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Title:
MEDICAL WORK STATION FOR ELECTRICAL THERAPIES
Document Type and Number:
WIPO Patent Application WO/2015/052641
Kind Code:
A1
Abstract:
The present invention concerns a medical work station for electrical therapies characterised in that it comprises : - at least one electrocatheter (10, 110) or an electroneedle able to be inserted in the body of a patient and able to be supplied with electricity to carry out at least one electrical therapy, - at least two testing systems (90, 91) of the positioning of the electrocatheter or of the electroneedle in the body of the patient; - the first testing system (91) comprises at least one display device (74) capable of displaying at least one image (73A) of the position of the electrocatheter or electroneedle in the body of the patient; - the second testing system (90) comprises at least one device for generating testing current (20, 120) capable of selectively generating a plurality of electrical testing stimuli of different magnitudes from each other.

Inventors:
PARI GILBERTO (IT)
Application Number:
PCT/IB2014/065102
Publication Date:
April 16, 2015
Filing Date:
October 07, 2014
Export Citation:
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Assignee:
PARI GILBERTO (IT)
International Classes:
A61N1/372
Domestic Patent References:
WO2006084194A22006-08-10
Foreign References:
US20090254134A12009-10-08
US20130053926A12013-02-28
US20080119737A12008-05-22
Other References:
None
Attorney, Agent or Firm:
BUSCA, Andrea (Via Valle 20, Montecolombo, IT)
Download PDF:
Claims:
CLAIMS

1. Medical work station for electrical therapies characterised in that it comprises:

- at least one electrocatheter (10, 110) or an electroneedle able to be inserted in the body of a patient and able to be supplied with electricity to carry out at least one electrical therapy,

- at least two testing systems (90, 91) of the positioning of the electrocatheter or of the electroneedle in the body of the patient;

the first testing system (91) comprises at least one display device (74) capable of displaying at least one image (73A) of the position of the electrocatheter or electroneedle in the body of the patient ;

the second testing system (90) comprises at least one device for generating testing current (20, 120) capable of selectively generating a plurality of electrical testing stimuli of different magnitude from each other.

2. Work station according to claim 1, characterised in that the display device (74) belongs to both of the systems (90, 91) , being able to display both the position image (73A) and at least one piece of information relating to the testing stimulus (73B, 60, 73C, 62) .

3. Work station according to claim 2, characterised in that the image (73A) and the piece of information (73B, 60, 73C, 62) can be displayed simultaneously .

4. Work station according to any one of the previous claims, characterised in that the second system comprises a feedback positioning testing device, wherein there is a reading device (20, 120) of a response to said testing stimulus.

5. Work station according to the previous claim, characterised in that said reading device (20, 120) is able to quantify the magnitude of the response to the stimulus with at least one parameter (60) .

6. Work station according to the previous claim, characterised in that the second system is able to relate at least one parameter of the stimulus (62) to at least one parameter of the response (60) to process at least one target reached and/or begin therapy signal.

7. Work station according to any one of the previous claims, characterised in that the generator device (20, 120) is also able to generate a therapy current, the delivery of the therapy current and of the testing current to the patient being selectively activatable, one excluding the other.

8. Work station according to the previous claim, characterised in that the stimulus current is comprised in the following parameters [0.01, 10] V and [1, 100] mA, and the therapy current is in the field of radiofrequency and/or microwaves and/or in a higher field.

9. Work station according to any one of the previous claims, characterised in that the first testing system comprises at least one from: ultrasound scanner, Computed Axial Tomography (CAT) apparatus, Nuclear magnetic resonance (NMR) apparatus, Standard Radiology apparatus .

10. Work station according to any one of the previous claims, characterised in that it comprises at least one printing device (75) through which said work station is able to print at least two types of information (73A, 73B, 73C) displayed on said display device .

11. Work station according to any one of the previous claims, characterised in that it comprises at least one pedal control for modulating the supply current of the electrocatheter or of the electroneedle (86) .

12. Work station according to claim 11, characterised in that it comprises a pedal control for sending a stimulus signal to the electrocatheter or to the electroneedle (85) for controlling its correct positioning .

