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CN115998367B - Folding and unfolding controllable double-layer intracranial thrombus taking support - Google Patents

Folding and unfolding controllable double-layer intracranial thrombus taking support

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Publication number
CN115998367B
CN115998367B CN202310003375.2A CN202310003375A CN115998367B CN 115998367 B CN115998367 B CN 115998367B CN 202310003375 A CN202310003375 A CN 202310003375A CN 115998367 B CN115998367 B CN 115998367B
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China
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stent
support
catheter
grid
layer
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CN115998367A (en
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吕胜男
吴硕
张天霄
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Beihang University
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Beihang University
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Abstract

本发明公开了一种展收可控双层颅内取栓支架,属于颅内取栓领域;具体包括:由外层支架和内层支架组成的支架本体、微导管、中间导管、球囊导管、支架方向导引管和控制导丝;当到达血栓所在位置后,依次回撤球囊导管、中间导管、微导管,露出支架本体;球囊打开作为固定支撑点;通过前后拉动控制导丝带动内外层支架本体的收缩或展开;支架方向导引管用于推拉控制导丝时限制支架的移动,支架捕获血栓进入微导管后,依次回撤中间导管和球囊导管,球囊收缩将所有装置撤出体外。本发明利用异型网格单元较强易操作的变形能力,引入了主动控制单元的元素用于对支架的展收运动进行控制,增加了支架径向力和展收状态的可控性,提高了血栓融合率。

This invention discloses a controllable double-layer intracranial thrombectomy stent, belonging to the field of intracranial thrombectomy. Specifically, it includes: a stent body composed of an outer and inner stent layer, a microcatheter, an intermediate catheter, a balloon catheter, a stent directional guide tube, and a control guidewire. Upon reaching the thrombus location, the balloon catheter, intermediate catheter, and microcatheter are sequentially retracted to expose the stent body. The balloon opens to serve as a fixed support point. Pulling the control guidewire back and forth causes the inner and outer stent bodies to contract or expand. The stent directional guide tube restricts stent movement when the control guidewire is pushed or pulled. After the stent captures the thrombus and enters the microcatheter, the intermediate catheter and balloon catheter are sequentially retracted, and the balloon contracts to remove all components from the body. This invention utilizes the strong and easily manipulated deformability of the irregularly shaped mesh unit and introduces an active control unit element to control the stent's expansion and contraction movement, increasing the controllability of the stent's radial force and expansion/contraction state, and improving the thrombus fusion rate.

Description

Folding and unfolding controllable double-layer intracranial thrombus taking support
Technical Field
The invention belongs to the field of intracranial thrombus taking, and particularly relates to a folding and unfolding controllable double-layer intracranial thrombus taking bracket.
Background
The brain is an extremely complex and important organ that controls various functions of the human body, and when blood vessels that deliver oxygen and nutrients to the brain are blocked, broken or ruptured by clots, a "stroke" (Cerebral Stroke), also known as a "stroke" occurs. If a stroke occurs, the blood flow will not reach the areas of the brain that control specific body functions, eventually leading to failure and even death of that part of the body. Cerebral stroke is the second most common cause of death worldwide, next to coronary artery disease.
Cerebral stroke IS mainly classified into three types, namely, stroke in which blood flow to the brain IS blocked by a clot IS called "ischemic stroke" (Ischemic Stroke, IS), stroke in which blood flow to the brain IS prevented by vascular rupture IS called "hemorrhagic stroke" (Hemorrhagic Stroke, HS), and stroke in which transient ischemic attacks are caused by a transient clot IS called "transient stroke" (TRANSIENT ISCHEMIC ATTACK, TIA) or "small stroke" (mini stroke).
About 85% of strokes are ischemic strokes, with acute ischemic strokes (Acute ischemic stroke, AIS) being one of the leading causes of mortality and disability worldwide. Recent global disease burden study data (Global Burden of Disease Study, GBD) show that chinese stroke is a long term leading worldwide occurrence. The data also show that the prevalence of Chinese stroke is generally rising, and the mortality rate of stroke is still at a high level.
The realization of cerebrovascular recanalization is the key treatment of acute ischemic cerebral apoplexy, and the treatment modes of cerebral apoplexy comprise drug thrombolysis and mechanical thrombolysis. The early evidence-based therapy of ischemic stroke is mainly drug thrombolysis therapy, namely, thrombolytic drugs are injected near the diseased site of blood vessels, and high thrombolytic drug concentration is formed near the diseased site instantaneously, so that the thrombolysis speed is accelerated, and the chance of vascular recanalization is further increased. However, according to the results of the authoritative study, the therapeutic time window for thrombolysis is shorter than that of mechanical thrombolysis, is only 3-6 hours, is only suitable for thromboembolism with smaller volume, and part of patients have rejection reaction to thrombolytic drugs, so that fewer patients are treated by thrombolytic drugs.
