WO2022237605A1

WO2022237605A1 - Delivery system

Info

Publication number: WO2022237605A1
Application number: PCT/CN2022/090795
Authority: WO
Inventors: 任静; 陈丽萍; 王永胜
Original assignee: 杭州德诺脑神经医疗科技有限公司
Priority date: 2021-05-10
Filing date: 2022-04-29
Publication date: 2022-11-17

Abstract

A delivery system, comprising a loader (3), a microcatheter (4), and a connector (5). The loader (3) is hollow and has a loading space, and the loading space is used for loading a shrunken blood flow guiding device (1). The microcatheter (4) is hollow and has a delivery space. The connector (5) connects the loader (3) and the microcatheter (4), such that the loading space is communicated with the delivery space to form a channel allowing for movement of the blood flow guiding device (1). The distal end of the connector (5) is sleeved on the proximal end of the microcatheter (4), and the proximal end of the connector (5) is sleeved on the periphery of the distal end of the loader (3). The connector (5) axially restrains the loader (3) and provides a support force, such that the loader (3) can be straightened as far as possible in the axial direction, thereby facilitating delivery of the blood flow guiding device (1) into the microcatheter (4), and thus improving the efficiency of the blood flow guiding device (1) reaching a lesion position.

Description

delivery system

This application claims the priority of the Chinese patent applications submitted to the State Intellectual Property Office of China with the application numbers 202110506351. The entire contents are incorporated by reference in this application.

technical field

This application relates to the technical field of medical devices, in particular to a delivery system.

Background technique

Intracranial aneurysm is a manifestation of localized or diffuse expansion or bulging of the arterial wall due to lesion or injury of the arterial wall. Limb trunk arteries, carotid arteries, and intracranial arteries are more common.

Endovascular interventional therapy is the main treatment method for intracranial aneurysms. One of the vascular interventional therapy methods is to place a blood flow guiding device at the hemangioma through a delivery system, thereby blocking the blood exchange between the hemangioma and the blood vessel. Currently, the delivery system provides a channel through a loader and a microcatheter, and a delivery guide wire is used to deliver the blood flow guiding device along the channel into the blood vessel. However, the proximal end of the loader is relatively soft and easy to bend, which makes it difficult for the blood flow guiding device to enter the microcatheter from the loader and difficult to operate.

technical problem

The purpose of this application is to provide an easy-to-operate delivery system to solve the problems in the prior art.

technical solution

In order to solve the above technical problems, this application adopts the following technical solutions: This application provides a delivery system, including: a loader, which is hollow inside and has a loading space, and the loading space is used to load the contracted blood flow guiding device; a conduit, the microcatheter is hollow inside and has a conveying space; a connector connects the loader and the microcatheter, and makes the loading space communicate with the conveying space to form a space for the blood flow guiding device to move channel; the distal end of the connector is sleeved on the proximal end of the microcatheter, and the proximal end of the connector is sleeved on the outer periphery of the distal end of the loader.

In some embodiments, the connector includes a main body, a branch, and a distal connector and a proximal connector respectively disposed at both ends of the main body; the lumen of the branch communicates with the lumen of the main body; The axial direction of the main body is parallel to the axial direction of the carrier; the proximal connector is connected to the distal end of the carrier and sleeved on the outer periphery of the carrier, the distal connector is connected to the micro The proximal end of the catheter is connected and sheathed on the outer periphery of the micro catheter, and the lumen of the main body communicates with the loading space and the delivery space at the same time, thereby forming a channel for the blood flow guiding device to move.

In some embodiments, the distal connector includes a mating joint and a distal connector; the distal connector is sheathed on the outer periphery of the main body, and the outer periphery of the distal connector is provided with external threads; The inner circumference of the matching joint is provided with an internal thread adapted to the external thread, so as to realize the screw connection between the matching joint and the distal connecting head; the proximal end of the microcatheter is inserted into the matching joint .

In some embodiments, the proximal connector includes: a proximal connector sleeved on the outer periphery of the main body; an end cap sleeved on the outer circumference of the proximal connector and connected to the proximal end The head is screwed to be able to rotate relative to the main body, and then move along the axial direction of the main body; the inner cylinder is arranged in the main body, and the proximal end of the inner cylinder is fixedly connected with the end cap, so that moves with the movement of the end cap; the elastic part is cylindrical and located in the main body; the distal end of the elastic part abuts against the inner peripheral wall of the main body to limit the movement of the elastic part to the distal end, The proximal end of the elastic part faces the distal end of the inner tube; the elastic part has elasticity so that it can shrink in the radial direction; When the distal end moves, the elastic portion is compressed to reduce its inner diameter, thereby clamping the cartridge protruding into the main body.

In some embodiments, the distal end of the end cap exceeds the distal end of the proximal connector, and the distal end of the end cap is provided with a limit ring; the limit ring is formed by the The end cap protrudes toward the main body; when the end cap moves toward the proximal end, the limiting ring can abut against the proximal connector to limit the movement of the end cap.

In some embodiments, the loader includes a loading cylinder and a plurality of collars sleeved on the outer periphery of the loading cylinder, and the plurality of collars are arranged at intervals along the axial direction of the loading cylinder.

In some embodiments, the blood flow guiding device includes a stent made of braided wires interlaced to form a network structure; the stent can shrink or expand along its radial direction.

In some embodiments, the radial compression ratio of the stent is 1/2˜1/10.

In some embodiments, the stent includes a proximal bell mouth, a connecting barrel and a distal bell mouth sequentially along its axial direction from the proximal end to the distal end; the diameter of the proximal bell mouth gradually increases from the distal end to the proximal end To make it trumpet-shaped, the diameter of the far-end flare gradually increases from the proximal end to the far-end to make it trumpet-shaped; the axial length of the proximal flare is greater than the axial length of the distal flare length.

In some embodiments, the axial length of the distal flare is 0.5 mm to 3 mm; the axial length of the proximal flare is 2 mm to 7 mm.

In some embodiments, the coverage of the proximal flare is greater than the coverage of the distal flare.

In some embodiments, the proximal flare is closed and the distal flare has an opening.

In some embodiments, the connecting cylinder includes a sparse mesh section and a dense mesh section sequentially connected from the far end to the proximal end; the coverage of the sparse mesh section is smaller than that of the dense mesh section.

In some embodiments, the coverage of the sparse network segment is 5% to 20%;

The coverage rate of the dense network segment is 20% to 60%.

In some embodiments, the blood flow guiding device further includes a polymer coating covering the surface of the stent; the polymer coating includes structural formula A and structural formula B, and the structural formula A is

; The structural formula B is

.

In some embodiments, the polymer coating has a thickness of 5-1000 nm.

In some embodiments, the delivery system further includes a delivery guide wire, the delivery guide wire is located in the blood flow directing device and pushes the blood flow directing device; the delivery guide wire includes: a mandrel; a pusher , fixedly sheathed on the outer periphery of the mandrel; the push member includes at least one pusher sleeve sheathed on the outer periphery of the mandrel and at least one push rod arranged on the outer periphery of the pusher, and the push rod is arranged along the outer periphery of the mandrel The mandrel radially protrudes from the outer periphery of the push cylinder, and extends into the mesh of the blood flow guiding device, thereby hooking the blood flow guiding device and driving the blood flow guiding device from the proximal end to the distal end. terminal moves.

In some embodiments, the push rod is elastic, and the push rod is straight in a natural state.

In some embodiments, a groove is provided on the side of the push rod facing the distal end, and the opening of the groove faces the distal end.

In some embodiments, the push rod has elasticity, and in a natural state, the push rod includes a rod body extending radially and a protruding part arranged on the rod body, and the protruding part is arranged on the rod body The side of the rod body faces the distal end, and is located at the end of the rod body away from the push cylinder.

In some embodiments, the push rod includes a radially extending rod body and an extension part provided on the rod body in a natural state, and the extension part extends along the axial direction of the push cylinder and is located on the distal end of the rod.

In some embodiments, a protruding portion protruding toward the pushing cylinder is further provided on the side of the extending portion facing the push cylinder, and the protruding portion is disposed at the distal end of the extending portion.

In some embodiments, the delivery guide wire further includes a retraction member; the retraction member is sheathed on the outer periphery of the mandrel and is located at the proximal end of the pusher member; the retraction member is connected to the pusher The pieces are arranged at intervals; the retraction element includes at least one retraction cylinder sleeved on the outer periphery of the mandrel and at least one retraction rod arranged on the outer periphery of each of the retraction cylinders, and the retraction rod is arranged along the outer periphery of the mandrel. The mandrel extends radially and can extend into the mesh of the blood flow guiding device, so as to hook the blood flow guiding device and drive the blood flow guiding device to move from the distal end to the proximal end.

In some embodiments, the retraction rod is elastic, and the retraction rod is straight in a natural state.

In some embodiments, the side of the retraction rod facing the proximal end is provided with a slot, and the opening of the slot faces the proximal end.

