An ablation catheter and ablation system

Abstract

The application relates to an ablation catheter and an ablation system, wherein the ablation catheter comprises a catheter body, a transducer and a plurality of wires electrically connected with the transducer; the transducer comprises a transducer body, an outer electrode, an inner electrode and a separation structure; the transducer body is sleeved on the catheter body, the outer electrode is arranged on the outer sidewall of the transducer body, the inner electrode is arranged on the inner sidewall of the transducer body, the separation structure is arranged on the transducer body, and the plurality of wires comprises an outer electrode wire and an inner electrode wire; the inner electrode is electrically connected with the inner electrode wire, the separation structure divides the outer electrode into a plurality of mutually independent electrode areas, each electrode area is electrically connected with the outer electrode wire, and each electrode area is arranged in parallel with each other, so that the plurality of electrode areas can be independently controlled. The transducer can generate a plurality of different ultrasonic focus points through the separation structure, and the focus points are used for ablation of a lesion position, so that the ablation efficiency is high, and the damage to the human body is small.

Description

Technical Field

[0001] This invention relates to the field of ablation technology, and more particularly to an ablation catheter and ablation system. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] Heart failure, hypertension, diabetes, pulmonary hypertension, and other diseases all exhibit similar processes during their development: over-excitation of the nerve bundle system surrounding the blood vessels. Under the influence of this over-excited nerve bundle, the body will produce various pathological phenomena, such as abnormal hormone secretion, elevated blood pressure, arterial hypertension, heart failure, diabetes, and stroke.

[0004] For example, hypertension is a common chronic disease, and the renin-angiotensin-aldosterone system (RAAS) plays a crucial role as an important blood pressure regulation system in its formation mechanism. The RAAS maintains the body's water, electrolyte, and blood pressure balance by regulating the heart, blood vessels, and kidneys. Studies have confirmed that the RAAS causes hypertension through the following three pathways: (1) RAAS activation causes sodium retention; (2) RAAS activation can increase the activity of the sympathetic nervous system; and (3) RAAS activation can directly constrict blood vessels. Among these, the renal artery sympathetic nerve plays a decisive role in inducing and maintaining systemic hypertension, and its overactivity makes it difficult for hypertensive patients to lower their blood pressure.

[0005] Therefore, existing technologies, such as transcatheter renal artery sympathetic nerve ablation, target the renal artery sympathetic nerves. The typical mechanism involves delivering electrodes into the patient's renal artery via a catheter and applying energy to the renal artery through these electrodes to ablate the renal sympathetic nerves within the renal artery wall, thereby lowering the patient's blood pressure.

[0006] During the dissection of nerves, researchers discovered that in the distribution of nerve bundles around the renal artery, the sympathetic and parasympathetic nerves are wrapped in the same bundle. When the sympathetic nerves are excited, the parasympathetic nerves inhibit the excitation of the sympathetic nerves, which has a certain positive effect on the symptoms of the aforementioned diseases. In the process of transcatheter renal artery sympathetic nerve ablation, the ablation catheter releases energy through a transducer at its distal end to ablate the lesion. This transducer usually releases energy in all directions simultaneously, ablating the surrounding nerve bundles while ablating the lesion. That is, while eliminating the lesion, it also damages the surrounding non-lesion tissues. Summary of the Invention

[0007] Therefore, it is necessary to provide a highly efficient and minimally invasive ablation catheter.

[0008] Furthermore, a highly efficient and minimally invasive ablation system is also provided.

[0009] An ablation catheter, characterized in that it comprises: a catheter body, a transducer disposed on the catheter body, and multiple wires electrically connected to the transducer; the transducer comprises: a transducer body, an outer electrode, an inner electrode, and a partition structure; the transducer body is sleeved on the catheter body, the outer electrode is disposed on the outer side wall of the transducer body, the inner electrode is disposed on the inner side wall of the transducer body, the partition structure is disposed on the transducer body, and the multiple wires include an outer electrode wire and an inner electrode wire; the inner electrode is electrically connected to the inner electrode wire, and the partition structure divides the outer electrode into multiple independent electrode regions, each electrode region being electrically connected to the outer electrode wire, and each electrode region being arranged in parallel with each other, so that multiple electrode regions can be independently controlled; or, the outer electrode is electrically connected to the outer electrode wire, the partition structure divides the inner electrode into multiple independent electrode regions, each electrode region being electrically connected to the inner electrode wire, and each electrode region being arranged in parallel with each other, so that multiple electrode regions can be independently controlled.

