阅读说明：本技术 递送系统 (Delivery system ) 是由 任静 陈丽萍 王永胜 于 2021-05-10 设计创作，主要内容包括：本发明提供了一种递送系统。该递送系统包括装载器、微导管、血流导向装置、输送导丝及连接器。装载器其部中空而具有装载空间；微导管位于装载器的远端；微导管内部中空而具有输送空间；血流导向装置能够收缩而装入装载空间内；输送导丝位于装载空间内,并位于血流导向装置内而推动血流导向装置；连接器包连接装载器和微导管,使装载空间和输送空间相连通而形成供血流导向装置移动的通道；连接器的远端套设于微导管的近端,连接器的近端套设于装载器远端的外周。连接器对装载器具有轴向的约束,并提供支撑力,使得装载器在轴向能够尽可能的拉直,便于将血流导向装置输送至微导管中,进而提升血流导向装置到达病变处的效率。(The invention provides a delivery system. The delivery system includes a loader, a microcatheter, a blood flow directing device, a delivery guidewire, and a connector. The loader is hollow and has a loading space; a microcatheter at the distal end of the loader; the micro-catheter is hollow and has a conveying space; the blood flow guiding device can be contracted and arranged in the loading space; the conveying guide wire is positioned in the loading space and positioned in the blood flow guiding device to push the blood flow guiding device; the connector pack is connected with the loader and the micro-catheter, so that the loading space is communicated with the conveying space to form a channel for moving the blood flow guide device; the distal end of the connector is sleeved on the proximal end of the micro catheter, and the proximal end of the connector is sleeved on the periphery of the distal end of the loader. The connector has axial restraint to the loader to provide the holding power, make the loader can straighten as far as possible in the axial, be convenient for carry the blood flow guider to in the little pipe, and then promote the efficiency that the blood flow guider reachd the pathological change department.)

1. A delivery system, comprising:

a loader having a hollow loading space therein;

a microcatheter at a distal end of the loader; the micro-catheter is hollow inside and provided with a conveying space;

a blood flow guide device which can be retracted and installed in the loading space;

the conveying guide wire is positioned in the loading space and positioned in the blood flow guiding device to push the blood flow guiding device;

a connector connecting the loader and the microcatheter to communicate the loading space with the delivery space to form a channel for movement of the blood flow directing device; the distal end of the connector is sleeved on the proximal end of the micro catheter, and the proximal end of the connector is sleeved on the periphery of the distal end of the loader.

2. The delivery system of claim 1, wherein the connector comprises a main body, a branch, and a distal connector and a proximal connector disposed at two ends of the main body, respectively; the inner cavities of the branches are communicated with the inner cavity of the main body; the axial direction of the main body is parallel to the axial direction of the loader; the proximal end connecting piece with the distal end of loader is connected and the cover is located the periphery of loader, the distal end connecting piece with the proximal end of little pipe is connected and the cover is located the periphery of little pipe, just the inner chamber of main part simultaneously with loading space with the delivery space communicates with each other, and then forms the confession the passageway that blood flow guider removed.

3. The delivery system of claim 2, wherein the distal connector comprises a mating connector and a distal connector;

the far-end connector is sleeved on the periphery of the main body, and external threads are arranged on the periphery of the far-end connector; the inner periphery of the matched joint is provided with an internal thread matched with the external thread, so that the matched joint is in threaded connection with the far-end connector;

the proximal end of the microcatheter is inserted into the mating fitting.

4. The delivery system of claim 2, wherein the proximal connector comprises:

the near-end connector is sleeved on the periphery of the main body;

the end cover is sleeved on the periphery of the near-end connector and is in threaded connection with the near-end connector so as to be capable of rotating relative to the main body and further moving along the axial direction of the main body;

the inner cylinder is arranged in the main body, and the near end of the inner cylinder is fixedly connected with the end cover so as to move along with the movement of the end cover;

an elastic part which is cylindrical and is positioned in the main body; the far end of the elastic part is abutted against the inner peripheral wall of the main body to limit the elastic part to move towards the far end, and the near end of the elastic part faces the far end of the inner cylinder; the elastic part has elasticity to enable the elastic part to contract along the radial direction;

when the inner cylinder moves along the axial direction of the main body along with the end cover to the far end, the elastic part is compressed to reduce the inner diameter of the elastic part, and the loader extending into the main body is clamped.

5. The delivery system of claim 4, wherein the distal end of the end cap extends beyond the distal end of the proximal connector, and the distal end of the end cap is provided with a stop collar; the limiting ring protrudes from the end cover to the main body;

when the end cover moves towards the near end direction, the limiting ring can be abutted to the near end connector to limit the movement of the end cover.

6. The delivery system of claim 1, wherein the loader comprises a loading barrel and a plurality of collars disposed around the loading barrel, the plurality of collars being spaced apart in an axial direction of the loading barrel.

7. The delivery system of claim 1, wherein the blood flow directing device comprises a stent having a mesh structure formed by interweaving braided wires; the stent can be contracted or expanded in the radial direction thereof.

8. The delivery system of claim 7, wherein the stent has a radial compression ratio of 1/2-1/10.

9. The delivery system of claim 7, wherein the stent comprises a proximal flare, a connector barrel, and a distal flare sequentially from a proximal end to a distal end in an axial direction thereof;

the diameter of the near-end bell mouth is gradually increased from the far end to the near end to enable the near-end bell mouth to be in a horn shape, and the diameter of the far-end bell mouth is gradually increased from the near end to the far end to enable the far-end bell mouth to be in the horn shape;

the axial length of the near-end bell mouth is greater than that of the far-end bell mouth.

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

the axial length of the near-end bell mouth is 2 mm-7 mm.

11. The delivery system of claim 9, wherein the coverage of the proximal flare is greater than the coverage of the distal flare.

12. The delivery system of claim 9, wherein the proximal flare is closed and the distal flare has an opening.

13. The delivery system of claim 9, wherein the connector barrel comprises a sparse mesh segment and a dense mesh segment connected in series from a distal end to a proximal end; and the coverage rate of the sparse network segment is less than that of the dense network segment.

14. The delivery system of claim 13, wherein the coverage of the sparse network segment is 5% to 20%;

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

15. The delivery system of claim 7, wherein the blood flow directing device further comprises a polymer coating overlying the stent surface;

the polymer coating comprises a structural formula A and a structural formula B,

the structural formula A is

The structural formula B is

16. The delivery system of claim 15, wherein the polymer coating has a thickness of 5-1000 nm.

17. The delivery system of claim 1, wherein the delivery guidewire comprises:

a mandrel;

the pushing piece is fixedly sleeved on the periphery of the mandrel; the pushing element comprises at least one pushing cylinder and at least one pushing rod, the pushing cylinder is sleeved on the periphery of the core shaft, the pushing rod is arranged on the periphery of the pushing cylinder, the pushing rod extends out of the periphery of the pushing cylinder in the radial direction of the core shaft and extends into a mesh hole of the blood flow guiding device, and therefore the blood flow guiding device is hooked and driven to move from a near end to a far end.

18. The delivery system of claim 17, wherein the inner circumferential wall of the cartridge is provided with at least a first guide groove; the first guide groove extends along the axial direction of the loader;

the push rod corresponds to the first guide groove, and the length of the push rod in the radial direction is larger than the depth of the first guide groove in the radial direction, so that the bent part of the push rod slides along the first guide groove.

