CN113116594A

CN113116594A - Blood flow guiding device and treatment device comprising same

Info

Publication number: CN113116594A
Application number: CN201911390539.1A
Authority: CN
Inventors: 孟繁鹤; 管生; 雷文斌; 候娟; �田�浩; 张涵
Original assignee: Microport Neurotech Shanghai Co Ltd
Current assignee: Microport Neurotech Shanghai Co Ltd
Priority date: 2019-12-30
Filing date: 2019-12-30
Publication date: 2021-07-16

Abstract

The present invention relates to a blood flow guiding device and a treatment device including the blood flow guiding device, wherein the blood flow guiding device comprises: the stent comprises a stent and a covering film, wherein the near end of the covering film is arranged on the stent, and the far end of the covering film is a free end. The stent is short, the covering membrane is long, and the far end of the covering membrane is in a free state. Compare in traditional covered stent, increased the compliance of support, reduced the propelling movement resistance of support, increased the support and passed through the ability of tortuous blood vessel, reduced covered stent conveying system's size. The blood flow guiding device can be conveyed to a finer lesion position of a blood vessel at a farther intracranial end through a micro catheter.

Description

Blood flow guiding device and treatment device comprising same

Technical Field

The invention relates to the technical field of medical instruments, in particular to a blood flow guiding device and a treatment device comprising the same.

Background

With the rapid development of national economy in China, the living standard of people is increasingly improved, and cardiovascular and cerebrovascular diseases become common diseases seriously threatening the life health of people due to factors such as bad living habits, continuously accelerated aging process of population and the like, and the tendency of aging is developed. According to the statistics of the world health organization, the number of deaths caused by cardiovascular and cerebrovascular diseases in China is up to 300 ten thousand every year, and accounts for 51 percent of the total deaths caused by China every year. The number of people who die of cardiovascular and cerebrovascular diseases every year in the world is as high as 1500 thousands of people, and the people live at the first position of various causes of death.

Intracranial Aneurysm (IAN) is a common hemorrhagic cerebrovascular disease, frequently occurs on the wall of Intracranial arterial blood vessels, is the most common cause of Subarachnoid hemorrhage (SAH), and has the incidence rate second to cerebral thrombosis and hypertensive cerebral hemorrhage. At present, Intracranial Aneurysms (IAN) are usually treated by intravascular intervention, mainly by spring coil embolization therapy, dense mesh stent therapy and covered stent therapy.

The spring coil embolism for treating intracranial aneurysm is an intravascular intervention technology which is widely applied, but for huge and wide-necked aneurysms, vesicular aneurysms, microaneurysms, fusiform aneurysms and dissected aneurysms of intracranial arteries, spring coil embolism and stent-assisted spring coil embolism still have the problems of low postoperative complete occlusion rate, high long-term follow-up recurrence rate, rupture and bleeding of the aneurysm during operation and the like, and ideal treatment effect is difficult to obtain.

The reason is that the dense packing spring ring of the intracranial giant aneurysm is easy to generate an occupying effect, and part of the aneurysm can not be densely packed; wide-necked aneurysms fill the remaining neck of the aneurysm; the wall of the hemangiosa aneurysm is thin, a complete three-layer arterial vessel structure is not formed, and a micro guide wire, a micro catheter and a spring ring touch the fragile aneurysm wall during operation, so that intraoperative hemorrhage is easily caused, and the disability rate and the fatality rate are high; the micro-aneurysm spring ring is difficult to stay in the aneurysm cavity, and part of the spring ring is easy to protrude into the parent artery; fusiform aneurysm and dissection aneurysm, the tumor cavity form is irregular, the tumor cavity has no obvious boundary with normal blood vessel cavity, and the support auxiliary spring ring can not carry out effective lumen remodeling in the fusiform aneurysm.

