Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-02-18
2001-05-15
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06231547
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a device for retaining a catheter, such as a gastrostomy or jejunostomy feeding tube, in place with respect to the skin of a patient. The present invention also relates to a catheter assembly and a method of using the same.
2. Description of Related Art
It is common practice in health care facilities or the like for an elongate flexible tube, generally known as a catheter, to be inserted percutaneously in a patient to assist in medical treatment. Such catheters are used in a variety of applications to inject fluids into or withdraw fluids from the canals, vessels, passageways or body cavities of a patient. Catheters also can be used to maintain an orifice or similar passage in an open condition.
For example, numerous patients receiving medical treatment are unable to ingest foods orally due to conditions such as facial injuries, esophageal injuries, or unconsciousness. Liquid nutritional products therefore have been developed for a process known as enteral feeding. Enteral feeding typically involves the insertion of a feeding tube percutaneously into the gastrointestinal tract of a patient, such as the stomach or intestine. To prevent injury to the patient and the feeding assembly, it is advantageous to retain the placement of the feeding tube relative to the skin of the patient. A variety of retaining devices have been developed for this purpose.
FIG. 1
demonstrates, for purpose of illustration only, a known catheter or feeding tube assembly including a gastrostomy tube
10
inserted percutaneously in a patient for the introduction of a liquid nutritional product. The gastrostomy tube
10
extends through the epidermis
11
, the fat layer
12
, the muscle layer
13
, the peritoneum
14
, the stomach lining
15
, and the gastric mucosa
16
. One end
17
of the gastrostomy tube is located within the stomach. An internal retaining member
18
is fastened proximate one end of the gastrostomy tube and located within the stomach, adjacent to the mucosa wall
16
. The internal retaining member
18
thereby reduces the possibility of inadvertent removal of the gastrostomy tube from the patient. As shown in
FIG. 1
, the internal retaining member can be an inflatable or expandable membrane, although it also is known to use a flange-type internal retaining member if desired. Furthermore, it is noted that catheter assemblies used for other applications, such as for jejunostomy or intravenous applications, may not require an internal retaining device.
The known feeding tube assembly of
FIG. 1
further includes an external retaining device
19
located externally of the person adjacent to the epidermis
11
. This particular external retaining device generally is a disk-shaped member having a cylindrical opening formed therethrough to maintain the feeding tube substantially perpendicular to the patient's skin. Similar external retaining devices are available for use with enteral feeding tubes distributed by Sandoz Nutrition Corporation, 5320 West Twenty Third Street, P.O. Box 370, Minneapolis, Minn. 55440, U.S.A., under trade names such as CALUSO® PEG and SUPER PEG™. Although the Sandoz external retaining device has a circular base portion, other shapes can be used, as demonstrated by U.S. Pat. No. 5,071,405. Because the feeding tube extends perpendicularly from the patient, this known feeding tube assembly can be susceptible to entanglement. To minimize such entanglement, it is advisable that the tube of this feeding tube assembly be wrapped or twisted into a loop. Care must be taken, however, to ensure that subsequent pulling or tugging does not kink the loop and thus occlude flow through the tube.
Several concepts for external retaining devices, which are also known in the medical device industry as skin disks, have been developed in an attempt to minimize or eliminate the disadvantages of the prior art design. Particularly, U.S. Pat. No. 5,267,969 discloses an external retaining device configured to receive a feeding tube extending substantially perpendicularly from a patient and then guide the feeding tube through a 90° bend without being kinked. The external retaining device of U.S. Pat. No. 5,267,969 includes a first hole to receive the feeding tube and a second hole of a larger diameter having a center axis arranged coplanar with but perpendicular to the center axis of the first hole. Although effective for its intended purpose, it has been found that this external retaining device can be difficult to adjust in position once properly placed against the patient with the feeding tube extending therethrough.
In view of the above, there remains a need for a readily adjustable external retaining device capable of bending and retaining a catheter in position against a patient without being kinked or occluded. Furthermore, there remains a need for a feeding tube assembly including this improved external retaining device and a method of using the same.
SUMMARY OF THE INVENTION
The purpose and advantages of the present invention will be set forth in and apparent from the description that follows, as well as will be learned by practice of the invention. Additional advantages of the invention will be realized and attained by the apparatus and method particularly pointed out in the written description and claims hereof, as well as from the appended drawings.
To achieve these and other advantages and in accordance with the purpose of the invention, as embodied and broadly described, the invention includes an external retaining device for use with a catheter having an elongate tube. The present invention also includes the catheter assembly incorporating the external retaining device and the method of using the same.
The external retaining device includes a base member having a lower surface and an upper surface. A passage having a central axis is defined between the lower and upper surfaces of the base member. Preferably, a tube guide portion extends from the upper surface of the base member. The tube guide portion has an elongate channel with a longitudinal axis defined therein. A first section of the channel is located proximate the passage with the longitudinal axis at the first section of the channel aligned substantially with the central axis of the passage. The second section of the channel is spaced from the first section of the channel with the longitudinal axis at the second section of the channel angled relative to the central axis of the passage. In this manner, the elongate tube can be directed through the passage and positioned within the channel to form approximately a 90° bend in the tube along a smooth transition without kinking or pinching of the tube.
A manually-operable clip assembly is provided on the base member to secure the placement of the external retaining device relative to the elongate tube and, thus, placement of the elongate tube relative to the base portion of the external retaining device. The clip assembly is moveable selectively between a closed position and an open position. The elongate tube thereby can be received by the clip assembly when the clip assembly is in the open position and secured in place, without occlusion, when the clip assembly is in the closed position.
In the preferred embodiment of the present invention, the clip assembly is located on the tube guide portion proximate the second section of the channel. Furthermore, the clip assembly preferably includes opposing clip elements mounted to the tube guide portion proximate the second section of the channel. Pivotal movement is accomplished by forming the side walls of the tube guide portion with an elastic material and affixing each clip element to a corresponding side wall such that flexure of each side wall toward the other moves the clip element to the open position. A finger grip can be provided on each side wall to further enhance flexure. The base member and the tube guide portion are preferably formed together as a single-piece polyurethane member, with the clip elements made of relatively rigi
Abbott Laboratories
Hayes Michael J.
Hulseberg Daniel J.
Seidel Richard K.
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