A deformable closed loop catheter

Abstract

The present application relates to the field of medical electrophysiological mapping and ablation catheter, and particularly relates to a deformable closed ring catheter, which comprises a head end structure, a core tube segment and a sheath tube segment, the head end structure comprises a joint part and a plurality of support arms, the support arm comprises a support member wire and an isolation layer, adjacent support arms form a combined arm on one side close to the joint part, and the middle part of the support arm is provided with a deformation segment. Through relative movement of the core tube segment and the sheath tube segment, the outer diameter of the head end structure is controlled, head end structures of different sizes are formed, so as to adapt to the catheter use in different use states and different tissue positions. Meanwhile, through mutual pulling of the plurality of support member wires and further setting of the deformation segment, the head end structure can maintain a stable structure shape in any state, the stability of electrode spacing and electrode adhesion provided on the head end structure can be ensured, a closed ring ablation ring can be quickly and stably formed, and the closed ring ablation ring can be adapted to use in different sizes and positions, so that the ablation efficiency and ablation effect are improved.

Description

Technical Field

[0001] This invention relates to the field of medical electrophysiological mapping and ablation catheters, and particularly to a deformable closed annular catheter. Background Technology

[0002] Currently, occlusive ablation and isolation within the pulmonary vein vestibule and pulmonary vein is an effective procedure in the treatment of atrial fibrillation. Ablation catheters are the primary instruments for this procedure, and common ablation catheters are mainly divided into two categories: basket-shaped and ring-shaped, each with independent electrode arms. Basket-shaped catheters with independent electrode arms, because each arm is independent, exhibit varying degrees of deformation during expansion or contraction, resulting in uneven electrode spacing between arms. This makes it difficult to quickly form an occlusive ring ablation loop, requiring multiple ablation cycles, increasing the risk of complications such as hemolysis, reducing surgical efficiency, and increasing the psychological burden on both the operator and the patient. Ring-shaped catheters, because they are not closed loops or rings connected end-to-end, have significant gaps. During use, uncontrollable deformation due to stress can affect the electrode spacing at these gaps. Furthermore, the electrodes at different potentials on the ring have different supporting arms, resulting in varying contact forces between the electrodes on the ring or ring, making it impossible to quickly form an occlusive ring ablation loop.

[0003] Furthermore, in current pulmonary vein isolation surgery, to achieve better isolation results, it is often necessary to perform isolation ablation at the pulmonary vein vestibule and within the pulmonary vein. The aim is to form two closed ablation zones at the pulmonary vein vestibule and within the pulmonary vein to achieve better isolation. However, due to the significant differences in tissue morphology and size between the pulmonary vein vestibule and the pulmonary vein, the mainstream catheters currently on the market generally cannot quickly adapt to the tissue morphology of the two different locations and form an effective annular ablation ring. Usually, multiple catheters are required to be used in combination, and X-rays are needed to confirm the relevant locations, affecting the efficiency and effectiveness of the procedure, and impacting the health of the surgeon and the patient. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of existing catheters in the prior art, which cannot efficiently adapt to tissues of different shapes and sizes to form a closed ablation zone, and require X-rays to confirm the relevant location, thus affecting the efficiency and effect of the procedure and the health of the operator and the patient. The invention provides a deformable closed ring catheter.

[0005] This invention provides a deformable closed annular catheter, comprising a tip structure, a core tube segment, and a sheath segment. The tip structure includes a connecting portion and several supporting arms. The connecting portion is connected to the core tube segment. The sheath segment is fitted onto the core tube segment. The core tube segment is coaxial with the sheath segment and can move relative to it, allowing the tip structure to move into or out of the sheath segment.

[0006] A plurality of the support arms are evenly distributed at the end of the joint away from the core tube segment. Each support arm includes a support member wire and an isolation layer. The support member wire passes through the isolation layer. Both ends of the support member wire are connected to or integrally formed with the joint. Adjacent support arms form a merged arm on the side near the joint. Each support arm is provided with a plurality of electrodes, and at least some of the electrodes are distributed in the merged arm.

[0007] The support arm has a deformation section in the middle, and the deformation section has a different strain than the associated support member wire.

[0008] This invention discloses a deformable closed-loop ablation catheter. Through the relative movement of the core segment and the sheath segment, the tip structure can be moved into or out of the sheath segment, allowing control of the tip structure's outer diameter and forming tip structures of different sizes to adapt to different usage states and tissue locations. Simultaneously, multiple supporting wires form a combined arm that pulls against each other, and a deformable segment further releases stress during the movement of the tip structure into or out of the sheath segment. This ensures the tip structure maintains a stable structural shape in any state during the movement, guaranteeing the stability of the electrode spacing and electrode contact on the tip structure. This leads to the rapid and stable formation of a closed-loop ablation ring, adaptable to different sizes and locations, improving ablation efficiency and effect.