19. The delivery system according to claim 18, wherein the inner peripheral wall of the micro-catheter is provided with at least one second guide groove, the second guide groove extends along the axial direction of the micro-catheter, and the second guide groove is arranged corresponding to the first guide groove;

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

Technical Field

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

Background

Intracranial aneurysms are manifestations of localized or diffuse dilatation or bulging of the arterial wall due to lesions or lesions of the arterial wall, mainly manifested by distending, pulsating masses, which can occur in any part of the arterial system, as is common in the trunk arteries of limbs, carotid arteries and intracranial arteries.

Endovascular intervention is the primary treatment for intracranial aneurysms, and one form of vascular intervention is to place a blood flow directing device at the aneurysm via a delivery system, thereby blocking the exchange of blood between the interior of the aneurysm and the blood vessel. Currently, delivery systems typically include a loader, a microcatheter, a delivery guidewire, and a blood flow directing device, the loader and microcatheter providing a channel through which the blood flow directing device is delivered into the blood vessel. However, the proximal end of the shuttle is relatively flexible and pliable, making the flow directing device difficult to maneuver and maneuver from the shuttle into the microcatheter.

Disclosure of Invention

It is an object of the present invention to provide a delivery system that is easy to operate to solve the problems of the prior art.

In order to solve the technical problems, the invention adopts the following technical scheme: a delivery system, comprising:

a loader having a hollow loading space therein;

a microcatheter at a distal end of the loader; the micro-catheter is hollow inside and provided with a conveying space;

a blood flow guide device which can be retracted and installed in the loading space;

the conveying guide wire is positioned in the loading space and positioned in the blood flow guiding device to push the blood flow guiding device;

a connector connecting the loader and the microcatheter to communicate the loading space with the delivery space to form a channel for movement of the blood flow directing device; the distal end of the connector is sleeved on the proximal end of the micro catheter, and the proximal end of the connector is sleeved on the periphery of the distal end of the loader.

In some embodiments, the connector comprises a main body, branches, and a distal connector and a proximal connector respectively disposed at both ends of the main body; the inner cavities of the branches are communicated with the inner cavity of the main body; the axial direction of the main body is parallel to the axial direction of the loader; the proximal end connecting piece with the distal end of loader is connected and the cover is located the periphery of loader, the distal end connecting piece with the proximal end of little pipe is connected and the cover is located the periphery of little pipe, just the inner chamber of main part simultaneously with loading space with the delivery space communicates with each other, and then forms the confession the passageway that blood flow guider removed.

In some embodiments, the distal connector comprises a mating connector and a distal connector;

the far-end connector is sleeved on the periphery of the main body, and external threads are arranged on the periphery of the far-end connector; the inner periphery of the matched joint is provided with an internal thread matched with the external thread, so that the matched joint is in threaded connection with the far-end connector;

the proximal end of the microcatheter is inserted into the mating fitting.

In some embodiments, the proximal connector comprises:

the near-end connector is sleeved on the periphery of the main body;

the end cover is sleeved on the periphery of the near-end connector and is in threaded connection with the near-end connector so as to be capable of rotating relative to the main body and further moving along the axial direction of the main body;

the inner cylinder is arranged in the main body, and the near end of the inner cylinder is fixedly connected with the end cover so as to move along with the movement of the end cover;

an elastic part which is cylindrical and is positioned in the main body; the far end of the elastic part is abutted against the inner peripheral wall of the main body to limit the elastic part to move towards the far end, and the near end of the elastic part faces the far end of the inner cylinder; the elastic part has elasticity to enable the elastic part to contract along the radial direction;

when the inner cylinder moves along the axial direction of the main body along with the end cover to the far end, the elastic part is compressed to reduce the inner diameter of the elastic part, and the loader extending into the main body is clamped.

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 stop collar; the limiting ring protrudes from the end cover to the main body;

when the end cover moves towards the near end direction, the limiting ring can be abutted to the near end connector to limit the movement of the end cover.

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

In some embodiments, the blood flow directing device comprises a stent having a mesh structure formed by interweaving braided wires; the stent can be contracted or expanded in the radial direction thereof.

In some embodiments, the stent has a radial compression ratio of 1/2-1/10.

In some embodiments, the stent comprises a proximal flare, a connecting cylinder and a distal flare sequentially from the proximal end to the distal end along the axial direction of the stent;

the diameter of the near-end bell mouth is gradually increased from the far end to the near end to enable the near-end bell mouth to be in a horn shape, and the diameter of the far-end bell mouth is gradually increased from the near end to the far end to enable the far-end bell mouth to be in the horn shape;

the axial length of the near-end bell mouth is greater than that of the far-end bell mouth.

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

the axial length of the near-end bell mouth is 2 mm-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 connector barrel comprises a sparse net segment and a dense net segment connected in sequence from the distal end to the proximal end; and the coverage rate of the sparse network segment is less than that of the dense network segment.

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

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

In some embodiments, the blood flow directing device further comprises a polymer coating overlying the stent surface;

the polymer coating comprises a structural formula A and a structural formula B,

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 guidewire comprises:

a mandrel;

the pushing piece is fixedly sleeved on the periphery of the mandrel; the pushing element comprises at least one pushing cylinder and at least one pushing rod, the pushing cylinder is sleeved on the periphery of the core shaft, the pushing rod is arranged on the periphery of the pushing cylinder, the pushing rod extends out of the periphery of the pushing cylinder in the radial direction of the core shaft and extends into a mesh hole of the blood flow guiding device, and therefore the blood flow guiding device is hooked and driven to move from a near end to a far end.

In some embodiments, the inner peripheral wall of the loader is provided with at least one first guide groove; the first guide groove extends along the axial direction of the loader;

the push rod corresponds to the first guide groove, and the length of the push rod in the radial direction is larger than the depth of the first guide groove in the radial direction, 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 formed on the inner peripheral wall of the micro-catheter, the second guide groove extends along the axial direction of the micro-catheter, and the second guide groove is arranged corresponding to the first guide groove;

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

According to the technical scheme, the invention has at least the following advantages and positive effects:

the delivery system of the present invention connects the microcatheter and the loader via a connector, with the distal end of the loader extending into the connector and the proximal end of the microcatheter extending into the connector. The connector has axial restraint to the loader to provide the holding power, make the loader can straighten as far as possible in the axial, be convenient for carry the blood flow guider to in the little pipe, and then promote the efficiency that the blood flow guider reachd the pathological change department.

Furthermore, the near end and the far end of the blood flow guiding device both adopt a horn mouth structure, the length of the near-end horn mouth is larger than that of the far-end horn mouth, and the coverage rate of the near-end horn mouth is larger than that of the far-end horn mouth, so that the sparse structure of the far-end horn mouth not only facilitates the blood flow guiding device to be installed in the loader, but also can reduce the risk of blocking branch vessels. The radial supporting force provided by the compact structure of the near-end bell mouth is large, and the structure is compact, so that after the near-end bell mouth is automatically expanded and attached to the wall of a blood vessel, the risk of a single braided wire penetrating into the blood vessel is small, and the risk of penetrating into the blood vessel is reduced. And the sparse and dense weaving structure of the far-end bell mouth and the near-end bell mouth ensures that the blood flow guiding device can provide effective supporting force at different vessel diameters at two sides of the aneurysm.

