An ablation catheter with adjustable support rod and apparatus
By using an adjustable ablation catheter with a support rod, and by generating a pulsed electric field with multiple electrodes and an energy generator, the problem of difficulty in real-time confirmation of ablation boundaries and thermal damage in existing technologies has been solved, achieving efficient and safe ablation of the heart.
Patent Information
- Application Number
- CN202210416189.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2022-01-27
- Publication Date
- 2025-12-09
- Estimated Expiration
- 2042-01-27
AI Technical Summary
Existing radiofrequency, microwave, and cryoablation techniques are difficult to confirm ablation boundaries in real time when treating heart lesions and may cause thermal damage to important tissues, thus failing to meet the needs of atrial fibrillation treatment using intracardiac pulmonary vein ostium catheter ablation.
An adjustable ablation catheter with support rods was designed, comprising first and second annular support rods, with multiple electrodes on the support rods. A pulsed electric field is formed by controlling the discharge between the electrodes through an energy generator. Combined with the mapping electrode and the ablation electrode, real-time monitoring of the ablation progress and safety control are achieved.
It achieves high-density electric field ablation of the heart, enabling timely confirmation of ablation effects, avoiding thermal damage to important tissues, and improving the safety and precision of ablation.
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Figure CN115024812B_ABST
Abstract
Description
[0001] Divisional Statement
[0002] This application is a divisional application of Chinese Patent Application No. CN202210098625.0 entitled "Ablation Catheter and Equipment" filed on January 27, 2022. TECHNICAL FIELD
[0003] The present application relates to the technical field of medical equipment, in particular to an ablation catheter with adjustable support rods and an equipment. BACKGROUND
[0004] Catheter ablation is commonly used to treat diseases such as atrial palpitation, atrial fibrillation, arrhythmia, etc. Common forms of catheter ablation include radiofrequency ablation, microwave ablation, cryoablation, and pulse field ablation, etc. Among them, pulse field ablation (PFA) is a technology that uses high-voltage discharge to cause irreversible electroporation of cells, which can directly act on cells to cause apoptosis and thus achieve the purpose of treatment. The irreversible electroporation ablation technology used by pulse field ablation is a non-thermal ablation technology, which has some theoretical advantages compared with other ablation methods. First, the ablation time of irreversible electroporation is very short; second, since irreversible electroporation is a non-thermal ablation, there is no heat sink effect, and it can produce complete cell death around blood vessels; third, irreversible electroporation can ablate living cells, which theoretically preserves the cell matrix and the structure around the cells; in addition, when using irreversible electroporation to ablate the edge or top of a lesion, the possibility of indirect damage to nearby structures is very small. At the same time, the mechanism by which irreversible electroporation causes cell death is apoptosis, rather than necrosis. The advantage of cell apoptosis is that the apoptotic cells are removed through immune intervention, and the phagocytic cells remove the apoptotic cells as a normal cell death process, thereby promoting the regeneration and repair of normal tissues, so that the treatment area after irreversible electroporation treatment can be replaced by normal cells in a short time to restore the original function. SUMMARY
[0005] One of the embodiments of the present application provides an ablation catheter with adjustable support rods, comprising: an inner tube, a first support rod and a second support rod, the first support rod and the second support rod are arranged on the inner tube, and a plurality of electrodes are arranged on the first support rod and the second support rod; the first support rod and the second support rod are annular support rods; the angle of the first support rod and / or the second support rod relative to the inner tube is adjustable.
[0006] One of the embodiments of the present application provides an ablation equipment comprising the ablation catheter as described in any one of the embodiments of the present application. BRIEF DESCRIPTION OF DRAWINGS
[0007] The present application will be further described in the way of exemplary embodiments, which will be described in detail with reference to the accompanying drawings. These embodiments are not restrictive, and in these embodiments, the same reference numbers represent the same structures, wherein:
[0008] Figure 1 is a schematic diagram of an application scenario of an ablation catheter according to some embodiments of the present application;
[0009] Figure 2 is a schematic diagram of a structure of an ablation catheter according to some embodiments of the present application;
[0010] Figure 3 is a schematic diagram of a structure of an ablation catheter according to another embodiment of the present application;
[0011] Figure 4 is a side view of an ablation catheter according to another embodiment of the present application;
[0012] Figure 5 is a top view of an ablation catheter according to another embodiment of the present application;
[0013] Figure 6 is a schematic diagram of a structure of an ablation catheter according to still another embodiment of the present application;
[0014] Figure 7 is a schematic diagram of an ablation catheter and a discharge mode thereof according to some embodiments of the present application;
[0015] Figure 8 is a schematic diagram of an electrode structure of an ablation catheter according to some embodiments of the present application;
[0016] Figure 9 is a schematic diagram of a structure corresponding to a first electrode and a second electrode of an ablation catheter according to some embodiments of the present application;
[0017] Figure 10 is a schematic diagram of an electrode structure including three sub-electrodes according to some embodiments of the present application;
[0018] Figure 11 is a schematic diagram of an electrode structure including five sub-electrodes according to some embodiments of the present application;
[0019] Figure 12 is a schematic diagram of a structure of an ablation catheter with varying electrode spacing according to some embodiments of the present application;
[0020] Figure 13 is a schematic diagram of a structure of an ablation catheter with varying electrode spacing according to another embodiment of the present application;
[0021] Figure 14is a structural schematic diagram of an ablation catheter with adjustable electrode spacing according to some embodiments of the present application;
[0022] Figure 15 is a structural schematic diagram of an ablation catheter with adjustable electrode spacing according to another embodiment of the present application;
[0023] Figure 16 is a first state schematic diagram of an ablation catheter with adjustable support rod according to some embodiments of the present application;
[0024] Figure 17 is a second state schematic diagram of an ablation catheter with adjustable support rod according to some embodiments of the present application;
[0025] Figure 18 is a third state schematic diagram of an ablation catheter with adjustable support rod according to some embodiments of the present application;
[0026] Figure 19 is a structural schematic diagram of an ablation catheter with adjustable support rod according to another embodiment of the present application;
[0027] Figure 20 is a working state schematic diagram of an ablation catheter with adjustable support rod according to another embodiment of the present application;
[0028] Figure 21 is a structural schematic diagram of an ablation catheter with adjustable support rod according to yet another embodiment of the present application;
[0029] Figure 22 is a working state schematic diagram of an ablation catheter with adjustable support rod according to yet another embodiment of the present application.
[0030] In the figure, 10 is an intra-cardiac annular pulmonary vein ostium, 100, 200, 300, 400, 600, 700 are ablation catheters, 110, 210, 710 are outer tubes, 120, 220, 720 are inner tubes, 130, 230, 330, 430, 630, 730 are first support rods, 131, 132, 133, 134, 135, 136, 141, 142, 143, 144, 145, 231, 232, 241, 242, 331, 332, 341, 431, 432, 433, 434, 435, 441, 442, 443, 444, 445, 510, 520, 530, 540, 550, 631, 641, 731, 741 are electrodes, 511, 521, 531, 541, 542, 551, 552, 553, 554, 555 are sub-electrodes, 140, 240, 340, 440, 640, 740 are second support rods, 150, 750 are first connecting rods, 160, 260, 760 are second connecting rods, 270 is a third connecting rod, 670 is an electrode position adjusting mechanism, 671 is a long strip-shaped through hole, 781, 782 are curvature adjusting ropes, 791 is an electromagnet, 791A is a coil, 791B is an iron bar, and 792 is a magnetic block. DETAILED DESCRIPTION
[0031] In order to make the purpose, technical solutions and advantages of the present application more clear, the present application is further described in detail below in combination with the drawings and examples. It should be understood that the specific examples described herein are only used to explain the present application and not used to limit the present application. On the contrary, the present application covers any alternative, modification, equivalent method and solution defined by the claims within the spirit and scope of the present application. Further, in order to make the public have a better understanding of the present application, some specific details are described in the following detailed description of the present application. The present application can also be completely understood without the description of these details by those skilled in the art.
[0032] Since the position of the product of the present application can be changed at will, the orientation words such as "upper", "lower", "left", "right", "front", "rear" and the like described in the present application only represent relative positional relationship and are not used to limit the absolute positional relationship. In addition, the "front end" described in the present application refers to the end far away from the surgical operator, and the "rear end" refers to the end close to the surgical operator.
[0033] Embodiments of the present application relate to an ablation catheter and device, which can be used for ablation of diseased tissue. In some embodiments, the ablation catheter and device can be used for ablation of various diseased tissues (e.g., lesions) in different parts of human body. For example, the ablation catheter and device can be used for ablation of lesions in trachea, bronchus, intestinal tract (e.g., large intestine, small intestine, duodenum, etc.), gallbladder, heart, etc. For another example, the ablation catheter and device can be used for ablation of lesions related to bronchitis, emphysema, bronchial gland hyperplasia, atrial fibrillation, local hyperplastic tumor, etc. In some embodiments, the ablation catheter and device related to embodiments of the present application can be applied to pulse field ablation. In some embodiments, at least some features of the ablation catheter and device related to embodiments of the present application can be applied to other ablation methods (e.g., radiofrequency ablation, microwave ablation, cryoablation, etc.), which are not limited by the present application. Hereinafter, the ablation catheter and device related to embodiments of the present application will be described by taking the application to pulse field ablation as an example.
[0034] Pulse field ablation (PFA) is a technology that uses high-voltage discharge to cause irreversible electroporation of cells, which can directly act on cells to cause cell apoptosis to achieve a therapeutic purpose. Irreversible electroporation refers to a process of causing permanent permeability of cell membranes by applying a high-intensity external electric field, and the transmembrane potential caused by the external electric field causes countless nanoscale micropores to form in the cell membrane, which destroys the intracellular homeostasis. If the applied electric field exceeds a certain threshold, it will cause permanent damage to the cell membrane structure and intracellular homeostasis, thereby causing cell death, and this effect is used as a new minimally invasive ablation technology. As a new treatment method, irreversible electroporation treatment technology has advantages that cannot be compared with existing physical treatment methods, and shows good clinical application prospects. In the treatment of lesions near important structures that need to be preserved, such as large blood vessels, important nerve tissues, bronchi, large bile ducts, gastrointestinal walls, and ureters, the treatment methods of radiofrequency, microwave, and cryoablation are often difficult to perform, and thermal ablation or cold ablation can cause protein denaturation of important tissues to cause necrosis of important tissue cells. Electroporation ablation is a new ablation technology that uses high-voltage short-pulse discharge to cause nanoscale perforation of cell membranes, leading to cell apoptosis, and is therefore considered as a "molecular ablation". From the experience of medical clinical feedback, it is a non-heat-producing ablation technology, which has the advantages of clear ablation zone boundary, preservation of important tissue structures such as nerves, large blood vessels, ureters, bronchi, large bile ducts, and gastrointestinal walls in the ablation zone, no influence of blood flow heat or cold suction, short ablation time, etc. This technology makes up for the shortcomings of radiofrequency, microwave, and cryoablation technologies.
[0035] In some embodiments, the ablation catheter and device according to the embodiments of the present application can be used for pulsed field ablation in cardiac sites. Cardiac pulsed electric field ablation belongs to irreversible electroporation ablation, which is a new type of ablation method using pulsed field as energy. It has been attracting more and more attention due to its characteristics such as preferential selectivity to myocardial tissue, non-thermal energy ablation, instantaneous energy release, and less damage to adjacent tissue organs. With the reports of human feasibility tests and clinical trials, cardiac pulsed electric field ablation has been proved to be a safe, reliable, and new energy ablation method with many advantages. However, when performing catheter ablation of the ostium of the pulmonary vein in the heart to treat atrial fibrillation, due to the non-thermal ablation characteristics of pulsed field ablation, it does not generate heat when ablating myocardial tissue and does not denature the protein of the myocardium, unlike traditional radiofrequency ablation and cryoablation, which can be seen in real time by CT, ultrasound and other imaging devices. The ablation boundary can only be confirmed by CT scanning after a few days (usually 2 weeks) and the ablation area and effect can only be confirmed by images. The ablation catheter and device according to some embodiments of the present application can not only achieve high-density electric field ablation, but also can confirm the ablation effect of the pulsed field ablation catheter in time.
