Multipolar catheter for pulse field ablation

Abstract

Disclosed is a multipolar catheter for pulse field ablation. The multipolar catheter for pulse field ablation according to various embodiments solves the problems of existing balloon catheters by using a shape memory alloy material, can be easily adjusted in size in accordance with the various sizes of pulmonary vein entrances, and can maximize the effect of a treatment by effectively coming into contact with target tissue.

Description

Multipolar catheter for pulsed field ablation

[0001] The present invention relates to a multipolar catheter for pulsed field ablation, and more particularly, to a multipolar catheter for pulsed field ablation that uses an umbrella-shaped shape memory alloy material to solve the problems of existing balloon catheters, is easy to adjust in size to correspond to pulmonary vein entrances of various sizes, and can effectively contact target tissue to maximize the treatment effect.

[0002] Catheter ablation treatment is a treatment that uses a catheter inserted into the body to ablate target areas within the body.

[0003] For example, diseases such as atrial fibrillation, endometriosis, and cancer are being treated by destroying the target area through ablation.

[0004] As a conventional technology regarding catheters used in such catheter ablation treatment, JP3611799B2 and JP4747141B2 disclose technology regarding balloon catheters.

[0005] In a conventional balloon catheter, when the balloon catheter is inserted into the body, the balloon is deflated and extended along its length. Thereafter, liquid is supplied to the balloon catheter inserted into the body, causing the balloon to expand. The liquid within the balloon is temperature-regulated, thereby controlling the surface temperature of the balloon. By controlling the surface temperature of the balloon, a target area, for example, the atrial junction of a vein, can be ablated at once by contacting it. However, the surface temperature of the balloon is controlled by heating the liquid using a heating device placed within the balloon. This conventional method has the disadvantage of being difficult to sufficiently increase the surface temperature of the balloon, and the problem of requiring a larger catheter size because the operation of adding and removing liquid within the balloon must be repeated.

[0006] Therefore, there is a need to develop a catheter that shrinks along the length of the catheter when inserted into the body, but expands into a predetermined shape after insertion into the body without the injection of a separate fluid, thereby enabling more effective ablation treatment of a target area in the body.

[0007] The purpose of the present invention is to provide a multipolar catheter for pulsed field ablation that can maintain an expanded shape spread out in an umbrella shape even when the fabric portion used in a conventional balloon catheter is deleted by using a shape memory alloy material in the shape of an umbrella rib, thereby making it easy to adjust the size to correspond to pulmonary vein entrances of various sizes and effectively contacting target tissues.

[0008] The objectives of the present invention are not limited to those mentioned above. Other objectives and advantages of the present invention not mentioned above can be understood through the following description and will be more clearly understood through the embodiments of the present invention. Furthermore, it will be readily apparent that the objectives and advantages of the present invention can be realized by the means and combinations thereof set forth in the claims.

[0009] In order to achieve the above object, according to one aspect of the present invention, by using a shape memory alloy material in the shape of an umbrella rib, the fabric part used in a conventional balloon catheter can be deleted, and the expanded shape spread out in an umbrella shape can be firmly maintained without the need for external fluid injection, thereby providing a catheter that is easy to adjust in size to correspond to pulmonary vein entrances of various sizes and can effectively contact target tissues.

[0010] According to one embodiment, a multipolar catheter for pulse field ablation comprises: a tubular body; a moving body capable of moving back and forth through a central hole of the tubular body; a first frame connected to a front end of the moving body and configured to unfold in an umbrella shape toward the front when the moving body moves back and forth so as to expand its volume or, conversely, to fold and contract its volume; a second frame positioned spaced back and forth from the first frame and configured to unfold in an umbrella shape toward the rear when the moving body moves back and forth so as to expand its volume or, conversely, to fold and contract its volume; and an electrode unit connected in a joint shape between a rear end of the first frame and a front end of the second frame and including at least one electrode.

[0011] Preferably, the first frame includes a plurality of first shape memory alloy frame units arranged in the shape of an umbrella rib and made of a nitinol material, and the second frame includes a plurality of second shape memory alloy frame units arranged in the shape of an umbrella rib and made of a nitinol material.

