CN117883140A - Turbulent flow device and conveying system - Google Patents

Abstract

The invention relates to a turbulence device and a conveying system, wherein the turbulence device comprises a first supporting net disc, a supporting piece and a bolt-making piece. The first support net plate is provided with a first plate body and a first combination part, the first plate body is used for being arranged at the inlet end of the tumor cavity and is connected with the inner wall of the tumor cavity in a fitting mode, and the first combination part is arranged on the outer side of the center of the first plate body. The proximal end of the support piece is connected with the first combining part and arranged on the inner side of the first tray body part, and the support piece has flexibility and is used for filling a tumor cavity. The number of the bolt-making pieces is multiple and the bolt-making pieces are all arranged on the supporting piece, and the multiple bolt-making pieces are used for filling the tumor cavity. According to the vortex device, the supporting piece and the bolt-making piece are placed in the tumor, the first supporting net disc which can be attached to the inner wall of the tumor cavity is released at the inlet end of the tumor cavity, the purposes of quickly making the bolt and preventing blood from entering the tumor cavity can be achieved, the tumor cavity can be filled once, so that the operation risk caused by multiple times of filling is avoided, and the vortex device has good applicability.

Description

Turbulent flow device and conveying system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a turbulence device and a conveying system.

Background

Intracranial aneurysms are a common cerebrovascular disease of the intracranial arterial vessels, mainly due to damage to the vessel wall caused by congenital anomalies or acquired injuries, and are formed by gradual expansion under the influence of hemodynamic loads and other factors. This cerebrovascular disease accounts for about 900 tens of thousands of patients in the united states, with about 3% of the total population, and about 3 tens of thousands of people developing subarachnoid hemorrhage of the brain each year, 40% of which are fatal.

The main current treatments for aneurysms include open surgery and endovascular interventions. The open operation, namely the aneurysm clamping method, can achieve the purpose of radical cure, but the risk of craniotomy is larger, the trauma to the patient is larger, and the recovery period is longer. In contrast, endovascular interventions can reduce the impact of blood flow on the vessel wall, reduce the risk of rupture of aneurysms, and provide less trauma and faster recovery time by embolizing or altering the direction of blood flow at the tumor.

In recent years, with the continuous progress of neuro-interventional technology, a spring coil and a blood flow guiding device have become two important instruments for neuro-interventional treatment of intracranial aneurysms. Coil interventional embolization is one of the most widely used methods of aneurysm treatment in clinical use at present, and has a very high success rate. However, this technique still has some drawbacks. First, the surgical costs are high because to achieve dense embolization, as many coils as possible need to be placed, while for wide-necked or larger aneurysms, stents are also needed to assist embolization. Second, the rate of aneurysm recurrence and the risk of delayed rupture bleeding are high, and patients need to take the drug for a long period of time.

The blood flow guiding device is a method for treating the aneurysm through vascular reconstruction, and has the advantages of high cure rate and low recurrence rate. However, this technique also has some drawbacks that are difficult to overcome. First, after implantation of the blood flow guiding device, the patient needs to take an antiplatelet drug for a long period of time. Second, the coverage of the branch vessel may lead to occlusion, especially in the treatment of bifurcation wide-carotid aneurysms, which is prone to stenotic vessel occlusion complications. Finally, blood flow-guiding device endoluminal thrombosis is one of the most serious complications in using the device, requiring dual anti-therapy both pre-and post-operatively. In recent years, a new type of device, the spoiler device, has been developed. The device is mainly characterized in that the device does not need antiplatelet treatment after operation, is more suitable for wide carotid aneurysm, especially bifurcation aneurysm, and is an important supplement for treating the aneurysm by a blood flow guiding device.

The existing turbulent flow device plays a role of reconstructing blood flow by being implanted into an aneurysm cavity, and cannot influence the aneurysm-carrying artery. However, this type of device still has some problems. First, they are spherical in overall morphology, and are difficult to select when filling aneurysms, while still having coil-like placements and neck-neck retention problems. Second, when such devices are placed within an aneurysm, the proximal marker thereof protrudes significantly, potentially into the lumen of the blood vessel, thereby initiating a thrombotic event. Furthermore, such devices are more suitable for bifurcation wide-neck saccular aneurysms, which are difficult or impossible to release for common vascular sidewall aneurysms. Furthermore, the morphology of such devices is difficult to fully occlude irregular morphology as well as recurrent aneurysms, which are only suitable for aneurysms smaller than 11 mm.

Disclosure of Invention

The invention aims to at least solve the problem of poor applicability of the existing turbulence device. The aim is achieved by the following technical scheme:

a first aspect of the present invention proposes a spoiler device comprising:

The first support net disc is provided with a first disc body and a first combination part, the first disc body is arranged at the inlet end of the tumor cavity and is in fit connection with the inner wall of the tumor cavity, and the first combination part is arranged outside the center of the first disc body;

The proximal end of the support piece is connected with the first combining part and is arranged on the inner side of the first disc body part, and the support piece has flexibility and is used for filling the tumor cavity;

The number of the bolt-making pieces is multiple, the bolt-making pieces are arranged on the supporting piece, and the bolt-making pieces are used for filling the tumor cavity.

The invention relates to a turbulent flow device which comprises a first supporting net disc, a supporting piece and a bolt-making piece. Through placing support piece and bolt piece in the tumour to release the first support net dish that can laminate the tumour intracavity wall at the entrance point of tumour chamber, not only can realize quick bolt and prevent the purpose of blood entering tumour chamber, can also realize once only packing tumour chamber, in order to avoid many times to pack the operation risk that brings, help reducing internal metal implant, reduce the cost of operation, reduce operation time. Simultaneously, this vortex device is in release in-process, and support piece can be used to fill the clearance between the thrombogenic pellet, realizes the effect that the compactness was filled to support piece and thrombogenic piece can provide physical carrier in order to accelerate adhesion and the gathering of platelet for the platelet, can reach and initiate thrombus fast in the tumour intracavity, blocks the effect that blood got into the tumour intracavity for need not anti-platelet treatment after the postoperative, help reducing patient's long-term medication. In addition, the turbulent flow device has better applicability and can be used for aneurysms of bifurcation parts and bifurcated vascular aneurysms.

