Nani (clear coupling, remarkable installation), electronic connector for ergonomic, quick, precise and safe connection between external electronic programmer (PEE) and artificial electrical stimulation electrode of implantable electronic device (IED), such as pacemaker, ressynchronizer, defibrillator, neurostimulator and others

Description

1 / 25 NANI (Clear Coupling, Remarkable Installation), Electronic Connector for Ergonomic, Fast, Precise and Safe Connection Between External Electronic Programmer (EEP) and Artificial Electrical Stimulation Electrode of Implantable Electronic Device (IED), such as Pacemaker, Resynchronizer, Defibrillator, Neurostimulator and Others Field of invention

[001] The present invention relates to NANI (Figures 1, 2 and 3), which is a specific type of electronic connector used in the fields of Medicine, Veterinary Medicine, Electronic Engineering and Clinical Engineering.

[002] In this context, some pathophysiological conditions are treated through a temporary or definitive treatment that aims to restore the physiological functions of a patient who needs artificial electrical stimulation, through an Implantable Electronic Device (IED), whether that patient is human or veterinary.

[003] The NANI function is to provide a fast, accurate and secure connection between an External Electronic Programmer (EEP) (Figure 4) and an Artificial Electrical Stimulation Electrode (Figure 5), during a surgical procedure for programming, implantation, replacement of generator units or other maintenance of IEDs.

[004] The PEE (Figure 4) is a type of clinical engineering equipment whose function is to provide the surgeon with the necessary means to program artificial electrical stimulation parameters to be applied to patients, and to then record these parameters in the memory of the IED, so that it can function according to the programming it has received.

[005] The electrode (Figure 5) is an electro-electronic connection element in medicine, whose function is to conduct artificial electrical stimuli from point A Petition 870260023281, dated 12 / 03 / 2026, page 5 / 69 2 / 25 to point B. In this case, point A will be connected to a PEE or a DEI, and B will be directly connected to a patient's tissue / organ.

[006] In the context of a dual-chamber cardiac pacemaker, for example, one end of its electrode is distal to the heart and has a universally shaped bipolar male plug (Figure 6), which consists of a conductive part relating to the negative pole (cathode) (6.a) and a conductive part relating to the positive pole (anode) (6.b). The function of this universally shaped bipolar male plug is to establish an electronic connection with the PEE.

[007] In the same context, the opposite end of the electrode is proximal to the heart and has another type of bipolar male plug, which can be of active fixation (Figure 7), passive fixation (Figure 8), or any other type in the state of the art. The active fixation type consists of a conductive part relating to the negative pole (cathode) (7.a) and a threaded screw tip relating to the positive pole (anode) (7.b and 7.c). The passive fixation type consists of a set of conductive rods relating to the negative pole (cathode) (8.a) and a conductive tip relating to the positive pole (anode) (8.b). The function of the bipolar male plug with active or passive fixation is to establish an electronic connection with the heart.

[008] The DEI (Figures 9 and 10) is a type of electronic device used in Medicine and Veterinary Medicine, whose function is to receive a program of artificial electrical stimulus parameters, be connected to the Electrode and be implanted in the patient's body, so that it functions autonomously and for a long period of time, providing the patient with an improvement in their quality of life.

[009] Depending on the pathophysiology in question, the IED may be materialized in the form of a cardiac pacemaker, implantable cardiac defibrillator (ICD), cardiac resynchronization device (CR), deep brain stimulator (DBS), spinal cord neurostimulator, diaphragmatic pacemaker (DM), gastric or intestinal pacemaker, colonic pacemaker, sacral neurostimulator or other forms of the state of the art. Petition 870260023281, dated 12 / 03 / 2026, page 6 / 69 3 / 25 Brief Considerations Regarding the Surgical Procedure

[0010] For purely descriptive and illustrative purposes, this patent application will consider, as a model of a surgical procedure for an IED, the implantation of a dual-chamber cardiac pacemaker in a human being. However, it is hereby clarified that the present invention applies to any type of IED.

[0011] In general terms, a dual-chamber cardiac pacemaker consists of two female sockets, a long-life battery, and an electronic control circuit (Figure 10). It should be noted that, also in general terms, these sub-parts are part of the composition of any other type of IED.

[0012] Thus, the female sockets (10.a) serve as a means for the electro-electronic connection between it and the male plug at the distal end of the Electrode. The control circuit (10.b) provides the electrical stimuli according to the previously defined parameters. And the long-life battery (10.b) allows the IED, after being implanted in the patient, to function for a long period of time, making the assembly autonomous with respect to the treatment of the patient's pathophysiological condition, so that he or she has improved quality of life, as described.

[0013] In this context, the Bicameral Cardiac Pacemaker is the type of IED used to treat certain pathophysiologies of the human heart (Figure 11), such as atrioventricular block, sinus node dysfunction requiring atrioventricular synchrony, carotid sinus syndrome or vasovagal hypersensitivity with severe pauses, symptomatic bradycardia, conduction system disease with risk of progression and others.

[0014] Thus, the surgical procedure begins with the preparation of the operating room, surgical equipment, supplies, and the patient himself. Once this is done, the surgeon makes an incision in the infraclavicular region of the patient's chest, through which he gains access to the superior vena cava (11.a), through which he introduces two electrodes (Figure 12). Petition 870260023281, dated 12 / 03 / 2026, page 7 / 69 4 / 25

[0015] During this procedure, the surgeon uses a Radioscopy / Fluoroscopy System, which is a piece of clinical engineering equipment capable of displaying real-time X-ray images on a screen, and which is used to guide the insertion of the electrodes through the veins to the right atrium (11.b) and the right ventricle (11.c) of the patient's heart.

