CN114504716A

CN114504716A - Blood diversion system

Info

Publication number: CN114504716A
Application number: CN202011290522.1A
Authority: CN
Inventors: 万杰清; 其他发明人请求不公开姓名
Original assignee: Shanghai Weimi Medical Technology Co ltd
Current assignee: Shanghai Weimi Medical Technology Co ltd
Priority date: 2020-11-17
Filing date: 2020-11-17
Publication date: 2022-05-17

Abstract

The invention provides a blood diversion system, comprising: the blood vessel sheath module comprises a first blood vessel sheath module, a second blood vessel sheath module and a diversion pipeline; two ends of the diversion pipeline are respectively connected with the first vascular sheath module and the second vascular sheath module; the first blood vessel sheath module comprises a first catheter sheath unit and a first dilator unit, and the first catheter sheath unit is sleeved on the first dilator unit; the second blood vessel sheath module comprises a second catheter sheath unit and a second dilator unit, and the second catheter sheath unit is sleeved on the second dilator unit; the diversion pipeline comprises a speed regulating unit and a filtering unit, the speed regulating unit can regulate the flow speed of blood flow, and the filtering unit can filter embolus particles in the blood flow. The blood diversion system provided by the invention can greatly shorten the length and the tortuosity of a path from a blood vessel entry point to a target treatment point, and effectively filter embolic particles in blood.

Description

Blood diversion system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a blood diversion system.

Background

Manifestations of carotid artery disease typically include deposits of plaque in the vessel that narrow the junction between the common carotid artery and the internal carotid artery. These plaque deposits increase the risk of embolic particles being produced and entering the cerebral vasculature, leading to neurological consequences such as transient ischemic attacks, ischemic strokes, or death. Furthermore, if this narrowing becomes severe, blood flow to the brain is prevented with serious, sometimes fatal, consequences.

Currently, two therapies are used primarily to treat carotid artery disease. The first therapy is open surgery, Carotid Endarterectomy (CEA), which relies on occluding the common, internal and external Carotid arteries, opening the Carotid artery at the site of the disease, cutting away and removing plaque, and then suturing the Carotid artery. The second therapy relies on stent placement of the Carotid artery, known as Carotid artery stent placement (CAS), generally at or across the branch from the common Carotid artery to the internal Carotid artery, or entirely in the internal Carotid artery. Typically, a vascular stent is introduced into the femoral artery in the groin by percutaneous puncture and ascends along the aortic arch into the targeted common carotid artery.

In carotid stenting CAS procedures, additional embolic protection devices are often used to at least partially mitigate the risk of embolism. One of these devices is a distal filter, which is deployed in the internal carotid artery distal to the stent placement region. The filter is intended to capture embolic particles to prevent their passage into the cerebral vasculature. However, these filtration devices have certain limitations. They must advance to the target vessel and cross the stenosis prior to deployment, which exposes the cerebral vessels to embolic flow; filters are not always easy to advance, deploy, and remove through tight stenoses and/or angled vasculature; the filter filters only particles larger than the pore size of the filter (typically 100 and 120 μm); the inability to filter 100% of the blood flow due to incomplete adherence of the filter itself; there is a risk of debris escaping during filter removal. On the other hand, the conventional interventional procedure has a long and complicated path from the vascular access point to the target treatment point, thereby resulting in a long procedure time and a difficult procedure.

Disclosure of Invention

In view of the deficiencies in the prior art, it is an object of the present invention to provide a blood diversion system that substantially reduces the length and tortuosity of the path from the vascular access point to the target treatment point and allows for effective filtration of embolic particles in the blood.

According to the present invention, there is provided a blood diverting system comprising:

the blood vessel sheath module comprises a first blood vessel sheath module, a second blood vessel sheath module and a diversion pipeline;

two ends of the diversion pipeline are respectively connected with the first vascular sheath module and the second vascular sheath module;

the first vascular sheath module comprises a first catheter sheath unit and a first dilator unit, wherein the first catheter sheath unit is sleeved on the first dilator unit, and the first catheter sheath unit is suitable for entering the common carotid artery and receiving blood flow from the common carotid artery in size and shape;

the second vessel sheath module comprises a second catheter sheath unit and a second dilator unit, the second catheter sheath unit is sleeved on the second dilator unit, and the size and the shape of the second catheter sheath unit are suitable for entering a target vessel and releasing blood flow received from a common carotid artery into the target vessel through a diversion pipeline;

the diversion pipeline comprises a speed regulating unit and a filtering unit, the speed regulating unit can regulate the flow speed of blood flow, and the filtering unit can filter embolus particles in the blood flow.

According to the above solution, a first vascular sheath module is placed within the lumen of the artery to establish access into the common carotid artery, the distal side of the sheath being generally located near the junction or bifurcation of the common carotid artery to the internal and external carotid arteries, and a second vascular sheath module is placed in the venous system, e.g. the femoral vein; the first and second sheath modules are connected to form an external arterio-venous shunt. Flow through the common carotid artery is occluded using an external vascular cuff or band, vascular clamp, or other type of occlusion device. When flow through the common carotid artery is blocked, the natural pressure gradient between the internal carotid artery and the venous system will cause blood to flow in a retrograde or countercurrent direction from the cerebral vasculature through the internal carotid artery and through the shunt into the venous system. Between first vascular sheath module and the connection of second vascular sheath module, be provided with the reposition of redundant personnel pipeline, the reposition of redundant personnel pipeline is including the speed governing unit that can adjust the velocity of flow of blood stream and the filter unit that can filter the embolus particle in the blood stream. The transcarotid access of the medical device can greatly shorten the length and the tortuosity of a path from a blood vessel access point to a target treatment point in a traditional interventional operation mode, thereby shortening the operation time and reducing the operation difficulty. In addition, this access route reduces the risk of emboli being created by passage from diseased, angled or tortuous aortic arch or common carotid artery anatomy. In addition, the embolus particles in the blood are effectively filtered, and the occurrence risk of ischemic diseases in operation and after operation is effectively reduced.