[0010] In one embodiment, multiple partition structures are provided, each extending along the axial direction of the transducer body, such that the electrode region formed by the partition is a circumferentially non-closed region; or, each partition structure is circumferentially closed along the transducer body, such that the electrode region formed by the partition is a circumferentially closed region; or, in the multiple partition structures, a portion extends along the axial direction of the transducer body and another portion closes circumferentially along the transducer body, such that the electrode region formed by the partition includes both a circumferentially closed region and a circumferentially non-closed region.

[0011] In one embodiment, the ablation catheter further includes a balloon and an electrode pair; the balloon is fitted onto the catheter body and encloses the transducer inside, and the electrode pair is disposed on the outer surface of the balloon, the electrode pair including a pair of electrodes with opposite polarities for determining the ablation location.

[0012] In one embodiment, multiple sets of electrode pairs are provided, and the positions of the multiple sets of electrode pairs correspond to the distribution positions of the multiple electrode regions.

[0013] In one embodiment, multiple partition structures extend linearly along the axial direction of the transducer body, multiple electrode regions are distributed circumferentially along the transducer body, and the focal position of the radiated sound field generated by the energization of the electrical stimulation point of each electrode pair and its corresponding electrode region coincides with the orthographic projection of the radiated sound field on the axial direction of the transducer body.

[0014] In one embodiment, the partition structure is a partition groove or a partition strip protruding from the side wall of the transducer body.

[0015] In one embodiment, the transducer body is a ceramic tube, the outer electrode is a conductive layer or conductive sheet disposed on the outer side wall of the ceramic tube, and the inner electrode is a conductive layer or conductive sheet disposed on the inner side wall of the ceramic tube.

[0016] In one embodiment, the catheter body has a guidewire lumen, the central axis of which is collinear with the central axis of the catheter body. The catheter body includes a first segment and a second segment, the distal end of the first segment is connected to the proximal end of the second segment, the guidewire lumen extends through the first segment and the second segment, and the outer diameter of the first segment is larger than the outer diameter of the second segment. The proximal end of the balloon is fitted onto the first segment, the distal end of the balloon is fitted onto the second segment, and the transducer body is fitted onto the second segment.

[0017] In one embodiment, the balloon has an inner cavity, and a first fluid cavity, a second fluid cavity, and a cable cavity are further disposed within the first tube segment; the first fluid cavity, the second fluid cavity, and the cable cavity all extend axially along the first tube segment, the first fluid cavity, the second fluid cavity, and the cable cavity are disposed around the guidewire cavity, and the first fluid cavity and the second fluid cavity are both in communication with the inner cavity of the balloon.

[0018] In one embodiment, a wiring groove is provided on the outer wall of the second pipe segment, the wiring groove is connected to the far end of the cable cavity, and at least one of the wires runs along the wiring groove in the second pipe segment and is connected to the transducer.

[0019] In one embodiment, a transition section is provided between the first pipe segment and the second pipe segment, with both ends of the transition section connected to the first pipe segment and the second pipe segment respectively, and the outer diameter of the transition section gradually decreases in the direction from the proximal end to the distal end.

[0020] In one embodiment, the distal end of the second tubing segment is fitted with a catheter tip, the catheter tip comprising a straight tubing segment and a tip segment connected to the distal end of the straight tubing segment, and the distal end of the balloon is fitted onto the straight tubing segment.

[0021] An ablation system includes: an ablation catheter as described above, an operating handle connected to the proximal end of the ablation catheter, and a control unit; the control unit is electrically connected to the transducer and the electrode pair via wires.

[0022] The aforementioned ablation catheter includes a catheter body, a transducer, and a lead wire. The transducer comprises a transducer body, an external electrode, an internal electrode, and a partition structure. The partition structure is located on the transducer body and divides the internal or external electrode into multiple independent electrode regions. After the transducer is energized, each of these independent electrode regions generates a corresponding focusing and outward-radiating sound field. The sound field generated by each electrode region radiates outward to form a focal point. Ablation is performed on the lesion site through this focal point. This approach helps reduce damage to non-lesion tissues during ablation. Furthermore, the concentrated energy at the focal point effectively increases the ablation speed and efficiency. Simultaneously, the parallel arrangement of multiple independent electrode regions allows for independent control of each region, further minimizing damage to non-lesion tissues during ablation. Therefore, this ablation catheter offers highly efficient ablation procedures with minimal damage to the human body. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0024] in:

[0025] Figure 1 This is a schematic diagram of the overall structure of the ablation catheter in one embodiment.

