WO2024100687A1

WO2024100687A1 - Portable electronic device for detecting the positioning of medical instruments and corresponding detection method

Info

Publication number: WO2024100687A1
Application number: PCT/IT2023/050141
Authority: WO
Inventors: Luca Giorgini; Alessandro Balboni
Original assignee: Plan 1 Health S.R.L.
Priority date: 2022-11-08
Filing date: 2023-06-01
Publication date: 2024-05-16

Abstract

Portable electronic device (10) for positioning medical instruments (100), which comprises at least one detection unit (11) configured to detect an electrical quantity and supply a correlated signal, and a processing unit (12) configured to process said signal and to display data generated by means of said processing.

Description

“PORTABLE ELECTRONIC DEVICE FOR DETECTING THE POSITIONING OF MEDICAL INSTRUMENTS AND CORRESPONDING DETECTION METHOD”

FIELD OF THE INVENTION

The present invention concerns a device, and the corresponding method, for detecting the positioning of a medical instrument inside the body of a patient, for example a catheter, for example of the central type, which can be used in cardiovascular medicine. In particular, the present invention concerns a portable device configured to always remain completely outside the patient’s body, such that it can be used effectively both in a hospital setting, in an emergency setting, as well as in a home setting.

BACKGROUND OF THE INVENTION

In the literature of cardiovascular medicine, it is known to use central catheters, which are suitably inserted into the blood system, to reach a desired cavoatrial or venous zone, in order to support or assist surgical operations, medical treatments, diagnostic analyses or other, in a hospital or emergency setting.

Some known examples of techniques for inserting this type of catheter, in medical literature, are known in English as Chest Inserted Central Catheter (CICC), Femoral Inserted Central Catheter (FICC), Central Venous Catheter (CVC), Peripherally Inserted Central Catheter (PICC), Totally Implantable Vascular Access Device (TIVAD).

One of the main things that operators in this field must pay attention to during these operations is to be able to accurately identify the actual position of the distal end, or tip, of the catheter, once it has been inserted into the patient’s blood system.

There are devices that exploit the measurement of the heart rate with electrocardiographic devices (ECG) to identify physiological variations, such as the positioning index of the catheter.

However, no matter how effective they are, these known devices are complicated and need to be operatively associated with normal ECG detection apparatuses in hospitals or doctors’ surgeries. Such apparatuses notoriously include bulky equipment which are therefore not very suitable for transportable and emergency use, for example on board emergency vehicles, or at the patient’s home.

Furthermore, since these apparatuses are developed mainly for cardiac detection purposes with sensors disposed outside the patient’s body, they provide an electronic power supply via an electrical network. Therefore, some known positioning devices, in the envisaged purposes of use, in addition to the risk of accidentally subjecting the patient to electric shocks, cannot be easily used outside the original installation locations, where the electrical network is not present, or is difficult to find.

Devices are also known which monitor the position of the tip of the catheter with spatial and non-physiological methods of detection. This type of known device provides a substantially constant radiological bombardment on the patient, in order to “show” the operator the position of the catheter inside the blood system. It is clear that these known devices, due to their complexity and operating delicacy, are mainly used in hospitals, or at most in doctors’ surgeries, and subject the patient to a strong radiological impact (not always possible due to the patient’s clinical condition).

Alternatively, it is also known to subject the patient to a single radiological examination at the end of the insertion protocols, but in the event of an incorrect positioning of the catheter it is necessary to subject the patient to the extraction of the catheter itself and to a second insertion operation, with a new medical kit.

Devices are also known for detecting the position of the tip of the catheter inside the human body, which are independent of normal cardiological, radiological or other apparatuses.

However, for their operation, these devices require a large number of detection elements, or cables, for example even up to six, to be applied both to the medical instruments to be inserted, and also to the patient’s body, in order to detect the necessary physiological data and an effective identification of the position of the tip of the catheter.

Moreover, this type of known device also comprises an integrated processing unit which deals with the complex management of the numerous data supplied by the detection elements, so that such data can be made usable by the operator, for example in the form of images, sounds or other.

This operation is complex, as it requires an articulated interpolation calculation of the numerous data detected, with a consequent high demand for energy for its operation, supplied either directly from the electrical network or from rechargeable battery packs.

