Note: Descriptions are shown in the official language in which they were submitted.
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ENTERAL FEEDING SAFETY RESERVOIR AND SYSTEM
Cross-Reference to Related Applications
100011 This application is a continuation-in-part of U.S. Patent
Application Serial
Number 12/690,845 filed January 20, 2010, which is a continuation-in-part of
U.S. Patent
Application Serial Number 12/546,577 filed August 24, 2009, which is a
continuation-in-part of
U.S. Patent Application Serial Number 12/028,736 filed February 8, 2008, the
contents of which
are incorporated herein by reference in their entireties.
Field of the Invention
[0002] The invention broadly relates to medical devices, systems and
methods and, more
particularly, to enteral feeding systems and methods.
Background of the Invention
[0003] Enteral feeding is a method of providing nutrition to a person or
animal that
cannot or will not eat by swallowing. Enteral feeding may be done temporarily,
as may be the
case for temporary or acute conditions, or indefinitely, as may be the case
for chronic or
uncurable conditions. An enteral feeding system generally includes a container
for holding the
feeding material and an apparatus for delivering the feeding material to the
patient. One of the
major issues with enteral feeding is contamination, as many of the persons or
animals that are fed
enterally are in a distressed or immunocompromised state. Contamination can
result from
various sources, but in many cases it results from exposure of the feeding
material to an external
environment.
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Summary of the Invention
[0004] Embodiments of the present invention provide systems and methods
for enteral
feeding a person or animal. In some embodiments, the systems of the present
invention include a
reservoir body configured to hold a reservoir liner, wherein the reservoir
liner is configured to
hold an enteral feeding material; a reservoir connector configured to connect
to the reservoir
liner in a manner that permits flow of an enteral feeding material; a
reservoir cap configured to
connect to the reservoir body in a manner that connects the reservoir
connector to the reservoir
liner disposed within the reservoir body; and a syringe adapter enteral
feeding assembly having a
distal end configured to connect to the reservoir cap in a manner that permits
flow of an enteral
feeding material and a proximal end configured to connect to an enteral
feeding device in a
manner that permits flow of an enteral feeding material. In other embodiments
the reservoir liner
is pre-filled with an enteral feeding material and sealed. In some such
embodiments the reservoir
cap is configured to pierce or open the reservoir liner pre-filled with an
enteral feeding material.
In some embodiments the system also includes an enteral feeding device. In
some such
embodiments the enteral feeding device is selected from the group consisting
of a nasogastric
feeding tube, a gastric feeding tube, jejunostomy tube, and a
gastrojejunostomy tube. In certain
embodiments the syringe adapter enteral feeding assembly is configured to
connect only to an
enteral feeding device. In some embodiments the syringe adapter enteral
feeding assembly is
configured to connect only to enteral feeding elements.
[0005] In some embodiments, the systems of the present invention include
a reservoir
body configured to hold a reservoir liner, wherein the reservoir liner is
configured to hold an
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enteral feeding material; a reservoir connector configured to connect to the
reservoir liner in a
manner that permits flow of an enteral feeding material and prevents
substantial exposure to an
external environment; a reservoir cap configured to connect to the reservoir
body in a manner
that permits flow of an enteral feeding material and that connects the
reservoir connector to the
reservoir liner disposed within the reservoir body in a manner that prevents
substantial exposure
to the external environment; and a syringe adapter enteral feeding assembly
having a distal end
configured to connect to the reservoir cap in a manner that permits flow of an
enteral feeding
material and prevents substantial exposure to the external environment, and a
proximal end
configured to connect to an enteral feeding device in a manner that permits
flow of an enteral
feeding material and that prevents substantial exposure to the external
environment. In various
embodiments the reservoir liner is pre-filled with an enteral feeding material
and sealed. In some
such embodiments the reservoir cap is configured to pierce or open the
reservoir liner pre-filled
with an enteral feeding material. In certain embodiments the system also
includes an enteral
feeding device. In some such embodiments the enteral feeding device is
selected from the group
consisting of a nasogastric feeding tube, a gastric feeding tube, jejunostomy
tube, and a
gastrojejunostomy tube. In certain embodiments the syringe adapter enteral
feeding assembly is
configured to connect only to an enteral feeding device. In some embodiments
the syringe
adapter enteral feeding assembly is configured to connect only to enteral
feeding elements.
[0006] In other embodiments the present invention is a method for
delivering an enteral
feeding material to a patient. In certain embodiments, the method includes the
use of a system as
described herein. In some embodiments, the present invention is a method for
delivering an
enteral feeding material to a patient, wherein the enteral feeding medium is
not substantially
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exposed to an external environment. In some such embodiments the methods
includes the use of
a system as described herein.
[0007] In certain embodiments, the methods include the steps of providing
a reservoir
body having a reservoir liner configured to hold an enteral feeding material;
providing a
reservoir connector connected with the reservoir liner and a reservoir cap
connected to the
reservoir connector and the reservoir body; providing a syringe adapter
enteral feeding assembly
having a proximal end connected to the reservoir liner via the reservoir
connector and a distal
end connected to an enteral feeding device; engaging the enteral feeding
device with a patient in
a manner that permits flow of the enteral feeding medium to a patient; and
providing the enteral
feeding medium to the patient. In some embodiments the methods provide the
enteral feeding
medium to the patient without substantial exposure to the external
environment. In other
embodiments the methods provide the enteral feeding medium to the patient
without exposure to
the external environment.
