CN114287989B - Blood flow guiding device bracket - Google Patents

Blood flow guiding device bracket Download PDF

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Publication number
CN114287989B
CN114287989B CN202111598685.0A CN202111598685A CN114287989B CN 114287989 B CN114287989 B CN 114287989B CN 202111598685 A CN202111598685 A CN 202111598685A CN 114287989 B CN114287989 B CN 114287989B
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stent
braided
strands
braiding
wires
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CN114287989A (en
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李峥
刘建民
刘享承
金飞龙
赵中
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Zhuhai Tongqiao Medical Technology Co ltd
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Zhuhai Tongqiao Medical Technology Co ltd
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Abstract

The application discloses a blood flow guiding device bracket, which is formed by braiding braided wires and comprises: when the diameter D of the bracket is more than or equal to 2.5mm and less than 4mm, the number of the braided strands is 40-60 strands; when the diameter D of the bracket is larger than or equal to 4mm and smaller than 6mm, the number of the braided strands is 64-84 strands; when the diameter D of the bracket is larger than or equal to 6mm and smaller than 7mm, the number of the braided strands is 88-108 strands; the distal end of the stent forms a closed loop; the braided wire comprises an inner layer and an outer layer, wherein the X-ray attenuation coefficient of the inner layer is larger than that of the outer layer. All the braided wires have developing property, so that richer stent details can be observed under subtraction angiography DSA, finer operation space is provided for doctors, and fine abnormal conditions can be adjusted in time; the stent has the advantages that the number of the knitting strands is changed for different diameter specifications, so that the metal coverage rate of the stent can be better controlled, and the safety is improved.

Description

Blood flow guiding device bracket
Technical Field
The application relates to the technical field of medical equipment, in particular to a blood flow guiding device bracket.
Background
Intracranial aneurysms are one of the common hemorrhagic cerebrovascular diseases, with major risk of rupture hemorrhage, high mortality and disability rate. Intracranial aneurysms rupture, resulting in subarachnoid hemorrhage, which severely jeopardizes the patient's life and health. If subarachnoid hemorrhage occurs, the mortality rate of untreated subarachnoid hemorrhage is approximately 50%, and the disability rate after treatment is as high as 60%. Hemodynamic disorders are believed to be a major factor in intracranial aneurysm occurrence, progression and rupture. Reconstruction of intracranial aneurysm-carrying arteries and correction of hemodynamic disturbance of the aneurysm-carrying arteries are endpoint targets for treating intracranial aneurysms.
At present, the method for treating the intracranial aneurysm mainly comprises two main types of intravascular interventional treatment and craniotomy clamping treatment. Craniotomy clamp treatment has a very high surgical risk and has been replaced in recent years by safer endovascular interventions. The vascular interventional therapy means mainly depend on two types of instruments: an intratumoral turbulence device and a tumor neck diversion device. Among them, coil embolization is a typical representation of intratumoral turbulators; the blood flow guiding device is representative of a flow guiding device, and the flow velocity of blood flow in the aneurysm is slowed down by means of larger braiding density and larger metal coverage rate, so that the aneurysm is induced to be closed automatically, and meanwhile, the fine grid can be used as a scaffold for growing on the inner wall of the blood vessel to remodel the malformed blood vessel. Compared with the spring coil embolization, the blood flow guiding device can greatly shorten the operation time under the condition that the stent is released smoothly, and the operation complexity is smaller.
Correspondingly, the blood flow guiding device puts higher requirements on the stent body:
firstly, the accuracy requirement of the bracket on the release position is high. In the operation implantation process of the blood flow guiding device stent, the distal end of the stent needs to be pushed out of the microcatheter at first, then the stent is released in a mode of retracting the microcatheter, the dense net part of the stent needs to completely cover the tumor neck of the aneurysm, the treatment effect is directly affected by the deviation of the release position of the stent, and the implantation position of the blood flow guiding device stent is slightly deviated, so that the normal passage of the blood flow of the bypass vessel is affected by the bypass vessel due to the fact that the bypass vessel is often arranged near the intracranial aneurysm. The anchoring properties of the distal end of the stent are critical during the release of the stent in the vessel.
