RU2260451C2 - Device for controlling smooth muscle operation - Google Patents

Abstract

FIELD: medical engineering.

SUBSTANCE: method involves selecting smooth muscle region and applying non-exciting electric field to the region that reduces mechanical activity in the region. Device has a set of electrodes for making contact with the smooth muscle region, control unit for supplying electric power to the electrodes with non-exciting electric field being created and causing no propagating action potential formation in the smooth muscle. Anastomosis cuff has a zone for joining two segments of gastrointestinal tract and electrodes. The control unit feeds the electrodes for reducing gastrointestinal tract contraction intensity with power. Probe has casing, end piece, a set of electrodes and control unit for producing non-exciting electric fields.

EFFECT: enhanced effectiveness in controlling smooth muscle operation.

59 cl, 19 dwg

Description

Field of Invention

The present invention relates to the field of controlling the mechanical and / or electrical activity of a smooth muscle by applying electric fields to the muscle.

BACKGROUND OF THE INVENTION

In many body tissues, the activity of individual cells, especially the contraction, is initiated by changes in transmembrane potentials. These types of tissue are also called excitable tissues, because when they are excited by an electric signal, they react by activation. Some examples of excitable tissue include: cardiac muscle, skeletal muscle, smooth muscle, and nerve tissue. In many cases, the activity of a large number of cells of such an excitable tissue is synchronized by propagating electrical activation signals. An activation signal is an electrical signal that, when it reaches an excitable cell, causes it to depolarize and carry out its activity. In addition to this, depolarization creates a new propagating activation signal, which then continues to propagate in the direction of the next unactivated cell. In most excitable tissues, the cell after depolarization is refractory, so that the activation signal cannot immediately pass in the opposite direction.

The gastrointestinal (GI) tract is an example of a basic physiological system in which many activities are coordinated by propagating electrical activation signals. The gastrointestinal tract includes the stomach, small intestine, and colon. In the normal digestion process, food is chewed in the mouth and passed into the stomach for digestion. Food periodically passes into the cavity for grinding and then passes back into the stomach. After a certain period of time, the pyloric sphincter opens and food passes into the small intestine. In the small intestine, food mixes and passes on through the rhythmic movement of the intestine until it reaches the colon. The one-sided sphincter makes it possible to move only from the small intestine into the colon. Once in the colon, the food is further mixed and compressed by movements of the colon. These movements also promote digestible food, which is now feces, to a pair of outlet sphincters that mark the end of the GI tract.

The gastrointestinal tract mainly consists of smooth muscles, which, being depolarized, contract. All the above movements of the LC tract are synchronized by propagating activation signals. As you can understand, in many cases, these electrical signals are not activated and / or do not respond properly, which leads to disease. In one example, an ulcer causes inflammation of the tissue of the gastrointestinal tract. Inflamed tissue can generate false activation signals that can cause the stomach to contract in a chaotic manner. Inflamed tissue can also affect stomach activation rates due to the fact that it does not conduct activation signals or has a conduction rate different from that of healthy tissue.

Stimulation of the LC tract is well known in the art, for example, as shown in US Pat. Nos. 5,292,344 and 5,540,730, the disclosures of which are incorporated herein by reference. Patent 730 describes both an increase and a decrease in the excitability of the LC tract by stimulating various sections of the vagus nerve. Patent 344 describes a stimulant that directly stimulates sections of the LC tract. It is also known that electrical stimulation of the LC tract is used to stimulate the LC tract of patients suffering from dumping syndrome after surgery, which is proved in SU 1039506, the description of which is incorporated into this description by reference.

The uterus also includes smooth muscle, which contracts in response to electrical activation signals. "Uterine Electromyography: A Critical Review D. Devedux et al., Am. J. Obstet Gvnecol 1993, 169: 1636-53, the description of which is incorporated herein by reference, describes various types of uterine muscles and electrical signals generated by such muscles. The important discovery that is described there is that the electrical activity in the uterus appears to be uncorrelated before childbirth, but when childbirth begins, contractions and the electrical activity associated with them become highly synchronized.

In current medical practice, delivery can be delayed by administering certain medications. However, the effect of these drugs is not exactly known to some extent. In addition, birth can be triggered using other medicines, such as oxytocin. Unfortunately, the required dose of oxytocin cannot be known in advance, and too large doses of the drug can result in excessive reduction, which can mechanically damage the fetus and / or mother.

SU 709078, the disclosure of which is incorporated herein by reference, describes uterine postpartum stimulation using an external electric current to increase contractions and assist in expelling the placenta and reducing bleeding by rapidly compressing the uterus.

The use of locally applied electric fields to reduce pain is well known in the art. "Electrical Field Stimulation - Meditated Relaxation of Rabbit Middle Cerebral Artery", D.A. Van Ripper and J. A. Bevan, Circulatirv Research 1992; 70: 1104-1112, the disclosure of which is incorporated herein by reference, describes the induction of relaxation of an artery by application of an electric field. U.S. Patent 4,537,195, the disclosure of which is incorporated herein by reference, describes a treatment for pain with the use of BSEC (Transcutaneous Electrical Nerve Stimulation) for the treatment of headaches. This patent hypothesizes that electrical stimulation prevents the contraction of arteries by stimulating the muscles in their walls, thereby preventing the expansion of capillaries, which causes headaches.

SU 1147408, the description of which is incorporated into this description by reference, describes a method for changing the distribution of blood flow in the liver and around it by applying electric fields to the arteries, changing the frequency of the field in synchronism with the heart rhythm.

US patent 5447526, the description of which is incorporated herein by reference, describes a percutaneous electrical smooth muscle control device for suppressing or reducing contraction of smooth muscle, especially uterine muscle. A control device that is applied to the outside of the abdomen can also perceive muscle contractions and produce suppressive or stimulating impulses in relation to the uterus as a whole, depending on medical use, in response to perceived contractions.

Summary of the invention

An object of certain aspects of the present invention is to provide a method for direct and local control of contraction and / or contraction power of smooth muscles. Such control is mainly used in particularly preferred embodiments of the invention in the gastrointestinal (GI) tract, uterus, bladder, endocrine glands, gall bladder, and blood vessels.

The inventors have found that the force of contraction of the smooth muscle can be either increased or decreased by the forced application of a non-exciting electric field. A non-exciting electric field is an electric field that does not cause the formation of a propagating action potential in a smooth muscle. Such a non-exciting electric field, however, alters the smooth muscle response to the exciting field. The inventors have also found that it is possible to desensitize a smooth muscle with respect to an activation signal, as a result of which a desensitized smooth muscle does not respond to an activation signal and also does not propagate an activation signal. Immediately after the field is harvested, its actions will be removed. It should be understood that many smooth muscles are characterized by multiple layers of fibers, which in each layer have a preferred direction. In a preferred embodiment of the invention, the individual layers are selectively controlled by applying an electric field substantially parallel to the direction of the fibers (in this case, the field is highly efficient). When a lower degree of interaction between the muscle layer and the field is desired, the field is preferably applied perpendicular to the muscle fibers.

The task of some embodiments of the present invention is to create a method for controlling the LCD tract, which will be more accurate than that which is possible using drugs and / or single or multi-site regulation. In a preferred embodiment of the present invention, the contraction force of the portion of the LC tract is increased in such a way as to compensate for the weakened contraction and / or advance the otherwise inserted bolus. Alternatively or additionally, the force of contraction can be reduced so as to treat a patient with too sensitive intestines. Alternatively or additionally, the intestinal region can be desensitized or blocked from electrical activation signals in order to facilitate the healing of the lesion in the region. Reducing or blocking contraction is also useful in the treatment of acute diarrhea and to stop the flow from the stoma when such flow is undesirable. Additionally or alternatively, the activation parameters of the LC tract, which typically include a direct wave and a back wave, are changed, for example, by blocking the back wave (reflux) so as to increase intestinal mobility. Blocking the backward wave can be accomplished by desensitizing one or more than one segment of the intestine after the forward wave has passed, so that the backward wave is stopped on the desensitized segment. Alternatively, the entire length of the intestine desensitizes during the backward wave. After the backward wave has stopped, the desensitizing field is preferably stopped in such a way as to allow the forward wave to propagate properly. Forward and backward waves can be detected either by their mechanical activity or, more preferably, by their electrical activity.

In a particularly preferred embodiment of the present invention, the tension of the lower end of the colon is reduced so as to improve local blood supply and promote healing of hemorrhoids and anal fissures. It has recently been suggested that most of the pain associated with hemorrhoids is caused by tissue ischemia, which in turn is caused by an abnormal increase in tension in the lower colon. Such stress has so far been treated using topical medications such as nitroglycerin.

An endoscope, in accordance with another preferred embodiment of the present invention, locally controls bowel activity in such a way as to make the smooth muscle move forward and / or push this endoscope. Alternatively or additionally, local electrical desensitization is used as a substitute and / or in addition to relaxing the intestines using drugs.

Although some of the embodiments of the present invention have been described with respect to an endoscope or colonoscope, it should be understood that these embodiments of the invention apply to invasive probes in general and to endoscopes, colonoscopes, hysteroscopes and rectoscopes in particular.

An object of another preferred embodiment of the present invention is to provide a method for more accurately managing childbirth, including delaying and / or accelerating the onset of labor, increasing or decreasing the duration of labor, and / or preventing childbirth from continuing after it has begun, or when they are all still in prenatal stages. Birth control is especially important for treating cases of premature birth. Such control is carried out in accordance with the preferred embodiment of the invention by reducing contractility of the uterine muscles, increasing their contractility or desensitizing them so that these synchronized contractions cannot occur. It has been suggested that childbirth is a self-developing process in which an increase in contraction forces generates even greater contraction forces in the next contraction cycle. By weakening the force of contraction, such a feedback loop can be broken. In addition, when the uterus is desensitized, contractions cannot occur and childbirth is delayed to a lesser extent without significant risk to the fetus, as might be expected with medications. Childbirths suspended in this manner can quickly re-start without problems associated with childbirths interrupted with medication. In a preferred embodiment of the invention, spurious electrical activation signals emanating from abnormal areas of the uterus, such as areas containing a fibrotic tumor, whose activation signals may cause premature birth, are reduced by local desensitization and / or blocking of the uterine tissue.

In accordance with another preferred embodiment of the invention, uterine contractions mediated by menstruation (cramping) are treated by detecting such cramping and applying a desensitizing electric field to the uterus to relieve such cramping. Alternatively, such a desensitizing electric field can be applied at a time when such spasms would be expected to occur.

An object of another preferred embodiment of the present invention is to control bladder contractility. In one preferred embodiment of the invention, the bladder is desensitized so that it does not contract spontaneously when such a contraction is undesirable. Preferably, the bladder control apparatus according to a preferred embodiment of the invention includes a feedback mechanism that stops its activity when the bladder becomes full. In an additional or alternative embodiment according to the invention, the force of contraction of the bladder is increased during urination. In a preferred embodiment of the invention, the force of contraction of the bladder is increased in patients having bladder hypertrophy, so that the bladder will gradually contract. Such treatment is preferably combined with drug treatment and / or stent implantation, which can be used to reduce urethral blockage.