A first disadvantage of this type of known device is the production cost of the device itself, since the complexity of the processing unit and the high number of detection elements require many precautions such as, for example, the shielding of the cables and of the other components, in order to prevent electromagnetic interference present, or produced, in the environment where the device is used.

Furthermore, since devices of this type are subject to compliance with specific regulations in this field, it is necessary to guarantee that the passive currents generated and/or transmitted by the device cannot reach the patient, jeopardizing his/her health.

Therefore, also considering the energy required for the implementation calculation of the numerous data collected, the processing unit also has to manage and provide alarms and/or methods for detecting the trend of the cardiac curve also for patients suffering from atrial fibrillation.

Above all, in the event that the system battery is running low, the processing unit itself has to prevent the active operation of the device, so as not to connect the patient directly to the electrical network. Furthermore, a hardware and software indicator of the battery level has to be provided, in order to allow the user to charge the device in time and not to interrupt the procedure due to the device being completely discharged.

US Patent Application US 2009/005675 Al describes an endovascular access and guidance system that has: an elongated body with a proximal end and a distal end; an imageless ultrasound transducer on the distal end of the elongated body, configured to provide in vivo information, not based on images, of the patient’s vascular system; an endovascular electrogram conductor that has an electrical detection segment, also disposed on the distal end of the elongated body in a position where, when the elongated body is in the vascular system, the electrical detection segment provides an in vivo electrogram signal of the patient; an external processor configured to receive and process both a signal provided by the imageless ultrasound transducer and also a signal provided by the endovascular electrogram conductor; and a display device configured to display the information processed by the processor. The presence of an ultrasound transducer and of the electrical detection segment on the distal end of the elongated body, configured to enter into the patient’s vascular system, makes this known system complex and impractical to use. US Patent Application US 2016/0278869 Al describes a system for facilitating vascular access and for positioning central devices with venous access, comprising both a portable wireless ultrasound scanner to acquire images and a Bluetooth ECG data acquisition module with an ECG cable on the patient and a sterile adapter connected to a central catheter that is inserted into the patient’s vascular system, and also a mobile medical app that can be run on a mobile platform. The images obtained by ultrasound, together with the ECG signals coming from the tip of the catheter, are used to display the catheter’s position in the vascular system. Therefore, this known system, which provides to acquire images by means of an ultrasound scanner, is also complex and impractical to use. In general, therefore, existing devices all have critical issues that make them not very versatile, not easily portable and not immediately usable.

There is therefore a need to perfect a device and a method which can overcome at least one of the disadvantages of the state of the art.

To do this, it is necessary to solve the technical problem of making an electronic device for positioning medical instruments, such as catheters, portable and effective.

In particular, one purpose of the present invention is to provide a device and to perfect a method for positioning medical instruments, in particular a central catheter, which can be used simply and effectively, both in operating conditions in hospitals or doctors’ surgeries, both in emergency settings or at home, and which allow physiological monitoring of the patient, so as to allow the operator to evaluate with sufficient precision when the tip of the catheter reaches, for example, the desired operating ventricular position.

Another purpose of the present invention is to provide a device and to perfect a method for positioning medical instruments which are simple and cheap to manufacture, and which do not require articulated calculations for interpolating the data detected and, consequently, neither a high energy requirement for the operation of the device, nor a direct power supply from the electrical network. Another purpose of the present invention is to provide a device and to perfect a method for positioning medical instruments which do not require complex systems for managing the battery charge and/or for signaling the recharge of the batteries.

The Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages.

SUMMARY OF THE INVENTION

The present invention is set forth and characterized in the independent claims. The dependent claims describe other characteristics of the present invention or variants to the main inventive idea.

In accordance with the above purposes and to resolve the technical problem disclosed above in a new and original way, also achieving considerable advantages compared to the state of the prior art, an electronic device according to the present invention, for positioning medical instruments, comprises at least one detection unit configured to detect an electrical quantity and supply a correlated signal, and a processing unit configured to process the signal and to display data generated through the processing, wherein the detection unit and the processing unit are connected by connection means by means of wireless technology. The medical instruments in question can be understood as central catheters that can be used in cardio-vascular medicine.