Drawings

Fig. 1 is a schematic structural view of a first embodiment of the delivery system of the present invention.

Fig. 2 is a schematic view of a first embodiment of a blood flow directing device of the delivery system of the present invention.

Fig. 3 is a schematic view of the blood flow directing device of fig. 2 positioned at a vascular lesion.

Fig. 4 is a schematic view of a pushwire according to a first embodiment of the delivery system of the present invention.

Fig. 5 is a schematic view of the delivery system of the present invention with the delivery guidewire and blood flow directing device positioned within the loader.

Fig. 6 is a cross-sectional view of fig. 5.

Fig. 7 is a schematic diagram of the structure at a in fig. 6.

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

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

Fig. 10 is a schematic diagram of the structure at C in fig. 8.

Fig. 11 is a schematic partial structure view of a second embodiment of the delivery system of the present invention.

Fig. 12 is a schematic view 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 view of a pusher in a second embodiment of the delivery system of the present invention.

Fig. 15 is a schematic view of a pusher in a third embodiment of the delivery system of the present invention.

Fig. 16 is a schematic view of a pusher in a fourth embodiment of the delivery system of the present invention.

FIG. 17 is a schematic view of a fourth embodiment of a delivery system of the present invention showing a pusher member engaging a blood flow directing device.

Fig. 18 is a schematic view of a fourth embodiment of the delivery system of the present invention with the retraction member engaged with the blood flow directing device.

Fig. 19 is a schematic view of a pushwire according to a fifth embodiment of the delivery system of the present invention.

Fig. 20 is a schematic view of the structure of the pullback member in a fifth embodiment of the delivery system of the present invention.

Fig. 21 is a schematic view of a pusher in a sixth embodiment of a delivery system of the present invention.

Fig. 22 is a schematic view of a pusher in a sixth embodiment of a delivery system of the present invention.

Fig. 23 is a schematic view of a pusher in a sixth embodiment of a delivery system of the present invention.

Fig. 24 is a schematic view of a pusher in a sixth embodiment of a delivery system of the present invention.

Fig. 25 is a schematic partial structure view of an eighth embodiment of the delivery system of the present invention.

The reference numerals are explained below:

1. a blood flow directing means; 11. a proximal flare; 12. a distal flare; 13. a connecting cylinder; 131. dredging a net section; 132. a secret network segment; 16. weaving silk;

2. delivering a guide wire; 21. a mandrel; 211. a first part; 212. an intermediate portion; 213. a second section; 221. a first developing member; 222. a second developing member; 23. pushing the identification points; 24. a pushing member; 241. a push cylinder; 242. a protruding portion; 25. a retraction member;

3. a loader; 31. a loading cartridge; 32. a collar;

4. a microcatheter;

5. a connector; 51. a main body; 52. branching; 53. a distal connector; 531. a distal connector; 532. a mating joint; 54. a proximal connector; 541. a proximal end connector; 542. an end cap; 543. an inner barrel; 544. an elastic portion; 545. a limiting ring; 55. a gasket;

64. a pushing member; 641. a push cylinder; 642. a push rod; 6421. a rod body; 6422. an extension portion; 6423. a projection; 643. a groove; 65. a retraction member; 651. a retraction cylinder; 652. retracting the rod; 6521. a rod portion; 6522. an extension portion;

71. a loading cartridge; 711. a first guide groove;

8. a blood vessel.

Detailed Description

Exemplary embodiments that embody features and advantages of the invention are described in detail below in the specification. It is to be understood that the invention is capable of other embodiments and that various changes in form and details may be made therein without departing from the scope of the invention and the description and drawings are to be regarded as illustrative in nature and not as restrictive.

In this context, the terms "proximal" and "distal" are relative orientations, relative positions, and directions of elements or actions with respect to each other from the perspective of an operator using the medical device, although "proximal" and "distal" are not intended to be limiting, but generally refer to the end of the medical device that is closer to the operator during normal operation, and generally refer to the end that enters the patient first.

The present invention provides a delivery system suitable for use in the treatment of intracranial aneurysms.

Referring to fig. 1, the delivery system includes a blood flow directing device 1, a delivery guidewire 2, a loader 3, a microcatheter 4, and a connector 5. The delivery system is constructed by tethering the blood flow directing device 1 to the delivery guidewire 2 and pre-installing the blood flow directing device 1 and the delivery guidewire 2 together in the loader 3. During operation delivery, firstly the micro-catheter 4 is inserted into a diseased blood vessel, then the loader 3 is connected with the micro-catheter 4 through the connector 5, an operator applies force to the delivery guide wire 2 in the axial direction, so that the blood flow guiding device 1 bound on the delivery guide wire 2 is delivered into the micro-catheter 4 from the loader 3 until the blood flow guiding device 1 is moved to the diseased blood vessel, and the tumor-carrying blood vessel is reconstructed through the blood flow guiding device 1, so that the intracranial aneurysm treatment is realized.

In this context, the left side of each view direction is distal and the right side is proximal.

The above-described respective structures of the delivery system are explained in detail below.

Referring to the structure shown in fig. 2, the blood flow guiding device 1 includes a stent having a mesh structure formed by interweaving knitting filaments 16. The stent can contract along the radial direction of the stent or expand along the radial direction of the stent by the elastic action of the stent, namely the stent is of a self-expanding reticular structure.

Referring to figure 3, there is shown the configuration of the blood flow directing device 1 delivered to a lesion in a blood vessel 8 to effect treatment by the reconstructive action of the blood flow directing device 1.

Since the blood flow guide device 1 is formed by knitting with the knitting yarn 16, it has a plurality of meshes.

Specifically, the material of the braided wire 16 is at least one of a metal wire or a polymer wire with biocompatibility. That is, the blood flow guide device 1 may be formed by weaving only metal wires, may be formed by weaving only polymer wires, or may be formed by weaving both metal wires and polymer wires.

The knitting yarn 16 may be at least one of vertical and horizontal, and may be selected according to the actual condition.

The radial compression ratio of the blood flow guiding device 1 is 1/2-1/10, and the blood flow guiding device can be loaded into the loader 3 or the micro catheter 4 after being compressed. In an exemplary embodiment, the compressed flow directing device 1 can be loaded into a loader 3 or microcatheter 4 having a tube diameter of 0.7 mm.

The blood flow guiding device 1 formed by weaving with the weaving yarns 16 has high flexibility and high flexibility, so that the blood flow guiding device 1 can be bent or twisted in space, and after the blood flow guiding device 1 is released into a blood vessel, the shape of the blood flow guiding device is closer to that of a natural blood vessel, the blood flow guiding device can conform to tortuous cerebral vessels, and the lumen shape of the blood vessel can be supported.

With continued reference to fig. 2, the blood flow guiding device 1 is substantially cylindrical and comprises, in its axial direction and from the proximal end to the distal end, a proximal flare 11, a connector barrel 13 and a distal flare 12 arranged in this order.

The connecting cylinder 13 is cylindrical, and the diameters of the connecting cylinder 13 at various positions in the axial direction are the same.

Specifically, the connector barrel 13 includes a sparse mesh segment 131 and a dense mesh segment 132 in its axial direction. Wherein, the sparse net section 131 is connected with the far-end bell mouth 12, and the dense net section 132 is connected with the near-end bell mouth 11.