[0012] Preferably, each of the plurality of first shape memory alloy frame units may have a different size from each of the plurality of second shape memory alloy frame units.

[0013] Additionally, each of the plurality of first shape memory alloy frame units may have a different strength from each of the second shape memory alloy frame units.

[0014] In addition, when the first frame and the second frame are each spread out in an umbrella shape and the volume is expanded to the maximum, the first diameter at the rear end of the first frame may have a different size from the second diameter at the front end of the second frame.

[0015] Additionally, the first diameter may have a smaller size than the second diameter. For example, the first diameter and the second diameter may have a ratio of 1:1.1 to 1.3. Preferably, the ratio may be 1:1.2.

[0016] Preferably, the first diameter may be 23 mm, and the second diameter may be 28 mm. In this way, the first diameter and the second diameter may be formed to have different sizes. This has the advantage of facilitating recapture.

[0017] In addition, a multipolar catheter for pulse field ablation according to one embodiment further includes a first connector that inserts and connects a front end of the moving body and simultaneously fixes a front end of the first frame to the front end of the moving body, and a second connector that penetrates a rear end of the moving body and supports a rear end of the second frame back and forth. The first connector moves back and forth in conjunction with the moving body while being fixed to the front end of the first frame when the moving body moves back and forth, and the second connector can support a rear end of the second frame to retreat while penetrating the moving body when the moving body moves back and forth.

[0018] Preferably, the first connector may be provided with at least one electrode. The electrode may be made of a platinum material.

[0019] Preferably, the electrode unit includes a thread connecting the rear end of the first frame and the front end of the second frame, a covering wrapping the thread and flexibly connecting the first frame and the second frame in a joint shape, and having the electrode disposed on at least one surface. By having such a joint-shaped connecting structure, the electrode can be brought into contact with a wider area of ​​tissue around the pulmonary vein entrance, and there is an advantage in guiding the current toward the target tissue, i.e., toward the heart tissue.

[0020] Preferably, the electrode unit includes a shape memory alloy joint frame hingedly connected in a joint shape between the rear end of the first frame and the front end of the second frame. The electrode may be arranged on at least one surface of the shape memory alloy joint frame. By having such a joint-shaped connection structure, the electrode can be brought into contact with a wider area of ​​tissue around the pulmonary vein entrance, and there is an advantage in guiding the current toward the target tissue, i.e., toward the heart tissue.

[0021] Preferably, the electrode is made of a platinum material and is formed to be in contact with a predetermined area in a set area including the target tissue and its surroundings, and can induce an externally applied current in the direction of the target tissue.

[0022] Preferably, the electrode unit may further include a sensor provided on the electrode that detects whether the electrode is in contact with a predetermined area.

[0023] A multipolar catheter for pulsed field ablation according to one embodiment may include a tubular body, an inner body inserted into the tubular body, a moving body capable of moving back and forth through a central hole of the inner body, a fixed tip fixed to a front end of the moving body, a shape memory alloy body connected to the fixed tip by penetrating between the tubular body and the inner body and expanding roundly according to the back and forth movement of the moving body or folding parallel to the tubular body, and a plurality of electrodes provided on the shape memory alloy body and having different lengths.

[0024] A multipolar catheter for pulse field ablation according to one embodiment may further include an insulating tube formed by wrapping the shape memory alloy body.

[0025] In addition, the shape memory alloy body may be formed to be externally exposed between the front end of the tubular body and the rear end of the fixed tip, and the shape memory alloy body may include a first shape memory alloy body positioned close to the tubular body, and a second shape memory alloy body positioned close to the fixed tip and integrally connected to the front end of the first shape memory alloy body.

[0026] Preferably, the plurality of electrodes can be arranged at a set distance from each other on the second shape memory alloy body.

[0027] Additionally, the plurality of electrodes may include a tubular long electrode having a first length and surrounding an outer diameter of the second shape memory alloy body, and a tubular short electrode having a second length shorter than the first length and surrounding an outer diameter of the second shape memory alloy body.

[0028] Preferably, the tubular single electrode is provided in multiple numbers, and the multiple tubular single electrodes can be arranged one at a time at a set distance from the front and rear ends of the tubular long electrode.

