Flow turning sheath

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 catheter body comprises a flow turning section, a plurality of side holes are formed in the flow turning section, the flow turning section is arranged between the far-end opening and the near-end opening, the catheter body receives blood of the aorta at the far-end opening, the blood is turned to the side holes of the flow turning section and is sent to the branch artery, and continuous ischemia is avoided; at least one section easy to bend is further arranged between the diversion section and the far-end opening, so that the diversion sheath better adapts to a bifurcated structure with an angle of the aorta and the branch artery; furthermore, the side hole is formed in the reinforcing spring tube of the tube body, so that the side hole can still keep a good shape even if the tube body is twisted, blocking is avoided, and smooth blood flow turning is ensured.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a bypass sheath. 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 vessels. For example, when the aneurysm involves the left subclavian artery, the thoracic aortic stent needs to be delivered to the lesion 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 blood flow in the left subclavian artery is blocked by the stent, causing ischemia. Based on this, stent fenestration and implantation of branch stents are then performed 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 health of the patient. Summary of the Invention

[0003] Based on this, it is necessary to provide a bypass sheath that can divert aortic blood to the left subclavian artery during the surgical time of stent fenestration, ensuring that the left subclavian artery is not ischemic during the fenestration operation of the thoracic aortic stent and avoiding unnecessary medical accidents.

[0004] A bypass sheath includes a tube body and a sheath base. The tube body includes a distal opening and a proximal opening that are opposite to each other, 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, and the bypass section is provided between the distal opening and the proximal opening; at least one bendable section is further included between the bypass section and the distal opening.

[0005] In one embodiment, the radial strength of the bendable section is less than that of other tube sections of the tube body, and the bendable section has a bending angle in the natural state.

[0006] In one embodiment, the tube body includes an inner tube layer, a reinforcing tube layer, and an outer tube layer along the radial direction. The reinforcing tube layer is provided between the inner tube layer and the outer tube layer, and the reinforcing tube layer is a spring tube structure, and different spring pitches are distributed along the axial direction of the spring tube.

[0007] In one embodiment, the tube body includes a distal tube section extending from the distal end of the bypass section to the distal opening, and a proximal tube section extending from the proximal end of the bypass section to the proximal opening. The spring tubes of the distal tube section and the proximal tube section have a first spring pitch, and the spring tube of the bypass section is provided with a second spring pitch, and the second spring pitch is greater than or equal to the first spring pitch.

[0008] In one embodiment, the side holes penetrate through the outer tube layer and the inner tube layer, and the side holes are provided in the gaps formed by the second spring pitch.

[0009] In one embodiment, the spring tube includes an extending body extending axially. A preset hole is provided at the same axial position of the extending body as that of the diversion section. The side holes penetrate through the outer tube, the preset hole and the inner tube.

[0010] In one embodiment, the extending body is further provided with a hole-forming portion protruding from the surface of the extending body, and the preset hole is provided on the hole-forming portion.

[0011] In one embodiment, the extending body includes a diversion member provided at a position of the extending body opposite to the diversion section. The preset hole is provided on the diversion member; the diversion member has a net cylinder structure, and the hole-forming portion is provided between the two end portions of the diversion member.

[0012] In one embodiment, there are a plurality of the hole-forming portions, which are circumferentially spaced along the diversion member. At least two first transition sections are connected between two adjacent hole-forming portions, and the two first transition sections and the two adjacent hole-forming portions enclose a transition hole portion.

[0013] In one embodiment, the diversion member includes a flexible side wall and a diversion side wall in the circumferential direction. The flexible side wall is located on the side opposite to the bending direction of the easily bendable section in the circumferential direction of the tube body, and the supporting force of the flexible side wall in the axial direction of the diversion member is less than that of the diversion side wall.