In addition, the turbulence device according to the invention can also have the following additional technical features:

In some embodiments of the invention, the bolt-causing member is provided in a ball shape, and an interior of the bolt-causing member is provided in a hollow.

In some embodiments of the invention, the bolt-causing member is fixedly connected to the support member;

and/or the two ends of the bolt-making piece are provided with connecting parts, and the connecting parts are detachably connected with the supporting piece.

In some embodiments of the invention, the bolt-causing member is provided with a connecting member at both ends, the connecting member comprising:

the fixing ring is connected and arranged on the bolt-making piece;

The lock catch comprises a plurality of elastic pieces, the elastic pieces are arranged around the axis of the fixed ring at intervals, the first ends of the elastic pieces are fixedly connected to the fixed ring, and the second ends of the elastic pieces are provided with hooks; the lock catch is provided with a first state and a second state, the second ends of the elastic pieces are close to each other in the first state, and the second ends of the elastic pieces are far away from each other and are clamped with the supporting pieces in the second state.

In some embodiments of the invention, the connecting member further comprises:

The operation ring is movably sleeved on the lock catch and provided with a first position and a second position, and when the operation ring is positioned at the first position, the elastic pieces keep a first working state; when the operating ring is at the second position, the operating ring presses the outer peripheral surface of the elastic piece and drives the second ends of the elastic pieces to be close to each other.

In some embodiments of the invention, the support is provided with a plurality of fiber hairs at intervals.

In some embodiments of the invention, further comprising:

The number of the spring rings is multiple, one spring ring is arranged between every two adjacent bolt-forming members, and the spring rings are used for filling the tumor cavity.

In some embodiments of the invention, further comprising:

The second support net plate is arranged at the far end of the supporting piece and is used for being attached to the inner wall of the tumor cavity.

In some embodiments of the invention, the support comprises a spring, and/or the support is developable.

The second aspect of the present invention also proposes a conveying system comprising a conveying assembly, and a spoiler device according to the present invention, the conveying assembly comprising:

one end of the pushing rod is detachably connected with the first combining part;

The pushing rod and the turbulent flow device can be arranged in the lumen of the conveying conduit in a penetrating way; wherein the first support mesh disc and the tethering member each have a compressed state within the lumen and a deployed state out of the lumen.

Drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like reference numerals are used to designate like parts throughout the figures. In the drawings:

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

FIG. 2 is a schematic cross-sectional view of a first support net tray according to an embodiment of the present invention;

FIG. 3 is a schematic view of a structure of a bolt-causing member according to an embodiment of the present invention;

FIG. 4 is a schematic view of an assembly of a bolt-causing member according to an embodiment of the present invention;

FIG. 5 is a diagram illustrating one of the effects of implementing the spoiler according to the present invention;

FIG. 6 is a diagram illustrating another use effect of the spoiler according to the present invention;

FIG. 7 is a schematic diagram of a conveyor system embodying the present invention;

FIG. 8 is an enlarged partial schematic view of FIG. 7A;

FIG. 9 is a schematic diagram of a conveyor system according to an embodiment of the present invention in a certain state;

FIG. 10 is a schematic view of a first support net tray according to a fifth embodiment of the present invention;

FIG. 11 is a schematic illustration of the fabrication of a bolt-causing member according to a fifth embodiment of the present invention;

FIG. 12 is a schematic structural view of a spoiler according to a second embodiment of the present invention;

FIG. 13 is a diagram showing the effect of one of the two delivery systems according to the second embodiment of the present invention;

FIG. 14 is a diagram showing another use effect of the conveying system according to the second embodiment of the present invention;

FIG. 15 is a schematic view illustrating a structure of a spoiler according to an embodiment of the present invention;

FIG. 16 is a schematic view of another structure of a spoiler according to an embodiment of the invention;

FIG. 17 is a diagram illustrating the effect of using the spoiler according to the third embodiment of the present invention;

FIG. 18 is a schematic view illustrating a spoiler according to a fourth embodiment of the present invention;

FIG. 19 is a schematic cross-sectional view of a second support net tray according to a fourth embodiment of the invention;

FIG. 20 is a schematic view of another structure of a spoiler according to the fourth embodiment of the present invention;

FIG. 21 is a schematic diagram of a conveying system according to a fourth embodiment of the present invention;

FIG. 22 is a schematic diagram of the use of a second delivery system according to a fourth embodiment of the present invention;

FIG. 23 is a diagram showing the effect of one of the use of the delivery system of the fourth embodiment of the present invention;

fig. 24 is a view showing another effect of using the conveying system according to the fourth embodiment of the present invention.

The various references in the drawings are as follows:

100. A spoiler device; 200. a transport assembly; 300. an aneurysm; 400. a first mold; 500. a second mold;

1. a first support net tray; 11. a first tray body; 12. a first joint;

2. A support;

3. A bolt-forming member; 31. a main body; 32. a connecting member; 321. a fixing ring; 322. locking; 323. an operating ring;

41. a first developing mark member; 42. a second developing mark member;

5. A fiber wool;

6. a spring ring;

7. A second support net tray; 71. a second tray body; 72. a second joint;

8. A delivery catheter;

9. a push rod; 91. and a release part.

Detailed Description

Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Accordingly, the example term "below … …" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.