Secondly, the stent needs to have good vascular compliance. Intracranial arterial vessels are often more tortuous and the stent needs to be flexible enough to allow the surface of the stent to be in close proximity to the inner wall of the vessel, otherwise a poorly attached stent may cause dissection of the vessel.
Thirdly, the stent needs to have excellent visibility under subtraction angiography DSA. When releasing the stent at the position of a vascular curve, a doctor often estimates the release condition of the stent by mistake because the adherence and the opening state of the stent in the blood vessel are difficult to be comprehensively observed, so that the postoperative recurrence rate is higher; or because the condition of the stent in the blood vessel is not fully known, when a doctor fine-adjusts the position of the stent, the metal wire of the stent accidentally injures the blood vessel.
Fourth, the stent needs to have good radial support force. After the stent implantation operation, the stent needs to be kept in place under the continuous contraction and relaxation of the blood vessel and the impact of blood flow, and the stent is mainly maintained stable in the blood vessel by virtue of the radial supporting force during the process.
In the patent application publication number CN 113693799A, a single radiopaque development wire is used in combination with a development spring coil wound around the development wire to enhance the visualization of the stent under intraoperative imaging. However, the implementation method can only enable the outer contour of the bracket and the positions of the two ends of the bracket to be observed under the irradiation of X-rays. The outline development effect of the single development wire can evaluate the approximate trend of the stent, but the details of local stent shrinkage, collapse or kink and the like cannot be well observed and analyzed. The judgment of the success of the operation is made only by the satisfactory general trend of the stent after the stent is released, and the safety is not enough.
In the patent application publication number CN 113143555A, a woven stent is provided, a part of the wires of the stent are radiopaque development wires, another part of the stent is a metal wire with no development property, a development spring coil is wound outside the wires, and the two wires are woven in a cross manner. This approach has similar drawbacks as the solution presented by CN 113693799 a: only the outline of the bracket can be developed, and the local bad phenomenon of the bracket can not be observed and analyzed, so that the safety of the product is reduced. In addition, the tips of the braiding wires at the two sides of the stent are exposed outside, and the tips of the wires at the distal end of the stent are easy to stab fragile blood vessels along with the advancement of the stent in the stent implantation process.
In the patent application publication No. CN 212382692U, a novel dense mesh stent is provided, in which the mesh weave on both sides of the stent is sparse, the mesh is large, and the stent has a flaring structure. Although the flaring structures on two sides of the stent can relieve the problem of shrinkage of the two sides of the stent in a blood vessel, the grid sparse braiding can reduce the influence of the stent on the collateral blood vessel, but the radial supporting force on two sides of the stent is greatly reduced by the sparse braiding grids, and after the stent is attached to the wall of the stent, each isolated braiding wire on two sides slides along the inner wall of the blood vessel easily, so that the anchoring effect of the stent is reduced.
In the patent application publication number CN 112386364A, a hybrid braided stent is presented that improves the overall radial support force of the stent by replacing a portion of the filaments on the stent with thicker filaments. Although the mixing of the thick wires does have the effect of improving the radial support force of the stent, the stent grid which is not covered by the thick wires is not reinforced from the viewpoint of the stent grid, and the stent is easy to cause local collapse due to uneven grid strength, so that the safety of the stent is reduced.
In view of the above drawbacks, the applicant has devised the present application to solve at least one of the technical problems described above.
Disclosure of Invention
In order to solve at least one technical problem in the background art, the application provides a blood flow guiding device bracket which has good developing effect and good radial supporting force.