The coverage of the sparse network segment 131 is less than the coverage of the dense network segment 132. In this context, coverage is the percentage of the vessel that the portion of the braided filaments 16 covering the vessel when the blood flow directing device 1 is fitted to the vessel wall.

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

In other embodiments, the connecting cylinder 13 may also be a uniform grid structure, i.e., the coverage rate is uniform throughout along its axial direction. The specific setting can be according to actual need.

The proximal flare 11 and the distal flare 12 are arranged at two ends of the connecting cylinder 13, the proximal flare 11 is connected to the proximal end of the connecting cylinder 13, and the distal flare 12 is connected to the distal end of the connecting cylinder 13.

The diameter of the proximal flare 11 gradually increases from the distal end to the proximal end, so that the structure is trumpet-shaped. The diameter of the distal flare 12 increases from the proximal end to the distal end, making the structure horn-like.

The length L1 of the proximal bell mouth 11 along the axial direction is 2mm to 7 mm. The length L2 of the far-end bell mouth 12 along the axial direction is 0.5 mm-3 mm. And the diameter of the distal flare 12 is smaller than the diameter of the proximal flare 11. By adopting the design, the diameter of the blood vessel at different positions is matched with the blood flow guiding device 1, the near end of the blood flow guiding device 1 can provide enough radial supporting force, so that the adherence of the blood flow guiding device 1 and a thick blood vessel at the near end is better, the overlarge outer diameter of the far end of the blood flow guiding device 1, which causes overlarge supporting force to the blood vessel, is reduced, and the injury to the blood vessel is reduced.

In particular, in the present embodiment, the minimum diameter of the distal flare 12 and the minimum diameter of the proximal flare 11 are both equal to the diameter of the connector barrel 13, and the maximum diameter of the distal flare 12 is smaller than the maximum diameter of the proximal flare 11.

Further, the distal flare 12 is a closed-loop structure, and the proximal flare 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 net structure at the position of the near-end bell mouth 11, the far-end bell mouth 12 is a sparse structure, and the near-end bell mouth 11 is a dense structure. Wherein sparse and dense is herein a relative concept, i.e. the coverage of the proximal flare 11 is larger than the coverage of the distal flare 12, compared to both the distal flare 12 and the proximal flare 11.

The sparse structure of the distal flare 12 not only facilitates the loading of the blood flow guiding device 1 into the loader 3, but also reduces the risk of occluding the blood vessel of the branch 52. The dense structure of the near-end bell mouth 11 provides a large radial supporting force firstly, and has a dense structure secondly, after the near-end bell mouth is automatically expanded and attached to the wall of a blood vessel, the risk that a single braided wire 16 penetrates into the blood vessel is small, so that the risk of penetrating into the blood vessel is reduced.

And the sparse and dense weaving structure of the far-end bell mouth 12 and the near-end bell mouth 11 enables the blood flow guiding device 1 to provide effective supporting force at different vessel diameters on two sides of the aneurysm.

The delivery guidewire 2 is used to deliver the blood flow directing device 1 to a predetermined location within the patient.

Referring to the structure shown in fig. 4, the pushwire 2 of the present embodiment includes a mandrel 21, a spring developing element, a push marker 23, a pusher 24, and a retraction 25.

The mandrel 21 is used for pushing and supporting the blood flow guiding device 1. Specifically, the mandrel 21 comprises a first portion 211, an intermediate portion 212 and a second portion 213, arranged in sequence from the proximal end to the distal end along its own axial direction.

The first portion 211 is cylindrical and has a uniform diameter. Further, the diameter D1 of the first part 211 is 0.3-0.5 mm.

The second portion 213 has a cylindrical shape with a uniform diameter. Diameter D2 of second portion 213 is less than diameter D1 of first portion 211. Further, the diameter D2 of the second portion 213 is 0.1 to 0.25 mm.

The intermediate portion 212 tapers in diameter from the proximal end to the distal end. And the diameter of the proximal end of the middle portion 212 is the same as the diameter of the first portion 211 and the diameter of the distal end of the middle portion 212 is the same as the diameter of the second portion 213.

The mandrel 21 adopts the design, so that the part of the mandrel 21, which is positioned in the loader 3 and used for conveying the blood flow guide device 1, is thin, and has enough softness when entering the blood vessel, thereby avoiding injury to the blood vessel, ensuring that the mandrel 21 positioned outside the loader 3 is thick, and providing enough pushing force.

The mandrel 21 may be made of at least one of stainless steel, nitinol, copper alloy, or aluminum alloy. That is, the mandrel 21 may be formed by grinding any one of the above materials, or may be formed by bonding or welding any two of the above materials.

The spring visualization element overlies the mandrel 21 for visualization to show the position of the bloodline device within the blood vessel.

Specifically, the spring developing member includes a first developing member 221 and a second developing member 222 disposed at an interval in the axial direction of the spindle 21. Wherein the first developing member 221 is disposed at a distal end of the mandrel 21. The second developing element 222 is provided at the intermediate portion 212 of the spindle 21.

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

The pushing mark point 23 is arranged at the proximal end of the mandrel 21 and is used for reminding an operator. Specifically, the pushing mark point 23 is arranged at a position 240-280 mm away from the proximal end of the mandrel 21. And the mark length of the pushing mark point 23 is 5-10 mm. In this context, the length of the pushed marking point 23 itself in the axial direction of the mandrel 21 is the marking length.

Wherein the push indication point 23 can be formed by grinding or engraving the mandrel 21.

The principle of use of the push identification point 23 is as follows:

when the pushing mark point 23 reaches the proximal end of the blood flow guiding device 1, the pushing mark point 23 plays a role in reminding an operator that only 100-120 mm is left for releasing from the blood flow guiding device 1, and the loader 3 and the connector 5 can be withdrawn at the moment to start to push slowly. When the pushing mark point 23 starts to enter the micro-catheter 4 and the blood flow guiding device 1 is about to be pushed out of the micro-catheter 4 for release, the pushing mark point 23 acts at this moment to remind an operator that the micro-catheter 4 can be slowly retracted to perform the release operation of the blood flow guiding device 1.

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

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

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

In the present embodiment, a plurality of protrusions 242 are provided at intervals in the axial direction and the circumferential direction of the push cylinder 241. That is, a plurality of protrusions 242 are provided at intervals in the same circumferential direction and form a set. The plural sets of protruding portions 242 are provided at intervals in the axial direction.

The protrusion 242 protrudes from the outer circumference of the push cylinder 241 in the radial direction of the spindle 21. The protruding portion 242 is embedded in the mesh of the blood flow guiding device 1, and drives the blood flow guiding device 1 to move from the proximal end to the distal end.

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

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

Specifically, in the present embodiment, the retraction member 25 has a cylindrical shape.

The withdrawing member 25 is sleeved on the periphery of the mandrel 21 and is fixedly connected with the mandrel 21. Specifically, the withdrawal member 25 is fixed to the outer periphery of the mandrel 21 by fusion or adhesion.

The shore hardness of the withdrawing piece 25 is 20-50 degrees, and the diameter is 0.4-0.6 mm, so that the withdrawing piece can be freely bent in a bent blood vessel.

Wherein the retracting member 25 also has a developing function.

The loader 3 has a cylindrical shape, and has a hollow loading space therein. The loading space is used for loading the blood flow guiding device 1 and the delivery guide wire 2. Referring to fig. 5, fig. 6 and fig. 7, the delivery guidewire 2 and the blood flow directing device 1 are pre-assembled in the cartridge 3.

