Guide wire

Abstract

The guidewire includes a proximal end and a distal end. The distal end includes a helical section and a distal tip. The filament elements are wound around a central axis extending from the proximal end to the distal end to form a filament winding. The mandrel is located within an internal cavity defined by the filament elements. The flexibility / rigidity properties of the guidewire vary along the axial direction due to the variability of the properties of one or both of the filament winding and / or the mandrel along the axial direction. The electrodes are positioned along the longitudinal direction of the guidewire.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 544,901, filed on October 19, 2023, entitled "Guide Wire with Electrode", the content of which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0002] The invention disclosed in the present specification relates to the field of medical devices, and in particular, to an intravascular guide wire. BACKGROUND ART

[0003] Transcatheter Aortic Valve Replacement (TAVR) is a minimally invasive treatment for aortic valve stenosis. Aortic valve stenosis is a disease in which the aortic valve narrows due to thickening, calcification, or adhesion of the valve leaflets. The valve leaflets with these lesions do not operate properly, so blood flow through the valve is restricted, creating a large pressure gradient between the left ventricle and the aorta. This condition can damage and weaken the heart muscle and other body tissues over time, leading to functional deterioration. The TAVR procedure has become the standard of care for minimally invasive percutaneous aortic valve replacement, rapidly replacing the need for surgical aortic valve replacement (SAVR) via thoracotomy for the majority of patients. Generally, the TAVR procedure requires delivering a large, rigid prosthetic valve to the native valve through the aortic arch, descending aorta, and iliofemoral arterial system. SUMMARY OF INVENTION MEANS FOR SOLVING THE PROBLEMS

[0004] According to one aspect, a guide wire includes a proximal end and a distal end. The distal end includes a helical section and a distal tip portion. A filament element is wound around a central axis extending from the proximal end to the distal end to form a filament winding. The mandrel is located within an internal cavity defined by filamentous elements. Furthermore, the varying properties of one or both of these filament windings and mandrels along the axial direction cause the flexibility / rigidity properties of the guidewire to change along the axial direction. At least one electrode is positioned along the length of the guidewire.

[0005] The technologies described herein relate to medical systems including guidewires. The guidewire comprises an elongated body with a mandrel and filamentary elements wound around the mandrel. The slender body is flexible and conforms to the surrounding tissue. The distal end contains multiple electrodes. Furthermore, this medical system includes a grounding spike that comprises a body having an exposed connection pad and a channel extending through the exposed connection pad. The pulse generator is electrically connected to multiple electrodes. The pulse generator is configured to provide pacing current to multiple electrodes. The guidewire extends through the channel of the grounding spike.

[0006] The technology described herein relates to a method for pacing cardiac rhythms using a guidewire. This pacing method includes the step of sensing electrophysiological (EP) signals using multiple electrodes placed on a guidewire. The guidewire includes an elongated body having a mandrel and filamentary elements wound around this mandrel. This elongated body is flexible and conforms to the surrounding tissue. The distal end contains multiple electrodes. The contact state of multiple electrodes is determined based on the detected EP signal. A pacing signal is selectively output to a selected electrode based on the determined contact state of each of the plurality of electrodes. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] [Figure 1] 1 is a schematic diagram of a medical system using a sensor-equipped guide wire.

[0008] [Figure 2] 1 is a schematic diagram of a sensor-equipped guide wire having a plurality of portions with varying flexibility, disposed within a heart.

[0009] [Figure 3] 1 is a cross-sectional view of a heart in which the distal end of a sensor-equipped guide wire is disposed in contact with a ventricular wall.

[0010] [Figure 4] 1 is a side view of a sensor-equipped guide wire having a first insulating element and a second non-insulating element wound at different pitches.

[0011] [Figure 5] 1 is a side view of a mandrel.

[0012] [Figure 6] 1 is a side view of the distal end of a sensor-equipped guide wire, in which a plurality of sensors are disposed at various positions along the length of the guide wire.

[0013] [Figure 7] 1 is a schematic view of the distal end of a sensor-equipped guide wire.

[0014] [Figure 8] 1 is a side view of a sensor-equipped guide wire having an elliptical distal end.

[0015] [Figure 9] 1 is a perspective view of a guide wire connector.

[0016] [Figure 10] It is a perspective view of a ground spike.

[0017] [Figure 11] It is a flowchart of a method for pacing a cardiac rhythm using a guide wire. [Mode for Carrying Out the Invention]

[0018] The apparatus, system, and / or method for placing a guide wire inside a body, which are the present invention, will be described. First, the guide wire is characterized by having flexibility to follow the internal structure of a patient, while having sufficient rigidity to support the placement of a catheter structure such as a valve replacement structure. This guide wire is composed of a mandrel and a coil structure surrounding the mandrel. Then, the flexibility / rigidity of the guide wire is selectively adjusted by modifying either one or both of the mandrel and the coil structure. For example, the flexibility / rigidity may be adjusted by changing the pitch of the coil surrounding the mandrel. Similarly, the flexibility / rigidity may be adjusted by changing the diameter of the mandrel. By selectively controlling the flexibility / rigidity along the axial length direction of the guide wire, the guide wire can follow and conform to the physiological structure of the patient. In addition, since the following portion of this guide wire is formed without providing a predetermined fixed curved portion on the guide wire, it is referred to as a "virtual curved portion" in the present specification (however, the guide wire may include a predetermined curved portion so as to be easily guided within the physiological structure of the patient). Further, the guide wire includes a flexible distal shaft for securing the guide wire, which facilitates providing optimal electrical contact between the electrode of the guide wire and cardiac tissue. The fixing force (or retaining force) between the guidewire and cardiac tissue can be increased by modifying the shape of the distal end (e.g., a double helix with primary and secondary curvature, and / or an oval curvature that follows the interventricular septal surface without risk of perforation). By fixing the guidewire to cardiac tissue, secondary medical devices (such as stents, valves, and balloons) can be delivered to the treatment area.