Preferably, the first catheter sheath unit comprises a first flexible tube and a Y-piece;

the Y-shaped part comprises a first straight branch and a first side branch;

the first straight support is connected with a first flexible pipe, a first joint is arranged at the far end of the first flexible pipe far away from the Y-shaped part, a first combined part is configured on the first joint, and the first combined part comprises a first combined part flexible pipe and a multi-way plug valve;

and a large-flux switch is connected at the port of the first side branch.

According to the technical scheme, on one hand, the pipeline part can be flushed, emptied or injected with contrast agents or medicines in an operation; on the other hand, the circulation state of the blood can be effectively controlled.

Preferably, the second catheter sheath unit comprises a second flexible tube and a V-shaped piece;

the V-shaped part comprises a second straight branch and a second side branch;

the second straight branch is connected with the second flexible pipe, a second joint is arranged at one end, far away from the second flexible pipe, of the second straight branch, the second side branch is connected with a second combined piece, and the second combined piece comprises a second combined piece flexible pipe and a multi-way plug valve.

According to the technical scheme, on one hand, the pipeline part can be flushed, or contrast agents or medicines can be injected in the evacuation operation; on the other hand, the pressure loss of the blood in the pipeline can be effectively reduced.

Preferably, the first vessel sheath module further comprises a limiting unit, and the limiting unit is sleeved on the first catheter sheath unit;

the limiting unit comprises a limiting pipe, a limiting pipe joint and a double-lug piece, the limiting pipe is fixedly connected with the limiting pipe joint, and the limiting pipe joint is fixedly connected with the double-lug piece.

According to the technical scheme, the limiting unit is arranged, so that the channel catheter sheath can be effectively prevented from being inserted too deeply into a blood vessel.

Preferably, the limiting pipe joint is in threaded connection with the double lugs.

According to the technical scheme, the limiting tube can be installed or taken down in a relatively short time in an operation.

Preferably, the first connector and the second connector each have a haemostatic valve.

According to the technical scheme, the hemostatic valve is arranged, so that blood is stopped in time, and the operation is convenient.

Preferably, the multi-way plug valve is a two-way or three-way plug valve.

According to the technical scheme, the plug valve can be flexibly selected according to actual conditions in the operation process.

Preferably, the speed regulating unit comprises a roller, a rolling groove and a blood transfusion pipeline;

the side surface of the roller is connected with a gear, a rack meshed with the gear extends along the notch of the rolling groove, and the wheel surface of the roller and the bottom surface of the rolling groove jointly clamp the blood transfusion pipeline arranged through the rolling groove;

the extending direction of the rack is inclined to the bottom surface of the rolling groove, so that the opening of the blood transfusion pipeline can be adjusted by the roller in the rolling process.

According to the technical scheme, the structural form of mechanical stepless speed regulation is realized, the method is different from an electric control mode that a power supply and various sensors are required to be used, and the pure mechanical structure is more stable and reliable while the economy is improved; and the speed regulating gear can be set at will according to the needs and is not limited by the fixed gear.

Preferably, the wheel surface is provided with a bulge, and the bulge comprises a straight type, a net type or a mixed type of the straight type and the net type.

According to the technical scheme, friction can be increased and slipping can be prevented when rolling operation is carried out.

Preferably, there are two sets of gears, which are symmetrically disposed on two sides of the roller respectively.

According to the technical scheme, the stable framework of the speed regulating unit is further increased.

Preferably, the speed regulating unit comprises a shell, a regulating block, a speed regulating slide and a blood transfusion pipeline; a speed regulation sliding chute is arranged above the shell, and a speed regulation sliding piece can move on the speed regulation sliding chute; a speed regulating block is fixedly connected below the speed regulating slide piece, the speed regulating block is positioned in the shell, and the bottom of the speed regulating block is designed to be an inclined plane; the side surface of the adjusting block is provided with a side wing which can move up and down in a side wing sliding groove in the shell; a compression spring is arranged between the shell and the side wing, the compression spring can apply continuous upward force to the side wing, and the adjusting block is always in contact with the inclined plane at the bottom of the speed regulating block under the action of the continuous upward force; the blood transfusion pipeline is positioned on the bottom surface inside the shell; when the speed regulation slider moves on the speed regulation sliding groove, the speed regulation block can be driven to move, the regulating block is positioned at different positions of the bottom inclined plane of the speed regulation block, the distance from the bottom of the regulating block to the bottom surface inside the shell is changed, and therefore the blood transfusion pipeline is pressed or loosened to regulate the opening degree of the blood transfusion pipeline.

According to the technical scheme, the structural form of mechanical stepless speed regulation is realized, the economy is improved, and the pure mechanical structure is more stable and reliable; on the other hand, the speed regulating gear can be set randomly according to the requirement and is not limited by a fixed gear.

Preferably, the shape of the end surface of the regulating block, which is in contact with the speed regulating block, is matched with the inclined surface at the bottom of the speed regulating block.

According to the technical scheme, the adjustment is smoother, and the operation efficiency and the operation hand feeling are improved.

Preferably, the filter unit comprises a first end cover, a second end cover, a cylinder body and a filter screen bracket;

the head end of the cylinder body is designed to be an opening, and the tail end of the cylinder body is provided with an opening;

the filter screen support comprises a support body and a filter screen, the support body is of a cylindrical structure and comprises a plurality of support columns connected with the head end and the tail end of the support body, the head end of the support body is provided with an opening, the tail end of the support body is provided with a base, and the filter screen is arranged on the inner side of the support body and covers the opening formed among the support columns;

the filter screen support is coaxial with the barrel, the head end of the support body is sleeved on the inner side of the head end of the barrel, a plurality of protruding ribs extending along the length direction are arranged on the inner wall of the barrel, the filter screen is abutted against the ribs, and the part of the inner wall of the barrel except the ribs is arranged at intervals with the filter screen;

the first end cover and the second end cover are respectively fixedly connected with the head end and the tail end of the barrel, and openings are formed in the first end cover and the second end cover.

According to the technical scheme, the embolus particles in the blood are effectively filtered, and the occurrence risk of ischemic diseases in operation and after operation is effectively reduced.

Preferably, a sealing ring is arranged between the first end cover and the filter screen bracket in an abutting mode.

