Revascularization system

Abstract

The present invention relates to a revascularization system, comprising an arterial sheath, a bypass system, and a venous sheath which are connected in sequence. The arterial sheath is configured to be connected to the carotid artery, and the venous sheath is configured to be connected to a vein. The arterial sheath comprises a main body and a catheter seat located at the proximal end of the main body, and the proximal end of the catheter seat is communicated with a stent system that is used for loading and delivering a stent to the distal end of the main body. The bypass system comprises an inflow tube, an outflow tube, and a bypass assembly. A tube cavity is arranged in the bypass assembly, a blood filter is arranged in the tube cavity, and the blood in the tube cavity flows from the artery sheath to the venous sheath. The revascularization system of the present invention can establish reverse flow of blood from the carotid artery to the femoral vein, preventing blood clots that have detached during surgery from entering the brain.

Description

Blood flow restoration system Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a blood flow reconstruction system. Background Art

[0002] Carotid artery disease typically occurs when blood clots accumulate on the sidewalls of the common and internal carotid arteries (the arteries that supply blood to the brain). This narrows the arteries. These clots can easily break off and form blood clots that travel with the bloodstream. If blood clots travel with the carotid arteries and enter the brain, they can cause a stroke.

[0003] Among surgical options for carotid artery stenosis, CEA (carotid endarterectomy) is the standard surgical procedure. The procedure involves making a large incision in the patient's neck. Clamps are placed upstream and downstream of the surgical site to block blood flow. The carotid artery is then opened to remove the accumulated material. After removal, the artery is sutured and circulation is restored. This surgical approach is highly invasive and can damage cranial nerves near the carotid artery. There is also a significant risk of postoperative stroke. CAS (carotid artery stenting) is a minimally invasive procedure for carotid artery stenosis. A delivery sheath is introduced percutaneously through the femoral artery and ascends along the aortic arch into the carotid artery. A self-expanding stent is then deployed in the carotid artery to restore normal circulation. However, the CAS procedure involves a longer trajectories, and the deployment of the delivery sheath and self-expanding stent can easily dislodge accumulated material from the carotid artery wall. The incidence of postoperative stroke is significantly higher than that of CEA, resulting in significant clinical limitations.

[0004] Summary of the Invention

[0005] Based on this, it is necessary to provide a medical device for treating carotid artery stenosis that reduces the risk of stroke and causes less trauma.

[0006] The present invention provides a blood flow reconstruction system, comprising a first sheath, a shunt system, and a second sheath connected in sequence; the first sheath comprises a main body and a catheter seat located at the proximal end of the main body, the proximal end of the catheter seat can be connected to a stent system, and the stent system is used to load and transport the stent to the distal end of the main body; the shunt system comprises an inflow tube connected to the first sheath, an outflow tube connected to the second sheath, and a shunt assembly, the shunt assembly is connected between the inflow tube and the outflow tube, the shunt assembly includes a lumen, a blood filter is provided in the lumen, and blood flows along the first sheath through the shunt system to the second sheath.

[0007] In one embodiment, the first sheath includes a tubular body and a balloon located at the distal end of the body, the balloon is located at the distal end of the first sheath, and the filling port of the balloon is connected to the balloon through the catheter seat.

[0008] In one embodiment, the main body includes a filling cavity therein, the filling cavity communicating with the balloon and the catheter seat, and when the balloon is inflated, it blocks the outer periphery of the main body and exposes the inner cavity of the main body.

[0009] In one embodiment, the main body further includes at least one angiography channel.

[0010] In one embodiment, the flow diversion system includes a flow controller; the flow controller is connected to an end of the inlet tube away from the first sheath; the flow controller includes a main body element having a flow channel and a flow control element, the flow control element is at least partially accommodated in the main body element and is movably connected to the flow channel, and the flow control element reduces or increases the flow area of ​​the flow channel under the action of external force.

[0011] In one embodiment, the diversion system includes a one-way check valve, which is connected between the blood filter and the outflow tube or connected to the outflow tube.

[0012] In one embodiment, the circulation channel has an inlet end and an outflow end, the inlet end is close to the inflow pipe, and the outflow end is far away from the inflow pipe; the flow control element has a guide surface, the guide surface faces the inflow end, and is enclosed with the inner surface of the circulation channel to form a flow regulation channel that gradually shrinks from the inflow end to the outflow end.

[0013] In one embodiment, the blood filter includes a filter mesh, and there is a gap between the filter mesh and the inner wall of the lumen, or the blood filter further includes a filter element, and the filter element includes a cylindrical structure with at least one end open, and the filter mesh is arranged in the filter element and there is a gap between the filter mesh and the inner wall of the filter element.

[0014] In one embodiment, the circulation channel includes a connecting section, a narrowing section and a main section sequentially connected from the inflow end to the outflow end; the inner diameter of the narrowing section is smaller than the inner diameters of the connecting section and the main section.

[0015] In one embodiment, the catheter seat includes at least a first cavity, a second cavity and a third cavity, the first cavity and the third cavity are respectively located on both sides of the second cavity, the first connecting plate connects the first cavity and the second cavity, the second connecting plate connects the third cavity and the second cavity, and the first connecting plate and the second connecting plate are respectively provided with at least one suture hole.

[0016] In one embodiment, the bracket includes several main wave coils, each of which includes at least two wave peaks and / or wave troughs of different heights. The main wave coil includes a first wave coil and a second wave coil, and the first wave coil and the second wave coil have a phase difference, so that the multiple troughs of the first wave coil are distributed relative to the multiple wave peaks of the second wave coil, and / or the multiple wave peaks of the first wave coil are distributed relative to the multiple troughs of the second wave coil.

[0017] In one embodiment, the first wave loops and the second wave loops are distributed obliquely.

[0018] In one embodiment, the bracket includes a main body section and developing sections located on both sides of the main body section, and the developing sections include a plurality of developing points distributed along the circumferential direction.

[0019] In one embodiment, in the developing section, the connecting section between adjacent coils extends along the axial direction.

[0020] In one embodiment, in the main body segment, the connecting segment between adjacent wave turns generally extends along the circumferential direction.

[0021] The blood flow reconstruction system of the present invention can establish a retrograde blood flow channel from the carotid artery to the femoral vein. Before placing a stent at the carotid artery stenosis site, the first sheath of the present invention is placed in the common carotid artery, and the second sheath is placed in the femoral vein. After the blood flow reconstruction system is formed, a pressure difference is formed between the high-pressure arterial blood flow in the brain and the low-pressure venous blood flow in the femoral vein, causing the blood flow from the carotid artery to flow reversely to the femoral vein through the blood flow reconstruction system. After the blood flow reconstruction system is established, the carotid artery stenosis site is pre-dilated and a self-expanding stent is placed. This allows thrombi that have fallen off during surgery to be intercepted as they flow through the blood filter with the reverse blood flow, preventing the thrombi from entering the brain blood vessels with the blood in the forward direction and causing a stroke. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] FIG1 is a schematic structural diagram of a blood flow reconstruction system according to an embodiment of the present invention;

[0023] FIG2 is a schematic diagram of a blood flow reconstruction system according to an embodiment of the present invention;

[0024] FIG3 is a schematic structural diagram of an arterial sheath according to an embodiment of the present invention;

[0025] FIG4 is a schematic structural diagram of an arterial sheath in another embodiment of the present invention;

[0026] FIG5 is a schematic diagram of the structure of the balloon portion of the arterial sheath according to one embodiment of the present invention;

[0027] FIG6 is a first working schematic diagram of the balloon portion of the arterial sheath according to one embodiment of the present invention;

[0028] FIG7 is a schematic diagram of the working of the balloon portion of the arterial sheath in one embodiment of the present invention;

[0029] FIG8 is a schematic structural diagram of the balloon portion of the arterial sheath in another embodiment of the present invention;

[0030] FIG9 is a schematic cross-sectional view taken along the AA line in FIG8 from the left side to the right side;

[0031] 10 is a schematic diagram of a first cross-sectional structure of the balloon portion of an arterial sheath in yet another embodiment of the present invention;

[0032] FIG11 is a schematic cross-sectional view taken along the BB line in FIG10 from the left side to the right side;

[0033] 12 is a schematic diagram of a second cross-sectional structure of the balloon portion of the arterial sheath in another embodiment of the present invention;

[0034] 13 is a schematic structural diagram of the balloon portion of the arterial sheath in another embodiment of the present invention;

[0035] FIG14 is a schematic cross-sectional view taken along the CC line in FIG13 from the left side to the right side.