[0019] The guidewire may include one or more electrodes used for sensing and / or pacing the heart. In particular, one or more of these electrodes are positioned axially along a portion of a guidewire (e.g., from the ascending aorta) that is placed within the myocardium. Such electrodes may be positioned along the outer circumference of the coil so as to be in contact with adjacent tissue. In other embodiments, a portion of the insulator surrounding the coil may be removed to expose the conductor underneath to the adjacent tissue, and the conductor associated with the coil may be used as an electrode. In other embodiments, a portion of the mandrel positioned to be in contact with the tissue (i.e., the distal tip) may be used as an electrode.

[0020] The advantage of placing one or more electrodes along the axial direction of the guidewire is that sensor information can be used to provide feedback on the procedure or to perform the treatment. For example, an electrocardiogram (EKG) signal may be used to detect the timing of each part of the guidewire entering the myocardium by sensing electrodes (combined with a sensing circuit). Similarly, the detected signals may also be used to detect malfunctions caused by the guidewire puncturing the heart and becoming dislodged. Furthermore, the sensed signals may be used to detect which of the multiple electrodes is in contact with adjacent tissue within the heart, and may also be used to select the electrode that transmits the pacing signal.

[0021] Figure 1 is a schematic diagram of a medical system 100 including a guide wire 102. This guidewire 102 includes a proximal end 104 and a distal end 106 that is placed inside the patient's body. The proximal end 104 of the guidewire 102 is terminated by a guidewire connector 126 located outside the patient's body.

[0022] Furthermore, the guidewire 102 is configured to have varying degrees of rigidity at various axial positions along its length from the proximal end 104 to the distal end 106. Furthermore, because the guidewire 102 has varying rigidity depending on its axial position, it can provide flexibility in areas where it needs to follow curves along the guidance path (for example, along the aortic arch in the left ventricle) and rigidity in areas where it does not need to follow bends or curves. Generally, the guide wire 102 does not include any pre-formed or predetermined curves to accommodate these curves along the guide path. Rather, the guide wire 102 is generally straight. In other words, the main body of the guidewire 102 between its proximal end 104 and distal end 106 is straight when stationary (i.e., when no external forces such as gravity or contact with tissue are applied). Furthermore, since the body of the guidewire 102 is not pre-formed or processed to match the anatomical structure of the patient, it is beneficial that the guidewire 102 is straight when no external force is applied. In some cases, if the body of the guidewire 102 is pre-formed or processed, it may cause excessive force or damage to the blood vessel wall when the guidewire 102 is guided through the blood vessel to the target site. Therefore, the fact that the guidewire 102 is substantially straight and flexible reduces the risk of excessive force on the blood vessel wall and damage.

[0023] Because the guidewire 102 has varying degrees of flexibility and rigidity, it can conform to the shape of the tissue when pressed against it within the body. As detailed below, this allows the guidewire 102, inserted into the left ventricle via the aortic valve, to conform to the shape of the aortic arch and the left ventricle, ensuring secure fixation of the guidewire 102 within the left ventricle during various procedures (such as transcatheter aortic valve replacement (TAVR)). As will be shown in more detail in Figures 4 and 5, the flexibility and rigidity of the guidewire 102 can be selectively controlled by the wire coil pitch, the mandrel diameter, and / or a combination thereof.

[0024] The guidewire 102 includes at least one first electrode located at the distal end 106 of the guidewire 102. Furthermore, the guide wire 102 includes a plurality of electrodes positioned at various axial locations along the longitudinal direction of the guide wire 102. One or more electrodes can be used for either sensing (e.g., sensing electrophysiological signals such as EKG signals) or pacing (e.g., generating electrical signals that cause cardiac tissue to contract) or both. The sensing circuit 120 is connected to receive signals sensed by one or more electrodes placed on the guidewire 102 and to sense electrocardiogram (EKG) signals. The pulse generator 122 is configured to transmit pulses to one or more electrodes located on the guide wire 102. The controller 124 is connected to provide control signals to either or both of the sensing circuit 120 and the pulse generator 122.

[0025] One or more electrodes, positioned at various axial locations along the length of the guide wire 102, are at least partially positioned around one or more wire coils (e.g., one or more filaments). For example, one or more electrodes may be ring electrodes positioned at various locations along the length of the guide wire 102. One or more (not shown) conductive wirings or wires may be connected to each electrode and extend proximal within an internal cavity defined by a wire coil (e.g., one or more filaments), and connected to the sensing circuit 120 and / or pulse generator 122. The proximal end 104 includes a grounding electrode configured to receive (or collect) the return pacing current from the pulse generator 122.

[0026] A portion of the wire coil included as part of the guide wire 102 is used as an electrode. For example, the guide wire 102 includes a double coil. This double coil then includes a pair of wires wound around a central axis (for example, as shown in Figure 4). Furthermore, the conductor may be electrically insulated by an insulator placed on or between the conductors, or by an insulator surrounding and covering the conductor. For example, the first conductor may be insulated and the second conductor may be bare (uninsulated) to provide an electrical connection, which may be used for sensing, pacing, or both sensing and pacing. The insulator may contain polymers such as polytetrafluoroethylene (PTFE) or other insulating coatings. For example, a single filament may be coated with an insulating coating, and a portion of the wire may be removed to expose the conductive filament at a specific position along the length of the guide wire 102. Each exposed portion of the conductor associated with the guide wire 102 functions as an electrode that can be used for sensing, pacing, or both. In another example, in a dual-filament design, the first wire is coated with an insulating polymer, while the second wire is uninsulated (a bare wire, or an insulated wire with some insulation removed), so that electrical conduction can be used for sensing and pacing. As a further example, the present invention may include a guidewire 102 coated with hydrophilic or hydrophobic properties to assist both electrical conduction and delivery to anatomical structures.