[0008] In some embodiments, the enteral feeding system features a capped
reservoir
comprising a one-piece bottle with no vent holes. The capped reservoir
includes a top end
having a threaded section dimensioned to mate with a threaded cap. The
threaded cap provides a
leak proof seal when tightened on the threaded section of the bottle, and
allows venting of the
bottle when loosened. Because the enteral feeding system comprises a closed
system, venting is
needed to allow the fluid to flow. The cap may be tethered to the bottle such
that it is not
misplaced. The bottom end of the one-piece bottle terminates in a funneled
connector port,
which may provide connections (e.g., through the use oral syringe connectors)
in a manner that is
not compatible with IV connections. The one-piece bottle and cap may be made
from a suitable
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material such as plastic. The plastic may be clear, partially transparent,
white, orange, purple, or
any other suitable color. In certain embodiments, a stand having a center hole
for slidably
receiving the one-piece bottle may be provided for supporting the bottle in an
upright position.
the stand may comprise a plurality of legs, or, alternatively, may comprising
a one-piece mold.
100091 In further embodiments, the one-piece bottle includes a cap having
a filtered air
vent port that may be selectively closed, for example, using a snap-fit seal.
Alternatively, the
selectively closable vent port may be non-filtered. In some embodiments, the
closable air vent
port may be located on the side of the bottle rather than on the cap. During
use, the closable vent
port provides air compensation when opened, and provides a leak proof seal
when closed. In
embodiments featuring a filtered vent port, the air filter may or may not
comprise a bacterial
barrier. By way of example, the filter may comprise a .2 micron filter for air
filtration providing
significant bacterial protection.
100101 In additional embodiments, the one-piece bottle includes a novel
vented cap that
prevents bacteria from entering the bottle. The vented cap allows the bottle
to be filled with
breast milk through the use of a breast pump that is attached to the cap in a
leak proof manner.
The bottle may be connected - snapped or screwed on - to the breast pump and
later disconnected
and recapped. Alternatively, the vented cap may be threaded such that it may
be loosened and
removed from the bottle, thereby allowing a manual feed of either breast milk
or other enteral
feeding solution, all without leakage. In manual feed embodiments, the cap may
be tethered to
the bottle such that it is not misplaced. When the cap is removed, the breast
milk or other enteral
feeding solution may be poured directly into the bottle. Once capped, the
bottle may be stored,
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frozen, and thawed with no exposure point until it is used for feeding a baby.
If no vent is
provided, the cap may be cracked or loosened slightly in order to begin the
flow of milk.
100111 Further embodiments provide a one-piece bottle containing enteral
feeding
material and having a top end with a threaded section and a bottom end
comprising a funneled
connector port; and a threaded cap dimensioned to mate with the threaded
section of the one-
piece bottle; wherein the funneled connector port connects to an enteral
feeding assembly;
wherein the threaded cap provides a leak proof seal such that there is no
exposure point until it is
used for feeding, thereby preventing contamination. In such embodiments, a
bottom narrow end
of the funneled connector port may terminate in a female luer lock, wherein
the female luer lock
is molded to the funneled connector port. A male luer lock may be attached to
the female luer
lock. By way of example, the male and female luer locks may comprise screw
type locks or snap
locks.
[0012] In some embodiments, the bottom narrow end of the funneled
connector port is
mechanically connected or bonded to a fluid transfer set. The fluid transfer
set may comprise
tubing that is attached to the funneled connector port at one end and includes
a connector
disposed at another end. The connector may comprise a male or female luer
lock, or an oral tube
port. The oral tube port may comprise a funneled connection port providing a
connection to a
syringe adapter enteral feeding assembly and enteral feeding device.
Alternatively, the oral tube
port may comprise an oral syringe connecting port, which provides attachment
to an oral syringe
connector of a syringe adapter feeding assembly. The oral syringe connector
may comprise a
clear step connector, a colored step connector, or a molded single oral
connector.
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[0013] In additional embodiments, the threaded cap may include a rotating
section that
rotates with respect to the cap such that apertures in the rotating section
may be aligned with
similarly dimensioned apertures in the cap. The rotating section includes a
raised tab for turning
the rotating section between a configuration where the apertures are aligned
and a sealed
configuration where the apertures are not aligned.
[0014] In other embodiments, the threaded cap may include squeeze points,
wherein
pressure is provides by a user at the squeeze points while rotating the cap in
order to open for
venting. The threaded cap locks in place when fully screwed on and vents when
squeezed and
cracked open.
[0015] In additional embodiments, a sealed membrane is provided on a top
of the bottle,
and the threaded cap includes a piercing element that pierces the sealed
membrane when the cap
is screwed onto the bottle. The threaded cap may further include a molded-in
breakaway area for
venting.
[0016] In further embodiments, the threaded section of the bottle
includes pockets, and
the threaded cap includes mirrored detents that provide a seal when aligned
with the pockets and
create vents when detached from the pockets. Alternatively, the threaded
section of the bottle
may include interrupted threads, wherein the threaded cap includes
corresponding interrupted
threads that align with the interrupted threads of the bottle for venting, but
otherwise form a seal.
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Brief Description of the Drawings
[0017] FIG. 1 is a schematic illustration of an embodiment of a system of
the present
invention.
[0018] FIGs. 2A and 2B are illustrations of reservoir bodies as may be
used in an
embodiment of the present invention.
