Pulse ablation cardiac catheter

Abstract

The utility model relates to the technical field of medical instruments, in particular to a pulse ablation cardiac catheter which comprises an outer tube, an inner tube, an ablation mesh basket, a balloon and a conveying device. One end of the inner tube extends into the outer tube, and the other end of the inner tube extends out of the outer tube and penetrates through the ablation basket and the balloon towards the far end in the axial direction; the outer pipe is slidably connected with the inner pipe; one end of the ablation basket is statically connected to the far end of the outer tube, and the other end is statically connected to the far end of the inner tube; one end of the balloon is statically connected to the far end of the inner tube, and the other end of the balloon extends to the near end, statically connected to the far end of the outer tube, extends to the far end for a certain distance and statically connected to the inner tube; the conveying device is used for controlling the expansion degree of the balloon; the balloon is arranged on the inner side of the ablation mesh basket and used for supporting the ablation mesh basket so as to increase the attaching degree of the ablation mesh basket and the focus position and improve the treatment effect of pulse ablation, meanwhile, the deformation degree of the ablation mesh basket can be controlled by adjusting the expansion degree of the balloon, and the support requirements of different positions can be met.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a pulse ablation cardiac catheter. Background Art

[0002] Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice. Stroke and other thromboembolic events caused by AF are the main causes of death or disability in patients. Non-drug treatment of AF has been a research hotspot in recent years. Many clinical studies at home and abroad have shown that successful electrical isolation of pulmonary veins using catheter ablation technology can effectively prevent the recurrence of AF and maintain sinus rhythm. Current catheter ablation is mainly based on radiofrequency energy, but there are also other energies (including cryotherapy, ultrasound, and laser ablation). Unlike traditional energy, pulsed electric field energy forms irreversible micropores on the cell membrane through instantaneous discharge, causing cell apoptosis and achieving the purpose of non-thermal ablation. Therefore, this ablation method is also called irreversible electroporation ablation. In theory, irreversible electroporation ablation can damage target cells without heating the tissue, has cell or tissue selectivity, and can effectively protect surrounding key structures, thereby reducing complications during surgery and reducing the recurrence rate of the disease. However, the head of the traditional pulse ablation catheter uses a memory metal stent, which has poor support and poor adhesion to the pulmonary vein orifice, which will reduce the therapeutic effect of pulse ablation.

[0003] Therefore, it is necessary to provide an improved technical solution to address the above-mentioned deficiencies in the prior art. Utility Model Content

[0004] The purpose of the present application is to provide a pulse ablation cardiac catheter to solve or alleviate the problems existing in the above-mentioned prior art.

[0005] In order to achieve the above objectives, this application provides the following technical solutions:

[0006] A pulse ablation cardiac catheter, comprising an outer tube, an inner tube, an ablation basket, a balloon, and a conveying device;

[0007] One end of the inner tube extends into the outer tube, and the other end extends out of the outer tube and penetrates the ablation basket and the balloon axially to the distal end; the outer tube is slidably connected to the inner tube;

[0008] One end of the ablation basket is statically connected to the distal end of the outer tube, and the other end is statically connected to the distal end of the inner tube; one end of the balloon is statically connected to the distal end of the inner tube, and the other end extends toward the proximal end to be statically connected to the distal end of the outer tube, and then extends toward the distal end for a certain distance and is statically connected to the inner tube;

[0009] The delivery device is used to control the degree of expansion of the balloon;

[0010] The balloon is arranged on the inner side of the ablation basket to support the ablation basket.

[0011] In the pulse ablation cardiac catheter as described above, preferably, a pressure relief port is provided at the distal end of the inner tube for opening and relieving pressure after the internal pressure of the balloon exceeds a threshold value.

[0012] In the pulse ablation cardiac catheter as described above, preferably, the distal fixing sleeve of the inner tube is provided with a protective sleeve;

[0013] The distal end of the ablation basket, the distal end of the balloon and the distal end of the inner tube are statically connected and then extend into the protective sleeve.