[0036] FIG15 is a schematic structural diagram of a catheter adapter according to an embodiment of the present invention;

[0037] 16 is a schematic structural diagram of a variant of the catheter adapter according to one embodiment of the present invention;

[0038] 17 is a schematic structural diagram of another variant of the catheter adapter according to one embodiment of the present invention;

[0039] 18 is a schematic structural diagram of a catheter adapter according to another embodiment of the present invention;

[0040] FIG19 is a cross-sectional view taken along line A in FIG2 ;

[0041] FIG20 is an exploded view of the structure of a flow controller according to one embodiment of the present invention;

[0042] FIG21 is a cross-sectional view of a flow controller according to an embodiment of the present invention (partial flow of the flow controller);

[0043] FIG22 is a cross-sectional view of a flow controller according to one embodiment of the present invention (flow controller closed);

[0044] FIG23 is an exploded view of the structure of a flow controller according to one embodiment of the present invention;

[0045] FIG24 is a cross-sectional view of a flow controller according to one embodiment of the present invention (flow controller flow);

[0046] FIG25 is a cross-sectional view of a flow controller according to one embodiment of the present invention (flow controller closed);

[0047] FIG26 is a perspective view of a flow controller according to an embodiment of the present invention;

[0048] FIG27 is a cross-sectional view of a flow controller according to one embodiment of the present invention (flow controller closed);

[0049] FIG28 is a cross-sectional view of a flow controller according to an embodiment of the present invention (flow controller flow);

[0050] FIG29 is a schematic diagram of the structure of a venous sheath (flow controller circulation) according to one embodiment of the present invention;

[0051] FIG30 is a schematic structural diagram of a support system according to an embodiment of the present invention;

[0052] FIG31 is a schematic structural diagram of a vascular stent according to an embodiment of the present invention;

[0053] FIG32 is a schematic structural diagram of a first wave coil of a vascular stent according to an embodiment of the present invention;

[0054] FIG33 is a schematic diagram showing the positions of the first and second wave coils of the vascular stent according to one embodiment of the present invention;

[0055] FIG34 is a schematic diagram of the surrounding areas of the first wave coil and the second wave coil of the vascular stent according to one embodiment of the present invention;

[0056] FIG35 is a schematic diagram of the overall state of a vascular stent in a compressed state according to one embodiment of the present invention;

[0057] FIG36 is a schematic diagram of a partial position of a vascular stent in a compressed state according to an embodiment of the present invention;

[0058] FIG37 is a schematic structural diagram of a vascular stent according to another embodiment of the present invention;

[0059] FIG38 is a schematic structural diagram of a vascular stent according to another embodiment of the present invention;

[0060] FIG39 is a schematic structural diagram of a vascular stent according to another embodiment of the present invention;

[0061] FIG40 is a schematic structural diagram of a vascular stent in another embodiment of the present invention. DETAILED DESCRIPTION

[0062] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0063] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. The terms used in this specification of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0064] To more clearly describe the structure of the blood flow reconstruction system, the terms "distal" and "proximal" are defined here. These terms are commonly used in the field of interventional medical devices. Specifically, "distal" refers to the end away from the operator during surgery, while "proximal" refers to the end closer to the operator during surgery.

[0065] As shown in Figures 1 and 2, the blood flow reconstruction system 100 of the present invention includes an arterial sheath 1 (first sheath), an inflow tube 2, a shunt assembly 3, an outflow tube 4 and a venous sheath 5 (second sheath) connected in sequence; generally speaking, the arterial sheath 1 is used to connect the carotid artery, and the venous sheath 5 is used to connect the femoral vein. The inflow tube 2, the shunt assembly 3 and the outflow tube 4 constitute the basic structure of the shunt system 200; specifically, when shunt is required, the distal end of the arterial sheath 1 receives blood from the carotid artery, flows it into the venous sheath 5 through the shunt assembly 3, and then flows into the vein, thereby forming a complete blood flow reconstruction system.

[0066] It should be noted that the above position is the connection position in the commonly used blood flow reconstruction surgery. The arterial sheath 1 and the venous sheath 5 are used to divert the blood flow of the carotid artery to the femoral vein. However, in some specific cases, it is also possible to achieve the requirements of artery to artery, vein to vein, etc. The blood flow direction always satisfies the requirement of flowing from the first sheath to the second sheath, that is, the arterial sheath 1 flows to the venous sheath 5 in this embodiment.

[0067] Referring to FIG3 , the arterial sheath 1 comprises a sheath tube 1100 and a sheath tube seat 1200 , as well as a sheath core 1210 that is inserted into the sheath tube 1100 via the sheath tube seat 1200 . The arterial sheath 1 is used for common carotid artery puncture and occlusion, stent system introduction, and blood flow transfer (arterial blood extraction). The front end of the arterial sheath 1 is pre-curved to conform to the vascular path, minimize contact with the vessel wall, and facilitate balloon centering.

[0068] Generally, the sheath 1100 includes a sheath body 1110, with a sheath seat 1200 disposed at the proximal end of the sheath body 1110. Specifically, the sheath seat 1200 includes a catheter seat system 1300 located at its distal end, with the proximal end of the sheath body 1110 connected to the catheter seat 1300. Generally speaking, in addition to being connected to the sheath body 1110, the catheter seat system 1300 is also connected to the diverter assembly 3 at its proximal end via a diverter valve 1230. A closure balloon 1120 is disposed at the distal end of the sheath body 1110. When the balloon 1120 is inflated to occlude the carotid artery, blood in the carotid artery is transported through the arterial sheath 1. Therefore, the other side of the catheter seat system 1300 is connected to the balloon filling valve 1220. In this embodiment, the balloon filling valve 1220 is provided with an extension tube to prevent the operator's hands from being exposed to radiation when filling the balloon 1120 at the front end of the sheath.

[0069] In another embodiment, referring to Figure 4, the sheath 2100 of another embodiment includes a sheath body 2110, and a sheath seat 2200 is provided at the proximal end of the sheath body 2110. Specifically, the sheath seat 2200 includes multiple branches, and the branch ports of each branch serve as connection points for different components. In this embodiment, the sheath seat 2200 is provided with a hemostatic valve 2210, a diverter valve 2222, and a corresponding balloon filling valve 2230. In addition, in order to better complete the diversion operation, in addition to an angiography port 2221, this embodiment also has a front-end angiography port 2220, so that in the initial state, the front-end angiography port is used to perform angiography on the front end of the sheath to confirm the sheath position and blood vessel size. After the occlusion is completed, angiography is performed through the angiography port 2221 to confirm whether the occlusion is completed, thereby ensuring the accuracy of the operation as much as possible.

[0070] The front end of the sheath 1100 is pre-bent (an adjustable bend can also be used) to facilitate the sheath 1100 to enter the common carotid artery, and there are at least two developing rings (not shown) in the balloon at the distal end of the sheath 1100 for marking the position of the balloon; a depth mark (not shown) is left on the surface of the sheath 1100 for observing the puncture depth during the puncture process.

[0071] Regarding the sheath tube 1100, there are multiple implementations, as follows:

[0072] 5-7, FIG6 is a first working schematic diagram of the sheath 1100, and FIG7 is a second working schematic diagram of the sheath 1100. In the first working state, the sheath 1100 has a guide wire or a sheath core. From the first working state to the second working state, the balloon 1120 in the sheath 1100 is filled.

[0073] In this embodiment, the sheath 1100 includes a tubular body 1110. The body 1110 comprises an outer sheath layer 1111, an inner sheath layer 1112, a balloon 1120 located mostly outside the outer sheath layer 1111, and an inner lumen 1130 for transporting medical devices within the inner sheath layer 1112. The body 1110 primarily serves as a passage for transporting medical devices. Since it is necessary to intervene in the human body, the sheath outer layer 1111 of the main body 1110 needs to have good biocompatibility and a certain strength. Therefore, in this embodiment, the sheath outer layer 1111 preferably includes PEBAX material, and the middle channel formed by the sheath inner layer 1112 is the transportation channel of the instrument. In order to make the transportation process smooth, the sheath inner layer 1112 preferably includes a PTFE membrane in this embodiment. In order to increase the strength of the sheath inner layer 1112 and avoid creases in the sheath inner layer 1112 that affect the transportation of the instrument, and at the same time, the flexibility of the main body 1110 cannot be caused by excessive increase in strength, the spring tube 1113 is wrapped around the outer surface of the sheath inner layer 1112, and the sheath outer layer 1111 is sleeved on the outside of the sheath inner layer 1112 and the spring tube 1113.

[0074] In this embodiment, a semi-compliant balloon 1120 is disposed at the distal end of the body 1110. As the inflation pressure increases, the diameter of balloon 1120 also increases, allowing balloon 1120 to adhere closely to the inner wall of the blood vessel, fully occluding the vessel and blocking blood flow. When balloon 1120 is inflated, the body 1110 is positioned directly in the center of the balloon 1120, preventing it from contacting the vessel wall during occlusion, thereby protecting the vessel from damage.

[0075] In this embodiment, as balloon 1120 gradually fills, it blocks blood flow, allowing the device to pass normally. When the internal filling pressure of balloon 1120 increases to exceed a specified value, the internal pressure of balloon 1120 causes main body 1110 to deform and cling to the device, achieving the effect of securing the device and stopping bleeding. It is worth noting that in this embodiment, the filling cavity 1121 of balloon 1120 extends through the interior of the sheath outer layer 1111, thereby having a significantly smaller volume than other designs that additionally cover the balloon filling cavity outside the sheath. More precisely, while ensuring a good filling rate, main body 1110 can have a smaller outer diameter and a larger inner diameter, leaving more space for device delivery.

[0076] In this embodiment, a developing ring (not shown) is provided at the distal end of the main body 1110 to facilitate positioning of the sheath tube 1100 after implantation.

[0077] Furthermore, in this embodiment, the proximal and distal sides of the body 1110 are configured to have different strengths. Specifically, the distal end of the body 1110 exhibits greater flexibility, preventing damage to blood vessels during transport and entry into the human body. The proximal side of the body 1110 also provides greater support, facilitating the maintenance of the overall strength of the body 1110 and preventing the inability to transmit proximal force to the distal end when movement to a predetermined position is required. Preferably, the outer sheath layer 1111 of the body 1110 comprises a first section 11111 and a second section 11112, wherein the first section 11111 is constructed of PEBAX 35D and the second section 11112 is constructed of PEBAX 63D.