[0029] Preferably, the first shape memory alloy body and the second shape memory alloy body may be made of a nitinol material.

[0030] Preferably, the first shape memory alloy body and the second shape memory alloy body may have different sizes.

[0031] Preferably, the first shape memory alloy body and the second shape memory alloy body can have strengths to each other.

[0032] Preferably, the tubular long electrode and the tubular single electrode may be made of a platinum material.

[0033] Preferably, the tubular long electrode and the tubular single electrode are formed to be in contact with a predetermined area in a set area including the target tissue and its surroundings, and can induce an externally applied current toward the target tissue.

[0034] Preferably, a sensor for detecting whether the tubular long electrode and the tubular single electrode are in contact may be further included.

[0035] According to the present invention, the umbrella-shaped shape-memory alloy material can be used to firmly maintain the expanded umbrella-shaped shape while eliminating the fabric portion used in conventional balloon catheters. This facilitates size adjustment to accommodate pulmonary vein entrances of various sizes and enables effective contact with target tissues. Consequently, it offers advantages in medical surgery or procedures utilizing catheters.

[0036] In addition to the effects described above, specific effects of the present invention are described below while explaining specific details for carrying out the invention.

[0037] FIG. 1 is a schematic conceptual diagram showing the overall structure of a multipolar catheter for pulse field ablation according to the first embodiment of the present invention.

[0038] FIG. 2 is a conceptual diagram illustrating an enlarged view of the main components of a multipolar catheter for pulse field ablation according to the first embodiment of the present invention.

[0039] Figures 3a and 3b are schematic enlarged views showing the structure of the electrode unit.

[0040] FIGS. 4 to 6 are drawings showing various examples of use of a multipolar catheter for pulse field ablation according to the first embodiment of the present invention.

[0041] FIG. 7 is a schematic conceptual diagram showing the overall structure of a multipolar catheter for pulse field ablation according to the second embodiment of the present invention.

[0042] FIG. 8 is a drawing showing a first structure in which a shape memory alloy body is expanded to be rounded in a multipolar catheter for pulse field ablation according to a second embodiment of the present invention.

[0043] FIG. 9 is a drawing showing a second structure in which a shape memory alloy body has a water droplet shape in a multipolar catheter for pulse field ablation according to a second embodiment of the present invention.

[0044] FIG. 10 is a drawing showing a third structure in which the moving body is completely pulled backwards in a multipolar catheter for pulse field ablation according to a second embodiment of the present invention, that is, the shape memory alloy body has a shape in which it is folded parallel to the tubular body.

[0045] FIGS. 11 to 13 are drawings showing various shapes of a multipolar catheter for pulse field ablation according to a second embodiment of the present invention, viewed from the front.

[0046] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings so that those skilled in the art can easily implement the present invention. The present invention may be implemented in various different forms and is not limited to the embodiments described herein.

[0047] In order to clearly explain the present invention, parts that are not related to the description have been omitted, and the same or similar components are designated by the same reference numerals throughout the specification. In addition, some embodiments of the present invention will be described in detail with reference to exemplary drawings. When adding reference numerals to components in each drawing, the same components may have the same numerals as much as possible even if they are shown in different drawings. In addition, when explaining the present invention, if it is determined that a specific description of a related known configuration or function may obscure the gist of the present invention, the detailed description may be omitted.

[0048] When describing components of the present invention, terms such as first, second, A, B, (a), (b), etc. may be used. These terms are only intended to distinguish the components from other components, and the nature, order, sequence, or number of the components are not limited by the terms. When it is described that a component is "connected," "coupled," or "connected" to another component, it should be understood that the component may be directly connected or connected to the other component, but that other components may also be "interposed" between each component, or that each component may be "connected," "coupled," or "connected" through another component.

[0049] In addition, in implementing the present invention, components may be described in detail for convenience of explanation, but these components may be implemented in one device or module, or one component may be implemented by being divided into multiple devices or modules.

[0050] Hereinafter, a multipolar catheter for pulsed field ablation according to various embodiments will be described in detail with reference to the attached drawings.