In accordance with one aspect of the present invention, connection means are provided to electronically connect the processing unit and the detection unit to each other, by means of wireless technology. By way of example only, by wireless technology we can mean a transmission by means of radio, Bluetooth®, WiFi™ protocol or other, as a function of the type of data and/or its desired transmission speed. In the same way, it is possible to provide a selective choice, even a mixed one, of the various transmission protocols available.

In this way, while the detection unit remains physically connected to the medical instruments, therefore in the immediate proximity of the patient to whom the medical instruments are dedicated, the processing unit can assume a remote position or, at least, one distanced from the patient.

In other words, according to the present invention, the detection unit which detects the physiological data on the patient has been physically separated from the processing unit which, on the other hand, receives such data by means of wireless technology and processes such data to make it usable by an operator, for example, but not only, in the form of visual inputs.

Doing so achieves at least the advantage of having easily transportable and, therefore, portable detection equipment, favoring a simple intervention substantially in any operating condition, in a hospital setting, in an emergency setting, as well as in a home setting.

Advantageously, the detection unit comprises at least one collection and transceiver member, which is provided with a transceiver circuit connected to the processing unit by means of wireless technology in order to transfer the data detected.

Moreover, with the solution according to the present invention, since the detection unit is only required to detect the physiological data and to send it with wireless technology to the processing unit, a direct connection to the electrical network is not necessary for the electric power supply of its components. An example of effective power supply for the device according to the present invention is that the detection unit can be electrically powered by integrated batteries, possibly rechargeable at low voltage, for example by means of standard USB (Universal Serial Bus) connections. In this way, the solution according to the present invention limits the risk of electric shocks to the patient to a minimum, if not completely eliminating them, and also makes the device according to the present invention independent and, therefore, able to be used substantially in any environment.

This solution also allows a possible recharge, also of the power supply, also during transport of the device according to the present invention.

One of the main advantages of the solution according to the present invention is that it allows an operator, for example a surgeon or a healthcare professional, to receive a scientific confirmation of the position of the catheter without having to subject the patient to a specific radiological examination, with consequent exposure to X-rays, for an ex post identification of the catheter.

Furthermore, the device according to the present invention is totally independent of the hospital structure and can therefore be used in home interventions, first aid interventions and in nursing homes that are not equipped with sophisticated resuscitation or continuous cardiac monitoring equipment.

Moreover, by intervening in a way that does not to require interventions to reset the medical instruments, the device according to the present invention causes a reduction in the time of possible infections. In accordance with another aspect of the present invention, the processing unit comprises at least processing means conformed to make the data detected by the detection unit available to an operator. In this advantageous solution, the processing unit comprises at least one transceiver circuit connected by means of wireless technology to the transmission element of the detection unit. Therefore, the processing unit is completely independent from the detection unit as regards the processing and supply of the data detected, for example by modulating it in graphic and/or audio form, so that it can be evaluated and interpreted by the operator.

In accordance with another aspect of the present invention, the processing unit comprises at least one display mean to display data processed by the processing means.

Advantageously, the processing unit has all its parts integrated in a single electronic medium or in a single electronic apparatus, preferably portable, such as a dedicated tablet, but also of any other type commercially available on the market, such as for example a personal computer, a smartphone or other similar apparatus, provided with a dedicated application or a correlated interface application.

In accordance with another aspect of the present invention, the detection unit comprises a first detection member which is directly connected to the medical instruments, and a second detection member which is directly connected to the patient subjected to the intervention.

In fact, by exploiting the fact that the cardiac sequence has an electrical nature and that the human body is conductive, it is possible to measure the electrochemical action directly on the surface of the body.

Therefore, by using the first detection member as an exploring intracavity electrode, the second member detects, together with the first, as will be explained in detail below, the variations of electric potential on the patient.

The entity of this variation of potential is, according to the present invention, sent by means of wireless technology to the processing unit, for example after having been collected by the collection and transceiver member, to which the two detection members can be directly connected.

In accordance with another aspect of the present invention, there is provided a method for positioning medical instruments, in which there is provided at least one step of detecting data on the position of the medical instruments by means of a detection unit which detects an electrical quantity and supplies a correlated signal containing the data. The method comprises at least one step of transmitting the signal to a processing unit by means of connection means which connect the processing unit and the detection unit to each other by means of wireless technology.

In accordance with another aspect of the present invention, the method comprises at least one processing step following the transmission step, in which the data is processed by means of processing means of the processing unit, and a display step in which the processed data is made viewable for an operator by means of a display mean of the processing unit.

