Blood flow reconstruction system

Abstract

The invention relates to a blood flow reconstruction system which comprises an artery sheath, a bypass system and a vein sheath which are sequentially connected. The artery sheath is used for being connected with the carotid artery, and the vein sheath is used for being connected with the vein. The artery sheath comprises a main body and a catheter seat located at the near end of the main body, the near end of the catheter seat is communicated with a stent system, and the stent system is used for loading and transporting a stent to the far end of the main body; the flow turning system comprises an inflow tube, an outflow tube and a flow turning assembly, the flow turning assembly comprises a tube cavity, a blood filter is arranged in the tube cavity, and blood in the tube cavity flows to the vein sheath along the artery sheath. By means of the blood flow reconstruction system, reverse flow of blood from the carotid artery to the femoral vein can be established, and thrombus falling off in the operation process is prevented from entering the brain.

Description

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 usually occurs when blood clots accumulate on the side walls of the common carotid artery and internal carotid artery (the arteries through which the heart supplies blood to the brain), causing the arteries to narrow. These accumulations are easily broken off to form blood clots that flow with the blood. Blood clots that flow with the carotid artery into the brain can cause cerebral stroke.

[0003] Among the surgical procedures for carotid artery stenosis, CEA (Carotid endarterectomy) is the standard surgical procedure for carotid artery stenosis. The specific process is to make a large surgical incision on the patient's neck, clamp the upstream and downstream of the surgical site on the carotid artery to block blood flow, then cut the carotid artery to remove the accumulation, suture the carotid artery after removal, and restore the circulation of the carotid artery. This surgical procedure is highly traumatic and easily damages the cranial nerves near the carotid artery. There is still a high probability of stroke after surgery. CAS (carotid artery stenting) is a minimally invasive surgery for the treatment of carotid artery stenosis. The specific process is to introduce the delivery sheath into the femoral artery through percutaneous puncture, and enter the carotid artery along the aortic arch, and release the self-expanding stent in the carotid artery to restore the normal circulation of the carotid artery. However, the overall path of CAS is relatively long, and the accumulation of the inner wall of the carotid artery is easily dropped during the deployment of the delivery sheath and the deployment of the self-expanding stent. The probability of stroke after surgery is much higher than that of CEA, and there are obvious shortcomings in clinical use. Summary of the invention

[0004] 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.

[0005] The present invention provides a blood flow reconstruction system, comprising 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 comprises an inflow tube connected to the first sheath, an outflow tube connected to the second sheath and a flow diversion assembly, the flow diversion assembly is connected between the inflow tube and the outflow tube, the flow diversion assembly includes a lumen, a blood filter is provided in the lumen, and blood flows along the first sheath to the second sheath through the flow diversion system.

[0006] 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.

[0007] In one embodiment, the main body includes a filling cavity therein, 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.

[0008] 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.

[0009] In one embodiment, 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.

[0010] In one embodiment, the circulation channel has an inlet end and an outlet end, the inlet end is close to the inlet pipe, and the outflow end is far away from the inlet pipe; the flow control element has a guide surface, the guide surface faces the inlet end, and is enclosed with the inner surface of the circulation channel to form a flow regulating channel that gradually shrinks from the inlet end to the outflow end.

[0011] 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.

[0012] In one embodiment, the circulation channel includes 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.

[0013] 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.

[0014] In one embodiment, 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, and 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.

[0015] In one embodiment, the first wave loop and the second wave loop are distributed obliquely.

[0016] The blood flow reconstruction system of the present invention can establish a blood retrograde 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, the high-pressure arterial blood flow of the brain and the low-pressure venous blood flow of the femoral vein form a pressure difference, so that the blood flow of the carotid artery flows 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, a self-expanding stent is placed, and other operations are performed, so that the thrombus detached during the operation is intercepted when it flows through the blood filter with the reverse blood flow, preventing the thrombus from entering the brain blood vessels with the blood in the forward direction, causing a stroke. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a schematic diagram of the structure of a blood flow reconstruction system in one embodiment of the present invention;

[0018] Figure 2 is a simplified schematic diagram of a blood flow reconstruction system in one embodiment of the present invention;

[0019] Figure 3 is a schematic diagram of the structure of an arterial sheath in one embodiment of the present invention;

[0020] Figure 4 is a schematic diagram of the structure of the balloon portion of the arterial sheath in one embodiment of the present invention;

[0021] Figure 5 is a first working schematic diagram of the balloon portion of the arterial sheath in one embodiment of the present invention;

[0022] Figure 6 is a schematic diagram of the operation of the balloon portion of the arterial sheath in one embodiment of the present invention;

[0023] Figure 7 is a schematic structural diagram of a balloon portion of an arterial sheath in another embodiment of the present invention;

[0024] Figure 8 yes Figure 7 A schematic cross-sectional view of the AA position from the left side to the right side of the figure;

[0025] Fig. 9 is a schematic diagram of a first cross-sectional structure of a balloon portion of an arterial sheath in yet another embodiment of the present invention;

[0026] Fig.10 yes Fig. 9 A schematic cross-sectional view of the middle BB position from the left side to the right side of the figure;

[0027] Fig.11 is a schematic diagram of a second cross-sectional structure of a balloon portion of an arterial sheath in another embodiment of the present invention;

[0028] Fig.12 is a schematic structural diagram of a balloon portion of an arterial sheath in another embodiment of the present invention;

[0029] Fig.13 yes Fig.12 Schematic diagram of the cross section from the left side to the right side of the figure at the CC position.