[0009] Preferably, the deformable segment gradually changes in cross-section symmetrically from both ends to the middle, with a cross-sectional dimension of 0.05mm ≤ 3mm in the middle of the deformable segment. The deformable segment is integrally formed or connected to the support member wire. This allows the support arm to produce a deformation in the middle of the deformable segment that differs from that at the ends of the support member wire under tension or thrust, thereby ensuring appropriate stress release of the head end structure during the movement into or out of the sheath segment, allowing the head end structure to contract or expand smoothly. At the same time, it also allows the support member to generate appropriate supporting force, keeping the head end in the desired shape.

[0010] Preferably, the deformable section includes a spring coil section, which is connected to or integrally wound from the support member wire. This ensures a tighter connection between the spring coil section and the support member wire, guaranteeing stress release and allowing the head end structure to contract or expand smoothly, while also ensuring that the support member wire has sufficient strength and reliability at the deformable section location.

[0011] Preferably, one end of the support member wire is integrally formed or connected to the connecting part, and the other end of the support member wire is provided with a limiting member;

[0012] The joint is provided with a limiting groove, and the limiting member is nested and connected to the limiting groove;

[0013] The joint is provided with a limiting ring, which is fitted outside the limiting groove and covers at least both ends of the limiting member in the axial direction.

[0014] This ensures that the support member wire is stably fixed at the joint position, preventing the support member wire from detaching from the joint during use. Furthermore, the setting of the limiting groove prevents the setting of the support member wire at the joint from affecting the external dimensions of the joint.

[0015] Preferably, the joint is a cylindrical structural component with several through channels inside. These through channels are used for injection channels or for threading wires. The limiting groove is disposed in the joint and penetrates the outer wall of the joint. This provides a joint that meets functional requirements, enabling the smooth installation of wires and pipes related to the head end structure.

[0016] Preferably, the joint is a ring-shaped structure with an insert inside. The insert has several through channels for use as injection channels or for threading wires. The limiting groove is disposed in the joint and penetrates both the inner and outer walls of the joint. Joints with different structures are provided, and the insert inside the joint prevents the limiting member from detaching from the inner ring of the joint.

[0017] Preferably, when the head end structure is completely removed from the sheath section, the support arm has a first arc segment, a first straight segment, an outer circumferential ring segment, a second straight segment, and a second arc segment arranged sequentially. The first arc segment and the second arc segment are respectively deflected in a direction away from the center of the joint. A plurality of the outer circumferential ring segments are located in the same plane, and the deformable segment is disposed in the middle of the outer circumferential ring segment.

[0018] The first straight segment and the second straight segment of adjacent support member wires, and / or the first arc segment and the second arc segment form the combined arm, which is formed by integral molding of adjacent support member wires, tubing wrapping, glue bonding or welding.

[0019] By employing a multi-segment support arm, the head end structure becomes trumpet-shaped after being removed from the sheath segment, which allows the electrodes on the outer circumferential segment to be positioned on a complete circle, thereby forming a closed annular ablation ring.

[0020] Preferably, the tip structure includes at least three support member wires, each with a cross-sectional dimension not exceeding 1 mm; each support member wire is provided with an electrode, the electrode length being 0.5-5 mm, and the spacing between adjacent electrodes being 1-6 mm. The dimensions and spacing between adjacent electrodes can be adjusted according to actual conditions to form a tip structure that meets different ablation requirements.

[0021] Preferably, the connecting portion and the supporting arm are each provided with a positioning element, which is any one of a 5D magnetic positioning sensor, a 6D magnetic positioning sensor, and an RFID tag. The positioning element is connected to a three-dimensional positioning system. This allows for the visualization and display of the catheter through the three-dimensional positioning system, avoiding the use of X-rays and improving the safety of catheter use.

[0022] Preferably, the sheath segment is connected to a handle, the handle is provided with a bending mechanism and a sliding mechanism, the bending mechanism is connected to the end of the sheath segment near the head end structure through a traction mechanism, and the sliding mechanism is connected to the core tube segment;

[0023] The handle contains a connector for connecting wires. This connector can interact with an information processing device that can establish a tissue adhesion strength model and display the ablation index. This allows the catheter to be bent and its tip structure adjusted as needed, enabling it to smoothly reach complex target locations without the aid of other instruments, achieving stable adhesion to different tissue locations, and improving the flexibility of catheter use.

[0024] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0025] 1. This invention provides a deformable closed annular catheter. By moving the core tube segment and the sheath tube segment relative to each other, the tip structure can be moved into or out of the sheath tube segment, thereby controlling the outer diameter of the tip structure and forming tip structures of different sizes to adapt to the use of catheters in different usage states and different tissue locations.

