WO2012150348A1

WO2012150348A1 - Device for electrical stimulation of a body and/or neurological site

Info

Publication number: WO2012150348A1
Application number: PCT/EP2012/058288
Authority: WO
Inventors: Valerio Cigaina
Original assignee: Valerio Cigaina
Priority date: 2011-05-05
Filing date: 2012-05-04
Publication date: 2012-11-08
Also published as: ITMI20110757A1

Abstract

The device for the electrical stimulation of a body and/or neurological site comprises an electrostimulator component having a base body (11) with external electrodes (5) for electrical stimulation, and as an integral part of the base body (11) a means (20) for the implantation thereof, through endoscopy, inside the wall thickness of the stomach, the implantation means (20) having a body (2) with two shells for containing the base body (11).

Description

DEVICE FOR ELECTRICAL STIMULATION OF A BODY AND/OR NEUROLOGICAL SITE

DESCRIPTION

The present invention refers to a device for the electrical stimulation of a body and/or neurological site.

The field of electrical stimulation of tissue has recently been broadened to include devices that electrically stimulate many organs, both intra- and extra-abdominal, by means of electrodes implanted in tissue.

The electrical connection between the pulse generator and the electrodes implanted in the body organ or tissue can be achieved by means of one or more wires defined as electro catheters (leads).

Several studies have recently pointed out that electrical stimulation of the stomach is effective against obesity, gastroesophageal reflux, arterial hypertension, type 2 diabetes, depressive syndrome and also psoriasis, all being pathologies characterized by a hypertonus of the orthosympathetic system.

Scientific research is engaged in the effort to comprehend the operating mechanisms, and the areas, of electrical stimulation in the modulation of the Autonomic Nervous System in the pathological processes associated with an imbalance thereof.

A prestigious publication (Gene-Jack Wang) describes the modifications that are detectable in some cerebral areas, mapped by brain imaging, in patients who have undergone electrical stimulation of the stomach.

This discovery reinforces the concept that the stomach should not be considered the intended site for stimulation, but rather a means through which to send information to the Central Nervous System (by means of encoded electrical pulses applied to the gastric wall and to the nervous fibres contained therein), the true final recipient. As in the case of the stomach, it is hoped that there are also other sites for stimulation that can be utilized for this purpose, in other areas of the human body.

The stimulation of these areas is used to correct some pathological decompensation conditions of the sympathetic/parasympathetic system.

The regulation of all electrical stimulation devices serving for the purpose of correcting such decompensation, is based on cardiac variability.

These data on cardiac variability, also called Heart Rate Variability (HRV), can also be used for early diagnosis of possible cardiovascular and/or metabolic events. All electrical stimulators or "pacemakers" currently in use, for gastric stimulation and for stimulation of the intra-abdominal organs and of other neurological tissue, require one or more electro catheters differing in shape and dimensions, connecting the apparatus and the organ or the tissue targeted for stimulation, as well as a battery as a source of electric energy for the stimulation.

The shape of the stimulator forces the surgeon to make an incision that is visible on the skin of the abdomen or another body site, and needed so as to create the subcutaneous pocket in which to house the stimulator.

Clinical experience has shown that the presence of the subcutaneous pocket and that of the electro catheter may be the cause of technical problems during the course of the therapy.

In particular, there are various drawbacks regarding electro catheters owing to the possibility of breakage, dislocation, and penetration thereof, to erosion and/or perforation of the organ at the point of insertion, increased duration of anaesthesia and surgery attributable to the procedures required for anchoring it to the tissue, to the risk of it bending or pinching near the pacemaker or of it twisting around surrounding organs.

As regards the pulse generator that is located inside a subcutaneous pocket, it can affect or obstruct normal movement of the patient, be rejected, undergo trauma- related damage resulting in lesions of the overlying skin and thus have to be removed prematurely, prove to be unsightly in that it becomes visible at a stage of advanced weight loss or makes the abdominal insertion scar visible, prolong the duration of time under general anaesthesia and the duration of surgical implantation procedures, and increase the duration of surgery. Moreover, upon depletion of the battery, it must be replaced, which requires another surgical operation.

