CN221308275U

CN221308275U - Turbulent flow device

Info

Publication number: CN221308275U
Application number: CN202322055203.8U
Authority: CN
Inventors: 李金峰; 张�杰
Original assignee: Juhui Medical Technology Shenzhen Co ltd
Current assignee: Juhui Medical Technology Shenzhen Co ltd
Priority date: 2023-08-01
Filing date: 2023-08-01
Publication date: 2024-07-12
Anticipated expiration: 2033-08-01

Abstract

The utility model discloses a turbulence device, wherein the turbulence device comprises an inner layer network management structure and an outer layer network management structure; the inner layer network management structure comprises an inner layer net, a first steel sleeve and a second steel sleeve, wherein the inner layer net is provided with a proximal end and a distal end which are oppositely arranged along the axial direction, the proximal end of the inner layer net is folded and fixed through the first steel sleeve, and the distal end of the inner layer net is folded and fixed through the second steel sleeve; the outer layer network management structure is sleeved outside the inner layer network management structure and is connected with the inner layer network management structure; the proximal end of the outer layer network management structure adopts a seal head-free structure. According to the technical scheme, the inner layer network management structure and the outer layer network management structure can provide a good blood flow guiding effect through the grid density, blood flow is guided to two sides outside the aneurysm, support auxiliary choking is not needed, the impact of blood flow on the wall of the aneurysm blood vessel is reduced, and therefore the risk of rupture and bleeding of the aneurysm is reduced.

Description

Turbulent flow device

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a turbulence device.

Background

Intracranial aneurysms are abnormal distensions formed by gradual expansion of intracranial arterial blood vessels due to local vascular wall damage caused by congenital anomalies or acquired injuries and other factors under the action of hemodynamic loads and other factors, are very common cerebrovascular diseases, and are about 900 ten thousands of patients in the United states, accounting for 3% of the total population. Subarachnoid hemorrhage of the brain occurs in more than 3 tens of thousands of people each year, 40% of which are fatal. In China, the detection rate of intracranial aneurysms is as high as 9%, and the disease is a cerebrovascular disease with incidence rate which is inferior to cerebral thrombosis and high-pressure cerebral hemorrhage.

Methods of treatment of intracranial aneurysms generally have two modes: one is craniotomy clamping, the traditional aneurysm clamping method can radically cure, but the risk of craniotomy is very large, the wound caused to a patient is large, and the recovery period is long; the other is interventional therapy, which reduces the impact of blood flow on the wall of the fluid vessel and reduces the risk of rupture by tumor embolism or blood flow-directed therapy. With the recent continued maturation of neuro-interventional techniques, interventional procedures have gradually replaced traditional surgical procedures, playing an irreplaceable role in the treatment of intracranial aneurysms.

Currently, coils and blood flow guides have become two typical instruments for treating aneurysms. The coil interventional embolization is the most widely used aneurysm treatment means in clinic at present, and the success rate is very high. However, the coil interventional embolization has certain defects: 1. the operation cost is high, if the dense embolism is to be achieved, the spring coils are required to be placed as much as possible, and the stent is required to assist in the embolism when the wide neck or larger aneurysm is encountered; 2. higher recurrence rate of the aneurysm and higher risk of delayed rupture bleeding of the aneurysm, patients need to take the drug for a long period of time. The blood flow guiding device treats the aneurysm by means of vascular reconstruction, and has the advantages of high cure rate and low recurrence rate. However, there are also some defects which are difficult to overcome in the using process: 1. after implantation of the blood flow guiding device, the patient needs to take the antiplatelet drug for a long time; 2. occlusion caused by covering a branch vessel, particularly for treating complications of narrow vessel occlusion caused by a bifurcation wide carotid aneurysm; 3. blood flow direction device endoluminal thrombosis, one of the most serious complications in blood flow direction device use, requires both pre-and post-operative treatment with a dual antibody.

Therefore, for intravascular treatment of a wide-necked aneurysm at a bifurcation portion of a blood vessel and other wide-necked aneurysms, the arterial rumen at the bifurcation portion is often caused by direct blood flow impact on the bifurcation portion of the blood vessel, and patients often suffer from basic diseases such as hypertension and diabetes. In the intravascular treatment process of the wide carotid aneurysm and other wide carotid aneurysms at the bifurcation part of the blood vessel, the existing spring ring and the blood flow guiding device have the problems of stable filling of the spring ring, influence of the stent auxiliary spring ring and the blood flow guiding device on branch blood vessels, recurrence of the aneurysm and the like, so that the intravascular treatment of the wide carotid aneurysms at the bifurcation part of the blood vessel and other wide carotid aneurysms is still difficult.

Disclosure of utility model

The utility model aims to provide a turbulent flow device, which aims to block blood flow from entering an aneurysm by using a double-layer reticular structure, guide the blood flow to two sides of a blood vessel, avoid the arrangement of a bracket for assisting in blocking flow, reduce the impact of the blood flow on the wall of the aneurysm vessel, and further reduce the risk of rupture of the aneurysm.

