Guiding device and membrane rupture system

Abstract

The invention discloses a guiding device and a membrane rupture system, the guiding device comprises a membrane rupture device, a conveying sheathing canal and a guiding rod piece, the guiding rod piece can slide in the axial direction of the conveying sheathing canal, and the far end of the guiding rod piece penetrates out of a far port of the conveying sheathing canal; at least the axial far-end part of the guide rod piece comprises a guide section, at least part of the guide section is magnetic, and the guide section is curled in the direction perpendicular to the axial direction of the guide rod piece in a natural state to form a spiral pipe structure; the guide section is curled to form a magnetic spiral tube which is used for guiding the membrane rupture device with the magnetic head end to rupture the membrane at the position, where the membrane is to be ruptured, of the covered stent, so that the accuracy of the membrane rupture position and the safety during membrane rupture are effectively ensured.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a guiding device and a membrane puncturing system. Background Art

[0002] When treating aortic diseases, currently, the interventional treatment method of implanting a vascular stent to isolate the diseased area is very common; since there are many important branch vessels on the aorta, in order to obtain a sufficiently safe anchoring area, it is usually necessary to cover these branch vessels with the main body stent implanted in the aorta for treatment. This requires implanting a small branch stent in the branch vessels to reconstruct the covered branch vessels and ensure the blood flow of the branch vessels and the blood supply of the organs; currently, the techniques used to reconstruct branch vessels include chimney technique, fenestration technique, and integrated stent technique with branch stents; due to the unique advantages of the fenestration technique, it is currently the most widely used clinically.

[0003] The fenestration technique is divided into extracorporeal fenestration and in vivo in-situ fenestration; the technical principle of in vivo in-situ fenestration is to first implant the main body stent into the body, and then use a puncture needle to make a small hole in the main body stent at the opening position of the covered branch vessel, and then gradually expand this small hole through a balloon catheter. Finally, implant a branch stent in the window to achieve the purpose of reconstructing the branch vessel, which avoids various problems of extracorporeal fenestration; however, the difficulty of this method is how to perform safe in-situ fenestration in the body.

[0004] Currently, there are already special products for in vivo in-situ fenestration, and its design principle is a hollow needle tube sheathed with a catheter (or balloon catheter) to form a membrane puncturing system. Since the angle of the branch vessel is usually not perpendicular to the aorta, it is impossible to puncture the membrane in this case. Therefore, this design usually requires the assistance of an adjustable bending sheath to adjust the angle of the needle tube so that the catheter of the membrane puncturing system can be as perpendicular to the membrane as possible, facilitating the needle tube to puncture the membrane. However, this also increases the cost of the operation, and sometimes the adjustable bending sheath simply cannot be adjusted to the required angle. The in vivo membrane puncturing of this method has uncertainty, increasing the risk of in vivo puncture and the uncertainty of the operation. Summary of the Invention

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

[0006] A guiding device includes a delivery sheath and a guiding rod. The guiding rod can slide axially along the delivery sheath, and the distal end of the guiding member can pass through the distal port of the delivery sheath; the distal part of the guiding rod includes a guiding section, at least part of the guiding section has magnetism, and the guiding section can form a spiral tube structure perpendicular to the axial direction of the guiding rod in the natural state.

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

[0008] In one embodiment, when the guiding section is located inside the delivery sheath tube, it has a delivery state. In the delivery state, the guiding section includes a plurality of first magnetic members arranged at intervals along the length direction, the magnetic poles of the first magnetic members are distributed perpendicular to the length direction of the guiding section, and the plurality of first magnetic members are embedded in the guiding section, and the same magnetic poles face the same direction.

[0009] In one embodiment, in the natural state, the spiral tube includes a plurality of spiral units along the axial direction. Each spiral unit includes at least two of the first magnetic members, and the first magnetic members of adjacent spiral units are opposite to each other in the circumferential direction.

[0010] In one embodiment, the guiding rod member includes a support section. The distal end of the support section is connected to the proximal end of the guiding section, and the proximal end of the support section passes through the proximal end of the delivery sheath tube; the hardness of the support section is greater than the hardness of the guiding section.

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

[0012] In one embodiment, at least a part of the distal port of the delivery sheath tube is provided with a developing structure, and the developing structure is at least configured to indicate the position of the distal port.