[0019] FIG. 3 is an illustration of an embodiment of a reservoir liner as
may be used in
an embodiment of the present invention.
[0020] FIG. 4A is a side view of an embodiment of a reservoir connector
as may be used
in an embodiment of the present invention.
[0021] FIG. 4B is a view of the proximal end of an embodiment of a
reservoir connector
as may be used in an embodiment of the present invention.
[0022] FIG. 5A is a side view of an embodiment of a reservoir cap as may
be used in an
embodiment of the present invention.
[0023] FIG. 513 is a view of the distal end of an embodiment of a
reservoir cap as may be
used in an embodiment of a system of the present invention.
[0024] FIG. 6 is a schematic illustration of an embodiment of a syringe
adapter enteral
feeding assembly as may be used in an embodiment of a system of the present
invention.
[0025] FIG. 7 illustrates a cross-sectional view of a capped reservoir
comprising a one-
piece bottle in accordance with the principles of the invention.
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[0026] FIG. 8A illustrates a cross-sectional view of a capped reservoir
comprising a one-
piece bottle including a vented cap (FIG. 8B) in accordance with the
principles of the invention.
[0027] FIG. 8C illustrates an alternative bottle cap having an RFID
device attached
thereto in accordance with the principles of the invention.
[0028] FIGs. 8D and 8E illustrate further alternative bottle caps
suitable for use with the
one-piece bottle of FIG. 7.
[0029] FIG. 8F illustrates a one-piece bottle having a sealed membrane,
while FIG. 8G
illustrates a corresponding cap having a piercing element for piercing the
sealed membrane.
[0030] FIG. 81 illustrates a one-piece bottle having threads with
pockets, while FIG. 8J
illustrates a corresponding cap having mirrored detents that seal when aligned
with the pockets
and create vents when detached from the pockets.
[0031] FIG. 8K illustrates a one-piece bottle having interrupted threads,
while FIG. 8L
illustrates a corresponding cap having interrupted threads that align with the
interrupted threads
of the bottle for venting, but otherwise form a seal.
[0032] FIGS. 9A and 9B illustrate a perspective view of a modified capped
reservoir
comprising a one-piece bottle having an oral syringe connecting port in
accordance with the
principles of the invention.
[0033] FIG. 1 OA illustrates a perspective view of a stand for supporting
the one-piece
bottles of FIGS. 7-9 in accordance with the principles of the invention.
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[0034] FIG. 10B illustrates a perspective view of an alternative stand
for supporting the
one-piece bottles of FIGS. 7-9 in accordance with the principles of the
invention.
[0035] FIG. 11A illustrates a side view of a one-piece reservoir having a
funneled
connector port in accordance with the principles of the invention.
[0036] FIG. 11B illustrates a side view of a one-piece reservoir having a
funneled
connector port mechanically connected or bonded to a fluid transfer set in
accordance with the
principles of the invention.
Detailed Description
[0037] In the following paragraphs, the present invention will be
described in detail by
way of example with reference to the attached drawings. Throughout this
description, the some
embodiment and examples shown should be considered as exemplars, rather than
as limitations
on the present invention. As used herein, the "present invention" refers to
any one of the
embodiments of the invention described herein, and any equivalents.
Furthermore, reference to
various feature(s) of the "present invention" throughout this document does
not mean that all
claimed embodiments or methods must include the referenced feature(s).
[0038] Systems of the present invention have multiple elements and may
include a
combination of two or more of a reservoir body, a reservoir liner, a reservoir
connector, a
reservoir cap, syringe adapter enteral feeding assembly, an enteral feeding
device and any other
compatible device or element. The system of the present invention may include
any suitable
combination of elements. The elements may be separate so long as they are
connectable to form
a working system.
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[0039] Figure 1 illustrates an embodiment of the present invention having
reservoir body
100, reservoir liner 200, reservoir connector 300, reservoir cap 400, syringe
adapter enteral
feeding assembly 500, and enteral feeding device 600. Figure 1 depicts the
various elements of
the embodiment of the system. In use, the elements may be connected in any
suitable manner.
In some cases, each connection will not mate with standard intravenous
administration couplings
and/or connections. In some embodiments, each connection is unique such that
it will only mate
and/or connect with elements of an enteral feeding system. In other
embodiments, each
connection prevents the enteral feeding material from substantial interaction
with an
environment external to the system and the patient. In various embodiments,
each connection
prevents the enteral feeding material from any interaction with the external
environment. In
addition, in some embodiments one or more of the elements is disposable. In
other
embodiments, each element is disposable.
[0040] Figure 2A illustrates an embodiment of reservoir body 100.
Reservoir body 100
may be of any suitable size, shape and capacity and may be made of any
suitable material. In
some configurations, reservoir body 100 is made of a rigid material. In some
embodiments,
reservoir body 100 is made of plastic and has a capacity of about 8 ml to
about 2000 ml. Figure
2B illustrates a further embodiment in which reservoir body 100' is made of
plastic and has a
capacity of about 8 ml. In additional embodiments, the reservoir body can be
less than 8 ml or
greater than 2000 ml. Reservoir body 100 is generally cylindrical in shape,
whereas reservoir
body 100' includes is tapered. In general, the reservoir body may have any
suitable shape.
Reservoir bodies 100, 100' are generally hollow such that they define an area
in which an
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optional reservoir liner may be disposed. Figure 3 illustrates a reservoir
liner 200 that may be
disposed within reservoir body 100.
