Medical appliance for the introduction of catheters into the human body

Abstract

The medical appliance (1) for the introduction of catheters into the human body comprises: an ECG device (2) provided with at least two electrodes (3a, 3b, 3c) which can be placed on a human body (4) for the detection of surface electric potential data and adapted to provide at least one surface ECG trace (28) at output; at least one catheter element (5) provided with a distal end (6) which can be located within the human body (4) and having an auxiliary electrode element (7) configured to detect representative data of the endocavitary electric field, operationally connected to the ECG device (2) for sending the representative data to the latter, the ECG device (2) being adapted to provide at least one endocavitary trace (8) at output defining a plurality of waves corresponding to the phases of a cardiac cycle; an electronic device (9) operationally connected to the ECG device (2) for the receipt of at least the endocavitary trace (8) and of the surface ECG trace (28); wherein: the electronic device (9) comprises at least one data processing module (10) configured to process at least the endocavitary trace (8) and the surface ECG trace (28) for obtaining usage information adapted at least to provide instructions about the insertion of the catheter element (5) within the human body (4); at least one of the usage information is of the type of at least one area (18) subtended by at least one reference stretch (19) of the endocavitary trace (8).

Description

[0001] MEDICAL APPLIANCE FOR THE INTRODUCTION OF CATHETERS INTO THE HUMAN BODY

[0002] Technical Field

[0003] The present invention relates to a medical appliance for the introduction of catheters into the human body for processing biomedical data.

[0004] Background Art

[0005] In the medical field, it is well known to use special devices to detect the electrical activity that is the basis of the functioning of the heart, both for diagnostic purposes and for simple monitoring of cardiac activity.

[0006] Generally, these devices are provided with at least three electrodes to be placed on the patient’s body in order to detect the potential differences that arise during cardiac activity.

[0007] The electrodes are positioned to form a triangle (Einthoven’s triangle) and are operationally connected to processing means which are adapted to graphically trace the signal pattern relating to the heart’s electrical activity over time.

[0008] The resulting trace is commonly known as an electrocardiogram (ECG) and provides useful information about the patient’s health.

[0009] In particular, the ECG records over time the electrical activity of the heart during the propagation of the Action Potential (AP) through the different regions of the heart. The AP is responsible for the depolarization and subsequent repolarization of the cell membranes of the cardiomyocytes, thus generating electric fields that propagate to the body surface.

[0010] These variations in electric fields, in terms of intensity and direction, are related to the processes of mechanical contraction and relaxation of the heart. The differences in electrical potential, which reflect these changes, can be measured between specific points on the body surface, thus providing useful information about the heart’s functionality and health.

[0011] In particular, three different ECG traces are obtained for each pair of electrodes in Einthoven’s triangle.

[0012] More specifically, the potential differences between the electrodes are related to the propagation of the AP on the cardiac surface and are plotted using a trace called a lead. The standard ECG leads are defined as follows:first lead (DI): represents the ECG trace obtained by measuring the potential difference between the electrode placed on the left shoulder (positive) and the electrode on the right shoulder (negative);

[0013] second lead (DII): represents the ECG trace obtained by measuring the potential difference between the electrode placed on the left groin (positive) and the electrode on the right shoulder (negative);

[0014] third lead (Dill): represents the ECG trace obtained by measuring the potential difference between the electrode placed on the left groin (positive) and the electrode on the left shoulder (negative).

[0015] By way of example, an ECG trace referring to a cardiac cycle of a patient not subject to fibrillation, in the first and second leads, shows the following notable points that follow one another over time:

[0016] wave P: this is the first stretch of the ECG that has a relative maximum point, conventionally positive with respect to the zero potential difference line defined as “isoelectric”, and is an indication of the atrial contraction timed by the sinoatrial node and which is most visible in DII;

[0017] group QRS: this is a complex of three successive waves that reflect the progressive depolarization of the ventricles, with the depolarization wave passing from the cavoatrial node to the surface of the ventricles. The wave Q is negative with respect to the isoelectric line and corresponds to the depolarization of the interventricular septum; the wave R is positive and has the maximum recordable peak and corresponds to the depolarization of the apex of the left ventricle; the wave S is negative and corresponds to the depolarization of the part of the ventricles in contact with the atria; wave T: has a relative positive maximum and corresponds to the repolarization phase of the ventricles’ cells.

