Catheter, catheter assembly and occlusion ablation system
Through the design of the catheter assembly, including the connector and the tube body, the conductor provides electrical energy within the extended channel, solving the problem that existing catheter designs cannot provide electrical energy without increasing the outer diameter, thus achieving occlusion and ablation of the left atrial appendage.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- HANGZHOU NUOMAO MEDTECH CO LTD
- Filing Date
- 2021-12-31
- Publication Date
- 2026-07-24
AI Technical Summary
Existing catheter designs struggle to provide electrical power without increasing the outer diameter, while also meeting the passage requirements of mapping catheters and guide wires, making the design of delivery catheters quite challenging.
The device employs a catheter assembly design, including a connector and a tube body. The connector is detachably connected to the occlusion and ablation device, and a conductor is inserted into the extended channel of the connector. The occlusion and ablation device is delivered into the body through the tube body and connector, and electrical energy is provided.
This technology enables the supply of electrical energy to the occlusion and ablation device without significantly increasing the catheter wall thickness, thus completing the occlusion and ablation of the left atrial appendage and reducing the impact of catheter wall thickness on the connector.
Smart Images

Figure CN116407264B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, and in particular to a catheter, catheter assembly, and occlusion ablation system. Background Technology
[0002] Atrial fibrillation (AF) is the most common sustained arrhythmia. The incidence of AF increases with age, reaching up to 10% in people over 75. During AF, the atrial contractions occur at a rate of 300-600 beats per minute, often with a rapid and irregular heartbeat, and the atria lose their effective contractile function. In AF, the contractility of the left atrial appendage decreases, and the unique shape of the left atrial appendage and its uneven trabecular structure create vortices and slow blood flow, promoting thrombus formation. In non-valvular AF patients, over 90% of left atrial thrombi are located in the left atrial appendage. After thrombi break off, they can travel through the aorta to the cerebral arteries, causing a stroke.
[0003] Some patients with atrial fibrillation can benefit from active left atrial appendage isolation (LAAI). LAAI often involves ablation therapy, which includes several approaches: one major aspect is thermal ablation such as radiofrequency ablation, laser ablation, microwave ablation, and thermoplasm ablation; another is pulsed ablation utilizing the principle of bioelectric perforation.
[0004] Left atrial appendage electrical isolation can be achieved on a left atrial appendage occluder, that is, by adding an ablation component for electro-ablation to the left atrial appendage occluder to form a left atrial appendage occlusion ablation device. The ablation component needs to be electrically connected to the delivery conduit of the left atrial appendage occlusion ablation device. Conductors and connectors, such as wires and connectors, need to be added to the delivery conduit to be electrically connected to the ablation component, thereby increasing the wall thickness of the delivery conduit.
[0005] However, the wall thickness of the delivery catheter is limited by many factors. On the one hand, the outer diameter of the delivery catheter is limited by the left atrial appendage occluder and the puncture incision. On the other hand, the inner diameter of the delivery catheter channel needs to meet the requirements of the mapping catheter and the guide wire. Therefore, the design of the delivery catheter used in conjunction with the left atrial appendage occlusion ablation device is quite difficult. Summary of the Invention
[0006] The purpose of this invention is to provide a catheter that can provide electrical energy to the catheter without increasing the outer diameter of the catheter.
[0007] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:
[0008] According to one aspect of the present invention, a catheter is provided for implanting an occlusion ablation device into a patient's body, comprising a connector, a tube body, and a conductor; the distal end of the connector is detachably connected to the occlusion ablation device; when the connector is connected to the occlusion ablation device, the connector is electrically connected to the occlusion ablation device; an extension channel is provided at the proximal end of the connector; the distal end of the tube body is fixed at the proximal end of the connector; the conductor extends axially along the tube body; the distal end of the conductor passes through the extension channel and is electrically connected to the connector for supplying electrical energy to the connector.
[0009] According to another aspect of the present invention, the present invention provides a catheter assembly including a first catheter and a second catheter, wherein the first catheter and the second catheter are both described above; the second catheter covers the periphery of the first catheter, and the distal end of the first catheter can extend beyond the distal end of the second catheter.
[0010] According to another aspect of the present invention, the present invention provides a sealing ablation system, including a sealing ablation device and at least one of the above-described catheters; the sealing ablation device is used to seal tissue defects and is capable of ablating tissue using electrical energy; the sealing ablation device is detachably connected to the distal end of the connector, and the catheter is used to deliver and release the sealing ablation device to the tissue defect and is capable of transmitting ablation electrical energy to the sealing ablation device.
[0011] As can be seen from the above technical solution, the present invention has at least the following advantages and positive effects:
[0012] In this invention, the proximal end of the connector is connected to the tube body, and the distal end of the connector is detachably connected to the occlusion and ablation device. After the occlusion device is delivered to a preset location within the patient's body via the tube body and connector, it can effectively seal tissue defects. A conductive element electrically connects to the connector to provide power to the occlusion and ablation device for ablation.
[0013] The conductor is inserted into the extension channel of the connector, which helps to reduce the impact of the conductor connection on the inner and outer diameters of the connector, so as to provide electrical energy to the connector without increasing the wall thickness of the conduit, or with a small increase.
[0014] The catheter assembly includes a first catheter and a second catheter, each with a connector. The two connectors can supply power to the occlusion ablation device to transmit the same or different ablation energy to the occlusion ablation device. Attached Figure Description
[0015] Figure 1 This is a schematic diagram of the structure of the first embodiment of the catheter of the present invention.
[0016] Figure 2This is a schematic diagram of the connector structure of the first embodiment of the catheter of the present invention.
[0017] Figure 3 This is a partial structural schematic diagram of the first embodiment of the catheter of the present invention, wherein the tube body is cut open radially.
[0018] Figure 4 This is a partial structural schematic diagram of the second embodiment of the catheter of the present invention, wherein the tube body is cut open radially.
[0019] Figure 5 This is a schematic diagram of the connector structure of the second embodiment of the catheter of the present invention.
[0020] Figure 6 This is a partial structural schematic diagram of the third embodiment of the catheter of the present invention, wherein the tube body is cut open radially.
[0021] Figure 7 This is a schematic diagram of the connector of the third embodiment of the catheter of the present invention.
[0022] Figure 8 This is a partial structural schematic diagram of the connector of the fourth embodiment of the catheter of the present invention, wherein the tube body is cut open radially.
[0023] Figure 9 This is a cross-sectional schematic diagram of the fifth embodiment of the catheter of the present invention.
[0024] Figure 10 This is a partial structural schematic diagram of the fifth embodiment of the catheter of the present invention.
[0025] Figure 11 This is a cross-sectional schematic diagram of the sixth embodiment of the catheter of the present invention.
[0026] Figure 12 This is a cross-sectional schematic diagram of the seventh embodiment of the catheter of the present invention.
[0027] Figure 13 This is a cross-sectional schematic diagram of the eighth embodiment of the catheter of the present invention.
[0028] Figure 14 This is a schematic diagram of a catheter assembly embodiment of the present invention.
[0029] Figure 15 This is a schematic diagram of a sealing and ablation device.
[0030] Figure 16 This is a cross-sectional schematic diagram of another embodiment of the conduit assembly of the present invention.
[0031] Figure 17 This is a schematic diagram of a connector according to the present invention.
[0032] The reference numerals in the attached drawings are explained as follows: 10, first conduit; 20, second conduit; 100, connector; 110, inner cavity; 120, extension channel; 130, connecting part; 140, insertion part; 150, step; 160, perforated window; 170, fixing groove; 180, clamping element; 190, annular protrusion; 200, tube body; 201, outer layer; 202, extension tube; 210, inner layer; 220, outer layer; 230, braided mesh; 240, PTFE layer; 250, inner... 260, outer wall; 280, insulating layer; 290, cavity; 300, conductor; 310, insulating sleeve; 400, connector; 420, extension channel; 430, connecting part; 440, plug-in part; 441, spring; 442, plug-in section; 50, sealing and ablation device; 510, sealing part; 520, anchoring part; 530, connector; 540, first ablation element; 550, second ablation element; 560, first conductor; 570, second conductor. Detailed Implementation
[0033] Typical embodiments embodying the features and advantages of the present invention will be described in detail in the following description. It should be understood that the present invention can have various variations in different embodiments without departing from the scope of the present invention, and the descriptions and illustrations herein are for illustrative purposes only and not intended to limit the present invention.
