Cardiac interventional catheter system

Abstract

This application relates to the field of medical device technology and proposes a cardiac interventional catheter system. The cardiac interventional catheter system includes: a handle; a catheter connected to the handle, the catheter including an outer catheter and an inner catheter located within the outer catheter; a first electrode disposed on the outer surface of the tip of the outer catheter, the first electrode being used to connect to a three-dimensional mapping system to acquire electrical signals from the endocardium; a microneedle connected to the inner catheter and located inside the outer catheter; and a push-pull member connected to the inner catheter to extend or retract the microneedle from the outer catheter, the push-pull member having an injection interface. This cardiac interventional catheter system first acquires electrical signals from the endocardium through a three-dimensional mapping system connected to the first electrode to accurately identify lesions, and then uses the push-pull member to extend the microneedle from the outer catheter for injection. Gene therapy drugs can be injected at the same location without changing the catheter, improving delivery accuracy.

Description

[0001] This application claims priority to Chinese patent application No. 202610275799.8, filed with the State Intellectual Property Office of China on March 6, 2026, entitled “Cardiac Intervention Catheter System”, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application relates to the field of medical device technology, and in particular to a cardiac interventional catheter system. Background Technology

[0003] Currently, traditional drug and surgical treatments have limited effectiveness in treating serious heart diseases such as myocardial infarction and heart failure. Emerging gene and cell therapies show great potential. However, gene therapy suffers from low delivery precision when injected into the myocardium. Summary of the Invention

[0004] In view of this, embodiments of this application provide a cardiac interventional catheter system to solve the problem of low delivery accuracy when injecting gene drugs into the myocardium.

[0005] The first aspect of this application discloses a cardiac interventional catheter system, comprising: handle; A catheter, connected to the handle, the catheter comprising an outer catheter and an inner catheter located within the outer catheter; The first electrode is disposed on the outer surface of the tip of the external catheter. The first electrode is used to connect to a three-dimensional mapping system to acquire electrical signals of the endocardium. Microneedles are connected to the inner catheter and located inside the outer catheter; A push-pull component, connected to the inner catheter, is used to extend or retract the microneedle from the outer catheter. The push-pull component has an injection port.

[0006] The beneficial effects of the cardiac interventional catheter system provided in this application are as follows: When the catheter is inserted into the endocardium, the first electrode at the tip of the external catheter is located within the endocardium. A three-dimensional mapping system connected to the first electrode collects electrical signals from the endocardium to accurately identify lesions (such as low-voltage areas). Subsequently, a push-pull mechanism extends the microneedle from the external catheter for injection. Therefore, gene therapy drugs can be injected at the same location without changing the catheter, improving delivery accuracy and reducing surgical time and operational risks.

[0007] In some embodiments, a plurality of first electrodes are provided, and the plurality of first electrodes are arranged at circumferential intervals along the outer conduit, with two adjacent first electrodes used to form a transmembrane electric field; or, the microneedle is a second electrode, and the second electrode and the first electrode are used to form a transmembrane electric field.

[0008] In some embodiments, the cardiac interventional catheter system further includes a guidewire located within the inner catheter and extendable from the microneedle, the guidewire being used for ablation of tissue or cells.

[0009] In some embodiments, the guidewire is a third electrode, which, together with the first electrode, is used to form a radial electric field covering the myocardial layer.

[0010] In some embodiments, a wire is pre-embedded in the external catheter, and the cardiac interventional catheter system further includes a connector connected to the handle, one end of the wire being connected to the first electrode, and the other end of the wire being connected to the connector.

[0011] In some embodiments, the wire is a liquid metal wire.

[0012] In some embodiments, the outer surface of the push-pull member is provided with a plurality of positioning portions, which are arranged at intervals along the extension and retraction direction of the push-pull member to position the length of the microneedle extending out of the outer conduit; and / or, the outer surface of the push-pull member is provided with a stop portion, which is used to stop and cooperate with the end face of the outer conduit.

[0013] In some embodiments, the tip of the external catheter is provided with a first ray marker; and / or, the tip of the microneedle is provided with a second ray marker.

[0014] In some embodiments, the external catheter includes an adjustable bend, the handle has an adjustment knob on its exterior, and the handle has a turntable arranged coaxially with the adjustment knob inside; the cardiac interventional catheter system also includes a traction member, which is wrapped around the turntable and both ends of the traction member are connected to the adjustable bend.