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

[0014] In one embodiment, the distal end of the guiding section includes a tapered tip with a tapered structure, and the taper of the tapered tip is equal to the angle of the spiral angle of the spiral tube formed by the guiding section in the natural state.

[0015] A membrane-breaking system includes a membrane-breaking device and the guiding device as described above. The membrane-breaking device includes a catheter member and a membrane-breaking member. A puncture channel extending along the length direction is provided in the catheter member, and the membrane-breaking member is movably disposed in the puncture channel and can penetrate out from the distal end of the catheter member; a second magnetic member is provided at the distal end of the catheter member, and the second magnetic member can be magnetically attracted and matched with the magnetic poles of the spiral tube.

[0016] Compared with the prior art, the beneficial effects of the present invention are as follows: A guiding device and a membrane-breaking system are provided, including a membrane-breaking device, a delivery sheath, and a guiding rod. The guiding rod can slide axially along the delivery sheath, and the distal end thereof passes through the distal port of the delivery sheath; at least the distal part of the guiding rod in the axial direction includes a guiding section, at least part of the guiding section has magnetism, and the guiding section curls in a direction perpendicular to the axial direction of the guiding rod in the natural state to form a spiral tube structure; the guiding section curls into a magnetic spiral tube, which is used to guide the membrane-breaking device with a magnetic head at the membrane-breaking position of the covered stent for membrane breaking, thereby effectively ensuring the accuracy of the membrane-breaking position and the safety during membrane breaking. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 Schematic diagram of the membrane-breaking system of the present invention entering the aortic blood vessel;

[0018] Figure 2 Schematic diagram of the guiding device of the present invention guiding the membrane-breaking device to break the membrane in the aortic blood vessel;

[0019] Figure 3 Schematic diagram of the structure of the membrane-breaking device in Embodiment 1 of the present invention;

[0020] Figure 4 Schematic diagram of the structure of the guiding device in Embodiment 1 of the present invention;

[0021] Figure 5 Schematic diagram of the guiding section forming a spiral tube structure in Embodiment 1 of the present invention;

[0022] Figure 6 Internal cross-sectional view of the guiding rod in Embodiments 1 and 2 of the present invention;

[0023] Figure 7 Schematic diagram of the spiral tube structure in Embodiments 1 and 2 of the present invention;

[0024] Figure 8 Internal cross-sectional view of the spiral tube in Embodiments 2 and 3 of the present invention;

[0025] Figure 9 Top view of the spiral tube in Embodiments 2 and 3 of the present invention;

[0026] Figure 10 Schematic diagram of the structure of the delivery sheath in Embodiments 1 and 4 of the present invention;

[0027] Figure 11 For the present invention Figure 10 Partial enlarged view of position A;

[0028] Figure 12 Schematic diagram of the structure of one of the catheter parts in Embodiment 2 of the present invention;

[0029] Figure 13 For the present invention Figure 12 Partial enlarged view of position C in the present invention;

[0030] Figure 14 Internal sectional view of the annular structure in Embodiment 3 of the present invention;

[0031] Figure 15 Internal sectional view of the loop structure in other embodiments in Embodiment 3 of the present invention;

[0032] Figure 16 Schematic diagram of the rectangular side of the first magnetic member in Embodiment 4 of the present invention;

[0033] Figure 17 Schematic diagram of the circular top of the first magnetic member in Embodiment 4 of the present invention;

[0034] Figure 18 Schematic diagram of a spiral tube with a conical tip in Embodiment 5 of the present invention;

[0035] Figure 19 Schematic diagram of the conical tip structure in Embodiment 5 of the present invention;

[0036] Figure 20 Schematic diagram of the smooth transition structure of the guide rod section in Embodiment 5 of the present invention. Detailed implementation manners

[0037] To better understand the concept of the present invention, the following specifically describes the implementation manners of the present invention with reference to the accompanying drawings. The following specific embodiments are only partial embodiments of the present invention and do not limit the present invention.

[0038] For ease of description, spatial relative relationship terms can be used in the text to describe the relationship of one element or feature shown in the figure relative to another element or feature. These relative relationship terms are, for example, "internal", "external", "inner side", "outer side", "below", "beneath", "above", "over". Such spatial relative relationship terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is flipped, then an element described as "below" or "beneath" other elements or features will subsequently be oriented as "above" or "over" other elements or features. Therefore, the exemplary term "below" can include both above and below orientations. The device can be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used in the text are accordingly interpreted.

