CN109965930B - Aneurysm embolism device and aneurysm embolism system - Google Patents

Aneurysm embolism device and aneurysm embolism system Download PDF

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Publication number
CN109965930B
CN109965930B CN201910355931.6A CN201910355931A CN109965930B CN 109965930 B CN109965930 B CN 109965930B CN 201910355931 A CN201910355931 A CN 201910355931A CN 109965930 B CN109965930 B CN 109965930B
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aneurysm
braiding
guide wire
supporting body
pushing guide
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CN109965930A (en
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李彬彬
吕纬岩
孙剑
余均武
张尧
李剑博
王磊
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Beijing Jiushi Shenkang Medical Technology Co ltd
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Beijing Jiushi Shenkang Medical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • A61B17/12145Coils or wires having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • A61B17/1215Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Neurosurgery (AREA)
  • Surgical Instruments (AREA)

Abstract

The invention discloses an aneurysm embolism device and an aneurysm embolism system, wherein the aneurysm embolism device comprises a braiding body which is arranged in an aneurysm neck opening and is attached to the aneurysm neck opening, and a supporting body which is arranged at the aneurysm neck opening and is used for carrying a tumor artery, one end of the supporting body is connected with the braiding body, the other end of the supporting body is connected with a pushing guide wire in an interventional operation process, and the braiding body and the supporting body are conveyed to a vascular lesion position through a microcatheter in the interventional operation process. Compared with the prior art, the intra-aneurysm embolism device provided by the invention has the beneficial effects of reducing the space occupation effect, saving the cost, being applicable to aneurysms with different shapes and different positions and reducing the risks of blocking other branches and delaying rupture of the aneurysms.

Description

Aneurysm embolism device and aneurysm embolism system
Technical Field
The invention relates to the field of medical equipment, in particular to an aneurysm embolism device and an aneurysm embolism system applied to aneurysm interventional therapy.
Background
Aneurysms are very common vascular diseases, which are the manifestations of limitation or diffuse expansion or distension of the arterial wall due to lesions or injuries of the arterial wall, and which are mainly manifested as distending, pulsating masses, which can occur in any part of the arterial system. Once the aneurysm ruptures, serious consequences may occur. If the intracranial aneurysm breaks, the subarachnoid hemorrhage is caused, and serious cases can cause vascular spasm to cause wide cerebral infarction, thereby causing hemiplegia, coma and the like. Current treatment regimens for aneurysms are mainly open surgery and endovascular interventions. The open surgical treatment scheme requires opening the body cavity surrounding the aneurysm, such as craniotomy and thoracotomy, causing great damage to the patient's body and long postoperative recovery period. The intravascular interventional therapy of the aneurysm is the preferred clinical treatment scheme of a plurality of medical professionals at present due to the advantages of minimally invasive, safe and effective intravascular interventional therapy of the aneurysm.
Currently, the endovascular interventional treatment technology of aneurysms mainly comprises a spring coil embolism technology, a spherical embolism technology, a blood flow guiding device and the like. The disadvantage of coil embolization is the increased cost due to the placeholder effect and the need for additional stent assistance. The drawbacks of the balloon embolization are the placeholder effect, the adaptation to only specific aneurysm shapes and the need for stent assistance, which leads to increased costs. Blood flow guides suffer from the disadvantages of delayed rupture of the aneurysm, occlusion of other small branches, and increased cost and space occupation effects that may be caused by the need for a packing coil assist.
Accordingly, in view of the above shortcomings, there is a need to provide an aneurysm embolization device that reduces the placeholder effect, saves costs, accommodates aneurysms of different aneurysm shapes, different sites, and reduces the risk of delayed rupture of the aneurysm and avoids occluding other branches.