100411 With further reference to Figures 2A and 2B, reservoir bodies 100,
100' include a
proximal end 120, 110' and a distal end 120, 120', respectively. References to
"proximal" and
"distal" elements are made from the perspective of the patient. Proximal end
110, 100' may be
open or closed. In some embodiments, proximal end 110, 100' includes
connection structure
150, 150'. Connection structure 150, 150' may be any structure or substance
that facilitates
connection between reservoir body 100, 100' and a reservoir cap 400. In the
illustrated
embodiment, connection structure 150, 150' comprise threads that interact with
corresponding
threads 480 on reservoir cap 400 to form a connection. In some embodiments of
the invention,
distal end 120, 120' is open. In various embodiments, reservoir body 100 has
measurement
indicators 130 that show the amount of material remaining within reservoir
body 100.
100421 With further reference to Figure 2B, distal end 120' for reservoir
body 100'
includes a funneled connector port 125 that may be of any suitable size and
shape and may be
made of any suitable material. In some embodiments, funneled connector port
125 includes a
removable cap on its bottom tip. In such embodiments, the attachment may be
made by any
suitable method. In the depicted embodiment, the bottom end of funneled
connector port 125 is
configured to connect with, for example, the syringe adapter enteral feeding
assembly 500
illustrated in Figure 1. Funneled connector port 125 can be made of a non-
rigid material, such as
rubber, and is tapered such that its bottom end has a diameter or area that is
less than the
diameter or area of its top end. The bottom end of the funneled connector port
125 includes an
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aperture 135 such that enteral feeding material may pass through aperture 135
and into the
syringe adapter enteral feeding assembly 500.
[0043] Figure 3 illustrates an embodiment of reservoir liner 200.
Reservoir liner 200 is
configured to hold and dispense enteral feeding material and may be of any
suitable size, shape
and capacity and may be made of any suitable material. In some cases,
reservoir liner 200 is
non-rigid and made of plastic. Reservoir liner 200 is configured to fit within
reservoir body 100.
In some embodiments, reservoir liner 200 is substantially cylindrical with a
diameter smaller
than the diameter of a substantially cylindrical reservoir body 100. Reservoir
liner 200 includes
distal end 220 and proximal end 210. In some embodiments, proximal end 210 has
a lip 250
around its circumference. Lip 250 may be made of the same material as the rest
of reservoir
liner 200 or it may be made of a different material. In certain embodiments,
lip 250 is sized and
configured to contact proximal end 110 of reservoir body 100 when reservoir
liner 200 is
disposed within reservoir body 100. In such embodiments, lip 250 is also
configured to contact
distal end 320 of reservoir connector 300. In some embodiments, reservoir
liner 200 may be
physically attached to reservoir body 100. In other embodiments, reservoir
liner 200 may be
unitary with reservoir body 100. In various embodiments, reservoir liner 200
is pre-filled with
enteral feeding material and sealed such that proximal end 320 is closed. In
some such
embodiments, reservoir liner 200 is sealed using a material that may be
pierced or opened as
reservoir cap 400 is attached to reservoir body 100.
[0044] Figures 4A and 4B illustrate an embodiment of reservoir connector
300.
Reservoir connector 300 may be of any suitable size and shape and may be made
of any suitable
material. In some embodiments, reservoir connector 300 may be attached to or
unitary with
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reservoir cap 400. In such embodiments, the attachment may be made by any
suitable method.
In the depicted embodiment, reservoir connector 300 has distal end 320 and
proximal end 310.
Distal end 320 is configured to contact reservoir liner 200 and/or reservoir
body 100, whereas
proximal end 310 is configured to connect with syringe adapter enteral feeding
assembly 500. In
some configurations, reservoir connector 300 is made of a non-rigid material,
such as rubber, and
is tapered such that proximal end 310 has a diameter or area that is less than
the diameter or area
of distal end 320. In the illustrated embodiment, proximal end 310 has
aperture 380 and is open
at its distal end 320 such that enteral feeding material may enter through
distal end 320 and pass
through aperture 380. Additionally, distal end 320 includes a lip 350 having a
proximal surface
330 and a distal surface 340. In some embodiments, lip 350 is generally
circular, is disposed
around the circumference or edge of distal end 320 and is sized and configured
such that distal
surface 340 will contact lip 250 of reservoir liner 200 and proximal surface
330 will contact edge
460 of reservoir cap 460. In some embodiments, proximal surface 330 of lip 350
has annular
groove 360 that is configured to mate with annular bump 440 of reservoir cap
400. Reservoir
connector 300 may have a structure capable of piercing or opening a reservoir
liner 200 that is
pre-filled with enteral feeding material and sealed at its proximal end 210.
100451 Figures 5A and 5B illustrate an embodiment of reservoir cap 400.
Reservoir cap
400 may be any suitable size, shape and configuration and may be made of any
suitable material.
Reservoir cap 400 is configured to connect with reservoir body 100. In some
embodiments,
reservoir cap 400 may be attached to or unitary with reservoir connector 300.
In some
embodiments, reservoir cap 400 is rigid and made of plastic. In the depicted
embodiment,
reservoir cap 400 has proximal end 410 having edge 460 and has distal end 420.
