Pulse electric field ablation catheter

Abstract

The utility model relates to a pulsed electric field ablation catheter. The pulsed electric field ablation catheter comprises a catheter body, a handle, an ablation component and a connector, one end of the tube body is connected with the handle; the ablation component comprises a connecting base and a plurality of supporting rods, the connecting base is connected with the end, away from the handle, of the tube body, the supporting rods extend from the connecting base to the direction away from the tube body, and each supporting rod comprises a first connecting part, a supporting part and a second connecting part which are sequentially connected; the first connecting part is connected with the connecting base, the ends, away from the supporting parts, of the second connecting parts are connected, the supporting parts are arranged in parallel, and the supporting parts are sleeved with a plurality of electrode rings at intervals; the connector is arranged on the side, away from the tube body, of the handle, and the connector is electrically connected with the electrode rings. According to the scheme, the operation duration of linear ablation can be shortened, and complications are reduced.

Description

Technical Field

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

[0002] Catheter ablation for atrial fibrillation was first used in clinical practice in the 1990s and has been widely used due to its good clinical efficacy and safety. Domestic and international guidelines have regarded catheter ablation as the first-line treatment for atrial fibrillation. Circumferential pulmonary vein isolation is the cornerstone of catheter ablation for atrial fibrillation. The one-year recurrence-free rate of patients with paroxysmal atrial fibrillation after circumferential pulmonary vein isolation can reach 90%, while the recurrence-free rate of persistent atrial fibrillation is only about 50%. Therefore, simple pulmonary vein isolation is far from enough for persistent atrial fibrillation, and linear ablation is also required.

[0003] In the related technology, a common method of linear ablation is to use radio frequency energy to mark lines for related treatment. However, this method often takes a long time to perform surgery and has a high probability of causing complications. Utility Model Content

[0004] In order to solve or partially solve the problems existing in the related art, the present application provides a pulsed electric field ablation catheter that can be used for linear ablation, which can reduce the operation time of linear ablation and reduce the occurrence of complications.

[0005] The present application provides a pulse electric field ablation catheter, comprising: a tube body, a handle, an ablation component and a connector;

[0006] One end of the tube body is connected to the handle;

[0007] The ablation component comprises a connection seat and a plurality of support rods, wherein the connection seat is connected to one end of the tube body away from the handle, and the support rod extends from the connection seat in a direction away from the tube body, and the support rod comprises a first connection part, a support part, and a second connection part connected in sequence, wherein the first connection part is connected to the connection seat, and each of the second connection parts is connected to one end away from the support part, and each of the support parts is arranged in parallel with each other, and a plurality of electrode rings are sleeved on the support part at intervals;

[0008] The connector is arranged on a side of the handle away from the tube body, and the connector is electrically connected to each of the electrode rings respectively.

[0009] Furthermore, the axes of the support rods are located in the same plane.

[0010] Furthermore, the ablation component is made of polymer material; or

[0011] The ablation component comprises a substrate made of nickel-titanium alloy material and a polymer material layer covering the substrate.

[0012] Further, the electrode ring is made of platinum-iridium alloy or gold.

[0013] Further, the electrode rings on two adjacent support rods are arranged in one-to-one correspondence.

[0014] Further, a first bending adjustment member for adjusting the bending degree of the tube body is provided on the handle. A wire is provided inside the tube body. One end of the wire is connected to the first bending adjustment member, and the other end of the wire is connected to one end of the tube body close to the ablation component. The first bending adjustment member can pull the wire to move relative to the tube body.

[0015] Further, the first bending adjustment member is slidably connected to the handle. One end of the tube body close to the ablation component has an adjustable bending section. The first bending adjustment member sliding relative to the handle can adjust the bending degree of the adjustable bending section through the wire.

[0016] Further, a second bending adjustment member for adjusting the bending degree of the support rod is provided on the handle. A pulling wire is provided inside the tube body. One end of the pulling wire is connected to the second bending adjustment member, and the other end of the pulling wire is connected to one end of the support rod away from the connecting seat. The second bending adjustment member can pull the pulling wire to move relative to the tube body.

