Guiding device and membrane breaking system

Abstract

A guiding device and membrane breaking system include a membrane breaking device, a delivery sheath, and a guiding rod. The guiding rod is slidable along the axial direction of the delivery sheath, and its distal end extends from the distal port of the delivery sheath. At least the distal portion of the guiding rod in the axial direction includes a guiding section, which is at least partially magnetic. In its natural state, the guiding section is coiled in a direction perpendicular to the axial direction of the guiding rod to form a helical tube structure. The magnetic helical tube formed by the guiding section is used to guide the membrane breaking device with a magnetic head end to break the membrane at the position to be broken on the membrane-covered stent, thereby effectively ensuring the accuracy of the membrane breaking position and the safety during membrane breaking.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a guiding device and membrane perforation system. Background Technology

[0002] In the treatment of aortic lumen disease, interventional therapy that isolates the lesion site by implanting a vascular stent is currently very common. Because the aorta has many important branch vessels, to obtain a sufficiently safe anchoring zone, it is usually necessary to cover these branch vessels with the main therapeutic stent implanted in the aorta. This requires implanting a small branch stent within the branch vessel to reconstruct these covered branch vessels, ensuring blood supply to the branch vessels and organs. Currently, the techniques used to reconstruct branch vessels include the chimney technique, fenestration technique, and integrated stent technique with branch stents. Due to its unique advantages, the fenestration technique is currently the most widely used in clinical practice.

[0003] Fenestration techniques are divided into external fenestration and in-situ fenestration. The principle of in-situ fenestration is to first implant the main stent into the body, then use a puncture needle to make a small hole in the main stent at the opening of the covered branch blood vessel, and then use a balloon catheter to gradually enlarge this small hole. Finally, the branch stent is implanted into the window to achieve the purpose of reconstructing the branch blood vessel, which avoids the various problems of external fenestration. However, the difficulty of this method is how to perform safe in-situ fenestration in the body.

[0004] Currently, there are specialized products for in-situ fenestration within the body. Their design principle involves a hollow needle fitted with a catheter (or balloon catheter) to form a membrane-perforating system. Since branch vessels are usually not perpendicular to the aorta, membrane perforation is impossible in such cases. Therefore, this design typically requires an adjustable sheath to adjust the needle angle, ensuring the catheter of the membrane-perforating system is as perpendicular as possible to the membrane, facilitating needle puncture. However, this also increases the cost of the procedure, and sometimes the adjustable sheath cannot be adjusted to the required angle. This method introduces uncertainty into in-situ membrane perforation, increasing the risk and uncertainty of in-situ puncture and perforation. Summary of the Invention

[0005] Therefore, it is necessary to provide a new guiding device and membrane breaking system to at least ensure the accuracy of the membrane breaking position and the safety during membrane breaking.

[0006] A guiding device includes a delivery sheath and a guide rod, the guide rod being slidable along the axial direction of the delivery sheath, and the distal end of the guide rod extending from the distal port of the delivery sheath; the distal portion of the guide rod includes a guide section, the guide section being at least partially magnetic, and the guide section being capable of forming a helical tube structure perpendicular to the axial direction of the guide rod in its natural state.

[0007] In one embodiment, the helical tube includes at least two magnetic poles, which are distributed along the axial direction of the helical tube.

[0008] In one embodiment, when the guide segment is located inside the delivery sheath, it is in a delivery state. In the delivery state, the guide segment includes a plurality of spaced-apart first magnetic elements along its length. The magnetic poles of the first magnetic elements are distributed along a direction perpendicular to the length of the guide segment. The plurality of first magnetic elements are embedded in the guide segment, and the same magnetic poles have the same orientation.

[0009] In one embodiment, in its natural state, the helical tube comprises a plurality of helical units along the axial direction, each helical unit comprising at least two of the first magnetic elements, and the first magnetic elements of adjacent helical units are circumferentially opposite each other.

[0010] In one embodiment, the guide rod includes a support section, the distal end of which is connected to the proximal end of the guide section, and the proximal end of the support section extends through the proximal end of the delivery sheath; the stiffness of the support section is greater than that of the guide section.

[0011] In one embodiment, in the conveying state, the axial length of the guide rod is greater than the axial length of the conveying sheath, and the axial length of the conveying sheath is less than or equal to the axial length of the support section.

