fluidly sealed with breast interface 235 by sealing element
255, displacement of the actuatable element 215 in the outward
direction away from the breast 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
one-way valve 280 to provide passage of milk while maintaining
vacuum pressure in expression area 260.
[0069] FIG. 3B illustrates another exemplary embodiment of a
pumping device 200a. 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 235a. The breast interface
235a comprises a flange 236, an interface housing 240, an
expandable membrane 245a, an expression reservoir 250, an
expression area 260, and a drain port 265. The flange 236 comprises
a frustoconical portion 237 and a tubular flange neck 238. The
flange neck connects to the expression area through the expression
mouth 261. The drain port 265 is coupled to a collection vessel 275
and includes a one-way valve 280.
[0070] Actuatable assembly 205 displaces fluid 230 contained within
tube 225, which can be a flexible line. Fluid 230 occupies
expression reservoir 250 within breast interface 235a and is
coupled with expandable membrane 245a. The expandable membrane 245a
is movable so as to move toward and away from the breast as the
actuatable element 215 is actuated. When a breast is engaged into
and fluidly sealed with breast interface 235a by the flange 236,
displacement of the actuatable element 215 in the outward direction
away from the breast produces substantial vacuum pressure against
the breast through expandable membrane 245a, 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 one-way valve 280 to provide
passage of milk while maintaining vacuum pressure in expression
area 260.
[0071] 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.
[0072] 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.
Peristaltic Pump
[0073] In previous hydraulic pump embodiments, the hydraulic fluid
in the pumping mechanism is often the same fluid used in the
transmission lines and also in the breast interface. It can be
advantageous to separate the fluids to prevent contamination, so
that various components of the system may be more easily separated
from one another, and also to avoid having to prime the pump or
other components with fluid prior to use. An alternative embodiment
of a pumping device that addresses some of these challenges uses a
peristaltic pump device to move fluid to or from the breast
interface device.
[0074] FIG. 16 illustrates an exemplary embodiment of a peristaltic
pump system 1602 for expression of breast milk. The system 1602
preferably includes two breast interfaces 1612, a transmission line
or tubing 1608 and a peristaltic pump 1604. The breast interfaces
1612 may be any of the embodiments disclosed herein or known in the
art. A transmission line or tubing 1608 is coupled to both breast
interfaces. A preferably incompressible fluid 1610 is disposed in
tubing 1608. This embodiment illustrates two breast interfaces
1612, however one of skill in the art will appreciate that a single
breast interface or multiple breast interfaces may be used. The
peristaltic pump includes one or more rollers 1614 that engage
tubing 1608. When the rollers move in a first direction, fluid 1610
is moved in a first direction toward one of the two breast
interfaces and away from the remaining breast interface. This
results in actuation of the flexible membrane in the breast
interfaces. One membrane is displaced outwardly thereby creating a
vacuum in the breast interface and allowing expression of breast
milk. The other membrane is displaced inwardly thereby either
returning pressure to normal pressure such as atmospheric pressure
in the breast interface, or a positive pressure may be applied in
the breast interface. When normal atmospheric pressure exists in
the breast interface, the expressed milk can then be collected as
previously described. Or when a positive pressure is applied, the
expressed milk may be forced out of the breast interface into a
collection container. One advantage of using a peristaltic pump
with two breast interfaces is that while one side is expressing
milk, the other side is collecting the milk in a container. The
pump 1604 may include any of the display features or communication
features 1606 described elsewhere in this application.
[0075] FIG. 17 illustrates a partial cross-section of the
peristaltic pump in FIG. 16. Tubing 1608 is positioned in a tight
channel between the rollers 1614 and an outer rim 1710 of pump
1604. As drive wheel 1708 rotates, rollers 1614 compress tubing
1608 thereby displacing fluid 1610 in the direction of rotation.
Thus, in the embodiment of FIG. 17, the drive wheel 1708 is
rotating in a clock-wise direction and thus fluid 1610 will be
displaced from left to right side of the tubing and positive
pressure will be formed in breast interface 1612a and expandable
membrane 1706 will be pushed outward toward the breast. Fluid 1608
will move away from breast interface 1612b thereby creating a
vacuum and membrane 1704 will move inward toward the back of the
breast interface. The negative pressure will then permit expression
of breast milk. The drive wheel 1708 may be a full circular wheel
as indicated in phantom, or it may be a partial circle. One or more
rollers 1614 maybe coupled to the wheel.