[0051] [Multipolar catheter for pulsed field ablation according to the first embodiment]

[0052] In the drawings, FIG. 1 is a schematic conceptual diagram showing the overall structure of a multipolar catheter for pulse field ablation according to an embodiment of the present invention, FIG. 2 is a schematic diagram showing the main components of a multipolar catheter for pulse field ablation according to an embodiment of the present invention in an enlarged manner, and FIGS. 3a and 3b are schematic enlarged drawings showing the structure of an electrode unit. In addition, FIGS. 4 to 6 are diagrams showing various use examples of a multipolar catheter for pulse field ablation according to an embodiment of the present invention.

[0053] The multipolar catheter (100) for pulse field ablation according to the first embodiment uses a shape memory alloy material in the shape of an umbrella rib, so that unlike existing catheters, it can firmly maintain an expanded shape spread out in an umbrella shape even when the fabric part is removed, making it easy to adjust the size to correspond to pulmonary vein entrances of various sizes and can effectively contact the target tissue.

[0054] A multipolar catheter (100) for pulse field ablation according to the first embodiment includes a tubular body (110), a moving body (120), a first frame (130), and a second frame (140).

[0055] The tubular body (110) has a tubular shape with a predetermined length.

[0056] A central hole (111) may be formed in the center of the tubular body (110) along the length of the tubular body (110).

[0057] The moving body (120) is formed to be able to move forward and backward a set distance from the front of the tubular body (110) and may have an axial shape.

[0058] The moving body (120) can move forward and backward through the central hole (111) of the tubular body (110).

[0059] The first frame (130) can be connected to the front end of the moving body (120).

[0060] Preferably, the first frame (130) can be spread out in an umbrella shape toward the front when the moving body (120) moves forward and backward, or can be folded to approach the moving body (120).

[0061] If the catheter (100) is inserted, the first frame (130) is brought close to the moving body (120) and contracts in the radial direction, and the moving body (120) moves rearward.

[0062] Conversely, when the first frame (130) manufactured using a shape memory alloy is spread forward in an umbrella shape, the moving body (120) moves forward.

[0063] In this way, the moving body (120) moves forward and backward according to the volume expansion and contraction of the first frame (130).

[0064] The second frame (140) can be connected to the moving body (120) together with the first frame (130), and can be positioned at a predetermined interval in the longitudinal direction of the moving body (120) at the rear of the first frame (130).

[0065] Preferably, the second frame (140) can be spread out in an umbrella shape toward the rear when the moving body (120) moves forward and backward, or can be folded to approach the moving body (120).

[0066] When the catheter (100) is inserted, the second frame (140) is brought close to the moving body (120) and contracts in the radial direction, and the moving body (120) moves rearward.

[0067] Conversely, when the second frame (140) manufactured using a shape memory alloy is unfolded in an umbrella shape toward the rear, the moving body (120) moves forward. In this way, the moving body (120) moves forward and backward according to the volume expansion and contraction of the second frame (140).

[0068] When the first and second frames (130, 140) are simultaneously opened in an umbrella shape, a structure can be inflated into a shape similar to a balloon (see Fig. 4).

[0069] Additionally, the first and second frames (130, 140) may have a structure in which they are simultaneously contracted and brought close to the moving body (120) (see FIG. 6).

[0070] In this way, the first and second frames (130, 140) can be manufactured using a shape memory alloy, so that they can have an expanded structure that is spread out in an umbrella shape as needed, or conversely, a contracted structure that is folded toward the moving body (120).

[0071] In addition, each of the first and second frames (130, 140) has the advantage of being able to adjust the expanded size that unfolds into an umbrella shape (see Figs. 4, 5, and 6).

[0072] The electrode unit (150) connects the rear end (132) of the first frame (130) and the front end (141) of the second frame (140) in a joint shape, and the electrode unit (150) includes at least one electrode (153) (see FIGS. 1 to 3).

[0073] The first frame (130) is arranged in the shape of an umbrella rib and includes a plurality of first shape memory alloy frame units (135) made of nitinol material.