[0014] In the pulse ablation cardiac catheter as described above, preferably, the distal end of the protective sleeve is a hemispherical structure.

[0015] In the pulse ablation cardiac catheter as described above, preferably, the distal end of the outer tube is statically connected with a fixing ring;

[0016] One end of the fixing ring extends into the outer tube, and the other end extends out of the outer tube and extends axially to the distal end; the other end of the inner tube extends out of the outer tube and the fixing ring in sequence and extends axially to the distal end, and the inner tube is slidably connected to the fixing ring;

[0017] The distal end of the fixing ring is provided with a plurality of grooves at intervals along the circumference; the ablation basket comprises a plurality of ablation stents arranged at intervals along the circumference, the proximal ends of the plurality of ablation stents are respectively fixedly connected to the inner wall of the distal end of the outer tube through the plurality of grooves, and the distal ends of the plurality of ablation stents are fixedly connected to the outer wall of the distal end of the inner tube;

[0018] The other end of the balloon extends toward the proximal end to be fixedly connected to the distal end of the fixing ring, and then extends toward the distal end for a certain distance and is fixedly connected to the outer wall of the inner tube.

[0019] In the pulse ablation cardiac catheter as described above, preferably, the ablation stent is made of a material with shape memory function.

[0020] In the pulse ablation cardiac catheter as described above, preferably, the plurality of ablation stents are evenly arranged along the circumference; and the plurality of grooves are evenly arranged along the circumference.

[0021] In the pulse ablation cardiac catheter as described above, preferably, a bending control wire is axially arranged in the tube wall of the outer tube for controlling the off-axis angle of the distal end of the outer tube.

[0022] In the pulse ablation cardiac catheter as described above, preferably, the delivery device is an air delivery tube axially arranged between the inner tube and the outer tube, and the distal end of the air delivery tube extends into the balloon.

[0023] A pulse ablation cardiac catheter as described above, preferably, the pulse ablation cardiac catheter comprises a handle;

[0024] The handle is arranged at the proximal end of the pulse ablation cardiac catheter;

[0025] The proximal end of the outer tube is fixedly connected to the handle, and the proximal end of the inner tube is slidably connected to the handle.

[0026] Compared with the closest prior art, the technical solution of the embodiment of the present application has the following beneficial effects:

[0027] A balloon is built into the ablation basket, and its expansion is controlled by a delivery device to provide stable support for the deformation of the ablation basket, thereby increasing the degree of contact between the ablation basket and the lesion site to enhance the therapeutic effect of pulse ablation. At the same time, the deformation degree of the ablation basket can also be controlled by adjusting the expansion degree of the balloon, which can adapt to the support requirements of different parts. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The drawings constituting part of the present application are used to provide a further understanding of the present application. The exemplary embodiments and descriptions of the present application are used to explain the present application and do not constitute an improper limitation on the present application. Among them:

[0029] Figure 1 A cross-sectional schematic diagram of an ablation basket in an expanded state according to some embodiments of the present application;

[0030] Figure 2 A side view of an ablation basket in an expanded state according to some embodiments of the present application;

[0031] Figure 3 A front view of an ablation basket in a contracted state according to some embodiments of the present application;

[0032] Figure 4 A schematic diagram of a fixing ring structure provided according to some embodiments of the present application;

[0033] Figure 5 This is a schematic diagram of the main structure of a pulse ablation cardiac catheter provided according to some embodiments of the present application.

[0034] Description of reference numerals:

[0035] 1. Outer tube; 2. Inner tube; 3. Ablation stent; 4. Balloon; 5. First fixing point; 6. Second fixing point; 7. Groove; 8. Delivery device; 9. Pressure relief port; 10. Protective sleeve; 11. Bending control wire; 12. Ablation electrode; 13. Handle; 14. Fixing ring; 15. Free section. DETAILED DESCRIPTION

[0036] The present application will be described in detail below with reference to the accompanying drawings and in conjunction with embodiments. Each example is provided by way of explanation of the present application and does not limit the present application. In fact, it will be clear to those skilled in the art that modifications and variations may be made in the present application without departing from the scope or spirit of the present application. For example, a feature shown or described as a part of an embodiment may be used in another embodiment to produce yet another embodiment. Therefore, it is desired that the present application includes such modifications and variations within the scope of the appended claims and their equivalents.