[0078] In this embodiment, a medium (such as a contrast agent) is injected into the filling cavity 1121 of the balloon 1120 to expand the balloon 1120 and thereby block the blood vessel, while at the same time, the device can be delivered and blood flow can be transported through the inner cavity 1130.

[0079] Referring to Figure 5 , when the inflation pressure of balloon 1120 gradually increases and falls below a preset value, balloon 1120 expands to block blood flow. At this point, balloon 1120 gradually expands to fill the gap between body 1110 and the blood vessel, but devices can pass through body 1110 normally. It should be noted that the preset value is determined based on the pressure intensity of the balloon and the overall strength of the distal end of body 1110 (i.e., first section 11111).

[0080] When it reaches the preset value, it means that the internal pressure of the balloon 1120 reaches the strength that can deform the distal segment of the main body 1110, as shown in Figure 6. At this time, the balloon 1120 not only fills the gap between the main body 1110 and the blood vessel, but also forces the corresponding position on the distal side of the main body 1110 to be squeezed and deformed inward, so that the inner wall of the main body 1110 is close to the device, forming the effect of fixing the device and blocking blood flow at the same time.

[0081] Since the expansion volume of the balloon 1120 can be controlled, when this embodiment is applied to blood flow transport, that is, the inner cavity 1130 serves as a channel participating in blood flow transport, it can also be achieved: when the balloon 1120 has just expanded to fill the gap between the main body 1110 and the blood vessel, the inner cavity 1130 connects to the blood vessel to participate in blood flow transport (that is, cooperates to achieve blood reflux); when the balloon 1120 continues to fill and the internal pressure gradually increases, driving the main body 1110 to deform, the channel diameter of the inner cavity 1130 gradually decreases, thereby reducing the flow rate of the transported blood until it finally stops, thereby achieving the effect of controlling the blood flow transport speed, thereby eliminating the need for intermediate components introduced to control the flow rate.

[0082] In this embodiment, in order to avoid damage to the blood vessel wall due to excessive pressure after the balloon 1120 is filled, this embodiment preferably does not set the spring tube 1113 in the area of ​​the sheath inner layer 1112 corresponding to the balloon 1120, that is, the strength of the main body 1110 in the balloon 1120 area is less than the strength of other areas of the main body 1110.

[0083] In another embodiment, an auxiliary channel is provided between the balloon 1120 and the sheath inner layer 1112, that is, the outer surface of the balloon 1120 and the sheath inner layer 1112 are connected. When the balloon 1120 is inflated, the pressure of the balloon 1120 can also directly act on the sheath inner layer 1112, thereby avoiding the deformation of the sheath outer layer 1111 leading to deformation of other areas, and at the same time reducing the difficulty of driving the main body 1110 to deform.

[0084] In another alternative embodiment, multiple balloons are circumferentially disposed at the distal end of the main body 1110. Referring to Figures 8-9, Figure 9 is a schematic cross-sectional view taken from the left side to the right side of Figure 8 along the AA position. Multiple balloons are circumferentially disposed at the distal end of the main body 1110 of the sheath 1100, including balloons 11221, 11222, 1223, and 11224. Each balloon has a separate filling chamber, and thus, balloons 11221, 11222, 11223, and 11224 can be individually controlled. By filling different balloons, the fixation of the device within the balloon sheath 11200 and the flow rate of blood counterflow can be flexibly controlled, providing greater adaptability than a single-balloon solution.

[0085] In another alternative embodiment, an intermediate layer is added to the distal end of the main body 1110, referring to Figures 10-12, Figure 10 is a first cross-sectional structural schematic diagram of the balloon sheath 11300, Figure 11 is a cross-sectional schematic diagram of the BB position in Figure 10 from the left to the right side of the figure, and Figure 12 is a second cross-sectional structural schematic diagram of the balloon sheath 11300, wherein the first section and the second section are both longitudinal sections, and the first section and the second section are perpendicular, and Figures 10 and 111 are both in the state where the balloon 1120 is filled, the purpose of which is to reflect the coverage area and function of the intermediate layer 11310.

[0086] The intermediate layer 11310 partially covers the surface of the sheath inner layer 1112 along the circumferential direction, thereby strengthening the strength of the sheath inner layer 1112 in some areas. In this embodiment, a spring tube can be used. Please refer to Figure 10 for the specific distribution position.

[0087] It should be noted that due to the presence of the intermediate layer 11310, when the balloon 1120 is subjected to a large inflation pressure, the area of ​​the main body 1110 that deforms toward the inward pressure becomes an area not covered by the intermediate layer 11310. This is because the intermediate layer 11310 provides support and can offset the pressure of the balloon 1120. The purpose of this is to leave a certain space between the inner wall of the balloon sheath 11300 (the area supported by the intermediate layer) and the device, allowing for reverse blood flow, while other areas can still deform normally, thereby achieving the purpose of both securing the device and promoting blood flow.

[0088] In general, when the filling pressure gradually increases, the balloon expands to block blood flow, and the device can pass normally; when the filling pressure increases to exceed the specified value, the balloon compresses part of the sheath longitudinally, so that the longitudinal inner wall of the sheath (no spring support in the longitudinal direction) is tightly attached to the fixed device, and the transverse inner wall of the sheath (with spring support in the transverse direction) forms a certain space with the device, allowing blood to flow back, thereby achieving the purpose of both fixing the device and transporting blood.

[0089] In this embodiment, the middle layer 11310 may be made of flexible elastic pieces such as springs and meshes. Its purpose is not to always leave a certain space between the inner wall of the balloon sheath 11300 (the area supported by the middle layer 11310) and the device, but rather that the area with the middle layer 11310 requires a relatively greater pressure to deform relative to the area without the middle layer 11310, thereby achieving a staged deformation. For example, when a medium is injected into the balloon 1120 and the pressure is gradually increased to the first stage, the balloon first completes the occlusion between the outer side of the main body 1110 and the blood vessel. gap; when the balloon 1120 is injected with pressure to the second stage, the area of ​​the main body 1110 without the intermediate layer 11310 is deformed, so that a certain space is left between the inner wall of the balloon sheath 11300 (the area supported by the intermediate layer) and the device, allowing blood to flow back, but other areas can still deform normally, thereby achieving the purpose of both fixing the device and transporting blood; when the balloon 1120 is injected with pressure to the third stage, the area of ​​the intermediate layer 11310 also begins to deform, and the gap between the inner wall of the main body 1110 and the device is also filled, thereby fixing the device and stopping blood transport.

[0090] It should be noted that if the balloon 1120 directly acts on the sheath inner layer 1112 (if the sheath outer layer 1111 does not deform), the intermediate layer 11310 needs to be correspondingly arranged on the sheath inner layer 1112.

[0091] In another alternative embodiment, multiple intermediate layers are provided. Specifically, referring to Figures 13-14, Figure 14 is a schematic cross-sectional view taken from the left side to the right side of Figure 13 along the CC line. In this embodiment, at least a first intermediate layer 11410 and a second intermediate layer 11420 are provided within the main body 1110. The first intermediate layer 11410 and the second intermediate layer 11420 partially overlap and cover the main body 1110 along the circumferential direction.

[0092] In this embodiment, the first intermediate layer 11410 is a spring tube structure, and the second intermediate layer 11420 is a spring sheet structure. In this embodiment, the strength of the first intermediate layer 11410 is limited to be greater than the strength of the second intermediate layer 11420. When the first intermediate layer 11410 and the second intermediate layer 11420 are distributed as shown in Figures 13 and 14, at least the following four regions are formed:

[0093] The first region D1 includes the first intermediate layer 11410 and the second intermediate layer 11420 . The first region D1 requires the greatest deformation pressure.

[0094] The second region D2 includes only the first intermediate layer 11410 , and the deformation pressure required for the second region D2 is smaller than that for the first region D1 ;

[0095] A third region D3, which includes only the second intermediate layer 11420, and the deformation pressure required for the third region D3 is smaller than that for the second region D2;

[0096] and a fourth region D4 not covered by the intermediate layer, wherein the fourth region D4 requires the smallest deformation pressure.

[0097] With this design, the filling phase of the balloon 1120 can be divided into the following four phases:

[0098] In the first stage, a medium is injected into the balloon 1120 to gradually increase the pressure, and the balloon completes the occlusion of the gap between the outside of the body 1110 and the blood vessel, allowing blood to be transported from the inside of the body 1110 in reverse flow.

[0099] In the second stage, the balloon 1120 continues to be pressurized, and the fourth area D4 in the main body 1110 is deformed. The main body 100 in the fourth area D4 moves inward, and the inner wall of the main body 100 in other areas (the area supported by the middle layer) still leaves a certain space with the device. The space for blood countercurrent transport becomes smaller, and the corresponding blood countercurrent transport flow rate decreases, thereby controlling the blood flow transport flow rate to the value of the second stage. If the fourth area D4 has a partial relative distribution, it also has the function of fixing the device (fixing by pressing the device from the relative position).

[0100] In the third stage, the balloon 1120 is continuously pressurized on the basis of the second stage, and the third region D3 also begins to deform. The space for blood countercurrent transport becomes smaller, and the corresponding blood countercurrent transport flow rate further decreases, thereby controlling the blood flow transport flow rate to the value of the third stage.

[0101] In the fourth stage, the balloon 1120 is continuously pressurized on the basis of the third stage, and the second region D2 also begins to deform. The space for blood countercurrent transport becomes smaller, and the corresponding blood countercurrent transport velocity further decreases, thereby controlling the blood flow velocity to the value of the fourth stage.