[0030] Fig.14 It is a structural schematic diagram of a catheter seat in one embodiment of the present invention;

[0031] Fig.15 is a schematic structural diagram of a variant of a catheter adapter in one embodiment of the present invention;

[0032] Fig.16 is a schematic structural diagram of another variant of a catheter adapter in one embodiment of the present invention;

[0033] Fig.17 is a schematic structural diagram of a catheter seat in another embodiment of the present invention;

[0034] Fig.18 for Figure 2 The cross-section at A in the middle;

[0035] Fig.19 It is a structural exploded view of a flow controller in one embodiment of the present invention;

[0036] Fig. 20 A cross-sectional view of a flow controller according to an embodiment of the present invention (partial flow of the flow controller);

[0037] Fig.21 A cross-sectional view of a flow controller in one embodiment of the present invention (the flow controller is closed);

[0038] Fig. 22 It is a structural exploded view of a flow controller in one embodiment of the present invention;

[0039] Fig.23 A cross-sectional view of a flow controller according to one embodiment of the present invention (flow controller circulation);

[0040] Fig.24 A cross-sectional view of a flow controller in one embodiment of the present invention (the flow controller is closed);

[0041] Fig.25 A three-dimensional diagram of a flow controller in one embodiment of the present invention;

[0042] Fig.26 A cross-sectional view of a flow controller in one embodiment of the present invention (the flow controller is closed);

[0043] Fig. 27 A cross-sectional view of a flow controller according to one embodiment of the present invention (flow controller circulation);

[0044] Fig.28 A schematic diagram of the structure of a venous sheath in one embodiment of the present invention (flow controller circulation);

[0045] Fig.29 is a schematic structural diagram of a support system in one embodiment of the present invention;

[0046] Fig.30 is a schematic structural diagram of a vascular stent in one embodiment of the present invention;

[0047] Fig.31 is a schematic structural diagram of a first wave coil of a vascular stent in one embodiment of the present invention;

[0048] Fig.32 is a schematic diagram of the positions of the first wave coil and the second wave coil of the vascular stent in one embodiment of the present invention;

[0049] Fig.33 is a schematic diagram of the surrounding area of ​​the first wave ring and the second wave ring of the vascular stent in one embodiment of the present invention;

[0050] Fig.34 is a schematic diagram of the overall state of a vascular stent in a compressed state according to an embodiment of the present invention;

[0051] Fig.35 is a schematic diagram of the local position of a vascular stent in a compressed state in one embodiment of the present invention;

[0052] Fig.36 is a schematic structural diagram of a vascular stent in another embodiment of the present invention;

[0053] Fig.37 is a schematic structural diagram of a vascular stent in another embodiment of the present invention;

[0054] Fig.38 It is a schematic structural diagram of a vascular stent in another embodiment of the present invention. DETAILED DESCRIPTION

[0055] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with 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 used to limit the present invention.

[0056] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0057] In order to more clearly describe the structure of the blood flow reconstruction system, the terms "distal end" and "proximal end" are defined here. The above terms are commonly used in the field of interventional medical devices. Specifically, "distal end" refers to the end away from the operator during the operation, and "proximal end" refers to the end close to the operator during the operation.

[0058] like Figure 1 and Figure 2 As shown, the blood flow reconstruction system 100 of the present invention includes an arterial sheath 1 (first sheath), an inflow tube 2, a flow diversion component 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 flow diversion component 3 and the outflow tube 4 constitute the basic structure of the flow diversion system 200; specifically, when diversion is required, the distal end of the arterial sheath 1 receives blood flow from the carotid artery, flows it into the venous sheath 5 through the flow diversion component 3, and then flows into the vein, thereby forming a complete blood flow reconstruction system.

[0059] It should be noted that the above-mentioned 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 into the femoral vein. However, in some specific cases, the requirements of artery to artery and vein to vein can also be achieved. 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.

[0060] For arterial sheath 1, refer to Figure 3 The arterial sheath 1 includes a sheath tube 1100 and a sheath tube seat 1200, and also includes a sheath core 1210 inserted into the sheath tube 1100 via the sheath tube seat 1200. The arterial sheath 1 as a whole is used for common carotid artery puncture and occlusion, stent system introduction and blood flow transportation (arterial blood extraction).

[0061] In general, the sheath 1100 includes a sheath body 1110, and a sheath seat 1200 is provided 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, and the proximal end of the sheath body 1110 is 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 through the diverter valve 1230 at its proximal end. A blocking balloon 1120 is provided at the distal end of the sheath body 1110. When the balloon 1120 is filled and blocked to block the carotid artery, the blood in the carotid artery will be 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 avoid exposing the operator's hands to the radiation environment when filling the balloon 1120 at the front end of the sheath.

[0062] The front end of the sheath 1100 is pre-bent (an adjustable bend may 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 balloon position; a depth mark (not shown) is left on the surface of the sheath 1100 for observing the puncture depth during the puncture process.

[0063] Regarding the sheath tube 1100, there are multiple embodiments, as follows:

[0064] Reference Figure 4-6 , Figure 5 is a first working schematic diagram of the sheath tube 1100, Figure 6 It is a second working schematic diagram of the sheath tube 1100. In the first working state, the sheath tube 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 tube 1100 is filled.

[0065] In this embodiment, the sheath 1100 includes a tubular body 1110. The body 1110 includes a sheath outer layer 1111, a sheath inner layer 1112, a balloon 1120 located mostly outside the sheath outer layer 1111, and an inner cavity 1130 for transporting medical devices inside the sheath inner layer 1112. The body 1110 is mainly used as a channel for transporting 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 in this embodiment preferably includes a PTFE membrane. 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. Therefore, 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.

[0066] In this embodiment, a balloon 1120 is provided at the distal end of the main body 1110. The balloon 1120 is a semi-compliant balloon. When the filling pressure increases, the diameter of the balloon 1120 also increases, so that the balloon 1120 can be closely attached to the inner wall of the blood vessel, fully blocking the blood vessel and blocking blood flow. When the balloon 1120 is filled, the main body 1110 is located in the center of the balloon 1120, so that when the balloon 1120 blocks the blood vessel, the main body 1110 will not touch the inner wall of the blood vessel, thereby protecting the blood vessel from damage.