Disclosure of Invention
First, the technical problem to be solved
The invention aims to solve the technical problems of providing an aneurysm embolism device and an aneurysm embolism system, which are used for solving the problems in the prior art: such as ① coils, to treat the presence of an aneurysm with a space-occupying effect and the increased cost of the need for additional stent assistance; ② The occupation effect of the spherical embolism device, the special shape of the aneurysm, and the additional support of other stents are needed to increase the cost; ③ The presence of the blood flow direction device delays rupture of the aneurysm, occlusion of other tiny branches, and possibly increased cost and placeholder effects due to the need for the assistance of a packing spring coil; ④ Treatment of bifurcation aneurysms.
(II) technical scheme
In order to solve the technical problems, the invention provides an aneurysm embolism device, which comprises a braiding body arranged in an aneurysm neck opening and attached to the aneurysm neck opening, and a supporting body arranged at the aneurysm neck opening and used for carrying a tumor artery, wherein one end of the supporting body is connected with the braiding body, the other end of the supporting body is connected with a pushing guide wire in an interventional operation process, and the braiding body and the supporting body are conveyed to a vascular lesion position through a microcatheter in the interventional operation process.
The braiding machine comprises a braiding body, wherein the braiding body is of a double-layer structure and comprises a main body part and a fitting part, the main body part is integrally formed, the fitting part is fitted with an aneurysm neck opening in an aneurysm, and the main body part is connected with a supporting body.
The sealing part of the braiding body is made of a radio-opaque metal material, and the braiding body is connected with the supporting body.
The braiding body can be formed by independently braiding nickel-titanium alloy wires, cobalt-chromium alloy wires or stainless steel wires or braiding the nickel-titanium alloy wires, cobalt-chromium alloy wires or stainless steel wires together with radiopaque wire.
Wherein the shape of the support body is single-line spiral or double-line spiral.
Wherein the shape of the support body is a sector or an ellipse, but is not limited to a sector or an ellipse.
The support body comprises an inner mandrel and an outer coil, wherein the inner mandrel is made of shape memory alloy, and the outer coil is made of radio-opaque material.
The support body is made of shape memory alloy, and one end of the support body connected with the pushing guide wire is provided with a release mark made of a radio-opaque wire material.
Wherein, the end of the support body connected with the pushing guide wire is a spherical or sphere-like end.
Wherein the supporting body is connected with the pushing guide wire in an electrolytic stripping mode.
On the basis of the invention, the invention further provides an aneurysm embolism system, which comprises the aneurysm embolism device, a pushing guide wire, an introducing sheath and a microcatheter, wherein the introducing sheath is used for loading a braiding body, a supporting body and the pushing guide wire and is in butt joint with the microcatheter in the interventional operation process, one end of the pushing guide wire connected with the supporting body is of a bifurcation structure, the end parts of two branches formed after bifurcation are respectively provided with a pushing point and a recovering point, and one end of the supporting body connected with the pushing guide wire is limited between the pushing point and the recovering point in the loading and conveying processes.
(III) beneficial effects
The technical scheme of the invention has the following advantages: in the aneurysm embolism device and the aneurysm embolism system provided by the invention, the braiding body is positioned in the aneurysm neck opening and is attached to the aneurysm neck opening, so that the aneurysm is not completely filled or a spring ring is added for assistance, and the occupation effect is reduced; the aneurysm embolism device and the aneurysm embolism system provided by the invention are provided with the supporting body connected with the braiding body, and the supporting body is positioned in the current-carrying arterial vessel at the neck of the aneurysm, so that the braiding body can be fixed, and the supporting body is prevented from protruding into the vessel or falling into the aneurysm, thereby avoiding the use of an auxiliary bracket or filling a spring ring, and saving the cost; in the aneurysm embolism device and the aneurysm embolism system provided by the invention, the braiding body can be completely attached to the neck of the aneurysm, and can adapt to aneurysms with different shapes relative to a spherical embolism device; because the support body of the aneurysm embolism device provided by the invention is of a spiral structure or a macroporous design, other tiny blood branches cannot be blocked after the aneurysm embolism device is released, and the risk of blocking other branches is reduced relative to a blood flow guiding device; in the aneurysm embolism device and the aneurysm embolism system provided by the invention, the braiding body completely seals the neck of the aneurysm, so that the risk of delayed rupture of the aneurysm is reduced relative to a blood flow guiding device.