According to another preferred embodiment of the invention, the production rate of the endocrine or neuroendocrine glands is controlled, preferably reduced, by applying a desensitizing electric field. In a preferred embodiment of the invention, a desensitizing electric field is applied to the pancreatic beta-insulocytes in such a way as to reduce the formation of insulin in patients suffering from levels of hyperinsulinemia. Preferably, such control is applied without measuring the electrical activity of beta insulocytes. Alternatively or additionally, such control is used to control blood glucose levels. The desensitizing field is preferably a locally applied dc field, the polarity of which is switched at a very low frequency, for example once per hour, so as to prevent polarization of the electrodes and / or tissue damage.

Another aspect of the present invention relates to the treatment of vascular spasm, angina pectoris and / or abnormal blood pressure by electrical control of large blood vessels in the body. According to a preferred embodiment of the invention, large veins, such as peritoneal veins, are relaxed by applying a local suppressing electric field to them. Alternatively or additionally, large arteries, such as the aorta, are relaxed by applying a local suppressing electric field to them. Alternatively or additionally, exciting fields are applied to arteries and / or veins so that they contract. As you can see, changes in arterial and vein volume can directly affect patients' blood pressure and / or cardiovascular performance. In addition, relaxation of the veins reduces the preload on the heart, which can stop cases of ischemia, such as angina pectoris. Further, aortic relaxation is useful in cases of vasospasm, which in many cases is the cause of angina pectoris.

The relaxing electric field is preferably applied during a spasm to blood vessels, which in certain cases may be coronary blood vessels. Electrically induced relaxation of blood vessels can be used in place of or in addition to pharmaceuticals. Also, forced relaxation of arteries and veins is useful in the treatment of acute ischemia. Typically, a case of ischemia causes an increase in heart rate, which further deforms ischemic heart tissue. Reducing the preload or afterload on the heart, reduce the need for the heart, which reduces the need for ischemic tissues in oxygen and / or makes it possible for better perfusion of ischemic tissues. In addition or alternatively, in order to facilitate perfusion of the heart muscle, diastole can be prolonged. Diastole prolongation can be achieved, for example, by desensitizing at least a portion of the heart using methods such as those described in PCT IL 97/00012, “Electrical Muscle Controller”, filed January 8, 1997, the disclosure of which is incorporated herein by reference.

Accordingly, it is proposed, in accordance with a preferred embodiment of the invention, a method for stimulating the healing of damage in smooth muscle, wherein:

a smooth muscle portion having damage is selected; and

a non-exciting electric field is applied to the site, which reduces the mechanical activity in the site.

Preferably, the application of an electric field includes desensitization of a smooth muscle site. Alternatively or additionally, the application of an electric field includes blocking the electrical activity of the smooth muscle surrounding the lesion.

Preferably, the damage is an ischemic region of the muscle. Alternatively or additionally, the damage is a sutured area of the muscle.

Preferably, the reduction in mechanical activity includes inhibition of mechanical activity in place.

In a preferred embodiment of the invention, the smooth muscle region is part of the gastrointestinal (GI) tract.

Also proposed, in accordance with a preferred embodiment according to the invention, is a method of treating diarrhea, in which:

choose a plot of irritated bowel; and

an electric field is applied to the site, which reduces the mechanical activity on the site.

Also proposed, in accordance with a preferred embodiment according to the invention, is a method of treating obesity, in which:

at least a portion of the stomach is selected; and

apply an electric field to the area that slows down or prevents the emptying of the stomach.

Also proposed, in accordance with a preferred embodiment according to the invention, is a method of treating nausea, in which:

at least a portion of the stomach is selected; and

an electric field is applied to the site, which reduces the mechanical activity of the stomach.

Also proposed, in accordance with a preferred embodiment according to the invention, is a method for controlling the emptying of a stoma, in which:

applying an electric field to the output section of the stoma, which reduces the mobility of the end section; and

remove the indicated field when stoma emptying is desired.

Preferably, the method further includes applying to the output portion of the second electric field, which increases the mobility of the stoma when emptying of the stoma is desired. The second field may be an exciting field. In addition or alternatively, the second field is a field that increases the force of contraction.

Also proposed, in accordance with a preferred embodiment according to the invention, is a method of treating hemorrhoids, in which:

take a patient having a colon; and

apply an electric field to the area of the colon, which relaxes at least the area of the colon located near the exit from it.

Preferably, the hemorrhoids are not located in the indicated area of the colon. Alternatively or additionally, the method includes:

measurement of tension in the area of the colon,

moreover, the application of an electric field includes the application of an electric field when the measured voltage exceeds a predetermined value.

In a preferred embodiment of the invention in the method described above, applying an electric field includes applying an electric field with a delay after a local activation time.

Also proposed, in accordance with a preferred embodiment according to the invention, a method of increasing the mobility of the LC tract, in which:

choose a section of the LCD tract; and

apply a non-exciting electric field to the area, which increases the contraction force in the area.

Preferably, the method includes applying to the second section of the LC path, located lower from the specified section, a second electric field, which reduces the force of contraction in the second section.

Also proposed, in accordance with a preferred embodiment according to the invention, a method of increasing the mobility of the LC tract, in which:

determining the timing of the backward wave in the LC tract; and

an electric field is applied to at least a portion of the LC path, which reduces the response of the LC path to the backward wave.

Preferably, the timing determination includes the detection of a direct wave, and the application of an electric field includes the application of an electric field only at times when it essentially does not interact with a direct wave.

Alternatively or additionally, timing determines the detection of a backward wave, and the application of an electric field includes the application of an electric field only at times when it essentially interacts with the backward wave.

Alternatively or additionally, the application of an electric field includes the application of an electric field that suppresses the propagation of an activation signal that synchronizes the backward wave.

Alternatively or additionally, the application of an electric field includes the application of an electric field that reduces the force of contraction at least in the area of the LC tract.

Also proposed, in accordance with a preferred embodiment according to the invention, a method of selectively exciting only a muscle layer in a smooth muscle having many muscle layers with different fiber directions, in which:

applying an overwhelming electric field to the muscle parallel to the direction of the fibers of the first muscle layer; and

a stimulating electric field is applied to the muscle, which excites the second layer of the muscle.

Also proposed, in accordance with a preferred embodiment of the invention, a method for selectively increasing the contraction force of only a muscle layer in a smooth muscle having many muscle layers with different fiber directions, in which:

applying an overwhelming electric field to the muscle parallel to the direction of the fibers of the first muscle layer; and

a second electric field is applied to the muscle, which is directed parallel to the direction of the fibers of the second muscle layer, and which increases the contraction force in the second muscle layer.

Also proposed, in accordance with a preferred embodiment according to the invention, a method of multipoint regulation of smooth muscle, in which:

exciting electric fields are applied to a plurality of places of said muscle; and

applying at least one suppressive electric field to a second plurality of locations located among said plurality of locations, said suppressive electric field preventing the propagation of an activation signal between said first plurality of stimulated locations.

Also proposed, in accordance with a preferred embodiment of the invention, an apparatus for controlling at least local activity of a smooth muscle region in vivo, including:

a plurality of electrodes adapted to be in contact with a portion of the smooth muscle to be controlled; and

a control device that supplies electricity to said electrodes with the creation of an electric field that does not cause the formation of a propagating action potential in the smooth muscle, and this electric field changes the smooth muscle response to the activation signal.

Preferably, the apparatus includes an electrical activity sensor that detects electrical activity in the area, said control device supplying electricity to said electrodes in accordance with signals from said sensor. Preferably, the control device supplies electric power to each of said electrodes in accordance with its local electrical activity. Additionally or alternatively, the electrical activity sensor senses electrical activity using electrodes from said plurality of electrodes.

Alternatively or additionally, the apparatus includes an impedance sensor that senses at least one impedance between selected electrodes from said plurality of electrodes.

Alternatively or additionally, the apparatus includes a dynamometric sensor that detects mechanical activity in the area, said control device supplying electricity to said electrodes in accordance with signals from said sensor. Preferably, said control device applies a suppressive electric field to the muscle when said mechanical activity exceeds a certain threshold. Alternatively or additionally, the supply of electricity to each of these electrodes is carried out in accordance with its local mechanical activity.

Alternatively or additionally, the non-exciting field suppresses mechanical activity in the area. Alternatively or additionally, the non-exciting field reduces the force of contraction in the area. Alternatively or additionally, the non-exciting field increases the contraction force in the region. In a preferred embodiment of the invention, the control device supplies electricity to at least one of said electrodes to generate an exciting electric field.

In a preferred embodiment of the invention, the plurality of electrodes are arranged in a two-dimensional array.

Alternatively or additionally, the control device selectively supplies electricity to the electrodes from the plurality of electrodes in order to selectively generate one of two perpendicular electric fields.

In a preferred embodiment of the invention, the control device is adapted to be implanted into the stomach and attached to the wall of the stomach.

Alternatively or additionally, the apparatus is adapted to be implanted into the uterus and attached to the uterine wall.

Alternatively or additionally, the apparatus is adapted to be implanted into the body and located outside the portion of the LC tract.

Alternatively or additionally, the apparatus is adapted to be implanted into the body and located outside the uterus.

In a preferred embodiment according to the invention, in which the control device is adapted for the uterus, it determines the frequency of contractions in the uterus, said control device supplying electricity to said electrodes in accordance with said determined frequency.

Preferably, the electrodes include elastic leads.

In a preferred embodiment of the invention, electrodes are attached to a plurality of remote areas of said uterus.

In a preferred embodiment of the invention, the control device senses and inhibits mechanical activity in substantially the entire uterus. Alternatively or additionally, the control device increases the force of contraction in essentially the entire uterus.

In a preferred embodiment of the invention, the control device is in a capsule adapted to be inserted into the rectum or vagina.

Alternatively or additionally, the electrodes are made with the possibility of implantation inside the body, while the specified control device is made with the possibility of its location outside the body. Preferably, the electrodes are adapted to detach from said smooth muscle outside the body.

Also proposed, in accordance with a preferred embodiment according to the invention, an anastamous cuff, including:

a connecting section for connecting two sections of the LCD tract;

at least two electrodes, adapted to be in electrical contact with the LCD tract on both sides of the cuff; and

a control device that supplies electricity to the electrodes to reduce the force of contraction in the LCD tract near the cuff.

Preferably, the control device transmits a stimulating signal from the LCD path on one side of the cuff to the LCD path on the other side of the cuff.

Alternatively or additionally, reducing the force includes suppressing the electrical activity of the LC tract on the cuff.

Also proposed, in accordance with a preferred embodiment according to the invention, an apparatus for suppressing a backward wave in the intestine, including:

at least one electrode for applying an inhibitory electric field to the intestinal region;

a sensor that senses the propagation of waves in the intestine; and

a control device that supplies electricity to the specified electrode in accordance with the propagating wave perceived by him.

Preferably, the sensor detects a backward wave.