13. Work station according to any one of claims 11 to 12, characterised in that there are a plurality of pedal controls (80) and the modulating pedal control (86) is arranged so as to be able to be actuated with the right foot.

14. Work station according to any one of the previous claims, characterised in that all of the functions of the work station are controlled through pedal controls (80) and/or digital, and/or vocal and/or ocular controls.

15. Work station according to any one of the previous claims, characterised in that an electrical connection area (20) between a plurality of its parts is associated with an operating table (88) intended to receive a patient (66) .

Description:
Title: Medical work station for electrical therapies.

* * * * *

DESCRIPTION

The present invention concerns a medical work station for electrical therapies . By electrical therapies we mean all therapies carried out by administering electrical current to the patient. The present invention has been developed with particular reference to electrostimulation therapies of the nervous system, for example through radio frequency electrical stimuli, however we do not rule out other types of therapies, including possible future electrical therapies that do not produce voluntary lesions of the nervous system. The invention is particularly suitable for stimulating the central nervous system (hereafter for the sake of brevity called CNS), however, in addition or alternatively, this does not rule out other applications, like for example the stimulation of the peripheral nervous system (hereafter for the sake of brevity called PNS ) . The present invention has also been developed with particular reference to the stimulation of the nervous system of human beings, the anatomy of which will be referred to for the sake of simplicity, however this does not rule out its application to any other living or non-living being, equipped with a nervous system. The present invention also concerns a process for controlling the correct positioning of the apparatus.

Hereafter we will refer for the sake of simplicity to the electrostimulation of the nervous system, without however excluding the other applications.

In the field of electrostimulation of the CNS it is normal to use electrocatheters , i.e. catheters equipped with electrodes, capable of being inserted into the spinal column of an individual and of reaching the spinal root/ganglion complex through the epidural space. Their task is to electrically stimulate such a complex according to what is established by a predetermined therapeutic procedure. Other applications of electrostimulation are known at the level of the PNS .

The steps of the intervention foresee preliminarily to send the patient to the radiology department to map their bone anatomy. Thereafter, the doctor studies the radiographs and then plans the actual operation, which foresees to penetrate into the spinal column of the patient with the catheter (or in other points in the case of other applications) based on the indications of the radiographs.

The correct positioning is thus determined solely by the ability of the doctor to use the information given by the radiographs . In order to check that the electrode is actually positioned at the desired target, "paraesthesia" is used, i.e. electrical testing stimulations are sent and the patient is asked to tell the doctor when he feels a predetermined sensation.

The effectiveness of such a testing procedure is quite uncertain and causes numerous failures of the subsequent therapy steps. Indeed, the level of sensitivity, and therefore of accuracy, varies from patient to patient based on personal and non-ob ective characteristics. Moreover, the electrical testing stimulation is at the doctor' s discretion, and therefore it could be of a magnitude such as to still provide a response of the patient even when the positioning is poor. This also places the well-being of the subject at risk, since the testing stimulus could not be of the physiologically correct magnitude.

A general purpose of the present invention is therefore to completely or partially solve the problems of the prior art.

A preferred purpose of the present invention is that of allowing faster and more efficient management of interventions .

Another preferred purpose of the present invention is to allow multiple testing of the correct positioning of the electrostimulation apparatus.

A further preferred purpose of the present invention is to allow the doctor to collect data during the intervention.

Another further preferred purpose of the invention is to allow electrical therapies to be carried out with fewer personnel.

According to a first general aspect the present invention concerns a medical work station for electrical therapies characterised in that it comprises:

at least one electrocatheter or an electroneedle able to be inserted in the body of a patient and able to be supplied with electricity to carry out at least one electrical therapy,

- at least two testing systems of the positioning of the electrocatheter or of the electroneedle in the body of the patient;

- the first testing system comprises at least one display device capable of displaying at least one image of the position of the electrocatheter or electroneedle in the body of the patient;

- the second testing system comprises at least one device for generating testing current capable of selectively generating a plurality of testing stimuli of different magnitudes from each other. Thanks to the invention the positioning of the electrocatheter and/or electroneedle can be much more precise than previously, since after a first positioning by visual means, it is possible to refine the positioning by electrical and/or electronic means.

