Deformable closed annular conduit

Abstract

The invention relates to the field of medical electrophysiology mapping and ablation catheters, in particular to a deformable closed annular catheter which comprises a head end structure, a core tube section and a sheath tube section, the head end structure comprises a combination part and a plurality of supporting arms, each supporting arm comprises a supporting component wire and an isolating layer, a merging arm is formed on the side, close to the combination part, of every two adjacent supporting arms, and the merging arms are connected with the core tube section. Deformation sections are arranged in the middles of the supporting arms. Through relative movement of the core tube section and the sheath tube section, control over the outer diameter of the head end structure is achieved, the head end structures of different sizes are formed so as to adapt to catheters in different use states and different tissue positions, meanwhile, through mutual traction of a plurality of supporting component wires and further arrangement of the deformation section, the head end structure is more flexible to use. The head end structure can keep a stable structure appearance in any state, the distance between electrodes arranged on the head end structure and the stability of electrode attaching can be ensured, then a closed annular ablation ring can be rapidly and stably formed, the head end structure can adapt to positions of different sizes to be used, and the ablation efficiency and the ablation effect are improved.

Description

Technical Field

[0001] The invention relates to the field of medical electrophysiological mapping and ablation catheters, and in particular to a deformable closed annular catheter. Background Art

[0002] At present, blocking ablation isolation in the pulmonary vein vestibule and pulmonary vein is an effective operation in the treatment of atrial fibrillation. The ablation catheter is the main surgical instrument for ablation isolation operation. Common ablation catheters are mainly divided into two categories: basket-shaped and ring-shaped with independent electrode arms. Because the electrode arms of the basket-shaped catheter with independent electrode arms are independent of each other, there are different degrees of deformation between the arms during expansion or contraction, resulting in uneven electrode spacing between different arms, and it is impossible to quickly form a blocking annular ablation circle. Multiple superimposed ablations are required, which increases the risk of complications such as hemolysis, reduces surgical efficiency, and increases the psychological burden of the surgeon and the patient; and the ring-shaped catheter is not a closed ring or circle connected end to end, and there is an obvious gap. During use, the deformation morphology after being stressed will be uncontrollable, affecting the electrode spacing at the gap position. In addition, because the electrodes with different potentials on the ring have different support force arms, the electrodes on the ring or circle have different adhesion forces, and it is impossible to quickly form a blocking annular ablation circle.

[0003] In addition, during the current pulmonary vein isolation surgery, in order to achieve a better isolation effect, isolation ablation is often required at the pulmonary vein vestibule and in the pulmonary veins. It is expected that two closed ablation zones will be formed at the pulmonary vein vestibule and in the pulmonary veins to achieve a better isolation effect. However, due to the significant differences in tissue morphology and size at the pulmonary vein vestibule and in the pulmonary veins, the mainstream catheters currently on the market are generally unable to quickly adapt to the tissue morphology of the two different locations and form an effective annular ablation circle. Multiple catheters are usually required for use in combination, and X-rays are required to confirm relevant positions, which affects the efficiency and effect of the operation and the health of the operator and the patient. Summary of the invention

[0004] The purpose of the present invention is to overcome the shortcomings of the existing catheters in the prior art that they cannot efficiently adapt to tissues of different shapes and sizes to form a closed ablation circle, and require X-rays to confirm the relevant positions, which affects the efficiency and effect of the operation and the health of the operator and the patient, and to provide a deformable closed ring catheter.

[0005] The present invention provides a deformable closed annular catheter, comprising a head end structure, a core tube segment and a sheath tube segment, wherein the head end structure comprises a joint portion and a plurality of support arms, wherein the joint portion is connected to the core tube segment, and the sheath tube segment is sleeved on the core tube segment, and the core tube segment can move coaxially with the sheath tube segment so that the head end structure moves into or out of the sheath tube segment; A plurality of the support arms are evenly distributed at one end of the joint away from the core tube segment, the support arms include support member wires and an isolation layer, the support member wires pass through the isolation layer, and both ends of the support member wires are connected to or integrally formed with the joint; adjacent support arms form a combined arm at one side close to the joint, the support arms are provided with a plurality of electrodes and at least some of the electrodes are distributed on the combined arm; A deformation section is provided in the middle of the support arm, and the deformation section has a different wire strain from the associated support member.

[0006] A deformable closed annular catheter of the present invention realizes the movement of the head end structure into or out of the sheath segment through the relative movement of the core tube segment and the sheath tube segment, realizes the control of the outer diameter of the head end structure, and forms head end structures of different sizes to adapt to the use of catheters in different usage states and different tissue positions. At the same time, a plurality of supporting component wires form a combined arm to pull each other, and a deformable segment is further provided to release stress during the process of the head end structure moving into or out of the sheath segment, so that the head end structure can maintain a stable structural shape in any state during the process of moving in or out of the sheath segment, and can ensure the stability of the electrode spacing and electrode abutment set on the head end structure, thereby quickly and stably forming a closed annular ablation circle, and can adapt to the use of positions of different sizes, thereby improving the ablation efficiency and ablation effect.