In order to achieve the above object, the present utility model provides a spoiler device, which includes:

The inner layer network management structure comprises an inner layer net, a first steel sleeve and a second steel sleeve, wherein the inner layer net is provided with a proximal end and a distal end which are oppositely arranged along the axial direction, the proximal end of the inner layer net is folded and fixed through the first steel sleeve, and the distal end of the inner layer net is folded and fixed through the second steel sleeve; and

The outer layer network management structure is sleeved outside the inner layer network management structure and is connected with the inner layer network management structure, and the near end of the outer layer network management structure adopts a seal head-free structure.

In an embodiment, a gap is formed between the inner layer network management structure and the outer layer network management structure.

In one embodiment, the outer mesh tube structure has a proximal end and a distal end disposed axially opposite each other, and the proximal end of the outer mesh tube structure is contoured to form a hemisphere.

In an embodiment, the distal end of the outer layer mesh tube structure is folded and fixed with the distal end of the inner layer mesh by the second steel sleeve.

In an embodiment, the proximal end of the outer layer mesh tube structure is formed with a plurality of folds enclosing a circle, and the proximal end of the outer layer mesh tube structure is fixed by tying after passing through each fold in turn to form a circle by adopting a suture line.

In one embodiment, the proximal end of the outer mesh structure is provided with a connection wire at the location of the suture, the connection wire being for connection to a delivery device.

In one embodiment, the connecting wire equally divides the suture into two semi-circles.

In one embodiment, the outer layer mesh tube structure is stitched with a plurality of fiber yarns for adsorbing blood.

In an embodiment, the inner layer mesh tube structure and the outer layer mesh tube structure are formed by interweaving a plurality of knitting wires, and the knitting wires adopted by the inner layer mesh tube structure and the outer layer mesh tube structure are made of metal materials.

In an embodiment, the braided wires adopted by the inner layer network management structure are developing materials, and the braided wires adopted by the outer layer network management structure are nickel-titanium alloy or cobalt-chromium alloy.

The turbulent flow device comprises an inner layer network management structure and an outer layer network management structure, wherein the inner layer network management structure comprises an inner layer network, a first steel sleeve and a second steel sleeve, and the inner layer network is provided with a near end and a far end which are oppositely arranged along the axial direction; the proximal end of the inner layer net is folded and fixed through the first steel sleeve; the far end of the inner layer net is folded and fixed through a second steel sleeve; the outer layer network management structure is sleeved outside the inner layer network management structure and is connected with the inner layer network management structure; the near end of the outer layer network management structure adopts a seal head-free structure; thus, the first steel sleeve and the second steel sleeve respectively seal the proximal end and the distal end of the inner layer net, and further the inner layer net management structure forms a relatively sealed structure; the seal head-free structure is beneficial to endothelialization of the turbulence device, and reduces the risk of external thrombosis of tumor bodies of patients; the inner layer network management structure and the outer layer network management structure are expanded and unfolded in the aneurysm after being separated from the conveying system, the inner layer network management structure and the outer layer network management structure have better supporting performance, so that the inner layer network management structure and the outer layer network management structure can be clung to the vascular wall in the aneurysm and seal the aneurysm opening of the aneurysm, arterial blood outside the aneurysm is blocked by the inner layer network management structure and the outer layer network management structure and cannot enter the aneurysm, a better flow blocking effect is provided, the inner layer network management structure and the outer layer network management structure can provide a good blood flow guiding effect through grid density, blood flow is guided to two sides outside the aneurysm, support auxiliary flow blocking is not needed, the impact of blood flow on the vascular wall of the aneurysm is reduced, and accordingly the risk of rupture and bleeding of the aneurysm is reduced.

Drawings

In order to more clearly illustrate the embodiments of the present utility model or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, and it is obvious that the drawings in the following description are only some embodiments of the present utility model, and other drawings may be obtained according to the structures shown in these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic view of a spoiler according to an embodiment of the present utility model;

FIG. 2 is a schematic view of a spoiler according to another embodiment of the present utility model;

FIG. 3 is a front view of the spoiler of the present utility model;

FIG. 4 is a schematic view of section A-A of FIG. 3;

FIG. 5 is a front view of the spoiler of the present utility model after stitching the fiber yarn;

FIG. 6 is a schematic structural view of a non-sealing structure of the spoiler of the present utility model;

FIG. 7 is a schematic view of the structure of the turbulent device of the present utility model after implantation in an aneurysm;

FIG. 8 is a schematic view of the structure of a conveying rod of the conveyor of the present utility model;

FIG. 9 is a schematic view of the configuration of the delivery rod of the delivery device of the present utility model as it enters the sheath;

FIG. 10 is a schematic view of the configuration of the delivery rod of the delivery device of the present utility model as it moves with the sheath;

FIG. 11 is a schematic view of the configuration of the delivery rod of the delivery device of the present utility model after it exits the sheath;

FIG. 12 is a schematic view showing the structure of the conveyor of the present utility model after the conveyor bar is separated from the turbulence generating means and pulled back to the sheath;

FIG. 13 is a schematic view of the turbulent device of the present utility model prior to being pushed into an aneurysm by a delivery rod of a delivery device;

FIG. 14 is a schematic view of the turbulent device of the present utility model when pushed into an aneurysm by the delivery rod of the delivery device;

fig. 15 is a schematic view of the structure of the turbulent device of the present utility model after it is pushed into an aneurysm by the delivery rod of the delivery device.