The dense-mesh stent therapy promotes the blood retention and slow thrombosis in the aneurysm by changing the blood flow direction, promotes the proliferation of endothelial cells and neointimal tissue in the stent, and plays a role in repairing the parent artery after a certain period by means of the gradual intimation of the neck of the aneurysm, thereby achieving the purpose of curing the pathological changes. However, the dense mesh stent therapy has the following problems: (1) after the stent is released, the stent is easy to shift and the shortening of the stent is difficult to expect; (2) the delayed rupture of the aneurysm is easy to cause, the exact reason of the delayed rupture is not completely clear, and the delayed rupture is related to that the neck opening of the aneurysm cannot realize immediate effective blocking; (3) there is a risk of rupture of the aneurysm or recurrence of the aneurysm after surgery.

The dense-mesh stent is used for treating the blood-bubble-like aneurysm and the fusiform aneurysm, and a multi-stent overlapping technology is widely used. But the treatment effect of the multi-stent overlapping technology is uncertain, the number of the used stents is 2-5, the economic burden of a patient is large, the operation time is long, the operation process is complex, and a certain recurrence rate still exists after the operation.

The treatment idea of the covered stent for treating the intracranial aneurysm is changed from 'intratumoral filling' of a spring ring to 'intracavity isolation', the treatment strategy is to embed the covered stent in a blood vessel under the condition of not using the spring ring, and a biological-physical barrier is embedded in a parent artery, so that the parent artery is remodeled in the parent artery and the parent artery is kept smooth, the intracranial aneurysm is isolated from the systemic circulation, and thrombus is formed in the parent artery, thereby achieving the purpose of curing lesion.

The covered stent has more outstanding advantages in the treatment of wide-neck, huge, blood-bubble-like, micro, fusiform and sandwich aneurysms without adjacent important branch vessels, can isolate a tumor cavity from a blood vessel cavity, can immediately seal the tumor neck and change the hemodynamics in a parent artery, realizes the real vascular reconstruction, avoids the risks of rupture and bleeding of the aneurysms caused by the contact of a micro guide wire, a micro catheter and a spring ring with a fragile tumor wall in the operation, strengthens the repair of the parent artery, can avoid the residue of the aneurysms neck, avoids and relieves the space occupying effect of the spring ring after filling operation, and avoids the relapse, the recanalization and the rupture bleeding of the postoperative aneurysms.

A typical intracranial covered stent on the existing market is a spherical expansion type laser carving stent, generally consists of a cobalt-based alloy stent and a polytetrafluoroethylene membrane sewn on the outer side of the stent, wherein the stent is arranged on a rapid exchange type balloon catheter in advance and is conveyed and released by the balloon catheter. Such a stent has the following problems: (1) failure of the covered stent in place: the laser engraving type cobalt-based alloy stent has poor flexibility, is often difficult to conform to intracranial tortuous vessels, and cannot ensure that the stent can smoothly reach a diseased part; (2) the balloon is easy to damage the blood vessel: the stent is placed at a blood vessel section with obvious tortuosity, and the tortuosity blood vessel is straightened when the saccule is expanded, so that the blood vessel wall is torn or the branch artery at the part is torn and damaged, and fatal hemorrhage is caused; in addition, the expansion of the balloon also damages cells on the inner wall of the blood vessel, so that neointimal tissue is formed, and stent stenosis is caused; (3) poor flexibility: after the stent is expanded, the stent can not be recovered again, and is difficult to move back and forth in the blood vessel, and if the stent is not accurately in place, the stent is difficult to adjust again.

Therefore, the intracranial covered stent is urgently needed to be improved, has better flexibility, can be applied to the pathological changes of intracranial distal blood vessels, does not need to be expanded and released by a saccule, and reduces the damage of the stent to arterial blood vessels and endothelial cells in the releasing process.

Disclosure of Invention

In view of the above-mentioned shortcomings of the prior art, it is an object of the present invention to provide a blood flow guiding device and a treatment device comprising the same, which can reduce the damage to arterial blood vessels and endothelial cells, is more flexible, has less push resistance, less volume to be compressed, and has stronger ability to pass through tortuous blood vessels, and can reach the farther end lesion sites in the cranium.