[0007] Preferably, the deformation section is symmetrically truncated from both ends to the middle, and the truncation size of the middle part of the deformation section is 0.05mm≤≤3mm, and the deformation section is integrally formed or connected with the support member. Under the action of tension or thrust, the support arm can produce a deformation in the middle part of the deformation section that is different from that at both ends of the support member, thereby ensuring that the head end structure is properly released in the process of moving in or out of the sheath section, so that the head end structure can be smoothly contracted or expanded, and at the same time, the support member can produce a suitable supporting force to keep the head end in the expected shape.

[0008] Preferably, the deformation section includes a spring coil section, which is connected to the support member wire or formed by winding the support member wire in one piece. The spring coil section is connected more tightly to the support member wire, which not only ensures stress release and allows the head end structure to shrink or expand smoothly, but also enables the support member wire to have sufficient strength and reliability at the deformation section position.

[0009] Preferably, one end of the support member wire is integrally formed or connected with the connecting portion, and the other end of the support member wire is provided with a limiter; The combination portion is provided with a limiting groove, and the limiting member is nested and connected with the limiting groove; The coupling portion is provided with a limiting ring, the limiting ring is sleeved outside the limiting groove, and the limiting ring at least covers the two end portions of the limiting member in the axial direction.

[0010] The support member wire is stably fixed at the joint position to prevent the support member wire from being disconnected from the joint during use, and the setting of the limiting groove prevents the setting of the support member wire at the joint from affecting the outer dimensions of the joint.

[0011] Preferably, the joint is a cylindrical structure, and a plurality of through-channels are provided in the joint, and the through-channels are used to be used as perfusion channels or to pass wires, and the limiting groove is provided in the joint and passes through the outer wall of the joint. A joint that satisfies the use function is provided, and the wires and pipelines related to the head end structure are smoothly arranged.

[0012] Preferably, the joint part is a circular ring-shaped structural part, an insert is arranged in the joint part, the insert is provided with a plurality of through-channels, the through-channels are used to be perfusion channels or to pass wires, and the limiting groove is arranged in the joint part and passes through the inner wall and the outer wall of the joint part. Joint parts with different structures are provided, and the setting of the insert in the joint part prevents the limiting part from being disconnected from the inner circle of the joint part.

[0013] Preferably, when the head end structure is completely moved out of the sheath section, the support arm has a first arc segment, a first straight segment, an outer peripheral ring segment, a second straight segment, and a second arc segment which are sequentially arranged, the first arc segment and the second arc segment are respectively deflected in a direction away from the center of the joint portion, a plurality of the outer peripheral ring segments are located in the same plane, and the deformation segment is arranged in the middle of the outer peripheral ring segment; The first straight segment and the second straight segment of adjacent supporting member wires, and / or the first arc segment and the second arc segment form the merging arm, and the merging arm is formed by integrally molding, tubing wrapping, gluing or welding adjacent supporting member wires.

[0014] By adopting a multi-segment support arm, the head end structure is trumpet-shaped after being moved out of the sheath segment, and a closed annular ablation circle can be formed by positioning the electrodes on the peripheral ring segment on a complete circle.

[0015] Preferably, the head end structure includes no less than three supporting member wires, and the maximum size of the cross section of each supporting member wire does not exceed 1 mm; each supporting member wire is provided with an electrode, the length of the electrode is 0.5-5 mm, and the spacing between adjacent electrodes is 1-6 mm. The size of adjacent electrodes and the spacing between adjacent electrodes can be adjusted according to actual conditions to form a head end structure that meets different ablation requirements.

[0016] Preferably, the joint and the support arm are respectively provided with positioning members, the positioning members are any one of a 5D magnetic positioning sensor, a 6D magnetic positioning sensor and an RFID tag, and the positioning members are connected to a three-dimensional positioning system, so as to realize the visual positioning and display of the catheter through the three-dimensional positioning system, avoid the use of X-rays, and improve the safety of the use of the catheter.

[0017] Preferably, the sheath tube segment is connected to a handle, the handle is provided with a bending mechanism and a sliding mechanism, the bending mechanism is connected to one end of the sheath tube segment close to the head end structure through a traction mechanism, and the sliding mechanism is connected to the core tube segment; The handle is provided with a connector for connecting a wire, and the connector can be connected to an information processing device for signal exchange, and the information processing device can establish a tissue adhesion strength model and display an ablation index, so that the catheter can be bent and the shape of the head end structure can be adjusted as needed, and can smoothly reach a complex target position without the help of other instruments, achieve stable adhesion with different tissue positions, and improve the flexibility of catheter use.