[0067] In this embodiment, when the balloon 1120 is gradually filled, the balloon 1120 blocks the blood flow, and the device can pass normally; when the internal filling pressure of the balloon 1120 increases to exceed the specified value, the internal pressure of the balloon 1120 causes the main body 1110 to deform and fit closely to the device, thereby achieving the effect of fixing the device and stopping bleeding. It is worth noting that in this embodiment, the filling cavity 1121 of the balloon 1120 runs through the interior of the sheath outer layer 1111, so that it has a significantly smaller volume than other designs that cover the filling cavity of the balloon to the outside of the sheath. To be precise, under the premise of ensuring a good filling rate, the main body 1110 can have a smaller outer diameter and a larger inner diameter to leave a larger space for device delivery.

[0068] 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.

[0069] In addition, in this embodiment, the proximal side and the distal side of the main body 1110 are set to different strengths. Specifically, the distal end of the main body 1110 has better flexibility to avoid damaging blood vessels during the transportation of the device and entering the human body. The proximal side of the main body 1110 has stronger support force, which is convenient for maintaining the overall strength of the main body 1110 and avoiding the inability to transmit the proximal force to the distal direction when it is necessary to move to a predetermined position. Preferably, the sheath outer layer 1111 of the main body 1110 includes a first section 11111 and a second section 11112, wherein the first section 11111 is made of the material type of PEBAX35D, and the second section 11112 is made of the material type of PEBAX63D.

[0070] In this embodiment, a medium (such as a contrast agent) is injected into the filling chamber 1121 of the balloon 1120 to expand the balloon 1120 and block the blood vessel, while at the same time, the inner chamber 1130 can be used for device delivery and blood flow transport.

[0071] Reference Figure 4 When the filling pressure of the balloon 1120 gradually increases and is less than the preset value, the balloon 1120 expands to block the blood flow. At this time, the balloon 1120 gradually expands to fill the gap between the body 1110 and the blood vessel, but at this time, the device in the body 1110 can pass normally. It should be noted that the preset value here is determined by combining the pressure strength of the balloon and the overall strength of the distal end (i.e., the first section 11111) of the body 1110.

[0072] When it reaches the preset value, it means that the internal pressure of the balloon 1120 reaches a strength that can deform the distal end section of the body 1110, such as Figure 5 As shown, 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, thereby achieving the effect of fixing the device and blocking blood flow at the same time.

[0073] Since the expansion volume of the balloon 1120 can be controlled, when the present 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 that: 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 to drive 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.

[0074] In this embodiment, in order to prevent damage to the blood vessel wall due to excessive pressure after the balloon 1120 is filled, this embodiment preferably does not provide a spring tube 1113 in the area of ​​the sheath inner layer 1112 corresponding to the balloon 1120. In other words, 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.

[0075] 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.

[0076] In another alternative embodiment, a plurality of balloons are disposed circumferentially at the distal end of the body 1110, Figure 7-8 , Figure 8 yes Figure 7 In the cross-sectional schematic diagram from the left side to the right side of the figure at the AA position, the distal end of the main body 1110 of the sheath tube 1100 is provided with multiple balloons along the circumferential direction, including balloons 11221, balloons 11222, balloons 1223, and balloons 11224, wherein each balloon has a separate filling cavity, and therefore, balloons 11221, balloons 11222, balloons 11223, and balloons 11224 can be controlled separately. By filling different balloons, the fixation of the device in the balloon sheath tube 11200 and the flow rate of blood counterflow can be flexibly controlled, which has better adaptability than the single balloon solution.

[0077] In another alternative embodiment, an intermediate layer is added at the distal end of the main body 1110. Figure 9-11 , Fig. 9 is a schematic diagram of a first cross-sectional structure of the balloon sheath tube 11300, Fig.10 yes Fig. 9 The cross-sectional view of the middle BB position from the left side to the right side of the diagram. Fig.11 is a schematic diagram of a second cross-sectional structure of the balloon sheath tube 11300, wherein the first cross-section and the second cross-section are both longitudinal cross-sections, and the first cross-section and the second cross-section are perpendicular, and Fig. 9 and Fig.10 The balloon 1120 is in a filled state, and its purpose is to reflect the coverage area and function of the middle layer 11310.

[0078] 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 selected. The specific distribution position is as shown in FIG. Fig. 9 .

[0079] It should be noted that due to the presence of the middle layer 11310, when the balloon 1120 is subjected to a large filling pressure, the area of ​​the main body 1110 that is deformed toward the inward pressure becomes an area that is not covered by the middle layer 11310, because the middle layer 11310 has a supporting force that 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 middle 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 enabling blood flow transportation.

[0080] 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.

[0081] In this embodiment, the middle layer 11310 may be made of flexible elastic pieces such as springs and meshes. The 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 achieve deformation compared to the area without the middle layer 11310, thereby achieving staged deformation. For example, the medium is injected into the balloon 1120 and the pressure is gradually increased to the first stage. The balloon first completes the occlusion of the outer side of the main body 1110 and the space between the blood vessels. gap; when the balloon 1120 is injected with pressure to the second stage, the area of ​​the main body 1110 without the middle layer 11310 is deformed, so that the inner wall of the balloon sheath 11300 (the area supported by the middle layer) and the device leave a certain space to allow blood countercurrent transport, but other areas can still deform normally, thereby achieving the purpose of both fixing the device and blood transport; when the balloon 1120 is injected with pressure to the third stage, the area of ​​the middle 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.

[0082] 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 .

[0083] In another alternative embodiment, multiple intermediate layers are provided, with specific reference to Figure 12-13 , Fig.13 yes Fig.12A cross-sectional view from the left side to the right side of the figure at the CC position. In this embodiment, at least a first intermediate layer 11410 and a second intermediate layer 11420 are provided in the main body 1110, wherein the first intermediate layer 11410 and the second intermediate layer 11420 partially overlap and cover the main body 1110 along the circumferential direction.