The manner in which mechanical thrombectomy is delivered to a vessel occlusion by minimally invasive interventional procedures and the removal of thrombus is known as mechanical thrombectomy (MECHANICAL THROMBECTOMY, MT). Mechanical thrombolysis has shown good therapeutic effect in the treatment of acute ischemic stroke caused by "large vessel occlusion" (LARGE VESSEL Occlusion, LVO). At present, the stent thrombolysis in mechanical thrombolysis is the main widely used clinical treatment and research of acute ischemic cerebral apoplexy. During treatment, the thrombus taking support is sent to the embolism position through the microcatheter, then released in a mode of withdrawing the microcatheter, and the thrombus taking support is recovered after thrombus at the embolism position is obtained, so that the thrombus is taken out. The stent thrombus taking has the advantages of small volume, less time limit, wide thrombus size application, small vascular injury, high vascular recanalization rate, ideal postoperative prognosis effect of patients and the like.
The existing bracket is mostly processed by shape memory alloy, and has good deformation and shape recovery capability. During operation, the shape memory alloy material is used to stretch and retract the rack into the micro-catheter in vitro, and the rack will automatically expand to restore to original state after the micro-catheter is withdrawn in place in vivo. However, the intracranial cerebral vascular environment is complicated in tortuous, and the passive expansion mode of the stent is often influenced by the vascular environment, so that the stent cannot be fully expanded, the fusion property of the stent and thrombus is poor, thrombus is easy to escape, and the thrombus can be completely taken out through multiple operations.
In the prior art, the grid units of the hollow circular tube grid type bracket are mostly formed by evolution of regular polygons, such as a water drop type formed by triangle, a spindle type formed by quadrilateral, a honeycomb type formed by hexagon and the like. In order to achieve the axial length required by the function, the existing grid-type stent occupies a larger volume and length, and the resistance of the stent passing through a bending part is easy to increase, as in document 1, the disclosure number is CN113855351B, namely, a thrombus taking stent formed by connecting a plurality of sections of stent bodies through a spring rod structure, so that the thrombus taking stent has the capability of high deformation and high structural toughness. However, the thrombus taking support only introduces a spring rod as a collision relieving part, and mesh units which are formed by polygonal evolution are adopted without changing the mesh parts which occupy most of the support and play a main role, and the end points on two sides of the mesh units respectively move along the two symmetrical axial ends in the axial stretching process of the support formed by the mesh units so as to achieve a contracted state. However, due to limitation of the limit characteristics of the memory alloy material, the axial stretching capability of the grid unit is weaker, so that the radial shrinkage of the grid unit is limited to a certain extent, if the material characteristics are ignored, the stent is forced to stretch and shrink into the microcatheter in vitro, the stent can not be restored in vivo, so that the radial supporting force and other properties of the stent are influenced, meanwhile, the deformation range of the spring rod is limited, and the flexibility of the stent when passing through a bending part can not be well ensured.
Most stents in the market adopt passive self-expansion deployment, and active control of the stent is not considered, so that the radial supporting force of the stent is uncontrollable and cannot be changed along with the vascular environment. The passive deployment mode makes the stent and thrombus not fused sufficiently, and cannot improve the once-through rate of the blood vessel. In the case of document 2, a main body with publication number CN216317846U is composed of a net-shaped bracket, a central core wire and a connecting sleeve and is provided with a bolt taking device with a control handle, and the core wire is controlled by the control handle to move along the front-back direction to apply force to the bracket, so that the purposes of expanding the bracket when the button is pulled or pulled backwards and contracting the bracket when the button is pushed or released forwards are achieved. The active control is considered, but the stent body is made of a plurality of metal wires, the radial supporting force of the mesh structure of the stent body is weak, the shape of the expanded stent is uneven, thrombus is easy to escape, and meanwhile, the movement of the stent is controlled only at the head and tail parts of the stent, so that the instability can be caused in the process of controlling the movement or the expansion of the stent.
Disclosure of Invention
The invention aims to provide a folding and unfolding controllable double-layer intracranial thrombus taking stent, and aims to solve the technical problems of poor fusion of the stent and thrombus and low vessel once-through rate caused by uncontrollable folding and unfolding of the stent and uncontrollable radial supporting force in the prior art.
The expanding and contracting controllable double-layer intracranial thrombus taking support comprises a support body, a microcatheter, a middle catheter, a balloon catheter, a support direction guide tube and a control guide wire, wherein the support body consists of an outer support and an inner support.
The outer layer support comprises an outer layer support frame body, an outer layer support thread tightening sleeve, a control unit tightening sleeve and an encryption basket, and the inner layer support comprises an inner layer support frame body and an inner layer support thread tightening sleeve.
