Nasogastric tube stabilizer

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Reexamination Certificate

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06464668

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to a method and apparatus for securing nasal tubes to patients, and more particularly, to a device for use in the securing of a nasogastric or nasoenteral tube to a patient.
BACKGROUND OF THE INVENTION
Nasal tubes, also known as nasoenteral, nasogastric, nasoduodenal, stomach tubes, or feeding tubes, collectively referred to as nasogastric tubes, are used commonly in the course of patient health care, most frequently in preparation for, during, and after surgery. The nasogastric tube has been a problem for patients and clinicians for some time. Patients, especially when agitated, have been known to pull out nasogastric tubes because they can be so uncomfortable. This creates a problem for both the patient and the clinicians because it is necessary to have a new nasogastric tube inserted for each on that is prematurely pulled out by the patient. The repeated insertion of nasogastric tube exacerbates the suffering of the patient and results in time being wasted by the clinician reinserting the tube.
These tubes typically are formed from a resilient plastic material such as polyurethane, polyethylene, or a silicone polymer. Typically, the tube has a proximal end, a distal end and a central lumen or passageway. Further details about nasogastric tubes can be found in U.S. Pat. No. 4,778,448 and 4,634,425, the disclosures of which are incorporated herein by reference, as though recited in full.
Various techniques have been developed for securing a nasogastric tube to the patient to prevent accidental or premature removal of the tube. Such techniques include using adhesive tape to secure the tube to the patient, using an adjustable or flexible tube holder for retaining the tube placed adjacent the nostril opening and secured to the patient by a harness going around the patient's head, and a tube holder that has a self-attached hook means that holds a nose piece that holds a nosepiece onto the nose. The problem with the aforementioned external harnesses is that they are clumsy, can be removed easily, for example, by an uncooperative patient, and can be easily dislodged accidentally, for example, during restless sleep. Further details about these and other prior art examples can be found in U. S. Pat. No. 4,778,448.
A further attempt to secure the tube to the patient has involved suturing the tube to the patient's tissue, most commonly the nasal columella. The problems with such stitching are that chronic pulling on the tube and constant nasal secretions can result in local infection and significant damage to the nasal columella, including, of example, sawing the columella in two.
U.S. Pat. No. 4,778,448 illustrates a method for anchoring or securing tubes in a nostril of a patient, particularly nasoenteral tubes for use in nutrient solution feeding or gastric fluid drainage. The '448 structure includes a harness for securing a tube to a patient, a nasoenteral tube, and means for securing the harness to the nasoenteral tube along the length of the tube. The harness comprises an elongated body having a first end disposed toward the distal end of the tube and a second end disposed toward the proximal end of the tube. The first end is adapted to be passed through the nostril (nasal choana), preferably simultaneously with insertion of the nasoenteral tube in a first nostril. The second end of the harness is adapted to be inserted into the second nostril and connected to the first end so that the first and second ends may be secured together to form a loop passing through both nostrils that can be adjusted to fit closely about the nasal columella and the posterior aspect of the nasal septum. The procedure is illustrated in FIGS. 2A through 2M. The end result is illustrated in FIG. 2N with an alternate shown in FIG. 2O. The system of the '448 patent produces a desirable end result, but is a long, complicated, tedious procedure.
SUMMARY OF THE INVENTION
The disclosed appliance enables the rapid insertion of a tube around the nasal septum of a patient to form a harness to support a medical tube. The appliance has a feed through arm having a first end angled to form a first handle member and a second end consisting of a hollow, tubular guide member having an approximately 90 degree curve at the distal end. A receiving arm, having. a first end angled to form a second handle member, forms a second member. A handle pivot forms a swivel juncture between the receiving arm and feed through arm to enable the receiving arm handle and the feed through arm handle to move relative to one another in a scissor action along a first plane.
An upper clamping member is formed from a portion of the receiving arm length. A fulcrum housing at the proximal end of the upper clamping member forms a swivel juncture to enable a lower clamping member, extending from the fulcrum housing to the second end of the receiving arm second end, to be moveable. The lower clamping member moves, in relation to the upper clamping member, along a second plane. Preferably both the upper and lower clamping members have gripping members along their adjacent surfaces.
A spring member within the housing biases the lower clamping member adjacent the upper clamping member. The lower clamping member is moved, relative to the upper clamping member, by a handle member affixed to the lower clamping arm.
The movement of the handles causes the feed through arm and receiving arm to move relative to one another on a first plane while movement of the handle member causes the upper clamping member and said lower clamping member to move relative to one another on a second plane.
The feed through arm/tubular guide member and the receiving arm have a length sufficient to place the distal end of the tubular guide member and second end of the receiving arm second end past the nasal septum. Once in position, the curved distal end of the tubular guide member directs a tube behind the nasal septum to be received by the receiving arm, where the tube is gripped by the upper and lower clamping members. The tube is maintained between the upper and lower clamping members during withdrawal of the appliance. Once withdrawn, the tube is secured below a patient's columella, such as by tying the ends together with a medically approved material.
Alternatively, the tube can be secured with a retaining device having a first end and a second end and multiple slots, each of the slots extending from the first end to the second end. At least two of the slots are dimensioned to retain the tube harness and at least a third of the slots is dimensioned to receive medical tubing. Thus, the harness serves as a securing point for a medical tube inserted into a patient's body through a nasal passage.
To form the harness by inserting the tube around the nasal septum of a patient, the tubular guide is inserted into a first nasal passage of a patient. The end of the tube is fed through the tubular guide and directed through an open end of the tubular guide and around the nasal septum. The first end of the tube is clamped, and held, by the receiving arm in the second nasal passage. The tube is then fed through the nasal passages as the appliance is withdrawn. The ends of the tube are then secured to one another to form the harness to enable the attachment of a medical tube that enters the patient's body through the nasal passages.


REFERENCES:
patent: 4634425 (1987-01-01), Meer
patent: 4778448 (1988-10-01), Meer
patent: 5185005 (1993-02-01), Ballantyne
patent: 5913852 (1999-06-01), Magram

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