[0014] The beneficial effects of the present invention are as follows: Compared with the prior art, the present invention provides a diversion sheath, including a tube body and a sheath base. The tube body includes a distal opening and a proximal opening arranged axially, and the sheath base is connected to the proximal opening of the tube body; the tube body includes a diversion section provided with a plurality of side holes. The diversion section is arranged between the distal opening and the proximal opening. The blood in the aorta is received at the distal opening of the tube body and diverted to the side holes of the diversion section and then sent to the branch artery, avoiding continuous ischemia; there is at least one easily bendable section between the diversion section and the distal opening, enabling the diversion sheath to better adapt to the angled bifurcation structure of the aorta and the branch artery; further, the side holes are provided on the reinforced spring tube of the tube body, enabling the side holes to still maintain a good shape even when the tube body is twisted, avoiding occlusion and ensuring the smooth flow of blood diversion. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0016] Figure 2Schematic diagram of the bypass sheath structure in Embodiment 1 of the present invention.

[0017] Figure 3 Schematic diagram of the layered structure of the tube body in Embodiment 1 of the present invention.

[0018] Figure 4 Schematic diagram of the pre-bent structure of the easily bendable section of the tube body in Embodiment 1 of the present invention.

[0019] Figure 5 Schematic diagram of the distribution of different spring pitches of the spring tube in Embodiment 1 of the present invention.

[0020] Figure 5a Schematic diagram of the side holes being arranged within the spring pitch of the bypass section in Embodiment 1 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 spring tube in Embodiment 2 of the present invention.

[0022] Figure 7 Schematic diagram of the preset holes being formed on the extended main body of the spring tube in Embodiment 2 of the present invention.

[0023] Figure 8 Schematic diagram of the hole-forming part of the extended main body in Embodiment 3 of the present invention.

[0024] Figure 9 Schematic diagram of the tube body being provided with a bypass member in Embodiment 4 of the present invention.

[0025] Figure 10 Schematic diagram of the bypass member in Embodiment 4 of the present invention.

[0026] Figure 10a Schematic diagram of the bypass member in some embodiments in Embodiment 4 of the present invention.

[0027] Figure 10b Schematic diagram of the bypass member being provided with a transition hole part in Embodiment 4 of the present invention.

[0028] Figure 10c Schematic diagram of the bypass member including a flexible side wall in one of the embodiments in Embodiment 4 of the present invention.

[0029] Figure 11 Schematic diagram of the preset hole being set as an annular member in another embodiment of Embodiment 4 of the present invention.

[0030] Figure 11a Schematic diagram of another structure of the annular member in another embodiment of Embodiment 4 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 Embodiment 5 of the present invention.

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

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

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

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

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

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

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

[0039] Figure 18 Schematic diagram of the structure of the shunt 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 in 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 in 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 shunt cavity side in the seventh embodiment of the present invention.

[0045] Figure 24 Schematic diagram of the internal structure of the pipe body provided 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 26Another embodiment of the eighth embodiment of the present invention is a schematic internal structure diagram of a tube body provided with a guiding member.

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

[0049] Figure 28 Schematic 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 embodiments 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, spatially 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 figure. For example, if the device in the figure is flipped, then an element described as "below" or "beneath" another element or feature will be subsequently oriented as "above" or "upper" another element or feature. Thus, the exemplary term "below" can include both the orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatially relative relationship descriptors used in the text are interpreted accordingly.

[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 commonly used terms in the field of interventional medicine. Specifically, the "distal end" refers to the end away from the operator, and the "proximal end" refers to the end close to the operator. For example, during the stent implantation process, the end inserted into the human body is the distal end, and the end held or operated by the operator is the proximal end; the "axial direction" refers to its length direction, and the "radial direction" refers to the direction perpendicular to the "axial direction".