[0026] 2. This invention provides a deformable closed annular catheter, which uses multiple supporting wires to form a combined arm that pulls each other together. Furthermore, a deformable section is provided to release stress during the process of moving the head structure into or out of the sheath segment. This allows the head structure to maintain a stable structural shape in any state during the process of moving into or out of the sheath segment, and ensures the stability of the electrode spacing and electrode contact on the head structure. This results in the rapid and stable formation of a closed annular ablation ring, which can be adapted to use in different sizes and positions, improving ablation efficiency and ablation effect. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the overall structure of a deformable closed annular catheter;

[0028] Figure 2 A schematic cross-sectional view of a deformable closed-loop catheter at the sheath section, as shown in the embodiment;

[0029] Figure 3 This is a schematic diagram of the head end structure described in the embodiment;

[0030] Figure 4This is a schematic diagram of the head-end structure forming a combined arm as described in the embodiment. Figure 1 ;

[0031] Figure 5 This is a schematic diagram of the head-end structure forming a combined arm as described in the embodiment. Figure 2 ;

[0032] Figure 6 This is a schematic diagram of the structure when the head end structure described in the embodiment is provided with a deformable section of the spring coil segment;

[0033] Figure 7 This is a schematic diagram of the positioning element provided in the head end structure of the embodiment;

[0034] Figure 8 This is a schematic diagram of the connection between the support member wire and the joint in the embodiment;

[0035] Figure 9 for Figure 8 A magnified structural diagram of part A in the middle;

[0036] Figure 10 This is a schematic cross-section of the joint described in the embodiment. Figure 1 ;

[0037] Figure 11 This is a schematic cross-section of the joint described in the embodiment. Figure 2 ;

[0038] Figure 12 The following is an example of the usage state of a deformable closed annular catheter. Figure 1 ;

[0039] Figure 13 The following is an example of the usage state of a deformable closed annular catheter. Figure 2 ;

[0040] Figure 14 The following is an example of the usage state of a deformable closed annular catheter. Figure 3 .

[0041] Marked in the image:

[0042] 1-Head end structure, 2-Core tube segment, 3-Sheath segment, 4-Joint, 41-Limiting groove, 5-Support arm, 51-Support component wire, 511-Limiting component, 52-Deformation segment, 521-Spring coil segment, 53-Merging arm, 54-First arc segment, 55-First straight segment, 56-Outer circumferential ring segment, 57-Second straight segment, 58-Second arc segment, 6-Electrode, 61-Wire, 7-Limiting ring component, 8-Insert, 81-Through channel, 82-Injection channel, 9-Positioning component, 10-Handle, 101-Bending mechanism, 102-Sliding mechanism, 103-Traction mechanism, 104-Luer connector. Detailed Implementation

[0043] The present invention will now be described in further detail with reference to specific embodiments. However, this should not be construed as limiting the scope of the present invention to the following embodiments; all technologies implemented based on the content of the present invention fall within the scope of the present invention.

[0044] Unless otherwise specified, the use of terms such as "upper," "lower," "left," "right," "center," "inner," and "outer" to indicate orientation or positional relationships in the description of specific embodiments of the present invention is based on the orientation or positional relationships shown in the accompanying drawings, or the orientation or positional relationship in which the product / equipment / device is typically placed during use. These terms are merely for the purpose of facilitating the description of the present invention or simplifying the description in specific embodiments, enabling those skilled in the art to quickly understand the solution, and do not indicate or imply that a particular device / component / element must have a specific orientation, or be constructed and operated in a specific positional relationship. Therefore, they should not be construed as limitations on the present invention.

[0045] Furthermore, the use of terms such as "horizontal," "vertical," "suspended," and "parallel" does not imply that the corresponding device / component / element must be absolutely horizontal, vertical, suspended, or parallel, but rather that it can be slightly tilted or have a deviation. For example, "horizontal" merely means that its direction is more horizontal relative to "vertical," not that the structure must be completely horizontal, but that it can be slightly tilted. Alternatively, it can be simplified to mean that the corresponding device / component / element, when set in a "horizontal," "vertical," "suspended," or "parallel" direction, can have an error / deviation of ±10% relative to the corresponding direction, more preferably within ±8%, more preferably within ±6%, more preferably within ±5%, and more preferably within ±4%. As long as the corresponding device / component / element is within the error / deviation range, it can still achieve its function in the present invention.

[0046] Furthermore, the use of terms such as "first," "second," and "third" in terminology is merely for distinguishing descriptions of identical or similar components and should not be interpreted as emphasizing or implying the relative importance of a particular component.

[0047] Furthermore, in the description of the embodiments of the present invention, "several", "more than", and "a number of" represent at least two. The number can be any number, such as 2, 3, 4, 5, 6, 7, 8, or 9, and can even exceed nine.

[0048] Furthermore, in the description of the technical solution of this invention, unless otherwise explicitly specified / limited / restricted, the terms "set up," "install," "connect," "link," "provided with," "laid out," and "arranged" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to common connection methods in the art, such as welding, riveting, bolting, and threaded connections. Such connections can be mechanical, electrical, or communication connections; they can be direct connections or indirect connections through an intermediate medium; and they can refer to the internal communication between two components. Example