[0034] In the description of this application, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," and "counterclockwise," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of the stated features. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.
[0035] For ease of description and understanding, 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. The location where the left atrium enters the left atrial appendage is defined as the opening of the left atrial appendage, and the location within the left atrial appendage adjacent to the opening is defined as the neck of the left atrial appendage. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.
[0036] This application provides a closure ablation system, including a catheter and a closure ablation device; the closure ablation device is connected to the distal end of the catheter and is detachable from the distal end of the catheter. The catheter is used to deliver and release the closure ablation device to the tissue defect and is capable of transmitting ablation electrical energy to the closure ablation device. The closure ablation device is used to close the tissue defect and is capable of ablating the tissue using electrical energy; the closure ablation device is detachably connected to the distal end of the connector.
[0037] During occlusion, the catheter moves distally, delivering the occlusion ablation device to the left atrial appendage (LAA). The device is released and unfolds within the LA, sealing its opening. The catheter provides ablation energy to the device, which ablates the inner wall of the LA, thus completing the occlusion and ablation of the left ACA. It is understood that this embodiment of the invention uses the left ACA occlusion ablation device as an example, meaning it is used to seal the opening of the left ACA to prevent thrombi from dislodging and entering the cerebral arteries via the aorta, forming a cerebral embolism. The occlusion ablation device can also be used for electroablation of tissues, such as left ACA tissue, thereby achieving the purpose of treating atrial fibrillation through electrical isolation of the left ACA. Electroablation can take the form of pulse ablation, radiofrequency ablation, or microwave ablation. It is understood that the occlusion and ablation device in the embodiments of this application can also be used to occlude and electro-ablate other tissues in the patient's body, and the specific occlusion and ablation sites are not limited.
[0038] Figure 1 This is a schematic diagram of the structure of the first embodiment of the catheter of the present invention. Figure 2 This is a schematic diagram of the connector structure of the first embodiment of the catheter of the present invention. Figure 3 This is a partial structural schematic diagram of the first embodiment of the catheter of the present invention, wherein the tube body is cut open radially.
[0039] See Figures 1 to 3This embodiment provides a catheter detachably connected to an ablation device for delivering and releasing the ablation device into the patient's body. The catheter transmits ablation energy to the ablation device, which is used to seal tissue defects and ablate the tissue using the ablation energy transmitted via the catheter. The catheter includes a connector 100 for connecting to the ablation device, a tube body 200 connected to the end of the connector 100 facing away from the ablation device, and a conductor 300 inserted within the tube body 200. The distal end of the conductor 300 is electrically connected to the connector 100. The distal end of the connector 100 is detachably connected to and electrically connected to the ablation device. The distal end of the tube body 200 is fixed to the proximal end of the connector 100, and the tube body 200 extends axially.
[0040] An occlusion ablation device is connected to connector 100, and the occlusion ablation device can be detached from the distal end of connector 100. During occlusion, the tube body 200 is pushed distally, causing connector 100 to move distally as well. Connector 100 delivers the occlusion ablation device to the left atrial appendage, where it is released and unfolded to seal the opening of the left atrial appendage. Conductor 300 provides ablation energy to the occlusion ablation device through connector 100. The occlusion ablation device uses the ablation energy transmitted through the catheter to ablate the inner wall of the left atrial appendage, thus completing the occlusion and ablation of the left atrial appendage. After occlusion ablation, the catheter and occlusion ablation device are separated and withdrawn from the body. Occlusion and ablation can be achieved simultaneously in a single procedure using a catheter and occlusion ablation device.
[0041] like Figure 3 As shown, the connector 100 has an axially extending inner cavity 110 that extends through the proximal and distal ends of the connector 100. The tube body 200 is a tubular structure with an internal lumen 290. The inner cavity 110 of the connector 100 and the lumen 290 of the tube body 200 are connected. The inner cavity 110 and the lumen 290 form a channel for the mapping catheter and guide wire to pass through, so that the mapping catheter or guide wire can enter the channel from the proximal end of the tube body 200 and extend to the distal end of the sealing and ablation device.
[0042] The radial cross-section of the connector 100 is circular, and the outer circumference of the tube 200 is also circular to facilitate the movement of the connector 100 and the tube 200 within the delivery sheath. To ensure that the inner lumen 110 of the connector 100 and the lumen 290 of the tube 200 have sufficiently large radial space for the passage of mapping catheters and guide wires, and to ensure that the outer diameter of the connector 100 and the outer diameter of the tube 200 are sufficiently small to pass through the corresponding blood vessel or tissue, the catheter wall thickness for which the connector 100 is located is limited.
[0043] The connector 100 has an extension channel 120 at its proximal end. The distal end of the conductor 300 passes through the extension channel 120 and is electrically connected to the connector 100 for supplying electrical energy to the connector 100. The extension channel 120 at the proximal end of the connector 100 allows the conductor 300 to be connected and pass through it. By passing the conductor 300 through the extension channel 120, all or part of the conductor 300 is accommodated within the extension channel 120 along its own radial direction, so as to provide electrical energy to the connector 100 without increasing the wall thickness of the conduit, or with a small increase.
[0044] The connector 100 includes a connecting portion 130 and a plug portion 140 protruding from the distal end of the connecting portion 130; both the connecting portion 130 and the plug portion 140 extend axially; the plug portion 140 is used for detachable connection with the sealing and ablation device. The tube body 200 is connected to the connecting portion 130.
[0045] An extension channel 120 is provided at the proximal end of the connector 130 so that the conductor 300 can be passed through and electrically connected to the connector 130 from the proximal end.
[0046] In this embodiment, both the connecting portion 130 and the insertion portion 140 are tubular, with the outer diameter of the connecting portion 130 being larger than that of the insertion portion 140. A step 150 is formed between the connecting portion 130 and the insertion portion 140. In some embodiments, the size between the outer diameter of the connecting portion 130 and the outer diameter of the insertion portion 140 is not limited. An annular groove is formed between the connecting portion 130 and the insertion portion 140, circumferentially disposed around the axis of the connector 100, and the annular groove is used to fix the distal end of the tube body 200.
[0047] The connector 100 is made of conductive material, and its insertion portion 140 extends axially and is detachably connected to the occlusion and ablation device. In this embodiment, the outer periphery of the insertion portion 140 is provided with external threads for threaded connection to the occlusion and ablation device, and for detachable connection to the occlusion and ablation device. It is understood that in other embodiments, the detachable connection between the insertion portion 140 and the occlusion and ablation device is not limited to a threaded connection.
[0048] In this embodiment, a guide groove is formed on the outer peripheral surface of the connecting portion 130, thus forming an extension channel 120. The guide groove is located at the proximal end of the connecting portion 130. The distal end of the conductor 300 passes through and is connected within the extension channel 120 to electrically connect to the connector 100. In other embodiments, the connecting portion 130 is provided with a hole penetrating its proximal and distal ends to form the extension channel 120.
[0049] In this embodiment, the guide groove is formed on the outer periphery of the connecting portion 130 and extends axially. In some embodiments, the guide groove is formed on the outer periphery of the connecting portion 130, and the shape of the guide groove is an arc, a broken line, or a spiral. In other embodiments, the guide groove is formed on the inner peripheral surface of the connecting portion 130.
[0050] In this embodiment, the extension channel 120 extends through the distal end of the connecting portion 130. In some embodiments, the distal end of the extension channel 120 does not extend through the distal end of the connecting portion 130.
[0051] See again Figures 1 to 3 The conductor 300 extends axially along the tube 200 and is located inside the tube 200. The distal end of the conductor 300 is connected to the peripheral wall of the extension channel 120 (such as the side wall or bottom wall of the guide groove) by means of welding, bonding or heat fusion, so as to electrically connect to the connector 100.