In some embodiments, the retraction rod is elastic, and in a natural state, the retraction rod includes a rod body extending radially and a protruding part arranged on the rod body, and the protruding part is arranged on The side of the rod body facing the proximal end is located at the end of the rod body away from the withdrawal cylinder.

In some embodiments, the retraction rod includes a radially extending rod body and an extension portion provided on the rod body in a natural state, and the extension portion extends along the axial direction of the retraction cylinder and is located at the proximal end of the rod.

In some embodiments, each of the extension parts is further provided with a protruding part protruding toward the direction of the retraction cylinder on the side facing the retraction cylinder, and the protruding part is arranged on the far side of the extension part. end.

In some embodiments, the material of the retraction rod is a material with a developing function.

In some embodiments, the mandrel includes a first part, a middle part and a second part in order from the proximal end to the distal end along its axial direction; the diameter of the first part is larger than the diameter of the second part, The diameter of the middle portion decreases from the proximal end to the distal end.

In some embodiments, the proximal end of the mandrel is provided with a push mark point; the length of the push mark point along the axial direction of the mandrel is 5-10 mm.

In some embodiments, the outer periphery of the mandrel is covered with a spring developing element capable of developing; the second developing element.

In some embodiments, at least one first guide groove is provided on the inner peripheral wall of the loader; the first guide groove extends along the axial direction of the loader; the push rod and the first guide groove Correspondingly, and the radial length of the push rod is greater than the radial depth of the first guide groove, so that the bent part of the push rod slides along the first guide groove.

In some embodiments, at least one second guide groove is provided on the inner peripheral wall of the microcatheter, the second guide groove extends along the axial direction of the microcatheter, and the second guide groove and the first A guide groove is provided correspondingly; the radial length of the push rod is greater than the radial depth of the second guide groove, so that the bent part of the push rod slides along the second guide groove.

Beneficial effect

It can be seen from the above technical solution that the present application has at least the following advantages and positive effects: the delivery system of the present application connects the microcatheter and the loader through a connector, and the distal end of the loader extends into the connector, and the proximal end of the microcatheter extends into the connector. inside the connector. The connector has axial constraints on the loader and provides support, so that the loader can be straightened as much as possible in the axial direction, which facilitates the delivery of the blood flow guiding device into the microcatheter, and then promotes the blood flow guiding device to reach the lesion s efficiency.

Further, both the proximal end and the distal end of the blood flow guiding device adopt a bell mouth structure, and the length of the proximal bell mouth is greater than the length of the distal bell mouth, and the coverage rate of the proximal bell mouth is greater than that of the distal end bell mouth, The sparse structure of the bell mouth at the distal end not only facilitates the loading of the blood flow guiding device into the loader, but also reduces the risk of blocking branch blood vessels. The dense structure of the proximal bell mouth provides large radial support force, and its compact structure. After it expands automatically and adheres to the wall of the blood vessel, the risk of a single braided wire being inserted into the blood vessel is small, thereby reducing risk of entrapment in blood vessels. Moreover, the weaving structure of the far-end bell mouth and the proximal-end bell mouth has a sparse and dense structure, so that the blood flow guiding device can provide effective supporting force at different blood vessel diameters on both sides of the aneurysm.

Further, the delivery guide wire of the present application passes through the mesh at the distal end of the blood flow guiding device through the push rod on the pushing member and bends toward the distal end to hook the blood flow guiding device. Therefore, when the guide wire is delivered toward the distal end, the anchoring force between the push rod and the blood flow guiding device is better, so that the blood flow guiding device can be effectively pushed to the distal blood vessel. Compared with using the friction force between the blood flow guiding device and the delivery guide wire to complete the push, the delivery guide wire can be more accurately delivered to the preset position because the delivery guide wire hooks the blood flow guiding device. At the same time, the contact area between the blood flow guiding device and the pushing member is reduced, and the wear of the blood flow guiding device is reduced.

Further, the delivery guide wire further includes a retracting part, which is used to retract the blood flow guiding device to the proximal end when adjusting the position of the blood flow guiding device. The retraction part also uses the method of hooking the blood flow guide device to drive the blood flow guide device to move. Therefore, the precision of retraction is high, and the contact area with the blood flow guide device is small, which reduces the wear of the blood flow guide device .

Description of drawings

Fig. 1 is a schematic structural diagram of the first embodiment of the delivery system of the present application.

Fig. 2 is a schematic structural diagram of the blood flow guiding device in the first embodiment of the delivery system of the present application.

Fig. 3 is a schematic diagram of the structure of the blood flow guiding device in Fig. 2 located at a vascular lesion.

Fig. 4 is a schematic structural diagram of the delivery guide wire in the first embodiment of the delivery system of the present application.

Fig. 5 is a schematic diagram of the structure of the delivery guide wire and the blood flow guiding device located in the loader in the first embodiment of the delivery system of the present application.

FIG. 6 is a sectional view of FIG. 5 .

FIG. 7 is a schematic diagram of the structure at point A in FIG. 6 .

Fig. 8 is a cross-sectional view of the first embodiment of the delivery system of the present application.

FIG. 9 is a schematic diagram of the structure at B in FIG. 8 .

FIG. 10 is a schematic diagram of the structure at point C in FIG. 8 .

Fig. 11 is a partial structural schematic diagram of the second embodiment of the delivery system of the present application.

FIG. 12 is a schematic diagram of the structure at D in FIG. 11 .

FIG. 13 is a schematic diagram of the structure at E in FIG. 11 .

Fig. 14 is a schematic structural diagram of the push piece in the second embodiment of the delivery system of the present application.

Fig. 15 is a schematic structural diagram of the push piece in the third embodiment of the delivery system of the present application.

Fig. 16 is a schematic structural diagram of the pushing piece in the fourth embodiment of the delivery system of the present application.

Fig. 17 is a structural schematic diagram of the pusher hooking the blood flow guiding device in the fourth embodiment of the delivery system of the present application.

Fig. 18 is a schematic diagram of the structure of the retracting member hooking the blood flow guiding device in the fourth embodiment of the delivery system of the present application.

Fig. 19 is a schematic structural view of the delivery guide wire in the fifth embodiment of the delivery system of the present application.

Fig. 20 is a schematic structural diagram of the retractable member in the fifth embodiment of the delivery system of the present application.

Fig. 21 is a schematic structural diagram of the pushing piece in the sixth embodiment of the delivery system of the present application.

Fig. 22 is a schematic structural diagram of the pushing piece in the sixth embodiment of the delivery system of the present application.

Fig. 23 is a schematic structural diagram of the pushing piece in the sixth embodiment of the delivery system of the present application.

Fig. 24 is a schematic structural diagram of the pushing piece in the sixth embodiment of the delivery system of the present application.

Fig. 25 is a schematic diagram of the partial structure of the eighth embodiment of the delivery system of the present application.

Reference numerals are explained below.

1. Blood flow guiding device; 11. Proximal bell mouth; 12. Distal bell mouth; 13. Connecting cylinder; 131. Sparse mesh segment; 132. Dense mesh segment; 16. Braided wire.

2. Convey guide wire; 21. Mandrel; 211. First part; 212. Middle part; 213. Second part; 221. First developing element; 222. Second developing element; 23. Push marking point; 24. Push piece; 241, push cylinder; 242, protruding part; 25, retraction piece.

3. Loader; 31. Loading cylinder; 32. Collar.

4. Microcatheter.

5, connector; 51, main body; 52, branch; 53, far-end connector; 531, far-end connector; 532, mating connector; 54, proximal connector; 541, proximal connector; 542, end cap ; 543, inner tube; 544, elastic part; 545, limit ring; 55, washer.

64. Push piece; 641. Push cylinder; 642. Push rod; 6421. Rod body; 6422. Extension; 6423. Protrusion; 643. Groove; Withdraw the rod; 6521, the rod; 6522, the extension.

71. Loading cylinder; 711. The first guide groove.

8. Blood vessels.

Embodiments of the present invention

Typical implementations embodying the features and advantages of the present application will be described in detail in the following description. It should be understood that the present application can have various changes in different embodiments without departing from the scope of the present application, and that the descriptions and illustrations therein are illustrative in nature and not limiting this application.

In this document, the terms "proximal" and "distal" refer to the relative orientation, relative position, direction of elements or actions relative to each other from the perspective of the operator using the medical device, although "proximal", " The term "distal" is not limiting, but "proximal" generally refers to the end of the medical device that is closer to the operator during normal operation, and "distal" generally refers to the end that first enters the patient.

The present application provides a delivery system suitable for treating intracranial aneurysms.

