Surgery – Internal organ support or sling
Reexamination Certificate
2000-02-14
2002-11-05
Shaver, Kevin (Department: 3736)
Surgery
Internal organ support or sling
C623S023650, C623S023670
Reexamination Certificate
active
06475136
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a heartburn and reflux disease treatment apparatus and method. 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. Moreover, the prosthesis was sutured to the stomach, in order to be properly positioned. Such a suture arrangement, however, is not reliable. 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.
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.
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 engaging the esophagus to form a restricted food passageway in the stomach or esophagus, an adjustment device implanted in the patient for adjusting the restriction device to restrict and enlarge the food passageway, and a hydraulic operation device implanted in the patient for operating the adjustment device. As a result, the restriction device works 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.
Preferably the restriction device is powered and controlled in a non-manual manner. The expression “non-manually manner” should be understood to mean that the restriction device is not adjusted by manually touching subcutaneously implanted components of the apparatus or not manipulated by touching the skin of the patient. Preferably, the adjustment device adjusts the restriction device in a non-invasive manner. The expression powered should be understood as energized with everything without manual force, preferably electric energy.
The adjustment device may adjust the restriction device in a non-magnetic manner, i.e. magnetic forces may not be involved when adjusting the restriction device.
The adjustment device may also adjust the restriction device in a non-thermal manner, i.e. thermal energy may not be involved when adjusting the restriction device.
Generally the implanted restriction device comprises a holding device for preventing the region of the cardia to pass through the esophageal hiatus diaphragmatica. This could be achieved by an enlarged area of the esophagus and/or the restriction device that prevents the esophagus from passing 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. Alternatively, the holding device may comprise sutures, or the restriction device itself could be shaped to prevent the region of the cardia from sliding up. It would also be possible to provide means for narrowing the triangular opening.
In the various embodiments hereinafter described the restriction device generally forms an at least substantially closed loop. However, the restriction device may take a variety of different shapes, such as the shape of a square, rectangle or ellipse. The substantially closed loop could for example be totally flat, i.e. thin as seen in the radial direction. The shape of the restriction device may also be changed during use, be rotated or turned or moved in any direction. A physical lumen, such as the passageway in the esophagus, often is easier to restrict by contracting two opposite side walls of the lumen against each other. Thus, the restriction device may be designed to perform such a contracting effect of the opposite walls of the esophagus. Either mechanical or hydraulic solutions may be employed to operate the restriction device. Alternatively, the restriction device may comprise an adjustable cuff, a clamp or a roller for bending or rotating the esophagus or stomach 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. The bending or rotating members may have any shape or form and be either hydraulic or non-inflatable.
In accordance with a first main embodiment of the invention, the adjustment device comprises an expandable cavity in the restriction device, wherein the food passageway is restricted upon expansion of the cavity and enlarged upon contraction of the cavity. The cavity may change shape or form to restrict the food passageway.
The hydraulic operation device may comprise an injection port implanted subcutaneously in the patient for transcutaneously adding fluid to and withdrawing fluid from the cavity for accomplishing necessary post-operation adjustments of the restriction device to restrict or enlarge the food passageway in the esophagus or stomach. It is preferred, however, that the apparatus of the invention further comprises a reservoir implanted in the patient and containing a predetermined amount of hydraulic fluid, wherein the hydraulic operation device operates the adjustment device by using the hydraulic fluid of the reservoir. For example, the operation device may distribute hydraulic fluid from the reservoir to expand the cavity, and distribute hydraulic fluid from the cavity to the reservoir to contract the cavity, to thereby control the restriction of the passageway. As a result, there is no need for an injection port. (In certain applications, however, an injection port connected to the reservoir may be provided for enabling, normally a single once-and-for-all, calibration of the predetermined amount of fluid in the reservoir. In this case, the injection port suitably is integrated in the reservoir.)
A fluid distribution tube may readily be connected between the reservoir and the cavity in a manner so that the tube does not interfere with other implanted components of the apparatus.
Preferably, the reservoir defines a chamber for the p
Cadugan Joseph A.
Nixon & Vanderhye P.C.
Obtech Medical AG
Shaver Kevin
LandOfFree
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