The loader 3 is made of transparent material to facilitate the operator to 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 delivered into the micro-catheter 4.

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

The loading barrel 31 includes an inner layer, an intermediate layer and an outer layer in this order from inside to outside in its own radial direction.

The inner layer has a low coefficient of friction and is made of Polytetrafluoroethylene (PTFE), High Density Polyethylene (HDPE), or Fluorinated Ethylene Propylene (FEP).

The material of the intermediate layer is polyether block polyamide (Pebax, trade name determined by the company ATOFINA, france for its block polyetheramide resin product) or Thermoplastic polyurethane elastomer rubber (TPU for short).

The material of the outer layer is perfluoroethylene propylene copolymer (FEP for short).

The inner layer, the intermediate layer and the outer layer are thermally fused to obtain the loading tube 31.

Referring to fig. 5 and 6, the proximal end of the loading barrel 31 is flared, and the caliber thereof gradually increases from the distal end to the proximal end. By adopting the structure, the blood flow guiding device 1 can conveniently enter the loading space from the near end, and the pre-installation of the blood flow guiding device 1 is facilitated.

Specifically, the number of the collars 32 is equal to or greater than four, that is, the collars 32 need four at a minimum. The collar 32 is sleeved on the outer periphery of the loading barrel 31 and protrudes radially outwards from the outer periphery of the loading barrel 31, so that the collar 32 and the outer periphery of the loading barrel 31 form a step structure, the step structure can provide friction force during the delivery of the blood flow guiding device 1 so as to ensure that sufficient pushing force is provided, and the step structure can also position the axial positions of the loading barrel 31 and the connector 5.

The collar 32 and the loading cylinder 31 are fixedly connected by fusion or adhesion.

With continued reference to fig. 1, a microcatheter 4 is disposed at the distal end of the loader 3. The micro-catheter 4 is hollow and has a delivery space, and the delivery space is communicated with the loading space to form a channel for moving the blood flow guiding device 1, so that the blood flow guiding device 1 can move into the blood vessel.

The connector 5 is used for connecting the loader 3 and the micro-catheter 4, so that the connector 5 provides a certain support for the loader 3, and the loader 3 is straightened as much as possible in the axial direction, and the blood flow guiding device 1 can be pushed into the micro-catheter 4 smoothly.

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

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

The branch 52 is obliquely disposed at the outer circumference of the body 51, and the inner cavity of the branch 52 communicates with the inner cavity of the body 51. Specifically, the branch 52 is Y-shaped integrally with the main body 51, i.e., the connector 5 is Y-shaped integrally. The other end of the branch 52 opposite to the body 51 is provided with an opening communicating with the internal cavity of the branch 52 for connection with other equipment.

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

The distal connector 531 is disposed on the outer circumference of the distal end of the main body 51 and protrudes out of the main body 51.

The distal end connector 531 is provided with an internal thread on the inner peripheral wall of a portion which is distally beyond the main body 51.

The periphery wall of the cooperation joint 532 is fitted with a contraceptive ring and is equipped with the external screw thread, and this external screw thread and the internal thread adaptation of distal end connector 531 realize the spiro union of cooperation joint 532 and distal end connector 531.

The fitting connector 532 is used for being inserted into the micro-catheter 4, that is, the fitting connector 532 is sleeved on the periphery of the proximal end of the micro-catheter 4, so as to connect the connector 5 with the micro-catheter 4. Specifically, the microcatheter 4 extends into the mating fitting 532.

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

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

The proximal connector 541 is fixedly secured to the outer circumference of the distal end of the main body 51. The outer circumference of the proximal connector 541 is provided with external threads.

The end cap 542 is disposed around the proximal connector 541. The inner periphery of the end cover 542 is provided with internal threads, and the internal threads of the end cover 542 are matched with the external threads of the proximal connector 541, so that the end cover 542 and the proximal connector 541 are in threaded connection. The end cap 542 is threaded onto the proximal connector 541 so that the end cap 542 is able to move axially relative to the body 51 when the end cap 542 is rotated about the connector.

The distal end of the end cap 542 extends beyond the distal end of the proximal connector 541, and the distal end of the end cap 542 is provided with a retaining ring 545. Since the retainer ring 545 extends from the end cap 542 to the body 51, when the end cap 542 moves in the proximal direction, the retainer ring 545 can abut against the proximal end connector 541 to restrict the proximal movement of the end cap 542, and prevent the end cap 542 from coming off the proximal end connector 541.

The inner barrel 543 is located within the inner cavity of the body 51. The proximal end of the inner barrel 543 is fixedly connected to the proximal end of the end cap 542. Therefore, the inner tube 543 can move in accordance with the movement of the end cover 542. For example, as the cap 542 is moved proximally to distally by rotation, the inner barrel 543 is also moved proximally to distally.

The elastic portion 544 has a cylindrical shape and is located in the inner cavity of the main body 51. The elastic part 544 is located at the distal end of the inner barrel 543 and abuts against the distal end of the inner barrel 543.

Specifically, a retaining ring is inwardly protruded from the inner peripheral wall of the body 51. The proximal end of the spring 544 abuts the stop ring, thereby limiting distal movement of the spring ring within the body 51.

The elastic portion 544 has elasticity and can contract in the radial direction to reduce or restore the inner diameter thereof. When the inner tube 543 moves to contact the elastic portion 544 and compresses the elastic portion 544, the inner diameter of the elastic portion 544 contracts. When the inner tube 543 moves back toward the proximal end and the compression of the elastic portion 544 by the inner tube 543 is released, the elastic portion 544 is elastically restored by itself.

The material of the elastic portion 544 may be various rubbers such as silicone rubber, fluororubber, isoprene, and natural rubber, various resins such as polyurethane, polyamide elastomer, polybutadiene, and soft vinyl chloride, or a mixture of the two materials.

When the proximal connector 54 is connected to the distal end of the cartridge 3, the cartridge 3 is inserted into the inner barrel 543, and by rotating the cap 542, the inner barrel 543 is moved distally, thereby compressing the resilient portion 544 and causing the resilient portion 544 to contract, thereby clamping the cartridge 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 circumference of the loading cylinder 31. The elastic part 544 between two adjacent collars 32 prevents the loader 3 from being forced too much to be separated from the connector 5, and ensures the connection between the connector 5 and the loader 3.

The delivery system in this embodiment connects the microcatheter 4 and the loader 3 by a connector 5, the distal end of the loader 3 extending into the connector 5, the connector 5 having axial restraint to the loader 3 and providing a holding force to straighten the loader 3 in the axial direction as much as possible to facilitate delivery of the blood flow directing device 1 into the microcatheter 4.

The method of use of the delivery system in this embodiment is as follows:

s1, the blood flow guiding device 1 is contracted and bound to the delivery guidewire 2, and the two are pre-installed in the loader 3.

Specifically, the blood flow guide device 1 is fitted around the outer periphery of the delivery guidewire 2, and is retracted and then placed in the loading space of the loader 3.

S2, inserting the micro-catheter 4 into the diseased blood vessel.

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

S3, the loader 3 provided with the blood flow guiding device 1 and the delivery guide wire 2 is connected with the micro-catheter 4 through the connector 5.

Specifically, the loader 3 is connected to the connector 5, and the connector 5 is connected to the micro-catheter 4.