Also proposed, in accordance with a preferred embodiment according to the invention, an apparatus for promoting a bolus, including:

at least one first electrode for applying an electric field to the first portion of the LC tract adjacent to the indicated bolus;

at least one second electrode for applying an electric field to the second section of the LC tract, located below the specified bolus;

and

a control device that supplies electricity to at least one first electrode with the formation of a non-exciting field, which increases the force of contraction in the first section, and which supplies electricity to at least one second electrode with the formation of a non-exciting electric field that relaxes the muscle in the second section.

Preferably, the apparatus includes an impedance sensor for detecting a bolus in the first portion of the LCD tract.

Also proposed, in accordance with a preferred embodiment according to the invention, a method of facilitating examination of the LCD tract, in which:

an elongated probe having a tip is inserted into the portion of the LC tract; and

applied to the portion of the LC tract adjacent to the tip of the probe, a non-exciting electric field that acts so as to relax the portion of the LC tract.

Preferably, the method includes inflating a portion of the LC tract after application of the indicated field.

Preferably, the portion of the LC tract is a portion adjacent to the bile duct.

Also proposed, in accordance with a preferred embodiment according to the invention, is a method for promoting an elongated probe having a tip and inserted into a portion of the LC tract, wherein:

apply the first electric field on the tip, which reduces the portion of the LCD tract for tight clamping of the probe; and

a second electric field is applied to the second portion of the LC tract adjacent to the portion of the probe distal from the tip, which causes elongation of the second portion of the LC tract.

Preferably, the method includes applying to the third portion of the LC tract adjacent to the probe portions distally from the tip a third electric field that relaxes the third portion of the LC tract so that it does not contract around the probe.

Alternatively or additionally, the method includes applying an suppressive electric field to block the propagation of activation signals between the first section and other sections of the LC tract.

Also proposed, in accordance with a preferred embodiment according to the invention, a method of promoting an elongated probe, in which:

an elongated probe having a tip is inserted into the portion of the LC tract; and

apply an exciting electric field to the portion of the LC tract, which causes the intestine to transport the probe in the desired direction.

Preferably, an exciting field is selectively applied either at the tip or elsewhere along the probe distal from the tip, depending on the desired direction of transport.

Alternatively or additionally, the method includes applying an suppressive electric field to the area to block the propagation of activation signals between the area and the rest of the LC tract.

In a preferred embodiment of the invention, the probe is an endoscope. Alternatively, the probe is a colonoscope.

It is also proposed, in accordance with a preferred embodiment according to the invention, an elongated probe adapted to advance in the LCD tract, including:

an elongated body having a tip;

a plurality of electrodes located at least at the tip; and

a control device that selectively delivers electricity to the electrodes to create non-exciting electric fields that affect smooth muscle contraction.

Preferably, the probe includes a second plurality of electrodes distributed along at least a portion of the probe body.

Alternatively or additionally, the control device supplies electricity to said first plurality of electrodes in order to cause said portion of the LC path to selectively advance or pop out said probe.

Alternatively or additionally, the control device supplies electric energy to the electrodes from said first and second sets of electrodes to suppress the propagation of activation signals from a portion of the LC tract adjacent to the probe tip to other sections of the LC path.

Also proposed, in accordance with a preferred embodiment according to the invention, a method for controlling the uterus, in which:

determining a portion of the uterus that is suspected of generating unwanted activation signals; and

apply to the muscle of the uterus surrounding the suspected area, a local suppressing electric field.

Also proposed, in accordance with a preferred embodiment according to the invention, a method for controlling the uterus, in which:

determining a portion of the uterus that is suspected of generating unwanted activation signals; and

a local desensitizing electric field is applied to the suspected area.

Also proposed, in accordance with a preferred embodiment according to the invention, is a method for managing labor, in which:

determine local activation in many places of the uterus; and

applying to each of the plurality of places a non-exciting electric field at a time delayed from the time of said local activation.

Preferably, the non-excitation field increases the contraction force at locations of the plurality.

Alternatively or additionally, said non-excitation field reduces the force of contraction in places of said set.

Alternatively or additionally, the non-excitatory field suppresses the propagation of propagating action potentials through the uterus.

In a preferred embodiment of the invention, the method includes implanting a plurality of electrodes in a plurality of locations. Preferably, the electrodes include encapsulated energy sources. Alternatively or additionally, implantation is performed during cesarean section.

It is also proposed, in accordance with a preferred embodiment of the invention, a method for facilitating labor, in which a non-exciting electric field is applied to the birth canal that relaxes the birth canal.

Also proposed, in accordance with a preferred embodiment of the invention, is a method for preventing premature birth, in which a non-exciting electric field is applied to the birth canal, which increases the force of contraction in the birth canal.

Also proposed, in accordance with a preferred embodiment according to the invention, is a method of treating uterine cramps, in which:

detect electrical or mechanical activity in at least one uterine site; and

applying a non-exciting electric field in at least one place.

Also proposed, in accordance with a preferred embodiment according to the invention, is a method of treating cramping, in which:

introducing into the uterus at least one electrode that is in contact with at least a portion of the uterus in at least one of its places; and

apply a non-exciting electric field to the site.

In a preferred embodiment of the invention, the non-excitation field suppresses the propagation of activation signals in at least one place. Alternatively or additionally, the non-exciting electric field reduces the force of contraction in at least one place.

Also proposed, in accordance with a preferred embodiment of the invention, is a smooth muscle control apparatus comprising a plurality of individual capsules, each of which includes at least one electrode and an energy source that supplies electricity to an electrode that applies a local non-excitation field . Preferably, each of said capsules includes a sensor that measures the local activity of smooth muscle.

Alternatively or additionally, the capsules act in such a way as to synchronize the supply of electricity to their electrodes without the intervention of an external automatic regulator.

Also proposed, in accordance with a preferred embodiment according to the invention, an apparatus for treating spasms, including:

a flexible body having an external portion and adapted to be tightly fixed inside the uterus,

a plurality of electrodes located outside said body; and

a control device that supplies electric power to said electrodes in order to generate a non-exciting electric field.

Preferably, the flexible body is inflatable. Alternatively or additionally, the apparatus includes a second electrode adapted to be placed outside the uterus.

Also proposed, in accordance with a preferred embodiment according to the invention, a method for controlling the circulatory system, including the heart, in which:

install electrodes adjacent to the vein; and

supplying electricity to the electrodes to reduce the vein so that the preload on the heart increases.

Also proposed, in accordance with a preferred embodiment according to the invention, a method for controlling the circulatory system, including the heart, in which:

install electrodes adjacent to the vein; and

supply electricity to the electrodes to expand the vein so that the preload on the heart is reduced.

Also proposed, in accordance with a preferred embodiment according to the invention, a method for controlling the circulatory system, including the heart, in which:

install electrodes adjacent to the artery; and

supply electricity to the electrodes to reduce the artery so that the afterload on the heart increases.

Also proposed, in accordance with a preferred embodiment according to the invention, a method for controlling the circulatory system, including the heart, in which:

install electrodes adjacent to the artery; and

supply electricity to the electrodes to expand the artery so that the afterload on the heart is reduced.

Also proposed, in accordance with a preferred embodiment according to the invention, a method of controlling vascular spasm in the circulatory system, having a heart, in which:

determine a vessel in a state of spasm, the result of which is an abnormally reduced lumen; and

apply a non-exciting electric field to the vessel, which causes the lumen to expand.

It should be understood that two or more than the above two methods of controlling the circulatory system can also be applied in practice together.

In a preferred embodiment of the invention, the method includes applying a non-exciting electric field to at least a portion of the heart.

Also proposed, in accordance with a preferred embodiment according to the invention, an apparatus for controlling the circulatory system having a heart, including:

a plurality of electrodes located near at least one main blood vessel;

a blood pressure sensor that measures blood pressure; and

a control device that supplies electric power to a plurality of electrodes in accordance with a measured blood pressure.

Preferably, the apparatus includes an external control that activates said control device.

Alternatively or additionally, the apparatus includes an ECG sensor that detects a heart rhythm. Alternatively or additionally, the control device relaxes said blood vessel to lower blood pressure. Alternatively or additionally, the control device reduces said blood vessel to increase blood pressure.

Also proposed, in accordance with a preferred embodiment according to the invention, a method for controlling the production of the gland, in which:

at least one electrode is installed near the gland; and

apply a non-exciting electric field to the iron.

Preferably, the non-exciting electric field suppresses the activity of the hormone producing cells in the gland. Alternatively or additionally, the non-exciting electric field is essentially a direct current field. Preferably, the method includes periodically changing the polarity of the field. Preferably, one polarity is applied over much of the time.

In a preferred embodiment of the invention, the gland is a pancreas. Preferably, the method includes controlling the level of glucose in the blood, wherein the application of said electric field includes the application of said field in accordance with said controlled level.

Also proposed, in accordance with a preferred embodiment according to the invention, an apparatus for controlling the production of the gland, including:

a sensor for measuring the level of a chemical compound in the bloodstream,

at least one electrode adjacent to said gland; and

a control device that supplies electricity to the specified electrode with the creation of a non-exciting electric field in accordance with the measured level.

Preferably, the chemical compound is glucose. Alternatively or additionally, the device is fully implantable.

Also proposed, in accordance with a preferred embodiment according to the invention, a method for controlling the activation profile of a smooth muscle organ, in which:

determine the desired activation profile for the organ; and

at least one non-exciting field is applied to the organ site to change its activation profile.

Preferably, the activation profile includes a mechanical activation profile.

In a preferred embodiment of the invention, the method includes:

measurement of tension in a smooth muscle; and

a change in the application of a non-exciting field in accordance with the measured voltage.

Alternatively or additionally, the method includes:

smooth muscle pressure measurement; and

a change in the application of a non-exciting field in accordance with the measured pressure.

Alternatively or additionally, the method includes applying to the smooth muscle at least one exciting electric field.

Alternatively or additionally, the method includes applying a non-exciting field, including applying to the muscle a suppressing electric field.

Alternatively or additionally, the application of a non-exciting field includes the application of an electric field, which reduces the force of contraction in the muscle.

Alternatively or additionally, the application of a non-exciting field includes the application of an electric field, which increases the contraction force in the muscle.

Preferably, the organ is a stomach. Alternatively or additionally, the organ is the small intestine. Alternatively or additionally, the organ is the colon. Alternatively or additionally, the organ is a uterus.

Also proposed, in accordance with a preferred embodiment according to the invention, an apparatus for defining a smooth muscle organ profile of mechanical activation, including:

at least three electrodes made with the possibility of their distribution over the body;

at least one sensor that senses local mechanical activity of an organ; and

a control device that supplies electricity to the electrodes from among these electrodes in accordance with the perceived local mechanical activity to set the body a specific activation profile.

Preferably, the organ is a uterus, the activation profile being a contraction pattern during childbirth.