For example it is possible to implement a refinement procedure of the positioning of the electrocatheter or electroneedle in which initially a predetermined stimulus is applied, and if a response is not obtained from the patient the electrocatheter or electroneedle is repositioned until a response is obtained, and after a response has been obtained one or more stimuli are applied in succession, each of a smaller magnitude than the last, each time the electrocatheter or electroneedle is possibly repositioned until a response to the stimulus is obtained from the patient before moving on to a subsequent lesser stimulus. The procedure ends when a response is obtained with a predetermined minimum stimulus. The responses can be of any kind, like feedback spoken by the patient himself of a perceived sensation, i.e. through paraesthesia, or they can be more complex like a printout that indicates that the objective has been reached, relating at least the reading of the actual response to the magnitude of the stimulus, and possibly to the response time. The operator is able at every stimulation step to move on to the next one by selecting a lower stimulus in the generator device.

It should be observed that the operator, thanks to the adjustment of the stimulus, is also able to work out whether he is getting closer to or moving away from the objective, so that he is able to decide in what direction to move the electrocatheter or electroneedle . The apparatus is thus able to give feedback also on movement away.

Preferably, the display device belongs to both of the systems, being able to display both the position image and at least one piece of information relating to the testing stimulus. In this way, the operator has a work station that is more practical to use.

In this case, it is even more preferable for the information to be able to be displayed simultaneously, so as to allow a direct human comparison between the results of the two positionings .

According to some preferred embodiments of the invention the second system comprises a feedback positioning testing device, where there is a reading device of a response to said testing stimulus.

In this case it is preferable for said reading device to be able to quantify with at least one parameter the magnitude of the response to the stimulus.

Even more preferably the second system is able to relate at least one parameter of the stimulus to at least one parameter of the response to process at least one signal of target reached and/or of start therapy.

In general, the generator device is preferably capable of also generating a therapy current, where preferably the delivery to the patient of the therapy current and of the testing current are selectively activatable, one excluding the other.

As an example, the stimulus currents could be comprised in the following parameters [0.01, 10] V and [1, 100] mA, whereas the therapy currents could be currents with higher parameter values. In any case, it should be noted that currently the therapy currents are in the field of radio frequency, but this does not rule out future applications in which they are in the field of microwaves or higher. A current concrete example is that in which the therapy currents, unlike the stimulus currents, are currents that produce micro-lesions of the nervous system.

In general, it should be observed that the first testing system preferably comprises at least one from: ultrasound scanner, Computed Axial Tomography apparatus (CAT) , Nuclear magnetic resonance apparatus (NMR) , Standard radiology apparatus.

According to another general preferred characteristic of the invention, the work station is able to print at least part of an image displayed by said display device.

This advantageously makes it possible to compose and store important data on the outcome of the intervention for medical reports.

For example, it is preferable for the display device to simultaneously display at least one type of testing information (73A, 73B, 60) relating to each of the two testing systems and for the printing system to be able to print at least said two pieces of information, where preferably said two pieces of information are printed in a single printout so as to provide a valid document recognising the correct positioning. For example, the two types of information are printed on a single sheet and preferably are the image provided by the ultrasound scanner device and the reading of the response to the stimulus signal. More preferably, the printout also represents the stimulus signal, for example reproducing the complete display that appears on the display device.

Of course, this does not rule out the possibility of the printout not faithfully reproducing the image displayed but only the information contained in it, for example by extrapolation.

According to another further general preferred characteristic of the invention, the work station comprises at least one pedal control for modulating the supply current of the electrocatheter or of the electroneedle .

This advantageously is ergonomic and practical for the operator, who can thus simultaneously use both hands to operate, for example by grasping the ultrasound scanner in one hand and the electrocatheter in the other.

According to some preferred embodiments the work station comprises a pedal control for sending a stimulus signal to the electrocatheter or to the electroneedle for testing its correct positioning.

