CN108742778B - Mechanical thrombus taking support and thrombus taking device - Google Patents

Mechanical thrombus taking support and thrombus taking device Download PDF

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CN108742778B
CN108742778B CN201810310960.6A CN201810310960A CN108742778B CN 108742778 B CN108742778 B CN 108742778B CN 201810310960 A CN201810310960 A CN 201810310960A CN 108742778 B CN108742778 B CN 108742778B
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thrombus
end part
stent
support body
mechanical
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CN108742778A (en
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宋朝阳
朱良付
吴立恒
李天晓
许斌
李航
周腾飞
王丽娜
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Vascular Medicine (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
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Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a mechanical thrombus taking support and a thrombus taking device, which comprise a net-shaped support body formed by connecting a plurality of meshes, wherein the support body comprises a proximal end part, a middle main body part and a distal end part which are integrally formed and smoothly connected and transited, the support body is folded under the action of external force, the support body is released and restored after the external force is eliminated, the proximal end part of the support body is approximately triangular after being unfolded in a flat mode, the middle main body part is approximately rectangular after being unfolded in a flat mode, the distal end part is approximately right trapezoid after being unfolded in a flat mode, the support body is integrally curled horizontally along the longitudinal direction by taking one corner of the inclined waist side of the tail part of the distal end part as a starting point, the proximal end part of the support body is in a conical structure which is approximately small and far away, the middle main body part is in a cylindrical structure, and the distal end part is in a cylindrical screen structure in a released state. The invention can prevent thrombus from escaping, improve the catching rate of thrombus, improve the clinical prognosis of patients and improve the life quality of patients.

Description

Mechanical thrombus taking support and thrombus taking device
Technical Field
The invention belongs to the technical field of medical appliances, and particularly relates to a mechanical thrombus taking bracket and a thrombus taking device.
Background
Thrombus is a clot formed by blood on the surface of a blood vessel inside or outside the heart of the cardiovascular system under pathological conditions, and is generally composed of red blood cells, fibrin, platelets, white blood cells and the like in different proportions. Ischemic stroke caused by thrombus in cerebral vessels is a refractory disease seriously endangering human health and life safety, and according to statistics, 300 ten thousand stroke patients occur annually in China, 120 ten thousand stroke patients die annually, the incidence rate of the stroke in China is rising at 8.7% annually at present, and the number of the stroke deaths in China exceeds the number of tumors and cardiovascular diseases annually, so that the stroke deaths in China become the first cause of death. Arterial and venous thrombolysis is a conventional method for treating acute ischemic stroke, but the method has high requirements on a treatment time window, patients are strictly required to receive treatment within 4.5 hours from the onset of the thrombus, and the short thrombolysis time window can lead less than 10 percent of patients to obtain effective thrombolysis treatment, has a plurality of limits on the selection of the patients, and a part of patients in the time window are excluded, and has low vascular recanalization rate of acute ischemic stroke caused by the most serious large vascular occlusion, and the thrombolysis medicine is basically ineffective for thrombus with the size of more than 8 mm. Therefore, the effect after treatment is poor, the disability is remained, and the life is difficult to self-care, so that the acute ischemic cerebral apoplexy patients and the families thereof have to face the problem. In order to solve the above-mentioned problem of thrombolysis, a method of mechanically removing thrombus (Mechanical Thrombectomy) has been a hot spot of research in recent years. Has satisfactory clinical effect on acute ischemic stroke vascular recanalization caused by large vessel occlusion. Arterial mechanical thrombolysis devices have gained widespread attention because of their numerous advantages: rapid recanalization, low bleeding rate, and prolonged time window for stroke intervention. The current DEFUSE 3 study extends the patient time window based on image screening to 16 hours, and the DAWN study extends the patient time window based on image screening even for 24 hours, with the latest release of the U.S. AHA/ASA acute stroke early management guidelines recommending 6-16 hours of thrombolytic therapy with the highest level of evidence and 6-24 hours of thrombolytic therapy with the B-R level of evidence.
