Catheter and method of operating same, in situ fenestration system

Abstract

This application provides a catheter, its operating method, and an in-situ fenestration system. The catheter includes a catheter body, an anchoring mechanism, and a handle. The catheter body includes a main segment and an adjustable bend segment disposed at the distal end of the main segment. The anchoring mechanism is disposed in the main segment and has an extended state and a retracted state. In the extended state, the anchoring mechanism is adapted to conform to the blood vessel wall. The handle includes a housing disposed at the proximal end of the catheter body, and an adjustment mechanism and a release mechanism disposed in the housing. In the catheter, its operating method, and the in-situ fenestration system of this application embodiment, an anchoring mechanism is provided in the main segment of the catheter body. This provides support for the catheter during actual use, reduces the probability of the catheter body shaking and shifting during in-situ fenestration operations, improves the success rate of in-situ fenestration, and reduces the risk of blood vessel puncture.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to the design of a catheter and its operation method, and an in-situ fenestration system. Background Technology

[0002] In situ fenestration is a technique used during endovascular treatment to reconstruct branch arteries, particularly suitable for complex abdominal aortic diseases involving visceral areas or the aortic arch. This technique allows operators to create openings (i.e., "fenestrations") within an already placed covered stent to maintain blood flow to critical branch vessels, thereby preventing complications such as organ ischemia.

[0003] Taking the thoracic and abdominal aortic region as an example, the thoracic and abdominal aorta gives rise to four visceral arteries (caecilia, superior mesenteric artery, left renal artery, and right renal artery). The openings of these visceral arteries are relatively close together, and the spacing and angles between their branches are not clearly defined. Therefore, when endovascular repair is used to treat lesions involving the thoracic and abdominal aorta, there are problems such as requiring too many different sizes of covered stent products, high operational difficulty, and altering the location of branch vessel inlets.

[0004] By applying in situ fenestration technology, the need for visceral artery reconstruction can be met by using only conventional straight covered stents. This can solve the problem of excessive covered stent sizes required for endovascular isolation of the thoracic and abdominal aorta, and the problem of altering the inlet position of branch vessels during reconstruction.

[0005] In-situ fenestration devices in related technologies have problems such as low success rate of fenestration and high risk of puncturing blood vessels. Summary of the Invention

[0006] This application provides a catheter and its operation method, as well as an in-situ fenestration system, which can provide stable support for the membrane rupture device during in-situ fenestration, thereby improving the success rate of in-situ fenestration and reducing the risk of puncturing blood vessels during fenestration.

[0007] A first aspect of this application provides a catheter, comprising: a catheter body including a main body segment and an adjustable bend segment disposed at the distal end of the main body segment; an anchoring mechanism disposed on the main body segment, the anchoring mechanism having an extended state and a retracted state, wherein, in the extended state, the anchoring mechanism is adapted to conform to the blood vessel wall; and a handle including a housing disposed at the proximal end of the catheter body, and an adjusting mechanism and a release mechanism disposed on the housing, the adjusting mechanism being used to control the bending or repositioning of the adjustable bend segment, and the release mechanism being used to control the extension or retraction of the anchoring mechanism.

[0008] In some embodiments, the bending mechanism is configured to control the adjustable bending segment to bend or reset in one direction.

[0009] In some embodiments, the adjustable bend is configured as an elastic structure, and the bend adjustment mechanism includes a traction wire connected to one side wall of the adjustable bend along the radial direction of the conduit. When the distal end of the traction wire moves toward the proximal end of the conduit, it causes the adjustable bend to bend toward the side where the traction wire is located.

[0010] In some embodiments, the adjustable bend has a plurality of perforated grooves formed on one side of the conduit toward the traction wire along the radial direction, and the plurality of perforated grooves are spaced apart along the axial direction of the conduit.

[0011] In some embodiments, the plurality of perforated grooves divide the adjustable bend into a plurality of first sub-segments and at least one second sub-segment, the distal end of the adjustable bend being configured as the first sub-segment, the second sub-segment protruding from the first sub-segment along the radial direction of the conduit, and the traction wire passing through the lumen of the second sub-segment and located outside the lumen of the first sub-segment.

[0012] In some embodiments, the catheter body includes one or more limiting members connected to the adjustable bend, the limiting members having limiting holes extending through the axial direction of the catheter, and the traction wire passing through the limiting holes.

[0013] In some embodiments, the bending mechanism includes a bending operation part and a movable part, the traction wire connects the bending operation part and the movable part, the bending operation part is at least partially exposed in the housing, the bending operation part can drive the movable part to move relative to the housing, and when the movable part moves relative to the housing, it drives the traction wire to move along the axial direction of the conduit.

[0014] In some embodiments, the bending adjustment part is configured to rotate relative to the housing about the axial direction of the conduit, and the bending adjustment part and the movable member form a threaded engagement so that when the bending adjustment part rotates relative to the housing, it drives the movable member to move linearly relative to the housing along the axial direction of the conduit.

[0015] In some embodiments, the anchoring mechanism includes an anchoring basket, and the release mechanism includes a release operation part and a transmission part. The distal end of the anchoring basket is connected to the conduit body, and the proximal end is connected to the transmission part. The release operation part can drive the transmission part to move linearly along the axial direction of the conduit to expand or retract the anchoring basket.

[0016] In some embodiments, the release operation unit includes a gear, the transmission unit includes a rack, and the gear and the rack mesh.

[0017] In some embodiments, the anchoring mechanism includes an anchoring basket with its proximal end connected to the catheter body and its distal end being a free end. The release mechanism includes a sheath slidably disposed outside the catheter body so that the anchoring basket can be retracted into or released from the sheath.

[0018] In some embodiments, the anchoring mechanism includes a balloon, and the release mechanism includes a channel communicating with the balloon.

[0019] The second aspect of this application provides a method for operating a catheter, applied to the catheter described in the first aspect of this application. The method includes: delivering the catheter body to a main blood vessel; bending an adjustable section of the catheter body to point towards a branch blood vessel; and switching the anchoring mechanism to an extended state and abutting against the wall of the main blood vessel.

[0020] A third aspect of the present application provides an in-situ fenestration system, the in-situ fenestration system including the conduit described in the first aspect of the present application, and a membrane breaking device, which is detachably disposed on the conduit body.

[0021] In some embodiments, the membrane rupture device includes a membrane rupture needle and a rotating operating part connected to the proximal end of the membrane rupture needle. The membrane rupture needle has a guide wire passage cavity, and the rotating operating part is configured to drive the membrane rupture needle to rotate about its own axis.

[0022] In some embodiments, the membrane-breaking needle includes a needle tube body and a hollow area disposed in the needle tube body, the hollow area extending circumferentially spirally along the needle tube body, and having a plurality of discontinuously distributed through grooves in the hollow area.

[0023] In some embodiments, each of the through slots extends spirally along the circumference of the needle tube body; and / or, the hollow area has a plurality of through slots arranged side by side along the axial direction of the needle tube body.

[0024] In some embodiments, the membrane-breaking needle includes a needle tube body and a plurality of through grooves disposed on the needle tube body. The needle tube body has a plurality of reference lines that extend spirally along the circumference of the needle tube body. The plurality of reference lines are staggered and distributed, and each reference line is provided with a plurality of through grooves that are discontinuously distributed.

