Flow diversion sheath and puncture system

Abstract

The bypass sheath comprises a tube body and a sheath tube seat, the tube body comprises a far-end opening and a near-end opening which are formed in the axial direction, and the sheath tube seat is connected with the near-end opening of the tube body; the tube body comprises a flow turning section, a plurality of side holes are formed in the flow turning section, and the flow turning section is arranged between the far-end opening and the near-end opening; the flow turning section can turn aorta blood into the left subclavian artery canal body within the stent membrane rupture windowing operation time, and long-time ischemia is avoided; the invention further provides a puncture system, a puncture pipeline is arranged in a tube body of the bypass sheath, a puncture opening is formed in the side wall, close to a far-end opening, of the tube body, the far end of the puncture pipeline is connected with the puncture opening, and the other end of the puncture pipeline is connected with a sheath tube seat; the puncture channel provides a pipeline for the puncture assembly to pass through, membrane rupture and windowing of the stent are synchronously carried out, the operation efficiency is improved, and the operation time is saved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a bypass sheath and a puncture system. Background Art

[0002] Currently, endovascular stent implantation is commonly used to treat aortic arch dissection aneurysms; when the aneurysm involves the supra-aortic branches, in-stent fenestration can be used to restore blood flow in the branch aortic vessels. For example, when the aneurysm involves the left subclavian artery, the thoracic aortic stent needs to be delivered to the lesion site first. Since the aneurysm involves the left subclavian artery, the thoracic aortic stent needs to cover the left subclavian artery, and the proximal end of the stent is fixed between the left common carotid artery and the left subclavian artery; at this time, the stent blocks the blood flow in the left subclavian artery, causing ischemia. Based on this, stent fenestration is then performed, and a branch stent is implanted to restore branch blood flow; however, stent fenestration requires surgical time, and the ischemia of the left subclavian artery needs to last for a certain period, which will affect the patient's health. Summary of the Invention

[0003] Based on this, it is necessary to provide a new puncture bypass sheath that can divert aortic blood to the left subclavian artery during the surgical time of stent fenestration, while providing a pipeline for the puncture device to pass through, synchronously performing stent fenestration, improving surgical efficiency, and saving surgical time.

[0004] A bypass sheath includes a tube body and a sheath base. The tube body includes a distal opening and a proximal opening opposite to each other along the axial direction, and the sheath base is connected to the proximal opening of the tube body; the tube body includes a bypass section provided with a plurality of side holes, and the bypass section is arranged between the distal opening and the proximal opening; a puncture pipeline is arranged in the tube body, and a puncture port is formed on the side wall of the tube body near the distal opening. The distal end of the puncture pipeline communicates with the outside through the puncture port, and the proximal end of the puncture pipeline is connected to the sheath base.

[0005] In one embodiment, the puncture pipeline has a variable diameter, and the maximum outer diameter of the puncture pipeline is smaller than the inner diameter of the tube body.

[0006] In one embodiment, at least a part of the puncture pipeline in the circumferential direction includes a flexible section that can be radially expanded or folded.

[0007] In one embodiment, the inner cavity of the tube body has a circular radial cross-section, and both sides of the flexible section in the circumferential direction are respectively connected to the inner cavity wall of the tube body. The flexible section and the inner cavity wall of the tube body on the side where the puncture port is provided enclose a section of the puncture pipeline.

[0008] In one embodiment, the inner cavity of the tube body has an 8-shaped radial cross-section. The two sides of the flexible section in the circumferential direction are respectively connected to the narrow parts of the inner cavity wall of the tube body. The flexible section and the inner cavity wall of the tube body on the side where the puncture port is provided enclose a section of the puncture pipeline.

[0009] In one embodiment, there is at least one bendable section between the bypass section and the distal opening, and the puncture port is provided on the bendable section.

[0010] In one embodiment, a guiding member is provided at the edge of the tube body on the side of the puncture port close to the distal opening. The guiding member protrudes radially from the inner cavity wall of the tube body, and the hardness of the guiding member is greater than that of the puncture pipeline.

[0011] In one embodiment, at least a part of the guiding member inclines towards the puncture port, and the inclined surface is an arc surface.

[0012] In one embodiment, an intercommunication hole is formed in the side wall of the puncture pipeline, and the intercommunication hole connects the side hole and the puncture channel.

[0013] A puncture system includes the above-mentioned bypass sheath and a puncture assembly. The puncture assembly includes a catheter member and a membrane piercing member. A channel extending along the length direction of the catheter member is provided in the catheter member. The membrane piercing member is movably inserted into the channel, and the diameter of the catheter member is less than or equal to the maximum inner diameter of the puncture pipeline.

[0014] The beneficial effects of the present invention are as follows: Compared with the prior art, the present invention provides a bypass sheath, which includes a tube body and a sheath base. The tube body includes a distal opening and a proximal opening arranged along the axial direction, and the sheath base is connected to the proximal opening of the tube body; the tube body includes a bypass section, and a plurality of side holes are formed in the bypass section. The bypass section is arranged between the distal opening and the proximal opening; the bypass section can divert aortic blood into the left subclavian artery tube body during the operation time of stent membrane piercing and windowing, avoiding ischemia for a long time; further, a puncture system is also provided. A puncture pipeline is arranged in the tube body of the bypass sheath. A puncture port is formed in the side wall of the tube body close to the distal opening. The distal end of the puncture pipeline is connected to the puncture port, and the other end is connected to the sheath base; the puncture channel provides a pipeline for the puncture assembly to pass through, and the membrane piercing and windowing of the stent are carried out synchronously, improving the operation efficiency and saving the operation time. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 It is a schematic diagram of the bypass sheath used in the aorta in the first embodiment of the present invention.

[0016] Figure 2 It is a schematic structural diagram of the bypass sheath in the first embodiment of the present invention.

[0017] Figure 3Schematic diagram of the layered structure of the tube body in the first embodiment of the present invention.

[0018] Figure 4 Schematic diagram of the pre-bent structure of the easily bendable section of the tube body in the first embodiment of the present invention.

[0019] Figure 5 Schematic diagram of the different spring pitch distributions of the bellows in the first embodiment of the present invention.

[0020] Figure 5a Schematic diagram of the side holes being arranged within the spring pitch of the flow diversion section in the first embodiment of the present invention.

[0021] Figure 6 Schematic diagram of the side holes of the tube body being arranged on the extended main body of the bellows in the second embodiment of the present invention.

[0022] Figure 7 Schematic diagram of the preset holes being opened on the extended main body of the bellows in the second embodiment of the present invention.

[0023] Figure 8 Schematic diagram of the hole-forming part of the extended main body in the third embodiment of the present invention.

[0024] Figure 9 Schematic diagram of the tube body being provided with a flow diversion member in the fourth embodiment of the present invention.

[0025] Figure 10 Schematic diagram of the flow diversion member in the fourth embodiment of the present invention.

[0026] Figure 10a Schematic diagram of the flow diversion member in some embodiments of the fourth embodiment of the present invention.

[0027] Figure 10b Schematic diagram of the flow diversion member being provided with a transition hole part in the fourth embodiment of the present invention.

[0028] Figure 10c Schematic diagram of the flow diversion member including a flexible side wall in one of the embodiments of the fourth embodiment of the present invention.

[0029] Figure 11 Schematic diagram of the preset hole being set as an annular member in another embodiment of the fourth embodiment of the present invention.

[0030] Figure 11a Schematic diagram of another structure of the annular member in another embodiment of the fourth embodiment of the present invention.

[0031] Figure 12 Schematic diagram of the preset hole provided in the hole-forming part having a cylindrical cross-section in the fifth embodiment of the present invention.

[0032] Figure 12a Schematic diagram of the preset hole having a cylindrical cross-section in the fifth embodiment of the present invention.