In this case it is preferable, for reasons of ergonomics and practicality of use, for the pedal control for modulating and the pedal control for stimulus to be distinct controls and for the former to be arranged to the right of the latter.

In general, it is preferable for there to be a plurality of pedal controls and for the pedal control for modulating to be arranged so as to be able to be actuated with the right foot.

According to yet another general preferred characteristic of the invention, all of the functions of the work station are controlled by pedal controls and/or digital, and/or vocal and/or ocular controls. This can, for example, include a plurality of the following functions: an emergency stop function, a blocking function of the image on the screen of the display device, a print function of the image on the screen, a send testing stimulus function, a function of modulating the supply current of the electrocatheter.

According to some preferred embodiments, the work station comprises an electrical connection area, a plurality of its parts being associated to an operating table intended to receive a patient.

For example, such an area is arranged below or at the side of it, and indeed these points have proven to allow the connection of all of the parts without causing particular obstruction to the operator in carryout out the intervention.

Beneath and/or at the side of the operating table there can be a pedal system for controlling one or more functions of the work station, while there can be a seat positioning in front of it.

Further characteristics and advantages of the present invention will become clearer from the following detailed description of preferred embodiments thereof, made with reference to the attached drawings and given for indicating and not limiting purposes. In such drawings :

figure 1 schematically represents a medical work station for electrostimulation of the nervous system according to the present invention;

- figure 2 schematically represents the apparatus for electrostimulation of the nervous system belonging to the work station of figure 1 ;

- figure 3 schematically represents an exploded view of the apparatus of figure 1 ;

figures 4 and 5 schematically represent respective enlarged details of the apparatus of figure 1 ;

figures 6 and 7 schematically represent two steps of use of the apparatus of figure 1.

figure 8 schematically represents an alternative embodiment of the work station of figure 1.

With reference to the diagram of figure 1, a medical work station according to the present invention is shown, wholly indicated with reference numeral 92. It comprises an apparatus for electrostimulation of the nervous system 1, an ultrasound scanner device 72, a display device 74, a printing device 75 and a control pedal system 80, operatively connected to one another.

The electrostimulation apparatus 1 comprises a electrocatheter 10 intended to be inserted in the body of a patient 66 and supplied with electric current.

The ultrasound scanner device 72 is able to be active at least during the insertion step of the electrocatheter 10 in the patient, giving a corresponding image on the display device 74.

The display device 74 comprises a screen 73 preferably divided into many windows, or a plurality of screens. Hereafter, for the sake of simplicity, we will refer to a display by windows, however this does not rule out displaying on distinct screens or a combination of the two displays.

In a first window 73A the image detected by the ultrasound scanner device 74 is displayed.

The screen 73 and the ultrasound scanner device can thus be considered a first visual testing system 91 of the correct positioning of the electrocatheter 10.

A second window 73B preferably displays the response 60 to an electrical stimulus for testing the correct positioning of the electrostimulation apparatus, for example such a response is in the form of a graphical translation of an electrical signal or impulse.

The screen 73 is then also part of a second electrical/electronic system 90 for testing the correct positioning of the electrocatheter 10, as will be made clearer hereafter.

A third window 73C displays the supply current 62 of the electrocatheter 10 that the electrostimulation apparatus is using at the time. It can thus be the therapy current or a stimulus current to check the correct positioning of the electrocatheter 10.

In some variants the windows 73B and 73C coincide and/or are displayed at different times of use. In any case, there is no limitation to the number of windows.

In the preferred variants, the display device simultaneously displays at least the three windows 73A, 73B and 73C (or more generally their three pieces of information) where it respectively shows the image detected by the ultrasound scanner device, the stimulus current with which the electrocatheter 10 is supplied and the reading of the response to said stimulus, and where these three pieces of information displayed refer at least to the same time of reading. This displaying of the three pieces of information, for the sake of simplicity, hereafter will be called "confirmation" display of the objective being reached.

According to other variants, the confirmation display has less than three pieces of information, for example leaving out the stimulus current and/or the image of the ultrasound scanner. However, it is preferable for the confirmation display to have at least the reading of the response to the stimulus.