[0054] Embodiment 1:

[0055] Please refer to Figure 1 and Figure 2 The bypass sheath 100 provided by the present application 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 bypass sheath 100 of the present application can be applied not only to the aorta 400 and the left subclavian artery; the bypass 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 axial direction. 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 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. The bypass 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 bypass sheath and reaches the branch artery 500, it flows out from the bypass section 23 to achieve the bypass function. In this embodiment, the distance from the distal opening 21 to the proximal end of the bypass section 23 is 25 mm - 200 mm, and the length of the bypass 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 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 arranged between the bypass section 23 and the distal opening 21, which can make the bypass 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 the 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 can make the bypass sheath 100 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, so as to provide 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 make the flexible section 24 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 with other tube sections at the position of the flexible section 24, so that the spring tube has a larger elastic coefficient at the flexible section 24 and is more likely to deform.

[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 larger 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, presenting an elliptical or other irregular shape, 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 segment 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 segment 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 segments 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; and 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; and 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; and 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 will be too small to affect blood passage when the side hole 204 is set at this position. 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 opened on the tube body 2 and are 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 opened 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 provided 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 be 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 extension main body 2034 extending along the axial direction of the tube body 2 and a preset hole 2035. The extension main body 2034 extends through the entire tube section of the tube body 2, and the preset hole 2035 is opened on the extension main body 2034. Further, the preset hole 2035 is opened at a position on the extension main body 2034 corresponding to the flow diversion section 23. With such a setting, after the side holes 204 on the flow diversion section 23 penetrate through the outer tube, they pass through the preset hole 2035 opened on the corrugated tube and then pass through the inner tube; before the side holes 204 are formed on the tube body 2 in the flow diversion sheath 100 of this embodiment, the preset hole 2035 is first opened 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 opened at positions corresponding to the preset hole 2035; after the preset hole 2035 is opened on the extension main body 2034 of the corrugated tube, the side holes 204 are provided at the positions of the preset hole 2035, such that the shape of the side holes 204 can be maintained well 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 maintained well.

[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 by the polymer material like the inner tube and the outer tube, so as to further ensure 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 part 205 for forming the preset hole 2035. The hole-forming part 205 protrudes from the surface of the extended body 2034, the preset hole 2035 is opened on the hole-forming part 205, and the radial thickness of the hole-forming part 205 is greater than the radial thickness of the extended body 2034; with such a setting, the hole-forming part 205 forms a boss protruding from the surface of the extended body 2034, and the preset hole 2035 is opened in the boss; the protruding setting of the hole-forming part 205 can make the thickness of the bourdon tube around the preset hole 2035 greater than the thickness of the bourdon tube at other positions, so as to provide stronger support and further ensure 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 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 bulge height 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 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 manufacturing the tube body 2, directly form a hole, and only need to process the position of the side hole 204 after manufacturing; 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 force conditions on both sides are the same, thereby further ensuring 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 junction 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 flow diversion sheath 100 is basically the same as that in the first to third embodiments. The difference is that the extension main body 2034 includes a flow diversion member 206, and the flow diversion member 206 is arranged at the relative position of the extension main body 2034 located in the flow diversion section 23. Different from the third embodiment, the part of the extension main body 2034 in the flow diversion section 23 is set as a separate flow diversion member 206, and the preset hole 2061 is opened on the flow diversion member; the independent setting of the flow diversion member 206 enables the part of the spring tube located in the flow diversion section 23 to be independently structured without being restricted by the original structure of the spring tube, so that the preset hole 2061 can be set across the extension main body 2034 and can have a larger aperture to ensure the blood outflow efficiency; the independent flow diversion member 206 can be integrally formed with the spring tube or can exist independently of the spring tube and is embedded in the flow diversion section 23 of the tube body 2;

[0072] Among them, please refer to Figure 10 and Figure 10a , the flow diversion member 206 has an axially extending length and is in a cylindrical structure. The preset hole 2061 is arranged on the side wall of the flow diversion member 206 between the two end parts. A plurality of cuts are opened in the cylindrical structure of the flow diversion member 206 to form a tube body in 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 metals and polymer materials are arranged alternately, which plays a role in reducing hardness and can improve the flexibility of the flow diversion 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 worse 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 holes 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 rings 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 bars 20631 of the transition hole part 20632 is the same as the thickness of the two connected 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 passing blood; 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 smaller apertures, 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 member 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, oval, and diamond, or irregular shapes.