[0036] The ablation catheter according to some embodiments of the present application comprises at least one support rod, and a plurality of electrodes are arranged on the support rod. In some embodiments, each electrode is individually electrically connected to the electrode output end of an external pulsed field energy generator through a wire. Thus, the pulsed field energy generator can control the polarity of each electrode respectively, so that the electrodes can discharge to form a pulsed electric field. In some embodiments, the plurality of electrodes can comprise mapping electrodes and ablation electrodes for mapping and ablation of tissue respectively. In some embodiments, part or all of the electrodes can be used for both discharging as ablation electrodes and mapping as mapping electrodes. By simultaneously (or alternately) arranging the mapping electrodes and the ablation electrodes, the ablation progress can be grasped in real time, and the release of electric field energy can be stopped in time, so that the ablation process is safer. In some embodiments, the ablation catheter can comprise a first support rod and a second support rod, and a plurality of electrodes can be arranged on the first support rod and the second support rod respectively, and the electrodes on the first support rod can discharge relative to the electrodes on the second support rod to form a pulsed electric field. In some embodiments, the electrodes on the first support rod can form a mapping loop with the electrodes on the second support rod for mapping tissue. In some embodiments, the electrodes on the same support rod or the electrodes on different support rods can have one or more differences (such as different electrode resistances, different electrode structures, different electrode spacings, etc.), so that different ablation electric fields can be generated between the electrodes to adapt to different ablation scenarios.
[0037] The following will be described in detail with reference to the accompanying drawings Figures 1-22Detailed description of the ablation catheter and device involved in the embodiments of the present application. It is worth noting that the following embodiments are only used to explain the present application and do not constitute a limitation on the present application.
[0038] Figure 1 is a schematic diagram of the application scene of the ablation catheter shown according to some embodiments of the present application. In some embodiments, as shown in Figure 1 , the ablation catheter 100 can be placed at the pulmonary vein ostium 10 for ablation and / or mapping of the diseased tissue at the pulmonary vein ostium 10. In some embodiments, the ablation catheter 100 can be used for ablation and / or mapping of diseased tissue at other sites such as trachea, bronchus, intestine, gallbladder, heart, etc.
[0039] Figure 2 is a structural schematic diagram of the ablation catheter shown according to some embodiments of the present application. In some embodiments, as shown in Figures 1-2 , the ablation catheter 100 can include at least one support rod, and a plurality of electrodes can be provided on the support rod. In some embodiments, the electrodes can be ring electrodes. For example, the electrodes can be thin sheet ring electrodes. In some embodiments, the material of the electrodes can include one or more of silver, silver chloride, platinum gold, gold, copper, molybdenum or stainless steel. In some embodiments, the ring electrodes can be provided on the support rod by welding, clamping, bonding or heat staking, etc.
[0040] In some embodiments, the ablation catheter 100 can include a first support rod 130 and a second support rod 140, and a plurality of electrodes can be provided on the first support rod 130 and the second support rod 140. In some embodiments, the first support rod 130 and the second support rod 140 can be linear, arc-shaped, ring-shaped, etc. In some embodiments, at least one support rod of the ablation catheter 100 is a ring-shaped support rod. In the embodiment shown in Figures 1-2 , the first support rod 130 and the second support rod 140 can both be ring-shaped support rods. By providing the support rod as a ring-shaped support rod, the support rod (and the electrodes thereon) can better adhere to the tissue lumen, thereby better ablation and / or mapping of the lesions on the tissue lumen. By providing the ablation catheter 100 as a double discharge ring structure (i.e. the first support rod 130 and the second support rod 140 are both ring-shaped support rods), the ablation catheter 100 can be more firmly adhered to the tissue lumen, and can have higher electric field strength and more controllable ablation range, while increasing the energy density and mapping density of ablation.
[0041] In some embodiments, the first support rod 130 and the second support rod 140 are both annular support rods, and the plane formed by the first support rod 130 is parallel to the plane formed by the second support rod 140. In some embodiments, the annular first support rod 130 and the annular second support rod 140 are coaxially arranged, i.e., the central axis of the annular first support rod 130 coincides with the central axis of the annular second support rod 140. By arranging the annular first support rod 130 and the annular second support rod 140 to be parallel and / or coaxial, the electrodes on the first support rod 130 and the second support rod 140 can be easily corresponded to each other. In some embodiments, a plurality of electrodes can be arranged on the first support rod 130 and the second support rod 140. In some embodiments, as shown in FIG. 1 15, the electrodes arranged on the first support rod 130 can correspond to the electrodes arranged on the second support rod 140 one by one. Figures 1-2
[0042] In some embodiments, the plurality of electrodes on the first support rod 130 have the same polarity (e.g., all are positive electrodes), the plurality of electrodes on the second support rod 140 also have the same polarity (e.g., all are negative electrodes), and the polarity of the electrodes on the first support rod 130 is opposite to the polarity of the electrodes on the second support rod 140. For example, the plurality of electrodes on the first support rod 130 are all connected to the positive electrode of the energy generator, and the plurality of electrodes on the second support rod 140 are all connected to the negative electrode of the energy generator. The discharge circuit can be formed between the positive electrode and the negative electrode through the tissue (e.g., myocardial tissue), so as to form the pulse electric field between the positive electrode and the negative electrode. The discharge of the tissue cells (e.g., myocardial cells) by the pulse electric field can achieve the pulse field ablation of the tissue (e.g., myocardial tissue). In some embodiments, the voltage difference between the positive electrode and the negative electrode can range from 500 V to 30,000 V. In some embodiments, the discharge time of one ablation can range from 200 nanoseconds to 100 microseconds. In some embodiments, the energy generator can control the plurality of electrodes on the first support rod 130 to discharge simultaneously relative to the plurality of electrodes on the second support rod 140, so as to form the pulse electric field between the first support rod 130 and the second support rod 140. By arranging the electrodes on the first support rod 130 and the electrodes on the second support rod 140 one by one, the pulse electric field formed between the first support rod 130 and the second support rod 140 can be more uniform.
[0043] In some embodiments, the plurality of electrodes on the first support rod 130 and the second support rod 140 can be connected to the electrode outputs of the pulse field energy generator through separate wires, respectively. For example, the plurality of electrodes on the first support rod 130 can be connected to a plurality of positive electrode outputs of the energy generator through separate wires, respectively; the plurality of electrodes on the second support rod 140 can be connected to a plurality of negative electrode outputs of the energy generator through separate wires, respectively. In some embodiments, the energy generator can control discharging of one or more electrodes on the first support rod relative to one or more electrodes on the second support rod, thereby forming a local pulse electric field between the first support rod 130 and the second support rod 140 to ablate the lesion tissue at a specific site. In some embodiments, the energy generator can control discharging of one electrode on the first support rod 130 relative to a corresponding electrode on the second support rod 140 (i.e., the rest of the electrodes are not discharged at the same time), thereby ensuring high concentration of electric field energy in a single discharge to ensure high energy density. In some embodiments, as shown in FIG. 1B, the first support rod 130 can include adjacent electrode 131 and electrode 132; the second support rod 140 can include adjacent electrode 141 and electrode 142; wherein electrode 131 corresponds to electrode 141, and electrode 132 corresponds to electrode 142. In some embodiments, the energy generator can control discharging of electrode 131 relative to electrode 141. In some embodiments, the energy generator can control discharging of electrode 132 relative to electrode 142. In some embodiments, the energy generator can control discharging of each two corresponding electrodes in turn. In some embodiments, the energy generator can control discharging of electrode 131 relative to electrode 141 and discharging of electrode 132 relative to electrode 142 at the same time. Figure 2
[0044] In some embodiments, the energy generator can control discharging of two non-corresponding electrodes on different support rods. In some embodiments, the energy generator can control discharging of an electrode on one support rod relative to an adjacent electrode of the electrode on another support rod. For example, as shown in FIG. 1B, electrode 131 on the first support rod 130 does not correspond to electrode 142 on the second support rod 140 (electrode 142 is the adjacent electrode of electrode 141 corresponding to electrode 131), and the energy generator can control discharging of electrode 131 relative to electrode 142 (or discharging of electrode 142 relative to electrode 131). By controlling discharging of two non-corresponding electrodes on different support rods, a pulse electric field of a specific shape can be configured, so that the ablation catheter 100 can more targetedly ablate specific lesion tissue. Figure 2
[0045] In some embodiments, the plurality of electrodes on the first support rod 130 are arranged at intervals, and the plurality of electrodes on the second support rod 140 are arranged at intervals. In some embodiments, a pulsed electric field can be formed between the plurality of electrodes (e.g., between adjacent electrodes) on the same support rod (e.g., the first support rod 130 or the second support rod 140) for ablation of the region between the electrodes. In some embodiments, the polarity of adjacent electrodes on the same support rod is opposite (e.g., connected to the positive and negative poles of the energy generator, respectively), so that a pulsed electric field can be formed between the adjacent electrodes on the same support rod.
[0046] In some embodiments, the electrodes on the first support rod 130 are arranged at equal intervals, and the electrodes on the second support rod 140 are arranged at equal intervals. Specifically, the angle between any two adjacent electrodes on the first support rod 130 relative to the center of the ring of the first support rod 130 is equal, and the angle between any two adjacent electrodes on the second support rod 140 relative to the center of the ring of the second support rod 140 is equal. By arranging the electrodes on the support rods at equal intervals, the electric field distribution formed between adjacent electrodes on the same support rod and / or the electric field distribution formed between corresponding electrodes on different support rods can be more uniform, thereby making the ablation catheter 100 easier to manipulate. In some embodiments, the interval L between any two adjacent electrodes is 10-15 mm. In some embodiments, the diameter of the ring of the first support rod 130 and / or the second support rod 140 can be the same as or close to the diameter of the tissue lumen (e.g., the ostium of the pulmonary vein). In some embodiments, the number of electrodes arranged on the first support rod 130 and / or the second support rod 140 can be determined according to the diameter of the tissue lumen and the interval L between adjacent electrodes. For example, assuming the number of electrodes on the first support rod 130 and / or the second support rod 140 is n, and the diameter of the ostium of the pulmonary vein identified by image recognition is d, then the preferred number of electrodes on the first support rod 130 and / or the second support rod 140 can be determined by the formula n = π*d / L. In some embodiments, the size (e.g., the diameter of the ring) of the first support rod 130 and / or the second support rod 140 can be set according to the different (e.g., different diameters) of the tissue lumens to be ablated. In some embodiments, the number of electrodes on the first support rod 130 and / or the second support rod 140 can be set according to the different (e.g., different diameters) of the tissue lumens to be ablated.
[0047] In some embodiments, the plurality of electrodes arranged on the support rods of the ablation catheter 100 can include mapping electrodes and ablation electrodes for mapping and ablation of the tissue, respectively.
[0048] In some embodiments, each of the plurality of electrodes can serve as both a mapping electrode and an ablation electrode. In some embodiments, each of the plurality of electrodes can be connected to an energy generator via a wire, which not only provides pulse voltage to the electrode but also acquires the potential signal mapped between the electrodes. In some embodiments, each of the plurality of electrodes can be connected to a mapping device via a wire, which acquires the potential signal mapped between the electrodes. In some embodiments, the mapping device and the energy generator can be the same device or different devices. By using the electrodes as both mapping electrodes and ablation electrodes, the ablation device can perform in-situ mapping immediately after ablation discharge, thereby promptly monitoring the ablation progress and obtaining the ablation results. In some embodiments, once the mapping electrode detects the disappearance of the potential signal corresponding to the lesion, the energy generator can control the ablation electrode to stop discharging to avoid excessive release of ablation energy, effectively protecting reliable tissue and preventing medical accidents. In some embodiments, the mapping device can control the corresponding electrodes on the first support rod 130 and the second support rod 140 to perform mapping. In some embodiments, the mapping device can control the mapping of an electrode on one support rod and an adjacent electrode on another support rod corresponding to that electrode. In some embodiments, such as Figure 2 As shown, the first support rod 130 may include adjacent electrodes 131 and 132; the second support rod 140 may include adjacent electrodes 141 and 142; wherein electrodes 131 and 141 correspond to each other, and electrodes 132 and 142 correspond to each other. Electrodes 131, 132, 141, and 142 can all serve as ablation electrodes. In some embodiments, the mapping device can sequentially control electrodes 132 and 142 to perform mapping, electrodes 142 and 131 to perform mapping, and electrodes 131 and 141 to perform mapping, thereby forming a Z-shaped mapping pattern. In some embodiments, the mapping device can map each group of electrodes on the entire circumference in a Z-shaped mapping manner. By using the Z-shaped mapping method, the mapping density can be effectively increased, thereby improving the accuracy of mapping lesion tissue.