[0037] In the following description, the terms "first / second / third" involved are merely used to distinguish similar objects and do not represent a specific ordering of the objects. It can be understood that "first / second / third" can be interchanged with a specific order or sequence where permitted, so that the embodiments of the present application described herein can be implemented in an order other than that illustrated or described herein.

[0038] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which the present disclosure belongs. The terms used herein are only for the purpose of describing the embodiments of the present disclosure and are not intended to limit the present disclosure.

[0039] In the description of the present application, the terms "longitudinal", "lateral", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present application and do not require that the present application must be constructed and operated in a specific orientation. Therefore, they cannot be understood as limitations on the present application. The terms "connected", "connected", and "set" used in the present application should be understood in a broad sense. For example, it can be a fixed connection or a detachable connection; it can be a direct connection or an indirect connection through an intermediate component; it can be a wired electrical connection, a radio connection, or a wireless communication signal connection. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

[0040] For the sake of clarity, in this article, "proximal end" refers to the end of the medical device close to the doctor when the doctor is using it, and "distal end" refers to the end of the medical device away from the doctor when the doctor is using it; "static connection" means that during normal operation, the relative positions of the two connected parts remain unchanged, specifically including detachable fixed connection and non-detachable fixed connection.

[0041] The following will be combined with the attached Figure 1-5 A pulse ablation cardiac catheter of the present application is further described in detail.

[0042] A pulse ablation cardiac catheter, the pulse ablation cardiac catheter comprising an outer tube 1, an inner tube 2, an ablation basket, a balloon 4, and a conveying device 8;

[0043] One end of the inner tube 2 extends into the outer tube 1, and the other end extends out of the outer tube 1 and penetrates the ablation basket and the balloon 4 axially to the distal end; the outer tube 1 is slidably connected to the inner tube 2;

[0044] One end of the ablation basket is statically connected to the distal end of the outer tube 1, and the other end is statically connected to the distal end of the inner tube 2; one end of the balloon 4 is statically connected to the distal end of the inner tube 2, and the other end extends proximally to statically connect to the distal end of the outer tube 1 and then extends a certain distance to the distal end and is statically connected to the inner tube 2;

[0045] The delivery device 8 is used to control the expansion degree of the balloon 4;

[0046] The balloon 4 is arranged on the inner side of the ablation basket to support the ablation basket.

[0047] In a specific embodiment of the present application, the outer tube 1 is coaxially arranged with the inner tube 2, and the ablation basket and the balloon 4 are located at the distal end of the pulse ablation cardiac catheter. The other end of the inner tube 2 extends axially toward the distal end of the pulse ablation cardiac catheter and axially penetrates the balloon 4 and the ablation basket. The proximal end of the ablation basket and the proximal end of the balloon 4 are both bonded and fixed to the inner wall of the distal end of the outer tube 1, and the distal end of the ablation basket and the distal end of the balloon 4 are both bonded and fixed to the outer wall of the distal end of the inner tube 2. The balloon 4 is built into the ablation basket. Further, the proximal end of the balloon 4 has two fixed points, namely, a first fixed point 5 and a second fixed point 6, wherein the first fixed point 5 is located on the inner wall of the distal end of the outer tube 1, and the second fixed point 6 is located on the outer wall of the inner tube 2 between the distal end of the outer tube 1 and the distal end of the inner tube 2, and there is a free section 15 of a certain length axially between the first fixed point 5 and the second fixed point 6.