The present invention provides a blood flow guiding device, comprising: the stent comprises a stent and a covering film, wherein the near end of the covering film is arranged on the stent, and the far end of the covering film is a free end.

Further, in the above blood flow guiding device, the material of the covering film is at least one selected from degradable polymers and non-degradable polymers.

Further, in the blood flow guiding device, the surface of the covering film is provided with a plurality of micropores with the diameter of 10 to 200 mu m.

Further, the blood flow guiding device may further include a first visualization element provided at a distal end of the cover film.

Further, in the blood flow guiding device, the first developing element may include a developing sheet and/or a spray developing material.

Further, the blood flow guiding device further comprises a second visualization element, and the second visualization element is arranged at the proximal end of the bracket.

Further, in the above blood flow guiding device, the support comprises a plurality of wave bars connected with each other, and distal ends of the wave bars at the farthest ends intersect with each other two by two and form at least 2 closed ends.

Further, in the blood flow guide device, the plurality of wave bars form at least 2 connection points, the plurality of wave bars form an XX-type structure which is continuous in the circumferential direction of the blood flow guide device, and at least 2 connection points are offset from each other in the axial direction of the blood flow guide device.

Further, in the above blood flow directing device, at least 2 of the closed ends have different axial distances from the proximal end of the stent.

Further, in the above blood flow guiding device, the holder has a closed loop structure.

Further, in the above blood flow guiding device, the proximal end of the stent is a beveled opening, and an angle between the beveled opening and the axial direction of the blood flow guiding device is 20 to 60 degrees.

Further, in the blood flow guide device, the stent has a length of 5mm to 20mm, and the cover has a length of 5mm to 60 mm.

Further, in the above blood flow guiding device, the material of the stent includes a super elastic material.

Furthermore, the blood flow guiding device further comprises a supporting wire arranged at the far end of the bracket, and the supporting wire extends along the axial direction of the blood flow guiding device.

Furthermore, in the above blood flow guiding device, a through hole is formed at the top end of the wave rod at the farthest end in the support, and the support wire is twisted and formed into a strip-shaped structure after passing through the through hole;

alternatively, the first and second electrodes may be,

the supporting wires are twisted together after being wound at the top end of the wave rod at the farthest end of the bracket and form a strip-shaped structure;

alternatively, the first and second electrodes may be,

the at least two supporting wires respectively penetrate through the bottom end of the wave rod at the farthest end in the bracket and are wound to the top end of the wave rod at the farthest end along the wave rod at the farthest end, and the at least two supporting wires are twisted at the top end of the wave rod at the farthest end in a doubling and twisting mode to form a strip-shaped structure;

alternatively, the first and second electrodes may be,

the bottom end of the wave rod at the farthest end is provided with a connecting rod, a spring structure is wound on the connecting rod, at least two supporting wires are inserted into a gap between the spring structure and the connecting rod, the supporting wires, the connecting rod and the spring structure are mutually connected through welding or bonding, and one supporting wire arranged on each connecting rod is doubled and twisted with one supporting wire arranged on the other connecting rod to form a strip-shaped structure.

Further, in the above blood flow guiding device, the cover film may be provided on an inner wall or an outer wall of the stent, or may be provided on all or part of the wave lever.

Further, in the above blood flow guiding device, the proximal end of the stent is a beveled opening, the covering film is disposed on the inner wall of the stent, the beveled opening and a part of the outer wall of the stent are covered by the proximal end of the covering film from inside to outside, and the closed end is exposed outside the covering film;

alternatively, the first and second electrodes may be,

the near end of the stent is a slope opening, the coating is arranged on the outer wall of the stent and covers the closed tail end, and the near end of the coating wraps the slope opening and part of the inner wall of the stent from outside to inside.

Further, in the above blood flow guiding device, the distal end of the support wire is provided with the first third visualization element, and the first third visualization element is flush with the distal end of the covering film at the same axial position of the blood flow guiding device.

