Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-05-19
2003-03-04
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S910000, C128SDIG008, C128S842000, C383S076000, C383S200000
Reexamination Certificate
active
06527748
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method of gastrostomy, and an infection preventive cover, kit or catheter kit and a gastrostomy catheter kit for use with the method.
2. Description of the Related Art
For a percutaneous endoscopic gastrostomy (PEG) enabling enteral feeding of a patient who finds swallowing food difficulty or who cannot swallow, it is sufficient to apply a local anethesia to the patient and the operation time is favorably short, i.e., about five to about ten minutes, and the patient can quickly recover after the operation. In a case where the patient in a good general condition after the operation, she or he may leave the hospital on the same day on which the operation is conducted. The PEG and its use has therefore developed rapidly worldwide. In the United States, for example, about 180,000 cases were reported in 1997. In the future, the number of the operations is in the world is expected to increase.
As commonly known, the PEG includes three methods, namely, “pull”, “push”, and “introducer” methods (techniques). Among these methods, the “pull” and “push” methods have been broadly adopted due to simplicity and safety of the operation. However, these methods include the drawbacks described below.
The endoscope is required to be twice inserted in the pertinent patient, which leads to a problem of complex operations and pain to patients. There exists a fear of damage to the larynx, the upper pharynx or the esophagus.
The PEG catheter (including a PEG tube and a dome connected to the tube) is infected in the oral cavity, the upper pharynx or the larynx and hence the wounded part of the patient is liable to be infected.
The first drawback above can be overcome by improving the sedation or anesthesia and by increasing the quality of skill of the endoscopist. However, the second drawback, i.e., the infection of the wound due to the contamination of the PEG tube and the dome has a high possibility of occupancy. The literature from Europe and America reported about 35% to about 45% of the infection of wound. When the infection of a wound occurs, antibiotics are required to be administered to the patient for a long period of time. This resultantly delays the starting point of the enteral feeding for the patient, and the immunity of the patient from diseases is weakened, this may lengthen the hospital treatment in some cases. The patient suffers from serious pains and the fee for medical treatment soars. Consequently, not only the patient but also family members of the patient must bear the expense and suffer from mental stress. When the cleaning of the oral cavity, the preoperation disinfection of the upper pharynx, and the preventive administration of antibiotics are completely carried out, the number of bacteria appearing on the PEG tube and the dome can be decreased. However, this is not the basic countermeasure.
SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide a method of gastrostomy capable of preventing the infection of a wound.
Another object of the present invention is to provide an infection preventive cover to prevent the infection of a wound in the method of gastrostomy.
Still another object of the present invention is to provide a gastrostomy catheter (PEG catheter) kit to prevent the infection of a wound in the method of gastrostomy.
Still another object of the present invention is to provide an infection preventive kit to prevent the infection of a wound in the method of gastrostomy.
Yet another object of the present invention is to provide an infection preventive catheter kit to prevent the infection of a wound in the method of gastrostomy.
Further another object of the present invention is to provide a gastrostomy catheter (PEG catheter) used in the method of gastrostomy which exhibits fine performance.
A method of gastrostomy in accordance with the present invention includes inserting a guide wire into a stomach through an outer tube pierced through a wall of an abdomen and a wall of the stomach of a patient and pulling the guide wire through an esophagus and an oral cavity into a space outside the patient, joining one end of a percutaneous endoscopic gastrostomy (PEG) catheter with the guide wire, delivering the PEG catheter into the stomach by pulling (“pulling method”) or pushing (“pushing method”) the guide wire, drawing the PEG catheter together with the outer tube through a hole in the wall of the stomach and the abdomen wall into a space outside the patient, keeping another end of the PEG catheter in the stomach (including a case in which the end is cut away from the catheter), characterized by enclosing entirely the PEG catheter with an infection preventive cover having a sheath, the sheath having one opening end, closing the opening end of the sheath in the vicinity of the position of a joint between the PEG catheter and the guide wire, delivering the PEG catheter through the oral cavity into the stomach with the PEG catheter covered with the infection preventive cover, opening the opening end of the sheath in the stomach, drawing the PEG catheter into a space outside the patient, while drawing the PEG catheter through the opening end of the sheath opened, and removing thereafter the infection preventive cover from the oral cavity into a space outside the patient. The present invention is applicable to either the “push method” or the “push method” of gastrostomy.
In accordance with the present invention, the PEG catheter and the joint section between the PEG catheter and the guide wire are covered outside the oral cavity with the infection preventive cover having a sheath to be delivered from the oral cavity into the stomach in the covered state. Since the opening end of the infection preventive cover is closed until the cover reaches the stomach, the PEG catheter does not directly contact the oral cavity, the larynx and the upper pharynx of the patient. The PEG catheter is therefore kept clean.
The opening end of the infection preventive cover is opened in the stomach of the patient, and the PEG catheter is withdrawn through the opening end of the cover and is drawn through a hole (wounded part of the patient) prepared in the abdominal and stomach walls into a space outside the patient. When the PEG catheter is delivered into the stomach, the catheter is kept clean, namely, is not inflected. Even when the clean PEG catheter is brought into contact with the hole (wound) in the abdominal and stomach walls, the hole (wound) is hardly inflected. Consequently, infection of the wound can be efficiently prevented.
An infection preventive cover in accordance with the present invention is used in the gastrostomy and comprises an elongated sheath having at least one opening end, a binding thread embroidered along a circumferential edge of the opening end of the sheath, and a cutting thread linked to the binding thread, the both ends of the binding thread being led outside the sheath at positions near to each other, and the cutting thread being stronger than the binding thread.
There can be considered various kinds of embroidering of the binding thread (a ligature) in the opening end of the sheath. For example, the ligature is reciprocally embroidered with an appropriate interval between an inner side and an outer side of the opening end portion of the sheath. Alternatively, the opening end portion of the sheath is folded back and the folded-back edge is fixed to the sheath by welding, melting or the like to thereby produce a threading bag, pass or guide, and the ligature is passed through the threading bag.
The cutting thread also includes a thread made of metal such as a metallic wire. Any chemical fiber such as nylon may be used if the cutting thread is stronger than the ligature. The sentence “a cutting thread is linked to the binding thread” includes a state in which the cutting thread is doubled to simply engage with the ligature.
For the infection preventive cover (the sheath), there is favorably employed thin, airtight, waterproof, flexible and strong
Casler Brian L.
Han Mark
McGinn & Gibb PLLC
LandOfFree
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