[0015] In some embodiments, the bending knob has a straight-line structure.

[0016] The above description is only an overview of the technical solution of this application. In order to better understand the technical means of this application and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of this application more obvious and understandable, the following are specific embodiments of this application. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1This is a schematic diagram of the structure of a cardiac interventional catheter system provided in some embodiments of this application; Figure 2 yes Figure 1 The cross-sectional view of the cardiac interventional catheter system shown at point A; Figure 3 yes Figure 2 The diagram shows a cross-sectional view of the microneedle extending from the outer catheter; Figure 4 yes Figure 2 Sectional view along the DD direction; Figure 5 yes Figure 2 A sectional view along the EE direction; Figure 6 yes Figure 1 A magnified view of the cardiac interventional catheter system shown at point B; Figure 7 yes Figure 6 A sectional view; Figure 8 yes Figure 1 The sectional view of the cardiac interventional catheter system shown at point C; Figure 9 This is a schematic diagram of the electric field formed by the first electrode and the microneedle provided in some embodiments of this application; Figure 10 This is a schematic diagram of the electric field formed by the first electrode and the guide wire provided in some embodiments of this application.

[0019] The markings in the diagram mean: 100. Cardiac interventional catheter systems; 10. Handle; 11. Bending knob; 12. Turntable; 20. Catheter; 21. External catheter; 211. Tip; 212. Adjustable bend; 22. Internal catheter; 30. First electrode; 40. Microneedles; 50. Push-pull component; 51. Injection port; 52. Positioning part; 53. Stop part; 54. Guide wire inlet; 60. Wire; 70. Connector; 80. Pulling components; 90. Guide wire. Detailed Implementation

[0020] The embodiments of the technical solution of this application will now be described in detail with reference to the accompanying drawings. These embodiments are only used to more clearly illustrate the technical solution of this application and are therefore merely examples, and should not be used to limit the scope of protection of this application.

[0021] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains; the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the application; the terms “comprising” and “having”, and any variations thereof, in the specification, claims, and foregoing description of the drawings are intended to cover non-exclusive inclusion.

[0022] In the description of the embodiments of this application, technical terms such as "first" and "second" are used only to distinguish different objects and should not be construed as indicating or implying relative importance or implicitly specifying the number, specific order, or primary and secondary relationship of the indicated technical features. In the description of the embodiments of this application, "multiple" means two or more, unless otherwise explicitly defined.

[0023] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0024] In the description of the embodiments in this application, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Additionally, the character " / " in this document generally indicates that the preceding and following related objects have an "or" relationship.

[0025] In the description of the embodiments of this application, the term "multiple" refers to two or more (including two), similarly, "multiple sets" refers to two or more (including two sets), and "multiple pieces" refers to two or more (including two pieces).

[0026] In the description of the embodiments of this application, the technical terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings. They are only for the convenience of describing the embodiments of this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of this application.

[0027] In the description of the embodiments of this application, unless otherwise expressly specified and limited, technical terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. For those skilled in the art, the specific meaning of the above terms in the embodiments of this application can be understood according to the specific circumstances.

[0028] Currently, traditional drug and surgical treatments have limited effectiveness in treating serious heart diseases such as myocardial infarction and heart failure. Emerging gene and cell therapies show great potential, but are limited by bottlenecks in delivery technology.

[0029] Lack of integrated tools for precise localization and delivery: Existing endocardial injection catheters (such as Noga, MyoStar™, etc.) typically only have a single injection function and cannot perform high-quality electrophysiological mapping. Physicians often need to first use a specialized mapping catheter (such as Pentray®) to determine the location of the lesion (such as low-voltage areas, fragmented potential areas), and then switch to an injection catheter for blind or semi-blind injection. This operation is complex, time-consuming, and prone to losing the target location, resulting in low delivery accuracy.

[0030] Low transfection efficiency of gene therapy drugs: Gene therapy drugs injected directly into the myocardium (such as plasmid DNA, mRNA, siRNA, etc.) have poor extracellular stability and are difficult to cross the cell membrane to enter the cell, resulting in extremely low transfection efficiency and poor therapeutic effects. Currently, methods to improve transfection efficiency (such as viral vectors) pose safety risks such as immunogenicity and carcinogenicity, while physical methods (such as electroporation), although safe, lack interventional tools that can safely and effectively perform electroporation in a beating heart.