In some
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embodiments, edge 460 is configured to contact the proximal surface 330 of
reservoir connector
300 when reservoir cap 400 is connected to reservoir body 100. Edge 460 has an
annular bump
440 which mates with annular groove 360 of reservoir connector 300. Also, the
distal end 310 of
reservoir connector passes through opening 450 such that distal end 310 is
connectable to
additional elements, including syringe adapter enteral feeding assembly 500.
In some
embodiments, the connection of reservoir cap 400 to reservoir body 100 is made
by interaction
of connection structures 150 with threads 480. The connection of reservoir cap
400 to reservoir
body 100 causes the distal end 320 of reservoir connector 300 to contact lip
250 of reservoir liner
200. Accordingly, in some embodiments, the connection of reservoir cap 400 to
reservoir body
100 secures reservoir liner 200 to reservoir body 200, secures reservoir
connector 300 to
reservoir liner 200 and secures reservoir connector 300 to reservoir cap 400,
all in a manner that
permits flow of an enteral feeding medium from reservoir liner 200 to the
distal end 310 of
reservoir connector 300. In certain embodiments, this connection is such that
the enteral feeding
medium is not exposed to the external environment. In some embodiments,
reservoir cap 400
may have a structure capable of piercing or opening a reservoir liner 200 that
is pre-filled with
enteral feeding material and sealed at its proximal end 210.
[0046] Figure 6 illustrates an embodiment of syringe adapter enteral
feeding assembly
500. Syringe adapter enteral feeding assembly 500 may be any suitable size and
may be made of
any suitable material and may have various combinations of elements. The
depicted
embodiment features syringe adapter 510, clamp 520, warning label 530, tubing
540, and
connection member 550. Syringe adapter 510 may be configured as described in
United States
Design Patent No. D542,406, which is hereby expressly incorporated by
reference in its entirety.
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Syringe adapter 510 has a distal end 560 configured to connect to reservoir
connector 300 and a
proximal end configured to connect to tubing 540. Distal end 560 may connect
to reservoir
connector 300 in any suitable manner. In certain embodiments, distal end 560
may connect to
reservoir connector 300 in a manner that prevents exposure of the enteral
feeding medium to the
external environment. Clamp 520 may be any suitable clamp. In some
embodiments, clamp 520
may be a roller clamp or a slide clamp. Tubing 540 may be made of any suitable
material and
may have any suitable width, length and thickness. In some embodiments, the
tubes may be
made of plastic, polyurethane or silicone. In some embodiments, warning label
530 indicates
that syringe adapter enteral feeding assembly 500 is to be used for enteral
feeding only.
100471 Figure 6 also depicts an embodiment of enteral feeding device 600.
Enteral
feeding device 600 may be any suitable device for any suitable method or type
of enteral
feeding. Enteral feeding device 600 may also include a guide wire assembly to
facilitate guiding
the assembly into a patient. In some embodiments, enteral feeding device 600
is a nasogastric
feeding tube passed through the flares, down the esophagus and into the
stomach. In other
embodiments, enteral feeding device 600 is a gastric feeding tube inserted
through a small
incision in the abdomen into the stomach and is used for long-term enteral
nutrition. The gastric
tube may be any type of gastric tube, including a percutaneous endoscopic
gastrostomy tube or a
gastronomy tube inserted in an open procedure. In yet other embodiments,
enteral feeding
device 600 is a jejunostomy tube that is generally surgically inserted into
the jejunum rather than
the stomach. Enteral feeding device 600 may comprise a dual lumen
gastrojejunostomy tube. In
some dual lumen embodiments one lumen is a gastric tube and the second lumen
is a jujnal
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lumen. In such embodiments, the gastric lumen is used for decompression and
the jejunal lumen
is used to administer feedings.
[0048] In some embodiments, the present invention is a method of
providing a patient
with an enteral feeding medium. The enteral feeding medium may be any material
suitable for
enteral feeding a patient. Such methods may include the use of a system as
described herein in
enteral feeding a patient. In some embodiments, the methods provide the
enteral feeding
medium to a patient without substantial exposure of the enteral feeding
material to an external
environment. Additionally, the methods may provide the enteral feeding medium
to a patient
without exposure to an external environment.
[0049] Referring to Figure 7, a capped reservoir 700 is illustrated
comprising a one-piece
bottle 710 with no vent holes, a top end having a threaded section 715
dimensioned to mate with
a threaded cap 720, and a bottom end having a funneled connector port 730,
which may provide
connections to an enteral feeding assembly. By way of example, the funneled
connection port
730 may provide a connection to the syringe adapter enteral feeding assembly
500 and enteral
feeding device 600 depicted and described with respect to Figure 1. For such
embodiments, the
one-piece bottle 710 is provided in lieu of the reservoir body 100 and
reservoir connector 300 of
Figure 1.
[0050] With further reference to Figure 7, the threaded cap 720 provides
a leak proof seal
when tightened on the threaded section 715 of the one-piece bottle 710, and
allows venting of the
bottle 710 when loosened. Because the enteral feeding system comprises a
closed system,
venting is needed to allow the fluid to flow. In some embodiments, the cap 720
may be attached
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to the bottle 710 using tether 740 such that it is not misplaced. As stated,
the bottom end of the
one-piece bottle 710 terminates in a funneled connector port 730, which may
provide
connections (e.g., through the use oral syringe connectors) to an enteral
feeding assembly in a
manner that is not compatible with IV connections. The one-piece bottle 710
and cap 720 may
be made from any suitable material. In some embodiments, one-piece bottle 710
is made of
plastic and has a capacity of about 10 ml to about 2000 ml. The bottle
material may be clear,
partially transparent, white, orange, purple, or any other suitable color. The
one-piece bottle 710
illustrated in Figure 7 is generally cylindrical in shape, but it may have any
suitable shape. In
various embodiments, one-piece bottle 710 has measurement indicators that show
the amount of
material remaining within bottle 710.