[0074] The second frame (140) is arranged in the shape of an umbrella rib and includes a plurality of second shape memory alloy frame units (145) made of nitinol material.

[0075] Preferably, each first shape memory alloy frame unit (135) may have a different size from each second shape memory alloy frame unit (145).

[0076] Additionally, each first shape memory alloy frame unit (135) may have a different strength from each second shape memory alloy frame unit (145).

[0077] In addition, when the first frame (130) and the second frame (140) are each spread out in an umbrella shape and the volume is expanded, the first diameter (D1) at the rear end (132) of the first frame (130) may have a different size from the second diameter (D2) at the front end (141) of the second frame (140) (see FIG. 2).

[0078] Referring to FIG. 2, the first diameter (D1) at the rear end (132) of the first frame (130) may have a smaller size than the second diameter (D2) at the front end (141) of the second frame (140).

[0079] Preferably, the first diameter (D1) and the second diameter (D2) may have a ratio of 1: 1.1 to 1.3. More preferably, the first diameter (D1) and the second diameter (D2) may have a ratio of 1: 1.2. For example, when the first diameter (D1) is 23 mm, the second diameter (D2) may be 28 mm. In this way, according to a preferred embodiment, the size of the first diameter (D1) and the size of the second diameter (D2) may be formed differently, and thus, there is an advantageous technical effect that recapture may be facilitated.

[0080] Additionally, the multipolar catheter (100) for pulse field ablation further includes a first connector (160) and a second connector (170).

[0081] The first connector (160) can be inserted and connected to the front end of the moving body (120), and at the same time, the front end (131) of the first frame (130) can be positioned and fixed to the front end of the moving body (120).

[0082] The second connector (170) penetrates the rear end of the moving body (120) and can support the rear end (142) of the second frame (140) forward and backward.

[0083] Additionally, a wire (210) may be further provided along the length of the multipolar catheter (100) for pulse field ablation.

[0084] The first connector (160) is fixed to the front end (131) of the first frame (130) when the moving body (120) moves forward and backward, and can move forward and backward in response to the forward and backward movement distance of the moving body (120) by linking with the moving body (120).

[0085] The second connector (170) can penetrate the moving body (120) when the moving body (120) moves forward and backward, thereby moving the rear end of the moving body (120) forward and backward through the central hole (111) of the tubular body (110). In addition, the second connector (170) can support the rear end (142) of the second frame (140) from moving backward.

[0086] Additionally, a multipolar electrode guide wire (220) may be further provided at the front end of the multipolar catheter (100) for pulse field ablation.

[0087] Figures 3a and 3b are schematic enlarged views showing the structure of the electrode unit.

[0088] According to the first embodiment, the electrode unit (150) can connect the first and second frames (130, 140) with a thread or covering to place the electrode (153), or the electrode unit (150) can connect the first and second frames (130, 140) and place the electrode (153) using a shape memory alloy joint frame (155) using nitinol material.

[0089] Referring to FIG. 3A, the electrode unit (150) includes a thread (152) and a covering (151). The thread (152) can be connected between the rear end (132) of the first frame (130) and the front end (141) of the second frame (140) at a predetermined length. Here, the thread (152) is not necessarily limited to a specific fiber material and can have various materials. In addition, the covering (151) can flexibly connect the first frame (130) and the second frame (140) in a joint shape by wrapping the thread (152). In addition, an electrode (153) can be arranged on at least one surface of the covering (151).

[0090] Referring to FIG. 3b, the electrode unit (150) may include a shape memory alloy joint frame (155) using a nitinol material. The shape memory alloy joint frame (155) may be connected in a joint form by being hinged between the first and second frames (130, 140). In addition, an electrode (153) may be arranged on at least one surface of the shape memory alloy joint frame (144).

[0091] Preferably, the electrode unit (150) may have a flexible joint-shaped connection structure between the first frame (130) and the second frame (140) as described above. Accordingly, the electrode (153) can be brought into contact with a wider area of ​​tissue surrounding the pulmonary vein entrance, and has a technically advantageous effect of directing the current toward the target tissue, i.e., toward the heart tissue.