The application provides a blood flow guiding device bracket, which is formed by braiding braided wires and comprises:
when the diameter D of the bracket is more than or equal to 2.5mm and less than 4mm, the number of the braided strands is 40-60 strands; when the diameter D of the bracket is larger than or equal to 4mm and smaller than 6mm, the number of the braided strands is 64-84 strands; when the diameter D of the bracket is larger than or equal to 6mm and smaller than 7mm, the number of the braided strands is 88-108 strands;
the distal end of the stent forms a closed loop;
the braided wire comprises an inner layer and an outer layer, wherein the X-ray attenuation coefficient of the inner layer is larger than that of the outer layer;
the braided wire comprises a first braided group arranged along a first direction and a second braided group arranged along a second direction, wherein the first direction is intersected with the second direction; wherein,
the first braiding group comprises a plurality of first braiding wires and a plurality of second braiding wires, wherein the plurality of first braiding wires and the plurality of second braiding wires are arranged at intervals, and the first braiding wires and the second braiding wires are different in wire diameter;
the second braiding group comprises a plurality of third braiding wires and a plurality of fourth braiding wires, wherein the third braiding wires and the fourth braiding wires are arranged at intervals, and the third braiding wires and the fourth braiding wires are different in wire diameter.
Preferably, the cross-sectional area of the inner layer is 30% -50% of the cross-sectional area of the braided filaments.
Preferably, the material of the inner layer is one or more of platinum, iridium, gold, silver or tantalum; the material of the outer layer is nickel-titanium alloy.
Preferably, the mesh formed by braiding the braided wires is diamond-shaped.
Preferably, the wire diameters of the first braided wire and the third braided wire are both a; and the wire diameters of the second braided wire and the fourth braided wire are b.
Preferably, a is 0.02-0.05mm; a-b=0.001-0.02 mm.
Preferably, the distal end of the bracket and the proximal end of the bracket are both provided with a developing ring.
Preferably, the density of the woven mesh at the distal end of the stent and the density of the woven mesh at the proximal end of the stent are both less than the density of the woven mesh at the middle section of the stent.
Preferably, the distal end of the stent and the proximal end of the stent are flared outwardly.
Preferably, the expansion forms an angle of 30-90 degrees.
The beneficial effects brought by one aspect of the application are as follows:
all the braided wires have developing property, so that richer stent details can be observed under subtraction angiography DSA, finer operation space is provided for doctors, and fine abnormal conditions can be adjusted in time; the distal closed loop structure of the stent can enable the stent to have better distal anchoring effect in the implantation operation process, the stent is released more stably, the closed loop can protect the inner wall of a human blood vessel, and the safety is higher; the mode of alternately weaving the thick filaments and the thin filaments can find balance between the strength and the flexibility of the stent, so that the radial supporting force and the vascular compliance of the stent are considered; the stent has the advantages that the number of the knitting strands is changed for different diameter specifications, so that the metal coverage rate of the stent can be better controlled, and the safety is improved.
Drawings
FIG. 1 is an axial view of the present disclosure;
FIG. 2 is a front view of the present disclosure;
FIG. 3 is an axial view of a braided wire of the present disclosure;
FIG. 4 is a schematic view of a portion of a braided wire of the present disclosure;
FIG. 5 is an angiographic simulation of a stent of the present disclosure;
FIG. 6 is an angiographic simulation of a prior-art stent;
fig. 7 is a schematic view of a mesh structure according to the present disclosure.
Detailed Description
It should be noted that, under the condition of no conflict, the embodiments of the present application and the features in the embodiments may be combined with each other; the following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
In the description of the present application, it should be understood that the directions or positional relationships indicated by the terms "upper", "lower", "front", "rear", "left" and "right", etc., are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present application and simplifying the description, and do not indicate or imply that the positions or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present application. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
Referring to fig. 1-7, a blood flow guiding device stent according to the present application is formed by braiding wires 11, wherein meshes formed by braiding the braided wires 11 are diamond-shaped, and the stent comprises:
when the diameter D of the bracket is more than or equal to 2.5mm and less than 4mm, the number of the braided strands is 40-60 strands; when the diameter D of the bracket is larger than or equal to 4mm and smaller than 6mm, the number of the braided strands is 64-84 strands; when the diameter D of the bracket is larger than or equal to 6mm and smaller than 7mm, the number of the braided strands is 88-108 strands. The diameter D of this embodiment refers to the diameter of the stent when uncompressed.