S4, the operator applies an axial force to the delivery guidewire 2 to deliver the blood flow guiding device 1 bound to the delivery guidewire 2 from the loader 3 to the micro-catheter 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 moves from the loading space of the loader 3 to the delivery space of the micro-catheter 4 and finally enters the blood vessel from the micro-catheter 4, and the blood flow guiding device 1 reconstructs the tumor-carrying blood vessel, thereby realizing the treatment of 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 method further comprises the following steps:

s5, when the blood flow guide device 1 is not released and the position of the blood flow guide device 1 needs to be adjusted, the operator applies an axial force to the delivery guidewire 2 to retract the blood flow guide device 1.

Specifically, the operator applies a distal-to-proximal force, which causes the blood flow directing device 1 to retract into the micro-catheter 4.

S6, adjusting the position of the micro-catheter 4 in the blood vessel.

Specifically, the microcatheter 4 is precisely positioned adjacent to the vascular aneurysm.

S7, the delivery guide wire 2 is pushed continuously, the blood flow guiding device 1 enters the blood vessel from the micro-catheter 4, and the blood flow guiding device 1 is released again.

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

Second embodiment of delivery System

Referring to the structures shown in fig. 11, 12, 13 and 14, the present embodiment differs from the first embodiment of the delivery system in that:

referring to fig. 14, the pushing member 64 for delivering a guide wire includes a pushing cylinder 641 and a plurality of pushing rods 642 disposed on the outer circumference of the pushing cylinder 641.

In this embodiment, a plurality of sets of push rods 642 are disposed at intervals in the axial direction of the push cylinder 641, and each set of push rods 642 includes a plurality of push rods 642 disposed at intervals in the circumferential direction of the push cylinder 641. In other embodiments, only one set of push rods 642 may be disposed in the axial direction of the push cylinder 641, and a plurality of push rods 642 may be disposed at intervals in the circumferential direction on the set of push rods 642. A plurality of sets of push rods 642 may be provided at intervals in the axial direction of the push cylinder 641, and only one push rod 642 may be provided in each set of push rods 642. Multiple sets of push rods 642 may be disposed at intervals along the axial direction of the push cylinder 641, and the number of the push rods 642 in each set of push rods 642 is selected according to the actual situation. Only one push rod 642 may be disposed on the outer periphery of the push cylinder 641. The specific configuration can be set according to the actual situation.

The push rod 642 protrudes out of the outer circumference of the push cylinder 641 in the radial direction of the mandrel. In this embodiment, the pushing rod 642 has a shape memory function and elasticity, and can extend 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 to move from the proximal end to the distal end. In other embodiments, the push rod 642 may not have elasticity.

In this embodiment, the push rod 642 is linear in a natural state. I.e. the push rod 642 extends in the radial direction of the mandrel in the natural state.

The push rod 642 is made of nickel titanium alloy. The nickel-titanium alloy is a shape memory alloy, which is a special alloy capable of automatically restoring the plastic deformation of the nickel-titanium alloy into the original shape at a certain specific temperature and has good plasticity.

With reference to fig. 11 and 12, the pushing principle of the pusher 64 is as follows:

when the delivery guidewire and blood flow guiding device 1 is pre-loaded into the loader, the push rod 642 on the pusher member 64 passes through the mesh opening at the distal end of the blood flow guiding device 1 and curves distally to hook over the blood flow guiding device 1. Therefore, when the guidewire is delivered to the distal end, the push rod 642 has a good anchoring force with the blood flow guiding device 1, and can effectively push the blood flow guiding device 1 to the distal blood vessel. Compared with the pushing completed by the friction force between the blood flow guiding device 1 and the conveying guide wire, the conveying guide wire can be more accurately conveyed to the preset position because the conveying guide wire hooks the blood flow guiding device 1. Meanwhile, the contact area between the blood flow guiding device 1 and the pushing member 64 is reduced, and the abrasion of the blood flow guiding device 1 is reduced.

The withdrawing member 65 is used to drive the blood flow guiding device 1 to move along the distal end to the proximal end, so as 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 provided at the outer periphery of the retracting cylinder 651.

The withdrawing cylinder 651 is sleeved on the periphery of the mandrel and is fixedly connected with the mandrel. Specifically, the retraction cylinder 651 is fixed to the outer periphery of the mandrel by fusion or bonding.

In this embodiment, a plurality of sets of retracting rods 652 are provided at intervals in the axial direction of the retracting cylinder 651, and each set of retracting rods 652 includes a plurality of retracting rods 652 provided at intervals in the circumferential direction of the retracting cylinder 651. In other embodiments, only one set of the retracting rods 652 may be provided along the axial direction of the retracting cylinder 651, and the plurality of the retracting rods 652 may be provided at intervals along the circumferential direction of the set of retracting rods 652. Multiple sets of retracting rods 652 may be provided at intervals along the axial direction of the retracting cylinder 651, and only one retracting rod 652 may be provided in each set of retracting rods 652. Multiple sets of the retracting rods 652 may be provided at intervals along the axial direction of the retracting cylinder 651, and the number of the retracting rods 652 in each set of the retracting rods 652 may be selected according to the actual situation. It is also possible to provide only one retracting rod 652 on the outer periphery of the retracting cylinder 651. The specific configuration can be set according to the actual situation.

The retracting rod 652 protrudes from the outer periphery of the retracting cylinder 651 in the radial direction of the spindle. In this embodiment, the retracting rod 652 has a shape memory function and elasticity, and can extend into the mesh holes 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 to move from the proximal end to the distal end. In other embodiments, the retraction rod 652 may not have any elastic properties.

In this embodiment, the retracting lever 652 is linear in a natural state. I.e. the retraction rod 652 extends in the radial direction of the mandrel in the natural state.

When the blood flow guiding device 1 is readjusted to withdraw the delivery guide wire, a part of the released blood flow guiding device 1 is constricted at the distal end opening of the micro-catheter 4 and a part of the meshes are penetrated one by the push rod 642 of the pushing member 64, at this time, the delivery guide wire is continuously withdrawn, and the withdrawing rod 652 of the withdrawing member 65 is limited by the inner diameter of the micro-catheter 4 and is bent to form a hook to withdraw the blood flow guiding device 1 into the micro-catheter 4 in a state of hooking the blood flow guiding device 1.

The retraction lever 652 is made of a material having a developing function. Specifically, the retraction rod 652 is made of thermoplastic polyurethane elastomer rubber, block polyether amide resin, or silicone rubber.

With reference to fig. 11 and 13, the position of the blood flow guiding device 1 by the retracting member 65 is adjusted as follows:

when the delivery guidewire and blood flow guiding device 1 are pre-loaded into the loader, the retraction rod 652 on the retraction member 65 passes through the mesh opening at the proximal end of the blood flow guiding device 1 and bends proximally to extend to hook the blood flow guiding device 1. When the blood flow directing device 1 is partially released within the vessel, the delivery guidewire may be withdrawn if the blood flow directing device 1 is not in place and the release site within the vessel needs to be readjusted. At this time, the delivery guidewire is withdrawn from the distal end to the proximal end, the proximal end of the blood flow guiding device 1 is hooked by the withdrawal member 65, the blood flow guiding device 1 is withdrawn into the micro-catheter 4, the position of the micro-catheter 4 in the blood vessel is adjusted, the micro-catheter is accurately positioned near the aneurysm of the blood vessel, and then the blood flow guiding device 1 is released from the micro-catheter 4 again. The contact area between the blood flow guiding device 1 and the retraction member 65 is reduced, and the abrasion of the blood flow guiding device 1 is reduced.