Referring to FIG. 1 and FIG. 2 , the delivery system includes a blood flow guiding device 1 , a delivery guide wire 2 , a loader 3 , a microcatheter 4 and a connector 5 . In this delivery system, the blood flow guiding device 1 is bound to the delivery guide wire 2 , and the blood flow guiding device 1 and the delivery guide wire 2 are preinstalled in the loader 3 together. During surgical delivery, the microcatheter 4 is first inserted into the diseased blood vessel, and then the loader 3 and the microcatheter 4 are connected through the connector 5, and the operator applies an axial force to the delivery guide wire 2, thereby binding the The blood flow guiding device 1 on the delivery guide wire 2 is transported from the loader 3 to the microcatheter 4 until the blood flow guiding device 1 is moved to the vascular lesion, and the reconstruction of the parent vessel is completed through the blood flow guiding device 1 , to achieve the treatment of intracranial aneurysms.

In this paper, the left side of each viewing direction is the distal end, and the right side is the proximal end.

The above structures of the delivery system will be described in detail below.

Referring to the structure shown in FIG. 2 , the blood flow guiding device 1 includes a stent in which braided wires 16 are braided interlaced to form a mesh structure. The stent can shrink in its radial direction or expand in its radial direction due to its own elastic action, that is, the stent is a self-expanding mesh structure.

Referring to FIG. 3 , it shows the structure in which the blood flow guiding device 1 is delivered to the lesion of the blood vessel 8 , so that the treatment can be realized through the reconstruction function of the blood flow guiding device 1 .

Since the blood flow guiding device 1 is formed by braiding with the braided wire 16, it has a plurality of mesh holes.

Specifically, the material of the braided wire 16 is at least one of biocompatible metal wire or polymer wire. That is to say, the blood flow guiding device 1 may be braided only by metal wires, or may be braided only by polymer wires, or may be jointly braided by metal wires and polymer wires.

Wherein, the braiding wire 16 can be braided in at least one of vertical or horizontal manners, which can be selected according to actual conditions.

The radial compression ratio of the blood flow guiding device 1 is 1/2-1/10, which can be loaded into the loader 3 or the microcatheter 4 after compression. In an exemplary embodiment, the compressed blood flow guiding device 1 can be loaded into a cartridge 3 or a microcatheter 4 with a diameter of 0.7 mm.

The blood flow guiding device 1 formed by braiding with braided wire 16 has high flexibility and flexibility, therefore, the blood flow guiding device 1 can be bent or twisted in space, and then the blood flow guiding device 1 can be released to After the blood vessel is inserted, it is closer to the shape of the natural blood vessel, which can conform to the tortuous cerebral blood vessel, and at the same time support the lumen shape of the blood vessel.

Continuing to refer to FIG. 2 , the blood flow guiding device 1 is roughly cylindrical, and includes a proximal bell mouth 11 , a connecting cylinder 13 and a distal bell mouth 12 arranged in sequence along its own axis and from the proximal end to the distal end.

The connecting cylinder 13 is cylindrical, and the diameters of the connecting cylinder 13 along the axial direction are the same.

Specifically, the connecting cylinder 13 includes a loose mesh section 131 and a dense mesh section 132 along its axial direction. Wherein, the sparse mesh section 131 is connected to the far-end bell mouth 12 , and the dense mesh section 132 is connected to the near-end bell mouth 11 .

The coverage rate of the sparse network segment 131 is smaller than the coverage rate of the dense network segment 132 . Herein, the coverage rate refers to the percentage of the part of the braided wire 16 covering the blood vessel to the blood vessel when the blood flow guiding device 1 is attached to the blood vessel wall.

In this embodiment, the coverage rate of the sparse network segment 131 is 5%-20%, and the coverage rate of the dense network segment 132 is 20%-60%.

In other embodiments, the connecting cylinder 13 may also have a uniform grid structure, that is, the coverage rate is uniform everywhere along its axial direction. Specifically, it may be set according to actual needs.

The proximal bell mouth 11 and the distal bell mouth 12 are arranged at both ends of the connecting cylinder 13 , and the proximal bell mouth 11 is connected to the proximal end of the connecting cylinder 13 , and the distal bell mouth 12 is connected to the far end of the connecting cylinder 13 .

The diameter of the proximal bell mouth 11 gradually increases from the distal end to the proximal end so that its structure is trumpet-shaped. The diameter of the distal bell mouth 12 gradually increases from the proximal end to the distal end so that its structure is trumpet-shaped.

The axial length L1 of the proximal bell mouth 11 is 2mm-7mm. The axial length L2 of the distal bell mouth 12 is 0.5mm-3mm. And the diameter of the far-end bell mouth 12 is smaller than the diameter of the proximal-end bell mouth 11 . With the above design, not only the blood flow guiding device 1 can match the diameters of blood vessels in different positions, but also the proximal end of the blood flow guiding device 1 can provide sufficient radial support force so that the blood flow guiding device 1 and the proximal end are thicker. The adherence of the blood vessel is better, and the excessive outer diameter of the distal end of the blood flow guiding device 1 causes excessive supporting force on the blood vessel, thereby reducing the damage to the blood vessel.

Specifically in this embodiment, the minimum diameter of the far-end flare 12 and the minimum diameter of the proximal flare 11 are equal to the diameter of the connecting cylinder 13, and the maximum diameter of the distal flare 12 is smaller than the maximum diameter of the proximal flare 11 .

Further, the distal bell mouth 12 is a closed-loop structure, and the proximal bell mouth 11 is an open-loop structure, that is, the distal end of the blood flow guiding device 1 is closed and the proximal end is open.

Compared with the mesh structure at the far-end bell mouth 12 and the near-end bell mouth 11, the far-end bell mouth 12 has a sparse structure, while the near-end bell mouth 11 has a dense structure. Among them, sparseness and density are relative concepts in this paper, that is, compared with the far-end bell mouth 12 and the near-end bell mouth 11 , the coverage rate of the near-end bell mouth 11 is greater than that of the far-end bell mouth 12 .

The sparse structure of the distal bell mouth 12 not only facilitates the loading of the blood flow guiding device 1 into the loader 3, but also reduces the risk of blocking the branch 52 blood vessels. The dense structure of the proximal bell mouth 11 provides large radial support on the one hand, and on the other hand, its compact structure, after it expands automatically and adheres to the wall of the blood vessel, the risk of a single braided wire 16 being inserted into the blood vessel is relatively small. Thereby reducing the risk of entrapment in blood vessels.

In addition, the weaving structure of the distal bell mouth 12 and the proximal bell mouth 11 is dense and dense, so that the blood flow guiding device 1 can provide effective supporting force at different vessel diameters on both sides of the aneurysm.

The delivery guide wire 2 is used to deliver the blood flow guiding device 1 to a predetermined position in the patient's body.

Please refer to the structure shown in FIG. 4 , the delivery guide wire 2 in this embodiment includes a mandrel 21 , a spring developing element, a pushing marking point 23 , a pushing piece 24 and a retracting piece 25 .

The mandrel 21 is used to push and support the blood flow guiding device 1 . Specifically, the mandrel 21 includes a first part 211 , a middle part 212 and a second part 213 arranged in sequence along its own axial direction from the proximal end to the distal end.

The first part 211 is columnar with a uniform diameter. Further, the diameter D1 of the first part 211 is 0.3-0.5 mm.

The second part 213 is columnar with a uniform diameter. The diameter D2 of the second part 213 is smaller than the diameter D1 of the first part 211 . Further, the diameter D2 of the second portion 213 is 0.1-0.25 mm.

The diameter of the middle portion 212 gradually decreases from the proximal end to the distal end. Moreover, the diameter of the proximal end of the middle part 212 is the same as that of the first part 211 , and the diameter of the distal end of the middle part 212 is the same as that of the second part 213 .

The mandrel 21 adopts the above design, so that the part of the mandrel 21 in the loader 3 used to deliver the blood flow guiding device 1 is thinner, so that it has sufficient flexibility when entering the inside of the blood vessel, avoiding damage to the blood vessel, and ensuring that it is located in the blood vessel. The mandrel 21 on the outside of the loader 3 is relatively thick so as to provide sufficient pushing force.

The material of the mandrel 21 can be at least one of stainless steel, nickel-titanium alloy, copper alloy or aluminum alloy. That is, the mandrel 21 can be ground from any one of the above materials, and can also be bonded or welded from any two of the above materials.

The spring developing element is covered on the mandrel 21 for developing, so as to display the position of the blood flow catheter device in the blood vessel.

Specifically, the spring developing element includes a first developing element 221 and a second developing element 222 arranged at intervals along the axial direction of the core shaft 21 . Wherein, the first developing element 221 is disposed at the distal end of the core shaft 21 . The second developing element 222 is disposed at the middle portion 212 of the core shaft 21 .

The material of the spring developing element is a developing material, such as platinum or platinum iridium.

The pushing marking point 23 is arranged on the proximal end of the mandrel 21, and is used to remind the operator. Specifically, the pushing marking point 23 is set at a distance of 240-280 mm from the proximal end of the mandrel 21 . And the length of the mark of the pushing mark point 23 is 5-10 mm. Herein, along the axial direction of the mandrel 21 , the length of the pushing marking point 23 itself is the marking length.

Wherein, the pushing marking point 23 can be shaped by grinding or engraving the mandrel 21 .

