WO2012150348A1 - Dispositif pour la stimulation électrique d'un corps et/ou d'un site neurologique - Google Patents

Dispositif pour la stimulation électrique d'un corps et/ou d'un site neurologique Download PDF

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Publication number
WO2012150348A1
WO2012150348A1 PCT/EP2012/058288 EP2012058288W WO2012150348A1 WO 2012150348 A1 WO2012150348 A1 WO 2012150348A1 EP 2012058288 W EP2012058288 W EP 2012058288W WO 2012150348 A1 WO2012150348 A1 WO 2012150348A1
Authority
WO
WIPO (PCT)
Prior art keywords
base body
electrostimulator
solenoid
component
wire
Prior art date
Application number
PCT/EP2012/058288
Other languages
English (en)
Inventor
Valerio Cigaina
Original Assignee
Valerio Cigaina
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Valerio Cigaina filed Critical Valerio Cigaina
Publication of WO2012150348A1 publication Critical patent/WO2012150348A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0507—Electrodes for the digestive system
    • A61N1/0509—Stomach and intestinal electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control

Definitions

  • 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).
  • 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.
  • 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.
  • the stimulation of these areas is used to correct some pathological decompensation conditions of the sympathetic/parasympathetic system.
  • Heart Rate Variability can also be used for early diagnosis of possible cardiovascular and/or metabolic events.
  • 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.
  • 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.
  • 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 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.
  • charge accumulators batteries, condensers, etc.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the electrostimulator component 1 comprises, from the exterior to the interior, the following components: a base body 1 1 made of biocompatible material, electrodes
  • 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.
  • the permanent magnet 9 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • the electrostimulator component 1 comprises, from the exterior to the interior, the following components: a base body 1 1 made of biocompatible material, electrodes
  • 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 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.
  • 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.
  • the sharp end 25 of the containing body 2 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.
  • 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un dispositif pour la stimulation électrique d'un corps et/ou d'un site neurologique, comprenant un composant électrostimulateur ayant un corps de base (11) ayant des électrodes externes (5) pour une stimulation électrique et en tant que partie intégrante du corps (11)de base, un moyen (20) pour l'implantation de celui-ci, par endoscopie, à l'intérieur de l'épaisseur de la paroi de l'estomac, le moyen d'implantation (20) ayant un corps (2) qui comporte deux enveloppes pour contenir le corps de base (11).
PCT/EP2012/058288 2011-05-05 2012-05-04 Dispositif pour la stimulation électrique d'un corps et/ou d'un site neurologique WO2012150348A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000757A ITMI20110757A1 (it) 2011-05-05 2011-05-05 Dispositivo per la elettrostimolazione di una sede corporea e/o neurologica
ITMI2011A000757 2011-05-05

Publications (1)

Publication Number Publication Date
WO2012150348A1 true WO2012150348A1 (fr) 2012-11-08

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Application Number Title Priority Date Filing Date
PCT/EP2012/058288 WO2012150348A1 (fr) 2011-05-05 2012-05-04 Dispositif pour la stimulation électrique d'un corps et/ou d'un site neurologique

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IT (1) ITMI20110757A1 (fr)
WO (1) WO2012150348A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMI20131992A1 (it) * 2013-11-28 2015-05-29 Valerio Cigaina Assieme comprendente un dispositivo per elettroneuromodulazione totalmente impiantabile ed uno strumento di impiantazione di detto dispositivo
CN110897609A (zh) * 2019-11-13 2020-03-24 袁红斌 联合刺激的痛觉测试装置

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1004267A2 (fr) * 1998-11-26 2000-05-31 Valerio Cigaina Dispositif d'implantation pour enregistrement interieur-exterieur électromyographique en particulier d'étude invivo d'activitté à moteur électrique du système digestif
US20020165589A1 (en) * 2001-05-01 2002-11-07 Imran Mir A. Gastric treatment and diagnosis device and method
WO2002089655A2 (fr) * 2001-05-01 2002-11-14 Intrapace, Inc. Dispositif et procede d'implantation dans la sous-muqueuse gastrique
WO2007080595A2 (fr) * 2006-01-12 2007-07-19 Metacure N.V. Ensembles d'électrodes, outils et procédés pour une implantation sur une paroi gastrique

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1004267A2 (fr) * 1998-11-26 2000-05-31 Valerio Cigaina Dispositif d'implantation pour enregistrement interieur-exterieur électromyographique en particulier d'étude invivo d'activitté à moteur électrique du système digestif
US20020165589A1 (en) * 2001-05-01 2002-11-07 Imran Mir A. Gastric treatment and diagnosis device and method
WO2002089655A2 (fr) * 2001-05-01 2002-11-14 Intrapace, Inc. Dispositif et procede d'implantation dans la sous-muqueuse gastrique
WO2007080595A2 (fr) * 2006-01-12 2007-07-19 Metacure N.V. Ensembles d'électrodes, outils et procédés pour une implantation sur une paroi gastrique

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMI20131992A1 (it) * 2013-11-28 2015-05-29 Valerio Cigaina Assieme comprendente un dispositivo per elettroneuromodulazione totalmente impiantabile ed uno strumento di impiantazione di detto dispositivo
WO2015079005A1 (fr) * 2013-11-28 2015-06-04 Valerio Cigaina Ensemble comprenant un dispositif entièrement implantable d'électroneuromodulation et instrument d'implantation dudit dispositif
US10441799B2 (en) 2013-11-28 2019-10-15 Valerio Cigaina Set comprising a totally implantable device for electroneuromodulation and an implantation tool of said device
CN110897609A (zh) * 2019-11-13 2020-03-24 袁红斌 联合刺激的痛觉测试装置
CN110897609B (zh) * 2019-11-13 2023-10-03 上海长征医院 联合刺激的痛觉测试装置

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Publication number Publication date
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