Drawings
FIG. 1 is a schematic illustration of an aneurysm embolization device of the invention implanted in a diseased vessel (support body in a single helical line) after release
FIG. 2 is a schematic illustration of the implantation of a diseased vessel (support body in double helix) after release of an aneurysm embolization device of the invention
FIG. 3 is a schematic view of an aneurysm embolization device of the invention implanted in a diseased vessel (support body in a fan-like shape) after release
FIG. 4 is a schematic view of the structure of the present invention in an aneurysm embolization system prior to release of the aneurysm embolization device of the invention
FIG. 5 is a schematic view of an aneurysm embolization device of the invention for treating a bifurcation aneurysm
In the figure, 1, an introducer sheath; 2. an aneurysm embolization device; 3. pushing the guide wire; 4. a braiding body; 5. a support body; 6. a connecting ring; 7. releasing the mark; 8. pushing points; 9. recovering the point; 10. recycling the marks; 11. aneurysms.
Detailed Description
The following describes in further detail the embodiments of the present invention with reference to the drawings and examples. The following examples are illustrative of the invention and are not intended to limit the scope of the invention.
In the description of the present invention, it is to be understood that the terms "distal" and "proximal" in the context should be understood as viewed from the direction of the operator. Distal is the side distal from the operator and proximal means toward the operator, wherein the terms "anterior", "posterior", "inner", "outer", "caudal", etc. refer to an orientation or positional relationship based on that shown in the drawings, merely for convenience in describing the present patent and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the present patent.
In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
As shown in fig. 1 to 4, an aneurysm embolism device 2 comprises a braiding body 4 arranged in an aneurysm 11 neck opening and attached to the aneurysm neck opening, and a supporting body 5 arranged in a blood vessel at the aneurysm neck opening, wherein one end of the supporting body 5 is connected with the braiding body 4, and the other end of the supporting body 5 is connected with a pushing guide wire 3 in an interventional operation process. Because the braiding body 4 is attached to the neck of the aneurysm, the aneurysm is not required to be completely filled, and the occupation effect can be effectively reduced. The supporting body 5 is positioned in a current-carrying artery vessel at the neck of the aneurysm and is connected with the braiding body 4, so that the braiding body can be fixed, and the supporting body can be prevented from protruding into the vessel or falling into the aneurysm, thereby avoiding the use of an auxiliary support or filling a spring ring.
The braiding part 4 has a double-layer structure, the sealing part of the braiding part 4 is connected with the supporting body 5, and the sealing part is made of a radio-opaque metal material and can be used as a release mark of the braiding part 4 in the interventional operation process. Preferably, the sealing part of the braiding 4 and the supporting body 5 can be connected by a connecting ring 6, and the connecting ring 6 is made of a radio-opaque metal material. The braid 4 may be braided from shape memory alloy wires, such as nitinol wires or cobalt chromium wires or shape memory stainless steel wires. The braid 4 includes a body portion and a fitting portion formed integrally with the periphery of the body portion, the fitting portion fits the neck of the aneurysm in the aneurysm, and is adaptable to aneurysms of different shapes, and the body portion is connected to the support 5. The braiding body 4 seals the neck of the aneurysm, avoids the impact of blood flow on the inner wall of the aneurysm, and reduces the risk of delayed rupture of the aneurysm.