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

[0040] To more clearly describe the structure of the present application, the terms "proximal" and "distal" are defined herein as common terms in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator, and "proximal" refers to the end close to the operator. For example, when a delivery device is inserted, it moves from the proximal position of the operator to the distal position away from the operator; "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial" direction.

[0041] To facilitate a comprehensive understanding of the membrane rupture system 1000 provided by the present application, the structures near the aortic arch will be described first. Please refer to Figures 1 - 2 , the aorta includes the aortic arch, ascending aorta, and descending aorta. A plurality of branch branches are connected to one side of the aortic arch, and one of them is the left subclavian artery. Blood flow successively passes through the ascending aorta, aortic arch, and descending aorta, and when flowing to the aortic arch region, part of the blood flow is shunted into each branch branch. Generally, for aortic dissection or aneurysm involving the aortic arch, during surgical treatment, a covered stent 300 needs to be placed in the aorta, and a branch vascular stent needs to be placed in the involved branch branch, such as the left subclavian artery, and the branch vascular stent is extended to communicate with the covered stent 300 placed in the aorta, so that the blood flow in the aorta can be shunted into the branch branch. Therefore, window holes need to be opened on the covered stent 300 for the branch vascular stent to extend into. In the specific embodiment of the present application, taking the case where the angle between the left subclavian artery and the aortic arch is small as an example, the membrane rupture of the covered stent 300 placed in the aortic arch is introduced, but in other embodiments, the membrane rupture system 1000 can also be used in other similar scenarios.

[0042] Embodiment 1

[0043] In this embodiment, please refer to Figure 2 and Figure 3, the present application provides a membrane puncturing system 1000, which includes a guiding device 100 and a membrane puncturing device 200. After the covered stent 300 is released in the blood vessel, the guiding device 100 can enter the blood vessel to guide the membrane puncturing device 200 to puncture the implanted covered stent 300; the membrane puncturing device 200 used in cooperation with the guiding device 100 at least includes a catheter member 202 and a membrane puncturing member 201. A puncturing channel extending along the length direction thereof is provided in the catheter member 202. In one embodiment, the membrane puncturing member 201 includes a puncturing needle placed in the puncturing channel. The puncturing needle can axially move relative to the catheter member 202 in the puncturing channel, and the distal end of the puncturing needle can extend out of the distal end surface of the catheter member 202 to puncture the stent to be punctured for membrane puncturing; then a guide wire and a balloon catheter are inserted to expand the window, and then a branch stent is implanted to complete the surgical treatment.

[0044] The membrane puncturing member 201 can be a laser membrane puncturing assembly. The energy is transmitted through an optical fiber pipeline by a laser generator, and the laser energy is applied to the membrane of the covered stent 300 to be punctured through the optical fiber pipeline to pierce the membrane. Then a guide wire and a balloon catheter are inserted to expand the window, and then a branch stent is implanted to complete the surgical treatment.