[0049] like Figures 1-3 As shown, an example of a deformable closed annular catheter includes a head structure 1, a core tube segment 2, a sheath segment 3, and a handle 10. The handle 10 is equipped with a bending mechanism 101 and a sliding mechanism 102. The bending mechanism 101 is connected to the end of the sheath segment 3 near the head structure 1 via a traction mechanism 103. The sliding mechanism 102 is connected to the core tube segment 2, forming an integrated catheter structure with bending function. Specifically, the head structure 1 includes a connecting part 4 and at least three support arms 5. The connecting part 4 is connected to the core tube segment 2, and the sheath segment 3 is fitted onto the core tube segment 2. Several support arms 5 are evenly distributed at the end of the connecting part 4 away from the core tube segment 2. The support arms 5 cover... The structure includes a support member wire 51 and an isolation layer. The support member wire 51 passes through the isolation layer. Both ends of the support member wire 51 are connected to the joint 4 or integrally formed. The support arm 5 is provided with several electrodes 6. The electrodes 6 are fitted on the outside of the isolation layer. An electrical signal path is formed between the isolation layer and the support member wire 51 for the passage of the related wires 61 of the electrodes 6 through the support arm 5. The core tube section 2 can move relative to the sheath tube section 3 on the same axis, so that the head end structure 1 moves into or out of the sheath tube section 3. The support arm 5 is constrained by the end of the sheath tube section 3, so that it can enter the sheath tube section 3 in a relatively closed manner or extend out of the sheath tube section 3 in a relatively open manner, thereby controlling the maximum size of the head end structure 1.

[0050] This embodiment provides a deformable closed annular catheter. The head end structure 1 has a minimum shape with all sections of the sheath 3 retracted, a fully extended state with all sections of the sheath 3 extended, and several intermediate states. It can be bent and the shape of the head end structure 1 can be adjusted as needed. It can smoothly reach complex target positions without the aid of other instruments, achieve stable contact with different tissue locations, and improve the flexibility of catheter use.

[0051] like Figures 3-8As shown, taking the head end structure 1 composed of three support arms 5 as an example, in its fully unfolded form, each support arm 5 has a first arc segment 54, a first straight segment 55, an outer circumferential ring segment 56, a second straight segment 57, and a second arc segment 58 arranged sequentially. The first arc segment 54 and the second arc segment 58 are respectively deflected in a direction away from the axial center of the joint 4. The first arc segment 54 is connected to the first straight segment 55. The end of the first straight segment 55 away from the first arc segment 54 is bent and deflected in a clockwise or counterclockwise direction to connect to the outer circumferential ring segment 56. The other end of the outer circumferential ring segment 56 is bent in a clockwise or counterclockwise direction. The needle is bent or deflected counterclockwise towards the axial center of the joint 4 and connected to the second straight section 57. The end of the second straight section 57 away from the outer peripheral ring section 56 is connected to the second arc section 58 to form a complete support arm 5. The three support arms 5 are evenly distributed at one end of the joint 4 and adopt the same structure. Each support arm 5 forms a stable triangular structure in space, so that the head end structure 1 is sufficiently stable in space and can maintain a stable state in any intermediate state, so as to stabilize the position of the electrode 6 on the support arm 5 and ensure that the electrode 6 is in stable contact.

[0052] In an optional embodiment, the support member wire 51 can be a metal wire with multiple segments of different sizes. The cross-section of the support member wire 51 can be circular or other geometric shapes. The maximum dimension of the cross-section of the support member wire 51, such as diameter, thickness or width, does not exceed 1 mm. The isolation layer can be an insulating material layer or an isolation material layer sleeved on the support member wire 51. The electrode 6 can be a ring-shaped or partially ring-shaped structure made of platinum-iridium alloy, gold, silver, platinum or stainless steel. The electrode 6 is used for the acquisition of electrical signals and the release of energy to realize the mapping and ablation functions of the catheter on the target area, and is stably set on the arm of the electrode 6.

[0053] In an optional embodiment, the joint 4 and the supporting member wire 51 can be manufactured separately and then welded together to ensure the overall structural stability of the head end structure 1.

[0054] In an optional embodiment, the connecting part 4 and the supporting member wire 51 can also be made of the same material as the tube or rod to form an integral structure, thereby improving the integrity of the head end structure 1 and ensuring the overall structural stability of the head end structure 1 during use to the greatest extent.

[0055] In an optional embodiment, the length of the electrode 6 can be 0.5-5mm, preferably 1.5-2.5mm. The number and spacing between adjacent electrodes 6 can be determined based on the maximum outer diameter of the head structure 1 in its fully extended state. The size of each electrode 6 and the spacing between adjacent electrodes 6 can be adjusted according to the actual situation to form a head structure 1 that meets different ablation requirements.

[0056] Preferably, the number of electrodes 6 can be 6-30, and the spacing between electrodes 6 can be 1-6 mm.

[0057] like Figures 4-8 As shown, an example of a deformable closed-loop annular catheter, based on the previous example, includes a combined arm 53 consisting of adjacent support arms 5, with multiple electrodes 6 arranged in the combined arm 53 and the outer ring segment 56. This allows adjacent support arms 5 to form a T-shaped or n-shaped structure through the combined arm 53 and the outer ring segment 56. During use, these structures can pull on each other and move synchronously, ensuring sufficient structural stability of the tip structure 1 in any intermediate state. This ensures the stability of the electrode spacing and electrode contact, avoiding the inability to form a closed annular ablation ring due to unstable contact or uneven spacing. In particular, in the fully unfolded form, the three outer ring segments 56 are located on the same plane, and the electrodes 6 on the circle formed by the three outer ring segments 56 are evenly distributed and have a stable relative distance. This allows for the fastest and most stable formation of a complete annular ablation ring through the circle formed by the outer ring segments 56, achieving efficient ablation and improving surgical efficiency.

