Pulse electric field ablation catheter device integrated with ultrasonic function

Abstract

The invention provides a pulsed electric field ablation catheter device integrated with an ultrasonic function, relates to the technical field of medical equipment, and aims to solve the problem that in the prior art, an ablation catheter and an ultrasonic probe are used separately, so that the surgical risk is high. The pulsed electric field ablation catheter device integrated with the ultrasonic function comprises an ablation catheter assembly and an ultrasonic module; the ablation catheter assembly comprises an ablation tube body, an ablation tube fitting and a plurality of ablation wires, the head end of the ablation tube body is connected with the ablation tube fitting, an inner tube is arranged in the ablation tube body, an inner cavity is formed in the inner tube, an outer cavity is formed between the ablation tube body and the inner tube, the ultrasonic module is rotatably arranged in the inner cavity, and the ablation wires are arranged in the outer cavity. The multiple ablation wires are arranged in the outer cavity and extend to the ablation pipe fitting from the interior of the ablation pipe fitting. According to the pulsed electric field ablation catheter device integrated with the ultrasonic function, only one-time puncture is needed, the puncture frequency is reduced, use is safer, and the ablation electrode can be better guided to reach the designated position in the heart.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a pulsed electric field ablation catheter device with integrated ultrasonic function. Background Art

[0002] PFA (Pulsed Field Ablation) is a novel ablation modality that induces cell death through irreversible electroporation. Its tissue-specific, non-thermal ablation characteristics hold great potential for atrial fibrillation ablation. However, PFA ablation carries certain risks (such as air embolism and hemolysis), which are positively correlated with the energy intensity and frequency of ablation. Excessive ablation can lead to severe hemolysis and acute renal failure. Clinically, the thickness of the atrial wall varies across different regions of the atrium. The thickness of the myocardium in the pulmonary vein region differs significantly from that in the base of the left atrial appendage, particularly the left atrial crest. PFA energy that can achieve ablation in the pulmonary vein region may not effectively ablate other atrial regions, often requiring repeated ablation procedures to achieve effective ablation. This significantly increases the number of ablation procedures and the risk of complications. Myocardial thickness also varies significantly between pulmonary veins. When this variation is significant, PFA energy cannot completely ablate the thicker myocardium in the pulmonary vein region, necessitating repeated ablation procedures. Objectively, clinicians need to observe the wall thickness of the cardiac chamber being ablated in real time to determine the ablation energy intensity (thicker walls require higher ablation intensity, and lower intensity requires lower intensity) to achieve optimal treatment effectiveness and minimize treatment risks. During the procedure, clinicians also use ultrasound to observe the atrial structure to facilitate accurate placement of the ablation catheter. Real-time monitoring of the relative position of the ablation catheter and the myocardium, as well as the catheter's contact during ablation, can reduce complications and improve ablation efficiency.

[0003] Existing PFA technology consists of a PFA system consisting of a pulsed potential ablation catheter and an energy generator. The energy generator provides pulsed energy, which is released through the tip of the pulsed ablation catheter, achieving the effect of electroporation and death of exposed myocardial cells. The pulsed ablation catheter includes a handle, an elastic push rod, a flexible catheter, and an ablation zone at the tip. Its energy output is fixed and cannot be adjusted according to actual conditions. PFA electric field ablation carries certain risks (such as air embolism, hemolysis, and renal failure). Objectively, physicians need to observe the thickness of the ablated cardiac chamber wall in real time to determine the ablation energy intensity to achieve optimal treatment effectiveness and reduce treatment risks.

[0004] Currently, the best imaging modality for real-time observation and measurement of cardiac cavity tissue wall thickness is intracardiac ultrasound (ICE). Existing technology uses the ablation catheter and ultrasound probe separately during cardiac ablation. This separate use results in two separate systems, requiring two punctures, increasing the risk of surgical complications. In addition, separate intracardiac ultrasound is expensive. Summary of the Invention

[0005] The purpose of the present invention is to provide a pulsed electric field ablation catheter device with integrated ultrasound function to solve the problem in the prior art that the ablation catheter and ultrasound probe are used separately, resulting in high surgical risks. The pulsed electric field ablation catheter device with integrated ultrasound function of the present invention only requires one puncture, reducing the number of punctures, making it safer to use, and can better guide the ablation electrode to reach the designated position in the heart.