[0018] Compared with the prior art, the present invention has the following beneficial effects: 1. The present invention provides a deformable closed annular catheter, which can move the head end structure into or out of the sheath tube section by relative movement of the core tube section and the sheath tube section, thereby realizing control of the outer diameter of the head end structure and forming head end structures of different sizes to adapt to the use of catheters in different use states and different tissue locations; 2. The present invention provides a deformable closed annular catheter, which is formed by a plurality of supporting component wires to form a combined arm that pulls each other, and further provides a deformable section to release stress during the process of the head end structure moving in or out of the sheath section. The head end structure can maintain a stable structural shape in any state during the process of moving in or out of the sheath section, and ensure the stability of the electrode spacing and electrode contact arranged on the head end structure, thereby quickly and stably forming a closed annular ablation circle, and can be adapted to use in positions of different sizes, thereby improving ablation efficiency and ablation effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a schematic diagram of the overall structure of a deformable closed annular conduit; Figure 2 A cross-sectional schematic diagram of a deformable closed annular catheter at a sheath section of an embodiment; Figure 3 is a schematic structural diagram of the head end structure described in the embodiment; Figure 4 Schematic diagram of the structure of the head end structure forming a merging arm in the embodiment Figure 1 ; Figure 5Schematic diagram of the structure of the head end structure forming a merging arm in the embodiment Figure 2 ; Figure 6 It is a structural schematic diagram of the head end structure described in the embodiment when a deformation section of a spring coil section is provided; Figure 7 A schematic diagram of the structure of the head end structure in the embodiment in which a positioning member is provided; Figure 8 It is a structural schematic diagram of the connection between the supporting member wire and the combining portion in the embodiment; Fig. 9 for Figure 8 A schematic diagram of the structure with a partial enlargement at the center; Fig.10 The cross-sectional view of the joint portion described in the embodiment is shown in FIG. Figure 1 ; Fig.11 The cross-sectional view of the joint portion described in the embodiment is shown in FIG. Figure 2 ; Fig.12 A deformable closed annular conduit in use according to an embodiment of the present invention Figure 1 ; Fig.13 A deformable closed annular conduit in use according to an embodiment of the present invention Figure 2 ; Fig.14 A deformable closed annular conduit in use according to an embodiment of the present invention Figure 3 .

[0020] Markings in the figure: 1-head end structure, 2-core tube section, 3-sheath tube section, 4-joint part, 41-limiting groove, 5-support arm, 51-support member wire, 511-limiting piece, 52-deformation section, 521-spring coil section, 53-merging arm, 54-first arc section, 55-first straight section, 56-peripheral ring section, 57-second straight section, 58-second arc section, 6-electrode, 61-guide wire, 7-limiting ring, 8-insert, 81-through channel, 82-perfusion channel, 9-positioning piece, 10-handle, 101-bending mechanism, 102-sliding mechanism, 103-traction mechanism, 104-Luer connector. DETAILED DESCRIPTION

[0021] The present invention is further described in detail below in conjunction with specific embodiments. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following embodiments, and all technologies realized based on the content of the present invention belong to the scope of the present invention.

[0022] Unless otherwise specified, in the description of the specific embodiments of the present invention, the terms indicating the orientation or position relationship such as "up", "down", "left", "right", "center", "inside", "outside", etc. are all expressions based on the orientation or position relationship shown in the drawings, or are the orientation or position relationship when the invented product / equipment / device is usually used. These terms of orientation or position relationship are only for the convenience of describing the scheme of the present invention or simplifying the description in the specific embodiments, so as to facilitate the technicians to quickly understand the scheme, and do not indicate or imply that a specific device / component / element must have a specific orientation, or be constructed and operated in a specific position relationship, and therefore cannot be understood as a limitation on the present invention.

[0023] In addition, if the terms "horizontal", "vertical", "overhanging", "parallel" and the like appear, it does not mean that the corresponding devices / components / elements are required to be absolutely horizontal or vertical or overhanging or parallel, but may be slightly tilted or have deviations. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but may be slightly tilted. Alternatively, it can be simplified to mean that the corresponding devices / components / elements are set in directions such as "horizontal", "vertical", "overhanging", "parallel", etc., and can have an error / deviation of ±10% relative to the corresponding direction setting, more preferably an error / deviation within ±8%, more preferably an error / deviation within ±6%, more preferably an error / deviation within ±5%, and more preferably an error / deviation within ±4%. As long as the corresponding device / component / element is within the error / deviation range, it can still achieve its role in the scheme of the present invention.

[0024] In addition, the expressions “first”, “second”, “third”, etc., which appear in the terms, are merely used to distinguish the description of the same or similar components and should not be understood as emphasizing or implying the relative importance of specific components.

[0025] In addition, in the description of the embodiments of the present invention, "several", "plurality" and "a number" represent at least 2. It can be any number such as 2, 3, 4, 5, 6, 7, 8, 9, and even more than 9.