[0012] In one embodiment, the distal port of the delivery sheath is at least partially provided with a imaging structure, which is at least configured to indicate the position of the distal port.

[0013] In one embodiment, the developing structure includes at least two developing elements, which are symmetrically arranged circumferentially along the wall of the delivery sheath. In its natural state, the line connecting the two developing elements is perpendicular to the central axis of the spiral tube.

[0014] In one embodiment, the distal end of the guide segment includes a tapered tip with a tapered structure, and the taper of the tapered tip is equal to the angle of the helix formed by the guide segment in its natural state.

[0015] A membrane-breaking system includes a membrane-breaking device and a guiding device. The membrane-breaking device includes a catheter and a membrane-breaking component. The catheter has a puncture channel extending along its length. The membrane-breaking component is movably inserted into the puncture channel and can exit from the distal end of the catheter. The distal end of the catheter is provided with a second magnetic component, which can magnetically engage with the magnetic poles of the spiral tube.

[0016] Compared with the prior art, the present invention is advantageous in that it provides a guiding device and a membrane breaking system, including a membrane breaking device, a delivery sheath, and a guiding rod. The guiding rod is slidable along the axial direction of the delivery sheath, and its distal end extends out from the distal port of the delivery sheath. At least the distal portion of the guiding rod in the axial direction includes a guiding section, which is at least partially magnetic. In its natural state, the guiding section is coiled in a direction perpendicular to the axial direction of the guiding rod to form a helical tube structure. The guiding section is coiled into a magnetic helical tube to guide the membrane breaking device with a magnetic head end to break the membrane at the position to be broken on the covered support, thereby effectively ensuring the accuracy of the membrane breaking position and the safety during membrane breaking. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the membrane-perforating system of the present invention entering the aortic blood vessel;

[0018] Figure 2 This is a schematic diagram of the guiding device of the present invention guiding the membrane perforation device in the aortic blood vessel;

[0019] Figure 3 This is a schematic diagram of the membrane breaking device in Embodiment 1 of the present invention;

[0020] Figure 4 This is a schematic diagram of the guiding device structure in Embodiment 1 of the present invention;

[0021] Figure 5 This is a schematic diagram of the spiral tube structure formed by the guide section in Embodiment 1 of the present invention;

[0022] Figure 6 These are internal sectional views of the guide rod in Embodiments 1 and 2 of the present invention;

[0023] Figure 7 These are schematic diagrams of the spiral tube structures in Embodiments 1 and 2 of the present invention;

[0024] Figure 8 These are cross-sectional views of the inside of the spiral tube in Embodiments 2 and 3 of the present invention;

[0025] Figure 9 These are top views of the spiral tube in Embodiments 2 and 3 of the present invention;

[0026] Figure 10 These are schematic diagrams of the delivery sheath structure in Embodiments 1 and 4 of the present invention;

[0027] Figure 11 For the present invention Figure 10 Enlarged view of a portion of position A in the middle;

[0028] Figure 12 This is a schematic diagram of the catheter structure in one embodiment of Embodiment 2 of the present invention;

[0029] Figure 13 For the present invention Figure 12 Enlarged view of the middle C position;

[0030] Figure 14 This is an internal cross-sectional view of the annular structure in Embodiment 3 of the present invention;

[0031] Figure 15 This is a cross-sectional view of the internal structure of the loop structure in other embodiments of Embodiment 3 of the present invention;

[0032] Figure 16 This is a rectangular side view of the first magnetic component in Embodiment 4 of the present invention;

[0033] Figure 17 This is a schematic diagram of the circular top of the first magnetic component in Embodiment 4 of the present invention;

[0034] Figure 18 This is a schematic diagram of a spiral tube with a tapered tip in Embodiment 5 of the present invention;

[0035] Figure 19 This is a schematic diagram of the conical tip structure in Embodiment 5 of the present invention;

[0036] Figure 20 This is a schematic diagram of the smooth transition structure of the guide rod segment in Embodiment 5 of the present invention. Detailed Implementation

[0037] To better understand the concept of the present invention, the embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The following specific embodiments are only some embodiments of the present invention and are not intended to limit the present invention.