The technical task of the present invention is thus to realize a device for the electrical stimulation of a body and/or neurological site that makes it possible to overcome the above-described technical drawbacks of the totally implantable stimulators of the prior art.

Within the scope of this technical task, an aim of the invention is to realize a device for the electrical stimulation of a body and/or neurological site that overcomes the drawbacks related to the presence of a subcutaneous pocket for emplacement therein and to the presence of one or more electro catheters.

Another aim of the invention is to realize a device for the electrical stimulation of a body and/or neurological site that overcomes the drawbacks related to the presence of a stimulator requiring periodic charging or replacement owing to depletion of the battery, as yet the sole source of the energy required for the stimulation.

A further aim of the invention is that of realizing a device for the electrical stimulation of a body and/or neurological site that overcomes the drawbacks related to the necessity of a surgical operation for the installation thereof and to the complications and marks on the skin resulting therefrom.

The technical task, as well as these and other aims, of this invention are achieved by realizing a device for the electrical stimulation of a body and/or neurological site according to claim 1.

The device for the electrical stimulation of a body and/or neurological site is equipped with an electrostimulator component possibly coupled with charge accumulators (batteries, condensers, etc.) and/or with various electronic circuits, microchips and micro devices for data storage and/or transmission.

The electrostimulator component can be entirely implanted through endoscopy or have a part not implanted through endoscopy that is autonomous and external to the base body, and suitable for interacting with a part positioned inside the base body. In this case, the autonomous external part can be used autonomously by the patient, and it is capable of amplifying and/or rendering even more effective the stimulation.

The electrostimulator component may be of a magnetic type with mechanical movement, with ultrasonic waves capable of exciting piezoelectric systems or with magnetic fields varying in intensity and duration.

In all cases, the electrostimulator component may be controlled by computerized systems that may also be incorporated therein, suitable for establishing precise and more effective stimulation, being based on the calculation of variables introduced by an external operator or collected autonomously by the apparatus.

Preferably, the electrostimulator component is capable of collecting information concerning the heart rate and/or heart rate variability of the patient and sending it to an external device, with the objective of defining better stimulation parameters and permitting the patient's physician to have data so as to arrive at all diagnoses that are also or solely based on the heart rate and/or heart rate variability data of the patient.

Other characteristics of the present invention are defined further in the claims herein below.

Further characteristics and advantages of the invention will become more apparent from the description of preferred, but not exclusive, embodiments of the device for the electrical stimulation of a body and/or neurological site according to the invention, as illustrated by way of approximate and non-limiting example in the accompanying drawings, wherein:

Figure 1 is a front view from the outside of only the electrostimulator component of the device for the electromechanical stimulation of a body and/or neurological site according to the invention;

Figure 2 is a longitudinal section of the electrostimulator component according to a first preferred mode of realization of the invention;

Figure 3 is a longitudinal section of the electrostimulator component according to a second preferred mode of realization of the invention;

Figure 4 is a longitudinal section of the electrostimulator component according to a third preferred mode of realization of the invention;

Figure 5 is a longitudinal section of the electrostimulator component according to a fourth preferred mode of realization of the invention;

Figure 6 shows the wire with which the base body is supplied so as to facilitate extraction of the electrostimulator component;

Figure 7 shows the device, which is the subject matter of the invention, with the sequence of steps of the procedure for implantation of the electrostimulator component.

With reference to the figures cited, a device for the electromechanical stimulation of a body and/or neurological site 12 is illustrated.

The device comprises an electrostimulator component 1 having a base body 1 1 with external electrodes 5 for electrical stimulation.

The salient aspect of the invention consists in the fact that the device provides, as an integral part of the base body 11 of the electrostimulator component 1 , a further component acting as a means 20 for the implantation of the base body 11 of the electrostimulator component 1 , through endoscopy, inside the wall thickness of the stomach.

The implantation means 20 has a body 2 with two shells for containing the base body 1 1.

With reference to the preferred mode of realization illustrated in Figure 2, the electrostimulator component 1 comprises, from the exterior to the interior, the following components: a base body 1 1 made of biocompatible material, electrodes

5 isolated from the base body 11 by means of rings 7 made of isolating material, a wire 6 anchored to one end of the base body 11, a cylindrical tube 10 in the thickness of which a solenoid 8 is incorporated, a permanent magnet 9 freely sliding inside the cylindrical tube 10, springs 13 applied on the internal side of caps 21 for closure of the bases of the cylindrical tube 10 so as to facilitate movement of the magnet 9, and connecting wires 14 needed for the transmission of current between the various components.