[0045] Please refer to Figures 4 - 6, in the guiding device 100 provided in this embodiment, it includes a delivery sheath 21 and a guiding rod 11. The guiding rod 11 can slide axially along the delivery sheath 21, and its distal end passes through the distal port of the delivery sheath 21. The proximal end of the delivery sheath 21 is connected to a hub 22. Moreover, an exhaust side hole is provided on the side wall of the hub 22. The exhaust side hole is connected to an exhaust pipe for discharging the gas in the sheath, and the exhaust pipe is connected with a Luer connector 23; wherein, at least the distal part of the guiding rod 11 in the axial direction includes a guiding section 112. The guiding section 112 is at least partially magnetic. The guiding section 112 can be magnetic throughout its entire rod body or only a part of its rod body. In some embodiments, the magnetic part or the whole is integrally processed from a magnetic material. The magnetic material can be neodymium iron boron material, which is mixed with a polymer resin in a certain proportion and then integrally injection molded or sintered; the integrally processed magnetic rod body itself has magnetism; the guiding section 112 curls in a direction perpendicular to the axial direction of the guiding rod 11 to form a spiral tube 1121 structure in the natural state. Here, the natural state refers to the state of the guiding section 112 without being affected by external forces and other components. In this state, the spiral tube 1121 structure formed by the curling of the guiding section 112 has a tubular main body, and the side wall is formed by the spirally rising guiding section 112, so that there is magnetism at least on the side wall of the spiral tube 1121. And the distal end of the catheter member 202 of the membrane piercing device 200 of the present application is also provided with magnetism. Therefore, when using the membrane piercing system 1000 provided by the present application, the magnetism of the spiral tube 1121 can be magnetically attracted and matched with the distal end of the catheter member 202 of the membrane piercing device 200 with magnetism, so as to realize the guiding of the guiding device 100 to the membrane piercing device 200. At this time, by adjusting the spiral tube 1121 to the correct membrane piercing position of the membrane covering stent 300, the catheter member 202 of the membrane piercing device 200 can be guided to the correct membrane piercing position for membrane piercing, thereby accurately and effectively improving the accuracy of membrane piercing; in this embodiment, the guiding section 112 of the guiding rod 11 also has a conveying state when it is in the delivery sheath 21. At this time, the guiding section 11 has a length in its axial direction, which is convenient for extending in the delivery sheath 21.,

[0046] Here, please continue to refer to Figure 5 , the perpendicular setting of the spiral tube 1121 to the guiding rod 11 enables the guiding section 112 to be guided into a straight state and enter the delivery sheath 21. After passing through the distal port and naturally restoring to the spiral tube 1121 structure, it naturally extends towards the inner side wall of the membrane covering of the membrane covering stent 300. This direction is the same as the direction that the catheter member 202 needs to present when the membrane covering stent 300 pierces the membrane. Therefore, there is no need to further adjust the guiding direction of the spiral tube 1121, and simple position adjustment can be carried out for guiding membrane piercing.

[0047] In this embodiment, please refer to Figures 7 - 8, in order to 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 curled to form the spiral tube 1121, a hollow pipeline 11212 structure is formed at the axial center position of the spiral tube 1121, and the magnetic part is located on the wall of the spiral tube 1121 formed by the guiding section 112. By setting the magnetic pole direction of the guiding section 112 along the radial direction of the guiding section 112, a magnetic pole structure distributed along the axial direction of the spiral tube 1121 can be formed when the guiding section 112 is curled into the spiral tube 1121. In this way, when any end of the spiral tube 1121 in the axial direction is magnetically attracted and matched with the distal end of the catheter member 202, the distal end of the catheter member 202 will be adsorbed by the spiral tube 1121 to be opposite to the axial end of the spiral tube 1121, so that the position is controllable when the membrane-breaking member 201 penetrates out of the catheter member 202 for membrane breaking, and it is avoided that the membrane-breaking position is inaccurate due to the elasticity of the catheter itself.

[0048] Further, when the distal port of the catheter member 202 is exactly opposite to the position of the hollow pipeline 11212 of the spiral tube 1121, the membrane-breaking member 201 can enter the hollow pipeline 11212 of the spiral tube 1121 to realize the calibration of the puncture position. Moreover, when the membrane-breaking member 201 enters the hollow pipeline 11212, the wall of the spiral tube 1121 formed by the guiding section 112 can play a protective role in membrane breaking, and it can prevent the membrane-breaking member 201 from causing damage to other positions except the puncture position, thereby improving the safety of membrane breaking.

[0049] In one embodiment, please continue to refer to Figure 4 and Figure 6, in order to better push the guiding rod 11 into the position of the covered stent 300 in the human blood vessel, the guiding rod 11 includes a supporting section 111. The distal end of the supporting section 111 is connected to the proximal end of the guiding section 112, and the proximal end of the supporting section 111 passes through the proximal end of the delivery sheath 21. The proximal end of the supporting section 111 is connected with a handle 12. The supporting section 111 is used to provide better support and pushing force when the guiding rod 11 is pushed, and the handle 12 at the proximal end is used for the user to hold and control when pushing; wherein, the hardness of the supporting section 111 is greater than that of the guiding section 112. The guiding section 112 itself needs to have the characteristics of elasticity and pre-shaped recovery, so it needs to be set with a lower hardness to meet the requirements of elasticity and pre-shaped recovery. While the supporting section 111 needs to play a role in pushing and supporting the whole guiding rod 11 itself, so providing a higher hardness can avoid its bending and losing support; further, the guiding section 112 contains magnetic materials, and when forming a spiral tube 1121 after passing through the distal end of the delivery sheath 21 for membrane penetration guidance, it needs to provide a force for it to lean against and fit the side wall of the covered stent 300, so the supporting section 111 needs to provide better supporting force for support.