According to the technical scheme, good sealing can be achieved between the first end cover and the filter screen support.

Preferably, the filter unit further comprises an anti-backflow device, the anti-backflow device can control the blood to flow only in a single direction, and the anti-backflow device is positioned between the second end cover and the tail end of the cylinder body.

According to the technical scheme, the backflow of blood or air at the lower end cover is prevented, so that the filtered blood is not mixed with the embolic particles again.

Preferably, the anti-reflux device is a duckbill anti-reflux device.

According to the technical scheme, the backflow prevention device for the blood or air at the lower end cover can be effectively prevented by arranging the duckbilled backflow prevention device.

Preferably, two ends of the diverting pipeline are respectively connected with the first blood vessel sheath module and the second blood vessel sheath module through quick-change connectors.

According to the technical scheme, the rapid assembly of the first blood vessel sheath module, the second blood vessel sheath module and the diversion pipeline in the operation process is facilitated, and the effective sealing connection among the modules can be realized only through simple plugging and unplugging actions.

Drawings

FIG. 1 is a schematic diagram of the general structure of a blood diversion system provided by the present invention;

FIG. 2 is a schematic view of the overall structure of a primary vascular sheath module according to the present invention;

FIG. 3 is a schematic view of the construction of a first catheter sheath unit according to the present invention;

FIG. 4 is a schematic structural view of the present invention including a position limiting unit;

FIG. 5 is a schematic structural view of a position limiting unit according to the present invention;

FIG. 6 is a schematic view of the overall structure of a secondary vascular sheath module of the present invention;

FIG. 7 is a schematic view of the construction of a second catheter sheath unit of the present invention;

FIG. 8 is a schematic view of the overall structure of a diverting piping according to the present invention;

fig. 9 is a schematic structural diagram of a first speed regulating unit according to the present embodiment;

FIG. 10 is a schematic view of the roller position when blood flow is at a maximum;

FIG. 11 is a schematic view of the roller position when blood flow is minimal;

fig. 12 is a first perspective view of the second governor unit according to the present embodiment;

fig. 13 is a second perspective view of the second governor unit according to the present embodiment;

FIG. 14 is a schematic view of the adjusting block with the A-side being a bevel;

fig. 15 is another schematic structural diagram of the second speed regulating unit according to the embodiment;

FIG. 16 is a schematic structural view of a blood diverting system relating to a filter unit according to the present invention;

FIG. 17 is a schematic view of a screen support structure of a filtration unit;

FIG. 18 is a schematic view of a ribbed drum;

FIG. 19 is a schematic view of a filter unit including an anti-reverse flow device;

figure 20 is a schematic view of an anti-reflux device duckbill style member;

figure 21 is a schematic view of two configurations of a duckbill type member through a liquid;

FIG. 22 is a schematic view of an anti-reflux device vane member.

Description of reference numerals:

1-a first vascular sheath module; 2-a second vascular sheath module; 3-a diversion pipeline; 31-a speed regulating unit; 32-a filtration unit; 110-sheath; 11-a first catheter sheath unit; 12 a first expander unit; 111-a first flexible tube; 112-Y-shaped piece; 1121-first straight leg; 1122-first side branch; 113-a first joint; 114-a first composite member; 1141-a first composite flexible tube; 115-multi-way plug valve; 1123-large flux switch; 116-a spacing unit; 1161-a limit tube; 1162-limit pipe joint; 117-binaural; 21-a second catheter sheath unit; 22-a second expander unit; 21-a second flexible tube; 212-a V-shaped piece; 2121-second straight branch; 2122-second side branch; 214-a second composite member; 2141-a second composite flexible tube; 213-a second linker; 31-a speed regulating unit; 32 a filtration unit; 33-an outer shell; 34-a pipeline body; 35-quick change coupler; 311-a roller; 312-rolling groove; 313-a blood transfusion line; 314-a gear; 315-rack; 3100-a housing; 3101-an adjusting block; 3102-speed governing slide; 3103-speed regulating runner; 3104-speed regulating block; 3105-blood transfusion channel; 3106-flanks; 3107-flank runner; 3108-a compression spring; 3201-first end cap; 3202-a second end cap; 3203-barrel; 3204-screen holder; 3205-the stent body; 3206-filtering net; 3207-ribs; 3208-support column; 3209-an anti-reflux device; 3210-base; 3211-sealing ring; 91-closing up; 92-upper end plane; 93-blade; 94-big end; 95-small end.

Detailed Description

The present invention will be described in detail with reference to specific examples. The following examples will assist those skilled in the art in further understanding the invention, but are not intended to limit the invention in any way. It should be noted that it would be obvious to those skilled in the art that various changes and modifications can be made without departing from the spirit of the invention. All falling within the scope of the present invention.

Fig. 1 is a schematic general structural diagram of a blood diverting system provided by the present invention, as shown in fig. 1, the blood diverting system includes a first blood sheath module 1, a second blood sheath module 2 and a diverting pipeline 3, and two ends of the diverting pipeline 3 are respectively connected with the first blood sheath module 1 and the second blood sheath module 2; the diversion pipeline 3 comprises a filtering unit 32 and a speed regulating unit 31, wherein the filtering unit 32 can filter the embolic particles in the blood flow, and the speed regulating unit 31 can regulate the flow rate of the blood flow.

The blood diversion system provided by the invention is applied to an operation, firstly, sheath tubes 110 of a first blood vessel sheath module 1 and a second blood vessel sheath module 2 are respectively punctured into a target blood vessel through a Seldinger technology or a micro-puncture technology; and then the first blood vessel sheath module 1 and the second blood vessel sheath module 2 are quickly connected with the diversion pipeline 3. The first vascular sheath module 1 is a withdrawal vascular sheath module, and the second vascular sheath module 2 is a return vascular sheath module. The flow of blood through the evacuated blood vessel is occluded using an external vascular cuff or band, vascular clamp, or other type of occlusion device. When the flow of blood through the withdrawal vessel is blocked, the pressure gradient between the withdrawal vessel and the return vasculature will cause blood to flow from the withdrawal vessel and into the return vessel. In the process, blood enters through the first blood vessel sheath module 1 of the pumping blood vessel sheath module at a certain speed, embolus particles in the blood are filtered through the diversion pipeline 3, and finally, the filtered blood flows back to a human blood vessel through the second blood vessel sheath module 2 of the back flow blood vessel sheath module. In the process, the medical devices such as guide wires, micro-catheters, balloons, stents, thrombus taking devices and the like can be entered by drawing out the special cavity of the first blood vessel sheath module 1 of the blood vessel sheath module to treat human diseases, and the device is suitable for performing angioplasty, cardiovascular surgery and any other interventional operations.