[0016] Thus, the active fixation bipolar male plug of the first Electrode (12.a) is introduced into the right atrium, and the active fixation bipolar male plug of the second Electrode (12.b) into the right ventricle, in order to be connected to the respective areas of the heart, by means of a screwing maneuver (12.c), so that the retractable screw tip of the Electrode, which is spiral-shaped, is literally screwed into the wall of the heart tissue.

[0017] Once the active fixation bipolar male plugs are properly connected to the right atrium and right ventricle of the heart, the corresponding universally shaped male plugs from the opposite ends, which are distal to the heart, remain outside the patient's body, exiting through the aforementioned incision in the subclavicular region.

[0018] From this point on, the surgeon must perform a series of movements, which, in summary, consist of connecting the PEE (Figure 13) to the heart, through the alligator clips of the negative pole (cathode) (13.a) and the positive pole (anode) (13.b), programming the electrical stimulation parameters indicated for the patient and, finally, disconnecting the PEE from the heart. However, the current state of the art for these movements is incompatible with best practice, best stability, best safety and best ergonomics, which is why it deserves to be improved.

[0019] In this context, the surgeon needs to perform several movements to ensure that the aforementioned connections, programming, and disconnections are executed, and all this effort can be divided into TWO stages, which in turn are subdivided into the complex, time-consuming, laborious, and excessive movements illustrated, in summary, in Figures 14 to 23. Petition 870260023281, dated 12 / 03 / 2026, page 8 / 69 5 / 25

[0020] STEP 1, which is focused on programming the artificial electrical stimulation parameters related to the RIGHT ATRIUM, is performed as follows: a) Hold the alligator clip corresponding to the negative pole (cathode) with one hand, and the male plug of the Electrode fixed to the right atrium with the other hand (Figure 14); b) Press the tabs of this alligator clip in a pinching motion to open it (Figure 15); c) Bring this open alligator clip close to the male plug of the Electrode fixed to the right atrium, in the specific area of ​​its conductive part corresponding to the same negative pole (cathode) (Figure 16); d) Fit this alligator clip into the exact location of the male plug of the Electrode fixed to the right atrium, and release the pressure of the pinching motion, which causes the elements to be fixed by gripping (Figure 17); e) Perform the same movement described in point “a”, but with the alligator clip of the positive pole (anode) and the electrode attached to the right atrium (Figure 18);f) Perform the same pinching movement described in point “b”, but with the alligator clip connector on the positive pole (anode) (Figure 19); g) Perform the same approximation movement described in point “c”, but between the positive poles (anode) of the alligator clip connector and the male plug of the electrode attached to the right atrium (Figure 20); h) Perform the same gripping fixation movement described in point “d”, but between the positive poles (anode) of the alligator clip connector and the male plug of the electrode attached to the right atrium (Figure 21); i) Perform the actual programming of the artificial electrical stimulation parameters, configuring the mode, frequency, voltage, and sensitivity indicated for the treatment of the patient's case; j) Disconnect the alligator clips from the negative (cathode) and positive (anode) poles and the male plug of the electrode attached to the right atrium (Figure 22), which completes the programming of this part of the heart.

[0021] The 2nd STAGE, which focuses on programming related to the RIGHT VENTRICLE, consists of: a) Performing the same movement described in point “a” of the 1st STAGE, but with the Right Ventricle Electrode; b) Performing the same pinch movement described in point “b” of the 1st STAGE; c) Performing the same movement described in point “c” of the 1st STAGE, but with the Right Ventricle Electrode; d) Performing the same movement described in Petition 870260023281, dated 12 / 03 / 2026, page 9 / 69 6 / 25 item “d” of STEP 1, using the right ventricle electrode; e) Perform the same movement described in item “e” of STEP 1, using the right ventricle electrode; f) Perform the same pinch movement described in item “f” of STEP 1; g) Perform the same movement described in item “g” of STEP 1, using the right ventricle electrode; h) Perform the same movement described in item “h” of STEP 1, using the right ventricle electrode (Figure 23); i) Perform the same parameter programming described in item “i” of STEP 1, referring to the right ventricle; j) Perform the same disconnection movement described in item “i” of STEP 1, using the right ventricle electrode, which completes the programming of this part of the heart.

[0022] Regarding the programming procedure itself, it should be noted that the surgeon, while performing it, simultaneously monitors the patient's vital signs using a Multiparameter Monitor, which is a piece of clinical engineering equipment capable of displaying, on a screen, a series of physiological data, such as heart rate, blood pressure, oxygen saturation, electrocardiogram (ECG), and others, according to the state of the art.

[0023] In this context, the surgeon is able to check if the parameters he has chosen for programming the dual-chamber cardiac pacemaker are working correctly, that is, producing the expected physiological results, and, in addition, also identify the existence of any complications, such as hemodynamic changes, respiratory arrest or cardiac arrest, which ensures the opportunity for the necessary medical interventions to be carried out for the success of the procedure and the safety of the patient.

[0024] Once the surgeon is satisfied with the programming performed, he then brings the dual-chamber cardiac pacemaker close to the PEE cabinet, so that, through telemetry, this action results in the recording of the aforementioned artificial electrical stimulation parameters in the electronic circuit responsible for the operation of the IED. Petition 870260023281, dated 12 / 03 / 2026, page 10 / 69 7 / 25

[0025] In the following action, the surgeon finally connects the Dual-Chamber Cardiac Pacemaker to the male electrode plugs (Figure 24), at which point the PEE, still via telemetry, performs the final tests to verify the integrity of the implanted system, mainly with regard to electrode impedance, stimulation threshold and detection sensitivity, and finally, the pacemaker is implanted inside the patient's body, with the incision being properly sutured.