[0076] FIG. 18 illustrates another exemplary embodiment of a
peristaltic pump 1604 with the tubing uncoupled from the rollers
1614. This embodiment of a pump system 1802 is substantially the
same as the previous embodiment in FIGS. 16-17 with the major
difference being that the tubing 1610 has varying compliance
regions. Tubing 1610 may have a central compliant region 1806
designed for engagement with the rollers 1614 and stiffer, less
compliant regions 1804 on either side of the compliant region 1806.
The compliant region 1804 allows the tubing to be compressed an
easily inserted into engagement with the rollers 1614.
Additionally, when the rollers roll over the complaint region, the
tubing conforms to the rollers and this facilitates transmission of
the fluid 1610 along the tubing. The other portions 1804 are more
rigid in order to transmit the pressure along the tubing.
Actuation Mechanism
[0077] 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.
[0078] FIGS. 3A and 3B illustrate exemplary embodiments 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.
[0079] FIG. 4 illustrates another exemplary embodiment of an
actuatable assembly 300 including a pair of pistons 305.
[0080] 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.
[0081] 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.
[0082] 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.
[0083] FIGS. 5A-5B illustrate an exemplary embodiment of an
actuatable assembly 350 that includes releasable coupling 355. FIG.
5A is a perspective view of the embodiment, and FIG. 5B is a
cross-sectional view of the embodiment. Preferably, 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.
[0084] 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.
Expandable Membrane
[0085] In many embodiments such as the embodiment depicted in FIG.
3B, the expandable membrane 245a is located within breast interface
235a and disposed over at least a portion thereof, forming
expression reservoir 250 between the interface housing 240 and the
expandable membrane 245a. Preferably, the expandable membrane 245a
comprises a resilient material that deforms substantially or a more
rigid material that is displaced when subject to the negative
pressures created when the fluid 230 is displaced from expression
reservoir 250 by actuatable assembly 205. The expandable membrane
returns to an unbiased position when the negative pressures
subside. The amount of deformation of the expandable membrane 245a
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).
[0086] FIG. 6 illustrates an exemplary expandable membrane 370 with
a specified thickness and durometer.
[0087] FIG. 7 illustrates another embodiment of expandable membrane
375 with corrugated features 380 for increased surface area. Other
configurations of the expandable membrane which may be used in any
of the embodiments of breast pumps described herein are disclosed
in U.S. Patent Provisional Application No. 62/021,597 (Attorney
Docket No. 44936-706.101) filed Jul. 7, 2014; the entire contents
of which are incorporated herein by reference.
[0088] Suitable materials for the expandable membrane are known to
those of skill in the art. In many embodiments, the expandable
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 expandable 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 expandable membrane without surpassing the yield
point of the material.
[0089] FIGS. 8A and 8B illustrate preferred embodiments of a breast
interface 400 in which an exit valve 405 is integrated into the
expandable 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 expandable membrane 410 is relaxed, as shown in FIG.
8A, and is closed to prevent fluid flow when the expandable
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 expandable 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 expandable membrane 410 such as exit
valve 405 reduces the number of parts to be cleaned.
[0090] One of skill in the art will appreciate that components and
features of any of the exemplary embodiments of the expandable
membrane can be combined or substituted with components and
features of any of the embodiments of the present invention as
described herein.
Milk Collection and Quantification System
[0091] With reference to FIG. 3B, expressed milk drains through
exit port 265 in expandable membrane 245a 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 expandable membrane 245a. Collection vessel
275 can be coupled directly or remotely via any suitable device
such as extension tubing.
[0092] In many instances, it can be desirable to track various data
related to milk expression and collection, such as the amount of
milk production or the chemical and nutritional content of the
produced milk. 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.
[0093] FIGS. 9A and 9B illustrate 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.
[0094] 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.
[0095] 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.
[0096] 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. The mobile application can also include
features that allow the user to control aspects of the pump, such
as pump power and pump states (e.g., let-down and stimulate modes),
adjust expression pressure and speed, and adjust the size of the
breast interface 235a or others described herein, where the breast
interface is automatically adjustable. The application may also
have resources for breastfeeding moms, such as advice or connection
to advice, social aspects such as peer comparisons, and an
accessory store for acquiring accessories for the pump.
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.
[0097] 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.
Mechanical Pumping Device
[0098] 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 245 or expandable membrane
245a. The mechanical deformable member 605 can be constructed from
similar techniques as those used for the flexible or expandable
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.