The two layers of support bodies are in a hollow column shape when being unfolded, and the whole appearance details are in a hollow grid form. The two-layer support is composed of a plurality of sections of grid modules, each section of grid module is composed of one or more groups of special-shaped grid units with strong axial expansion capacity and radial supporting capacity in series connection, any two adjacent sections of grid modules are connected through rod-shaped bridge ribs, and the lengths of the bridge ribs are not identical.
The inner and outer layer support thread tightening sleeves are respectively used for inwards tightening and fixing the proximal initial end and the distal end of the inner and outer layer support frame bodies. The inner layer support thread tightening sleeve is arranged in the outer layer support thread tightening sleeve and used for adjusting the relative position of the inner layer support body and the outer layer support body and balancing the axial deformation difference value of the inner layer support and the outer layer support body caused by different diameters;
The control unit is positioned at the middle part of the outer layer bracket body and used for controlling the expansion and contraction of the bracket body, is integrally processed with the outer layer bracket body, is fixed by the control unit tightening sleeve after the outer layer bracket body is contracted inwards, and is internally provided with the connection points of control guide wires, preferably 2-4 and uniformly distributed.
The control guide wire passes through the inner support thread tightening sleeve and the outer support thread tightening sleeve simultaneously, a clamping groove is arranged in the outer support thread tightening sleeve and used as a movement limiting point of the inner support thread tightening sleeve, and a fixed connection point of the control guide wire is arranged in the outer support thread tightening sleeve.
The outer layer support frame body is provided with an encryption basket at the far end, and is realized through the design of an encryption grid at the far end of the outer layer support for reducing escape of broken thrombus, and the near end of the outer layer support frame body is provided with a slide-shaped structure for facilitating thrombus entering the catheter.
The stent body is positioned in a micro-catheter, the micro-catheter is positioned in an intermediate catheter, and the intermediate catheter is positioned in a balloon catheter. The control guide wire is connected with the head and tail control point positions of the support body and each connection point of the control unit in sequence, and the unfolding and folding of the support are realized through the push-pull operation of the control guide wire, specifically:
After the expanding and contracting controllable double-layer intracranial thrombus taking stent reaches the position of thrombus, the balloon catheter, the middle catheter and the microcatheter are sequentially retracted to expose the stent body; when the balloon catheter is retracted to a preset position, the balloon is opened and used as a fixed supporting point after the device reaches a lesion part to assist the inner and outer stent frames to perform controllable unfolding and folding movements in the body, at the moment, the proximal end of the stent frame body is fixed, and the control wire is pulled backwards to realize the unfolding of the stent frame body control unit, so that the inner and outer stent frame bodies are driven to slowly unfold in the body;
The control guide wire is pushed forward to realize the shrinkage of the support frame body control unit, so that the inner and outer support frame bodies are driven to shrink, and when the inner and outer support frame bodies shrink to a preset value of the support, the control guide wire is pulled backward to drive the whole support to move towards the microcatheter until the support enters the microcatheter. After the stent body is exposed, the unfolding and folding degree and state of the stent can be adjusted at any time through the push-pull control guide wire so as to be better fused with thrombus.
The guiding tube in the direction of the stent is used for pushing and pulling the control guide wire to limit the movement of the stent, after the stent captures thrombus and enters the microcatheter, the microcatheter is retracted to the middle catheter, the middle catheter is retracted to the balloon catheter, the balloon is contracted, and the balloon catheter is pulled to withdraw all devices from the body.
The invention has the advantages that:
1. The double-layer intracranial thrombus taking support with controllable expansion and contraction has super axial and radial deformation capacity during expansion and contraction, and is favorable to operation of the distal end of the support entering cerebral blood vessel.
2. The double-layer intracranial thrombus taking support with controllable expansion and contraction has stable structure, the support formed by the serial arrangement and combination of the special-shaped grid units has stronger radial supporting force, and the cylindrical support formed by the units has fewer sharp corners and reduces the stimulation injury to the vessel wall.
3. The utility model provides a controllable double-deck intracranial thrombus taking support of exhibition is received, utilizes the deformability of the stronger easy operation of abnormal shape grid unit, has introduced the element of initiative control unit to be used for controlling the exhibition of support and receives the motion, has increased the controllability of support radial force and exhibition receipts state, has improved thrombus fusion rate, and initiative control unit and support body are as an organic whole, can process out simultaneously, need not to carry out the secondary concatenation equipment, has reduced the degree of difficulty of processing.
4. A folding and unfolding controllable double-layer intracranial thrombus taking support is connected with a grid module through bridge ribs so as to achieve dense and dense combination, and the flexibility of the support in a bent blood vessel can be ensured.