[0025] In some embodiments, along the axial direction of the needle body, the distribution density of the reference line in at least one region of the needle body is higher than the distribution density of the reference line in other regions.

[0026] In some embodiments, the rotating operating part includes an operating body and a locking member disposed on the operating body. The locking member has a locked position and an unlocked position. In the unlocked position, the operating body is capable of moving along the axial direction of the membrane-breaking needle. In the locked position, the relative position of the operating body and the membrane-breaking needle is fixed.

[0027] In the catheter and its operation method, and in-situ fenestration system of this application embodiment, an anchoring mechanism is provided in the main body of the catheter. This provides support for the catheter during actual use, reducing the probability of the catheter body shaking or shifting during in-situ fenestration, improving the success rate of in-situ fenestration, and reducing the risk of blood vessel puncture. Furthermore, in the catheter of this application embodiment, the anchoring mechanism and the release mechanism are integrated into the catheter. Thus, after the catheter body is delivered in place, the anchoring mechanism can be directly deployed to support and fix the catheter body without the need for additional anchoring devices, which helps improve operational convenience, reduce operational difficulty, and lower usage costs. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the structure of a conduit according to an embodiment of this application, wherein the adjustable bend is in an unbent state and the anchoring mechanism is in a retracted state; Figure 2 yes Figure 1 A schematic diagram of the axial section of the conduit, in which the adjustable bend is in a bent state and the anchoring mechanism is in a retracted state; Figure 3 yes Figure 1 A schematic diagram of another usage state of the conduit, in which the anchoring mechanism is in the deployed state; Figure 4 yes Figure 2 A magnified view of part A in the middle; Figure 5 This is a schematic diagram of the structure of an adjustable bending section according to an embodiment of this application; Figure 6 This is a schematic diagram of the adjustable bending section according to another embodiment of this application; Figure 7 for Figure 5 A schematic diagram of the adjustable bending section in a bending state; Figure 8 for Figure 5 A schematic diagram of the radial section of the adjustable bend in the middle; Figure 9 This is a schematic diagram of the adjustable bending section according to another embodiment of this application; Figure 10 This is a schematic diagram of the adjustable bending section according to another embodiment of this application; Figure 11 for Figure 9 Schematic diagram of the radial section of the adjustable bending segment; Figure 12 This is a schematic diagram of the conduit according to another embodiment of this application, wherein the anchoring mechanism is in the deployed state; Figure 13 This is a schematic diagram of the structure of a catheter according to another embodiment of the present application, wherein the anchoring mechanism is in a retracted state; Figure 14 for Figure 13 A schematic diagram of another usage state of the conduit, in which the anchoring mechanism is in the deployed state; Figure 15 This is a schematic diagram of the structure of a catheter according to another embodiment of this application, wherein the anchoring mechanism is in a retracted state; Figure 16 for Figure 15 A schematic diagram of another usage state of the conduit, in which the anchoring mechanism is in the deployed state; Figure 17 This is a schematic flowchart illustrating the catheter operation method according to an embodiment of this application; Figure 18 This is a schematic diagram of the in-situ window opening system according to an embodiment of this application; Figure 19 This is a schematic diagram of the membrane breaking device according to an embodiment of this application; Figure 20 This is a schematic diagram of the structure of a membrane-breaking needle according to an embodiment of this application; Figure 21 This is a schematic diagram of the structure of a membrane-breaking needle according to another embodiment of this application.

[0029] Explanation of reference numerals in the attached figures 1000, In-situ window opening system; 100, Conduit; 1, Conduit body; 11, Main section; 12, Adjustable bending section; 12a, Hollowed-out groove; 121, First sub-section; 122, Second sub-section; 13, Limiting component; 2, Anchoring mechanism; 21, Anchoring basket; 22, Ball bladder; 3, Handle; 31, Housing; 32, Bending mechanism; 321, Traction wire; 322, Bending operation part; 3221, Slide groove; 3222, Internal thread; 323, Movable part; 3 231. External thread; 33. Release mechanism; 331. Release operating part; 3311. Gear; 332. Transmission part; 3321. Rack; 333. Tube sheath; 334. Channel; 200. Membrane breaking device; 201. Membrane breaking needle; 201a. Guide wire passage cavity; 2011. Needle tube body; 2011a. Hollowed-out area; 2011b. Reference line; 2012. Through groove; 202. Rotation operating part; 2021. Operating body; 2022. Locking element. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.

[0031] The specific technical features described in the specific embodiments can be combined in any suitable manner without contradiction. For example, different combinations of specific technical features can form different embodiments and technical solutions. To avoid unnecessary repetition, the various possible combinations of the specific technical features in this application will not be described separately.

[0032] In the following description, the terms "first," "second," etc., are used merely to distinguish different objects and do not indicate that the objects have the sameness or relationship. It should be understood that the directional descriptions "above," "below," "outside," and "inside" refer to the orientation under normal use conditions, while "left" and "right" refer to the left and right directions shown in the corresponding diagrams, which may or may not be the left and right directions under normal use conditions.

[0033] It should be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element. "A plurality of" means two or more.

[0034] In the description of the embodiments of this application, the technical terms "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "circumferential", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the embodiments of this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed, operated or used in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of this application.

[0035] In the description of the embodiments of this application, unless otherwise expressly specified and limited, technical terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of this application according to the specific circumstances.

[0036] In the description of the embodiments of this application, unless otherwise expressly specified and limited, the technical term "contact" should be interpreted broadly, and can be direct contact, contact through an intermediate medium layer, contact between two contacting parties with substantially no interaction force, or contact between two contacting parties with interaction force.

[0037] In this application, the distal end refers to the end of the catheter and at least some of the components constituting the catheter that are exemplary away from the operator during use (or, the distal end refers to the end of the catheter that, exemplary when used on a living organism, first contacts / intervenes in the tissues of the organism), and the proximal end refers to the end of the catheter and at least some of the components constituting the catheter that, exemplary when used on a living organism, is close to the operator (or, the proximal end refers to the end of the catheter / device / system and at least some of the components constituting the catheter / device / system that, exemplary when used on a living organism, is further away from the tissues of the organism than the distal end).

[0038] The embodiments of this application first provide a catheter, exemplarily, referring to... Figure 18 The conduit 100 is used to deliver the membrane rupture device 200 when opening a window in situ.

[0039] Reference Figures 1-4 The catheter 100 of this application embodiment includes a catheter body 1, an anchoring mechanism 2, and a handle 3. The catheter body 1 includes a main body segment 11 and an adjustable bend segment 12 disposed at the distal end of the main body segment 11. The anchoring mechanism 2 is disposed on the main body segment 11 and has an extended state and a retracted state. In the extended state, the anchoring mechanism 2 is adapted to conform to the blood vessel wall. The handle 3 includes a housing 31 disposed at the proximal end of the catheter body 1, and an adjusting mechanism 32 and a release mechanism 33 disposed on the housing 31. The adjusting mechanism 32 is used to control the bending or repositioning of the adjustable bend segment 12, and the release mechanism 33 is used to control the extension or retraction of the anchoring mechanism 2.