[0050] In one embodiment, the guiding section 112 and the supporting section 111 can be processed and formed by using PE material. The supporting section 111 is internally provided with a reinforcing member to further improve its overall supporting performance, so as to provide sufficient supporting force for the attachment of the spiral tube 1121 to the inner side wall of the covered stent 300.

[0051] In this embodiment, please further refer to Figure 4 , in order to enable the guiding section 112 of the guiding rod 11 to completely pass through the delivery sheath 21 to form a complete spiral tube 1121 for guidance, the axial length of the guiding 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 supporting section 111; thus, when holding the handle 12 at the proximal end to push the guiding rod 11 distally in the delivery sheath 21 until the handle 12 abuts against the socket 22 of the delivery sheath 21, it is ensured that the guiding section 112 is completely released from the distal port of the delivery sheath 21 and restored to the spiral tube 1121 structure; further, when the axial length L1 of the delivery sheath 21 is equal to the axial length L2 of the supporting section 111, the supporting section 111 and the delivery sheath 21 can simultaneously provide supporting force at the position where the guiding section 112 and the supporting section 111 are joined, so as to further enhance the supporting force when the supporting section 111 forms the spiral tube 1121 and adheres to the inner side wall of the covered stent.

[0052] Embodiment 2

[0053] In this embodiment, please continue to refer to Figure 6 and Figure 8, the overall structures of the guiding device 100 and the membrane-breaking system 1000 are substantially the same as those in Embodiment 1. The difference lies in that the magnetism of the guiding section 112 is provided by a plurality of embedded first magnetic members 1122. And when the guiding section 112 is in the conveying state within the conveying sheath 21, the plurality of first magnetic members 1122 are arranged at intervals along the length direction of the guiding section 112, so that the guiding section 112 has magnetism at multiple positions; further, in order to make the guiding section 112 curl into a spiral tube 1121 in the natural state, the magnetic pole distribution direction of the spiral tube 1121 is distributed along its axial direction. The magnetic pole direction of a single first magnetic member 1122 is distributed perpendicular to the axial direction of the guiding section 112, and the magnetic pole distribution direction of the first magnetic member 1122 is the same as the axial extension direction of the spiral tube 1121. Thus, when the guiding section 112 extends in a direction perpendicular to the axial direction of the guiding rod 11, the two magnetic poles of the first magnetic member 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 axis, and the magnetic induction 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 guiding section 112 curls into a spiral tube 1121 in the natural state, the spiral tube 1121 may include a plurality of spiral units 11211 along its axis. A single spiral unit 11211 forms a complete circular structure in the top view direction or the bottom view direction. In order to make the structure of the spiral tube 1121 more stable after forming and increase the magnetic force in the axial direction, the plurality of first magnetic members 1122 are arranged at the same interval within the guiding section 112, and the orientations of the same magnetic poles are the same, so that when it curls into a spiral tube 1121, the first magnetic members 1122 within the spiral units 11211 at different axial positions are located on the same axis; thus, the plurality of first magnetic members 1122 at the same axis position attract each other end to end, and can provide magnetic force to maintain the shape of the spiral tube 1121. Further, the stacked first magnetic members 1122 can enhance the overall magnetic force of the spiral tube 1121 as the stacking number increases, which helps the spiral tube 1121 provide better magnetic force to quickly and firmly adsorb the distal port of the catheter member 202 and avoid accidents caused by magnetic adsorption failure during the membrane-breaking process; wherein, in order to provide sufficient adsorption force on the two end faces of the spiral tube 1121, at least two first magnetic members 1122 are included on a single spiral unit 11211 to provide sufficient magnetic force; in some embodiments, more first magnetic members 1122 may also be provided on a single spiral unit 11211, such as three, four, etc. The plurality of first magnetic members 1122 are arranged at intervals along the circumferential direction of the spiral unit 11211 and have the same interval distance. Thus, the uniform distribution of the magnetic force is ensured, and the magnetic force is prevented from deviating to one side.