[0038] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0039] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0040] To more clearly describe the structure of this application, the terms "proximal" and "distal" are used herein as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end furthest from the operator, and "proximal" refers to the end closest to the operator, for example, when the delivery device is inserted, it is moved from the proximal position to the distal position furthest from the operator; "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial".

[0041] To facilitate a comprehensive understanding of the membrane perforation system 1000 provided in this application, the structures near the aortic arch will first be described. Please refer to... Figures 1-2 The aorta includes the aortic arch, the ascending aorta, and the descending aorta. Multiple branching arteries connect to one side of the aortic arch, one of which is the left subclavian artery. Blood flows sequentially through the ascending aorta, the aortic arch, and the descending aorta, and upon reaching the aortic arch region, some blood flow is diverted into the various branching arteries. Typically, for aortic dissections or aneurysms involving the aortic arch, surgical treatment requires placing a covered stent 300 within the aorta and placing branch vessel stents in the affected branching arteries, such as the left subclavian artery, extending these stents to communicate with the covered stent 300 placed within the aorta, allowing blood flow from the aorta to be diverted into the branching arteries. Therefore, a fenestration is required on the covered stent 300 to allow the branch vessel stent to extend into it. This specific embodiment describes the perforation of the covered stent 300 placed within the aortic arch when the angle between the left subclavian artery and the aortic arch is small. However, in other embodiments, this perforation system 1000 can also be used in other similar scenarios.

[0042] Example 1

[0043] In this embodiment, please refer to Figure 2 and Figure 3This application provides a membrane perforation system 1000, including a guiding device 100 and a membrane perforation device 200. After the endovascular stent 300 is released within the blood vessel, the guiding device 100 enters the blood vessel to guide the membrane perforation device 200 to perforate the implanted endovascular stent 300. The membrane perforation device 200, used in conjunction with the guiding device 100, includes at least a catheter 202 and a membrane perforation device 201. The catheter 202 has a puncture channel extending along its length. In one embodiment, the membrane perforation device 201 includes a puncture needle placed within the puncture channel. The puncture needle can move axially relative to the catheter 202 within the puncture channel, and the distal end of the puncture needle can extend beyond the distal end face of the catheter 202 to puncture and perforate the stent to be punctured. Then, a guidewire and a balloon catheter are inserted to enlarge the window, and a branch stent is implanted to complete the surgical treatment.

[0044] The membrane-breaking component 201 can be a laser-based membrane-breaking assembly. Energy is transmitted through a laser generator and fiber optic cable, and the laser energy is applied to the membrane of the covered stent 300 to be broken, causing the membrane to rupture. Then, a guidewire and balloon catheter are inserted to enlarge the opening, and a branch stent is implanted to complete the surgical treatment.

[0045] Please see Figures 4-6The guiding device 100 provided in this embodiment includes a delivery sheath 21 and a guiding rod 11. The guiding rod 11 is slidable along the axial direction of the delivery sheath 21, and its distal end extends out from the distal port of the delivery sheath 21. The proximal end of the delivery sheath 21 is connected to a tube seat 22, and the side wall of the tube seat 22 is provided with an exhaust side hole. The exhaust side hole is connected to an exhaust pipe for discharging gas from the sheath, and the exhaust pipe is connected to a Luer connector 23. At least the distal portion of the guiding rod 11 in the axial direction includes a guiding section 112, and the guiding section 112 at least partially has… The guide section 112 may be entirely or partially magnetic. In some embodiments, the magnetic part or the entire part is integrally formed from a magnetic material. The magnetic material may be neodymium iron boron material, mixed with a polymer resin in a certain proportion and then integrally injection molded or sintered. The integrally formed magnetic rod itself possesses magnetism. In its natural state, the guide section 112 is curled in a direction perpendicular to the axis of the guide rod 11 to form a spiral tube 1121 structure. Here, the natural state refers to the guide section. In the state of 112, unaffected by external forces and other components, the spiral tube 1121 structure formed by the coiling of the guide section 112 has a tubular body, with the spiraling guide section 112 forming the sidewalls, thus possessing magnetism at least on the sidewalls of the spiral tube 1121. The distal end of the conduit 202 of the membrane-breaking device 200 of this application is also magnetic. Therefore, when using the membrane-breaking system 1000 provided in this application, the magnetism of the spiral tube 1121 can interact with the distal end of the conduit 202 of the magnetic membrane-breaking device 200. The end magnetic attraction allows the guiding device 100 to guide the membrane-breaking device 200. By adjusting the spiral tube 1121 to the correct membrane-breaking position on the covering support 300, the conduit 202 of the membrane-breaking device 200 can be guided to the correct position for membrane breaking, thus precisely and effectively improving the accuracy of membrane breaking. In this embodiment, the guiding section 112 of the guiding rod 11 also has a conveying state within the conveying sheath 21. In this state, the guiding section 11 has axial length, facilitating extension within the conveying sheath 21.

