Surgery – Body inserted urinary or colonic incontinent device or...
Reexamination Certificate
2000-03-29
2002-03-19
Winakur, Eric F. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Reexamination Certificate
active
06358197
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention pertains to the treatment of a portion of a wall forming a cavity in a body. More particularly, this invention pertains to an apparatus for forming implants in a portion of the wall forming the gastrointestinal tract.
2. Description of Related Art
Gastroesophageal reflux disease (GERD) is a failure of the anti-reflux barrier, allowing abnormal reflux of gastric contents into the esophagus of the gastrointestinal tract. Gastroesophageal reflux disease is a disorder which is usually characterized by a defective lower esophageal sphincter (LES), a gastric emptying disorder with or without failed esophageal peristalsis. The disease usually manifests itself during “transient lower esophageal sphincter relaxation” episodes, the frequency of which is greatly increased in patients who reflux. Medical or drug therapy is the first line of management for gastroesophageal refluxes. However, drug management does not address the condition's mechanical etiology. Thus symptoms recur in a significant number of sufferers within one year of drug withdrawal. In addition, while medical therapy may effectively treat the acid-induced symptoms of gastroesophageal reflux disease, esophageal mucosal injury may continue due to ongoing alkaline reflux. Since gastroesophageal reflux disease is a chronic condition, medical therapy involving acid suppression and/or promotility agents may be required for the rest of a patient's life.
The expense and psychological burden of a lifetime of medication dependence, undesirable life style changes, uncertainty as to the long term effects of some newer medications and the potential for persistent mucosal changes despite symptomatic control, all make surgical treatment of gastroesophageal reflux disease an attractive option. Unfortunately, surgical intervention is a major operation with all attendant morbidities, mortality and risk of failure requiring further surgery in the case of over-correction. Laparoscopic surgery requires a very high level of skill and special training for it to be successful.
Minimally invasive procedures have been provided for forming implants in the wall of the gastrointestinal tract to treat GERD and other ailments. It would be desirable to have a method and device for forming implants of a predetermined size in a consistent manner to enhance the reproducability of such procedures.
OBJECTS AND SUMMARY OF THE INVENTION
In general, it is an object of the present invention to provide a minimally invasive apparatus for injecting a material into a portion of a wall forming a cavity in a body, such as the gastrointestinal tract, to form one or more implants of a substantially consistent size in the wall.
Another object of the invention is to provide an apparatus of the above character in which a recess in a probe is utilized to shape the portion of the wall into a protrusion into which the material is injected.
Another object of the present invention is to provide an apparatus of the above character in which the probe guides and positions an injection needle into the protrusion.
Another object of the present invention is to provide an apparatus of the above character in which consistently sized multiple implants may be formed in a portion of the wall of the cavity.
Another object of the present invention is to provide an apparatus of the above character which can inhibit the injection need from being pushed through the wall.
Another object of the present invention is to provide an apparatus of the above character which can be used for treating gastroesophageal reflux disease (GERD).
In general, an apparatus comprising an elongate probe member having proximal and distal extremities has been provided for use with a suction source to treat a portion of a wall forming a cavity in a body having a natural body opening for accessing the cavity. The elongate probe member has a length so that when the distal extremity is in the vicinity of the portion of the wall the proximal extremity is outside of the body. The distal extremity of the elongate probe member has an outer surface and is provided with at least one recess opening onto the outer surface and an internal passageway communicating with the recess. When the suction source is coupled to the apparatus a suction is created in the recess by means of the passageway to draw the portion of the wall into the recess. A hollow needle is slidably disposed in the elongate probe member and has a distal end portion. The needle is actuatable from outside the body for movement from a retracted position in which the distal end portion of the needle is out of the recess and an extended position in which the distal end portion of the needle extends into the recess. The needle can be extended into the portion of the wall drawn into the recess so as to introduce a material into the portion of the wall and form an implant in the portion of the wall.
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Gough Edward J.
Silverman David E.
Stein Alan
Enteric Medical Technologies, Inc.
Flehr Hohbach Test Albritton & Herbert LLP
Szmal Brian
Winakur Eric F.
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