The control pedal system 80 illustrated comprises five pedal controls, where a first pedal 82 is an emergency stop command, capable of interrupting the supply of current to the electrostimulation apparatus 1.

A second pedal 83 is a print command, capable of ordering the device 75 to print at least part of the image that appears at that time on the screen of the display device 74. Preferably, such a printed image comprises the image sent to the screen by the ultrasound scanner device 72.

More generally, it is preferable for the work station 92 to be able to print the entire "confirmation" display, or at least the information contained in it, through the printing device 75. In the case in which said screen comprises more than one piece of information, they will be printed relative to the same predetermined moment, for example blocking the display with a block image command. The display indeed preferably is variable over time, reproducing moment by moment the information received from the testing system(s) .

Regarding this, it is possible to foresee a third pedal 84 with block image function, which blocks at least one desired part of an image on the screen of the display device 74. The blocked image is the "confirmation" display at a predetermined time, which is thus prepared for printing.

A fourth pedal 85 is a command for testing the correct positioning of the electrostimulation apparatus 1 inside the patient, and it allows an electrical testing stimulus 62 to the electrocatheter 10, preferably of predetermined or adjustable magnitude.

The response to this stimulus is translated into the signal 60 displayed on the screen 73B. The magnitude of the stimulus is preferably the current 62 displayed in the window 73C.

A fifth pedal 85 is an electrical supply command of the electrostimulation apparatus 1, capable of modulating the electrical therapy current. Such a current is the current 62 displayed on the screen 73C at a time after the end of the procedure for testing the correct positioning through the sending of the testing stimulus. Alternatively, the therapy current can be displayed in a fourth window.

According to some variants, the fourth and the fifth pedal coincide and the current sent through it to the apparatus 1 is of the modulable type, in which case the windows 73B and 73C also preferably coincide.

The order of arrangement of the pedals from left to right preferably coincides with that illustrated, and more generally it foresees that the pedals 85 and 86 are those arranged most to the right, so as to be actuated with the right foot, more suitable for managing modulation. In any case, this does not rule out any other arrangement different from that described and shown in the figures.

It should be observed that according to some more basic variants, the printing device 75 and the relative block image and printing pedals 83 and 84 can be absent .

Figure 1 also shows an operating table 88 on which the patient 66 lays. Such an operating table is preferably part of the work station 92 and even more preferably it is used as a joining element between some or all of the operative parts thereof.

In particular, beneath and/or at the side of it an apparatus 20 is fixed that comprises a plurality of electrical connection ports to each of the other operative parts, as will be described better hereafter.

The work station can be equipped with a seat 94 in a position such that the doctor sitting on it can simultaneously hold the ultrasound scanner 72 and the electrocatheter 10 and act with them on the patient 66 laying on the operating table 88, while at the same time being able to act with his feet on the pedal system 80 and having full vision of the screen 73.

The seat 94 preferably is fixed to the work station 92. The pedal system 80 is preferably positioned under the operating table 88.

In general, it should be observed that the connections between the parts to exchange information and/or commands have been illustrated as of the cable type, however, where possible, wireless connections are not ruled out.

With reference to figure 2 a preferred embodiment of the apparatus for electrostimulation of the nervous system according to the present invention is shown, wholly indicated with reference numeral 1.

The apparatus 1 comprises a electrocatheter 10

(or electroneedle ) and an apparatus 20 capable of both delivering at least one electrical therapy current and at least one electrical testing current and therefore hereafter also called current generator device or supply device 20. The apparatus 20 is also able to read at least one response generated in the patient by said testing current. Such a reading is for example the translation into an electrical potential of said response, therefore called evoked or induced potential by the stimulus on the CNS or SNP due to the testing current. The elicited response is preferably detected in an area remote from the area of application of the testing current.

Some examples of response in which the translation into an evoked potential is particularly applicable are sensitive responses at the level of the peripheral nervous system, the skin, the muscles, the non-nervous structures, the central nervous system and the brain.

For example, the evoked potentials in such cases are said to be of the somato-sensory (PESS), visual (PEV) and acoustic (PEA) type.