[0099] 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.
[0100] 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.
[0101] 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.
Adjustable Breast Interface
[0102] Referring to the exemplary embodiment of FIG. 3B, the breast
interface 235a or any other embodiment described herein may be
adjustable in size or shape to fluidly seal against and perform
efficiently with a plurality of sizes or shapes of human breast. In
some embodiments, the flange 236 may be adjustable in one or both
of the frustoconical portion 237 and the inner diameter of the
tubular flange neck 238, so as to adjust the size or shape of the
breast interface. In some embodiments, the expression area 260 may
be adjustable in size or shape, including in the size of the
expression mouth 261, so as to adjust the size or shape of the
breast interface and improve the efficiency of milk expression. Yet
other embodiments may comprise a combination of an adjustable
flange and an adjustable expression area.
[0103] FIG. 19A is a cross-sectional view of an exemplary
embodiment of an adjustable flange 1900. A flange includes a
tapered or frustoconical portion 1905 that engages the breast, and
a tubular flange neck 1915 on the opposite end that transitions
into expression area 1920 of the breast interface 1910 through the
expression mouth 1921. The flange has an exterior surface 1925 and
an interior surface 1930 with a wall 1935 defined therebetween.
Physical properties and construction of the wall 1935 may vary in
different embodiments, allowing the thickness of the wall to be
adjusted so as to adjust the size of the flange 1910 to fit a
particular size or shape of breast. The flange 1910 may be sized
fixedly or adjustably, and flanges of various fixed or adjusted
sizes may be detachable from or integrated with the breast
interface 1910. The thickness of the wall 1935 may vary in
different embodiments.
[0104] FIGS. 19B and 19C illustrate exemplary embodiments of
adjustable flanges 1901 and 1902 of different sizes. Whereas the
flange 1900 in FIG. 19A has a wall 1935 of a thickness such that
the inner diameter of flange neck 1915 is about 30 mm, the flange
1901 in FIG. 19B has a wall 1936 thicker than wall 1935 such that
the inner diameter of the flange neck 1906 is about 27 mm. The
flange 1907 in FIG. 19C has a wall 1937 thicker yet than wall 1936,
such that the inner diameter of the flange neck 1907 is about 24
mm. One of skill in the art will appreciate that these dimensions
are not limiting, and that any size is possible.
[0105] FIGS. 20A and 20B are perspective views of an exemplary
embodiment of an adjustable flange 2000 with a sizing element 2005.
The sizing element 2005 may be a fully closed ring or a partial
ring, which encircles the engagement region 2010 disposed on the
flange neck 2015, thereby decreasing or increasing the inner
diameter of flange neck. The sizing element 2005 may be releasably
coupled to the engagement region 2010 by any one of several
mechanisms well-known in the art, such as a snap fit, press fit, or
magnetic engagement mechanism. The sizing element 2005 may be
provided in various sizes, all of which are releasably coupleable
to the engagement region 2010 in the same manner. The sizing
element 2005 can be coupled to and released from the engagement
region 2010 repeatedly, so as to allow the flange 2000 to be
adjustable in size throughout the course of a user's use of the
breast milk expression device. FIG. 20A shows the sizing element
2005 coupled to the flange 2000, while FIG. 20B shows the sizing
element 2005 released from the flange 2000.
[0106] FIGS. 21A, 21B, and 21C are cross-sectional views of an
exemplary embodiment of an adjustable flange 2100 with a sizing
element. Sizing elements 2105 and 2106 can be releasably coupled to
the engagement region 2110, which may comprise a compliant material
that is reversibly deformed when a sizing element 2105 or 2106 is
coupled. The deformation of the engagement region 2110 can result
in the narrowing of the flange neck 2115 so as to adjust the size
of the flange 2100 to fluidly seal against a particular size or
shape of human breast. The release of a coupled sizing element 2105
or 2106 can reverse the deformation of the engagement region 2110,
resulting in the widening of the flange neck 2115. FIG. 21A shows
the adjustable flange 2100 with no coupled sizing element, having a
flange neck 2115 with an inner diameter of about 30 mm. FIG. 21B
shows the flange 2100 with sizing element 2105 coupled to the
engagement region 2110, resulting in the narrowing of the flange
neck 2115 such that the inner diameter of the flange neck decreases
to about 27 mm. FIG. 21C shows the flange 2100 with sizing element
2106 coupled to the engagement region 2110, resulting in the
further narrowing of the flange neck 2115 such that the inner
diameter of the flange neck decreases to about 24 mm. The sizing
element may be a ring, split ring, or other clip such as those
previously described.