[0027] The sensing signal may be used to provide the physician with additional information regarding the procedure. For example, in TAVR procedures, the guidewire 102 is guided through the descending aorta, aortic arch, ascending aorta, and aortic valve to the left ventricle. Signals sensed by one or more electrodes and processed by the sensing circuit 120 may be used to sense the timing of when different parts of the guidewire 102 enter the heart (i.e., the left ventricle). Furthermore, the sensed signals may be used to detect whether the electrodes are inside or outside the heart. For example, EKG signals detected from inside the heart exhibit the opposite polarity to those detected from outside the heart. This information may be used to sense whether a portion of the guidewire 102 has perforated the heart and is outside the heart. Furthermore, sensing signals from one or more electrodes may be used to detect which of the multiple electrodes is in contact with adjacent tissue. If necessary, electrodes in contact with adjacent tissue may be selected, and pacing therapy may be performed using the pulse generator 122. Thus, the guidewire 102 described herein offers many advantages compared to conventional guidewires.

[0028] Figure 2 is a schematic diagram of a guidewire 202 having multiple compartments 210, 212, and 214, each compartment having varying degrees of rigidity / flexibility depending on its location within the patient's body. The guidewire 202 is positioned within the descending aorta 203, the aortic arch 204, and the ascending aorta 205, and is partially located within the left ventricle 206. The flexibility / rigidity of the guidewire 202 may vary along its axial length to match the patient's physiological structure / curvature. Depending on the application, it may be advantageous for the compartment containing the guidewire 202 located within the descending aorta 203 (guidewire compartment 210) to be more rigid (i.e., less flexible) than the compartment located within the aortic arch 204 (guidewire compartment 212). Similarly, a guidewire compartment 212 located within the aortic arch 204 may be more flexible than a guidewire compartment 214 located within the ascending aorta 205, as this can accommodate the curves required to pass through the aortic arch 204. Because the guidewire compartment 212 is flexible, the guidewire 202 follows the shape of the aortic arch 204, and the curved portion of the guidewire compartment 212 within the aortic arch 204 is referred to herein as the first "virtual curve". The distal compartment, including the helical compartment 216, may be more flexible to accommodate the second U-shaped curve of the guidewire 202 within the left ventricle 206. In one embodiment, the first guidewire section 210 (proximal section) has a first rigidity, the second guidewire section 212 has a second rigidity, and the third guidewire section 214 has a third rigidity. Furthermore, the first stiffness is greater (i.e., harder) than the second and third stiffnesses. The third stiffness is greater than the second stiffness. In other words, the second guidewire compartment 212, which passes through the aortic arch 204, is the most flexible, allowing the guidewire 202 to follow the curvature of the aortic arch 204. The advantage of having varying flexibility / rigidity along the length of the guidewire 202 is that the guidewire 202 is nearly straight when not inserted (i.e., not pre-curved), and the portion of the guidewire 202 that needs to bend to conform to the patient's physiological structure can be made more flexible. In other words, the guidewire compartment 212 located in the aortic arch 204 does not need to be pre-curved to accommodate the shape of the aortic arch 204. Rather, because the guidewire compartment 212 is more flexible than the adjacent guidewire compartments 210 and 214, it can conform to the shape of the aortic arch 204, which is desirable for securely fixing the guidewire 202. Each guidewire section 210, 212, and 214 may include materials, dimensions, and structures configured to provide the desired rigidity / flexibility.

[0029] Furthermore, the guidewire 202 includes a helical section 216 located at the distal end of the guidewire 202 (i.e., distal to the third guidewire section 214). The spiral compartment 216 in this invention facilitates tracking and placement within anatomical structures by allowing it to conform to anatomical structures, and reduces stress that would straighten blood vessels during use. This spiral compartment 216 reduces trauma, enhances compressive capacity, and minimizes buckling by allowing it to conform to anatomical structures. In this example, the spiral section 216 is located proximal to the distal tip. The disclosed configuration enables uninterrupted monitoring by maintaining conductivity and position relative to the vascular wall (for example, the wall of the left ventricle 206 shown in Figure 2). These configurations also reduce the possibility or incidence of ventricular wall perforation during placement procedures. This spiral section 216 is useful in several human body structures and can be deformed to conform to those structures.

[0030] (As shown in Figures 5 and 6) The core or mandrel extends distal to the ring coil, and the non-traumatic tip of the mandrel is exposed. Furthermore, this non-traumatic tip (and the rest of the mandrel) is conductive and, when used as an electrode, enables the sensing of electrical and physiological signals to tissue adjacent to the non-traumatic tip, and the execution of pacing therapy. The detected signals may be related to potential complications of catheter-based cardiac procedures, such as arrhythmias (conduction block, arrhythmia-inducing manipulation). Furthermore, the detected signals may be related to structural complications (such as in the left ventricle) or other damage or perforation of a cardiac chamber, or other structural damage (e.g., valve perforation or damage).

[0031] Figure 3 is a cross-sectional view of the heart showing how the guidewire 202 forms a second "virtual curve" 300 so as to follow the shape of the left ventricle 206. The spiral compartment 216 and the second "virtual curved section" 300 facilitate fixation within the anatomical structure. This fixation means that the selected position is stably maintained by closely following the blood vessel during the procedure, thereby reducing both the procedure time and the risks associated with movement to delicate tissue, as demonstrated with current wires.

[0032] The spiral compartment 216 is positioned such that the heart wall does not exert compressive force on the spiral compartment 216. For example, as shown in Figure 3, the helical compartment 216 is located within the left ventricle 206 (i.e., below the aortic valve), but does not come into contact with the apex 209 of the left ventricle 206. For example, if the helical compartment 216 is located at the apex 209, the compression of the heart (the movement of the heart) can compress the helical compartment 216, causing friction and potentially damaging the cardiac tissue. The distal end, i.e., the third guidewire section 214, may have a predetermined shape such that the helical section 216 is spaced apart from the apex 209, as shown in Figure 3.