Further, in the blood flow guide device, an elastic modulus of the support wire is larger than an elastic modulus of the cover film;

and/or the presence of a gas in the gas,

the supporting wire is at least one of a nickel-titanium alloy wire, a nickel-titanium wire with a developing core material inside, a cobalt-chromium alloy wire and a polylactic acid wire.

The invention provides a treatment device, which comprises a conveying pipe and the blood flow guiding device of any one of the preceding items; the conveying pipe is provided with an inner cavity which is axially communicated and is used for accommodating the blood flow guiding device, and the wall of the inner cavity extrudes the blood flow guiding device so as to enable the blood flow guiding device to be in a compressed state; the lumen has a radial dimension of 0.017 inches to 0.029 inches.

The blood flow guiding device of the present invention comprises: the stent comprises a stent and a covering membrane, wherein the near end of the covering membrane is arranged on the stent, the stent is short, the covering membrane is long, and the far end of the covering membrane is a free end and is in a free state. Compare in traditional covered stent, increased the compliance of support, reduced the propelling movement resistance of support, increased the support and passed through the ability of tortuous blood vessel, reduced covered stent conveying system's size.

Drawings

FIG. 1 is a schematic diagram illustrating the components of a blood flow directing device according to an embodiment of the present invention;

FIG. 2 shows a schematic diagram of a stent structure comprising 2 closed ends according to an embodiment of the present invention;

FIG. 3 shows a schematic representation of a stent structure comprising 3 closed ends according to an embodiment of the present invention;

FIG. 4 is a schematic view showing the support wires of the embodiment of the present invention passing through the top through holes of the most distal wave bars in the stent and then twisted together to form a strip-like structure;

FIG. 5 is a schematic view showing an embodiment of the invention where the support wires are twisted and formed into a strip-like configuration after being wound around the distal-most wave bar tip of the stent;

FIG. 6 is a schematic view showing two support wires of an embodiment of the present invention wound around the wave bars at the junction of the bottom ends of the most distal wave bars in the stent and extending to the top ends of the most distal wave bars where the wires are twisted and formed into a strip-like structure;

FIG. 7 is a schematic diagram showing a structure in which a connecting rod is arranged at the bottom end of the most distal wave rod and a spring is wound on the connecting rod according to the embodiment of the invention;

FIG. 8 shows a schematic view of a stent having a stent graft attached to an inner wall thereof according to an embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

In the description of the present invention, it is to be understood that the terms "center", "lateral", "upper", "lower", "left", "right", "vertical", "horizontal", "top", "bottom", "inner" and "outer" etc. indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplicity of description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed in a particular orientation, and be operated, and thus, are not to be construed as limiting the present invention.

The blood flow guiding device claimed by the embodiments of the present invention will be described in detail with reference to the accompanying drawings. In this application, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions with respect to each other from the perspective of a physician using the product, although "proximal" and "distal" are not intended to be limiting, but "proximal" generally refers to the end of the product that is closer to the physician during normal operation, and "distal" generally refers to the end that is first introduced into the patient.

A blood flow directing apparatus as shown in figure 1, comprising: support 3 and tectorial membrane 2, the near-end setting of tectorial membrane 2 is in on the support 3, support 3 is shorter, and tectorial membrane 2 is longer, just the distal end of tectorial membrane 2 is the free end, and the free end is not connected or overlaps mutually with support 3 promptly, is free state. Compare in traditional covered stent, increased the compliance of support 3, reduced support 3's propelling movement resistance, increased support 3 and passed through tortuous blood vessel's ability, reduced covered stent delivery system's size. The material of the film 2 of this embodiment is selected from at least one of degradable polymers and non-degradable polymers, such as polyester, polytetrafluoroethylene, Polyurethane (PU) or polyethylene terephthalate (PET). The length of the coating 2 of this example is in the range of 5mm to 60 mm. The surface of the covering film 2 is provided with a plurality of micropores with the diameter of 10 to 200 mu m. The shape of the micropores in the coating film 2 is not limited in the present invention, and may be a circle, a quadrangle, a triangle, or other regular or irregular shape, and the arrangement of the micropores in the coating film 2 is not limited in the present invention, and may be a uniform distribution arrangement, a non-uniform distribution arrangement, or the like.