The specific modules and components of a blood diversion system provided by the present invention will be described in detail below.

[ first vessel sheath Module ]

Fig. 2 is a schematic view of the overall structure of the first blood sheath module 1 according to the present invention, and as shown in fig. 2, the first blood sheath module 1 comprises a first catheter sheath unit 11 and a first dilator unit 12, the first catheter sheath unit 11 is sleeved on the first dilator unit 12, and the first catheter sheath unit 11 is sized and shaped to enter the common carotid artery and receive blood flow from the common carotid artery.

Specifically, the first introducer sheath unit 11 is a flexible tube inserted into a blood vessel, and is usually sleeved on the first dilator unit 12, and after the first dilator unit 12 is withdrawn, a guide wire or a catheter can be inserted into the blood vessel through the first introducer sheath unit 11. The first dilator unit 12 is a flexible tubular instrument for dilating a percutaneous puncture channel into a human blood vessel. The first catheter sheath unit 11 and the first dilator unit 12 each have a tip configuration with a certain length at the head end point, so that the phenomenon of returning and returning when entering human tissues is minimized. The tip of the first introducer sheath unit 11 fits snugly against the first dilator unit 12 and does not break during normal use.

Fig. 3 is a schematic structural view of a first catheter and sheath unit 11 according to the present invention, and as shown in fig. 3, the first catheter and sheath unit includes a first flexible tube 111 and a Y-shaped member 112; the Y-shaped member 112 includes a first leg 1121 and a first side leg 1122; the first straight support 1121 is connected with a first flexible pipe 111, the distal end of the first flexible pipe 111, which is far away from the Y-shaped member 112, is provided with a first joint 113, the first joint 113 is provided with a first closing element 114, and the first closing element 114 comprises a first closing element flexible pipe 1141 and a multi-way stopcock 115; a large-flux switch 1123 is connected to the port of the first side branch 1122.

Preferably, the multi-way stopcock 115 is a matching medical three-way or two-way stopcock. The multi-way stopcock 115 enables flushing, or purging, or intraoperative injection of contrast or medication of the tubing segment.

In this embodiment, the first straight leg 1121 of the Y-shaped member 112 is connected to the first flexible tube 111, preferably, the length of the first flexible tube 111 ranges from 50 mm to 200mm, and the other end of the first flexible tube 111 is connected to the first joint 113 engaged with the first expander unit 12. Preferably, the first connector 113 may be configured with a hemostatic valve. The first adapter 113 carries a first adapter 114. the first adapter 114 comprises a first adapter flexible tube 1141 and a multi-way stopcock 115, shown as a mating medical three-way stopcock, which enables flushing or evacuation of a portion of the tubing, or injection of contrast or medication during surgery. The first side branch 1122 of the Y-shaped member 112 is designed as a larger inner diameter tube, and is a blood flow passage, a port of the first side branch 1122 is connected to a large-flux switch 1123, and the large-flux switch 1123 is used for controlling the flow state of blood.

In the present embodiment, the first leg 1121 of the Y-shaped member 112 is used as the abscissa, and the medical device with the contour of 6 to 10Fr can be accommodated in the inner cavity of the channel from the first joint 113 to the opening of the sheath tip. In performing angioplasty, cardiovascular surgery, and any other interventional procedure, medical devices such as guidewires, microcatheters, balloons, stents, thrombectomy devices, etc. may be passed through the passageway into the body's blood vessel for treatment. Compared with the traditional interventional operation mode of transfemoral approach, the treatment mode greatly shortens the length and the tortuosity of the path from the blood vessel entry point to the target treatment point, thereby shortening the operation time and reducing the operation difficulty. As the access path is shortened, the total length of the matched surgical device is correspondingly shortened, and the device is beneficial to the operation and control of the surgical process. In addition, this route of entry reduces the risk of emboli being created by passage from diseased, angled or tortuous aortic arch or common carotid artery anatomy, thereby reducing the probability of developing intra-or post-operative ischemic disease.

Fig. 4 is a schematic structural diagram of the present invention including a limiting unit, and as shown in fig. 4, based on the above embodiment, preferably, the first vessel sheath module 1 further includes a limiting unit 116, and the limiting unit 116 is sleeved on the first catheter sheath unit 11.

Fig. 5 is a schematic structural view of the limiting unit according to the present invention, and as shown in fig. 5, the limiting unit 116 includes a limiting tube 1161, a limiting tube connector 1162, and a dual-lug piece 117, the limiting tube 1161 is fixedly connected to the limiting tube connector 1162, and the limiting tube connector 1162 is fixedly connected to the dual-lug piece 117.

In particular, the stop unit 116 prevents the access sheath from being inserted too far into the vascular section. The limiting unit 116 includes a limiting tube 1161 and a limiting tube connector 1162. The limiting tube 1161 is made of soft materials with good biocompatibility, such as silica gel, PU, Pebax, LDPE, PTFE and the like, and damage of the materials to blood vessels is prevented. The part of the limiting tube 1161, which is close to the blood vessel, is designed into an inclined plane 1164 with an angle of 15-75 degrees, the thickness of the limiting tube is 0.5-5 mm, and the radian of the outer wall of the limiting tube can be well and stably attached to the skin and the radian of the outer wall of the blood vessel. The distance between the head of the inclined plane of the limiting tube 1161 and the head of the sheath tube 110 of the first catheter sheath unit 11 is set to be 1-5 cm; namely, the depth of the sheath tube 110 of the first catheter sheath unit 11 entering the blood vessel is limited to 1-5 cm. Preferably, the connection part of the limiting pipe joint 1162 and the limiting pipe 1161 is designed as a pagoda joint or is designed as a straight pipe; the connecting part of the limiting tube 1162 and the limiting tube 1161 shown in fig. 4 is designed as a pagoda joint 1163. The limiting tube 1161 can be directly inserted and fixed or fixed by gluing. If the rubber coating is not adopted for fixation, the limiting tube 1161 can move circumferentially with the limiting tube joint 1162, and the limiting tube 1161 can adjust the contact surface of the head inclined plane and the skin or the blood vessel wall according to actual conditions in the operation.