Reference numerals illustrate:

Reference numerals	Name of the name	Reference numerals	Name of the name
				100	Turbulent flow device	210	Rod body
10	Inner layer network management structure	211	Proximal section
				11	Inner layer net	212	Distal section
12	First steel sleeve	220	Locking piece
				13	Second steel sleeve	220a	Lock position
20	Outer layer network management structure	221	Deformation section
				21	Folding angle	222	Guide section
22	Suture thread	222a	Ball part
				23	Connecting wire	300	Developing spring
20a	Fiber knitting wool	1	Aneurysms
				200	Conveying rod	2	Blood vessel

The achievement of the objects, functional features and advantages of the present utility model will be further described with reference to the accompanying drawings, in conjunction with the embodiments.

Detailed Description

The following description of the embodiments of the present utility model will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the utility model. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to be within the scope of the utility model.

It should be noted that all directional indicators (such as up, down, left, right, front, and rear … …) in the embodiments of the present utility model are merely used to explain the relative positional relationship, movement, etc. between the components in a particular posture (as shown in the drawings), and if the particular posture is changed, the directional indicator is changed accordingly.

Furthermore, the description of "first," "second," etc. in this disclosure is for descriptive purposes only and is not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In addition, the technical solutions of the embodiments may be combined with each other, but it is necessary to base that the technical solutions can be realized by those skilled in the art, and when the technical solutions are contradictory or cannot be realized, the combination of the technical solutions should be considered to be absent and not within the scope of protection claimed in the present utility model.

In the present application, the end that is closer to the operator in use is referred to as "proximal end", the end that is farther from the operator is referred to as "distal end", and the "proximal end" and "distal end" of any component of the spoiler are defined according to this principle.

The present utility model proposes a spoiler 100.

In the embodiment of the present utility model, referring to fig. 1, 2 and 4, the spoiler 100 includes an inner layer mesh tube structure 10 and an outer layer mesh tube structure 20, the inner layer mesh tube structure 10 includes an inner layer mesh tube 11, a first steel sleeve 12 and a second steel sleeve 13, the inner layer mesh tube 11 has a proximal end and a distal end which are oppositely disposed along an axial direction; the proximal end of the inner net 11 is folded and fixed through the first steel sleeve 12; the distal end of the inner net 11 is folded and fixed through the second steel sleeve 12; the outer layer network management structure 20 is sleeved outside the inner layer network management structure 10 and is connected with the inner layer network management structure 10, and the proximal end of the outer layer network management structure 20 adopts a seal head-free structure.

Specifically, the first steel sleeve 12 and the second steel sleeve 13 respectively close the proximal end and the distal end of the inner layer mesh 11, so that the inner layer mesh tube structure 10 forms a relatively sealed structure, and further, the flow blocking effect of the inner layer mesh tube structure 10 on the aneurysm 1 is improved. The proximal end of the outer mesh tube structure 20 is a dead head-free structure. Namely, the external implant protrusion is reduced without being folded and fixed through the steel sleeve, the external implant protrusion is smoother than blood vessels 2 at two sides, the endothelialization of the turbulence device 100 is facilitated, and the risk of external thrombus formation of the tumor of a patient is reduced, so that the patient does not need to take an anti-platelet drug for a long time, and the postoperative life quality of the patient is improved.

Referring to fig. 3 and 7, the spoiler 100 is driven by the conveying system to enter the blood vessel 2 of the patient until the spoiler 100 is pushed to the lesion position of the patient under the guidance of the conveying system; the turbulent flow device 100 is released in the aneurysm 1 at the lesion position of the patient, at this time, after the inner layer network management structure 10 and the outer layer network management structure 20 are separated from the conveying system, the inner layer network management structure 10 and the outer layer network management structure 20 are expanded and unfolded in the aneurysm 1, and have better supporting property, so that the inner layer network management structure 10 and the outer layer network management structure 20 can be closely attached to the inner wall of a blood vessel in the aneurysm 1, and the tumor opening of the aneurysm 1 is plugged, arterial blood flow outside the aneurysm 1 is blocked by the inner layer network management structure 10 and the outer layer network management structure 20 and cannot enter the aneurysm 1, a better flow blocking effect is provided, the inner layer network management structure 10 and the outer layer network management structure 20 can provide a good blood flow guiding effect through grid density, blood flow is guided to two sides outside the aneurysm 1, no support auxiliary flow blocking is needed, the impact of blood flow on the wall of the blood vessel of the aneurysm is reduced, and the risk of rupture and bleeding of the aneurysm is reduced.

In an embodiment, referring to fig. 4, a gap is formed between the inner layer mesh tube structure 10 and the outer layer mesh tube structure 20, so that the impact of blood flow can be effectively slowed down, and the pressure on the aneurysm wall can be reduced.

In one embodiment, referring to fig. 1 and 4, the outer mesh structure 20 has axially opposed proximal and distal ends, the proximal end of the outer mesh structure 20 being contoured to form a hemisphere.

The outer layer network management structure 20 is sleeved on one side of the inner layer network management structure 10 facing the aneurysm 1 and is arranged in an arc shape, so that the inner layer network management structure 10 and the outer layer network management structure 20 form a hemispherical turbulence device 100; after the patient implants the turbulence device 100, the hemispherical turbulence device 100 can be tightly attached to the neck of the aneurysm 1, and effectively fixed in the blood vessel 2, and cannot be displaced due to continuous contraction, relaxation or impact of blood flow of the blood vessel 2. The diameter of the hemisphere of the spoiler device 100 is primarily sized according to the width and size of the neck of the aneurysm 1 of the patient.