Compared with the blood flow guiding device 1 driven by friction force, the conveying guide wire in the embodiment uses the pushing member 64 to hook the blood flow guiding device 1 to drive the blood flow guiding device 1 to move, so that the conveying position of the blood flow guiding device 1 can be accurately positioned in the whole conveying process. The delivery guide wire further reduces the contact area between the blood flow guiding device 1 and the pushing member 64, and reduces the abrasion of the blood flow guiding device 1.

And the pushwire of this embodiment further comprises a retraction member 65 for proximally retracting the blood flow directing device 1 when it is positioned. The withdrawing member 65 also hooks the blood flow guiding device 1 to move the blood flow guiding device 1, so that the withdrawing accuracy is high, the contact area with the blood flow guiding device 1 is small, and the abrasion of the blood flow guiding device 1 is reduced.

Other features of the delivery system of this embodiment can be found in the first embodiment and will not be described in detail.

Third embodiment of delivery System

Referring to fig. 15, the difference between this embodiment and the second embodiment of the delivery system is:

the push rod 642 of the pusher 64 comprises a rod body 6421 and an extension 6422 in a natural state. In this embodiment, the push rod 642 has elasticity. In other embodiments, the push rod 642 may not have elasticity.

The rod 6421 extends in a radial direction. That is, one end of the rod 6421 is connected to the push tube 641, and the other end extends in the radial direction to make the rod 6421 protrude out of the outer circumference of the push tube 641.

The extending portion 6422 is disposed at the other end of the rod 6421 opposite to the pushing cylinder 641 and extends distally along the axial direction of the pushing cylinder 641. That is, the extension 6422 is located at the distal end of the shaft 6421.

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

After the blood flow guiding device 1 is released, it is expanded by its own expansion property, so that the braided wire 16 is released from the clamping groove, i.e. the pushing member 64 no longer hooks the blood flow guiding device 1.

The retraction rod of the retraction member of the delivery guidewire naturally includes a rod portion and an extension portion.

The rod body extends in the radial direction. That is, one end of the rod body is connected with the withdrawing cylinder, and the other end extends along the radial direction to make the rod body protrude out of the periphery of the withdrawing cylinder.

The extension part is arranged at the other end of the rod body relative to the retraction cylinder and extends towards the near end along the axial direction of the retraction cylinder. I.e. the extension is located at the proximal end of the shaft.

Specifically, the periphery, the rod body and the extension part of the retraction cylinder form a clamping groove, and the braided wire 16 of the blood flow guiding device 1 is located in the clamping groove, so that the retraction part hooks the blood flow guiding device 1, and therefore, when the conveying guide wire moves from the far end to the near end, the retraction part drives the blood flow guiding device 1 to move towards the near end.

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

Fourth embodiment of delivery System

Referring to the structures shown in fig. 16, 17 and 18, the present embodiment differs from the third embodiment of the delivery system in that:

referring to fig. 16, the push rod 642 of the pusher 64 includes a rod body 6421 and a protrusion 6423 in a natural state.

The rod 6421 extends in the radial direction of the push cylinder 641 in a natural state.

The projection 6423 is provided on the side of the rod 6421 facing the distal end, and projects in the distal direction. And a protrusion 6423 is disposed at the other end of the rod 6421 opposite to the push cylinder 641.

Referring to fig. 17, when the delivery guidewire and blood flow directing device 1 are in the loader 3, the end of the shaft 6421 away from the pushing cylinder 6411 is bent distally, the projection 6423 passes through the mesh of the blood flow directing device 1 and catches the braided wire 16 of the blood flow directing device 1, and the projection 6423 can provide further pushing force by snapping. And the projections 6423 also prevent the braided wire 16 from escaping the pusher member 64.

The retracting lever 652 includes a lever body 6521 and a projection 6523 in a natural state.

The lever 6521 naturally extends in the radial direction of the retraction cylinder 651.

The protrusion 6523 is provided on a proximal side of the rod 6521 and protrudes in the proximal direction. And the projection 6523 is provided at the other end of the lever 6521 with respect to the retracting cylinder 651.

Referring to fig. 18, when the delivery guidewire and blood flow directing device 1 are positioned in the shuttle 3, the end of the shaft 6521 distal to the retraction barrel 651 is bent proximally, the protrusion 6523 passes through the mesh of the blood flow directing device 1 and catches the braided wire 16 of the blood flow directing device 1, and the protrusion 6523 may provide further retraction force by snapping. And the projections also prevent the braided wire 16 from escaping the retractor.

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

Fifth embodiment of delivery System

Referring to the structure shown in fig. 19 and 20, the present embodiment differs from the fourth embodiment of the delivery system in that:

referring to fig. 20, the withdrawing rod 652 includes a rod body 6521, an extending portion 6522 and a protrusion 6523 in a natural state.

In this embodiment, the retracting rod 652 has elasticity. In other embodiments, the retraction rod 652 may also be non-resilient.

The lever 6521 naturally extends in the radial direction of the retraction cylinder 651.

The extension 6522 is provided at the other end of the rod 6521 with respect to the retraction cylinder 651, and extends proximally in the axial direction of the retraction cylinder 651. That is, the extension 6522 is located at the proximal end of the shaft 6521.

The protruding portion 6523 is provided on the side of the extending portion 6522 facing the retracting cylinder 651, and protrudes in a direction approaching the retracting cylinder 651.

Referring to fig. 18, when the delivery guidewire and blood flow directing device 1 are positioned in the shuttle 3, the extension 6522 and the projection 6523 pass through the mesh of the blood flow directing device 1 and the projection 6523 catches the braided wire 16 of the blood flow directing device 1, the projection 6523 may further provide a withdrawal force by snapping. The projections 6523 also prevent the braided wire 16 from escaping the retractor 65.

The pusher 64 for delivering the guide wire according to this embodiment can refer to the fourth embodiment, and other features of the delivery guide wire such as the structure of the mandrel 61, the first visualization element 621, the second visualization element 622, and the pushing mark 63 can refer to the fourth embodiment, which will not be described in detail.

Sixth embodiment of delivery System

Referring to the structures shown in fig. 21, 22, 23 and 24, the present embodiment differs from the second embodiment of the delivery system in that:

the push rod 642 of the pusher is further provided with a groove 643 at a side facing the distal end. The groove 643 opens distally.

The shape of the groove 643 may be an arc shape or a square shape. Illustratively, as shown in fig. 21 and 23, the groove 643 is arcuate in shape. As shown in fig. 22 and 24, the groove 643 has a square shape.

The grooves 643 may start from an end portion or from a middle portion. For example, as shown in fig. 21 and 22, the pusher is opened from one end to the other end when the groove 643 is opened. As shown in fig. 23 and 24, when the groove 643 is opened, the pusher extends from the middle region to the other end of the pusher, and the end position is also in the middle region.

The groove 643 is configured such that the push rod 642 is easily bent toward the distal end and not easily bent toward the proximal end, and thus the push rod 642 is difficult to be detached from the mesh of the blood flow guiding device 1, and the anchoring force of the push rod 642 is ensured.