[0026] After the patient is discharged, the PEE is used in their future follow-up appointments in order to readjust parameters according to changes in the patient's condition, activate or deactivate advanced functions such as rate response, which adjusts stimulation based on physical activity, resolve electromagnetic interference problems, correct sensitivity failures, and replace the battery. State of the Art of External Electronic Programmer (EEP) Connectors

[0027] The current state of the art of the External Electronic Programmer (EEP), specifically with regard to the connectors present in its bipolar coaxial electronic cables, whose functions are to establish connection with the Electrode, is summarized in the use of alligator clip connectors, as exemplified by patents US963425A, US1356491A and US1521903A.

[0028] However, the use of alligator clips in surgical procedures for implanting, programming, and changing IED generators presents a number of disadvantages, given that, as already mentioned, their handling depends on the surgeon's excessive concentration and dexterity, which ends up demanding a lot of attention and precision, as well as forcing them to use both hands, in addition to not guaranteeing special safety against accidental disconnections.

[0029] From a biomechanical standpoint, it is worth highlighting again that the current state of the art requires the surgeon to perform numerous movements with the upper limbs of his body, as already mentioned. Petition 870260023281, dated 12 / 03 / 2026, page 11 / 69 8 / 25

[0030] In the context of Figure 14, one of your hands must hold the EEP cable, with your fingertips positioned towards the tabs of the alligator clip corresponding to the negative pole (cathode), ensuring that this grip is secure and controlled (14.a). With the other hand, the surgeon must hold the cable of the first electrode, which is attached to the right atrium, in its portion immediately anterior to the universal bipolar male plug, ensuring a firm and precise grip (14.b).

[0031] Once this sequence of movements is stable, he still has to perform a pinching motion with his fingers on the alligator clip, as shown in Figure 15, in order to press its spring so that it opens in a rocking / jaw motion (15.a).

[0032] After opening, the surgeon still has to maintain the pressure of the clamp movement on the alligator clip connector in order to perform a series of movements with the shoulder, elbow, forearm and hand joints, combining pronation, supination, flexion and circumduction of axes, in order to position the alligator clip connector at the exact contact point corresponding to the negative pole (cathode) of the male plug of the first electrode, as shown in Figure 16, where the parts will be joined in the continuous act.

[0033] Only then can the surgeon release the pressure he had been exerting on the tabs of the alligator clip, allowing it to be fixed by gripping the male plug of this electrode attached to the right atrium, as shown in Figure 17.

[0034] Next, the surgeon has to repeat the same procedure with the other alligator clip connector, referring to the positive pole (anode), connecting it to the same first electrode, in the exact location where the contact corresponding to the same pole of its male plug is located, as shown in Figures 18 to 21.

[0035] Thus, the PEE is now connected to the negative (cathode) and positive (anode) poles of the electrode attached to the right atrium, at which point the surgeon must perform the aforementioned procedures for programming the artificial electrical stimulation parameters related to this Petition 870260023281, dated 12 / 03 / 2026, page 12 / 69 9 / 25 part of the heart. Once this step is completed, the surgeon must disconnect the PEE from this first electrode (Figure 22).

[0036] Thus, the surgeon moves on to the second stage, which consists of repeating all the same procedures that have just been performed between the PEE and the first electrode, but with the second electrode, which is attached to the right ventricle. From then on, the surgeon performs the connection, the programming of the electrical stimulation parameters of this part of the heart (Figure 23), and finally, the disconnection of the elements.

[0037] As already mentioned, these biomechanical efforts are incompatible with best practice, best stability, best safety, and best ergonomics. Furthermore, these maneuvers require additional attention from the surgeon, in that he must identify which alligator clip corresponds to the positive pole (anode) and which corresponds to the negative pole (cathode), as well as ensuring that the electronic connection is firm and stable.

[0038] Thus, any adverse event that may interrupt the connection between the PEE and any of the electrodes, consequently interrupting the artificial electrical stimulation of the heart, will result in a drop in the patient's cardiac and cerebral output, so that, depending on their clinical condition, this fact may cause harm to their health or even death.

[0039] As an example, it is common for surgical procedures involving the programming, stimulation, and generator replacement of a dual-chamber cardiac pacemaker to be performed under conditions of great risk, given that the patient may be extremely bradycardic, or present with this dangerous and delicate clinical condition of low heart rate during surgery. Furthermore, the patient may depend on cardiac pacing to maintain their life during the surgical procedure.

[0040] As can be seen, the state of the art demands an unnecessary additional effort from the surgeon, since it imposes excessive concentration and dexterity on him to perform all the aforementioned maneuvers. Petition 870260023281, dated 12 / 03 / 2026, page 13 / 69 10 / 25 surgical procedures, and all of this should be provided in a faster, more precise, stable, and safer manner.

[0041] Thus, the current state of the art deserves due improvement, both with a view to improving the surgeon's working conditions from an ergonomic point of view, and with a view to patient safety and the effectiveness of the procedure. Fundamentals of the invention

[0042] The NANI was designed to replace the alligator clips installed at the end of the PEE test cable (Figure 25), in order to allow the surgeon to make the connection to the electrode in a fast, precise, stable and safe manner (Figures 26 and 27).

[0043] Regarding the term “FAST”, it is understood that the surgeon can fit the universally shaped bipolar male plug of the Electrode to the NANI of the PEE in a fraction of a second. This concept stems from the fitting movement that was specially designed for the present invention. In biomechanical terms, the surgeon's hand simply has to hold the Electrode by the portion of the cable immediately preceding the universally shaped bipolar male plug, and, with a flexion of their elbow, simply bring said plug towards the ergonomic female connection socket of the NANI (26.a). Thus, with a slight pressure, said plug will simply lie on the cavity (Figure 27), achieving a perfect fit, and at the same time providing an improvement from an ergonomic point of view.

[0044] Regarding the term “PRECISE”, it is understood that the female ergonomic connection socket of the NANI has a fitting guide, which is able to make the surgeon's movement precise, and dependent on only one of his hands.