[0018] It is therefore common practice to use the cardiac activity measuring devices described above, referred to simply as ECG devices, as supporting tools in the implantation of central venous catheters (CVCs), of fully implantable systems, and of hemodialysis catheters.

[0019] CVC implantation, in fact, involves inserting the catheter into a blood vessel and making it slide along the vessel itself until the tip of the catheter itself ispositioned at the cavoatrial junction.

[0020] The most widely used technique today involves the use of an ECG device connected to the tip of the catheter, which tip is used as an electrode to detect potential differences in order to “guide” the physician in positioning the tip itself

[0021] In other words, the ECG device allows displaying an endocavitary trace acquired through the catheter.

[0022] In particular, the characteristics of the trace acquired by the catheter vary depending on the position of the latter as it is pushed towards the cavoatrial junction.

[0023] Consequently, the trace acquired via the catheter behaves differently from the ECG trace acquired via the Eindhoven’s triangle electrodes.

[0024] In particular, unlike the ECG trace acquired by the Eindhoven’s triangle electrodes, the trace acquired via the catheter undergoes variations as the distance from the Atrial Sinus Node (ASN) decreases.

[0025] More specifically, the trace acquired via catheter has a reference wave that substantially occurs in conjunction with the wave P and increases as the catheter approaches the ASN.

[0026] Consequently, according to established practice, physicians refer to the variations in the height of the reference wave, considering the position where the endocavitary trace acquired by the catheter has the maximum value of this height as its end point.

[0027] Specifically, the physician inserts the catheter and pushes it with progressive forward movements towards the cavoatrial junction through the superior vena cava, observing the endocavitary trace with each forward movement.

[0028] Based on experience, the physician monitors the reference wave pattern and determines the final position of the catheter.

[0029] Usually, when the reference wave begins to decrease, the physician returns to the immediately preceding position, confident that they are in the proximity of the cavoatrial junction.

[0030] This prior art has drawbacks related to the fact that much of the work is entrusted to the physician’s experience and the final position chosen may not beoptimal, as many accidental factors affect the correct detection of the distance of the catheter tip from the cavoatrial junction.

[0031] To overcome this type of drawback, it is common practice to use X-ray imaging which is adapted to detect the position of the catheter tip.

[0032] This solution also has drawbacks related to both exposure to X-rays, which are known to be harmful to human health, and the difficulty of controlling the position when the tip of the catheter is covered by bone.

[0033] Furthermore, exposure to X-rays allows providing a two-dimensional image of a three-dimensional structure, with the potential risk of inaccuracy.

[0034] Description of the Invention

[0035] The main aim of the present invention is to devise a medical appliance for the introduction of catheters into the human body that allows catheter implantation to be improved.

[0036] One object of the present invention is to devise a medical appliance for the introduction of catheters into the human body that allows for effective support for the implantation of central venous catheters.

[0037] Another object of the present invention is to devise a medical appliance for the introduction of catheters into the human body that allows the safety and health conditions of patients undergoing central venous catheter implantation to be improved.

[0038] A further object of the present invention is to devise a medical appliance for the introduction of catheters into the human body that allows providing information on the operating conditions of the already implanted central venous catheters. Another object of the present invention is to devise a medical appliance for the introduction of catheters into the human body that allows the aforementioned drawbacks of the prior art to be overcome in a simple, rational, easy and effective to use, as well as affordable solution.

[0039] The aforementioned objects are achieved by the present medical appliance for the introduction of catheters into the human body having the characteristics of claim 1.

[0040]

[0041] of the

[0042] Other characteristics and advantages of the present invention will become moreapparent from the description of the following preferred, but not exclusive, embodiments of a medical appliance for the introduction of catheters into the human body, illustrated by way of an indicative yet non-limiting example, in the accompanying drawings, in which:

[0043] Figure 1 is a general schematic view of the medical appliance according to the invention;

[0044] Figure 2 is a detailed schematic view of some components of the medical appliance according to the invention;

[0045] Figures 3 to 6 are schematic illustrations of the operation of the appliance according to the invention;

[0046] Figure 7 graphically illustrates the surface ECG trace and the endocavitary trace;

[0047] Figure 8 is a schematic general view of another embodiment of the medical appliance according to the invention.