[0048] When the medical device is used specifically, after the pulse ablation cardiac catheter moves along the microcatheter to the lesion site, the adjustable catheter sheath retreats a certain distance, so that the ablation basket partially passes through the adjustable catheter sheath. At this time, the balloon 4 and the ablation basket are in a contracted state, and the balloon 4 is controlled by the conveying device 8 to expand, thereby supporting the ablation basket to begin to deform. At the same time, the inner tube 2 slides with the outer tube 1 under the deformation of the ablation basket. Specifically, the inner tube 2 slides proximally along the axial direction of the outer tube 1. At this time, the balloon 4 and the ablation basket are in an expanded state (working state), and the balloon 4 is able to maintain a relative position with the ablation basket unchanged under the action of the free section 15. At the same time, the free section 15 also serves to limit the sliding distance of the inner tube 2 to prevent excessive expansion of the ablation basket.

[0049] A balloon 4 is built into the ablation basket, and the expansion of the balloon 4 is controlled by a conveying device 8 to provide stable support for the deformation of the ablation basket, thereby increasing the degree of contact between the ablation basket and the lesion site to enhance the therapeutic effect of pulse ablation. At the same time, the deformation degree of the ablation basket can also be controlled by adjusting the expansion degree of the balloon 4, which can adapt to the support requirements of different parts.

[0050] A pressure relief port 9 is provided at the distal end of the inner tube 2 for opening and releasing pressure when the internal pressure of the balloon 4 exceeds a threshold value.

[0051] In a specific embodiment of the present application, the pressure relief port 9 is located between the second fixing point 6 of the balloon 4 and the distal fixing point of the balloon 4. A one-way valve is provided at the pressure relief port 9, which automatically opens when the internal pressure of the balloon 4 exceeds a preset limit to achieve automatic pressure relief and prevent the balloon 4 from bursting.

[0052] The distal fixed sleeve of the inner tube 2 is provided with a protective sleeve 10;

[0053] The distal end of the ablation basket, the distal end of the balloon 4 and the distal end of the inner tube 2 are statically connected and then extend into the protective sleeve 10 .

[0054] In a specific embodiment of the present application, the protective sleeve 10 is bonded and fixed to the outer wall of the distal end of the inner tube 2, and the distal end of the ablation basket and the distal end of the balloon 4 are bonded and fixed to the outer wall of the distal end of the inner tube 2 and then extended into the protective sleeve 10 to avoid falling off from the outer wall of the inner tube 2 during use.

[0055] The distal end of the protective sleeve 10 is a hemispherical structure.

[0056] In a specific embodiment of the present application, the distal end of the protective sleeve 10 is an anti-damage hemispherical structure, which can improve the smoothness of movement of the device in the blood vessel on the one hand, and prevent the device from cutting or hooking the inner wall of the blood vessel when moving in the blood vessel on the other hand.

[0057] The distal end of the outer tube 1 is statically connected with a fixing ring 14;

[0058] One end of the fixing ring 14 extends into the outer tube 1, and the other end extends out of the outer tube 1 and extends axially to the distal end; the other end of the inner tube 2 extends out of the outer tube 1 and the fixing ring 14 in sequence and extends axially to the distal end, and the inner tube 2 is slidably connected to the fixing ring 14;

[0059] The distal end of the fixing ring 14 is provided with a plurality of grooves 7 at intervals in the circumferential direction; the ablation basket comprises a plurality of ablation stents 3 arranged at intervals in the circumferential direction, the proximal ends of the plurality of ablation stents 3 are respectively fixedly connected to the inner wall of the distal end of the outer tube 1 through the plurality of grooves 7, and the distal ends of the plurality of ablation stents 3 are fixedly connected to the outer wall of the distal end of the inner tube 2;

[0060] The other end of the balloon 4 extends toward the proximal end to be fixedly connected to the distal end of the fixing ring 14 , and then extends toward the distal end for a certain distance to be fixedly connected to the outer wall of the inner tube 2 .