[0076] In this embodiment, there may be not only one flow diverter 206, but also multiple flow diverters 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 diverters 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 diverter 206 by an embedding method. With such a setting, the spring tube or the flow diverter 206 does not need to be processed with the hole-forming part 205 on the inner and outer surfaces during processing, which simplifies the processing steps of the spring tube or the flow diverter 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 diverter 206 may include a flexible side wall 2066 and a flow diversion 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 diverter 206 is less than that of the flow diversion side wall 2067; specifically, the first transition section 2063 and the second transition section 2062 of the flow diverter 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 bypass 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 bypass sheath. Therefore, the preset holes 2035 are only provided on the bypass side wall 2067, and there are no bypass holes 2035 at the position of the flexible side wall 2066. The support bars 20631 of the first transition section 2063 on the side of the flexible side wall 2066 extend circumferentially and are connected to the two bypass side walls 2067 after passing through the side of the flexible side wall 2066, forming spaced support bars 20631 on the side of the flexible side wall 2066, which have the same structure as the annular support member on the flexible side wall 2066. Thus, the bypass member 206 only has a circumferential support structure with intervals on the side of the flexible side wall 2066 and no axial support structure. In this way, when the tube body 2 is located at the bypass section 23, due to the weak axial support force of the bypass member 206 in the circumferential direction on the side of the flexible side wall 2066, good flexibility can also be obtained on the flexible side wall 2066 of the bypass member 206, so that the bypass section 23 can also pass smoothly in the curved blood vessel, avoiding the tube body from being bent at the position of the bypass member 206 due to 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 bypass member 206 to provide a better shape retention effect for the bypass side holes, while avoiding the fracture due to stress concentration between the bypass member 206 and the spring tubes connected to both sides of the bypass member 206 due to excessive support force changes 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 bypass 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 of the radial force can be presented in various ways, such as having a thickness change 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 a sudden change in the supporting force, and thus effectively avoiding bending and breaking at this position.

[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 it flows to the position of the side hole 204 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 this embodiment provides a bypass sheath 100, 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 breaking the membrane 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 communicated 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, when it 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, and then introducing other guiding tubes for the puncture step is complicated and increases the operation time and the operation 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 close to 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 be opposite to or pass 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 out, for puncturing and breaking the membrane 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 puncture hole for breaking the membrane of the covered stent 300 is located. Then the puncture opening 27 can be arranged at the bending section. When the puncture piece breaks the membrane, the position of the puncture opening 27 is opposite to the position where the covered stent 300 needs to be broken, which is convenient for the operator to directly and quickly break 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 section 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. In order to ensure that the setting of the puncture tube 28 does not affect the blood diversion function of the blood 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 of 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 of 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 , in order to prevent the puncture assembly 200 from passing through the intercommunication hole 282 or piercing it 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 when the puncture assembly 200 passes through, it is inverted at the opening position of the inner cavity 210 of the intercommunication hole 282, resulting in passing through or piercing the intercommunication hole 282.