The shape of the support body 5 can be a single-wire spiral or a double-wire spiral, so that the position of the support body 5 after release cannot cover other blood flow branches, the braiding body 4 is released in the neck of the aneurysm, and the support body 5 can be fixed to the neck of the aneurysm and can be used for treating the aneurysm at the bifurcation part, as shown in fig. 5. The shape of the support 5 may also be a sector or an ellipse. The support body 5 of the above-described shapes does not occlude other branches of the fine blood flow after release. The support body 5 comprises an inner core shaft and an outer coil, wherein the inner core shaft is made of shape memory alloy (such as nickel-titanium alloy, etc.), the outer coil is made of radio-opaque material, and the radio-opaque material can be used as a release mark of the support body 5 in the interventional operation process. As a variant, the support body 5 may also be entirely of shape memory alloy, while the end of the support body 5 connected to the push wire 3 carries a release marker ring 7 made of radiopaque material. The end of the supporting body 5 connected with the pushing guide wire 3 is a spherical end part. The support body 5 and the pushing guide wire 3 can be connected and disconnected through an electrolytic or mechanical connection mode.
As shown in fig. 4, the aneurysm embolization system comprises an aneurysm embolization device 2, a push guidewire 3, an introducer sheath 1 and a microcatheter. The aneurysm embolism device 2 can be contracted in the introducing sheath 1 before being released, the introducing sheath 1 is used for loading protection of the aneurysm embolism device 2 and the pushing guide wire 3, and after the introducing sheath 1 is in butt joint with the microcatheter in the interventional operation process, the pushing guide wire 3 is pushed forward, so that the aneurysm embolism device 2 can reach a vascular lesion position through the microcatheter.
The end that propelling movement seal wire 3 is connected with supporter 5 is bifurcation structure, and the tip of two branches that form after the bifurcation is equipped with propelling movement point 8 and recovery point 9 respectively, and in loading and transportation process, the one end that supporter 5 and propelling movement seal wire 3 are connected is spacing between propelling movement point 8 and the recovery point 9, recovery point 9 is equipped with recovery mark 10.
In order to further understand the technical scheme of the invention, the following specifically describes the operation process of using the aneurysm embolism device provided by the invention in the interventional operation process: before use, the aneurysm embolism system is taken out of the coil, the preparation work such as preoperative cleaning is carried out on the instrument, the distal end of the introducer sheath 1 is in butt joint with the microcatheter base, the pushing guide wire 3 is pushed forward, the aneurysm embolism device 2 is pushed into the microcatheter, the distal end opening of the microcatheter is positioned in the aneurysm, the braiding body 4 is slowly and completely released under X rays due to the development design of the braiding body 4 of the aneurysm embolism device 2, the braiding body 4 is proved to be completely released after the connecting ring 6 is out of the microcatheter, and at the moment, the braiding body 4 can be clung to the neck of the aneurysm through the pushing guide wire 3 or the whole pushing guide wire 3 and the microcatheter. At this time, the push wire 3 is fixed, the microcatheter is retracted, the support body 5 of the aneurysm embolism device 2 is slowly released, before the retrieval mark 10 does not completely exit the microcatheter, the position of the support body 5 and the whole retrieval of the aneurysm embolism device 2 can be carried out by retracting the push wire 3, and when the release mark 7 is completely located outside the microcatheter, the aneurysm embolism device 2 is completely released. At this time, the covering condition of the braiding body 4 on the tumor neck and the adherence condition of the supporting body 5 in the parent artery can be observed through the imaging device.
The foregoing is merely a preferred embodiment of the present invention, and it should be noted that it will be apparent to those skilled in the art that modifications and variations can be made without departing from the technical principles of the present invention, and these modifications and variations should also be regarded as the scope of the invention.

