Description:
This invention relates to an infant tube feeding adapter. More specifically, this invention relates to an infant tube feeding adapter which permits the passage of small, accurately measured quantities of fluid from a calibrated container 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. Efforts 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. However, 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 measurement, 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 transfer 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 infant'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's stomach.
In the past, many infant feeding 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. Pat. 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 of feeding is commonly used, as discussed above, except no provision for accurate measurement of consumed formula nor elimination of entrapped air is disclosed. Harrigan (U.S. Pat. No. 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 is 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. Pat. No. 2,600,798) discloses a nursing bottle having a nipple of relatively small dimensions. The bottle is hand held 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 sucking air into the bottle upon release of finger pressure on the nipple. Barton et al. (U.S. Pat. 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 members, 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 chamber 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 of fluid passed from the pump chamber of Barton would be difficult 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 flexible connector, 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 an object 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 object 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 object of the present invention is to utilize means in the flow clamp for regulating fluid flow to the gavage tube.
A further object of the present invention is to provide an infant tube feeding device which requires less handling and involves a lesser probability of error in accurately measuring the quantity of formula received by the infant.
Other object and advantages of the present invention will become apparent from the following description of the preferred 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 another embodiment with parts broken away, of the device of the present invention.
As illustrated in FIGS. 1-4, the infant tube feedng adapter device of the present invention includes a flexible connector, 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 shown 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 has a longitudinal slot 9 through which flexible connector 1 passes. Longitudinal slot 9 is formed in flow clamp 2 by nonparallel 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.
Semi-rigid fitment 3 os 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 5. 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 undetermined 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 tube 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 diameter of slot 9 restricts fluid flow through flexible connector 1 as desired. Thus, in feeding of a premature infant where forceable efforts are 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 quantities.
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 diameter, the possibility of cutting gavage tube 5 with a resulting contamination or loss of fluid exists. 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 5 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.
Flow clamp 2 may be forced over male tip 10 of flexible connector so that the entire device can be packaged in a sterile bag, ready to be used without disassembly during shipment 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.