[0049] In some embodiments, the mapping electrodes and the ablation electrodes can be arranged on the same support rod, such as the first support rod 130 and / or the second support rod 140. In some embodiments, the ablation electrodes can be connected to an energy generator through wires, and the mapping electrodes can be connected to a mapping device through wires. In some embodiments, the mapping device and the energy generator can be the same device or different devices. In some embodiments, the ablation electrodes can be used to ablate tissue, and the mapping electrodes can be used to map tissue at the same time. By arranging the mapping electrodes and the ablation electrodes in an interval, the ablation device can ablate and map tissue at the same location at the same time, so as to monitor the ablation of the lesion in real time. In some embodiments, the ablation device can alternatively ablate and map tissue when the mapping electrodes and the ablation electrodes are arranged in an interval. For example, the ablation device can first control the ablation electrodes to ablate tissue, and then control the mapping electrodes to map the tissue after ablation. In some embodiments, as shown in Figure 2 In some embodiments, the electrodes 131, 133, and 135 can ablate tissue at the same time, and the electrodes 132 and 134 can be used to map tissue. In some embodiments, the ablation device can first control the electrodes 131, 133, and 135 to ablate tissue, and then control the electrodes 132 and 134 to map the tissue.
[0050] In some alternative embodiments, one of the support rods can be provided with mapping electrodes, and the other support rod can be provided with ablation electrodes. For example, the electrodes on the first support rod 130 can be mapping electrodes, and the electrodes on the second support rod 140 can be ablation electrodes. In some embodiments, the first support rod 130 can be used to map a circle of tissue, and then the ablation electrodes on the second support rod 140 can be used to ablate the tissue (or a lesion region on the tissue) according to the mapping result. In some embodiments, the mapping electrodes on the first support rod 130 can be used to further map the tissue after ablation.
[0051] In some embodiments, as shown in Figures 1-2 In some embodiments, as shown in Figures 1-2As shown, the first support rod 130 and the second support rod 140 can be disposed at a front end of the inner tube 120, where the front end can refer to an end distal to an operator of a surgical procedure. The outer tube 110 is disposed around the inner tube 120, and the inner tube 120 is movable relative to the outer tube 110 (e.g., along a length of the inner tube / outer tube) to enable the first support rod 130 and the second support rod 140 to be retracted into the outer tube 110 or extended from the outer tube 110 to form a looped support rod. In some embodiments, the outer tube 110 and the inner tube 120 are each hollow cylindrical tubes, and the outer tube 110 is disposed around an outer circumference of the inner tube 120, and an interior of the inner tube 120 can be used to pass wires and / or cords (e.g., a flexibility adjustment cord). In some embodiments, the ablation device can include the ablation catheter 100 and a control handle (not shown), which can be used to control movement of the inner tube 120 relative to the outer tube 110 along the length. Movement of the inner tube 120 relative to the outer tube 110 can cause the first support rod 130 and the second support rod 140 on the inner tube 120 to move, thereby controlling retraction or extension of the first support rod 130 and the second support rod 140 into or from the outer tube 110.
[0052] In some embodiments, the first support rod 130 and the second support rod 140 can be made of an insulating material and have a certain elasticity and shape memory capability after being made. The insulating material can include, but is not limited to, plastic (e.g., high-elasticity nylon material, etc.), thermoplastic elastomer (e.g., thermoplastic polyurethane elastomer (TPU), styrene-based thermoplastic elastomer (TPS), etc.), etc. In some embodiments, when the first support rod 130 and the second support rod 140 are retracted into the outer tube 110 along with movement of the inner tube 120, the first support rod 130 and the second support rod 140 can be retracted into the interior of the outer tube 110 in a long strip shape, thereby facilitating delivery of the ablation catheter 100 into a human body and withdrawal of the ablation catheter 100 from the human body. In some embodiments, when the first support rod 130 and the second support rod 140 are extended from the outer tube 110, the first support rod 130 and the second support rod 140 can automatically form a looped support rod due to the shape memory capability of the material.
[0053] In some embodiments, the inner tube and / or the outer tube can be made of an insulating material, and the inner tube and the outer tube after being made can have a certain elasticity, capable of being bent under force and not easy to be deformed. In some embodiments, the inner tube 120 and / or the outer tube 110 can be made of a high polymer insulating material. The high polymer insulating material can include, but is not limited to, a combination of one or more of polyurethane (PU), polyethylene (PE), polyether block polyamide (PEBAX), TPU, TPS, etc. In some embodiments, the materials of the inner tube 120 and the outer tube 110 can be the same or different. In some embodiments, the materials of the first support rod 130 and / or the second support rod 140 can be the same as or different from the material of the inner tube. In some embodiments, for example, the first support rod 130 and / or the second support rod 140 can be fixedly connected with the inner tube 120 by welding, clamping, bonding, hot melting, threaded connection or one-piece forming, etc.
[0054] In some embodiments, the diameters of the first support rod 130 and the second support rod 140 can be 0.3-3 mm (such as 0.3 mm, 0.5 mm, 0.7 mm, 1 mm, 2 mm, 3 mm, etc.). The diameters of the first support rod 130 and the second support rod 140 can be the same or different. In some embodiments, the diameter of the inner tube 120 can be equal to or slightly larger than the diameters of the first support rod 130 and the second support rod 140. In some embodiments, the diameter of the inner wall of the outer tube 110 can be slightly larger than the diameter of the inner tube 120. For example, the diameter of the inner wall of the outer tube 110 can be 0.4-3.5 mm (such as 0.4 mm, 0.6 mm, 0.8 mm, 1.2 mm, 2.2 mm, 3.5 mm, etc.). In some embodiments, when the first support rod 130 and the second support rod 140 form a ring-shaped support rod, the maximum diameter of the ring shape can be 5-40 mm (such as 5 mm, 8 mm, 15 mm, 25 mm, 40 mm, etc.). In some embodiments, the sizes of the inner tube 120 and the outer tube 110, and the sizes of the first support rod 130 and the second support rod 140 can be adaptively adjusted according to the ablation site, the type of diseased tissue, the age of the patient, etc., which are not limited in the present application.
[0055] In some embodiments, as shown in FIG. 1, the first support rod 130 and the second support rod 140 can be arranged in a ring shape, and the inner tube 120 can be arranged in the ring-shaped first support rod 130 and the second support rod 140. In some embodiments, the first support rod 130 and the second support rod 140 can be arranged in a ring shape, and the outer tube 110 can be arranged in the ring-shaped first support rod 130 and the second support rod 140. Figures 1-2As shown, the first support rod 130 can be connected with the inner tube 120 through the first connecting rod 150, and the second support rod 140 can be connected with the inner tube 120 through the second connecting rod 160. By arranging the first connecting rod 150 and the second connecting rod 160, the first support rod 130 and the second support rod 140 can be more easily formed into a ring shape. By independently arranging the first support rod 130 and the second support rod 140 on the inner tube 120, the first support rod 130 and the second support rod 140 can be controlled individually to adapt to more ablation scenarios. In some embodiments, the materials of the first connecting rod 150 and the second connecting rod 160 can be plastic (such as high-elasticity nylon material, etc.), thermoplastic elastomer (such as TPU, TPS, etc.), or the like. In some embodiments, the materials of the first connecting rod 150 and the second connecting rod 160 can be the same as or different from the materials of the first support rod 130 and the second support rod 140. In some embodiments, one end of the first connecting rod 150 and the second connecting rod 160 can be fixedly connected with one end of the first support rod 130 and the second support rod 140, respectively, by means of bonding, heat welding, or one-piece forming, etc. The other end of the first connecting rod 150 and the second connecting rod 160 can be fixedly connected with the inner tube 120, respectively, by means of bonding, heat welding, or one-piece forming, etc. In some embodiments, the other end of the first support rod 130 and the second support rod 140 can be a free end, in a free-hanging state. By sequentially connecting the support rods (such as the first support rod 130 or the second support rod 140) and the connecting rods (such as the first connecting rod 150 or the second connecting rod 160) end to end and connecting them to the inner tube 120, the support rods and the connecting rods can be contracted into a long strip shape inside the outer tube 110, reducing the size of the outer tube 110. In some alternative embodiments, the first support rod 130 and the second support rod 140 can be directly connected with the inner tube 120.
[0056] In some embodiments, the ring-shaped diameter of the first support rod of the ablation catheter is the same as the ring-shaped diameter of the second support rod. In some embodiments, the ring-shaped diameter of the first support rod of the ablation catheter is different from the ring-shaped diameter of the second support rod. By arranging the ring-shaped diameter of the first support rod to be different from the ring-shaped diameter of the second support rod, the ablation catheter can be better adapted to ablation and / or mapping of variable-diameter tissue lumens.
[0057] Figure 3 is a structural schematic diagram of an ablation catheter according to another embodiment of the present application; Figure 4 is a side view of an ablation catheter according to another embodiment of the present application; Figure 5 is a top view of an ablation catheter according to another embodiment of the present application.
[0058] In some embodiments, as shown in FIG. 1, the ablation catheter 100 can include an outer tube 110, an inner tube 120, a first support rod 130, a second support rod 140, a first connecting rod 150, and a second connecting rod 160. The outer tube 110 can be arranged in a long strip shape, and the inner tube 120 can be arranged in a long strip shape and arranged inside the outer tube 110. The first support rod 130 and the second support rod 140 can be arranged in a ring shape and arranged on the inner tube 120. The first connecting rod 150 can be arranged on the inner tube 120 and connected with the first support rod 130, and the second connecting rod 160 can be arranged on the inner tube 120 and connected with the second support rod 140. Figures 3-5As shown, the ablation catheter 200 may include a first support rod 230 and a second support rod 240; the first support rod 230 is closer to the tip of the ablation catheter 200 than the second support rod 240. In some embodiments, the annular diameter of the first support rod 230 may be smaller than the annular diameter of the second support rod 240 to facilitate ablation and / or mapping of tissue lumens with varying diameters. In some embodiments, the annular diameters of the first support rod 230 and the second support rod 240 can be adaptively adjusted according to the ablation site, lesion tissue type, patient age, etc. In some embodiments, such as Figure 4 As shown, the annular portion of the first support rod 230 and the annular portion of the second support rod 240 have parallel end faces. In some embodiments, such as Figure 5 As shown, the annulus of the first support rod 230 and the annulus of the second support rod 240 have the same central axis. By setting the annulus of the first support rod 130 and the second support rod 140 to be parallel and / or coaxial, it is easier for the electrodes on the first support rod 130 and the second support rod 140 to correspond to each other, making the boundary of the ablation zone clearer, the ablation of the lesion tissue more uniform, and also making it easier for the doctor performing the ablation surgery to control the ablation catheter.
[0059] In some embodiments, see Figure 3 The first support rod 230 and the second support rod 240 can be connected end-to-end by a third connecting rod 270. By providing the third connecting rod 270, the first support rod 230 and the second support rod 240 can be more easily formed into a ring shape. In some embodiments, the material of the third connecting rod 270 can be plastic (such as high-elasticity nylon), thermoplastic elastomer (such as TPU, TPS, etc.), etc. In some embodiments, the material of the third connecting rod 270 can be the same as or different from the material of the first support rod 230 and the second support rod 240. In some embodiments, one end of the first support rod 230 can be connected to one end of the third connecting rod 270, and the other end of the first support rod 230 can be a free end. The other end of the third connecting rod 270 can be connected to the second support rod 240, and the other end of the second support rod 240 can be fixedly connected to the inner tube 220 via the second connecting rod 260. By connecting the first support rod 230, the third connecting rod 270, the second support rod 240, and the second connecting rod 260 end to end to form a long strip structure, the support rod and connecting rod can be easily retracted into the outer tube 210, reducing the size of the outer tube 210, thereby facilitating the delivery and withdrawal of the catheter before and after surgery.
[0060] In some embodiments, such as Figures 3-5As shown, the electrodes disposed on the first support rod 230 can correspond to the electrodes disposed on the second support rod 240 one by one. In some embodiments, the electrodes on the first support rod 230 are equally spaced, and the electrodes on the second support rod 240 are equally spaced. Specifically, the included angle of any two adjacent electrodes on the first support rod 230 relative to the center of the ring of the first support rod 230 is equal, and the included angle of any two adjacent electrodes on the second support rod 240 relative to the center of the ring of the second support rod 240 is equal. In some embodiments, the first support rod 130 can include adjacent electrodes 231 and 232; the second support rod 240 can include adjacent electrodes 241 and 242; wherein the electrode 231 corresponds to the electrode 241, and the electrode 232 corresponds to the electrode 242. In some embodiments, more information about the ablation catheter 200 and its ablation / mapping process can be found in Figures 1-2 and the related description.
