Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
1997-05-02
2001-04-10
Jastrzab, Jeffrey R. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06216039
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to implanted medical devices and, more particularly, relates to a method and apparatus for use in treating irregular gastric rhythms.
BACKGROUND OF THE INVENTION
The gastrointestinal system includes the stomach, small intestine and large intestine. Like other organs of the body, most notably the heart, these organs naturally undergo regular rhythmic contractions. In particular these contractions take the form of peristaltic contractions and are essential for the movement of food through each of the respective organs. Like the heart, these contractions are the result of regular rhythmic electrical depolarizations of the underlying tissue. With regards to the small intestine and large intestine, normal electrical depolaraziations (“slow waves”) typically occur at a rate of approximately 15 and 1 beats per minute (bpm) respectively. Similarly, in the stomach, normal slow waves typically occur at a rate approximately 3 bpm. Not all of these depolaraziations, however, normally result in a contraction of the organ. Rather contractions occur upon the occurrence of a normal electrical depolaraziations followed by a series of high frequency spike activity.
In some individuals, however, either the regular rhythmic peristaltic contractions do not occur or the regular rhythmic electrical depolaraziations do not occur or both do not occur. In each of these situations the movement of food may be seriously inhibited or even disabled. Such a condition is often called “gastroparesis” when it occurs in the stomach. Gastroparesis is a chronic gastric motility disorder in which there is delayed gastric emptying of solids or liquids or both. Symptoms of gastroparesis may range from early satiety and nausea in mild cases to chronic vomiting, dehydration, and nutritional compromise in severe cases. Similar motility disorders occur in the other organs of the gastrointestinal tract (“GI tract”), although by different names.
Diagnosis of gastroparesis is based on-demonstration of delayed gastric emptying of a radio-labeled solid meal in the absence of mechanical obstruction. Gastroparesis may occur for a number of reasons. Approximately one third of patients with gastroparesis, however, have no identifiable underlying cause (often called idiopathic gastroparesis). Management of gastroparesis involves four areas: (1) prokinetic drugs, (2) antiemetic drugs, (3) nutritional support, and (4) surgical therapy (in a very small subset of patients.) Gastroparesis is often a chronic, relapsing condition; 80% of patients require maintenance antiemetic and prokinetic therapy and 20% require long-term nutritional supplementation. Other maladies such as tachygastria or bradygastria can also hinder coordinated muscular motor activity of the GI tract, possibly resulting in either stasis or nausea or vomiting or a combination thereof.
The undesired effect of these conditions is a reduced ability or complete failure to efficiently propel intestinal contents down the digestive tract. This results in malassimilation of liquid or food by the absorbing mucosa of the intestinal tract. If this condition is not corrected, malnutrition or even starvation may occur. Moreover nausea or vomiting or both may also occur. Whereas some of these disease states can be corrected by medication or by simple surgery, in most cases treatment with drugs is not adequately effective, and surgery often has intolerable physiologic effects on the body.
Presently, however, there is no practically effective device or system to intelligently stimulate. Therefore, there is a need in the art for a system and method to properly stimulate the GI tract to thereby treat ineffective or absent electrical muscular activity of the GI tract.
SUMMARY OF THE INVENTION
Thus it is an object of the present invention to provide a method and apparatus to treat gastric arrhythmia, as occurs in patients with gastroparesis.
It is a further object of the present invention to provide a method and apparatus which treats gastric arrythmias with electrical stimulation.
It is a still further object of the present invention to provide a method and apparatus which treats gastric arrythmias by sensing the underlying gastric rhythm, determining whether it is an arrhythmia, and provides the appropriate electrical stimulation to the sensed arrhythmia.
The above and other objects are met by the present invention which is a method and apparatus for treating gastric arrhythmia. The apparatus features an implantable pulse generator which may be coupled to the gastric system through one or more medical electrical leads. In the preferred embodiment the leads couple to the circular muscle layer of the stomach. The apparatus further features a sensor to sense slow waves and determines whether the slow waves are occurring in an irregular or unstable manner. The apparatus further permits such slow waves to be diagnosed as either occurring in a bradygastria or a tachygastria and provides the appropriate electrical stimulation in response. Thus the present invention diagnoses and treats irregular gastric rhythm such as bradygastria and tachygastria.
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Ectopic Jejun
Jaro Michael J.
Jastrzab Jeffrey R.
Medtronic Inc.
Patton Harold
Woods Thomas F.
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