[0046] Please continue reading here. Figure 5 The spiral tube 1121 is perpendicular to the guide rod 11, so that the guide section 112 is guided into the delivery sheath 21 in a straight state. When it exits the distal end and naturally returns to the spiral tube 1121 structure, it naturally extends towards the inner wall of the membrane of the membrane-covered stent 300. This direction is consistent with the direction that the catheter 202 needs to present when the membrane of the membrane-covered stent 300 is broken. Therefore, there is no need to make further directional adjustments to the guiding direction of the spiral tube 1121. Simple position adjustments are sufficient to guide the membrane breaking.

[0047] In this embodiment, please refer to Figures 7-8To further improve the accuracy of the guiding device 100 in guiding the membrane breaking device 200, the spiral tube 1121 includes at least two magnetic poles, and the two magnetic poles are distributed along the axial direction of the spiral tube 1121. Here, when the guiding rod 11 is coiled to form the spiral tube 1121, the spiral tube 1121 forms a hollow tube 11212 structure at its axial position. The magnetic part is located on the wall of the spiral tube 1121 formed by the guiding section 112, and the magnetic pole direction of the guiding section 112 is along the radial direction of the guiding section 112. By setting the direction, a magnetic pole structure distributed along the axial direction of the spiral tube 1121 can be formed when the guide section 112 is curled into a spiral tube 1121. In this way, when any end of the spiral tube 1121 is magnetically attracted to the distal end of the conduit 202, the distal end of the conduit 202 will be attracted by the spiral tube 1121 to be opposite to the axial end of the spiral tube 1121. Thus, the position of the membrane-breaking element 201 when it passes through the conduit 202 to break the membrane is controllable, avoiding inaccurate membrane-breaking position due to the elasticity of the conduit itself.

[0048] Furthermore, when the distal end of the catheter 202 is directly opposite the hollow tube 11212 of the spiral tube 1121, the membrane-breaking component 201 can enter the hollow tube 11212 of the spiral tube 1121 to calibrate the puncture position. Moreover, the membrane-breaking component 201 entering the hollow tube 11212 allows the wall of the spiral tube 1121 formed by the guide section 112 to play a protective role in membrane breaking, preventing the membrane-breaking component 201 from causing damage to other locations besides the puncture position, thereby improving the safety of membrane breaking.

[0049] In one embodiment, please continue to refer to Figure 4 and Figure 6To facilitate the insertion of the guide rod 11 into the location of the covered stent 300 within the blood vessel, the guide rod 11 includes a support segment 111. The distal end of the support segment 111 connects to the proximal end of the guide segment 112, and the proximal end of the support segment 111 extends from the proximal end of the delivery sheath 21. A handle 12 is connected to the proximal end of the support segment 111. The support segment 111 provides better support and pushing force for the guide rod 11 during insertion, and the handle 12 at the proximal end is used by the user to hold and control it during insertion. The rigidity of the support segment 111 is greater than that of the guide segment 112. The guide section 112 itself needs to have elasticity and pre-shaping recovery characteristics, so it needs to be set with low hardness to meet the requirements of elasticity and pre-shaping recovery. The support section 111 needs to play a pushing and supporting role for the guide rod 11 itself, so providing high hardness can prevent it from bending and losing support. Furthermore, the guide section 112 contains magnetic material, and when it forms a spiral tube 1121 after passing through the distal end of the delivery sheath 21 for membrane rupture guidance, it needs to provide a force to adhere to the side wall of the membrane support 300. Therefore, the support section 111 needs to provide good support force for support.

[0050] In one embodiment, the guide section 112 and the support section 111 can be made of PE material. The support section 111 is reinforced with internal reinforcement to further improve its overall support performance, thereby providing sufficient support for the attachment of the spiral tube 1121 to the inner wall of the film-coated bracket 300.

