Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone
Patent
1997-09-23
1999-01-19
Milano, Michael J.
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Bone
623 11, A61F 204
Patent
active
058610367
DESCRIPTION:
BRIEF SUMMARY
This application is the national phase of international application PCT/IB96/00149, filed Feb. 28, 1996 which designated the U.S.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a medical prosthesis stopping gastric content from refluxing into the esophagus, including a tube made in a biocompatible polymer material resistant to gastric acid. One end is attached above the stomach and the other one is left free in the stomach.
2. Discussion of the Related Art
This type of prosthesis, described in WO91 01117, describes the shape of a valve with an opening passage kept closed elastically. The section of the passage is progressively narrowed to a permanent shape so as to close the lower end of the tube so that in a position of maximum opening, the section is approximately as wide as the upper end attached to the lower end of the esophagus. This is a description of a valve that is opened by a force capable of overcoming the elastic forces that tend to keep it closed. Such a concept implies a relatively rigid prosthesis that will allow its closure in the absence of any force capable of opening it, this force being generated by the peristaltic pressure exerted on the food bolus by the esophagus.
This solution is unsatisfactory as it creates a situation that is contrary to what naturally occurs, so that the peristaltic pressure has to open the valve.
In certain cases, for example when food is swallowed that has not been sufficiently chewed, an increased force is necessary to allow passage of the food bolus through the esophagus and if a further force is necessary to open the valve, there is either a risk of blocking food or of causing pain or both.
SUMMARY OF THE INVENTION
The aim of the present invention is to overcome, at least in part, the flaws of the abovementioned solution.
We have noticed that another solution, significantly different from the previous one, although at first sight it may appear similar, allows to obtain an equivalent result without the abovementioned flaws. This concept is based on a simple soft tubular element of a fairly constant section which will prolong the esophagus into the stomach. As the stomach has an asymetrical shape in relationship to the axis of the esophagus, in case of gastric reflux, the exerted pressure has a oblique direction in relationship to the axis of the esophagus. Therefore, if one prolongs the esophagus with a soft tube extending for a certain length into the stomach, in case of gastric reflux the soft tube collapses under the oblique pressure and stops the exit of gastric acid into the esophagus.
To this end, the subject of this invention is a medical prosthesis for preventing gastric reflux in the esophagus, including a tube made of a biocompatible polymer that is resistant to gastric acids, one end of which is implanted at the upper opening of the stomach while the other hangs freely below it in the stomach cavity, characterized in that the tube has a section diameter between 25 and 30 millimeters from one end to the other and that its length ranges between 5 and 10 centimeters, the thickness of the wall has been chosen to allow it to collapse under lateral pressure applied to its external wall, when the level of pressure generated by gastric reflux is reached.
Besides the advantages already mentioned, the medical prosthesis which is the object of this invention is easier to introduce into the esophagus with an endoscope because of its increased softness; the prosthesis is also easier to attach in place for the same reasons. As the tubular prosthesis is normally open, contrary to the abovementioned valve which is normally closed, the force exerted on the means used to implant this prosthesis on the walls of the esophagus or of a hiatus hernia is very much decreased, as the only force exerted on the prosthesis is a low friction force of the food bolus on the walls of the prosthesis.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a sectional view of the stomach and the esophagus with the prosthesis that is the subject o
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Biomedix S.A. Switzerland
Milano Michael J.
Nguyen Tram A.
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