[0107] FIGS. 22A, 22B, and 22C illustrate exemplary embodiments of
an adjustable flange 2200 that comprises a fillable pocket 2205.
The pocket 2205 may be disposed between the interior surface 2206
and exterior surface 2207 of the flange 2200 or the pocket may be a
discrete reservoir on an interior or exterior surface of the
flange. The pocket 2205 comprises a material that prevents any
filling material from leaking out. Filling of the pocket 2205 with
a filling material displaces the interior surface of the flange
2200 towards the breast to better seal against the surface of the
breast and also to narrow the flange neck 2210. The filling of the
pocket 2205 can be reversible, such that the removal of a filling
material from a filled pocket 2205 results in the widening of the
flange neck 2210. Preferably, the pocket 2205 may be filled or
emptied repeatedly, so as to allow the flange 2200 to be adjustable
in size throughout the course of a user's use of the breast milk
expression device. The pocket 2205, whether filled or emptied, does
not obstruct the flange 2200 from forming a fluid seal against the
breast.
[0108] The pocket 2205 can be accessed for filling with a filling
material by various means, depending on the physical and chemical
properties of the filling material. As shown in FIG. 22B, the
pocket 2205 may comprise a flexible material 2215 that can be
punctured without being permanently deformed, such as a butyl
rubber or other elastomer, thereby allowing the addition or removal
of a filling material through a sharp apparatus such as a needle
2220. Alternatively, as shown in FIG. 22C, the pocket 2205 may
comprise an access port 2225 such as a cap 2230 that can be opened
or closed mechanically, disposed on the surface of the pocket 2205,
through which the filling material may be added or removed.
[0109] FIG. 22D is a cross-sectional view of an exemplary
embodiment of an adjustable flange 2250 with a pocket 2255 filled
with a fluid 2260. Filling of the pocket 2255 with the fluid 2260
displaces the interior surface 1956 of the flange 2250 towards the
breast to better seal against the surface of the breast and also to
narrow the flange neck 2210. The fluid 2260 may comprise any
suitable material, such as a saline solution or other fluids
including gases. Adding the fluid 2260 to or removing the fluid
from the pocket 2255 can adjust the size of the flange 2250 to fit
a particular size or shape of human breast.
[0110] FIG. 22E is a cross-sectional view of an exemplary
embodiment of an adjustable flange 2280 with a pocket 2285 filled
with a plurality of bead-like elements 2290. The plurality of
bead-like elements 2290 may comprise any suitable material, such as
polystyrene beads or silica nanoparticles. The pocket 2285 can be
filled with the plurality of bead-like elements 2290, then molded
against the user's breast. Once the pocket 2285 with the bead-like
elements 2290 is disposed against the breast and molded
therearound, application of a vacuum to the filled pocket 2285 can
lock the plurality of bead-like elements 2290 into a fixed
configuration for fluidly sealing against a particular size or
shape of human breast. This concept is well known in the art and is
sometimes referred to as dilatancy.
[0111] FIGS. 23A and 23B illustrate another exemplary embodiment of
an adjustable flange 2300 comprising a fillable pocket 2305. The
pocket 2305 is fluidly coupled to the air pump 2310 and the exhaust
valve 2315. The air pump comprises a vault 2320 having an
integrated valve, such that the valve closes when the vault is
compressed and opens when the vault expands. The air pump also
comprises an inlet valve 2325 which fluidly couples the vault 2320
with the pocket 2305. When vault 2320 is depressed, air flows from
the vault into the pocket 2305 through the inlet valve 2325. Inlet
valve 2325 is a check valve, such as a duckbill valve, that allows
air to flow in one direction only, from the vault to the pocket. A
secondary relief valve, separate from or integrated with valve
2325, may be configured to release excessive pressure in the pocket
2305. The exhaust valve 2315 is configured to be in a closed
position by default, for example by means of a spring mechanism.
When depressed, the exhaust valve opens, allowing air to flow out
from the pocket 2305, through the exhaust valve. FIG. 23A shows the
pocket 2305 in the empty configuration, while FIG. 23B shows the
pocket filled with air, whereby the interior surface 2330 of the
flange is displaced towards the breast and the flange neck 2335 is
narrowed. Adding air to or removing air from the pocket 2305 can
adjust the size of the flange 2300 to fit a particular size or
shape of human breast.