[0051] In some embodiments, one-piece bottle 710 is generally hollow and
defines an
area in which a reservoir liner 750 may be disposed. The reservoir liner 750
may be configured
to hold and dispense enteral feeding material and may be of any suitable size,
shape, capacity
and material. By way of example, reservoir liner 750 may be non-rigid and made
of plastic. In
some embodiments, reservoir liner 750 is substantially cylindrical with a
diameter smaller than
the diameter of a substantially cylindrical one-piece bottle 710. Reservoir
liner 750 may be
unitary with one-piece bottle 710. In various embodiments, reservoir liner 750
is sealed using a
material that may be pierced or opened as cap 720 is attached to one-piece
bottle 710.
[0052] With continued reference to Figure 7, the funneled connector port
730 of one-
piece bottle 710 may be of any suitable size and shape and may be made of any
suitable material.
In some embodiments, funneled connector port 730 includes a removable cap 760
on its bottom
tip. In such embodiments, the attachment may be made by any suitable method.
In the depicted
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embodiment, the top end of funneled connector port 730 is configured to
contact reservoir liner
750 and/or one-piece bottle 710, whereas the bottom end is configured to
connect with, for
example, the syringe adapter enteral feeding assembly 500 illustrated in
Figure 1. Funneled
connector port 730 can be made of a non-rigid material, such as rubber, and is
tapered such that
its bottom end has a diameter or area that is less than the diameter or area
of its top end. The
bottom end of the funneled connector port 730 includes an aperture 770 such
that enteral feeding
material may pass through aperture 770 and into the syringe adapter enteral
feeding assembly
500.
[0053] Referring to Figures 8A and 8B, a capped reservoir 800 is
illustrated comprising a
one-piece bottle 810, a top end having a threaded section 815 dimensioned to
mate with a
threaded cap 820 having a filtered air vent port 825, and a bottom end having
a funneled
connector port 830, which may provide connections to an enteral feeding
assembly. Similar to
the embodiment of Figure 7, the funneled connection port 830 may provide a
connection to the
syringe adapter enteral feeding assembly 500 and enteral feeding device 600
depicted and
described with respect to Figure 1. In some embodiments, the cap 820 may be
attached to the
bottle 810 using tether 840 such that it is not misplaced.
100541 In the illustrated embodiment, the threaded cap 820 includes
filtered air vent port
825, which may be selectively closed, for example, using a snap-on seal 835
attached via a hinge
845 comprising an area of reduced thickness. In certain embodiments, the
selectively closable
vent port 825 may be non-filtered. In some embodiments, the closable air vent
port 825 may be
located on the side of the one-piece bottle 810 rather than on the cap 820.
During use, the
closable vent port 825 provides air compensation when opened, and provides a
leak proof seal
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CA 02823317 2013-08-13
when closed. In embodiments featuring a filtered vent port 825, the air filter
may or may not
comprise a bacterial barrier. By way of example, the filter may comprise a .2
micron filter for
air filtration providing significant bacterial protection. The one-piece
bottle 810 is generally
hollow and defines an area in which a reservoir liner 850 may be disposed.
Like the embodiment
of Figure 7, the bottom end of the funneled connector port 830 includes an
aperture 870 such that
enteral feeding material may pass through aperture 870 and into the syringe
adapter enteral
feeding assembly 500. The funneled connector port 830 may include a removable
cap 860 on its
bottom tip.
[0055] In the embodiments of Figures 7 and 8, the one-piece bottle may
include a novel
vented cap that prevents bacteria from entering the bottle. The vented cap
allows the bottle to be
filled with breast milk through the use of a breast pump that is attached to
the cap in a leak proof
manner. Additionally, the cap may be removed and the bottle may then be
connected ¨ snapped
or screwed on ¨ to the breast pump. In further embodiments, the vented cap may
be threaded
such that it may be loosened and removed from the bottle, thereby allowing a
manual feed of
either breast milk or other enteral feeding solution, all without leakage. In
manual feed
embodiments, the cap may be tethered to the bottle such that it is not
misplaced. When the cap is
removed, the breast milk or other enteral feeding solution may be poured
directly into the bottle.
Once capped, the bottle may be stored, frozen, and thawed with no exposure
point until it is used
for feeding a baby, thereby avoiding contamination. If no vent is provided,
the cap may be
cracked or loosened slightly in order to begin the flow of milk. Referring to
Figure 8C, in some
embodiments, an alternative cap 855 may include an RFID tag 865 that is
attached to the cap 855
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CA 02823317 2013-08-13
via mounting post 875. By way of example, the RFID tag 865 may be used for
mother/baby
identification of appropriately matching breast milk.