The solenoid 8 consists of windings made of material with high electrical conductivity and it is connected by means of the connecting wires 14 to the electrodes 5.

Passing through the solenoid 8, during oscillation, the permanent magnet 9 produces an electrical current in the solenoid 8 and, through the electrodes 5, the current is transmitted to the surrounding biological tissues with characteristics relating to duration, amplitude, frequency and power being compatible with the neurobiological needs of the patient undergoing the stimulation.

With reference to the preferred mode of realization illustrated in Figure 3, the electrostimulator component 1 comprises, from the exterior to the interior, the following components: a base body 1 1 made of biocompatible material, electrodes 5 isolated from the base body 11 by means of rings 7 made of isolating material, a wire 6 anchored to one end of the base body 11, a cylindrical tube 10 in the thickness of which a solenoid 8 is incorporated, and connecting wires 14 needed for the transmission of current between the various components.

In this case, the electrostimulator component 1 comprises a part that is autonomous and external to the base body 11, and suitable for interacting with the solenoid 8.

The autonomous part of the electrostimulator component 1 is a variable magnetic field generator that excites the solenoid 8 in such a manner that the current produced is transmitted, through the electrodes 5, to the surrounding biological tissues with characteristics relating to duration, amplitude, frequency and power compatible with the neurobiological needs of the patient undergoing the stimulation.

The autonomous part of the electrostimulator component 1 can be worn by the patient, for example it can be worn in a belt to be tied around the waist of the patient.

With reference to the preferred mode of realization illustrated in Figure 4, the electrostimulator component 1 comprises, from the exterior to the interior, the following components: a base body 1 1 made of biocompatible material, electrodes 5 isolated from the base body 11 by means of rings 7 made of isolating material, a wire 6 anchored to one end of the base body 11, a cylindrical tube 10 in the thickness of which a solenoid 8 is incorporated, a permanent magnet 9 freely sliding inside the cylindrical tube 10, springs 13 applied on the internal side of caps 21 for closure of the bases of the cylindrical tube 10 so as to facilitate movement of the magnet 9, and connecting wires 14 needed for the transmission of current between the various components.

In this case, the electrostimulator also comprises an accumulator of electric energy 16 (battery, condenser, etc.) and an integrated electric circuit 15.

The solenoid 8 consists of windings made of material with high electrical conductivity and it is connected by means of the connecting wires 14 to the integrated circuit 15.

Passing through the solenoid 8, during oscillation, the magnetic material 9 produces an electrical current in the solenoid 8 and, through the connecting wires

14, the current is transmitted to the integrated circuit 15, which manages it in a manner suited to the purpose of charging or maintaining the charge of the electric energy accumulator 16. The electric energy for the stimulation is taken from the electric energy accumulator 16 to be transmitted to the surrounding biological tissues with characteristics relating to duration, amplitude, frequency and power compatible with the neurobiological needs of the patient undergoing the stimulation, and managed and regulated by the integrated circuit 15.

With reference to the preferred mode of realization illustrated in Figure 5, the electrostimulator component 1 comprises, from the exterior to the interior, the following components: a base body 1 1 made of biocompatible material, electrodes

5 isolated from the base body 11 by means of rings 7 made of isolating material, a wire 6 anchored to one end of the base body 11, a cylindrical tube 10 in the thickness of which a solenoid 8 is incorporated, and connecting wires 14 needed for the transmission of current between the various components.

In this case, in addition to the part inside the base body 11, represented by the solenoid 8, by an integrated circuit 15 and by an accumulator 16, the electrostimulator component 1 comprises a part that is autonomous and external to the base body 11, and suitable for interacting with the solenoid 8.