In one embodiment, the distal end of the outer mesh structure 20 is secured to the distal end of the inner mesh 11 by a second steel sheath 13. The proximal end of the outer mesh structure 20 is secured by suture knots.

In an embodiment, referring to fig. 2 and 6, a plurality of corners 21 are formed at the proximal end of the outer layer mesh tube structure 20 to form a circle, and the proximal end of the outer layer mesh tube structure 20 is fixed by knotting after passing through each corner 21 sequentially with a suture thread 22.

In one embodiment, referring to fig. 2 and 6, a connection wire 23 is provided at the proximal end of the outer mesh structure 20 at the location of the suture 22, the connection wire 23 being for connection to a delivery device.

The suture line 22 passes through the diagonal line after forming a circle at the folded angle position, a connecting line 23 is formed in the circle, and the connecting line 23 equally divides the circle into two semicircles. When being connected with the conveyer, the conveyer passes connecting wire 23 and hooks connecting wire 23, can guarantee like this that every dog-ear 21 can all be pulled by suture 22, and suture 22's cover is more comprehensive, can increase the effect of shutoff aneurysm 1 tumor mouth on the one hand, reduces the pressure that the blood flow impacted aneurysm 1 chamber wall, on the other hand can promote and go into the sheath performance, and every dog-ear 21 can be pulled into the sheath intraductal simultaneously. In one embodiment, the suture material is PA wire, PET wire, or the like.

In one embodiment, referring to fig. 5 and 6, the outer mesh tube structure 20 is stitched with a plurality of fiber yarns 20a, and the fiber yarns 20a are used to adsorb blood.

Specifically, when the turbulence device is implanted in the aneurysm 1, the fiber wool 20a is sewn on the outer layer of the net pipe structure 20, and the fiber wool can adsorb blood cells, coagulate and block blood outside the aneurysm, so that the effect of plugging the embolism is better achieved, and the aneurysm 1 is filled rapidly. The fiber wool 20a is sewed in the protruding cavity of the outer layer net management structure 20, and after the turbulent flow device is released, the fiber wool is released into the aneurysm 1 due to the pressure of blood flow impact; thereby playing a good role in blocking, having short operation time and lower requirement on operation experience of doctors, and not requiring patients to perform double antiplatelet treatment for a long time after operation. The fiber knitting wool 20a is made of polymer materials such as polyamide or PET, and is characterized in that a plurality of spun yarns are kneaded and combined together to form a fiber line which is not easy to scatter, and scattered knitting wool fibers are arranged on the surface of the fiber line.

In an embodiment, referring to fig. 6 and 7, the inner layer mesh tube structure 10 and the outer layer mesh tube structure 20 are formed by interweaving a plurality of knitting wires, and the knitting wires used in the inner layer mesh tube structure 10 and the outer layer mesh tube structure 20 are made of metal materials.

In an embodiment, referring to fig. 6 and 7, the woven wires used in the inner layer mesh structure 10 are made of developing materials, and the woven wires used in the outer layer mesh structure 20 are made of nickel-titanium alloy or cobalt-chromium alloy.

The inner layer network management structure 10 and the outer layer network management structure 20 are both of woven structures, the mesh density of the network management of the inner layer network management structure 10 and the outer layer network management structure 20 is changed mainly through the mesh number of the weaving machine, the better choke effect and the metal coverage rate are provided, the mesh number of the weaving is 170-285 meshes, and the metal coverage rate at the neck of the tumor can reach 40-60%. One end of the outer layer mesh tube structure 20 facing the aneurysm 1 is woven by a wire hanging mode, for example, 12 inner layer inserted bars and 24 outer layer inserted bars are arranged, the inner layer inserted bars and the outer layer inserted bars respectively surround one circle, and the two circles are concentric circles. The inserted link material can be nickel titanium alloy wire.

The woven wires adopted by the inner layer mesh tube structure 10 and the outer layer mesh tube structure 20 are metal materials, such as nickel-titanium alloy, nickel-titanium-cobalt alloy, cobalt-chromium alloy, double-layer composite metal woven wires and the like. To increase the development effect, the above metal braided wire may be mixed with noble metal wires such as platinum, gold, iridium, tantalum, etc., which may facilitate positioning and release of the spoiler 100 during the surgical procedure. The double-layer composite metal braided wire adopts the braided wire of the inner layer network management structure as a developing material, such as platinum, gold, iridium, tantalum and the like, and the braided wire of the outer layer network management structure is nickel-titanium alloy or cobalt-chromium alloy and the like

The spoiler 100 provides a manufacturing method:

(1) Weaving the inner layer network management structure 10: adopting a braiding form of a normal net pipe;

(2) Heat setting of the inner layer network management structure 10: binding and fixing the head and tail parts of the woven inner layer network management structure 10 on a mould rod of a heat setting mould by adopting copper wires, and carrying out heat setting on the mould rod with the inner layer network management structure 10 by using a hot air gun, wherein the aim is mainly to remove bending stress in the metal wire weaving process, and setting the heat setting temperature to be between 450 and 550 ℃ and setting time to be 5 to 8 minutes;