[0026] Figure 2 This is a schematic diagram of the ablation catheter structure after partial dissection of the balloon in one embodiment.

[0027] Figure 3 This is a top view of the ablation catheter in one embodiment.

[0028] Figure 4 For the corresponding Figure 3 A sectional view after being cut along the central section line AA.

[0029] Figure 5 For the corresponding Figure 3 A sectional view after cutting along the center section line BB.

[0030] Figure 6 This is a schematic diagram of the structure of the catheter body in one embodiment.

[0031] Figure 7 For the corresponding Figure 6 A magnified view of detail C.

[0032] Figure 8 This is a schematic diagram of the transducer in one embodiment.

[0033] Figure 9 For the corresponding Figure 8 Right view of the transducer.

[0034] Figure 10 This is a schematic diagram showing the positional relationship between the ultrasonic focusing point M generated in the electrode region and the corresponding stimulation point N of the electrode pair.

[0035] Figure 11 This is a schematic diagram of the transducer in another embodiment.

[0036] Figure 12 This is a schematic diagram of the transducer in another embodiment.

[0037] Figure 13 This is a schematic diagram of the transducer in another embodiment. Detailed Implementation

[0038] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0039] In the description of the embodiments of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the embodiments of the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0040] In the description of the embodiments of the present invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a replaceable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of the present invention based on the specific circumstances.

[0041] In the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length of the medical device during delivery, while "radial direction" generally refers to the direction of the medical device that is not parallel to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined. "Circumferential direction" refers to the circumferential direction, that is, the axial direction surrounding a tubular structure or cylinder.

[0042] This embodiment relates to an ablation system for ablating tissues, including but not limited to ablating overactive nerve bundles around the renal artery in the human body.

[0043] In one embodiment, the ablation system includes: a delivery sheath, an ablation catheter, an operating handle, and a control unit. The proximal end of the delivery sheath is connected to the operating handle. The ablation catheter is housed within the lumen of the delivery sheath and can move within the sheath to reach the location of the lesion. Simultaneously, when the ablation catheter reaches the location of the lesion, it can also extend out of the lumen of the delivery sheath to perform ablation on the lesion. The control unit is connected to the ablation catheter and is mainly used to control the ablation operation. In addition, the control unit can also measure blood pressure.

[0044] Please see Figure 1 and Figure 2 In one embodiment, the ablation catheter includes: a catheter body 100, a transducer 200, a balloon 300, and multiple sets of electrode pairs 400.

[0045] Specifically, transducer 200 is fitted at the distal end of catheter body 100 and connected to a control unit at the proximal end via wire a. The control unit generates an outwardly radiating sound field. Balloon 300 is also fitted at the distal end of catheter body 100, enclosing transducer 200. Electrode pair 400 is positioned on the outer wall of balloon 300 and connected to the control unit at the proximal end via wire b. The electrode pair 400, controlled by the control unit, electrically stimulates the vascular wall and measures the patient's blood pressure after stimulation to determine the location of lesions around the blood vessel.

[0046] In this embodiment, the transducer 200 generates ultrasonic waves by being powered on, and the ultrasonic waves are concentrated at the lesion tissue to generate heat energy, thereby achieving the effect of ablating the lesion tissue.

[0047] In one embodiment, the catheter body 100 is made of an elastic polymer material, such as polyether block polyamide (Pebax), polyamide (PA), or other polymer materials.

[0048] Please see Figure 2 Each electrode pair 400 includes a positive electrode 410 and a negative electrode 420. Multiple leads b are provided; some leads b are connected to the positive electrode 410, and others are connected to the negative electrode 420. Specifically, the multiple leads b can be fixed to the electrode pair 400 using conductive adhesive or welding. The electrode pair 400 is used to generate an electrical stimulation source to electrically stimulate the contact point within the blood vessel. The control unit measures the blood pressure of the stimulated individual and uses this blood pressure value to identify the lesion tissue, thus improving the selectivity of ablation.

[0049] In one embodiment, electrodes of opposite polarity are brushed onto the surface of the balloon 300 to form multiple electrode pairs 400. The electrode pairs 400 formed in this way are relatively soft, resulting in better overall permeability of the ablation catheter.

[0050] In another embodiment, the electrode pair 400 is an electrode sheet fixed to the surface of the balloon 300.