[0017] Further, the second bending adjustment member is slidably connected to the handle. The second bending adjustment member sliding relative to the handle can adjust the bending degree of the support rod through the pulling wire.

[0018] Further, a flow channel cavity for conveying fluid is provided inside the pulling wire.

[0019] The technical solution provided by this application may include the following beneficial effects: The support rod includes a first connection portion, a support portion, and a second connection portion that are connected in sequence. The first connection portion is connected to the connection seat. One ends of the second connection portions away from the support portion are connected to each other. The support portions are arranged in parallel with each other. A plurality of electrode rings are sleeved on the support portion at intervals. This forms a ring with two different support rods. The electric field formed by the electrode rings on the support portion can simultaneously ablate a relatively large range of myocardial cells. Compared with the radiofrequency energy dot ablation method, it can ablate more quickly, shorten the operation time, and reduce the occurrence of complications.

[0020] It should be understood that the above general description and the following detailed description are only exemplary and explanatory, and cannot limit this application. Description of the Drawings

[0021] The above and other objects, features, and advantages of the present application will become more apparent by describing the exemplary embodiments of the present application in more detail with reference to the accompanying drawings, wherein, in the exemplary embodiments of the present application, the same reference numerals generally represent the same components.

[0022] Figure 1 It is a schematic structural diagram of a pulsed electric field ablation catheter shown in an embodiment of the present application;

[0023] Figure 2 It is a partial schematic diagram of the pulsed electric field ablation catheter at the ablation component shown in an embodiment of the present application;

[0024] Figure 3 It is a schematic structural diagram of the pulsed electric field ablation catheter in a bent state of the tube body shown in an embodiment of the present application;

[0025] Figure 4 is Figure 3 a side view of;

[0026] Figure 5 It is a schematic structural diagram of the pulsed electric field ablation catheter in a bent state of the support rod shown in an embodiment of the present application;

[0027] Figure 6 is Figure 5 a side view of;

[0028] Figure 7 It is a cross-sectional view of the pulsed electric field ablation catheter shown in an embodiment of the present application;

[0029] Figure 8 is Figure 7 a partial enlarged view at the ablation component.

[0030] Reference numerals:

[0031] 1 - tube body, 11 - adjustable bending section, 2 - handle, 3 - ablation component, 31 - connecting seat, 32 - support rod, 321 - first connecting part, 322 - supporting part, 323 - second connecting part, 33 - electrode ring, 4 - connector, 5 - first bending adjustment member, 6 - second bending adjustment member, 7 - pulling wire, 71 - flow channel cavity, 72 - liquid injection hole, 8 - pulling wire. Detailed implementation manners

[0032] The embodiments of the present application will be described in more detail below with reference to the accompanying drawings. Although the embodiments of the present application are shown in the drawings, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided to make the present application more thorough and complete, and to fully convey the scope of the present application to those skilled in the art.

[0033] It should be understood that although the terms "first", "second", "third", etc. may be used in this application to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from each other. For example, without departing from the scope of this application, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of this application, the meaning of "a plurality" is two or more, unless otherwise specifically defined.

[0034] In the description of this application, it should be understood that the orientation or positional relationship indicated by the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing this application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to this application.

[0035] Unless otherwise clearly specified and limited, the terms "installed", "connected", "connected to", "fixed", etc. should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0036] In the related art, the common way of linear ablation is to use radiofrequency energy to dot and draw lines for related treatment. However, the single ablation area of radiofrequency energy dotting is small, and it realizes the linear isolation of the target position by connecting multiple points into a line. This method often takes a long time for the operation, and the ablation method of radiofrequency energy causes damage to tissues through the temperature effect, lacks selectivity for the ablation of myocardial tissues, and will cause damage to other tissues during the ablation process, resulting in a relatively high probability of complications, such as complications like cardiac perforation and esophageal injury.

[0037] In view of the above problems, the embodiments of this application provide a pulsed electric field ablation catheter, which can reduce the operation time of linear ablation and reduce the occurrence of complications.

[0038] The technical solutions of the embodiments of this application will be described in detail below with reference to the drawings.