(3) Argon arc welding of the first steel sleeve 12: after heat setting and cooling, the inner layer network management structure 10 is taken down from the mold rod, a 3-5cm length network management is cut by scissors, wires at the proximal end of the inner layer network management structure 10 are penetrated and fixed by the first steel sleeve 12, and the first steel sleeve 12 and the proximal end of the inner layer network management structure 10 are welded together by an argon arc welding machine;

(4) And (5) die filling: sleeving the welded inner-layer net pipe structure 10 into an inner mold of a mold, pressing the inner-layer net pipe structure 10 and the mold core in the middle through an upper outer mold and a lower outer mold, pulling redundant metal wires out of the mold through a middle hole of the upper mold by metal wires at the far end of the inner-layer net pipe structure 10, and locking and fixing the mold;

(5) And (5) heat setting: the die is placed in a heat treatment furnace for heat setting, and the purpose is mainly to remove internal stress in the process of extruding metal wires by the die, so that the inner layer network management structure 10 can still keep the original shape after the die is removed, the heat setting temperature is set between 450 ℃ and 550 ℃, and the setting time is 5min to 10min;

(6) Braiding of the outer mesh tube structure 20: in the knitting process, firstly inserting an inserted bar with the same aperture as that on a mould rod of a thermal forming mould into a hole of an inner layer, taking 72 strands of knitting wires as an example, folding 36 wires in half, and presetting a V-shaped angle by using a hot air gun, wherein the angle is as follows: between 15 and 30 degrees, the braiding machine spool is wound with silk threads in advance, the silk threads can be suture threads, and the material is: PA wire, PET wire, etc. have certain elasticity, and the broken wire is difficult in the knitting process. And then knotting and butting the suture lines on the preset metal wires and the bobbins, butting one metal wire with two adjacent bobbins respectively, butting the metal wires at intervals of 4 bobbins in the same way, hanging the butted metal wires on the inserted bars at the central inner layer of the mould rod one by one, starting the braiding machine after all the metal wires at the first stage are hung, stopping rotating the spindle rod on the rotary table of the braiding machine after rotating 120 degrees, inserting the inserted bars into the rest 24 holes at the second stage on the mould rod, butting the rest 24 wires in the same way, hanging the rest 24 wires on the inserted bars at the second stage one by one, and starting the braiding machine to carry out braiding until the braiding is stopped after the braiding is long enough. If 144 strands of wire are woven, two wires are butted between two adjacent bobbins, and the like; such a threading facilitates access to the finer sheath.

(7) Heat setting of the outer layer mesh tube structure 20: operating according to step (2);

(8) Argon arc welding of the second steel sleeve 13: after the outer layer network management structure 20 is subjected to heat setting and cooling, the outer layer network management structure 20 is taken down from a mould rod, the inner layer network management structure 10 formed by the mould is placed in the middle of the outer layer network management structure 20, the second steel sleeve 13 is adopted to fix the far-end braiding wires of the inner layer network management structure 10 and the outer layer network management structure 20 through the fixing, and the second steel sleeve 13 is used to weld the inner layer braiding wires and the outer layer braiding wires together by using an argon arc welding machine;

(9) And (5) die filling: sleeving the welded inner die into a die inner die, pressing the inner layer network management structure 10, the outer layer network management structure 20 and the die core in the middle through an upper outer die and a lower outer die, and locking and fixing;

(10) And (3) heat setting of the device: the die is placed in a heat treatment furnace for heat setting, and the purpose is mainly to remove internal stress in the process of extruding metal wires by the die, so that the device can still keep the original shape after the die is removed, the heat setting temperature is set between 450 ℃ and 550 ℃, and the setting time is set between 10min and 25min.

(11) Proximal suturing of the outer mesh structure 20: the proximal end of the outer layer mesh tube structure 20 forms a plurality of folded corners 21, the folded corners 21 form a circle, and the suture line 22 sequentially passes through each folded corner 21 to form a circle and then is needled to the diagonal position for knotting and fixing.

Referring to fig. 13, the spoiler conveying system includes a spoiler 100 and a conveyor, the conveyor is used for conveying the spoiler 100 to a lesion position (aneurysm), and after the conveyor conveys the spoiler 100 to the lesion position, the spoiler 100 is disconnected from the conveyor and released to the lesion position, so that the spoiler 100 can block the aneurysm orifice of the aneurysm.

Referring to fig. 8, 9 and 12, the conveyor includes a conveying rod 200, the conveying rod 200 includes a rod body 210 and a locking member 220 connected to an end of the rod body 210, the locking member 220 includes a deformation section 221 and a guiding section 222, the deformation section 221 is connected to an end of the rod body 210, and the guiding section 222 is connected to an end of the deformation section 221 away from the rod body 210; the delivery rod 200 has a locked state and an expanded state; when in the locking state, the deformation section 221, the guide section 222 and the rod 210 enclose to form a locking position 220a, and the locking position 220a is used for limiting the spoiler 100; when in the unfolded state, the deformation section 221 deforms to drive the guide section 222 and the rod 210 to form an opening, and the opening is used for releasing the spoiler 100.