[0051] In this embodiment, please refer to further details. Figure 4 In order to allow the guide section 112 of the guide rod 11 to completely pass through the delivery sheath 21 to form a complete spiral tube 1121 for guiding, the axial length of the guide rod 11 in the delivery state is greater than the axial length of the delivery sheath 21, and the axial length L1 of the delivery sheath 21 is less than or equal to the axial length L2 of the support section 111; thus, when the handle 12 is held at the proximal end to push the guide rod 11 distally within the delivery sheath 21, the tube of the handle 12 and the delivery sheath 21 is connected. When the seats 22 abut each other, ensure that the guide section 112 is completely released from the distal end of the delivery sheath 21 and returns to the structure of the spiral tube 1121; furthermore, when the axial length L1 of the delivery sheath 21 is equal to the axial length L2 of the support section 111, the support section 111 and the delivery sheath 21 can simultaneously provide support force at the junction of the guide section 112 and the support section 111, thereby further enhancing the support force when the support section 111 forms the spiral tube 1121 and attaches towards the inner wall of the covered support.

[0052] Example 2

[0053] In this embodiment, please continue to refer to Figure 6 and Figure 8The overall structure of the guiding device 100 and the membrane breaking system 1000 is largely the same as that in Embodiment 1. The difference is that the magnetism of the guiding section 112 is provided by a plurality of embedded first magnetic elements 1122. Furthermore, when the guiding section 112 is in the conveying state within the conveying sheath 21, the plurality of first magnetic elements 1122 are spaced apart along the length direction of the guiding section 112, thereby making multiple positions of the guiding section 112 magnetic. Further, in order to allow the guiding section 112 to naturally curl into a spiral tube 1121, the magnetic pole distribution direction of the spiral tube 1121 is along... Its axial direction distribution is such that the magnetic poles of the single first magnetic element 1122 are distributed along the axial direction perpendicular to the guide section 112, and the magnetic pole distribution direction of the first magnetic element 1122 is the same as the axial extension direction of the spiral tube 1121. Thus, when the guide section 112 extends in the axial direction perpendicular to the guide rod 11, the two magnetic poles of the first magnetic element 1122 are distributed along the axial direction of the spiral tube 1121, so that the spiral tube 1121 has a magnetic field distributed along the axial direction, and the magnetic field lines start from one end of the spiral tube 1121 and return to the other end of the spiral tube 1121.

[0054] In this embodiment, please refer to Figures 7-9 After the guide section 112 is naturally curled to form a spiral tube 1121, the spiral tube 1121 can include multiple spiral units 11211 along its axial direction. A single spiral unit 11211 has a complete circular structure when viewed from above or below. In order to make the structure of the spiral tube 1121 more stable after forming and to increase the magnetic force in the axial direction, multiple first magnetic elements 1122 are arranged at the same intervals in the guide section 112, and the same magnetic poles are oriented in the same direction. This ensures that when it is curled into a spiral tube 1121, the first magnetic elements 1122 in the spiral units 11211 at different axial positions are located on the same axis. In this way, the multiple first magnetic elements 1122 at the same axis position attract each other end to end, which can provide magnetic force to maintain the spiral tube 1121. Furthermore, the stacked first magnetic elements 1122, as the number of stacked elements increases, enhance the overall magnetic force of the spiral tube 1121. This helps the spiral tube 1121 provide better magnetic force to quickly and firmly attract the distal port of the conduit 202, preventing accidental magnetic failure during membrane rupture. To provide sufficient attraction force on both ends of the spiral tube 1121, each spiral unit 11211 includes at least two first magnetic elements 1122 to provide sufficient magnetic force. In some embodiments, a single spiral unit 11211 may also have more first magnetic elements 1122, such as three or four, with multiple first magnetic elements 1122 spaced circumferentially along the spiral unit 11211 and having the same spacing. This ensures a uniform distribution of magnetic force and prevents the magnetic force from being biased to one side.