[0058] In an optional embodiment, the merging arm 53 may be formed by means of integral molding, tubing wrapping, glue bonding or welding of the support member wire 51 of the adjacent support arm 5 in the first straight section 55 and the second straight section 57 as well as the first arc section 54 and the second arc section 58.

[0059] Specifically, such as Figure 4 As shown, three integral merging arms 53 are evenly distributed at one end of the joint 4, and two relatively smaller support member wires 51 are branched off from the side of the three merging arms 53 away from the joint 4.

[0060] Specifically, such as Figure 5 , Figure 6 As shown, six supporting wires 51 are evenly distributed in pairs at one end of the joint 4. Adjacent supporting wires 51 can be combined within the first arc segment 54 and the first straight segment 55 by means of pipe wrapping, glue bonding or welding to form a combined arm 53.

[0061] In an optional embodiment, the merging arm 53 may also be formed by the support member wire 51 of the adjacent support arm 5 through integral molding, tubing wrapping, glue bonding or welding in the first straight section 55 and the second straight section 57, while the first arc section 54 and the second arc section 58 are kept in close contact through the joint 4 and the merging arm 53 to meet different production needs.

[0062] Preferably, the width or thickness of the support member wire 51 at the merging arm 53 is smaller than the corresponding size of the outer circumferential ring segment 56, and the ratio is not less than 2 times, so that the cross-sectional size of the merging arm 53 is similar to the cross-sectional size of the outer circumferential ring segment 56, thereby reducing the overall external size of the head end and ensuring that the head end structure 1 can be smoothly moved into or out of the sheath segment 3.

[0063] Preferably, the number of electrodes 6 in the outer ring segment 56 can be 18 or 24, and the spacing between the electrodes 6 can be 1.5-2.5 mm; the number of electrodes 6 in the merging arm 53 can be 6-9, and the spacing between the electrodes 6 can be 1-5 mm.

[0064] This embodiment provides a deformable closed-loop conduit, which, when in use, such as... Figure 12 As shown, the sliding mechanism 102 can fully retract the head structure 1 into the sheath segment 3. At this time, the head structure 1 is in its smallest form. Combined with the bending adjustment mechanism 101, the bending shape of the distal end of the sheath segment 3 is controlled, facilitating the delivery of the catheter to the target tissue. Figure 13 As shown, by pushing the sliding mechanism 102, a portion of the support arm 5 of the tip structure 1 can be pushed out of the sheath section 3, forming a trumpet-shaped tip structure 1. At this time, the tip structure 1 is in an intermediate state, and the electrodes 6 arranged on the support arm 5 are serrated. This allows it to form a closed ablation ring on the inner wall of cavity-like tissues, such as pulmonary veins. Furthermore, by adjusting the opening size of the formed trumpet-shaped tip structure 1, it can adapt to cavity tissues of different sizes, thus expanding the applicability of the catheter. Figure 14 As shown, by continuing to push the sliding mechanism 102, the support arm 5 is pushed out more and more of the sheath segment 3, and the opening of the funnel-shaped head structure 1 increases until the head structure 1 is fully unfolded. At this time, the electrodes 6 arranged on the support arm 5 can be evenly distributed on at least the same plane circle, which is suitable for forming a closed annular ablation ring on the surface tissue, such as the atrial wall, or the opening of the cavity tissue, such as the vestibule of the pulmonary vein.

[0065] like Figure 8 As shown, an example of a deformable closed annular conduit is provided. Based on the previous example, one end of the support member wire 51 is integrally formed with the connecting part 4, and the other end of the support member wire 51 is provided with a limiting member 511. The connecting part 4 is provided with a limiting groove 41. The limiting member 511 and the limiting groove 41 are mechanically nested together to fix the end of the support member wire 51 to the connecting part 4. This facilitates the preparation of the connecting part 4 with the support member wire 51, reduces the preparation cost, and ensures that the connection between the support member wire 51 and the connecting part 4 is stable during use.

[0066] In optional implementations, such as Figures 8-9As shown, the limiting member 511 can be an I-shaped block structure or other irregular structure with a locally enlarged size at the end of the supporting member wire 51. Its thickness is consistent with the depth of the limiting groove 41. It can be embedded in the limiting groove 41 without affecting the outer dimensions of the joint 4. Since the size of the limiting member 511 is larger than that of the supporting member wire 51, after being embedded in the limiting groove 41, it can prevent the supporting member wire 51 from moving out along the axis of the joint 4 during the use of the head end structure 1. Through the interaction between the limiting member 511 and the limiting groove 41 in the axis of the joint 4, the thrust or pull force can be smoothly transmitted during the use of the head end structure 1, ensuring the smooth deformation and stable contact and ablation of the supporting member wire 51 on the head end structure 1.