The conveying system also comprises a sheath pipe, and the sheath pipe is provided with a conveying groove; before the locking piece 220 does not enter the sheath, the deformation section 221 and the guide section 222 of the locking piece 220 and the rod body 210 form a gap, and at this time, the spoiler 100 can enter the locking position 220a through the gap; then, the conveying rod 200 drives the spoiler device 100 to enter the conveying groove of the sheath tube, the deformation section 221 of the conveying rod 200 moves towards the direction close to the rod body 210 under the restriction of the sheath tube until the deformation section 221 is clung to the rod body 210, and at the moment, the locking position 220a is completely closed and is in a locking state, so that the spoiler device 100 can be locked in the locking position 220 a; the distal pushing of the delivery rod 200 drives the spoiler 100 to move to the distal end of the sheath, the distal pushing of the delivery rod 200 is continued, the spoiler 100 is released to the aneurysm from the sheath, the sheath is retracted proximally, the distal end of the delivery rod 200 is withdrawn from the delivery groove of the sheath, the delivery rod 200 is in an unfolding state, the locking piece 220 of the delivery rod 200 is restored to the original shape due to the fact that the sheath is not limited, namely, the deformation section 221 deforms and drives the guide section 222 to move in a direction away from the rod body 210 until the deformation section 221 and the guide section 222 form an opening with the rod body 210, and the delivery rod 200 is pulled proximally, so that the locking piece 220 of the delivery rod 220 is separated from the spoiler 100, and separation of the conveyor and the spoiler 100 is achieved. After the conveying rod 200 is separated from the spoiler 100, the conveying rod 200 is pulled to the proximal end to enable the locking piece 220 to enter the sheath, and due to the restriction of the sheath, one end, connected with the rod body 210, of the deformation section 221 is deformed, the deformation section 221 drives the guide section 222 and the rod body 210 to be approximately arranged along the same straight line, so that the guide section 222, the deformation section 221 and the rod body 210 are approximately in a straight strip shape, and when the conveying rod 200 is pulled back to the sheath, the conveying rod 200 can be smoothly retracted in the sheath.

In one embodiment, referring to fig. 9 and 10, in the locked state, the deformation section 221 and the guide section 222 form an "S" shape. Specifically, the outer walls of the S-shaped deformation section 221 and the guide section 222 are smooth, so that when the conveying rod 200 is in the conveying groove of the sheath or is out of the sheath, the outer walls of the deformation section 221 and the guide section 222 do not scratch the walls of the sheath and the blood vessel 2, and the function of protecting the blood vessel 2 and the sheath is achieved.

In an embodiment, referring to fig. 11, in an expanded state, i.e. in an unstressed state, the deformation section 221 and the guide section 222 are both arc-shaped, and the arc shape of the guide section 222 is tangent to the arc shape of the deformation section 221, the radian of the guide section 222 is 180 °, and the radian of the deformation section 221 is 90 °.

The connection part of the deformation section 221 and the guide section 222 is arranged in an arc shape, the arc of the connection part is tangent to the semicircular arc, the arc of the connection part is a quarter arc, and the diameter range of the arc is 0.5mm-1.2mm. So, make the junction that guide section 222 links up with deformation section 221 more smooth and even, avoid guide section 222 to be formed with the arch with the junction of deformation section 221, on the one hand make guide section 222 and deformation section 221's junction be difficult to scratch the sheath, on the other hand conveying pole 200 is in the in-process of propelling movement, circular-arc deformation section 221 is in the thrust effect and can hug closely the body of rod 210 more with the junction of guide section 222 more, namely the junction of deformation section 221 and guide section 222 can airtight locking position 220a more easily this moment, thereby make vortex device 100 more stable in locking position 220a, be difficult to release from the locking position 220a of conveying pole 200, guarantee that vortex device 100 carries to aneurysm 1 department steadily.

In one embodiment, referring to fig. 11, the distal end of the guide section 222 is provided with an arcuate structure. In this way, the locking member 220 is mainly prevented from scraping the sheath when pushing and pulling the sheath, so that the resistance of the delivery rod 200 entering the sheath is reduced, and the delivery rod 200 can conveniently enter and exit the delivery groove of the sheath, thereby improving the delivery performance of the delivery rod 200.

In an embodiment, referring to fig. 9 and 10, a ball portion 222a is disposed at an end of the guiding section 222 away from the deformation section 221. When the conveying rod 200 is in any state, the ball portion 222a of the guiding section 222 is not easy to scratch the sheath and the wall of the blood vessel 2, so that the safety of the conveying rod 200 in the process of conveying the turbulent flow device 100 is improved.

In an embodiment, referring to fig. 8, the locking member 220 is formed by bending and shaping a metal wire, and the metal wire is made of elastic metal or shape memory metal.

Specifically, the method for manufacturing the locking member 220 includes: firstly, putting a smooth spherical shape at the far end point of a metal wire into a mould groove with a shape like an unfolding state by adopting a laser welding machine or an argon arc welding machine for heat setting, wherein the heat setting temperature is set between 450 ℃ and 550 ℃, and the setting time is 10min to 25min; and then the shaped conical wire and the hypotube are welded together by laser. Is made of a shape memory material or a metal material of an elastic material, such as nickel-titanium alloy, nickel-titanium-cobalt alloy, cobalt-chromium alloy, double-layer composite metal wire, etc.