[0055] In one embodiment, please refer to Figure 12 and Figure 13 The distal end of the catheter 202 of the membrane rupture device 200 is provided with a second magnetic element 2022. The two magnetic poles of the second magnetic element 2022 are distributed along the axial direction of the catheter 202. Here, the magnetic poles of the spiral tube 1121 are also distributed along its axial direction. Therefore, when the spiral tube 1121 guides the distal end of the catheter 202 for magnetic attraction connection, if the second magnetic element 2022 is located at the distal end of the catheter 202 as the N pole, then the end of the spiral tube 1121 with both ends of the axial direction as the S pole is attached to the puncture position of the covered stent, thereby magnetically engaging with the distal end of the N pole catheter 202 for guidance. The spiral tube 1121 can be N pole at the end near the support section 111 and S pole at the end away from the support section 111, or it can be S pole at the end near the support section 111 and N pole at the end away from the support section 111.

[0056] In some other embodiments, the diameter of the distal end of the conduit 202 may be less than or equal to the diameter of the spiral tube 1121, so that the membrane-breaking element 201 that passes through the conduit 202 can more easily pass through the hollow tube 11212 structure of the spiral tube 1121 to complete the membrane breaking.

[0057] In one embodiment, please refer to further details. Figure 8 The first magnetic component 1122 can be embedded into the guide section 112 of the guide rod 11 by hot melting during the processing of the guide rod 11. After embedding, the guide rod 11 has through holes 1123 at the two magnetic pole positions of the first magnetic component 1122. The through holes 1123 connect the two magnetic poles of the first magnetic component 1122 to the outside, exposing the magnetic poles to the outside, thereby enhancing the adsorption of the magnetic poles.

[0058] Example 3

[0059] In this embodiment, please refer to Figure 14 and Figure 15 The overall structure of the guiding device 100 and the membrane breaking system 1000 is largely the same as that in Embodiments 1 and 2. The difference is that the spiral tube 1121 may only have a single layer of spiral unit 11211 in the axial direction. That is, after the guiding section 112 passes through the far port of the conveying sheath tube 21, it bends to form an annular structure 1125. Here, multiple first magnetic elements 1122 are embedded in the annular structure 1125 in the circumferential direction, and the multiple first magnetic elements 1122 are arranged at the same interval. The magnetic pole distribution direction of the first magnetic elements 1122 in the annular structure 1125 may be perpendicular to the axial direction of the guiding section 112 and perpendicular to the plane where the annular structure 1125 is bent, forming a structure in which the magnetic poles are radially distributed along the annular structure 1125.

[0060] In another embodiment, please refer to Figure 15The magnetic pole direction of the first magnetic element 1122 within the annular structure 1125 can be perpendicular to the axial direction of the guide section 112, and the magnetic pole distribution direction of the first magnetic element 1122 coincides with or is parallel to the plane where the annular structure 1125 is bent and formed. Here, the two poles of the multiple first magnetic elements 1122 are respectively located in the inner and outer ring positions of the annular structure 1125. Setting the magnetic pole of the inner ring position to be opposite to the magnetic pole of the distal port of the conduit 202 of the membrane breaking device 200 will make the conduit 202 tend to be attracted to the inner ring position when it is magnetically engaged with the annular structure 1125, thereby making the distal port of the conduit 202 opposite to the hollow position in the middle of the annular structure 1125. The annular structure 1125 plays a protective role when the membrane breaking device 201 breaks the membrane.