[0033] Figure 13 Schematic diagram of the preset hole with a conical hole in another embodiment of the fifth embodiment of the present invention for the pore-forming part.

[0034] Figure 13a Schematic diagram of the preset hole with a conical hole in another embodiment of the fifth embodiment of the present invention.

[0035] Figure 14 Schematic diagram of the bypass sheath for puncturing a covered stent in the aorta in the sixth embodiment of the present invention.

[0036] Figure 15 Schematic diagram of the structure of the bypass sheath in the sixth embodiment of the present invention.

[0037] Figure 16 Schematic diagram of the internal structure of the bypass sheath in the sixth embodiment of the present invention.

[0038] Figure 17 Schematic diagram of the inclined structure of the through-hole for the puncture channel in the sixth embodiment of the present invention.

[0039] Figure 18 Schematic diagram of the structure of the bypass sheath with an easily bendable section in the sixth embodiment of the present invention.

[0040] Figure 19 Schematic diagram of the radial cross-section of the puncture pipe being a flexible pipe in the sixth embodiment of the present invention.

[0041] Figure 20 Schematic diagram of the radial cross-section of the inner cavity of the pipe body with a flexible section in another embodiment of the sixth embodiment of the present invention.

[0042] Figure 21 Schematic diagram of the structure of the inner cavity with an 8-shaped radial cross-section in the seventh embodiment of the present invention.

[0043] Figure 22 Schematic diagram of the structure where the flexible section is set as a flexible pipe in some embodiments of the seventh embodiment of the present invention.

[0044] Figure 23 Schematic diagram of the structure where the diameter of the circular contour of the inner cavity on the puncture channel side is equal to the diameter of the bypass cavity channel side in the seventh embodiment of the present invention.

[0045] Figure 24 Schematic diagram of the internal structure of the pipe body with a guide in the eighth embodiment of the present invention.

[0046] Figure 25 Schematic diagram of the structure of the guide in the eighth embodiment of the present invention.

[0047] Figure 26 Schematic diagram of the internal structure of the pipe body with a guide in another embodiment of the eighth embodiment of the present invention.

[0048] Figure 27 Schematic structural diagram of the puncture system in the ninth embodiment of the present invention.

[0049] Figure 28 Schematic structural diagram of the puncture assembly in the ninth embodiment of the present invention. Detailed implementation manners

[0050] 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.

[0051] For ease of description, spatial relative relationship terms may 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 such as "inner", "outer", "inner side", "outer side", "below", "beneath", "above", "upper" etc. are intended to include different orientations of the device in use or operation other than the orientation depicted in the figures. 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 "upper" other elements or features. Thus, the exemplary term "below" can include both the upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used in the text are accordingly interpreted.

[0052] Although terms such as first, second, third, etc. may be used in the text 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 only be used 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", "second", etc. and other numerical terms do not imply an order or sequence when used in the text. Thus, a first element, component, region, layer, or section discussed below may be referred to as a second element, component, region, layer, or section without departing from the teachings of the exemplary embodiments.

[0053] To more clearly describe the structure of the present application, the terms "proximal end" and "distal end" are defined herein as common terms in the field of interventional medicine. Specifically, the "distal end" represents the end far from the operator, and the "proximal end" represents the end close to the operator. For example, during the stent implantation process, the end entering the human body is the distal end, and the end held or operated by the operator is the proximal end; the "axial direction" represents its length direction, and the "radial direction" represents the direction perpendicular to the "axial direction".

[0054] Embodiment 1:

[0055] Please refer to Figure 1 and Figure 2 For the flow diversion sheath 100 provided in the present application, it is mainly used in the aorta 400 and the branch artery 500 connected to the aorta 400. In the present application, the aorta 400 and the left subclavian artery are taken as examples for description, but the flow diversion sheath 100 of the present application can not only be applied to the aorta 400 and the left subclavian artery; the flow diversion sheath of the present application includes a tube body 2 and a sheath base 1. The tube body 2 includes a distal opening 21 and a proximal opening 22 arranged along the axis. The sheath base 1 is connected to the proximal opening 22 of the tube body 2; the distal opening 21 is used to be placed inside the aorta 400 blood vessel to receive the blood flow in the aorta 400, and the proximal opening 22 is arranged outside the body, connected to the sheath base 1 and communicated with the outside; the tube body 2 includes a flow diversion section 23, and a plurality of side holes 204 are opened in the flow diversion section 23. The flow diversion section 23 is arranged between the distal opening 21 and the proximal opening 22. Among them, after the blood flow at the distal opening 21 enters the flow diversion sheath and reaches the branch artery 500, it flows out from the flow diversion section 23 to achieve the function of flow diversion. In this embodiment, the distance from the distal opening 21 to the proximal end of the flow diversion section 23 is 25 mm - 200 mm, and the length of the flow diversion section 23 is set to 10 mm - 100 mm; since there must be a branch angle between the aorta 400 blood vessel and the branch artery 500 blood vessel, when the flow diversion sheath 100 enters the aorta 400 from the branch artery 500, it will need to bend and turn to enter the aorta 400. At least one easily bendable section 24 is arranged between the flow diversion section 23 and the distal opening 21, which can make the flow diversion sheath 100 have better flexibility when entering the aorta 400 blood vessel, be easy to bend and enter, and reduce the input difficulty.

[0056] In this embodiment, please further refer to Figure 1 and Figure 2, when the tube body 2 of the bypass sheath 100 is inserted into a human blood vessel, it satisfies that when the distal opening 21 is placed in the first blood vessel, the bypass section 23 of the tube body 2 is located in the second blood vessel. The first blood vessel and the second blood vessel are two adjacent blood vessels, such as the aorta 400 and the left subclavian artery. The flexible section 24 is located at the intersection of the first blood vessel and the second blood vessel. The intersection of the first blood vessel and the second blood vessel is usually a bifurcated and curved position. The design of the flexible section 24 of the bypass sheath 100 enables the bypass sheath 100 to have better flexibility and adaptability in this tube section, so that when the bypass sheath 100 and the covered stent 300 are simultaneously arranged in the aorta 400, the bypass sheath 100 can better adhere to the wall, avoiding excessive extrusion of the covered stent 300 caused by poor bending performance and poor wall adhesion. Among them, the flexible section 24 has a smaller radial strength than the tube sections at other positions of the bypass sheath 100, thereby providing better flexibility. In some embodiments, the distance between the flexible section 24 and the distal opening 21 is at least 10 mm - 185 mm. Setting the flexible section 24 within this distance range can enable the flexible section 24 to be at least partially located at the junction of the first blood vessel and the second blood vessel.

[0057] In this embodiment, please refer to Figure 2 and Figure 3 , the tube wall of the tube body 2 includes an inner tube layer 202, a reinforcing tube layer 203, and an outer tube layer 201 along the radial direction. The reinforcing tube layer 203 is arranged between the inner tube layer 202 and the outer tube layer 201. Among them, the outer tube layer 201 can be made of a PEBAX tube, the inner tube layer 202 is made of a PTFE tube, and the reinforcing tube layer 203 can be a braided mesh layer or a spring tube. In order to make the flexible section 24 have a smaller radial strength than the tube sections at other positions of the bypass sheath 100, the hardness of the outer tube layer 201 of the flexible section 24 is less than the hardness of the outer tube of the tube sections at other positions; or the strength of the reinforcing tube layer 203 of the flexible section 24 is lower than the strength of the reinforcing tube layer 203 of the tube sections at other positions. Among them, the reinforcing tube layer 203 can be set as a spring tube structure, and the spring tube can be set to have a smaller spring tube thickness or a larger spring pitch compared to other tube sections at the position of the flexible section 24, so that the spring tube has a larger spring coefficient and is more likely to deform at the flexible section 24.