In accordance with another aspect of the present invention, a portable electronic device for positioning a catheter of the central type, having both a distal end configured to be inserted inside the body of a patient and also a proximal end configured to remain constantly outside the body of the patient, as well as electrical conduction means disposed between the distal end and the proximal end, comprises a detection unit and a processing unit which are configured to both remain completely and constantly outside the body of the patient.

The detection unit comprises both detection means configured to detect, by connecting during use to the skin surface of the patient and to the proximal end, at least one electrical quantity, preferably a difference of potential, generated by the heart of the patient, and also amplification means configured to generate a correlated electrical signal, as well as first transceiver means to transmit the electrical signal to the processing unit, preferably by means of wireless technology.

The processing unit comprises both second transceiver means configured to receive the electrical signal and also processing means connected to the transceiver means and configured to process the electrical signal and transform it into a sequence of data, preferably digital, as well as display means controlled by the processing means and configured to display, preferably in a traditional graphical form of the cardiac cycle, the sequence of data.

In accordance with another aspect of the present invention, the detection means comprise a first transducer electrode which is connected to the amplification means by means of a first electric cable and is configured to be placed in contact, during use, with the skin surface.

In accordance with another aspect of the present invention, the detection means comprise a second transducer electrode which is connected to the amplification means by means of a second electric cable and is configured to be placed in contact, during use, with the proximal end, preferably by means of a sterile conductor medium.

In accordance with another aspect of the present invention, the electric cables are shielded to prevent electromagnetic interference from the external environment.

In accordance with another aspect of the present invention, the detection unit also comprises optional electronic memory means, connected to the amplification means and configured to selectively store the electrical signal.

In accordance with another aspect of the present invention, the detection unit also comprises battery electric power supply means, preferably of the rechargeable type, configured to power the amplification means and the first transmission means, as well as, optionally, also the electronic memory means, if present.

In accordance with another aspect of the present invention, the detection unit also comprises a box-shaped body inside which there are disposed the battery electric power supply means, the amplification means and the transmission means, as well as, optionally, also the electronic memory means, if present. In accordance with another aspect of the present invention, the processing unit consists of, or is integrated in, an electronic apparatus, preferably of the portable type.

In accordance with another aspect of the present invention, there is provided a method for detecting, by using a detection unit provided with detection means, the positioning of a catheter of the central type having both a distal end configured to be inserted inside the body of a patient and also a proximal end configured to remain constantly outside the body of the patient as well as electrical conduction means disposed between the distal end and the proximal end, wherein the method comprises a preparatory step in which, keeping the detection unit completely and constantly outside the body of the patient, the detection means are connected both to the skin surface of the patient and also to the proximal end. Moreover, the method comprises at least: a detection step in which the detection unit detects an electrical quantity, preferably a difference of potential, generated by the heart of the patient, and generates a correlated electrical signal; a transmission step in which the detection unit transmits, preferably by means of wireless technology, the electrical signal to a processing unit which is also configured to remain completely and constantly outside the body of the patient; a processing step in which the electrical signal is transformed into a sequence of digital data; and a display step in which the sequence of data is displayed, preferably in a traditional graphical form of the cardiac cycle.

In accordance with another aspect of the present invention, a transformation step is provided between the detection step and the transmission step, in which the electrical signal is transformed into a unique datum.

In accordance with another aspect of the present invention, a storage step is also optionally provided between the detection step and the transmission step, in which the unique datum is stored before being transmitted to the processing unit.

DESCRIPTION OF THE DRAWINGS These and other aspects, characteristics and advantages of the present invention will become apparent from the following description of some embodiments, given as a non-restrictive example with reference to the attached drawings wherein:

- fig. 1 schematically shows a portable electronic device for detecting the positioning of medical instruments, in particular of a catheter inserted with its distal end into the cavoatrial zone of the heart of a patient, according to the present invention;

- fig. 2 schematically shows the device of fig. 1 , in a first condition of use, with a corresponding graphic display derived from an electrical signal detected by a detection unit; - fig. 3 schematically shows the device of fig. 1 , in a second condition of use, with a corresponding graphic display derived from an electrical signal detected by the same detection unit;

- fig. 4 shows a block diagram of a method for detecting the positioning of medical instruments, according to the present invention.