For example, the number of knitting strands may be 40 when the stent diameter D is 2.7mm, 50 when the stent diameter D is 3.2mm, 60 when the stent diameter D is 3.7mm, 64 when the stent diameter D is 4.2mm, 74 when the stent diameter D is 4.7mm, 88 when the stent diameter D is 6.2mm, and 108 when the stent diameter D is 6.7 mm.
Preferably, in another embodiment, when the stent diameter D is greater than or equal to 2.5mm and less than 4mm, the number of braided strands is 48 strands; when the diameter D of the bracket is larger than or equal to 4mm and smaller than 6mm, the number of the braiding yarns is 72 strands; when the stent diameter D is 6mm or more and less than 7mm, the number of braided strands is 96 strands.
The distal end 12 of the stent 1 forms closed loops 122, 123. When the stent 1 is extruded in a blood vessel and naturally stretched, the closed loops 122 and 123 of the distal end 12 can well protect the inner wall of the blood vessel and prevent the exposed tip of the braided wire from stabbing the inner wall of the blood vessel; after the stent 1 is attached within a vessel, the closed loops 122, 123 of the distal end 12 are embedded in the tissue of the inner wall of the vessel, and the closed loops 122, 123 are configured to secure the distal end 12 of the stent 1 in place as a "loop". Thus, the closed loop configuration may enhance the anchoring properties of the stent 1 during release.
The braided wire 11 includes an inner layer 111 and an outer layer 112, wherein an X-ray attenuation coefficient of the inner layer 111 is greater than an X-ray attenuation coefficient of the outer layer 112. The material of the inner layer 111 is one or more of platinum, iridium, gold, silver or tantalum; the material of the outer layer 112 is nickel-titanium alloy. The material of the inner layer 111 is more X-ray opaque. The inner layer 111 is visible under subtraction angiography DSA.
The cross-sectional area of the inner layer 111 is 30% -50% of the cross-sectional area of the braided filaments. To ensure that the filaments have sufficient developing definition.
The bracket 1 can realize full-segment development. As shown in fig. 5, under the simulated irradiation of the actual X-ray, the barrier of the human tissue is added outside the stent 1, and there are many noise points on the radiography picture, so that the trend of each wire of the stent 1 cannot be clearly seen, but because each wire has the developability, the outer contour of the stent 1 is clearer and continuous. Compared with the prior art, as shown in fig. 6, the partial wire development scheme can lead to intermittent loss of the development effect, and if once the abnormal condition of the stent 1 occurs at the intermittent missing development part, the doctor cannot observe the abnormality of the stent 1, so that the doctor can erroneously judge that the stent 1 is normal, which increases the risk of recurrence of the postoperative pathology. In contrast, the present embodiment enhances the developability, safety of the implantation of the stent 1.
The braided wire 11 includes a first braided set arranged in a first direction 113 and a second braided set arranged in a second direction 114, the first direction 113 intersecting the second direction 114; wherein,
the first braiding group includes a plurality of first braiding wires 1131 and a plurality of second braiding wires 1132, wherein the plurality of first braiding wires 1131 and the plurality of second braiding wires 1132 are arranged at intervals, and the diameters of the first braiding wires 1131 and the second braiding wires 1132 are different.
The second knitting set includes a plurality of third knitting wires 1141 and a plurality of fourth knitting wires 1142, where the plurality of third knitting wires 1141 and the plurality of fourth knitting wires 1142 are arranged at intervals, and the wire diameters of the third knitting wires 1141 and the fourth knitting wires 1142 are different.
The wire diameters of the first braided wire 1131 and the third braided wire 1141 are a; the wire diameters of the second braided wire 1132 and the fourth braided wire 1142 are b.