[0058] In another embodiment, please refer to Figure 4, the flexible section 24 has a pre-bent structure. In the natural state, the flexible section 24 has a bending angle, that is, an angle is formed between the distal opening 21 and the bypass section 23. This angle is adapted to the angle formed by the first blood vessel and the second blood vessel where the bypass sheath 100 is located, or the angle formed between the distal opening 21 and the bypass section 23 is greater than the angle formed by the first blood vessel and the second blood vessel. Thus, after the bypass sheath 100 enters the blood vessel, due to the greater bending angle, the distal opening 21 can be closely attached to the blood vessel wall, avoiding squeezing the covered stent 300. Further, pre-bending the flexible section 24 of the bypass sheath 100 can enable the bypass sheath 100 to have a better bending shape in the natural state, ensuring that the cross-section of the cavity of the inner passage in the sheath tube always remains circular. Compared with a straight sheath tube that is bent after entering, a straight sheath tube often has difficulty maintaining a circular cross-section of the inner passage cavity at the bending point, showing an elliptical or other irregular shapes, which will make the blood passageability at the bending point poor and affect the blood transfusion efficiency.

[0059] In this embodiment, please refer to Figure 5 and Figure 5a , the spring tube has different spring pitches distributed axially. The purpose of setting different spring pitches is to enable the bypass sheath 100 to have better blood vessel adaptability. For example, setting a wider spring pitch in the flexible section 24 can make the flexible section 24 more compliant and easier to deform. Among them, please refer to Figure 5, in the present application, the spring tubes of the proximal tube section 25 between the proximal end of the flow diversion section 23 of the tube body 2 and the proximal opening 22, and the spring tubes of the distal tube section 25 between the distal end of the flow diversion section 23 and the distal opening 21 are provided with a first spring pitch 2031. The flow diversion section 23 is provided with a second spring pitch 2032 different from other tube sections of the flow diversion sheath 100, and the flexible section 24 is provided with a third spring pitch 2033. The first spring pitch 2031, the second spring pitch 2032, and the third spring pitch 2033 are all different. Between the proximal end of the flow diversion section 23 of the tube body 2 and the proximal opening 22, and between the distal end of the flow diversion section 23 and the distal opening 21, the tube body 2 requires a certain radial strength to maintain its shape. Therefore, the first spring pitch 2031 is smaller than the second spring pitch 2032 and the third spring pitch 2033 to ensure higher strength. Since the third spring pitch 2033 is provided in the flexible section 24, it has the largest spring pitch to reduce the strength of the tube body 2 and thus provide better flexibility. The second spring pitch 2032 is related to the side hole 204 and can be set to be greater than or equal to the first spring pitch 2031 according to the size of the side hole 204. In an implemented example, the first spring pitch 2031 is set between 0.1 mm and 5 mm. If the first spring pitch 2031 is less than 0.1 mm, the flexibility of the flow diversion sheath 100 will be poor due to the too small pitch. If it is greater than 5 mm, the supportability of the flow diversion sheath 100 will be poor. The second spring pitch 2032 is set between 0.5 mm and 10 mm. When the second spring pitch 2032 is less than 0.5 mm, the aperture of the side hole 204 at this position will be too small to affect blood passage. When it is greater than 10 mm, the supportability of the flow diversion sheath 100 at this position will be poor and it is easy to bend.

[0060] In this embodiment, please refer to Figure 5a, the side holes 204 penetrate through the inner cavity of the tube body 2, enabling the inner cavity of the tube body 2 to communicate with the blood vessel, so that the blood in the tube body 2 can enter the blood vessel; among them, the side holes 204 are formed on the tube body 2 and located within the spring gap of the corrugated tube, such that the side holes 204 are arranged to bypass the corrugated tube itself; the corrugated tube is usually a metal tube structure with high hardness and great difficulty in forming holes, while the inner tube layer 202 and the outer tube layer 201 are usually made of polymer materials with relatively lower difficulty in forming holes. This enables, after the tube body 2 is formed, the side holes 204 to be formed only between the polymer layers on the flow diversion section 23 without the need to penetrate through the corrugated tube itself, which is easier and more convenient; generally, the diameter or axial width of the side holes 204 is greater than the first spring pitch 2031. At this time, the second spring pitch 2032 of the corrugated tube on the flow diversion section 23 is set to be greater than the first spring pitch 2031 and greater than or equal to the diameter or axial width of the side holes 204 to adapt to the size of the side holes 204. In some embodiments, the diameter or axial width of the side holes 204 ranges from 0.5 mm to 5 mm; it can be understood that since the side holes 204 in this embodiment are arranged within the spring gap of the corrugated tube, the side holes 204 are spirally distributed on the flow diversion section 23. However, the present application does not limit the distribution pattern of the side holes 204 on the tube body 2 to a spiral distribution, and they can also be linearly distributed or distributed in other patterns through specific position selection.

[0061] Embodiment Two:

[0062] In this embodiment, please refer to Figure 6 and Figure 7 , the structure of the flow diversion sheath 100 is basically the same as that in Embodiment One. The difference lies in that the corrugated tube includes an extended main body 2034 extending along the axial direction of the tube body 2 and a preset hole 2035. The extended main body 2034 extends through the entire tube section of the tube body 2, and the preset hole 2035 is formed on the extended main body 2034. Further, the preset hole 2035 is formed at a position on the extended main body 2034 corresponding to the flow diversion section 23. With such an arrangement, after the side holes 204 on the flow diversion section 23 penetrate through the outer tube, they pass through the preset hole 2035 formed on the corrugated tube and then pass through the inner tube; before forming the side holes 204 on the tube body 2 in the flow diversion sheath 100 of this embodiment, the preset hole 2035 is first formed on the corrugated tube, and then the outer tube and the inner tube are formed on the surface of the corrugated tube to form the outer tube layer 201 and the inner tube layer 202. The corrugated tube is embedded within the tube body 2, and then the side holes 204 are formed at positions corresponding to the preset hole 2035; after forming the preset hole 2035 on the extended main body 2034 of the corrugated tube, the side holes 204 are arranged at the positions of the preset hole 2035, such that the shape of the side holes 204 can be well maintained due to the strength support of the corrugated tube. In this way, when the flow diversion sheath 100 extends in the body, even when subjected to deformations such as torsion and bending, the shape of the holes can still be well maintained.

[0063] Among them, please refer to Figure 7, the extended body 2034 of the bourdon tube includes a plurality of axially extending and helically wound spring coils, and a single spring coil has an axial width. The width of the spring coils of the extended body 2034 between the proximal end of the diversion section 23 of the tube body 2 and the proximal opening 22, and between the distal end of the diversion section 23 and the distal opening 21 is smaller than the width of the spring coils on the diversion section. It can be understood that the preset hole 2035 is opened on the spring coil on the diversion section 23, so the spring coil at this position needs to reserve the width for opening the preset hole 2035.

[0064] In this embodiment, in order to facilitate the formation of the side hole 204 at the position of the preset hole 2035, the aperture of the preset hole 2035 is at least greater than or equal to the size of the side hole 204, so as to ensure that the side hole 204 can be formed within the range of the preset hole 2035. When the aperture of the preset hole 2035 is equal to the aperture of the side hole 204, after the side hole 204 is formed, the outer tube layer 201, the bourdon tube and the inner tube layer 202 jointly form the side wall of the side hole 204; in a specific implementation example, the aperture of the preset hole 2035 is greater than the aperture of the side hole 204. Such a setting can avoid the bourdon tube being exposed on the side wall of the side hole 204 when the side hole 204 is opened, and can ensure that the side wall of the side hole 204 is covered with a polymer material like the inner tube and the outer tube, thereby further ensuring the smooth passage of blood through the side hole 204.