The principle of use of the push marker point 23 is as follows: when the push marker point 23 reaches the proximal end of the blood flow guiding device 1 , the function of the push marker point 23 at this time is to remind the operator that there is only one time left before the release of the blood flow guiding device 1 . 100~20mm, at this time, the loader 3 and the connector 5 can be withdrawn, and start to push slowly. When the push marker point 23 starts to enter the microcatheter 4 and the blood flow guiding device 1 is about to be pushed out of the microcatheter 4 for release, the function of the push marker point 23 at this time reminds the operator that the microcatheter 4 can be withdrawn slowly for blood flow control. Release operation of guide 1.

The pusher 24 is disposed on the outer periphery of the core shaft 21 . Specifically, the pushing member 24 is located at the distal end of the mandrel 21 to provide a pushing force for delivering the blood flow guiding device 1 .

The push member 24 includes a push cylinder 241 and a plurality of protrusions 242 disposed on the outer periphery of the push cylinder 241 .

The pushing cylinder 241 is sheathed on the outer periphery of the mandrel 21 and fixedly connected with the mandrel 21 . Specifically, the pushing cylinder 241 is fixed on the outer periphery of the mandrel 21 by fusion or bonding.

In this embodiment, a plurality of protrusions 242 are arranged at intervals along the axial direction and the circumferential direction of the pushing cylinder 241 . That is, a plurality of protrusions 242 are arranged at intervals along the same circumferential direction, and form a group. The plurality of sets of protruding portions 242 are arranged at intervals along the axial direction.

The protruding portion 242 protrudes from the outer periphery of the pushing cylinder 241 along the radial direction of the core shaft 21 . The protruding part 242 is inserted into the mesh of the blood flow guiding device 1 to drive the blood flow guiding device 1 to move from the proximal end to the distal end.

The retracting member 25 is used to drive the blood flow guiding device 1 to move from the distal end to the proximal end, and then can be used to adjust the release position of the blood flow guiding device 1 in the blood vessel.

The retracting member 25 is disposed on the outer periphery of the mandrel 21 and spaced from the pushing member 24 , and the retracting member 25 is located at the proximal end of the pushing member 24 .

Specifically, in this embodiment, the retracting member 25 is cylindrical.

The retracting member 25 is sheathed on the outer periphery of the mandrel 21 and is fixedly connected with the mandrel 21 . Specifically, the retracting member 25 is fixed on the outer periphery of the mandrel 21 by fusion or bonding.

The retractable part 25 has a Shore hardness of 20-50 degrees and a diameter of 0.4-0.6 mm, so that it can be bent freely in a curved blood vessel.

Wherein, the retracting member 25 also has a developing function.

The loader 3 is cylindrical and has a hollow interior with a loading space. The loading space is used for loading the blood flow guiding device 1 and the delivery guide wire 2 . Referring to the structure shown in FIG. 5 , FIG. 6 and FIG. 7 , the delivery guide wire 2 and the blood flow guiding device 1 are pre-installed in the loader 3 .

The loader 3 is made of transparent material, so that the operator can observe the condition of the blood flow guiding device 1 in the loading space, and clearly observe when the blood flow guiding device 1 is transported into the microcatheter 4 .

Referring to FIG. 5 , the loader 3 includes a loading cylinder 31 and a plurality of collars 32 sleeved on the outer periphery of the loading cylinder 31 , and the plurality of collars 32 are arranged at intervals along the axial direction of the loading cylinder 31 .

The loading cylinder 31 includes an inner layer, a middle layer and an outer layer sequentially from inside to outside along its own radial direction.

The friction coefficient of the inner layer is low, and its material is polytetrafluoroethylene (PTFE for short), high density polyethylene (High Density Polyethylene, HDPE for short) or perfluoroethylene propylene copolymer (Fluorinated ethylene propylene, referred to as FEP).

The material of the middle layer is polyether block polyamide (trade name determined by French ATOFINA company for its block polyether amide resin product, Pebax) or thermoplastic polyurethane elastomer rubber (Thermoplastic polyurethanes, referred to as TPU).

The material of the outer layer is perfluoroethylene propylene copolymer (Fluorinated ethylene propylene, referred to as FEP).

The above-mentioned inner layer, middle layer and outer layer are thermally fused to obtain the loading cylinder 31 .

Referring to FIG. 5 and FIG. 6 , the proximal end of the loading cylinder 31 is a trumpet port, and its diameter gradually increases from the distal end to the proximal end. Adopting the above-mentioned structure facilitates the entry of the blood flow guiding device 1 into the loading space from the proximal end, that is, it facilitates the pre-installation of the blood flow guiding device 1 .

Specifically, the number of collars 32 is greater than or equal to four, that is, at least four collars 32 are required. The collar 32 is sleeved on the outer periphery of the loading cylinder 31, and protrudes radially outwards from the outer periphery of the loading cylinder 31, so that the collar 32 and the outer periphery of the loading cylinder 31 form a stepped structure, and the stepped structure can be transported in the blood flow guiding device 1. The frictional force is provided to ensure sufficient pushing force, and the stepped structure can also locate the axial position of the loading cylinder 31 and the connector 5 .

The collar 32 is fixedly connected to the loading cylinder 31 through fusion or bonding.

Continuing to refer to FIG. 1 , the microcatheter 4 is disposed at the distal end of the loader 3 . The microcatheter 4 is hollow inside and has a delivery space, and the delivery space communicates with the loading space to form a channel for the blood flow guiding device 1 to move, so that the blood flow guiding device 1 can move into the blood vessel.

The connector 5 is used to connect the loader 3 and the microcatheter 4. Therefore, the connector 5 provides a certain support for the loader 3, so that the loader 3 can be straightened as far as possible in the axial direction, and then the blood flow can be smoothly guided to the device 1. Push it into the microcatheter 4.

Referring to FIG. 8 , the connector 5 includes a main body 51 , a branch 52 , a distal connecting piece 53 and a proximal connecting piece 54 .

The axial direction of the main body 51 is parallel to the axial direction of the cartridge 3 , and the interior of the main body 51 is hollow and has a cavity.

The branch 52 is obliquely disposed on the outer periphery of the main body 51 , and the inner cavity of the branch 52 communicates with the inner cavity of the main body 51 . Specifically, the branch 52 and the main body 51 have a Y shape as a whole, that is, the connector 5 has a Y shape as a whole. The other end of the branch 52 opposite to the main body 51 is provided with an opening, and the opening communicates with the inner cavity of the branch 52 for connecting with other devices.

Referring to FIG. 9 , the distal connector 53 includes a distal connector 531 and a mating connector 532 .

The distal connector 531 is sheathed on the outer periphery of the distal end of the main body 51 and protrudes from the main body 51 toward the distal end.

An internal thread is provided on the inner peripheral wall of the part of the distal end of the distal connecting head 531 that exceeds the main body 51 .

The upper ring of the outer peripheral wall of the matching joint 532 is provided with external threads, and the external threads are adapted to the internal threads of the distal connecting head 531 to realize the screw connection between the matching joint 532 and the distal connecting head 531 .

The mating joint 532 is used for inserting into the microcatheter 4 , that is, the mating joint 532 is sheathed on the outer periphery of the proximal end of the microcatheter 4 , so as to realize the connection between the connector 5 and the microcatheter 4 . Specifically, the microcatheter 4 protrudes into the mating joint 532 .

Further, a washer 55 is provided between the distal end of the main body 51 and the inner peripheral wall of the distal connecting member 53 .

Referring to FIG. 10 , the proximal connector 54 includes a proximal connector 541 , an end cap 542 , an inner cylinder 543 and an elastic portion 544 .

The proximal connector 541 is fixedly sleeved on the outer periphery of the distal end of the main body 51 . The outer peripheral ring of the proximal connection head 541 is provided with external threads.

The end cap 542 is sleeved on the outer periphery of the proximal connector 541 . The inner circumference of the end cap 542 is provided with internal threads, and the internal threads of the end cap 542 are adapted to the external threads of the proximal connector 541 , so that the end cap 542 and the proximal connector 541 are screwed together. Since the end cap 542 is screwed to the proximal connector 541 , when the end cap 542 rotates around the connector, the end cap 542 can move axially relative to the main body 51 .

The distal end of the end cap 542 is beyond the distal end of the proximal connector 541 , and a limiting ring 545 is disposed on the distal end of the end cap 542 . The stop ring 545 extends from the end cover 542 to the main body 51, so when the end cover 542 moves proximally, the stop ring 545 can abut against the proximal connector 541 to limit the movement of the end cover 542 to the proximal end, Prevent the end cap 542 from coming off the proximal connector 541 .

The inner barrel 543 is located in the cavity of the main body 51 . The proximal end of the inner cylinder 543 is fixedly connected with the proximal end of the end cap 542 . Therefore, the inner cylinder 543 can move along with the movement of the end cap 542 . For example, when the end cap 542 moves from the proximal end to the distal end due to rotation, the inner cylinder 543 also moves from the proximal end to the distal end.