[0051] Please refer to the following: Figure 3 and Figure 4 In one embodiment, the catheter body 100 mainly includes a first tube segment 110 and a second tube segment 120. The distal end of the first tube segment 110 is connected to the proximal end of the second tube segment 120, and the outer diameter of the first tube segment 110 is larger than the outer diameter of the second tube segment 120.

[0052] In this embodiment, the proximal end of the balloon 300 is fitted onto the first tube segment 110, and the distal end of the balloon 300 is fitted onto the second tube segment 120. Specifically, both ends of the balloon 300 are connected to the outer walls of the first tube segment 110 and the second tube segment 120 by means of laser welding, adhesive bonding, or snap-fit ​​structures. The transducer 200 is fitted onto the second tube segment 120 and located inside the balloon 300.

[0053] It should be noted that, since the outer diameter of the second tube segment 120 is smaller than that of the first tube segment 110, installing the transducer 200 on the second tube segment 120 helps to reduce the radial dimension of the catheter body 100 at the second tube segment 120. In other words, after the transducer 200 is fitted onto the second tube segment 120, its radial dimension is the same as or substantially the same as that of the first tube segment 110. Thus, after the transducer 200 and balloon 300 are installed, the catheter body 100 can also pass smoothly through the delivery sheath, which helps to improve the passage of the catheter body 100 within the delivery sheath.

[0054] Please see Figures 3 to 5 In one embodiment, a guidewire cavity 101 is provided on the catheter body 100 (see details). Figure 7 Furthermore, the central axis of the guidewire lumen 101 is collinear with the central line of the catheter body 100. Specifically, the guidewire lumen 101 extends through the first tube segment 110 and the second tube segment 120.

[0055] Understandably, the central axis of the guidewire lumen 101 within the first tube segment 110 is collinear with the central axis of the guidewire lumen 101 within the second tube segment 120. This prevents the guidewire 500 from bending when passing through the guidewire lumen 101, allowing it to pass smoothly and improving its passability. Simultaneously, the collinearity of the central axis of the guidewire lumen 101 with the central axis of the catheter body 100 ensures that the portion of the guidewire 500 exiting the distal end of the second tube segment 120 is positioned in the middle of the blood vessel. This effectively reduces friction against the vessel wall after the guidewire 500 enters the vessel, minimizing vascular complications.

[0056] Please see Figure 5 A lubrication layer 1011 is provided on the cavity wall of the guidewire cavity 101. When the guidewire 500 passes through the guidewire cavity 101, it helps to improve the smoothness of the guidewire 500's passage, thereby improving the passability of the guidewire 500 in the guidewire cavity 101.

[0057] In one embodiment, the lubricating layer 1011 can be a polytetrafluoroethylene (PTFE) layer or a silicone oil layer, etc. The PTFE layer or silicone oil layer can reduce the resistance of the guide wire 500, thereby improving the throughput of the guide wire 500. Specifically, the PTFE layer or silicone oil layer can be applied to the cavity wall of the guide wire cavity 13 through processes such as heat welding, integral molding, or spraying.

[0058] Please see Figure 2 and Figure 6 A wiring groove 121 is provided on the second pipe section 120. The wiring groove 121 is located on the side of the second pipe section 120 near the first pipe section 110, and extends along the axial direction of the second pipe section 120. The wiring groove 120 is used to accommodate wires a. Specifically, multiple wires a are provided, and at least one of the multiple wires a runs along the wiring groove 121 to connect with the transducer 200. In this embodiment, all multiple wires a run along the wiring groove 121 to connect with the transducer 200.

[0059] It should be noted that the cable routing groove 121 is formed by the indentation of the outer wall of the second tube segment 120. In this way, at least one wire a does not protrude from the surface of the second tube segment 120, or the radial dimension of the portion protruding from the surface of the second tube segment 120 is small. This helps to avoid the radial dimension of wire a and the radial dimension of the second tube segment 120 from overlapping in the radial direction, thereby reducing the radial dimension of the ablation catheter in the second tube segment 120 and improving the passage of the ablation catheter in the delivery sheath.