[0033] Figure 4 is a side view of a double-filament guidewire 402 having a first filament element 408 and a second filament element 410 wound around a central axis at different pitches. The first filament element 408 is an insulated conductive element, while the second filament element 410 is not insulated (i.e., a bare conductive element). The first filament element 408 and the second filament element 410 provide electrical connections that can be used for sensing, pacing, or both. The insulator surrounding the first filament element 408 is a polymer such as polytetrafluoroethylene (PTFE) or other insulating coating. To provide electrical connections at selected locations along the longitudinal direction of the guide wire 402, a portion of the insulating coating on the first filament element 408 may be removed to expose the conductive element beneath. Exposed conductive elements may be used for sensing / pacing operations. Similarly, a second, uninsulated filament element 410 may also be used for sensing / pacing operations.

[0034] Conductivity includes a physical electrical connection between one or more filaments of a coil and body tissue. Its conductivity allows it to detect electrical activity detected in tissue sites. For sensing purposes, a measuring instrument connected to the coil (e.g., the sensing circuit 120 shown in Figure 1) is configured to process the sensed signal and generate an output containing meaningful information about tissue and chamber parameters, electrical characteristics, or other characteristics related to the tissue. This measuring instrument may include a processor or circuit that analyzes the sensed electrical signal and generates an output. For example, sensing signals such as PQRS electrocardiogram signals can help predict a condition known as atrioventricular block.

[0035] Instead of using the first filament element 408 and the second filament element 410 (including the exposed portions of the first filament element 408 and the second filament element 410) as electrodes, one or more electrodes 412a, 412b, and 412c are attached to the outer circumference of the first filament element 408 and the second filament element 410. Electrodes 412a, 412b, and 412c are ring electrodes surrounding the first filament element 408 and the second filament element 410. The outer periphery of electrodes 412a, 412b, and 412c is larger than the outer periphery of the first filament element 408 and the second filament element 410. The advantage of this configuration is that electrodes 412a, 412b, and 412c can easily come into contact with adjacent tissue. One or more wires connected to each of the multiple electrodes 412a, 412b, and 412c extend proximal through an internal cavity defined by the first filament element 408 and the second filament element 410. The signals sensed by each of the multiple electrodes 412a, 412b, and 412c are transmitted to the sensing circuit 120 via these wires. Similarly, multiple electrodes 412a, 412b, and 412c may be selected to transmit pulses supplied by the pulse generator 122.

[0036] The flexibility / rigidity of the guidewire 402 is adjusted by changing the pitch at which the first filament element 408 and the second filament element 410 are wound around the central axis. For example, the first section 404 of the guide wire 402 has a first winding pitch, the second section 405 has a second winding pitch, and the third section 406 has a third winding pitch. Because the first winding pitch is shorter than the second winding pitch, the coil of the first winding is denser and provides higher rigidity than the second winding pitch. As described above, it is beneficial for the various sections 404, 405, and 406 of the guide wire 402 to have different flexibility / rigidity characteristics, and changing the winding pitch is one way to adjust the flexibility / rigidity. Although not shown in Figure 4, the mandrel (shown in Figure 5) is located within an internal cavity defined by the first filament element 408 and the second filament element 410. The flexibility of the guidewire 402 can also be adjusted by changing the diameter of the mandrel located within the internal cavities of the first filament element 408 and the second filament element 410.

[0037] The first filament element 408 and the second filament element 410 are configured to provide rigidity along the axial direction (i.e., the direction parallel to the winding axis of the first filament element 408 and the second filament element 410) and flexibility along all other directions. For example, adjacent windings within the first filament element 408 and the second filament element 410 will come into close contact with each other when compressed axially, thereby providing rigidity and support performance. However, if they are not parallel axially, adjacent windings within the first filament element 408 and the second filament element 410 will not come into close contact with each other.

[0038] Figure 5 is a side view of the mandrel 500. The Mandrel 500 is used as a core placed within an internal cavity defined by one or more filamentary elements. The Mandrel 500 is positioned along the entire length of the guide wire. In other embodiments, the mandrel 500 is positioned along only a portion of the length of the guide wire. The Mandrel 500 is composed of multiple sections with different diameters. By changing the diameter of the mandrel 500, the flexibility / rigidity characteristics can be changed between each section, with sections with larger diameters (e.g., the first section 502 and the second section 504) being more rigid than sections with smaller diameters (e.g., the third section 6, the fourth section 8, and the fifth section 510). Because of its varying flexibility / rigidity properties, the portion of the mandrel 500 that needs to be bent possesses a combination of flexibility and rigidity that allows for the desired bend while maintaining the desired rigidity in other sections. In the embodiment shown in Figure 5, the proximal compartment 502 has a maximum diameter that is constant along the longitudinal direction of the compartment in the axial direction. The second section 504 has a decreasing diameter along its axial length. Due to the decrease in diameter, the flexibility / rigidity changes along the axial length of the section. The third section 506 has a certain diameter that is smaller than most of the first section 502 and the second section 504. Section 4, 508, has a decreasing diameter along its axial length, resulting in a change in flexibility / rigidity along its axial length. The fifth compartment or distal compartment 510 has a constant diameter that is smaller than the diameters of the other compartments. In the embodiment shown in Figure 5, the diameter of the compartment decreases towards the distal end of the mandrel 500. In other embodiments, the diameter of the compartment may decrease or increase along the axial direction of the mandrel 500, depending on the desired flexibility / rigidity. Furthermore, the mandrel 500 may include a non-traumatic tip 512 that extends beyond the coil wire (i.e., is exposed distal to the coil wire). The non-traumatic tip 512 is designed to prevent perforation of adjacent tissue. Furthermore, the non-traumatic tip portion 512 may be conductive and may be used as an electrode for sensing and / or pacing. The mandrel 500 is conductive and may transmit signals from the sensing circuit 120 and / or the pulse generator 122.