We must clarify that in the present description the phraseology and terminology used, as well as the figures in the attached drawings also as described, have the sole function of better illustrating and explaining the present invention, their function being to provide a non-limiting example of the invention itself, since the scope of protection is defined by the claims.

To facilitate comprehension, the same reference numbers have been used, where possible, to identify identical common elements in the drawings. It is understood that elements and characteristics of one embodiment can be conveniently combined or incorporated into other embodiments without further clarifications.

DESCRIPTION OF SOME EMBODIMENTS OF THE PRESENT INVENTION With reference to fig. 1 , a device 10 according to the present invention is applied to monitor the positioning of a catheter 100, for example a central catheter, in the cavoatrial zone 111 of the heart 110 of a patient, during interventions or monitoring operations in cardiovascular medicine. We must clarify that the catheter 100 does not form part of the present invention and comprises both a distal end, or tip, 101 configured to be inserted into the cavoatrial zone 111 of the patient’s heart 110, and also a proximal end 102 configured to be kept constantly outside the patient’s body, that is, toward the healthcare professional, such as a surgeon or their assistant for example. Moreover, the catheter 100 is advantageously of the armored type, known to the persons of skill in the art, that is, provided with an electrical conducting element, which can be a metal guide wire, or a standard saline solution at 0.9% NaCl.

The device 10 according to the present invention substantially comprises a detection unit 11 and a processing unit 12, the latter for example remote with respect to the detection unit 11. The detection unit 11 and the processing unit 12 are connected to each other by means of any wireless technology whatsoever, such as Bluetooth® or WiFi™.

The entire device 10 is configured to remain completely and constantly outside the patient’s body.

The detection unit 11 is configured to detect, by connecting both to the patient’s skin surface 112 and also to the proximal end 102 of the catheter 100, preferably by means of a sterile conductor cable 103, an electrical quantity, in particular the electrical impulses, of the order of millivolts, emitted by the known cells present in the cavoatrial zone of the heart, and supply a correlated electrical signal S. The detection unit 11 comprises a box-shaped body 13 inside which there is a battery power supply 15 of the rechargeable type and an electronic collection and transceiver member 16.

The collection and transceiver member 16 comprises an amplifier 1 configured to amplify the electrical signal generated by the heart 110, an optional electronic memory 18 and a first transceiver circuit 24. According to a simplified variant, not shown in the drawings, the electronic memory 18 may not be present, so that the electric values at output from the amplifier 14 can be sent directly to the first transceiver circuit 24.

The battery power supply 15 is of the low voltage type and is selectively rechargeable by means of any traditional system for recharging portable electronic devices, such as a USB connection for example. The values of the electrical signals S detected, as well as sequences of data or other values chosen as a function of the parameters defined by the user during use, can be selectively recorded in the electronic memory 18. The collection and transceiver member 16 also comprises a Bluetooth® or WiFi™ transceiver, or other, as a function of the wireless transmission protocol to be adopted, in order to put the detection unit 11 and the processing unit 12 in communication with each other.

The detection unit 11 also comprises a first transducer electrode 20 connected, by means of a first detection cable 17, to the amplifier 14 and a second transducer electrode 21 connected, by means of a second detection cable 19, to the amplifier 14. Both the detection cables 17 and 19 are shielded to prevent electromagnetic interference from the external environment.

Both transducer electrodes 20 and 21 are of the biological type. The operational characteristics of the detection unit 11 will be explained in detail below.

The processing unit 12 comprises a second transceiver circuit 23, which uses the same wireless transmission protocol as the first transceiver circuit 24 and is configured both to receive the electrical signal S transmitted by the latter, and also to transmit command information to the detection unit 11 , by means of the same second transceiver circuit 23, as will be described in detail below. The processing unit 12 also comprises a processing group 25 and a display screen 26.

The processing unit 12 is configured to process the electrical signal S sent by the detection unit 11 and transform it into a sequence of digital data SD, in order to then display the latter, on the display screen 26, preferably in a traditional graphical form of the cardiac cycle.

The processing group 25 is electronically connected to the transceiver circuit 23 and comprises an electronic processor, of a substantially known type, aided by dedicated software, which processes the electrical signals S detected by the detection unit 11 and encodes them in a desired manner, for example in the form of a physiological curve from which to derive the information necessary to detect the positioning of the catheter 100.