[0061] Example 4

[0062] In this embodiment, please refer to Figure 16 and Figure 17 The overall structure of the guiding device 100 and the membrane breaking system 1000 is largely the same as that in Embodiments 1 to 3. The difference is that the first magnetic element 1122 has an axial thickness and a radial width, and the first magnetic element 1122 can be any one of neodymium iron boron magnets, samarium cobalt magnets, ferrite magnets, and alnico magnets. In one embodiment, neodymium iron boron magnets are used as the material of the first magnetic element 1122. Neodymium iron boron (NdFeB) permanent magnets, as rare earth permanent magnet materials, have high magnetic energy product, coercivity, and high energy density, and good mechanical properties. The axial cross-sectional shape of the first magnetic element 1122 is different from the radial cross-sectional shape. Here, since the first magnetic element 1122 itself is made of metal, it can be developed under the observation of the developing equipment. Therefore, in order to facilitate the orientation of the guiding section 112 before it passes through the conveying sheath 21, the orientation of the guiding section 112 is observed and adjusted so that the guiding section 112 forms a spiral after passing through the far end of the conveying sheath 21. In the spiral tube 1121 structure, the axial direction of the spiral tube 1121 is directly facing the position to be punctured. Specifically, the first magnetic element 1122 is set as a cylindrical structure. The cross-section of the cylindrical structure in the axial direction is rectangular, while the cross-section in the radial direction is circular, and the magnetic poles are distributed along its axial direction. Here, since the magnetic poles of the first magnetic element 1122 are distributed along its axial direction, and the distribution direction of its magnetic poles needs to be such that the guide section 112 forms the spiral tube 1121 along the axial direction, the first magnetic element 1122 inside the spiral tube 1121 appears as a series of rectangular elements under the observation of the developing equipment. Therefore, when the guide section 112 is inside the transport sheath 21, the guide rod 11 is rotated until the developing equipment observes that multiple first magnetic elements 1122 form a rectangular structure. The opening of the transport sheath 21 is aligned with the position to be punctured and coated, and the guide section 112 is pushed out to form the spiral tube 1121. The spiral tube 1121 is then curled and formed towards the position to be punctured and coated, without the need for further adjustment of direction and position.

[0063] In this embodiment, please refer to Figure 10 and Figure 11 To better identify the location of the distal end of the delivery sheath 21 within the blood vessels, the distal end is at least partially provided with a contrast-enhancing structure, which is configured to indicate the location of the distal end. The contrast-enhancing structure can be embedded within the distal end of the delivery sheath 21, allowing observation of the positional relationship between the distal end of the delivery sheath 21 and the location of the covered stent to be ruptured using contrast-enhancing equipment after insertion into the body. In some embodiments, the contrast-enhancing structure is also configured to indicate the orientation of the guide segment 112. Here, two contrast-enhancing elements 24 can be embedded on opposite sides of the distal end in the circumferential direction, with the two contrast-enhancing elements 24 symmetrically arranged along the circumferential direction of the delivery sheath 21 wall. This allows the angle at which the delivery sheath 21 has rotated inside the body to be identified. Thus, the direction in which the guide segment 112 of the guide rod 11 is inserted outside the body can be aligned with the straight line connecting the two developing elements 24. That is, before the guide rod 11 is inserted into the delivery sheath 21 outside the body, the line connecting the two developing elements 24 is perpendicular to the central axis of the spiral tube 1121. When the developing equipment observes that the two developing elements 24 are aligned and located at the puncture position, the guide segment 112 is inserted out of the distal end of the delivery sheath 21. This allows the guide segment 112 to extend towards the puncture position to form a guide structure when forming the spiral tube 1121, without the need for further adjustment of direction and position.

[0064] In one embodiment, to ensure a smoother retraction of the guide segment 112 of the guide rod 11 into the delivery sheath 21 after guiding the membrane breaking device 200, and to prevent bending of the distal end or body of the delivery sheath 21, the hardness of at least the distal end of the delivery sheath 21 is set to be greater than the hardness of the guide segment 112. In other embodiments, the overall hardness of the delivery sheath 21 may also be greater than the hardness of the guide segment 112. This ensures that during retraction, the distal end of the delivery sheath 21 has sufficient hardness to support a greater tangential force, thereby releasing the magnetic attraction connection between the first magnetic elements 1122 of different spiral units 11211 when the guide segment 112 forms the spiral tube 1121, without damaging the distal end or the conduit body of the delivery sheath 21, ensuring smooth retraction of the guide rod 11 and the delivery sheath. The hardness of the distal end can be enhanced by embedding a imaging element, or by increasing the hardness of the material itself of the delivery sheath 21.