[0065] Embodiment Three:

[0066] In this embodiment, please refer to Figure 8 , the structure of the diversion sheath 100 is basically the same as that in Embodiment Two. The difference is that the extended body 2034 is further provided with a hole-forming portion 205 for forming the preset hole 2035. The hole-forming portion 205 protrudes from the surface of the extended body 2034, the preset hole 2035 is opened on the hole-forming portion 205, and the radial thickness of the hole-forming portion 205 is greater than the radial thickness of the extended body 2034; with such a setting, the hole-forming portion 205 forms a convex platform protruding from the surface of the extended body 2034, and the preset hole 2035 is opened in the convex platform; the protruding setting of the hole-forming portion 205 can make the thickness of the bourdon tube around the preset hole 2035 greater than that at other positions, thereby providing stronger support and further ensuring the morphological stability of the side hole 204 when subjected to forces such as twisting and bending.

[0067] Among them, the hole-forming part 205 can bulge on one side of the inner and outer sides of the spring tube, or can also bulge on both the inner and outer sides of the spring tube at the same time; regardless of which side it bulges on, the maximum height of the bulge is flush with the inner wall and / or the outer wall of the tube body 2, that is, the radial thickness of the hole-forming part 205 is equal to the wall thickness of the tube body 2; in some embodiments, the hole-forming part 205 of the extending main body 2034 bulges on both the inner and outer sides of the spring tube at the same time and is flush with the inner wall and the outer wall of the tube body 2, which can make the side hole 204 completely replaced by the preset hole 2035 of the spring tube. Such a setting can make the outer tube layer 201 and the inner tube layer 202 form an avoidance position at the position of the preset hole 2035 when the tube body 2 is manufactured, directly form a hole, and only need to process the position of the side hole 204 after the manufacture is completed; at the same time, the preset hole 2035 replaces the side hole 204, which can avoid the burrs generated by directly opening holes on the outer tube layer 201 and the inner tube layer 202. From the processing perspective, it can reduce the steps of processing burrs, optimize the manufacturing process, and facilitate the formation of the side hole 204; at the same time, reducing the generation of burrs can effectively protect blood vessels; further, the bulge heights of the hole-forming part 205 on both sides of the spring tube are respectively the same as the thicknesses of the outer tube layer 201 provided on the outer side of the spring tube and the inner tube layer 202 provided on the inner side of the spring tube, or the bulge heights of the hole-forming part 205 on both sides of the spring tube are the same, so that the stress conditions on both sides are the same, which can further ensure the overall shape of the side hole 204 when stressed.

[0068] In this embodiment, the bulging surface of the hole-forming part 205 is an arc surface that conforms to the outer wall surface and / or the inner wall surface of the tube body 2, so as to ensure the overall smoothness and flatness of the inner wall and the outer wall of the tube body 2; further, the intersection of the inner wall of the preset hole 2035 and the bulging surface of the hole-forming part 205 adopts an arc fillet transition, so as to avoid forming edges and corners that may scratch the human blood vessels.

[0069] In another embodiment, the hole-forming part 205 bulges on one side of the spring tube, and can bulge on the outer side of the spring tube. After bulging, it is flush with the outer wall of the tube body 2. Such a setting can avoid the generation of burrs by directly opening holes on the outer tube layer 201. The outer tube layer 201 is the part that directly contacts the human blood vessels, so reducing the formation of burrs can effectively protect blood vessels.

[0070] Embodiment 4:

[0071] In this embodiment, please refer to Figures 9 - 10, the structure of the bypass sheath 100 is basically the same as that in the first to third embodiments. The difference is that the extension body 2034 includes a bypass member 206, and the bypass member 206 is arranged at the relative position of the extension body 2034 located in the bypass section 23. Different from the third embodiment, the part of the extension body 2034 in the bypass section 23 is set as a separate bypass member 206, and the preset hole 2061 is opened on the bypass member; the independent setting of the bypass member 206 enables the part of the spring tube located in the bypass section 23 to have an independent structural setting, without being restricted by the original structure of the spring tube, so that the preset hole 2061 can be arranged across the extension body 2034, and a larger aperture can be made to ensure the efficiency of blood outflow; the independent bypass member 206 can be integrally formed with the spring tube or can exist independently of the spring tube and be embedded in the bypass section 23 of the tube body 2;

[0072] Among them, please refer to Figure 10 and Figure 10a , the bypass member 206 has an axially extending length and is of a cylindrical structure. The preset hole 2061 is arranged on the side wall of the bypass member 206 between the two ends. The cylindrical structure of the bypass member 206 is provided with a plurality of cuts to form a tube body with a net-like cylindrical structure; a plurality of annular support members 20641 are arranged at intervals along the axis of the net-like tube body, and adjacent annular support members 20641 are connected by support columns 20642; the spaced annular support members 20641 can provide radial support force for the tube body 2, and at the same time, the spaced arrangement can provide axial movement space to provide flexibility; the annular support members 20641 are connected by support columns 20642 to provide axial support force. The gaps between the annular support members 20641 can provide flexibility, and when the tube body 2 is formed, the outer tube layer 201 can be embedded into the gaps to form a structure in which metal and polymer materials are arranged alternately, playing a role in reducing hardness and improving the flexibility of the bypass section 23.

[0073] In some embodiments, please refer to Figure 10a and Figure 10b, the hole-forming part 2065 is arranged between the two axial ends of the flow-turning part 206, so that a second transition section 2062 is formed between the proximal end of the flow-turning part 206 and the proximal end of the preset hole 2061, and a third transition section 2064 is formed between the distal end of the flow-turning part 206 and the distal end of the preset hole 2061. The flow-turning part 206 is connected to other pipe sections of the spring tube through the second transition section 2062 and the third transition section 2064. The second transition section 2062 and the third transition section 2064 can play a role of transitional connection when the flow-turning part 206 is connected to other pipe sections of the spring tube; there are multiple preset holes 2061, which are arranged at intervals in the circumferential direction of the flow-turning part. A first transition section 2063 is also arranged between two adjacent hole-forming parts 2065 in the circumferential direction. The first transition section 2063 connects and supports the hole-forming parts 2065 of two adjacent preset holes 2061 through multiple support bars 20631; because multiple preset holes 2061 are opened at this pipe section position, the overall hardness and supportability of the pipe section are poorer than those of other pipe sections. The connection of multiple support bars 20631 can improve the supportability of this pipe section, so that the preset hole 2061 can better maintain the overall shape.

[0074] In another embodiment, please refer to Figure 10b , the first transition section 2063 includes at least two adjacent support bars 20631. The gap formed between two adjacent support bars 20631 is larger than the gap of the support ring in the second transition section 2062 and the third transition section 2064, so as to form a transition hole part 20632; further, the thickness of the support bar 20631 of the transition hole part 20632 is the same as the thickness of the two adjacent hole-forming parts 2065, penetrating the entire wall thickness of the pipe body 2. And when the pipe body 2 is formed, the transition hole part 20632 also forms one of the side holes 204 for blood to pass through; a transition hole is opened in the middle of the transition hole part 20632, and the aperture or axial width of the transition hole is less than or equal to the aperture or axial width of the preset hole 2061, and can be set to be less than the aperture or axial width of the preset hole 2061. With such a setting, the transition hole part 20632 can form a support structure for two adjacent hole-forming parts 2065, ensuring the shape retention of the preset hole 2061. Further, the transition hole can provide side holes 204 with a smaller aperture, increasing the blood flow through amount.

[0075] In this embodiment, please refer to Figure 10a and Figure 10b , the preset hole 2061 is set as a rectangular hole. The rectangular hole can better adapt to the net-shaped structure set in this application and is convenient for processing. The axis of the rectangular hole is basically parallel to the support column 20642, and the radial direction is basically parallel to the annular support 20641; however, this application does not limit the shapes of the preset hole 2061 and the side hole 204 to be rectangular holes, and they can be regular shapes such as circular, elliptical and diamond-shaped or irregular shapes.