[0060] Please see Figure 4 , Figure 6 and Figure 7 The balloon 300 has an inner lumen 310. A first fluid chamber 102 and a second fluid chamber 103 are also provided within the first tubing segment 110. The first fluid chamber 102 has a first opening 1021 at its distal end, communicating with the inner lumen 310 through the first opening 1021. The second fluid chamber 103 has a second opening (not shown in the attached figure) at its distal end, communicating with the inner lumen 310 through the second opening. After the balloon 300 is released from the distal end of the delivery sheath, fluids such as saline or contrast agents can be delivered into the inner lumen 310 of the balloon 300 through the first fluid chamber 102, thereby inflating the balloon 300 and allowing the outer wall of the balloon 102 to adhere to the inner wall of the blood vessel.

[0061] It should be noted that the first fluid cavity 102, the second fluid cavity 103, and the inner cavity 310 form a fluid inlet and outlet channel. The inflow and outflow of fluid remove the heat generated during the ablation of the transducer 200, thus cooling the transducer 200. Moreover, after the balloon 300 is inflated, its outer wall abuts against the inner wall of the blood vessel. While cooling the transducer 200, it can also cool the blood vessel wall at the ablation site, reducing the damage to the blood vessel wall caused by the heat from the transducer 200 during the ablation process.

[0062] In this embodiment, the first fluid cavity 102 is a fluid inlet channel, and the second fluid cavity 103 is a fluid outlet channel. In other embodiments, the first fluid cavity 102 may also serve as a fluid outlet channel, while the corresponding second fluid cavity 103 serves as a fluid inlet channel.

[0063] Understandably, since the inner lumen 310 of balloon 300 connects the first fluid chamber 102 and the second fluid chamber 103, balloon 300 has both a compressed and an inflated state. When the ablation catheter is housed in the lumen of the delivery sheath, balloon 300 is in a compressed state, facilitating the movement of the ablation catheter within the lumen of the delivery sheath. When balloon 300 extends out of the delivery sheath, fluid (such as saline or contrast agent) is injected into the inner lumen 310 through the first fluid chamber 102, thereby inflating balloon 300. This allows the outer wall of balloon 300 to contact the inner wall of the blood vessel. This facilitates electrical stimulation of the blood vessel wall by the electrode 400, making it easier to locate the specific location of the lesion. Furthermore, it helps cool the blood vessel wall during ablation, reducing damage to surrounding tissues at the lesion site.

[0064] Please continue reading. Figure 6 and Figure 7 The first pipe section 110 also includes a cable cavity 104, which extends along the axial direction of the first pipe section 110. The cable cavity 104 contains a first cable composed of multiple conductors a and a second cable composed of multiple conductors b. For details, please refer to... Figure 6 The first pipe section 110 has a third opening 1041 on its side wall that communicates with the cable cavity 104, and the wire b passes through the third opening 1041. The far end of the cable cavity 104 is connected to the cable tray 121, and the wire a passes through the cable cavity 104 into the cable tray 121.

[0065] Please return Figure 3 and Figure 4 It should be noted that the balloon 300 encloses the first opening 1021 and the second opening (not shown in the attached figure), thereby achieving communication with the inner cavity 310. However, the portion of the balloon 300 that is in contact with the first tube segment 110 does not cover the first opening 1021, the second opening, and the third opening 1041. Moreover, the third opening 1041 is located outside the coverage area of ​​the balloon 300, that is, on the side of the first tube segment 110 closer to the balloon 300, to facilitate the laying of the wire b.

[0066] Please see Figure 6 A transition section 130 is provided between the first pipe segment 110 and the second pipe segment 120. The proximal end of the transition section 130 is connected to the distal end of the first pipe segment 110, and the distal end of the transition section 130 is connected to the proximal end of the second pipe segment 120. The outer diameter of the transition section 130 gradually decreases along the direction from the proximal end to the distal end, so that the connection between the first pipe segment 110 and the second pipe segment 120 is smooth, which is beneficial to improving the overall structural strength and reliability of the conduit body 100. In this embodiment, the cable tray 121 passes through the transition section 130 and is connected to the cable cavity 104.

[0067] In one embodiment, the conduit body 100, comprising a first pipe section 110, a second pipe section 120, and a transition section 130, can be manufactured using an integral molding process. In other embodiments, the transition section 130 may also be a separate component, connected to the first pipe section 110 and the second pipe section 120 respectively by welding.

[0068] Please see Figure 2 , Figure 3 and Figure 4 In one embodiment, a catheter tip 140 is sleeved at the distal end of the second tubing segment 120. The catheter tip 140 can be connected to the outer wall of the distal end of the second tubing segment 120 by adhesive bonding or heat fusion. Specifically, the catheter tip 140 includes a straight tubing segment 141 and a tip segment 142 connected to the distal end of the straight tubing segment 141. In one embodiment, the catheter tip 140 can be manufactured in a one-piece molding process. The outer wall of the tip segment 140 gradually decreases in radial dimension along the proximal-to-distal direction, which is beneficial for the delivery of the ablation catheter in the patient's body.