[0026] In addition, in the description of the technical solution of the present invention, unless otherwise clearly specified / defined / restricted, the terms "set", "install", "connect", "connected", "provided with", "laid", and "arranged" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection, and can be welding, riveting, bolting, threading, and other commonly used connection means in the field. This connection can be a mechanical connection, an electrical connection, or a communication connection; it can be a direct connection, or an indirect connection through an intermediate medium, and it can be the internal connection of two elements. Example

[0027] like Figure 1-Figure 3 As shown, an example of a deformable closed annular catheter includes a head end structure 1, a core tube segment 2, a sheath tube segment 3 and a handle 10, wherein the handle 10 is provided with a bending mechanism 101 and a sliding mechanism 102, wherein the bending mechanism 101 is connected to an end of the sheath tube segment 3 close to the head end structure 1 through a traction mechanism 103, and the sliding mechanism 102 is connected to the core tube segment 2 to form an integrated catheter structure with a bending function. Specifically, the head end structure 1 includes a joint 4 and a number of not less than three support arms 5, wherein the joint 4 is connected to the core tube segment 2, the sheath tube segment 3 is sleeved on the core tube segment 2, and a plurality of support arms 5 are evenly distributed at an end of the joint 4 away from the core tube segment 2, and the support arms 5 include a plurality of support arms 5. It includes a support member wire 51 and an isolation layer, the support member wire 51 passes through the isolation layer, and both ends of the support member wire 51 are respectively connected to the joint 4 or formed as one piece, the support arm 5 is provided with a plurality of electrodes 6, the electrode 6 is mounted on the outside of the isolation layer, and an electrical signal path is formed between the isolation layer and the support member wire 51, which is used for the electrode 6 related wire 61 to pass through the support arm 5, the core tube segment 2 can move relative to the coaxial line of the sheath segment 3, so that the head end structure 1 moves in or out of the sheath segment 3, and the support arm 5 is constrained by the end of the sheath segment 3 to enter the sheath segment 3 relatively or to extend the sheath segment 3 relatively, so as to realize the control of the maximum size of the head end structure 1.

[0028] A deformable closed annular catheter in this embodiment has a head end structure 1 with a minimum form in which the sheath segment 3 is fully retracted, a fully expanded state in which the sheath segment 3 is fully pushed out, and several intermediate states. The catheter 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 positions, and improve the flexibility of catheter use.

[0029] like Figure 3-Figure 8As shown, taking the head end structure 1 composed of three support arms 5 as an example, in the fully expanded state, each support arm 5 has a first arc segment 54, a first straight segment 55, an outer peripheral 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 in the direction away from the axial center of the joint 4, the first arc segment 54 is connected to the first straight segment 55, the first straight segment 55 is bent and deflected in the clockwise or counterclockwise direction at the end away from the first arc segment 54 to connect to the outer peripheral ring segment 56, and the other end of the outer peripheral ring segment 56 is bent and deflected in the clockwise direction. The second straight segment 57 is connected to the end of the second straight segment 57 away from the outer ring segment 56 and is bent and deflected in a needle-like or counterclockwise direction toward the axial center of the joint 4. The end of the second straight segment 57 away from the outer ring segment 56 is connected to the second arc segment 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 is enclosed in space to form a stable triangular structure, 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 achieve the purpose of stabilizing the position of the electrode 6 on the support arm 5 and ensuring that the electrode 6 is stably attached.

[0030] In an optional embodiment, the support member wire 51 can be a metal wire with multiple sections of different sizes, the cross-section of the support member wire 51 can be a circle or other geometric shape, and the maximum size 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 circular or partially circular structure made of platinum-iridium alloy, gold, silver, platinum or stainless steel. The electrode 6 is used for collecting electrical signals and releasing energy, and is used to realize the catheter's mapping and ablation functions of the target area, and is stably set on the electrode 6 arm.

[0031] In an optional embodiment, the joint 4 and the supporting member wire 51 can be prepared separately and then welded to ensure the overall structural stability of the head end structure 1.

[0032] In an optional embodiment, the joint 4 and the supporting member wire 51 can also be made of pipes or rods of the same material to form an integrated 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.

[0033] In an optional embodiment, the length of the electrode 6 can be 0.5-5 mm, preferably 1.5-2.5 mm. The number and spacing between adjacent electrodes 6 can be determined based on the maximum outer diameter of the head end structure 1 in a fully expanded state. The size of each electrode 6 and the spacing between adjacent electrodes 6 can be adjusted according to actual conditions to form a head end structure 1 that meets different ablation requirements.

[0034] Preferably, the number of electrodes 6 may be 6-30, and the distance between electrodes 6 may be 1-6 mm.

[0035] like Figure 4-Figure 8 As shown, an example of a deformable closed annular catheter, based on the previous example, adjacent support arms 5 constitute a part of a merging arm 53, a plurality of electrodes 6 are arranged on the merging arm 53, and a plurality of electrodes 6 are arranged on a peripheral ring segment 56, so that the adjacent support arms 5 form a T-type or n-type structure with the peripheral ring segment 56 through the merging arm 53, and can pull each other and act synchronously during use, so that the head end structure 1 can have sufficient structural stability in any intermediate state, ensure the stability of the spacing between the electrodes 6 and the abutment of the electrodes 6, and avoid the situation where a closed annular ablation circle cannot be formed due to unstable abutment and uneven spacing. In particular, in the fully expanded form, the three peripheral ring segments 56 are located in the same plane, and the circular upper electrodes 6 formed by the three peripheral ring segments 56 are evenly distributed and the relative distance is stable, so that a complete annular ablation circle can be formed most quickly and stably through the circle formed by the peripheral ring segments 56, thereby achieving efficient ablation and improving surgical efficiency.