Although many embodiments of the present invention are described herein mainly as methods, it should be understood that the scope of the invention includes an apparatus configured to implement these methods. In particular, the scope of the invention includes programmable electric field generators that are programmed to create an electric field in accordance with a preferred embodiment of the invention. In a preferred embodiment of the invention, programmable variables include waveforms, amplitudes, frequencies, durations, delays, synchronization, and response to locally measured parameters of muscle activity. It should be understood that the behavior of a muscle in one of its sections can be changed by applying an electric field to its second section, for example, by suppressing the propagation of an activation signal to one section or by changing the aggregate of forces acting in one section.

A brief description of the graphic materials

The present invention can be more clearly understood from the following detailed description of preferred embodiments of the invention together with the accompanying drawings, where:

figure 1 is a schematic representation of the gastrointestinal (GI) tract;

FIG. 2 is a schematic illustration of an expanded LCD tract illustrating various preferred embodiments of the present invention; FIG.

figure 3 is a partial schematic sectional view of a straightened open portion of the LCD tract, showing the direction of the fibers of the smooth muscle of the LCD tract;

4 illustrates a method for advancing a colonoscope using local LCD control;

5 is a schematic illustration of a capsule for the treatment of hemorrhoids in accordance with a preferred embodiment of the present invention;

6 is a schematic diagram of the uterus illustrating the application of local suppressive electric fields to small areas of the uterus in accordance with a preferred embodiment of the present invention;

7 illustrates an implantable multi-site stimulator / suppressor attached to the uterus in accordance with a preferred embodiment of the invention;

Fig. 8 illustrates a uterine balloon-type liner for controlling spasms;

Fig.9 illustrates a control device that changes the production of a gland, such as a pancreas;

10 illustrates a blood pressure and / or heart load control device attached to major blood vessels in accordance with a preferred embodiment of the invention;

11 is a schematic representation of an experimental device used to determine the effects of a non-exciting field on smooth muscle cells;

12 is a graph of experimental results showing an increase in smooth muscle contraction force as a result of applying a non-excitation electric field in accordance with a preferred embodiment of the invention;

13-17 are graphs of experimental results, each of which shows a significant decrease in smooth muscle contraction force as a result of the application of a non-exciting electric field in accordance with a preferred embodiment of the invention;

Fig. 18 is a graph of experimental results showing an increase in the contraction force of the smooth muscle of the bladder as a result of applying a non-exciting electric field in accordance with a preferred embodiment of the invention; and

FIG. 19 is a graph of experimental results showing a decrease in smooth muscle contraction force of an unstimulated uterus as a result of applying a non-excitation electric field in accordance with a preferred embodiment of the invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Figure 1 is a schematic representation of the gastrointestinal (GI) tract 22 of patient 20. According to a preferred embodiment of the invention, local control of the contraction force and / or sensitivity of sections of the GI tract to excitation is achieved by applying local non-exciting electric fields directly to the site to be management. Although such non-exciting electric fields do not create a propagating action potential in the regulated region, they alter the response of the region to an artificial or naturally occurring activation signal when it arrives. In particular, the inventors have found that it is possible to increase or decrease the force of contraction of the portion of the LC tract. In addition, it is possible to desensitize the muscle segment in such a way that it has a reduced reaction, or in such a way that it does not react at all amplitudes of activation signals up to normal. This desensitization, despite the fact that it is reversible, can be created so that it lasts a certain period of time after the removal of the control electric field.

Two particular waveforms of non-exciting electric fields have been found to be useful. The first type is a substantially constant field (the polarity of which can sometimes be switched to reduce the effects of ion polarization). This field can be applied without any synchronization with the controlled muscle. However, the inventors have found that it is useful to stop the suppressive field just before the activation signal reaches the controlled muscle in order to reduce the amplitude of the activation signal required to drive the controlled muscle. The second type of non-exciting field is a pulse that is applied synchronously with the arrival of the activation signal. A pulse is applied either before, during the arrival of the signal, or with a delay after it arrives (a sufficiently long delay after activation is equivalent to applying a pulse before activation). The inventors believe that the non-exciting electric field applied after the activation signal tends to increase the contraction force of the adjustable muscle by increasing the duration of the plateau of the contraction of the muscle. It has been hypothesized that a non-exciting electric field applied with a greater delay after the arrival of the activation signal lengthens the refractory period (possibly by hyperpolarizing muscle cells in such a way that the activation signal does not cause depolarization). As a result, at least some of the muscle cells do not respond to the activation signal and the strength of the muscle contraction decreases. Thus, the stronger the non-excitation signal, the more cells will be hyperpolarized and the lower the contraction force. In an extreme case, not one of the muscle cells will respond to the activation signal, and its distribution will be suppressed. It is also possible that the non-excitation field directly reduces the effects of the contraction force achieved by a single muscle fiber.

It should be noted that various embodiments of the present invention, as described in this invention, can be used in combination with drug therapy, synergistic interaction and / or in order to provide the possibility of obtaining the desired effect with a lower dose of the drug, and / or in order to provide the opportunity to use increased doses of drugs while limiting their harmful side effects using electrical control. In addition, such electrical control can be used in practice together with electrical stimulation of the LC tract, including multi-site regulation. According to a preferred embodiment of the present invention, substantially any activation profile of the LC tract can be achieved by selectively adjusting the sections of the LC tract and creating desensitized regions between the stimulated regions so that the activation signal does not propagate from one stimulated region to the next. In addition, such electrical control can also be used in practice in combination with electrical stimulation of the vagus nerve.

The term "electric field" is used to describe a non-exciting field used to control muscle. The terms "field" and "current pulse" are used in this description, replacing each other, since both of them are generated in the body when a voltage potential is formed between the two electrodes. In a preferred embodiment of the invention, a field is applied by maintaining a direct current between at least two electrodes. Alternatively, instead of controlling the current, a voltage potential can be controlled.

Muscle tissue, as a rule, adapts to constant and / or intense activation by increasing its mass. In a preferred embodiment of the invention, a regulatory site is selected to increase muscle strength at that location. Preferably, the area around this place is desensitized so that the activation signal does not propagate to the rest of the LC tract. Alternatively or additionally, the local muscle mass is increased by changing the force of contraction in this place. As a rule, a maximum contraction force is desired, since it usually causes the greatest increase in muscle mass.

FIG. 2 is a schematic illustration of an LCD tract 22, deployed for illustrative purposes, to illustrate various preferred embodiments of the present invention. The GI tract 22 includes a stomach 24, a duodenum 26, a small intestine 27, and a large intestine 29.

According to a first preferred embodiment of the invention, the portion of the LC tract is desensitized and / or electrically isolated from activation signals. Isolation from electrical signals can be achieved by desensitizing the tissue that surrounds the site.

Ulcers cause inflammation of the tissue of the LC tract, this inflamed tissue can generate false activation signals. Alternatively, inflamed tissue may exhibit a very low threshold of excitability. Both of these abnormalities can cause arrhythmias in the stomach 24. In a preferred embodiment of the invention, the generation of abnormal electrical activity in the stomach 24 by the ulcer 28 is prevented by desensitizing the tissue surrounding the ulcer. Depending on the exact configuration, ulcer 28 itself may be desensitized. Alternatively or additionally, a non-excitation field is applied to the areas surrounding the ulcer 28 to enclose it with tissue that does not spread the action potential.

The term "enclosure" as used in this description refers to the electrical isolation of one muscle segment from other segments by suppressing electrical activity in the tissue surrounding this one segment. Thus, the activation signal can neither enter nor leave this single segment. Alternatively, to completely close the segment, you can use barriers to conduct the activation signal along the desired path by creating barriers on either side of the desired path. It should be noted that during the conduct, it may be sufficient to significantly reduce the conductivity in the tissue in which the barrier is applied, since this also changes the propagation vector of the activation front.

In a preferred embodiment of the invention, tissue desensitization is performed using a control device 32 including an electrode 30 in contact with the tissue surrounding the ulcer 28. Although it is shown in this embodiment that the control device 32 is external to the stomach 24 and is located or is inside, or outside the body, in an alternative preferred embodiment of the invention, the control device 32 is implanted inside the stomach, preferably placed with an endoscope and / or probe that displays electrical ac activity, and is preferably fixed to the wall of the stomach 24, for example, by using clamps.

According to another preferred embodiment of the invention, the pacemaker portion of the stomach 24, which is usually located in the upper portion of the stomach 24, is electrically isolated from other sections of the stomach. In FIG. 2, this is accomplished by applying a barrier 25 in the strand around the stomach 24. Alternatively or additionally, the rest of the stomach 24 can be desensitized. Alternatively or additionally, the pacemaker section itself can be desensitized to reduce its degree of excitation. Gastric desensitization 24 is useful in the treatment of nausea, nausea associated with pregnancy, reflective vomiting, and other conditions of the stomach characterized by undesired stomach activation.

A specific example of the condition is a treatment for obesity, which is treatable by desensitizing the stomach, in which delaying the emptying of the stomach 24 leads to “complete” sensitivity and reduces the patient’s food intake. Gastric desensitization is preferably used in conjunction with gastric regulation to achieve the desired activation. Alternatively or additionally, the intestines 27 are also controlled in a similar manner, especially by preventing the entry of electrical activation signals from the stomach 24 into the intestines 27, for example by applying a barrier on the duodenum 26 and / or on the cavity. In such examples, the control device 32 is preferably controlled outside the body, for example, by using magnetic reed switches or using high frequency telemetry. Thus, the control device 32 can be activated and deactivated when the patient needs it. Alternatively or additionally, the control device 32 includes sensors that sense various conditions of the LC tract 22, including the place of food in its area and local electrical activity. In such an embodiment, the control device 32 may change the activation profile of the LC tract 22 in accordance with the presence and position of food material therein.

According to another preferred embodiment of the invention, the portion of the LC tract 22 is desensitized and / or enclosed to enable it to heal. 2 shows a sutured region 38 and a control device 40 that imposes a pair of barriers 42 and 44 so that the region 38 is electrically isolated and local muscle activity will not damage the suture. Area 38 may also include the area from which the ulcer was recently removed. In a preferred embodiment of the invention, such a control device is enclosed in an anastomotic cuff, which is used to connect two segments of the intestine. Preferably, such an anastomotic cuff perceives electrical activity on one side of it and applies an exciting signal on its opposite side to provide a natural contraction of the intestine. As an alternative to completely suppress electrical activity in region 38, it may be desirable to periodically allow local electrical and / or mechanical activity. Alternatively or additionally, the local contraction force can be substantially reduced so as to reduce the local extension of the joints. In a preferred embodiment of the invention, electrodes are implanted in the affected area during a laproscopy procedure (or peritoneal dissection procedure). The suppressing electric field is applied until it is considered as unnecessary from a medical point of view.

In a preferred embodiment of the invention, the electrodes are connected to an external muscle control device. As soon as the field is no longer necessary, the electrodes can be removed, for example, using retractable electrodes, as is known in the art, for example, by twisting the electrodes or by dissolving the seam that attaches the electrode to the muscle.

In a preferred embodiment of the invention, emptying the stoma is suppressed by desensitizing the last few inches of the stoma until it becomes undesirable. The control device for the stoma preferably includes electrodes implanted along the last few inches of the stoma to apply suppressive or exciting pulses. The stoma control device preferably also includes an external control button that allows the patient to choose between suppressing the stoma to stop the release of solid waste and stop suppressing and / or stimulating the stoma to allow solid waste to move along the stoma.