[0069] In one embodiment, the outer diameter of the straight tube segment 141 is the same as or substantially the same as the outer diameter of the first tube segment 110. The distal end of the balloon 300 is fitted onto the straight tube segment 141. A catheter tip 140 is provided to facilitate the connection of the balloon 300 to the second tube body 120 with a smaller outer diameter and thinner wall when the second tube body 120 with a smaller outer diameter and thinner wall can be used. Simultaneously, when the balloon 300 is thermally fused with the catheter tip 140 and when the catheter tip 140 is thermally fused with the second tube segment 120, the catheter tip 140 can provide sufficient thermal fusion material, which is beneficial for a reliable connection between the balloon 300, the catheter tip 140, and the second tube segment 120. It should be noted that the distal end of the second tube segment 120 is provided with a tip (not labeled in the figures), and the distal radial dimension of the tip segment 142 is the same as the proximal radial dimension of the tip, so that the tip segment 142 can be adapted to the distal end of the second tube segment 120, which is beneficial for the delivery of the ablation catheter in the patient's body.

[0070] Please see Figure 8 and Figure 9 In one embodiment, the transducer 200 includes a transducer body 210, an outer electrode 220, an inner electrode 230, and a partition structure. Specifically, the transducer body 210 is a tube with an internal cavity. The outer electrode 220 is disposed on the outer side wall of the transducer body 210, and the inner electrode 230 is disposed on the inner side wall of the transducer body 210. The partition structure is disposed on the transducer body 210, and the multiple wires a include outer electrode wires and inner electrode wires.

[0071] In one embodiment, the inner electrode 230 is electrically connected to an inner electrode wire. A partition structure is disposed on the outer wall of the transducer body 210, dividing the outer electrode 220 into multiple independent electrode regions. Each electrode region is electrically connected to an outer electrode wire, and each electrode region is arranged in parallel to each other so that multiple electrode regions can be controlled independently.

[0072] In one embodiment, the outer electrode 220 is connected to an outer electrode wire. A partition structure is disposed on the inner sidewall of the transducer body 210, dividing the inner electrode 230 into multiple independent electrode regions. Each electrode region is electrically connected to the inner electrode wire, and each electrode region is arranged in parallel with each other so that multiple electrode regions can be controlled independently.

[0073] It should be noted that multiple electrode regions can be independently controlled, allowing the transducer 200 to generate focused ultrasound waves from different electrode regions individually. These focused ultrasound waves then ablate the lesion tissue. On one hand, this avoids the transducer 200 radiating ultrasound waves in a circular pattern, reducing damage to non-lesion tissues during ablation. On the other hand, the concentrated ultrasound energy at the focal point effectively increases the ablation speed and efficiency.

[0074] In one embodiment, the transducer body 210 is a ceramic tube, shaped like a hollow cylinder. The outer electrode 220 is a conductive layer electroplated on the outer wall of the ceramic tube. The inner electrode 230 is a conductive layer electroplated on the side wall of the internal cavity. In other embodiments, the outer electrode 220 may also be a conductive sheet glued to the ceramic tube by adhesive or snap-fit. Similarly, the inner electrode 230 may also be a conductive sheet glued to the ceramic tube by adhesive or snap-fit. Alternatively, one of the outer electrode 220 and the inner electrode 230 may be an electroplated conductive layer, and the other may be a conductive sheet.

[0075] In one embodiment, the partition structure is disposed on the outer side wall of the transducer body 210, and the partition structure is a partition groove 240 or a partition protrusion disposed on the outer side wall of the transducer body 210 (not shown in the figure).

[0076] In one embodiment, multiple partition structures are provided, and all multiple partition structures extend along the axial direction of the transducer body 210, so that the electrode region formed by the partition is a circumferentially non-closed region. In this article, a circumferentially non-closed region refers to a portion of the arc surface of the entire circumference, such as 1 / 3 or 1 / 4 of the entire circumference.

[0077] Please continue reading. Figure 8 and Figure 9In one embodiment, three partition structures are provided, and all three partition structures are partition grooves 240. The three partition grooves 240 are all strip-shaped grooves, and are parallel to the axis of the transducer body 210, extending axially from one end of the transducer body 210 to the other end. The three partition grooves 240 divide the outer surface of the transducer body 210 into three arc-shaped electrode regions.