Currently, the us FDA has approved Merci thrombolytic devices (2004) and the Penumbra system (2008) solitaire blood flow reconstruction device (2012) and Trevo thrombolytic device (2012) for mechanical thrombolytic treatment of acute ischemic stroke. However, with respect to the mechanical thrombolysis device, there are still problems in the process of thrombolysis: if the design development points of most thrombus taking devices are fewer, the contact condition of the thrombus taking device and thrombus can not be clearly observed in the thrombus taking process, and the position and the form of the thrombus can not be clearly determined, so that the thrombus capturing rate is low. The prior device has fixed model, the mesh size of the bracket and the diameter of the nickel-titanium alloy wire forming the bracket are fixed between different models and in the same bracket, thus the radial supporting force is fixed, and the device cannot adapt to the specific requirements of different diameters and different anatomical parts of the cerebral vascular system, thereby leading to thrombus taking failure and damage to the vascular wall. The key point and difficulty of the intravascular treatment method for acute cerebral apoplexy are that the thrombus is captured by the thrombus capturing device used in the operation and the damage to the vessel wall in the operation process is avoided, and the vessel wall damage can cause the reocclusion of the vessel, so that the clinical prognosis effect is poor.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide the mechanical thrombus taking support and the thrombus taking device which can prevent thrombus from escaping, so that the thrombus capturing rate is high and the clinical prognosis effect is good.
In order to solve the technical problems, the invention adopts the following technical scheme:
the utility model provides a machinery is got and is tied support, includes the network management form support body that forms by a plurality of mesh connection, and this support body is including integrated into one piece and smooth connection transition's proximal end portion, middle main part and distal end portion, and support body is closed under the exogenic action, release after the exogenic elimination resumes, be approximate triangle-shaped after the support body proximal end portion tiling is expanded, is approximate rectangle after middle main part tiling is expanded, is approximate right trapezoid after the distal end portion tiling is expanded, and this support body is by the afterbody oblique waist side one corner of distal end portion as the starting point, wholly takes the design after vertically horizontal curling to handle, and this support body proximal end portion is nearly little taper structure far away under the release state, and middle main part is cylindric structure, and distal end portion is cylindric screen cloth structure.
Preferably, in the mechanical embolectomy stent described above, the mesh size of the distal end portion of the stent body is larger than the mesh sizes of the proximal end portion and the intermediate main body portion; the distal portion of the stent body has a material diameter that is thinner than the material diameters of the proximal portion and the intermediate main portion.
Preferably, in the mechanical thrombus-removing stent, a plurality of developing marks are sequentially arranged along the mesh from the proximal end to the distal end of the stent body, so that the whole stent has developing property.
Preferably, in the mechanical thrombus-removing stand, the developing marks are distributed along the mesh in a continuous or interval staggered manner.
Preferably, in the mechanical thrombus taking stent, the stent body is formed by heat treatment and shaping of a metal material with a shape memory effect or a high polymer material with high elasticity.
Preferably, in the mechanical thrombus removing stent, the proximal opening of the stent body is a shuttle.
In addition, still design a thrombus extraction device, including the mechanical thrombus extraction support of any one above, wherein the proximal end of support body is connected with push-and-pull seal wire, and the during operation support body can retrieve in the thrombus extraction microcatheter under push-and-pull seal wire effect.
In the above technical solution, the "distal end" and the "proximal end" are viewed from the direction of the surgeon, wherein the "distal end" is the end far away from the surgeon, and the "proximal end" is the end near the surgeon.
The working principle of the invention is as follows:
the thrombus taking-out device is conveyed to a thrombus position through the thrombus taking microcatheter during operation, is released and unfolded during thrombus taking operation, clamps and embeds the thrombus through the mesh of the middle main body part of the stent body, then recovers a part of the stent, enables the stent to firmly fix the thrombus, combines with the cylindrical screen structure of the distal end part, thereby filtering the thrombus and preventing the thrombus from escaping, and then takes out the thrombus taking-out stent together with the microcatheter under negative pressure suction.
The technical scheme of the invention has the beneficial technical effects that:
1. in terms of structure, the mechanical thrombus taking bracket and the thrombus taking device are characterized in that the far end part of the bracket body is designed to be approximately right trapezoid after being tiled and unfolded, and is in a cylindrical screen structure in a release state, and after thrombus is clamped by the mesh holes of the middle main body part of the bracket body, the cylindrical screen structure of the far end part is combined, so that the thrombus is effectively filtered and prevented from escaping. Therefore, the thrombus capture rate is high, the clinical prognosis can be improved, and the life quality of patients can be improved.
2. In the structure, even if the distal end part of the stent body is designed to be approximately right trapezoid after being spread, namely, the cross section area of the distal end part is larger than that of the proximal end part and the middle main body part after being spread, the mesh size of the distal end part of the stent body is larger than that of other parts, and the material diameter of the distal end part of the stent body is also smaller than that of other parts, so that the occupied space and the volume of the distal end part are correspondingly reduced in a release state after crimping and shaping, the volume of the distal end part and the volume of other parts of the stent body can be basically kept consistent no matter in the release state or in the process of being recovered into the thrombus taking microcatheter, and the distal end part of the stent body can be smoothly recovered into the thrombus taking microcatheter under the action of a push-pull guide wire in the release state of the stent body in the working process after the whole crimping and shaping treatment of the stent body.