Preferably, the limiting pipe joint 1162 is in threaded connection with the double-lug piece 117, the thread part of the threads is set to be 0.5-3 circles in length, and the limiting pipe can be rapidly installed or removed in an operation through the embodiment.

[ second vascular sheath Module ]

Fig. 6 is a schematic diagram of the overall structure of the second blood sheath module 2 according to the present invention, and as shown in fig. 6, the second blood sheath module 2 comprises a second introducer sheath unit 21 and a second dilator unit 22, the second introducer sheath unit 21 is sleeved on the second dilator unit 22, and the second introducer sheath unit 21 is sized and shaped to enter a target blood vessel and release blood flow received from the common carotid artery into the target blood vessel via the diversion pipeline 3.

Specifically, the second introducer sheath unit 21 is a flexible tube inserted into the blood vessel, and is usually fitted over the second dilator unit 22, and after the second dilator unit 22 is withdrawn, a guide wire or a catheter can be inserted into the blood vessel through the second introducer sheath unit 21. The second dilator unit 22 is a flexible tubular instrument capable of dilating a percutaneous puncture channel into a human blood vessel. The head end points of the second catheter sheath unit 21 and the second dilator unit 22 are provided with tip configurations with certain lengths, so that the phenomenon of returning and returning when the catheter sheath unit enters human tissues is minimized. The tip of the second catheter sheath unit 21 is preferably closely fitted to the second dilator unit 22 without breaking during normal use.

Fig. 7 is a schematic structural view of the second catheter sheath unit according to the present invention, and as shown in fig. 7, the second catheter sheath unit comprises a second flexible tube 211 and a V-shaped member 212, the V-shaped member 212 comprises a second straight support 2121 and a second side support 2122, the second straight support 2121 is connected with the second flexible tube 211, one end of the second straight support 2121 away from the second flexible tube 211 is provided with a second joint 213, the second side support 2122 is connected with a second joint member 214, and the second joint member 214 comprises a second joint member flexible tube 2141 and a multi-way stopcock 115.

In particular, the second straight leg 2121 of the V-shaped element 212 comprises a second joint 213 that can pass through the second expander unit 22, the second joint 213 being provided with a stop valve; the second leg 2122 of the V-shaped element 212 is connected to a second coupling element 214, the second coupling element 214 mainly comprising a second flexible tube 211 and a mating multi-way stopcock 115, preferably the multi-way stopcock 115 is a medical three-way or two-way stopcock, which enables flushing, or draining, or injection of contrast or drugs into the tubing section, or during surgery. At the same time, the second closing element 214 can be used to convey the returned blood, so the inner diameter of the second flexible tube 211 is correspondingly larger, and the stopcock valve should be designed to have a large flow rate to reduce the pressure loss of the blood in the pipeline.

It should be noted that the first dilator element 12 is longer than the second dilator element 22. During surgery, the first dilator unit 12 and the second dilator unit 22 need to be advanced into the inner wall of the blood vessel. This operation requires that the tubing itself have a certain hardness to provide a more comfortable pushing feel, but inevitably causes damage to the inner wall of the blood vessel. In order to avoid the damage of hard materials to the inner wall of the blood vessel, the head of the dilator is provided with a tip structure, and the head of the dilator can be connected with soft materials, so that the defects caused by the materials can be overcome. For example, the pipe body is made of HDPE, and the LDPE is connected at the position 2-15mm of the head part; or the main body of the pipe adopts harder Pebax (such as Pebax7233), the 2-15mm position of the head adopts softer Pebax (such as Pebax3533), and the like; the two materials with different hardness can be connected into a whole by hot melting, adhesive bonding, ultrasonic welding and other modes.

[ diversion pipeline ]

Fig. 8 is a schematic view of the overall structure of the diversion pipeline according to the present invention, the diversion pipeline 3 includes a speed regulation unit 31, a filtering unit 32, an outer housing 33 and a pipeline body 34, the speed regulation unit 31 and the filtering unit 32 are located inside the outer housing 33, the speed regulation unit 31 can regulate the flow rate of blood flow, and the filtering unit 32 can filter embolic particles in the blood flow.

Preferably, both ends of the diverting pipeline 3 are respectively connected with the first blood vessel sheath module 1 and the second blood vessel sheath module 2 through quick-change connectors 35. According to the above embodiment, the quick-change connector 35 can be quickly docked with the first and second sheath modules 1 and 2 during the operation. Through setting up quick change coupler, effective sealing connection just can be realized to simple plug action. The quick-change connector form comprises all commercial structures suitable for fluids on the market at present. The quick-change connector is made of ABS, PC, PE, Silicon, Nylon, PTFE, PP, POM and other materials with good biocompatibility.

[ SPEED-REGULATING UNIT ]

Fig. 9 is a schematic structural diagram of a first governor unit according to the present embodiment, and as shown in fig. 9, the governor unit 31 includes a roller 311, a rolling groove 312, and a blood transfusion line 313; a gear 314 is connected to the side surface of the roller 311, a rack 315 meshed with the gear 314 extends along the notch of the rolling groove 312, and the wheel surface of the roller 311 and the bottom surface of the rolling groove 312 jointly clamp the blood transfusion pipeline 313 arranged through the rolling groove 312; the rack 315 extends obliquely to the bottom surface of the rolling groove 312, so that the roller 311 can adjust the opening of the transfusion line 313 during rolling.