In an advantageous embodiment, the processing unit 12 can consist of, or be integrated in, an electronic apparatus 22 of any type whatsoever known per se, preferably of the portable type such as, for example, a tablet, a smartphone, a laptop or other. In this case, a suitable application with corresponding dedicated software is installed in the electronic apparatus 22, so that the hardware technology already present in the electronic apparatus 22 can perform the operating functions of the processing unit 12.

The operation of the device 10 described heretofore, which corresponds to the method according to the present invention, comprises the following steps.

Initially, in a preparatory step, the processing unit 12 (fig. 1) is activated, for example by activating the suitable application present in the electronic apparatus 22. Thus the wireless connection between the processing unit 12 and the detection unit 11 is created, by means of the corresponding transceiver circuits 23 and 24. The first transducer electrode 20 is then positioned on the skin surface 112 of the patient, for example by means of a sterile accessory, such as a standard ECG patch, adhesives, or other, and the second transducer electrode 21 is connected to the proximal end 102 of the catheter 100 by means of the sterile conductor cable 103, for example crocodile clips. The correct positioning of the two transducer electrodes 20 and 21 causes the immediate start of a detection step D (fig. 4), in which the two electrodes 20 and 21 detect the changes in the cardiac electric potential. Indeed, by exploiting the biological principle according to which the cardiac sequence has an electrical nature and, considering that the human body is conductive, it is possible to measure the electro-chemical action generated by the heartbeat directly on the skin surface 112 of the patient and by means of the catheter 100 itself.

Thus, during the propagation of the impulse in the different parts of the heart 110, the depolarization-repolarization phenomena generate electric fields that extend over the body surface. The instantaneous variations in magnitude and direction of these electric fields are reflected in variations in the differences of potential, which can be measured, in fact, by means of the two transducer electrodes 20 and 21. Therefore, when a variation of the signal is detected, the amplifier 14 generates a low amplification of the differential signal, filtering it from interferences and transforming the electrical signal S, in a transformation step T, substantially into a unique datum DU.

This unique datum DU can be selectively stored in a storage step M managed by the processing unit 12, according to a determinate storage protocol, or in the electronic memory 18, or in a memory of the electronic apparatus 22 itself.

According to one variant, the unique datum DU can be transferred directly to the first transceiver circuit 24, bypassing the storage step M.

A transmission step B then follows, in which the unique datum DU is transmitted by the first transceiver circuit 24 to the second transceiver circuit 23 and from the latter to the processing group 25 in order to start a processing step C, in which the same unique datum DU is transformed into a sequence of data SD, preferably digital.

Subsequently, in a display step V, the sequence of data SD is translated and graphically displayed on the display screen 26 according to the traditional graphical representation of the cardiac cycle (P; QRS; T) in which, in particular, the part P is visible.

At this point, as shown schematically in figs. 2 and 3, as a function of the actual position reached by the distal end 101 of the catheter 100, the detection unit 11 detects a different signal perturbation which is translated graphically with different trend curves.

This graphical representation determines a consequent physiological indication to an operator, for example a surgeon or a healthcare operator, who interpolates this indication with other operating parameters, being able to precisely identify the actual position of the distal end 101 of the catheter 100.

In particular, in the example of fig. 2, the peak will be visible on the display screen 26, present in correspondence with the part P, when the distal end 101 of the catheter 100 has reached exactly the cavoatrial zone 111 of the heart 110 of the patient.

According to the invention, the collected data can be synchronized by means of the software installed in the processing group 25, for example to manage its archiving, display, interface language, as well as sharing and protection relating to privacy.

It is clear that modifications and/or additions of parts may be made to the device 10 and to the method as described heretofore, without departing from the field and scope of the present invention, as defined by the claims.

It is also clear that, although the present invention has been described with reference to some specific examples, a person of skill in the art will be able to achieve other equivalent forms of portable electronic devices for detecting the positioning of medical instruments, in particular central catheters, and corresponding detection methods, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby. In the following claims, the sole purpose of the references in brackets is to facilitate their reading and they must not be considered as restrictive factors with regard to the field of protection defined by the claims.