[0055] In one of the embodiments, please refer toFigure 12 and Figure 13 A second magnetic member 2022 is provided at the distal end of the catheter member 202 of the membrane puncturing device 200. The two magnetic poles of the second magnetic member 2022 are distributed along the axial direction of the catheter member 202. Here, the magnetic pole direction of the solenoid 1121 also distributes along its axial direction. Therefore, when the solenoid 1121 guides the distal end of the catheter member 202 for magnetic attraction connection, if the distal end of the catheter member 202 where the second magnetic member 2022 is located is the N pole, then one end of the two ends of the solenoid 1121 in the axial direction with the S pole is attached to the puncture position of the covered stent, so as to magnetically attract and cooperate with the distal end of the catheter member 202 with the N pole for guidance; wherein, one end of the solenoid 1121 close to the support section 111 can be the N pole, and the end far from the support section 111 can be the S pole, or one end of the solenoid 1121 close to the support section 111 can be the S pole, and the end far from the support section 111 can be the N pole.

[0056] In some other embodiments, the diameter of the distal end of the catheter member 202 can be set to be less than or equal to the diameter of the solenoid 1121, so that the membrane puncturing member 201 passing through the catheter member 202 can more easily penetrate into the hollow pipeline 11212 structure of the solenoid 1121 to complete membrane puncturing.

[0057] In one embodiment, please further refer to Figure 8 , the first magnetic member 1122 can be embedded in the guiding section 112 of the guiding rod 11 by means of hot melting during the processing and forming of the guiding rod 11. And after embedding, the guiding rod 11 is provided with through holes 1123 at the positions of the two magnetic poles of the first magnetic member 1122. The through holes 1123 communicate the two ends of the magnetic poles of the first magnetic member 1122 with the outside, exposing the magnetic poles to the outside to enhance the adsorption of the magnetic poles.

[0058] Embodiment 3

[0059] In this embodiment, please refer to Figure 14 and Figure 15 , the overall structures of the guiding device 100 and the membrane puncturing system 1000 are substantially the same as those in Embodiment 1 and Embodiment 2. The difference is that the solenoid 1121 can be provided with only a single-layer spiral unit 11211 in the axial direction, that is, the guiding section 112 forms an annular structure 1125 after bending out of the far port of the delivery sheath 21. Here, a plurality of first magnetic members 1122 are embedded in the annular structure 1125 along the circumferential direction, and the plurality of first magnetic members 1122 are arranged at the same interval; wherein, the distribution direction of the magnetic poles of the first magnetic members 1122 in the annular structure 1125 can be perpendicular to the axial direction of the guiding section 112 and perpendicular to the plane where the annular structure 1125 is bent and formed, forming a structure in which the magnetic poles are distributed along the radial direction of the annular structure 1125.

[0060] In another embodiment, please refer to Figure 15, the magnetic pole direction of the first magnetic member 1122 in 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 member 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 members 1122 are respectively located at the inner ring position and the outer ring position of the annular structure 1125, and the magnetic pole at the inner ring position is set to be opposite to the magnetic pole of the distal port of the catheter member 202 of the membrane rupturing device 200. This can make the catheter member 202 tend to be adsorbed with the inner ring position when magnetically cooperating with the annular structure 1125, so that the distal port of the catheter member 202 can be opposite to the middle hollow position of the annular structure 1125, and the annular structure 1125 plays a protective role when the membrane rupturing member 201 ruptures the membrane.