[0061] In the specific embodiment of the present application, the fixing ring 14, the outer tube 1, and the inner tube 2 are coaxially arranged, and the fixing ring 14 is bonded and fixed to the inner wall of the distal end of the outer tube 1. One end of the groove 7 circumferentially spaced at the distal end of the fixing ring 14 extends into the outer tube 1 along with the fixing ring 14, and the other end extends axially toward the distal end. The ablation basket includes an ablation stent 3 and an ablation electrode 12. The ablation electrode 12 is specifically a ring electrode, which is tied or bonded to the ablation stent 3 and is used to release high-voltage pulses to the lesion site to achieve electrical isolation. The ablation stent 3 corresponds to the groove 7 one by one, and the proximal end of the ablation stent 3 is axially extended along the corresponding groove 7 and fixed on the inner wall of the distal end of the outer tube 1. The setting of the groove 7 improves the stability of the connection between the proximal end of the ablation stent 3 and the outer tube 1 on the one hand, and also guides the deformation of the ablation stent 3 on the other hand. Specifically, when the ablation stent 3 is deformed under the support of the balloon 4, under the circumferential constraint of the proximal groove 7, each ablation stent 3 can always expand along the fixed radial direction to achieve structural stability of the ablation stent 3. The first fixing point 5 of the balloon 4 is located on the fixing ring 14 fixed on the inner wall of the distal end of the outer tube 1.

[0062] The ablation stent 3 is made of a material with shape memory function.

[0063] In a specific embodiment of the present application, the ablation stent 3 is made of nickel-titanium alloy with shape memory function. By presetting the expansion state of the ablation stent 3, the demand for the supporting force of the balloon 4 is reduced. Specifically, after the ablation basket part is separated from the microcatheter, the ablation stent 3 automatically deforms and expands under the action of the shape memory function, and the supporting function of the balloon 4 is reduced to only play an auxiliary supporting and regulating role.

[0064] A plurality of ablation stents 3 are evenly arranged along the circumferential direction; a plurality of grooves 7 are evenly arranged along the circumferential direction.

[0065] In a specific embodiment of the present application, five ablation stents 3 are evenly spaced along the circumference of the inner tube 2 , and five grooves 7 are evenly spaced along the circumference of the fixing ring 14 , and the ablation stents 3 correspond to the grooves 7 one by one.

[0066] A bending control wire 11 is axially arranged in the tube wall of the outer tube 1 to control the eccentric angle of the distal end of the outer tube 1 .

[0067] In a specific embodiment of the present application, two axially extending bending control wires 11 are symmetrically arranged in the wall of the outer tube 1. The distal ends of the two bending control wires 11 axially penetrate the wall of the outer tube 1, and the proximal ends extend out of the wall of the outer tube 1. By pulling any bending control wire 11, the radial swing of the distal end of the outer tube 1 can be controlled, thereby facilitating the device to enter the bend of the blood vessel and improving the flexibility of the device.

[0068] The delivery device 8 is an air delivery tube axially arranged between the inner tube 2 and the outer tube 1 , and the distal end of the air delivery tube extends into the balloon 4 .

[0069] In a specific embodiment of the present application, the air tube is bonded and fixed to the outer wall of the inner tube 2, and the second fixing point 6 of the balloon 4 is located on the outer wall of the air tube and the outer wall of the inner tube 2 between the first fixing point 5 of the balloon 4 and the distal fixing point of the balloon 4.

[0070] The pulse ablation cardiac catheter includes a handle 13;

[0071] The handle 13 is arranged at the proximal end of the pulse ablation cardiac catheter;

[0072] The proximal end of the outer tube 1 is fixedly connected to the handle 13 , and the proximal end of the inner tube 2 is slidably connected to the handle 13 .

[0073] In a specific embodiment of the present application, an air inlet adjustment pulley and a push button are provided on the handle 13, wherein the proximal end of the air supply pipe is fixedly connected to the air inlet of the handle 13, the proximal end of the bending control wire 11 is fixedly connected to the adjustment pulley, and the proximal end of the inner tube 2 is fixedly connected to the push button.