The a is 0.02-0.05mm; a-b=0.001-0.02 mm. Specifically, a is 0.02mm, b is 0.018mm; a is 0.028mm, b is 0.02mm; a is 0.03mm, b is 0.02mm; a is 0.035mm, b is 0.03mm; a is 0.044mm and b is 0.04mm.
The first braided wire 1131 and the third braided wire 1141 are thick wires, and the second braided wire 1132 and the fourth braided wire 1142 are filaments.
The way of knitting alternately with each other has the advantage that: firstly, thick wires and thin wires are alternated with each other, so that each diamond-shaped woven grid of the bracket 1 is composed of two thick wire adjacent sides and two thin wire adjacent sides, thus the density of the meshes 15 of the bracket 1 at different positions is the same, that is, the radial supporting force and the metal coverage rate of the bracket 1 at different positions are all stable constant values, and the stability of the bracket 1 is realized; secondly, the support 1 can obtain larger radial supporting force to a certain extent by thick wires, and meanwhile, the thin wires can maintain the flexibility of the support 1, so that the way that the thick wires and the thin wires are mutually spaced can realize hardness and softness.
Further, the distal end 12 of the holder 1 and the proximal end 14 of the holder 1 are provided with a developing ring 17. Can further enhance the development effect of the two end faces of the bracket 1
Further, the density of the woven mesh at the distal end 12 of the stent 1 and the density of the woven mesh at the proximal end 14 of the stent 1 are both less than the density of the woven mesh at the intermediate section 13 of the stent 1. Reducing the influence on the collateral blood vessel
Further, the distal end 12 of the stent 1 and the proximal end 14 of the stent 1 are flared outwardly to form a flare 121. The angle alpha formed by expansion is 30-90 degrees. By expanding the both ends of the stent 1 outward, the anchoring effect of the both ends of the stent 1 can be improved.
The metal coverage rate of the stent 1 with different diameters D can be adjusted by the way of knitting yarn number, so that the stent has more stable intravascular metal coverage rate in actual clinical use. As shown in fig. 7, the metal coverage of the stent body is related to the height c and width d of the diamond mesh and the wire diameter of the braided wire, and the metal coverage of the stent when compressed in the blood vessel can be controlled by adjusting the above three parameters. In practical clinical use, the stent is compressed in a blood vessel according to the thickness of the inner cavity of the blood vessel to different degrees, and generally the same stent diameter has a maximum applicable blood vessel diameter and a minimum applicable blood vessel diameter, wherein the stent diameter D is 6.7mm, the maximum applicable blood vessel diameter is 6.5mm, and the minimum applicable blood vessel diameter is 6.0mm. The intravascular metal coverage rate of the working area of the stent needs to be controlled between 25% and 35% so as to achieve the effect of effectively plugging the tumor neck. To illustrate the beneficial effects of the above design, the stent diameter D is exemplified here as 3.3mm and 6.7 mm. 1) When the diameter D of the bracket is 3.3mm, the number of the braiding strands is 48, the diameters of the minimum and maximum applicable blood vessels are 2.5mm and 3.0mm, as shown in the table 1, the metal coverage rates are 30.6 and 26.7%, and the metal coverage rates are stable in the effective range; 2) When the diameter D of the stent is 6.7mm, the diameters of the smallest and largest applicable blood vessels are 6.0mm and 6.5mm, if the number of braiding strands is 48 strands, as shown in table 2, the diameters of the first braiding wire 1131 and the third braiding wire 1141 are 0.044, and the diameters of the second braiding wire 1132 and the fourth braiding wire 1142 are 0.04 by adjusting the braiding parameters and the diameters of the wires, and the widths d=0.085 mm and the heights c=0.875 mm. Those skilled in the art will appreciate that these parameters are merely examples, and are not unique combinations. The metal coverage rate under the largest applicable blood vessel can be adjusted within the effective range, namely 34.4%, but at the moment, the metal coverage rate under the smallest applicable blood vessel is too low to meet the requirement, if the number of knitting strands is adjusted to 96 strands, the metal coverage rate of the stent under the largest and smallest applicable blood vessel diameters is more stable by adjusting the knitting parameters and the wire diameters, at the moment, the diamond grid width d=0.159 mm and the height c=0.438 mm, the wire diameters of the first knitting wire 1131 and the third knitting wire 1141 are all 0.035, and the wire diameters of the second knitting wire 1132 and the fourth knitting wire 1142 are all 0.03.