In a preferred embodiment of the invention, an electrical control device is used instead of pharmaceuticals to relax the intestines. An example in which such use is desired is spastic constipation, in which a vicious circle of tension-pain-constipation can be broken by relieving tension in the colon. The relaxing electric field can be applied through the skin by implantation of the electrodes, or it can be applied using an inserted probe.

In another preferred embodiment of the invention, pain caused by intestinal ischemia is reduced by decreasing muscle contractility in the painful area, thereby reducing oxygen consumption and / or allowing better perfusion. Preferably, such a control device includes a pressure sensor, the control device is adapted to reduce the contraction force after the set local contraction force is achieved.

In another preferred embodiment of the invention, acute diarrhea is treated by relaxing the small intestine 27 and / or colon 29 so that they do not release fluid. Such treatment can be successfully applied using a probe with electrodes mounted on it. The electrodes are preferably elastic electrodes that extend (radially) from the probe to ensure good contact with the intestinal wall. This treatment is also suitable for patients with chronically irritated bowels, such as patients using a powerful treatment tool and patients suffering from AIDS. In patients with a chronic problem, the electrodes are preferably implanted on the outer surface of the sections of the LC tract.

Another aspect of the present invention relates to increasing contractility of at least a portion of the LC tract 22, typically to compensate for medical conditions in which the contractility of at least a portion of the LC tract 22 is reduced below normal levels. Such conditions are typical in elderly patients. Subnormal contraction forces are also found in patients in whom the intestinal section is denervated, especially in patients with aclasia (acquired or chronic), and other disorders such as diffuse systemic sclerosis, diabetic enteropathy, and primary visceral myopathies. Under such conditions, a non-exciting electric field is preferably applied using wire electrodes, which are either attached to the inner surface of the LCD tract 22, or implanted into the muscle of the LCD tract 22 itself, and / or using electrodes that are implanted on the outer surface of the LCD tract 22. Preferably, such electrodes implanted by advancing the surgical probe along the outer surface of the LC tract 22 and attaching electrodes in places along the outer surface of the tract. Alternatively, a plurality of encapsulated control devices can be implanted at a number of points along the LCD path 22. Each encapsulated control device includes a power source, electrodes, and a control device that can be activated by an external command to apply a non-excitation field. Alternatively, each such encapsulated control device includes an induction coil, which converts the high-frequency radiation, which is transmitted to the coil from an external source, into a non-exciting electric field.

Another aspect of the present invention relates to the simultaneous use of several different types of control so as to achieve more precise control of the activation profile of the LC tract 22. In one preferred embodiment of the invention, the motility of the small intestine 27 and / or colon 29 is increased by suppressing the backward wave. In a normally activated intestine, there is a direct wave that promotes the food material in the intestine, as well as a backward wave, which causes food to move back along the intestine and helps mix food. In this preferred embodiment of the invention, the forward wave is not suppressed, and the backward wave is suppressed so as to provide greater mobility. Preferably, the back wave is suppressed at its source, at the end of the intestine, by applying a barrier to the site. Figure 2 shows a control device 46 in which a barrier 48 is mounted at the end of the small intestine 27. Preferably, the control device 46 uses a sensor 52 and / or a sensor 50 to detect a direct wave and / or backward wave, either by their electrical activity or by their mechanical action. In a preferred embodiment of the invention, the barrier 48 is synchronized with the forward wave and is only activated for a time sufficient to block the backward wave. The control device 46 is preferably inserted using an endoscope, preferably from within the small intestine.

According to another preferred embodiment of the invention, electric control is used to advance the inserted bolus 56. To advance the bolus 56, electric control is used in the area 60 in front of the bolus 56 to relax it. Area 58 located behind and around the bolus 56 is preferably managed to increase its contractility. The control device 54 may be permanently implanted at location 58 if boluses are expected to be inserted at that location due to damage to the nerve and / or muscle. In a preferred embodiment of the invention, wiring is mounted on a significant portion of the LC tract 22. Many sensors are placed along the site to detect a bolus in the site. Accordingly, the above-described method of promoting a bolus is applied at a detected location. The plurality of sensors may be impedance sensors, which preferably use the same electrodes as electrodes applying a field.

Figure 3 is a partial schematic sectional view of a straightened open portion 72 of the LC tract 22, showing the direction of the smooth muscle fibers of the LCD tract. The LC tract 22 usually consists of three muscle layers, a thin, electrically conductive layer (not shown), an inner layer of fibers 72, typically located along the length of the LC duct 22, and an outer layer 74 of fibers, typically perpendicular to the fibers in the layer 72. Layer 72 regulates local changes in the length of the LC tract 22, while layer 74 regulates local changes in the diameter of the LC tract 22.

In a preferred embodiment of the invention, a non-exciting electric field is selectively applied to either layer 72 or layer 74 to increase or decrease the local contraction force. Such selectivity can be achieved by arranging the direction of the electric field either parallel to the fibers of the layer 72 or parallel to the fibers of the layer 74. It should be noted that this type of selectivity is not possible when an exciting electric field is used, since such a field excites both layers 72 and 74.

In a preferred embodiment of the invention, a mesh electrode 76 having a plurality of individual electrodes 78 is used to influence this selectivity. If the network is placed in such a way that its main axes are parallel to the directions of the fibers, then an electric field having a direction parallel to one of the layers can be generated by selecting some of the electrodes 78. Some of the electrodes 78 can also be selected for applying a field that is diagonal in relation to the fibers in both layers. Alternatively or additionally, electrodes 78 are alternatively supplied with electricity in such a way that electric fields in both directions are applied alternatively. In particular, the suppression field can be applied in one direction, while the field that increases contractility can be applied in the perpendicular direction. As is understood, electrodes 78 can also be used to provide a stimulus signal. In a preferred embodiment of the invention, electrodes 78 are also used to sense local electrical activity in such a way as to improve the duration of the non-exciting field.

Another type of electrode that is preferred for use in controlling smooth muscle is an elongated electrode, which is suitable for applying a suppressive electric field to create a barrier. The propagation of the activation signal is most favorably controlled (increase or decrease) by applying an electric field that is parallel to the fibers in the innermost layer of the muscle, since this muscle layer conducts the activation signal. The propagation of the activation signal can be increased by applying an electric field to the inner layer that increases contractility. Another way to selectively apply an electric field to only one layer is to introduce electrodes into the muscle between the layers so that essentially only one layer is inside the field.

Various apparatuses and methodologies for applying a non-exciting electric field to the heart muscle are described in six PCT applications filed by New Technologies (SA-YSY) Ltd., et al., In the receiving Office in Israel: PCT / IL 97/00012 "Electrical Muscle Controller, "filed January 8, 1997, and five PCT applications filed July 9, 1997: PCT / IL 97/00231," Apparatus and Methods for Controlling the Contractility of Muscles ", PCT / IL 97/00232," Drug-Device Combination for Controlling the Contractility of Muscles. " PCT / IL 97/00233, "Fencing of Cardiac Muscle", PCT / IL 97/00235 "Cardiac Output Controller" and PCT / IL 97/00236, "Cardiac Output Enhanced Pacemaker", the descriptions of which are incorporated herein by reference. In particular, these PCT applications describe various waveforms that can be used to apply non-exciting electric fields, including DC fields, AC fields, unipolar and bipolar fields, and combinations of such fields. PCT / IL 97/00012 also describes the possibility of using light radiation and high-frequency radiation to influence the transfer of calcium in the cells of the heart muscle and thereby affect the strength of their contraction. This apparatus can be adapted, in accordance with preferred embodiments of the present invention, for application to non-excitatory electric fields to smooth muscles.

When the apparatus described in this invention is adapted for private physiology, it is expected that it may be necessary to adapt the amplitudes, delays and frequencies of the non-excitation field. In a preferred embodiment of the invention, the apparatus is programmable using high frequency radiation. Thus, it can be implanted, and various sets of pulse parameters can be tested to determine the optimal set. In addition, it may be necessary, after some time, to adjust the parameters due to adaptation of the controlled muscle, changes in the impedance of the electrodes or changes in the function of the control device.

Obviously, some patients require only a short course of treatment, while other patients require a longer course, in some cases, ongoing treatment may be required. In a preferred embodiment of the invention, the apparatus described in this invention is adapted to be implanted in the body. Alternatively, such an apparatus is adapted to be introduced into the body for a shorter period of time, such as a period of less than a month. Such a device may include the use of different materials for the electrodes and a different compromise between battery life and degree of control. Alternatively, such an apparatus is adapted to be located outside the body or carried by the patient, or located separately. Preferably, at least the electrodes are implanted in the body or inserted into the body cavity.

It should also be noted that the activity of smooth muscles also changes by their tension. In a preferred embodiment of the invention, the smooth muscle control device includes sensors that measure muscle tension and changes the applied field in accordance with the measured voltage. Preferably, the voltage is measured on the outer surface of the cavity formed by the smooth muscle. Alternatively or additionally, stress is measured inside a cavity formed by a smooth muscle. Alternatively or additionally, stress is measured inside the smooth muscle.

In a preferred embodiment of the invention, the direction and polarity of the electric field relative to the muscle fibers is also changed in order to determine the optimal direction and / or polarity that perform the desired muscle control. It should be noted that two perpendicular muscle layers have different characteristics, such as residual stress, and, possibly, a different response to a non-exciting field. In a preferred embodiment of the invention, different directions of the electric field relative to the muscle fibers, such as 0 °, 5 °, 10 °, 30 ° and 45 °, are tested without moving the electrodes. This is preferably achieved by using an electrode such as a network, where electricity can be supplied separately for each connection in the network. Thus, essentially any effective field direction and polarity can be tested without moving the electrodes. Such a network electrode can also be used as a network of sensors to more accurately determine the direction of propagation of the activation front, since this direction of propagation, as a rule, is perpendicular to isochronal lines, which indicate equal activation times. In addition, changes in the activation profile, such as the action of regulatory fields and / or arrhythmias, can be detected by changes in electrical signals sensed by multiple network connections. In addition, mechanical activity can be localized by measuring the impedance between individual compounds or adjacent compounds, in which case the characteristics of the muscle, or compounds that are on opposite sides of the smooth muscle, are measured, in which case the fullness of the LC tract can be determined.

It should be noted that the smooth muscle contraction rate is usually much lower than the heart muscle contraction frequency, which makes it possible to use simpler electronic devices and power sources with a slower response to control the smooth muscle. Moreover, the propagation time along the smooth muscle is usually much shorter than for the heart muscle. As a result, several seconds may elapse between the activation time in one place and the activation time in the second place. Thus, to provide a suitable delay between local activation and local application of a non-excitation field, local determination of the activation time is particularly preferred for controlling smooth muscle. Such local determination is preferably carried out by local perception, however, in another preferred embodiment of the invention, the local activation time is calculated using the set propagation speed.