[0040] For example, the catheter body 1 is used to engage with the membrane rupture device 200. In other words, the catheter body 1 is configured to allow the membrane rupture device 200 to be inserted or removed. Here, the membrane rupture device 200 is used to perform the membrane rupture operation when opening a window in situ. The membrane rupture device 200 includes, but is not limited to, a flexible membrane rupture needle known to those skilled in the art.

[0041] Reference Figure 1 and Figure 2 The adjustable bend 12 specifically refers to a tubular structure that can be bent and reset relative to the main body 11. The specific structural form of the adjustable bend 12 is not limited; for example, it can be configured as a spring tube structure, a serpentine structure, a slotted tube structure, etc., without limitation. It can be understood that the adjustable bend 12 is formed as the distal end of the conduit 100.

[0042] The bending mechanism 32 is used to control the bending or resetting of the adjustable bending section 12. The specific structural form of the bending mechanism 32 is not limited. For example, the bending mechanism 32 includes a traction structure connected to the adjustable bending section 12. The bending mechanism 32 drives the adjustable bending section 12 to bend and reset by controlling the movement of the traction structure.

[0043] For example, in actual use, the catheter body 1 can first be delivered into the main blood vessel, and then the bending mechanism 32 can be operated to control the bending of the adjustable section 12 so that the adjustable section 12 points towards the branch blood vessel. In this way, when the membrane rupture device 200 (e.g., a flexible membrane rupture needle) is delivered by means of the catheter body 1, the distal end of the membrane rupture device 200 can be guided by the adjustable section 12 to point towards the branch blood vessel, thereby enabling the operator to operate the membrane rupture device 200 to complete the in-situ fenestration operation.

[0044] This application proposes that when the operator operates the membrane rupture device 200 to perform a fenestration operation, the membrane rupture device 200 will generate a reaction force, causing the catheter 100 to shake during the membrane rupture process. This results in the distal end of the membrane rupture device 200 being unable to accurately point to the branch blood vessel, leading to a decrease in the success rate of in-situ fenestration and an increase in the risk of puncturing the blood vessel.

[0045] In response to the above problems, refer to Figure 2 and Figure 3 In this embodiment, the conduit 100 is further provided with an anchoring mechanism 2, which is located on the main body section 11, that is, on the proximal side of the adjustable bend section 12. The anchoring mechanism 2 has an extended state and a retracted state, as shown in the figure. Figure 1 and Figure 2 During the delivery of the catheter body 1, the anchoring mechanism 2 is in a retracted state, as shown in the reference. Figure 3After the catheter body 1 is delivered into place and the distal end of the adjustable bend 12 points towards the branch vessel, the operator can operate the release mechanism 33 to switch the anchoring mechanism 2 from the retracted state to the extended state, so that the anchoring mechanism 2 fits against the vessel wall of the main vessel. In this way, the anchoring mechanism 2 can provide support and fixation for the catheter body 1, reducing the probability of the catheter body 1 shaking during the in-situ fenestration operation, thereby helping to improve the success rate of in-situ fenestration and reduce the risk of puncturing the vessel.

[0046] In this embodiment, the specific structural form of the anchoring mechanism 2 is not limited. For example, the anchoring mechanism 2 may include a self-expanding structure, such as a net basket, etc., or, for example, a passively expanding structure, such as a balloon 22, etc. The structure of the release mechanism 33 can be specifically determined according to the structure of the anchoring mechanism 2, as long as it can control the unfolding or retraction of the anchoring device.

[0047] It should be noted that in this embodiment, the number of anchoring mechanisms 2 can be one or more. In the case of multiple anchoring mechanisms 2, the multiple anchoring mechanisms 2 are distributed along the axial direction of the guide tube 100 in the main body section 11.

[0048] In the catheter 100 of this embodiment, an anchoring mechanism 2 is provided in the main body section 11 of the catheter body 1. This provides support for the catheter 100 during actual use, reducing the probability of the catheter body 1 shaking or shifting during in-situ fenestration, improving the success rate of in-situ fenestration, and reducing the risk of puncturing blood vessels. Furthermore, in the catheter 100 of this embodiment, the anchoring mechanism 2 and the release mechanism 33 are integrated into the catheter 100. Thus, after the catheter body 1 is delivered to its position, the anchoring mechanism 2 can be directly deployed to support and fix the catheter body 1 without the need for additional anchoring devices, which helps improve operational convenience, reduce operational difficulty, and lower usage costs.

[0049] In some embodiments, the bending mechanism 32 is configured to control the adjustable bending segment 12 to bend or reset in one direction.

[0050] Here, the bending mechanism 32 is configured to control the adjustable bending section 12 to bend or reset in one direction. Specifically, the bending mechanism 32 can only control the adjustable bending section 12 to bend in one direction and reset in the opposite direction.

[0051] It should be noted that, in this embodiment, the adjustable bending segment 12 itself can be configured to only bend in one direction. Alternatively, the adjustable bending segment 12 itself can be configured to bend in multiple directions or even in any direction, but the bending mechanism 32 is configured to only control the adjustable bending segment 12 to bend in one of the directions.

[0052] In this embodiment, the bending mechanism 32 is configured to control the unidirectional bending of the adjustable bending segment 12. This helps to simplify the structure, reduce manufacturing difficulty and assembly cost. On the other hand, the unidirectional bending of the adjustable bending segment 12 helps to reduce the difficulty of operation and the possibility of misoperation, and also helps to improve the positional stability of the adjustable bending segment 12 after bending. Thus, it helps to further improve the success rate of in-situ window opening and reduce the possibility of puncturing blood vessels.

[0053] In some embodiments, refer to Figures 5-7 The adjustable bend 12 is configured as an elastic structure. The bending mechanism 32 includes a traction wire 321. The traction wire 321 is connected to one side of the tube wall of the adjustable bend 12 along the radial direction of the conduit 100. When the distal end of the traction wire 321 moves toward the proximal end of the conduit 100, it causes the adjustable bend 12 to bend toward the side where the traction wire 321 is located.

[0054] When adjustment is needed, the operator can tighten the traction wire 321, causing the distal end of the traction wire 321 to move towards the proximal end of the catheter 100, thereby causing the adjustable section 12 to bend. When reset is needed, the operator can release the traction wire 321, and the adjustable section 12 will reset under its own elastic restoring force.

[0055] In this embodiment, the specific implementation of tensioning and releasing of the traction wire 321 can be referred to the relevant technology in the field. The relevant parts below will also give the specific implementation method, which will not be repeated here.

[0056] In this embodiment, this configuration only requires a traction wire 321 on one side to achieve unidirectional bending or resetting of the adjustable bending section 12. This helps to further reduce the difficulty and cost of manufacturing and assembly. On the other hand, it allows operators to achieve bending and resetting of the adjustable bending section 12 by operating only one traction wire 321, reducing the difficulty of operation and improving the convenience of operation.

[0057] Of course, in some other embodiments, the adjustable bending section 12 can also be configured as a non-elastic structure. In this embodiment, traction wires 321 can be provided on both sides of the adjustable bending section 12 in the radial direction. Bending or resetting can be achieved by tightening one side of the traction wire 321 and releasing the other side of the traction wire 321.