Drawings
FIG. 1 is a schematic view of a deployment and retraction controllable double-layer intracranial thrombolysis stent according to the present invention;
FIG. 2 is a schematic view of the outer layer frame of the folding and unfolding controllable double-layer intracranial thrombus taking-out bracket;
FIG. 3 is a schematic view of the structure of an inner layer frame body of a folding and unfolding controllable double-layer intracranial thrombus taking frame;
FIG. 4 is a schematic perspective view of a shaped grid cell of the outer stent of the present invention;
FIG. 5 is a plan expanded view of a shaped grid cell of the outer stent of the present invention;
FIG. 6 is a schematic view of the deployment and retraction process of the opposite grid cells of the outer stent of the present invention;
FIG. 7 is a schematic view of the structure of the outer layer thrombus removal stent of the present invention in a contracted and stretched state;
fig. 8 is a schematic diagram of a thrombus taking device according to an embodiment of the present invention in operation;
FIG. 9 is a schematic view of the structure of the middle control unit of the outer frame before processing;
FIG. 10 is a schematic view of the structure of the control unit in the middle of the outer frame of the present invention;
FIG. 11 is a schematic view showing the positional relationship between the components of the thrombus formation device of the present invention
In the figure, the 1-outer stent, the 1.1-outer stent screw tightening sleeve, the 1.2-control unit, the 1.2.1-control unit tightening sleeve, the 1.3-encryption basket, the 2-inner stent, the 2.1-inner stent screw tightening sleeve, the 3-micro catheter, the 4-intermediate catheter, the 5-balloon catheter, the 6-distal stent directional guide catheter and the 7-control guide wire
Detailed Description
The present invention is further described in detail below with reference to the drawings and examples for the purpose of facilitating understanding and practicing the present invention by those of ordinary skill in the art. It is apparent that the described embodiments are only some embodiments, not all embodiments, of the present invention, and that all other embodiments obtained by persons of ordinary skill in the art without making creative efforts based on the embodiments of the present invention shall fall within the protection scope of the present invention.
The invention discloses a controllable intracranial double-layer thrombus taking support with adjustable deployment and retraction and adaptability to complex variability of blood vessels, wherein a support main body consists of an inner support and an outer support, special-shaped grid units which are flexible and stable in axial deformation and radial deformation are adopted, the grid units are serially arranged to form a plurality of grid modules, the grid modules are connected through bridge ribs, a control unit which is not separated from the support is additionally arranged at the end part of each module, the head end and the tail end of a support body of the inner support and the tail end of the outer support are respectively retracted into a spiral sleeve with an adjusting function and simultaneously pass through a control guide wire as a head control point and a tail control point, the support device also comprises a distal support direction guide tube, a proximal microcatheter, a middle catheter and a balloon catheter. The invention has simple motion control, the control unit is integrated with the bracket, the production and the processing are convenient, the control of the appearance and the radial supporting force of the bracket can be realized by operating the control guide wire in the operation, the operation space is enlarged, and the adaptability of the thrombus taking bracket to the operation environment is improved.
The invention relates to a near end and a far end, which are used for referring to the distance between surgical equipment and a doctor when the doctor performs minimally invasive surgical operation, wherein the near end refers to the end which is closer to the doctor, and the far end refers to the end which is farther from the doctor and enters a human body first.
As shown in fig. 1, the deployment and retraction controllable double-layer intracranial thrombus taking stent comprises a stent body consisting of an outer stent 1 and an inner stent 2, a microcatheter 3, a middle catheter 4, a balloon catheter 5, a stent directional guide tube 6 and a control guide wire 7.
The outer layer bracket 1 comprises an outer layer bracket body, an outer layer bracket thread tightening sleeve 1.1, a control unit 1.2, a control unit tightening sleeve 1.2.1 and an encryption basket 1.3, and the inner layer bracket comprises an inner layer bracket body and an inner layer bracket thread tightening sleeve 2.1.
The inner and outer layer bracket bodies of the bracket body are preferably provided with 3-5 sections, the two layers of bracket bodies are hollow columnar when unfolded, and the whole appearance detail is in a hollow grid form. The two-layer support is composed of a plurality of sections of grid modules, each section of grid module is composed of one or more groups of special-shaped grid units with strong axial expansion capacity and radial supporting capacity in series connection, any two adjacent sections of grid modules are connected through rod-shaped bridge ribs, and the lengths of the bridge ribs are not identical.