[0052] The conductor 300 is a wire, which can be a metal wire or an enameled wire. The distal end of the wire is connected to the peripheral wall of the extension channel 120 by means of welding, bonding, or other methods. The portion of the wire other than its distal end can be insulated from the connector; for example, the surface of the portion of the wire other than its distal end may be provided with an insulating layer, which can be insulating varnish, insulating sleeve, or insulating varnish with an insulating sleeve on the outside. The distal end of the wire is used for electrical connection with the connector; therefore, the insulating layer at the distal end of the wire is stripped away, exposing the conductive metal portion for electrical connection with the connector. It is understood that in some embodiments, the surface of the wire in contact with the connector 100 is conductive. Optionally, the portion of the wire with the insulating layer is fixedly connected to the connector, such as by bonding or heat fusion.
[0053] The portion of the wire facing away from the connector 100 is located within the diameter of the tube 200, or within the wall thickness of the tube.
[0054] The diameter of the wire is smaller than the width of the extension channel 120 so that the extension channel 120 can accommodate the wire. In some embodiments, the depth of the extension channel 120 in the radial direction is greater than the diameter of the wire to ensure that the distal end of the wire can be accommodated within the extension channel 120 and will not extend radially outward beyond the outer peripheral surface of the connector 100, thereby not increasing the thickness at the overlap of the connector 100 and the conductor 300. In some embodiments, the extension channel 120 is interference-fitted with the wire in the circumferential width direction to clamp the wire.
[0055] See again Figures 1 to 3The tube body 200 includes an inner layer 210 and an outer layer 220 covering the outer periphery of the inner layer 210; the distal end of the inner layer 210 extends into the inner cavity 110 of the connector 100 and is attached to the inner periphery of the connector 100; the outer layer 220 covers the outer periphery of the connecting portion 130 and covers the connecting portion 130 and the portion of the conductor 300 located in the connector 100.
[0056] Both the connecting portion 130 and the insertion portion 140 of the connector 100 are tubular structures. The distal end of the inner layer 210 passes through the inner cavity 110 of the connector 100, and the outer peripheral surface of the inner layer 210 abuts against the inner peripheral wall of the inner cavity 110 of the connector 100. A stepped surface is formed in the inner cavity 110 of the connector 100 between the connecting portion 130 and the insertion portion 140. The inner diameter of the connecting portion 130 is larger than the inner diameter of the insertion portion 140. The inner peripheral wall of the connecting portion 130 is fitted onto the outer periphery of the inner layer 210. The cavity of the insertion portion 140 communicates with the chamber of the inner layer 210.
[0057] The distal peripheral end of the inner layer 210 is attached to the inner peripheral end of the connecting portion 130; the inner peripheral wall of the inner layer 210 is flush with the inner peripheral wall of the insertion portion 140, so that there are no steps on the inner wall surface of the catheter, which facilitates the insertion of guidewires or other catheters, avoids damage to the inner layer 210 during the insertion of guidewires or catheters, prevents the inner layer material from falling into the patient's body, and improves product safety.
[0058] The outer layer 220 of the tube body 200 is made of thermoplastic material, and the outer layer 220 is heat-fused and covers the connecting portion 130 of the connector 100. The outer layer 220 covers the step 150 between the connecting portion 130 and the insertion portion 140 to effectively ensure the reliability of the connection between the tube body 200 and the connector 100.
[0059] The outer layer 220 of the tube body 200 is made of plastic materials such as PA, PEBAX, HDPE and nylon.
[0060] In this embodiment, the portion of the conductor 300 away from the connector 100 is located within the wall thickness range of the tube body 200. Specifically, the conductor 300 is located between the inner layer 210 and the outer layer 220. When the outer layer 220 covers the inner layer 210, the portion of the conductor 300 away from the connector 100 is covered between the inner layer 210 and the outer layer 220.
[0061] In some embodiments, the portion of the conductor 300 away from the connector 100 is located within the lumen 290 of the tube body 200.
[0062] Figure 4 This is a partial structural schematic diagram of the second embodiment of the catheter of the present invention, wherein the tube body is cut open radially. Figure 5 This is a schematic diagram of the connector structure of the second embodiment of the catheter of the present invention.
[0063] See Figure 4 and Figure 5 In this embodiment, the catheter includes a connector 100 for connecting to an ablation device, a tube body 200 connected to the connector 100 at one end facing away from the ablation device, and a conductor 300 inserted within the tube body 200. The distal end of the conductor 300 is electrically connected to the connector 100. The distal end of the connector 100 is detachably connected to and electrically connected to the ablation device. The distal end of the connector 100 is used to connect to the ablation device, and the distal end of the tube body 200 is fixed to the proximal end of the connector 100, with the tube body 200 extending axially.
[0064] The connector 100 has an axially extending inner cavity 110 that extends through the proximal and distal ends of the connector 100.
[0065] The connector 100 has an extension channel 120 at its proximal end, and the conductor 300 passes through the extension channel 120 and is electrically connected to the connector 100 for supplying electrical energy to the connector 100.
[0066] The connector 100 includes a connecting portion 130 and a plug portion 140 protruding from the distal end of the connecting portion 130; both the connecting portion 130 and the plug portion 140 extend axially; the plug portion 140 is used for detachable connection with the sealing and ablation device. The tube body 200 is connected to the connecting portion 130.
[0067] The tube body 200 includes an inner layer 210 and an outer layer 220 covering the outer periphery of the inner layer 210. The distal end of the inner layer 210 extends into the connector 100 and is attached to the inner periphery of the connector 100. The outer layer 220 covers the outer periphery of the connecting portion 130 and covers the portion of the conductor 300 located in the connector 100.
[0068] The structure and connection relationship of connector 100, tube 200 and conductor 300 are the same as those of connector 100, tube 200 and conductor 300 in the first embodiment, and will not be repeated here.
[0069] The difference between this embodiment and the first embodiment is that:
[0070] A perforated window 160 extending into the inner cavity 110 is radially formed on the outer periphery of the connecting portion 130. In this embodiment, multiple perforated windows 160 are spaced apart circumferentially along the connecting portion 130. In some embodiments, a single perforated window 160 is provided. In other embodiments, multiple perforated windows 160 are staggered on the connecting portion 130.
[0071] When the outer layer 220 is heat-fused and covered by the connecting part 130, the outer layer 220 of the tube body 200 is heat-fused to the inner layer 210 through the hollow window 160 to enhance the stability and reliability of the connection between the tube body 200 and the connector 100.
[0072] In this embodiment, the outer diameter of the connecting portion 130 is larger than the outer diameter of the insertion portion 140, and a stepped surface 150 is formed between the connecting portion 130 and the insertion portion 140. The stepped surface 150 connects the outer peripheral wall of the connecting portion 130 and the outer peripheral wall of the insertion portion 140. The distal end of the extension channel 120 penetrates the stepped surface 150, and the distal end of the conductor 300 extends out of the extension channel 120 and is fixed (e.g., by winding, welding, etc.) to the outer surface of the insertion portion 140 or the stepped surface 150, making the connection of the conductor 300 more stable.
[0073] The wall thickness of the distal end of the tube 200 covering the connecting portion 130 is D, and the wall diameter of the tube 200 not connected to the connecting portion 130 is d, where Dd < 0.2 mm. That is, at the portion of the tube 200 away from the connector 100, the distance between the inner circumferential surface of the inner layer 210 and the outer circumference of the outer layer 220 is d; at the portion of the tube 200 connected to the connecting portion 130, the distance between the inner circumferential surface of the inner layer 210 and the outer circumference of the outer layer 220 is D.
[0074] Figure 6 This is a partial structural schematic diagram of the third embodiment of the catheter of the present invention, wherein the tube body is cut open radially. Figure 7 This is a schematic diagram of the connector of the third embodiment of the catheter of the present invention.
[0075] See Figure 6 and Figure 7 In this embodiment, the catheter includes a connector 100 for connecting to an ablation device, a tube body 200 connected to the connector 100 at one end facing away from the ablation device, and a conductor 300 inserted within the tube body 200. The distal end of the conductor 300 is electrically connected to the connector 100. The distal end of the connector 100 is detachably connected to and electrically connected to the ablation device. The distal end of the connector 100 is used to connect to the ablation device, and the distal end of the tube body 200 is fixed to the proximal end of the connector 100, with the tube body 200 extending axially.