[0006] The present invention provides a pulsed electric field ablation catheter device with integrated ultrasonic function, including an ablation catheter assembly and an ultrasonic module. The ablation catheter assembly includes an ablation tube body, an ablation tube fitting and multiple ablation wires. The head end of the ablation tube body is connected to the ablation tube fitting. An inner tube is arranged in the ablation tube body, an inner cavity is formed in the inner tube, and an outer cavity is formed between the ablation tube body and the inner tube. The ultrasonic module can be rotatably arranged in the inner cavity, and multiple ablation wires are arranged in the outer cavity and extend from the ablation tube body to the ablation tube fitting.

[0007] As a preferred solution of the present invention, the head end of the inner tube is sealed, and the ultrasonic module includes an ultrasonic probe, which is arranged in the inner cavity near the head end of the inner tube.

[0008] As a preferred embodiment of the present invention, the ultrasonic module also includes an ultrasonic catheter, which is connected to the ultrasonic probe and arranged in the inner cavity. An ultrasonic signal line is arranged in the ultrasonic catheter, and the ultrasonic signal line is connected to the ultrasonic probe. A limit block is arranged along the inner wall of the inner tube, and a limit groove adapted to the limit block is provided on the outer wall of the ultrasonic catheter.

[0009] As a preferred solution of the present invention, a plurality of traction wires are provided in the outer cavity, and the traction wires are arranged along the axial direction of the ablation tube body.

[0010] As a preferred solution of the present invention, it further includes a handle, which is connected to the tail end of the ablation tube body. The ablation wire and the ultrasound signal line both pass through the tail end of the handle and are connected to a host device.

[0011] As a preferred solution of the present invention, the host device includes a signal receiving module, a signal conversion module, a control module and an ablation tube adjustment module. The signal receiving module is used to receive the ultrasonic image signal detected by the ultrasonic probe, and the signal conversion module is used to convert the ultrasonic image signal received by the signal receiving module into the cavity wall thickness. The control module controls the ablation tube adjustment module according to the cavity wall thickness converted by the signal conversion module to adjust the energy output of the ablation electrode.

[0012] As a preferred solution of the present invention, a control knob is provided on the handle, and the control knob is connected to the ultrasonic catheter through a transmission assembly. The control knob can drive the ultrasonic catheter and the ultrasonic probe to rotate synchronously in the inner cavity.

[0013] As a preferred solution of the present invention, the transmission assembly includes a first helical gear and a second helical gear, the control knob is coaxially connected to the first helical gear, the second helical gear is meshed with the first helical gear, and the second helical gear is coaxially connected to the ultrasonic catheter.

[0014] As a preferred solution of the present invention, the ablation tube is in the shape of a ring tube, and a plurality of ablation electrodes distributed at intervals are provided on the ablation tube.

[0015] Compared with the prior art, the present invention has the following positive effects: The pulsed electric field ablation catheter device with integrated ultrasound function provided by the present invention includes an ablation catheter assembly and an ultrasound module. The ablation catheter assembly includes an ablation tube body, an ablation tube fitting, and multiple ablation wires. The head end of the ablation tube body is connected to the ablation tube fitting. An inner tube is provided in the ablation tube body, an inner cavity is formed in the inner tube, and an outer cavity is formed between the ablation tube body and the inner tube. The ultrasound module can be rotatably arranged in the inner cavity. Multiple ablation wires are arranged in the outer cavity and extend from the ablation tube body to the ablation tube fitting. The pulsed electric field ablation catheter device with integrated ultrasound function of the present invention integrates the ablation catheter assembly and the ultrasound module. Before ablation is officially performed, the ultrasound module can be used to scan the atrium and obtain an atrial model. During the atrial fibrillation ablation process, the ultrasound probe can be used to observe the wall thickness of the heart cavity to be ablated in real time, and the degree of contact between the ablation electrode and the inner wall in real time, so as to guide the operator to better contact the ablation tube fitting and achieve a better ablation effect. Compared with the existing method of using the ablation catheter and ultrasound probe separately, only one puncture is required, which reduces the number of punctures, is safer to use, and can better guide the ablation electrode to reach the designated position in the heart. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0017] Figure 1 This is a schematic structural diagram of a pulsed electric field ablation catheter device with integrated ultrasound function according to the present invention; Figure 2This is a schematic diagram of the structure inside the ablation tube of the present invention; Figure 3 is a cross-sectional view of the interior of the ablation tube of the present invention; Figure 4 It is a schematic diagram of the connection between the handle and the transmission assembly in the handle of the present invention. In the figure: 1. ablation tube body; 11. outer cavity; 12. inner tube; 13. inner cavity; 14. limit block; 2. ultrasound module; 21. ultrasound catheter; 22. ultrasound probe; 23. limit groove; 3. ablation wire; 4. ablation tube; 41. ablation electrode; 5. host device; 51. signal receiving module; 52. signal conversion module; 53. control module; 54. ablation tube adjustment module; 6. handle; 61. control knob; 62. first bevel gear; 63. second bevel gear; 7. traction wire. DETAILED DESCRIPTION