[0031] Insufficient operational safety: Existing injection catheters have exposed needles or uncontrollable extension lengths, which can easily cause serious complications such as myocardial perforation and cardiac tamponade.

[0032] Lack of multimodal image-guided compatibility: Many catheters are poorly visualized under X-ray or intracardiac echocardiography (ICE), increasing the difficulty and risk of operation.

[0033] An embodiment of the first aspect of this application provides a cardiac interventional catheter system. Please refer to... Figures 1 to 3The cardiac interventional catheter system 100 includes a handle 10, a catheter 20, a first electrode 30, a three-dimensional mapping system, a microneedle 40, and a push-pull component 50. The catheter 20 is connected to the handle 10 and includes an outer catheter 21 and an inner catheter 22 located within the outer catheter 21. The first electrode 30 is located on the outer surface of the tip 211 of the outer catheter 21 and is used to connect to the three-dimensional mapping system to acquire electrical signals from the endocardium. The microneedle 40 is connected to the inner catheter 22 and is located inside the outer catheter 21. The push-pull component 50 is connected to the inner catheter 22 to drive the microneedle 40 to extend or retract from the outer catheter 21. The push-pull component 50 has an injection port 51.

[0034] Understandably, the handle 10 is ergonomically designed to facilitate one-handed or two-handed operation by doctors. The outer shell of the handle 10 is injection molded, with internal functional modules assembled to ensure smooth operation and a good seal.

[0035] Optionally, the external catheter 21 adopts a multi-layered composite structure. For example, the external catheter 21 includes an outer layer, a middle layer, and an inner liner. The outer layer can be made of materials such as Pebax (polyether block amide), POM (polyoxymethylene), or PA (polyamide) through an extrusion process. The middle layer can be woven from stainless steel wire / nickel-titanium wire to enhance physical properties. The inner liner can be made of PTFE (polytetrafluoroethylene) to reduce friction. Therefore, the external catheter 21 has good pushability, flexural strength, and torsion control. The outer diameter of the external catheter 21 can be adjusted as needed, for example, designed as 7.5F, where F is a common unit of measurement for medical devices used to describe the outer diameter of tubular instruments. The length of the external catheter 21 meets the requirements for reaching the left / right ventricle via the femoral artery / femoral vein.

[0036] The head end 211 of the external conduit 21 is made of a softer material and is connected to the body of the external conduit 21 through processes such as thermal bonding.

[0037] Understandably, the inner catheter 22 is an injection tube, and the inner catheter 22 can move axially relative to the outer catheter 21. The inner catheter 22 can be made of a polymer material.

[0038] For example, the first electrode 30 is made of a material with excellent biocompatibility and conductivity. For instance, the material of the first electrode 30 can be a platinum-iridium alloy, TPU-Ag, graphene, or carbon nanotubes.

[0039] Optionally, the first electrode 30 can be fixed to the outer surface of the head end 211 of the outer conduit 21 by laser welding or crimping.

[0040] Understandably, the first electrode 30 can be connected to a three-dimensional mapping system (such as EnSite™, CARTO®) to acquire electrical signals from the endocardium to construct a high-resolution three-dimensional voltage map and electrokinetic map, thereby accurately locating lesions (such as infarct areas, scar areas, marginal areas, etc.).

[0041] Understandably, the microneedle 40 is positioned close to the tip 211 of the external catheter 21 and is movable relative to the tip 211 of the external catheter 21 to extend or retract the external catheter 21.

[0042] Alternatively, the microneedle 40 can be made of materials such as medical-grade stainless steel or nickel-titanium alloy. The microneedle 40 features a beveled tip for easier puncture and a small outer diameter (e.g., 27G-30G) to minimize tissue damage.

[0043] Understandably, the microneedle 40 is connected to one end of the inner catheter 22, and the push-pull element 50 is connected to the other end of the inner catheter 22. When it is necessary to inject drugs or gene agents, after ensuring that the target position is accurate and the tip 211 of the outer catheter 21 is well attached, the push-pull element 50 pushes the microneedle 40 out of the outer catheter 21 by a predetermined length (e.g., 2-4 mm) through the inner catheter 22, and the microneedle 40 pierces the myocardial tissue of the endocardium; after the drug or gene agent injection is completed, the push-pull element 50 pulls the microneedle 40 back into the outer catheter 21 through the inner catheter 22 to avoid scratching blood vessels and the endocardium.