[0102] In the fifth stage, the balloon 1120 continues to be pressurized on the basis of the fourth stage, the first area D1 also begins to deform, the space for blood countercurrent transport becomes further smaller, and the corresponding blood countercurrent transport flow rate further decreases, until the main body 1110 of the first area D1 also sticks to the device, so that the inner wall of the main body 1110 is completely close to the device, thereby achieving the effect of completely fixing the device. At this time, the blood flow transport flow rate is almost 0, and the blood flow transport stops.

[0103] Therefore, as described in this embodiment, by partially overlapping the two intermediate layers, more complex multi-level regulation of blood countercurrent transport is achieved.

[0104] In another embodiment, the first intermediate layer 11410 and the second intermediate layer 11420 have the same structural setting but different thicknesses, which can also achieve a similar technical effect as in this embodiment, but may increase the overall thickness of the tube body or cause the distal center of gravity of the main body 1110 to deviate from the axis.

[0105] In another embodiment, the areas covered by the first intermediate layer 11410 and the second intermediate layer 11420 do not overlap at all, that is, they are separated from each other.

[0106] In another embodiment, the body 1110 includes a plurality of first intermediate layers 11410 and / or a plurality of second intermediate layers 11420 .

[0107] In another embodiment, the main body 1110 includes multiple first intermediate layers 11410 and / or multiple second intermediate layers 11420, and the first intermediate layers 11410 are distributed along the axial direction, and the second intermediate layers 11420 are distributed along the circumferential direction, thereby obtaining multiple regions with different strengths and uniform distribution that can deform with the balloon 1120.

[0108] In addition to serving as a connection, the catheter adapter 1300 itself also has a special design, as follows:

[0109] 15 , the catheter adapter 1300 includes a catheter adapter body 1310, which includes a first cavity 1311, a second cavity 1312 and a third cavity 1313. The ends of the first cavity 1311, the second cavity 1312 and the third cavity 1313 are all Luer external connectors. In terms of distribution, the second cavity 1312 extends straight along the direction of the catheter, and the first cavity 1311 and the third cavity 1313 are respectively located on both sides of the second cavity 1312; when the catheter adapter 1300 is used in carotid artery blood flow reconstruction surgery, the first cavity 1311 is connected to the balloon 1120 to inflate and depressurize the balloon, that is, the first cavity 1311 is connected to the filling cavity of the balloon 1120, and the second cavity 1312 serves as a accommodating cavity to accommodate the entry and exit of the guide wire or sheath core, thereby realizing the delivery of interventional instruments, and the third cavity 1313 serves as a blood transfer channel to realize blood transfer.

[0110] In another embodiment, the second cavity 1312 serves as a receiving cavity to accommodate the entry and exit of a guide wire or sheath core, thereby realizing the delivery of interventional devices, and the side branch opening of the second cavity 1312 is connected to a countercurrent channel for blood circulation, and the third cavity 1313 serves as an angiography channel.

[0111] In another embodiment, the second cavity 1312 serves as a receiving cavity to accommodate the entry and exit of a guidewire or sheath core, thereby enabling the delivery of an interventional device, and the side branch opening of the second cavity 1312 is connected to a countercurrent channel for blood circulation. In addition, the side branch of the second cavity 1312 is also connected to a fourth cavity (not shown). The fourth cavity and the third cavity are both angiography channels, wherein the third cavity 1313 is mainly used for angiography of the rear end area of ​​the balloon (i.e., the proximal side), and the fourth cavity is mainly used for angiography of the front end area of ​​the balloon (i.e., the distal side, also known as the distal end of the sheath or the front end of the sheath). Specifically, the operator can confirm the implantation position and blood vessel size through angiography of the front end of the balloon (sheath). After the balloon is filled and blocked, the operator can confirm whether the blockage is completed through angiography of the rear end area of ​​the balloon.

[0112] In this embodiment, a first connecting plate 1320 is further provided between first cavity 1311 and second cavity 1312. First connecting plate 1320 is provided with at least one suture hole 1321. Similarly, a second connecting plate 1330 is provided between third cavity 1313 and second cavity 1312. Second connecting plate 1330 is provided with at least one suture hole 1331. Both suture holes 1321 and 1331 can secure catheter adapter body 1310 to the skin. This design of this embodiment can shorten the overall length of the entire catheter adapter system, thereby simultaneously shortening the overall length of the entire catheter system, thereby minimizing the size of the implantable catheter system. Furthermore, the securing position is close to the position of catheter adapter body 1310, which can also prevent excessive micro-movement of catheter adapter body 1310.

[0113] In this embodiment, the edge of the first connecting plate 1320 is a curve. In order to make the suture position of the suture hole 1321 as close as possible to achieve a good fixing effect, the edge of the first connecting plate 1320 is recessed toward the connection position of the first cavity 1311 and the second cavity 1312, and it is satisfied that the line connecting the position of the maximum curvature of the edge of the first connecting plate 1320 and the position of the edge of the suture hole 1321 closest to the first connecting plate 1320 passes through the center of the suture hole 1321. In this state, the path passed by the suture thread when passing through the suture hole 1321 and the edge of the first connecting plate 1320 to fix the catheter seat body 1310 is the shortest.

[0114] Similarly, in this embodiment, the edge of the second connecting plate 1330 is a curve. In order to make the suturing position of the suture hole 1331 as close as possible to achieve a good fixing effect, the edge of the second connecting plate 1330 is recessed toward the connection position of the third cavity 1313 and the second cavity 1312, and it is satisfied that the line connecting the position of the maximum curvature of the edge of the second connecting plate 1330 and the position of the edge of the suture hole 1331 closest to the second connecting plate 1330 passes through the center of the suture hole 1331. In this state, the path passed by the suture thread when passing through the suture hole 1331 and the edge of the second connecting plate 1330 to fix the catheter seat body 1310 is the shortest.

[0115] Preferably, the line connecting the center of the suture hole 1321 and the center of the suture hole 1331 is substantially perpendicular to the axis of the second cavity 1312 .

[0116] Preferably, the first connecting plate 1320 and the second connecting plate 1330 are both arranged on the side of the catheter seat body 1310 close to the human body. Furthermore, the first connecting plate 1320 and the second connecting plate 1330 are coplanar with at least one side of the first cavity 1311, the second cavity 1312 and the third cavity 1313. In other words, the first connecting plate 1320 and the second connecting plate 1330 are not arranged in the plane formed by the axes of the first cavity 1311, the second cavity 1312 and the third cavity 1313, but are arranged in a plane tangent to the first cavity 1311, the second cavity 1312 and the third cavity 1313 at the same time. The side surfaces of the first connecting plate 1320 and the second connecting plate 1330 are coplanar with the outer shells of the first cavity 1311, the second cavity 1312 and the third cavity 1313, thereby reducing the influence of the diameters of the various cavities of the catheter seat body 1310, so that the first connecting plate 1320 and the second connecting plate 1330 are as close to the skin as possible.

[0117] In this embodiment, the angle between the first cavity 1311 and the second cavity 1312 is between 30° and 60°, preferably 45°, and the angle between the third cavity 1313 and the second cavity 1312 is between 30° and 90°, preferably 45°.

[0118] It should be noted that, in this embodiment, the connection position between the first cavity 1311 and the second cavity 1312 is different from the connection position between the third cavity 1313 and the second cavity 1312, and the edge of the first connecting plate 1320 is located proximal to the connection position between the first cavity 1311 and the second cavity 1312, and the edge of the second connecting plate 1330 is located distal to the connection position between the third cavity 1313 and the second cavity 1312.

[0119] In another embodiment, referring to Figure 16, Figure 16 is a structural schematic diagram of a variant of the catheter seat 1300. In Figure 16, the connection position of the first cavity 1311 and the second cavity 1312 and the connection position of the third cavity 1313 and the second cavity 1312 are located at the same position in the axial direction. At this time, in order to make the line connecting the center of the suture hole 1321 and the center of the suture hole 1331 as perpendicular to the axis of the second cavity 1312 as possible, preferably, the edge of the first connecting plate 1320 is located proximal to the connection position of the first cavity 1311 and the second cavity 1312, and the edge of the second connecting plate 1330 is located proximal to the connection position of the third cavity 1313 and the second cavity 1312.

[0120] In another embodiment, referring to Figure 17, Figure 17 is a structural schematic diagram of another variant of the catheter seat 1300. In Figure 17, the connection position of the first cavity 1311 and the second cavity 1312 is different from the connection position of the third cavity 1313 and the second cavity 1312, but the angle between the third cavity 1313 and the second cavity 1312 is 90°. At this time, in order to make the line connecting the center of the suture hole 1321 and the center of the suture hole 1331 as perpendicular as possible to the axis of the second cavity 1312, preferably, the edge of the first connecting plate 1320 is located proximal to the connection position of the first cavity 1311 and the second cavity 1312, and the edge of the second connecting plate 1330 is located distal to the connection position of the third cavity 1313 and the second cavity 1312.

[0121] In another alternative embodiment, multiple suture holes are provided on the connecting plate, referring to Figure 18, wherein a first connecting plate 1320 is provided between the first cavity 1311 and the second cavity 1312, and the first connecting plate 1320 is respectively provided with a first suture hole 13211, a second suture hole 13212 and a third suture hole 13213; a second connecting plate 1330 is provided between the third cavity 1313 and the second cavity 1312, and the second connecting plate 1330 is respectively provided with a fourth suture hole 13311, a fifth suture hole 13312 and a sixth suture hole 13313. This is to meet the needs under certain conditions that multiple suture positions are required to strengthen fixation, or that multiple suture holes are combined to meet different suture needs.

