Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-09-13
2004-10-26
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C285S148230, C604S175000, C604S523000, C604S534000
Reexamination Certificate
active
06808521
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to enteral feeding devices, and more particularly to an enteral feeding adapter which may be used with infusion sets of various sizes.
It is a known medical procedure to catheterize a body in order to provide nutritional solutions directly into the stomach or intestines of a patient. A stoma is formed in the stomach or intestinal wall and a catheter is placed through the stoma. Feeding solutions can be injected through a catheter inserted in the stoma to provide nutrients directly to the stomach or intestines (known as enteral feeding).
To ensure that the catheter is maintained in the proper position, it is common to use a balloon disposed near the distal (patient) end of the catheter shaft. Inflating the balloon causes the balloon to contact the anatomical structure (i.e., a duct or stomach wall) and thereby prevent the catheter from moving out of the proper position. Such balloon catheter devices may include a “low-profile” head at the proximal end of the catheter shaft. The head, which also helps hold the balloon catheter in place, includes an opening for receiving the feeding solution and a one-way valve for preventing fluids from passing out of the patient via the catheter. U.S. Pat. No. 5,997,503 and 5,997,546, both owned by Applicants' Assignee and incorporated by reference herein for all purposes, disclose examples of low-profile balloon catheters suitable for enteral feeding.
The balloon catheters of the cited patents are configured to have a low profile above the user's skin so that the catheters do not significantly interfere with the patient's other activities. Because feeding solutions must be fed through the relatively small head of the balloon catheter located atop the patient's skin, an enteral feeding adapter is often used to transfer the solutions from a source to the catheter.
Such adapters often include an elongate feeding tube having connecting elements on each end of the tube. On the distal end of the tube, one of the connecting elements engages the head of the balloon catheter to place the tube in communication with the catheter. The proximal end of the tube typically includes another connecting element in the form of an adapter body for receiving the distal end of an infusion set and also possibly a syringe. The infusion set, in turn, may be connected to an enteral feeding pump, a drip chamber, or any other mechanism for providing a feeding solution.
One problem with available enteral feeding adapters is that the adapter bodies are typically configured specifically for use with a particular infusion set of a given diameter and configuration. Most of the commercially available infusion sets, however, are not of a standardized size or configuration. For example, infusion sets marketed by various companies have widely different distal end configurations. Some have substantially cylindrical surfaces at the infusion set distal end, and some have substantially frustoconical surfaces at this location. Additionally, although infusion sets and mating enteral feeding adapters are made in varying sizes, only a very limited range exists where infusion sets and adapters of differing sizes might work together. For example, if a portion of the distal end of an infusion set is configured to be received in an adapter having a cross-sectional diameter of 0.22 inches, the distal end will likely not work in an adapter with a cross-sectional diameter of 0.24 inches. While the infusion set distal end would be received by the adapter body, the engagement would be so loose that the distal end could easily be pulled from the adapter.
Thus, infusion sets and the adapters are generally not interchangeable. To provide an enteral feeding adapter for a patient, the infusion set and the enteral feeding adapter typically must be matched. This situation can lead to inventory and supply problems, added cost and complexity, etc. The situation can be compounded greatly where the enteral feeding adapter distal end does not work with all balloon catheters.
Frustoconically shaped feeding ports, although they may allow infusion sets of differing sizes to be inserted, inherently may provide only limited contact between the exterior of the distal end of the infusion set and the frustoconical port's wall. Thus, the distal end of the infusion set may be easily pulled from the feeding port.
Thus, there is a need for an improved enteral feeding adapter which can be used with a wide variety of infusion sets while inhibiting inadvertent removal of the distal end of the infusion set from the feeding port of the adapter body.
SUMMARY OF THE INVENTION
Objects and advantages of the invention will be set forth in part in the following description, or may be apparent from the description, or may be learned through practice of the invention.
It should be noted that any given range presented herein is intended to include any and all lesser included ranges. For example, a range of from 45-90 would also include 50-90, 45-80, 46-89, and the like.
According to the invention, an adapter is provided for use with an enteral feeding device for delivering substances into a patient. The enteral feeding adapter is suitable for use with a plurality of infusion sets having distal connectors of differing dimensions. The enteral feeding adapter includes an adapter body containing at least a first port configured for receiving a distal connector of an infusion set, the first port having at least one arcuate sidewall for frictionally engaging the distal connector to sealingly secure the distal connector to the adapter body. The arcuate sidewall may have various radii of curvatures, for example between about 0.18 inches to about 0.55 inches. The enteral feeding adapter also includes a tube extending between the first port and the medical device for transmitting substances that pass through the first port to the medical device.
A second port may also be defined in the adapter for delivering medicine to the patient, for example by a syringe.
The at least one arcuate sidewall may define a proximal portion of the first port, and the first port may further include a second arcuate sidewall, which may be located distally the first arcuate sidewall. If so, the first arcuate sidewall may have a radius of curvature greater than that of the second arcuate sidewall. For example, the first arcuate sidewall may have a radius of curvature of between 0.45 and 0.55 inches and the second arcuate sidewall may have a radius of curvature between 0.22 and 0.24 inches.
The first port may also include a third arcuate sidewall distal of the second arcuate sidewall. If so, the first arcuate sidewall may have a radius of curvature of between 0.45 and 0.55 inches, the second arcuate sidewall may have a radius of curvature of between 0.22 and 0.24 inches, and the third arcuate sidewall may have a radius of curvature of between 0.18 and 0.22 inches.
The first arcuate sidewall may have a varying diameter between 0.330 and 0.220 inches, the second arcuate sidewall may have a varying diameter between 0.220 and 0.153 inches, and the third arcuate sidewall may have a varying diameter between 0.153 and 0.127 inches.
In accordance with another aspect of the invention, an enteral feeding adapter is provided and configured for receiving the distal end of an infusion set for delivering substances into a patient. The enteral feeding adapter includes an adapter body having a first port, the first port having at least a cylindrical first section and a second section defined by a first arcuate sidewall disposed distally of the first section, the first arcuate sidewall being configured to frictionally engage the distal end of the infusion set. The adapter also includes a tube extending between the adapter body and the medical device for transmitting the substances from the infusion set to the medical device and thereafter into the patient.
The present invention also includes the methods of utilizing the enteral feeding adapter described herein.
REFERENCES:
patent: 4666433 (1
Casler Brian L.
Dority & Manning P.A.
Kimberly--Clark Worldwide, Inc.
Maiorino Roz
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