Optionally, the wire diameter of the wire decreases gradually from the proximal end to the distal end. The wire diameter of the metal wire is between 0.15mm and 0.25mm, and the taper angle formed by gradual change of the wire diameter is between 145 and 165 degrees. This arrangement allows the wire to be more deformable, thereby making the delivery device easier to pass through a curved vessel.

In one embodiment, referring to fig. 8, the rod 210 includes a proximal section 211 and a distal section 212 connected to the proximal section 211, the proximal section 211 is a hypotube, the distal section 212 is connected to the locking element 220, and the proximal section 212 is formed by extending a wire forming the locking element 220.

The hypotube is cut from a metal tube along the circumferential direction to form a spiral line penetrating through the sidewall of the metal tube, and the design of the hypotube increases the bending performance of the rod body 210, so that the rod body 210 can convey the spoiler device 100 to the position of the aneurysm 1 through the more tortuous blood vessel 2. The proximal section 211 of the shaft 210 may be made of: 304 stainless steel, 316 stainless steel, nickel-titanium alloy material. The outer diameter of the hypotube is between 0.3 and 0.8mm, and the inner diameter is between 0.1 and 0.5 mm. Distal section 211 is formed from a wire extension of locking element 220, from a shape memory material or from a metallic material of an elastomeric material, such as nitinol, cobalt-chromium alloy, double layer composite wire, or the like.

In one embodiment, referring to fig. 8, the conveyor further comprises a developing spring 300, the developing spring 300 being sleeved over the wire and extending to the distal end of the wire.

Specifically, to increase the developing effect of the delivery rod 200, an operator can more clearly know the position of the delivery rod 200 in the patient's blood vessel 2, and the developing springs 300 are sleeved on the outer walls of the wires, so that the developing springs 300 can not only display the distal end position of the delivery rod 200, but also the developing springs 300 have a certain elasticity and can be tightly wound on the distal end sections 212 and the outer walls of the locking members 220.

The developing spring 300 is made of platinum tungsten, gold, platinum iridium, tantalum, etc. The developing spring 300 is formed by winding a developing wire along the distal end section 212 and the outer wall of the locking member 220, and the inner diameter of the developing spring 300 coincides with the outer diameters of the distal end section 211 and the locking member 220. The developing wire of the developing spring 300 has a wire diameter of 0.03mm to 0.06mm and is wound to have an inner diameter identical to the wire diameter of the metal wire, so that the developing wire can be perfectly matched with the metal wire for welding, and the step with the protrusion is prevented from affecting the feeding and discharging of the conveying rod 200 into and out of the sheath.

In an embodiment, referring to fig. 8, both the hypotube and the outer wall of the developing spring 300 are provided with a thermoplastic polyurethane rubber layer, and the developing spring 300 is further provided with a hydrophilic coating layer, which is disposed on the thermoplastic polyurethane rubber layer.

The thermoplastic polyurethane rubber layer is coated on the surfaces of the developing spring 300 and the hypotube, the thickness of the thermoplastic polyurethane rubber layer is 0.005-0.010 mm, the developing spring 300 and the hypotube cutting part are protected, and the sheath tube is prevented from being damaged. The developing spring 300 part of the conveying rod 200 is coated with a hydrophilic coating on the surface, so that the outer wall of the conveying rod 200 is smoother, the conveying rod 200 is prevented from being adhered to the wall of a conveying groove of a sheath tube and the wall of a blood vessel 2, the trafficability of a conveying system is further improved, the hydrophilic coating can be PTFE or Parylene (Parylene nano) coating, and the thickness of the coating is 3-8 mu m.

Throughout the advancement and advancement of the locking member 220 into and out of the sheath, the delivery rod 200 may take on different shapes at different stages, including:

When the delivery rod 200 enters the sheath, referring to fig. 9 and 14, the locking member 220 of the delivery rod 200 is designed into a hippocampal shape "S" at this time, so that the contact area between the deformation section 221 and the guiding section 222 of the locking member 220 and the delivery groove of the sheath is reduced, the wall of the delivery rod 200 is prevented from being pulled in the sheath, and the internal resistance of the locking member 220 in the sheath is reduced. The guide section 222 of the locking member 220 passes through the proximal end of the outer layer mesh structure 20 of the spoiler device 100 and hooks the proximal suture thread so that the locking member 220 pulls the spoiler device 100 into the sheath.

② In the pushing stage, referring to fig. 10 and 14, namely, in a form that the spoiler 100 is in the sheath, and the sheath is in the sheath and pushes the conveying rod 200, when the locking member 220 of the conveying rod 200 is pushed forward, the S-shaped locking member 220 is acted by a resistance force in a reverse direction, and when the resistance force is transmitted to a position of a pressing point between a connection position of the deformation section 221 and the guide section 222 and the rod body 210, the resistance force is decomposed into a pressure force and a residual partial resistance force on the conveying rod 200, and the pressure force can tightly attach the connection position of the deformation section 221 and the guide section 222 of the locking member 220 to the rod body 210, so that the locking position 220a is more closed, and the spoiler 100 can be stably driven to move in the sheath;