[0036] In an optional embodiment, the merging arm 53 can be formed by integrally molding, tubing wrapping, gluing or welding the supporting member wire 51 of the adjacent supporting arm 5 at the first straight segment 55 and the second straight segment 57 and the first arc segment 54 and the second arc segment 58.

[0037] Specifically, Figure 4 As shown, three integral merging arms 53 are evenly distributed at one end of the joint 4 , and the three merging arms 53 separate into two relatively smaller supporting member wires 51 on a side away from the joint 4 .

[0038] Specifically, Figure 5 , Figure 6 As shown, six supporting member wires 51 are evenly distributed side by side at one end of the joint 4. Adjacent supporting member wires 51 can be compounded within the first arc segment 54 and the first straight segment 55 by means of tubing wrapping, gluing or welding to form a merging arm 53.

[0039] In an optional embodiment, the merging arm 53 can also be a supporting member wire 51 of an adjacent supporting arm 5, formed by one-piece molding, tubing wrapping, gluing or welding in the first straight segment 55 and the second straight segment 57, while the first arc segment 54 and the second arc segment 58 are maintained in a close contact state through the joint 4 and the merging arm 53 to meet different production requirements.

[0040] Preferably, the width or thickness of the supporting member wire 51 at the merging arm 53 is smaller than the corresponding size of the peripheral ring segment 56, and the proportional relationship is not less than 2 times, so that the cross-sectional size of the merging arm 53 is close to the cross-sectional size of the peripheral ring segment 56, thereby reducing the overall external dimensions of the head end and ensuring that the head end structure 1 can be smoothly moved in or out of the sheath segment 3.

[0041] Preferably, the number of electrodes 6 of the peripheral ring segment 56 may be 18 or 24, and the distance between the electrodes 6 may be 1.5-2.5 mm; the number of electrodes 6 of the merging arm 53 may be 6-9, and the distance between the electrodes 6 may be 1-5 mm.

[0042] A deformable closed annular catheter of this embodiment, when used, Fig.12 As shown, the head end structure 1 can be completely retracted into the sheath section 3 through the sliding mechanism 102. At this time, the head end structure 1 is in the smallest form, and the bending adjustment mechanism 101 controls the bending change of the distal end of the sheath section 3 to facilitate pushing the catheter to the target tissue; Fig.13 As shown, by pushing the sliding mechanism 102, part of the support arm 5 of the head end structure 1 can be pushed out of the sheath section 3 to form a trumpet-shaped head end structure 1. At this time, the head end structure 1 is in an intermediate state, and the electrodes 6 arranged on the support arm 5 are distributed in a zigzag shape. At this time, it can be suitable for forming a closed ablation circle on the inner wall of a cavity-shaped tissue, such as a pulmonary vein, and the opening size of the trumpet-shaped head end structure 1 can be adjusted to adapt to cavity tissues of different sizes, thereby expanding the application range of the catheter; Fig.14 As shown, by continuing to push the sliding mechanism 102, the support arm 5 is pushed out of the sheath segment 3 more and more, and the opening of the trumpet-shaped head end structure 1 is enlarged until the head end structure 1 is fully expanded. At this time, the electrodes 6 arranged on the support arm 5 can at least be evenly distributed on the circle of the same plane, which is suitable for forming a closed annular ablation circle for surface tissues, such as the atrial wall, or the mouth of the cavity tissue, such as the vestibule of the pulmonary vein.

[0043] like Figure 8 As shown, an example of a deformable closed annular catheter is shown. Based on the previous example, one end of the supporting member wire 51 is integrally formed with the coupling part 4, and the other end of the supporting member wire 51 is provided with a limiting piece 511, and the coupling part 4 is provided with a limiting groove 41. The limiting piece 511 and the limiting groove 41 are mechanically nested and connected to each other, so as to realize the fixation of the end of the supporting member wire 51 and the coupling part 4, facilitate the preparation of the coupling part 4 with the supporting member wire 51, reduce the preparation cost, and ensure that the supporting member wire 51 is stably connected to the coupling part 4 during use.

[0044] In an optional embodiment, if Figure 8-Figure 9As shown, the limiting member 511 can be an I-shaped block structure or other special-shaped structure with a locally enlarged size arranged at the end of the supporting member wire 51, and the thickness is consistent with the depth of the limiting groove 41. It can not affect the outer dimensions of the joint 4 after being embedded in the limiting groove 41. Moreover, 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 axial direction 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 axial direction of the joint 4, the thrust or pull force can be smoothly transmitted during the use of the head end structure 1, thereby ensuring the smooth deformation and stable ablation of the supporting member wire 51 on the head end structure 1.

[0045] In an optional embodiment, the limit member 511 can be further connected to the limit groove 41 by means of gluing, melting, welding, etc. on the basis of the nested connection, so as to ensure the firm connection between the limit member 511 and the joint 4 and prevent the end of the supporting member wire 51 from moving out in the radial direction of the joint 4 during the use of the head end structure 1.