The inner and outer layer support thread tightening sleeves are respectively used for inwards tightening and fixing the proximal initial end and the distal end of the inner and outer layer support frame bodies. The inner layer support thread tightening sleeve is arranged in the outer layer support thread tightening sleeve and used for adjusting the relative position of the inner layer support body and the outer layer support body and balancing the axial deformation difference value of the inner layer support and the outer layer support body caused by different diameters;
As shown in fig. 2 and fig. 3, the outer bracket body and the inner bracket body provided in this embodiment are respectively schematic structural diagrams. The embodiment adopts a special-shaped grid unit with round ends at two ends and a concave middle, wherein a perspective view and a plane expansion view are respectively shown in fig. 4 and 5, and the grid unit has extremely strong axial deformability within the elastic limit range of the material and can ensure the recovery. The deformation of the shaped grid cells during the axial stretching of the stent is shown in fig. 6. The special-shaped grid involves a number of design parameters, such as the radius of the arc of the grid, the length, the width, the inclination angle, etc., and the required diameter and length of the bracket can be realized by changing the design parameters of the special-shaped grid. When the support is stretched, namely, the two ends of the special-shaped grid are stretched, the special-shaped grid can present different grid shapes due to deformation. Preferably, a shaped mesh within these shape ranges can be used as a range of variation in the mesh design profile. Through reasonable design, in the material deformation range, when the stent is radially contracted to 50% of the radius, the axial deformation of the stent can reach 150%, so that the operation space of the stent near the intracranial lesion is greatly improved.
In one example, one opposite grid unit of the outer layer bracket is formed by connecting 4 special-shaped grids through short straight bar bridge ribs, one grid module is formed by connecting 2-4 opposite grid units in series, and every two adjacent grid modules are connected through the bar bridge ribs. For the outer layer bracket, a control unit is arranged at the end of each grid module, and the control unit and the bracket grid units are in an undivided whole. The control unit in this example is formed by two independent horn-shaped grid units, as shown in fig. 9, and is only connected with the former section of grid module, and the two horn-shaped grid units are combined inwards into a sleeve by using a proper gap between the two horn-shaped grid units and the latter section of grid module to form a control unit, as shown in fig. 10, for controlling the threading of the guide wire. The outer stent in this example has a meniscus at the proximal end for facilitating the sliding of thrombus near the microcatheter, and the meniscus is retracted inwardly into the proximal screw sleeve after processing, which is to be placed in the microcatheter.
In one example, the opposite grid units of the inner layer support are formed by connecting 2 special-shaped grids which are the same as the outer layer support through short straight bar bridge ribs, one grid module is formed by connecting 2-4 opposite grid units in series, every two adjacent grid modules are connected through the bar-shaped bridge ribs, and the length of the bridge ribs needs to be correspondingly adjusted according to the design of the outer layer support so as to avoid interference between the outer layer control unit and the inner layer support. Similarly, the grid modules at the head and tail positions of the inner layer support can respectively add two sections of bridge ribs to two ends, and the two sections of bridge ribs need to be respectively contracted inwards into the head and tail spiral sleeve.
The inside of the head and tail screw sleeve of the outer layer bracket in the example is also in a screw shape, and the inner diameter is consistent with the outer diameter of the head and tail screw sleeve of the inner layer bracket. In this example, the inner layer support and the outer layer support are both composed of the same special-shaped grids, but because the number of special-shaped grids is different, the diameter of the inner layer support is smaller than that of the outer layer support, meanwhile, the length of the inner layer support is different from that of the outer layer support, the axial deformation lengths of the inner layer support and the outer layer support are different due to the difference between the diameter and the length, as shown in fig. 11, the length L of the inner layer support and the outer layer support can be changed along with the unfolding and folding states of the support, and the design is used for adjusting and balancing the difference.
The control unit is located the middle part of outer support body for control the exhibition of support body is received, and can form with outer support on same pipe tubular product simultaneous processing, and it is fixed with the control unit tightening sleeve pipe with the inward shrink later, very big reduction the complexity and the stability of equipment in support processing. The control unit tightening sleeve is internally provided with connection points for controlling the guide wires, preferably 2-4 and uniformly distributed.
The control guide wire passes through the inner support thread tightening sleeve and the outer support thread tightening sleeve simultaneously, a clamping groove is arranged in the outer support thread tightening sleeve and used as a movement limiting point of the inner support thread tightening sleeve, and a fixed connection point of the control guide wire is arranged in the outer support thread tightening sleeve.
The mesh module at the distal end of the outer stent body of this example is followed by a mesh basket structure formed of encrypted mesh for catching escaping thrombus during thrombus acquisition, and the distal end of the mesh basket structure is also required to be fixed by a distal screw sleeve, which is required to be placed in a guide tube for controlling the stent direction at the distal end. Meanwhile, the slide-shaped structure is arranged at the proximal end of the outer layer bracket body, so that thrombus can enter the catheter conveniently.