[0039] Such as Figure 1 And Figure 2As shown in the figure, an embodiment of the present application provides a pulsed electric field ablation catheter, which includes a catheter body 1, a handle 2, an ablation component 3, and a connector 4.

[0040] One end of the catheter body 1 is connected to the handle 2, and the other end of the catheter body 1 is connected to the ablation component 3. The ablation component 3 includes a connection seat 31 and a plurality of support rods 32. The connection seat 31 is connected to the end of the catheter body 1 far from the handle 2. The support rods 32 extend from the connection seat 31 in a direction away from the catheter body 1. The ablation component 3 and the catheter body 1 can extend into the patient's body during the operation, and the handle 2 is located outside the patient's body for the operator to hold.

[0041] Among them, the support rod 32 includes a first connection portion 321, a support portion 322, and a second connection portion 323 connected in sequence. The first connection portion 321 is connected to the connection seat 31. The ends of the second connection portions 323 far from the support portion 322 are connected to each other, that is, the ends of the second connection portions 323 converge together. The support portions 322 are arranged parallel to each other, and a plurality of electrode rings 33 are sleeved on the support portion 322 at intervals. The ablation component 3 can be an integrally formed structure and is fixed to the end of the catheter body 1. In this embodiment, the ablation component 3 has two support rods 32, and the two support rods 32 form a ring. In other embodiments, the support rods 32 can also be three or four and are all arranged in parallel, and a ring is formed between every two support rods 32.

[0042] The connector 4 is arranged on the side of the handle 2 far from the catheter body 1, and the connector 4 is electrically connected to each electrode ring 33 respectively. On the one hand, the connector 4 can be connected to a pulsed energy emitter, and the pulsed energy emitter transmits pulsed electric energy to each electrode ring 33 through the connector 4. On the other hand, the connector 4 can also be connected to a mapping host, and the mapping host receives the electrical signals detected in real time by each electrode ring 33 through the connector 4 and displays the potential of the part where the electrode is attached in real time to help the operator judge the ablation situation. That is, the electrode ring 33 can be used as both an ablation electrode and a mapping electrode, so that the pulsed electric field ablation catheter has both ablation and mapping functions at the same time.

[0043] The electric field formed by the electrode rings 33 on the support portion 322 can ablate a large range of myocardial cells simultaneously. Compared with the radiofrequency energy dot ablation method, it can ablate more quickly, shorten the operation time, and because of the characteristics of the pulsed electric field, it can selectively ablate myocardial cells with less influence on other tissues, and can reduce the occurrence of complications.

[0044] Specifically, the connector 4 and the electrode ring 33 are electrically connected through a wire, and the wire can be buried in the catheter body 1 and the ablation component 3. Each electrode ring 33 is connected to the pulsed energy emitter and the mapping host through an independent wire. The pulsed energy emitter can control the discharge of the electrode ring 33 individually, so that each electrode ring 33 can be set with different polarities to meet different electric field combination requirements. For example, Figure 2As shown, two adjacent electrode rings 33 on each support rod 32 are set to different polarities, and the electrode rings 33 that are vertically opposite on the two support rods 32 are also set to different polarities, forming different forms of electric field combinations between different electrode rings 33. The mapping host is used for electrophysiological mapping and can be connected to the mapping host of a two-dimensional system or a three-dimensional system for the transmission and acquisition of electrical signals. When the electrode rings 33 are attached to different positions in the atrium, the electrocardiogram signals at different positions will be collected and transmitted out.

[0045] The effective length of the pulsed electric field ablation catheter is the total length of the tube body 1 except for the part connected to the handle 2 and the ablation component 3. The effective length part is the part that can enter the human blood vessel, and generally the effective length is more than 50 cm.

[0046] In some embodiments, the axes of the support rods 32 are located in the same plane. Specifically, as Figure 2 shown, the ring formed by the two support rods 32 is located in a plane to facilitate the fitting of the ablation component 3 to the part to be ablated.

[0047] In some embodiments, the ablation component 3 is made of a polymer material and has a certain flexibility.

[0048] In some embodiments, the ablation component 3 includes a substrate made of nitinol alloy material and a polymer material layer coated on the substrate, having a certain softness and a certain toughness at the same time.