[0018] In the description of the present invention, it should be noted that, unless otherwise specified, "plurality" means two or more; the terms "upper", "lower", "front", "back", "left", "right", "top", "bottom", "inside", "outside", "front end", "back end", "head", "tail", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplification, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be understood as limiting the present invention. In addition, the terms "first", "second", "third", etc. are used for descriptive purposes only and should not be understood as indicating or implying relative importance.

[0019] It should also be noted that, in the description of the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; and direct or indirect connections through an intermediary. Those skilled in the art will understand the specific meanings of the above terms in the present invention depending on the specific circumstances.

[0020] The specific embodiments of the present invention will be further described in detail below with reference to the accompanying drawings.

[0021] Example 1: This embodiment provides a pulsed electric field ablation catheter device with integrated ultrasound function, such as Figure 1-Figure 4As shown, it includes an ablation catheter assembly and an ultrasound module 2. The ablation catheter assembly includes an ablation tube body 1, an ablation tube part 4 and a plurality of ablation wires 3. The head end of the ablation tube body 1 is connected to the ablation tube part 4, and an inner tube 12 is provided in the ablation tube body 1. The ablation tube body and the inner tube 12 can be fixedly connected to form a multi-cavity tube body. An inner cavity 13 is formed in the inner tube 12, and an outer cavity 11 is formed between the ablation tube body 1 and the inner tube 12. The ultrasound module can be rotatably arranged in the inner cavity 13, and a plurality of ablation wires 3 are arranged in the outer cavity 11 and extend from the ablation tube body 1 to the ablation tube part 4. Preferably, the head end of the ablation tube body 1 extends to the outside of the inner tube 12.

[0022] Multiple ablation wires 3 are used to connect to multiple ablation electrodes 41 on the ablation tube 4. Each ablation electrode 41 is connected to the ablation device through the ablation wire 3 to transmit the voltage pulse of the ablation device to the ablation electrode 41 for release, so that each ablation electrode 41 can be independently addressed, and the ablation device can independently set the polarity of each ablation wire 3 or control the discharge of each ablation wire 3.

[0023] The pulsed electric field ablation catheter device with integrated ultrasound function in this embodiment integrates the ablation catheter assembly and the ultrasound module 2. Before ablation is officially performed, the ultrasound module 2 can scan the atria to obtain an atrial model. During atrial fibrillation ablation, the ultrasound module can be used to observe the thickness of the heart chamber wall to be ablated in real time, as well as the degree of contact between the ablation electrode and the inner wall, guiding the operator to better contact the ablation tube 4 and achieve a better ablation effect. Compared with the existing method of using the ablation catheter and ultrasound probe separately, only one puncture is required, reducing the number of punctures, making it safer to use, and better guiding the ablation electrode to reach the designated position in the heart.

[0024] In a preferred embodiment, the tip of the inner tube 12 is sealed, and the ultrasound module 2 includes an ultrasound probe 22, which is positioned within the inner cavity 13 near the tip of the inner tube 12. This sealed tip of the inner tube 12 prevents blood from entering the multi-lumen tube and potentially affecting the ultrasound probe. The ultrasound probe 22 is positioned approximately at the head of the ablation tube 1, near the tail of the ablation tube 4.

[0025] As a preferred embodiment, Figure 2As shown, the ultrasonic module 2 also includes an ultrasonic catheter 21, which is connected to an ultrasonic probe 22 and is disposed in the inner cavity 13. An ultrasonic signal line is disposed in the ultrasonic catheter 21, and the ultrasonic signal line is connected to the ultrasonic probe 22. A limit block 14 is disposed along the inner wall of the inner tube 12, and a limit groove 23 is disposed on the outer wall of the ultrasonic catheter 21 to match the limit block 14. The ultrasonic signal line transmits the signal detected by the ultrasonic probe 22. The limit groove 23 is disposed at the head end of the ultrasonic catheter 21 near the ultrasonic probe 22. The limiting action of the limit groove 23 and the limit block 14 can ensure that the ultrasonic probe 22 will not slip out of the inner tube 12.