The stent body is positioned in a micro-catheter, the micro-catheter is positioned in an intermediate catheter, and the intermediate catheter is positioned in a balloon catheter. The control guide wire sequentially passes through the control points of the head and tail spiral sleeves of the support body and all connection points of the control unit to be connected, the support is unfolded and folded through the push-pull operation of the control guide wire, and meanwhile the control guide wire is limited by all control points;
The method comprises the following steps:
as shown in figure 8, after the expanding and contracting controllable double-layer intracranial thrombus taking stent reaches the position of thrombus, the balloon catheter, the middle catheter and the microcatheter are sequentially retracted to expose the stent body, when the balloon catheter is retracted to the preset position, the balloon is opened and used as a fixed supporting point after the device reaches a lesion to assist the inner and outer stents to perform controllable expanding and contracting movement in the body, at the moment, the proximal end of the stent frame body is fixed, and the control wire is pulled backwards to realize the expansion of the stent frame body control unit, so that the inner and outer stent frame bodies are driven to slowly expand in the body;
As shown in fig. 7, the control wire is pushed forward to realize the contraction of the control unit of the support frame body, so that the inner and outer support frame bodies are driven to contract, and when the inner and outer support frame bodies contract to the preset value of the support, the control wire is pulled backward to drive the whole support to move towards the microcatheter until the support enters the microcatheter. After the stent body is exposed, the unfolding and folding degree and state of the stent can be adjusted at any time through the push-pull control guide wire so as to be better fused with thrombus.
The guiding tube in the direction of the stent is used for pushing and pulling the control guide wire to limit the movement of the stent, after the stent captures thrombus and enters the microcatheter, the microcatheter is retracted to the middle catheter, the middle catheter is retracted to the balloon catheter, the balloon is contracted, and the balloon catheter is pulled to withdraw all devices from the body.
In this example, the stent body is stretched and contracted in place outside the body and then placed in the microcatheter, after entering the body, the balloon of the balloon catheter is opened, the microcatheter is retracted, the stent is released, at this time, the stent is in a completely contracted state, the control point at the distal end of the stent, namely, the control point in the distal spiral sleeve of the inner stent, is in the maximum state with the distance value of the microcatheter, and the length is determined by the length of the outer stent. After the support in this example is in place, the control guide wire can be pushed and pulled by the controller such as the handle of the external operation control device, so as to change the unfolding and folding state of the support.
In the embodiment, the fixing device is arranged at the joint of the microcatheter and the proximal screw sleeve of the outer layer bracket, the control can be performed by introducing a screw thread which is consistent with the outer diameter of the proximal screw sleeve of the outer layer bracket into the microcatheter, and the microcatheter with the limiting device can be custom-manufactured or purchased. For the in-place judgment of the microcatheter, a limiting device needs to be added into the middle catheter. And judging the in-place condition of the middle catheter. The balloon catheter is used as the whole device to fix and judge the position in place. Therefore, in this example, the extending distance of the proximal spiral sleeve of the outer stent relative to the microcatheter is set in advance, and the distances of the microcatheter relative to the middle catheter and the middle catheter relative to the balloon catheter are also set in advance, and as shown in fig. 11, the lengths L1, L2, and L3 are all preset constant values.
In the example, because the hollow grid circular tube type bracket can be stretched in the shrinkage process, in order to prevent the condition that the outer layer bracket is unstable in the expansion process due to the overlength of the shrinkage length, the distance between adjacent control points is set to be equal in value during design, so that the control is convenient.
Preferably, after the stent is processed and molded, a hydrophobic coating can be added on the surface to increase the flexibility of the movement of the stent in the body. The developing point of the support can be added at the control point, and if a clearer developing effect is required, the developing point can be added at the bridge rib of the outer support. Optimally, platinum wires can be added in stent processing to achieve the effect of whole body development.
The connecting bridge rib of the outer layer support grid module shown in the example is a linear rod, and the bridge rib can be changed into a triangular wave-shaped bridge rib according to requirements so as to reduce the preshrinking of the support and improve the stability of the support in the moving process. The function of the inner layer support is to improve the fusion of the support and thrombus, realize the function of opening the vascular access as soon as possible, the design of the inner layer support can be constrained by the outer layer support, so the lengths of the bridge ribs connected with the grid modules of the inner layer support can be different, and the shapes of the bridge ribs can be changed according to the requirements.
The catheter in the balloon catheter in the embodiment is a common catheter, and preferably, the catheter in the balloon catheter can be replaced by a suction catheter with matched size, so that the thrombus escape phenomenon adjacent to the catheter opening in the stent retracting process is reduced, and the once-through rate of the blood vessel is improved.
The control units at the middle part of the outer layer frame body of the support body are 2-4, 4-6 control points are added at the head and tail parts of the support, and the control points are distributed uniformly as much as possible, namely the distances between adjacent points are kept as consistent as possible, so that the stability of the support in the moving and unfolding process is ensured.
The bracket body is made of shape memory alloy, preferably nickel-titanium alloy, and is formed by cutting round tubes by laser.