It should be noted that "distal end" and "proximal end" are used as terms of orientation, which are terms commonly used in the field of interventional medical devices, where "distal end" refers to an end that is away from an operator during a surgical procedure and "proximal end" refers to an end that is near the operator during a surgical procedure. Axial, refers to a direction parallel to the line connecting the distal center and the proximal center of the medical instrument; radial refers to a direction perpendicular to the axial direction.

Example 1

As shown in fig. 1-9, according to an embodiment of the present invention, a spoiler device 100 is provided that can be applied to a bifurcation aneurysm 300 and a side-wall vascular aneurysm 300. The turbulent device 100 can be implanted to rapidly initiate a dense thrombus filling of the aneurysm 300. Long-term administration of antiplatelet drugs is not required, which is helpful for reducing the cost and risk of surgery.

Specifically, the spoiler 100 comprises a first supporting net plate 1, a supporting member 2 and a bolt-making member 3. The first supporting net disc 1 is provided with a first disc body 11 and a first combining part 12, the first disc body 11 is used for being arranged at the inlet end of the tumor cavity and is connected with the inner wall of the tumor cavity in a fitting mode, and the first combining part 12 is arranged on the outer side of the center of the first disc body 11. The proximal end of the support member 2 is connected to the first coupling portion 12 and is disposed inside the first disk portion 11, and the support member 2 has flexibility and is used for filling the tumor cavity. The number of the bolt-causing members 3 is plural, and plural bolt-causing members 3 are provided on the support member 2, and plural bolt-causing members 3 are used to fill the tumor cavity.

According to the turbulence device 100, the support piece 2 and the thrombus forming piece 3 are placed in a tumor, and the first support net disk 1 which can be attached to the inner wall of the tumor cavity is released at the inlet end of the tumor cavity, so that the purposes of quickly forming the thrombus and preventing blood from entering the tumor cavity can be achieved, the tumor cavity can be filled once, the operation risk caused by filling for a plurality of times can be avoided, the reduction of in-vivo metal implants is facilitated, the operation cost is reduced, and the operation time is shortened. Meanwhile, in the release process of the turbulent flow device 100, the supporting piece 2 can be used for filling gaps between the thrombus-causing pellets to achieve the effect of dense filling, and the supporting piece 2 and the thrombus-causing piece 3 can provide physical carriers for platelets to accelerate adhesion and aggregation of the platelets, so that the effects of rapidly inducing thrombus in a tumor cavity and blocking blood from entering the tumor cavity can be achieved, so that anti-platelet treatment is not needed after operation, and long-term medication of patients can be reduced. In addition, the turbulent device 100 has good applicability, and can be used for the aneurysm 300 of the bifurcation and the bifurcated vascular aneurysm 300.

As shown in fig. 1 and 2, the first support net tray 1 has a first tray body 11 and a first joint 12. Specifically, the first supporting net disk 1 is woven from metal wires. Because of the lack of fixation points between the wires, the first support net disc 1 can slide relatively, with good compliance and compliance, both in the delivery catheter 8 described below and in the lumen of the tumor. In this embodiment, the diameter of the wire is between 0.05mm and 0.08 mm. Preferably, the metal wire is made of developable and elastic metal, and the first tray body 11 is made of elastic metal wire, so that the first supporting net tray 1 can be tightly attached to the inner wall of the aneurysm and the neck of the aneurysm, thereby improving the support property of the wall of the aneurysm 300. As a preferable implementation mode, the metal wire is one or more of nickel-titanium alloy wires, cobalt-chromium alloy wires and platinum-core nickel-titanium wires.

In this embodiment, the number of the wires may be 48, 64, 72, 96 or 128. The first disc portion 11 is specifically woven by a single-layer mesh tube, and the double-layer mesh structure is formed by shaping, specifically, the single-layer mesh tube is folded to collect wires at two ends to one end to form a first joint portion 12, and at this time, the first joint portion 12 is disposed at the outer side of the center of the first disc portion 11, so as to be fixedly connected with a first development marker 41 described below, preferably, by welding. It should be noted that, the first supporting net disc 1 after being folded and shaped is a double-layer structure, as shown in fig. 2, the double-layer net improves the metal coverage rate, the net disc can form a compact structure after being unfolded, the blood flow entering the tumor cavity is reduced, the blocking of the blood flow at the tumor neck is realized, and the impact of the blood flow on the wall of the tumor body blood vessel can be reduced rapidly.

It should be further understood that the first supporting net plate 1 is configured in a bowl-shaped structure, so as to increase the contact area with the inner wall of the tumor cavity, thereby being helpful to increase friction force and preventing displacement or falling. Simultaneously, adopt bowl formula structure to make first support net dish 1 can laminate with the inner wall in tumour chamber, and can firm card in the entrance point in tumour chamber.

In addition, the mesh density of the wire braiding described above achieves density variation primarily through the braiding mesh number (PPI) set by the braiding machine, providing better choke flow and metal coverage. Preferably, the number of the weaving meshes is set to be 100-180 meshes, so that the metal coverage rate of the double-layer net disc can reach 40-60%.

As shown in fig. 1 and 2, a first developing marker 41 is disposed on the outer side of the first joint portion 12, and the first developing marker 41 and the first joint portion 12 are welded and fixed, in this embodiment, the first developing marker 41 is disposed as a developing ring, and the developing ring is made of one or more of gold, tantalum, platinum iridium alloy or platinum tungsten alloy, preferably, the developing ring is disposed as a solid ring structure, so that radiopaque marking can be performed, so as to achieve the developing function in operation.

At this time, the proximal end of the support member 2 is connected to the first coupling portion 12 and disposed inside the first tray portion 11. Specifically, the supporting members 2 are provided on both sides of the first tray body 11 in correspondence with the first developing marks 41. In the present embodiment, the proximal end of the supporting member 2 is welded to the first development mark member 41 together with the first joint portion 12. As shown in fig. 5 and 6, when the first support net tray 1 is fixed at the inlet end of the tumor cavity, the support member 2 can be filled in the tumor cavity to reduce the blood flow in the tumor cavity.