[0067] In an optional embodiment, the limiting member 511 can be further connected to the limiting groove 41 by means of adhesive, melting, welding or other methods on the basis of nested connection, to ensure the firmness of the connection between the limiting member 511 and the joint 4, and to prevent the end of the support member wire 51 from moving out along the radial direction of the joint 4 during the use of the head end structure 1.

[0068] In an optional embodiment, the limiting member 511 can also be limited by setting a limiting ring 7 on the joint 4. The limiting ring 7 is fitted outside the limiting groove 41 and covers at least both ends of the limiting member 511 in the axial direction. The limiting member 511 is stably limited on the joint 4 by at least one limiting ring 7, so that the end of the support member wire 51 is stably fixed at the joint 4, and the support member wire 51 is prevented from disengaging from the joint 4 during use. The limiting member 511 can be fixed on the joint 4 by one method or multiple methods depending on the actual situation.

[0069] In optional implementations, such as Figure 10 As shown, the joint 4 can be a cylindrical structure. The joint 4 has several through channels 81, which are used to create injection channels 82 or to pass through wires 61. A limiting groove 41 is provided in the joint 4 and penetrates its outer wall. The joint 4 provides functional connections, enabling the smooth installation of the relevant wires 61 and pipes in the head structure 1.

[0070] In optional implementations, such as Figure 11 As shown, the joint 4 can also be a ring-shaped structure, and the limiting groove 41 has penetrated the inner wall and outer wall of the joint 4 in the thickness direction. Then, an insert 8 is provided in the joint 4, and the through channels 81 are distributed on the insert 8 to provide joints 4 with different structures. The setting of the insert 8 in the joint 4 prevents the limiting member 511 from detaching from the inner ring of the joint 4, thus ensuring structural stability.

[0071] Preferably, the infusion channel 82 can be a flexible tube made of metal wire or polymer material, which is inserted at the central axis of the joint 4. Multiple through channels are distributed around it for inserting wires 61 of different polarities or purposes. The infusion channel 82 starts from and is fixed to the joint 4, is laid in the center of the catheter axis, extends along the catheter axis to the handle 10 and communicates with the Luer connector 104 at the end of the handle 10. During the operation, it can be used for liquid infusion and insertion of wire instruments.

[0072] like Figures 4-6 As shown, an example of a deformable closed annular conduit is provided. Based on the previous example, the support arm 5 is further provided with a deformable section 52 in the middle. The deformable section 52 has a different strain from the associated support member wire 51, and the deformable section 52 is located in the middle of the outer circumferential section 56 to ensure that the head end structure 1 can undergo appropriate stress release when it is moved into the sheath section 3, so that it can be reduced in size smoothly.

[0073] In one or more embodiments, the length of the deformed segment 52 is 0-4 mm.

[0074] In an optional embodiment, the deformable segment 52 can be a strip-shaped structural member that gradually changes in cross-section symmetry from both ends toward the middle, such as... Figure 4 , Figure 5 As shown, the deformable segment 52 is a strip-shaped structural member that tapers symmetrically from both ends towards the middle. The cross-sectional dimension of the middle part of the deformable segment 52 is 0.05mm ≤ 3mm. The deformable segment 52 is integrally formed or connected to the support member wire 51. This allows the support arm 5 to preferentially deform in the middle part of the deformable segment 52 under tension or thrust, thereby ensuring appropriate stress release for the head end structure 1 during the process of moving into or out of the sheath section 3, allowing the head end structure 1 to contract or expand smoothly. At the same time, it also allows the support member 51 to generate appropriate supporting force, so that the head end structure 1 maintains the expected shape.

[0075] In optional implementations, such as Figure 6 As shown, the deformable section 52 can also be a spring coil section 521. The spring coil section 521 can be integrally wound from the support member wire 51, or it can be separately prepared and connected to the support member wire 51 by welding or other means, so that the connection between the spring coil section 521 and the support member wire 51 is stable. This ensures stress release, allowing the head end structure 1 to contract or expand smoothly, and also ensures that the support member wire 51 has sufficient strength and reliability at the position of the deformable section 52.

[0076] like Figure 7As shown, an example of a deformable closed annular catheter is provided, based on the previous example, with positioning elements 9 respectively provided at the joint 4 and the support arm 5. The positioning element 9 is any one or more of 5D magnetic positioning sensor, 6D magnetic positioning sensor and RFID tag. The positioning element 9 is connected to a three-dimensional positioning system to realize the visual positioning and display of the catheter through the three-dimensional positioning system, realize visual operation, avoid the use of X-rays, and improve the safety of catheter use.

[0077] In an optional embodiment, a through-face slot can be opened at the end of the joint 4 away from the support arm 5, and a positioning element 9 can be provided on the core tube section 2 so that the positioning element 9 is embedded in the slot to achieve the consistency of the catheter. At the same time, a positioning element 9 can be provided on each outer circumferential section 56 and / or each merging arm 53. When used in conjunction with a three-dimensional system that can identify the positioning element 9, the visualization and positioning of the catheter can be achieved.