[0084] In this embodiment, the first intermediate layer 11410 adopts a spring tube structure, and the second intermediate layer 11420 adopts 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. Fig.12 and Fig.13 When the distribution of manifestation is carried out, at least the following four areas are formed:

[0085] A first region D1, the first region D1 includes a first intermediate layer 11410 and a second intermediate layer 11420, and the first region D1 requires the largest deformation pressure;

[0086] A second region D2, the second region D2 only includes the first intermediate layer 11410, and the deformation pressure required for the second region D2 is less than that of the first region D1;

[0087] A third region D3, the third region D3 only includes the second intermediate layer 11420, and the deformation pressure required for the third region D3 is less than that of the second region D2;

[0088] and a fourth region D4 not covered by the intermediate layer, wherein the deformation pressure required by the fourth region D4 is minimal.

[0089] With such a design, the filling stage of the balloon 1120 can be divided into the following four stages:

[0090] In the first stage, a medium is injected into the balloon 1120 to gradually increase the pressure, and the balloon completes the blockage of the gap between the outside of the main body 1110 and the blood vessel, and blood is allowed to be transported from the inside of the main body 1110 in reverse flow;

[0091] In the second stage, the balloon 1120 continues to be pressurized, the fourth area D4 in the main body 1110 is deformed, and the main body 100 in the fourth area D4 moves inward. 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 flow rate of blood countercurrent transport decreases, thereby controlling the flow rate of blood flow transport 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 against the relative position).

[0092] 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 flow rate of blood countercurrent transport further decreases, thereby controlling the flow rate of blood flow transport to the value of the third stage.

[0093] 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 flow rate further decreases, thereby controlling the blood flow transport flow rate to the value of the fourth stage.

[0094] In the fifth stage, the balloon 1120 is continuously pressurized on the basis of the fourth stage, and the first area D1 also begins to deform. The space for blood countercurrent transport becomes smaller, and the corresponding flow rate of blood countercurrent transport 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 in close contact with the device, thereby achieving the effect of completely fixing the device. At this time, the flow rate of blood flow transport is almost 0, and blood flow transport stops.

[0095] Therefore, as described in this embodiment, by partially overlapping the two intermediate layers, more complex multi-level regulation of blood countercurrent transport is achieved.

[0096] 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.

[0097] 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.

[0098] In another embodiment, the body 1110 includes a plurality of first intermediate layers 11410 and / or a plurality of second intermediate layers 11420 .

[0099] 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 extended and distributed along the axial direction, and the second intermediate layers 11420 are extended and distributed along the circumferential direction, thereby obtaining multiple regions with different strengths and uniform distribution that can deform with the balloon 1120.

[0100] In addition to the connection function, the catheter adapter 1300 itself also has a special design, as follows:

[0101] Reference Fig.14The catheter seat 1300 includes a catheter seat body 1310, and the catheter seat body 1310 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 seat 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 is used as a accommodating cavity to accommodate the entry and exit of the guide wire or the sheath core, thereby realizing the delivery of the interventional device, and the third cavity 1313 is used as a blood transport channel to realize the transfer of blood.

[0102] In another embodiment, the second cavity 1312 is used as a receiving cavity to accommodate the entry and exit of a guide wire or a sheath core, thereby achieving the delivery of an interventional device, and the side branch opening of the second cavity 1312 is connected to a reverse flow channel for blood circulation, and the third cavity 1313 is used as an angiography channel.

[0103] In another embodiment, the second cavity 1312 is used as a receiving cavity to accommodate the guide wire or sheath core to enter and exit, so as to realize the delivery of the 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 in the figure), and the fourth cavity and the third cavity are both imaging channels, wherein the third cavity 1313 mainly acts on the imaging of the rear end area of ​​the balloon (that is, the proximal side), and the fourth cavity mainly acts on the imaging of the front end area of ​​the balloon (that is, the distal side, which can also be called the distal end of the sheath or the front end of the sheath). Specifically, the operator can confirm the implantation position and the size of the blood vessel through the imaging of the front end of the balloon (sheath), and after the balloon is filled and blocked, the imaging of the rear end area of ​​the balloon can be used to confirm whether the blocking is completed.

[0104] In this embodiment, further, a first connecting plate 1320 is provided between the first cavity 1311 and the second cavity 1312, and at least one suture hole 1321 is provided on the first connecting plate 1320. Similarly, a second connecting plate 1330 is provided between the third cavity 1313 and the second cavity 1312, and at least one suture hole 1331 is provided on the second connecting plate 1330. Both the suture holes 1321 and the suture holes 1331 can achieve the function of fixing the catheter seat body 1310 to the skin. Such a design of this embodiment can shorten the total length of the entire catheter seat system, that is, shorten the total length of the entire catheter system at the same time, thereby minimizing the volume of the implantable system, and the fixed position is close to the position of the catheter seat body 1310, which can also avoid excessive micro-movement of the catheter seat body 1310.

[0105] In this embodiment, the edge of the first connecting plate 1320 is a curve. In order to make the suturing 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 is the shortest when passing through the suture hole 1321 and the edge of the first connecting plate 1320 to fix the catheter seat body 1310.

[0106] 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 connecting 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.

[0107] Preferably, a 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 .

[0108] 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 a 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 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.

[0109] 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°.

[0110] It should be noted that, in the present 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 at the proximal end of the connection position between the first cavity 1311 and the second cavity 1312, and the edge of the second connecting plate 1330 is located at the distal end of the connection position between the third cavity 1313 and the second cavity 1312.

[0111] In another embodiment, referring to Fig.15 , Fig.15 is a schematic diagram of a variant of the catheter adapter 1300. Fig.15 In the embodiment, the connection position between the first cavity 1311 and the second cavity 1312 and the connection position between 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 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 between 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 between the third cavity 1313 and the second cavity 1312.

[0112] In another embodiment, referring to Fig.16 , Fig.16 is a schematic diagram of another variant of the catheter adapter 1300. Fig.16 In the figure, 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, 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 at the proximal end of the connection position between the first cavity 1311 and the second cavity 1312, and the edge of the second connecting plate 1330 is located at the distal end of the connection position between the third cavity 1313 and the second cavity 1312.