[0076] The connector 100 has an axially extending inner cavity 110 that extends through both the proximal and distal ends of the connector 100. An extension channel 120 is formed at the proximal end of the connector 100, and the distal end of the conductor 300 passes through the extension channel 120 and is electrically connected to the connector 100 for supplying electrical energy to the connector 100. The connector 100 includes a connecting portion 130 and a plug portion 140 protruding from the distal end of the connecting portion 130; both the connecting portion 130 and the plug portion 140 extend axially; the plug portion 140 is used for detachable connection with a sealing and ablation device. The tube body 200 is connected to the connecting portion 130.
[0077] In this embodiment, a guide groove is formed on the outer peripheral surface of the connecting portion 130 to create an extension channel 120. The guide groove is located at the proximal end of the connecting portion 130 and extends through the distal end of the connecting portion 130. The tube body 200 includes an inner layer 210 and an outer layer 220 covering the outer periphery of the inner layer 210. The distal end of the inner layer 210 extends into the connector 100 and is attached to the inner periphery of the connector 100. The outer layer 220 covers the outer periphery of the connecting portion 130 and covers the portion of the conductor 300 located in the connector 100.
[0078] The structure and connection relationship of connector 100, tube 200 and conductor 300 are the same as those in the second embodiment, and will not be repeated here.
[0079] The difference between this embodiment and the second embodiment is that:
[0080] The connector 100 has a fixing groove 170 at the far end of the extension channel 120. The extension direction of the fixing groove 170 is different from the extension direction of the extension channel 120. The far end of the extension channel 120 is connected to the fixing groove 170.
[0081] In this embodiment, the outer diameter of the connecting portion 130 is larger than the outer diameter of the insertion portion 140. An annular protrusion 190 is provided on the outer periphery of the insertion portion 140 at the distal end of the connecting portion 130. The annular protrusion 190 extends axially around the insertion portion 140. The annular protrusion 190 and the connecting portion 130 are spaced apart axially, and a fixing groove 170 is formed between the annular protrusion 190 and the connecting portion 130.
[0082] In this embodiment, the fixing groove 170 is circumferentially disposed on the outer peripheral surface of the connecting portion 130 around the axis of the connecting portion 130. In some embodiments, the fixing groove 170 may not be a circumferential annular structure, but a spiral structure.
[0083] A through-hole window 160 extending to the inner cavity 110 is provided radially on the outer periphery of the connecting portion 130. In this embodiment, multiple through-hole windows 160 are spaced apart along the circumference of the connecting portion 130.
[0084] See again Figure 6 and Figure 7 The conductor 300 extends axially along the tube 200 and is located inside the tube 200. The conductor 300 is a wire, and its distal end extends out of the extension channel 120. The portion of the distal end of the conductor 300 extending out of the extension channel 120 is wrapped within the fixing groove 170.
[0085] The conductor is a metal wire. The metal portion at the distal end of the conductor is wound inside the fixing groove 170. The surface of the conductor wound inside the fixing groove 170 is conductive. The insulation layer is removed, which increases the conductive contact area between the conductor and the connector 100 and improves the stability of the connection between the conductor 300 and the connector 100.
[0086] The radial depth of the fixing groove 170 is greater than the radial depth of the extension channel 120, so as to facilitate the winding of multiple turns of wire within the fixing groove 170, thereby enhancing the reliability and stability of the wire connection within the fixing groove 170. The depths of the fixing groove 170 and the extension channel 120 are their respective radial dimensions. Specifically, in some embodiments, the fixing groove 170 is formed at the connection between the connecting portion 130 and the insertion portion 140. The formation of the fixing groove 170 is not affected by the wall thickness of the connecting portion 130, allowing the fixing groove 170 to have a greater depth, i.e., the depth of the fixing groove 170 is greater than the thickness of the connecting portion 130. In one specific embodiment, the fixing groove 170 extends radially toward the inner periphery of the insertion portion 140 and penetrates into the insertion portion 140.
[0087] The width of the fixing groove 170 is adapted to the diameter of the wire to press the wire tightly between the two side walls of the fixing groove 170. The wire is wound inside the fixing groove 170, eliminating the need for other fixing methods to secure the wire and the connector 100. In this embodiment, the fixing groove 170 is arranged circumferentially in a direction perpendicular to the axial direction of the connector 100, and the width of the fixing groove 170 is its axial dimension.
[0088] The diameter of the wire is smaller than the width of the extension channel 120 so that the extension channel 120 can accommodate the wire. In some embodiments, the radial depth of the extension channel 120 is greater than the diameter of the wire to ensure that the portion of the wire within the extension channel 120 is contained within the extension channel 120 and does not radially outward toward the outer peripheral surface of the connector 100, thereby not increasing the thickness at the overlap of the connector 100 and the conductor 300.
[0089] Figure 8 This is a partial structural schematic diagram of the connector of the fourth embodiment of the catheter of the present invention, wherein the tube body is cut open radially.
[0090] See Figure 8In this embodiment, the catheter includes a connector 100 for connecting to an ablation device, a tube body 200 connected to the connector 100 at one end facing away from the ablation device, and a conductor 300 inserted within the tube body 200. The distal end of the conductor 300 is electrically connected to the connector 100. The distal end of the connector 100 is detachably connected to and electrically connected to the ablation device. The distal end of the connector 100 is used to connect to the ablation device, and the distal end of the tube body 200 is fixed to the proximal end of the connector 100, with the tube body 200 extending axially.
[0091] The connector 100 has an axially extending inner cavity 110 that extends through both the proximal and distal ends of the connector 100. An extension channel 120 is formed at the proximal end of the connector 100, and the distal end of the conductor 300 passes through the extension channel 120 and is electrically connected to the connector 100 for supplying electrical energy to the connector 100. The connector 100 includes a connecting portion 130 and a plug portion 140 protruding from the distal end of the connecting portion 130; both the connecting portion 130 and the plug portion 140 extend axially; the plug portion 140 is used for detachable connection with a sealing and ablation device. The tube body 200 is connected to the connecting portion 130.
[0092] In this embodiment, a guide groove is formed on the outer peripheral surface of the connecting portion 130 to create an extension channel 120. The guide groove is located at the proximal end of the connecting portion 130 and extends through the distal end of the connecting portion 130. The tube body 200 includes an inner layer 210 and an outer layer 220 covering the outer periphery of the inner layer 210. The distal end of the inner layer 210 extends into the connector 100 and is attached to the inner periphery of the connector 100. The outer layer 220 covers the outer periphery of the connecting portion 130 and covers the portion of the conductor 300 located in the connector 100.
[0093] The structure and connection relationship of connector 100, tube 200 and conductor 300 are the same as those in the second embodiment, and will not be repeated here.
[0094] The difference between this embodiment and the second embodiment is that:
[0095] The outer diameter of the connecting portion 130 is larger than the outer diameter of the insertion portion 140. The connector 100 also includes a clamping member 180 connected to the outer periphery of the insertion portion 140. The clamping member 180 is located on the distal end side of the connecting portion 130 and is spaced apart from the distal end face of the connecting portion 130. The distal end of the conductor 300 is fixedly disposed in the gap between the clamping member 180 and the connecting portion 130. Specifically, the conductor 300 is a wire, and the wire is clamped between the clamping member 180 and the connecting portion 130. It should be noted that the gap between the connecting portion 130 and the clamping member 180 can be understood as the fixing groove 170 in the above embodiment.
[0096] In this embodiment, the outer periphery of the insertion part 140 is provided with external threads, and the clamping member 180 is a nut threadedly connected to the insertion part 140. The outer diameter of the clamping member 180 is not greater than the outer diameter of the connecting part 130.
[0097] Figure 9 This is a cross-sectional schematic diagram of the fifth embodiment of the catheter of the present invention. Figure 10 This is a partial structural schematic diagram of the fifth embodiment of the catheter of the present invention.
[0098] See Figure 9 and Figure 10 In this embodiment, the catheter includes a connector 100 for connecting to an ablation device, a tube body 200 connected to the connector 100 at one end facing away from the ablation device, and a conductor 300 inserted within the tube body 200. The distal end of the conductor 300 is electrically connected to the connector 100. The distal end of the connector 100 is detachably connected to and electrically connected to the ablation device. The distal end of the connector 100 is used to connect to the ablation device, and the distal end of the tube body 200 is fixed to the proximal end of the connector 100, with the tube body 200 extending axially.