[0026] In this embodiment, the ultrasound module 2 removes the ultrasonic bending function from the ultrasound catheter 21, reducing non-core modules within the ICE. This reduces complexity and size, allowing the ultrasound catheter 21 to be less than 8 French, while the main body of the ablation tube 1 is thicker, at 12 French. This reduction in non-core components and functions reduces the cost of the ICE.

[0027] As a preferred embodiment, multiple traction wires 7 are disposed within the outer cavity 11, arranged along the axis of the ablation tube 1. Preferably, two traction wires 7 are provided, with the two traction wires 7 being disposed on opposite sides of the outer cavity 11. The traction wires 7 are made of a flexible material, such as metal wire, and can be bent to control the curvature of the ablation tube 1, thereby adapting to different application requirements and providing greater flexibility.

[0028] As a preferred embodiment, Figure 2 As shown, the pulsed electric field ablation catheter device with integrated ultrasound function in this embodiment also includes a handle 6, which is connected to the rear end of the ablation tube body 1. The ablation wire 3 and the ultrasound signal line both pass through the rear end of the handle 6 and connect to the host device 5. A connecting tail line branches out from the handle 6, through which the ablation wire 3 and the ultrasound signal line are both transmitted. The handle 6 facilitates handheld operation.

[0029] As a preferred embodiment, as shown in Figure 1, the host device 5 includes a signal receiving module 51, a signal conversion module 52, a control module 53, and an ablation tube adjustment module 54. The signal receiving module 51 is used to receive ultrasound image signals detected by the ultrasound probe 22, the signal conversion module 52 is used to convert the ultrasound image signals received by the signal receiving module 51 into atrial wall thickness, and the control module 53 controls the ablation tube adjustment module 54 to adjust the energy output of the ablation electrode 41 based on the atrial wall thickness converted by the signal conversion module 52. During atrial fibrillation ablation, the signal conversion module 52 is used to convert the ultrasound image signals received by the signal receiving module 51 into atrial myocardium thickness.

[0030] In this embodiment, during ablation, the ultrasound probe 22 can scan the thickness of the atrial myocardium in real time and output the information to the device, optimizing the energy output of the ablation electrode 41 through real-time calculation. This allows the output energy intensity of the ablation electrode 41 to be adjusted in real time based on the thickness of the cardiac chamber wall, achieving optimal treatment effectiveness and reducing treatment risks.

[0031] As a preferred embodiment, a control knob 61 is provided on the handle 6, and the control knob 61 is connected to the ultrasonic catheter 21 through a transmission assembly. The control knob 61 can drive the ultrasonic catheter 21 and the ultrasonic probe 22 to rotate synchronously in the inner cavity 13. As a preferred embodiment, Figure 4 As shown, the transmission assembly includes a first bevel gear 62 and a second bevel gear 63 , the control knob 61 is coaxially connected to the first bevel gear 62 , the second bevel gear 63 is meshed with the first bevel gear 62 , and the second bevel gear 63 is coaxially connected to the ultrasonic catheter 21 .

[0032] The operator controls the rotation of the ultrasound catheter within the inner cavity 13 using the control knob 61 on the handle. During use, the control knob 61 can be rotated a certain number of times to match the rotation angle of the ultrasound probe 22, thereby facilitating control of the rotation angle of the ultrasound probe 22. The ultrasound module 2 utilizes 2D and phased array modes, enabling observation of the ablation electrode and distal tissue in a 2D sector. Regardless of whether the ablation catheter assembly tip is in a large or small circle, observation is possible by varying the rotation angle of the ultrasound probe 22.

[0033] As a preferred embodiment, Figure 1 As shown, the ablation tube 4 is an annular tube with multiple spaced-apart ablation electrodes 41 disposed thereon. The cross-section of the ablation tube 4 can be circular, elliptical, or other shapes. The multiple ablation electrodes 41 are used to deliver pulsed electric fields to tissue to achieve ablation. The annular shape of the ablation tube 4 can prevent or reduce tissue trauma caused by the ablation catheter. The ablation electrodes 41 can also be ring electrodes, forming a full ring that fits over the outside of the ablation tube 4.