[0056] Referring to Figure 8D, a further cap 801 suitable for use with
the one-piece
bottle 810 is illustrated. Cap 801 includes a rotating section 803 that
rotates with respect to the
cap 810 such that apertures 806 in rotating section 803 may be aligned with
similarly
dimensioned apertures 807 in the cap 801. Similar to a salt shaker, the
rotating section 803
includes a raised section 808 for turning the rotating section 803 between a
configuration where
the apertures 806, 807 are aligned and a sealed configuration where the
apertures 806, 807 are
not aligned, as depicted in Figure 8D. Referring to Figure 8E, another cap 811
may include
squeeze points 813, similar to a child proof pill cap, wherein pressure is
provided by a user at the
squeeze points 813 while rotating the cap 811 in order to open for venting. In
operation, the cap
811 locks in place when fully screwed on and vents when squeezed and cracked
open.
[0057] Referring to Figure 8F, in some embodiments, a sealed membrane 816
is provided
on a pre-filled or empty bottle 814. Referring to Figure 8G, an alternative
cap 817 having
piercing element 819 is provided for use with the bottle of Figure 8F having
sealed membrane
816. In particular, when cap 817 is screwed into place on bottle 814, piercing
element 819 is
forced downward such that it pierces sealed membrane 816. Referring to Figure
811, cap 817
further includes a molded-in breakaway area 821 for venting. Assuming a
sterile pre-filled bottle
814 is provided, there is no exposure point until it is used for feeding,
thereby avoiding
contamination.
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100581 Referring to Figure 81, bottle 824 includes threads having pockets
826. Referring
to Figure 8J, corresponding cap 828 includes mirrored detents 831 that seal
when aligned with
pockets 826 and create vents when detached from pockets 826. Referring to
Figure 8K, bottle
836 includes interrupted threads 838. Referring to Figure 8L, corresponding
cap 844 includes
interrupted threads 842 that align with threads 838 for venting, but otherwise
form a seal. Again,
assuming a sterile pre-filled bottle 824 is provided, there is no exposure
point until it is used for
feeding, thereby avoiding contamination
100591 Referring to Figures 9A and 9B, a modified capped reservoir 900 is
illustrated
comprising a one-piece bottle 910, a top end having a removable threaded cap
920, and a bottom
end having a funneled connector port 930. An adapter comprising an oral
syringe connecting
port 940 is attached to the bottom end of the funneled connector port 930 such
that the oral
syringe connecting port 940, as an ID connection, may provide attachment to an
oral syringe
connector 950 of a syringe adapter feeding assembly 960. Specifically, the
oral syringe
connector 950 is dimensioned to slide into place within the oral syringe
connecting port 940,
thereby providing fluid communication with the one-piece bottle 910. Figure 9A
depicts the
funneled connection port 930 connected with oral syringe stem connector 950,
while Figure 9B
depicts the funneled connection port 930 disconnected from oral syringe stem
connector 950.
The oral syringe connecting port 940 may be molded integral with the one-piece
bottle 910, or
may be a separate component that is mated with the bottom end of the funneled
connector port
930. In addition, the oral syringe connecting port 940 may be clear plastic,
or may have any
suitable color. The oral syringe stem connector 950 may comprise a clear step
connector, a
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colored step connector, or a molded single oral connector, for example having
an oral stem found
on an oral syringe.
100601 Referring to Figure 10A, some embodiments of the invention include
a stand
1000 having a center hole 1010 for slidably receiving any of the one-piece
bottles 710, 810, 910
of Figures 7-9. The stand 1000 is provided for supporting a one-piece bottle
710, 810, 910 in an
upright position. In the illustrated embodiment, the stand 1000 includes a
bottle support 1020
having center hole 1010 for receiving bottle 710, 810, 910, and a plurality of
legs 1030 for
supporting the bottle support 1020. The legs 1030 may be attached to the
bottle support 1020 in
any suitable fashion, such as using threaded fasteners 1040.
100611 Referring to Figure 10B, in further embodiments the stand may also
comprise a
one-piece mold 1050 having a base 1060 and two upwardly extending members 1070
forming a
slot 1080 therebetween for receiving the bottle 710, 810, 910 and allowing the
tubing to pass
through the slot 1080. The slot 1080 is tapered such that the bottle 710, 810,
910 slides into the
slot 1080 before becoming wedged between the two members 1070.
[0062] Referring to Figure 11A, a reservoir 1100 is illustrated
comprising a one-piece
bottle 1110, a top end having a threaded section 1115 dimensioned to mate with
a threaded cap
(such as any of the threaded caps depicted in Figures 7 and 8), and a bottom
end having a
funneled connector port 1130, which may provide connections to an enteral
feeding assembly.
By way of example, the funneled connection port 1130 may provide a connection
to the syringe
adapter enteral feeding assembly 500 and enteral feeding device 600 depicted
and described with
respect to Figure 1. Similar to previous embodiments, the threaded cap (not
shown) provides a
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CA 02823317 2013-08-13
leak proof seal when tightened on the threaded section 1115 of the one-piece
bottle 1110, and
allows venting of the bottle 1110 when loosened. The funneled connector port
1130 provides
connections to an enteral feeding assembly, as set forth below.
100631 With further reference to Figure 11A, the bottom end of the
funneled connector
port 1130 terminates in a female luer lock 1140. In particular, the female
luer lock 1140 may be
part of a one-piece mold including the bottle portion and the funneled
connector port 1130.