[0099] The connector 100 has an axially extending inner cavity 110 that extends through both the proximal and distal ends of the connector 100. An extension channel 120 is formed at the proximal end of the connector 100, and the distal end of the conductor 300 passes through the extension channel 120 and is electrically connected to the connector 100 for supplying electrical energy to the connector 100. The connector 100 includes a connecting portion 130 and a plug portion 140 protruding from the distal end of the connecting portion 130; both the connecting portion 130 and the plug portion 140 extend axially; the plug portion 140 is used for detachable connection with a sealing and ablation device. The tube body 200 is connected to the connecting portion 130.
[0100] In this embodiment, a guide groove is formed on the outer peripheral surface of the connecting portion 130 to create an extension channel 120. The guide groove is located at the proximal end of the connecting portion 130 and extends through the distal end of the connecting portion 130. The tube body 200 includes an inner layer 210 and an outer layer 220 covering the outer periphery of the inner layer 210. The distal end of the inner layer 210 extends into the connector 100 and is attached to the inner periphery of the connector 100. The outer layer 220 covers the outer periphery of the connecting portion 130 and covers the portion of the conductor 300 located in the connector 100.
[0101] The structure and connection relationship of connector 100, tube 200 and conductor 300 are the same as those in the third or fourth embodiment, and will not be repeated here.
[0102] The difference between this embodiment and the third and fourth embodiments is that:
[0103] In this embodiment, the tube body 200 further includes a braided mesh 230, which covers the outer periphery of the inner layer and extends along the axis of the inner layer 210; the braided mesh 230 is thermally fused between the inner layer 210 and the outer layer 220. In this embodiment, the braided mesh 230 is a metal mesh. In some embodiments, the braided mesh 230 is made of other materials.
[0104] The distal ends of the inner layer 210 and the braided mesh 230 pass through the inner cavity 110 of the connector 100, and the braided mesh 230 adheres to the inner peripheral wall of the inner cavity 110 of the connector 100. In embodiments where the braided mesh 230 is made of metal, the braided mesh 230 and the connector 100 are mutually insulated. For example, an insulating material, such as an insulating device, is sandwiched between the braided mesh 230 and the connector 100, or an insulating layer is provided on the surface of the braided mesh 230 and the connector 100.
[0105] The inner cavity 110 of the connector 100 has a stepped surface formed between the connecting portion 130 and the insertion portion 140. The inner diameter of the connecting portion 130 is larger than the inner diameter of the insertion portion 140. The connecting portion 130 is fitted onto the outer periphery of the inner layer 210, and the cavity of the insertion portion 140 communicates with the chamber of the inner layer 210. The outer layer 220 of the tube body 200 is made of thermoplastic material, and the outer layer 220 is heat-fused and covers the connecting portion 130 of the connector 100.
[0106] When the outer layer 220 is heat-melted and covered by the connecting part 130, the outer layer 220 can pass through the braided mesh 230 to heat-melt the inner layer 210. On the basis of ensuring that the tube body 200 has sufficient structural strength, the conductor 300 is pressed tightly on the surface of the inner layer 210 to prevent the conductor 300 from bending towards the outer layer 220. After heat melting and shaping, the conductor 300 is at different positions in the axial direction and the distance from the outer surface of the tube body is not equal. In particular, a part of the conductor 300 is closer to the outer surface of the tube body, and the conductor is easy to be exposed from the outer surface of the tube body. Or, when the conductor 300 transmits high voltage signals, it is easy to generate electric sparks on the surface of the tube body.
[0107] The outer layer 220 passes through the perforated window 160 of the connecting part 130 and heat-melts the braided mesh 230 and the inner layer 210, making the connection between the connector 100 and the pipe body tighter and more reliable.
[0108] The portion of the conductor 300 away from the connector 100 is located within the wall thickness range of the tube 200. In this embodiment, the portion of the conductor 300 away from the connector 100 is sandwiched between the braided mesh 230 and the inner layer 210. In some embodiments, the portion of the conductor 300 away from the connector 100 is sandwiched between the braided mesh 230 and the outer layer 220 of the tube 200.
[0109] like Figure 9As shown, a fixing groove 170 is formed at the connection between the connecting portion 130 and the insertion portion 140, and the fixing groove 170 extends radially toward the inner periphery of the insertion portion 140. Specifically, the insertion portions 140 on both sides of the fixing groove 170 are flush with the outer peripheral walls of the connecting portion 130. Specifically, the portion of the insertion portion 140 on the far side of the fixing groove 170 is a convex ring. The outer peripheral wall of the convex ring is not flush with the outer peripheral wall of the far end of the insertion portion 140. The outer diameter of the convex ring is larger than the outer diameter of the insertion portion 140. The inner peripheral wall of the convex ring is flush with the inner peripheral wall of the far end of the insertion portion 140. The inner peripheral wall of the connecting portion 130 adjacent to the fixing groove 170 in the axial direction is flush with the inner peripheral wall of the insertion portion 140. Furthermore, the inner peripheral wall of the far end of the connecting portion 130 is flush with the inner peripheral wall of the far end of the insertion portion 140. Therefore, the depth of the fixing groove 170 extends from the outer peripheral wall of the connecting portion 130 to a depth close to the inner peripheral wall of the insertion portion 140. The depth of the fixing groove 170 is greater than the thickness of the connecting portion and greater than the thickness of the far end of the insertion portion (the portion of the insertion portion excluding the convex ring).
[0110] In other embodiments, the outer diameter of the outer peripheral wall of the convex ring may be smaller than the outer peripheral wall of the connecting portion 130 and larger than the outer peripheral wall of the distal end of the insertion portion 140. In other embodiments, the inner diameter of the inner peripheral wall of the connecting portion 130 at the position axially adjacent to the fixing groove 170 is smaller than the inner diameter of the distal end of the connecting portion and larger than the inner diameter of the distal end of the connecting portion.
[0111] Figure 11 This is a cross-sectional schematic diagram of the sixth embodiment of the catheter of the present invention.
[0112] See Figure 11 In this embodiment, the catheter includes a connector 100 for connecting to an ablation device, a tube body 200 connected to the connector 100 at one end facing away from the ablation device, and a conductor 300 inserted within the tube body 200. The distal end of the conductor 300 is electrically connected to the connector 100. The distal end of the connector 100 is detachably connected to and electrically connected to the ablation device. The distal end of the connector 100 is used to connect to the ablation device, and the distal end of the tube body 200 is fixed to the proximal end of the connector 100, with the tube body 200 extending axially.
[0113] The connector 100 has an axially extending inner cavity 110 that extends through the proximal and distal ends of the connector 100. The tube body 200 is a tubular structure with an internal lumen 290. The inner cavity 110 of the connector 100 and the lumen 290 of the tube body 200 are connected, and a channel for the mapping catheter and guide wire to pass through is formed between the inner cavity 110 and the lumen 290.
[0114] The connector 100 includes a connecting portion 130 and a plug portion 140 protruding from the distal end of the connecting portion 130; both the connecting portion 130 and the plug portion 140 extend axially; the plug portion 140 is used for detachable connection with the sealing and ablation device. The tube body 200 is connected to the connecting portion 130.
[0115] The connector 100 is made of conductive material, and its insertion portion 140 extends axially and is detachably connected to the sealing and ablation device. The outer periphery of the insertion portion 140 is provided with external threads for threaded connection to the sealing and ablation device. The structure of the connector 100 is the same as that in any of the above embodiments, and will not be described again here.
[0116] The conductor 300 extends along the axial direction of the tube body 200 and is located inside the cavity of the tube body 200. The distal end of the conductor 300 passes through the connecting part 130 and is connected to the connecting part 130 by means of welding, pasting or heat fusion, so as to electrically connect to the connector 100.