The elastic portion 544 is cylindrical and located in the cavity of the main body 51 . The elastic portion 544 is located at the distal end of the inner cylinder 543 and abuts against the distal end of the inner cylinder 543 .

Specifically, a retaining ring protrudes inward from the inner peripheral wall of the main body 51 . The proximal end of the elastic portion 544 abuts against the retaining ring, thereby limiting the movement of the elastic ring in the main body 51 to the distal end.

The elastic portion 544 has elasticity and can shrink in the radial direction, so as to reduce or restore its inner diameter. When the inner tube 543 moves to abut against the elastic portion 544 and compresses the elastic portion 544 , the inner diameter of the elastic portion 544 shrinks. When the inner cylinder 543 retreats toward the proximal end to release the compression of the inner cylinder 543 on the elastic portion 544 , the elastic portion 544 is elastically restored by itself.

Wherein, the material of the elastic part 544 can be various rubbers such as silicone rubber, fluororubber, isoprene, natural rubber, etc., or various materials such as polyurethane, polyamide elastomer, polybutadiene, soft vinyl chloride, etc. One kind of resin can also be a mixture obtained by combining the above two materials.

When the proximal connector 54 is connected to the distal end of the loader 3, the loader 3 extends into the inner cylinder 543, and by rotating the end cap 542, the inner cylinder 543 is moved to the distal end, and then the elastic part 544 is compressed, so that the elastic part 544 Retract, and then clamp the loader 3. At this time, the elastic portion 544 is located between two adjacent collars 32 , and the elastic portion 544 is sleeved on the outer periphery of the loading cylinder 31 . The elastic portion 544 located between two adjacent collars 32 can prevent the loader 3 from being detached from the connector 5 due to excessive force, thereby ensuring the connection between the connector 5 and the loader 3 .

The delivery system in this embodiment connects the microcatheter 4 and the loader 3 through the connector 5, the distal end of the loader 3 extends into the connector 5, and the connector 5 has an axial constraint on the loader 3 and provides a supporting force , to make the loader 3 as straight as possible in the axial direction, so as to facilitate the delivery of the blood flow guiding device 1 into the microcatheter 4 .

The method of use of the delivery system in this example is as follows.

S1. The blood flow guiding device 1 is shrunk and bound to the delivery guide wire 2, and the two are pre-installed in the loader 3 together.

Specifically, the blood flow guiding device 1 is sheathed on the outer periphery of the delivery guide wire 2 , and is installed in the loading space of the loader 3 after being shrunk.

S2. Inserting the microcatheter 4 into the diseased blood vessel.

Specifically, the microcatheter 4 is delivered into the blood vessel through the surgical wound.

S3 , connecting the loader 3 equipped with the blood flow guiding device 1 and the delivery guide wire 2 with the microcatheter 4 through the connector 5 .

Specifically, the loader 3 is connected to the connector 5 first, and then the connector 5 is connected to the microcatheter 4 .

S4 , the operator applies an axial force to the delivery guide wire 2 , so as to transport the blood flow guiding device 1 bound on the delivery guide wire 2 from the loader 3 to the microcatheter 4 .

Specifically, the operator holds the collar 32 of the loader 3 with one hand, and applies an axial force to the delivery guide wire 2 with the other hand, and the direction of the force is from the proximal end to the distal end, so that the blood flow guiding device 1 is loaded. The loading space of the device 3 is moved to the delivery space of the microcatheter 4, and finally the microcatheter 4 enters the blood vessel, and the blood flow guiding device 1 reconstructs the parent vessel to realize the treatment of the intracranial aneurysm.

When the blood flow guiding device 1 is not released in place and the position of the blood flow guiding device 1 needs to be adjusted, the following steps are also included.

S5. When the blood flow guiding device 1 is not released in place and the position of the blood flow guiding device 1 needs to be adjusted, the operator applies an axial force to the delivery guide wire 2 to withdraw the blood flow guiding device 1 .

Specifically, the operator applies a force from the distal end to the proximal end, thereby driving the blood flow guiding device 1 to retreat into the microcatheter 4 .

S6. Adjust the position of the microcatheter 4 in the blood vessel.

Specifically, the microcatheter 4 is precisely positioned near the vascular aneurysm.

S7. Continue to push the delivery guide wire 2, so that the blood flow guiding device 1 enters the blood vessel from the microcatheter 4, and release the blood flow guiding device 1 again.

Specifically, after the blood flow guiding device 1 is released, the connector 5 and the loader 3 are removed.

Delivery system second embodiment.

Referring to the structures shown in Fig. 11, Fig. 12, Fig. 13 and Fig. 14, the difference between this embodiment and the first embodiment of the delivery system is that: referring to Fig. A plurality of push rods 642 on the periphery of the barrel 641.

In this embodiment, multiple sets of push rods 642 are arranged at intervals along the axial direction of the push cylinder 641 , and each set of push rods 642 includes a plurality of push rods 642 arranged at intervals along the circumferential direction of the push cylinder 641 . In other embodiments, only one set of push rods 642 may be provided along the axial direction of the push cylinder 641 , and the set of push rods 642 may be provided with a plurality of push rods 642 at intervals along the circumferential direction. It is also possible to arrange multiple sets of push rods 642 at intervals along the axial direction of the push cylinder 641 , and only one push rod 642 is set in each set of push rods 642 . It is also possible to arrange multiple sets of push rods 642 at intervals along the axial direction of the push cylinder 641 , and the number of push rods 642 in each set of push rods 642 is selected according to actual conditions. It is also possible that only one push rod 642 is provided on the outer periphery of the push cylinder 641 . The details can be set according to the actual situation.

The push rod 642 protrudes from the outer periphery of the push cylinder 641 along the radial direction of the core shaft. In this embodiment, the push rod 642 has a shape memory function and is elastic and can be inserted into the mesh of the blood flow guiding device 1, so as to hook the blood flow guiding device 1 and drive the blood flow guiding device 1 from the proximal end to the distal end. move. In other embodiments, the push rod 642 may not have elasticity.

In this embodiment, the push rod 642 is straight in a natural state. That is, the push rod 642 extends radially of the mandrel in a natural state.

The push rod 642 is made of nickel-titanium alloy. Nickel-titanium alloy is a shape memory alloy, which is a special alloy that can automatically restore its own plastic deformation to its original shape at a certain temperature, and has good plasticity.

11 and 12, the pushing principle of the pusher 64 is as follows: when the delivery guide wire and the blood flow guiding device 1 are preloaded into the loader, the push rod 642 on the pushing member 64 passes through the distal end of the blood flow guiding device 1 The mesh is bent and extended toward the distal end to hook the blood flow guiding device 1 . Therefore, when the guide wire is delivered toward the distal end, the anchoring force between the push rod 642 and the blood flow guiding device 1 is better, so that the blood flow guiding device 1 can be effectively pushed to the distal blood vessel. Compared with using the frictional force between the blood flow guiding device 1 and the delivery guide wire to complete the push, the delivery guide wire hooks the blood flow guiding device 1 , so it can be delivered to the preset position more accurately. At the same time, the contact area between the blood flow guiding device 1 and the pushing member 64 is reduced, and the wear of the blood flow guiding device 1 is reduced.

The retracting member 65 is used to drive the blood flow guiding device 1 to move from the distal end to the proximal end, and then can be used to adjust the release position of the stent in the blood vessel.

Specifically, the retracting member 65 includes a retracting cylinder 651 and a plurality of retracting rods 652 disposed on the outer periphery of the retracting cylinder 651 .

The withdrawal cylinder 651 is sheathed on the outer periphery of the mandrel and fixedly connected with the mandrel. Specifically, the withdrawal cylinder 651 is fixed on the outer periphery of the mandrel by fusion or bonding.

In this embodiment, multiple sets of retraction rods 652 are arranged at intervals along the axial direction of the retraction cylinder 651 , and each set of retraction rods 652 includes a plurality of retraction rods 652 arranged at intervals along the circumferential direction of the retraction cylinder 651 . In other embodiments, only one set of retraction rods 652 may be provided along the axial direction of the retraction cylinder 651, and the group of retraction rods 652 may be provided with a plurality of retraction rods 652 at intervals along the circumferential direction. It is also possible that multiple sets of retraction rods 652 are arranged at intervals along the axial direction of the retraction cylinder 651 , and only one retraction rod 652 is provided in each group of retraction rods 652 . It is also possible to arrange multiple groups of retraction rods 652 at intervals along the axial direction of the retraction cylinder 651, and the number of retraction rods 652 in each group of retraction rods 652 is selected according to the actual situation. It is also possible that only one retraction rod 652 is provided on the outer periphery of the retraction cylinder 651 . The details can be set according to the actual situation.