[0078] Please see Figure 10 It should be noted that the three arc-shaped electrode regions generate corresponding outward-radiating ultrasonic waves after being energized, and the ultrasonic waves form a focal point M on the side (radial direction) away from the transducer body 210. Three sets of electrode pairs 400 are provided for the corresponding electrode regions, and all three sets of electrode pairs 400 are disposed on the outer surface of the balloon 300. The orthogonal projection of the focal point M of the ultrasonic waves generated by each electrode region onto the axis of the transducer body 210 coincides with the orthogonal projection of the stimulation point N of the corresponding electrode pair 400 onto the axis of the transducer body 210. This facilitates the determination of the ablation location by the electrode pairs 400 and reduces damage to surrounding tissues at the lesion site during ablation.

[0079] It should be noted that since the focal point M and the stimulation point N are both a single point, their projections onto the orthographic projection plane are also a single point. The orthographic projection plane of the ultrasound focal point M passes through the axis of the transducer body 210. The projection point of the focal point M on this orthographic projection plane lies on the axis of the transducer body 210; that is, the projection line intersects and is perpendicular to the axis of the transducer body 210. The orthographic projection plane is a plane that passes through the axis of the transducer body 210 and is perpendicular to the projection line. The orthographic projection position of point N on this orthographic projection plane coincides with or substantially coincides with the orthographic projection position of point M on this orthographic projection plane. This ensures a more precise determination of the position of the electrode pair 400.

[0080] It should also be noted that when using the ablation system, the ablation catheter is first delivered to the vicinity of the lesion tissue through the delivery sheath; then the ablation catheter extends from the distal end of the delivery sheath. After the balloon 300 is fully extended from the delivery sheath, fluid is injected into the inner lumen 310 through the first fluid chamber 102 and the first opening 1021 on the catheter body 100, causing the balloon 300 to inflate. The inflated balloon 300 presses the electrode pair 400 against the inner wall of the blood vessel. The inner wall of the blood vessel is electrically stimulated by energizing the electrode pair 400. During the stimulation, the control unit measures the human blood pressure. Once the control unit determines the location of the lesion tissue (by rotating the balloon 300, the electrode pair 400 rotates relative to the blood vessel along the axial direction of the blood vessel, and continuously electrically stimulates the inner wall of the blood vessel during the rotation; if a significant change in the human blood pressure is observed after electrical stimulation of the blood vessel wall at a certain location, then that location is determined to be the location of the lesion tissue); finally, the control unit controls the electrode area corresponding to the electrode pair 400 to be energized, generating corresponding ultrasound waves for ablation.

[0081] In one embodiment, multiple partition structures are provided, and all multiple partition structures are closed circumferentially along the transducer body 210, so that the electrode region formed by the partition is a circumferentially closed region.

[0082] Please continue reading. Figure 11 In one embodiment, three partition structures are provided, and all three partition structures are partition grooves 240. Each of the three partition grooves 240 is annular, and each partition groove 240 surrounds the axis of the transducer body 210, with the axis of the transducer body 210 perpendicular to the plane enclosed by the annular groove (this plane is parallel to the bottom surface of the transducer body 210). The three partition grooves 240 divide the outer surface of the transducer body 210 into three annular electrode regions.

[0083] Please see Figure 12 In one embodiment, six partition structures are provided, and all six partition structures are partition grooves 240. Among them, three partition grooves 240 are annular grooves, which divide the left half of the outer electrode 220 into three annular electrode regions; the other three partition grooves 240 are strip grooves, which divide the remaining part of the outer electrode 220 into three arc-shaped electrode regions.

[0084] Please see Figure 13 In one embodiment, the partition structure is disposed on the inner sidewall of the transducer body 210, that is, the partition structure is disposed on the sidewall of the internal cavity of the transducer body 210. The partition structure can be a partition groove 240 or a partition strip protruding from the sidewall of the internal cavity (not shown in the figure). Similarly, the partition groove 240 can be an annular groove or a strip groove, or the partition groove 240 includes an annular groove or a strip groove.

[0085] It should be noted that regardless of how the separation structure is positioned on the transducer body 210, the multiple sets of electrode pairs 400 on the balloon 300 are positioned corresponding to the multiple electrode regions formed by the separation, and the multiple electrode regions are connected in parallel and can operate independently. Therefore, after identifying the ablation site (lesion site) through the electrode pairs 400, selective ablation can be performed through the corresponding electrode regions, thereby achieving targeted ablation, improving ablation efficiency, and reducing tissue damage to non-lesion sites.