Specifically, the governor unit 31 mainly includes a roller 311 and a rolling groove 312. The contour of the roller 311 is provided with a protrusion, preferably in a shape including a straight shape, a net shape, and other geometric shapes, which has the effect of increasing friction to prevent slippage when the thumb is operated to roll thereon. The roller 311 has a pinion 314 on one or both sides, and the pinion 314 is in a meshing relationship with a rack 315 of a rack groove formed in a side wall of the rolling groove 312. The blood transfusion pipeline 313 can be accommodated below the rolling groove 312, and the surface of the bottom surface of the rolling groove 312 opposite to the roller 311 is designed to be an inclined surface.

Fig. 10 is a schematic view showing the position of the roller when blood flow is maximal, and as shown in fig. 10, when roller 311 has a sufficiently large clearance from the bevel, the passage in blood line 313 is not compressed, and the blood flow rate is maximal.

Fig. 11 is a schematic view of the roller position when blood flow is minimal, and as shown in fig. 11, when roller 311 has a sufficiently small clearance from the ramp, the passageway in blood line 313 is compressed to a minimum where blood flow is minimal, i.e., where the passageway is blocked and the blood flow rate is zero.

When roller 311 is in the middle of the two limits, the passage in transfusion line 313 is compressed to a certain extent, and blood flows at a non-maximum flow rate.

By the above manner, the speed regulating unit 31 can realize stepless speed regulation of blood flow. Due to the meshing action of the gear 314 and the rack 315, the movement of the roller 311 is in a certain rhythm, and the blood transfusion pipeline 313 is compressed or expanded in a certain rhythm, so that the speed regulation function is more accurate than that of the two modes of sliding only in a plane. And due to the meshing action of the gear 314 and the rack 315, the sliding of the movement or unexpected backward movement of the roller 311 after stopping can be effectively prevented, so that the speed regulation fails.

Fig. 12 is a schematic view from a first perspective of a second type of speed regulating unit according to the present embodiment, and as shown in fig. 12, the speed regulating unit comprises a housing 3100, a regulating block 3101, a speed regulating slider 3102 and a blood line 313; a speed regulation sliding groove 3103 is arranged above the shell 3100, and a speed regulation slider 3102 can move on the speed regulation sliding groove 3103; the speed regulating block 3104 is fixedly connected below the speed regulating slide piece 3102, the speed regulating block 3104 is positioned inside the shell, and the bottom of the speed regulating block 3104 is designed as an inclined surface.

Fig. 13 is a schematic diagram showing a second perspective view of the second speed adjusting unit according to the present embodiment, and as shown in fig. 13, a side wing 3106 is provided on a side surface of the adjusting block 3101, and the side wing 3106 is vertically movable in a side wing chute 3107 inside the housing 3100; a compression spring 3108 is arranged between the shell 3100 and the side wing 3106, the compression spring 3108 can apply continuous upward force to the side wing 3106, and the adjusting block 3105 is always in contact with the inclined surface at the bottom of the speed regulating block 3104 under the action of the continuous upward force; blood transfusion line 313 is located on the bottom surface inside housing 3100; when the speed regulation slider 3102 moves in the speed regulation chute 3103, the speed regulation block 3104 can be driven to move, so that the regulation block 3101 is positioned at different positions of the bottom inclined surface of the speed regulation block 3104, the distance from the bottom of the regulation block 3101 to the bottom surface inside the shell 3100 is changed, and the blood transfusion pipeline 313 is pressed or loosened to regulate the opening degree of the blood transfusion pipeline 313.

Specifically, the adjusting block 3101 is symmetrically provided with side wings 3106 on both sides, and the side wings 3106 can move up and down along preset side wing sliding grooves 3107 in the housing 3100. A compression spring 3108 is mounted between the housing 3100 and the side wing 3106 such that the adjustment block 3101 is constantly forced upwardly. When the speed regulation slider 3102 slides axially along the speed regulation slide groove 3103 positioned above the shell 3100, the speed regulation block 3104 is driven to slide axially, and the regulation block 3105 moves up and down along the flank slide groove 3107 in the shell 3100.

According to the above embodiment, when the blood circulation system is switched from high flow rate to low flow rate, when the speed regulation slider 3102 is operated to slide in the axial direction, the lower slope of the speed regulation block 3104 drives the upper slope of the regulation block 3105, the height of the regulation block 3101 from the bottom surface inside the housing 3100 is reduced, and the edge of the lowest end of the regulation block 3101 presses the blood transfusion line 313, thereby changing the cross-sectional area of the blood transfusion line 313 and achieving the purpose of switching the flow rate. On the other hand, when the system is switched from a low flow rate state to a high flow rate state, the speed control slider 3102 is operated to slide in the axial direction, the lower slope surface of the speed control block 3104 is separated from the upper slope surface of the adjustment block 3101, and the side wings 3106 of the adjustment block 3101 are continuously urged upward by the compression spring 3108, so that the adjustment block 3101 is lifted, the cross-sectional area of the blood transfusion tube 313 is increased, and the flow rate in the tube is increased.

FIG. 14 is a schematic view of the adjustment block with the A surface being a bevel, and as shown in FIG. 14, the surface of adjustment block 3101 near the blood transfusion line 313 may be a bevel with a certain angle or a flat surface, depending on the actual situation.

Fig. 15 is another schematic structural diagram of the second type of speed regulation unit according to this embodiment, and as shown in the figure, a blood transfusion duct 3105 may be formed by using a separately formed tubular object through a blood pipeline, or by directly forming a chute material of the side chute 3107, and the size of the opening of the formed duct is controlled by the lower slope of the adjusting block 3101. With the latter structure, there is a tight seal between the relevant portions.

[ FILTERING UNIT ]

Fig. 16 is a schematic structural diagram of a blood diverting system relating to a filtering unit, and as shown in fig. 16, the filtering unit 32 includes a first end cap 3201, a second end cap 3202, a cylinder 3203 and a screen holder 3204; the head end of the cylinder 3203 is designed as an opening, and the tail end of the cylinder 3203 is provided with an opening; the screen holder 3204 includes a holder body 3205 and a screen 3206; the first end cap 3201 and the second end cap 3202 are respectively fixedly connected with the head end and the tail end of the cylinder 3203, and openings are respectively arranged on the first end cap 3201 and the second end cap 3202. Preferably, a seal ring 3211 is disposed in abutment between the first end cap 3201 and the screen holder 3204.