[0044] The push-pull component 50 has an injection interface 51, which can be understood as a hollow structure. When the syringe or injection pump is connected to the injection interface 51, the drug or gene preparation can be delivered into the microneedle 40 through the push-pull component 50 and the inner catheter 22 to achieve the injection of the drug or gene preparation.

[0045] The cardiac interventional catheter system 100 provided in this application includes a handle 10, a catheter 20, a first electrode 30, a three-dimensional mapping system, a microneedle 40, and a push-pull component 50. When the catheter 20 is inserted into the endocardium, the first electrode 30 on the tip 211 of the outer catheter 21 is located within the endocardium. The three-dimensional mapping system connected to the first electrode 30 collects electrical signals from the endocardium to construct a high-resolution three-dimensional voltage map and electrokinetic map, thereby accurately locating lesions (such as infarct areas, scar areas, marginal areas, etc.). Subsequently, the push-pull component 50 pushes the microneedle 40 out of the outer catheter 21 through the inner catheter 22 for injection. After injection, the push-pull component 50 pulls the microneedle 40 back into the outer catheter 21 through the inner catheter 22 to avoid scratching blood vessels and the endocardium. Therefore, gene therapy drugs can be injected at the same location without replacing the catheter 20, improving delivery accuracy and reducing surgical time and operational risks.

[0046] Please refer to Figure 4 and Figure 5In some embodiments, multiple first electrodes 30 are provided, and the multiple first electrodes 30 are arranged at intervals along the circumference of the outer conduit 21. Two adjacent first electrodes 30 are used to form a transmembrane electric field.

[0047] Understandably, two, three, four, or more first electrodes 30 can be provided. When three first electrodes 30 are provided, the manufacturing cost can be reduced while still achieving accurate lesion localization.

[0048] For example, three first electrodes 30 are provided, and the three first electrodes 30 are evenly spaced around the circumference of the outer conduit 21, that is, the central angle between two adjacent first electrodes 30 is 120°.

[0049] The two adjacent first electrodes 30 are used to form a transmembrane electric field. This can be understood as one of the two adjacent first electrodes 30 being the positive electrode and the other being the negative electrode, i.e., a bipolar mode.

[0050] Each of the first electrodes 30 is connected to a pulse generator. The pulse generator is used to create a transmembrane electric field between two adjacent first electrodes 30, so that the myocardial cell membrane in the area covered by the first electrode 30 forms a reversible micropore, i.e., electroporation.

[0051] Understandably, the voltage, pulse width, and number of pulses of the pulse electric field applied by the pulse generator are adjustable to ensure that irreversible tissue damage and arrhythmias are avoided while achieving reversible micropores. Optionally, the pulse electric field applied by the pulse generator is a high-voltage short-pulse magnetic field (such as 500V voltage, nanosecond / microsecond level pulses).

[0052] Each of the first electrodes 30 provided in this application embodiment can form reversible micropores in situ at the injection site by connecting to a pulse generator, overcoming the barrier of gene agents / drugs entering cardiomyocytes, significantly improving the transfection efficiency and expression level of non-viral vector gene therapy, thereby enhancing the therapeutic effect.

[0053] In some other embodiments, a single first electrode 30 may be provided, with one of the first electrode 30 and the body surface reference electrode being the positive electrode and the other being the negative electrode, i.e., a unipolar mode. In this case, the first electrode 30 may be a ring electrode.

[0054] Please refer to Figure 9 In some embodiments, the microneedle 40 is a second electrode, and the second electrode and the first electrode 30 are used to form a transmembrane electric field. In this way, the electroporation formed by the second electrode and the first electrode 30 is more focused on the injection area of ​​the microneedle 40.

[0055] Understandably, one of the second electrode (i.e., microneedle 40) and the first electrode 30 is the positive electrode, and the other of the second electrode (i.e., microneedle 40) and the first electrode 30 is the negative electrode.

[0056] A wire connecting the microneedle 40 and the pulse generator can be installed inside the wall of the inner catheter 22.

[0057] In some embodiments, the first electrode 30 has a sheet-like structure.

[0058] Understandably, the first electrode 30 is attached to the outer surface of the outer conduit 21, that is, the first electrode 30 is an arc-shaped sheet structure.

