Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2000-01-10
2002-04-30
Layno, Carl (Department: 3737)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C607S116000, C607S115000
Reexamination Certificate
active
06381495
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a medical implant device which is designed and adapted for use in laparoscopic surgery. This medical implant device is especially adapted for electrostimulation and/or electrical monitoring of endo-abdominal tissue or viscera. This medical implant device comprises an elongated body equipped with immobilizing or securing devices to secure it to the tissue or viscera to be treated and two or more electric poles that are electrically connected to an electric connection terminal for connection to a power source, a mechanism to penetrate the tissue or viscera to be treated and quick-release connecting devices to separate the penetration device from the elongated body. The securing devices are especially adapted to properly positioned the implant device within or around tissue to be treated so that good electrical contact with the tissue to be treated can be established and maintained.
BACKGROUND OF THE INVENTION
It is well known that more than 70% of illnesses affecting the digestive tract are of a functional nature. Today such illnesses are treated predominantly using pharmacological means. Since drugs generally have side effects, particularly when the drugs cure the symptom and not the underlying problem or dysfunction, they must often be administered temporally. Indeed, if the side effects are sufficiently serious, the drug may have to be discontinued before full benefit to the patient is realized; in many cases the underlying illness remains.
The important role played by electrophysiology in controlling gastrointestinal activity has become increasingly apparent in recent years. Thus, the possibility exits of correcting dysfunction by means of electrostimulation applied at specific frequencies, sites, and modalities and with regard to the self-regulating electromotor physiology of the gastrointestinal organs or tract. It has recently been shown, for example, that changes occur in the motility and electromotor conduct of the gastric tract in eating disorders (e.g., obesity, thinness, bulimia, anorexia). Disturbances in electromotor activity in diabetic gastroparesis, reflux in the upper digestive tract, and numerous other gastroenterological functional pathologies have also been observed.
Stimulation of the intrinsic nervous system of the stomach is likely to have two major consequences or effects: (1) the correction and direct control of the electromotor activity of the intestines and (2) the stimulation of increased incretion of specific substances (i.e., gastroenteric neuromediators) produced by the intrinsic nervous system itself through the myenteric plexus. Curing of functional illnesses involving the digestive system and, more broadly, involving disorders in any way connected to, or associated with, the digestive system is, therefore, closely linked to the progress of research in the field of electrophysiology.
An indispensable condition for modifying the electrical activity of the digestive system's intestinal tract and related neurohormonal incretions is the use of an implant system to generate electrical impulses (electrical stimuli) and means (e.g., electrocatheters) to connect them to the viscera and/or intestines to be stimulated. These treatment methods involve an “invasive” surgical technique to implant the electrocatheter in the abdomen. This may involve open or, preferably, micro-invasive surgery (i.e., video-laparoscopic surgery). Current electrocatheters to stimulate electrically and/or monitor endo-abdominal viscera may have metal microbarbs which are angled in such a way as to permit application of the end of the catheter and to prevent it subsequently from being dislodged. However, metal microbarbs can damage surrounding tissue especially when exposed to the vigorous action of the digestive tissue and/or organs. Among the undesirable consequences of such damage is erosion of the electrode into the lumen of the gastrointestinal tract. This would result in contamination of the abdominal cavity and the electrode The subsequent infection would, at a minimum, require removal of the catheter and involve an additional operation.
During laparoscopic procedures, after administering a general anesthetic, the patient's abdomen is inflated with CO
2
or another inert inflammable gas, thereby transforming the abdominal cavity from a virtual to a real cavity. Rigid tubes with air-tight valve mechanisms (“trocars”) are then inserted into the gas-filled abdominal cavity so that a video camera and other surgical instruments can be introduced into the abdomen. The operation then proceeds by viewing the video images transmitted by the camera. Multiple trocars are required. Generally, the first trocar provides access to the abdomen by the video camera in order to monitor the surgical procedure. A clamp is normally inserted in the second trocar to move or retain the hepatic edge that normally covers the lesser curve of the stomach or other viscera depending on the type of operation to be performed. A third trocar provides access for a maneuvering clamp or laparoscopic forceps. The fourth trocar is used for the introduction of instruments as well as the electrocatheter to be implanted in the stomach wall of the patient. The structure of the electrocatheter plays an important part in facilitating the specific operation for whichever of the patient's organs and/or viscera the surgeon aims to stimulate.
Each of the trocars used, of course, requires a separate tract through the skin and abdominal wall. To keep the abdomen inflated, valves are used with the trocars to provide a gas-tight seal. Introduction of a medical device, such as an electrocatheter or implantable electrode, into the abdomen generally requires the use of laparoscopic forceps to grasp the device. Such devices, which are generally inherently fragile in nature, could be damaged if grasped too firmly by the forceps. Thus, for example in the case of an electrocatheter having electrode leads, the interior conductor wires could be broken, rendering the device dysfunctionally or completely useless.
It is also desirable to place the electrocatheter adjacent to the tissue or organ of interest and “lock” it in place so that the target tissue or organ can then be electrostimulated and/or electrically monitored. As noted above, metal microbarbs have been used to lock the device in place. Such metal microbarbs can damage or tear surrounding tissue—especially when the implant device is subjected to the vigorous action or peristaltic movement of the digestive organs. More recently, flexible microbarbs have been used for such implant device. Although such flexible microbarbs are less likely to damage the surrounding tissue, so-equipped electrocatheters can be difficult to precisely place and position relative to the tissue to be treated. In some cases, one of the electrodes is actually outside the penetration tunnel and, thus, not in direct contact with the tissue to be treated. Indeed, both electrodes can be outside the penetration tunnel. Of course, the lack of contact of at least one electrode with the tissue will result in inferior electrostimulation and/or monitoring of the tissue to be treated. Moreover, since, for example, stomach muscle is somewhat flaccid, it is often difficult to push or pull the implant device, especially under conditions of laparoscopic surgery, so that both electrodes are in good electrical contact with the target tissue. Even in cases where the electrodes are initially positioned properly (i.e., both electrodes within the penetration tunnel and in contract with the tissue walls forming the penetration tunnel), movement of the elongated body within the penetration tunnel can sometimes allow at least one of the electrodes to move outside the penetration tunnel and lose contact with the tissue. Of course, with tissue or organs undergoing vigorously movement (e.g., the stomach during digestion), there is an increased likelihood that one of the electrodes may migrate to a position outside the penetration tunnel.
It would be desirable, theref
Fitch Even Tabin & Flannery
Layno Carl
Transneuronix Inc.
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