[0065] Example 5

[0066] In this embodiment, please refer to Figure 18 and Figure 19The overall structure of the guiding device 100 and the membrane breaking system 1000 is largely the same as that in Embodiments 1 to 4. The difference is that, in order to make the extended end of the spiral tube 1121 fit more tightly against the inner wall of the membrane support when the guiding segment 112 is curled to form the spiral tube 1121, the distal end of the guiding segment 112 is configured to include a tapered tip 1124 with a tapered structure, the taper β of the tapered tip 1124 being equal to the helix angle α of the spring. Here, the distal end of the guiding segment 112 can be configured to have a tapered tip 1124 with a tapered structure only on the side that fits against the next spiral unit 11211 in the circumferential direction. Here, the guiding segment 112 itself is in the shape When the spiral tube 1121 is formed, it has a helix angle α, which causes the distal end of the guide segment 112 to form a partially inclined spiral structure at the extended end of the spiral tube 1121. This results in the extended end of the spiral tube 1121 not being a plane, making it difficult to fit with the inner wall of the covered stent. The setting of the tapered tip 1124 allows the distal end of the guide segment 112 to be inclined and attached towards the next spiral unit 11211. When the angle of the inclined taper β of the proximal end of the tapered tip is the same as the angle of the helix angle α of the spiral tube 1121, the extended end of the spiral tube 1121 is basically a plane, which can fit well with the inner wall of the covered stent, thereby improving the accuracy and stability of the spiral tube 1121 guidance.

[0067] In another embodiment, please refer to Figure 20 The surface of the formed guide section 112 is smooth and has no through holes 1123. Here, smooth transition means that the surface of the guide section 112 is free of burrs, protrusions or grooves, so as to effectively avoid jamming or poor passage when the guide rod 11 is inserted into or withdrawn from the conveying sheath 21.

[0068] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A guiding device, characterized in that, The device includes a delivery sheath and a guide rod. The guide rod is slidable along the axial direction of the delivery sheath, and its distal end extends from the distal port of the delivery sheath. The distal portion of the guide rod includes a guide section, which is at least partially magnetic. In its natural state, the guide section can be coiled to form a magnetic spiral tube structure perpendicular to the axial direction of the guide rod. This structure guides a membrane-breaking device with a magnetic head end to break the membrane at the membrane-breaking position within the membrane-covering support. The spiral tube includes multiple spiral units along its own axial direction. Each spiral unit has a complete circular structure when viewed from above or below. Each spiral unit includes multiple first magnetic elements, which are spaced circumferentially along the spiral unit and at equal intervals. The first magnetic elements have the same magnetic pole facing the same direction. When the guide section is coiled into a spiral tube structure, the spiral units at different axial positions attract each other end-to-end with the multiple first magnetic elements at the same axial position, providing magnetic force to maintain the shape of the spiral tube structure.

2. The guide device of claim 1, wherein The helical tube includes at least two magnetic poles, which are distributed along the axial direction of the helical tube.

3. The guide device of claim 2, wherein, When the guide section is located inside the conveying sheath, it is in a conveying state. In the conveying state, the guide section includes a plurality of spaced first magnetic elements along its length. The magnetic poles of the first magnetic elements are distributed along a direction perpendicular to the length of the guide section. The plurality of first magnetic elements are embedded in the guide section, and the same magnetic poles have the same orientation.

4. The guide device of claim 3, wherein The first magnetic elements of adjacent spiral units are circumferentially opposite each other.

5. The guide device of claim 1, wherein, The guide rod includes a support section, the distal end of which is connected to the proximal end of the guide section, and the proximal end of the support section extends through the proximal end of the delivery sheath; the rigidity of the support section is greater than that of the guide section.

6. The guide device of claim 5, wherein, In the conveying state, the axial length of the guide rod is greater than the axial length of the conveying sheath, and the axial length of the conveying sheath is less than or equal to the axial length of the support section.

7. The guide device of claim 1, wherein, The distal port of the delivery sheath is at least partially provided with a developing structure, which is configured to indicate the position of the distal port.

8. The guiding device according to claim 7, characterized in that, The developing structure includes at least two developing elements, which are symmetrically arranged circumferentially along the wall of the conveying sheath. In its natural state, the line connecting the two developing elements is perpendicular to the central axis of the spiral tube.

9. The guide device of claim 1, wherein, The distal end of the guide segment includes a tapered tip with a tapered structure, and the taper of the tapered tip is equal to the angle of the helix formed by the guide segment in its natural state.

10. A membrane breaking system characterized by, The device includes a membrane-breaking device and a guiding device as described in any one of claims 1-9. The membrane-breaking device includes a catheter and a membrane-breaking component. The catheter has a puncture channel extending along its length. The membrane-breaking component is movably inserted into the puncture channel and can exit from the distal end of the catheter. The distal end of the catheter has a second magnetic component that can magnetically engage with the magnetic poles of the spiral tube.

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