[0074] When the medical device is used specifically, the inflation port of the handle 13 is connected to the air source device to inflate the balloon 4 through the air supply tube to meet the support and adjustment requirements of the ablation basket; the bending control wire 11 is pulled by rotating the adjustment pulley to control the eccentric angle of the distal end of the outer tube 1 to achieve stable ablation of different bending parts; the inner tube 2 is driven to move by the sliding push button to control the relative sliding between the inner tube 2 and the outer tube 1, thereby achieving manual adjustment of the deformation of the ablation basket.

[0075] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A pulse ablation cardiac catheter, characterized in that: The pulse ablation cardiac catheter comprises an outer tube, an inner tube, an ablation basket, a balloon, and a delivery device; One end of the inner tube extends into the outer tube, and the other end extends out of the outer tube and penetrates the ablation basket and the balloon axially to the distal end; the outer tube is slidably connected to the inner tube; One end of the ablation basket is statically connected to the distal end of the outer tube, and the other end is statically connected to the distal end of the inner tube; one end of the balloon is statically connected to the distal end of the inner tube, and the other end extends toward the proximal end to be statically connected to the distal end of the outer tube, and then extends toward the distal end for a certain distance and is statically connected to the inner tube; The delivery device is used to control the degree of expansion of the balloon; The balloon is arranged on the inner side of the ablation basket to support the ablation basket.

2. A pulse ablation cardiac catheter as claimed in claim 1, characterized in that: A pressure relief port is provided at the distal end of the inner tube, which is used to open and relieve pressure after the internal pressure of the balloon exceeds a threshold value.

3. A pulse ablation cardiac catheter as claimed in claim 1, characterized in that: The distal fixed sleeve of the inner tube is provided with a protective sleeve; The distal end of the ablation basket, the distal end of the balloon and the distal end of the inner tube are statically connected and then extend into the protective sleeve.

4. A pulse ablation cardiac catheter as claimed in claim 3, characterized in that: The distal end of the protective sleeve is a hemispherical structure.

5. The pulse ablation cardiac catheter according to claim 1, characterized in that: The distal end of the outer tube is statically connected with a fixing ring; One end of the fixing ring extends into the outer tube, and the other end extends out of the outer tube and extends axially to the distal end; the other end of the inner tube extends out of the outer tube and the fixing ring in sequence and extends axially to the distal end, and the inner tube is slidably connected to the fixing ring; The distal end of the fixing ring is provided with a plurality of grooves at intervals along the circumference; the ablation basket comprises a plurality of ablation stents arranged at intervals along the circumference, the proximal ends of the plurality of ablation stents are respectively fixedly connected to the inner wall of the distal end of the outer tube through the plurality of grooves, and the distal ends of the plurality of ablation stents are fixedly connected to the outer wall of the distal end of the inner tube; The other end of the balloon extends toward the proximal end to be fixedly connected to the distal end of the fixing ring, and then extends toward the distal end for a certain distance and is fixedly connected to the outer wall of the inner tube.

6. A pulse ablation cardiac catheter as claimed in claim 5, characterized in that: The ablation stent is made of a material with shape memory function.

7. The pulse ablation cardiac catheter according to claim 5, characterized in that: The multiple ablation stents are evenly arranged along the circumferential direction; the multiple grooves are evenly arranged along the circumferential direction.

8. The pulse ablation cardiac catheter according to claim 1, characterized in that: A bending control wire is axially arranged in the tube wall of the outer tube for controlling the eccentric angle of the distal end of the outer tube.

9. The pulse ablation cardiac catheter according to claim 1, characterized in that: The delivery device is an air delivery tube axially arranged between the inner tube and the outer tube, and the distal end of the air delivery tube extends into the balloon.

10. A pulse ablation cardiac catheter according to any one of claims 1 to 9, characterized in that: The pulse ablation cardiac catheter includes a handle; The handle is arranged at the proximal end of the pulse ablation cardiac catheter; The proximal end of the outer tube is fixedly connected to the handle, and the proximal end of the inner tube is slidably connected to the handle.

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