[0117] The conductor 300 is a wire, which is a metal wire. The distal end of the wire passes through the extension channel 120, and the portion of the wire facing away from the connector 100 is located in the cavity 290 of the tube body 200. In some embodiments, the connector 100 is provided with a fixing groove 170 as described above, and the distal end of the conductor 300 is fixed in the fixing groove 170.
[0118] In this embodiment, the distal end of the tube 200 includes an integrally formed inner wall 250 and an outer wall 260; the inner wall 250 and the outer wall 260 are arranged radially spaced apart, and the proximal end of the inner wall 250 and the outer wall 260 are connected as one piece; the connecting part 130 is clamped between the inner wall 250 and the outer wall 260.
[0119] The pipe body 200 is made of materials such as PA, PEBAX, and HDPE. The distal end of the outer wall 260 protrudes radially inward, and the distal end of the outer wall 260 overlaps the step between the connecting part 130 and the insertion part 140, thereby enhancing the stability of the connection between the pipe body 200 and the connector 100. The pipe body 200 is integrally molded, eliminating the need for heat fusion to connect the pipe body 200 and the connector 100. Furthermore, the connector 100 does not require corresponding perforations, saving production and processing steps, improving production efficiency, and reducing production costs.
[0120] Figure 12 This is a cross-sectional schematic diagram of the seventh embodiment of the catheter of the present invention.
[0121] See Figure 12In this embodiment, the catheter includes a connector 100 for connecting to an ablation device, a tube body 200 connected to the connector 100 at one end facing away from the ablation device, and a conductor 300 inserted within the tube body 200. The distal end of the conductor 300 is electrically connected to the connector 100. The distal end of the connector 100 is detachably connected to and electrically connected to the ablation device. The distal end of the connector 100 is used to connect to the ablation device, and the distal end of the tube body 200 is fixed to the proximal end of the connector 100, with the tube body 200 extending axially.
[0122] In this embodiment, the structure and connection relationship of the connector 100, tube 200 and conductor 300 are the same as those of the connector 100, tube 200 and conductor 300 in the sixth embodiment of the conduit, and will not be described again here.
[0123] In this embodiment, the conductor 300 is surrounded by an insulating sleeve 310, which reduces energy loss. Furthermore, the conduit effectively prevents injury to the human body when it moves within the human body assembly. It should be noted that in any of the above embodiments, the insulating sleeve 310 surrounding the conductor effectively reduces energy loss and prevents injury to the human body.
[0124] Figure 13 This is a cross-sectional schematic diagram of the eighth embodiment of the catheter of the present invention.
[0125] See Figures 11 to 13 In this embodiment, the catheter includes a connector 100 for connecting to an ablation device, a tube body 200 connected to the connector 100 at one end facing away from the ablation device, and a conductor 300 inserted within the tube body 200. The distal end of the conductor 300 is electrically connected to the connector 100. The distal end of the connector 100 is detachably connected to and electrically connected to the ablation device. The distal end of the connector 100 is used to connect to the ablation device, and the distal end of the tube body 200 is fixed to the proximal end of the connector 100, with the tube body 200 extending axially.
[0126] The connector 100 has an axially extending inner cavity 110 that extends through the proximal and distal ends of the connector 100. The tube body 200 is a tubular structure with an internal lumen 290. The inner cavity 110 of the connector 100 and the lumen 290 of the tube body 200 are connected, and a channel for the mapping catheter and guide wire to pass through is formed between the inner cavity 110 and the lumen 290.
[0127] In this embodiment, the structure and connection relationship of the connector 100, tube 200 and conductor 300 are the same as those of the connector 100, tube 200 and conductor 300 in the sixth embodiment of the conduit, and will not be described again here.
[0128] In this embodiment, the tube body 200 has multiple cavities 290 inside. The conductor 300 is a wire, with the distal end of the wire passing through the connector 130. The portion of the wire facing away from the connector 100 is located in one cavity 290 of the tube body 200. The other cavities 290 are used for the passage of mapping catheters or guide wires, and the multiple cavities 290 do not interfere with each other.
[0129] Figure 14 This is a schematic diagram of a catheter assembly embodiment of the present invention.
[0130] In related technologies, the sealing and ablation device is equipped with two ablation components for transmitting the same or different ablation energy. In some embodiments, one is connected to the positive output terminal of the signal source, and the other is connected to the negative output terminal of the signal source.
[0131] This application provides a closure ablation system, including a catheter and a closure ablation device as described in embodiments of this application. The closure ablation device is connected to the distal end of the catheter and is detachable from the distal end of the catheter. The catheter is used to deliver and release the closure ablation device to the tissue defect and is capable of transmitting ablation electrical energy to the closure ablation device. The closure ablation device is used to close the tissue defect and is capable of ablating the tissue using electrical energy. In some embodiments, the closure ablation device can selectively ablate or map the tissue. The closure ablation device is detachably connected to the distal end of the connector.
[0132] Figure 15 This is a schematic diagram of a sealing and ablation device.
[0133] See Figure 15 This application provides a sealing and ablation device 50, wherein the portion of the sealing and ablation device 50 near the catheter is a sealing portion 510, and the portion away from the catheter is an anchoring portion 520. Figure 1 For example, Figure 1 The near-end portion (lower side panel) is the sealing part 510, and the far-end portion (upper side portion) is the anchoring part 520. The sealing part 510 and the anchoring part 520 are connected by a connector 530.
[0134] The sealing and ablation device 50 is equipped with ablation elements. Specifically, a first ablation element 540 is provided on the sealing part 510, and a second ablation element 550 is provided on the anchoring part 520. A first conductor 560 electrically connected to the first ablation element is provided on the sealing part 510, and a second conductor 570 electrically connected to the second ablation element 550 is provided on the anchoring part 520. The conduit assembly provided in this application provides a first conduit and a second conduit to supply power to the first conductor 560 and the second conductor 570, respectively. It should be noted that in some embodiments, only the sealing part 510 or only the anchoring part 520 is equipped with an ablation element, and the corresponding sealing part 510 or anchoring part 520 is equipped with a conductor. The conduit provided in this application is used to transmit electrical energy to the ablation element. The first conductor 560 and the second conductor 570 are spaced apart in the axial direction. The first conductor 560 is disposed on the proximal side of the second conductor 570. Specifically, the first conductor 560 is disposed on the proximal end of the sealing part 510, and the second conductor 570 is disposed on the distal end of the connector 530.
[0135] The first ablation element 540 and the second ablation element 550 are used to deliver the same or different ablation energy to the tissue. The first ablation element 540 and the second ablation element 550 are electrically connected via a conductor and a catheter, respectively, to deliver two different ablation energies. The first ablation element 540 and the second ablation element 550 can also be used for electrophysiological signal mapping. For example, during one period, both the first ablation element 540 and the second ablation element 550 may be used for ablation, and during another period, both may be used for mapping; or some of the first ablation elements 540 and the second ablation element 550 may always be used for ablation, and some may always be used for mapping.
[0136] It should be noted that the ablation energy in this embodiment can be pulse energy, radio frequency energy, microwave energy, etc., and is not specifically limited here.
[0137] The first ablation element 540 can be a conductive metal skeleton on the sealing part 510, or it can be an electrode disposed on the sealing part 510. Similarly, the second ablation element 550 can be a metal skeleton on the anchoring part 520, or it can be an electrode disposed on the anchoring part 50. The electrode can be in the form of a ring electrode, a point electrode, a rod electrode, etc. Figure 1 In the structure shown, the first ablation element 540 is at least a portion of the conductive metal skeleton on the sealing part 510, and the second ablation element 550 is an electrode disposed on the anchoring part 520, the electrode being filamentous or sheet-like and arranged in a ring around the anchoring part.
[0138] The placement of the first ablation element 540 and the second ablation element 550 is not limited; that is, both ablation portions can be located in the sealing portion 510 or both in the anchoring portion 520. The specific implementation of the first ablation element 540 and the second ablation element 550 is also not limited. Correspondingly, the specific placement of the first conductor 560 and the second conductor 570 is not limited.
[0139] The first conductor 560 and the second conductor 570 can each be part of the connector 530, or they can be structures separately disposed on the connector 530. The first conductor 560 is connected to the proximal end of the sealing portion 510. It is understood that at least one part of the connector 530 can be made of insulating material, thereby ensuring that the first ablative element 540 and the second ablative element 550 are mutually insulated, and that the sealing portion 510 and the anchoring portion 520 are mutually insulated.