[0048] Embodiments of the Invention

[0049] With particular reference to these figures, reference numeral 1 globally denotes a medical appliance for the introduction of catheters into the human body.

[0050] According to the invention, the appliance 1 comprises an electrocardiogram device, referred to hereinafter for simplicity’s sake as an ECG device and given reference numeral 2.

[0051] However, the term electrocardiogram device should not be meant as limited to an ECG device, but comprises any electronic device configured to acquire electrical potential signals via electrodes, e.g. to acquire a time trace of the electrical potential generated by the heart during its cycle of activity, i.e., the electrical impulse that triggers or generates cardiac movement.

[0052] The ECG device 2 is provided with at least three electrodes 3a, 3b, 3c which can be placed on a human body 4 for the detection of surface electric potential data, i.e., electric potential data detectable at the body surface.

[0053] In particular, the ECG device 2 comprises at least one positive electrode 3a arranged, in use, at the left groin and at least one negative electrode 3 b arranged, in use, at the right shoulder.

[0054] More specifically, the signal acquired by the positive electrode 3a and thenegative electrode 3b refers to measurements of potential differences on the surface of the body that represent the module of a vector the direction of which is given by the line connecting the two positioning points of the two electrodes. Advantageously, the ECG device 2 comprises at least one common mode electrode 3c.

[0055] Consistently with the above, the ECG device 2 is adapted to provide a surface ECG trace 28 at output.

[0056] In particular, the surface ECG trace 28 corresponds to second Einthoven lead, illustrated in Figure 7.

[0057] In particular, the surface ECG trace 28 defines the wave P, the group QRS, and the wave T, as is known for ECG traces.

[0058] According to the invention, the appliance 1 also comprises at least one catheter element 5, schematically illustrated in the figures as a hollow tubular element. In particular, the catheter element 5 is provided with a distal end 6, illustrated in a simplified maimer in the figures, which can be located within the human body 4.

[0059] More specifically, the distal end 6 has an auxiliary electrode element 7 configured to detect representative data of the endocavitary electric field, for example as a function of distance.

[0060] In other words, the auxiliary electrode 7 is configured to detect the electric field detectable within a cavity of the human body, e.g. within a vein.

[0061] In this case, the auxiliary electrode element 7 is the catheter itself which, once filled with saline solution, serves as an electrical conductor post.

[0062] Usefully, the appliance 1 has no electrodes other than electrodes 3a, 3b, 3c, and the auxiliary electrode 7.

[0063] Conveniently, the catheter element 5 is operationally connected to the ECG device 2 for sending the representative data to the latter, with the ECG device 2 which is adapted to provide at output at least one endocavitary trace 8 in the form of a processable signal.

[0064] This feature allows the same ECG device 2 to be used to obtain both surface ECG traces and endocavitary traces 8, i.e., endocavitary electric field signals. Appropriately, the surface ECG traces are obtained from the data provided bythe electrode elements 3a, 3b, 3c, while the endocavitary traces 8 are obtained from the data provided by the auxiliary electrode 7, preferably combined with the data provided by at least some of the electrode elements 3a, 3b, 3c.

[0065] In the present embodiments, the surface ECG traces and the endocavitary traces refer to the “second lead”, but the same considerations can also be made for the first and third lead traces.

[0066] Advantageously, the appliance 1 comprises an electronic device 9 operationally connected to the ECG device 2 for the receipt of the endocavitary trace 8 and of the surface ECG trace 28.

[0067] In particular, the electronic device 9 comprises at least one data processing module 10 configured to process at least the endocavitary trace 8 and the surface ECG trace 28 for obtaining usage information adapted at least to provide instructions about the insertion of the catheter element 5 into the human body 4.

[0068] In other words, the module 10 is configured to calculate and / or process one or more pieces of usage information.

[0069] It cannot be ruled out that the module 10 may also be configured for other ECG traces in order to obtain usage information.

[0070] The usage information provides indications on the insertion of the catheter element 5 into the human body 4 and, together with all other information, data, and parameters derived from the electronic device 9, is useful to medical staff during the insertion operations of the catheter element 5 into the human body 4. According to the invention, at least one piece of usage information is of the type of at least one area 18 subtended by at least one reference stretch 19 of the endocavitary trace 8.