The present embodiment further includes a first developing element 5, and the first developing element 5 is disposed at the distal end of the coating film 2, and is used to display the distal end boundary of the coating film 2. Preferably, the first developing member 5 includes a developing sheet and/or a sprayed developing material.

The embodiment further comprises a second developing element 6, wherein the second developing element 6 is arranged at the proximal end of the bracket 3 and is used for displaying the opening condition of the bracket 3.

The stent 3 comprises a plurality of interconnected wave bars 302, and the distal ends of the wave bars 302 at the most distal ends intersect two by two and form at least 2 closed ends 303. The closed end 303 may assume a V-shape, U-shape, sinusoidal waveform, parabolic shape, etc.

In this embodiment, the wave bars 302 are formed with at least 2 connection points, the wave bars 302 form a continuous XX-type structure in the circumferential direction of the blood flow guiding device, and at least 2 connection points are offset from each other in the axial direction of the blood flow guiding device, that is, the projections of the at least 2 connection points on a plane parallel to the axial direction of the blood flow guiding device are not on the same straight line perpendicular to the axial direction of the blood flow guiding device. The design enables the compressed profile of the support 3 to be smaller, and the functions of reducing the pushing resistance and the recovery resistance of the support 3 can be achieved.

The axial distance between at least 2 of the closed ends 303 of this embodiment and the proximal end of the stent 3 is different, so that the compressed closed end regions are axially staggered, reducing the compressed volume at the distal end, enabling a smaller delivery system to be adapted.

As shown in fig. 2, in an embodiment of the present invention, the proximal link 301 is disposed on the left side of the stent 3, and the 2 closed ends 303 are disposed on the right side of the stent 3, which reduces the amount of metal by reducing the number of the closed ends 303, and the compressed profile of the stent 3 is smaller by the axially displaced connecting point of the wave lever (shown at A, B), thereby functioning to reduce the pushing and retrieving resistance of the stent 3.

In another embodiment of the present invention, as shown in fig. 3, the stent 3 has 3 closed ends 303 on the right side, which are uniformly arranged in the circumferential direction to provide uniform radial force to the cover membrane 2 in the circumferential direction to ensure that the cover membrane 2 is adhered to the wall. The 3 closed ends 303 of this embodiment are different in length in the axial of blood flow guiding device, and closed ends 303 stagger in the axial after compressing into conveying system, have reduced the distal compressed volume, can adapt to littleer conveying system.

One of the at least 2 connection points of the present invention may be provided as a separate structure, where the separation of the connection points means that a plurality of said wave bars 302 abut or are close to each other, but are not connected or only part of the wave bars 302 are connected. For example, along the dotted line in fig. 3, in which the stent 3 has an open ring shape, the compressed volume of the stent 3 can be further reduced.

The material of the stent 3 in this embodiment includes super elastic material, and can be woven or cut, and is preferably a cut stent. Superelastic materials refer to materials having a non-linear stress-strain relationship that automatically recover from strain when unloaded, such as nitinol materials. Specifically, the stent 3 can be formed by laser cutting a nickel-titanium alloy tube, and is in a super-elastic state at body temperature after heat treatment, and the radial support force is large. The embodiment uses the nickel-titanium alloy self-elastic material, the stent 3 can be opened to adhere to the wall by self-elasticity, the balloon is not used for conveying, and the problem of fatal bleeding caused by tearing of the blood vessel wall or tearing and damage of the branch artery at the part of the blood vessel wall due to straightening of the tortuous blood vessel during the expansion of the balloon is avoided.