[0140] Understandably, to clearly show the placement of the first conductor 560 and the second conductor 570, the covering membrane is omitted in the device diagram. That is, at least one covering membrane can be provided in the occlusion and ablation device to prevent thrombi in the left atrial appendage from dislodging and entering the left atrium. The specific location of the covering membrane can be set at the anchoring part and / or the sealing part, without limitation.
[0141] This embodiment provides a sealing and ablation device with two ablation elements. It can be understood that this sealing and ablation device may only have one ablation element, such as the first ablation element 540. The first conductor in the sealing and ablation device is connected to the connector 100 at the distal end of the conduit, thereby enabling electrical connection with an external energy source.
[0142] In some implementations, the occlusion ablation device is provided with more than two ablation elements, and each ablation element may be provided with a conductor for connection to the corresponding conduit.
[0143] It is understood that the sealing and ablation device provided in this embodiment has a dual-disc structure, that is, both the sealing part and the anchoring part are disc-shaped. In some embodiments, the sealing and ablation device has a single-disc structure (such as a plunger-shaped structure) or a multi-disc structure (such as a three-disc or more-disc structure). In this embodiment, the sealing part is made by a braiding process and the anchoring part is made by a cutting process. It is understood that the manufacturing process of the sealing part and the anchoring part is not limited, and the sealing part and the anchoring part can be made by a braiding process or a cutting process, respectively.
[0144] See Figure 14 and Figure 16 This embodiment provides a catheter assembly for use with Figure 1The catheter assembly is used in conjunction with the occlusion ablation device provided in the middle, that is, the distal end of the catheter assembly is used to connect to the occlusion ablation device 50 and deliver and release the occlusion ablation device 50 into the patient's body. The catheter assembly is also used to transmit the same or different ablation energy to the two ablation elements in the occlusion ablation device 50.
[0145] Specifically, the conduit assembly includes a first conduit 10 and a second conduit 20, both of which refer to the conduits in any of the above embodiments. The structure and connection relationship of the connector 100, tube body 200, and conductor 300 of the first conduit 10 and the second conduit 20 refer to the structure of the connector 100, tube body 200, and conductor 300 in any of the above embodiments, and will not be repeated here.
[0146] In this embodiment, the second conduit 20 covers the outer periphery of the first conduit 10, and the distal end of the first conduit 10 can extend beyond the distal end of the second conduit 20. Specifically, the distal end of the tube body 200 of the first conduit 10 can extend beyond the distal end of the tube body 200 of the second conduit 20; two connectors 100 are spaced apart along the axial direction, one connector 100 is connected to the distal end of the tube body 200 of the first conduit 10; the other connector 100 is connected to the distal end of the tube body 200 of the second conduit 20; the two connectors 100 are respectively connected to corresponding conductors 300.
[0147] Both connectors 100 are detachably connected to the occlusion ablation device for supplying the same or different ablation electrical energy to the occlusion ablation device. Connector 100 of the first conduit 10 is used to connect to the second conductor 570 of the occlusion ablation device 50, and connector 100 of the second conduit 20 is used to connect to the first conductor 560 of the occlusion ablation device 50. In some embodiments, the two connectors 100 are respectively used to transmit the output energy from the positive output terminal and the negative transmission terminal of the external ablation energy generator.
[0148] The first catheter 10 and the second catheter 20 can move relative to each other, thereby causing the two connectors 100 to separate from the occlusion and ablation device. In this embodiment, the connectors 100 are detachably connected to the occlusion and ablation device via a threaded connection. The first catheter 10 can slide axially and rotate radially relative to the second catheter 20, thereby causing the two connectors 100 to separate from the occlusion and ablation device. In one embodiment, the connectors 100 are detachably connected to the occlusion and ablation device axially, and the first catheter 10 can slide axially relative to the second catheter 20, thereby causing the two connectors 100 to separate from the occlusion and ablation device.
[0149] In this embodiment, an insulating layer 280 is provided on the outer periphery of the tube body 200 of the first conduit 10. The insulating layer 280 at least covers the proximal portion of the connector 100 on the first conduit 10 to increase the breakdown voltage between the first conduit 10 and the second conduit 20, thereby facilitating the transmission of high-voltage pulse energy. The insulating layer 280 can be a heat-shrinkable film with a low dielectric constant, such as ET or PTFE, and is sleeved on the outer periphery of the tube body 200 of the first conduit 10. Alternatively, the insulating layer 280 can be one or more insulating coatings coated on the proximal portion of the connector 100 on the first conduit 10, such as a pyrene coating, PTFE coating, or PI coating. In some embodiments, the insulating layer 280 covers the proximal end of the connector 100, for example, the connecting portion of the connector 100, and can extend proximally to the first tube body 10 to cover a larger area. In some embodiments, the above-mentioned insulating layer is provided on the inner or outer periphery of the second conduit 20, and the insulating layer at least covers the proximal end of the connector 100 in the second conduit 20.
[0150] Two connectors 100 are connected to two conductors 300 respectively. The conductors 300 connected to the connectors 100 on the second conduit 20 are sandwiched between the tube body 200 of the first conduit 10 and the tube body 200 of the second conduit 20. The conductors 300 connected to the connectors 100 on the first conduit 10 are sandwiched between the tube body 200 of the first conduit 10 and the corresponding braided mesh 230.
[0151] Figure 16 This is a cross-sectional schematic diagram of another embodiment of the conduit assembly of the present invention.
[0152] In this embodiment, the first conduit 10 includes a connector 100 for connecting to an ablation and occlusion device, a tube body 200 connected to the connector 100 at one end opposite to the ablation and occlusion device, and a conductor 300 inserted within the tube body 200. The second conduit 20 includes a connector 100 for connecting to an ablation and occlusion device, a tube body 200 connected to the connector 100 at one end opposite to the ablation and occlusion device, and a conductor 300 inserted within the tube body 200.
[0153] In this embodiment, the structure of the connector 100 of the first conduit 10 and the second conduit 20, as well as the conductor 300, are the same as those in the previous conduit assembly embodiment, and will not be described again here.
[0154] The differences between the first catheter 10 and the second catheter 20 in this embodiment and those in the previous catheter assembly embodiment are as follows:
[0155] The tube body 200 of the first conduit 10 includes an outer layer 201, a braided mesh 230 attached to the inner peripheral wall of the outer layer 201, and an inner layer 240 attached to the inner peripheral surface of the braided mesh. The inner layer 240 may be made of PTFE membrane.
[0156] The body 200 of the second catheter 10 includes only the extension tube 202. The extension tube 202 is sleeved on the outer periphery of the outer layer 201, and the distal end of the outer layer 201 extends distally beyond the extension tube 202. The bodies 200 of the first catheter 10 and the second catheter 20 are integrally formed, so that both connectors 100 can be simultaneously separated from the sealing and ablation device. Specifically, the extension tube 202 and the first extension tube 201 are integrally formed, so that the extension tube 202 and the first extension tube 201 are configured as a single unit.
[0157] The conductor 300 on the first conduit 10 is held between the outer layer 201 and the corresponding braided mesh 230, or between the braided mesh 230 and the inner layer 240. The conductor 300 on the second conduit 10 is held between the extension tube 202 and the outer layer 201.
[0158] It is understood that the embodiments of this application provide conduit forms with one conductor and two conductors in the corresponding occlusion and ablation device. For embodiments with more than two conductors in the occlusion and ablation device, please refer to... Figure 14 The implementation method adds multiple catheters in a separate nested design, or refers to... Figure 16 The implementation method provides an integrated nested design for multiple catheters and connectors.
[0159] Figure 17 This is a schematic diagram of a connector according to the present invention.
[0160] See Figure 17 This embodiment provides a connector 400, which can be used to replace the connector 100 in any of the above embodiments. The connector 400 includes a connecting portion 430 and a plug-in portion 440 protruding from the distal end of the connecting portion 430; both the connecting portion 430 and the plug-in portion 440 extend axially; the plug-in portion 440 is used for detachable connection with a sealing and ablation device. An extension channel 420 is provided on the connecting portion 430.