[0122] In this embodiment, the edge of the first connecting plate 1320 is a curve. In order to make the suture positions of the first suture hole 13211, the second suture hole 13212 and the third suture hole 13213 as close as possible to achieve a good fixing effect, the edge of the first connecting plate 1320 is recessed toward the connection position of the first cavity 1311 and the second cavity 1312, and it is satisfied that, in the area near the suture hole 13211, the maximum curvature position of the edge of the first connecting plate 1320 is aligned with the edge of the suture hole 13211 closest to the first connecting plate 1320. The line connecting the positions of the first connecting plate 1320 and the edge of the first connecting plate 1320 passes through the center of suture hole 13211. In the area near suture hole 13212, the line connecting the position of maximum curvature of the edge of the first connecting plate 1320 and the position of the edge of suture hole 13212 closest to the first connecting plate 1320 passes through the center of suture hole 13212. In the area near suture hole 13213, the line connecting the position of maximum curvature of the edge of the first connecting plate 1320 and the position of the edge of suture hole 13213 closest to the first connecting plate 1320 passes through the center of suture hole 13213. Overall, the edge of the first connecting plate 1320 is an undulating curve.

[0123] In this embodiment, the edge of the second connecting plate 1330 is a curve. In order to make the suture positions of the fourth suture hole 13311, the fifth suture hole 13312 and the sixth suture hole 13313 as close as possible to achieve a good fixing effect, the edge of the second connecting plate 1330 is recessed toward the connection position of the third cavity 1313 and the second cavity 1312, and it is satisfied that, in the area near the suture hole 13311, the maximum curvature position of the edge of the second connecting plate 1330 is aligned with the edge of the suture hole 13311 closest to the second connecting plate 1330. The line connecting the positions of the second connecting plate 1330 and the edge of the second connecting plate 1330 passes through the center of suture hole 13311. In the area near suture hole 13312, the line connecting the position of maximum curvature of the edge of the second connecting plate 1330 and the position of the edge of suture hole 13312 closest to the second connecting plate 1330 passes through the center of suture hole 13312. In the area near suture hole 13313, the line connecting the position of maximum curvature of the edge of the second connecting plate 1330 and the position of the edge of suture hole 13313 closest to the second connecting plate 1330 passes through the center of suture hole 13313. Overall, the edge of the second connecting plate 1330 is an undulating curve.

[0124] Preferably, the line connecting the center of suture hole 13212 and the center of suture hole 335 is basically perpendicular to the axis of the second cavity 1312. At the same time, the line connecting the center of suture hole 1321 and the center of suture hole 334 is basically perpendicular to the axis of the second cavity 1312, or the line connecting the center of suture hole 13213 and the center of suture hole 336 is basically perpendicular to the axis of the second cavity 1312.

[0125] In an alternative embodiment, the connecting plate is detachable, that is, the second connecting plate 1330 is fixed between the third cavity 1313 and the second cavity 1312 via a slot structure. The purpose is to select different shapes of connecting plates according to different implant locations to ensure close contact with the skin. In another embodiment, the catheter adapter 1300 includes a stress tube at its proximal end. The stress tube has a high strength (but not higher than the hardness of the sheath tube), thereby preventing the sheath tube from buckling at the connection point when the sheath tube is bent.

[0126] Regarding the shunt assembly 3, when the stent is implanted, the shunt assembly 3 can control the blood flow rate on the one hand, and the one-way valve setting of the shunt assembly 3 can also make the blood flow in a specific direction to the vein outside the body. Specifically:

[0127] 19 , the flow diversion assembly 3 includes a housing 31 and a flow controller 32, a blood filter 33, and a one-way check valve 34 disposed within the housing 31 and connected in sequence. The flow controller 32 is connected to the end of the inflow tube 2 away from the arterial sheath 1, and the one-way check valve 34 is connected to the end of the outflow tube 4 away from the venous sheath 5.

[0128] Furthermore, the one-way check valve 34 is connected between the blood filter 33 and the outflow tube 4 .

[0129] In which, the flow controller 32 includes a main body element 321 having a circulation channel 3211 and a flow control element 322. The flow control element 322 is at least partially accommodated in the main body element 321 and is movably connected to the circulation channel 3211. The flow control element 322 reduces or increases the circulation area of ​​the circulation channel 3211 under the action of external force.

[0130] Before stent placement at the carotid artery stenosis site, the arterial sheath 1 of the present invention is placed into the common carotid artery, and the venous sheath 5 is placed into the femoral vein. This creates a pressure differential between the high-pressure arterial blood flow in the brain and the low-pressure venous blood flow in the femoral vein, causing the carotid blood flow to flow reversely through the blood flow reconstruction system to the femoral vein. After the reverse blood circulation system is established, the carotid artery stenosis site is pre-dilated and a self-expanding stent is placed. During surgery, any thrombus dislodged during the reverse blood flow is intercepted when it passes through the blood filter, preventing it from entering the body. The flow controller 32 allows the doctor to adjust the reverse blood flow in real time.

[0131] In this embodiment, as shown in Figures 20 and 21 , the main body 321 further comprises a movable channel 3212 in communication with the circulation channel 3211. The flow control element 322 is movably disposed within the movable channel 3212. Under the action of an external force, the distal end of the flow control element 322 moves toward the circulation channel 3211, extending beyond the movable channel 3212 and entering the circulation channel 3211. This creates a certain degree of obstruction to the circulation channel 3211, reducing the flow area of ​​the circulation channel 3211 and, in turn, reducing the flow rate of the blood flow reconstruction system. Conversely, under the action of an external force, the distal end of the flow control element 322 moves away from the circulation channel 3211, gradually reducing the obstruction to the circulation channel 3211, increasing the flow rate of the blood flow reconstruction system and achieving stepless regulation of blood flow velocity, thereby preventing discomfort to the human body.

[0132] In other embodiments, the movable channel may not be provided on the main body component, and a through hole may be directly provided on the side wall of the circulation channel. The flow control element is passed through the through hole and moves along the through hole to adjust the flow area in the circulation channel.

[0133] For ease of explanation, FIG20 shows an inflow end 3211a and an outflow end 3211b of the circulation channel 3211, with the inflow end 3211a being close to the inflow tube 2 and the outflow end 3211b being away from the inflow tube 2. In actual use, blood flows into the circulation channel 3211 through the inflow end 3211a and flows out from the outflow end 3211b. The arrows in FIG21 indicate the direction of blood flow.

[0134] The flow control element 322 has a guide surface 3223, which is an inclined surface or a curved surface and faces the inlet end 3211a. It is enclosed with the inner surface of the circulation channel 3211 to form a flow regulating channel 3214 that gradually shrinks from the inlet end 3211a to the outlet end 3211b.

[0135] In this embodiment, the distal end of the flow control element 322 has an inclined surface, which forms the flow guide surface 3223. Because the blood flow reconstruction system of the present invention is used in conjunction with carotid artery stent implantation surgery, thrombi in the carotid artery will inevitably fall off during the surgery and flow through the blood flow reconstruction system. Due to the presence of thrombi, any obstruction or bend in the flow channel 3211 will increase the risk of thrombus accumulation, thereby creating a risk of blockage of the flow controller 32.

[0136] Therefore, the flow control element 322 of the present invention has a guide surface 3223, and it is difficult for thrombus to accumulate on the guide surface inclined relative to the blood flow direction. Even if the flow controller 32 is in a small flow state, thrombus is not easy to accumulate into a large volume of thrombus at the flow controller 32, which is beneficial to ensuring the smooth flow of the blood flow reconstruction system.

[0137] As shown in FIG22 , the circulation channel 3211 comprises a connecting section 32111, a narrowing section 32112, and a main section 32113, which are sequentially connected from the inflow end 3211a to the outflow end 3211b. The movable channel 3212 is disposed on the main section 32111 and adjacent to the narrowing section 32112. The inner diameter of the narrowing section 32112 is smaller than that of the connecting section 32111 and the main section 32113. The connecting section 32111 is used to connect to the inflow tube 2. The narrowing section 32112, which has a smaller inner diameter, is connected behind the connecting section 32111. This increases the velocity of blood flowing through the narrowing section 32112, allowing blood to flow through the flow regulating channel 3214 at a higher velocity, further preventing thrombus accumulation on the inflow side of the flow control element 322.

[0138] As shown in Figure 21, the distal end surface of the flow control element 322 matches the bottom shape of the circulation channel 3211. As a result, the distal end of the flow control element 322 can fit tightly against the circulation channel 3211, that is, the flow controller 32 is in a closed state, so that the flow controller 32 has the function of stopping bleeding.

[0139] Specifically, in this embodiment, with reference to Figures 20-22, a slide groove 32221 is provided on the side of the sliding member 3222, and a protrusion 3213 is provided in the movable channel 3212. The protrusion 3213 slidably cooperates with the slide groove 32221 to enable the sliding member 3222 to move axially within the movable channel 3212. The outer wall of the knob 3221 has an annular groove, and the inner wall of the movable channel 3212 has a protrusion that plugs into the annular groove, so that the knob 3221 can rotate along the movable channel 3212 but cannot move axially. The distal end of the knob 3221 has a receiving cavity, and the sliding member 3222 is inserted into the cavity and is screwed to the knob 3221. Because the slider 3222 slidably engages the movable channel 3212, when the knob 3221 is rotated under the action of an external force, the slider 3222, which is threadedly connected to the knob 3221, can only move along the axial direction of the movable channel 3212, ensuring that the guide surface always faces the inflow end 3211a of the circulation channel 3211. Furthermore, because the slider 3222, which comes into direct contact with blood, is housed within the accommodating cavity of the knob 3221, the doctor can move the slider 3222 within the movable channel 3212 by rotating the knob 3221, preventing contamination of the blood in the movable channel 3212 by the external environment.