Claims (10)

1.一种展收可控双层颅内取栓支架,其特征在于,具体包括:由外层支架和内层支架组成的支架本体、微导管、中间导管、球囊导管、支架方向导引管和控制导丝;1. A controllable double-layer intracranial thrombectomy stent, characterized in that it specifically comprises: a stent body consisting of an outer stent and an inner stent, a microcatheter, an intermediate catheter, a balloon catheter, a stent directional guide tube, and a control guidewire; 所述支架本体位于微导管内,微导管位于中间导管内,中间导管位于球囊导管内;The stent body is located inside the microcatheter, the microcatheter is located inside the intermediate catheter, and the intermediate catheter is located inside the balloon catheter. 所述外层支架包括外层支架架体、外层支架螺纹收紧套管、控制单元、控制单元收紧套管和加密网篮;内层支架包括内层支架架体和内层支架螺纹收紧套管;The outer support includes an outer support frame, an outer support threaded tightening sleeve, a control unit, a control unit tightening sleeve, and a reinforced mesh basket; the inner support includes an inner support frame and an inner support threaded tightening sleeve. 所述内层支架螺纹收紧套管放置于外层支架螺纹收紧套管内,两层支架架体两端分别通过各自的螺纹收紧套管固定,且在内外层支架螺纹收紧套管内均设有控制导丝的固定连接点;The inner support threaded tightening sleeve is placed inside the outer support threaded tightening sleeve. The two supports are fixed at both ends by their respective threaded tightening sleeves, and a fixed connection point for the control guide wire is provided inside both the inner and outer support threaded tightening sleeves. 所述控制单元位于外层支架架体的中间部位,用于控制支架架体的展收,且与外层支架一体加工而成,通过控制单元收紧套管将其向内收缩固定,控制单元收紧套管内设有控制导丝的固定连接点;The control unit is located in the middle of the outer support frame and is used to control the extension and retraction of the support frame. It is integrally processed with the outer support frame. The control unit tightens the sleeve to retract and fix it inward. The control unit tightening sleeve is provided with a fixed connection point for the control guide wire. 所述控制导丝同时穿过内、外层支架螺纹收紧套管和控制单元,依次与支架本体的首尾固定连接点及控制单元的各固定连接点相连接,通过对控制导丝的推拉操作实现支架的展收,具体为:The control guide wire passes through the inner and outer layer support threaded tightening sleeves and the control unit, and is sequentially connected to the beginning and end fixed connection points of the support body and each fixed connection point of the control unit. The extension and retraction of the support is achieved by pushing and pulling the control guide wire, specifically as follows: 当所述取栓支架到达血栓所在位置后,依次回撤球囊导管、中间导管、微导管,露出支架本体;球囊导管回撤至预设位置时,球囊打开作为固定支撑点,用以辅助内、外层支架在体内进行可控展收运动;此时内、外层支架架体近端固定,通过向后拉动控制导丝实现控制单元的展开,从而带动内、外层支架架体在体内的缓慢展开;Once the thrombectomy stent reaches the location of the thrombus, the balloon catheter, intermediate catheter, and microcatheter are retracted sequentially to expose the stent body. When the balloon catheter is retracted to the preset position, the balloon opens to serve as a fixed support point, which assists the inner and outer stents in performing controllable extension and retraction movements within the body. At this time, the proximal ends of the inner and outer stents are fixed, and the control unit is deployed by pulling the guidewire backward, thereby driving the inner and outer stents to slowly unfold within the body. 通过向前推动控制导丝实现控制单元的收缩,从而带动内、外层支架架体收缩,当收缩至支架预设值后,控制导丝向后拉动即可带动支架整体向微导管移动直至进入微导管;支架本体露出后,可随时通过推拉控制导丝调整支架的展收程度及状态,以更好地与血栓融合;By pushing the control guidewire forward, the control unit is contracted, thereby causing the inner and outer layers of the stent to contract. Once the stent has contracted to the preset value, the control guidewire is pulled backward to move the entire stent toward the microcatheter until it enters the microcatheter. After the stent body is exposed, the degree and state of the stent can be adjusted at any time by pushing and pulling the control guidewire to better fuse with the thrombus. 所述支架方向导引管用于推拉控制导丝时限制支架的移动,支架捕获血栓进入微导管后,微导管回撤至中间导管,中间导管撤回球囊导管,球囊收缩,拉动球囊导管将所有装置撤出体外。The stent directional guide tube is used to restrict the movement of the stent when pushing and pulling the guidewire. After the stent captures the thrombus and enters the microcatheter, the microcatheter retracts to the intermediate catheter, the intermediate catheter retracts to the balloon catheter, the balloon contracts, and pulls the balloon catheter to remove all devices from the body. 2.如权利要求1所述的一种展收可控双层颅内取栓支架,其特征在于,所述支架本体展开时呈空心柱状,外形为镂空网格形式,两层支架均由多段网格模块组成,且每段网格模块均由一组或多组兼具较强轴向伸缩能力和径向支撑能力的异型网格单元串联排布组成,任意相邻两段网格模块之间通过杆状桥筋连接。