[0058] In some embodiments, exemplarily, reference Figure 5 and Figure 6 The adjustable bend 12 forms multiple hollow grooves 12a along the radial side of the conduit 100 toward the traction wire 321, and the multiple hollow grooves 12a are distributed at intervals along the axial direction of the conduit 100.

[0059] Here, the specific structural form of the hollowed-out groove 12a is not limited; for example, refer to... Figure 5The hollow groove 12a can be set as a V-shaped groove, or, refer to Figure 6 The cutout groove 12a can be set as a rectangular groove, or the cutout groove 12a can be any other suitable shape of groove.

[0060] In this embodiment, this arrangement makes the adjustable bending section 12 a unidirectional bending structure, which helps to reduce manufacturing difficulty and cost.

[0061] Of course, in some other embodiments, the adjustable bend 12 can also be configured as a structure such as a bellows or a spiral tube.

[0062] In some embodiments, refer to Figure 5 , Figure 6 and Figure 8 Multiple perforated grooves 12a divide the adjustable bend 12 into multiple first sub-segments 121 and at least one second sub-segment 122. The distal end of the adjustable bend 12 is set as the first sub-segment 121. Along the radial direction of the conduit 100, the second sub-segment 122 protrudes from the first sub-segment 121. The traction wire 321 passes through the lumen of the second sub-segment 122 and is located outside the lumen of the first sub-segment 121.

[0063] For example, along the axial direction of the conduit 100, the first segment 121 and the second segment 122 are alternately distributed.

[0064] For example, in the actual manufacturing process, multiple hollow grooves 12a can be formed on the adjustable bending section 12 first. The multiple hollow grooves 12a divide the adjustable bending section 12 into multiple sub-segments. Then, some of the sub-segments are pressed and shaped radially inward to form the first sub-segment 121, and the sub-segments that are not pressed are formed as the second sub-segment 122.

[0065] In this embodiment, this configuration can provide positional constraints for the traction wire 321 and improve the stability of the relative position between the traction wire 321 and the adjustable bend 12. This will help reduce the probability of changes in the bending angle of the adjustable bend 12, enabling the adjustable bend 12 to provide more stable and reliable bending guidance for the membrane rupture device 200, thereby further improving the success rate of in-situ fenestration and reducing the probability of puncturing blood vessels.

[0066] In some embodiments, refer to Figure 9 , Figure 10 and Figure 11 The catheter body 1 includes one or more limiting members 13 connected to the adjustable bend 12. The limiting member 13 has a limiting hole that extends through the axial direction of the catheter 100, and the traction wire 321 passes through the limiting hole.

[0067] For example, the limiting member 13 is configured as a tubular structure, and multiple hollow grooves 12a divide the adjustable bending section 12 into multiple sub-segments, with the limiting member 13 disposed on the outer side of at least some of the sub-segments. Similarly, in this embodiment, referring to... Figure 9 The perforated groove 12a can be a V-shaped groove with its opening facing the traction wire 321, or, refer to Figure 10 The cutout groove 12a can be a rectangular groove with its opening facing the traction wire 321, or the cutout groove 12a can be any other suitable shape of groove.

[0068] As a further example, in the actual manufacturing process, a first tube structure and a second tube structure can be manufactured side by side first, and then cut from the side where the second tube structure is located to form multiple hollow grooves 12a on the first tube structure. In this way, the first tube structure is formed into an adjustable bend 12, and the second tube structure is cut into multiple limiting members 13.

[0069] In this embodiment, this configuration can also provide positional constraints for the traction wire 321, improving the stability of the relative position between the traction wire 321 and the adjustable bend 12. This will help reduce the probability of changes in the bending angle of the adjustable bend 12, enabling the adjustable bend 12 to provide more stable and reliable bending guidance for the membrane rupture device 200, thereby further improving the success rate of in-situ window opening and reducing the probability of puncturing blood vessels.

[0070] In some embodiments, refer to Figure 4 The bending mechanism 32 includes a bending operation part 322 and a movable part. The movable part is disposed inside the housing 31. The bending operation part 322 is at least partially exposed on the outer surface of the housing 31. The traction wire 321 connects the adjustable bending section 12 and the movable part. When the bending operation part 322 is operated, it drives the movable part to move relative to the housing 31. When the movable part moves relative to the housing 31, it drives the traction wire 321 to move along the axial direction of the conduit 100 to bend or reset the adjustable bending section 12.

[0071] The specific structural form of the bending operation unit 322 and the movable part, as well as the specific movement mode when the bending operation unit 322 drives the movable part to move relative to the housing 31, are not limited, as long as it can drive the traction wire 321 to move along the axial direction of the guide tube 100 when the movable part moves relative to the housing 31.

[0072] The bending operation part 322 is partially or completely exposed on the outer surface of the housing 31, so that the operator can operate the bending operation part 322 by finger movements while holding the housing 31. The specific structural form of the bending operation part 322 is not limited, as long as the bending operation part 322 can drive the moving part to move relative to the housing 31 when it is operated.

[0073] For example, the bending operation unit 322 is configured to drive the movable member to move relative to the housing 31 along the axial direction of the conduit 100. The distal end of the traction wire 321 is fixed relative to the distal end of the adjustable bending section 12, and the proximal end is fixed relative to the movable member. In this way, when the movable member moves along the axial direction of the conduit 100, it can drive the traction wire 321 to move along the axial direction of the conduit 100.

[0074] As another example, the movable element is configured as a winding wheel that can rotate radially relative to the housing 31 about the conduit 100, with the proximal end of the traction wire 321 wound around the winding wheel, such that when the winding wheel rotates, it drives the distal end of the traction wire 321 to move along the axis of the conduit 100.

[0075] In an embodiment where the movable element is configured to move relative to the housing 31 along the axial direction of the conduit 100, exemplarily, refer to Figure 4 The bending mechanism 32 may include a fixed pulley disposed within the housing 31. The proximal end of the traction wire 321 is connected to the movable component via the fixed pulley. The fixed pulley provides constraint and guidance for the movement of the traction wire 321, thereby improving the stability and reliability of the movement of the traction wire 321. Of course, the proximal end of the traction wire 321 may also be directly connected to the movable component without using a fixed pulley.

[0076] Furthermore, in an embodiment where the movable component is configured to move relative to the housing 31 along the axial direction of the conduit 100, the bending operation part 322 may, exemplarily, be configured to slide in conjunction with the housing 31 along the axial direction of the conduit 100, thereby allowing an operator to move the movable component relative to the housing 31 along the axial direction of the conduit 100 by sliding the bending operation part 322. Also exemplarily, the bending operation part 322 may be rotatably connected to the housing 31, thereby allowing an operator to move the movable component relative to the housing 31 along the axial direction of the conduit 100 by rotating the bending operation part 322.

[0077] In this embodiment, the bending mechanism 32 is integrated into the housing 31. In actual use, the user can hold the housing 31 and operate the bending operation part 322 with the movement of the fingers to bend and reset the adjustable bending section 12, which helps to improve the ease of operation.

[0078] In some embodiments, the bending operation part 322 is configured to rotate relative to the housing 31 about the axial direction of the conduit 100. The bending operation part 322 and the movable member form a threaded engagement so that when the bending operation part 322 rotates relative to the housing 31, it drives the movable member to move linearly along the axial direction of the conduit 100 relative to the housing 31.

