Surgery – Internal organ support or sling
Reexamination Certificate
2000-02-09
2002-09-24
Shaver, Kevin (Department: 3736)
Surgery
Internal organ support or sling
C623S023650
Reexamination Certificate
active
06454700
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 for surgical application in the abdomen of a patient for forming a restricted food passageway in the esophagus or stomach, and a method of implantation and/or use thereof. 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 practised.
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 convenient heartburn and reflux disease treatment apparatus, the performance of which may be affected by the patient at any time after operation, in particular when various needs arise over the course of a day, so that the patient substantially always is satisfied and comfortable.
Accordingly, in accordance with a first aspect of the invention there is provided a heartburn and reflux disease treatment apparatus comprising: An energy transmission device for wireless transmission of energy of a first form from outside a patient's body. An operable restriction device implanted in a patient and engaging the stomach close to the cardia or engaging the esophagus to form a restricted passageway in the stomach or esophagus the device operable in response to a second energy form different than the first form to vary the restricted passageway. And, an energy transfer device implanted in the patient for transferring energy of the first form transmitted by the energy transmission device into energy of the second form to operate the restriction device to vary the restricted passageway.
As a result, the advantage is achieved that the heartburn and reflux disease treatment apparatus of the invention provides simple and effective energy transmission which ensures an extended and reliable functionality of the apparatus, possibly for the rest of the patient's natural life, and at least many years.
The restriction device preferably controls the cross-sectional area of the food passageway in the stomach or esophagus, which gives the advantage that the patient is enabled to adjust the cross-sectional area of the food passageway whenever he likes during the day. This advantage should not be underestimated, because if the patient would need to vomit it would be very difficult for him to do so if he were unable to enlarge the cross-sectional area of the food passageway.
Advantageously, the implanted energy transfer device directly operates the restriction device with the energy of the second form, preferably in a non-magnetic and/or non-mechanical manner, as the external energy transmission device transmits the energy of the first form. The restriction device may be directly operated with the energy of the second form without externally touching subcutaneously implanted components of the apparatus. The advantage of directly using energy as it is transmitted is that the apparatus can be of a very simple design and the few components involved makes the apparatus extremely reliable.
The restriction device may be non-inflatable, i.e. with no hydraulic or pneumatic fluid involved for the adjustments of the restriction device. This eliminates problems with fluid leaking from the restriction device.
Preferably, the energy of the second form comprises electric energy. In consequence, the restriction device suitably is electrically operated, whereby the energy transfer device supplies electric energy for the operation of the restriction device. The apparatus suitably comprises implanted electric conductors connected to the energy transfer device, whereby the energy transfer device is capable of supplying an electric current, such as direct current, a pulsating direct current, a combination of a direct and pulsating direct current, an alternating current or a combination of a direct and alternating current, via the conductors. Furthermore, the electrical junction element may be capable of supplying a frequency, amplitude, or frequency and amplitude modulated analog, digital, or a combination of analog and digital signal, which is used in connection with control of the restriction device.
The energy transfer device, preferably in the form of an electrical semiconductor junction element, suitably forms a flat and thin sheet and has a volume of less than 2000 cm
3
to be suited for subcutaneous implantation, so that the electrical junction element is located just behind the skin of the patient. The electrical junction element should be designed to generate an output current exceeding 1 mA when exposed to the energy of the first form transmitted by the energy transmission device. Of course, all the components of the energy transfer device including the electrical junction element in contact with the patient's body should be of a biocompatible material. Alternatively, it would be possible to implant the energy transfer device in the thorax or cephal region of the patient, or in an orifice of the patient's body and under the mucosa or intraluminar outside the mucosa of the orifice.
For in vitro appliances, a particular type of an electrical semiconductor junction element has been commonly used, namely a so called p-n (positive
egative) junction element, typically in the form of solar cells. A solar cell transfers solar energy in the form of visible light into electric energy in the form of direct current. For example, a p-n junction element may comprise two layers of semiconductor, one p-type (positive) and the other n-type (negative), sandwiched together to form a “p-n junction”. This p-n junction induces an electric field across the element when absorbing quanta of, light (photons).
To be more precise, the quanta of light transfer their energy to some of the semiconductor's electrons, which are then able to move about through the material. For each such negatively charged electron, a corresponding positive charge—a “hole”—is created. In an ordinary semiconductor, these electrons and holes recombine after a short time and their energy is wasted as heat. However, when the electrons and holes are swept across the p-n junction in opposite directions by the action of the electric field, the separation of charge induces a voltage across the p-n junction element. By connecting the p-n junction element to an external
Cadugan Joseph A.
Nixon & Vanderhye P.C.
Obtech Medical AG
Shaver Kevin
LandOfFree
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