FIG. 4 illustrates a method for advancing a colonoscope 90 using local control of a portion of the LC tract 92. As the minimum penetration procedure is approved, periodic examination of the colon using a colonoscope and small intestine using an endoscope becomes more common. When examining the colon, the colonoscope is inserted into the anus and is advanced along the colon. Promotion periodically is stopped and the colon surrounding the tip of the colonoscope is inflated using air in such a way as to promote the advancement of the colonoscope and accelerate the examination of the colon wall. Medications that relax the colon are usually administered to the patient before the examination.

According to a preferred embodiment of the invention, the colonoscope 90 has a plurality of electrodes 94 at least at its tip. In a preferred embodiment of the invention, these electrodes are used to apply a relaxing electric field to the colon and thus reduce the air pressure required to inflate it. In addition, such relaxation reduces the force required to advance the colonoscope, thereby reducing the risk of perforation. In a preferred embodiment of the invention, the electrodes are extensible from the tip of the colonoscope 90 so that they can occupy the portion 92 of the colon, even when it is inflated. Preferably, the electrodes may be temporarily engaged in the area 92 of the colon.

According to another preferred embodiment of the invention, electricity is supplied to the electrodes 94 in such a way as to force the portion of the colon 92 to advance or facilitate the advancement of the colonoscope 90. Such advancement can be achieved in one of two ways, or by blocking the direct wave and allowing to return the colonoscope 90, or by selectively exciting the muscle fibers in layers 72 and 74 (FIG. 3), in such a way as to advance the colonoscope. One mode of selective excitation includes: controlling the layer 74 to compress the colonoscope 90 more firmly at its tip and exciting the layer 72 to advance the colonoscope 92. The excitation order and the point at which the colon is excited will greatly determine the direction of movement of the colonoscope 92. Preferably, additional electrodes along the colonoscope 90 (not shown) are used either to carry out the same advancement action or to relax the layer 74 along the length of the colonoscope 92 so that s facilitate its advancement. Selective excitation of muscle fibers with a specific direction can be achieved first by suppressing muscle fibers in a different direction, and then by applying an excitatory stimulus. Colonoscope ejection can be facilitated by adjusting the colon section 92 at the tip of the colonoscope 90 so as to use the natural rhythm of the colon section 92 to eject the colonoscope 90.

It is understood that what has been described with respect to the colonoscope is equally applied to the endoscope, especially with respect to its ejection. In a preferred embodiment of the invention, the colonoscope 90 includes electrodes that apply a blocking field that blocks any local excitations from propagating to the rest of the LC tract 22.

According to another preferred embodiment of the invention, an endoscope that is used to penetrate the bile duct includes electrodes at its tip to apply a relaxing electric field so as to expand the sphincter from the bile duct into the intestine. Preferably, such an expansion, when realized with a device that does not clog the bile duct, is used in combination with a treatment to break up gallbladder stones so as to facilitate the release of broken stone fragments into the intestine. Alternatively, such a device is used to excite and / or increase contractility of the bile duct in order to facilitate the movement of such stones and / or in order to facilitate its normal functioning. A non-clogging device can be implanted outside the duct of the gallbladder, for example, from the inside of the small intestine 27, and it is only necessary that the leads of the electrodes are in the duct. Alternatively, the findings are also implanted outside the duct.

5 is a schematic illustration of a capsule 102 for the treatment of hemorrhoids 100 in accordance with a preferred embodiment of the present invention. It has recently been determined that the main cause of hemorrhoids and the main factor in the non-healing of hemorrhoids and anal fissures is increased tension in the lower part of the colon. Increased stress reduces blood flow, slowing healing and at the same time causing pain. It should be noted that tension in the lower part of the colon blocks blood from the rectal zone, i.e. at some distance from her. Nitroglycerin for topical application (both on hemorrhoids and inside the colon) has been proposed to reduce stress in the lower part of the colon. However, this medicine has several side effects, such as dizziness. According to a preferred embodiment of the invention, capsule 102 is inserted into the lower part of the colon where it creates relaxing electric fields that either completely suppress local contraction or at least reduce it. The capsule 102 preferably includes a plurality of electrodes 104, a power source 106 for supplying electricity to the electrodes, and preferably a mount 110 for easily removing the capsule 102. Preferably, the capsule 102 senses an abnormal colon pressure using a pressure sensor (not shown), and applies a relaxing electric field only during such periods of time or after such abnormal pressure has lasted for a considerable period of time. Alternatively or additionally, a voltage sensor and / or an electrical activity sensor is used to sense local activity of the colon.

In a preferred embodiment of the invention suitable for female patients, the capsule 102 is adapted to be inserted into the vagina and apply an electric field that affects the lower part of the colon. Preferably, the electrodes 104 are positioned so that the field is applied asymmetrically and mainly in the direction of the colon, since, as a rule, the effect of the relaxing field on the muscles of the bladder or on the rectal sphincter is undesirable. Thus, the electrodes 104 are preferably located on only one side of the capsule 102. The capsule 102 preferably includes a marking so that the patient enters it in the proper direction. As an alternative to using the capsule, the control device 108 may be implanted outside the colon.

6 is a schematic diagram of the uterus 120 illustrating the application of local suppressive electric fields to its small areas. Unwanted electrical activity in the uterus can cause premature birth in a woman. It has been hypothesized that such undesirable electrical activity can, in many cases, be caused by small areas of tissue, for example, near fibroids or fibroids, where uterine extension can be maximized, or in places of inflammation. Unlike the heart, it may be undesirable to remove parts of the uterus, as this can reduce fertility and / or can permanently damage the uterus. In a preferred embodiment of the invention, the propagation of electrical excitation from the fibroid 122 is blocked by enclosing the fibroid or by desensitizing the fibroid 122 and the tissue surrounding it. 6 depicts a control device 124 that applies such non-exciting electric fields using a plurality of electrodes 126. Preferably, the control device 124 is external to the uterus 120, but it is preferable to implant it into the body. However, in other embodiments of the invention, only the electrodes 126 of the control device 124 are inserted into the body, for example, using a laproscopy procedure. Electrodes that must be inserted into the back of the uterus can be inserted through the intestines.

Areas of the uterus that can cause such premature electrical activity may include inflamed tissue, scar tissue, fibrous and ugly areas of the uterus. These types of tissue can be detected either by visual inspection (using a hysteroscope) or, preferably, using an electric mapping probe, as is known from the level of electrophysiology. Such mapping can also be carried out during pregnancy, in which case electrodes can be implanted inside the uterus, during or immediately after the mapping procedure. The control device will then preferably be external to the body or, if possible, located in the vagina.

It has been suggested that there is a small area of the uterus shown in FIG. 6, such as region 128, which generates a stimulus signal for the entire uterus, at least during labor. In a preferred embodiment of the invention, childbirth is delayed by selectively suppressing this zone or by enclosing it using non-exciting electric fields.

One aspect of the present invention relates to providing more accurate control of the labor process than is possible with medications. Some situations in which the drug response time is not sufficient, side effects are too large, or it may be difficult to determine the appropriate dose, include:

(a) stopping preterm birth;

(b) cessation of labor, in which a cesarean section is indicated;

(c) situations in which precise control of the force of contraction of the uterus is required;

(d) promoting childbirth that does not proceed properly; and

(e) stopping childbirth, even already begun when they are contraindicated;

(e) setting a preferred profile of contractions during childbirth.

7 illustrates an implantable multi-site stimulator / suppressor 130 attached to the uterus 120, in accordance with an embodiment of the invention. The control device 130 includes a plurality of electrodes 132, preferably positioned so as to cover substantially the entire uterus 120. These electrodes can be attached to the outer surface of the uterus 120, for example, during a laproscopy procedure. Alternatively, electrodes 132 are attached to the inner surface of the uterus 120, for example, using a hysteroscopy procedure. Alternatively, these electrodes can be external to the body, for example on the skin, and possibly can be introduced into the intestine adjacent to the uterus. In a preferred embodiment of the invention, electrodes 132 are implanted before pregnancy, for example during a previous cesarean section and / or using a laproscopy procedure. Alternatively or additionally, electrodes for controlling smooth muscle are implanted in blood vessels that are adjacent to the smooth muscle, such as vessels that feed the smooth muscle. Preferably, the power supply to the individual electrodes 132 is confined to local electrical activity. Electrodes 132 can also be used to provide a stimulating signal that both induces and supports childbirth.

In accordance with another preferred embodiment of the invention, multisite regulation is used to specify preferred uterine activation (contraction). Preferably, multisite regulation is supplemented by local contraction force control (usually magnification). Alternatively or additionally, barriers are used in the uterus to conduct activation signals in the desired manner. It should be noted that the enclosure can be used on its own, in combination with a single regulation site or in combination with multiple activation sites, in various preferred embodiments of the invention.

According to a preferred embodiment of the invention, labor is accelerated and / or assisted by an increase in contraction force. An increase in contraction force causes a positive reverse effect, which further increases the contraction force. An increase in contraction force is also suitable for promoting artificial abortion. In other situations, it may be necessary to reduce the force of contraction or completely stop the birth, as, for example, in cases of embryonic distress or when there is a risk of rupture of the uterus, in these cases, a cesarean section should be performed. In cases of an ugly or severely scarred uterus and in patients having a previous case of premature birth, the control device 130 is preferably used to stop even the birth that has already begun. Preferably, electricity is supplied to the electrodes 132 to form an overwhelming electric field. Preferably, they are supplied with electricity only when the control device 130 detects local electrical activity. Alternatively or additionally, electrodes 132 are supplied with electric power in accordance with the contraction rate of the uterus 120.

According to another preferred embodiment of the invention, the birth canal 134 and / or cervix 120 is relaxed by using a locally applied electric field in order to facilitate the exit of the baby. Alternatively, the force of contraction of the birth canal is increased before birth in order to avoid a miscarriage. Alternatively or additionally, the birth canal muscles are also stimulated using stimulatory signals in order to cause them to contract and avoid miscarriage.

It should be understood that the uterus 120 undergoes very significant changes in size during the course of pregnancy. Thus, the terminals of the electrodes 132 are preferably made very flexible and elastic. In one preferred embodiment of the present invention, the leads are made of spiral wire in such a way that if the terminal is pulled, the spiral is pulled rather than tearing the wire. Preferably, the spiral is wound around a flexible rod. Preferably, the terminals of the electrodes 132 include weak points, so that if a load exceeding a predetermined value is applied to the terminals, it breaks at one of the pre-selected points, and does not damage tissue structures adjacent to the terminals.

In a preferred embodiment of the invention, each of the electrodes 132 includes an encapsulated power source, and a control device 130 coordinates the individual electrodes using radio communication. Thus, it is not necessary that the electrodes 132 are connected by wires. Alternatively, electrodes 132 coordinate the power supply using methods well known in the art of distributed computing and without a central control device. As an alternative to synchronizing their activity, each of the electrodes 132 acts in accordance with local activity.