[0071] In particular, the module 10 is configured to calculate and / or process this area 18.

[0072] More specifically, the term area 18 subtended refers to the value of that area. In fact, the area 18 represents the force of cardiac contraction.

[0073] Preferably, the reference stretch 19 of the endocavitary trace 8 is substantially correlated with the wave P of the surface ECG trace 28.

[0074] In particular, the endocavitary trace 8 indicates the contraction of the cardiaccells activated by the Action Potential (AP). This is due to the fact that the auxiliary electrode element 7, in use, is immersed in a liquid, namely blood (not on the body surface).

[0075] Consequently, the area 18 subtended to the reference stretch 19 indicates the atrial contraction caused by the AP spreading along the atria.

[0076] In fact, the reference stretch 19 of the endocavitary trace 8 substantially occurs at the same time as the wave P of the surface ECG trace 28.

[0077] In addition, the shape of the reference stretch 19 of the endocavitary trace 8 is similar to that of the wave P of the surface ECG trace 28.

[0078] As the catheter element 5 moves forward, and therefore as the endocavitary trace 8 varies, the value of the area 18 increases or decreases depending on the position of the auxiliary electrode 7.

[0079] This information allows the operator to easily find the position wherein the area 18 is at its maximum, i.e., the position corresponding to the cavoatrial junction, indicated by reference letter G.

[0080] The operator can therefore work in a precise and repeatable maimer, placing the catheter element 5 at the cavoatrial junction 29 by identifying the maximum value of the area 18.

[0081] An important advantage of calculating the area 18 is the high reliability of this working method, which systematically returns accurate results even in the presence of partly disturbed endocavitary traces 8.

[0082] In fact, any disturbances in the signal picked up by the auxiliary electrode element 7 do not cause significant variations in the value of the area 18 calculated by the module 10, with the result that the catheter element 5 can still be correctly inserted into the cavoatrial junction 29.

[0083] Conveniently, the module 10 is configured to identify at least a first and a second extreme 22, 23 of the reference stretch 19 on the endocavitary trace 8. Furthermore, the module 10 is configured to obtain the area 18 depending on at least the extremes 22, 23.

[0084] In particular, the module 10 is configured to:

[0085] calculate the difference between each value on the surface ECG trace 28 and the value immediately following it;compare the calculated difference with a reference value;

[0086] acquire a useful value 32 corresponding to the time instant related to the value of the surface ECG trace 28 which has a difference from the next value and / or the previous value exceeding the reference value.

[0087] Preferably, the module 10 is configured to acquire the values of the surface ECG trace 28 with a predefined acquisition time, e.g. configurable by an operator.

[0088] In particular, in the surface ECG trace 28, the useful value 32 substantially identifies the beginning of the peak / wave QRS and substantially the end of the wave P.

[0089] This is due to the fact that the wave P has a slope (i.e., the speed of rise and fall of the wave) that is generally lower than that of the peak / wave QRS.

[0090] It cannot, however, be ruled out that the useful value 32 identifies other points on the surface ECG trace 28 that (temporally) follow the wave P.

[0091] Furthermore, it cannot be ruled out that the module 10 may be configured to identify the useful value 32 directly on the endocavitary trace 8.

[0092] For example, it cannot be ruled out that the module 10 is configured to:

[0093] calculate the difference between each value on the endocavitary trace 8 and the value immediately following it;

[0094] compare the calculated difference with a reference value;

[0095] acquire a useful value 32 corresponding to the time instant related to the value of the endocavitary trace 8 which has a difference from the next value and / or the previous value exceeding the reference value.

[0096] Furthermore, it cannot be ruled out that the module 10 may be configured to identify the useful value 32 on the surface ECG trace 28 and / or on the endocavitary trace 8 using analysis methods known in the literature.

[0097] Furthermore, the module 10 is configured to identify the extremes 22, 23 according to at least the useful value 32.

[0098] More specifically, the module 10 is configured to:

[0099] proceed backward, for decreasing values of time starting from the useful value 32, along the endocavitary trace 8 until a first instant of time is identified at which a plurality of values of the same trace are substantiallyequal, the first instant of time defining the first extreme 22 of the reference stretch 19;

[0100] identify, for increasing values of time with respect to the first instant of time, a second instant of time at which the endocavitary trace 8 has a value substantially equal to that of the plurality of substantially equal values, the second instant of time defining the second extreme 23 of the reference stretch 19.