[0076] In this embodiment, there may be not only one flow deflector 206, but multiple flow deflectors 206, which are arranged adjacent to each other along the axial direction of the tube body 2, and the side holes 204 of two adjacent flow deflectors 206 are staggered in the circumferential direction. In this way, the number of side holes 204 can be increased to ensure that blood flow can better enter the branch artery 500. Further, the staggered side holes 204 enable the blood flow in different orientations in the tube body 2 to have the opportunity to flow out from the side holes 204, thereby increasing the probability of blood outflow.

[0077] In another embodiment, please refer to Figure 11 and Figure 11a , the preset hole 2035 and the hole-forming part 205 are independent annular members 2051. The annular member 2051 can be a circular ring, a square ring or a closed annular member 2051 of other shapes. When the tube body 2 is formed, the annular member 2051 is embedded in the preset position 207 of the spring tube or the flow deflector 206 by an embedding method. With such a setting, the spring tube or the flow deflector 206 does not need to be processed with the hole-forming part 205 on the inner and outer surfaces during the processing and forming process, which simplifies the processing steps of the spring tube or the flow deflector 206. Only the preset position 207 of the annular member 2051 needs to be processed. After the annular member 2051 is installed in the preset position by a matching method, the outer tube layer 201 and the inner tube layer 202 are then formed.

[0078] In one of the embodiments, please refer to Figure 10c , the flow deflector 206 may include a flexible side wall 2066 and a flow deflecting side wall 2067 in the circumferential direction. The flexible side wall 2066 is located on the side of the tube body 2 in the circumferential direction opposite to the bending direction of the easily bendable section 24, and the supporting force of the flexible side wall 2066 in the axial direction of the flow deflector 206 is less than that of the flow deflecting side wall 2067. Specifically, the first transition section 2063 and the second transition section 2062 of the flow deflector 206 are hollowed out between the adjacent annular support members 20641 on the side of the flexible side wall 2066, and no support columns 20642 are provided, so that there is an active gap between the adjacent annular support members 20641, providing better flexibility when the tube body is bent.

[0079] Furthermore, since the flexible side wall 2066 generally adheres to the blood vessel wall when the shunt sheath 100 of the present application enters the left subclavian artery of the human body, it can not only reduce the damage of the flexible side wall 2066 to the blood vessel wall, but also provide better passability of the shunt sheath. Therefore, the preset holes 2035 are only provided on the shunt side wall 2067, and there are no shunt holes 2035 at the position of the flexible side wall 2066. The support bars 20631 of the first transition section 2063 on the flexible side wall 2066 side extend circumferentially and are connected to the two shunt side walls 2067 on the flexible side wall 2066 side, forming spaced support bars 20631 on the flexible side wall 2066 side, which have the same structure as the annular support member on the flexible side wall 2066 side. Thus, the shunt member 206 only has a circumferential support structure with intervals on the flexible side wall 2066 side and no axial support structure. In this way, when the tube body 2 is located at the shunt section 23, due to the weak axial support force of the shunt member 206 in the circumferential direction on the flexible side wall 2066 side, good flexibility can also be obtained on the flexible side wall 2066 of the shunt member 206, so that the shunt section 23 can also pass smoothly in the curved blood vessel, avoiding the bending of the tube body at the position of the shunt member 206 caused by excessive support performance.

[0080] In some embodiments, please refer to Figure 10b , in order to enable the tube body 2 to be provided with the shunt member 206 to provide a better shape retention effect for the side holes of the shunt, while avoiding the fracture caused by stress concentration between the shunt member 206 and the spring tubes connected to both sides of the shunt member 206 due to excessive change in the support force when the tube body is bent, the radial support forces of the second transition section 2062 and the third transition section 2064 at the proximal and distal ends of the shunt member 206 gradually change. Specifically, the radial support force of the second transition section 2062 gradually decreases from the distal side to the proximal side, and the radial support force of the third transition section 2064 gradually increases from the proximal side to the distal side. Among them, the change in the radial force can be presented in various ways, such as having a change in thickness in the axial direction, or having different hollow designs in the axial direction, etc.

[0081] Specifically, the thickness change is set such that the thickness of the second transition section 2062 decreases in a tapered manner from the distal side to the proximal side, and the thickness of the third transition section 2063 decreases in a tapered manner from the proximal side to the distal side; while different hollow designs can be set such that the hollow ratio of the second transition section 2062 increases in a tapered manner from the distal side to the proximal side, and the hollow ratio of the third transition section 2063 increases in a tapered manner from the proximal side to the distal side; thus, after the proximal end of the second transition section 2062 is connected to the spring tube and the distal end of the third transition section 2063 is connected to the spring tube, the change in thickness or the change in the hollow ratio results in a change in the supporting force, thereby forming a process of the supporting force change transition from the flow diversion member 206 to the spring tube, avoiding sudden changes in the supporting force, and thus effectively avoiding bending and breaking at this position when bending.

[0082] Embodiment Five:

[0083] In this embodiment, please refer to Figure 12 and Figure 12a , the structure of the flow diversion sheath 100 is basically the same as that in Embodiments One to Four. The difference is that the preset hole 2035 has an outer opening located outside the tube body 2 and an inner opening located inside the tube body 2 along the depth direction of the hole. In this embodiment, the preset hole 2035 has a cylindrical cross-section, that is, the width of the outer opening is equal to the width of the inner opening.

[0084] In another embodiment, please refer to Figure 13 and Figure 13a , the preset hole is a tapered hole 2036, where the width or aperture of the outer opening is smaller than the width or aperture of the inner opening. The tapered hole 2036 has an increased pressure at the outer opening with a smaller aperture, so that the blood has an effect of increasing the flow rate in the preset hole, thereby providing a better blood outflow effect for the side hole 204.

[0085] In another other embodiment, in order to enable the blood to flow better out of the side hole 204 and into the branch artery 500 when flowing to the side hole 204 position in the flow diversion sheath 100, a blocking member can be provided on the side of the inner opening of the side hole 204 close to the proximal end of the flow diversion sheath 100. The blocking member can protrude from the inner cavity surface of the flow diversion sheath 100, thereby partially blocking the blood passing through this position and making it flow out of the side hole 204, increasing the flow rate flowing out of the side hole 204.

[0086] Embodiment Six

[0087] In this embodiment, please refer to Figure 14 and Figure 15, the structure of the bypass sheath 100 is basically the same as that in the first to fifth embodiments. The difference is that in this embodiment, a bypass sheath 100 is provided, which can provide a passage for the puncture assembly 200 while providing the blood bypass function from the aorta 400 blood vessel to the branch artery 500 blood vessel, and can simultaneously realize the functions of blood bypass and puncturing and membrane rupture of the covered stent 300. Specifically, the bypass sheath 100 includes a tube body 2 and a sheath base 1. The tube body 2 includes a distal opening 21 and a proximal opening 22 arranged along the axis. The sheath base 1 is connected to the proximal opening 22 of the tube body 2. The distal opening 21 is used to be placed in the aorta 400 blood vessel to receive the blood flow in the aorta 400, and the proximal opening 22 is arranged outside the body, connected to the sheath base 1 and communicating with the outside. The tube body 2 includes a bypass section 23, and a plurality of side holes 204 are opened in the bypass section 23. After the blood flow at the distal opening 21 enters the bypass sheath and reaches the branch artery 500, it flows out from the bypass section 23 to realize the bypass function. The bypass section 23 is arranged between the distal opening 21 and the proximal opening 22. At this time, since the bypass sheath 100 is retained in the body, introducing other guiding tubes for the puncture step is complicated and increases the operation time and surgical risk.