[0061] Figure 6 is a structural schematic diagram of an ablation catheter according to still another embodiment of the present application.
[0062] In some embodiments, two or more electrodes disposed on one support rod can correspond to one electrode disposed on another support rod. In some embodiments, as Figure 6 shown, in the ablation catheter 300, two adjacent electrodes (such as electrodes 331 and 332) disposed on the first support rod 330 can correspond to one electrode (such as electrode 341) disposed on the second support rod 340. The two adjacent electrodes (such as electrodes 331 and 332) on the first support rod 330 can form a pulsed electric field with the corresponding electrode (such as electrode 341) on the second support rod 340. Specifically, the two adjacent electrodes 331 and 332 on the first support rod 330 can be connected to the positive pole of an external energy generator through separate wires, and the electrode 341 on the second support rod 340 can be connected to the negative pole of the external energy generator through a separate wire. The energy generator can control the electrodes 331 and 332 to discharge simultaneously relative to the electrode 341 to form two discharge loops between the electrodes 331 and 341 and between the electrodes 332 and 341, thereby forming a pulsed electric field between the electrodes 331, 332 and the electrode 341. By forming a pulsed electric field between two or more electrodes on one support rod and one electrode on another support rod, a specific electric field range can be configured to be suitable for ablation of lesioned tissue in a specific area (such as a specific shape). For example, by forming a pulsed electric field between two electrodes on one support rod and one electrode on another support rod, it can be suitable for ablation of lesioned tissue in an approximately triangular area.
[0063] In some embodiments, as Figure 6As shown, the electrode 341 on the second support rod 340 can correspond to the middle point between the two adjacent electrodes 331 and 332 on the first support rod 330. Specifically, the first support rod 330 and the second support rod 340 can be two parallel and coaxial annular support rods, and the line connecting the electrode 341 and the middle point between the two adjacent electrodes 331 and 332 on the first support rod 330 can be perpendicular to the plane formed by the first support rod 330. By setting the electrode 341 on the second support rod 340 to correspond to the middle point between the two adjacent electrodes (electrodes 331 and 332) on the first support rod 330, the distance between the two adjacent electrodes on the first support rod 330 and the electrode 341 can be the same, so that the pulsed electric field formed between the electrodes 331, 332 and the electrode 341 can be more easily controlled.
[0064] In some embodiments, three or more electrodes (such as 3, 4, 5 electrodes, etc.) can be provided on the first support rod 330 to correspond to one electrode on the second support rod, so as to obtain different electric field ranges to adapt to the ablation of lesion tissues of different regions (such as different shapes). In some embodiments, the number of electrodes on the first support rod 330 corresponding to one electrode on the second support rod can be adaptively adjusted according to the ablation site, the type of lesion tissue, the shape of lesion tissue, etc., and can also be adjusted according to the ablation progress / mapping results during the ablation operation.
[0065] In some embodiments, among the plurality of electrodes provided on the first support rod and the second support rod, different first electrodes and second electrodes can be included. In some embodiments, the "first electrode" or "second electrode" can be used to refer to a certain type of electrode. In some embodiments, the "first electrode" or "second electrode" can be used to refer to a certain specific electrode. In some embodiments, the first electrode and the second electrode have different resistances. In some embodiments, the first electrode and the second electrode are different in material and / or size, so that the first electrode and the second electrode have different resistances. In some embodiments, the first electrode and the second electrode can be provided on the same support rod. For example, the first electrode and the second electrode can be adjacent electrodes provided on the same support rod. In some embodiments, the first electrode and the second electrode can be provided on different support rods. For example, the first electrode and the second electrode can be provided on the first support rod and the second support rod, respectively, and the first electrode and the second electrode correspond to each other. In some embodiments, an ablation electric field can be formed between the first electrode and the second electrode. In some embodiments, an ablation electric field can be formed between two or more first electrodes; an ablation electric field can be formed between two or more second electrodes. By providing different first electrodes and second electrodes, the ablation catheter can form an ablation electric field (such as a non-uniform electric field) of a specific range, shape or strength, so as to be suitable for the ablation of different lesion tissues.
[0066] In some embodiments, the materials of the first electrodes and the second electrodes can be different. In some embodiments, the material of the first electrodes can include, but is not limited to, a combination of one or more of silver, silver chloride, platinum gold, gold, copper, molybdenum, or stainless steel, etc. In some embodiments, the material of the second electrodes can include, but is not limited to, a combination of one or more of silver, silver chloride, platinum gold, gold, copper, molybdenum, or stainless steel, etc.
[0067] In some embodiments, the first electrodes and the second electrodes can be disposed on the same support rod. In some embodiments, a pair of first electrodes and a pair of second electrodes can be included on one support rod. In some embodiments, as shown in FIG. 1, the electrodes 131 and 132 on the first support rod 130 can be first electrodes, and the electrodes 133 and 134 can be second electrodes. For example, the materials of the electrodes 131 and 132 can be molybdenum; the materials of the electrodes 133 and 134 can be stainless steel. In some embodiments, a pulsed electric field can be formed between the electrodes 131 and 132; a pulsed electric field can be formed between the electrodes 133 and 134. Since the materials of the first electrodes and the second electrodes are different, the electric fields formed between the first electrodes (such as between the electrodes 131 and 132) and the electric fields formed between the second electrodes (such as between the electrodes 133 and 134) are different (such as different in electric field strength), so that different electric fields can be formed between different electrodes on the same support rod (such as the first support rod 130), so that the support rod can be suitable for ablation of more types of diseased tissue. Figure 2
[0068] In some embodiments, the first electrodes and the second electrodes can be disposed on different support rods, respectively. In some embodiments, as shown in FIG. 2, the electrode 131 on the first support rod 130 can be a first electrode, and the electrode 132 can be a second electrode; correspondingly, the electrode 141 on the second support rod 140 can be a first electrode, and the electrode 142 can be a second electrode. For example, the materials of the electrodes 131 and 141 can be platinum gold; the materials of the electrodes 132 and 142 can be stainless steel. In some embodiments, a pulsed electric field can be formed between the electrodes 131 and 141; a pulsed electric field can be formed between the electrodes 132 and 142. Since the materials of the first electrodes and the second electrodes are different, the electric fields formed between the first electrodes (such as between the electrodes 131 and 141) and the electric fields formed between the second electrodes (such as between the electrodes 132 and 142) are different (such as different in electric field strength), so that different electric fields can be formed between different corresponding electrodes on two support rods, so that the ablation catheter can be suitable for ablation of more types of diseased tissue. Figure 2
[0069] In some embodiments, electrodes of different materials can be suitable for ablation of different lesion tissues. In some embodiments, different lesion tissues with different impedance values can be preferably ablated by electrodes of different materials, for example, as distinguished by the impedance values of the lesion tissues measured before the electrodes. For example, when the impedance value of the lesion tissue is less than 50 ohms, a stainless steel electrode can be selected; when the impedance value of the lesion tissue is 50-200 ohms, a molybdenum electrode can be selected; when the impedance value of the lesion tissue is 200-400 ohms, a platinum electrode can be selected; and when the impedance value of the lesion tissue is 400-600 ohms, a silver / silver chloride electrode can be selected. In some embodiments, for electrodes made of silver / silver chloride, platinum, molybdenum and stainless steel respectively, the electrodes have conductive properties from strong to weak, and the electrodes have resistance values from small to large. Since the electrodes are made of different materials and have different resistance values, under the same external conditions (such as an external voltage applied to the electrodes), the electrodes form different electric fields, so that electrodes of different materials can be suitable for ablation of different lesion tissues.
[0070] In some embodiments, the first electrodes and the second electrodes can have different sizes. In some embodiments, the first electrodes and the second electrodes can have different electrode lengths. In some embodiments, the electrodes can be ring electrodes arranged on the support rods. For example, the electrodes can be thin sheet-shaped metal spliced end to end to form a ring shape and attached to the outer circumference of the support rods. The electrode length can refer to the distance of the ring electrodes along the extension direction of the support rods. In some embodiments, the electrode length can be 1-8 mm. Preferably, the electrode length can be 3-5 mm. In some embodiments, the first electrodes and the second electrodes of different electrode lengths can be arranged on the same support rod. For example, a support rod can include a pair of first electrodes and a pair of second electrodes. Since the first electrodes and the second electrodes have different electrode lengths, the first electrodes and the second electrodes have different resistance values, and the electric fields formed between the first electrodes and the electric fields formed between the second electrodes are different (such as different electric field strengths and different electric field shapes), so that the support rod can be suitable for ablation of different types of lesion tissues. In some embodiments, the first electrodes and the second electrodes can be arranged on different support rods, respectively, so that different corresponding electrodes on the two support rods can form different electric fields, and thus the ablation catheter can be suitable for ablation of more types of lesion tissues.
[0071] In some embodiments, the first electrodes and the second electrodes can have different materials and sizes, so that the first electrodes and the second electrodes have different resistance values. The electric fields formed between the first electrodes and the electric fields formed between the second electrodes are different (such as different electric field strengths and different electric field shapes), so that the ablation catheter can be suitable for ablation of different types of lesion tissues.
[0072] Figure 7 is a schematic diagram of an ablation catheter and its discharging mode according to some embodiments of the present application.
[0073] In some embodiments, the energy generator is capable of controlling the multiple electrodes on the ablation catheter to discharge the multiple electrodes simultaneously to increase the electric field range and improve the ablation efficiency. In some embodiments, as shown in FIG. 4, the ablation catheter 400 includes a first support rod 430 and a second support rod 440. The first support rod 430 is provided with adjacent electrodes 431, 432, 433, 434 and 435. The second support rod 440 is provided with corresponding adjacent electrodes 441, 442, 443, 444 and 445. In some embodiments, the energy generator is capable of controlling three adjacent electrodes (such as electrodes 431, 432 and 433) on the first support rod 430 to discharge three corresponding electrodes (such as electrodes 441, 442 and 443) on the second support rod 440. In some embodiments, the energy generator is capable of controlling five adjacent electrodes (such as electrodes 431, 432, 433, 434 and 435) on the first support rod 430 to discharge five corresponding electrodes (such as electrodes 441, 442, 443, 444 and 445) on the second support rod 440. Figure 7
[0074] In some embodiments, the first support rod 430 can include first electrodes (e.g., electrode 431), second electrodes (e.g., electrode 432), and third electrodes (e.g., electrode 433) arranged adjacently and equidistantly, with the second electrodes arranged between the first electrodes and the third electrodes. In some embodiments, the first electrodes and the third electrodes have the same resistance, and the second electrodes have a resistance greater than that of the first electrodes and the third electrodes. In some embodiments, the second electrodes have a material and / or size different from those of the first electrodes and the third electrodes, so that the second electrodes have a resistance greater than that of the first electrodes and the third electrodes. For example, the first electrodes and the third electrodes are made of platinum material, and the second electrodes are made of stainless steel material. For another example, the first electrodes and the third electrodes have the same electrode length, and the second electrodes have an electrode length smaller than that of the first electrodes and the third electrodes. By setting the resistance of the second electrodes to be greater, the three electrodes (e.g., electrodes 431, 432, and 433) can form a more uniform electric field when discharging relative to the other three electrodes (e.g., electrodes 441, 442, and 443). In some embodiments, when multiple electrodes discharge simultaneously, due to the edge effect of the electric field, the electric field formed by the electrodes on the edge (e.g., electrodes 431 and 441, or electrodes 433 and 443) can affect the area between the electrodes in the middle (e.g., electrodes 432 and 442). If the electric field formed by the electrodes in the middle is the same as that formed by the electrodes on the edge at this time, the overall electric field formed will not be uniform (e.g., the electric field intensity in the middle area will be greater). By setting the resistance of the electrodes in the middle (e.g., the second electrodes) to be greater, the electric field intensity formed by the electrodes in the middle can be reduced, so that the overall electric field formed is more uniform.