③ In the stage after the sheath is pushed out, please refer to fig. 11 and 14, namely, after the locking member 220 is pulled out of the sheath, the deformed section 221 of the locking member 220 will recover the original shape and spring open automatically, and the deformed section 221 drives the guiding section 222 to move away from the rod 210, so that the guiding section 222 and the rod 210 form an open configuration, and at this time, the locking member 220 can be separated from the spoiler 100. During the operation, after the spoiler device 100 is placed at the designated position, the locking member 220 is still in the sheath, at this time, the delivery rod 200 is kept still, the sheath is retracted slightly proximally, the locking member 220 is only removed from the sheath, the locking member 220 returns to the unfolded state, and at this time, the delivery rod 200 is retracted again to separate the locking member 220 from the spoiler device 100. It should be noted that, when the locking member 220 is still in the sheath, if the spoiler 100 is not properly positioned, the spoiler 100 may be pulled back to the sheath by the locking member 220, and then repositioned and released.

④ In the retraction stage, referring to fig. 1 and 12, the locking member 220 is separated from the spoiler 100 and is in a substantially straight shape, and the locking member 220 is retracted by pulling the sheath.

The turbulent flow device conveying system comprises a turbulent flow device 100 and a conveyor, wherein the turbulent flow device 100 comprises an inner layer network management structure 10 and an outer layer network management structure 20, and the outer layer network management structure 20 is sleeved on the inner layer network management structure 10; in the locked state, the locking member 220 hooks the proximal end of the outer mesh tube 20 to lock the proximal end of the outer mesh tube 20 in the locking position 220a; in the deployed state, the distal end of the outer mesh structure 20 is released from the opening to the outside of the locking position 220a to separate the spoiler 100 from the conveyor.

In use, the spoiler 100 is connected to the conveyor. The locking member 220 of the delivery device is passed through the suture at the proximal end of the outer mesh structure 20 and hooked around the suture at the proximal end of the outer mesh structure 20, and the delivery device is pushed distally so that the locking member 220 is pushed into the sheath with the spoiler device 100 (at which point the sheath has reached the lesion). Referring to fig. 14, the delivery rod 200 is continuously pushed distally until the spoiler 100 is pushed to the distal end of the sheath. Referring to fig. 15, the delivery rod 200 is pushed distally, the spoiler device 100 is pushed out of the sheath tube to release the device in the aneurysm, and then the sheath tube is retracted proximally to release the locking member 220 from the sheath tube, at this time, the locking member 220 is automatically restored to the deployed state without restriction of the sheath tube. Referring to fig. 1, 7 and 8, the conveying rod 200 is pulled proximally, and the locking member 220 is pulled out from the proximal end of the spoiler 100 to separate the conveyor from the spoiler 100. Continuing to pull the delivery rod 200 proximally to pull the locking member 220 back into the sheath, the deformed portion 221 of the locking member 220 is pulled into the sheath first closer to the end than the guiding portion 222, and due to the restriction of the sheath, the deformed portion 221 and the guiding portion 222 gradually move distally to be substantially aligned with the rod body 210 (as shown in fig. 12), so that smooth retraction of the delivery device can be achieved.

According to the conveying system of the turbulent flow device, the conveying device and the turbulent flow device 100 can be locked in the sheath by utilizing different forms of the conveying device in the unfolding state and the locking state, after the sheath is pushed out, the conveying device and the turbulent flow device 100 can be automatically released, the releasing time is quick, and the retraction can be controlled before releasing, so that the turbulent flow device 100 can be accurately released. In addition, the conveyer has a simpler structure, a simpler process flow and convenient production, and the conveyer can be recovered into the sheath after being automatically released from the sheath without complex operation.

The foregoing description is only of the preferred embodiments of the present utility model and is not intended to limit the scope of the utility model, and all equivalent structural changes made by the description of the present utility model and the accompanying drawings or direct/indirect application in other related technical fields are included in the scope of the utility model.

Claims

1. A spoiler device, comprising:

2. The spoiler device according to claim 1, wherein a gap is formed between said inner and outer web structures.

3. The spoiler device according to claim 1, wherein said outer web structure has axially opposed proximal and distal ends, said outer web structure proximal end being contoured to form a hemisphere.

4. The spoiler device according to claim 3, wherein a distal end of said outer layer mesh tube structure is folded and fixed with a distal end of said inner layer mesh by said second steel sleeve.

5. The spoiler device according to claim 1, wherein a plurality of folds surrounding a circle are formed at a proximal end of the outer layer mesh tube structure, and the proximal end of the outer layer mesh tube structure is fixed by knotting after passing through each fold in turn by using a suture line.

6. The spoiler device according to claim 5, wherein a proximal end of said outer web structure is provided with a connecting wire at the location of said suture, said connecting wire being adapted for connection to a conveyor.

7. The spoiler of claim 6, wherein said connecting wire equally divides said suture line into two semi-circular shapes.

8. The spoiler of claim 1, wherein said outer mesh tube structure is stitched with a plurality of fiber yarns for adsorbing blood.

9. The spoiler device according to claim 1, wherein said inner and outer web structures are each formed by interlacing a plurality of woven wires, said woven wires being metallic.

10. The spoiler of claim 9, wherein said inner layer mesh tube structure is formed of a developed material and said outer layer mesh tube structure is formed of a nickel-titanium alloy or cobalt-chromium alloy.