[0113] In another alternative embodiment, a plurality of suture holes are provided on the connecting plate, Fig.17A first connecting plate 1320 is provided between the first cavity 1311 and the second cavity 1312, and a first suture hole 13211, a second suture hole 13212 and a third suture hole 13213 are respectively provided on the first connecting plate 1320; a second connecting plate 1330 is provided between the third cavity 1313 and the second cavity 1312, and a fourth suture hole 13311, a fifth suture hole 13312 and a sixth suture hole 13313 are respectively provided on the second connecting plate 1330. This is to meet the need for multiple suture positions to strengthen fixation under certain conditions, or to combine multiple suture holes to meet different suture needs.

[0114] In this embodiment, the edge of the first connecting plate 1320 is a curve. In order to make the suturing positions of the first suturing hole 13211, the second suturing hole 13212 and the third suturing hole 13213 as close as possible to achieve a good fixing effect, the edge of the first connecting plate 1320 is recessed toward the connecting position of the first cavity 1311 and the second cavity 1312, and it is satisfied that, in the area close to the suturing hole 13211, the maximum curvature position of the edge of the first connecting plate 1320 is aligned with the edge of the suturing hole 13211 closest to the first connecting plate 1320. In the area near the suture hole 13212, 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 13212 closest to the first connecting plate 1320 passes through the center of the suture hole 13212; in the area near the suture hole 13213, 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 13213 closest to the first connecting plate 1320 passes through the center of the suture hole 13213. Overall, the edge of the first connecting plate 1320 is a wavy curve.

[0115] In this embodiment, the edge of the second connecting plate 1330 is a curve. In order to make the suturing positions of the fourth suturing hole 13311, the fifth suturing hole 13312 and the sixth suturing 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 between the third cavity 1313 and the second cavity 1312, and it is satisfied that, in the area close to the suturing hole 13311, the maximum curvature position of the edge of the second connecting plate 1330 is aligned with the edge of the suturing hole 13311 closest to the second connecting plate 1330. The line connecting the position of the second connecting plate 1330 and the position of the edge of the second connecting plate 1330 passes through the center of the suture hole 13311; in the area close to the suture hole 13312, 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 13312 closest to the second connecting plate 1330 passes through the center of the suture hole 13312; in the area close to the suture hole 13313, 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 13313 closest to the second connecting plate 1330 passes through the center of the suture hole 13313. Overall, the edge of the second connecting plate 1330 is a wavy curve.

[0116] 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.

[0117] In another 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 through a slot structure, and the purpose is to select connecting plates of different shapes according to different implantation positions to fit closely to the skin. In another embodiment, the catheter seat 1300 includes a stress tube at its proximal end, and the strength of the stress tube is relatively high (but not higher than the hardness of the sheath tube), so as to avoid the sheath tube from being bent at the connection position.

[0118] For the flow diversion component 3, when the stent is implanted, the flow diversion component 3 can control the blood flow rate on the one hand, and the one-way valve setting of the flow diversion component 3 can also make the blood flow to the vein in a specific direction outside the body, specifically:

[0119] Reference Fig.18 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 which are arranged in the housing 31 and are connected in sequence; the flow controller 32 is connected to an end of the inflow tube 2 away from the arterial sheath 1, and the one-way check valve 34 is connected to an end of the outflow tube 4 away from the venous sheath 5;

[0120] Furthermore, the one-way check valve 34 is connected between the blood filter 33 and the outflow tube 4 .

[0121] In which, the flow controller 32 includes a main body element 321 having a flow 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 flow channel 3211, and the flow control element 322 reduces or increases the flow area of ​​the flow channel 3211 under the action of external force.

[0122] Before placing a stent at the carotid artery stenosis site, the arterial sheath 1 of the present invention is placed in the common carotid artery, and the venous sheath 5 is placed in the femoral vein. The high-pressure arterial blood flow of the brain and the low-pressure venous blood flow of the femoral vein form a pressure difference, so that the blood flow of the carotid artery flows reversely to the femoral vein through the blood flow reconstruction system. After the reverse blood circulation system is established, the carotid artery stenosis site is pre-dilated, a self-expanding stent is placed, and other operations are performed. During the operation, the thrombus that falls off is intercepted when it flows through the blood filter with the reverse blood flow, so as to prevent the thrombus from entering the human body with the blood. The flow controller 32 facilitates the doctor to adjust the flow size of the reverse blood flow in real time.

[0123] In this embodiment, if Fig.19 and Fig. 20 As shown, the main body element 321 is also provided with a moving channel 3212 connected to the circulation channel 3211; the flow control element 322 is movably arranged in the moving channel 3212. Under the action of external force, the distal end of the flow control element 322 moves toward the circulation channel 3211, and the distal end of the flow control element 322 exceeds the moving channel 3212 and enters the circulation channel 3211, forming a certain degree of obstruction to the circulation channel 3211, reducing the circulation area of ​​the circulation channel 3211, and further reducing the flow of the blood flow reconstruction system. On the contrary, under the action of 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 of the blood flow reconstruction system, and realizing stepless speed regulation of the blood flow velocity, so as to avoid causing discomfort to the human body.

[0124] In other embodiments, the movable channel may not be provided on the main component, and a through hole may be directly provided on the side wall of the circulation channel. The flow control element passes through the through hole and moves along the through hole to adjust the flow area in the circulation channel.

[0125] For ease of explanation, Fig.1932 shows the inflow end 3211a and the outflow end 3211b of the circulation channel 3211, wherein the inflow end 3211a is close to the inflow tube 2, and the outflow end 3211b is far 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. Fig. 20 The middle arrow indicates the direction of blood flow.

[0126] The flow control element 322 has a guide surface 3223, which is an inclined surface or a curved surface facing the inlet end 3211a and is enclosed with the inner surface of the flow channel 3211 to form a flow regulating channel 3214 that gradually contracts from the inlet end 3211a to the outlet end 3211b.