[0078] In an optional embodiment, the limiting ring 7, which is sleeved on the joint 4 to limit the limiting member 511 within the limiting groove 41, can also be configured as a positioning member 9.

[0079] Preferably, each positioning element 9 can also be used to collect electrical signals for electrical positioning, so as to further optimize the visualization accuracy and effect of the catheter.

[0080] This embodiment of a deformable closed-loop catheter involves each electrode 6 being connected to a connector within the handle 10 via a wire 61. After the connector is connected to a matching information processing device, information exchange between the device and the tissue can be achieved. The device transmits tissue information collected by the electrodes 6, such as electrophysiological signals, impedance, and waveforms, to the information processing device. This information is then processed, converted, and displayed as technical information identifiable by the operator, such as electrocardiograms, electrode 6 morphology, tissue adhesion strength models, and ablation indices. Furthermore, the device can establish a real-time correlation between the adhesion effect of the electrodes 6 and the tissue and the tissue information collected by the electrodes 6, such as impedance or waveforms. The displayed information can determine whether the current catheter shape is suitable for the current tissue shape. The bending mechanism 101 or the sliding mechanism 102 can be used to make the electrode 6 fit the tissue in the optimal contact state. This allows for efficient and rapid closure of the pulmonary vein vestibule and pulmonary vein in a band-like isolation, or selective closure of the pulmonary vein vestibule and pulmonary vein in a band-like isolation by selectively choosing the well-fitted ring electrode 6. At the same time, the information processing device transmits information expected to act on the tissue, such as high-voltage pulse waves, radio frequency waves, and ultrasound waves used for treatment, and stimulation signals and detection signals used for diagnosis, to the tissue to complete treatment, diagnosis, or provide a basis for judgment for surgical operation. This information exchange improves the safety and effectiveness of the surgery.

[0081] A method for using a deformable closed-loop catheter according to this embodiment includes:

[0082] Step 1: Establish a vascular access and connect the catheter to the associated information processing equipment;

[0083] Step 2: Adjust the sliding mechanism 102 of the catheter to retract the entire tip structure 1 into the sheath layer, making it in its smallest form;

[0084] Step 3: Push the catheter and adjust the bending mechanism 101 to bring the catheter into the pulmonary vein or the pulmonary vein orifice;

[0085] Step 4: Based on the information displayed by the supporting information processing equipment, such as tissue adhesion strength and ablation index, guide the catheter to adhere to the tissue. For example, when performing ablation in the pulmonary vein, adjust the sliding mechanism 102 of the catheter to slowly push the annular segment out of the sheath layer, so that it is in the middle shape, so that the serrated electrode 6 is stably attached to the inner wall of the pulmonary vein; when performing ablation in the pulmonary vein vestibule, the annular segment can be in a fully extended state, and the catheter can be pushed further so that the peripheral ring is positively pressed against the pulmonary vein vestibule and a stable adhesion is formed.

[0086] Step 5: Using the supporting information processing equipment, release therapeutic energy, such as high-voltage pulse energy or radiofrequency energy, to the electrode 6 set in the outer peripheral ring 56 to form a closed serrated ablation circle or a closed annular ablation circle in the target tissue area.

[0087] Step 6: Adjust the expansion shape of the head structure 1, push the head structure 1 deep into the pulmonary vein, and then release a stimulation signal to check whether the expected closed ring ablation circle is formed. Based on the information displayed by the supporting equipment, such as tissue adhesion strength and ablation index, establish an ablation index with the tissue information before and after ablation, such as impedance or waveform collected by electrode 6, to confirm whether the ablation is effective and whether to continue ablation.

[0088] Step 7: After confirming that the ablation is effective, adjust the tip structure 1 to restore the catheter to its smallest shape, and then withdraw the catheter from the body to complete the operation.

[0089] This embodiment presents a deformable closed-loop catheter. Through the relative movement of the core segment 2 and the sheath segment 3, the tip structure 1 can be moved into or out of the sheath segment 3, allowing control of the outer diameter of the tip structure 1 and creating tip structures 1 of different sizes to adapt to different usage states and tissue locations. Combined with a bending adjustment function, it avoids the cost and inconvenience of requiring an additional sheath during surgery, improving the flexibility of catheter use and enabling successful achievement of complex target locations, thus improving ablation efficiency and effect. Simultaneously, by forming a combined arm 53 through adjacent support member wires 51, the tip structure 1 forms multiple triangular-like structures in space. The mutual traction of adjacent support member wires 51 in a T-shaped or n-shaped structure allows the tip structure 1 to be in any intermediate state. All of these features possess sufficient stability to ensure the stability of the spacing and contact between the electrodes 6 on the electrode 6 arm, avoiding the inability to form a closed annular ablation ring due to unstable contact and uneven spacing. This achieves efficient ablation, improving ablation efficiency and effectiveness. Furthermore, in this embodiment, a deformable closed annular catheter further includes a deformable section 52 to release stress during the process of moving the head structure 1 into or out of the sheath segment 3. This ensures that the head structure 1 maintains a stable structural shape and sufficient strength and reliability in any state during the process of moving into or out of the sheath segment 3, further ensuring the stability of the spacing and contact between the electrodes 6 on the head structure 1, thereby quickly and stably forming a closed annular ablation ring.