Examples of motor response are contractions, for which reasons in this case the potentials evoked are called muscular and the reading device is for example an electromyograph .

An example of skin response can be sweating.

The reading of the potential evoked can for example be carried out at the level of the skin with simple sensors, thus being non-invasive, or at the level of the nervous system or of the cerebral cortex through needles with electrodes.

In general, this does not rule out the reading of any type of response, for example: a sensitive response, a motor response, a bio-humoral response.

In order for the delivery of the electrical testing current and of the electrical therapy current to be commanded through the pedal system 80, the apparatus 20 has at least one electrical connection port with it, indicated with reference numeral 76A. More preferably, the port 76A is intended for connection with the pedal for commanding the testing current 85, whereas a second port 76B is intended for connection with the pedal 86 for modulating the therapy current. Such ports are then associated with respective output ports 77A and 77B towards the display device 74 to allow the graphical displaying of the therapy and impulse currents.

The apparatus 20 can also support the entry and exit ports 78A and 78B of the signal of the ultrasound scanner from the ultrasound scanner and towards the video device 74, respectively, .

The apparatus 20 can also support a connection port 79 to the emergency stop pedal 82.

Optionally, there can be another two ports (not illustrated) connected to the block image and print pedals 83 and 84 and to the display device 74 and to the printing device 75, respectively.

The electrocatheter 10 is the whole of the part represented above the dashed line A, and comprises a penetration device 12, a first electrical interface and support element 14, a second electrical interface element 16 and a plurality of sensors 18 (even just one is sufficient) . The electrocatheter is completed with the electrical connection cables 22, 23, 24 and 25, preferably attachable and detachable.

With reference to figure 3, the penetration device 12 comprises a catheter 30 (or a needle - more suitable for example for the PNS ) equipped with at least one electrode 32 at an end thereof 33 intended to penetrate the body of the patient, and for the sake of simplicity called "tip". The electrode 32 is intended to come into contact with the nervous system to be stimulated .

At the opposite end 35, for the sake of simplicity called "tail", the catheter 30 comprises at least one electrical connection port 34, electrically connected to the electrode 32 and intended to electrically connect to the first interface element 14.

As can be seen in the enlargement of figure 3, the catheter 30 is hollow, so as to form a duct with an outlet opening 36 at the tip 33 and oriented in the direction of longitudinal extension L of the catheter.

The catheter in this way is able to dispense fluids, for example drugs, through the outlet opening 36 according to said direction of longitudinal extension L.

It should be noted that the electrode 32 is arranged on the end edge 33b of the catheter, actually acting as a penetration tip. In this way the dispensing of the fluid takes place exactly at the electrode and therefore is precise. Preferably, the electrode 32 develops around the opening 36, for example in the form of a perforated cylinder.

Figure 3 also shows the inner electric cable 37 for the electrical connection between the electrode 32 and the port 34.

With reference again to figure 3, the first interface element 14 comprises a housing seat 38 of the catheter 30, that preferably also comprises an electrical connection port 39 intended to couple with the connection port 34 of the catheter 30. As can be seen in figure 3 the catheter 30 is able to be physically (and electrically) coupled with and decoupled from the first interface element 14.

The interface element also comprises an electrical connection port 40 able to be coupled and decoupled (physically and electrically) with respect to the cable 22 (from which it receives current) and coupled with the port 39 to supply current to the catheter.

Through the cable 22 the first interface device 14 is able to be electrically and physically connected to and disconnected from the second interface device 16. The electric cable 22 preferably has a length of over 30 cm, more preferably over 50 cm, even more preferably over lm.

With reference to figure 5, the second interface device 16 comprises a support element 41 on which there are at least one electrical connection port 42 with the first interface device 14, at least two electrical connection ports 44 and 46 with the apparatus 20 and at least one connection port 48 with an electrode 18.

The port 44 is preferably in electrical contact solely with the port 42, so as to form a direct supply bridge between the apparatus 20 and the catheter 30, capable of transmitting both the therapy current and the testing current. Such a bridge is electrically insulated from the port 46, which on the other hand is in electrical connection with the ports 48, so as to electrically interface the sensors 18 with the apparatus 20 so as to read possible evoked potentials generated by the testing current.