[0046] In an optional embodiment, the limit member 511 can also be limited by providing a limit ring 7 on the coupling part 4. The limit ring 7 is mounted on the outside of the limit groove 41. The limit ring 7 at least covers the two end parts of the limit member 511 in the axial direction. The limit member 511 is stably limited on the coupling part 4 by at least one limit ring 7, so that the end part of the supporting member wire 51 is stably fixed at the position of the coupling part 4, thereby preventing the supporting member wire 51 from being disconnected from the coupling part 4 during use. The fixing method of the limit member 511 on the coupling part 4 can adopt one or more methods according to actual conditions.

[0047] In an optional embodiment, if Fig.10 As shown, the joint part 4 can be a cylindrical structural member, and a plurality of through-channels 81 are provided in the joint part 4, and the through-channels 81 are used to form a perfusion channel 82 or to pass the wire 61, and the limiting groove 41 is provided in the joint part 4 and passes through the outer wall of the joint part 4. The joint part 4 that meets the use function is provided to realize the smooth arrangement of the wire 61 and the pipeline related to the head end structure 1.

[0048] In an optional embodiment, if Fig.11 As shown, the coupling part 4 may also be an annular structural part, and the limiting groove 41 has penetrated the inner wall and the outer wall of the coupling part 4 in the thickness direction, then an insert 8 is arranged in the coupling part 4, and the through-channel 81 is distributed on the insert 8 to provide coupling parts 4 with different structures, and the setting of the insert 8 in the coupling part 4 prevents the limiting part 511 from being disconnected from the inner circle of the coupling part 4, thereby ensuring the structural stability.

[0049] Preferably, the perfusion channel 82 can be a flexible pipe composed of metal wires or polymer materials, which is passed through the central axis of the joint 4, and multiple through channels are distributed around it for passing the wires 61 of different polarities or different purposes. The perfusion channel 82 starts from and is fixed to the joint 4, is centrally laid in the center of the catheter axis, extends along the catheter axis to the handle 10 and is interconnected with the Luer connector 104 arranged at the end of the handle 10. It can be used for liquid infusion and insertion of filamentary instruments during surgery.

[0050] like Figure 4-Figure 6 As shown, an example of a deformable closed annular catheter is provided. Based on the previous example, a deformation section 52 is further provided in the middle of the support arm 5. The deformation section 52 has a different strain from the associated support member wire 51, and the deformation section 52 is arranged in the middle of the peripheral ring section 56 to ensure that the head end structure 1 can perform appropriate stress release when moving into the sheath section 3 so that it can shrink smoothly.

[0051] In one or several embodiments, the length of the deformation section 52 is 0-4 mm.

[0052] In an optional embodiment, the deformation section 52 may be a strip-shaped structural member that gradually changes from both ends to the middle in a truncation plane symmetrical manner, such as Figure 4 , Figure 5 As shown, the deformation section 52 is a strip-shaped structural member that tapers symmetrically from both ends to the middle in a truncation plane, and the truncation plane size of the middle of the deformation section 52 is 0.05mm≤≤3mm, and the deformation section 52 is integrally formed or connected with the support member wire 51. Under the action of tension or thrust, the support arm 5 can be deformed preferentially in the middle of the deformation section 52, thereby ensuring that the head end structure 1 is properly released in the process of moving in or out of the sheath section 3, so that the head end structure 1 can be smoothly contracted or expanded, and at the same time, the support member 51 can generate a suitable supporting force, so that the head end structure 1 maintains the expected shape.

[0053] In an optional embodiment, if Figure 6 As shown, the deformation section 52 may also be a spring coil section 521, which may be formed by winding the supporting member wire 51 in one piece, or may be prepared separately and then connected with the supporting member wire 51 by welding or other methods, so that the spring coil section 521 and the supporting member wire 51 are stably connected, which not only ensures stress release and allows the head end structure 1 to contract or expand smoothly, but also enables the supporting member wire 51 to have sufficient strength and reliability at the deformation section 52 position.

[0054] like Figure 7As shown, an example of a deformable closed annular catheter is shown. Based on the previous example, positioning members 9 are respectively provided at the joint 4 and the support arm 5. The positioning member 9 is a mixture of any one or more of a 5D magnetic positioning sensor, a 6D magnetic positioning sensor and an RFID tag. The positioning member 9 is connected to a three-dimensional positioning system to realize 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.

[0055] In an optional embodiment, a slot penetrating the end surface can be opened on the end of the coupling portion 4 away from the support arm 5, and a positioning piece 9 is provided on the core tube segment 2 so that the positioning piece 9 is embedded in the slot to achieve the consistency of the catheter. At the same time, a positioning piece 9 is respectively provided on each peripheral ring segment 56 and / or each merging arm 53. When used in conjunction with a three-dimensional system that can identify the positioning piece 9, visual positioning and display of the catheter can be achieved.