[0088] Please refer to Figure 16 , in this application, a puncture channel 28 is provided in the tube body 2 for the passage of the puncture assembly 200. The puncture channel 28 has a puncture opening 27 on the side wall of the tube body 2 near the distal opening 21. The distal end of the puncture channel 28 is connected to the puncture opening 27, and the proximal end is connected to the sheath base 1. The puncture opening 27 is used for the distal end of the puncture assembly 200 to face or penetrate through the puncture opening 27, so that the puncture assembly 200 can penetrate into the puncture channel 28 of the tube body 2 from the proximal end of the sheath base 1 and then extend to the position of the puncture opening 27 to penetrate through, for puncturing and membrane rupture of the covered stent 300. In one embodiment, when the bypass sheath 100 enters the aorta 400 blood vessel from the branch aorta 400 blood vessel for bypass, after the covered stent 300 is implanted, there must be a part of the bending section between the distal end of the bypass sheath 100 and the bypass section 23 between the aorta 400 blood vessel and the branch aorta 400 blood vessel, and the bending section is opposite to the orifice of the branch aorta 400 blood vessel. Usually, this position is the position where the membrane rupture hole for the covered stent 300 to rupture the membrane is located. Then the puncture opening 27 can be arranged at the bending section. When the puncture piece ruptures the membrane, the position of the puncture opening 27 is opposite to the position where the covered stent 300 needs to rupture the membrane, which is convenient for the operator to directly and quickly rupture the membrane.

[0089] In this embodiment, please refer to Figure 16 and Figure 17, the puncture tube 28 can be connected to the sheath base 1 and the puncture port 27 only at the proximal and distal ends respectively. The tube segment between the proximal and distal ends can be in a free state within the tube body 2, or partially connected to the inner wall of the tube body 2. To ensure that the setting of the puncture tube 28 does not affect the blood diversion function of the diversion sheath 100, an intercommunication hole 282 can be provided on the side wall of the puncture tube 28. The setting of the intercommunication hole 282 enables the puncture tube 28 to also serve as a blood diversion channel before the puncture assembly 200 is inserted, and the puncture port 27 can serve as another blood inlet for blood diversion. When the blood reaches the intercommunication hole 282, it is discharged from the intercommunication hole 282, enters the inner cavity 210 of the tube body 2, and then enters the branch aorta 400 through the side hole 204, thus completing the blood diversion process. Or when the puncture tube 28 is partially connected to the inner wall of the tube body 2, the intercommunication hole 282 can be provided at the position where the puncture tube 28 is connected to the inner wall of the tube body 2. Therefore, when the blood reaches the position of the intercommunication hole 282, the blood flowing out from the intercommunication hole 282 can directly flow into the branch aorta 400. Among them, in some embodiments, the intercommunication hole 282 is at least provided at the same axial position as the side hole 204 in the axial direction of the puncture tube 28. With this setting, the blood flowing out from the intercommunication hole 282 can directly flow out from the side hole 204 and enter the branch aorta 400 without conflicting with the blood flow direction in the tube body 2 when flowing out, resulting in unsmooth blood flow in the tube body 2 and the problem of the tube body 2 pulsating.

[0090] Among them, please further refer to Figure 17 , to prevent the puncture assembly 200 from passing through or piercing through the intercommunication hole 282 during the process of passing through the puncture tube 28, the intercommunication hole 282 can be set as an inclined hole, that is, the opening positions on both sides of the intercommunication hole 282 are misaligned, and the opening located in the inner cavity 210 is closer to the circumferential distal end than the opening located outside the puncture tube 28. In this way, it can be avoided that the puncture assembly 200 is inverted at the opening position of the inner cavity 210 of the intercommunication hole 282 during passing through, resulting in passing through or piercing through the intercommunication hole 282.

[0091] In this embodiment, please refer to Figure 18, since there must be a branch angle between the aortic blood vessel 400 and the branch artery blood vessel 500, when the bypass sheath 100 enters the aorta 400 from the branch artery 500, it will need to bend and turn to enter the aorta 400. At least one easily bendable section 24 is provided between the bypass section 23 and the distal opening 21, which can make the bypass sheath 100 have better flexibility when entering the aortic blood vessel 400, be easily bent to enter, and reduce the input difficulty. The design of the easily bendable section 24 of the bypass sheath 100 can make the bypass sheath 100 have better flexibility and adaptability in this pipe section, so that when the bypass sheath 100 and the stent are simultaneously arranged in the aorta 400, the bypass sheath 100 can better adhere to the wall, avoiding excessive extrusion of the stent due to poor bending performance and poor wall adhesion.

[0092] Among them, the easily bendable section 24 has a smaller radial strength than the pipe sections at other positions of the bypass sheath 100, so as to provide better flexibility; among them, the easily bendable section 24 is also the position of the bypass sheath 100 opposite to the branch aorta blood vessel 400. The puncture port 27 is arranged on the easily bendable section 24. Since the easily bendable section 24 makes the pipe body 2 have better turning characteristics, arranging it on the easily bendable section 24 can make the orientation of the puncture port 27 better face the puncture site of the covered stent 300 after bending, or directly face the puncture site of the covered stent 300, so that when the puncture assembly 200 punctures the target covered stent 300 through the puncture pipeline 28, there is no need to further adjust the position too much, reducing the operation steps to improve the surgical efficiency; among them, the easily bendable section 24 can be that the hardness of the outer pipe layer 201 of the easily bendable section is less than the hardness of the outer pipe layer 201 of the pipe sections at other positions; or the strength of the reinforcing pipe layer 203 of the easily bendable section is lower than the strength of the reinforcing pipe layer 203 of the pipe sections at other positions.

[0093] In this embodiment, please refer to Figure 19, in order to minimize the impact on the passability of the tube body 2 for blood shunting before the puncture tube 28 is inserted into the puncture assembly 200, the puncture tube 28 has a variable inner diameter and outer diameter. Here, the variable inner diameter and outer diameter refer to the simultaneous change of the inner diameter and outer diameter of the puncture tube 28. Among them, the puncture tube 28 is set as a foldable flexible tube 281, so that the inner diameter of the puncture tube 28 can be folded to the minimum inner diameter of 0 mm before the puncture assembly 200 is inserted. At this time, the outer diameter is only the wall thickness of the puncture tube 28 itself, that is, the puncture tube 28 is completely folded, and the space occupied in the tube body 2 is only the space occupied by the wall of the puncture tube 28 itself. The inner cavity of the puncture tube 28 is completely squeezed, so that the tube body 2 has the largest inner diameter for blood shunting, which can ensure the best passing effect of blood shunting; further, in order to ensure that there is still space in the tube body 2 for blood shunting after the puncture tube 28 is inserted into the puncture assembly 200, the maximum outer diameter H1 of the puncture tube 28 is set to be smaller than the inner diameter H2 of the tube body 2. In this way, after the puncture tube 28 is inserted into the puncture assembly 200, the maximum outer diameter H1 supported is also smaller than the inner diameter H2 of the tube body 2, which can ensure that the inner cavity 210 of the tube body 2 always has a space for blood to pass through, avoiding the occlusion of the side hole 204; it can be understood that the maximum outer diameter H1 of the puncture tube 28 here is the maximum outer diameter size of the elastic wall of the puncture tube 28 that can be supported and expanded by the puncture assembly 200.