[0090] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A deformable closed-loop conduit, characterized in that, The device includes a head end structure (1), a core tube segment (2), and a sheath segment (3). The head end structure (1) includes a connecting part (4) and several support arms (5). The connecting part (4) is connected to the core tube segment (2). The sheath segment (3) is fitted onto the core tube segment (2). The core tube segment (2) can move relative to the sheath segment (3) on the same axis, so that the head end structure (1) can move into or out of the sheath segment (3). A plurality of the support arms (5) are evenly distributed at one end of the joint (4) away from the core tube segment (2). Each support arm (5) includes a support member wire (51) and an isolation layer. The support member wire (51) passes through the isolation layer. Both ends of the support member wire (51) are connected to or integrally formed with the joint (4). Adjacent support arms (5) form a combined arm (53) on the side close to the joint (4). Each support arm (5) is provided with a plurality of electrodes (6), and at least some of the electrodes (6) are distributed in the combined arm (53). The support arm (5) has a deformation section (52) in the middle, and the deformation section (52) has a different strain than the associated support member wire (51); When the head end structure (1) is completely removed from the sheath section (3), the support arm (5) has a first arc segment (54), a first straight segment (55), an outer circumferential ring segment (56), a second straight segment (57), and a second arc segment (58) arranged in sequence. The first arc segment (54) and the second arc segment (58) are respectively deflected away from the center of the joint (4). A plurality of the outer circumferential ring segments (56) are located on the same plane. The deformable segment (52) is arranged in the middle of the outer circumferential ring segments (56). The circular upper electrode (6) formed by the outer circumferential ring segments (56) is evenly distributed.

2. The deformable closed-loop conduit according to claim 1, characterized in that, The deformable segment (52) gradually changes in cross-section symmetrically from both ends to the middle. The cross-sectional dimension of the middle part of the deformable segment (52) is 0.05mm≤3mm. The deformable segment (52) is integrally formed or connected with the support member wire (51).

3. The deformable closed-loop conduit according to claim 1, characterized in that, The deformable section (52) includes a spring coil section (521), which is connected to or integrally wound by the support member wire (51).

4. The deformable closed-loop conduit according to claim 1, characterized in that, One end of the support member wire (51) is integrally formed or connected to the connecting part (4), and the other end of the support member wire (51) is provided with a limiting member (511); The connecting part (4) is provided with a limiting groove (41), and the limiting member (511) is nested and connected with the limiting groove (41); The joint (4) is provided with a limiting ring (7), which is fitted outside the limiting groove (41) and covers at least the two ends of the limiting member (511) in the axial direction.

5. A deformable closed-loop conduit according to claim 4, characterized in that, The connecting part (4) is a cylindrical structural component. The connecting part (4) is provided with several through channels (81). The through channels (81) are used to make injection channels (82) or to pass through wires (61). The limiting groove (41) is provided in the connecting part (4) and passes through the outer wall of the connecting part (4).

6. A deformable closed-loop conduit according to claim 4, characterized in that, The connecting part (4) is a ring-shaped structural component. An insert (8) is provided inside the connecting part (4). The insert (8) is provided with several through channels (81). The through channels (81) are used to make an injection channel (82) or to pass through a wire (61). The limiting groove (41) is provided in the connecting part (4) and passes through the inner wall and outer wall of the connecting part (4).

7. A deformable closed annular catheter according to any one of claims 1-6, characterized in that, The first straight segment (55) and the second straight segment (57) of the adjacent support member wire (51), and / or the first arc segment (54) and the second arc segment (58) form the combined arm (53), which is formed by integral molding of the adjacent support member wire (51), tubular wrapping, glue bonding or welding.

8. A deformable closed-loop conduit according to claim 1, characterized in that, The head end structure (1) includes no less than three support member wires (51), and the maximum cross-sectional dimension of each support member wire (51) is no more than 1 mm; each support member wire (51) is provided with an electrode (6), the electrode (6) is 0.5-5 mm long, and the spacing between adjacent electrodes (6) is 1-6 mm.

9. A deformable closed annular conduit according to claim 1, characterized in that, The connecting part (4) and the supporting arm (5) are respectively provided with positioning components (9), which are any one of 5D magnetic positioning sensor, 6D magnetic positioning sensor and RFID tag, and the positioning components (9) are connected to the three-dimensional positioning system.

10. A deformable closed-loop conduit according to claim 1, characterized in that, The sheath section (3) is connected to a handle (10), the handle (10) is provided with a bending mechanism (101) and a sliding mechanism (102), the bending mechanism (101) is connected to one end of the sheath section (3) near the head end structure (1) through a traction mechanism (103), and the sliding mechanism (102) is connected to the core tube section (2); The handle (10) is provided with a connector for connecting wires (61), which can be connected to an information processing device for signal interaction. The information processing device can establish a tissue adhesion strength model and display the ablation index.

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