[0112] FIGS. 24A and 24B illustrate an exemplary embodiment of a
device 2400 for expressing breast milk comprising an adjustable
expression area 2402. The device further comprises an adjustable
reservoir 2405 in fluid communication with an actuatable assembly
2410, which is operatively coupled by tube 2415 to the breast
interface 2420. The breast interface comprises an expandable
membrane 2425 and an expression reservoir 2440, which is fluidly
coupled by tube 2415 to the adjustable reservoir 2405 and the
actuatable assembly 2410.
[0113] The actuation of the actuatable assembly 2410 delivers the
fluid 2435 from the adjustable reservoir 2405 through the tube 2415
to the expression reservoir 2440, and returns the fluid 2435 from
the expression reservoir through the tube to the adjustable
reservoir. The change in the volume of fluid in the expression
reservoir causes the expandable membrane 2425 to expand or
collapse, thereby adjusting the size of the expression area 2402.
The volume of fluid 2435 in the adjustable reservoir can be
adjusted so as to adjust the volume of the fluid in the expression
reservoir. When the volume of fluid in the expression reservoir
decreases, the expandable membrane 2425 expands and moves closer to
the interface housing 2421, thereby increasing the size of the
expression area 2402. FIG. 24A shows the device whereby the
adjustable reservoir 2405 contains a small volume of fluid and the
expression reservoir 2440 contains a corresponding larger volume of
fluid, thereby resulting in a smaller expression area 2402. FIG.
24B shows the device whereby the adjustable reservoir 2405 contains
a large volume of fluid and the expression reservoir 2440 contains
a corresponding smaller volume of fluid, thereby resulting in a
larger expression area 2402. Adjusting the size of the expression
area 2402 can adjust the size of the breast interface 2420 to
fluidly seal against a particular size or shape of human
breast.
[0114] The volume of fluid in the adjustable reservoir 2405 may be
adjusted manually by various means. For example, the adjustable
reservoir 2405 may comprise threaded walls 2406 and a threadably
engaged plug 2407, such that turning the plug increases or
decreases the volume of fluid in the adjustable reservoir.
[0115] The volume of fluid in the adjustable reservoir 2405 may
also be adjusted automatically, whereby the device 2400 comprises a
closed-loop system that is capable of sensing the engagement of the
breast interface with the breast and accordingly adjusting the
volume of fluid in the adjustable reservoir to adjust the size of
the expression area 2402. FIG. 25 illustrates an exemplary
embodiment of an automatically adjustable system for adjusting the
size of the expression area. A mobile phone 2500 may be in
communication with a pendant unit 2501 that controls the breast
milk expression device. The device may operate in several different
states, such as pumping state 2502 and adjustment state 2503. The
phone can put the pendant unit into an adjustment state, which
drives the motor 2505, disposed within the actuatable assembly, for
adjustment of the volume of fluid in the expression reservoir 2510.
The adjustable reservoir 2515 may be integrated with and in fluid
communication with the actuatable assembly, such that the volume of
fluid in the expression reservoir may be adjusted by changing a
setting of the actuatable assembly. For example, the actuatable
assembly may comprise a piston assembly in fluid communication with
the expression reservoir, and the piston may be set at a preset
resting position so as to result in a preset volume of fluid in the
expression reservoir. Changing the resting position of the piston
can accordingly increase or decrease the volume of fluid the
expression reservoir. An adjustable reservoir integrated with the
actual assembly in this manner, compared to a separate adjustable
reservoir, can reduce the number of parts in the system as well as
simplify the adjustment operation. The motor may steadily increase
the volume of fluid in the expression reservoir, providing motor
current feedback to the pendant unit. The motor current feedback
may be used to determine when the breast interface has fluidly
sealed against the breast, by sensing the timepoint at which the
motor current begins to rise in response to greater resistance in
the system. When the pendant unit receives feedback that the breast
interface has sealed against the breast, it may end the adjustment
state. Preferably, the volume of fluid in the adjustable reservoir
may be reset to an initial default value at any point, so that a
user may readjust the size of the expression area as necessary.
[0116] One of skill in the art will appreciate that components and
features of any of the exemplary embodiments of the adjustable
breast interface can be combined or substituted with components and
features of any of the embodiments of the present invention as
described herein.
Experimental Data
[0117] 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.
[0118] 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.
[0119] 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.
[0120] 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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