[0045] Regarding the term “SECURE”, it is understood that the NANI’s click-lock mechanism is able to confirm that the connection is indeed stable (Figures 28 and 29), as well as after its cover is closed. Petition 870260023281, dated 12 / 03 / 2026, page 14 / 69 11 / 25 (28.ae 28.b), can prevent the occurrence of an eventual accidental disconnection. Furthermore, confirmation of the stability of the electro-electronic connection can also occur from any state-of-the-art mechanism installed in the NANI, such as a flashing light signal on an LED, an audible signal being reproduced in a small speaker, a digital visual signal being sent to a screen, or any other state-of-the-art signal that allows the surgeon to obtain confirmation of the connection, whether it is installed directly on the NANI, directly on the PEE, or anywhere in or around it.

[0046] As can be seen, NANI functionalities reduce the influence of the human factor on the success of the surgical procedure, as well as considerably minimizing the risks to which the patient is subjected.

[0047] Furthermore, the NANI locking function, in addition to eliminating an ergonomic concern for the surgeon, also prevents any unwanted occurrence regarding the variation of the sensitivity parameters of the intracardiac electrical waves (in millivolts), the resistance to the passage of the stimulus (impedance in Ohms), the heart stimulation threshold (in volts), etc.

[0048] Thus, the present invention proposes to improve the system and the way of connecting the PEE to the Electrode, by replacing the alligator clips with NANI, so that it can be installed directly at the end of the PEE test cable, providing all the advantages described above.

[0049] Furthermore, the present invention also proposes a more improved version of the NANI (Figures 30, 31 and 32), whose function is to allow the surgeon to simultaneously connect more than one electrode. Within this hypothesis, the product may contain any type of switching system, such as a selector switch (selection button) (30.a), which allows the surgeon to choose to which electrode the electrical current from the PEE should be sent. Similarly, the product may also contain an alert system capable of signaling to the surgeon which electrode is currently energized (30.b). Finally, the product must have two female sockets for connections. Petition 870260023281, dated 12 / 03 / 2026, page 15 / 69 12 / 25 simultaneous, one of which refers to the Right Atrial Electrode (31.a) and the other to the Right Ventricular Electrode (31.b), this system may have as many female sockets as necessary.

[0050] Therefore, after the two electrodes are properly connected to the female sockets of the enhanced version of the NANI (Figure 33), the surgeon can press the switch to one of its sides (33.a), which causes the LED lamp corresponding to the same side to light up (33.b), and stabilizes the electronic connection with the right atrial electrode (33.c).

[0051] Using the same principle (Figure 34), the surgeon can press the switch to the other side (34.a), which causes the other LED lamp to light up (34.b), and consequently stabilizes the electronic connection with the Right Ventricle Electrode (34.c).

[0052] It turns out that, in addition to this improved version of NANI, the present invention proposes an even more improved version of the product, whose function is to be adaptable to any PEE in circulation that still operates with alligator clips, until all this equipment from the current state of the art, also called "device park", "active base or base in use", is definitively replaced / obsoleted.

[0053] In response to this issue, the present invention also provides an extra functionality for the NANI (Figures 35 to 39), which allows its adaptation to the PEE based on alligator clip connectors.

[0054] This extra functionality, therefore, is a cavity present in the base (bottom part) of the NANI (Figures 36 to 37), in which are contained two male plugs (36.a, 37.a and 37.b), or any other type of state-of-the-art connection system, whose function is to allow alligator clips to be directly connected to the bottom part of the NANI (Figure 38).

[0055] Because of this extra functionality, NANI can also use any state-of-the-art locking system (Figure 39). Petition 870260023281, dated 12 / 03 / 2026, page 16 / 69 13 / 25

[0056] Thus, until all PEEs are manufactured directly with the NANI at the end of their electrode connection cable, replacing alligator clips, this extra functionality can provide the surgeon with the same advantages described in this patent application. Examples of embodiments of the invention

[0057] In addition to the possibility of implementing NANI in surgical procedures for implantation, programming, replacement of generator units and other maintenance in Bicameral Cardiac Pacemakers, as a treatment indicated for human patients with certain cardiological pathologies, the present invention can also be implemented in any other type of IED, in any other area of ​​medicine, including veterinary medicine, with respect to animal patients, such as dogs, cats, horses and others.

[0058] Thus, the present invention can also be used in other fields of cardiology, such as in the surgical procedure of an Implantable Cardiac Defibrillator (ICD), whose function is to detect serious arrhythmias and treat them immediately with electrical stimuli, or a Cardiac Resynchronization (CR) device, whose function is to reduce the contraction delay between the ventricles and adjust the contraction interval between the atria and ventricles.

[0059] Furthermore, it can be used in surgical procedures involving Deep Brain Stimulation (DBS), whose function is to perform micro-electrical stimulation at strategic and deep points in the brain, in order to improve tremors, rigidity, excessive involuntary movements and other symptoms.

[0060] It can also be used in surgical procedures involving a Spinal Cord Neurostimulator, whose function is to deliver mild stimuli to the spinal cord in order to block pain impulses that would be transmitted to the patient's brain.

[0061] It can also be used in surgical procedures involving a Diaphragmatic Pacemaker (DP), whose function is to prevent and treat diaphragmatic muscle atrophy in patients who are exposed to prolonged exposure to Petition 870260023281, dated 12 / 03 / 2026, page 17 / 69 14 / 25 Mechanical ventilation (MV). The PEE of this type of IED is also called an external pulse generator or external pacing device.

[0062] It can also be used in surgical procedures involving a gastric or intestinal pacemaker, whose function is to transmit electrical impulses that trick the stomach and brain, giving the patient a feeling of fullness.

[0063] It can also be used in surgical procedures involving a Colonic Pacemaker, whose function is to initiate electrical activity in the colon in order to treat constipation caused by Total Colonic Inertia (TCI) and bring the patient to the typical physiological condition of evacuation through the rectum.