[0059] The first electrode 30 in this embodiment is a sheet-like structure, which can help determine the adhesion between the tip 211 of the external catheter 21 and the endocardium (by observing the potential amplitude and morphology), ensuring the effectiveness of injection and electroporation.

[0060] Please refer to Figure 2 and Figure 3 In some embodiments, the cardiac interventional catheter system 100 further includes a guidewire 90, which is located within the inner catheter 22 and can extend from the microneedle 40. The guidewire 90 is used to ablate tissue or cells. The guidewire 90 can deliver radio frequency (RF) or pulsed field (PFA) energy.

[0061] For example, the push-pull member 50 is provided with a guide wire inlet 54, through which the guide wire 90 enters the inner catheter 22. The guide wire inlet 54 is provided with a sealing ring to prevent the medication from flowing out of the guide wire inlet 54 during injection.

[0062] It should be noted that since the guide wire 90 extends from the microneedle 40, the guide wire 90 can serve as a hydrodynamic enhancement component. That is, the movement of the guide wire 90 within the microneedle 40 can adjust the injection pressure and distribution pattern of the drug solution.

[0063] Please refer to Figure 10 In some embodiments, the guidewire 90 is a third electrode, and the third electrode and the first electrode 30 are used to form a radial electric field covering the myocardial layer.

[0064] After the microneedle 40 pierces the myocardium and injects the drug solution, the guidewire 90 extends further into the deep myocardium (such as the subepicardium). At this point, the deep guidewire 90 serves as the third electrode (i.e., the central electrode), forming a centripetal converging electric field with the first electrode 30, which is attached to the endocardial surface. Because the electric field lines radiate from the deep myocardium towards the surface, they can completely cover the diffusion cloud of the drug in the intermyocardial space, thereby achieving highly efficient gene transfection of the entire myocardial layer in the infarcted area and improving the delivery range.

[0065] Since the guidewire 90 extends directly from the microneedle 40, the "injection center" and the "electric field center" are aligned or nearly aligned. This design eliminates the eccentricity error caused by the bending of the catheter or the change in the contact angle of the traditional lateral electrode, ensuring that the electroporation pulse is accurately applied to the distribution area of ​​the highest concentration of drug solution, maximizing the transfection efficiency and reducing electrical damage to non-target tissues.

[0066] It should be noted that the transmembrane electric field formed by the first electrode 30 and the microneedle 40 is the conventional delivery mode; the radial electric field formed by the first electrode 30 and the extended guidewire 90 covering the entire myocardial layer is the enhanced delivery mode; and the guidewire 90, as the active electrode, releases radio frequency (RF) or pulsed field (PFA) energy, which is the ablation mode. The conventional delivery mode, enhanced delivery mode, and ablation mode can be switched as needed.

[0067] Please refer to Figure 1 , Figure 4 and Figure 5 In some embodiments, a wire 60 is pre-embedded in the external catheter 21, and the cardiac interventional catheter system 100 also includes a connector 70 connected to the handle 10. One end of the wire 60 is connected to the first electrode 30, and the other end of the wire 60 is connected to the connector 70.

[0068] Understandably, the number of wires 60 is the same as the number of first electrodes 30. For example, when there are two first electrodes 30, there are correspondingly two wires 60; when there are three first electrodes 30, there are correspondingly three wires 60.

[0069] Understandably, multiple conductors 60 are arranged circumferentially along the outer conduit 21, and each conductor 60 extends axially along the outer conduit 21.

[0070] Optionally, a connector 70 is provided, and all wires 60 pass through the handle 10 and are connected to the same connector 70. The connector 70 connects both the 3D mapping system and the pulse generator via an adapter box.

[0071] In some embodiments, the conductor 60 is a liquid metal conductor to improve its flexibility and fatigue resistance. The liquid metal conductor is encapsulated in a flexible polymer tube to prevent leakage.

[0072] Of course, wire 60 can also be made of traditional thin metal wire.

[0073] Please refer to Figure 6 and Figure 7 In some embodiments, the outer surface of the push-pull member 50 is provided with a plurality of positioning portions 52, which are arranged at intervals along the extension and retraction direction of the push-pull member 50 to position the length of the microneedle 40 extending out of the outer guide tube 21.

[0074] Optionally, the push-pull component 50 is a push-pull rod, and the outer surface of the push-pull rod is provided with an exhaust groove to facilitate gas exhaust when the push-pull rod is pushed or pulled, thereby improving the smoothness of the push-pull rod.