[0061] Example 4

[0062] In this example, see Figure 16 and Figure 17 The overall structure of the guiding device 100 and the membrane breaking system 1000 is substantially the same as that in Examples 1 to 3, except that the first magnetic member 1122 has an axial thickness and a radial width, and the first magnetic member 1122 can be made of any one of a neodymium iron boron magnet, a samarium cobalt magnet, a ferrite magnet and an aluminum nickel cobalt magnet. In one embodiment, a neodymium iron boron magnet is used as the material of the first magnetic member 1122. Neodymium iron boron (NdFeB) permanent magnet is a rare earth permanent magnet material with high magnetic energy product, coercive force and high energy density, and good mechanical properties. The cross-sectional shape of the first magnetic member 1122 in the axial direction is different from the cross-sectional shape in the radial direction. Here, since the first magnetic member 1122 itself is made of metal material and can be developed under the observation of the developing device, in order to facilitate the guide section 112 to pass through the delivery sheath 21 before the direction of the guide section 112 is observed so as to adjust the guide section 112 to form a spiral after passing through the distal end of the delivery sheath 21. When the spiral tube 1121 structure is formed, the axial direction of the spiral tube 1121 is directly toward the position to be punctured. Specifically, the first magnetic member 1122 is set to a cylindrical structure. The cross-section of the cylindrical structure in the axial direction is rectangular, and the cross-section in the radial direction is circular, and the direction of the magnetic poles is distributed along its axial direction. Here, since the magnetic poles of the first magnetic member 1122 are distributed along its axial direction, and the distribution direction of its magnetic poles requires that the guide section 112 is distributed along the axial direction when forming the spiral tube 1121, at this time, the first magnetic members 1122 in the spiral tube 1121 are rectangular members under the observation of the developing device. Therefore, when the guide section 112 is in the conveying sheath 21, the guide rod 11 is rotated until the developing device observes that multiple first magnetic members 1122 are in a rectangular structure, and the tube mouth of the conveying sheath 21 is aligned with the coating position to be punctured, and the guide section 112 is pushed out to form the spiral tube 1121. Then, the spiral tube 1121 is curled toward the coating position to be punctured, and no further adjustment of direction and position is required.

[0063] In this embodiment, please refer to Figure 10 and Figure 11 , in order to better identify the position of the distal port of the delivery sheath 21 in the blood vessel in the body, at least a part of the distal port is provided with a visualization structure, and the visualization structure is configured to indicate the position of the distal port; the visualization structure can be embedded in the distal port of the delivery sheath 21. After entering the human body, the positional relationship between the distal port of the delivery sheath 21 and the position where the membrane-covered stent is to be punctured can be observed through a visualization device. In some embodiments, the visualization structure is also configured to indicate the orientation of the guiding section 112. Here, two visualization members 24 can be respectively embedded on two opposite sides in the circumferential direction of the distal port, and the two visualization members 24 are symmetrically arranged along the circumferential direction of the tube wall of the delivery sheath 21, so as to be able to identify the angle by which the delivery sheath 21 rotates in the body. In this way, when the guiding section 112 of the guiding rod 11 is passed out of the delivery sheath 21 outside the body, the direction can coincide with the straight line where the connection line of the two visualization members 24 is located. That is, before the guiding rod 11 is sent into the delivery sheath 21 outside the body, the connection line of the two visualization members 24 is perpendicular to the central axis of the spiral tube 1121. Thus, when the two visualization members 24 are observed to coincide and are located at the position to be punctured through the visualization device, the guiding section 112 is passed out of the distal end of the delivery sheath 21, and the guiding section 112 can form a guiding structure extending towards the position to be punctured when forming the spiral tube 1121, without further adjusting the direction and position.

[0064] In one embodiment, in order to make the guiding section 112 of the guiding rod 11 retract into the delivery sheath 21 more smoothly after guiding the membrane puncturing device 200 and avoid bending the distal port or the tube body of the delivery sheath 21, the hardness of at least the distal port of the delivery sheath 21 is set to be greater than the hardness of the guiding section 112. In some other embodiments, the hardness of the entire delivery sheath 21 can also be made greater than the hardness of the guiding section 112. Thus, when retracting, the distal port of the delivery sheath 21 has sufficient hardness to support a greater tangential force, so as to release the magnetic attraction connection structure between the first magnetic members 1122 of different spiral units 11211 when the guiding section 112 forms the spiral tube 1121, and does not cause damage to the distal port and the catheter body of the delivery sheath 21, ensuring the smooth retraction of the guiding rod 11 and the delivery sheath. Among them, the hardness of the distal port can be enhanced by embedding a visualization member, or can be achieved by increasing the hardness of the material of the tube body of the delivery sheath 21 itself.

