Note: Descriptions are shown in the official language in which they were submitted.
1035~ 4
This invention relates to an infant tube feeding
adapter. More specifically, this invention relates to an in-
fant tube feeding adapter which permits the passage of small,
accurately measured quantities of fluid from a calibrated con~
tainer to a gavage tube and the expulsion of air from the fluid.
There is a great need for a simple and accurate device
for the gavage feeding of premature infants. Ef~forts to satisfy
this need have been directed towards transfer of formula from a
nursing container to a gavage tube, by means of a plastic or
glass syringe or pouring of the formula into a graduated cylinder
before attachment to the gavage tube. ~owever, because of the
small quantity of formula consumed by the premature infant and the
necessity of knowing exactly how much nourishment has actually
been received, it is more desirable to have an accurate measure-
ment, without utilizing a separate measuring container, of the
quantity of formula remaining after feeding. It is desirable to
eliminate any measuring error which arises where the formula level
has been reduced but the formula not actually received by the
infant. Also , transfer of formula from one container to another
to achieve accurate measurement may necessitate the use of various
components, which requires that the hospital employ facilities,
such as washing devices and an autoclave to conduct aseptic trans-
fer of formula for gavage feeding.
Another problem inherent in the transfer method of
gavage feeding, where formula is poured into a calibrated container
before feeding, is the presence of entrapped air in the formula
or container. In gavage feeding, a tube is placed through the
inant's nose or mouth into the stomach. Any air trapped in the
formula will be transferred into the gavage tube during feeding,
making feeding much more difficult because of the small diameter
of the gavage tube; and increase the probability of air reaching
the infant' 8 stomach.
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In the past, many infant fe~ding assemblies have been
proposed however, none have satisfied the need for a simple,
aseptic, accurate device for gavage feeding of known quantities
of formula. Sheridan (U. S. Patent No. 3,153,415) discloses a
gavage feeding arrangement, utilizing a formula reservoir and
gavage tubing, having a sealing cap for closing off the proximal
end of the tubing when not in use to prevent contamination. This
method o feeding is commonly used, as discussed above, except no
provision for accurate measurement of consumed formula nor elimin-
ation of entrapped air is disclosed. Harrigan (U. S. Patent ~o.
3,645,262) discloses a calibrated container, gavage tubing, and
a means for transfer of formula from a nursing container to the
calibrated container. Although a calibrated container ~ utilized
in Harrigan, an accurate measurement of the quantity of formula
consumed is not possible because of small amounts of formula
left in the device, which are not actually received by the infant,
and the presence of entrapped air. DeMarco (U. S. Patent No. 2,
600,798) discloses a nuxsing bottle having a nipple of relatively
~mall dimensions. The bottle is hand hald and the nipple squeezed
to force formula into the infant's mouth. This reference does not
disclose a device for gavage feeding and possesses the disadvantage
of ~ucking air into the bottle upon release of finger pressure on
the nipple. Barton et al. (U. S. Patent No. 3,003,500) discloses
an intravenous administrating device for the transfusion of blood.
The device comprises a drip meter and filter, pump, and tubing
arrangement. The pump has flexible walls, rigid end member~, and
a floating check valve. The check valve seats on the rigid end
member to close the inlet when the flexible wall is compressed in
order to force fluid through the pump cha~ber outlet. Barton
does not disclose a totally flexible pump or connector but rather
necessitates having a pump with a rigid end member for the seating
of the check valve. Also, accurate measurement of the quantity
-3-
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of fluid passed from the pump chamber o Barton would be diffi-
cult because of the absence of any means for regulating fluid
flow and the absence of close calibration means.
The infant tube feeding adapter of the present invention
constitutes an improvement over the prior art devices in that
it provides an accurate measurement of formula received by
the infant, by the elimination of formula loss in the device
and entrapped air in the fluid.
The present invention is generally characterized in an
infant tube feeding device, adapted for delivering fluid from a
calibrated container to a gavage tube, comprising a translucent
flexible connector, said connector having a reduced diameter
proximate said gavage tube and being calibrated to permit
delivery to said gavage tube of accurately measured, small
quantities of fluid, a flow clamp positioned on the flexible
connector proximate the gavage tube and having means for
regulating fluid flow, and a semi-rigid fitment providing a
connection for the flexible connector to the gavage tube.
Accordingly, it is a feature of the present invention
to utilize a flexible connector between the calibrated container
and gavage tube to accurately measure and facilitate the flow
of formula delivered to the infant.
Another feature of the present invention is to provide a
flow clamp on the flexible connector for use in expelling air
trapped in the formula and to permit attachment of the flexible
connector-to the implanted gavage tube without loss of formula.
Another feature of the present invention is to utilize
means in the flow clamp for regulating fluid flow to the gavage
tube.
The present invention provides an infant tube feeding
device which requires less handling and involves a lesser prob-
ability of error in accurately measuring the quantity of formula
received by the infant.
4 _
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Other objects and advantage~ of the present invention
will become apparent from the following description of the pre-
ferred embodiment taken in conjunction with the accompanying
drawings.