[0127] In this embodiment, the distal end of the flow control element 322 has an inclined surface, and the inclined surface forms the guide surface 3223. Since the blood flow reconstruction system of the present invention is used in conjunction with the carotid artery stent implantation surgery, the thrombus in the carotid artery will inevitably fall off and flow through the blood flow reconstruction system during the surgery. Due to the presence of the thrombus, any obstruction or bend in the circulation channel 3211 will increase the risk of thrombus accumulation, thereby generating the risk of blocking the flow controller 32.

[0128] 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.

[0129] like Fig.21 As shown, the circulation channel 3211 includes 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 moving channel 3212 is arranged on the main section 32111 and close to the narrowing section 32112, and the inner diameter of the narrowing section 32112 is smaller than the inner diameters of the connecting section 32111 and the main section 32113. The connecting section 32111 is used to connect the inflow tube 2, and the narrowing section 32112 with a smaller inner diameter is connected behind the connecting section 32111, so that the blood speed increases when flowing through the narrowing section 32112, and flows through the flow regulating channel 3214 at a higher speed, further preventing the accumulation of thrombus on the inflow side of the flow control element 322.

[0130] like Fig. 20As shown, the distal end surface of the flow control element 322 matches the bottom shape of the circulation channel 3211. Thus, the distal end of the flow control element 322 can fit tightly with 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.

[0131] Specifically, in this embodiment, combined with Figure 19-21 The sliding member 3222 has a sliding groove 32221 on its side, and a protrusion 3213 is provided in the moving channel 3212. The protrusion 3213 is slidably matched with the sliding groove 32221 to enable the sliding member 3222 to move axially in the moving channel 3212. The outer wall of the knob 3221 has an annular groove, and the inner wall of the moving channel 3212 has a protrusion plugged into the annular groove, so that the knob 3221 can rotate along the moving channel 3212 but cannot move axially. The far end of the knob 3221 has a receiving cavity, and the sliding member 3222 is inserted into the cavity and is spirally connected to the knob 3221. Since the sliding member 3222 is in sliding cooperation with the moving channel 3212, when the knob 3221 is rotated under the action of external force, the sliding member 3222 threadedly connected to the knob 3221 can only move along the axial direction of the moving channel 3212, ensuring that the guide surface is always facing the inflow end 3211a of the circulation channel 3211. In addition, 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 moves the sliding member 3222 in the moving channel 3212 by rotating the knob 3221, thereby preventing the external environment from contaminating the blood in the moving channel 3212.

[0132] In other embodiments, the outer wall of the knob 3221 has a protrusion, and the inner wall of the moving channel 3212 has an annular groove that is plugged into the protrusion; or the outer wall of the moving 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 moving channel 3211 but cannot move axially. In other embodiments, the proximal end of the sliding member 3222 has a cavity, and the distal end of the knob 3221 is inserted into the cavity and is spirally connected to the sliding member 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 that is away from the operator in the axial direction of the flow control element.

[0133] Replay Fig.18The blood filter 33 of this embodiment includes a filter element 331 and a filter screen 332 disposed in the filter element 331. The filter element 331 includes a cylindrical structure with two ends (or at least one end) open, and there is a gap between the filter screen 332 and the filter element 331, so as to play a filtering role without affecting the flow rate; the filter screen 332 includes 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 the blood flows out of the flow controller 32 and enters the filter screen 332, the thrombus is blocked in the filter screen 332, and the filtered blood flows out of the filter screen 332. Since the filter screen is a semi-enclosed structure with one end open, blood can flow out from all directions of the filter screen 332. Even if the filter screen 332 is partially blocked by the thrombus, other parts of the filter screen 332 still have a filtering function to prevent the blood flow reconstruction system from being blocked during surgery.

[0134] In another embodiment, the filter screen 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.

[0135] Since the blood flow reconstruction system of this embodiment is used for carotid artery stent implantation surgery, thrombus may fall during the entire operation. 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 filtering area to prevent the 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 prevent the circumference of the minimum cross section of the filter 332 from being too large, resulting in a too small gap between the filter 332 and the filter element 331.

[0136] Based on this, Fig.21 As shown, the circulation channel 3211 also includes a flared section 32114 disposed behind the main section 32113 , and the inner diameter of the flared section 32114 gradually increases from the inlet end 3211a to the outlet end 3211b to connect the circulation channel 3211 and the filter 332 .

[0137] In other embodiments, the blood filter may include a plurality of axially spaced filter screens, and the mesh diameter components of the plurality of filter screens increase from the inflow direction to the outflow direction of the blood filter, thereby performing multi-layer filtration on the blood and enhancing the filtering effect of the blood flow reconstruction system.

[0138] The 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, sealing ring valves, protector valves, ball check valves, diaphragm check valves, swing check valves, belt check valves, lifting check valves, duckbill valves, etc. It should be noted that in actual use, if the blood flow reconstruction system is used to connect arteries to veins, when the pressure difference between arteries and veins is large, the one-way check valve 34 can be used to achieve the same effect, that is, the device can be omitted under certain circumstances; but when the blood flow reconstruction system is used in an environment where the pressure difference is not large, such as from artery to artery, or from vein to vein, the one-way check valve 34 is necessary.

[0139] Replay Fig.18 , the blood filter has a filter outlet channel 3311, and the filter outlet channel 3311 is connected to the one-way check valve 34. The inner diameter of the filter outlet channel 3311 is d, the inner diameter of the blood filter is D, and d≤1 / 3D. In this embodiment, d=3 / 16D. When the blood flows through the blood filter 33, due to the large diameter of the blood filter 33, the blood flow velocity is greatly slowed down, and the one-way check valve is mainly opened by the impact force of the blood flow. The filter outlet channel 3311 with a smaller inner diameter can increase the flow velocity of the blood, thereby causing the blood to generate a greater impact force on the one-way check valve and pass through the one-way check valve smoothly. At the same time, the blood flow with a higher flow rate can further prevent blood reflux.