[0092] An electrode (161) may be further provided on at least one side of the first connector (160). The shape and arrangement structure of the electrode (161) may be appropriately changed and is not limited to a specific shape and structure.

[0093] The electrode (153) may be made of a platinum material. The electrode (153) made of a platinum material is formed to be in contact with a predetermined area in a set area including the target tissue and its surroundings, and can induce an externally applied current in the direction of the target tissue.

[0094] Preferably, the electrode unit (150) may further include a sensor (not shown) provided on the electrode (153). The sensor can detect whether the electrode (153) is in contact with a predetermined area. Here, the mounting position and shape of the sensor, as well as the arrangement structure, can be appropriately changed depending on the size, shape, and structure of the electrode (153), and are not limited to a specific shape and structure.

[0095] Referring to Fig. 4, the first and second frames (130, 140) using shape memory alloy are shown in a structure that expands radially while unfolding into an umbrella shape. It can be confirmed that the structure expands into a shape similar to a balloon. At this time, the electrode (153) located in the electrode unit (150) can be positioned so as to be in contact with the target tissue. In addition, in this case, the moving body (120) is moved backwards by a predetermined distance.

[0096] Referring to Fig. 5, compared to the first and second frames (130, 140) illustrated in Fig. 4, the structure is unfolded in an umbrella shape but is less expanded in the radial direction. In this way, the expanded size of the first and second frames (130, 140) can be appropriately adjusted, and the size can be easily adjusted to correspond to pulmonary vein entrances of various sizes, thereby effectively contacting the target tissue.

[0097] Referring to Fig. 6, the first and second frames (130, 140) are shown in a contracted structure that is close to the moving body (120). In this case, the moving body (120) has moved forward a predetermined distance.

[0098] PFA (Pulse Field Ablation) is a method that can selectively kill only the target treatment target, for example, cardiac muscle cells, without damaging the surrounding tissues of the treatment target. However, since the size of the pulmonary vein varies from person to person, it is desirable to be able to adjust the expansion size of the first and second frames (130, 140). In the present invention, a shape memory alloy, preferably nitinol, is used for the first and second frames (130, 140). By using nitinol, there is an advantage in that it can be contracted to a sufficient size when approaching or inserting into a blood vessel, and can be expanded to an appropriate size when necessary.

[0099] In addition, by connecting the electrode unit (150) in a joint shape between the first and second frames (130, 140) that are expanded to have different diameters (D1, D2), there is an advantage in that it is advantageous for contacting the tissue to be treated over a large area, and the necessary amount of electric energy can be applied.

[0100] In addition, since the electrode unit (150) has a joint shape, there is an advantage in that the electrode (153) can come into greater contact with the pulmonary vein and the tissues surrounding the pulmonary vein entrance.

[0101] In addition, in order for the electrode (153) to adhere to the pulmonary vein, it is good to have a form that pushes out by applying a certain force. Considering the rigid structure for this force, the first and second frames (130, 140) have a structure that unfolds in an umbrella shape, and in addition, they can be formed to have different sizes and / or different strengths.

[0102] For example, it is preferable that the number of each of the first and second shape memory alloy frame units (135, 146) forming each of the first and second frames (130, 140) be six, but it is not necessarily limited to this number. Accordingly, the number can be changed to various numbers, such as eight or ten, as needed.

[0103] [Multipolar catheter for pulsed field ablation according to the second embodiment]

[0104] In the drawings, FIG. 7 is a schematic conceptual diagram showing the entire structure of a multipolar catheter for pulse field ablation according to the second embodiment of the present invention, FIG. 8 is a diagram showing a first structure in which a shape memory alloy body is expanded to be round in a multipolar catheter for pulse field ablation according to the second embodiment of the present invention, FIG. 9 is a diagram showing a second structure in which a shape memory alloy body has a water droplet shape in a multipolar catheter for pulse field ablation according to the second embodiment of the present invention, FIG. 10 is a diagram showing a third structure in which a moving body is completely pulled backward in a multipolar catheter for pulse field ablation according to the second embodiment of the present invention, that is, a shape memory alloy body is folded parallel to a tubular body, and FIGS. 11 to 13 are diagrams showing various shape structures of a multipolar catheter for pulse field ablation according to the second embodiment of the present invention as viewed from the front.