The stent 3 of the embodiment is of a closed loop structure, and can be completely recycled to the microcatheter and also released. Preferably, the proximal end of the stent 3 is an oblique groove, that is, the stent 3 adopts a single-point electrolytic detachment design, so that detachment and recovery are more convenient. The design of the oblique groove at the near end of the stent 3 in the embodiment is not limited by the shape of the blood vessel, and the oblique groove does not bend, adheres well to the wall, and ensures that the head end of the film adheres to the wall. And the single-point release and recovery stent 3 has small influence on blood flow in the lumen, and can judge whether the stent 3 leaks inwards after being released before being released. This embodiment is flexible and can be repeatedly retrieved for release to adjust the position of the device in the blood vessel. The angle between the oblique groove and the axial direction of the blood flow guiding device is 20-60 degrees. The length d of the bracket 3 is 5 mm-20 mm.

As shown in fig. 1, the present invention further includes a support wire 4 disposed at the distal end of the stent 3, wherein the support wire 4 extends in the axial direction of the blood flow guiding device. The elastic modulus of the supporting wire 4 in the embodiment is larger than that of the covering film 2, and the supporting wire has certain deformability. In this embodiment, the supporting wire 4 is selected from at least one of a nickel-titanium alloy wire, a nickel-titanium wire with a developing core material (tantalum core or platinum core) inside, a cobalt-chromium alloy wire, and a polylactic acid wire, and mainly plays roles of stress transition, supporting the film 2, and developing.

In order to enhance the supporting and visualization effects, the supporting wires 4 of the present embodiment may be twisted together, and a third visualization element 7 is additionally disposed at the distal end of the supporting wires, where the third visualization element 7 and the distal end of the covering film 2 are at the same axial position of the blood flow guiding device, so as to display the distal boundary of the covering film 2, and achieve the purpose of displaying the length of the covering film 2.

The support wire 4 may be a woven wire or a monofilament wire, which is not limited in the present invention. The support wires 4 have a diameter of 0.001 inch to 0.002 inch.

In one embodiment of the present invention, as shown in fig. 4, the top end of the wave rod 302 at the most distal end of the stent 3 is provided with a through hole, and the support wire 4 is twisted spirally and forms a strip-like structure after passing through the through hole, wherein the strip-like structure is parallel to the axial direction of the blood flow guiding device.

In another embodiment of the present invention, as shown in fig. 5, the supporting wires 4 are twisted and formed into a strip-like structure after being wound around the top end of the wave bar 302 at the most distal end of the stent 3.

In yet another embodiment of the present invention, as shown in fig. 6, at least two support wires 4 respectively pass through the bottom end of the most distal wave rod 302 in the stent 3, and are wound along the most distal wave rod 302 to the top end of the most distal wave rod 302, and the at least two support wires 4 are combined at the top end of the most distal wave rod 302 and are twisted to form a strip-shaped structure. The two supporting wires 4 can also be formed by folding and separating one supporting wire 4.

It should be noted that, in this embodiment, the two support wires 4 are respectively located on the inner side and the outer side of the top end of the wave rod 302 at the farthest end, and may not be on the same side, and if the two support wires 4 are located on the same side of the top end of the wave rod 302 at the farthest end, the starting point of the kink of the support wire 4 may not be fixed, and the function of enhancing support or releasing stress may not be achieved.

Preferably, the present embodiment may weld a developing coil at the distal end of the strip-shaped structure, so that the stent 3 presents a continuous YY/YYY type developing pattern in the circumferential direction of the blood flow guiding device under fluoroscopy, and the developing effect is good.

In yet another embodiment of the present invention, as shown in fig. 7, a connection rod 305 is disposed at the bottom end of the wave rod 302 at the farthest end, a spring structure 306 is wound on the connection rod 305, at least two support wires 4 are inserted into a gap between the spring structure 306 and the connection rod 305, the support wires 4, the connection rod 305 and the spring structure 306 are connected to each other by welding or bonding, and one support wire 4 disposed on each connection rod 305 is twisted with one support wire 4 disposed on another connection rod 305 to form a strip-shaped structure, and the strip-shaped structures are spaced apart in the circumferential direction.

The spring structure 306 of the present embodiment is a developing spring for fixing the opening condition of the supporting wire 4 and the display stand 3. In other embodiments, the spring structure 306 may not be developed, but merely serves as a fixation.