Table one:
diameter after compression/mm Stent metal coverage/%
3 30.6
2.5 26.7
And (II) table:
the foregoing is only a preferred embodiment of the present application, but the scope of the present application is not limited thereto, and any person skilled in the art, who is within the scope of the present application, should make equivalent substitutions or modifications according to the technical scheme of the present application and the inventive concept thereof, and should be covered by the scope of the present application.

Claims (8)

1. A blood flow guiding device stent for use in intracranial aneurysm surgery, formed by braiding wires, comprising:
when the diameter D of the bracket is more than or equal to 2.5mm and less than 4mm, the number of the braided strands is 40-60 strands; when the diameter D of the bracket is larger than or equal to 4mm and smaller than 6mm, the number of the braided strands is 64-84 strands; when the diameter D of the bracket is larger than or equal to 6mm and smaller than 7mm, the number of the braided strands is 88-108 strands;
the distal end of the stent forms a closed loop;
the braided wire comprises an inner layer and an outer layer, wherein the X-ray attenuation coefficient of the inner layer is larger than that of the outer layer;
the braided wire comprises a first braided group arranged along a first direction and a second braided group arranged along a second direction, wherein the first direction is intersected with the second direction; wherein,
the first braiding group comprises a plurality of first braiding wires and a plurality of second braiding wires, wherein the plurality of first braiding wires and the plurality of second braiding wires are arranged at intervals, and the first braiding wires and the second braiding wires are different in wire diameter;
the second braiding group comprises a plurality of third braiding wires and a plurality of fourth braiding wires, wherein the third braiding wires and the fourth braiding wires are arranged at intervals, and the third braiding wires and the fourth braiding wires are different in wire diameter;
the wire diameters of the first braided wire and the third braided wire are a; the wire diameters of the second braided wire and the fourth braided wire are b, and a is 0.02-0.05mm; a-b=0.001-0.02 mm;
the first knitting yarn and the third knitting yarn are thick yarns, the second knitting yarn and the fourth knitting yarn are thin yarns, and the thick yarns and the thin yarns are knitted alternately, so that each diamond knitting grid of the support is composed of two thick yarn adjacent sides and two thin yarn adjacent sides.
2. The blood flow guiding device stent for intracranial aneurysm surgery as recited in claim 1, wherein the inner layer has a cross-sectional area that is 30% -50% of the cross-sectional area of the braided wire.
3. The stent of claim 1, wherein the material of the inner layer is one or more of platinum, iridium, gold, silver, or tantalum; the material of the outer layer is nickel-titanium alloy.
4. The stent of claim 1, wherein the mesh formed by the braiding of the braided filaments is diamond-shaped.
5. The stent of claim 1, wherein the distal end of the stent and the proximal end of the stent are each provided with a visualization ring.
6. The blood flow guiding device stent for intracranial aneurysm surgery of claim 1, wherein the woven mesh density of the distal end of the stent, the woven mesh density of the proximal end of the stent are each less than the woven mesh density of the middle section of the stent.
7. The blood flow guiding device stent for use in intracranial aneurysm surgery as recited in claim 1, wherein the distal end of the stent and the proximal end of the stent are each flared outwardly.
8. The stent of claim 7, wherein the angle formed by the expansion is between 30 degrees and 90 degrees.
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CN112386364A (en) * 2020-11-10 2021-02-23 苏州中天医疗器械科技有限公司 Hybrid braided stent
CN113017753A (en) * 2021-02-26 2021-06-25 珠海通桥医疗科技有限公司 Blood vessel support

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