[0105] Referring to FIGS. 7 to 13, a multipolar catheter (300) for pulse field ablation according to the second embodiment includes a tubular body (310), an inner body (320), a moving body (330), a fixed tip (340), a shape memory alloy body (350), and a plurality of electrodes, i.e., a tubular long electrode (370) and a tubular single electrode (380).

[0106] The tubular body (310) is a member having a tubular shape with a predetermined length.

[0107] The inner body (320) is inserted into the inside of the tubular body (310) and is a hollow member, i.e., a central hole is formed.

[0108] The moving body (330) is inserted through the center hole of the inner body (320) and can move back and forth by pulling or releasing.

[0109] The fixed tip (340) is a round cap-shaped member fixed to the front end of the moving body (330).

[0110] The shape memory alloy body (350) can be fixed by being connected to the fixed tip (340) through a shear connection between the tubular body (310) and the inner body (320).

[0111] The shape memory alloy body (350) can be expanded to be rounded according to the forward and backward movement of the moving body (330) by pulling or releasing the moving body (330), or conversely, can be folded parallel to the tubular body (310).

[0112] For example, referring to FIG. 8, when the moving body (330) is not pulled backward, the shape memory alloy body (350) can be expanded to have a round shape as shown.

[0113] For example, referring to FIG. 9, if the moving body (330) is slightly pulled backward, the shape memory alloy body (350) can be deformed to have an overall water drop shape.

[0114] For example, referring to FIG. 10, when the moving body (330) is fully pulled backward, the shaped alloy body (350) can maintain a shape that is folded parallel to the tubular body (310). Accordingly, the movement of the multipolar catheter (300) can be made smooth.

[0115] Electrodes (370, 380) may be provided on the shape memory alloy body (350). Preferably, the electrodes (370, 380) may include a plurality of electrodes (370, 380) having different lengths.

[0116] Meanwhile, the multipolar catheter (300) for pulse field ablation according to the second embodiment may further include an insulating tube (360).

[0117] Referring to FIG. 8, an insulating tube (360) can be formed by wrapping the shape memory alloy body (350).

[0118] Preferably, the shape memory alloy body (350) can be formed so as to be externally exposed (i.e., exposed to the outside while being wrapped in an insulating coating (360)) between the front end of the tubular body (310) and the rear end of the fixed tip (340).

[0119] As a specific example, the shape memory alloy body (350) may include a first shape memory alloy body (351) positioned close to the tubular body (310) and a second shape memory alloy body (352) positioned close to the fixed tip (340). The second shape memory alloy body (352) may be integrally connected to the front end of the first shape memory alloy body (351).

[0120] Preferably, a plurality of electrodes (370, 380) can be arranged at a set distance from each other on the second shape memory alloy body (352).

[0121] As a specific example, the plurality of electrodes (370, 380) may include a tubular long electrode (370) and a tubular single electrode (380).

[0122] The tubular electrode (370) has a first length and can be arranged to surround the outer diameter of the second shape memory alloy body (352).

[0123] The tubular single electrode (380) has a second length shorter than the first length and can be arranged to surround the outer diameter of the second shape memory alloy body (352).

[0124] Preferably, a plurality of the above tubular single electrodes (380) may be provided.

[0125] A plurality of tubular single electrodes (380) surround the outer diameter of the second shape memory alloy body (352), and can be arranged one by one at the front and rear ends of the tubular long electrode (370) with a set distance between them.

[0126] Additionally, the first shape memory alloy body (351) and the second shape memory alloy body (352) may be made of nitinol material.

[0127] Additionally, the first shape memory alloy body (351) and the second shape memory alloy body (352) may have different sizes and may have strengths.

[0128] And the tubular long electrode (370) and the tubular single electrode (380) can be made of platinum. The tubular long electrode (370) and the tubular single electrode (380) are formed to be in contact with a predetermined area in a set area including the target tissue and its surroundings, and can induce an externally applied current in the direction of the target tissue.

[0129] In addition, a sensor (not shown) that detects whether the tubular long electrode (370) and the tubular short electrode (380) are in contact may be further included.