The coating 2 of the present invention is disposed on the inner or outer wall of the stent 3, or on all or a portion of the wave bar 302. The fixing mode of the film 2 and the stent 3 or the wave rod 302 is sewing, hot melting, hot pressing, electrostatic spinning or the combination of one or more of the modes.

As shown in fig. 8, in an embodiment provided by the present invention, the proximal end of the stent 3 is a beveled opening, the covering membrane 2 is disposed on the inner wall of the stent 3, the beveled opening and a part of the outer wall of the stent 3 are covered by the proximal end of the covering membrane 2 from inside to outside through a hot melting process, and the closed end 303 is exposed outside the covering membrane 2.

In another embodiment provided by the present invention, the covering membrane 2 may also be disposed on the outer wall of the stent 3 and covers the closed end 303, and the proximal end of the covering membrane 2 is covered by the oblique groove and a part of the inner wall of the stent 3 from outside to inside through a hot melting process.

Preferably, the covering film 2 of the present invention may not completely cover the oblique groove, but cover all or part of the wave rod 302, and this covering mode significantly reduces the covering area of the oblique groove, and avoids the occlusion of the branch vessel caused by the covering film of the oblique groove.

The invention also provides a treatment device, which comprises a delivery pipe and the blood flow guiding device; the conveying pipe is provided with an inner cavity which is axially communicated, the inner cavity is used for accommodating the blood flow guiding device, and the wall of the inner cavity extrudes the blood flow guiding device so as to enable the blood flow guiding device to be in a compressed state. The lumen has a radial dimension of 0.017 inches to 0.029 inches. The blood flow guiding device can be conveyed by a microcatheter to reach a lesion position with thinner blood vessels at the far end in the cranium.

In conclusion, the blood flow guiding device provided by the invention has the advantages that the stent 3 can be opened to adhere to the wall by self-springing, balloon conveying is not used, and the problem of fatal bleeding caused by tearing of the blood vessel wall or tearing and damage of the branch artery at the part caused by straightening of the tortuous blood vessel during balloon expansion is avoided. Meanwhile, the blood flow guiding device claimed by the invention has smaller compression volume and better flexibility, and can reduce the damage to arterial blood vessels and endothelial cells and the pushing resistance in the releasing process. Compared with the prior art, the invention has stronger capability of passing through the tortuous vessels, can reach the farther end lesion position in the cranium, and further optimizes the current treatment method aiming at intracranial aneurysm.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A blood flow directing apparatus, comprising: the stent comprises a stent (3) and a coating (2), wherein the near end of the coating (2) is arranged on the stent (3), and the far end of the coating (2) is a free end.

2. The blood flow directing device according to claim 1, wherein the material of the cover membrane (2) is selected from at least one of degradable polymers and non-degradable polymers.

3. The blood flow guiding device according to claim 1 or 2, characterized in that the surface of the cover film (2) has a plurality of micropores with a diameter of 10 to 200 μm.

4. The blood flow guiding device according to claim 1 or 2, further comprising a first visualization element (5), the first visualization element (5) being arranged at a distal end of the cover membrane (2).

5. The blood flow guiding device according to claim 4, wherein the first visualization element (5) comprises a visualization foil and/or a spray visualization material.

6. The blood flow guiding device according to claim 1 or 2, further comprising a second visualization element (6), the second visualization element (6) being arranged at a proximal end of the stent (3).

7. The blood flow directing device according to claim 1, wherein the stent (3) comprises a plurality of interconnected wave bars (302), the distal ends of the most distal wave bars (302) intersecting two by two and forming at least 2 closed ends (303).

8. The blood flow guiding device according to claim 7, wherein a plurality of wave bars (302) are formed with at least 2 connection points, and a plurality of wave bars (302) are formed in a continuous XX pattern in a circumferential direction of the blood flow guiding device, and at least 2 of the connection points are offset from each other in an axial direction of the blood flow guiding device.