[0079] For example, refer to Figure 4The bending operation part 322 is configured to have a slide groove 3221 extending along the axis of the guide tube 100. An internal thread 3222 is provided in the slide groove 3221. The movable part is configured as a screw structure with an external thread 3231 and is configured to engage with the housing 31 to prevent rotation. In this way, when the operator rotates the bending operation part 322, the movable part can be driven to move along the axis of the housing 31.

[0080] As another example, the bending operation unit 322 and the movable part can be configured as a ball screw structure.

[0081] In this embodiment, the bending operation part 322 and the movable part form a threaded engagement. This helps to improve the adjustment accuracy during the bending operation, allowing the adjustable bending section 12 to more accurately point to the branch blood vessel and provide more precise guidance for the membrane rupture device 200. On the other hand, it helps to improve the positional stability of the movable part, thereby reducing the possibility of the bending angle of the adjustable bending section 12 changing unexpectedly. This allows the adjustable bending section 12 to provide more stable and reliable bending guidance for the membrane rupture device 200, thereby further improving the success rate of in-situ fenestration and reducing the probability of puncturing blood vessels.

[0082] In some embodiments, refer to Figure 3 and Figure 12 Anchoring mechanism 2 includes anchoring basket 21, as shown in the reference. Figure 4 The release mechanism 33 includes a release operation part 331 and a transmission part 332. The distal end of the anchoring basket 21 is connected to the conduit body 1, and the proximal end is connected to the transmission part 332. The release operation part 331 can drive the transmission part 332 to move linearly along the axial direction of the conduit 100 to make the anchoring basket 21 unfold or retract.

[0083] Here, the specific structural form of the anchoring basket 21 is not limited, as long as it can conform to the blood vessel wall in the unfolded state. For example, refer to Figure 3 The anchoring basket 21 can be configured as a woven basket, for example, a basket woven from shape memory metal wire (e.g., spun titanium alloy), or, refer to Figure 13 The anchor basket 21 can be configured as a cut basket, for example, a basket formed by cutting a shape memory metal tube (e.g., nickel-titanium alloy), without limitation.

[0084] The specific structural form of the release operation unit 331 and the transmission unit 332 is not limited, as long as the release operation unit 331 can drive the transmission unit 332 to move linearly along the axial direction of the conduit 100.

[0085] In this embodiment, the distal end of the anchoring basket 21 is connected to the conduit body 1, and the proximal end is connected to the transmission part 332. When the transmission part 332 moves toward the distal end along the axial direction of the conduit 100, it will push the proximal end of the anchoring basket 21 toward the distal end of the conduit body 1 (that is, in the direction where the adjustable bend 12 is located), causing the anchoring basket 21 to expand radially and move towards the unfolded state. When the transmission part 332 moves toward the proximal end along the axial direction of the conduit 100, it will pull the proximal end of the anchoring basket 21 toward the proximal end of the conduit body 1 (that is, away from the adjustable bend 12), thereby causing the anchoring basket 21 to contract radially and move towards the closed state. Understandably, the radial expansion and contraction of the anchoring basket 21 are related to the amount of movement of the transmission part 332 along the axial direction of the catheter 100. Therefore, in actual use, the operator can control the diameter of the anchoring basket 21 in the unfolded state by adjusting the amount of movement of the transmission part 332, so that the anchoring basket 21 can be adapted to blood vessel walls of different diameters and improve its versatility.

[0086] In some embodiments, refer to Figure 4 The release operation unit 331 includes a gear 3311, and the transmission unit 332 includes a rack 3321. The gear 3311 and the rack 3321 mesh.

[0087] For example, the transmission part 332 includes a transmission tube sleeved on the outside of the guide tube body 1, a rack 3321 connected to the proximal end of the transmission tube, and the proximal end of the anchoring basket 21 connected to the distal end of the transmission tube.

[0088] In this embodiment, the release operation unit 331 and the transmission unit 332 are configured as a gear 3311-rack 3321 transmission structure. This helps to improve the adjustment accuracy of the transmission unit 332 when the operator operates the release operation unit 331 to adjust the position of the transmission unit 332, thereby enabling the operator to more accurately control the diameter of the anchoring basket 21. On the other hand, it helps to improve the positional stability of the transmission unit 332, reduce the possibility of accidental displacement of the transmission unit 332, and enable the anchoring basket 21 to provide more stable and reliable support for the catheter body 1, thereby further improving the success rate of in-situ fenestration and reducing the risk of puncturing blood vessels.

[0089] In some embodiments, refer to Figure 13 and Figure 14 The anchoring mechanism 2 includes an anchoring basket 21, the proximal end of which is connected to the catheter body 1 and the distal end is a free end. The release mechanism 33 includes a sheath 333, which is slidably disposed on the outside of the catheter body 1 so that the anchoring basket 21 can be retracted into or released from the sheath 333.

[0090] Similar to the above embodiments, in this embodiment, the anchoring basket 21 can be a woven basket or a cut basket, and there is no limitation on the latter.

[0091] For example, during delivery, the anchoring basket 21 can be retracted into the sheath 333. After the catheter body 1 is delivered in place and the adjustable bend 12 points towards the branch vessel, the operator can retract the sheath 333 or push the catheter body 1 forward to release the anchoring basket 21 from the sheath 333. After being released, the anchoring basket 21 can expand radially under its own expansion force, thereby switching to the unfolded state. After the fenestration operation is completed, the operator can push the sheath 333 forward or retract the catheter body 1 to retract the anchoring basket 21 back into the sheath 333.

[0092] Understandably, in this embodiment, the anchor basket 21 can adapt to blood vessels of different diameters through its own expansion force.

[0093] Compared with the above embodiments, in this embodiment, this arrangement helps to reduce the manufacturing difficulty and cost of the catheter 100, and improves the ease of operation when the anchoring mechanism 2 is released and retrieved.

[0094] In some embodiments, refer to Figure 15 and Figure 16 The anchoring mechanism 2 includes a balloon 22, and the release mechanism 33 includes a channel 334 communicating with the balloon 22.

[0095] Here, the specific structural form of the channel 334 is not limited, as long as it can enable the introduction of gas into the balloon 22 or the discharge of gas from the balloon 22. For example, the proximal end of the channel 334 can be fixed relative to the housing 31 and the axis of the proximal end can intersect with the axis of the conduit 100. The channel 334 can be configured as a Y-shaped tube fixed relative to the housing 31, thereby improving the ease of operation.

[0096] For example, during delivery, the balloon 22 can be in an uninflated state. After the catheter body 1 is delivered in place and the adjustable bend 12 points to the branch vessel, the operator can introduce gas into the balloon 22 through the channel 334 to inflate the balloon 22 and switch it to the deployed state. After the fenestration operation is completed, the operator can expel the gas from the balloon 22 through the channel 334, thereby switching the balloon 22 to the retracted state.

[0097] Compared to the embodiment of the anchoring mechanism 2 including the anchoring basket 21 described above, this embodiment has lower manufacturing difficulty and cost, and is more convenient to operate. Furthermore, the embodiment of the anchoring mechanism 2 including the anchoring basket 21 can better adapt to blood vessels of different diameters.