As a preferred embodiment, the support 2 is a spring, and/or the support has developability. In the present embodiment, the support member 2 is a developing spring, and the material of the support member 2 may be a metal material such as platinum tungsten alloy, platinum iridium alloy, tantalum alloy, gold, etc. The support 2 is formed by winding metal wires, the diameter of the metal wires is 0.04 mm-0.12 mm, and the outer diameter of the support 2 is 0.25 mm-0.65 mm.

Here, it should be noted that the support member 2 is used to connect the first support net plate 1 and the bolt-making member 3, and can be inserted and plugged between the bolt-making member 3 and the first support net plate 1 at the time of the later implantation to increase the plugging volume in the tumor cavity. Meanwhile, the spring is more accurate in positioning through the visual effect of development, and the operation risk is reduced.

As also shown in fig. 1, the number of the above-mentioned bolt-causing members 3 is plural, and plural bolt-causing members 3 are provided on the support member 2, and the plural bolt-causing members 3 are used for filling the tumor cavity. In the present embodiment, the bolt 3 is made of a metal material such as one of a nickel-titanium alloy, a nickel-titanium-cobalt alloy, a cobalt-chromium alloy, a double-layer composite wire, a nickel-titanium-platinum alloy, and a platinum-core wire, of a shape memory material or an elastic material. And the diameter of the wire is 0.03mm to 0.06mm. The bolt-making member 3 is arranged into a net pipe weaving and shaping structure, which is helpful for increasing the flexibility of the spoiler 100.

It should be understood that the bolt-forming member 3 is provided in a spherical shape, and the inside of the bolt-forming member 3 is provided in a hollow. The bolt-making piece 3 is spherical, so that the sliding and filling effect in the implantation process can be improved, the bolt-making piece 3 can independently find the gap position to carry out relative sliding filling, and the densification effect is improved. Meanwhile, the bolt-making piece 3 is arranged into a hollow shaping structure, which is not only helpful for reducing the implant of in-vivo metal, but also can furthest reduce the risk of introducing foreign matters into the tumor cavity, effectively reduce complications, and can rapidly initiate thrombus, so that the use of anticoagulant medicaments can be reduced or not required in operation.

It should be further understood that the diameter of the bolt-making member 3 is 1.5 mm-3 mm, and the bolt-making member 3 is a single-layer net structure and is integrally woven by 48, 64, 72, 96 or 128 wires. Preferably, the wire is made of a shape memory alloy, so that the thrombus forming member 3 can be integrally compressed into a delivery catheter 8, and when the thrombus forming member 3 is released in a tumor cavity, the shape can be restored to the original shape, namely, the shape can be quickly restored to a spherical state after the thrombus forming member reaches the tumor cavity, and the filling can be quickly completed, so that the treatment of the aneurysm 300 can be realized. At the same time, the spherical bolt-making piece 3 is soft and flexible, can conform to the tumor cavity of the aneurysm 300 and is stably placed in the tumor cavity.

In this case, the thrombus formation member 3 may be made of not only a metal material but also a degradable polymer biomaterial, and may be polylactic acid (PLA), polylactic acid-glycolic acid copolymer (PLGA), polyglycolic acid (PGA), polyethylene glycol (PEG), polycaprolactone (PCL), polylactic acid-caprolactone copolymer (PLC), ethylene-vinyl acetate copolymer (PEVA), polyvinyl alcohol (PVA), or a mixture of two or more of the above.

Since the spoiler device 100 provides a platform for endothelialised growth during occlusion, the plug member 3 also acts as a scaffold to promote the growth of new intima. When the filling of the tumor body is completely realized, the original scaffold can be disassembled, so that the degradable material plays a role at the moment, the in-vivo implant gradually reduces along with the extension of time, and the treatment of the aneurysm 300 is finally realized.

It will be appreciated that the thrombus formation member 3 is required to provide a higher woven mesh density in order to promote rapid thrombus formation, thus providing better metal coverage for the thrombus formation and resistance. In this embodiment, the metal coverage is between 30% and 50%.

In this embodiment, the bolt-making member 3 and the supporting member 2 are connected in series, that is, one section of the supporting member 2 carries one bolt-making member 3, so that the positioning and developing problems of the bolt-making member 3 can be solved, the condition that the bolt-making members 3 are densely stacked is effectively avoided, the filling effect is ensured, the filling efficiency is improved, and meanwhile, the risk of an operation is reduced.

As shown in fig. 3 and 4, the bolt-making member 3 includes a main body 31 and a connecting member 32, the main body 31 is provided with a ball shape, both ends of the main body 31 are provided with the connecting member 32, and the connecting member 32 is fixedly connected or detachably connected with the support 2. Preferably, the connection member 32 is removably connected to the support 2, so arranged as to facilitate the free assembly and disassembly of the bolt 3. In the actual use process, the number of the units of the bolt-making piece 3 can be matched and assembled according to the size of the aneurysm 300, and the number of the units is 1-10, so that the spoiler device 100 does not need to provide a large number of model specifications to adapt to the size of the tumor body, does not need to be stuffed for many times, only needs to calculate the volume of the tumor body before or during operation, and determines the number of the bolt-making pieces 3 with different occupied volume combinations according to the size of the aneurysm 300, thereby realizing disposable stuffing to finish the operation and being beneficial to further reducing the operation cost and operation risk.