[0101] Usefully, the first instant of time corresponds to the first of the values of the endocavitary trace 8, substantially equal.

[0102] In this way, it is possible to easily identify the left extreme of the reference stretch 19.

[0103] The operating methodology just described allows a curve in the endocavitary trace 8 corresponding to the reference stretch 19 to be identified simply and accurately.

[0104] To further clarify the concepts just illustrated, an example table is provided below showing some experimental values obtained for the surface ECG trace 28 (shown in column “y 1”) and of the endocavitary trace 8 (shown in column “y2”) as the sampling times of the ECG device 2 vary (shown in column “ ’).

[0105] In particular, the times t are found on the ordinates of the graph in Figure 7, while the values yl and y2 are found on the abscissas.

[0106] t yi y2

[0107] 81 90 in

[0108] 82 90 in

[0109] 83 91 in

[0110] 84 91 in

[0111] 85 92 in

[0112] 86 91 in

[0113] 87 91 in

[0114] 88 90 112

[0115] 89 90 113

[0116] 90 91 116

[0117]

[0118] 94 162 96 185 98 202 100 211 102 215 104 212 106 206 107 196 107 184 108 172 107 162 106 153 105 145 105 138 104 131 102 124 101 118 100 112 99 108 98 98 97 94 95 92 94 88 92 85 91 82 89 79 88 76 86 74 84 71

[0119]

[0120] 122 82 68

[0121] 123 80 66

[0122] 124 78 64

[0123] 125 79 64

[0124]

[0125] In particular, in the aforementioned table, the value 112 of the endocavitary trace 8 sampled at the first instant of time 87 corresponds to the first extreme 22, while the value 112 of the endocavitary trace 8 sampled at the second instant of time 110 corresponds to the second extreme 23.

[0126] It is, among other things, easily deducible that the value 215 of the endocavitary trace 8, corresponding to the maximum value between the first extreme 22 and the second extreme 23, corresponds to the maximum point 24 of the reference stretch 19.

[0127] Usefully, the module 10 is configured to:

[0128] identify a plurality of values of the endocavitary trace 8 comprised between the extremes 22 and 23 ;

[0129] obtain the area 18 according to the identified values comprised between the extremes 22, 23.

[0130] In particular, the module 10 is configured to sum these identified values to obtain the area 18.

[0131] It cannot be ruled out that the module 10 is configured to:

[0132] multiply each of the identified values comprised between the extremes 22, 23 by a predetermined interval of time to obtain corresponding reference values;

[0133] add the reference values together to obtain the area 18.

[0134] In particular, the predetermined interval of time corresponds to the sampling time at which the measurements are obtained from the ECG device 2.

[0135] If necessary, the module 10 can be configured to approximate the value of one or more of the points comprised between the first extreme 22 and the second extreme 23, e.g. by making them equal to unity.

[0136] By performing this calculation starting from the data provided in the table above, it is therefore possible to obtain a value of area 18 equal to 1082.Usefully, the module 10 is configured to repeat the calculation of the area 18 a predetermined number of times to obtain a corresponding amount of numerical values.

[0137] For example, the module 10 is configured to repeat the calculation of the area 18 three times.

[0138] In this regard, the module 10 is configured to:

[0139] compare the numerical values with each other so as to determine whether they are substantially equal to each other;

[0140] provide the area 18 when the numerical values are substantially equal to each other.

[0141] In this way, it is possible to accurately validate the data collected by the ECG device 2, guiding the medical staff with a high degree of accuracy in inserting the catheter 5 into the human body 4.

[0142] Usefully, the module 10 is configured to obtain an isoelectric line 26 of the endocavitary trace itself.

[0143] In this regard, the term “isoelectric line 26” refers to a line of the endocavitary trace 8 the points of which have substantially equal or slightly different electrical potential values.

[0144] In this way, the module 10 is configured to calculate the area 18 subtended between the latter and a predefined level, preferably indicated by the “isoelectric line 26”.

[0145] Therefore, the area 18 is comprised between the reference stretch 19 and the isoelectric line 26.