Fig. 17 is a schematic view of a filter screen support structure of a filter unit, as shown in fig. 17, a support body 3205 is a cylindrical structure, the support body 3205 includes a plurality of support pillars 3208 connecting the head and tail ends of the support body 3205, the head end of the support body 3205 is an opening, the tail end of the support body 3205 is provided with a base 3210, and a filter screen 3206 is disposed inside the support body 3205 and covers the opening formed between the plurality of support pillars; the screen holder 3204 is coaxial with the cylinder 3203, and the head end of the holder body 3205 is sleeved inside the head end of the cylinder 3203.

Fig. 18 is a schematic view of a ribbed cylinder structure, in which a plurality of ribs 3207 extending in the longitudinal direction are provided on the inner wall of a cylinder 3203, a filter screen 3206 abuts against the ribs 3207, and a portion of the inner wall of the cylinder 3203 other than the ribs 3207 is spaced apart from the filter screen 3206.

Specifically, the filter screen support 3204 is integrally cylindrical in configuration and comprises a support body 3205 and a filter screen 3206, the support body 3205 comprises a plurality of support columns 3208 which are connected with the head end and the tail end of the support body 3205, the head end of the support body 3205 has a hollow cylindrical configuration with a larger diameter, and the two ends are open; the tail end is closed and is provided with a base 3210. The filter screen 3206 is a grid-shaped filter screen, and is made of nylon monofilament, and is woven by single warp and single weft, the yarn diameter is 100 μm + -10 μm, and the pore size is 200 μm + -20 μm. The screen holder 3204 is designed coaxially with the cylinder 3203. The sealing ring 3211 has a circular ring configuration with a certain thickness. The filter screen support 3204 is placed in the cylinder 3203, the support body 3205 can be clamped at the step of the cylinder, the height of the support body 3205 and the step depth of the cylinder 3203 have a height difference, and the end part of the opening of the support body 3205 is exposed by about 0.2-5 mm. By this height difference, the packing 3211 installed in the first end cap 3201 is pressed and deformed by the screen holder 3204, thereby sealing the cylinder 3203 and the first end cap 3201. Preferably, the barrel 3203 and the first end cap 3201 may be connected by a screw thread, or by an interference fit extrusion, ultrasonic welding, or gluing.

According to the above embodiment, the inner wall of the barrel 3203, which is engaged with the filter screen 3206, is provided with a plurality of ribs 3207 which are axially aligned with the filter screen holder 3204. The filter screen 3206 is tightly matched with the ribs 3207, so that the filter screen support 3204 can be stably fixed in the cylinder 3203 without shaking. The gaps between the inner walls of the barrel 3203 and the filter screen 3206 are larger except for the ribs 3207. Blood flows in through the holes of the first end cap 3201 and is filtered by the filter screen 3206, embolic particles larger than the mesh of the filter screen 3206 are trapped on the mesh of the filter screen 3206, and other portions flow out of the mesh and through the gap between the filter screen 3206 and the barrel 3203 toward the opening of the second end cap 3202 downstream of the pressure.

Preferably, the outer casing 33 can be designed to be visible at the filtering screen portion, for example, a hollow window is provided, or a transparent material is used for the outer casing to observe the filtering condition of blood in real time. The outer casing 33 is made of PC, ABS, PE, Nylon, PP, POM, etc. which have good biocompatibility and certain hardness. The components mounted in the outer housing 33, or the components of the outer housing 33 themselves, may be fixed together by means of snap-fitting, gluing, interference crimping, ultrasonic welding, overlapping, etc.

Fig. 19 is a schematic diagram of the filtering unit including an anti-backflow device, as shown in fig. 19, the filtering unit further includes an anti-backflow device 3209, the anti-backflow device 3209 can control the blood to flow only in one direction, and the anti-backflow device 3209 is located between the second end cap 3202 and the tail end of the barrel 3203.

Specifically, an anti-reflux device 3209 is provided near the second end cap 3202, i.e., under pressure of the filtration unit 32, for preventing blood or air at the second end cap 3202 from being refluxed such that the filtered blood is not remixed with embolic particles.

Preferably, the anti-backflow device 3209 may be a duckbill-type member made of a soft material.

Figure 20 is a schematic view of an anti-reflux device duckbill pattern member, wherein figure 20(a) is a schematic view from a first perspective of the duckbill pattern member and figure 20(b) is a schematic view from a second perspective of the duckbill pattern member, as shown in figure 20, wherein the upper planar surface 92 of the member is circular and the lower end has an angled constriction 91; as shown in fig. 21, the cuff 91 is elongated and the material has a relatively thin wall thickness.

Figure 21 is a schematic view of two configurations of a duckbill type member through a liquid, wherein figure 21(a) is a schematic view of a forward flow of the liquid and figure 21(b) is a schematic view of a reverse flow of the liquid. When the liquid flows in the forward direction, even a low resistance can blow the closed duckbill end open, as shown in figure 21(a), so that the liquid can flow out smoothly; as shown in fig. 21(b), when the liquid flows in the reverse direction, the duckbill is automatically closed due to the force acting on the angular slope of the end of the duckbill, thereby achieving the purpose of intercepting the flow. The soft material may be soft material with low hardness such as silica gel, PU, Pebax, etc. with good biocompatibility.

Fig. 22 is a schematic view of the blade member of the anti-backflow device, wherein fig. 22(a) is a schematic view of a first view angle, fig. 22(b) is a schematic view of a second view angle, and as shown in fig. 22, the anti-backflow device 3209 of the present embodiment may also be a blade member made of a soft material, and the middle portion of the blade member has a plurality of swirl-shaped blades 93 with connected centers. When the fluid flows from the large end 94, the vanes 93 are pushed away, and the fluid can flow forwards; when the fluid flows in the opposite direction to the member, the force of the fluid will act on the flat surface of the small end 95, and the vane 93 is pressed and gathered, thereby performing the function of fluid interception. The member is also made of a soft material such as silicone, PU, Pebax, etc.