[0075] In some embodiments, the second support rod 440 can include fourth electrodes (e.g., electrode 441), fifth electrodes (e.g., electrode 442), and sixth electrodes (e.g., electrode 443) corresponding to the first electrodes (e.g., electrode 431), the second electrodes (e.g., electrode 432), and the third electrodes (e.g., electrode 433), respectively. In some embodiments, the first electrodes, the second electrodes, and the third electrodes can be connected to the positive electrode of an energy generator; the fourth electrodes, the fifth electrodes, and the sixth electrodes can be connected to the negative electrode of the energy generator; and the energy generator can control the first electrodes, the second electrodes, and the third electrodes to discharge to the fourth electrodes, the fifth electrodes, and the sixth electrodes simultaneously. In some embodiments, the fourth electrodes, the fifth electrodes, and the sixth electrodes can have the same resistance. In some embodiments, the resistance of the fourth electrodes, the fifth electrodes, and the sixth electrodes can be set corresponding to the first electrodes, the second electrodes, and the third electrodes. For example, the fourth electrodes and the sixth electrodes have the same resistance, and the fifth electrodes have a resistance greater than that of the fourth electrodes and the sixth electrodes. By setting the resistance of the fourth electrodes, the fifth electrodes, and the sixth electrodes corresponding to the first electrodes, the second electrodes, and the third electrodes, the electric field intensity can be more uniform.
[0076] In some embodiments, simultaneous discharge of multiple electrodes on the ablation catheter may include: discharge of 4 electrodes to 4 electrodes, discharge of 5 electrodes to 5 electrodes, discharge of 6 electrodes to 6 electrodes, etc. In some embodiments, the resistance of the middle electrode may be greater than the resistance of the edge electrodes. In some embodiments, the resistance of the multiple electrodes may decrease sequentially from the middle to both sides. This electrode arrangement allows for a more uniform electric field formed when multiple electrodes discharge simultaneously. In some embodiments, such as... Figure 7 As shown, electrodes 431, 432, 433, 434, and 435 are arranged sequentially and adjacently at equal intervals on the first support rod 430. Electrodes 441, 442, 443, 444, and 445 are arranged sequentially and adjacently at equal intervals on the second support rod 440. Electrodes 431, 432, 433, 434, and 435 are arranged in a one-to-one correspondence with electrodes 441, 442, 443, 444, and 445. In some embodiments, electrodes 431, 432, 433, 434, and 435 can be connected to the positive terminal of the energy generator; electrodes 441, 442, 443, 444, and 445 can be connected to the negative terminal of the energy generator; the energy generator can control electrodes 431, 432, 433, 434, and 435 to simultaneously discharge onto electrodes 441, 442, 443, 444, and 445. In some embodiments, electrodes 431, 435, 441, and 445 have equal resistance values; electrodes 432, 434, 442, and 444 have equal resistance values and greater than the former; and electrodes 433 and 443 have equal resistance values and greater than the former. In some embodiments, the materials and / or dimensions of the electrodes are different, resulting in different resistance values between the electrodes. For example, the outer electrodes 431, 435, 441, and 445 can be made of silver / silver chloride material with good conductivity; the middle electrodes 432, 434, 442, and 444 can be made of platinum material with slightly lower conductivity; and the innermost electrodes 433 and 443 can be made of stainless steel material with relatively poor conductivity.
[0077] In some embodiments, the energy generator can control the multiple electrodes on the ablation catheter to discharge simultaneously in multiple electrode pairs, and the voltage difference between different corresponding electrodes is not completely the same. For example, the energy generator can control three adjacent electrodes (such as electrodes 431, 432, and 433) on the first support rod 430 to discharge to three corresponding electrodes (such as electrodes 441, 442, and 443) on the second support rod 440; the voltage difference between electrodes 432 and 442 is smaller than the voltage difference between electrodes 431 and 441 and the voltage difference between electrodes 433 and 443. By controlling the voltage difference between the middle corresponding electrodes to be smaller, the electric field strength formed by the middle electrodes can be reduced, so that the overall formed electric field is more uniform. In some embodiments, compared to controlling multiple electrodes to discharge in multiple electrode pairs by using voltage difference to achieve a more uniform electric field during discharge, the difference in the characteristics (such as material and / or size) of the electrodes can effectively improve the convenience of control and reduce the requirements on medical personnel.
[0078] In some embodiments, the first support rod (such as the first support rod 130) can include a first electrode (such as the electrode 131), and the second support rod (such as the second support rod 140) can include a second electrode (such as the electrode 141), and the first electrode corresponds to the second electrode. In some embodiments, the first electrode and the second electrode are different in structure. The structure of the electrode can be understood as the form of composition of the electrode. In some embodiments, the first electrode (such as the electrode 131) and the second electrode (such as the electrode 141) can form a pulsed electric field. By setting the structure of the first electrode and the second electrode to be different, a specific electric field form can be generated between the first electrode and the second electrode, so that it can be suitable for ablation of specific diseased tissues.
[0079] Figure 8 is a schematic diagram of the electrode structure of the ablation catheter according to some embodiments of the present application. Figure 9 is a schematic diagram of the structure of the first electrode corresponding to the second electrode of the ablation catheter according to some embodiments of the present application.
[0080] In some embodiments, the first electrode can be composed of multiple (such as two or more) sub-electrodes spliced end to end in the length direction. In some embodiments, the materials and / or sizes of the adjacent two sub-electrodes are different; so that the resistance values of the adjacent two sub-electrodes are different. In some embodiments, as shown in Figure 8 is a schematic diagram of the electrode structure of the ablation catheter according to some embodiments of the present application. Figure 8As shown, the four sub-electrodes 511 of electrode 510 can have the same size (e.g., sub-electrode length), and any two adjacent sub-electrodes 511 can be made of different materials. In some embodiments, the materials of the four sub-electrodes 511 of electrode 510 can be silver chloride, platinum, silver chloride, and platinum, respectively. In some embodiments, the materials of the four sub-electrodes 511 of electrode 510 can be silver chloride, platinum, molybdenum, and stainless steel, respectively. In some embodiments, multiple sub-electrodes can be connected end-to-end and fixed (e.g., glued) to a support rod to form a first electrode. In some embodiments, multiple sub-electrodes can be connected end-to-end (e.g., welded, glued, etc.) to form a first electrode before being fixed to the support rod. In some embodiments, each sub-electrode can be connected to an external energy generator via a separate wire. In some embodiments, multiple sub-electrodes of the first electrode can be connected to an external energy generator via the same wire. For example, one end of the wire can be evenly attached to the four sub-electrodes using a patch. In some embodiments, multiple sub-electrodes are interconnected, and the wire can be connected to only one or some of the sub-electrodes.
[0081] In some embodiments, such as Figure 9 As shown, electrode 520 can be a first electrode, and electrode 520 can be formed by splicing four sub-electrodes 521 end to end. In some embodiments, such as Figure 9 As shown, among the four sub-electrodes 521 of electrode 520, the dimensions (e.g., sub-electrode lengths) of any two adjacent sub-electrodes 521 can be different. For example, the dimensions of the four sub-electrodes 521 can be completely different. For another example, as... Figure 9 As shown, the spaced sub-electrodes 521 can be of the same size; the four sub-electrodes 521 can include both long and short sizes, with long and short sub-electrodes arranged alternately. In some embodiments, the four sub-electrodes 521 can be made of the same material, so that the four sub-electrodes differ from each other only in size. In some embodiments, the materials of the four sub-electrodes 521 may not be exactly the same. For example, the material of the long sub-electrode can be silver chloride, and the material of the short sub-electrode can be platinum.
[0082] In some embodiments, the second electrode corresponding to the first electrode (such as electrode 510 or electrode 520) can be a single, integral electrode. Each sub-electrode of the first electrode can discharge relative to the second electrode to form a pulsed electric field. By setting different materials and / or sizes for adjacent sub-electrodes of the first electrode, the resistance of adjacent sub-electrodes can be different, resulting in pulsed electric fields formed by each sub-electrode and the second electrode that are not entirely identical (e.g., different in intensity, shape, and / or range), thereby creating a non-uniform electric field between the first and second electrodes. When ablating certain special lesions (such as mixed lesions, unclear lesions, etc.), the non-uniform electric field has a wider tissue applicability and better ablation effect.
[0083] In some embodiments, the second electrode corresponding to the first electrode may be formed by splicing multiple sub-electrodes (e.g., two or more) end-to-end along the length direction. In some embodiments, adjacent sub-electrodes of the second electrode may have different materials and / or sizes, resulting in different resistance values. In some embodiments, each sub-electrode may be connected to an external energy generator via a separate wire. In some embodiments, multiple sub-electrodes of the second electrode may be connected to an external energy generator via the same wire. In some embodiments, multiple sub-electrodes are interconnected, and the wire may be connected to only one or some of the sub-electrodes. In some embodiments, multiple sub-electrodes of the first electrode may be connected to the positive terminal of an external energy generator via a wire, and multiple sub-electrodes of the second electrode may be connected to the negative terminal of an external energy generator via a wire, thereby enabling the energy generator to control the discharge of multiple sub-electrodes of the first electrode relative to multiple sub-electrodes of the second electrode. In some embodiments, the number of sub-electrodes of the first electrode is equal to the number of sub-electrodes of the second electrode. By providing a number of sub-electrodes equal to the number of sub-electrodes on the second electrode, the electric field configuration can be more easily controlled and more diverse, thus making it better suited for ablation of different lesions.
[0084] In some embodiments, the sub-electrodes of the first electrode correspond one-to-one with the sub-electrodes of the second electrode; the corresponding two sub-electrodes are made of different materials and / or have different dimensions. In some embodiments, such as Figure 9 As shown, electrode 520 can be a first electrode, and electrode 530 can be a second electrode. Electrode 520 can be disposed on the first support rod 130; electrode 530 can be disposed on the second support rod 140; electrode 520 and electrode 530 correspond to each other. In some embodiments, such as Figure 9 As shown, electrode 520 may include four sub-electrodes 521, and electrode 530 may include four sub-electrodes 531, with a one-to-one correspondence between the four sub-electrodes 521 and the four sub-electrodes 531. In some embodiments, such as Figure 10As shown, the dimensions (e.g., sub-electrode lengths) of corresponding sub-electrodes (i.e., corresponding sub-electrodes 521 and 531) can be different. For example, the dimensions of the four sub-electrodes 521 of electrode 520 can be, in order, long, short, long, short; the dimensions of the four sub-electrodes 531 of corresponding electrode 530 can be, in order, short, long, short, long. In some embodiments, the materials of corresponding sub-electrodes can be different. For example, the materials of the four sub-electrodes 521 of electrode 520 can be, in order, silver chloride, platinum, molybdenum, and stainless steel; the materials of the four sub-electrodes 531 of corresponding electrode 530 can be, in order, stainless steel, molybdenum, platinum, and silver chloride. In some embodiments, both the materials and dimensions of corresponding sub-electrodes can be different. By setting the materials and / or dimensions of corresponding sub-electrodes to be different, a non-uniform electric field can be generated during discharge. Simultaneously, by having multiple sub-electrodes of the first electrode discharge relative to multiple sub-electrodes of the second electrode, cross-discharge between non-corresponding sub-electrodes may occur, further increasing the non-uniformity of the electric field, thereby expanding the applicable range of the electric field and improving the ablation effect.
[0085] In some embodiments, the first electrode may include at least three sub-electrodes. Figure 10 This is a schematic diagram of an electrode structure including three sub-electrodes according to some embodiments of this application. In some embodiments, the first electrode may be electrode 540. In some embodiments, such as Figure 10 As shown, electrode 540 may include three sub-electrodes 541, 542, and 543. The three sub-electrodes 541, 542, and 543 are sequentially joined end-to-end to form electrode 540. In some embodiments, the resistance of the middle sub-electrode of the first electrode may be greater than the resistance of the sub-electrodes at its edges. For example, as... Figure 10 As shown, the resistance of the middle sub-electrode 542 can be greater than the resistance of its edge sub-electrodes 541 and 543. In some embodiments, the material and / or size of the middle sub-electrode can be different from that of the edge sub-electrodes, such that the resistance of the middle sub-electrode is greater than that of its edge sub-electrodes. In some embodiments, as... Figure 11As shown, the length of the middle sub-electrode 542 can be smaller than that of the edge sub-electrodes 541 and 543, so that the resistance of the middle sub-electrode 542 is greater than that of the edge sub-electrodes 541 and 543. In some embodiments, the middle sub-electrode can be made of stainless steel with poor electrical conductivity, and the edge sub-electrodes can be made of silver / silver chloride with good electrical conductivity, so that the resistance of the middle sub-electrode is greater than that of the edge sub-electrodes. By setting the resistance of the middle sub-electrode to be greater than that of the edge sub-electrodes, the electric field formed between the first electrode and the second electrode when the first electrode discharges relative to the second electrode can be more uniform. In practice, when using two integrated and uniform electrodes for discharge ablation, the tissue ablation intensity in the middle region can be greater than that in the edge region, which can cause excessive tissue ablation in the middle region or insufficient tissue ablation in the edge region. The present embodiment forms the first electrode by splicing multiple sub-electrodes, and sets the resistance of the middle sub-electrode to be greater than that of the edge sub-electrodes, so that the electric field formed by the middle sub-electrode is relatively weak, and the electric field formed between the first electrode and the second electrode is more uniform, effectively avoiding uneven ablation effect. In some embodiments, the second electrode has a different structure from the first electrode. For example, the second electrode can be an integrated electrode. For another example, the second electrode can include the same number of sub-electrodes as the first electrode, but the materials and / or sizes of the sub-electrodes of the second electrode are not completely consistent with those of the first electrode. In some embodiments, the second electrode can have the same structure as the first electrode.