Meanwhile, the shape of the bolt-making member 3 may be set to other types including elliptical, cylindrical, polyhedral, hemispherical and combinations thereof, thereby realizing one to a plurality of interconnected combinations. As shown in fig. 5 and 6, the operator can combine the number of units of the different thrombus formation members 3 according to the size of the aneurysm and the required occupied volume of the geometry of the aneurysm 300, and can also realize the interconnection combination filling of one to a plurality of units, ensure that the dense filling of the cavity shape of the aneurysm 300 is satisfied, achieve the purpose of treating the aneurysm 300, contribute to the improvement of the applicability of the turbulence device 100, and enable the same to be applied to the aneurysm 300 of the bifurcation and the bifurcated vascular aneurysm 300, or other types of aneurysms 300.

Most of the existing mechanical connectors cannot realize quick and effective self-locking connection by a screw locking or more complex connection mode, and complex connecting components 32 cannot be realized in devices with smaller sizes; in addition, the screw thread type connection has long time consumption in the locking and disassembling operation process, increases the risk of operation and reduces the operation efficiency. The screw connection strength mainly depends on the length of the screw thread, but if the screw thread is too long, the vessel wall is easy to puncture during sheath discharging in the operation process, so that bleeding is caused, and the operation risk is increased; in addition, the threads are too long, and the more turns of the knob are needed during assembly and disassembly, the time and risk of operation are increased; if the threads are short, they tend to disengage or fall off, as the device is prone to rotation during delivery in the catheter, which may have resulted in the rotation disengaging within the catheter during delivery, resulting in failure to retract.

As shown in fig. 4, the connection member 32 includes a fixing ring 321, a latch 322, and an operating ring 323. Wherein the fixing ring 321 is arranged on the bolt 3 in a connecting way. The lock catch 322 includes a plurality of elastic members, and the plurality of elastic members are arranged around and spaced apart from the axis of the fixing ring 321. The first ends of the elastic pieces are fixedly connected to the fixing ring 321, and the second ends of the elastic pieces are provided with hooks and action parts. The hook is used for being connected and fixed with the supporting piece 2, and the action part is used for being matched with an operation ring 323 described below. In the present embodiment, the lock catch 322 has a first state and a second state, wherein the second ends of the elastic members are close to each other in the first state, and the hook is engaged with the supporting member 2 in the second state. The fixing ring 321 and the lock catch 322 are adopted for matching use, so that the bolt-making piece 3 and the supporting piece 2 can be simply and effectively connected and fixed, assembly and disassembly of the spoiler device 100 in operation are facilitated, and convenience and rapidness are realized.

It should be understood that the operating ring 323 is movably sleeved on the lock catch 322. Meanwhile, the operating ring 323 has a first position and a second position, and when the operating ring 323 is in the first position, the plurality of elastic pieces maintain a first working state; when the operating ring 323 is at the second position, the operating ring 323 presses the acting part and drives the second ends of the elastic pieces to approach each other. The cooperation of the operating ring 323 and the acting portion can further improve the assembly efficiency of the spoiler 100, and helps to reduce the operation time.

During assembly, the fixing ring 321 is sleeved on the net knot tail of the bolt-making piece 3, the redundant net is cut off to be level with the fixing ring 321, and then the operating ring 323 is sleeved on the lock catch 322. Finally, the proximal end of the lock catch 322 is inserted into the fixed ring 321 and welded and fixed with the fixed ring 321 and the net tube.

In the present embodiment, a certain gap is provided between the operation ring 323 and the lock catch 322, and the gap is 0.05mm to 0.25mm. As shown in fig. 4, the above-mentioned action portion is provided as a chamfer. Preferably, another chamfer is provided at one end of the operating ring 323 near the acting portion and is provided in parallel with the acting portion, and the operating ring 323 can be moved left and right in the horizontal direction. In the actual assembly process, step 1 is performed first, that is, the operating ring 323 is slid along the first direction a, and the chamfer of the operating ring 323 abuts against and presses the acting portion of the lock catch 322, so that the second ends of the elastic pieces are together drawn toward the center, and the outer diameter of the second ends of the lock catch 322 is reduced. Step 2 is then performed to connect the second end of the lock 322 with the support 2, i.e. the second end of the lock 322 penetrates into the cavity of the support 2 in the first direction a. Finally, step three is executed, and then the operating ring 323 slides along the second direction b, and at this time, the second ends of the lock catches 322 are restored to the original outer diameter by the aid of the resilience of the elastic pieces, so that the bolt-making piece 3 can be connected and fixed with the supporting piece 2.

As shown in fig. 4, the hooks are disposed on the upper and lower sides of the lock catch 322, the hooks are disposed in a semicircle shape, and a third of the gap is reserved between the two hooks, when the operating ring 323 slides along the first direction a, the two hooks have enough space to get close to the center, the outer diameter of the two hooks on the lock catch 322 is larger than the inner diameter of the supporting member 2, in addition, a concave portion is disposed between the spirals of the supporting member 2, when the elastic member rebounds, the semicircular hook at the second end of the lock catch 322 can be pressed against the concave portion between the two spirals by using the rebound resilience, so that the lock catch 322 and the spirals maintain a stable connection relationship, and the tensile property of the lock catch can be improved. Preferably, to increase the connection strength of the support 2, one to two turns of the spring at the end of the spring may be subjected to a welding process, preventing unwinding during transport.

In this embodiment, the length above the chamfer of the second end of the lock catch 322 is about 2-3 times of the pitch of the supporting member 2, so that the hook at the head end of the lock catch 322 can be guaranteed to be just pressed against the spiral recess of the spring 2-3, that is, the strength of connection and the stability of the conveying process are guaranteed, and meanwhile, the risk of puncturing the blood vessel due to overlong connecting component 32 can be prevented.

It should be further appreciated that the connecting member 32 is provided as a metallic material member, and specifically one or more of nickel-titanium alloy, cobalt-chromium alloy, stainless steel, platinum-tungsten alloy, and platinum-iridium alloy may be used. Preferably, the connecting member 32 is a radiopaque visualization material that can enhance visualization for convenient handling by the operator. As a preferred embodiment, the latch 322 is a shape memory material or an elastic material.