[0098] Embodiments of this application also provide a method for operating a catheter, applied to the catheter 100 described in any of the above embodiments, referring to... Figure 17 The catheter operation method includes the following steps: Step S101: Deliver the catheter body 1 to the main blood vessel.

[0099] Step S102: Bend the adjustable bend 12 of the catheter body 1 to point towards the branch vessel.

[0100] Step S103: Switch the anchoring mechanism 2 to the unfolded state and make it fit against the vessel wall of the main blood vessel.

[0101] In this embodiment, the specific implementation of each step can be referred to the description in the relevant parts above, and will not be repeated here.

[0102] The catheter manipulation method of this application helps to improve the stability of the position of the catheter body 1 during in-situ fenestration, thereby helping to improve the success rate of in-situ fenestration and reduce the risk of puncturing blood vessels.

[0103] Reference Figure 18 The embodiments of this application also provide an in-situ fenestration system 1000, including a conduit 100 as described in any of the above embodiments, and a membrane breaking device 200, which is detachably disposed on the conduit body 1.

[0104] The in-situ fenestration system 1000 of this application embodiment has all the advantages of the conduit 100 described in any of the above embodiments, and will not be repeated here.

[0105] Furthermore, this application proposes that the membrane-breaking device in the relevant technology has defects, resulting in long in-situ fenestration surgery time and high failure rate, for the following specific reasons.

[0106] Some related techniques use solid needles (such as TIPS puncture needles) for fenestration. This application points out that solid needles have drawbacks: they are too stiff, making it difficult to pass through tortuous access routes and easily puncturing the access vessels, causing damage. Furthermore, after the needle punctures the diaphragm, the outer cannula has difficulty passing through the diaphragm, easily leading to fenestration failure. After the outer cannula passes through the diaphragm, the needle needs to be withdrawn and the guidewire inserted; this process easily causes the outer cannula to detach from the pre-drilled diaphragm hole, resulting in fenestration failure. In addition, the diameter of the hole perforated by a solid needle is small, requiring a non-compliant balloon to drill a larger hole in the diaphragm to pass through, thus leading to longer operation times and higher failure rates for in-situ fenestration.

[0107] Other related techniques use biopsy needles for fenestration. This application points out that biopsy needles also suffer from problems such as excessively stiff needles, difficulty in navigating tortuous access routes, and the risk of puncturing blood vessels and causing damage. Furthermore, biopsy needles can easily get stuck in guidewires under bending conditions, causing the guidewire to detach from the pre-drilled endovascular opening and resulting in fenestration failure. In addition, the diameter of the puncture hole created by the biopsy needle is relatively small, requiring a non-compliant balloon to drill a large endovascular opening to pass through, leading to longer procedure times and a higher failure rate.

[0108] In some related technologies, a flexible needle is used to puncture the endovascular stent graft, and a .018" guidewire is inserted into the needle. After puncture, the guidewire is left in place. After the puncture needle and guiding catheter are withdrawn, a non-compliant balloon is inserted along the guidewire. This application points out the following problems with this product: 1. The needle extension length beyond the guiding catheter is only selectable in a few increments, making puncture difficult when the branch vessels and aorta deflect at large angles. 2. The puncture orifice is too small, making it difficult for the non-compliant balloon to pass through the endovascular stent graft. Multiple non-compliant balloons are required for progressive expansion, and guidewires need to be exchanged (after fenestration, a .035" guidewire is needed to deliver the endovascular stent graft), resulting in high consumable costs and a long operation time. 3. The fenestration center position lacks selectability relative to the branch vessel opening position (with a balloon guiding catheter, the fenestration center position is relatively consistent with the vessel's central opening position; without a balloon catheter, the position is random and uncontrollable). 4. Membrane rupture is highly dependent on needle sharpness. This needle is designed to be exceptionally sharp, easily puncturing the guiding catheter and subsequently the opening of the access vessel or branch vessel, posing a high operational risk. 5. The catheter body has a prominent groove design, posing a risk of needle jamming with the membrane. 6. The needle and catheter body are welded together; under severe twisting conditions, there is a risk of needle detachment.

[0109] This application summarizes and analyzes the relevant technologies mentioned above, concluding that fenestration relies on the sharpness of the needle, while guidewire delivery depends on the diameter of the needle tubing. These two aspects cannot be simultaneously optimized, leading to the aforementioned problems. Specifically, needle length and tubing diameter are proportional; to maintain the same penetration performance, a thicker tubing results in a sharper needle, but also a higher risk of puncturing a blood vessel during delivery. Furthermore, the needle is a rigid structure; the longer the needle, the worse its ability to navigate tortuous pathways. Additionally, during fenestration, the needle tip risks puncturing the contralateral endothelial membrane and blood vessel.

[0110] Based on this, the technical solution of this application is proposed.

[0111] Specifically, in this embodiment, the membrane breaking device 200 includes a membrane breaking needle 201 and a rotating operation part 202 connected to the proximal end of the membrane breaking needle 201. The membrane breaking needle 201 has a guide wire passage cavity 201a, and the rotating operation part 202 is configured to drive the membrane breaking needle 201 to rotate around its own axis.

[0112] Here, the specific structural form of the rotating operating part 202 is not limited. For example, the rotating operating part 202 and the membrane rupture needle 201 form an anti-rotation cooperation so that the operator can drive the membrane rupture needle 201 to rotate around its own axis by rotating the rotating operating part 202.

[0113] In this embodiment, the rotating operating unit 202 can drive the perforation needle 201 to rotate around its own axis. This allows for fenestration via rotational friction, significantly improving operational safety compared to direct puncture methods in related technologies. Furthermore, the rotational friction method reduces the reliance on the sharpness (penetration performance) of the perforation needle 201 during fenestration, thereby freeing the needle's diameter from constraints. This allows for a larger diameter of the perforation needle 201, enabling the guidewire passage lumen 201a to accommodate thicker guidewires, such as a .035″ guidewire. The diameter of the fenestrated window is also increased, allowing for the passage of non-compliant balloons with a maximum diameter of 7mm (e.g., .035″). This eliminates the need for guidewire exchange and reduces the number of balloon dilations required during in-situ fenestration, thus reducing surgical time and increasing the success rate.

[0114] Furthermore, as mentioned above, the catheter in this embodiment of the application can provide relatively stable support during the in-situ fenestration operation, thereby enabling the needle position to remain relatively stable during the rotation of the membrane rupture needle 201, thus further improving the success rate.

[0115] In some embodiments, refer to Figure 20 The membrane-breaking needle 201 includes a needle tube body 2011 and a hollow area 2011a disposed in the needle tube body 2011. The hollow area 2011a extends spirally along the circumference of the needle tube body 2011, and has a plurality of through grooves 2012 distributed intermittently within the hollow area 2011a.

[0116] Here, the needle body 2011 specifically refers to a structure that is roughly tubular and has a tip at the distal end. The lumen of the needle body 2011 is formed as a guidewire passage cavity 201a, and the distal tip of the needle body 2011 is formed as the needle tip of the membrane rupture needle 201.

[0117] Here, the through groove 2012 specifically refers to a groove-shaped structure that penetrates the tube wall of the needle tube body 2011. For example, the through groove 2012 can be formed in the needle tube body 2011 by means such as laser etching or physical cutting.