[0049] In some embodiments, the electrode rings 33 are made of metals or metal alloys such as platinum-iridium alloy and gold.

[0050] In some embodiments, as Figure 2 shown, the electrode rings 33 on two adjacent support rods 32 are arranged in one-to-one correspondence, and the electrode rings 33 that are vertically opposite on the two support rods 32 are opposite, so as to form a corresponding electric field.

[0051] In some embodiments, as Figure 3 、 Figure 4 、 Figure 7 and Figure 8 shown, a first bending adjustment member 5 for adjusting the bending degree of the tube body 1 is provided on the handle 2. A pull wire 8 is provided in the tube body 1. The first bending adjustment member 5 is connected to one end of the pull wire 8, and the other end of the pull wire 8 is connected to the end of the tube body 1 close to the ablation component 3. The first bending adjustment member 5 can pull the pull wire 8 to move relative to the tube body 1.

[0052] Specifically, a channel for the pull wire 8 to pass through is provided in the tube wall of the tube body 1. The pull wire 8 is fixedly connected to the end of the tube body 1 close to the ablation component 3. The first bending adjustment member 5 pulls the pull wire 8 to bend the tube body 1.

[0053] In some embodiments, the first bending member 5 is slidably connected to the handle 2. One end of the tube body 1 close to the ablation component 3 has an adjustable bending section 11. The relative sliding of the first bending member 5 with respect to the handle 2 can adjust the bending degree of the adjustable bending section 11 through the pull wire 8.

[0054] Specifically, as Figure 4 shown, the first bending member 5 is arranged at the distal end of the handle 2. The first bending member 5 is rod-shaped and sleeved on the tube body 1. The first bending member 5 can slide back and forth relative to the handle 2, so as to control the back-and-forth movement of the pull wire 8, and further control the bending of the adjustable bending section 11. Figure 4 In the figure, the angle a is the bending angle of the adjustable bending section 11, and this bending angle can be 0 - 180°. The hardness of the adjustable bending section 11 is less than that of other parts of the tube body 1, so as to facilitate the bending of the adjustable bending section 11. After the ablation component 3 reaches the inside of the heart cavity, the operator can operate the first bending member 5 to achieve the abutment and treatment of the operator at different direction positions during the operation.

[0055] In some embodiments, as Figure 2 、 Figures 5 to 8 shown, the handle 2 is provided with a second bending member 6 for adjusting the bending degree of the support rod 32. A pull wire 7 is arranged inside the tube body 1. One end of the pull wire 7 is connected to the second bending member 6, and the other end of the pull wire 7 is connected to the end of the support rod 32 far from the connection seat 31. The second bending member 6 can pull the pull wire 7 to move relative to the tube body 1.

[0056] Among them, the pull wire 7 can penetrate through the tube body 1 along the axis of the tube body 1. A channel for the pull wire 7 to pass through can be provided on the side wall of the tube body 1. The second bending member 6 pulls the pull wire 7 to make the pull wire 7 slide relative to the tube body 1; In some embodiments, as Figure 8 shown, the pull wire 7 is located inside the lumen of the tube body 1. As Figure 6 shown, the angle b in the figure is the bending angle of the support rod 32, and this bending angle can be 0 - 180°. As Figure 5 and Figure 6 shown, during the operation, the operator can pull the pull wire 7 to move left and right through the second bending member 6 to control the bending and straightening of the distal ablation component 3. Thus, in some places where scribing ablation is required under certain curved surface conditions, bending the support rod 32 and then abutting it will obtain a better abutment effect, so as to achieve a better ablation effect, which can greatly simplify the operation of the operator.

[0057] In some embodiments, the second bending member 6 is slidably connected to the handle 2. The relative sliding of the second bending member 6 with respect to the handle 2 can adjust the bending degree of the support rod 32 through the pull wire 7. Specifically, the second bending member 6 can be a slider, and the handle 2 is provided with a chute corresponding to the slider, so that the slider slides back and forth in the chute.