[0086] In some embodiments, the number of sub-electrodes of the first electrode can include 4, 5, 6, etc. In some embodiments, the resistance of the middle sub-electrode of the first electrode can be greater than that of the edge sub-electrodes. In some embodiments, the resistance of the multiple sub-electrodes can decrease from the middle to both sides. By such sub-electrode arrangement, the electric field formed when the first electrode discharges relative to the second electrode (e.g., when the multiple sub-electrodes of the first electrode simultaneously discharge relative to the multiple sub-electrodes of the second electrode) can be more uniform. Figure 11 is a schematic diagram of an electrode structure including five sub-electrodes according to some embodiments of the present application. In some embodiments, the first electrode can be electrode 550. As shown, Figure 11 The electrode 550 can include five sub-electrodes 551, 552, 553, 554, and 555. The five sub-electrodes 551, 552, 553, 554, and 555 are spliced together in sequence to form the electrode 550. In some embodiments, the material and / or size of the middle sub-electrode can be different from that of the edge sub-electrodes, so that the resistance of the middle sub-electrode is greater than that of the edge sub-electrodes. In some embodiments, as shown, Figure 12As shown, the size (e.g., the length) of the middle sub-electrode 553 can be smaller than the size of the edge sub-electrodes 551 and 555, so that the resistance of the middle sub-electrode is greater than the resistance of the edge sub-electrodes. In some embodiments, the size of the sub-electrodes 552 and 554, which are next to the middle sub-electrode, can be between the size of the middle sub-electrode and the size of the edge sub-electrodes, so that the resistance of the plurality of sub-electrodes decreases from the middle to the edges.
[0087] In some embodiments, a voltage difference can be formed between the plurality of sub-electrodes of the first electrode, so that an electric field can be formed between the plurality of sub-electrodes for ablation of the diseased tissue near the first electrode. In some embodiments, among the plurality of sub-electrodes of the first electrode, some sub-electrodes can be connected to the positive pole of the energy generator, and some sub-electrodes can be connected to the negative pole of the energy generator, so that the sub-electrodes connected to the positive pole can discharge relative to the sub-electrodes connected to the negative pole. In some embodiments, the first electrode can include three sub-electrodes, the middle sub-electrode can be connected to the positive pole, and the edge sub-electrodes can be connected to the negative pole. In some embodiments, the first electrode can include four sub-electrodes, and the four sub-electrodes can be alternately connected to the positive pole and the negative pole of the energy generator.
[0088] Figure 12 is a structural schematic diagram of an ablation catheter with varying electrode spacing according to some embodiments of the present application.
[0089] In some embodiments, referring to Figure 12The ablation catheter 600 may include a first support rod 630. In some embodiments, only one support rod (such as the first support rod 630) may be provided on the ablation catheter 600. In some embodiments, the first support rod 630 may include a plurality of electrodes 631 (e.g., at least three), wherein the distance between two adjacent electrodes among the plurality of electrodes 631 is a first distance, and the distance between two other adjacent electrodes is a second distance. The first distance and the second distance are different. In some embodiments, each electrode 631 on the first support rod 630 may be connected to an external energy generator through a separate wire, with some electrodes connected to the positive terminal of the energy generator and some electrodes connected to the negative terminal of the energy generator. In some embodiments, the plurality of electrodes 631 may be alternately connected to the positive and negative terminals of the energy generator. During use, the energy generator can control the electrode connected to the positive terminal to discharge to the electrode connected to the negative terminal to form a pulsed electric field (or current loop), thereby ablating the lesion tissue. By setting different first and second distances, different pulsed electric fields can be generated between different adjacent electrodes, thus making it suitable for ablation of different lesions. During the ablation procedure, medical staff can use adjacent electrodes with different spacing to ablate the lesions at different ablation sites. By using the ablation catheter with the above structure, medical staff can select different ablation electric field strengths simply by rotating the ablation catheter.
[0090] In some embodiments, the spacing between any two adjacent electrodes in the plurality of electrodes is not the same. In some embodiments, such as Figure 12 As shown, multiple electrodes 631 on the first support rod 630 can be arranged at intervals from one end of the first support rod 630 to the other end. The spacing between any two adjacent electrodes 631 is different from one end to the other. By setting the spacing between any two adjacent electrodes to be different, the first support rod 630 can accommodate more adjacent electrodes with different spacings, thus adapting to more diseased tissues and improving the utilization rate of the support rod.
[0091] In some embodiments, the spacing between adjacent electrodes 631 can vary regularly from one end of the first support rod 630 to the other. In some embodiments, this regular variation can include arithmetic progression, arithmetic progression, geometric progression, or geometric progression. For example, the spacing between adjacent electrodes 631 can increase arithmetic progression from one end of the first support rod 630 to the other. Figure 12 As shown, the first support rod 630 can be equipped with six electrodes 631, and the spacing between any two adjacent electrodes 631 is different. Starting from one end of the first support rod 630 and moving towards the other end, the five electrode spacings between any two adjacent electrodes are all different and gradually increase proportionally. Figure 13In the embodiment shown, the ratio between the five electrode spacings can be 1:2:3:4:5. By setting the spacings of adjacent electrodes to vary regularly, the ablation catheter can be more easily controlled. Specifically, the regularly varying electrode spacings can cause the electric field formed between adjacent electrodes to also vary regularly, thereby making it easier for medical personnel to select and control the electric field.
[0092] Figure 13 is a structural schematic diagram of an ablation catheter with varying electrode spacings according to another embodiment of the present application. In some embodiments, as shown in Figure 14 the ablation catheter 600 can include a first support rod 630 and a second support rod 640. In some embodiments, the first support rod 630 can include a plurality (e.g., at least three) of electrodes 631, among which the spacings of two adjacent electrodes are a first spacing, and the spacings of another two adjacent electrodes are a second spacing. In some embodiments, the second support rod 640 can include a plurality (e.g., at least three) of electrodes 641. In some embodiments, the plurality of electrodes 641 on the second support rod 640 correspond one-to-one to the plurality of electrodes 631 on the first support rod 630. By setting two support rods, each of which includes electrodes with varying spacings, and the electrodes on the two support rods corresponding one-to-one, the ablation catheter can not only form an ablation electric field between different electrodes on the same support rod, but also form an ablation electric field between electrodes on different support rods, thereby increasing the ablation range of the ablation catheter, improving the utilization of the ablation catheter, and improving the ablation efficiency of the diseased tissue.
[0093] Figure 14 is a structural schematic diagram of an ablation catheter with adjustable electrode spacings according to some embodiments of the present application.
[0094] In some embodiments, the first support rod 630 of the ablation catheter 600 can be provided with an electrode position adjusting mechanism 670. The electrode position adjusting mechanism 670 can be used to adjust the position of the electrodes 631 on the first support rod 630. In some embodiments, the position of at least one electrode 631 can be adjusted by the electrode position adjusting mechanism 670, so that the first spacing and the second spacing are different. Among the plurality of electrodes 631 of the first support rod 630, the spacings of two adjacent electrodes are a first spacing, and the spacings of another two adjacent electrodes are a second spacing. Different electrode spacings can produce ablation electric fields of different intensities. By setting the electrode position adjusting mechanism, different electrode spacings can be obtained according to actual needs (e.g., different diseased tissues), thereby making the ablation catheter have a greater range of applications and enabling precise ablation of diseased tissues.
[0095] In some embodiments, as shown in Figure 15As shown, the first support rod 630 of the ablation catheter 600 is provided with a plurality of electrodes 631, and each electrode 631 can be provided with a corresponding electrode position adjusting mechanism. By providing each electrode with a corresponding electrode position adjusting mechanism, the spacing between any two adjacent electrodes can be adjusted, thereby making the adjustment of electrode spacing more flexible and the adjustment results more diverse. In some alternative embodiments, among the plurality of electrodes 631, every other electrode can be provided with a corresponding electrode position adjusting mechanism.
[0096] In some embodiments, the electrode position adjusting mechanism 670 can include a long strip-shaped through hole 671 formed on the first support rod 630. In some embodiments, due to the connection of the electrode with a wire, the electrode can be arranged to move before the two ends of the long strip-shaped through hole 671. In some embodiments, the electrode position adjusting mechanism 670 can further include an electrode limiting structure (not shown in the figure). The electrode limiting structure is fixedly connected with the electrode, and the electrode limiting structure cooperates with the long strip-shaped through hole 671 and can move along the long strip-shaped through hole 671. In some embodiments, the electrode 631 can be a ring electrode sleeved on the first support rod 630. The electrode limiting structure can be a limiting block penetrating through the long strip-shaped through hole, and the limiting block is fixedly connected with the inner wall of the corresponding electrode at both ends. The limiting block can move along the long strip-shaped through hole 671 to drive the electrode to move, thereby adjusting the spacing between adjacent electrodes. In some embodiments, the electrode position can be adjusted manually. For example, medical personnel can manually move the electrode or the limiting block before the operation, thereby adjusting the position of the electrode relative to the long strip-shaped through hole 671. In some embodiments, the electrode position can be adjusted by a control mechanism. In some embodiments, the ablation device can include a control handle for controlling the ablation catheter, the electrode limiting structure can be connected with a rope and can move under the pulling of the rope, and the control handle is provided with a rope control mechanism, the rope control mechanism can pull the rope to control the movement of the electrode limiting structure, thereby adjusting the electrode position. By adjusting the electrode position by the control mechanism, the adjustment of the electrode position during the ablation operation can be realized in time to achieve precise ablation of the diseased tissue.
[0097] In some embodiments, the electrode position adjusting mechanism 670 can include other mechanisms capable of adjusting the electrode position. In some embodiments, the electrode position adjusting mechanism 670 can include a long slot formed on the first support rod 630, and a clamping block can be fixed on the electrode and matched with the slot. The electrode can be arbitrarily moved relative to the first support rod 630, and the clamping block can keep the electrode from being deflected during the movement. In some embodiments, the electrode position adjusting mechanism 670 can not be included in the ablation catheter 600. In some embodiments, the electrode can be sleeved on the first support rod and connected with the first support rod in an interference fit. The electrode can be moved relative to the first support rod under the action of an external force, so as to realize the adjustment of the electrode position without the electrode position adjusting mechanism 670.
[0098] Figure 15 is a structural schematic diagram of an ablation catheter with adjustable electrode spacing according to another embodiment of the present application. In some embodiments, as shown in Figure 16 , the ablation catheter 600 can include a first support rod 630 and a second support rod 640. In some embodiments, the first support rod 630 is provided with a plurality of electrodes 631, and each electrode 631 can be provided with a corresponding electrode position adjusting mechanism 670. In some embodiments, the second support rod 640 can include a plurality of electrodes 641, and the number of the electrodes 641 is equal to that of the electrodes 631. In some embodiments, the plurality of electrodes 641 on the second support rod 640 are fixed relative to the second support rod 640. In some embodiments, the plurality of electrodes 641 on the second support rod 640 can be respectively provided with corresponding electrode position adjusting mechanisms. By providing two support rods, the ablation catheter can not only form an ablation electric field between different electrodes of the same support rod, but also form an ablation electric field between electrodes of different support rods, so as to increase the ablation range of the ablation catheter and improve the utilization rate of the ablation catheter and the ablation efficiency of the lesion tissue.
[0099] Figure 17 is a first state schematic diagram of an ablation catheter with adjustable support rods according to some embodiments of the present application; Figure 18 is a second state schematic diagram of an ablation catheter with adjustable support rods according to some embodiments of the present application; Figure 19 is a third state schematic diagram of an ablation catheter with adjustable support rods according to some embodiments of the present application; Figure 20 is a structural schematic diagram of an ablation catheter with adjustable support rods according to another embodiment of the present application; Figure 21 is a working state schematic diagram of an ablation catheter with adjustable support rods according to another embodiment of the present application; Figure 22 is a structural schematic diagram of an ablation catheter with adjustable support rods according to still another embodiment of the present application; Figures 16-22This is a schematic diagram of the working state of an ablation catheter with adjustable support rod according to another embodiment of this application.