[0118] Here, "discontinuous distribution" specifically means that the multiple channels 2012 are not interconnected, but rather have a certain interval between them.

[0119] In this embodiment, by setting a spirally extended hollow area 2011a, the flexibility of the needle body 2011 can be improved, allowing the needle body 2011 to bend to a certain extent, facilitating the passage of the membrane-breaking needle 201 through tortuous blood vessels. Furthermore, the through grooves 2012 are intermittently arranged within the hollow area 2011a, which can improve the flexibility of the needle body 2011 while maintaining a certain rigidity, giving the needle body 2011 good support and operability, so that the force of the rotating operating part 202 can be better transmitted to the membrane-breaking needle 201 to drive the membrane-breaking needle 201 to rotate. In addition, in this embodiment, the flexibility and rigidity can be adjusted by further adjusting the discontinuity ratio of the intermittent distribution of the through grooves 2012 to adapt to different usage requirements.

[0120] In some embodiments, each through-slot 2012 extends circumferentially spirally along the needle body 2011.

[0121] In this embodiment, the through groove 2012 in the hollow area 2011a is further configured to extend spirally along the circumference of the needle tube body 2011, which helps to further improve the flexibility of the needle tube body 2011.

[0122] In some embodiments, refer to Figure 20 The hollow area 2011a has multiple through grooves 2012 arranged side by side along the axial direction of the needle tube body 2011.

[0123] In this embodiment, this arrangement helps to increase the width of the hollow area 2011a, thereby further improving the flexibility of the needle tube body 2011. Furthermore, in this embodiment, the flexibility and rigidity can be adjusted by further specifying the number of parallel through slots 2012, or by adjusting the width of the hollow area 2011a along the axial direction of the needle tube body 2011, to better suit different usage requirements.

[0124] In addition, in this embodiment, this arrangement helps to reduce the width of a single through groove 2012, improve the smoothness of the outer surface of the membrane breaking needle 201, and reduce the possibility of the membrane breaking needle 201 getting stuck with the coating.

[0125] In some embodiments, the membrane-breaking needle 201 includes a needle tube body 2011 and a plurality of through grooves 2012 disposed on the needle tube body 2011. The needle tube body 2011 has a plurality of reference lines 2011b, which extend spirally along the circumference of the needle tube body 2011. The plurality of reference lines 2011b are staggered, and each reference line 2011b is provided with a plurality of through grooves 2012 that are discontinuously distributed.

[0126] Here, the staggered distribution of multiple reference lines 2011b specifically means that there are intersection points between multiple reference lines 2011b.

[0127] The specific implementation of the through slot 2012 can be referred to the relevant embodiments above, and will not be repeated here.

[0128] Unlike the embodiments described above, in this embodiment, multiple through-slots 2012 are discontinuously distributed on multiple spirally extending reference lines 2011b, and the reference lines 2011b are staggered. This makes the distribution of the through-slots 2012 more uniform, and they are no longer limited to the hollow area 2011a, thereby helping to further improve the overall flexibility of the needle body 2011. However, compared to the above embodiments, the method of setting through-slots 2012 in the hollow area 2011a has a lower manufacturing cost.

[0129] In addition, in this embodiment, this arrangement helps to reduce the width of a single through groove 2012, improve the smoothness of the outer surface of the membrane breaking needle 201, and reduce the possibility of the membrane breaking needle 201 getting stuck with the coating.

[0130] In some embodiments, along the axial direction of the needle body 2011, the distribution density of reference line 2011b in at least one region of the needle body 2011 is higher than the distribution density of reference line 2011b in other regions.

[0131] Understandably, the higher the density of reference line 2011b, the higher the compliance of the corresponding region; conversely, the lower the density of reference line 2011b, the higher the stiffness of the corresponding region. Therefore, by making the distribution density of reference line 2011b in some regions higher than that in other regions, the compliance and / or stiffness of a certain region can be increased in a targeted manner, thereby better balancing the compliance and stiffness of the membrane rupture needle 201.

[0132] For example, along the axial direction of the needle body 2011, the needle body 2011 has a proximal region near the proximal end and a distal region near the distal end, with the distribution density of the reference line 2011b in the distal region being higher than that in the proximal region. This allows the distal end of the needle body 2011 to have better throughput performance, and enables the force of the rotating operating part 202 at the proximal end to be better transmitted to the distal end of the needle body 2011, driving the needle body 2011 to rotate.

[0133] In some embodiments, the needle body 2011 is configured as an integral metal part. This helps to improve the rigidity of the needle body 2011, making it easier for the force provided by the rotating operating part 202 to be transmitted to the membrane breaking needle 201, so that the membrane breaking needle 201 can rotate around its own axis. On the other hand, it helps to reduce the risk of needle tip detachment.

[0134] In some embodiments, the rotating operation unit 202 includes an operation body 2021 and a locking member 2022 disposed on the operation body 2021. The locking member 2022 has a locked position and an unlocked position. In the unlocked position, the operation body 2021 can move along the axial direction of the membrane rupture needle 201. In the locked position, the relative position of the operation body 2021 and the membrane rupture needle 201 is fixed.

[0135] Here, the specific structural form of the locking component 2022 is not limited, as long as it can achieve the above-mentioned locking and unlocking functions.

[0136] For example, the distal end of the operating body 2021 has a slotted threaded portion, and the locking member 2022 is configured as a nut with a tapered transition at its distal end. Thus, when the locking member 2022 is tightened onto the threaded portion of the operating body 2021, the slotted gap is compressed and narrowed by the locking member 2022, and its inner diameter decreases, forming a fixed relationship with the membrane-breaking needle 201, thereby fixing the relative position of the operating body 2021 and the membrane-breaking needle 201. When the locking member 2022 is loosened, the slotted gap returns to its initial shape, the inner diameter increases, the membrane-breaking needle 201 loosens, and the operating body 2021 can slide along the axial direction of the membrane-breaking needle 201.

[0137] In this embodiment, this configuration allows the rotating operating part 202 to be infinitely adjustable in the axial position of the membrane rupture needle 201. As a result, the effective length of the membrane rupture needle 201 can be adjusted as needed, making it compatible with different guiding catheters such as balloon guiding catheters, adjustable curved sheaths, or vascular sheaths, and enabling the center position of the relative branch vessel opening to be selected.

[0138] Embodiments of this application also provide a membrane-breaking device 200, see reference to Figures 19-21 The membrane breaking device 200 includes a membrane breaking needle 201 and a rotating operating part 202 connected to the proximal end of the membrane breaking needle 201. The membrane breaking needle 201 has a guide wire passage cavity 201a, and the rotating operating part 202 is configured to drive the membrane breaking needle 201 to rotate around its own axis.

[0139] In some embodiments, the membrane-breaking needle 201 includes a needle tube body 2011 and a hollow area 2011a disposed on the needle tube body 2011. The hollow area 2011a extends spirally along the circumference of the needle tube body 2011, and has a plurality of through grooves 2012 discontinuously distributed within the hollow area 2011a.

[0140] In some embodiments, each through groove 2012 extends spirally along the circumferential direction of the needle tube body 2011; and / or, the hollow area 2011a has a plurality of through grooves 2012 arranged side by side along the axial direction of the needle tube body 2011.