The electric energy is generated in the solenoid 8 by means of a variable magnetic field coming from the autonomous part of the electrostimulator component 1 , and transmitted to the integrated circuit 15, which manages it in a manner suited to the purpose of charging or maintaining the charge of the electric energy accumulator 16. The electric energy for the stimulation is taken from the electric energy accumulator 16 to be transmitted to the surrounding biological tissues with characteristics relating to duration, amplitude, frequency and power compatible with the neurobiological needs of the patient undergoing the stimulation, and managed and regulated by the integrated circuit 15.

The component portion illustrated in Figure 6 refers to the end part of the wire 6; this portion is equipped with a rigid end 19, which is hinged to the end part of the wire 6. After the implant step, during which the wire 6 and the end 19 thereof are contained in the semi-rigid sheath 17; the wire 6 and the end 19 thereof lie freely inside the stomach. During the stage consisting of the extraction of the base body

11, the end 19 will allow the gastroscopic device utilized to hook firmly onto the wire 6 so as to produce more effective traction for the actual extraction.

The means 20 for implantation in the tissue 12, through endoscopy, consists of a containing body 2 with two shells and that can be activated by means 3 for opening and closing, which can be controlled externally through remote controls contained in the operating channel 4; the wire 6 that is part of the device is instead contained in the semi-rigid sheath 17, which is also contained in the operating channel 4.

Penetration in the tissue is made possible by the sharp end 25 of the containing body 2, the sharp end 25 being covered by the spherical safety element 18 until it reaches the implant site so as not to damage other tissues in the stage consisting of introduction from the oral cavity. Prior to penetration of the tissue 12, the spherical safety element 18 is dropped and subsequently expelled from the body spontaneously. Following sufficient penetration of the containing body 2 into the tissue 12, the containing body 2 is opened thanks to the means for opening 3 controlled by the remote controls contained in the operating channel 4; the base body 11 is then pushed inside the tissue 12 by means of the semi-rigid sheath 17, while the implantation means 20 is withdrawn from the tissue 12 by means of traction that the operator carries out on the operating channel 4. Following the extraction of the implantation means 20 from the tissue 12, the semi-rigid sheath 17 is also withdrawn; this procedure is performed in this order so as to avoid the risk of the base body 11 coming back out of the tissue 12 along with the implantation means 20.

Once implantation has been completed, the base body 11 lies completely inside the tissue 12, while the wire 6 passes through the wall, lying outside of the tissue 12. More specifically, the electrostimulator component of the device modulates the autonomic nervous system, particularly the sympathetic/parasympathetic balance, through electromechanical stimulation of the neuromuscular tissue of the stomach and the digestive system, obtained by administering electrical pulses generated by the pulse generator.

The electrostimulator component is designed for the purpose of ensuring the production of output parameters of the electrical stimulation based on the characteristics of the autonomic response of the subject being treated. The personalized electrical stimulation parameters permit utilization of the most effective stimulation to modulate the autonomic system, that is to say, the Sympathetic/Parasympathetic ratio.

The base body 11 has a functional form for the implantation; in this particular case, it has a side boundary wall that is cylindrical in shape and with rounded bases, both being functional for introduction into the stomach through the oral cavity with a gastroscope (thereby avoiding any type of scar on the abdominal skin) for stable positioning in the thickness of the gastric wall without any possibility of movement thereafter.

Once it is inserted into the gastric wall, the base body 11 then remains in place owing to the shape and the finish of the surface, and also owing to the spontaneous closure of the gastric mucosa in the step shortly after implantation. The only element of the base body 11 that remains visible inside the stomach is the wire 6, which will be used in the event of removal of the base body 11 to apply traction thereto; extraction of the base body 11 is also carried out through endoscopy, by means of a gastroscope equipped in a manner that is functionally suited to the purpose, with apparatuses morphologically suited for hooking onto the wire 6 remaining in the stomach. The wire 6 remaining within the gastric lumen does not involve problems or changes affecting the functioning of the digestive system.

In the case where the electrostimulator component 1 is totally implantable, owing to the presence of the generator inside the system, with the peristaltic movements of the stomach, with the vibrations of vascular and visceral arterial pulsatility and body movement (ambulation or running), the production of the electric energy necessary for the stimulation and functioning of the electrostimulator component 1 of the device is ensured. The stimulation is not guaranteed solely by the electrical pulses, but also by the slight vibration of the oscillating system and by the intraparietal mechanical component of the object itself.