It should be noted that, common check valve structures such as plunger type and spherical spring can also be used as the anti-reflux device, but the structure is complex compared with the two anti-reflux devices. Either duckbill or vane anti-reflux devices can be provided with a larger diameter large end plane. In the use process, the annular edge of the second end cap 3202 can press the large-end plane part on the corresponding inner circle end surface of the cylinder 3203, and the sealing effect is realized by utilizing the elasticity of the soft material. The barrel 3203 and the second end cap 3202 can be connected in a threaded manner, and can also be connected in interference fit extrusion, ultrasonic welding, gluing and other manners.

In the description of the present application, it is to be understood that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience in describing the present application and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present application.

In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, various embodiments or examples and features of different embodiments or examples described in this specification can be combined and combined by one skilled in the art without contradiction.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.

The foregoing description of specific embodiments of the present invention has been presented. It is to be understood that the present invention is not limited to the specific embodiments described above, and that various changes or modifications may be made by one skilled in the art within the scope of the appended claims without departing from the spirit of the invention. The embodiments and features of the embodiments of the present application may be combined with each other arbitrarily without conflict.

Claims

1. A blood diversion system, comprising:

the first vascular sheath module comprises a first catheter sheath unit and a first dilator unit, the first catheter sheath unit is sleeved on the first dilator unit, and the first catheter sheath unit is sized and shaped to enter the common carotid artery and receive blood flow from the common carotid artery;

the second vascular sheath module comprises a second introducer sheath unit and a second dilator unit, the second introducer sheath unit is sleeved on the second dilator unit, and the second introducer sheath unit is sized and shaped to enter a target blood vessel and release the blood flow received from the common carotid artery to the target blood vessel through the diversion pipeline;

the diversion pipeline comprises a speed regulating unit and a filtering unit, the speed regulating unit can regulate the flow speed of the blood flow, and the filtering unit can filter the embolus particles in the blood flow.

2. The blood diverting system of claim 1, wherein:

the first catheter sheath unit comprises a first flexible pipe and a Y-shaped piece;

the Y-shaped part comprises a first straight branch and a first side branch;

the first straight support is connected with the first flexible pipe, a first joint is arranged at the far end of the first flexible pipe far away from the Y-shaped part, a first combined piece is configured at the first joint, and the first combined piece comprises a first combined piece flexible pipe and a multi-way plug valve;

and a port of the first side branch is connected with a large-flux switch.

3. The blood diverting system of claim 2, wherein:

the second catheter sheath unit comprises a second flexible tube and a V-shaped piece;

the V-shaped member comprises a second straight leg and a second side leg;

the second is directly propped up with the second flexible tube is connected, the second is directly propped up the one end of keeping away from the second flexible tube and is equipped with the second and connect, second side props up and connects the second and closes the piece, the second closes the piece and includes second and closes piece flexible tube and multi-way plug valve.

4. The blood diverting system according to claim 3, wherein:

the first blood vessel sheath module also comprises a limiting unit which is sleeved on the first catheter sheath unit;

5. The blood diverting system of claim 4, wherein:

the limiting pipe joint is connected with the double-lug piece through threads.

6. The blood diverting system of claim 4, wherein:

the first and second connectors each have a hemostasis valve.

7. The blood diverting system of claim 4, wherein:

the multi-way plug valve is a two-way or three-way plug valve.

8. The blood diverting system of claim 1, wherein:

the speed regulating unit comprises a roller, a rolling groove and a blood transfusion pipeline;

9. The blood diverting system of claim 8, wherein:

the wheel surface is provided with a bulge, and the bulge comprises a straight type, a net type or a mixed type of the straight type and the net type.

10. The blood diverting system of claim 8, wherein:

the two groups of gears are respectively and symmetrically arranged on two side surfaces of the roller.

11. The blood diverting system of claim 1, wherein:

the speed regulating unit comprises a shell, a regulating block, a speed regulating slider and a blood transfusion pipeline;

a speed regulation sliding groove is formed above the shell, and the speed regulation sliding piece can move on the speed regulation sliding groove; a speed regulating block is fixedly connected below the speed regulating slide piece, the speed regulating block is positioned in the shell, and the bottom of the speed regulating block is designed to be an inclined plane;

the side surface of the adjusting block is provided with a side wing which can move up and down in a side wing sliding groove in the shell; a compression spring is arranged between the shell and the side wing, the compression spring can apply continuous upward force to the side wing, and the adjusting block is always in contact with the inclined plane at the bottom of the speed regulating block under the action of the continuous upward force; the blood transfusion pipeline is positioned on the bottom surface of the interior of the shell;

when the speed regulation slider moves on the speed regulation sliding groove, the speed regulation block can be driven to move, the adjusting block is positioned at different positions of the bottom inclined plane of the speed regulation block, the distance between the bottom of the adjusting block and the bottom surface inside the shell is changed, and therefore the blood transfusion pipeline is pressed or loosened to adjust the opening degree of the blood transfusion pipeline.

12. The blood diversion system of claim 11, wherein:

the shape of the end surface of the adjusting block, which is in contact with the speed regulating block, is matched with the inclined surface at the bottom of the speed regulating block.

13. The blood diverting system of claim 1, wherein:

the filtering unit comprises a first end cover, a second end cover, a cylinder body and a filter screen bracket;

the first end cover and the second end cover are respectively and fixedly connected with the head end and the tail end of the barrel, and openings are formed in the first end cover and the second end cover.

14. The blood diversion system of claim 13, wherein:

and a sealing ring is arranged between the first end cover and the filter screen bracket in a butt joint manner.

15. The blood diversion system of claim 13, wherein:

the filtering unit further comprises an anti-backflow device, the anti-backflow device can control blood to flow in a single direction only, and the anti-backflow device is located between the second end cover and the tail end of the cylinder body.

16. The blood diverting system of claim 15, wherein:

the anti-backflow device is a duckbilled anti-backflow device.

17. The blood diversion system of claim 1, wherein:

and two ends of the diversion pipeline are respectively connected with the first vascular sheath module and the second vascular sheath module through quick change connectors.