9. The blood flow guiding device of claim 7, wherein the axial distance between at least 2 of the closed ends (303) and the proximal end of the stent (3) differs.

10. The blood flow guiding device of claim 1, wherein the stent (3) is a closed loop structure.

11. The blood flow guiding device according to claim 10, wherein the proximal end of the stent (3) is beveled, and the angle between the beveled edge and the axial direction of the blood flow guiding device is 20-60 degrees.

12. The blood flow guiding device according to claim 1, wherein the stent (3) has a length of 5mm to 20mm and the cover (2) has a length of 5mm to 60 mm.

13. The blood flow directing device according to claim 1, wherein the material of the stent (3) comprises a super-elastic material.

14. The blood flow guiding device according to claim 7, further comprising a support wire (4) disposed at a distal end of the stent (3), the support wire (4) extending in an axial direction of the blood flow guiding device.

15. The blood flow guiding device according to claim 14, characterized in that the top end of the wave rod (302) at the most distal end in the bracket (3) is provided with a through hole, and the supporting wires (4) are twisted and formed into a strip-shaped structure after passing through the through hole;

alternatively, the first and second electrodes may be,

the supporting wires (4) are twisted together after being wound at the top end of the wave rod (302) at the farthest end of the bracket (3) and form a strip-shaped structure;

alternatively, the first and second electrodes may be,

at least two supporting wires (4) respectively penetrate through the bottom end of the wave rod (302) at the farthest end in the bracket (3), and are wound to the top end of the wave rod (302) at the farthest end along the wave rod (302), and the at least two supporting wires (4) are combined at the top end of the wave rod (302) at the farthest end and are twisted to form a strip-shaped structure;

alternatively, the first and second electrodes may be,

the wave rod (302) is arranged at the bottom end of the farthest end, a connecting rod (305) is arranged at the bottom end of the wave rod (302), a spring structure (306) is wound on the connecting rod (305), at least two supporting wires (4) are inserted into a gap between the spring structure (306) and the connecting rod (305), the supporting wires (4), the connecting rod (305) and the spring structure (306) are connected with each other through welding or bonding, and one supporting wire (4) arranged on each connecting rod (305) is connected with one supporting wire (4) arranged on the other connecting rod (305) in a parallel twisting mode to form a strip-shaped structure.

16. The blood flow guiding device according to claim 7, wherein the cover (2) is arranged on an inner or outer wall of the stent (3) or on all or part of the wave lever (302).

17. The blood flow guiding device according to claim 16, wherein the proximal end of the stent (3) is obliquely beveled, the covering membrane (2) is arranged on the inner wall of the stent (3), the proximal end of the covering membrane (2) covers the obliquely beveled bevel and part of the outer wall of the stent (3) from inside to outside, and the closed end (303) is exposed on the outer side of the covering membrane (2);

alternatively, the first and second electrodes may be,

the near end of the stent (3) is an oblique groove, the coating (2) is arranged on the outer wall of the stent (3) and covers the closed tail end (303), and the near end of the coating (2) coats the oblique groove and part of the inner wall of the stent (3) from outside to inside.

18. The blood flow guiding device according to claim 14, wherein the distal end of the support wire (4) is provided with a third visualization element (7), the third visualization element (7) being at the same axial position of the blood flow guiding device as the distal end of the cover membrane (2).

19. The blood flow directing device according to claim 14, wherein the support wires (4) have a modulus of elasticity greater than the modulus of elasticity of the cover (2);

and/or the presence of a gas in the gas,

the supporting wires (4) are at least one selected from nickel-titanium alloy wires, nickel-titanium wires with developing core materials inside, cobalt-chromium alloy wires and polylactic acid wires.

20. A treatment device comprising a delivery tube and a blood flow directing device according to any one of claims 1 to 19; the conveying pipe is provided with an inner cavity which is axially communicated and is used for accommodating the blood flow guiding device, and the wall of the inner cavity extrudes the blood flow guiding device so as to enable the blood flow guiding device to be in a compressed state; the lumen has a radial dimension of 0.017 inches to 0.029 inches.