In the present embodiment, the number of elastic members is two, and the number of elastic members may be three, four, or the like by using the same locking principle. Preferably, the latch 322 is provided as two elastic members, and the greater the number of elastic members, the greater the machining difficulty and the greater the manufacturing cost.

The connecting part 32 is connected in a quick self-locking mode, quick assembly and disassembly are realized through the left-right sliding operation ring 323, the operation is simple, the connection and the disassembly are time-saving and labor-saving, the locking degree is high, and the loosening condition can not occur; the connection mode is simple and firm without other tools; the elastic resilience of the lock catch 322 is utilized to press the inner cavity of the spring to lock, so that the device does not need to be worried about rotating and falling off in a conveying guide pipe 8.

As shown in fig. 7-9, the present embodiment further relates to a conveying system, including a conveying assembly 200, and the spoiler 100 described above. The delivery assembly 200 comprises a push rod 9 and a delivery catheter 8. Wherein, the one end and the first joint portion detachable connection of push rod 9, the other end and the trip connection setting of push rod 9. The push rod 9 and the spoiler device 100 can be arranged in the lumen of the delivery catheter 8 in a penetrating manner, and the first support net disk 1 and the bolt-making member 3 are in a compressed state in the lumen and in a deployed state out of the lumen. Wherein the delivery conduit 8 is used for delivering the first support net tray 1 and the bolt-causing member 3.

In the actual use process, the turbulence device 100 is connected with one end of the pushing rod 9, and is pulled into the conveying conduit 8 through the action of the pushing rod 9, and as the bolt-making piece 3 and the first supporting net disk 1 are both of a woven structure, the wires can slide relatively without fixed points, so that the resistance is small when the conveying conduit 8 is pulled into the conveying conduit, and meanwhile, the bending flexibility of the conveying conduit 8 in a blood vessel can be increased. The double-layer woven wires of the first supporting net disk 1 are bound together through the first developing mark piece 41, fixed through glue solidification or riveting mode, and connected with the releasing part 91 of the push rod 9 through the first developing mark piece 41. The disengaging portion 91 is broken by the electrolytic separation system or the electrothermal separation system.

As shown in fig. 9, when the spoiler 100 is pushed out of the delivery conduit 8, the supporting member 2 is smaller than the inner diameter of the delivery conduit 8, and is bent against the wall of the delivery conduit 8 during pushing out, but the first supporting net disk 1 and the bolt-making member 3 are compressed into a long strip-shaped bundle in the delivery conduit 8, so as to provide a delivery channel for the supporting member 2.

The turbulent flow device 100 of the invention adopts the weaving structure to connect with the spring structure, thereby not only meeting the compact embolism of the aneurysm 300, reducing the implantation times, but also reducing the metal quantity of the implant and reducing the release quantity of the metal; on one hand, the spherical and bowl-shaped woven mesh structure can rapidly trigger thrombus, and compact filling is formed in a tumor cavity; on the other hand, the high-density grid is beneficial to endothelialization of the turbulence device 100, restricts the speed and the direction of blood flow, has outstanding action effect and realizes effective blocking. The spoiler device 100 with the woven structure has good overbending performance and is suitable for straight blood vessels, tortuous blood vessels, bifurcated blood vessels and the like.

Meanwhile, the spoiler device 100 of the application can be used for electrolytic detachment, so that the time is short, the operation time is shortened, and the operation risk is reduced. Can reduce the long-term medication after operation, and does not need to be subjected to antiplatelet treatment. The turbulent device 100 has a developing effect and can be accurately positioned in operation. The spoiler 100 may be repositioned and redeployed prior to disengagement, enhancing the positioning and stability of the spoiler 100.

The embodiment also relates to a manufacturing method of the turbulence device, which specifically comprises the following steps:

preparing a supporting piece 2, and weaving metal wires to form a metal net pipe;

Fixing the metal net pipe on the mold rod, and performing heat setting treatment on the metal net pipe and the mold rod;

obtaining a part of the metal mesh tube after heat setting and cooling;

folding part of the metal mesh tube outwards, converging two ends of the part of the metal mesh tube and fixing the two ends of the part of the metal mesh tube on the developing mark;

filling part of the metal mesh tube into a first mold 400 or a second mold 500 and performing heat setting treatment to obtain a first support mesh disc 1 mold or a bolt-forming piece 3;

and fixedly connecting the die of the first support net disk 1, the support piece 2 and the bolt-forming piece 3 after the heat treatment is finished.

Specifically, first, the corresponding mandrel is selected to be clamped on the spring coiling machine for manufacturing the support piece 2, wherein the spring coiling machine is existing equipment and can be directly purchased and used, and the outer diameter and the material selection of the support piece 2 can be selected according to actual conditions. Meanwhile, the metal wires are woven to form a metal net pipe, and the metal net pipe comprises a net pipe of the bolt-forming piece 3 and a net pipe of the first supporting net disk 1, and can be woven normally by using a braiding machine with corresponding spindle numbers.

And then binding and fixing the ending part of the braided net pipe on a die rod by adopting copper wires, and carrying out heat setting on the die rod with the net pipe by using a heat treatment furnace, wherein the aim is mainly to remove bending stress in the metal wire braiding process, and setting the heat setting temperature to be between 450 and 550 ℃ and setting time to be 5 to 8 minutes.

After heat setting and cooling, the net pipe is taken down from the mold rod, the net pipe with the length of 3 cm to 5cm is cut by scissors, the net pipe is turned outwards, wires at two ends are gathered to one end and welded and fixed with the first developing marker 41, and at the moment, argon arc welding or laser welding can be used for fixation.