[0140] The blood flow reconstruction system also has a heat preservation function. Specifically, the inflow tube 2 and the outflow tube 4 in this embodiment are covered with heat insulation materials, such as rubber-plastic insulation tubes, foam insulation tubes, etc. In other embodiments, a constant temperature heating device can be added to the inflow tube 2, the outflow tube 4, and the venous sheath 5 to keep the blood at a constant temperature.

[0141] In an alternative embodiment, the flow controller 32 differs from the flow controller 32 mainly in that Fig. 22 and Fig.23 As shown, the included angle between the central axis of the circulation channel 3211 and the central axis of the moving channel 3212 is an acute angle, and the moving 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 a cylindrical body, and 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, so that thrombus is difficult to accumulate, which is conducive to ensuring the smooth flow of the blood flow reconstruction system.

[0142] Preferably, the flow control element 322 includes a knob 3221 and a sliding member 3222, wherein the knob 3221 is rotatably disposed at the proximal end of the moving channel 3212, and a receiving chamber is disposed at the distal end of the knob 3221, wherein the sliding member 3222 is disposed in the receiving chamber. The sliding member 3222 has a radially extending protrusion, and the protrusion passes through a through groove on the side wall of the receiving chamber and is threadedly connected to the moving channel 3212. When the knob 3221 rotates under the action of an external force, the protrusion abuts against the through groove so that the sliding member 3222 rotates together, and since the sliding member 3222 is threadedly connected to the moving channel 3212, the sliding member 3222 moves spirally along the moving channel 3212 as the knob 3221 rotates. 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 can move the sliding member 3222 in the movable channel 3212 by rotating the knob 3221 , thereby preventing the external environment from contaminating the blood in the movable channel 3212 .

[0143] 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. Fig.24 As shown, the distal end of the sliding member can be closely fitted with the circulation channel 3211, so that the flow controller 32 can achieve the function of hemostasis. The peripheral surface of the sliding member 3222 forms the guide surface. It should be noted that the 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.

[0144] In an alternative embodiment, if Figure 25 to Figure 27 As shown, the flow control element 322 is provided with a plurality of connecting holes 3224, 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 overall in the shape of a funnel that gradually shrinks from the inlet end 3211a to the outlet 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 transitioned to the inner wall of the circulation channel 3211.

[0145] The flow control element 322 is provided with a plurality of communicating holes 3224 of different apertures, such as Fig.26 and Fig. 27As shown, under the action of external force, the blood moves along the moving channel 3212, and the blood flows through the connecting holes 3224 with different diameters to achieve different degrees of regulation of the blood flow. When all the connecting holes are not directly facing the circulation channel, the circulation channel is blocked and the flow controller is in a closed state. In addition, since the edge of the inflow end of the speed regulating section 32241 can be smoothly connected to the inner wall of the circulation channel 3211, it is difficult for thrombus to accumulate at the flow control element 322.

[0146] The main body element 321 is provided with a plurality of first matching parts 3215, and the flow control element 322 is provided with a plurality of second matching parts 3225. When any of the first matching parts 3215 and the second matching parts 3225 are matched, the edge of the inflow end of the corresponding speed regulating section 32241 is smoothly transitioned and connected with the inner wall of the circulation channel 3211. In this embodiment, the first matching part 3215 is an arc-shaped hole on the inner wall of the circulation channel 3211, and the first matching part 3215 is a spring block that can be extended and retracted along the radial direction of the flow control element 322, and the end of the spring block is arc-shaped. When the slider is inserted into the arc-shaped hole, the connecting hole 3224 is opposite to the circulation channel 3211, and the edge of the inflow end of the corresponding speed regulating section 32241 is smoothly transitioned and connected with the inner wall of the circulation channel 3211. The flow control element 322 moves along the moving channel 3212 under the action of external force, and the bullet is squeezed back into the flow control element 322 until the bullet reaches the next arc hole. With the above structure, the doctor can accurately operate the flow control element 322 so that the connecting hole 3224 faces the circulation channel 3211.

[0147] Reference Fig.28 In this embodiment, the venous sheath 5 diverts the blood from the artery to the vein. The venous sheath 5 includes a sheath body 510, and there is no need to set a balloon structure on the side of the sheath body 510 close to the vein.

[0148] In addition, the venous sheath 5 is provided with a stress tube 530 with suture holes, thereby avoiding the risk of bending of the sheath and facilitating the fixation of the sheath.

[0149] 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 the present circulatory system also involves multiple implementations of the stent itself, as follows: Fig.29 The stent system 6 includes a stent sheath 610 , a stent loading area 620 is provided at the distal end of the stent sheath 610 , and the stent sheath 610 is connected to a handle 630 .

[0150] Continue to combine Figure 30-35 , Fig.30is a schematic structural diagram of a bracket 6100 in the first embodiment of the present invention; Fig.31 is a schematic structural diagram of a first wave ring 61111 of a bracket 6100 in a first embodiment of the present invention; Fig.32 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; Fig.33 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; Fig.34 is a schematic diagram of the overall state of the bracket 6100 in the first embodiment of the present invention in a compressed state; Fig.35 is a schematic diagram of the partial position of the bracket 6100 in the first embodiment of the present invention in a compressed state;

[0151] 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 and other materials. The coating 612 is made of a polymer material with good biocompatibility, such as ePTFE, PET, polyester cloth and the like.

[0152] The main body 611 includes a plurality of wave coils 6111 , and 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.

[0153] In this embodiment, the wave circle 6111 includes a plurality of first wave circles 61111, a second wave circle 61112 arranged in sequence, and a proximal wave circle 61113 and a distal wave circle 61114 located at the proximal end and the distal end respectively, wherein the first wave circle 61111 and the second wave circle 61112 are adjacent wave circles among the plurality of wave circles 6111.

[0154] In the present 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 the present 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.

[0155] In this embodiment, the first wave circle 61111 includes a first wave 61113 and a second wave 61114 that are continuously distributed, wherein the first wave 61113 is a high wave, 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:

[0156] 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.