[0034] The pulsed electric field ablation catheter device with integrated ultrasound function of this embodiment integrates ultrasound function into the technology of the original ablation catheter assembly. Its catheter retains structures such as the handle, flexible ablation tube body, and head end ablation area, but its flexible ablation tube body is arranged on the outer layer of a special multi-lumen tube. The inner layer of the multi-lumen tube is an intravascular ultrasound module. The head end of the inner cavity 13 is closed to prevent possible blood from entering the inner cavity 13. The rear part of the ultrasound probe is limited to ensure that the ultrasound probe will not slip out of the inner cavity 13. There is a connecting tail line at the handle of the ablation catheter assembly, and the ablation wire and the ultrasound signal line are both transmitted through the connecting tail line. The ultrasound probe collects images and transmits them to the host device through the connecting tail line. Then, it is converted by the signal conversion module in the host device. The host device receives the converted signal and adjusts the energy output of the ablation catheter assembly according to the myocardial thickness signal it receives, and then the ablation electrode 41 is used to release it.

[0035] The above description is only a preferred embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with this technical field can make several modifications and improvements without departing from the creative concept of the present invention, which should be included in the protection scope of the present invention.

Claims

1. A pulsed electric field ablation catheter device with integrated ultrasound function, characterized in that: The invention comprises an ablation catheter assembly and an ultrasound module (2), wherein the ablation catheter assembly comprises an ablation tube body (1), an ablation tube component (4) and a plurality of ablation wires (3), wherein the head end of the ablation tube body (1) is connected to the ablation tube component (4), an inner tube (12) is arranged in the ablation tube body (1), an inner cavity (13) is formed in the inner tube (12), and an outer cavity (11) is formed between the ablation tube body (1) and the inner tube (12), wherein the ultrasound module (2) can be rotatably arranged in the inner cavity (13), and the plurality of ablation wires (3) are arranged in the outer cavity (11) and extend from the ablation tube body (1) to the ablation tube component (4).

2. The pulsed electric field ablation catheter device with integrated ultrasound function according to claim 1, characterized in that: The head end of the inner tube (12) is sealed, and the ultrasonic module (2) comprises an ultrasonic probe (22). The ultrasonic probe (22) is arranged in the inner cavity (13) near the head end of the inner tube (12).

3. The pulsed electric field ablation catheter device with integrated ultrasound function according to claim 1, characterized in that: The ultrasonic module (2) further comprises an ultrasonic catheter (21), the ultrasonic catheter (21) being connected to the ultrasonic probe (22), an ultrasonic signal line being provided in the ultrasonic catheter (21), the ultrasonic signal line being connected to the ultrasonic probe (22), a limiting block (14) being provided along the inner wall of the inner tube (12), and a limiting groove (23) being adapted to the limiting block (14) being provided on the outer wall of the ultrasonic catheter (21).

4. The pulsed electric field ablation catheter device with integrated ultrasound function according to claim 1, characterized in that: It also includes a handle (6), which is connected to the tail end of the ablation tube body (1), and the ablation wire (3) and the ultrasound signal line both pass through the tail end of the handle (6) and are connected to the host device (5).

5. The pulsed electric field ablation catheter device with integrated ultrasound function according to claim 4, characterized in that: The host device (5) includes a signal receiving module (51), a signal conversion module (52), a control module (53) and an ablation tube adjustment module (54), wherein the signal receiving module (51) is used to receive an ultrasonic image signal detected by an ultrasonic probe (22), the signal conversion module (52) is used to convert the ultrasonic image signal received by the signal receiving module (51) into a cavity wall thickness, and the control module (53) controls the ablation tube adjustment module (54) to adjust the energy output of the ablation electrode (41) according to the cavity wall thickness converted by the signal conversion module (52).

6. The pulsed electric field ablation catheter device with integrated ultrasound function according to claim 1, characterized in that: A plurality of traction wires (7) are arranged in the outer cavity (11), and the traction wires (7) are arranged along the axial direction of the ablation tube body (1).

7. The pulsed electric field ablation catheter device with integrated ultrasound function according to claim 4, characterized in that: A control knob (61) is provided on the handle (6), and the control knob (61) is connected to the ultrasonic catheter (21) via a transmission assembly. The control knob (61) can drive the ultrasonic catheter (21) and the ultrasonic probe (22) to rotate synchronously in the inner cavity (13).

8. The pulsed electric field ablation catheter device with integrated ultrasound function according to claim 7, characterized in that: The transmission assembly comprises a first bevel gear (62) and a second bevel gear (63), the control knob (61) is coaxially connected to the first bevel gear (62), the second bevel gear (63) is meshed with the first bevel gear (62), and the second bevel gear (63) is coaxially connected to the ultrasonic catheter (21).

9. The pulsed electric field ablation catheter device with integrated ultrasound function according to claim 1, characterized in that: The ablation tube (4) is in the shape of a ring tube, and a plurality of ablation electrodes (41) distributed at intervals are provided on the ablation tube (4).

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