As shown in fig. 7, the welded net tray is pressed in the middle by the upper and lower molds, and the second mold 500 is locked and fixed. As shown in fig. 8, a 2-3cm length of mesh tube is cut by scissors, a mold core is placed at the center of the mesh tube, then two ends of the mesh tube respectively pass through the center holes of the upper and lower molds, the mesh tube and the mold core are pressed in the middle, the redundant mesh tube passing through the upper and lower molds is pulled out of the second mold 500, and the second mold 500 is locked and fixed.

Then, the first die 400 and the second die 500 are respectively 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 dies, so that the device can still keep the original shape after the dies are removed, and at the moment, the heat setting temperature is set between 450 ℃ and 550 ℃, and the setting time is 5min to 10min;

Finally, the support 2, the bolt 3 and the first support net disk 1 are connected and fixed by welding, which can be performed by soldering or laser welding.

Example two

As shown in fig. 12, the present embodiment provides a turbulence device 100, wherein a plurality of fiber hairs 5 are arranged on a supporting member 2 of the turbulence device 100 at intervals, that is, on the basis of the first embodiment, fiber hair 5 wires are embedded in the supporting member 2 of the turbulence device 100, when the turbulence device 100 is implanted in an aneurysm 300, the fiber hairs 5 can adsorb blood cells, coagulate and block blood outside the aneurysm, thereby having a better effect of blocking embolism and rapidly filling the aneurysm 300.

In addition, the fibre fleece 5 can also be sewn to the bolt 3 and the first support screen 1. As shown in fig. 13 and 14, after the spoiler 100 is released, the fiber hairs 5 are released into the aneurysm 300 due to the pressure of the 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.

It should be understood that the fiber wool 5 is made of polymer materials such as polyamide or PET, and is formed by kneading and combining a plurality of strands of spun yarns, so that a fiber thread which is not easy to scatter is formed, and scattered wool fibers are arranged on the surface of the fiber thread. In the present embodiment, the length of the fiber hairs 5 is 2mm to 4mm, and the distance between two adjacent fiber hairs 5 is 2mm to 4mm.

As shown in fig. 13 and 14, in the working schematic diagram of the turbulence device 100 in the tumor cavity provided in the second embodiment, the turbulence device 100 is conveyed by the conveying conduit 8, the turbulence device 100 is pushed out of the conveying conduit 8 by the pushing rod 9 and is conveyed into the aneurysm 300, the flow device is released at the inlet end of the tumor cavity, the first supporting net disc 1 is attached to the inner wall of the tumor cavity at the inlet end of the tumor cavity, and the device is prevented from being separated from the tumor cavity and blocking blood from entering the tumor cavity. Simultaneously, in the release process, the supporting piece 2 and the bolt-making piece 3 can be used for rapidly filling the tumor cavity, the supporting piece 2 can be used for filling gaps between the bolt-making pieces 3 in a sliding manner, and the effect of dense filling is achieved. The support member 2 and the thrombus formation member 3 provide a physical carrier for platelets to accelerate adhesion and aggregation of platelets, so that thrombus can be rapidly initiated in the tumor cavity to block blood from entering the tumor cavity.

Example III

As shown in fig. 15-17, the present embodiment provides a spoiler 100, wherein the spoiler 100 includes a spring coil 6, and the spoiler 100 as described in embodiment one. The number of the spring rings 6 is multiple, the multiple spring rings 6 are arranged on the supporting piece 2 at intervals, one spring ring 6 is arranged between every two adjacent bolt-making pieces 3, and the spring rings 6 are used for filling the tumor cavity.

It should be understood that the spring ring 6 is made of one of platinum-tungsten alloy, platinum-iridium alloy, tantalum alloy, gold and other metal materials. Specifically, the spring coil 6 is formed by winding a spring, and the middle of the spring coil is hollow. The spring is wound by metal wires, and the diameter of the metal wires is 0.04 mm-0.12 mm. The outer diameter of the spring is 0.25-0.65 mm. The spring coil 6 acts as a dense embolic effect as does the spring coil 6 in embolization.

As shown in fig. 15 and 16, the spring ring 6 may be provided in a spherical cavity structure or a 3D cavity structure. The spring ring 6 is connected with the bolt-making piece 3 and fills the tumor cavity so as to increase the filling volume in the tumor cavity. Through the visual effect of development of spring, the location is more accurate, reduces the operation risk. The spring ring 6 is preformed by heat treatment before being connected with the bolt-making piece 3, and the shaping shape can be: hollow cage shape, lantern shape, sugarcoated haws shape, spherical shape and cylinder shape. The spring coil 6 can return to its original set shape after being detached from the delivery catheter 8 and expand against the vessel wall of the aneurysm 300. The cavity structure can increase the filling volume efficiency and reduce the metal content in the implanted body.

As shown in fig. 5 and 6, when the aneurysm 300 is accompanied by a larger ascus, the thrombus formation member 3 can be relatively moved and filled by utilizing its own spherical structure, so as to ensure that each ascus can be densely filled; in addition, the rebound resilience of the bolt-making piece 3 is utilized to improve the adherence effect of the spoiler 100, and the space is inflated and filled, so that the displacement of the spoiler 100 can be effectively avoided. The same can be done when the aneurysm 300 is elongated, and the device can be withdrawn for positioning during release until the most appropriate shape is found and then released, helping to reduce the risk of surgery.

Example IV

The present embodiment provides a spoiler device 100, as shown in fig. 18 and 19, the spoiler device 100 includes a second supporting net 7, and the spoiler device 100 as described in the embodiment one.