[0130] As described above, according to the configuration and operation of the present invention, the umbrella-shaped shape-memory alloy material can be used to firmly maintain the expanded umbrella-shaped shape even without the fabric portion used in existing balloon catheters, thereby facilitating size adjustment to accommodate pulmonary vein entrances of various sizes and enabling effective contact with target tissues. Accordingly, it has advantageous technical effects that are more effective in medical surgeries or procedures using catheters.

[0131] Although the present invention has been described with reference to the drawings exemplified above, it is to be understood that the present invention is not limited to the embodiments and drawings disclosed herein, and that various modifications may be made by those skilled in the art within the scope of the technical idea of ​​the present invention. Furthermore, even if the operational effects according to the configuration of the present invention were not explicitly described while describing the embodiments of the present invention, it is natural that the effects predictable by the corresponding configuration should also be acknowledged.

Claims

1. Tubular body; A moving body capable of moving back and forth through the center hole of the above tubular body; A first frame connected to the front end of the moving body and unfolded into an umbrella shape so that the volume expands when the moving body moves back and forth, or conversely, folded so that the volume contracts; A second frame positioned at a forward and backward distance from the first frame, and which unfolds in an umbrella shape toward the rear when the moving body moves forward and backward, thereby expanding its volume, or conversely, folds and contracts its volume; and An electrode unit comprising at least one electrode and connecting the first frame and the second frame in a joint shape; A multipolar catheter for pulsed field ablation including:

2. In paragraph 1, The above first frame, A plurality of first shape memory alloy frame units arranged in the shape of an umbrella rib and made of nitinol material; The second frame above, A plurality of second shape memory alloy frame units arranged in the shape of an umbrella rib and made of nitinol material; Each of the plurality of first shape memory alloy frame units, Each of the plurality of second shape memory alloy frame units above has a different size and a different strength. Multipolar catheter for pulsed field ablation.

3. In paragraph 1, A first connector that inserts and connects the front end of the moving body and simultaneously fixes the front end of the first frame to the front end of the moving body; and A second connector that penetrates the rear end of the above moving body and supports the rear end of the second frame forward and backward; A multipolar catheter for pulsed field ablation including:

4. In paragraph 1, The above electrode is made of platinum material and is formed to be in contact with a predetermined area in a set area including the target tissue and its surroundings, and induces an externally applied current toward the target tissue. Multipolar catheter for pulsed field ablation.

5. In paragraph 1, The above electrode unit, A sensor provided on the above electrode and detecting whether the electrode is in contact with a predetermined area; A multipolar catheter for pulsed field ablation including:

6. Tubular body; An inner body inserted into the interior of the above tubular body; A moving body capable of moving back and forth through the center hole of the inner body; A fixed tip fixed to the front end of the above moving body; A shape memory alloy body that is connected to the fixed tip by penetrating between the tubular body and the inner body and is expanded to be rounded according to the forward and backward movement of the moving body or folded parallel to the tubular body; and A plurality of electrodes having different lengths and provided on the shape memory alloy body; A multipolar catheter for pulsed field ablation including:

7. In paragraph 6, An insulating tube formed by wrapping the above shape memory alloy body; A multipolar catheter for pulsed field ablation including:

8. In paragraph 6, The above shape memory alloy body is formed so as to be externally exposed between the front end of the tubular body and the rear end of the fixed tip, The above shape memory alloy body, a first shape memory alloy body positioned close to the tubular body; and A second shape memory alloy body positioned close to the above fixed tip and integrally connected to the front end of the first shape memory alloy body; A multipolar catheter for pulsed field ablation including:

9. In paragraph 8, The above plurality of electrodes are, In the above second shape memory alloy body, they are arranged at a set distance from each other. Multipolar catheter for pulsed field ablation.

10. In paragraph 9, The above plurality of electrodes are, A tubular electrode surrounding the outer diameter of the second shape memory alloy body; and A tubular single electrode having a length shorter than the length of the tubular long electrode and surrounding the outer diameter of the second shape memory alloy body; A multipolar catheter for pulsed field ablation including:

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