[0039] The mandrel 500 is insulated, preventing electrical conduction between the mandrel 500 and one or more filament elements (as shown in Figure 4). Furthermore, the mandrel 500 may be manufactured from various conductive materials such as stainless steel. Mandrel 500 may contain 304 series stainless steel. 304 series refers to alloy steel according to the Society of Automotive Engineers (SAE) standards, containing chromium (18% to 20%) and nickel (8% to 10.5%) as non-ferrous components. In other embodiments, various other types of materials may be used to provide the desired conductivity and flexibility / rigidity.

[0040] Figure 6 is a side view of the distal end 604 of the sensor-equipped guidewire 600. This sensor-equipped guidewire 600 includes an elongated body 602 positioned between a proximal end (not shown) and a distal end 604. The distal end 604 of the sensor-equipped guidewire 600 has a distal tip portion 612 and is spirally wound. The distal end 604 has a rotation angle of at least 536°. The distal end 604 has a rotation angle of approximately 540°, or 1.5 rotations (in this case, "approximately" means ±30°). The distal end 604 is spirally wound to have a rotation angle of 324° to 539°. The distal end 604 is spirally wound to have a rotation angle from 536° to 1440°. The distal end 604 is spirally wound and has a first dimension 606 and a second dimension 608, the second dimension 608 being larger than the first dimension 606.

[0041] The spiral shape of the distal end 604 allows the sensor-equipped guidewire 600 to be non-invasively fixed inside the heart (e.g., the left ventricle). The distal tip 612 of the sensor-equipped guidewire 600 is located inside or in the center of the helical winding of the distal end 604, and is positioned away from the heart wall, which could cause trauma if the insertion force is too strong. The filament winding terminates proximal to the distal tip 612, and the distal tip 612 of the sensor-equipped guidewire 600 is an exposed mandrel (e.g., mandrel 500). The distal tip 612 (and the distal tip of the mandrel 500) has a non-invasive shape, such as a rounded shape, which is configured to reduce the possibility of perforation.

[0042] The outer helical winding portion of the distal end 604 engages with or adheres to the wall of the heart. The insertion force exerted by the sensor-equipped guidewire 600 on the heart is distributed over a wider surface area (i.e., the entire helical winding portion outside the distal end 604). For example, if the distal end 604 of the sensor-equipped guidewire 600 is not spirally wound, the distal tip 612 of the sensor-equipped guidewire 600 may transmit all of the insertion load and / or fixation force to the cardiac tissue at a single point (and parallel to the insertion angle into the heart), increasing the risk of perforation. The spiral winding at the distal end 604 reduces the possibility of perforation of cardiac tissue by distributing the insertion load and / or fixation force over a wider area and / or at an angle not parallel to the insertion angle.

[0043] The rotation angle of the spirally wound distal end 604, and / or the respective dimensions of the first dimension 606 and the second dimension 608, may be configured to accommodate various anatomical sizes of the heart (for example, based on the patient's size). The helically wound distal end 604 of the sensor-equipped guidewire 600 conforms to the shape of the cardiac tissue and, in some embodiments, flexibly changes as the cardiac tissue expands and contracts during the heart rhythm. The first dimension, 606, ranges from 25 mm to 60 mm. The second dimension, 608, ranges from 25mm to 80mm. The first dimension 606 and the second dimension 608 are pre-formed curved portions. After guiding the device to the treatment site, the sheath may be removed from the distal end 604 so that the distal end 604 has a predetermined spiral shape.

[0044] The sensor-equipped guidewire 600 includes a slender body 602 and a plurality of electrodes 610 arranged along the distal end 604. Each of the multiple electrodes 610 is electrically connected to a conductor (or wire) that extends along the sensor-equipped guidewire 600. For example, each of the multiple electrodes 610 may be configured to sense impedance (e.g., related to an impedance-based medical positioning system) and / or electrophysiological signals such as cardiac voltage, cardiac activity, heart rate timing, or EKG signals. The sensing circuits (such as the sensing circuit 120) may be electrically connected to each of the multiple electrodes 610 via individual conductors extending along the sensored guide wire 600 (for example, in the first section 404, the second section 405, and / or the third section 406).

[0045] Multiple electrodes 610 are electrically connected to a pacing generator (e.g., a pulse generator 122). Multiple electrodes 610 are configured to output pacing current to cardiac tissue. Two or more of the multiple electrodes 610 are connected to the pacing generator via a single (shared) wire. The multiple electrodes 610 include a first group of electrodes for pacing and a second group of electrodes for sensing. Each of the multiple electrodes 610 is configured to sense an electrophysiological signal and output a pacing signal.

[0046] The outer helical winding portion of the distal end 604 engages with and / or adheres to the cardiac wall (e.g., the left ventricular wall), thereby enabling close contact between the multiple electrodes 610 and cardiac tissue. The continuous close contact between multiple electrodes 610 and cardiac tissue is beneficial because it improves the accuracy of sensing electrophysiological signals and / or improves the transmission of pacing signals to cardiac tissue. The distal tip portion 612 includes a distal electrode (not shown). The distal tip 612 of the sensor-equipped guidewire 600 is positioned inside or in the center of the helical winding of the distal end 604, thereby positioning it away from the heart wall. The distal electrode may be configured to sense the impedance (or other electrophysiological properties) of the blood within the heart.