With reference again to figure 2, the apparatus 20 comprises at least one outlet port 54 of the therapy current and of the testing current, and an inlet port 56 of the reading of the evoked potential.

The cable 23 makes it possible to electrically and physically connect and disconnect the port 44 with respect to the port 54, the cable 24 makes it possible to electrically and physically connect and disconnect the port 46 with respect to the port 56, and the cables 25 make it possible to electrically and physically connect and disconnect the ports 48 with respect to the sensors 18.

As can be seen, therefore, the electrocatheter 10 comprises a first electrical connection channel 50 (indicated in figure 1) intended to transmit the supply current from the apparatus 20 to the catheter 30 comprising the port 54, the cable 23, the second support device 16, the cable 22 and the first support device 14. The electrocatheter 10 also comprises a second electrical connection channel 52, distinct from the first, intended to place the apparatus 20 in electrical communication with the sensors 18. It comprises the port 56, the cable 24, the second support device, and the cables 25.

Such channels are physically joined by the second interface device 16, which for this reason is also called "physical connection and electrical junction point".

Through the port 54, the apparatus is able to transmit at least one testing current that has at least one of the following characteristics (more preferably both) from 0.01 V to 10 V (V=Volt) (where 0.1-0.3V is preferred, for example in the case of use of reading of the response with an electromyograph) , from 1 to 100 mA (A=Ampere) (more preferably from 20 to 100 mA) .

In this case the impedance is preferably between 140 and 700 OHM.

The application frequency in general is preferably less than or equal to 10 Hz, more preferably less than or equal to 5 Hz, even more preferably less than or equal to 3 Hz where 2 Hz is a preferred value.

Through the same port the apparatus 20 is able to deliver a therapy current, for example of the type known as current in the radio frequency field, i.e. with a frequency comprised in the range [30KHz, 300GHz] including extremes, and more preferably of the sub-type known as current in the field of microwaves, i.e. with a frequency comprised in the range [ 300Mhz-300GHz ] including extremes.

Through the port 56, the apparatus 20 receives from the sensors 18 at least one reading signal of a potential evoked by the testing current. As a consequence of the reading signal the apparatus 20 sends to the display device 74 the positioning information 60 to be displayed in the window 73B, and able to be used as signal to start the therapy. There are no particular limitations to the start signal, which can simply be the graphical display of the reading signal, as well as a message or an acoustic signal or a light signal in addition to the graphical display of the current corresponding to the reading of the evoked potential.

In the preferred embodiments the apparatus 20 also has the function of a processing device that compares the testing current with the evoked potential and produces the start signal based on the result of said comparison. For example, such a comparison can take into account the response time (i.e. the time that passes between the emission of the testing current and the reading of the potential evoked) and/or the magnitude of the testing current and of the evoked potential read.

It is thus clear that the apparatus 20 and the channels 50 and 52 are part of the electrical testing system 90 of the correct positioning of the electrode 32.

It should be observed that preferably the port 54 is dedicated exclusively to the delivery of current whereas the port 56 is dedicated exclusively to the reading of the evoked potential, so that they cannot be operatively exchanged with one another and must be suitably identified as being distinct by the operator.

With reference to figures 6 and 7 the use of the apparatus 1 is shown. In particular, figure 6 shows a step of insertion of the penetration device 12 in the spinal cord 65 of a patient 66 to position the electrode 32 in contact with its central nervous system 67. The electrodes 18, on the other hand, are arranged on the skin of the patient in a predetermined position corresponding to the points at which it is possible to read an evoked potential as a consequence of the stimulation of the ganglion that constitutes the objective of the subsequent therapy.

In this case, the evoked potential read is a muscle contraction and is translated by the sensors into an electrical signal.

In order to correctly position the electrode 32 at a desired ganglion (not shown) a first visual testing procedure is carried out through the ultrasound scanner, and a second electrical/electronic testing procedure is carried out in which the testing current is sent by the apparatus 20 to the electrode through the first channel 50. Through the second channel 52 the evoked potential is read and a comparison of the reading is provided through the apparatus 20, which in this case therefore has the function of an electromyograph.