The base body 11 does not require implantation at the level of the subcutaneous tissue and it does not have an electro catheter, thus eliminating all the problems arising from the presence thereof.

The electrostimulator component 1 also ensures long-term autonomy and duration given that it does not require battery replacement, as it is able to have autonomous production of electric energy.

The electrostimulator component 1 generates a voltage pulsed stimulus with a voltage squared wave having a voltage value comprised between 0.04 and 1.5 Volts, preferably between 0.3 and 1 Volt, a duration of the single pulse comprised between 50 and 250 microseconds, preferably equal to 180 microseconds, and a pulse frequency comprised between 4 and 10 Hz, preferably equal to 5 Hz.

The application plan varies from one patient to another, but the best results have been seen with a therapy cycle of a total of 24 hours, preferably carried out by activating the stimulation for a time comprised between 0.5 and 2 seconds, and deactivating it for a time comprised between 3 and 20 seconds.

The device for the electrical stimulation of a body and/or neurological site as conceived herein is susceptible to numerous modifications and variants, all falling within the scope of the inventive concept; moreover, all the details are replaceable by technically equivalent elements. The materials used, as well as the dimensions, may in practice be of any type according to requirements and the state of the art.

Claims

1. A device for the electrical stimulation of a body and/or neurological site comprising an electrostimulator component (1) having a base body (11) with external electrodes (5) for electrical stimulation, characterized in that it provides, as an integral part of said base body (11), implantation means (20), through endoscopy, of the base body (11) inside the wall thickness of the stomach, said implantation means (20) having a body (2) with two shells for containing said base body (11).

2. The device according to claim 1, characterized in that said base body (11) has a functional configuration for both its positioning inside said implantation means (20) and stable maintaining of the position of said implantation means (20) inside the wall thickness of the stomach.

3. The device according to the preceding claim, characterized in that said electrodes (5) are integrated and electrically isolated in said base body (11) made of biocompatible material.

4. The device according to the preceding claim, characterized in that said base body (11) has a side wall of cylindrical shape and rounded bases.

5. The device according to the preceding claim, characterized in that a wire (6) is connected to one base of said base body (1 1), said wire (6) extending outside the base body (11) and being able to be hooked for the endoscopic removal of the base body (11)..

6. The device according to the preceding claim, characterized in that a rigid end

(19) is fulcred to the end of the wire (6) external to the base body (11), said rigid end (19) being able to be hooked for the endoscopic removal of the base body (11)..

7. The device according to any preceding claim, characterized in that inside the base body (11) at least one electrical solenoid (8) connected to said electrodes (5) is present..

8. The device according to the preceding claim, characterized in that said electrostimulator component (1) has a source for excitation of the solenoid (8) positioned inside the base body (11) and comprising at least one permanent magnet (9) freely sliding inside the solenoid (8)..

9. The device according to claim 7, characterized in that said electrostimulator component (1) has a source for excitation of the solenoid (8) external to said base body (11)..

10. The device according to any of claims 7 to 9 , characterized in that said solenoid (8) is connected to an electric energy accumulator (16) and to an integrated electric circuit (15) contained inside the base body (11).

11. The device according to one or more of the previous claims, characterized in that it has means for the collection and /or sending of information relating to heart rate and heart rate variability.

12. The device according to any preceding claim characterized in that said implantation means (20) comprises means (3) for opening and closing the containing body (2) with two shells, which, in turn, is provided with a sharp end (25) for its penetration inside the wall thickness of the stomach.

13. The device according to the preceding claim, characterized in that an operating channel (4) is associated with the end of said containing body (2) opposite the sharp end (25), said operating channel (4) containing said means (3) for opening and closing the containing body (2) and a semi-rigid containing sheath of the wire (6)..

14. The device according to any of claims 12 and 13, characterized in that said containing body (2) has an internal shape conjugated to the external shape of the base body (11)..

15. The device according to any preceding claim, characterized in that it creates a voltage pulsed stimulus with a voltage squared wave having a voltage value comprised between 0.04 and 1.5 Volts, a duration of the single pulse comprised between 50 and 250 microseconds and a pulse frequency comprised between 4 and 10 Hz.