[0100] In some embodiments, such as Figures 16-18 As shown, the ablation catheter 700 may include a first support rod 730, a second support rod 740, and an inner tube 720. The first support rod 730 and the second support rod 740 are disposed on the inner tube 720, and multiple electrodes (such as electrode 731 on the first support rod 730 or electrode 741 on the second support rod 740) are provided on the first support rod 730 and / or the second support rod 740. In some embodiments, both the first support rod and the second support rod are annular support rods. In some embodiments, the angle of the first support rod 730 and / or the second support rod 740 relative to the inner tube 720 is adjustable. For example, the angle between the plane containing the first support rod 730 and / or the second support rod 740 and the inner tube 720 is adjustable. In some embodiments, the inner tube 720 may be located on the center line connecting the annular first support rod 730 and the second support rod 740. The first support rod 730 and / or the second support rod 740 may rotate (e.g., flip) around their respective centers under the control of an angle adjustment mechanism (such as a curvature adjustment rope, an electromagnet, etc.) to change the angle of the first support rod 730 and / or the second support rod 740 relative to the inner tube 720. In some embodiments, the first support rod 730 and the second support rod 740 may rotate in the same direction. In some embodiments, one of the first support rod 730 and the second support rod 740 may remain stationary while only the other rotates. In some embodiments, the first support rod 730 and the second support rod 740 may rotate in different directions. By making the angle of the first support rod 730 and / or the second support rod 740 relative to the inner tube 720 adjustable, the ablation catheter 700 can be adapted to fit against tissue lumens of different shapes to better ablate and / or map lesions in the tissue lumen. Furthermore, after the angles of the first support rod 730 and / or the second support rod 740 relative to the inner tube 720 are adjusted, the distance between the corresponding electrodes on the first support rod 730 and the second support rod 740 changes accordingly, thereby forming different ablation electric fields suitable for ablation of different lesions. In some embodiments, the ablation catheter 700 may include only one support rod (such as the first support rod 730), the angle of which is adjustable relative to the inner tube 720.
[0101] In some embodiments, the first support rod 730 can be connected with the inner tube 720 through a first connecting rod 750, and the second support rod 740 can be connected with the inner tube 720 through a second connecting rod 760. The bending degree of the first connecting rod 750 and / or the second connecting rod 760 can be adjusted, so that the angle of the first support rod 730 and / or the second support rod 740 relative to the inner tube 720 can be adjusted. By independently arranging the first support rod 730 and the second support rod 740 on the inner tube 720 through the connecting rods respectively, the first support rod 730 and the second support rod 740 can be controlled individually, so that the ablation catheter 700 can be suitable for more ablation scenarios. In some embodiments, the ablation catheter 700 further comprises an outer tube 710, the outer tube 710 is sleeved outside the inner tube 720, and the inner tube 720 can move relative to the outer tube 710, so that the first support rod 730 and the second support rod 740 can be retracted into the outer tube 710 or extended from the outer tube 710 to form a ring-shaped support rod.
[0102] In some embodiments, referring to Figures 16-18 , the first connecting rod 750 and / or the second connecting rod 760 of the ablation catheter 700 is provided with a bending degree adjusting rope. One end of the bending degree adjusting rope is connected with the first connecting rod and / or the second connecting rod; the bending degree adjusting rope can be used to control the bending degree of the first connecting rod 750 and / or the second connecting rod 760, so as to adjust the angle of the first support rod 730 and / or the second support rod 740 relative to the inner tube 720. As shown in Figure 2 , the first connecting rod 750 is provided with a bending degree adjusting rope 781, one end of the bending degree adjusting rope 781 can be fixedly connected at one end of the first connecting rod 750 (such as the connection between the first connecting rod 750 and the first support rod 730), and the other end of the bending degree adjusting rope 781 can be extended to the outside of the ablation catheter 700 and connected with an external control mechanism (such as a control handle). In some embodiments, the second connecting rod 760 can be similarly provided with a bending degree adjusting rope 782. In some embodiments, the user can pull the bending degree adjusting rope 781 and / or the bending degree adjusting rope 782 through the control mechanism (such as the control handle), so that the first connecting rod 750 and / or the second connecting rod 760 are bent, thereby driving the first support rod 730 and / or the second support rod 740 to rotate relative to the inner tube 720. In some embodiments, the user can relax the bending degree adjusting rope 781 and / or the bending degree adjusting rope 782 through the control mechanism, so that the first connecting rod 750 and / or the second connecting rod 760 restore the natural shape under the action of their own elasticity, thereby driving the first support rod 730 and / or the second support rod 740 to restore the natural state.
[0103] In some embodiments, the angle between the first support rod 730 and the second support rod 740 of the ablation catheter 700 and the inner tube 720 in the natural state can be 90 degrees (such as Figure 16the state of the ablation catheter 100). In some embodiments, as shown in FIG. 7A, the first support rod 730 and the second support rod 740 can be kept in a natural state, i.e., the first support rod 730 and the second support rod 740 are parallel to the inner tube 720. In some embodiments, as shown in FIG. 7B, the first support rod 730 and the second support rod 740 can be rotated relative to the inner tube 720. In some embodiments, as shown in FIG. 7C, the first support rod 730 can be kept in a natural state, and the second support rod 740 can be rotated relative to the inner tube 720. In some embodiments, as shown in FIG. 7D, the second support rod 740 can be kept in a natural state, and the first support rod 730 can be rotated relative to the inner tube 720. Figure 17 In some embodiments, as shown in FIG. 7B, the bending adjustment ropes 781 and 782 can be pulled simultaneously by the same distance, so that the first connecting rod 750 and the second connecting rod 760 are bent by the same degree, and then the first support rod 730 and the second support rod 740 are rotated by the same angle. In some embodiments, during the rotation of the first support rod 730 and the second support rod 740, the plane formed by the first support rod 730 and the plane formed by the second support rod 740 can remain parallel to each other. In some embodiments, as shown in FIG. 7C, the bending adjustment rope 781 can not exert a pulling force, and only the bending adjustment rope 782 exerts a pulling force, so that the first support rod 730 can be kept in a natural state, and the second support rod 740 is rotated under the pulling of the bending adjustment rope 782. In some embodiments, as shown in FIG. 7D, the bending adjustment rope 782 can not be pulled, and only the bending adjustment rope 781 is pulled, so that the second support rod 740 is kept in a natural state, and the first support rod 730 is rotated under the pulling of the bending adjustment rope 781. Figure 18 Figures 19-20 In some embodiments, as shown in FIG. 7D, the bending adjustment rope 782 can not be pulled, and only the bending adjustment rope 781 is pulled, so that the second support rod 740 is kept in a natural state, and the first support rod 730 is rotated under the pulling of the bending adjustment rope 781. In some embodiments, if the first support rod 730 or the second support rod 740 does not need to be rotated during ablation / mapping, the corresponding first connecting rod 750 or the second connecting rod 760 can not be provided with a bending adjustment rope. In some embodiments, the user can control the pulling distance of the bending adjustment rope 781 and / or the bending adjustment rope 782 through the control mechanism, so as to control the degree of bending of the first connecting rod 750 and / or the second connecting rod 760, and then accurately control the angle of the first support rod 730 and / or the second support rod 740 relative to the inner tube 720. By providing the bending adjustment rope, the angle of the first support rod 730 and / or the second support rod 740 relative to the inner tube 720 can be conveniently and reliably adjusted.
[0104] In some embodiments, the adjustment of the angle of the first support rod 730 and / or the second support rod 740 relative to the inner tube 720 can be realized by other mechanisms. In some embodiments, the adjustment of the angle of the first support rod 730 and / or the second support rod 740 relative to the inner tube 720 can be realized by providing an electromagnet.
[0105] In some embodiments, the first support rod 730 can be provided with an electromagnet (such as an electromagnet), and the position corresponding to the electromagnet of the first support rod 740 on the second support rod 740 is provided with a magnetic block (such as an iron block); or, the first support rod 730 is provided with a magnetic block, and the position corresponding to the magnetic block of the first support rod 730 on the second support rod 740 is provided with an electromagnet. In some embodiments, the electromagnet can attract the magnetic block in the energized state, so that the first support rod 730 and the second support rod 740 are both flipped relative to the inner tube 720.
[0106] In some embodiments, as shown in FIG. 8A, the first support rod 730 and the second support rod 740 can be kept in a natural state, i.e., the first support rod 730 and the second support rod 740 are parallel to the inner tube 720. In some embodiments, as shown in FIG. 8B, the first support rod 730 and the second support rod 740 can be rotated relative to the inner tube 720. In some embodiments, as shown in FIG. 8C, the first support rod 730 can be kept in a natural state, and the second support rod 740 can be rotated relative to the inner tube 720. In some embodiments, as shown in FIG. 8D, the second support rod 740 can be kept in a natural state, and the first support rod 730 can be rotated relative to the inner tube 720.Figure 19 As shown, the first support rod 730 can be provided with a magnetic block 792, and the second support rod 740 can be provided with an electromagnet 791 at a position corresponding to the magnetic block 792. In some embodiments, the magnetic block 792 and the electromagnet 791 can be arranged between two adjacent electrodes. In some embodiments, the magnetic block 792 and / or the electromagnet 791 can be arranged inside the support rod or on the surface of the support rod. In some embodiments, the electromagnet 791 can be connected to an external controller through a separate wire. The controller can control the power supply of the electromagnet 791. In some embodiments, the controller can control the current of the electromagnet 791, thereby controlling the magnetic force of the electromagnet 791. In some embodiments, the electromagnet 791 in the power-on state can attract the magnetic block 792, so that the positions of the first support rod 730 and the second support rod 740 provided with the magnetic block 792 and the electromagnet 791 are attracted to each other and close to each other, thereby realizing the overturning of the first support rod 730 and the second support rod 740 relative to the inner tube 720. In some embodiments, the controller can control the current of the electromagnet 791, thereby controlling the attraction between the electromagnet 791 and the magnetic block 792, and further controlling the angle of the overturning of the first support rod 730 and the second support rod 740 relative to the inner tube 720. In some embodiments, the electromagnet 791 can include an iron bar 791B fixedly installed on the second support rod 740 and a coil 791A wound outside the iron bar 791B, and the coil 791A can be electrically connected to the external controller. In some embodiments, the magnetic block 792 can be fixedly installed on the second support rod 740. The magnetic block 792 can be understood as a block that can be attracted by a magnet, such as an iron block. When the external controller controls the current to pass through the coil 791A, according to the magnetic effect of the current, a magnetic field is generated in the coil 791A, and the iron bar 791B is magnetized by the magnetic field in the coil 791A, so that the iron bar 791B generates magnetism. Therefore, the iron bar 791B with magnetism and the magnetic block 792 can be attracted to each other.
[0107] In some embodiments, Figure 20 As shown, the first support rod 730 and the second support rod 740 are in a natural state, and the angle between the first support rod 730, the second support rod 740 and the inner tube 720 can be 90 degrees. In some embodiments, Figures 21-22The first support rod 730 and the second support rod 740 are both flipped relative to the inner tube 720 when the electromagnet 791 is powered on. The electromagnet and the magnetic block are arranged on the first support rod and the second support rod to control the flipping of the support rods, so that the flipping control is simple, reliable, and fast in response. The ablation catheter 700 forms a specific shape by flipping the first support rod and the second support rod relative to the inner tube, so as to be more suitable for fitting into a specific tissue lumen. In some embodiments, after the first support rod and the second support rod are both flipped relative to the inner tube, the distance between the corresponding electrodes on the side where the first support rod and the second support rod are close to each other is reduced, and the electric field strength formed between the corresponding electrodes is increased; and the distance between the corresponding electrodes on the side where the first support rod and the second support rod are away from each other is increased, and the electric field strength formed between the corresponding electrodes is reduced. Therefore, by controlling the flipping of the first support rod and the second support rod relative to the inner tube, a variety of pulse electric fields can be obtained to be suitable for ablation of different diseased tissues. In some embodiments, the first support rod 730 and the second support rod 740 have the same structure, and the absolute values of the flipping angles of the two support rods relative to the inner tube 720 are equal. By symmetrically flipping the first support rod and the second support rod (i.e., the absolute values of the flipping angles of the two support rods are equal), the ablation catheter is easier to control (e.g., it is more convenient to determine the distance between every two corresponding electrodes).