2. The controllable double-layer intracranial thrombectomy stent as described in claim 1, characterized in that the stent body is hollow columnar when unfolded, with a hollow grid shape, both layers of the stent are composed of multiple grid modules, and each grid module is composed of one or more sets of irregular grid units with strong axial expansion and contraction capabilities and radial support capabilities arranged in series, and any two adjacent grid modules are connected by rod-shaped bridging tendons. 3.如权利要求1所述的一种展收可控双层颅内取栓支架,其特征在于,所述外层支架架体远端设有加密网篮,通过加密外层支架远端的网格设计实现,用于减少破碎血栓逃逸;外层支架架体近端设有滑梯状结构,方便血栓进入导管。3. The controllable expansion and contraction double-layer intracranial thrombectomy stent as described in claim 1, characterized in that the distal end of the outer stent body is provided with a dense mesh basket, which is achieved by the dense mesh design of the distal end of the outer stent body to reduce the escape of fragmented thrombi; the proximal end of the outer stent body is provided with a slide-like structure to facilitate the entry of thrombi into the catheter. 4.如权利要求2所述的一种展收可控双层颅内取栓支架,其特征在于,所述异型网格单元的设计参数包括:网格圆弧半径、长度、宽度和倾斜角,通过改变异型网格单元的设计参数来实现所需的支架直径和长度;当对内外层支架架体进行拉伸时,即相当于对异型网格单元两端进行拉伸,由于变形使得异型网格单元呈现不同的网格形状,均可作为网格设计外形的变化范围,在材料合理的变形范围内,当支架径向收缩至半径50%时,轴向变形可达到150%。4. The expandable and contractable double-layer intracranial thrombectomy stent as described in claim 2, characterized in that the design parameters of the irregular grid unit include: grid arc radius, length, width and tilt angle, and the required stent diameter and length can be achieved by changing the design parameters of the irregular grid unit; when the inner and outer stent frames are stretched, it is equivalent to stretching both ends of the irregular grid unit. Due to the deformation, the irregular grid unit presents different grid shapes, which can all be used as the range of variation of the grid design shape. Within the reasonable deformation range of the material, when the stent is radially contracted to 50% of its radius, the axial deformation can reach 150%. 5.如权利要求1所述的一种展收可控双层颅内取栓支架,其特征在于,所述外层支架螺纹收紧套管内部也是螺纹状,内径与内层支架螺旋套管外径一致;内层支架的直径小于外层支架,同时内层支架的长度与外层支架也存在差异,直径和长度不同会导致内外层支架轴向变形长度不同。5. The controllable expansion and contraction double-layer intracranial thrombectomy stent as described in claim 1, characterized in that the outer stent's threaded tightening sleeve is also threaded inside, with its inner diameter matching the outer diameter of the inner stent's spiral sleeve; the inner stent's diameter is smaller than that of the outer stent, and the length of the inner stent also differs from that of the outer stent, and the difference in diameter and length will result in different axial deformation lengths of the inner and outer stents. 6.如权利要求2所述的一种展收可控双层颅内取栓支架,其特征在于,外层支架的网格模块的连接桥筋为:直线杆或波浪形桥筋;内层支架的设计受到外层支架的约束,所以连接内层支架网格模块的桥筋长度选择不同或根据需求改变桥筋外形。6. The controllable expansion and contraction double-layer intracranial thrombectomy stent as described in claim 2, characterized in that the connecting bridging bars of the grid module of the outer stent are: straight bars or wavy bridging bars; the design of the inner stent is constrained by the outer stent, so the length of the bridging bars connecting the grid module of the inner stent can be selected differently or the shape of the bridging bars can be changed according to requirements. 7.如权利要求1所述的一种展收可控双层颅内取栓支架,其特征在于,所述球囊导管中的导管为尺寸匹配的抽吸导管。7. The controllable expansion and contraction double-layer intracranial thrombectomy stent as described in claim 1, characterized in that the catheter in the balloon catheter is a size-matched aspiration catheter. 8.如权利要求1所述的一种展收可控双层颅内取栓支架,其特征在于,所述支架首尾两处设置的固定连接点为4-6个,控制单元设有2-4个,且均匀分布,即相邻点位间的距离保持一致。8. The controllable double-layer intracranial thrombectomy stent as described in claim 1, characterized in that the stent has 4-6 fixed connection points at both ends, and 2-4 control units, which are evenly distributed, i.e., the distance between adjacent points is consistent. 9.如权利要求1所述的一种展收可控双层颅内取栓支架,其特征在于,所述支架本体的材质为形状记忆合金,支架由圆管激光切割而成。9. The expandable and retractable double-layer intracranial thrombectomy stent as described in claim 1, characterized in that the stent body is made of shape memory alloy and the stent is laser-cut from a round tube. 10.如权利要求9所述的一种展收可控双层颅内取栓支架,其特征在于,所述形状记忆合金为镍钛合金。10. The expandable and retractable double-layer intracranial thrombectomy stent as described in claim 9, wherein the shape memory alloy is a nickel-titanium alloy.
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