[0075] Understandably, the positioning parts 52 can be arranged in two, three, four or more at intervals along the extension and retraction direction of the push-pull member 50.

[0076] Optionally, the positioning part 52 includes a plurality of positioning teeth arranged circumferentially along the push-pull member 50. Of course, the positioning part 52 can also be a positioning ring.

[0077] In this embodiment, the positioning part 52 will make a collision sound with the end face of the outer guide tube 21 when the push-pull member 50 is pushed, so as to remind the operator of the size of the microneedle 40 extending out of the outer guide tube 21; and if the push-pull member 50 is continued to be pushed, the positioning part 52 can enter the interior of the outer guide tube 21 to realize the subsequent positioning of the positioning part 52.

[0078] In some other embodiments, instead of providing a positioning part 52 on the outer surface of the push-pull member 50, a scale may be provided on the outer surface of the push-pull member 50, and the size of the microneedle 40 extending out of the outer guide tube 21 may be confirmed by observing the scale.

[0079] In some embodiments, the outer surface of the push-pull member 50 is provided with a stop portion 53, which is used to stop and cooperate with the end face of the external catheter 21 to avoid the push-pull member 50 being pushed too much, causing the microneedle 40 to extend too far out of the external catheter 21, thereby causing serious complications such as myocardial perforation and cardiac tamponade.

[0080] For example, the stop portion 53 is a stop ring.

[0081] In some embodiments, the tip 211 of the external catheter 21 is provided with a first X-ray marker to ensure that the tip 211 of the external catheter 21 is clearly visible under X-ray fluoroscopy, so as to clearly show the contact between the tip 211 of the external catheter 21 and the endocardium, providing doctors with intuitive real-time image navigation and ensuring the accuracy and safety of the operation; moreover, the material and structural design of the external catheter 21 takes into account acoustic impedance matching, improving the imaging effect under intracardiac ultrasound (ICE).

[0082] Understandably, the first ray marker can be a first electrode; or, the first ray marker can be an additional component. The first ray marker can be made of a platinum-iridium alloy, gold, or tantalum, etc.

[0083] In some embodiments, the tip of the microneedle 40 is provided with a second X-ray marker to ensure that the tip of the microneedle 40 is clearly visible under X-ray fluoroscopy, so as to clearly show the extension and insertion process of the microneedle 40, providing doctors with intuitive real-time image navigation and ensuring the accuracy and safety of the operation.

[0084] The material of the second ray marker can be a platinum-iridium alloy, gold, or tantalum.

[0085] Please refer to Figure 1 , Figure 2 , Figure 5 and Figure 8 In some embodiments, the external catheter 21 includes an adjustable bend 212, the handle 10 is provided with an adjustment knob 11 on the outside, and the handle 10 is provided with a turntable 12 arranged coaxially with the adjustment knob 11 inside; the cardiac interventional catheter system 100 also includes a traction member 80, which is wrapped around the turntable 12 and both ends of the traction member 80 are connected to the adjustable bend 212.

[0086] For example, the adjustable bend 212 is located 5-10 cm from the tip 211 of the external catheter 21.

[0087] The bending adjustment knob 11 is rotatably connected to the main body of the handle 10. Exemplarily, the bending adjustment knob 11 has a straight-line structure to facilitate rotation by the doctor. Of course, the bending adjustment knob 11 can also be a circular knob. The bending adjustment knob 11 can be located at the end of the handle 10 or in the middle of the handle 10.

[0088] The turntable 12 and the bending knob 11 are arranged coaxially. Understandably, when the doctor turns the bending knob 11, the bending knob 11 can drive the turntable 12 to rotate synchronously.

[0089] The traction element 80 is wound around the turntable 12, which can be understood as the turntable 12 dividing the traction element 80 into two segments; exemplarily, the two segments of the traction element 80 are respectively located on both sides of the inner catheter 22. The traction element 80 engages with the turntable 12, and when the turntable 12 rotates, it can drive the traction element 80 wound around it to move, thereby controlling the bending direction and angle of the adjustable bend 212, achieving flexible manipulation within the heart. The rotation direction of the turntable 12 is consistent with the bending direction of the adjustable bend 212 to facilitate physician operation.

[0090] For example, the tension member 80 is a wire drawing member.