[0146] This means that the module 10 is configured to calculate the area 18 subtended by the reference stretch 19 with respect to the isoelectric line 26, thus obtaining results that are greater the more the reference stretch 19 vertically deviates from the isoelectric line itself and vice versa.

[0147] Specifically, the endocavitary trace 8 defines two joining points between the isoelectric line 26 and the reference stretch 19, which substantially coincide with the extremes 22, 23.

[0148] Usefully, the electronic device 9 comprises at least one memory unit 14 operationally connected to at least the module 10.As shown in Figure 2, the memory unit 14 is operationally connected to both the ECG device 2 and to the module 10 so as to allow the storage of one or more ECG traces, the endocavitary traces 8, and / or the data that are processed within the module itself.

[0149] In this way, it is possible to record the processed data and usage information in order to obtain a history of the ECG traces and of the data related thereto.

[0150] Usefully, the electronic device 9 comprises at least one output unit 15 operationally connected to at least the module 10 and configured to provide at output the usage information or other data such as ECG traces, data processed in the module 10, and other information stored in the memory unit 14.

[0151] As schematically shown in the figures, the output unit 15 is connectable to a screen so that the usage information and other data can be displayed.

[0152] This feature allows the operating physician to view all the information needed to insert the catheter element 5 into the patient’s human body 4 on a simple monitor.

[0153] The output unit 15 also comprises connection means, not shown for simplicity’s sake, which allow data and information to be transmitted from the electronic device 9 to any other destination unit, such as e.g. external peripherals (USB sticks, hard disks, and other similar solutions), cable data transmission networks, transceiver devices for data transmission via electromagnetic waves (Wi-Fi, Bluetooth, radio).

[0154] The appliance 1 also comprises a user interface module 16, which is operationally connected to the electronic device 9.

[0155] The user interface module 16 allows the operating physician, or any operator, to enter data and information directly into the electronic device 9, or to manage the data and information processed according to requirements.

[0156] Advantageously, the appliance 1 comprises an ultrasound device 17 operationally connected to the electronic device 9 for obtaining ultrasound images.

[0157] Usefully, the ultrasound device 17 is operationally connected to the memory unit 14 for recording and transmitting the ultrasound images.

[0158] In this way, in addition to the information and data processed in the module 10,the operator can view, either live or later, ultrasound images showing the vein and the catheter element 5.

[0159] Usefully, the ECG device 2 and the electronic device 9 are operationally connected to each other wirelessly, preferably via a private WI-FI network only visible to the ECG device 2 and to the electronic device 9.

[0160] In particular, the appliance 1 comprises at least a first transceiver element 11 connected to ECG device 2 and at least a second transceiver element 12 connected to the electronic device 9 and operationally connected, wirelessly, to the first transceiver device 11.

[0161] In this way, the ECG device 2 and the electronic device 9 are operationally connected to each other, wirelessly, via the interposition of the transceiver elements 11, 12.

[0162] Further embodiments of the appliance 1 cannot however be ruled out wherein the ECG device 2 may be provided with at least two or more electrodes 3a, 3b, 3c.

[0163] For example, in this embodiment, the ECG device 2 comprises at least one positive electrode 3a and at least one negative electrode 3b, as shown in Figure XX.

[0164] In particular, in this embodiment, the ECG device comprises the positive electrode 3a and the negative electrode 3b and otherwise retains the characteristics of the embodiment described above.

[0165] It has, in practice, been ascertained that the described invention achieves the intended objects and, in particular, the fact should be emphasized that the medical appliance for the introduction of catheters into the human body allows the operations necessary for catheter implantation to be improved.

[0166] The operating physician can in fact rely on effective support, with information that is reliable and validated by the fact that it is obtained from a high-resolution ECG trace, which is higher than the resolution achievable by eye from printed traces.

[0167] In addition, this appliance allows minimizing errors due to the physician’s assessments based on the observations of the endocavitary trace.

[0168] The information used is derived from the average of three values measured, so itcan be considered a true measurement.

[0169] As a result, the safety and health conditions of patients undergoing central venous catheter implantation are improved.

[0170] Finally, the medical appliance for the introduction of catheters into the human body allows providing information on the operating conditions of already implanted central venous catheters.

[0171] The aforementioned described operations can also be easily carried out on already implanted catheters.