[0108] In some embodiments, a plurality of electromagnets 791 and a plurality of magnetic blocks 792 can be arranged on the second support rod 740 and the first support rod 730, respectively. In some embodiments, a plurality of electromagnets 791 are arranged on the second support rod 740, and a plurality of magnetic blocks 792 are arranged on the first support rod 730. In some embodiments, the number of magnetic blocks 792 can be equal to the number of electrodes 731 on the first support rod 730, and the electrodes 731 and the magnetic blocks 792 are arranged at intervals (i.e., one magnetic block 792 is arranged between every two adjacent electrodes 731). Correspondingly, the number of electromagnets 791 can also be equal to the number of electrodes 741 on the second support rod 740, and the electrodes 741 and the electromagnets 791 are arranged at intervals. In some embodiments, each electromagnet 791 can be connected to an external power source through a separate wire. The electromagnet 791 can attract the corresponding magnetic block 792 in the powered state. By arranging a plurality of electromagnets 791 and magnetic blocks 792, the first support rod 730 and the second support rod 740 can be flipped relative to the inner tube 720 from multiple directions, so that the ablation catheter can be suitable for ablation of more diseased tissues. By accurately controlling the flipping positions of the first support rod 730 and the second support rod 740, the size of the ablation electric field can be accurately controlled, thereby ensuring the accurate control of the ablation site and the ablation effect.
[0109] In some embodiments, the first support rod 730 and / or the second support rod 740 is provided with an electromagnet 791, and the inner tube 720 is provided with a magnetic block 792 at a position corresponding to the electromagnet 791 on the first support rod 730 and / or the second support rod 740; or, the first support rod 730 and / or the second support rod 740 is provided with a magnetic block, and the inner tube 720 is provided with an electromagnet at a position corresponding to the magnetic block on the first support rod 730 and / or the second support rod 740. The electromagnet can attract the magnetic block in the energized state, so as to make the first support rod 730 and / or the second support rod 740 flip relative to the inner tube 720.
[0110] In some embodiments, referring to Figure 21 , the second support rod 740 can be provided with an electromagnet 791, and the inner tube 720 is provided with a magnetic block 792 at a position corresponding to the electromagnet 791 on the second support rod 740. In some embodiments, the electromagnet 791 can be arranged between two adjacent electrodes. In some embodiments, the electromagnet 791 can be connected to an external controller through a separate wire. The electromagnet 791 can attract the magnetic block 792 in the energized state, and the magnetic block 792 is fixed on the inner tube 720, so as to make the end of the second support rod 740 provided with the electromagnet 791 close to the corresponding magnetic block 792 on the inner tube 720, and realize the flip of the second support rod 740 relative to the inner tube 720. In some embodiments, the electromagnet 791 can include an iron bar 791B fixedly installed on the second support rod 740 and a coil 791A wound outside the iron bar 791B, and the coil 791A can be electrically connected to the external controller. In some embodiments, the controller can control the current of the electromagnet 791 (such as the coil 791A), so as to control the attraction between the electromagnet 791 and the magnetic block 792, and further control the angle of the flip of the second support rod 740 relative to the inner tube 720. In some embodiments, Figure 22 , the first support rod 730 and the second support rod 740 are in a natural state, and the angle between the first support rod 730 and the second support rod 740 and the inner tube 720 can be 90 degrees. In some embodiments, Figures 3-5 , the second support rod 740 is flipped relative to the inner tube 720.
[0111] In some embodiments, the electromagnet 791 (or the magnetic block 792) can be arranged on the first support rod 730, and the magnetic block 792 (or the electromagnet 791) can be arranged on the corresponding position of the inner tube 720. In some embodiments, the electromagnet 791 (or the magnetic block 792) can be arranged on the first support rod 730 and the second support rod 740, and the magnetic block 792 (or the electromagnet 791) can be arranged on the corresponding position of the inner tube 720. By arranging the electromagnet 791 (or the magnetic block 792) on the first support rod 730 and / or the second support rod 740, the first support rod 730 and the second support rod 740 can be independently controlled to flip relative to the inner tube 720, so that the ablation catheter 700 can be suitable for more ablation scenarios.
[0112] In some embodiments, a plurality of electromagnets 791 can be arranged on the first support rod 730 and / or the second support rod 740, and the magnetic block 792 can be arranged on the corresponding position of the inner tube 720 corresponding to the plurality of electromagnets 791. In some embodiments, one or more magnetic blocks 792 can be arranged on the corresponding position of the first support rod 730 (or the second support rod 740) corresponding to the plurality of electromagnets 791. In some embodiments, one magnetic block 792 can be arranged around the inner tube 720, so that the magnetic block 792 can be suitable for attracting the plurality of electromagnets 791 at the same time. In some embodiments, a plurality of magnetic blocks 792 can be arranged around the inner tube 720 at intervals, and each magnetic block 792 can be arranged on the position corresponding to each electromagnet 791. By arranging the plurality of electromagnets 791 and the corresponding magnetic blocks 792, the first support rod 730 and the second support rod 740 can be flipped relative to the inner tube 720 from multiple directions, so that the ablation catheter 700 can be suitable for more ablation of pathological tissues. By precisely controlling the flipping position of the first support rod 730 and the second support rod 740, the size of the ablation electric field can be precisely controlled, thereby ensuring the precise control of the ablation site and the ablation effect.
[0113] Some embodiments of the present application also relate to an ablation device, which can include the ablation catheter of any of the embodiments of the present application. In some embodiments, the ablation device can further include a control handle, which can be used to control the ablation catheter. For example, the control handle can control the ablation catheter to be delivered into a human body and to be withdrawn from the human body. For another example, the control handle can be used to control the inner tube of the ablation catheter to move relative to the outer tube in a length direction. For yet another example, the control handle can be provided with a string control mechanism, which can pull the string to control the electrode limiting structure to move. For still another example, the control handle can be used to control the bending adjustment string to make the connecting rod (e.g., the first connecting rod and / or the second connecting rod) bend. In some embodiments, the ablation device can further include an energy generator, which can be used to control the electrodes to discharge to form a pulsed electric field. In some embodiments, the ablation device can further include a mapping device, which can be used to acquire a potential signal mapped between the electrodes. In some embodiments, the mapping device and the energy generator can be the same device or different devices.
[0114] It should be noted that the above description of the ablation catheter and the ablation device is merely for illustration and explanation, and does not limit the scope of the present application. Those skilled in the art can make various modifications and changes to the ablation catheter and the ablation device under the guidance of the present application; however, these modifications and changes are still within the scope of the present application. For example, the first support rod and the second support rod in some embodiments can be interchangeable, e.g., the second support rod can be closer to the front end of the ablation catheter. For another example, on the basis of the ablation catheter 200 shown in the figures, the electrodes can be configured to discharge between multiple electrodes, the distance between the electrodes can be changed, the support rod can be flipped relative to the inner tube, etc. For yet another example, different electrodes can be provided on one ablation catheter, which can be different in material, size and structure. For still another example, an ablation catheter can be provided with both the functions of adjustable electrode distance and the support rod flipped relative to the inner tube. For yet another example, the technical features of the various embodiments described in the present specification can be arbitrarily split and combined to form a new ablation catheter or device. Such modifications and changes are within the scope of the present application. For example, the electrodes can be configured to discharge between multiple electrodes, the distance between the electrodes can be changed, the support rod can be flipped relative to the inner tube, etc. For another example, different electrodes can be provided on one ablation catheter, which can be different in material, size and structure. For yet another example, an ablation catheter can be provided with both the functions of adjustable electrode distance and the support rod flipped relative to the inner tube. For still another example, the technical features of the various embodiments described in the present specification can be arbitrarily split and combined to form a new ablation catheter or device. Such modifications and changes are within the scope of the present application.
[0115] The ablation catheter and device disclosed in some embodiments of the present application can bring the following beneficial effects, including but not limited to: (1) high-density electric field ablation can be achieved while the ablation effect of the pulse field ablation catheter can be confirmed in time; (2) the ablation catheter can firmly adhere to the tissue lumen and can adapt to different shapes of the tissue lumen to reliably ablate the diseased tissue; (3) high-density mapping and in-situ mapping can be achieved to effectively improve the accuracy and timeliness of mapping; (4) ablation electric fields of different ranges, shapes and strengths can be formed to ablate and map different diseased tissues; (5) the ablation electric field is accurately controllable, thereby making the ablation site and ablation effect accurately controllable; (6) simple operation, suitable for application. It should be noted that different embodiments can have different beneficial effects, and in different embodiments, the beneficial effects can be any one or a combination of the above, or any other beneficial effects that can be obtained.
[0116] The above are only preferred embodiments of the present application and are not intended to limit the present application. Any modification, equivalent replacement and improvement made within the spirit and principle of the present application shall be included in the protection scope of the present application. The present application uses specific words to describe the embodiments of the present application. For example, "one embodiment", "an embodiment", and / or "some embodiments" means that a certain feature, structure or characteristic is related to at least one embodiment of the present application. Therefore, it should be emphasized and noted that the "some embodiments" or "one embodiment" or "some alternative embodiments" mentioned in different positions in the specification do not necessarily refer to the same embodiment. In addition, some features, structures or characteristics in one or more embodiments of the present application can be properly combined.
[0117] Similarly, it should be noted that, in order to simplify the description of the present application and to help understand one or more embodiments of the present application, in the foregoing description of the embodiments of the present application, various features are sometimes combined into one embodiment, figure or description thereof. However, this disclosure method does not mean that the features required by the present application are more than the features mentioned in the claims. In fact, the features of the embodiments are less than all the features of the disclosed single embodiment.
Claims
1. An ablation catheter with adjustable support rod, characterized in that, The ablation catheter comprises: an inner tube, a first support rod and a second support rod, the first support rod and the second support rod are arranged on the inner tube, and a plurality of electrodes are arranged on the first support rod and the second support rod; the first support rod and the second support rod are annular support rods; the angle of the first support rod and / or the second support rod relative to the inner tube is adjustable; an electromagnet is arranged on the first support rod, and a magnetic block is arranged at a position corresponding to the electromagnet of the first support rod on the second support rod; or a magnetic block is arranged on the first support rod, and an electromagnet is arranged at a position corresponding to the magnetic block of the first support rod on the second support rod; the electromagnet can attract the magnetic block in the energized state, and the angle of the first support rod and the second support rod relative to the inner tube is controlled by controlling the current of the electromagnet.
2. The ablation catheter of claim 1, wherein, the first support rod is connected with the inner tube through a first connecting rod, and the second support rod is connected with the inner tube through a second connecting rod; the bending degree of the first connecting rod and / or the second connecting rod is adjustable, so that the angle of the first support rod and / or the second support rod relative to the inner tube is adjustable.
3. The ablation catheter of claim 2, wherein, a bending degree adjusting rope is arranged in the first connecting rod and / or the second connecting rod, one end of the bending degree adjusting rope is connected with the first connecting rod and / or the second connecting rod; the bending degree adjusting rope can be used to control the bending degree of the first connecting rod and / or the second connecting rod.
4. The ablation catheter of claim 1, wherein, a plurality of electromagnets and magnetic blocks are arranged on the first support rod and the second support rod respectively and correspondingly.
5. The ablation catheter of claim 1, wherein, an electromagnet is arranged on the first support rod and / or the second support rod, and a magnetic block is arranged at a position corresponding to the electromagnet on the inner tube; or a magnetic block is arranged on the first support rod and / or the second support rod, and an electromagnet is arranged at a position corresponding to the magnetic block on the inner tube; the electromagnet can attract the magnetic block in the energized state, so that the first support rod and / or the second support rod is flipped relative to the inner tube.
6. The ablation catheter of claim 5, wherein, a plurality of electromagnets are arranged on the first support rod and / or the second support rod, and a magnetic block is arranged at a position corresponding to the plurality of electromagnets on the inner tube.
7. The ablation catheter of claim 1, wherein, the plane formed by the first support rod is parallel to the plane formed by the second support rod.
8. The ablation catheter of claim 1, wherein, the first support rod is closer to the front end of the ablation catheter relative to the second support rod; the annular diameter of the first support rod is smaller than the annular diameter of the second support rod; and the first support rod and the second support rod are connected in series through a third connecting rod.
9. An ablation device, characterized by, The ablation catheter comprises any one of claims 1-8.
Citation Information
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