The retracting rod 652 protrudes out of the outer periphery of the retracting cylinder 651 along the radial direction of the mandrel. In this embodiment, the retraction rod 652 has a shape memory function and is elastic and can be inserted into the grid hole of the blood flow guiding device 1, so as to hook the blood flow guiding device 1 and drive the blood flow guiding device 1 from the proximal end to the remote movement. In other embodiments, the retraction rod 652 may not have elasticity.

In this embodiment, the retraction rod 652 is straight in a natural state. That is, the retraction rod 652 extends radially of the mandrel in a natural state.

When readjusting the blood flow guiding device 1 and withdrawing the delivery guide wire, the released part of the blood flow guiding device 1 is constricted at the distal end of the microcatheter 4 and part of the mesh is passed through by the push rod 642 of the pushing member 64 one by one. Continuing to withdraw the delivery guide wire, the retraction rod 652 of the retraction member 65 is limited by the inner diameter of the microcatheter 4 and bends to form a hook to retract into the microcatheter 4 in a posture of hooking the blood flow guiding device 1 .

The retracting rod 652 is made of a material with a developing function. Specifically, the retraction rod 652 is made of thermoplastic polyurethane elastomer rubber, block polyetheramide resin or silicone.

Referring to Figure 11 and Figure 13, the adjustment principle of the retraction member 65 to the position of the blood flow guiding device 1 is as follows: when the delivery guide wire and the blood flow guiding device 1 are preloaded into the loader, the retracting rod on the retracting member 65 652 passes through the mesh at the proximal end of the blood flow guiding device 1 and bends toward the proximal end to hook the blood flow guiding device 1 . When the blood flow guiding device 1 is partially released in the blood vessel, if it is not fully released and the release position of the blood flow guiding device 1 in the blood vessel needs to be readjusted, the delivery guide wire can be withdrawn. At this time, the delivery guide wire is withdrawn from the distal end to the proximal end, and the proximal end of the blood flow guiding device 1 is hooked by the retracting member 65 to withdraw the blood flow guiding device 1 into the microcatheter 4, and the microcatheter 4 is adjusted to The position in the blood vessel is accurately positioned near the vascular aneurysm, and then the blood flow guiding device 1 is released from the microcatheter 4 again. The contact area between the blood flow guiding device 1 and the retracting member 65 is reduced, and the wear of the blood flow guiding device 1 is reduced.

Compared with driving the blood flow guiding device 1 by friction, the delivery guidewire in this embodiment uses the pusher 64 to hook the blood flow guiding device 1 to drive the blood flow guiding device 1 to move. Therefore, during the whole delivery process , which can accurately locate the delivery position of the blood flow guiding device 1 . The delivery guide wire of the present application also reduces the contact area between the blood flow guiding device 1 and the pushing member 64 , reducing wear of the blood flow guiding device 1 .

Moreover, the delivery guide wire in this embodiment further includes a withdrawal member 65 for withdrawing the blood flow guiding device 1 to the proximal end when adjusting the position thereof. The retracting member 65 also uses the method of hooking the blood flow guiding device 1 to drive the blood flow guiding device 1 to move. Therefore, the precision of retraction is high, and the contact area with the blood flow guiding device 1 is small, which reduces the blood flow. Wear of guide 1.

Other features of the delivery system in this embodiment can refer to the first embodiment, and will not be described in detail again.

Delivery system third embodiment.

Referring to FIG. 15 , the difference between this embodiment and the second embodiment of the delivery system is that the push rod 642 of the push member 64 includes a rod body 6421 and an extension part 6422 in a natural state. In this embodiment, the push rod 642 is elastic. In other embodiments, the push rod 642 may not have elasticity.

The rod body 6421 extends radially. That is, one end of the rod body 6421 is connected to the push tube 641 , and the other end extends radially so that the rod body 6421 protrudes from the outer periphery of the push tube 641 .

The extension part 6422 is disposed at the other end of the rod body 6421 relative to the pushing cylinder 641 , and extends distally along the axial direction of the pushing cylinder 641 . That is, the extension part 6422 is located at the distal end of the rod body 6421 .

Specifically, the outer circumference of the push cylinder 641, the rod body 6421 and the extension 6422 jointly form a slot, and the braided wire 16 of the blood flow guiding device 1 is located in the slot, so that the pushing piece 64 hooks the blood flow guiding device 1, therefore, When the delivery guide wire moves from the proximal end to the distal end, the pushing member 64 drives the blood flow guiding device 1 to move to the distal end.

After the blood flow guiding device 1 is released, it stretches due to its self-expandability, so that the braided wire 16 is disengaged from the slot, that is, the pushing member 64 no longer hooks the blood flow guiding device 1 .

The retraction rod of the retraction member of the delivery guidewire comprises a shaft portion and an extension portion in a natural state.

The rod body extends radially. That is, one end of the rod body is connected to the retraction cylinder, and the other end extends radially so that the rod body protrudes from the outer periphery of the retraction cylinder.

The extension part is arranged at the other end of the rod body relative to the withdrawal cylinder, and extends toward the proximal end along the axial direction of the withdrawal cylinder. That is, the extension portion is located at the proximal end of the rod body.

Specifically, the outer circumference of the retraction cylinder, the rod body and the extension form a slot, and the braided wire 16 of the blood flow guiding device 1 is located in the slot, so that the retracting part hooks the blood flow guiding device 1. Therefore, when the delivery guide When the wire moves from the distal end to the proximal end, the retracting member drives the blood flow guiding device 1 to move toward the proximal end.

Other features of the delivery system in this embodiment can refer to the second embodiment, and will not be described in detail.

Delivery system fourth embodiment.

Referring to the structures shown in Figure 16, Figure 17 and Figure 18, the difference between this embodiment and the third embodiment of the delivery system is that: Referring to Figure 16, the push rod 642 of the push piece 64 includes a rod body 6421 and a protrusion in a natural state 6423.

The rod body 6421 extends radially of the pushing cylinder 641 in a natural state.

The protruding portion 6423 is disposed on the side of the rod body 6421 facing the distal end, and protrudes toward the distal end. And the protruding portion 6423 is disposed on the other end of the rod body 6421 opposite to the push tube 641 .

Referring to Fig. 17, when the delivery guide wire and the blood flow guiding device 1 are located in the loader 3, the end of the rod body 6421 away from the pushing cylinder 6411 is bent to the distal end, and the protruding part 6423 passes through the mesh of the blood flow guiding device 1, and The braided wire 16 of the blood flow guiding device 1 is clamped, and the protruding part 6423 can further provide pushing force through engagement. And the protrusion 6423 can also prevent the braided wire 16 from detaching from the pusher 64 .

The retraction rod 652 includes a rod body 6521 and a protrusion 6523 in a natural state.

The rod body 6521 extends radially of the retraction barrel 651 in a natural state.

The protruding portion 6523 is disposed on the proximal side of the rod body 6521 and protrudes toward the proximal direction. And the protruding portion 6523 is disposed on the other end of the rod body 6521 relative to the retracting cylinder 651 .

Referring to Fig. 18, when the delivery guide wire and the blood flow guiding device 1 are located in the loader 3, the end of the rod body 6521 away from the withdrawal cylinder 651 is bent toward the proximal end, and the protruding part 6523 passes through the mesh of the blood flow guiding device 1, And hold the braided wire 16 of the blood flow guiding device 1, and the protruding part 6523 can further provide a retraction force through engagement. And the protruding portion can also prevent the braided wire 16 from breaking away from the retraction member.

Other features of the delivery system in this embodiment can refer to the third embodiment and will not be described in detail.

Delivery system fifth embodiment.

Referring to the structure shown in Fig. 19 and Fig. 20, the difference between this embodiment and the fourth embodiment of the delivery system is: referring to Fig. 20, the retraction rod 652 includes a rod body 6521, an extension part 6522 and a protruding part 6523 in a natural state.

In this embodiment, the retraction rod 652 is elastic. In other embodiments, the retraction rod 652 may not have elasticity.

The extension part 6522 is disposed at the other end of the rod body 6521 relative to the withdrawal cylinder 651 , and extends proximally along the axial direction of the withdrawal cylinder 651 . That is, the extension part 6522 is located at the proximal end of the rod body 6521 .

The protruding portion 6523 is disposed on the side of the extension portion 6522 facing the retraction cylinder 651 , and protrudes toward the direction close to the retraction cylinder 651 .

Referring to Fig. 18, when the delivery guide wire and the blood flow guiding device 1 are located in the loader 3, the extension part 6522 and the protruding part 6523 pass through the mesh of the blood flow guiding device 1, and the protruding part 6523 catches the blood flow guiding device 1 The braided wire 16 of the device 1 and the protruding part 6523 can further provide retraction force by engaging. The protrusion 6523 can also prevent the braided wire 16 from breaking away from the retractor 65 .

The pusher 64 of the delivery guide wire in this embodiment can refer to the fourth embodiment, other features of the delivery guide wire such as the structure of the mandrel 61, the first developing element 621, the second developing element 622 and the push marking point 63 can all be referred to The fourth embodiment will not be described in detail.

Delivery system sixth embodiment.