[0094] In this embodiment, please refer to again Figure 19 , the inner cavity 210 of the tube body 2 can have a circular radial cross-section, and the puncture tube 28 also has a circular radial cross-section. At least a part of the puncture tube 28 that is circumferentially on the same side as the puncture port 27 is fixedly connected to the inner cavity 210 of the tube body 2. After connection, two circular pipeline structures with one large and one small and tangent to each other on the inner side are formed with the tube body 2. Such a setting can fix the puncture tube 28 relative to the tube body 2 and avoid the risk of blocking the side hole 204 due to random shaking of the puncture tube 28 in the inner cavity 210 of the tube body 2; moreover, the overlapping and film covering area of the puncture tube 28 and the tube body 2 is minimized, so that the area of the puncture tube 28 covering the side hole 204 of the tube body 2 is also minimized, and the tube body 2 can still maintain good shunting passability when the puncture assembly 200 is inserted.

[0095] In another embodiment, please refer to Figure 20, the puncture duct 28 has at least a flexible section 283 that can be radially unfolded or folded in the circumferential direction; in this embodiment, the puncture duct 28 is not entirely a foldable flexible duct 281, but has a partially foldable flexible section 283. Thus, the flexible section 283 can still ensure the foldability of the puncture duct 28 within the inner cavity 210 of the duct body 2, thereby ensuring a larger bypass space for blood bypass when the puncture assembly 200 is not inserted, and ensuring smooth bypass; further, both sides of the flexible section 283 in the circumferential direction are respectively connected to the inner cavity wall 2101 of the duct body 2, and together with the inner cavity wall 2101 of the duct body 2 where the puncture opening 27 is provided, they enclose the puncture duct 28; wherein, the flexible section 283 is arranged as a sheet-shaped isolation layer that extends along the axial length of the duct body 2 and has a width in the circumferential direction; at least enclose the inner cavity wall 2101 on the side of the duct body 2 where the puncture opening 27 is provided in the circumferential direction, cover the puncture opening 27 into the flexible section 283, and the puncture opening 27 is located at the farthest end position of the puncture duct 28 enclosed by the flexible section 283, that is, the flexible section 283 divides the inner cavity of the duct body 2 into a bypass cavity part and a puncture cavity part, and the puncture opening 27 is located in the puncture cavity; thus, when the puncture assembly 200 does not penetrate into the puncture duct 28, the flexible section 283 collapses and folds towards the puncture cavity direction, avoiding the bypass cavity to form the largest bypass channel; and when the puncture assembly 200 penetrates into the puncture duct 28, the flexible section 283 unfolds towards the bypass cavity direction, at least forming a space convenient for the puncture assembly 200 to pass through, and not blocking the side holes 204, to ensure simultaneous blood bypass.

[0096] Among them, the radian turned by the two connection positions where both sides of the flexible section 283 are respectively connected to the inner cavity wall 2101 of the duct body 2 on the side of the inner cavity wall 2101 of the duct body 2 where the puncture opening 27 is provided in the circumferential direction should be less than 180°, so as to ensure that the maximum diameter of the formed puncture duct 28 is smaller than the inner diameter of the duct body 2, and avoid blocking and sealing the side holes 204.

[0097] In this embodiment, the flexible duct 281 and the flexible section 283 can be formed of PTFE material, which is soft in texture and has a certain elasticity, can be easily folded and expanded, and has a certain support strength to resist the expansion of the side wall when the puncture assembly 200 penetrates.

[0098] Embodiment Seven

[0099] In this embodiment, please refer to Figures 21 - 23, the structure of the flow diversion sheath 100 is basically the same as that in the sixth embodiment. The difference is that the radial cross-section of the inner cavity of the tube body 2 is not circular, but an inner cavity with an 8-shaped radial cross-section. It can be understood that by forming raised portions 2102 on both sides of the inner cavity wall 2101 of the tube body 2, the inner cavity is formed into an 8-shaped channel with two circular contours. At this time, the two sides in the circumferential direction of the flexible section 283 are respectively connected to the two raised portions 2102 formed on both sides of the inner cavity wall 2101 of the tube body 2, that is, the narrow part of the inner cavity. Then, the flexible section 283 isolates the two circular contours of the 8-shaped channel into two relatively independent channels, and the channel formed by the flexible section 283 and the inner cavity wall 2101 of the tube body 2 with the puncture port 27 in the circumferential direction is the puncture channel 28; the other channel is the flow diversion channel. Among them, compared with the circular inner cavity of the tube body 2 with an 8-shaped radial cross-section, the separated puncture channel 28 can have better adhesion to the puncture assembly 200. Therefore, when the puncture assembly 200 is inserted, it can reach the position of the puncture port 27 more smoothly, and the puncture assembly 200 will not swing randomly during the insertion process due to poor adhesion of the puncture channel 28, and the insertion will not be smooth or even pierce through the flexible section 283.

[0100] Among them, please continue to refer to Figure 21 , when the flexible section 283 is inserted into the puncture assembly 200 and unfolds, it encloses a substantially circular channel with the inner cavity wall 2101 of the tube body 2 with the puncture port 27 in the circumferential direction. The substantially circular channel can make the adhesion between the puncture channel 28 and the puncture assembly 200 better, and the puncture assembly 200 has better passability when passing through the puncture channel.

[0101] In this embodiment, please continue to refer to Figure 22 and Figure 23 , the diameter of the circular contour of the inner cavity with an 8-shaped radial cross-section on the puncture channel side can be less than or equal to the diameter on the flow diversion channel side. In one embodiment, it is set to be less than the diameter on the flow diversion channel side. The purpose of such a setting is to ensure that there is still a larger inner cavity on the flow diversion channel side after the puncture assembly 200 is inserted, so as to ensure the smoothness of blood flow diversion.

[0102] In this embodiment, the intercommunication hole 282 can be set at the same axial position on the flexible section 283 as the side hole 204, or on the inner cavity wall 2101 of the tube body 2 with the puncture port 27 in the circumferential direction to ensure the smoothness of flow diversion.

[0103] In some embodiments, please continue to refer to Figure 22, the flexible section 283 can not only be a sheet structure covering circumferentially, but also an integral flexible pipe 281 with a circular cross-section. Part of the flexible pipe 281 is attached to the circular contour of the inner cavity of the pipe body 2 on the side of the puncture channel, and the remaining part of the flexible pipe 281 is located between the narrow parts formed by the two protruding parts 2102 to form a movable free part.

[0104] Embodiment VIII

[0105] In this embodiment, please refer to Figure 24 and Figure 25 , the structure of the bypass sheath 100 is basically the same as that in Embodiments VI and VII. The difference is that since the puncture port 27 is provided on the side wall, when the puncture assembly 200 penetrates axially along the pipe body 2 and exits from the puncture port 27, there is a change in the movement direction from axial movement to radial puncture. In order to prevent the puncture assembly 200 from piercing out from the distal end of the puncture pipe 28 when changing the movement direction to reach the puncture port 27, in this embodiment, a guiding member 29 is provided at the edge of the pipe body 2 near the distal opening 21 on the side of the puncture port 27. Among them, the guiding member 29 protrudes radially from the inner cavity wall 2101 of the pipe body 2, and the hardness of the guiding member 29 is greater than that of the puncture pipe 28; the protruding guiding member 29 is used to guide the puncture assembly 200 to change the movement direction from axial to radial at the edge of the puncture port 27 near the distal opening 21, and specifically provides an axial blocking function at this position to prevent the puncture assembly 200 from further moving axially to pierce through the puncture pipe 28.

[0106] In order to avoid the guiding member 29 being pierced through as well, the hardness of the guiding member 29 is set to be greater than that of the puncture pipe 28, so as to provide stronger support and impact resistance; in some embodiments, the guiding member 29 can be formed by the inner pipe layer 202 of the pipe body 2 protruding towards the inner cavity, or the inner pipe layer 202 and the reinforcing pipe layer 203 can protrude simultaneously. In this way, the reinforcing pipe layer 203 is a metal structure and is basically not pierced through, so as to provide a high resistance strength and achieve a good guiding effect.