[0064] It can also be used in surgical procedures involving a Sacral Neurostimulator whose function is to administer mild electrical impulses to stimulate the sacral nerves, and help control the sphincters and symptoms of urinary incontinence.

[0065] Therefore, it can be used in any other surgical procedure involving DEI, whose basic operating principles are similar to those described here. Brief description of the drawings Figure 1 presents the top, front, and side orthographic views of an example of the NANI, illustrating the device in its closed and click-locked state. In 1.aa, the base of the NANI. In 1.ba, the "top" cover, whose articulation is exemplified in the form of hinges. The concept exemplified in this figure can also consist of any other state-of-the-art format or technology that gives it the same function. Figure 2 presents the same exemplified view of the NANI, illustrating the device in its open state, where its sub-parts can be seen. In Figure 2, the parallel cable coming out of the PEE cabinet, whose visible end in the image is the NANI itself, is installed in a way... Petition 870260023281, dated 12 / 03 / 2026, p. 18 / 69 15 / 25 permanent, replacing the alligator clips of the current state of the art, as illustrated in Figure 13. In 2.b the female socket, which consists of a recessed cavity with a shape corresponding to the universal bipolar male plug of the Electrode. The edges of this cavity are equipped with a fitting guide, which facilitates the connection maneuver and results in a significant increase in the speed and precision of the fitting. In 2.c the electronic conduction terminals, which are present at the bottom and on the inner walls of the female socket cavity, and which are arranged in a manner compatible with the conductive parts of the universal bipolar male plug of the Electrode to be fitted in that location. Below the terminals are connected the sub-parts that correspond to the poles of the coaxial bipolar electronic cable (2.a) of the PEE. In 2.d the cut-window in the side wall of the "top" cover of the NANI, through which the Electrode cable passes after it is fitted into the female socket (2.b) In 2.e, the male element (protrusion) of the locking system is positioned at the top and center of the front face of the NANI. In 2.fo, the female element (cavity loop) of the locking system is positioned at the bottom and center of the front face of the NANI's "top" cover. By closing the "top" cover and hearing the click, the surgeon can ensure that the system is locked and secure. The subparts exemplified in Figure 2 may be made of any other shape or technology of the state of the art that confers the same function, especially regarding the most varied types of quick-release and locking mechanisms known. Figure 3 presents the top orthographic view of an example of the NANI, still illustrating the device in its open state. Figure 4 presents the frontal, superior, and lateral orthographic views of an example of the PEE, which, when used in surgical procedures for programming, stimulation, and generator replacement of a dual-chamber cardiac pacemaker, has a series of functions, such as testing and adjusting the electrodes implanted in cardiac tissues, sending temporary electrical impulses to verify the positioning and functioning of these electrodes, and modifying the... Petition 870260023281, dated 12 / 03 / 2026, page 19 / 69 16 / 25 parameters of stimulation intensity and heart rate, customizing the pacemaker according to the patient's needs. Furthermore, the PEE has the function of storing the pacemaker settings before its final implantation, as well as, in some cases, performing subsequent pacemaker reconfigurations without the need for a new invasive procedure. In 4. to the PEE housing itself, which could be generically described as a mobile computing unit of any size, shape, and functionality according to the state of the art. In 4. the bipolar coaxial electronic cable that serves as a bridge for the connection between the PEE and the electrodes, with more details in Figure 13, it is possible to note that one of its ends is directly fixed to the PEE housing. Figure 5 shows a side view of an example of two electrodes. In 5.a, each electrode has a universal bipolar male plug installed at one end. This plug consists of a pin-shaped electronic contact, which is divided into two sub-parts: one for the positive pole (anode) and the other for the negative pole (cathode). This plug can also be of any other shape or number of electrical poles, according to the state of the art. In 5.b, the coaxial bipolar electronic cable of each electrode is shown, whose function is to conduct electrical energy from one end of the electrode to the other.Each electrode has a bipolar male plug with active fixation installed at its other end, which, in its central portion, has a sub-part made of conductive material in a spiral shape, whose function is to attach to the cardiac tissue to establish the electronic connection through which the electrical stimuli related to the indicated treatment will be sent to the patient. The concept exemplified in this figure can be applied to any type of electrode in the state of the art, including any type of electronic cable and plug for connection to a PEE, as well as any type of plug for connection to biological tissues. Petition 870260023281, dated 12 / 03 / 2026, page 20 / 69 17 / 25 Figure 6 shows a side view and enlarged image of an example of the electrode end where the same universal bipolar male plug illustrated in the previous figure is installed, located distal to the heart. 6.aa shows the sub-part of the male plug corresponding to the negative pole (cathode). 6.ba shows the sub-part of the male plug corresponding to the positive pole (anode). 6.c shows the bipolar coaxial electronic cable. 6.da shows a cross-sectional view of the bipolar coaxial electronic cable, illustrating the outer conductor mesh corresponding to the negative pole (cathode). 6.e illustrates the inner conductor corresponding to the positive pole (anode). Figure 7 shows a lateral and enlarged view of an example of the other end of the electrode, where the same bipolar active fixation male plug illustrated previously is installed, proximal to the heart. In 7.aa, a subpart of the bipolar active fixation male plug, made of conductive material corresponding to the negative pole (cathode). In 7.b, the spiral-shaped screw tip, made of conductive material corresponding to the positive pole (anode), is illustrated in its position retracted inside the bipolar active fixation male plug. In 7.c, the same spiral-shaped screw tip is illustrated in its position extended outside the same bipolar active fixation male plug, after being screwed towards the cardiac tissue. Figure 8 shows a lateral and enlarged view of an example of the electrode tip proximal to the heart, which contains a bipolar male plug for passive fixation. In 8.a the set of conductive rods relating to the negative pole (cathode). In 8.b the conductive tip relating to the positive pole (anode). Figure 9 presents a slightly tilted, top orthographic view of an example of a dual-chamber cardiac pacemaker, illustrating the device in its sealed state. This example can be applied to any type of state-of-the-art IED. Petition 870260023281, dated 12 / 03 / 2026, p. 21 / 69 18 / 25 Figure 10 shows a horizontal cross-section in the top view of the same example of a pacemaker, illustrating the interior of the device. This example can be applied to any other type of IED in the state of the art, considering any differences in their specific sub-parts. In 10.a, the female sockets of the pacemaker are shown, into which the male electrode plugs must be inserted to establish the electronic connection. In 10.bo, the electronic circuit responsible for the pacemaker's operation is shown, which follows a program previously customized by the surgeon for the patient's case. In 10.ca, the battery where electrical energy is stored is shown. Figure 11 shows a vertical