[0140] In other embodiments, the outer wall of the knob 3221 has a protrusion, and the inner wall of the movable channel 3212 has an annular groove that engages with the protrusion; or the outer wall of the movable channel 3212 is provided with an annular groove, and the knob 3221 is provided with a protrusion that engages with the annular groove; as long as the knob 3221 can rotate along the movable channel 3211 but cannot move axially. In other embodiments, the proximal end of the slider 3222 has a cavity, and the distal end of the knob 3221 is inserted into the cavity and is spirally connected to the slider 3222. It should be noted that the "proximal end" refers to the end of the flow control element that is closer to the operator in the axial direction, and the "distal end" refers to the end of the flow control element that is farther away from the operator in the axial direction.

[0141] Referring back to Figure 19 , the blood filter 33 of this embodiment comprises a filter element 331 and a filter screen 332 disposed within the filter element 331. The filter element 331 comprises a cylindrical structure with both ends (or at least one end) open, and a gap is provided between the filter screen 332 and the filter element 331, thereby providing a filtering effect without affecting the flow rate. The filter screen 332 comprises a semi-enclosed structure with one end open, and the opening of the filter screen 332 is connected to the outflow end of the flow controller 32. The filter screen 332 is made of a woven material with mesh. When blood flows out of the flow controller 32 and into the filter screen 332, thrombi are blocked within the filter screen 332, and the filtered blood flows out of the filter screen 332. Because the filter screen is a semi-enclosed structure with one end open, blood can flow out of the filter screen 332 in all directions. Even if the filter screen 332 is partially blocked by thrombi, the remaining parts of the filter screen 332 still have a filtering function, preventing the blood flow reconstruction system from clogging during surgery.

[0142] In another embodiment, the filter 332 is directly embedded in the lumen and has a certain gap with the inner wall of the lumen, thereby playing a filtering role without affecting the flow rate.

[0143] Because the blood flow reconstruction system of this embodiment is used for carotid artery stent implantation surgery, there is a possibility of thrombus release throughout the entire surgical procedure. Therefore, in this embodiment, the circumference of the minimum cross-section of the filter 332 is at least twice the circumference of the maximum cross-section of the circulation channel 3211, so that the filter 332 has a larger filtration area and prevents thrombus from completely blocking the filter 322. Preferably, the circumference of the minimum cross-section of the filter 332 is 2.5 times that of the main body section 32113 of the circulation channel 3211, to avoid the circumference of the minimum cross-section of the filter 332 being too large, thereby preventing the gap between the filter 332 and the filter element 331 from being too small.

[0144] Based on this, as shown in Figure 22, the circulation channel 3211 also includes a flared section 32114 arranged behind the main section 32113, and the inner diameter of the flared section 32114 gradually increases along the direction from the inlet end 3211a to the outlet end 3211b to connect the circulation channel 3211 and the filter 332.

[0145] In other embodiments, the blood filter may include multiple axially spaced filter screens, and the mesh diameter components of the multiple filter screens increase from the inflow direction to the outflow direction of the blood filter, performing multi-layer filtration on the blood and enhancing the filtering effect of the blood flow reconstruction system.

[0146] One-way check valve 34 can be any suitable type of check valve used in medical devices to allow fluid to flow in only one direction. Examples of suitable check valves include, but are not limited to, seal ring valves, protector valves, ball check valves, diaphragm check valves, swing check valves, belt check valves, poppet check valves, duckbill valves, and the like. It should be noted that in actual use, if the blood flow reestablishment system is used to connect an artery to a vein, and the pressure differential between the artery and vein is large, the natural pressure differential can achieve the same effect as one-way check valve 34, meaning that this device can be omitted in certain circumstances. However, when the blood flow reestablishment system is used in an environment where the pressure differential is small, such as from artery to artery or vein to vein, one-way check valve 34 is required.

[0147] Referring back to Figure 19 , the blood filter has a filter outlet channel 3311, which is connected to the one-way check valve 34. The inner diameter of the filter outlet channel 3311 is d, and the inner diameter of the blood filter is D, with d ≤ 1 / 3D. In this embodiment, d = 3 / 16D. When blood flows through the blood filter 33, the blood flow velocity is greatly slowed due to the large diameter of the blood filter 33. The one-way check valve is primarily opened by the impact force of the blood flow. Providing a filter outlet channel 3311 with a smaller inner diameter can increase the blood flow velocity, thereby causing the blood to exert a greater impact force on the one-way check valve, allowing it to pass smoothly through the one-way check valve. Furthermore, the higher blood flow velocity further prevents blood backflow.

[0148] The blood flow reconstruction system also features heat preservation. Specifically, in this embodiment, the inflow tube 2 and outflow tube 4 are covered with thermal insulation materials, such as rubber-plastic insulation tubes or foam insulation tubes. In other embodiments, a constant-temperature heating device may be added to the inflow tube 2, outflow tube 4, and venous sheath 5 to maintain a constant blood temperature.

[0149] In an alternative embodiment, the flow controller 32 differs from the flow controller 32 mainly in that, as shown in Figures 23 and 24, the angle between the central axis of the circulation channel 3211 and the central axis of the movable channel 3212 is an acute angle, and the movable channel 3212 is inclined toward the inflow end of the main element 321, and part of the outer peripheral surface of the flow control element 322 forms the guide surface 3223. Specifically, the distal end of the flow control element 322 is cylindrical. When the distal end of the flow control element 322 extends into the circulation channel 3211 to block the circulation channel 3211, blood flows along the outer peripheral surface of the flow control element 322. The outer peripheral surface of the flow control element 322 is inclined relative to the blood flow direction and is a curved surface, which makes it difficult for thrombus to accumulate, thereby ensuring the smooth flow of the blood flow reconstruction system.

[0150] Preferably, the flow control element 322 includes a knob 3221 and a slider 3222. The knob 3221 is rotatably disposed at the proximal end of the movable channel 3212. A receiving chamber is disposed at the distal end of the knob 3221, and the slider 3222 is disposed within the receiving chamber. The slider 3222 has a radially extending protrusion that passes through a through slot in the sidewall of the receiving chamber and is threadedly connected to the movable channel 3212. When the knob 3221 is rotated under the action of an external force, the protrusion abuts against the through slot, causing the slider 3222 to rotate together. Since the slider 3222 is threadedly connected to the movable channel 3212, as the knob 3221 rotates, the slider 3222 moves spirally along the movable channel 3212. Since the sliding member 3222 that is in direct contact with the blood is accommodated in the accommodating cavity of the knob 3221 , the doctor rotates the knob 3221 to move the sliding member 3222 in the movable channel 3212 , thereby preventing the external environment from contaminating the blood in the movable channel 3212 .

[0151] Preferably, the sliding member 3222 is cylindrical in shape as a whole, and its diameter is the same as the diameter of the circulation channel 3211. The end of the sliding member 3222 is spherical, and the diameter of the end of the hemispherical head is equal to the inner diameter of the circulation channel 3211. Thus, as shown in Figure 25, the distal end of the sliding member can fit tightly with the circulation channel 3211, so that the flow controller 32 can achieve the function of stopping bleeding. The outer peripheral surface of the sliding member 3222 forms the guide surface. It should be noted that the outer peripheral surface includes a curved surface coaxial with the central axis of the sliding member 3222, and also includes a curved surface at the distal end of the sliding member 3222.

[0152] In an alternative embodiment, as shown in Figures 26 to 28, a plurality of connecting holes 3224 are provided on the flow control element 322, and the extending direction of the connecting holes 3224 is the same as the extending direction of the circulation channel 3211, wherein at least one connecting hole 3224 includes a speed regulating section 32241, and the speed regulating section 32241 is funnel-shaped as a whole, which gradually shrinks from the inlet end 3211a to the outflow end 3211b, and the inner wall of the speed regulating section 32241 forms the guide surface 3223; the edge of the inlet end of the speed regulating section 32241 can be smoothly connected to the inner wall of the circulation channel 3211.

[0153] The flow control element 322 is provided with a plurality of communication holes 3224 of varying diameters. As shown in Figures 27 and 28, under the action of an external force, the flow control element 322 moves along the movable channel 3212. Blood flows through the communication holes 3224 of varying diameters, regulating the blood flow to varying degrees. When all communication holes are not directly facing the circulation channel, the circulation channel is blocked, and the flow controller is in a closed state. Furthermore, because the edge of the inflow end of the speed regulating section 32241 smoothly transitions with the inner wall of the circulation channel 3211, blood clots are less likely to accumulate on the flow control element 322.