[0091] The cardiac interventional catheter system 100 provided in this application integrates precise three-dimensional electroanatomical mapping, safe and controllable endocardial injection, and efficient physical transfection (electroporation) functions into one, realizing integrated operation of diagnostic functions (mapping) and therapeutic functions (injection + electroporation). Through ingenious structural design, it achieves functional synergy, reduces the equipment and steps required for surgery, simplifies the surgical procedure, and lowers the requirements for doctors' operating skills.

[0092] The cardiac interventional catheter system 100 provided in this application embodiment is mainly used for minimally invasive interventional diagnosis and treatment of cardiovascular diseases, specifically including but not limited to: Treatment of ischemic heart disease (myocardial infarction): It is used to precisely deliver gene drugs (such as plasmids / mRNAs such as VEGF, HGF, MGT, etc.), stem cells, exosomes or small molecule drugs to the infarct area and marginal area, and to improve efficacy by combining electroporation.

[0093] Heart failure treatment: Drugs or gene agents used to deliver to dilated or hypertrophic areas of the myocardium that improve myocardial contractility and reverse remodeling.

[0094] Arrhythmia matrix mapping and intervention: High-density mapping capabilities are used to precisely map the arrhythmia matrix and explore precise drug / gene ablation or regulation in this region.

[0095] Other heart diseases: localized and precise treatment of cardiomyopathy, myocarditis, etc.

[0096] Scientific research: As a medical tool, it is used to study the mechanisms of heart disease and to develop and validate new therapies in large animal models.

[0097] Application: Catheter 20 is inserted into the target cardiac chamber via a conventional cardiac interventional route (e.g., femoral vein puncture → atrial septal puncture → left atrium → left ventricle, femoral artery puncture → across the aortic arch → left ventricle, or directly via the internal jugular vein / femoral vein → right ventricle), under X-ray and / or ICE guidance. Three-dimensional electroanatomical mapping is performed using the integrated first electrode 30 to construct a ventricular model and identify lesions (e.g., low-voltage areas). The tip 211 of the external catheter 21 is maneuvered to align with the target area. After confirming good alignment, the microneedle 40 is extended and inserted into the myocardium for gene drug injection, followed by an electroporation pulse. After completion, the microneedle 40 is retracted, and the procedure is repeated at the next target site.

[0098] The specific working principle of the cardiac interventional catheter system 100 provided in this application embodiment is as follows: Mapping: The physician manipulates the handle 10 to move the tip 211 of the external catheter 21 within the heart chamber and bring it into contact with the endocardium. The three first electrodes 30 of the tip 211 sense the electrical signals of the endocardium and transmit them to the three-dimensional mapping system via the lead wire 60. Based on the signal characteristics (time and amplitude) fed back by each first electrode 30 and the spatial position information of the external catheter 21 (which may require the use of magnetic or impedance positioning sensors, and existing technologies can be referenced), the three-dimensional mapping system constructs a three-dimensional geometric model of the ventricle and a superimposed voltage / electrokinetic map, thereby visually identifying lesion areas (such as infarct scars displayed as low-voltage areas).

[0099] Positioning and Alignment: Based on the mapping results, the physician manipulates the external catheter 21 to precisely move the tip 211 to the target lesion area and adjusts the angle of the tip 211 to ensure it is perpendicular or nearly perpendicular to the endocardium. At this point, the alignment quality can be confirmed by observing a real-time electrocardiogram (increased signal amplitude, stable morphology), ICE imaging, or X-ray fluoroscopy.

[0100] Injection: After confirming good adhesion, the doctor uses the push-pull component 50 to push out the microneedle 40, inserting it into the subendocardium to a certain depth (e.g., 3mm). The injection pump is connected through the injection interface 51, and the predetermined dose of gene drug solution is injected into the interstitial space of the myocardial tissue through the microneedle 40.

[0101] Electroporation: After injection (or simultaneously with injection), an external pulse generator is triggered. A high-voltage, short-pulse electric field is applied to the myocardial tissue in the injection area via multiple first electrodes 30 (as one or more poles) at the tip 211 of the external catheter 21, or between the first electrode 30 and the microneedle 40, or between the first electrode 30 and the guidewire 90. The electric field creates transient micropores in the cell membrane, facilitating the entry of extracellular gene drug molecules into the cell.

[0102] Needle retraction: After electroporation is completed, operate the push-pull component 50 to retract the microneedle 40, and prepare for the next step.