[0056] In an optional implementation, the limiting ring 7 sleeved on the coupling portion 4 for limiting the limiting member 511 in the limiting groove 41 may also be configured as the positioning member 9 .

[0057] Preferably, each positioning member 9 can also be used to collect electrical signals for electrical positioning to further optimize the visualization accuracy and effect of the catheter.

[0058] In the deformable closed annular catheter of the present embodiment, when in use, each electrode 6 is connected to the connector in the handle 10 through a wire 61. After the connector is connected to the matching information processing device, information interaction between the information processing device and the tissue can be realized, and the tissue information collected by the electrode 6, such as the electrophysiological signal, impedance, waveform, etc. of the tissue, can be transmitted to the information processing device. The information processing device can process the tissue information, convert and display it into technical information that can be recognized by the operator, such as electrocardiogram, electrode 6 morphology, tissue adhesion strength model, ablation index, etc., and can establish a connection between the adhesion effect of the electrode 6 and the tissue and the tissue information such as impedance or waveform collected by the electrode 6 for real-time display, so that the operator can The displayed information can be used to determine whether the current catheter morphology is suitable for the current tissue morphology, and the bending mechanism 101 or the sliding mechanism 102 can be used to place the electrode 6 and the tissue in the optimal contact state, thereby efficiently and quickly achieving closed strip isolation of the pulmonary vein vestibule and the pulmonary vein, or selectively selecting the well-contacted ring electrode 6 to perform non-closed strip isolation of the pulmonary vein vestibule and the pulmonary vein. At the same time, the information processing device transmits information intended to act on the tissue, such as high-voltage pulsed electric waves, radio frequency waves, ultrasound waves for treatment, and stimulation signals and detection signals for diagnosis, to the tissue to complete treatment, diagnosis, or provide a basis for judgment for surgical operations, so as to improve the safety and effectiveness of the operation through such information exchange.

[0059] A method for using a deformable closed annular catheter in this embodiment includes: Step 1: Establish vascular access and connect the catheter to the supporting information processing equipment; Step 2: Adjust the sliding mechanism 102 of the catheter to retract the entire head end structure 1 into the sheath layer to make it in the smallest form; Step 3: Push the catheter and adjust the bending mechanism 101 to make the catheter reach the pulmonary vein or the pulmonary vein orifice; Step 4: According to the information displayed by the supporting information processing equipment, such as tissue adhesion strength, ablation index, etc., guide the catheter to adhere to the tissue. For example, when ablation is performed in the pulmonary vein, the sliding mechanism 102 of the catheter is adjusted to slowly push the ring segment out of the sheath layer to make it in an intermediate shape, so that the zigzag-shaped electrodes 6 can be stably adhered to the inner wall of the pulmonary vein; when ablation is performed in the vestibule of the pulmonary vein, the ring segment can be in a fully expanded state, and the catheter can be continuously pushed so that the peripheral ring can be positively pressed against the vestibule of the pulmonary vein and form a stable adhesion; Step 5: Using the matching information processing equipment, release treatment energy, such as high-voltage pulse energy, radio frequency energy, etc., to the electrode 6 disposed in the peripheral ring segment 56 to form a closed sawtooth ablation circle or a closed annular ablation circle in the target tissue area; Step 6: Regulate the expansion shape of the head end structure 1, push the head end structure 1 deep into the pulmonary vein, and then release the stimulation signal to check whether the expected closed annular ablation circle is formed. According to the information displayed by the supporting equipment, such as tissue adhesion strength, ablation index, etc., the ablation effect and the tissue information before and after ablation, such as impedance or waveform collected by the electrode 6, can be used to establish an ablation index to confirm whether the ablation is effective and whether to continue ablation; Step 7: After confirming that the ablation is effective, adjust the head end structure 1 to restore the catheter to its smallest shape, and then withdraw the catheter from the body to complete the operation.

[0060] A deformable closed annular catheter in the present embodiment realizes the movement of the head end structure 1 into or out of the sheath tube segment 3 through the relative movement of the core tube segment 2 and the sheath tube segment 3, realizes the control of the outer diameter of the head end structure 1, and forms head end structures 1 of different sizes to adapt to the use of catheters in different usage states and different tissue positions. In combination with the bending adjustment function, the cost and mismatch trouble caused by the need for additional sheaths during surgery are avoided, the flexibility of catheter use is improved, and complex target positions can be smoothly reached, and the ablation efficiency and ablation effect are improved. At the same time, the merging arms 53 are formed by adjacent supporting member wires 51, so that the head end structure 1 forms a plurality of quasi-triangles in space. The adjacent supporting member wires 51 are mutually pulled in a T-shaped or n-shaped structure, so that the head end structure 1 is in any intermediate state. They can all have sufficient stability, which can ensure the spacing between the electrodes 6 set on the electrode 6 arm and the stability of the electrodes 6 being abutted, avoid the situation where a closed annular ablation circle cannot be formed due to unstable abutment and uneven spacing, achieve efficient ablation, and improve ablation efficiency and effect. In addition, a deformable closed annular catheter in this embodiment is further provided with a deformation segment 52 to release stress during the process of the head end structure 1 moving in or out of the sheath segment 3, so that the head end structure 1 can maintain a stable structural shape and have sufficient strength and reliability in any state during the process of moving in or out of the sheath segment 3, which can further ensure the spacing between the electrodes 6 set on the head end structure 1 and the stability of the electrodes 6 being abutted, thereby quickly and stably forming a closed annular ablation circle.

