Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
2000-01-26
2001-11-20
Evanisko, George R. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
C600S377000
Reexamination Certificate
active
06321124
ABSTRACT:
FIELD OF THE INVENTION
This invention provides an implant device specifically for electrostimulation and/or electrical monitoring of endo-abdominal tissue or viscera. The present implant device has an elongated body equipped with 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, means to penetrate the tissue or viscera to be treated and quick-release connecting devices to separate the penetration device from the elongated body.
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 dsyfunction, 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 the specific frequency, sites, and modalities and with regard to the self-regulating electromotor physiology of the gastrointestinal tube. 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 gastro-enterological 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) increased production of specific substances (i.e., gastroenteric neuromediators) by the intrinsic nervous system through the myenteric plexus. Curing of functional illnesses involving the digestive system and more broadly involving disorders in any way connected to 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 systems's intestinal tract and the related neurohormonal incretions is the use of an implant system to generate electrical impulses (electrical stimuli) and electric tubes (electrocatheters) to connect them to the tissue or viscera to be stimulated. These treatment methods involve a surgical technique to implant the electrocatheter in the abdomen which is known as micro-invasive surgery or video-laparoscopic surgery. Current electrocatheters to stimulate electrically and/or monitor endo-abdominal viscera normally have metal microbarbs which are angled in such a way as to permit application of the end of the catheter and to prevent it from being dislodged. However, this type of catheter is often very complicated to make and consequently is very costly.
Moreover, current electrocatheters are generally very difficult to handle and use. More particularly, surgeons generally find them very difficult to insert because of the many arduous operations required to be performed during the laparoscopic procedure. In such procedures, the patient is first given a general anesthetic, after which his or her abdomen is inflated with CO
2
or another inert inflammable gas so as to transform the abdominal cavity from a virtual to a real cavity. Rigid tubes with air-tight membranes (i.e., “trocars”) are then inserted into the abdominal cavity filled with CO
2
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. Normally four or more trocars are used. Generally the first trocar provides access to the abdomen by the video camera in order to monitor the surgical procedure. A service clamp is normally inserted in the second trocar to move or retain the hepatic edge that normally covers the small gastric curve or other viscus depending on the type of operation to be performed. A third trocar provides access for a maneuvering clamp. The fourth trocar is used for the introduction of the electrocatheter to be implanted in the patient. The structure of the electrocatheter plays an important part in facilitating the specific operation for whichever of the patient's viscera the surgeon aims to stimulate.
SUMMARY OF THE INVENTION
An improved implant device for electrostimulation and/or electrical monitoring of the endo-abdominal viscera is provided. The improved implant device of the present invention is simple to handle and use, thereby simplifying the surgical procedure required to implant the device. This implant device can be easily inserted and anchored in the viscera to be stimulated without using any type of suture or requiring any maneuvers that might be difficult and risky for the other viscera or for the integrity of the electrocatheter itself. This improved implant device is especially adapted for electrostimulation and/or electrical monitoring of the tissue or viscera of the mammalian body (especially the human body), especially tissue and internal organs the endo-abdominal cavity. Examples of such tissue and internal organs include, but are not limited to, the stomach, intestines, spleen, bladder, muscles, and the like.
One object of the invention is to provide an implant device specifically for electrostimulation and/or electrical monitoring of the endo-abdominal visceral tract that has significant flexibility of use since it is capable of having multiple poles and of being adapted to any surgical requirement without substantially modifying its structure. Another object of the invention is to provide an implant device specifically for electrostimulation and/or electrical monitoring of the endo-abdominal viscera that the surgeon is able to locate easily in order to determine the orientation of its two ends.
Still another object of the invention is to provide an implant device which, once it is anchored in the viscera, is capable of reducing to a minimum its excessive length inside the abdomen. Another object of the invention is to provide an implant device that effectively protects the electrical connection terminal that connects to a power source so as to be able to perform this operation in a dry arena, thereby permitting the entire procedure, including anesthesia, to be carried out in an extremely short time.
A further object of the invention is to provide an implant device specifically for electrostimulation or electrical monitoring of tissue to be treated within the endo-abdominal cavity, said implant device comprising (1) an elongated body having a distal end and a proximal end, (2) a penetration mechanism at the distal end to penetrate the tissue to be treated, (3) a quick release connecting mechanism adjacent to the penetration mechanism, (4) a first and second sets of flexible tines adjacent and proximal to the quick release connecting mechanism to secure the implant device to the tissue to be treated wherein the first and second sets of tines are spaced apart along the elongated body a distance sufficient to span the tissue, such that the first set of tines are located between the quick release connecting mechanism and the second set of tines, (5) at least two electric poles located between the two sets of flexible tines, and (6) an electrical connection terminal at the proximal end for connection to a power source wherein the two or more electric poles are electrically connected to electrical connection terminal, and wherein the quick release connecting mechanism is effective to separate the penetration device from the elongated body once t
Evanisko George R.
Fitch Even Tabin & Flannery
Transneuronix Inc.
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