The second supporting net disc 7 has a second disc body 71 and a second combining portion 72, the second combining portion 72 is disposed at a proximal end of the first disc body 11 and is connected with a distal end of the supporting member 2 through the second developing mark member 42, and the second disc body 71 is used for being attached to an inner wall of the tumor cavity and is disposed opposite to an inlet end of the tumor cavity. In this embodiment, the second supporting net disk 7 is designed to have an umbrella-like structure and a reverse-buckling structure, which helps to prevent rupture of the aneurysm 300 while increasing the supporting force of the vessel wall. As a preferred embodiment, as shown in fig. 20, a plurality of fiber hairs 5 are provided on the support 2.

As shown in fig. 21 to 24, in the actual use process, the spoiler device 100 is firstly placed in the delivery catheter 8, reaches the tumor cavity of the aneurysm 300 through the delivery catheter 8, then pushes out the second supporting net disk 7, and forms the elastic restoration of the original shape through the second supporting net disk 7, and expands from the edge of the delivery catheter 8 to the periphery when pushing out the delivery catheter 8, and is adhered and unfolded along the vascular wall of the aneurysm 300, so that the vascular wall is prevented from being burst, and the intratumoral stability and the use safety are increased. The second supporting net disk 7 has stronger anti-blood flow impact capability, and plays a role in slowing down or preventing the risk of blood bursting through the blood vessel wall, so that the thrombosis of the aneurysm 300 and the endothelialization of the position of the net disk in the aneurysm are promoted, the second supporting net disk 7 is ensured not to deform and shift due to the impact of the blood, and the overall filling effect of the turbulent flow device 100 is ensured.

At this time, the second supporting net disk 7 has no pressure on the tumor top, so that the risk of bleeding and rupture of the aneurysm can be greatly reduced; the second supporting net disk 7 is attached to the vessel wall of the aneurysm 300 after being unfolded, and a clamping hook structure is not provided, so that branch vessels possibly existing near the tumor top can be prevented from being extruded; meanwhile, the occupying effect can be reduced, and the compression of the aneurysm 300 on brain tissues, nerves and the like can be reduced.

In addition, the first supporting net disk 1 is matched with the aneurysm wall of the aneurysm 300 to be tightly attached, so that better structural stability can be obtained, at the moment, the first supporting net disk 1 blocks blood flow to enter the neck of the aneurysm 300, blood flow in the aneurysm 300 is slowed down, thrombus formation of the thrombus forming piece 3 and the supporting piece 2 in the aneurysm 300 is promoted, and then the thrombus-filled aneurysm 300 is mechanically blocked by the thrombus forming piece 3, so that blood is prevented from continuously flowing into the aneurysm 300, the weakened aneurysm 300 wall is isolated from a blood circulation system, and the risk of rupture of the aneurysm 300 can be effectively reduced. The release of the first support mesh disc 1 at the neck provides a good platform for endothelialised growth, helping the neointima to cover the neck of the aneurysm more quickly, isolating the aneurysm 300 from the blood flow of the carrying artery, and thus achieving the purpose of treating the aneurysm 300.

The present invention is not limited to the above-mentioned embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present invention are intended to be included in the scope of the present invention. Therefore, the protection scope of the invention is subject to the protection scope of the claims.

Claims (10)

1. A spoiler device, comprising:

The first support net disc is provided with a first disc body and a first combination part, the first disc body is arranged at the inlet end of the tumor cavity and is in fit connection with the inner wall of the tumor cavity, and the first combination part is arranged outside the center of the first disc body;

The proximal end of the support piece is connected with the first combining part and is arranged on the inner side of the first disc body part, and the support piece has flexibility and is used for filling the tumor cavity;

The number of the bolt-making pieces is multiple, the bolt-making pieces are arranged on the supporting piece, and the bolt-making pieces are used for filling the tumor cavity.

2. The spoiler according to claim 1, wherein said bolt-causing member is provided in a spherical shape and an interior of said bolt-causing member is provided in a hollow.

3. The spoiler according to claim 2, wherein said bolt-causing member is fixedly connected to said support member;

and/or the two ends of the bolt-making piece are provided with connecting parts, and the connecting parts are detachably connected with the supporting piece.

4. A spoiler according to claim 3, wherein both ends of the bolt-causing member are provided with connecting members, the connecting members comprising:

the fixing ring is connected and arranged on the bolt-making piece;

The lock catch comprises a plurality of elastic pieces, the elastic pieces are arranged around the axis of the fixed ring at intervals, the first ends of the elastic pieces are fixedly connected to the fixed ring, and the second ends of the elastic pieces are provided with hooks; the lock catch is provided with a first state and a second state, the second ends of the elastic pieces are close to each other in the first state, and the second ends of the elastic pieces are far away from each other and are clamped with the supporting pieces in the second state.

5. The spoiler according to claim 4, wherein the connecting member further comprises:

The operation ring is movably sleeved on the lock catch and provided with a first position and a second position, and when the operation ring is positioned at the first position, the elastic pieces keep a first working state; when the operating ring is at the second position, the operating ring presses the outer peripheral surface of the elastic piece and drives the second ends of the elastic pieces to be close to each other.

6. The spoiler according to claim 1, wherein a plurality of fiber hairs are provided at intervals on the support member.

7. The spoiler device according to claim 1, further comprising:

The number of the spring rings is multiple, one spring ring is arranged between every two adjacent bolt-forming members, and the spring rings are used for filling the tumor cavity.

8. The spoiler device according to claim 1, further comprising:

The second support net plate is arranged at the far end of the supporting piece and is used for being attached to the inner wall of the tumor cavity.

9. The spoiler according to any one of claims 1 to 8, wherein the support comprises a spring and/or the support is developable.

10. A conveyor system comprising a conveyor assembly and a spoiler device according to any one of claims 1-9, the conveyor assembly comprising:

one end of the pushing rod is detachably connected with the first combining part;

The pushing rod and the turbulent flow device can be arranged in the lumen of the conveying conduit in a penetrating way; wherein the first support mesh disc and the tethering member each have a compressed state within the lumen and a deployed state out of the lumen.