cross-section in the frontal view of an example of the human heart, illustrating the subparts of its anatomy. This example can be adapted to any other human or animal organ capable of being treated by means of artificial electrical stimulation. In 11.aa the entrance of the superior vena cava, through which the electrode is introduced by the surgeon towards the inner part of the heart. In 11.b the right atrium of the heart, located immediately after the termination of the superior vena cava. In 11.c the right ventricle, located immediately after the right atrium. Figure 12 shows the same illustrated view of the human heart, but with the electrodes implanted inside. In 12.a, the active fixation male plug is screwed into the cardiac tissue of the right atrium, usually on its lateral wall or atrial appendage. In 12.b, the active fixation male plug is screwed into the cardiac tissue of the right ventricle, usually at its apex or interventricular septum. In 12.c, a zoomed-in view of the screw tip screwed into the cardiac tissue indicates that the electronic connection between the electrode and the heart is now properly established. Figure 13 presents the same view of the PEE as in Figure 4, but with a complete illustration of the state-of-the-art bipolar coaxial electronic cable, in order to continue what is shown in the following figures, whose main focus is the operation of the alligator clips. Therefore, in 13.ao Petition 870260023281, dated 12 / 03 / 2026, page 22 / 69 19 / 25 alligator clip connector referring to the negative pole (cathode), and 13.bo alligator clip connector referring to the positive pole (anode), both being installed directly on the opposite end of the aforementioned bipolar coaxial electronic cable. The function of the alligator clip connectors is to establish an electronic connection, by gripping, between the PEE and the electrode. Figure 14 illustrates the first part of the movement related to the interaction between the alligator clip of the negative pole (cathode) and the conductive part of the same pole of the male plug of the electrode that is attached to the right atrium. In 14.aa, the illustration shows the alligator clip in its closed position, due to the spring in its mechanism, with one of the surgeon's hands near the tabs of the alligator clip, so that his index finger and thumb are open and prepared to perform a pinching movement. In 14.ba, the surgeon's other hand is holding the end of the IED cable that has the universal bipolar male plug. Figure 15 presents the same view, illustrating the second part of the movement the surgeon needs to make with their hands, showing their index finger and thumb pressing the tabs of the alligator clip. In 15.aa, the illustration shows the alligator clip in its open position, due to the surgeon's pinching motion. Figure 16 presents the same view, illustrating the third part of the movement, which corresponds to the effort the surgeon needs to make to bring the alligator clip of the negative pole (cathode), already open, closer to the conductive part of the male plug of the electrode of the same electrical pole. Figure 17 presents the same view, illustrating the fourth part of the movement, demonstrating the first alligator clip connector of the PEE already attached to the electrode, which, in turn, is attached to the right atrium, after the surgeon has relieved the pressure of the clamping movement he was making, resulting in the fixation of the elements by gripping, due to the spring force of the alligator clip connector. Petition 870260023281, dated 12 / 03 / 2026, page 23 / 69 20 / 25 Figure 18 presents a view of the same dynamics exemplified in Figure 14, illustrating the fifth part of the movement, demonstrating that the surgeon needs to repeat the same effort with the other alligator clip connector, in this case referring to the positive pole (anode), while holding with the other hand the electrode cable that is still attached to the right atrium. In 18, the alligator clip connector of the negative pole (cathode) is already connected to the male plug of the electrode. Figure 19 presents a view of the same dynamics exemplified in Figure 15, illustrating the sixth part of the movement, demonstrating the same pincer movement that the surgeon needs to make with their fingers to open the other alligator clip connector, referring to the positive pole (anode), in order to connect it to the conductive part of the same pole of the male plug of the electrode that is fixed to the right atrium. Figure 20 presents the same view exemplified in Figure 16, illustrating the seventh part of the movement, which corresponds to the same effort that the surgeon needs to exert to bring the alligator clip of the positive pole (anode), already open, closer to the other conductive part of the male plug of the electrode of the same electrical pole. Figure 21 shows an example of the eighth part of the movement, demonstrating the second alligator clip, corresponding to the positive pole (anode), already attached to the electrode, after the surgeon has also relieved the pressure of the clamping movement he was making, resulting in the fixation of the elements by gripping, due to the spring force of the alligator clip. At this point, the two alligator clips are connected to the two poles of the male plug of the electrode, which establishes the proper connection between the PEE and the heart, so that the surgeon can begin programming the parameters of artificial electrical stimulation in the right atrium, which will later be recorded in the dual-chamber cardiac pacemaker. Figure 22 presents the same view exemplified in the previous figures, illustrating the ninth part of the movement, which corresponds to the disconnection between the alligator clips of the PEE and the electrode that is attached to the Petition 870260023281, dated 12 / 03 / 2026, page 24 / 69 21 / 25 right atrium, after the surgeon has finished programming the artificial electrical stimulation parameters for that region of the heart. In 22.aa illustration of the separation movement between the alligator clips and the male plug of the electrode. Figure 23 presents the same type of view exemplified in Figure 21, after the surgeon has repeated the same first eight movements required for the connection between the PEE and the electrode attached to the right atrium. In 23.aa, the connection is now properly established between the alligator clips of the PEE and the electrode attached to the right ventricle, at which point the surgeon can begin programming the parameters for artificial electrical stimulation of this other part of the heart, which will also be subsequently recorded in the dual-chamber cardiac pacemaker. Finally, the surgeon disconnects the elements, completing the entire cycle of the current state of the art for the connection, programming, and disconnection procedures between a PEE and the electrodes implanted in the right atrium and right ventricle of a patient, which requires at least eighteen movements, as shown in the sequence of illustrations between Figure 14 and Figure 23. Figure 24 presents an example of the assembly composed of the pacemaker, electrodes, and heart, illustrating all these elements properly connected, this assembly being the final result of the surgical procedure. From this point, the pacemaker should be inserted into the cavity of the infraclavicular region of the patient's thorax, and subsequently sutured to its internal tissue, so that the surgeon can then close the surgical incision by suture or another medical technique. Figure 25 shows the front, top, and side orthographic views of an example of the improved version of the PEE, with the NANI already installed at the end of its bipolar coaxial cable, replacing the alligator clips of the current state of the art. In 25.aa, the NANI is illustrated in its open state. Petition 870260023281, dated 12 / 03 / 2026, page 25 / 69 22 / 25 Figure 26 presents the same exemplified view of the NANI, illustrating the surgeon's hand holding the electrode