[0154] The main body element 321 is provided with a plurality of first mating portions 3215, and the flow control element 322 is provided with a plurality of second mating portions 3225. When any one of the first mating portions 3215 and the second mating portions 3225 are mated, the edge of the inlet end of the corresponding speed regulating section 32241 smoothly transitions to the inner wall of the circulation channel 3211. In this embodiment, the first mating portion 3215 is an arc-shaped hole on the inner wall of the circulation channel 3211. The first mating portion 3215 is a spring block that can be extended and retracted along the radial direction of the flow control element 322. The end of the spring block is arc-shaped. When the slider is inserted into the arc-shaped hole, the connecting hole 3224 is aligned with the circulation channel 3211, and the edge of the inlet end of the corresponding speed regulating section 32241 smoothly transitions to the inner wall of the circulation channel 3211. Under the action of external force, the flow control element 322 moves along the movable channel 3212, and the elastic block is squeezed back into the flow control element 322 until it reaches the next arc-shaped hole. With this structure, the doctor can accurately operate the flow control element 322 so that the connecting hole 3224 is aligned with the circulation channel 3211.

[0155] 29 , in this embodiment, the venous sheath 5 diverts blood from the artery to the vein. The venous sheath 5 includes a sheath body 510 , and a balloon structure is not required on the side of the sheath body 510 close to the vein.

[0156] In addition, the venous sheath 5 is provided with a stress tube 530 with suture holes, thereby avoiding the risk of the sheath being bent and facilitating the fixation of the sheath.

[0157] In this embodiment, the proximal end of the sheath seat 1200 is connected to a stent system 6 for implanting a stent into the carotid artery. It should be noted that, with respect to the stent itself, this circulatory system also involves multiple implementations, as follows: Referring to Figure 30, the stent system 6 includes a stent sheath 610, and a stent loading area 620 is provided at the distal end of the stent sheath 610, and the stent sheath 610 is connected to the handle 630 position.

[0158] Continuing with Figures 31-36, Figure 31 is a schematic diagram of the structure of the bracket 6100 in the first embodiment of the present invention; Figure 32 is a schematic diagram of the structure of the first wave ring 61111 of the bracket 6100 in the first embodiment of the present invention; Figure 33 is a schematic diagram of the positions of the first wave ring 61111 and the second wave ring 61112 of the bracket 6100 in the first embodiment of the present invention; Figure 34 is a schematic diagram of the surrounding area of ​​the first wave ring 61111 and the second wave ring 61112 of the bracket 6100 in the first embodiment of the present invention; Figure 35 is a schematic diagram of the overall state of the bracket 6100 in the first embodiment of the present invention in a compressed state; Figure 36 is a schematic diagram of a partial position of the bracket 6100 in the first embodiment of the present invention in a compressed state;

[0159] In this embodiment, the stent 6100 includes a body 61 stent main body 611 and a coating 612 covering the surface of the body 61 stent main body 611. The body 61 stent main body 611 includes a plurality of wavy rings arranged axially along the center line of the stent, and is generally made of materials with good biocompatibility, such as nickel titanium, stainless steel, cobalt-chromium alloy, etc. The coating 612 is made of a polymer material with good biocompatibility, such as ePTFE, PET, polyester cloth, etc.

[0160] The main body 611 includes a plurality of wave coils 6111 . The waveform of the wave coils 6111 can be a Z-shaped wave, a U-shaped wave, a sine wave or other shapes, and can also be freely changed.

[0161] In this embodiment, the wave ring 6111 includes a plurality of first wave rings 61111 and second wave rings 61112 arranged in sequence, and a proximal wave ring 61113 and a distal wave ring 61114 located at the proximal end and the distal end, respectively. The first wave ring 61111 and the second wave ring 61112 are adjacent wave rings among the plurality of wave rings 6111.

[0162] In this embodiment, the crests of the waveforms of the proximal wave coil 61113 are at the same height, that is, the proximal side of the proximal wave coil 61113 is flush, and the troughs of the waveforms of the distal wave coil 61114 are flush, that is, the distal side of the distal wave coil 61114 is flush. As a result, the wave coils located at the ends in this embodiment are always flush after compression and release, thereby maintaining the stability of the two ends of the main body 611, and at the same time ensuring that the proximal wave coil 61113 and the distal wave coil 61114 provide relatively uniform support for the coating 612 on the proximal side and the distal wave coil 61114 provides relatively uniform support for the coating 612 on the distal side.

[0163] In this embodiment, the first wave circle 61111 includes a continuously distributed first wave 61113 and a second wave 61114, wherein the first wave 61113 is a high wave and the second wave 61114 is a low wave. The first wave 61113 includes a first wave bar 611131 and a second wave bar 611132, and the second wave 61114 includes a third wave bar 611141 and a fourth wave bar 611142, which satisfies:

[0164] For the entire first wave circle 61111, the first wave rod 611131 is adjacent to the second wave rod 611132 and the fourth wave rod 611142, the second wave rod 611132 is adjacent to the first wave rod 611131 and the third wave rod 611141, and the third wave rod 611141 is adjacent to the second wave rod 611132 and the fourth wave rod 611142, and there is a smooth transition between the wave rods.

[0165] Therefore, in this embodiment, for the first wave circle 61111, it includes at least two wave peaks: a high wave peak 61121 (the wave peak between the first wave rod 611131 and the second wave rod 611132) and a low wave peak 61122 (the wave peak between the third wave rod 611141 and the fourth wave rod 611142); it also includes two wave troughs: a high wave trough 61123 (the wave trough between the first wave rod 611131 and the adjacent fourth wave rod 611142) and a low wave trough 61124 (the wave trough between the second wave rod 611132 and the third wave rod 611141).

[0166] In this embodiment, the second wave coil 61112 adopts the same waveform structure as the first wave coil 61111, but with a phase difference between the second wave coil 61112 and the first wave coil 61111, so that the low trough 61124 of the first wave coil 61111 corresponds to the low peak 61122 of the second wave coil 61112, and the high trough 61123 corresponds to the high peak 61113 of the second wave coil 61112. Therefore, with this design, when the stent body 611 of this embodiment is compressed, the adjacent first and second wave coils 61111 and 61112 do not overlap axially, that is, they do not overlap each other by axially squeezing the coating 612. Instead, the peaks and troughs abut against each other to prevent excessive stent shortening and reduce the risk of stent jump before deployment. During stent deployment, the wave coils are staggered, which not only prevents local collapse due to excessive pores in the coating 612, but also prevents interference with each other and affects the compliance of the stent.

[0167] In this embodiment, the insertion height h between the first wave coil 61111 and the second wave coil 61112 and the height H of the first wave 61113 satisfy h<H, thereby preventing the stent from twisting and damaging the blood vessel wall during release.

[0168] In addition, in order to ensure that the amount of compression of the coating 612 is uniform between the first wave coil and the second wave coil when the bracket 6100 of this embodiment is compressed, that is, the axial cross-sectional area in the conveyor will not increase abnormally due to compression, for this embodiment, the area S1 of the coating 612 between the first wave coil 61111 and the second wave coil 61112 is equal to the area S2 of the coating 612 between the adjacent first wave coil 61111 and the second wave coil 61112, thereby ensuring that the deformation conditions of the coating 612 on the upper and lower sides are almost the same when multiple first wave coils 61111 and second wave coils 61112 are compressed.

[0169] In this embodiment, the multiple low troughs 61124 of the first wave ring 61111 and the multiple high peaks 61121 of the adjacent second wave ring 61112 are located at the same height (i.e., the same position in the axial direction). This can avoid the situation where the coating 612 between the first wave ring 61111 and the second wave ring 61112 has no wave ring support in the axial direction, thereby avoiding the axial shortening of the stent.

[0170] In another embodiment, referring to Figure 32, for the high peak 61131 of the second wave ring 61112, its axial position is between the axial positions of the high trough 61133 and the low trough 61134 of the first wave ring 61111, so that when the bracket is twisted, the high peak 61131 will be restricted by the high trough 61133 and the low trough 61134, thereby avoiding excessive twisting of the bracket.

[0171] It should be noted that, in another embodiment, the stent 6100 is a bare stent.

[0172] In another alternative embodiment, the first wave coils and the second wave coils are distributed in a spiral. Referring to FIG37 , the first wave coils 62111 and the second wave coils 62112 of this embodiment are distributed in a spiral.

[0173] In order to ensure that the amount of compression of the coating 622 is uniform between the first and second coils when the vascular stent 6200 of this embodiment is compressed, that is, the axial cross-sectional area of ​​the coating 622 in the conveyor is not abnormally increased due to compression, for this embodiment, the area of ​​the coating 622 between the first coil 62111 and the second coil 62112 is equal to the area of ​​the coating 622 between the adjacent first coil 62111 and the second coil 62112, thereby ensuring that the deformation conditions of the coating 622 on the upper and lower sides are almost the same when the multiple first coils 62111 and the second coil 62112 are compressed. However, unlike the original embodiment, the area S1 of the coating 622 between the first coil 62111 and the second coil 62112 and the area S2 of the coating 622 between the adjacent first coil 62111 and the second coil 62112 in this embodiment both refer to the first coil 62111 and the second coil 62112 that have completed a full circle.

[0174] In another embodiment, the first wave and the second wave are continuous, that is, the first wave and the second wave are continuous waves of the same thread distribution.

[0175] In an alternative embodiment, the first and second wave coils are connected to each other. Referring to FIG38 , which is a schematic structural diagram of a vascular stent according to another embodiment of the present invention, the first and second wave coils 63111, 63112 of this embodiment include multiple connection points 63113. Specifically, the connection points 63113 are located between high troughs 63123 of the first wave coil 63111 and high peaks 63121 of the second wave coil 63112. Furthermore, two adjacent connection points 63113 are located between two low peaks 63122 of the second wave coil 63112.