[0141] In some embodiments, the membrane-breaking needle 201 includes a needle tube body 2011 and a plurality of through grooves 2012 disposed on the needle tube body 2011. The needle tube body 2011 has a plurality of reference lines 2011b, which extend spirally along the circumference of the needle tube body 2011. The plurality of reference lines 2011b are staggered, and each reference line 2011b is provided with a plurality of through grooves 2012 that are discontinuously distributed.

[0142] In some embodiments, along the axial direction of the needle body 2011, the distribution density of reference line 2011b in at least one region of the needle body 2011 is higher than the distribution density of reference line 2011b in other regions.

[0143] In some embodiments, the rotating operation unit 202 includes an operation body 2021 and a locking member 2022 disposed on the operation body 2021. The locking member 2022 has a locked position and an unlocked position. In the unlocked position, the operation body 2021 can move along the axial direction of the membrane rupture needle 201. In the locked position, the relative position of the operation body 2021 and the membrane rupture needle 201 is fixed.

[0144] The specific technical details of the membrane breaking device 200 can be found in the relevant sections above, and will not be repeated here.

[0145] It should be noted that the membrane breaking device 200 mentioned in the above embodiments can be applied not only to the catheter 100 provided in the embodiments of this application, but also to any suitable delivery device provided in the related art.

[0146] In the description of this application, the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the embodiments of this application. In this application, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Furthermore, without contradiction, those skilled in the art can combine different embodiments or examples described in this application, as well as features of different embodiments or examples.

[0147] The above description is merely a preferred embodiment of this application and is not intended to limit the application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A catheter, characterized in that, The catheter includes: The catheter body includes a main body segment and an adjustable bend segment disposed at the distal end of the main body segment; An anchoring mechanism is disposed in the main body section. The anchoring mechanism has an extended state and a retracted state. In the extended state, the anchoring mechanism is adapted to conform to the blood vessel wall. The handle includes a housing disposed at the proximal end of the catheter body, and a bending adjustment mechanism and a release mechanism disposed on the housing. The bending adjustment mechanism is used to control the bending or resetting of the adjustable section, and the release mechanism is used to control the unfolding or retraction of the anchoring mechanism.

2. The catheter according to claim 1, characterized in that, The bending mechanism is configured to control the adjustable bending segment to bend or reset in one direction.

3. The catheter according to claim 2, characterized in that, The adjustable bend is configured as an elastic structure, and the bend adjustment mechanism includes a traction wire. The traction wire is connected to one side of the wall of the adjustable bend along the radial direction of the conduit. When the distal end of the traction wire moves toward the proximal end of the conduit, it causes the adjustable bend to bend toward the side where the traction wire is located.

4. The catheter according to claim 3, characterized in that, The adjustable bend has multiple perforated grooves formed on one side of the conduit toward the traction wire along the radial direction, and the multiple perforated grooves are spaced apart along the axial direction of the conduit.

5. The catheter according to claim 4, characterized in that, The plurality of perforated grooves divide the adjustable bend into a plurality of first sub-segments and at least one second sub-segment. The distal end of the adjustable bend is set as the first sub-segment. Along the radial direction of the conduit, the second sub-segment protrudes from the first sub-segment. The traction wire passes through the lumen of the second sub-segment and is located outside the lumen of the first sub-segment.

6. The catheter according to claim 4, characterized in that, The catheter body includes one or more limiting members connected to the adjustable bend, the limiting members having limiting holes that extend through the axial direction of the catheter, and the traction wire passing through the limiting holes.

7. The catheter according to any one of claims 3-6, characterized in that, The bending mechanism includes a bending operation part and a movable part. The traction wire connects the bending operation part and the movable part. The bending operation part is at least partially exposed in the housing. The bending operation part can drive the movable part to move relative to the housing. When the movable part moves relative to the housing, it drives the traction wire to move along the axial direction of the conduit.

8. The catheter according to claim 7, characterized in that, The bending adjustment part is configured to rotate relative to the housing about the axial direction of the conduit. The bending adjustment part and the movable part are threaded together so that when the bending adjustment part rotates relative to the housing, it drives the movable part to move linearly relative to the housing along the axial direction of the conduit.

9. The catheter according to claim 1, characterized in that, The anchoring mechanism includes an anchoring basket, and the release mechanism includes a release operation part and a transmission part. The distal end of the anchoring basket is connected to the conduit body, and the proximal end is connected to the transmission part. The release operation part can drive the transmission part to move linearly along the axial direction of the conduit to make the anchoring basket expand or retract.

10. The catheter according to claim 9, characterized in that, The release operation unit includes a gear, and the transmission unit includes a rack, the gear and the rack meshing together.

11. The catheter according to claim 1, characterized in that, The anchoring mechanism includes an anchoring basket, the proximal end of which is connected to the catheter body and the distal end is a free end. The release mechanism includes a sheath, which is slidably disposed outside the catheter body so that the anchoring basket can be retracted into the sheath or released from the sheath.

12. The catheter according to claim 1, characterized in that, The anchoring mechanism includes a balloon, and the release mechanism includes a channel communicating with the balloon.

13. A method for operating a catheter, applied to the catheter according to any one of claims 1-12, characterized in that, The catheter operation method includes: The catheter body is delivered to the main blood vessel; The adjustable bend of the catheter body is bent to point towards the branch vessel; The anchoring mechanism is switched to the deployed state and fits against the vessel wall of the main blood vessel.

14. An in-situ window opening system, characterized in that, The in-situ window opening system includes: The catheter according to any one of claims 1-12, and The membrane-breaking device is removably and insertably mounted on the catheter body.

15. The in-situ window opening system according to claim 14, characterized in that, The membrane rupture device includes a membrane rupture needle and a rotating operating part connected to the proximal end of the membrane rupture needle. The membrane rupture needle has a guide wire passage cavity, and the rotating operating part is configured to drive the membrane rupture needle to rotate around its own axis.

16. The in-situ window opening system according to claim 15, characterized in that, The membrane-breaking needle includes a needle tube body and a hollow area disposed in the needle tube body. The hollow area extends spirally along the circumference of the needle tube body and has multiple through grooves distributed intermittently within the hollow area.

17. The in-situ window opening system according to claim 16, characterized in that, Each of the aforementioned through-slots extends circumferentially spirally along the body of the needle tube; and / or, The hollowed-out area has multiple through grooves arranged side by side along the axial direction of the needle body.

18. The in-situ window opening system according to claim 15, characterized in that, The membrane-breaking needle includes a needle tube body and multiple through grooves disposed on the needle tube body. The needle tube body has multiple reference lines that extend spirally along the circumference of the needle tube body. The multiple reference lines are staggered, and each reference line is provided with multiple through grooves that are discontinuously distributed.

19. The in-situ window opening system according to claim 18, characterized in that, Along the axial direction of the needle body, the distribution density of the reference line in at least one region of the needle body is higher than the distribution density of the reference line in other regions.

20. The in-situ window opening system according to any one of claims 15-19, characterized in that, The rotating operating part includes an operating body and a locking member disposed on the operating body. The locking member has a locked position and an unlocked position. In the unlocked position, the operating body can move along the axial direction of the membrane rupture needle. In the locked position, the relative position of the operating body and the membrane rupture needle is fixed.

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