[0047] Figure 7 is a schematic diagram of the distal end 700 of the sensor-equipped guidewire 702. The distal end 700 is configured to be inserted into the left ventricle via the aortic valve. The distal end 700 of the sensor-equipped guidewire 702 is flexible and conforms to the structure of the surrounding tissue. For example, as shown in Figure 9, the distal end 700 includes a first portion 704 having a radius of curvature (ROC) 710. The first portion 704 is deflected through the wall of the left ventricle, extending toward the apex of the left ventricle, while the second portion 706 extends toward the aortic valve. The ROC710 of the first part 704 is 25 mm to 85 mm, and in some embodiments, the ROC710 of the first part 704 is 40 mm to 60 mm. The second portion 706 has a length of 712. The length of 712 is shorter than the length of the left ventricle.

[0048] The distal end 700 of the sensor-equipped guidewire 702 includes a helical portion 708 and a distal tip portion 714. Furthermore, the followability and / or flexibility of the distal end 700 of the sensor-equipped guidewire 702 is configured to facilitate proper positioning of the helical portion 708 and the distal tip portion 714. For example, if the helical portion 708 and / or distal tip portion 714 are positioned at the apex of the left ventricle, the sensor-equipped guidewire 702 may compress the cardiac tissue, potentially causing damage or perforation (see Figure 3). Furthermore, if the distal tip 714 is positioned outside the helical portion 708, the distal tip 714 may come into contact with the mitral valve and / or other valve structures, potentially causing damage or perforation. Therefore, the distal end 700 of the sensor-equipped guidewire 702 can be flexibly deformed to conform to the structure of the surrounding tissue, thereby enabling the safe positioning of the helical portion 708 and the distal tip portion 714. The distal end 700 has any or all of the features of the distal end 604 described above.

[0049] Figure 8 is a side view of a sensor-equipped guidewire 800 having an elliptical distal end 804. The sensor-equipped guidewire 800 includes a body 802 positioned between a proximal end (not shown) and a distal end 804. The distal end 804 of the sensor-equipped guidewire 800 has a distal tip and is spirally wound in an elliptical shape. The distal end 804 has a first dimension 806 and a second dimension 808. The first dimension 806 is 1.1 to 2.5 times the second dimension 808. Furthermore, the first dimension 806 is 1.25 to 1.75 times the second dimension 808. The elliptical shape of the distal end 804, i.e., the elongated ellipse shape, improves the fixing and holding force. For example, the elliptical shape of the distal end 804 is configured to follow the elliptical shape of the apex of the left ventricle. The distal end 804 may have any or all of the features of the distal ends 604 and 700 described above.

[0050] Figure 9 is a perspective view of the guide wire connector 900. The guidewire connector 900 includes a guidewire insertion port 902, a connection indicator 908, a first wing 904, and a second wing 906. The guidewire connector 900 is configured to connect the pacing generator and / or sensing unit to the guidewire. For example, a guidewire (including any or all features of, for example, guidewires 102, 202, 600, 702, 800) is inserted into a guidewire insertion port 902, and the conductive portion of the guidewire is connected to a pacing unit and / or sensing unit located at the opposite end of the guidewire insertion port 902. The connection indicator 908 is configured to indicate whether or not there is an electrical connection between the conductive element of the guide wire and the pacing unit and / or sensing unit. The connection indicator 908 includes a light-emitting diode (LED) that indicates whether the conductive element of the guide wire is connected to the pacing unit and / or sensing unit. The first wing 904 and the second wing 906 each include holes for securing the guidewire connector 900 to the surgical drape via clips, fasteners, or sutures.

[0051] Figure 10 is a perspective view of the grounding spike 1000. The grounding spike 1000 includes a conductor exit port 1002, a flange 1006 located at the proximal end, a body 1012 extending to the distal end 1010, a channel 1004 passing through the body 1012, and an exposed connection pad 1008 including a first electrical wiring 1014 and a second electrical wiring 1016. The body 1012 of the grounding spike 1000 is then inserted into the tissue of the insertion site (for example, at the incision site), and the distal end 1010 and body 1012 of the grounding spike 1000 enter a vein or artery (for example, the femoral artery). The main body 1012 is secured with tape, and the distal end 1010 defines a region smaller than the region adjacent to the flange 1006. The flange 1006 provides a stopper surface to prevent the grounding spike 1000 from being fully inserted into the patient, i.e., the flange 1006 remains outside the incision site. A guidewire having any or all features of guidewires 102, 202, 600, 702, and 800 is inserted through channel 1004 and led out from the distal end 1010 of grounding spike 1000. For example, a guidewire containing one or more electrodes for cardiac pacing, i.e., electrodes connected to a pacing generator, is inserted through channel 1004 and guided to the treatment site.

[0052] The exposed connection pad 1008 is in contact with venous or arterial blood, and the exposed connection pad 1008 is in contact with tissue or other bodily fluids. The exposed connection pad 1008 includes a first electrical wire 1014 and a second electrical wire 1016, and is configured to receive the return current from the pacing electrode, thereby providing grounding for the pacing generator. For example, a guidewire including one or more electrodes and a conductive element 1022 connected to a pacing unit 1020 for cardiac pacing is inserted through the channel 1004 to supply a pacing current to cardiac tissue. The return pacing current is collected at the exposed connection pad 1008 via the blood flow and / or other tissues. The exposed connection pad 1008 is made of a conductive material, while the body 1012 of the grounding spike 1000 is made of an insulating material (e.g., PTFE).

[0053] The conductor exit port 1002 is connected to the return conductor 1024, which is electrically connected to the exposed connection pad 1008. Therefore, the return pacing current is collected by the first electrical wiring 1014, the second electrical wiring 1016, and / or the exposed connection pad 1008 and discharged from the grounding spike 1000 through the conductor exit port 1002. The return conductor 1024 is connected to the pacing current return section 1018, which provides grounding for the return pacing current.

