Surgery – Miscellaneous – Devices placed entirely within body and means used therewith
Reexamination Certificate
2000-02-10
2002-10-29
Shaver, Kevin (Department: 3736)
Surgery
Miscellaneous
Devices placed entirely within body and means used therewith
C623S023650, C623S023670
Reexamination Certificate
active
06470892
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a heartburn and reflux disease treatment apparatus and mehtod. More specifically, the invention relates to a heartburn and reflux disease treatment apparatus and method for surgical application in the abdomen of a patient for forming a restricted food passageway in the esophagus or stomach. The term “patient” includes an animal or a human being.
Chronic heartburn and reflux disease is a widespread medical problem. This is often due to hiatal hernia, i.e. a portion of the stomach immediately below the gastric fundus slides upwardly through the esophageal hiatus. In consequence, stomach acids and foods are regurgitated into the esophagus.
In the late 1970s a prior art prosthesis called Angelchik, according to U.S. Pat. No. 3,875,928, was used to operatively treat heartburn and reflux disease. However, the Angelchik prosthesis had a major disadvantage in that it was not possible to adjust the size of the restriction opening after the operation. A further disadvantage was that the prosthesis did not satisfactorily protect the esophagus and the surrounding area against injuries due to poor shape of the prosthesis. Therefore, operations using the Angelchik prosthesis are no longer practiced.
An operation technique, semi-fundoduplicatio, is currently in use for treating heartburn and reflux disease. A most common operation is Nissen semi-fundoduplicatio, in which one takes the fundus of the stomach and makes a three quarter of a turn around the esophagus and suture between the stomach and esophagus. Although this operation works fairly well it has three main disadvantages. Firstly, most patients treated in accordance to “ad modum Nissen” lose their ability to belch. Secondly, many of these patients get dysphagia, i.e. have difficulties in swallowing after the operation. Thirdly, it is not possible to adjust the food passageway in the esophagus or stomach in any way after the operation. Characteristic for these patients is the variation of their problems over the course of a day. For example, many patients have difficulties during the night when they lie down because of stomach acid leaking up into the esophagus.
The present invention relates to a heartburn and reflux treatment apparatus. More specifically, the invention relates to a heartburn and reflux treatment for surgical application in the abdomen of a patient for forming a food passageway in the esophagus or stomach having a restricted cross-sectional area. The term “patient” includes an animal or a human being.
SUMMARY OF THE INVENTION
The object of the present invention is to provide a new heartburn and reflux disease treatment apparatus which permits post-operation adjustments that are comfortable for the patient.
Accordingly, the present invention provides a heartburn and reflux disease treatment apparatus comprising an adjustable restriction device implanted in the patient and engaging the stomach close to the cardia or esophagus to form a restricted cross-sectional area of the food passageway in the stomach or esophagus, and a post-operation adjustment device which mechanically adjusts the restriction device to change the size of the cross-sectional area. The post-operation adjustment device preferable adjusts the restriction device in a non-invasive manner. As a result, the restriction device performs like an artificial sphincter, which can be adjusted by the patient in connection with every food intake during the day, or possibly only in the morning to open up the food passageway and in the evening to close the food passageway.
The adjustment device may be incorporated in the restriction device as well as being controlled by hydraulic means. The expression “post-operation non-invasive adjustment device” means that the adjustment device is capable of adjusting the restriction device after the operation without the need for invasive measures, such as penetration of the skin for example by injection needles or surgery, or by any other means that penetrate the skin. Though an injection port could be used in embodiments using hydraulic means, the port preferably would be for enabling a single, once and for all, calibration of the amount of liquid contained by the hydraulic means. In this case, the injection port suitably is integrated in the reservoir.)
Generally the implanted restriction device comprises a holding device to prevent the region of the cardia to pass through the esophageal hiatus diaphragmatica. This could be achieved by an enlarged area that should pass the hole in the diaphragmatic muscle where the esophagus passes (a triangular opening surrounded by the crus muscles) or by fixing or holding the region of the cardia in place. The holding device may take the shape of a support member that provides a support for the restriction device upwardly against the diaphragm muscle or sutures or anything formed by human tissue. Alternatively, the restriction device itself could prevent the region of the cardia from sliding up. Means for narrowing the triangular opening could also be provided.
In all applicable embodiments, the restriction device may take any shape and be either hydraulic or non-inflatable. Suitably, the support member is soft.
Preferably, the restriction device comprises an elongated, suitably non-inflatable, restriction member and forming means for forming the restriction member into at least a substantially closed loop around the esophagus or stomach, the loop defining a restriction opening, whereby the adjustment device adjusts the restriction member in the loop to change the size of the restriction opening.
In the various embodiments hereinafter described the restriction member generally forms an at least substantially closed loop. However, the restriction member may take a variety of different shapes, such as the shape of a square, rectangle or ellipse. The restriction member in the substantially closed loop could for example be totally flat, like a belt. The shape of the restriction member may also be changed during use, by rotation or movment in any direction. A physical lumen, such as the passageway in the esophagus, is often easier to restrict by contracting at least two opposite or different side walls of the lumen against each other. Thus, the restriction member may be designed to perform such a contracting effekt of the opposite walls of the esophagus. Either mechanical or hydraulic solutions may be employed to operate the restriction member. Alternatively, the restriction member may comprise an adjustable cuff, a clamp or a roller for bending the esophagus to close or almost close its passageway. Such a cuff, clamp or roller may also be utilized for squeezing the esophagus against human material inside the body of the patient or against implanted structures of the apparatus.
In accordance with a preferred first adjustment principle, the adjustment device adjusts the longitudinal extension of the elongated restriction member in a loop form.
In a preferred embodiment of the invention utilizing the first adjustment principle, the restriction member comprises a main portion and two elongated end portions, and the adjustment device establishes longitudinal relative displacement between the end portions of the restriction member, so that the size of the restriction opening is adjusted. The forming means may comprise any suitable known or conventional device capable of practicing the desired function, such as a spring material forming the elongated restriction member into the loop, so that the restriction opening has a predetermined size, and the adjustment device may adjust the restriction member against the spring action of the spring material. In other words, the restriction member may comprise a spring clip. The spring material may be integrated in the restriction member.
Preferably, the adjustment device comprises a movement transferring member, suitably a drive wheel, in engagement with at least one of the end portions of the restriction member and operable to displace the one end portion relative to the other end portion of the r
Cadugan Joseph A.
Nixon & Vanderhye P.C.
Obtech Medical AG
Shaver Kevin
LandOfFree
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