cable slightly above. In 26.a, the arrow indicates the vertical, top-to-bottom movement that should be performed so that the plug can easily fit, thanks to the fitting guides on the edges of the NANI female socket. This is all done quickly, precisely, and safely, replacing the non-ergonomic movements illustrated in the previous figures. Figure 27 presents the same example of the NANI, illustrating the device while still open, with the universal bipolar male plug already fitted into the ergonomic female connection socket, making the electronic connection stable. Figure 28 presents the frontal, superior, and lateral orthographic views of the PEE, the NANI, and the electrode implanted in the right atrium of the heart. In 28.aa, the NANI is illustrated with the male electrode plug inserted into its female socket, with its "top" cover in the closed position, ensuring that the connection has been made quickly, accurately, and securely, for the same purposes of supplying electrical energy to the heart, as well as performing tests and defining parameters for programming the dual-chamber cardiac pacemaker. Figure 29 presents the same type of view as the enhanced version illustrated in the previous figure, exemplifying the connection between the PEE and the electrode implanted in the right ventricle of the heart, after the surgeon has performed the simple, easy, quick, precise and safe movement illustrated in Figures 26 and 27. Figure 30 presents a top orthographic view of a further refined example of the NANI, illustrating the device in its closed state. It is noticeable that this version has two inputs for its female sockets and also has some additional elements installed on its surface. Figure 30.aa illustrates a switching key (button). Petition 870260023281, dated 12 / 03 / 2026, page 26 / 69 23 / 25 selector), with two positions, which allows the surgeon to select which electrode the NANI should send the electrical current supplied by the PEE to. The function of this switch can be replaced by any other state-of-the-art technology capable of providing the same result, and can have as many switching and redirection paths of the electrical current as necessary. Figure 30.ba exemplifies two unlit LED lamps, whose function is to alert the surgeon, through a light signal, which electrode is connected, according to the position selected on the switch. The LED lamps can be replaced by any other state-of-the-art technology capable of providing the same alert to the surgeon, such as an audible alert or a digital signal sent to a screen. Figure 31 presents the same enhanced view of the NANI, but in its open state, demonstrating two female sockets instead of just one, which allows the surgeon to connect two electrodes simultaneously. Figure 31.aa illustrates the female socket into which the electrode connected to the right atrium should be inserted. Figure 31.bo shows the female socket corresponding to the electrode connected to the right ventricle. Regarding the number of female sockets, the NANI can be manufactured with as many sockets as necessary for any number of simultaneous connections, all in order to make the connection maneuver between the PEE and the electrodes as optimized and ergonomic as possible.In the case of a Cardiac Resynchronization (CR) device, for example, the NANI can have a third female socket to allow simultaneous connection to the additional electrode, which is implanted in the patient's left ventricle in order to synchronize the contraction of both ventricles, improving blood ejection and reducing desynchrony. Figure 32 shows the top orthographic view of the same enhanced version of NANI, still illustrated in its open state. Figure 33 shows the front, top, and side orthographic views of the electronic connection properly established between the PEE, the even more improved version of the NANI, and simultaneously, the electrodes implanted in the atrium. Petition 870260023281, dated 12 / 03 / 2026, page 27 / 69 24 / 25 right and in the right ventricle of the heart. In 33.aa the switch is turned to one side, which causes the PEE to supply electrical current to the electrode implanted in the right atrium, allowing the surgeon to perform the programming procedures for the artificial electrical stimulation parameters of that part of the heart, while the other electrode remains off, although already plugged into the NANI. In 33.b one of the LED lamps is lit, sending a light signal to the surgeon, which assures him that it is the right atrial electrode that is properly connected. In 33.c cable of the electrode that is attached to the right atrium. Figure 34 shows the same orthographic view from the front, top, and side of the electronic connection properly established between the PEE, the even more improved version of the NANI, and simultaneously, the electrodes implanted in the right atrium and right ventricle of the heart. In 34.aa the switch is turned to the other side, causing the PEE to supply electrical current to the right ventricular electrode, allowing the surgeon to perform the programming procedures for the artificial electrical stimulation parameters of this part of the heart, while the other electrode is now disconnected, although still plugged into the NANI. In 34.ba another LED light is lit, assuring the surgeon that it is now the right ventricular electrode that is properly connected. In 34.co the electrode cable is attached to the right ventricle. Figure 35 presents the top, front, and side orthographic views of a further improved embodiment of the NANI, rotated 180 degrees, illustrated in its closed and click-locked state. In 35.aa, the "bottom" cover of this further improved version of the NANI, whose articulation is exemplified in the form of hinges, and which can also be locked with a click or any other locking system of the prior art, represents a safety system against accidental disconnection. In 35.bo, a cut-out window in the side wall of the NANI base serves as a space through which the PEE cable will pass after being properly connected. In 35.ca, the "top" cover of the NANI, which, as already shown... Petition 870260023281, dated 12 / 03 / 2026, page 28 / 69 The 25 / 25 indicator is at the bottom of the image due to the product being rotated 180 degrees. Figure 36 presents the same view of the even more improved version of the NANI, illustrating the device in its open state, where the presence of an additional connection system can be noted. This system consists of a cavity containing two male plugs corresponding to the negative (cathode) and positive (anode) poles, which are directly connected to the corresponding poles of the female socket on the "top" surface. This, in turn, allows the connection between the NANI and the corresponding electrical poles of the electrode. This even more improved version of the NANI allows it to adapt to any commercially available PEE that still has alligator clips on its test leads, according to the current state of the art. This allows the surgeon to make a manual and temporary connection between the elements, without the outdated PEE having to be obsoleted. The present connection concept can be replaced by any other format that provides the same function. Figure 37 shows the top orthographic view of the same even more refined version of NANI, still illustrated in its open state. Figure 38 shows a view of the same even more improved version of the NANI contained in Figure 36, where, in 37.a, the alligator clips of the PEE cable are already connected by gripping to the male plugs inside the "bottom" cavity of the NANI, and it is possible to notice that the PEE cable is exiting this cavity through its cut-window. Figure 39, finally, presents the same view, but with the "bottom" cover of the NANI closed and locked with a click, illustrating a stable connection between the device and the end of the PEE cable, even if temporarily, giving the assembly the same function as the NANI version illustrated in Figure 1. Petition 870260023281, dated 12 / 03 / 2026, page 29 / 69