Some embodiments feature the use of a funneled connector port 1130' without an
integral bottle,
wherein the female luer lock 1140' may be manufactured integrally with the
funneled connector
port 1130' as part of a one-piece mold. Alternatively, a male luer slip or
male luer lock 1150
may be molded onto the bottom end of the funneled connector port 1130, thereby
replacing the
female luer lock 1140 or 1140'. The male luer slip comprises the male luer
lock 1150 without
threaded nut 1160. Such connections can be customized based upon the IV type.
By way of
example, the connectors can be IV type locking connectors and/or custom sized
locking
connectors. Such connectors may be screw type, snap lock, or another
customized type of
locking connector.
100641 Referring to Figure 11B, in an alternative configuration, the
bottom narrow end of
funneled connector port 1130 is mechanically connected or bonded to a fluid
transfer set 1165 at
junction 1167. In the illustrated embodiment, the fluid transfer set 1165
comprises tubing 1170
with a connector 1180 disposed at the distal end. The connector 1180 may
comprise a male or
female luer lock, or an oral tube port. As described above with respect to
Figure 7, the oral tube
port may comprise a funneled connection port 730 providing a connection to the
syringe adapter
enteral feeding assembly 500 and enteral feeding device 600 depicted and
described with respect
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to Figure 1. As described above with respect to Figure 9, the oral tube port
may alternatively
comprise an oral syringe connecting port 940, such as an ID connection, which
provides
attachment to an oral syringe connector 950 of a syringe adapter feeding
assembly 960. The oral
syringe connector may comprise a clear step connector, a colored step
connector, or a molded
single oral connector, for example having an oral stem found on an oral
syringe.
[0065] Thus, it is seen that enteral feeding systems and methods are
provided. One
skilled in the art will appreciate that the present invention can be practiced
by other than the
various embodiments, which are presented in this description for purposes of
illustration and not
of limitation, and the present invention is limited only by the claims that
follow. It is noted that
equivalents for the particular embodiments discussed in this description may
practice the
invention as well.
[0066] While various embodiments of the present invention have been
described above,
it should be understood that they have been presented by way of example only,
and not of
limitation. Likewise, the various diagrams may depict an example configuration
for the
invention, which is done to aid in understanding the features and
functionality that may be
included in the invention. The invention is not restricted to the illustrated
example
configurations, but the desired features may be implemented using a variety of
alternative
configurations. Indeed, it will be apparent to one of skill in the art how
alternative functional,
logical or physical configurations may be implemented to implement the desired
features of the
present invention. Also, a multitude of different constituent part names other
than those depicted
herein may be applied to the various parts. Additionally, with regard to
method claims, the order
in which the steps are presented herein shall not mandate that various
embodiments be
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CA 02823317 2013-08-13
implemented to perform the recited functionality in the same order unless the
context dictates
otherwise.
[0067] Although the invention is described above in terms of various
exemplary
embodiments and implementations, it should be understood that the various
features, aspects and
functionality described in one or more of the individual embodiments are not
limited in their
applicability to the particular embodiment with which they are described, but
instead may be
applied, alone or in various combinations, to one or more of the other
embodiments of the
invention, whether or not such embodiments are described and whether or not
such features are
presented as being a part of a described embodiment. Thus the breadth and
scope of the present
invention should not be limited by any of the above-described exemplary
embodiments.
[0068] Terms and phrases used in this document, and variations thereof,
unless otherwise
expressly stated, should be construed as open ended as opposed to limiting. As
examples of the
foregoing: the term "including" should be read as meaning "including, without
limitation" or the
like; the term "example" is used to provide exemplary instances of the item in
discussion, not an
exhaustive or limiting list thereof; the terms "a" or "an" should be read as
meaning "at least
one," "one or more" or the like; and adjectives such as "conventional,"
"traditional," "normal,"
"standard," "known" and terms of similar meaning should not be construed as
limiting the item
described to a given time period or to an item available as of a given time,
but instead should be
read to encompass conventional, traditional, normal, or standard technologies
that may be
available or known now or at any time in the future. Likewise, where this
document refers to
technologies that would be apparent or known to one of ordinary skill in the
art, such
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technologies encompass those apparent or known to the skilled artisan now or
at any time in the
future.
[0069] A group of items linked with the conjunction "and" should not be
read as
requiring that each and every one of those items be present in the grouping,
but rather should be
read as "and/or" unless expressly stated otherwise. Similarly, a group of
items linked with the
conjunction "or" should not be read as requiring mutual exclusivity among that
group, but rather
should also be read as "and/or" unless expressly stated otherwise.
Furthermore, although items,
elements or components of the invention may be described or claimed in the
singular, the plural
is contemplated to be within the scope thereof unless limitation to the
singular is explicitly
stated.
[0070] The presence of broadening words and phrases such as "one or
more," "at least,"
"but not limited to" or other like phrases in some instances shall not be read
to mean that the
narrower case is intended or required in instances where such broadening
phrases may be absent.
The use of the term "module" does not imply that the components or
functionality described or
claimed as part of the module are all configured in a common package. Indeed,
any or all of the
various components of a module, whether control logic or other components, may
be combined
in a single package or separately maintained and may further be distributed
across multiple
locations.
[0071] Additionally, the various embodiments set forth herein are
described in terms of
exemplary block diagrams, flow charts and other illustrations. As will become
apparent to one
of ordinary skill in the art after reading this document, the illustrated
embodiments and their
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various alternatives may be implemented without confinement to the illustrated
examples. For
example, the figures and their accompanying description should not be
construed as mandating a
particular configuration.
SMRH=406362066.1 -29-