Claims

1. Portable electronic device (10) for positioning a catheter (100) of the central type having both a distal end (101) configured to be inserted inside the body of a patient, and also a proximal end (102) configured to remain constantly outside the body of said patient, as well as electrical conduction means disposed between said distal end (101) and said proximal end ( 102), characterized in that said electronic device (10) comprises a detection unit (11) and a processing unit (12) which are configured to both remain completely and constantly outside the body of said patient, wherein said detection unit (11) comprises both detection means (20, 21) configured to detect, by connecting during use to the skin surface (112) of said patient and to said proximal end (102), at least one electrical quantity, preferably a difference of potential, generated by the heart (110) of said patient, and also amplification means (14) configured to generate a correlated electrical signal (S), as well as first transceiver means (24) to transmit said electrical signal (S) to said processing unit ( 12), preferably by means of wireless technology, and wherein said processing unit (12) comprises both second transceiver means (23) configured to receive said electrical signal (S), and also processing means (25) connected to said transceiver means (23) and configured to process said electrical signal (S) and transform it into a sequence of data (SD), preferably digital, as well as display means (26) controlled by said processing means (25) and configured to display, preferably in a traditional graphical form of the cardiac cycle, said sequence of data (SD).

2. Electronic device (10) as in claim 1, characterized in that said detection means (20, 21) comprise a first transducer electrode (20) which is connected to said amplification means (14) by means of a first electric cable (17) and is configured to be placed in contact, during use, with said skin surface (112).

3. Electronic device (10) as in claim 1 or 2, characterized in that said detection means (20, 21) comprise a second transducer electrode (21) which is connected to said amplification means (14) by means of a second electric cable (19) and is configured to be placed in contact, during use, with said proximal end (102), preferably by means of a sterile conductor medium (103).

4. Electronic device (10) as in claims 2 and 3, characterized in that said electric cables (17, 19) are shielded to prevent electromagnetic interference from the external environment.

5. Electronic device (10) as in any claim hereinbefore, characterized in that said detection unit (11) also comprises optional electronic memory means (18), connected to said amplification means (14) and configured to selectively store said electrical signal (S).

6. Electronic device (10) as in claim 4, characterized in that said detection unit (11) also comprises battery electric power supply means (15), preferably of the rechargeable type, configured to power said amplification means (14) and said transmission means (24), as well as, optionally, also said electronic memory means (18), if present.

7. Electronic device (10) as in claims 5 and 6, characterized in that said detection unit (11) also comprises a box-shaped body (13) inside which there are disposed said battery electric power supply means (15), said amplification means (14) and said transmission means (24), as well as, optionally, also said electronic memory means ( 18), if present.

8. Electronic device (10) as in any claim hereinbefore, characterized in that said processing unit (12) consists of, or is integrated in, an electronic apparatus (22), preferably of the portable type.

9. Method for detecting, by using a detection unit (11) provided with detection means (20, 21), the positioning of a catheter (100) of the central type having both a distal end (101) configured to be inserted inside the body of a patient, and also a proximal end (102) configured to remain constantly outside the body of said patient, as well as electrical conduction means disposed between said distal end (101) and said proximal end (102), wherein said method comprises a preparatory step in which, keeping said detection unit (11) completely and constantly outside the body of said patient, said detection means (20, 21) are connected both to the skin surface (112) of said patient and also to said proximal end (102), characterized in that it comprises at least: a detection step (D) in which said detection unit (11) detects an electrical quantity, preferably a difference of potential, generated by the heart (110) of said patient, and generates a correlated electrical signal (S); a transmission step (B) in which said detection unit (11) transmits, preferably by means of wireless technology, said electrical signal (S) to a processing unit (12) which is also configured to remain completely and constantly outside the body of said patient; a processing step (C) in which said electrical signal (S) is transformed into a sequence of data (SD), preferably digital; and a display step (V) in which said sequence of data (SD) are displayed, preferably in a traditional graphical form of the cardiac cycle.

10. Method as in claim 9, characterized in that a transformation step (T) is provided between said detection step (D) and said transmission step (B), in which said electrical signal (S) is transformed into a unique datum (DU).

11. Method as in claim 10, characterized in that a storage step (M) is also optionally provided between said detection step (D) and said transmission step (B), in which said unique datum (DU) is stored before being transmitted to said processing unit (12).