Claims (11)

1. An aneurysm embolization device, characterized by: the device comprises a braiding body which is arranged in an aneurysm neck opening and is attached to the aneurysm neck opening, and a supporting body which is arranged at the aneurysm neck opening and is used for carrying the aneurysm artery, wherein one end of the supporting body is connected with the braiding body, the sealing part of the braiding body is connected with the supporting body through a connecting ring, the other end of the supporting body is connected with a pushing guide wire in the interventional operation process, one end of the supporting body, which is connected with the pushing guide wire, is provided with a release marking ring made of a radio-opaque wire material, and the braiding body and the supporting body are conveyed to a vascular lesion position through a microcatheter in the interventional operation process;
The end part of two branches formed after branching is respectively provided with a pushing point and a recovery point, one end of the support body connected with the pushing guide wire is limited between the pushing point and the recovery point, and the recovery point is provided with a recovery mark;
The operation process of the aneurysm embolism device comprises:
pushing the pushing guide wire to push the aneurysm embolism device into the microcatheter, completely releasing the braiding body from the microcatheter after the microcatheter is connected, and retracting the pushing guide wire or integrally retracting the pushing guide wire and the microcatheter to enable the braiding body to be clung to the neck of the aneurysm;
Fixing the pushing guide wire, retracting the microcatheter, slowly releasing the support body, retracting the pushing guide wire to adjust the position of the support body and integrally recovering the aneurysm embolism device before the recovery mark is not completely out of the microcatheter, and completely releasing the aneurysm embolism device when the release mark ring is completely positioned outside the microcatheter.
2. The aneurysm embolization device of claim 1, wherein: the braiding part is of a double-layer structure, the braiding part comprises a main body part and a laminating part, wherein the main body part and the laminating part are integrally formed, the laminating part is laminated with a neck opening of an aneurysm, and the main body part is connected with a supporting body.
3. The aneurysm embolization device of claim 1, wherein: the sealing part of the braiding body is made of a radio-opaque metal material, and the braiding body is connected with the supporting body.
4. The aneurysm embolization device of claim 1, wherein: the braiding body is formed by independently braiding nickel-titanium alloy wires, cobalt-chromium alloy wires or stainless steel wires or braiding the nickel-titanium alloy wires, cobalt-chromium alloy wires or stainless steel wires together with radiopaque wire.
5. The aneurysm embolization device of claim 1, wherein: the shape of the support body is single-line spiral or double-line spiral.
6. The aneurysm embolization device of claim 1, wherein: the shape of the support body is a sector or an ellipse.
7. The aneurysm embolization device of claim 1, wherein: the support body comprises an inner mandrel and an outer coil, wherein the inner mandrel is made of shape memory alloy, and the outer coil is made of radio-opaque material.
8. The aneurysm embolization device of claim 1, wherein: the support body is made of shape memory alloy, and one end of the support body connected with the pushing guide wire is provided with a release mark made of a radio-opaque wire material.
9. The aneurysm embolization device of claim 1, wherein: one end of the supporting body, which is connected with the pushing guide wire, is a spherical or spheroid end.
10. The aneurysm embolization device of claim 1, wherein: the supporting body is connected with the pushing guide wire in an electrolytic stripping mode.
11. An aneurysm embolization system, characterized by: the aneurysm embolism device comprises the aneurysm embolism device as claimed in any one of claims 1-9, a pushing guide wire, an introducing sheath and a microcatheter, wherein the introducing sheath is used for loading a braiding body, a supporting body and the pushing guide wire and is in butt joint with the microcatheter in the interventional operation process, one end of the pushing guide wire connected with the supporting body is of a bifurcation structure, the end parts of two branches formed after bifurcation are respectively provided with a pushing point and a recovering point, and one end of the supporting body connected with the pushing guide wire is limited between the pushing point and the recovering point in the loading and conveying processes.
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CN113208685A (en) * 2020-02-05 2021-08-06 江苏暖阳医疗器械有限公司 Degradable braided body system for embolizing aneurysm
CN111195164A (en) * 2020-02-27 2020-05-26 北京久事神康医疗科技有限公司 Aneurysm treatment device
CN112206031A (en) * 2020-11-11 2021-01-12 北京久事神康医疗科技有限公司 Aneurysm embolization device
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