[0086] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0087] The above description discloses only preferred embodiments of the present invention and should not be construed as limiting the scope of the present invention. Therefore, equivalent variations made in accordance with the claims of the present invention are still within the scope of the present invention.

Claims

1. An ablation catheter, characterized in that, include: The conduit body, a transducer disposed on the conduit body, and multiple wires electrically connected to the transducer; the transducer includes: a transducer body, an outer electrode, an inner electrode, and a partition structure; the transducer body is sleeved on the conduit body, the outer electrode is disposed on the outer side wall of the transducer body, the inner electrode is disposed on the inner side wall of the transducer body, the partition structure is disposed on the transducer body, and the multiple wires include an outer electrode wire and an inner electrode wire; The inner electrode is electrically connected to the inner electrode wire, and the partition structure divides the outer electrode into multiple independent electrode regions. Each electrode region is electrically connected to the outer electrode wire, and each electrode region is arranged in parallel with each other, so that multiple electrode regions can be controlled independently. The partition structure is provided in multiple ways, and all of the partition structures extend along the axial direction of the transducer body, so that the electrode area formed by the partition is a circumferentially non-closed area. The ablation catheter also includes a balloon and an electrode pair; the balloon is fitted onto the catheter body and encloses the transducer inside, and the electrode pair is disposed on the outer surface of the balloon, the electrode pair including a pair of electrodes with opposite polarities for determining the ablation location; The electrode pairs are provided in multiple sets, and the positions of the multiple sets of electrode pairs correspond to the distribution positions of the multiple electrode regions. Multiple electrode regions are distributed circumferentially along the transducer body, and the focal position of the radiated sound field generated by the energization of the corresponding electrode region of each electrode pair coincides with the orthographic projection of the energized point on the axis of the transducer body.

2. The ablation catheter according to claim 1, characterized in that, The dividing structure is a dividing groove or a dividing strip protruding from the side wall of the transducer body.

3. The ablation catheter according to claim 2, characterized in that, The transducer body is a ceramic tube, the outer electrode is a conductive layer or conductive sheet disposed on the outer side wall of the ceramic tube, and the inner electrode is a conductive layer or conductive sheet disposed on the inner side wall of the ceramic tube.

4. The ablation catheter according to claim 3, characterized in that, The catheter body has a guidewire lumen, the central axis of which is collinear with the central axis of the catheter body. The catheter body includes a first segment and a second segment, the distal end of the first segment is connected to the proximal end of the second segment, the guidewire lumen passes through the first segment and the second segment, and the outer diameter of the first segment is larger than the outer diameter of the second segment. The proximal end of the balloon is fitted onto the first segment, the distal end of the balloon is fitted onto the second segment, and the transducer body is fitted onto the second segment.

5. The ablation catheter according to claim 4, characterized in that, The balloon has an inner cavity, and a first fluid cavity, a second fluid cavity, and a cable cavity are further provided in the first tube segment; the first fluid cavity, the second fluid cavity, and the cable cavity all extend along the axial direction of the first tube segment, the first fluid cavity, the second fluid cavity, and the cable cavity are arranged around the guidewire cavity, and the first fluid cavity and the second fluid cavity are both in communication with the inner cavity of the balloon.

6. The ablation catheter according to claim 5, characterized in that, A cable routing groove is provided on the outer wall of the second pipe section. The cable routing groove is connected to the far end of the cable cavity. At least one of the wires runs along the cable routing groove in the second pipe section and is connected to the transducer.

7. The ablation catheter according to claim 4, characterized in that, A transition section is provided between the first pipe section and the second pipe section. The two ends of the transition section are connected to the first pipe section and the second pipe section respectively, and the outer diameter of the transition section gradually decreases in the direction from the proximal end to the distal end.

8. The ablation catheter according to claim 4, characterized in that, The distal end of the second tubing segment is fitted with a catheter tip, which includes a straight tubing segment and a tip segment connected to the distal end of the straight tubing segment, and the distal end of the balloon is fitted onto the straight tubing segment.

9. An ablation system, characterized in that, include: The ablation catheter as described in any one of claims 5-8, wherein an operating handle and a control unit are connected to the proximal end of the ablation catheter; The control host is electrically connected to the transducer and the electrode pair via wires.

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