[0091] In this embodiment, please refer to Figure 18, since there must be a branch angle between the aorta 400 blood vessel and the branch artery 500 blood vessel, 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. By providing at least one bendable section 24 between the bypass section 23 and the distal opening 21, the bypass sheath 100 can have better flexibility when entering the aorta 400 blood vessel, making it easier to bend and enter, and reducing the difficulty of insertion. The design of the bendable section 24 of the bypass sheath 100 enables the bypass sheath 100 to have better flexibility and adaptability in this pipe section. When the bypass sheath 100 and the stent are simultaneously disposed 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 bendable section 24 has a smaller radial strength compared to the pipe sections at other positions of the bypass sheath 100, thus providing better flexibility; among them, the bendable section 24 is also the position of the bypass sheath 100 opposite to the branch aorta 400 blood vessel. The puncture port 27 is disposed on the bendable section 24. Since the bendable section 24 enables the pipe body 2 to have better turning characteristics, disposing it on the 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 conduit 28, there is no need for further excessive position adjustment, reducing the operation steps to improve the surgical efficiency; among them, the bendable section 24 can be a pipe section where the hardness of the outer pipe layer 201 is less than that of the outer pipe layer 201 at other positions; or the strength of the reinforcing pipe layer 203 of the 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 diversion 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 mean that both the inner diameter and the outer diameter of the puncture tube 28 change simultaneously. Among them, the puncture tube 28 is set as a foldable flexible tube 281, so that the diameter of the puncture tube 28 can be folded to a 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 diversion, ensuring that the blood diversion effect reaches the best; further, in order to ensure that there is still space in the tube body 2 for blood diversion 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, avoiding 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-covered 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, enabling the tube body 2 to still maintain good passability for blood diversion when the puncture assembly 200 is inserted.

[0095] In another embodiment, please refer to Figure 20, the puncture tube 28 has at least a flexible section 283 in the circumferential direction that can be radially expanded or folded; in this embodiment, the puncture tube 28 is not an overall foldable flexible tube 281, but rather has a foldable flexible section 283 in part. In this way, the flexible section 283 can still ensure the foldability of the puncture tube 28 within the inner cavity 210 of the tube body 2, thereby ensuring that a larger blood diversion space is vacated for blood diversion when the puncture assembly 200 is not inserted, ensuring smooth blood diversion; further, the two sides of the flexible section 283 in the circumferential direction are respectively connected to the inner cavity wall 2101 of the tube body 2, and together with the inner cavity wall 2101 of the tube body 2 where the puncture port 27 is provided, they enclose the puncture tube 28; among them, the flexible section 283 is arranged as a sheet-shaped isolation layer that extends along the axial length of the tube body 2 and has a width in the circumferential direction; at least enclose the inner cavity wall 2101 on the side of the tube body 2 where the puncture port 27 is provided in the circumferential direction, cover the puncture port 27 into the flexible section 283, and the puncture port 27 is located at the outermost distal position of the puncture tube 28 enclosed by the flexible section 283, that is, the flexible section 283 divides the inner cavity of the tube body 2 into a blood diversion cavity part and a puncture cavity part, and the puncture port 27 is located in the puncture cavity; in this way, when the puncture assembly 200 does not penetrate into the puncture tube 28, the flexible section 283 collapses and folds towards the puncture cavity direction, avoiding the blood diversion cavity to form the largest blood diversion channel; and when the puncture assembly 200 penetrates into the puncture tube 28, the flexible section 283 expands towards the blood diversion cavity direction, at least forming a space for the puncture assembly 200 to pass through, and at the same time not blocking the side holes 204, to ensure that blood diversion occurs simultaneously.

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

[0097] In this embodiment, the flexible tube 281 and the flexible section 283 can be formed of PTFE material. This material 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 bypass 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 enclosure of the flexible section 283 and the inner cavity wall 2101 of the tube body 2 with a puncture port 27 in the circumferential direction is the puncture channel 28; the other channel is the bypass 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, so that when the puncture assembly 200 is introduced, it can reach the position of the puncture port 27 more smoothly, and the puncture assembly 200 will not swing randomly during the penetration process due to poor adhesion of the puncture channel 28, and the introduction is not 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 unfolded by introducing the puncture assembly 200, a substantially circular channel is formed by the enclosure of the flexible section 283 and the inner cavity wall 2101 of the tube body 2 with a 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 passing performance of the puncture assembly 200 through the puncture channel is better.

[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 bypass channel side. In one embodiment, it is set to be less than the diameter on the bypass channel side. The purpose of such a setting is to ensure that there is still a larger inner cavity on the bypass channel side after the puncture assembly 200 is introduced, so as to ensure the smoothness of blood bypass.