[0176] In order to ensure that the amount of compression of the coating 632 is uniform between the first wave coil and the second wave coil when the vascular stent 6300 of this embodiment is compressed, that is, the axial cross-sectional area of ​​the coating 632 in the conveyor will not increase abnormally due to compression, for this embodiment, the area of ​​the coating 632 between the first wave coil 63111 and the second wave coil 63112 is equal to the area of ​​the coating 632 between the adjacent first wave coil 63111 and the second wave coil 63112, thereby ensuring that the deformation conditions of the coating 632 on the upper and lower sides are almost the same when the multiple first wave coils 63111 and the second wave coil 63112 are compressed. However, unlike the original embodiment, this embodiment also ensures that the deformation conditions of the coating 632 on both sides of the connection point 63113 are almost the same, that is, the area of ​​the area enclosed by the two adjacent connection points 63113 and the first wave coil 63111 and the second wave coil 63112 is S and is equal.

[0177] In this embodiment, the overall size of the mesh area can be adjusted by adjusting the number of connection points 63113. Generally speaking, the more connection points 63113 there are, the more areas enclosed by two adjacent connection points 63113 and the first wave circle 63111 and the second wave circle 63112, and the closer it is to a closed-loop structure, and the lower the flexibility; conversely, the fewer connection points 63113 there are, the fewer areas enclosed by two adjacent connection points 63113 and the first wave circle 63111 and the second wave circle 63112, and the closer it is to an open-loop structure, and the higher the flexibility.

[0178] In another embodiment, a plurality of low peaks 63122 are included between two adjacent connection points 63113 .

[0179] In another embodiment, the number of connection points at the two end positions of the vascular stent is set to be smaller, that is, the end positions are close to or form an open-loop structure, thereby having a larger coating area, which can not only prevent the stenotic plaque from falling off, but also avoid the problem of the vascular stent end being too flexible and unable to conform to the blood vessel.

[0180] In another embodiment, referring to FIG. 39 , FIG. 39 is a schematic structural diagram of a vascular stent according to another embodiment of the present invention, in which the first wave ring 63111 and the second wave ring 63112 are both inclinedly distributed.

[0181] Overall, the blood flow restoration system of this embodiment is relatively short, which avoids the problems of high stent release force and release position deviation caused by long torque control distances. It also prevents damage to the blood vessel walls during long-distance operation. In addition, the blood flow restoration system of this embodiment is a proximal brain protection system, which has advantages over distal brain protection systems. Specifically, distal brain protection systems are a routine procedure for CAS stenting. Generally, a guidewire is first used to pass through the stenosis, and then a protective umbrella is delivered along the guidewire. The distal brain protection system is characterized by not changing the direction of blood flow. When devices such as balloons and stents are used in stenotic areas, detached plaques will flow toward the umbrella with the forward blood flow. After the stent is placed, the umbrella will be removed. Proximal brain protection achieves reverse blood flow by blocking the proximal blood flow. When devices such as balloons and stents are used in stenotic areas, detached plaques will be led out of the body with the reverse blood flow. Since there is no need to remove the umbrella, there is no risk of plaques escaping as the umbrella is retracted. In addition, during the delivery process, there will be no problem of the distal brain protection system scraping off plaques when passing through the stenotic area, nor will there be a risk of plaques escaping from the umbrella during the recovery phase due to poor umbrella contraction or overly large hole design.

[0182] In another embodiment, referring to Figure 40, Figure 40 is a structural schematic diagram of a vascular stent in another embodiment of the present invention, showing a schematic structural configuration of the stent 7100 after being unfolded as an optional configuration. For the stent 7100, the stent 7100 generally adopts an isotropic wave structure, and a developing section 7110 is respectively provided at the proximal and distal ends, and the middle area is the main section 7120. Specifically, the developing section 7110 includes a plurality of developing points 7111 located at the end and distributed circumferentially, wherein the outer ring 7112 of the developing section 7110 is located at the edge of the end, and the inner ring 7113 is located close to the side of the main section 7120. A plurality of intermediate rings can also be provided between the outer ring 7112 and the inner ring 7113 of the developing section 7110.

[0183] In another embodiment, as an optional solution when the volume of the stent needs to be reduced as much as possible, the developing segment 7110 can be set on a single side of the main segment 7120, that is, the developing segment 7110 is located on the proximal side or the distal side of the main segment 7120, so as to facilitate the separate determination of the position of the proximal side or the distal side of the main segment 7120.

[0184] It should be noted that, inside the developing section 7110 , the connecting section between adjacent coils extends along the axial direction, thereby ensuring the axial integrity of the developing section 7110 and avoiding overlapping of the developing section 7110 that affects the developing effect.

[0185] In the main body section 7120, the connecting sections between adjacent coils extend generally circumferentially, and adjacent coils are offset circumferentially by 1 / 4 wavelength, so that the peaks and troughs of adjacent coils are not collinear. Because the connecting sections between adjacent coils extend generally circumferentially (forming a "∫" shape), the main body section 7120 is less likely to overlap circumferentially during compression or expansion, and thus less likely to rotate. This prevents internal stress from shifting and concentrating on one side, potentially affecting the stent's lifespan or preventing smooth insertion and exit of the stent from the sheath.

[0186] In another embodiment, the developing point 7111 is located at the crest of the edge wave circle, and the connecting point 7112 between the edge wave circle and the middle wave circle is located at the circumferential center of the two adjacent developing points.

[0187] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0188] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A blood flow reconstruction system, characterized in that: It includes a first sheath, a flow diversion system, and a second sheath connected in sequence; The first sheath comprises a main body and a catheter seat located at the proximal end of the main body, the proximal end of the catheter seat can be connected to a stent system, and the stent system is used to load and transport the stent to the distal end of the main body; The flow diversion system includes an inflow tube connected to the first sheath, an outflow tube connected to the second sheath, and a flow diversion component. The flow diversion component is connected between the inflow tube and the outflow tube. The flow diversion component includes a lumen in which a blood filter is provided. Blood flows along the first sheath through the flow diversion system to the second sheath.

2. The blood flow reconstruction system according to claim 1, characterized in that: The first sheath includes a tubular main body and a balloon located at the distal end of the main body. The balloon is located at the distal end of the first sheath, and the filling port of the balloon is connected to the balloon through the catheter seat.

3. The blood flow reconstruction system according to claim 2, characterized in that: The main body comprises a filling cavity inside, the filling cavity communicates with the balloon and the catheter seat, and when the balloon is expanded, the outer periphery of the main body is blocked and the inner cavity of the main body is exposed.

4. The blood flow reconstruction system according to claim 3, characterized in that: The main body also includes at least one angiography channel.

5. The blood flow reconstruction system according to claim 1, characterized in that: The flow diversion system includes a flow controller; the flow controller is connected to an end of the inflow tube away from the first sheath; the flow controller includes a main body element with a flow channel and a flow control element, the flow control element is at least partially accommodated in the main body element and is movably connected to the flow channel, and the flow control element reduces or increases the flow area of ​​the flow channel under the action of external force.

6. The blood flow reconstruction system according to claim 1, characterized in that: The flow diversion system comprises a one-way check valve, which is connected between the blood filter and the outflow tube or connected to the outflow tube.

7. The blood flow reconstruction system according to claim 1, characterized in that: The circulation channel has an inflow end and an outflow end, the inflow end is close to the inflow pipe, and the outflow end is far away from the inflow pipe; the flow control element has a guide surface, the guide surface faces the inflow end, and is enclosed with the inner surface of the circulation channel to form a flow regulating channel that gradually shrinks from the inflow end to the outflow end.

8. The blood flow reconstruction system according to claim 4, characterized in that: The blood filter comprises a filter mesh, and there is a gap between the filter mesh and the inner wall of the lumen, or the blood filter further comprises a filter element, and the filter element comprises a cylindrical structure with at least one end open, and the filter mesh is arranged in the filter element and there is a gap between the filter mesh and the inner wall of the filter element.

9. The blood flow reconstruction system according to claim 1, characterized in that: The circulation channel comprises a connecting section, a narrowing section and a main section which are sequentially connected from the inflow end to the outflow end; the inner diameter of the narrowing section is smaller than the inner diameters of the connecting section and the main section.

10. The blood flow reconstruction system according to claim 2, characterized in that: The catheter seat includes at least a first cavity, a second cavity and a third cavity, the first cavity and the third cavity are respectively located on both sides of the second cavity, the first connecting plate connects the first cavity and the second cavity, the second connecting plate connects the third cavity and the second cavity, and at least one suture hole is respectively provided on the first connecting plate and the second connecting plate.

11. The blood flow reconstruction system according to claim 1, characterized in that: The bracket includes a plurality of main wave coils, each of which includes at least two wave crests and / or wave troughs of different heights. The main wave coil includes a first wave coil and a second wave coil, and the first wave coil and the second wave coil have a phase difference, so that the multiple troughs of the first wave coil are distributed relative to the multiple wave crests of the second wave coil, and / or the multiple wave crests of the first wave coil are distributed relative to the multiple troughs of the second wave coil.

12. The blood flow reconstruction system according to claim 11, characterized in that: The first wave loops and the second wave loops are distributed obliquely.

13. The blood flow reconstruction system according to claim 1, characterized in that: The bracket includes a main body section and a developing section located at at least one side of the main body section, and the developing section includes a plurality of developing points distributed along the circumferential direction.

14. The blood flow reconstruction system according to claim 13, characterized in that: In the developing section, the connecting section between adjacent coils extends along the axial direction.

15. The blood flow reconstruction system according to claim 13, characterized in that: In the main body section, the connecting section between adjacent wave coils generally extends along the circumferential direction.

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