[0054] Furthermore, the grounding spike 1000 is beneficial in that it provides a stable, sterile insertion point for pacing guidewires (such as the guidewires 102, 202, 600, 702, and 800 mentioned above) via the channel 1004, collects internal return current via the exposed connection pad 1008, and provides a port for discharging the return current via the conductor exit port 1002. In other words, the pacing signal passes through the grounding spike 1000 (via the conductive element 1022), the return current is collected by the grounding spike 1000 (via the exposed connection pad 1008), and the return current is discharged from the grounding spike 1000 (via the conductor exit port 1002 and / or return conductor 1024). The multi-functionality of the Grounding Spike 1000 reduces the number of devices and incisions required for cardiac pacing treatment using a pacing guidewire, leading to shorter procedure times and a reduction in potential failures and complications during the procedure.

[0055] Figure 11 is a flowchart of a cardiac rhythm pacing method using a guidewire. In step 1110, the pacing method 1100 includes the step of sensing an electrophysiological (EP) signal using a plurality of electrodes located at the distal end of a guidewire. The guidewire includes any or all of the features of the guidewires 102, 202, 600, 702, and 800 described above. In step 1120, the pacing method 1100 includes the step of determining the contact state of a plurality of electrodes based on the sensed electrophysiological signals. The controller 124 and / or the sensing circuit 120 determine the contact state of each electrode. In step 1130, the pacing method 1100 includes the step of selectively outputting a pacing signal based on the determined contact state of a plurality of electrodes. Pacing signals are supplied only to electrodes in contact with the target tissue. The pacing signal is then generated by the pulse generator 122.

[0056] Although the present invention has been described with reference to embodiments, those skilled in the art will be able to make various modifications and replace components with equivalents without departing from the scope of the invention. Furthermore, numerous modifications are possible to adapt the teachings of the present invention to specific situations or materials without departing from the essential scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed, but includes all embodiments included in the appended claims. Consideration of Possible Embodiments

[0057] The following is a non-limiting description of possible embodiments of the present invention.

[0058] The invention described herein relates to a guidewire comprising a proximal end, a distal end including a helical section having electrodes and a distal tip, a filament element wound around a central axis extending from the proximal end to the distal end to form a filament winding, and a mandrel disposed within an internal cavity defined by the filament element, wherein the flexibility / rigidity properties of the guidewire vary along the axial direction due to the varying properties of one or both of the filament winding and the mandrel along the axial direction.

[0059] The invention described herein relates to a guide wire, wherein the helical section has a rotation angle of at least 536°.

[0060] The invention described herein relates to a guidewire, wherein the mandrel extends distally in the axial direction to the filament winding, and the portion of the mandrel extending distally to the filament winding is the distal tip of the guidewire.

[0061] The invention described herein relates to a guidewire, in which a portion of the mandrel extending axially beyond the filament winding is used as an electrode.

[0062] The invention described herein relates to a guidewire, wherein the electrode is configured to sense one or more electrophysiological signals, and the electrode is configured to output a pacing signal.

[0063] The invention described herein relates to a guidewire, wherein the helical section at the distal tip includes an elliptical shape having a first dimension and a second dimension, the first dimension being 1.1 to 2.5 times the second dimension.

[0064] The invention described herein relates to a guide wire, wherein the rotation angle of the helical section is from 536° to 1440°, the first dimension of the helical section is from 25 mm to 60 mm, and the second dimension of the helical section is from 25 mm to 80 mm.

[0065] The invention described herein relates to a guide wire, wherein the guide wire, positioned between a proximal end and a distal end near a helical section, does not include a predetermined curved portion.

[0066] The invention described herein relates to a guidewire, which includes a first compartment passing through the descending thoracic aorta, a second compartment passing through the aortic arch, and a third compartment passing through the ascending aorta, wherein the first compartment is more rigid than the second and third compartments.

[0067] The invention described herein relates to a guide wire, the guide wire comprising a first section and a second section, wherein the first width of the mandrel in the first section is greater than the second width of the mandrel in the second section.

[0068] The invention described herein relates to a guide wire in which the first pitch of the filament winding in the first section is greater than the second pitch of the filament winding in the second section.

[0069] The invention described herein relates to a guide wire, further comprising a second filament element wound around a mandrel together with the filament element.

[0070] The invention described herein relates to a guide wire in which a filament winding is insulated, and a portion of the insulation is removed to expose the conductive elements of the filament winding, thereby functioning as an electrode.

[0071] The invention described herein relates to a guidewire, wherein the guidewire is provided with a plurality of electrodes at various axial positions selected along the longitudinal direction of the guidewire.

[0072] The invention described herein relates to a guide wire, in which a plurality of electrodes are arranged on the outer surface of a filament winding, circumferentially outward from the filament winding.

[0073] The invention described herein relates to a medical system, the medical system comprising: a guidewire, which includes a proximal end; a distal end having a helical section having an electrode; a filament element being wound around a central axis extending from the proximal end to the distal end to form a filament winding; and a mandrel disposed within an internal cavity defined by the filament element; and a grounding spike, which includes a body having an exposed connection pad and a channel extending through the exposed connection pad, wherein the guidewire transmits electrical pulses extending through the channel and supplied from a pulse generator to the electrode, and the exposed connection pad provides a return path to the pulse generator.

[0074] The invention described herein relates to a medical system, and includes one or more electrical wires configured such that an exposed connection pad provides a return path to a pulse generator.

[0075] The invention described herein relates to a medical system in which a grounding spike includes a conductor exit port, which is electrically connected to an exposed connection pad and configured to accept a terminal connected to provide a return path to a pulse generator.

[0076] The invention described herein relates to a medical system, further comprising a sensing unit electrically connected to an electrode, the sensing unit being configured to receive a sensing signal from the electrode.

[0077] The invention described herein relates to a medical system in which the distal end includes a helical winding portion and a distal tip portion, the distal tip portion being located radially inward of the helical winding portion of the distal end.