Referring to the structures shown in Fig. 21, Fig. 22, Fig. 23 and Fig. 24, the difference between this embodiment and the second embodiment of the delivery system is that the push rod 642 of the push piece is also provided with a groove 643 on the side facing the distal end . The groove 643 opens toward the distal end.

The shape of the groove 643 can be arc or square. Exemplarily, as shown in FIG. 21 and FIG. 23 , the groove 643 is arc-shaped. As shown in FIG. 22 and FIG. 24 , the shape of the groove 643 is square.

The groove 643 can start from the end or from the middle. Exemplarily, as shown in FIG. 21 and FIG. 22 , when the push member opens the groove 643 , it is opened from one end to the other end. As shown in FIG. 23 and FIG. 24 , when the push piece is provided with a groove 643 , it extends from the middle area of the push piece to the other end, and the end position is also in the middle area.

The setting of the groove 643 makes it easy for the push rod 642 to bend toward the distal end, but not easy to bend toward the proximal end, thereby making it difficult for the push rod 642 to disengage from the mesh of the blood flow guiding device 1, thereby ensuring the anchoring force of the push rod 642 .

Delivery system seventh embodiment.

The difference between this embodiment and the second embodiment of the delivery system is that: the retracting rod of the retracting member is also provided with a groove on the side facing the proximal end. The opening of the groove is towards the proximal end.

Wherein, the shape of the groove can be arc or square.

The groove can start from the end or from the middle.

The setting of the groove makes it easy for the retraction rod to bend toward the proximal end, but not easy to bend toward the distal end, thereby making it difficult for the retraction rod to disengage from the mesh of the blood flow guiding device 1 and ensuring the anchoring force of the retraction rod.

Eighth embodiment of the delivery system.

Referring to the structure shown in FIG. 25 , the difference between this embodiment and the second embodiment of the delivery system is that: the inner circumference of the loading cylinder 71 is provided with a plurality of first guide grooves 711 . A plurality of first guide grooves 711 are arranged at intervals along the circumference of the loading cylinder 71 , and are arranged in one-to-one correspondence with the push rods 642 located on the outer periphery of the push cylinder 641 .

Specifically, the first guiding groove 711 extends along the axial direction of the loading cylinder 71 , that is, the first guiding groove 711 runs through the proximal end and the distal end of the loading cylinder 71 .

The depth of the first guide groove 711 along the radial direction of the loading cylinder 71 is smaller than the length of the push rod 642 along the radial direction, so that after the push rod 642 is bent, the push rod 642 still partially contacts the blood flow guiding device 1 . After the push rod 642 is bent, a part is located in the first guide groove 711 and slides in the first guide groove 711 to ensure that the curved part does not change its bending direction when sliding, that is, to ensure that the push rod 642 is bent toward the distal end.

Moreover, the setting of the first guide groove 711 also reduces the contact area between the blood flow guiding device 1 and the loader, reduces friction, and facilitates the delivery of the guide wire to the blood flow guiding device 1 .

The inner circumference of the micro-catheter 4 is provided with a plurality of second guide grooves. A plurality of second guide grooves are arranged at intervals along the circumference of the microcatheter 4 , and are arranged in one-to-one correspondence with the first guide grooves 711 .

The structure of the second guide groove can refer to the structure of the first guide groove 711 , which will not be repeated here.

Ninth embodiment of the delivery system.

The difference between this embodiment and the first embodiment of the delivery system is that the blood flow guiding device in this embodiment further includes a polymer coating covering the surface of the stent.

The polymer coating is insoluble in water and is not easy to degrade, so after the blood flow guiding device enters the blood vessel, the polymer coating on the surface of the stent will not be washed away by blood.

Moreover, the polymer coating has a certain degree of firmness, and the polymer coating will not dissolve, be damaged, or fall off in simulated body fluids for at least two weeks. Therefore, after the blood flow diversion device is implanted in the human body, it can continue to play an anticoagulant effect and reduce the risk of thrombosis before endothelialization. The specific in vitro evaluation method is: put the blood flow guiding device, that is, the stent covered with polymer coating, into a certain volume of PBS solution, so that the blood flow guiding device is completely submerged, and put it in a water bath shaker at 37°C, 100r/min After shaking, after 14 days, the samples were taken out to observe the polymer coating on the surface of the stent.

Wherein, the thickness of the polymer coating is 5-1000nm. Further, the thickness of the polymer coating is 10-100 nm. The thinner the thickness of the polymer coating, the smaller the particles that are shed during use, and the smaller the risk of causing blood clots.

The material of the polymer coating is a polymer, and the structural formula of the polymer includes structural formula A and structural formula B.

Wherein, structural formula A is:

.

Structural formula B is:

.

The functional group -Si-O-Si- in the structural formula A is mainly formed by a chemical reaction after the polymer solution is coated on the surface of the stent, which acts as a curing effect, making the polymer coating itself firm and tightly adhered to the stent.

The functional group in the structural formula B mainly plays an anticoagulant effect.

Among them, the anticoagulant effect of the blood flow guiding device can be evaluated in vitro. The details are as follows: take fresh pig blood, add a certain amount of heparin, then soak the blood flow guiding device, that is, the stent covered with polymer coating, in the blood for 1 hour, then take it out, and observe the thrombus on the surface of the blood flow guiding device.

The preparation method of the above-mentioned polymer coating includes the following steps.

S1. Dissolving the polymer raw material with a solvent to obtain a coating solution.

S2. Activate the surface of the stent so that more hydroxyl groups (-OH) are formed on the surface of the stent.

S3. Coating the coating solution on the surface of the stent.

S4. Place the stent coated with the coating solution in an environment containing moisture, so that the coating solution reacts chemically on the surface of the stent, and solidifies to form a polymer coating.

The polymer raw material used to make the coating solution can be formed by the copolymerization of two or more monomers and small molecules.

Exemplarily, the structure of the polymer raw material in the coating solution is shown in the figure below.

.

Wherein, a, b, c and d respectively represent the number of corresponding functional groups. a determines the anticoagulant effect of the polymer coating, d determines the degree of crosslinking of the polymer coating, which directly affects the firmness of the polymer coating, and b and c affect the overall performance of the polymer coating.

Specifically, a is 10-500, both b and c are 0-500, and d is 3-100.

Further, a is 20-100, both b and c are 10-60, and d is 3-20.

The method for coating the surface of the stent with the coating solution includes various methods of covering the surface of the stent with the coating solution such as soaking, spraying or dripping.

The blood flow guiding device in this embodiment is covered with a polymer coating on the surface of the stent, and the mesh of the stent is covered by the polymer coating, which reduces the occurrence of thrombus when the blood flow guiding device contacts blood when it enters the blood vessel, and increases product safety. sex. And the polymer coating also has an anticoagulant effect, which further increases product safety.

The polymer coating can also be used on vascular stent products for the treatment of vascular stenosis, devices for occlusion, or related implant devices for the treatment of valve diseases, that is, the polymer coating is covered on the surface of the above-mentioned products. Wherein, the substrate of the above-mentioned products may be materials such as nickel-titanium alloy, stainless steel, iron alloy, magnesium alloy, polylactic acid, polyetheretherketone, polyethylene or biological valves. Other features of the delivery system in this embodiment can refer to the first embodiment, and will not be described in detail again.

Further, both the proximal end and the distal end of the blood flow guiding device adopt a bell mouth structure, and the length of the proximal bell mouth is greater than the length of the distal bell mouth, and the coverage rate of the proximal bell mouth is greater than that of the distal end bell mouth, The sparse structure of the bell mouth at the distal end not only facilitates the loading of the blood flow guiding device into the loader, but also reduces the risk of blocking branch blood vessels. The dense structure of the proximal bell mouth provides large radial support force, and its compact structure. After it expands automatically and adheres to the wall of the blood vessel, the risk of a single braided wire being inserted into the blood vessel is small, thereby reducing risk of entrapment in blood vessels. Moreover, the weaving structure of the far-end bell mouth and the proximal-end bell mouth has a sparse and dense structure, so that the blood flow guiding device can provide effective supporting force at different blood vessel diameters on both sides of the aneurysm. It should be noted that the specific technical solutions in the above implementation manners can be applied to each other.

While the present application has been described with reference to several exemplary embodiments, it is understood that the terms which have been used are words of description and illustration, rather than limitation. Since the present application can be embodied in various forms without departing from the spirit or essence of the invention, it should be understood that the above-described embodiments are not limited to any of the foregoing details, but should be construed broadly within the spirit and scope of the appended claims. , all changes and modifications falling within the scope of the claims or their equivalents shall be covered by the appended claims.