Fig. 8 illustrates an insertion of the type of balloon 140 for the uterus 120 for adjusting contractions. The insert 140 includes a plurality of electrodes 142 located on the outer surface of the device to which electricity is supplied by the power source 144. The insert 140 is preferably inflated to provide better contact with the inner wall of the uterus 120. In a preferred mode of operation, the various electrodes 142 function as sensors of electrical activity . As soon as such electrical activity is perceived, an overwhelming electric field is applied in these places to prevent the future occurrence of electrical activation and / or to prevent its propagation. Alternatively, such a device constantly applies an overwhelming electric field. In a preferred embodiment of the invention, a suppressive electric field is applied between the electrodes 142 and the external electrode, which is placed on the stomach and / or on the back. Although the point electrodes are shown in the figure, it should be understood that other forms of electrodes, such as elongated electrodes, may also be used. Preferably, the device is removed from the body when contractions are not expected.

Fig. 9 depicts a control device 150 that changes the production of a gland, such as a pancreas 152. In some glands, such as a pancreas 152, the release of hormones into a blood vessel 154 is mediated by the electrical stimulation of hormone-producing cells (beta cells in the pancreas ) Electrical excitation, such as in many smooth muscles, is triggered by chemical signals. According to a preferred embodiment of the invention, hormone-releasing cells are desensitized in such a way that they do not respond to these chemical signals, or if some of the cells do respond, then these cells cannot generate a propagating activation signal, since the surrounding cells are electrically deactivated. Thus, the amount of released hormone decreases. This method is particularly suitable for diseases such as tumors in which iron overproduces its hormone.

The control device 150 preferably includes an electrode 158 and, preferably, a second electrode 156 to create an electric field that suppresses or decreases the electrical activity of hormone producing cells. The shell of the control device 150 can be used as a second electrode in this and in other of the preferred embodiments described above. It is clear that the levels of the hormone in the blood and the electrical activity of the cells that produce the hormone are quite difficult to detect using modern technology. Thus, in a preferred embodiment of the invention, a substantially constant suppressive electric field is applied. Preferably, the field polarity is changed periodically so as to prevent ion-mediated damage and ionization of the electrodes 156 and 158. Alternatively, the control device 150 may measure local electrical activity, hormone levels or may measure a physical indicator such as glucose that correlates with hormone levels, and apply voltage to the electrodes 156 and 158, as indicated.

Another aspect of the present invention relates to the management of blood pressure and / or other parameters of the circulatory system, such as a load on the heart. Preferably, control is carried out in combination with the use of a heart control device, such as described in the PCT applications referred to above. FIG. 10 illustrates a control device 160 for blood pressure and / or heart load connected to major blood vessels in accordance with a preferred embodiment of the invention. Heart 162 receives blood from the vena cava 168 and pumps it into the aorta 164, and from there into the abdominal aorta 166. In the event of a spasm in the aorta 164, it is significantly reduced, increasing the afterload on the heart. In many cases, these types of spasms will cause dizziness. In patients with contracted coronary arteries, an increased heart requirement can also cause a painful attack of angina pectoris.

According to a preferred embodiment of the invention, the afterload on the heart 162 is instantly reduced by relaxing the large arteries. Alternatively or additionally, the preload on the heart 162 is instantly reduced by relaxing large veins. Reducing either preload and / or afterload reduces the work required of the heart 162, and, in many cases, pain in angina pectoris remains. Alternatively or additionally, the walls of large blood vessels are relaxed to lower blood pressure during an acute attack of high blood pressure. Alternatively, blood vessels may be contracted, for example, during an acute attack of low blood pressure. Reducing the load on the heart 162 is especially useful if it is performed during the extension of the diastole of the left ventricle of the heart 162, for example, by prolonging the refractory periods of the muscle cells in it, for example, as described in the aforementioned PCT applications.

The choice of a particular blood vessel for relaxation depends, in particular, on the type of load that it is desirable to reduce, on whether the hypertension is pulmonary or systemic, and, in the case of a spasm, on whether the vessel in a state of spasm has implanted electrodes.

In a preferred embodiment of the invention, a vessel in a state of spasm is detected using a measurement of changes in impedance between the electrodes surrounding the blood vessel. Alternatively, instead of determining which blood vessel is in a state of spasm, all blood vessels with mounted wire electrodes are relaxed.

In a preferred embodiment of the invention, the control device 160 includes a pair of electrodes 170 and 172 for controlling the vena cava vein 168. Alternatively or additionally, the control device 160 includes a pair of electrodes 174 and 176 for controlling the abdominal aorta. Alternatively or additionally, the control device 160 includes a pair of electrodes 178 and 180 for controlling the aorta, preferably located on or near the aortic arch. In a preferred embodiment of the invention, the electrodes are network-type electrodes since the muscle fibers in the blood vessels are generally directed perpendicular to the direction of the blood flow, and a field perpendicular to the direction of the blood flow is desirable. Alternatively, the electrodes are elongated electrodes arranged parallel to the blood flow to apply a field perpendicular to the blood flow between the pairs of electrodes. Preferably, the control device 160 is controlled externally so that the patient can activate it when he feels pain and / or dizziness. Alternatively or additionally, the control device 160 includes a blood pressure sensor (not shown) for automatic control with feedback of blood pressure. Alternatively or additionally, the control device 160 includes an ECG sensor or a blood pressure sensor, so that the application of fields to the circulatory system can be synchronized with the heart rhythm. Preferably, the control device 160 includes a safety stop that prevents the patient from decreasing or increasing the blood pressure, which is outside the scope of acceptable restrictions.

11-16 describe experiments that demonstrate that the force of contraction of the smooth muscle can be increased or decreased by applying non-exciting electric fields directly to the muscle.

Male New Zealand white rabbits (body weight 1-2 kg) were dissected, various sections of their LC tract were extracted and used for subsequent experiments. Animals were anesthetized using pentobarbitone (Ceva, France), 60 mg / kg of body weight intravenously. The abdominal wall was opened to open the internal organs of the peritoneum. The required sections of the LC tract were removed and placed in a cold (4 ° С) oxygenated (95/5 O ₂ / CO ₂ ) Krebs-Hesleit solution (Krebs-Heseleit) containing (in mM): KCl 4,5, NaCl 118, NaHCO ₃ 24, MgSO ₄ 1,19, KH ₂ PO ₄ 1,18, glucose 11 and CaCl ₂ 2,52. The extracted areas were then further excised in a preparation chamber (Hugo Sachs Electronik (HSE), Germany) to obtain a separate strip of muscle of the LC tract, which was then placed in an organ bath. The organ bath is type 813 (1-18 E) from HSE, and it includes a type 319 temperature control device and a type F30 load cell with a type 660 amplifier. The time for the removal procedure is about 3-5 minutes.

11 is a schematic representation of an experimental setup used to determine the effects of a non-exciting field on smooth muscle cells. Section 200 of the muscle of the LCD tract is fixed in the chamber of the organ bath, one end is fixed to the chamber using a plastic clip, while the other end is attached to the pressure sensor 202. The length of the muscles of the LCD tract is adjusted so as to provide maximum isometric force. The temperature in the organ bath is regulated, and the muscle of the LC tract is constantly washed (7-12 ml / min) with the above-described oxygenated solution, maintained at approximately 36.1 ° C. The muscle is allowed to remain in the organ bath before experimenting for a period of 30 minutes.

The organ bath includes two Ag-AgCl 206 electrodes, which are used to apply a stimulating pulse when required by the experimental protocol. These electrodes are chlorinated before each experiment. Stimulating stimuli provide a constant current source. The stimulating waveform is a square wave impulse. A non-exciting electric field is applied using carbon electrodes 208 (formed from carbon rods obtained from Goodfellow, UK), which are placed at a distance of approximately 2-3 millimeters from each other. Electricity is supplied to the electrodes using a direct current source 210. Two direct current sources are self-made direct current sources, the constant level of which is changed by computer control. The output of these current sources is constantly monitored to ensure that direct current is produced. The entire experiment was controlled using computer 212, and the data was obtained using specialized data acquisition systems, such as PCI-MI0-16XE50 or AT-M10-16E-2 (National Instrument, USA). The organ bath is placed on an anti-vibration table (TMS, USA). Both the stimulating current and the non-exciting current are direct current pulses. The amplitude of the stimulation varies between the following experiments, mainly in order to prevent the polarization of the electrodes. Non-excitation field delay (NT current) begins at the start of the stimulus signal.

12-17 show experimental results using the jejunum section of the LC tract. The fields are applied, and the sensor measures the force approximately along the direction of the LCD path. As described above, differences in direction can alter the effect of a non-excitation pulse. Field polarity is sometimes chosen so as to cause an effect that increases the force, and sometimes so as to cause an effect that reduces the force.

12 is a graph of experimental results showing an increase in smooth muscle contraction force as a result of the application of a non-excitation electric field in accordance with a preferred embodiment of the invention. The non-excitation field is shown as a filled bar marked “NT”.

In this experiment, the stimulation is 0.15 Hz, duration 30 ms, current 3 mA. A non-exciting field is created by a current pulse of 200 ms at 10 mA applied with a delay of 50 ms after stimulation. As can be seen in FIG. 12, an increase in contraction force of approximately 300% is achieved.

13-16 are graphs of experimental results showing a significant decrease in smooth muscle contraction force as a result of applying a non-excitation electric field in accordance with a preferred embodiment of the invention.

13, a 70% reduction in contraction force is achieved. The stimulation was the same as in Fig. 12, while the non-excitation pulse was applied for 100 ms with a delay of 100 ms after stimulation and at 10 mA. It should be noted that the action of the non-exciting field continues after its removal. In addition, the non-excitatory field also reduces the main muscle tone, that is, it relaxes it.

On Fig achieved a significant reduction in the force of contraction. The stimulation was faster than in FIGS. 12 and 13: 0.25 Hz, duration 30 ms and amplitude 10 mA. A non-excitation pulse is applied for 50 ms with a delay of 50 ms after stimulation with an amplitude of 10 mA. In this experiment, a decrease in muscle tone is also observed.

On Fig achieved a significant reduction in the force of contraction. The stimulation was different from the stimulation in FIG. 14: 0.25 Hz, duration 30 ms and amplitude 3 mA. A non-excitation pulse is applied for 60 ms with a delay after stimulation of 200 ms and at 10 mA. In this experiment, a decrease in muscle tone is also observed.

In Fig.16, a significant reduction in contraction force is achieved. The stimulation was similar to the stimulation in FIG. 12 and FIG. 13: 0.15 Hz, a duration of 30 ms and an amplitude of 3 mA. A non-excitation pulse is applied for 100 ms with a delay after stimulation of 50 ms and at 10 mA. In this experiment, a decrease in muscle tone is also observed.

17, a substantial reduction in contraction force is achieved by using a substantially constant non-exciting field. Stimulation: 0.25 Hz, duration 2 ms and amplitude 5 mA. A non-excitation pulse is applied for 3990 ms with a delay after stimulation of 5 ms and with an amplitude of 15 mA. Observe an almost complete blockage of contraction. In this experiment, a decrease in muscle tone is also observed.