[0061] 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 in the protection scope of the present invention.

Claims

1. A deformable closed annular conduit, characterized in that: The invention comprises a head end structure (1), a core tube segment (2) and a sheath tube segment (3), wherein the head end structure (1) comprises a joint portion (4) and a plurality of support arms (5), wherein the joint portion (4) is connected to the core tube segment (2), and the sheath tube segment (3) is sleeved on the core tube segment (2), and the core tube segment (2) can move coaxially with the sheath tube segment (3) so that the head end structure (1) moves into or out of the sheath tube segment (3); A plurality of support arms (5) are evenly distributed at one end of the joint portion (4) away from the core tube section (2), the support arm (5) comprising a support member wire (51) and an isolation layer, the support member wire (51) passing through the isolation layer, and both ends of the support member wire (51) being connected to or integrally formed with the joint portion (4); adjacent support arms (5) form a merging arm (53) at a side close to the joint portion (4), the support arm (5) being provided with a plurality of electrodes (6), and at least some of the electrodes (6) being distributed on the merging arm (53); A deformation section (52) is provided in the middle of the support arm (5), and the deformation section (52) has a different strain from the associated support member wire (51).

2. A deformable closed annular conduit according to claim 1, characterized in that: The deformation section (52) is symmetrically truncated from both ends to the middle, and the truncation dimension of the middle part of the deformation section (52) is 0.05 mm or less and 3 mm or less. The deformation section (52) is integrally formed or connected with the supporting member wire (51).

3. A deformable closed annular conduit according to claim 1, characterized in that: The deformation section (52) comprises a spring coil section (521), and the spring coil section (521) is connected to the supporting member wire (51) or is formed by winding the supporting member wire (51) in one piece.

4. A deformable closed annular conduit according to claim 1, characterized in that: One end of the support member wire (51) is integrally formed or connected with the connecting portion (4), and the other end of the support member wire (51) is provided with a limiting member (511); The combination portion (4) is provided with a limiting groove (41), and the limiting member (511) is nested and connected with the limiting groove (41); The coupling portion (4) is provided with a limiting ring (7), the limiting ring (7) is sleeved outside the limiting groove (41), and the limiting ring (7) at least covers the two end portions of the limiting member (511) in the axial direction.

5. A deformable closed annular conduit according to claim 4, characterized in that: The connecting portion (4) is a cylindrical structural member, and a plurality of through-channels (81) are arranged in the connecting portion (4). The through-channels (81) are used to form perfusion channels (82) or to pass wires (61). The limiting groove (41) is arranged in the connecting portion (4) and passes through the outer wall of the connecting portion (4).

6. A deformable closed annular conduit according to claim 4, characterized in that: The connecting portion (4) is a circular ring-shaped structural member, an insert (8) is arranged inside the connecting portion (4), the insert (8) is provided with a plurality of through-channels (81), the through-channels (81) are used to form perfusion channels (82) or to pass wires (61), and the limiting groove (41) is arranged on the connecting portion (4) and passes through the inner wall and the outer wall of the connecting portion (4).

7. A deformable closed annular conduit according to any one of claims 1 to 6, characterized in that: When the head end structure (1) is completely moved out of the sheath section (3), the support arm (5) has a first arc segment (54), a first straight segment (55), an outer ring segment (56), a second straight segment (57) and a second arc segment (58) which are arranged in sequence, the first arc segment (54) and the second arc segment (58) are respectively deflected in a direction away from the center of the joint (4), a plurality of the outer ring segments (56) are located in the same plane, and the deformation segment (52) is arranged in the middle of the outer ring segment (56); The first straight segment (55) and the second straight segment (57) of the adjacent supporting member wires (51), and / or the first arc segment (54) and the second arc segment (58) form the merging arm (53), and the merging arm (53) is formed by integrally molding, tubing wrapping, gluing or welding the adjacent supporting member wires (51).

8. The deformable closed annular conduit according to claim 1, characterized in that: The head end structure (1) comprises no less than three supporting member wires (51), and the maximum size of the cross-section of each supporting member wire (51) does not exceed 1 mm; each supporting member wire (51) is provided with an electrode (6), the length of the electrode (6) is 0.5-5 mm, and the spacing between adjacent electrodes (6) is 1-6 mm.

9. The deformable closed annular conduit according to claim 1, characterized in that: The combining portion (4) and the supporting arm (5) are respectively provided with a positioning member (9), and the positioning member (9) is any one of a 5D magnetic positioning sensor, a 6D magnetic positioning sensor and an RFID tag, and the positioning member (9) is connected to a three-dimensional positioning system.

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

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