When the reading with the electromyograph 20 provides a confirmation signal of the ganglion having been reached, the therapy begins through the delivery of the therapy current through the first channel 50, or a fine adjustment procedure of the position begins using stimuli of smaller magnitude than the last. In this second case it is necessary to use a generator device 20 capable of selectively generating a plurality of stimuli of different magnitude from each other.

Preferably, the electrical testing system 90 foresees to prevent the delivery of the therapy current until the confirmation signal occurs.

In this step the information relating both to the first and to the second testing process are simultaneously displayed on the screen 73.

During the testing step it is useful for the first and the second support element 14 and 16 to be distinct and spaced apart by the section of cable 22, since, in the case of intervention of two operators, one can take care of the catheter and the other the electrical connections and the electromyograph 20. Additionally or as an alternative, the second support element 16 can be rested on the operating table, avoiding an increase in the weight bearing down on the catheter, facilitating the operations of insertion of the "tip" 33 in the patient and making them more precise. Finally, thanks to the cable 22 the other cables and connections are kept far from the sterile field, avoiding contamination .

With reference to figure 7, at the end of the stimulation with the therapy current, the catheter 30 is physically disconnected from the other parts of the apparatus 1 and it is left in the body of the patient, so as to be able to be subsequently used as a duct for the administration of drugs.

As already stated, all of the parts described above can preferably physically detach from one another.

At this point it is possible to consider which parts of the apparatus 1 can be considered "consumable portions", i.e. able to be used in a single intervention and necessarily needing replacement or sterilization for the next intervention.

Firstly, it is possible to consider the entire electrocatheter 10 to be consumable material.

From this observation the man skilled in the art will realise that not all of the connections to physically attach and detach the various parts are necessary. For example, notwithstanding the need to attach and detach the catheter 30 to/from the first interface element 14, all or some of the remaining parts of electrocatheter 10 can be permanently connected together and separable only from the apparatus 20.

In the case in which the consumable material is just the assembly of the catheter 30 and its support element 14 (and possibly the cable 22), it is necessary for them to be separable from the remaining elements that overall can, on the other hand, for example, be inseparable from each other (i.e. all that which is located below the line B in figure 1 forms a single inseparable part of the equipment) .

According to a preferred variant, the elements to the right of the line C (figure 1), i.e. the sensors 18, can be separable, for example to be adapted to the type of reading to be carried out.

Of course, no type of connection or separation between the parts can be ruled out.

It should be observed in general that the points of physical and/or electrical coupling and decoupling between the parts can also be in different points from what is described, for example along the electrical connection cables instead of at their ends, and in a different number from what is shown.

Although up to now an embodiment of the invention has been described that uses a dual positioning check of the apparatus 1, in particular a visual check through an ultrasound scanner, and an electrical check through reading of evoked potentials, the man skilled in the art will not rule out embodiments in which a single type of check is used.

The man skilled in the art will not rule out the use in the invention of electrocatheters , electroneedles and/or electrostimulation apparatuses that are different from those illustrated.

For example, figure 7 shows an alternative work station, indicated with reference numeral 192, in which, unlike the work station 92 illustrated earlier, there is only the visual testing system 91 through an ultrasound scanner, whereas the electrocatheter 110 is of the known type, i.e. not suitable for providing the testing stimulus .

The device for supplying power (also called generator device) and for the electrical connection of the parts 120 does not have the function of reading the evoked potential, and the pedal system 180 does not have the pedal for commanding the testing stimulus.

Consequently, the screen 73 will not display the window 73B.

It should be observed that the power supply devices (current generators) in general should be considered to be devices that transform the mains current into the therapy and/or stimulus current, however this does not rule out generator devices not powered by mains current .

Of course, the embodiments and the variants described and illustrated up to now are purely examples and a man skilled in the art, in order to satisfy specific and contingent requirements, can bring numerous modifications and variants, including for example the combination of said embodiments and variants, all of which are in any case covered by the scope of protection of the present invention as defined by the following claims .