Claims

A delivery system, characterized in that it comprises:

The loader is hollow inside and has a loading space, and the loading space is used for loading the contracted blood flow guiding device;

A microcatheter, the microcatheter is hollow inside and has a delivery space;

A connector, connecting the loader and the microcatheter, making the loading space communicate with the delivery space to form a channel for the blood flow guiding device to move; the distal end of the connector is sheathed on the the proximal end of the microcatheter, and the proximal end of the connector is sheathed on the outer periphery of the distal end of the loader.
The delivery system according to claim 1, wherein the connector comprises a main body, a branch, and a distal connector and a proximal connector respectively arranged at both ends of the main body; the lumen of the branch is connected to the The inner cavity of the main body communicates; the axial direction of the main body is parallel to the axial direction of the carrier; the proximal connector is connected to the distal end of the carrier and sleeved on the outer periphery of the carrier, the The distal connecting piece is connected to the proximal end of the microcatheter and sleeved on the periphery of the microcatheter, and the lumen of the main body communicates with the loading space and the delivery space at the same time, thereby forming a The channel through which the flow guide moves.
The delivery system of claim 2, wherein the distal connector comprises a mating joint and a distal connector;

The distal connecting head is sheathed on the outer periphery of the main body, and the outer periphery of the distal connecting head is provided with external threads; the inner periphery of the mating joint is provided with internal threads adapted to the external threads, so as to realize the The screw connection of the matching joint and the distal connection head;

The proximal end of the microcatheter is inserted into the mating joint.
The delivery system of claim 2, wherein the proximal connector comprises:

The proximal connector is sleeved on the outer periphery of the main body;

The end cap is sleeved on the outer circumference of the proximal connector, and is screwed to the proximal connector so as to be able to rotate relative to the main body, and then move along the axial direction of the main body;

The inner cylinder is arranged in the main body, and the proximal end of the inner cylinder is fixedly connected with the end cap, so that it can move with the movement of the end cap;

The elastic part is cylindrical and located in the main body; the distal end of the elastic part abuts against the inner peripheral wall of the main body to limit the movement of the elastic part to the distal end, and the proximal end of the elastic part faces the the distal end of the inner cylinder; the elastic part has elasticity so that it can contract radially;

When the inner cylinder moves distally along the axial direction of the main body with the end cover, the elastic part is compressed to reduce its inner diameter, and then clamp the loader.
The delivery system according to claim 4, wherein the distal end of the end cap exceeds the distal end of the proximal connector, and the distal end of the end cap is provided with a stop ring ; The limit ring protrudes from the end cover to the main body;

When the end cap moves in the proximal direction, the limiting ring can abut against the proximal connector to limit the movement of the end cap.
The delivery system according to claim 1, wherein the loader comprises a loading cylinder and a plurality of collars sleeved on the outer periphery of the loading cylinder, and the plurality of collars are arranged along the axial direction of the loading cylinder. interval setting.
The delivery system according to claim 1, wherein the blood flow guiding device comprises a stent formed by braiding wires interlaced to form a network structure; the stent can be contracted or expanded along its radial direction.
The delivery system according to claim 7, wherein the radial compression ratio of the stent is 1/2-1/10.
The delivery system according to claim 7, wherein the stent includes a proximal bell mouth, a connecting barrel, and a distal bell mouth sequentially from the proximal end to the distal end along its axial direction;

The diameter of the proximal bell mouth gradually increases from the distal end to the proximal end to make it a trumpet shape, and the diameter of the distal bell mouth gradually increases from the proximal end to the distal end to make it a trumpet shape;

The axial length of the proximal flare is greater than the axial length of the distal flare.
The delivery system according to claim 9, wherein the axial length of the distal flare is 0.5 mm to 3 mm;

The axial length of the proximal bell mouth is 2 mm to 7 mm.
The delivery system of claim 9, wherein the coverage of the proximal flare is greater than the coverage of the distal flare.
The delivery system of claim 9, wherein the proximal flare is closed and the distal flare has an opening.
The delivery system according to claim 9, wherein the connecting cylinder comprises a sparse mesh section and a dense mesh section sequentially connected from the far end to the proximal end; the coverage of the sparse mesh section is smaller than that of the dense mesh section coverage.
The delivery system according to claim 13, wherein the coverage of the sparse network segment is 5% to 20%;

The coverage rate of the dense network segment is 20% to 60%.
The delivery system according to any one of claims 7-14, wherein the blood flow guiding device further comprises a polymer coating covering the surface of the stent;

The polymer coating comprises structural formula A and structural formula B,

The structural formula A is
;

The structural formula B is
.
The delivery system of claim 15, wherein the polymer coating has a thickness of 5-1000 nm.
The delivery system according to any one of claims 1-16, wherein the delivery system further comprises a delivery guide wire, the delivery guide wire is located in the blood flow guiding device and pushes the blood flow guiding device ; The delivery guide wire comprises:

Mandrel;

The pusher is fixedly sleeved on the outer periphery of the mandrel; the pusher includes at least one pusher sleeved on the outer periphery of the mandrel and at least one pusher arranged on the outer periphery of the pusher, and the pusher Radially protruding from the outer periphery of the push cylinder along the mandrel, and protruding into the mesh of the blood flow guiding device, thereby hooking the blood flow guiding device, driving the blood flow guiding device from the proximal end Move to the far end.
The delivery guide wire according to claim 17, wherein the push rod is elastic, and the push rod is straight in a natural state.
The delivery guide wire according to claim 18, wherein a groove is provided on the side of the push rod facing the distal end, and the opening of the groove faces the distal end.
The delivery guide wire according to claim 17, wherein the push rod is elastic, and in a natural state, the push rod comprises a radially extending rod body and a protrusion provided on the rod body, The protruding part is arranged on the side of the rod body facing the distal end, and is located at the end of the rod body away from the push cylinder.
The delivery guide wire according to claim 17, characterized in that, in a natural state, the push rod comprises a rod body extending radially and an extension part arranged on the rod body, and the extension part is arranged along the push cylinder. extends axially and is located at the distal end of the rod.
The delivery guide wire according to claim 21, characterized in that, on the side of the extension part facing the pushing cylinder, there is also a protruding part protruding toward the direction of the pushing cylinder, and the protruding part is arranged on the distal end of the extension.
The delivery guide wire according to any one of claims 17-22, characterized in that, the delivery guide wire further comprises a withdrawal member;

The retracting member is sleeved on the outer periphery of the mandrel and is located at the proximal end of the pushing member; the retracting member is spaced apart from the pushing member;

The retraction member includes at least one retraction cylinder sheathed on the outer periphery of the mandrel and at least one retraction rod arranged on the outer periphery of each of the retraction cylinders, and the retraction rod is along the diameter of the mandrel. Extending in the direction, and can be inserted into the mesh of the blood flow guiding device, so as to hook the blood flow guiding device and drive the blood flow guiding device to move from the distal end to the proximal end.
The delivery guide wire according to claim 23, wherein the retraction rod is elastic and the retraction rod is straight in a natural state.
The delivery guide wire according to claim 24, wherein a slot is provided on the side of the retraction rod facing the proximal end, and the opening of the slot faces the proximal end.
The delivery guide wire according to claim 23, wherein the retraction rod is elastic, and in a natural state, the retraction rod comprises a rod body extending radially and a protrusion arranged on the rod body part, the protruding part is arranged on the side of the rod body facing the proximal end, and is located at the end of the rod body away from the retracting cylinder.
The delivery guide wire according to claim 23, characterized in that, in a natural state, the retraction rod comprises a rod body extending radially and an extension part provided on the rod body, and the extension part is The withdrawal cylinder extends axially and is located at the proximal end of the rod body.
The delivery guide wire according to claim 27, characterized in that, on the side of each of the extending parts facing the retracting cylinder, there is also a protruding part protruding toward the retracting cylinder, and the protruding part is The portion is disposed at the distal end of the extension portion.
The delivery guide wire according to claim 23, wherein the material of the retraction rod is a material with a developing function.
The delivery guide wire according to claim 17, characterized in that, the mandrel includes a first part, a middle part and a second part sequentially from the proximal end to the distal end along its axial direction; the diameter of the first part Greater than the diameter of the second portion, the diameter of the middle portion decreases from the proximal end to the distal end.
The delivery guide wire according to claim 17, characterized in that, the proximal end of the mandrel is provided with a pushing marking point; the length of the pushing marking point along the axial direction of the mandrel is 5-10 mm.
The delivery guide wire according to claim 17, wherein the outer periphery of the mandrel is covered with a spring imaging element capable of developing; element and a second developing element located in the central region of the mandrel.
The delivery system according to any one of claims 17-32, wherein at least one first guide groove is provided on the inner peripheral wall of the carrier; the first guide groove is along the axial direction of the carrier extend;

The push rod corresponds to the first guide groove, and the radial length of the push rod is greater than the radial depth of the first guide groove, so that the bent part of the push rod along the first guide groove The guide groove slides.
The delivery system according to claim 33, wherein at least one second guide groove is provided on the inner peripheral wall of the microcatheter, and the second guide groove extends along the axial direction of the microcatheter, and the The second guide groove is arranged correspondingly to the first guide groove;

The radial length of the push rod is greater than the radial depth of the second guide groove, so that the bent part of the push rod slides along the second guide groove.