[0078] The invention described herein relates to a method for pacing a cardiac rhythm using a guidewire, the method comprising the steps of sensing an electrophysiological (EP) signal using one or more electrodes arranged on a guidewire, wherein the guidewire includes a mandrel, a filament element wound around the mandrel, and one or more electrodes arranged at various axial positions along the length of the guidewire; determining the contact state of one or more electrodes based on the sensed EP signal; and selectively outputting a pacing signal to a selected electrode based on the determined contact state of one or more electrodes.

[0079] The invention described herein relates to a method for pacing a cardiac rhythm using a guidewire, wherein the contact state of one or more electrodes is determined by a sensing unit, and a pacing signal is generated by a pacing unit.

[0080] The invention described herein relates to a method for pacing a cardiac rhythm using a guidewire, wherein the EP signal includes one or more of impedance, electrocardiogram (EKG), and / or voltage.

[0081] The invention described herein relates to a method for pacing a cardiac rhythm using a guidewire, wherein a pacing signal is output to at least one of a plurality of electrodes in contact with tissue.

Claims

1. The proximal end and The distal end includes a spiral section and a distal tip, A filament element that is wound around a central axis extending from the proximal end to the distal end to form a filament winding, A mandrel disposed within an internal cavity defined by the filament element, wherein the properties of one or both of the filament winding and the mandrel vary along the axial direction, causing the flexibility / rigidity properties of the guidewire to change along the axial direction. At least one electrode arranged along the longitudinal direction of the guide wire, A guide wire equipped with this feature.

2. The guide wire according to claim 1, wherein the helical section has a rotation angle of at least 536°.

3. The mandrel extends distally in the axial direction compared to the filament winding, The guide wire according to claim 1, wherein the portion of the mandrel that extends axially beyond the filament winding is the distal tip portion of the guide wire.

4. The guide wire according to claim 3, wherein the portion of the mandrel extending axially beyond the filament winding is used as the electrode.

5. The electrode is configured to sense one or more electrophysiological signals. The guide wire according to claim 1, wherein the electrode is configured to output a pacing signal.

6. The helical section of the distal tip includes an elliptical shape having a first dimension and a second dimension, The guide wire according to claim 1, wherein the first dimension is 1.1 to 2.5 times the second dimension.

7. The rotation angle of the helical section is between 536° and 1440°. The first dimension of the spiral section is 25 mm to 60 mm. The guide wire according to claim 1, wherein the second dimension of the helical section is 25 mm to 80 mm.

8. The guide wire according to claim 1, wherein the guide wire, which is positioned between the proximal end and the distal end near the helical section, does not include a predetermined curved portion.

9. The guidewire according to claim 1, wherein the guidewire includes a first section passing through the descending thoracic aorta, a second section passing through the aortic arch, and a third section passing through the ascending aorta, the first section having higher rigidity than the second and third sections.

10. The guide wire includes a first section and a second section, The guide wire according to claim 1, wherein the first width of the mandrel in the first section is greater than the second width of the mandrel in the second section.

11. The guide wire according to claim 10, wherein the first pitch of the filament winding in the first section is greater than the second pitch of the filament winding in the second section.

12. The guide wire according to claim 1, further comprising a second filament element wound around the mandrel together with the aforementioned filament element.

13. The aforementioned filament winding is insulated, The guide wire according to claim 1, wherein a portion of the insulating portion is removed to expose the conductive element of the filament winding, thereby functioning as the electrode.

14. The guide wire according to claim 1, wherein the guide wire is provided with a plurality of electrodes at various axial positions selected along the longitudinal direction of the guide wire.

15. The guide wire according to claim 14, wherein the plurality of electrodes are arranged on the outer surface of the filament winding, circumferentially outward from the filament winding.

16. It is a guide wire, The proximal end and A distal end having a spiral section with electrodes, A filament element that is wound around a central axis extending from the proximal end to the distal end to form a filament winding, A mandrel is disposed within an internal cavity defined by the aforementioned filament element, Includes a guide wire, A grounding spike including a body having an exposed connection pad and a channel extending through the exposed connection pad, A medical system equipped with, The guide wire extends through the channel and transmits electrical pulses supplied from the pulse generator to the electrode. A medical system in which the exposed connection pad provides a return path to the pulse generator.

17. The medical system according to claim 16, wherein the exposed connection pad includes one or more electrical wires configured to provide the return path to the pulse generator.

18. The aforementioned grounding spike includes a conductor outlet port, The medical system according to claim 17, wherein the conductor exit port is configured to accept a terminal that is electrically connected to the exposed connection pad and connected to provide the return path to the pulse generator.

19. The system further comprises a sensing unit electrically connected to the electrode, The medical system according to claim 16, wherein the sensing unit is configured to receive sensing signals from the electrodes.

20. The distal end includes a spiral winding portion and a distal tip portion, The medical system according to claim 16, wherein the distal tip portion is located radially inward of the helical winding portion of the distal end.

21. A method for pacing cardiac rhythm using a guidewire, A step of sensing an electrophysiological (EP) signal using one or more electrodes arranged on the guide wire, The aforementioned guide wire, Mandrel and, The filament element wrapped around the mandrel, One or more electrodes are arranged at various axial positions along the length of the guide wire, The steps include sensing an electrophysiological (EP) signal, The steps include determining the contact state of one or more electrodes based on the sensed EP signal, The steps include: selectively outputting a pacing signal to a selected electrode based on the determined contact state of one or more electrodes; A method of pacing cardiac rhythm using a guidewire, including

22. The contact state of one or more electrodes is determined by the sensing unit. A method for pacing a cardiac rhythm using a guidewire according to claim 21, wherein the pacing signal is generated by a pacing unit.

23. A method for pacing a cardiac rhythm using a guidewire according to claim 21, wherein the EP signal includes one or more of impedance, electrocardiogram (EKG), and / or voltage.

24. A method for pacing a cardiac rhythm using a guidewire according to claim 21, wherein the pacing signal is output to at least one of the plurality of electrodes in contact with tissue.

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