[0103] The method for endocardial targeted delivery using the cardiac interventional catheter system 100 provided in this application embodiment is as follows: 1. Preparation: Establish a standard cardiac interventional access and insert a long sheath (or an adjustable curved sheath).

[0104] 2. Catheter insertion and navigation: Under X-ray and / or ICE guidance, the catheter is inserted through a long sheath into the target ventricle (left or right ventricle).

[0105] 3. Three-dimensional mapping and matrix identification: The catheter is manipulated to make multiple contact samplings in the ventricle, and the first electrode at the tip is used to collect electrical signals to construct a high-density three-dimensional voltage map / electrokinetic map, and to identify and mark the lesion area of ​​interest (such as the infarct border area).

[0106] 4. Target localization and engagement: Navigate the head unit to the marked target point and adjust the angle to achieve stable engagement. Confirm engagement quality using electro-optical features and imaging (ICE / X-Ray).

[0107] 5. Microneedle insertion and injection: Operate the push-pull device to extend the microneedle and insert it into the myocardium, and inject the drug / gene agent according to the predetermined plan.

[0108] 6. In situ electroporation: Keeping the catheter in place, an electroporation pulse with preset parameters is applied to promote cellular uptake of drugs / gene agents.

[0109] 7. Repeat the operation: retract the microneedle, move the catheter to the next target point, and repeat steps 4-6 until all planned target points have been delivered.

[0110] 8. Postoperative assessment and withdrawal: Immediate response can be assessed again by mapping (such as observing potential changes). Once it is confirmed that there are no complications, the catheter can be withdrawn and the procedure can be completed.

[0111] The above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application, and should all be included within the protection scope of this application.

Claims

1. A cardiac interventional catheter system, characterized in that, include: handle; A catheter, connected to the handle, the catheter comprising an outer catheter and an inner catheter located within the outer catheter; The first electrode is disposed on the outer surface of the tip of the external catheter. The first electrode is used to connect to a three-dimensional mapping system to acquire electrical signals of the endocardium. Microneedles are connected to the inner catheter and located inside the outer catheter; A push-pull component, connected to the inner catheter, is used to extend or retract the microneedle from the outer catheter. The push-pull component has an injection port.

2. The cardiac interventional catheter system as described in claim 1, characterized in that, The first electrode is provided in multiple ways, and the multiple first electrodes are arranged at intervals along the circumference of the outer conduit. Two adjacent first electrodes are used to form a transmembrane electric field; or, the microneedle is a second electrode, and the second electrode and the first electrode are used to form a transmembrane electric field.

3. The cardiac interventional catheter system as described in claim 1, characterized in that, The cardiac interventional catheter system also includes a guidewire, which is located within the inner catheter and can extend from the microneedle, and the guidewire is used to ablate tissue or cells.

4. The cardiac interventional catheter system as described in claim 3, characterized in that, The guidewire is a third electrode, and the third electrode and the first electrode are used to form a radial electric field covering the myocardial layer.

5. The cardiac interventional catheter system as described in any one of claims 1-4, characterized in that, The external catheter has a pre-embedded wire, and the cardiac interventional catheter system also includes a connector connected to the handle. One end of the wire is connected to the first electrode, and the other end of the wire is connected to the connector.

6. The cardiac interventional catheter system as described in claim 5, characterized in that, The conductor is a liquid metal conductor.

7. The cardiac interventional catheter system as described in any one of claims 1-4, characterized in that, The outer surface of the push-pull member is provided with a plurality of positioning portions, which are arranged at intervals along the extension and retraction direction of the push-pull member to position the length of the microneedle extending out of the outer guide tube; and / or, the outer surface of the push-pull member is provided with a stop portion, which is used to stop and cooperate with the end face of the outer guide tube.

8. The cardiac interventional catheter system as described in any one of claims 1-4, characterized in that, The tip of the external catheter is provided with a first ray marker; and / or, the tip of the microneedle is provided with a second ray marker.

9. The cardiac interventional catheter system as described in any one of claims 1-4, characterized in that, The external catheter includes an adjustable bend, and the outside of the handle is provided with an adjustment knob. The inside of the handle is provided with a turntable arranged coaxially with the adjustment knob. The cardiac interventional catheter system also includes a traction member, which is wrapped around the turntable and both ends of the traction member are connected to the adjustable bend.

10. The cardiac interventional catheter system as described in claim 9, characterized in that, The bending knob has a straight-line structure.

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