Claims

1 / 3 CLAIMS 1. NANI PRODUCT, characterized by being an electronic connector installed at the distal end of the electronic cable of an External Electronic Programmer (EEP), or state-of-the-art equipment with an analogous function, for interfacing with an Electrode of an Implantable Electronic Device (IED), or state-of-the-art equipment with an analogous function.

2. NANI PRODUCT, according to the previous claim, characterized by being made of electrically insulated material and having a female socket with a shape compatible with the shape of the male electrode plug, or state-of-the-art equipment with an analogous function.

3. NANI PRODUCT, according to the preceding claims, characterized by the female socket having, inside, electronic conduction terminals with a shape compatible with the shape of the sub-parts of the male electrode plug, whatever its shape, where the electronic contacts related to the positive (anode), negative (cathode), neutral poles or any other number of poles that may be necessary are located.

4. NANI PRODUCT, according to the preceding claims, characterized by the female socket having a fitting guide on its edges, providing an ergonomic function capable of enabling an easy, quick, precise, stable and secure fit with the male plug of the Electrode.

5. NANI PRODUCT, according to the preceding claims, characterized by having more than one female socket, in which case it contains a selector switch (selector button), or any other state-of-the-art technology that provides an analogous function, so that the surgeon can choose which of the electrodes connected to the NANI should be energized by the PEE.

6. NANI PRODUCT, according to the preceding claims, characterized by having a device that, after the male plug of the electrode is inserted into the female socket, or after switching, signals to the surgeon that the electronic connection is stable, by any means of signaling in the state of the art, such as an audible alert, LED light, digital signal sent to a screen or other technologies.

7. NANI PRODUCT, according to the preceding claims, characterized by not being directly installed at the distal end of the PEE test cable, consisting of a loose and movable piece, in this case possessing all the other characteristics described in the preceding claims, except for that described in Claim 1, and containing a second electronic connection system capable of allowing the surgeon to make a manual and temporary connection between the NANI and the PEE, enabling this specific version of the NANI to adapt to any PEE in the state of the art, making it an even more specific version of the product, due to this additional function.

8. NANI PRODUCT, according to the preceding claims, comprising an even more specific version than that described in Claim 7, characterized by its second electronic connection system consisting of another cavity installed anywhere on the surface of the NANI, within which there are two or more male plugs in which alligator clips can be attached by gripping, each corresponding to the negative (cathode), positive (anode), neutral poles or any other number of poles required, or within which there is any other type of female socket that is compatible with any male plug of a PEE test cable of the prior art, allowing the surgeon to perform any type of manual and temporary electronic connection between the NANI and the PEE.

9. NANI PRODUCT, according to the preceding claims, characterized by having as many door (lid) locking systems as necessary, with click locking, or any other state-of-the-art technology that provides an analogous locking function, preventing accidental disengagement and ensuring safety to the connection system between the PEE, the NANI and the Electrode.

10. NANI PRODUCT, according to the preceding claims, characterized by being constituted of a set of three or more pieces, connected to each other by hinges or other state-of-the-art device capable of providing an analogous function, one of which is the base and the others the covers, this set which, when opened, allows the exposure of the surfaces that were previously covered, which may be the "top", "bottom", side or any other part of the NANI, depending on the shape in which it is manufactured.

11. NANI PRODUCT, according to the preceding claims, comprising an even more specific version than those described in claims 9 and 10, characterized by its locking system being specifically equipped with a fixed arm installed on its moving parts, and by its base having protrusions on its side walls, so that, from the closing movement of these doors (lids), the arms gradually cover the protrusions of the base, until a click confirms the engagement, consequently locking the assembly against any accidental uncoupling. Petition 870260023281, dated 12 / 03 / 2026, p. 32 / 69

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