Fig. 18 is a graph of experimental results representing an increase in smooth muscle contraction force of the bladder as a result of application of a non-excitation electric field in accordance with a preferred embodiment of the invention. A bladder segment was prepared as described above. It was stimulated at 0.2 Hz, duration 30 ms and with an amplitude of 6 mA. Non-exciting field: a pulse of 60 ms duration applied with a delay after stimulation of 30 ms and having an amplitude of 10 mA. It should be noted that the residual stress of the bladder segment also increases as a result of the application of a non-exciting field.

FIG. 19 is a graph of experimental results representing a decrease in contractile force of a smooth muscle of a rabbit uterus as a result of application of a non-excitation electric field in accordance with a preferred embodiment of the invention. A uterine segment was prepared as described above. The muscle segment was not artificially stimulated; it was self-stimulating. Non-excitation field: a pulse of 20 ms duration with an amplitude of 10 mA applied at 0.2 Hz. It should be noted that the contraction force is not only significantly reduced; after approximately 30 seconds of application of a non-excitation field, the contraction of the tissue is apparently completely suppressed. The effects of the field also last for a short period of time after its removal.

One skilled in the art will understand that although the present invention has been described with reference to preferred embodiments, the scope of the invention is not limited to what has been described. It is believed that with a specific modification of the above durations, setting the amplitude and delay of non-exciting signals for specific patients will be within the competence of a specialist and also within the scope of the present invention. Thus, the scope of the present invention is limited only by the following claims.

Claims (59)

1. A method for controlling the emptying of a stoma, wherein a non-exciting electric field is applied to the output of the stoma, which reduces the mobility of the end portion, and the field is removed when emptying of the stoma is desired. 2. The method according to claim 1, further comprising applying to the output portion of the second electric field, which increases the mobility of the stoma when it is desired to empty the stoma. 3. A method of increasing the mobility of the LC tract, in which a portion of the LC tract is selected and a non-exciting electric field is applied to the portion, which increases the contraction force in the portion. 4. The method according to claim 3, in which a second non-exciting electric field is applied to the second section of the LC tract, which is lower from the specified section, which reduces the force of contraction in the second section. 5. A method of increasing the mobility of the LC tract, in which the timing of the backward wave in the LC path is determined and a non-excitation electric field is applied to at least a portion of the LC path, which reduces the response of the LC path to the backward wave. 6. The method according to claim 5, in which the determination of the timing includes detecting a direct wave, and in which the application of a non-exciting electric field includes the application of a non-exciting electric field only at times when it does not interact substantially with the direct wave. 7. The method according to claim 5, wherein determining the timing includes detecting a backward wave, and wherein applying a non-exciting electric field includes applying a non-exciting electric field only at times when it interacts with the backward wave. 8. The method according to any one of claims 5 to 7, wherein the application of a non-exciting electric field includes the application of a non-exciting electric field that suppresses the propagation of an activation signal that synchronizes the backward wave. 9. The method according to any one of claims 5 to 7, wherein the application of a non-exciting electric field includes the application of a non-exciting electric field, which reduces the force of contraction in at least a portion of the LC tract. 10. A method for selective excitation of only a muscle layer in a smooth muscle having many muscle layers with different fiber directions, in which: a non-exciting suppressive electric field is applied to the muscle parallel to the direction of the fibers of the first muscle layer; and applying a stimulating electric field to the muscle that excites the second layer of the muscle. 11. A method for selectively increasing the contraction force of only a muscle layer in a smooth muscle having a plurality of muscle layers with different fiber directions, wherein a non-exciting suppressive electric field is applied to the muscle parallel to the direction of the fibers of the first muscle layer, and a second non-exciting electric field is applied to the muscle, which directed parallel to the direction of the fibers of the second muscle layer and which increases the contraction force in the second muscle layer. 12. A method of multipoint regulation of a smooth muscle, in which exciting electric fields are applied to a plurality of places on said muscle and at least one non-exciting suppressing electric field is applied to a second set of places located among said plural places where said non-exciting suppressing electric field prevents the activation the signal between the specified first set of adjusted places. 13. An apparatus for controlling at least the local activity of the smooth muscle region in vivo, including a plurality of electrodes configured to be in contact with the smooth muscle region to be controlled, and a control device that supplies electric power to said electrodes to generate a non-exciting electric a field that does not cause the formation of a propagating action potential in the smooth muscle and which changes the smooth muscle response to the activation signal. 14. The apparatus according to item 13, which includes an electrical activity sensor that detects electrical activity in the area, and the specified control device supplies electric power to these electrodes in accordance with the signals from the specified sensor. 15. The apparatus according to 14, where the supply of electricity to each of these electrodes is carried out in accordance with local electrical activity in this area. 16. The apparatus of claim 14, wherein said electrical activity sensor senses electrical activity using electrodes from said plurality of electrodes. 17. The apparatus of claim 13, including an impedance sensor that senses at least one impedance between selected electrodes from said plurality of electrodes. 18. The apparatus according to item 13, which includes a torque sensor that detects mechanical activity in the area, and the specified control device supplies electricity to these electrodes in accordance with the signals from the specified sensor. 19. The apparatus of claim 18, wherein said control device applies a non-exciting suppressive electric field to the muscle when said mechanical activity exceeds a certain threshold. 20. The apparatus according to p, where the supply of electricity to each of these electrodes is carried out in accordance with local mechanical activity in this area. 21. The apparatus according to item 13, where the specified non-exciting field suppresses mechanical activity in the area. 22. The apparatus according to item 13, where the specified non-exciting field reduces the force of contraction in the area. 23. The apparatus according to item 13, where the specified non-exciting field increases the force of contraction in the area. 24. The apparatus according to item 13, where the specified control device is additionally capable of supplying electricity to at least one of these electrodes with the creation of an exciting electric field. 25. The apparatus according to item 13, where the specified set of electrodes is located in a two-dimensional matrix. 26. The apparatus according to item 13, where the specified control device selectively supplies electricity to the electrodes from the specified set of electrodes in order to selectively generate one of two perpendicular non-exciting electric fields. 27. The apparatus according to any one of paragraphs.13-26, where the specified control device is configured to be implanted into the stomach and attached to the wall of the stomach. 28. The apparatus according to any one of paragraphs.13-26, where the specified control device is configured to be implanted into the uterus and attached to the wall of the uterus. 29. The apparatus according to any one of paragraphs.13-26, where the specified control device is made with the possibility of implantation inside the body and outside of the LCD tract. 30. The apparatus according to any one of paragraphs.13-26, where the specified control device is made with the possibility of implantation into the body and outside of the uterus. 31. The apparatus of claim 30, wherein said control device determines the frequency of contractions in the uterus, said control device supplying electricity to said electrodes in accordance with said determined frequency. 32. The apparatus of claim 30, wherein said electrodes include elastic leads. 33. The apparatus of claim 30, wherein said electrodes are attached to a plurality of regions of said uterus. 34. The apparatus of claim 33, wherein said control device senses and inhibits mechanical activity in substantially the entire uterus. 35. The apparatus of claim 33, wherein said control device increases contraction force substantially throughout the uterus. 36. The apparatus according to any one of paragraphs.13-26, where the specified control device is located in a capsule made with the possibility of introduction into the rectum. 37. The apparatus according to any one of paragraphs.13-26, where these electrodes are made with the possibility of implantation inside the body, while the specified control device is made with the possibility of its location outside the body. 38. The apparatus of claim 37, wherein said electrodes are capable of being disconnected from said smooth muscle from outside the body. 39. An anastomotic cuff including a connecting portion for connecting two sections of the LCD tract, at least two electrodes configured to be in electrical contact with the LCD tract on either side of the cuff, and a control device that supplies electric power to the electrodes to reduce force contractions in the LCD tract near the cuff. 40. Anastamosis cuff according to § 39, where the specified control device transmits a control signal from the LCD path on one side of the cuff to the LCD path on the other side of the cuff. 41. Anastamosis cuff according to § 39, where the decrease in strength includes the suppression of electrical activity of the LC tract on the cuff. 42. An apparatus for suppressing a backward wave in the intestine, including at least one electrode for applying a non-exciting electric field suppressing the backward wave to the intestinal region, a sensor that senses the propagation of waves in the intestine, and a control device that supplies electricity to said electrode in accordance with the perceived propagating wave. 43. The apparatus of claim 42, wherein said sensor detects a backward wave. 44. An apparatus for promoting a bolus, comprising at least one first electrode for applying an electric field to the first section of the LCD tract adjacent to the indicated bolus, at least one second electrode for applying an electric field to the second section of the LCD tract, located lower from the specified bolus, and a control device that supplies electricity to at least one first electrode with the creation of a non-exciting field that increases the force of contraction in the first section and which supplies electricity gi to at least one second electrode with the creation of a non-exciting electric field that relaxes the muscle in the second section. 45. The apparatus according to item 44, including an impedance sensor for detecting the presence of a bolus in the first section of the LCD tract. 46. A method of facilitating an examination of the LC tract, in which an elongated probe having a tip is inserted inside the portion of the LC tract and applied to the portion of the LC tract adjacent to the probe tip, a non-excitation electric field that relaxes the portion of the LC tract. 47. The method according to item 46, in which inflate the plot of the LCD tract after application of the specified field. 48. An elongated probe adapted to advance in the LC tract, including an elongated body having a tip, a plurality of electrodes located at least on the tip, and a control device that selectively supplies electrical energy to the electrodes to create non-exciting electric fields that affect to smooth muscle contraction. 49. The probe of claim 48, comprising a second plurality of electrodes distributed along at least a portion of the probe body. 50. The probe of claim 48 or 49, wherein said control device supplies electric power to said first plurality of electrodes in order to cause said portion of the LC path to selectively advance or pop out said probe. 51. The probe according to claim 48 or 49, wherein said control device supplies electricity to the electrodes from said first and said second sets of electrodes to suppress the propagation of activation signals from a portion of the LC tract adjacent to the tip of the probe to other sections of the LC path. 52. The apparatus for controlling smooth muscle, which includes many individual capsules, each of which includes at least one electrode and a power source that supplies electricity to the electrode to create a local non-exciting field. 53. The apparatus according to paragraph 52, where each of these capsules includes a sensor that measures the local activity of smooth muscle. 54. The apparatus according to paragraph 52 or 53, where these capsules synchronize the supply of electricity to their electrodes without the mediation of an external control device. 55. An apparatus for treating spasms, including a flexible casing having an external portion and configured to tightly clamp it inside the uterus, a plurality of electrodes located outside the specified casing, and a control device that supplies electricity to these electrodes in order to generate a non-excitatory electric field. 56. The apparatus of claim 55, wherein said flexible body is inflated. 57. The apparatus of claim 55 or 56, comprising an electrode configured to be located outside the uterus. 58. An apparatus for setting a smooth muscle body profile of mechanical activation, including at least three electrodes made with the possibility of their distribution over the body, at least one sensor that senses the local mechanical activity of the body, and a control device that supplies electricity to the selected electrodes from these electrodes in accordance with the perceived local mechanical activity to set the body a specific activation profile. 59. The apparatus of claim 58, wherein the organ is the uterus and where the activation profile is a contraction pattern during childbirth.

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