Fig. 1 is a perspective view of the device embodied in
the present invention, with a calibrated container and gavage
tube shown:
Fig. 2 is a longitudinal sectional view, partially in
elevation, of the device shown in Fig. 1, taken through line 2-2
of Fig. 1:
Fig. 3 is a top plan view of the device shown in Fig. 1,
taken through line 3-3 of Fig. 2:
Fig. 4 is an elevational view of anotherembodiment with
parts broken away, of the device of the present invention.
As illustrated in Figs. 1-4, the infant tube feeding
adapter device of the present invention includes a flexible connec-
tor, generally designated 1, a flow clamp 2, and a semi-rigid
fitment 3. A calibrated container 4 is utilized to introduce fluid
into flexible connector 1 and a gavage tube 5 delivers the fluid
from flexible connector 1 to the infant.
Flexible connector 1 is a generally elongated container,
being open at both ends. At the proximal end, flexible connector 1
has an orifice 6 for receiving the male tip of calibrated container 4,
as ~hown in Fig. 1. A body portion 7 of flexible connector 1 has
on its outer surface calibrations 8. Body portion 7 is reduced
in diameter at the end proximate and attached to the female
portion of gavage tube 5.
Flow clamp 2 is a generally flat, slidable clamp located
proximate gavage tube 5 on flexible connector 1. In order to
regulate fluid flow through flexible connector 1, flow clamp 2
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has a longitudinal slot 9 through which flexible connector 1
pa~ses. Longitudinal slot 9 is formed in flow clamp 2 by non-
parallel sides, thus, the diameter of longitudinal slot 9 varies
to provide a closed position, where the diameter of slot 9 is
small enough to completely restrict fluid flow through flexible
connector 1 and several open positions, where the diameter of
slot 9 restricts fluid flow through flexible connector 1 as
desired.
,;emi-rigid fitment 3 of flexible connector 1 is in the
form of a male fitment for attachment with the female portion of
gavage tube 5 to allow delivery of formula from flexible connector 1
to gavage tube 5.
In operation, the infant tube feeding adapter device of
the present invention allows an accurate measurement of fluid flow
from calibrated container 4 to gavage tube S. Even though the
fluid in calibrated container 4 could be measured, no means for
determining the quantity of fluid remaining in the container 4 and
gavage tube 5 exist, which is crucial when the small amount of
fluid given to a premature infant is considered. Flexible connector 1
provides a means of determining from calibrations 8 the exact amount
of fluid delivered to the infant, because, in addition to gravity,
pressure applied to the walls of flexible connector 1 facilitates
fluid flow through gavage tube 5 and reduces the quantity of un-
determined fluid remaining in the device.
Flexible connector 1 and flow clamp 2, in conjunction,
provide the advantages of the device of this invention discussed
above. Flow clamp 2 allows a voluntary regulation of the rate of
fluid flow to gavage t~e 5 by the use of longitudinal slot 9.
Longitudinal slot 9 in flow clamp 2 may be slidably moved on
flexible connector 1 to a position where the dia~eter of slot 9
restricts fluid flow through flexible connector 1 as desired.
Thus, in feeding of a premature infant where forceable efforts are
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needed to provide a pumping action that will eliminate the necessity
of the infant sucking to empty the contents of a container, flexible
connector 1 and flow clamp 2 may be utilized to deliver fluid at
predetermined intervals and ~uantities.
Another feature of the device embodied in the present
invention lies in providing a means for eliminating air trapped in
the fluid of flexible connector 1. Flow clamp 2 may be slidably
moved to the closed position where longitudinal slot 9 has its
narrowest diameter so that fluid flow from flexible connector 1
to gavage tube 5 is completely restricted. Upon the application
of pressure to flexible connector 1, air trapped in the fluid will
be forced out through calibrated container 4.
The utilization of flexible connector 1 in conjunction
with flow clamp 2 provides in the infant tube feeding adapter
device of the present invention an inherent advantage over the
devices shown in the prior art. As discussed above, when using a
rigid container, such as calibrated container 4, in conjunction
with gavage tube 5, without the addition of flexible connector 1,
a conventional clamp for regulating fluid flow from calibrated
container 4 to gavage tube 5 would have to be placed on gavage tube 5.
Since gavage tubing generally has thin walls and is of small dia-
meter, the possibility of cutting gavage tub~ 5 with a resulting
contamination or loss of fluid exi3ts. With the inclusion of
flexible connector 1 between calibrated container 4 and gavage tube 5,
flow clamp 2 can be utilized to fit over flexible connector 1 rather
than over the fragile gavage tube S and eliminate these possibilities.
Semi-rigid fitment 3 is provided for ease of attachment
of male tip 10 of flexible connector 1 to the female portion of
gavage tube 5. Semi-rigid fitment 3 is molded integrally with
flexible connector 1, as shown in Fig. 1, so as to have a degree
of rigidity sufficient for this purpose, but may be a separate
piece, as shown in Fig. 4.
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Flow clamp 2 may be forced over male tip 10 of
flexible connector 1 so that the entire device can be packaged
in a sterile bag, ready to be used without disassembly during
sbipment or useage.
Inasmuch as the present invention is subject to many
variations, modifications and changes in detail, it is intended
that all matter above-described or shown in the drawing be
interpreted as illustrative and not in a limiting sense.