[0157] Therefore, in this embodiment, for the first wave circle 61111, it includes at least two wave peaks: a high wave peak 61121 (a wave peak between the first wave rod 611131 and the second wave rod 611132) and a low wave peak 61122 (a 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 (a wave trough between the first wave rod 611131 and the adjacent fourth wave rod 611142) and a low wave trough 61124 (a wave trough between the second wave rod 611132 and the third wave rod 611141).

[0158] In this embodiment, the second wave coil 61112 uses the same waveform structure as the first wave coil 61111, but the second wave coil 61112 has a phase difference with 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, under such a design, when the body 61 of the stent body 61 of this embodiment is compressed, the adjacent first wave coil 61111 and the second wave coil 61112 will not overlap axially, that is, they will not overlap each other by axially squeezing the coating 612, but the peaks and troughs will be mutually supported and limited to avoid excessive shortening of the stent, thereby reducing the risk of stent jump before release. When the stent is deployed, the waves are staggered to avoid local collapse due to excessive pores in the coating 612, and will not interfere with each other to affect the flexibility of the stent.

[0159] 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 when released.

[0160] 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 stent 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 the multiple first wave coils 61111 and the second wave coil 61112 are compressed.

[0161] In this embodiment, the multiple low troughs 61124 of the first wave circle 61111 and the multiple high peaks 61121 of the adjacent second wave circle 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 circle 61111 and the second wave circle 61112 has no wave circle support in the axial direction, thereby avoiding axial shortening of the stent.

[0162] In another embodiment, referring to Fig.31 For the high peak 61131 of the second wave coil 61112, its axial position is between the axial positions of the high trough 61133 and the low trough 61134 of the first wave coil 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.

[0163] It should be noted that in another embodiment, the stent 6100 is a bare stent.

[0164] In an alternative embodiment, the first wave coil and the second wave coil are spirally distributed. Fig.36 , wherein the first wave circle 62111 and the second wave circle 62112 of this embodiment are distributed in a spiral.

[0165] In order to ensure that the amount of compression of the coating 622 is uniform between the first wave coil and the second wave coil when the vascular stent 6200 of this embodiment is compressed, that is, the axial cross-sectional area thereof in the conveyor will not increase abnormally due to compression, for this embodiment, the area of ​​the coating 622 between the first wave coil 62111 and the second wave coil 62112 is equal to the area of ​​the coating 622 between the adjacent first wave coil 62111 and the second wave coil 62112, thereby ensuring that when multiple first wave coils 62111 and second wave coils 62112 are compressed, the deformation conditions of the coating 622 on the upper and lower sides are almost the same. However, what is different from the original embodiment is that in this embodiment, the area S1 of the coating 622 between the first wave coil 62111 and the second wave coil 62112 and the area S2 of the coating 622 between the adjacent first wave coil 62111 and the second wave coil 62112 both refer to the first wave coil 62111 that makes a complete circle and the second wave coil 62112 that makes a complete circle.

[0166] In another embodiment, the first wave and the second wave are continuous, that is, the first wave and the second wave themselves are continuous waves of the same thread distribution.

[0167] In another alternative embodiment, the first wave coil and the second wave coil are connected to each other. Fig.37 , Fig.37 It is a schematic diagram of the structure of a vascular stent in another embodiment of the present invention, wherein the first wave circle 63111 and the second wave circle 63112 of this embodiment include multiple connection points 63113, specifically, the connection point 63113 is located between the high trough 63123 of the first wave circle 63111 and the high peak 63121 of the second wave circle 63112, and two adjacent connection points 63113 include two low peaks 63122 of the second wave circle 63112.

[0168] 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 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 when multiple first wave coils 63111 and second wave coils 63112 are compressed, the deformation conditions of the coating 632 on the upper and lower sides are almost the same. 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 region 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.

[0169] 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.

[0170] In another embodiment, a plurality of low wave peaks 63122 are included between two adjacent connection points 63113 .

[0171] In another embodiment, the number of connection points at the two end positions of the vascular stent is set to be small, that is, the end positions are close to or form an open-loop structure, so as to have a larger coating area, which can not only prevent the stenotic plaque from falling off, but also avoid the problem of poor flexibility of the end of the vascular stent and inability to conform to the blood vessel.

[0172] In another embodiment, referring to Fig.38 , Fig.38 3 is a schematic diagram of the structure of a vascular stent in another embodiment of the present invention, in which the first wave circle 63111 and the second wave circle 63112 are both inclined.

[0173] In general, the blood flow reconstruction system of this embodiment is relatively short in overall length, which can avoid the problem of large stent release force and release position deviation caused by long twist control distance; at the same time, it can also avoid damaging the blood vessel wall in the path during long-distance operation. In addition, the blood flow reconstruction system of this embodiment belongs to the proximal brain protection system, which has advantages over the distal brain protection system. Specifically, the distal brain protection system is a routine operation of CAS stenting. Generally, a guide wire is first used to pass through the narrow area, and then the protective umbrella is sent along the guide wire. Its characteristic is that it does not change the direction of blood flow. When devices such as balloons and stents are used in stenotic areas, detached plaques will flow toward the protective umbrella with the forward blood flow. After the stent is placed, the protective umbrella will be removed. Proximal brain protection is achieved by blocking the proximal blood flow and achieving blood reverse 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 protective 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 protective umbrella due to poor umbrella contraction or excessive hole design during the recovery phase.

[0174] Diverter component 3 Diverter component 3 Diverter component 3 Blood flow reconstruction system Blood flow reconstruction system Blood flow reconstruction system Blood flow reconstruction system Blood flow reconstruction system Blood flow reconstruction system Blood flow reconstruction system Blood flow reconstruction system Blood flow reconstruction system Blood flow reconstruction system Blood flow reconstruction system Blood flow reconstruction system

[0175] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described 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.

[0176] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached 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 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. The blood flow reconstruction system according to claim 10, characterized in that: The first wave loops and the second wave loops are distributed obliquely.

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