[0058] In some embodiments, as Figure 8As shown, the pulling wire 7 has a flow channel cavity 71 for fluid conveyance, that is, the pulling wire 7 is tubular with an internal cavity. Liquid can enter the flow channel cavity 71 from one end of the pulling wire 7 located at the handle 2 and flow out from one end of the pulling wire 7 located at the ablation component 3, thereby playing a role in cooling and fluid replenishment. Continuous perfusion can prevent thrombus formation. Specifically, a liquid injection hole 72 is provided on the side wall of one end of the pulling wire 7 located at the ablation component 3, and the liquid flows out from the liquid injection hole 72. The liquid can be physiological saline.

[0059] In some embodiments, the pulling wire 7 is made of a polymer material or a metal material.

[0060] The solutions of the present application have been described in detail above with reference to the accompanying drawings. In the above embodiments, the descriptions of the respective embodiments have their own emphases. For parts not described in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments. Those skilled in the art should also be aware that the actions and modules involved in the specification are not necessarily essential to the present application. Additionally, it can be understood that the steps in the method embodiments of the present application can be adjusted, combined, and deleted according to actual needs, and the modules in the device embodiments of the present application can be combined, divided, and deleted according to actual needs.

[0061] The various embodiments of the present application have been described above. The above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and variations are obvious to those of ordinary skill in the art in the technical field without departing from the scope and spirit of the described embodiments. The choice of terms used herein is intended to best explain the principles of the embodiments, their practical applications, or improvements to technologies in the market, or to enable other ordinary skilled persons in the technical field to understand the embodiments disclosed herein.

Claims

1. A pulsed electric field ablation catheter, characterized in that, Comprising: A tube body, a handle, an ablation component, and a connector; One end of the tube body is connected to the handle; The ablation component includes a connection seat and a plurality of support rods. The connection seat is connected to the end of the tube body away from the handle. The support rods extend from the connection seat in a direction away from the tube body. The support rods include a first connection portion, a support portion, and a second connection portion connected in sequence. The first connection portion is connected to the connection seat. One ends of the second connection portions away from the support portion are connected to each other. The support portions are arranged parallel to each other. A plurality of electrode rings are sleeved on the support portions at intervals; The connector is arranged on the side of the handle away from the tube body, and the connector is electrically connected to each of the electrode rings respectively.

2. The pulsed electric field ablation catheter according to claim 1, wherein: The axes of the support rods are located in the same plane.

3. The pulsed electric field ablation catheter according to claim 1, wherein: The ablation component is made of a polymer material; or The ablation component includes a matrix made of a nitinol alloy material and a polymer material layer coated on the matrix.

4. The pulsed electric field ablation catheter according to claim 1, wherein: The electrode rings are made of platinum-iridium alloy or gold.

5. The pulsed electric field ablation catheter according to claim 1, wherein: The electrode rings on two adjacent support rods are arranged in one-to-one correspondence.

6. The pulsed electric field ablation catheter according to claim 1, wherein: A first bending adjustment member for adjusting the bending degree of the tube body is provided on the handle. A pull wire is arranged in the tube body. One end of the first bending adjustment member is connected to the pull wire, and the other end of the pull wire is connected to the end of the tube body close to the ablation component. The first bending adjustment member can pull the pull wire to move relative to the tube body.

7. The pulsed electric field ablation catheter according to claim 6, wherein: The first bending adjustment member is slidably connected to the handle. One end of the tube body close to the ablation component has an adjustable bending section. The first bending adjustment member sliding relative to the handle can adjust the bending degree of the adjustable bending section through the pull wire.

8. The pulsed electric field ablation catheter according to claim 1, wherein: A second bending adjustment member for adjusting the bending degree of the support rod is provided on the handle. A pulling wire is arranged in the tube body. One end of the pulling wire is connected to the second bending adjustment member, and the other end of the pulling wire is connected to the end of the support rod away from the connection seat. The second bending adjustment member can pull the pulling wire to move relative to the tube body.

9. The pulsed electric field ablation catheter according to claim 8, wherein: The second bending adjustment member is slidably connected to the handle. The second bending adjustment member sliding relative to the handle can adjust the bending degree of the support rod through the pulling wire.

10. The pulsed electric field ablation catheter according to claim 8, wherein: A flow channel cavity for conveying fluid is provided in the pulling wire.

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