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

[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 shunt 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 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 to be punctured; 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 is changed to radial extension so as to dock with the puncture opening 27. 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 large bending side position 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 connection position with 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 on the side facing the puncture channel. 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 its axial movement trend is changed 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, the overall wall thickness of the tube section from the puncture opening 27 to the distal opening 21 is increased, and the overall hardness of the tube section can also be increased, thereby providing better support force for the tube body 2 and better maintaining the shape of the tube body 2 when being pressed.

[0110] Wherein, after the tube section from the puncture opening 27 to the distal opening 21 is implanted with the covered stent 300, it is usually parallel to the distal section of the covered stent 300 and is mutually pressed in the blood vessel on the arch side of the aorta 400 blood vessel. Usually, affected by the stent deployment support force, the tube body 2 will be deformed, and the thickening of the partial 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, and 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 this embodiment also provides a puncture system 1000, which 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 disposed in the channel. The front end of the membrane piercing member 4 generally 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 holes 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 can be reached 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 deployment may not necessarily be a perfect circle. Therefore, the maximum inner diameter of the puncture conduit 28 refers to the height from the highest point of the flexible section 283 after deployment to the bottom of the puncture channel.

[0116] The above specific embodiments are only part of the embodiments of the present invention and do not limit the present invention. This specification cannot enumerate all the embodiments of the inventive concept of the present invention, and some features of the above different embodiments can be mutually replaced or combined. 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 includes a distal opening and a proximal opening which are 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. There is at least one bendable section between the bypass section and the distal opening.

2. The flow diversion sheath according to claim 1, characterized in that, The radial strength of the bendable section is less than that of other sections of the tube body, and the bendable section has a bending angle in the natural state.

3. The flow diversion sheath according to claim 1, characterized in that, The tube body includes an inner tube layer, a reinforcing tube layer and an outer tube layer in the radial direction. The reinforcing tube layer is arranged between the inner tube layer and the outer tube layer. The reinforcing tube layer is of a spring tube structure, and different spring pitches are distributed along the axial direction of the spring tube.

4. The flow diversion sheath according to claim 3, wherein The tube body includes a distal tube section extending from the distal end of the bypass section to the distal opening, and a proximal tube section extending from the proximal end of the bypass section to the proximal opening. The spring tube of the distal tube section and the proximal tube section has a first spring pitch, and the spring tube of the bypass section is provided with a second spring pitch, and the second spring pitch is greater than or equal to the first spring pitch.

5. The flow diversion sheath according to claim 4, wherein The side holes penetrate through the outer tube layer and the inner tube layer, and the side holes are arranged in the gaps formed by the second spring pitch.

6. The flow diversion sheath according to claim 4, characterized in that, The spring tube includes an extending body extending along the axial direction. A preset hole is formed in the extending body at the same axial position as the bypass section. The side holes penetrate through the outer tube, the preset hole and the inner tube.

7. The flow diversion sheath according to claim 6, characterized in that, The extending body is further provided with a hole-forming part which protrudes from the surface of the extending body, and the preset hole is formed in the hole-forming part.

8. The shunt sheath according to claim 6 or 7, characterized in that, The extending body includes a bypass member which is arranged at the relative position of the extending body corresponding to the bypass section, and the preset hole is formed in the bypass member. The bypass member has a net cylinder structure, and the hole-forming part is arranged between the two ends of the bypass member.

9. The flow diversion sheath according to claim 8, wherein, There are a plurality of the hole-forming parts, and they are spaced apart along the circumferential direction of the bypass member. At least two first transition sections are connected between two adjacent hole-forming parts, and the two first transition sections and the two adjacent hole-forming parts enclose a transition hole part.

10. The flow diversion sheath according to claim 2, wherein The bypass member includes a flexible side wall and a bypass side wall in the circumferential direction. The flexible side wall is located on the side of the tube body in the circumferential direction opposite to the bending direction of the bendable section, and the supporting force of the flexible side wall in the axial direction of the bypass member is less than that of the bypass side wall.

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