[0161] The insertion portion 440 includes a spring 441, which is used to expand or contract radially relative to the connection portion 430 to connect or disconnect with the sealing and ablation device.
[0162] In this embodiment, the insertion portion 440 includes two insertion segments 442 spaced apart along the axial direction, and a plurality of spring tabs 441 disposed between the two insertion segments 442; one insertion segment 442 is connected to the distal end of the connecting portion 430; the two ends of the plurality of spring tabs 441 are respectively connected to the two insertion segments 442; the plurality of spring tabs 441 are distributed around the axis of the insertion portion 440. The elastic force of the spring tabs 441 enables the insertion portion 440 and the occlusion ablation device to be detachably connected. When the catheter and the occlusion ablation device are connected or disconnected, only the catheter needs to be moved along the axial direction, without rotating the catheter.
[0163] In this application, the conductor 300 is disposed in the extension channel (120, 420) of the connector (100, 400), so that the connection of the conductor 300 on the connector (100, 400) will not affect the inner diameter and outer diameter of the connector (100, 400), so as to provide electrical energy to the connector (100, 400) without increasing the outer diameter of the conduit.
[0164] The connector 100 in any embodiment of this application can be replaced by the connector 400. The connecting portion 440 of the connector 400 can adopt all the specific technical solutions of the connecting portion in the connector 100, which will not be described in detail here.
[0165] The various specific technical solutions in the above embodiments can be used in combination without contradiction.
[0166] Although the invention has been described with reference to several typical embodiments, it should be understood that the terminology used is illustrative and exemplary, and not restrictive. Since the invention can be embodied in many forms without departing from the spirit or essence of the invention, it should be understood that the above embodiments are not limited to any of the foregoing details, but should be interpreted broadly within the spirit and scope defined by the appended claims. Therefore, all variations and modifications falling within the scope of the claims or their equivalents should be covered by the appended claims.
Claims
1. A catheter for implanting an occlusion ablation device into a patient, characterized in that, include: A connector, the distal end of which is detachably connected to the sealing and ablation device; When the connector is connected to the occlusion and ablation device, the connector is electrically connected to the occlusion and ablation device; an extension channel is provided at the proximal end of the connector; The tube body, the distal end of which is fixed to the proximal end of the connector; A conductor extends axially along the tube body; the distal end of the conductor passes through the extension channel and is electrically connected to the connector for supplying electrical energy to the connector. The connector includes a connecting portion and a plug portion protruding from the distal end of the connecting portion; both the connecting portion and the plug portion extend axially; the plug portion is used for detachable connection with the sealing and ablation device; the extension channel is opened at the proximal end of the connecting portion, and the tube body is connected to the connecting portion; The connector has a fixing groove at the distal end of the extension channel, and the extension direction of the fixing groove is different from the extension direction of the extension channel; the distal end of the extension channel is connected to the fixing groove, and the conductor is a wire; the distal end of the conductor is fixed in the fixing groove. Both the connecting part and the plug-in part are tubular; the outer diameter of the connecting part is larger than the outer diameter of the plug-in part.
2. The catheter according to claim 1, characterized in that, The extended channel is a guide groove formed on the outer peripheral surface of the connecting part.
3. The catheter according to claim 1, characterized in that, The fixing groove is circumferentially disposed on the outer peripheral surface of the connecting part around the axis of the connecting part; the distal end of the conductor protruding from the extension channel is wrapped inside the fixing groove.
4. The catheter according to claim 1, characterized in that, The radial depth of the fixing groove is greater than the radial depth of the extending channel.
5. The catheter according to claim 1, characterized in that, The fixing groove is formed at the connection between the connecting part and the plug-in part; the fixing groove extends radially toward the inner circumference of the plug-in part.
6. The catheter according to claim 1, characterized in that, The width of the fixing groove is adapted to the diameter of the wire to press the wire between the two side walls of the fixing groove.
7. The catheter according to claim 1, characterized in that, A step is formed between the distal end of the connecting part and the plug-in part. An annular protrusion is provided on the outer periphery of the plug-in part at the distal end of the connecting part. The annular protrusion extends axially around the plug-in part. The annular protrusion and the step are spaced apart, and the fixing groove is formed between the annular protrusion and the step.
8. The catheter according to claim 2, characterized in that, The extension channel extends through the distal end of the connector; the distal end of the conductor extends out of the extension channel; the distal end of the conductor is connected to the outer periphery of the connector or the distal surface of the connector.
9. The catheter according to claim 8, characterized in that, The connector also includes a clamping member connected to the outer periphery of the plug portion. The proximal end face of the clamping member presses against the conductor to press the conductor between the clamping member and the connector portion.
10. The catheter according to claim 1, characterized in that, The tube body has a cavity inside, and the distal end of the tube body covers the outer periphery of the connecting part.
11. The catheter according to claim 10, characterized in that, The wall thickness of the distal end of the tube covering the connecting part is D, and the wall thickness of the tube not connected to the connecting part is d, where Dd < 0.2 mm.
12. The catheter according to claim 10, characterized in that, The connector has an axially extending inner cavity that communicates with the lumen of the tube body. The tube body includes an inner layer and an outer layer that covers the outer periphery of the inner layer. The distal end of the inner layer extends into the inner cavity of the connector and is attached to the inner periphery of the connector. The outer layer covers the outer periphery of the connector.
13. The catheter according to claim 12, characterized in that, The distal outer periphery of the inner layer is attached to the inner periphery of the connecting portion; the inner peripheral wall of the inner layer is flush with the inner peripheral wall of the insertion portion.
14. The catheter according to claim 12, characterized in that, A perforated window extending radially through the outer periphery of the connecting part to the inner cavity is provided, and the outer layer of the tube body is heat-fused to the inner layer through the perforated window.
15. The catheter according to claim 12, characterized in that, The tube body also includes a braided mesh, which covers the outer periphery of the inner layer and extends along the axis of the inner layer; the braided mesh is thermally fused between the inner layer and the outer layer; the portion of the conductor away from the connector is clamped between the braided mesh and the outer layer, or between the braided mesh and the inner layer.
16. The catheter according to claim 1, characterized in that, The distal end of the tube includes an integrally formed inner wall and an outer wall; the inner wall and the outer wall are arranged radially spaced apart, and the proximal end of the inner wall and the outer wall are connected as one piece; the connecting part is clamped between the inner wall and the outer wall; the conductor is a wire, and the portion of the conductor away from the connecting head is located inside the tube cavity or within the wall thickness range of the tube.
17. The catheter according to claim 16, characterized in that, The tube body is provided with multiple cavities, and the portion of the conductor away from the connector is housed in one of the cavities.
18. The catheter according to claim 1, characterized in that, The outer periphery of the plug is provided with external threads for connection with the sealing and ablation device.
19. The catheter according to claim 15, characterized in that, The woven mesh is insulated from the connector.
20. The catheter according to claim 1, characterized in that, The surface of the conductor is covered with an insulating sleeve.
21. A catheter assembly, characterized in that, It includes a first catheter and a second catheter, both of which are catheters as described in any one of claims 1-20; the second catheter covers the periphery of the first catheter, and the distal end of the first catheter can extend beyond the distal end of the second catheter.
22. The catheter assembly according to claim 21, characterized in that, An insulating layer is provided on the outer periphery of the first catheter body, and the insulating layer at least covers the proximal portion of the connector on the first catheter.
23. The catheter assembly according to claim 21, characterized in that, The first catheter is capable of sliding axially and rotating radially relative to the second catheter, thereby causing the corresponding connectors to separate from the sealing and ablation device.
24. The catheter assembly according to claim 21, characterized in that, The tube bodies of the first catheter and the second catheter are integrated into one piece.
25. A sealing and ablation system, characterized in that, The invention includes a sealing and ablation device and at least one catheter as described in any one of claims 1-20; the sealing and ablation device is used to seal tissue defects and is capable of ablating tissue using electrical energy; the sealing and ablation device is detachably connected to the distal end of the connector, and the catheter is used to deliver and release the sealing and ablation device to the tissue defect and is capable of transmitting ablation electrical energy to the sealing and ablation device.