Other features of the delivery system of this embodiment can be found in the first embodiment and will not be described in detail.

Seventh embodiment of delivery System

This embodiment differs from the second embodiment of the delivery system in that:

a groove is formed in one side surface of the retraction rod of the retraction piece towards the proximal end. The recess opens proximally.

The shape of the groove can be arc-shaped or square.

The grooves may start from the ends or from the middle.

The setting of recess for the withdrawal pole is easy to the near-end crooked, and is not flexible to the distal end, and then makes the withdrawal pole be difficult to break away from in the mesh of blood flow guider 1, has guaranteed the anchoring force of withdrawal pole.

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

Eighth embodiment of delivery System

Referring to the structure shown in fig. 25, the difference between this embodiment and the second embodiment of the delivery system is:

the loading cylinder 71 has a plurality of first guide grooves 711 formed in the inner periphery thereof. The plurality of first guide grooves 711 are provided at intervals in the circumferential direction of the loading cylinder 71, and are provided in one-to-one correspondence with the push rods 642 provided on the outer periphery of the push cylinder 641.

Specifically, the first guide groove 711 extends in the axial direction of the loading barrel 71, i.e., the first guide groove 711 extends through the proximal end and the distal end of the loading barrel 71.

The depth of the first guide groove 711 in the radial direction of the loading cylinder 71 is smaller than the length of the push rod 642 in the radial direction, so that after the push rod 642 is bent, a part of the push rod 642 is still in contact with the blood flow guiding device 1. The curved portion of the push rod 642 is located in the first guide groove 711 and slides in the first guide groove 711, ensuring that the curved portion does not change its curved direction during sliding, i.e., ensuring that the push rod 642 curves distally.

Moreover, the arrangement 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 deliver the blood flow guiding device 1.

The inner periphery of the micro-catheter 4 is provided with a plurality of second guide grooves. The plurality of second guide grooves are provided at intervals in the circumferential direction of the micro duct 4, and are provided in one-to-one correspondence with the first guide grooves 711.

The structure of the second guiding groove can refer to the structure of the first guiding groove 711, which is not described herein.

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

Ninth embodiment of delivery System

This embodiment differs from the first embodiment of the delivery system in that:

the blood flow directing device of this embodiment further comprises a polymer coating overlying the surface of the stent.

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

The polymer coating has certain firmness, and can not be dissolved, damaged or shed in simulated body fluid for at least two weeks. Therefore, after the blood flow guiding device is implanted into a human body and before endothelialization, the anticoagulation effect is continuously performed, and the risk of thrombosis is reduced. The specific in vitro evaluation method comprises the following steps: placing the blood flow guiding device, namely the stent covered with the polymer coating, into a PBS solution with a certain volume to ensure that the blood flow guiding device is completely immersed, oscillating at 100r/min in a water bath shaker at 37 ℃, taking out a sample after 14 days, and observing the polymer coating on the surface of the stent.

Wherein the thickness of the polymer coating is 5-1000 nm. Further, the polymer coating has a thickness of 10-100 nm. The thinner the thickness of the polymer coating, the smaller the particles that are released during use, and the less risk of causing thrombosis.

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

Wherein, the structural formula A is:

structural formula B is:

the functional group of-Si-O-Si-in the structural formula A is mainly formed by chemical reaction after a polymer solution is coated on the surface of the stent, and plays a role in curing, so that the polymer coating is firm and tightly adhered to the stent.

The functional group in the structural formula B mainly plays a role in anticoagulation.

Wherein, the anticoagulation effect of the blood flow guiding device can be evaluated in an in vitro mode. The method comprises the following specific steps: taking fresh pig blood, adding a certain amount of heparin, then soaking the blood flow guiding device, namely the stent covered with the polymer coating, in the blood for 1h, then taking out the stent, and observing the thrombus condition on the surface of the blood flow guiding device.

The preparation method of the polymer coating comprises the following steps:

s1, dissolving the polymer raw material by using a solvent to obtain a coating solution.

And S2, activating the surface of the stent to form more hydroxyl groups (-OH).

And S3, coating the coating solution on the surface of the stent.

S4, placing the stent coated with the coating solution in a moisture-containing environment, and enabling the coating solution to perform chemical reaction on the surface of the stent and solidify to form the polymer coating.

The polymer raw material used for preparing the coating solution can be copolymerized by two or more than two monomers.

Illustratively, the polymer feedstock structure in the coating solution is shown in the following figure:

wherein a, b, c and d represent the number of corresponding functional groups, respectively. a determines the anticoagulation effect of the polymer coating, d determines the degree of crosslinking of the polymer coating, directly influences the firmness of the polymer coating, and b and c influence the comprehensive performance of the polymer coating.

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

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

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

The blood flow guiding device in the embodiment is characterized in that the polymer coating covers the surface of the stent, and meshes of the stent are covered by the polymer coating, so that thrombus generated by contact of the blood flow guiding device and blood when entering a blood vessel is reduced, and the safety of a product is improved. And the polymer coating also has an anticoagulation effect, so that the product safety is further improved.

The polymer coating can also be used for products of blood vessel stents for treating blood vessel stenosis, devices for plugging or implanted devices related to treating valvular diseases, namely the polymer coating is covered on the surface of the products. The substrate of the product can be nickel-titanium alloy material, stainless steel, iron alloy, magnesium alloy, polylactic acid, polyether ether ketone, polyethylene or biological valve material. Other features of the delivery system of this embodiment can be found in the first embodiment and will not be described in detail.

According to the technical scheme, the invention has at least the following advantages and positive effects:

the delivery system of the present invention connects the microcatheter and the loader via a connector, with the distal end of the loader extending into the connector and the proximal end of the microcatheter extending into the connector. The connector has axial restraint to the loader to provide the holding power, make the loader can straighten as far as possible in the axial, be convenient for carry the blood flow guider to in the little pipe, and then promote the efficiency that the blood flow guider reachd the pathological change department.

Furthermore, the near end and the far end of the blood flow guiding device both adopt a horn mouth structure, the length of the near-end horn mouth is larger than that of the far-end horn mouth, and the coverage rate of the near-end horn mouth is larger than that of the far-end horn mouth, so that the sparse structure of the far-end horn mouth not only facilitates the blood flow guiding device to be installed in the loader, but also can reduce the risk of blocking branch vessels. The radial supporting force provided by the compact structure of the near-end bell mouth is large, and the structure is compact, so that after the near-end bell mouth is automatically expanded and attached to the wall of a blood vessel, the risk of a single braided wire penetrating into the blood vessel is small, and the risk of penetrating into the blood vessel is reduced. And the sparse and dense weaving structure of the far-end bell mouth and the near-end bell mouth ensures that the blood flow guiding device can provide effective supporting force at different vessel diameters at two sides of the aneurysm. The specific technical means in the above embodiments can be applied to each other.

While the present invention has been described with reference to several exemplary embodiments, it is understood that the terminology used is intended to be in the nature of words of description and illustration, rather than of limitation. As the present invention may be embodied in several forms without departing from the spirit or essential characteristics thereof, it should also be understood that the above-described embodiments are not limited by any of the details of the foregoing description, but rather should be construed broadly within its spirit and scope as defined in the appended claims, and therefore all changes and modifications that fall within the meets and bounds of the claims, or equivalences of such meets and bounds are therefore intended to be embraced by the appended claims.