[0107] In this embodiment, please continue to refer to Figure 25, in order for the guiding member 29 to achieve a better guiding effect instead of only providing a blocking effect, the guiding member 29 is at least partially inclined towards the puncture opening 27 to form a guiding structure; it can be understood that when the puncture tube 28 extends to the position of the puncture opening 27, the trend of its axial extension changes to radial extension so as to dock with the puncture opening 27, and at least a bending arc is formed in the direction of the large bending side of the puncture opening 27 so that the distal end docks with the puncture opening 27. The guiding member 29 is arranged at the position of the large bending side and is arranged along the bending arc of the large bending side to form an inclined surface 291 with an arc surface, thereby conforming to the structural characteristics of the puncture tube 28 at the position where it is connected to the puncture opening 27 and better playing a guiding role.

[0108] Wherein, the side of the guiding member 29 facing away from the puncture tube 28 can be set as a second inclined surface 292 parallel to the inclined surface 291 facing the puncture channel side. The second inclined surface 292 is in arc transition with the inner cavity wall 2101 of the tube body 2 to form a streamlined curved surface, thereby minimizing the blockage of blood flow as much as possible and ensuring the smooth blood flow during blood diversion.

[0109] In another embodiment, please refer to Figure 26 , the guiding member 29 can be such that the wall thickness of the tube body 2 on the same side as the puncture opening 27 in the circumferential direction of the tube section from the puncture opening 27 to the distal opening 21 is set to be greater than the wall thickness at other circumferential positions and greater than the wall thickness of other tube sections; thus, due to the increase in the wall thickness on the distal side of the puncture opening 27, when the puncture assembly 200 moves axially to the position of the puncture opening 27, it is blocked at the distal end of the puncture opening 27, so that the trend of its axial movement changes to radially penetrate from the puncture opening 27; similarly, the guiding member 29 is inclined towards the puncture opening 27 to form a guiding structure. In this embodiment, setting the wall thickness of the entire tube section from the puncture opening 27 to the distal opening 21 to increase can also increase the overall hardness of the tube section, thereby providing better support for the tube body 2 and better maintaining the shape of the tube body 2 when being pressed.

[0110] Wherein, after the membrane stent 300 is implanted, the tube section from the puncture opening 27 to the distal opening 21 is usually parallel to the distal section of the membrane stent 300 and is mutually pressed in the blood vessel on the arch side of the aorta 400 blood vessel. Usually, affected by the expansion and support force of the stent, the tube body 2 will be deformed, and the thickening of the tube wall of the tube section from the puncture opening 27 to the distal opening 21 can provide better support force and effectively weaken the degree of compression deformation.

[0111] In other embodiments, in order to facilitate the operator to better observe whether the puncture position of the puncture assembly 200 of the present application is accurate during the operation of the puncture system 1000, a developing member may be provided at the puncture port 27, so that the operator can observe the position of the puncture port 27 outside the body through a developing device, so as to quickly adjust it to align with the puncture part of the covered stent 300; accurately position the puncture position and improve the surgical efficiency.

[0112] Embodiment Nine

[0113] In this embodiment, please refer to Figure 27 and Figure 28 , the structure of the bypass sheath 100 is basically the same as that in Embodiments Six to Eight. The difference is that in this embodiment, a puncture system 1000 is further provided. The puncture system 1000 includes the bypass sheath 100 and the puncture assembly 200 provided in the foregoing embodiments; among them, please continue to refer to Figure 28 , the puncture assembly 200 includes a catheter member 3 and a membrane piercing member 4. A channel extending along its length direction is provided in the catheter member 3, and the catheter member 3 is used to extend through the puncture channel and exit from the puncture port 27 for preparing to pierce the membrane. The membrane piercing member 4 is movably inserted into the channel. The front end of the membrane piercing member 4 usually includes a membrane piercing needle. When the catheter member 3 reaches the position of the puncture port 27, the membrane piercing needle is pushed out of the catheter member 3 and the puncture port 27 to pierce the surface membrane of the covered stent 300 to complete the membrane piercing.

[0114] Among them, in order for the catheter member 3 to pass through the puncture channel and not block the side hole 204 for blood diversion, the diameter of the catheter member 3 is less than or equal to the maximum inner diameter of the puncture conduit 28. The maximum inner diameter of the puncture conduit 28 refers to the maximum inner diameter that it can reach within the elastic limit of its flexible section 283 or flexible conduit 281. A diameter less than or equal to this inner diameter can prevent the catheter member 3 from bursting the puncture conduit 28 and ensure the passability of the catheter member 3.

[0115] In this embodiment, the shape of the puncture conduit 28 after unfolding may not be a perfect circle. Therefore, the maximum inner diameter of the puncture conduit 28 refers to the height from the highest point after the flexible section 283 is unfolded to the bottom of the puncture channel.

[0116] The above specific embodiments are only partial embodiments of the present invention and do not limit the present invention. This specification cannot list all embodiments of the inventive concept of the present invention. Moreover, some features of the above different embodiments can be replaced or combined with each other, and those skilled in the art can also make simple replacements according to actual needs. The inventive concept of the present invention is subject to the scope of protection required.

Claims

1. A bypass sheath, characterized in that, It includes a tube body and a sheath base. The tube body axially includes a distal opening and a proximal opening opposite to each other. The sheath base is connected to the proximal opening of the tube body. The tube body includes a bypass section which is provided with a plurality of side holes, and the bypass section is arranged between the distal opening and the proximal opening. A puncture channel is arranged in the tube body, and a puncture port is formed in the side wall of the tube body near the distal opening. The distal end of the puncture channel communicates with the outside through the puncture port, and the proximal end of the puncture channel is connected to the sheath base.

2. The flow diversion sheath according to claim 1, wherein The puncture channel has a variable inner diameter, and the maximum outer diameter of the puncture channel is smaller than the inner diameter of the tube body.

3. The flow diversion sheath according to claim 2, wherein, At least part of the puncture channel circumferentially includes a flexible section that can be radially unfolded or folded.

4. The flow diversion sheath according to claim 3, wherein, The inner cavity of the tube body has a circular radial cross-section. The two sides of the flexible section in the circumferential direction are respectively connected to the inner cavity wall of the tube body, and the flexible section and the inner cavity wall of the tube body on the side where the puncture port is provided enclose a section of the puncture channel.

5. The flow diversion sheath according to claim 3, characterized in that, The inner cavity of the tube body has an 8-shaped radial cross-section. The two sides of the flexible section in the circumferential direction are respectively connected to the narrow part of the inner cavity wall of the tube body, and the flexible section and the inner cavity wall of the tube body on the side where the puncture port is provided enclose a section of the puncture channel.

6. The flow diversion sheath according to claim 1, characterized in that, At least one easily bendable section is further included between the bypass section and the distal opening, and the puncture port is arranged on the easily bendable section.

7. The flow diversion sheath according to claim 1, characterized in that, A guiding member is provided at the edge of the tube body on the side of the puncture port close to the distal opening. The guiding member protrudes radially from the inner cavity wall of the tube body, and the hardness of the guiding member is greater than that of the puncture channel.

8. The flow diversion sheath according to claim 7, characterized in that, At least part of the guiding member inclines towards the puncture port direction, and the inclined surface is an arc surface.

9. The flow diversion sheath according to any one of claims 1-8, characterized in that, An intercommunication hole is formed in the side wall of the puncture channel, and the intercommunication hole connects the side hole and the puncture channel.

10. A puncture system, characterized in that, It includes the bypass sheath and the puncture assembly according to any one of claims 1-9. The puncture assembly includes a catheter member and a membrane piercing member. A channel extending along its length direction is arranged in the catheter member, and the membrane piercing member is movably inserted into the channel. The diameter of the catheter member is smaller than or equal to the maximum inner diameter of the puncture channel.

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