[0172] In this case, it would be possible to monitor the position of the implanted catheter without manipulating the catheter itself, allowing the physician to assess the status of the implant before actually operating.

[0173] This has advantages both in terms of procedure, as it can reduce the number of interventions if the check is successful, and in terms of patient health and safety, as it reduces the risk of infections due to catheter manipulation or repositioning.

Claims

CLAIMS1) Medical appliance (1) for the introduction of catheters into the human body, comprising:an ECG device (2) provided with at least two electrodes (3a, 3b, 3c) which can be placed on a human body (4) for the detection of surface electric potential data and adapted to provide at least one surface ECG trace (28) at output;at least one catheter element (5) provided with a distal end (6) which can be located within said human body (4) and having an auxiliary electrode element (7) configured to detect representative data of the endocavitary electric field, operationally connected to said ECG device (2) for sending said representative data to the latter, said ECG device (2) being adapted to provide at least one endocavitary trace (8) at output defining a plurality of waves corresponding to the phases of a cardiac cycle;an electronic device (9) operationally connected to said ECG device (2) for the receipt of at least said endocavitary trace (8) and of said surface ECG trace (28);characterized by the fact that:said electronic device (9) comprises at least one data processing module (10) configured to process at least said endocavitary trace (8) and said surface ECG trace (28) for obtaining usage information adapted at least to provide instructions about the insertion of said catheter element (5) within said human body (4);at least one of said usage information is of the type of at least one area (18) subtended by at least one reference stretch (19) of said endocavitary trace (8).2) Appliance (1) according to claim 1, characterized by the fact that said ECG device (2) comprises at least three electrodes (3a, 3b. 3c).3) Appliance (1) according to one or more of the preceding claims, characterized by the fact that said surface ECG trace (28) corresponds to the second Einthoven lead.4) Appliance (1) according to one or more of the preceding claims,characterized by the fact that said reference stretch (19) corresponds to at least one wave-P of said endocavitary trace (8).5) Appliance (1) according to one or more of the preceding claims, characterized by the fact that said module (10) is configured to locate on said endocavitary trace (8) at least a first and a second extreme (22, 23) of said reference stretch (19), said module (10) being configured to obtain said area (18) according to at least said extremes (22, 23).6) Appliance (1) according to one or more of the preceding claims, characterized by the fact that said module (10) is configured to:calculate the difference between each value on said surface ECG trace (28) and the value immediately following it;compare said calculated difference with a reference value;acquire a useful value (32) corresponding to the time instant related to the value of said surface ECG trace (28) which has a difference from the next value and / or the previous value exceeding said reference value;said module (10) being configured to detect said extremes (22, 23) according to at least said useful value.7) Appliance (1) according to one or more of the preceding claims, characterized by the fact that said module (10) is configured to:proceed backward for decreasing values of time starting from said useful value, along said endocavitary trace (8) until a first instant of time is identified at which a plurality of values of the same trace are substantially equal, said first instant of time defining the first extreme (22) of said reference stretch (19);identify, for increasing values of time with respect to said first instant of time, a second instant of time at which said endocavitary trace (8) has a value substantially equal to that of said plurality of substantially equal values, said second instant of time defining the second extreme (23) of said reference stretch (19).8) Appliance (1) according to one or more of the preceding claims, characterized by the fact that said module (10) is configured to:identify a plurality of values of said endocavitary trace (8) comprisedbetween said extremes (22, 23);obtain said area (18) according to said identified values comprised between said extremes (22, 23).9) Appliance (1) according to one or more of the preceding claims, characterized by the fact that said module (10) is configured to sum said identified values comprised between said extremes (22, 23) to obtain said area (18).10) Appliance (1) according to one or more of the preceding claims, characterized by the fact that said module (10) is configured to repeat the calculation of said area (18) a predetermined number of times to obtain a corresponding amount of numerical values and by the fact that said module (10) is programmed to:compare said numerical values with each other so as to determine whether they are substantially equal to each other; and toprovide said area (18) at output when said numerical values are substantially equal to each other.11) Appliance (1) according to one or more of the preceding claims, characterized by the fact that said module (10) is configured to obtain an isoelectric line (26) of said endocavitary trace (8), said area (18) being comprised between said reference stretch (19) and said isoelectric line (26).

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