[0065] Embodiment 5

[0066] In this embodiment, please refer to Figure 18 and Figure 19, the overall structures of the guiding device 100 and the membrane-breaking system 1000 are substantially the same as those in Embodiments 1 to 4. The difference is that, in order to make the extended end of the spiral tube 1121 formed by curling the guiding section 112 fit more closely to the inner wall of the covered stent, the distal end of the guiding section 112 is set to include a tapered tip 1124 with a tapered structure, and the taper β of the tapered tip 1124 is equal to the angle of the helix angle α of the spring; here, the distal end of the guiding section 112 can be set to have a tapered tip 1124 with a tapered structure only on the side that circumferentially fits with the next spiral unit 11211. Here, the guiding section 112 itself has a helix angle α when forming the spiral tube 1121, so that the distal end of the guiding section 112 forms a partially inclined spiral structure at one end where the spiral tube 1121 extends, resulting in the extended end of the spiral tube 1121 not being a flat surface and being difficult to fit with the inner wall of the covered stent; the setting of the tapered tip 1124 enables the distal end of the guiding section 112 to be inclined and attached in the direction of the next spiral unit 11211. When the inclination taper β of the tapered proximal end is the same as the angle of the helix angle α of the spiral tube 1121, the extended end of the spiral tube 1121 basically presents a flat surface and can fit well with the inner side wall of the covered stent, thereby improving the accuracy and stability of the guidance of the spiral tube 1121.

[0067] In another embodiment, please refer to Figure 20 , the surface of the formed guiding section 112 has a smooth transition and no through holes 1123. Here, the smooth transition means that there are no burrs, protrusions or grooves on the rod surface of the guiding section 112, thereby effectively avoiding jamming or poor access when the guiding rod 11 passes in or out of the delivery sheath 21.

[0068] The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. A guiding device, characterized in that, It includes a delivery sheath and a guiding rod. The guiding rod can slide axially along the delivery sheath, and the distal end of the guiding member can extend out of the distal port of the delivery sheath. The distal part of the guiding rod includes a guiding section, at least part of the guiding section has magnetism, and the guiding section can form a spiral tube structure perpendicular to the axial direction of the guiding rod in the natural state.

2. The guiding device according to claim 1, characterized in that, The spiral tube includes at least two magnetic poles, and the two magnetic poles are distributed along the axial direction of the spiral tube.

3. The guiding device according to claim 2, characterized in that, When the guiding section is located inside the delivery sheath, it has a delivery state. In the delivery state, the guiding section includes a plurality of first magnetic members arranged at intervals along the length direction. The magnetic poles of the first magnetic members are distributed perpendicular to the length direction of the guiding section. The plurality of first magnetic members are embedded in the guiding section, and the same magnetic poles face the same direction.

4. The guiding device according to claim 3, characterized in that, In the natural state, the spiral tube includes a plurality of spiral units along the axis. A single spiral unit includes at least two of the first magnetic members, and the first magnetic members of adjacent spiral units are opposite to each other in the circumferential direction.

5. The guiding device according to claim 1, characterized in that, The guiding rod includes a support section. The distal end of the support section is connected to the proximal end of the guiding section, and the proximal end of the support section extends out of the proximal port of the delivery sheath. The hardness of the support section is greater than the hardness of the guiding section.

6. The guiding device according to claim 5, characterized in that In the delivery state, the axial length of the guiding rod is greater than the axial length of the delivery sheath, and the axial length of the delivery sheath is less than or equal to the axial length of the support section.

7. The guiding device according to claim 1, characterized in that At least part of the distal port of the delivery sheath is provided with a developing structure, and the developing structure is at least 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 members, and the two developing members are symmetrically arranged circumferentially along the wall of the delivery sheath. In the natural state of the guiding section, the connection line of the two developing members is perpendicular to the central axis of the spiral tube.

9. The guiding device according to claim 1, characterized in that The distal end of the guiding section includes a tapered tip with a tapered structure, and the taper of the tapered tip is equal to the angle of the spiral angle of the spiral tube formed by the guiding section in the natural state.

10. A membrane-breaking system, characterized in that, It includes a membrane-breaking device and the guiding device according to any one of claims 1-9. The membrane-breaking device includes a catheter member and a membrane-breaking member. A puncture channel extending along its length direction is provided inside the catheter member. The membrane-breaking member is movably inserted into the puncture channel and can extend out of the distal end of the catheter member. A second magnetic member is provided at the distal end of the catheter member, and the second magnetic member can be magnetically attracted and matched with the magnetic poles of the spiral tube.

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