3. In terms of structure, the mesh size of the far end part of the stent body is larger than that of other parts, and the material diameter of the part is smaller than that of other parts, so that the radial supporting force of the surface of the stent body at different positions along the longitudinal direction is adjustable, thereby adapting to the specific requirements of vessels with different diameters and different anatomical positions in a cerebral vascular system, and being capable of smoothly taking out emboli. Simultaneously, the radial supporting force of the distal end part of the stent body can be weakened, so that the damage to the vascular wall is avoided as much as possible, and the clinical prognosis effect is good.
4. In terms of structure, a certain number of developing mark points are integrally arranged on the thrombus taking support from the near end to the far end, so that the technical problems that the contact condition of a thrombus taking device and thrombus cannot be clearly observed and the position and the form of the thrombus cannot be clearly determined in the thrombus taking process are effectively solved, the operation of the thrombus taking process is facilitated, and the thrombus capturing rate is further improved.
Drawings
The invention is described in further detail below with reference to the attached drawing figures, wherein:
FIG. 1 is a schematic view of a mechanical thrombolysis stent of the present invention (in a flat deployment state);
FIG. 2 is a schematic structural view of a mechanical thrombolysis stent of the present invention (in a crimped release state);
FIG. 3 is a schematic cross-sectional view of the distal portion shown in FIG. 2;
FIG. 4 is a schematic view of the longitudinal cross-sectional configuration of the distal portion shown in FIG. 2;
FIG. 5 is a schematic view of the structure of the thrombus removal device of the present invention (the stent body is in a released state);
FIG. 6 is a schematic view of the thrombus removal device of the present invention (with the stent body in a collapsed state);
FIG. 7 is a schematic view showing a first state of a thrombus removal process of the thrombus removal device of the present invention;
FIG. 8 is a schematic view showing a second state of the thrombus removal device of the present invention in the process of removing thrombus;
number in the figure: 100. a bracket body;
101. a proximal portion;
102. a distal portion;
103. a proximal opening;
104. a mesh;
105. intermediate body portion
200. Developing the mark;
300. pushing and pulling a guide wire;
400. a thrombus removal microcatheter;
500. a blood vessel;
600. thrombus.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings, and it is apparent that the described embodiments are only illustrative of some specific implementations of the present invention and are not intended to limit the scope of the present invention, and any equivalent changes and modifications made by those skilled in the art without departing from the spirit and principles of the present invention should fall within the scope of the present invention.
Embodiment one:
referring to fig. 1-4, the mechanical thrombus taking stent of the present invention comprises a net-shaped stent body 100 formed by connecting a plurality of meshes 104, wherein the stent body comprises a proximal end portion 101, a middle main body portion 105 and a distal end portion 102 which are integrally formed and smoothly connected and transited, the stent body is folded under the action of external force, released and restored after the external force is eliminated, the proximal end portion of the stent body has a conical structure which is nearly small and far, the middle main body portion has a cylindrical structure, and the distal end portion has a cylindrical screen structure in a released state; the proximal end part of the bracket body is approximately triangular after being spread in a flat manner, the middle main body part is approximately rectangular after being spread in a flat manner, and the distal end part is approximately right trapezoid after being spread in a flat manner. The proximal opening 103 of the stent body is fusiform. The bracket body is made of a metal material with shape memory effect or a high-elasticity polymer sheet material, and is formed by taking a corner of the tail inclined waist side of the distal end part as a starting point, and integrally and horizontally curling along the longitudinal direction and then shaping.
According to the invention, the distal end part of the bracket body is designed to be approximately right trapezoid after being tiled and unfolded, and is in a cylindrical screen structure in a release state, and after thrombus is clamped and embedded by the mesh holes of the middle main body part of the bracket body, the cylindrical screen structure of the distal end part is combined, so that the thrombus is effectively filtered and prevented from escaping. Therefore, the thrombus capture rate is high, and the clinical prognosis effect is good.
Embodiment two:
the illustration of this embodiment is not shown. The mechanical thrombus taking support of the embodiment is similar to the mechanical thrombus taking support of the embodiment, and the same parts of the structure are not repeated here, and the difference is that: the mesh of the distal portion of the stent body of this embodiment is larger than the mesh sizes of the proximal portion and the intermediate main body portion; the distal portion of the stent body has a material diameter that is thinner than the material diameters of the proximal portion and the intermediate main portion.
Compared with the first embodiment, even though the cross section area of the far-end part is larger than that of the near-end part and the middle main body part after the far-end part is tiled and unfolded, the mesh size of the far-end part of the stent body is larger than that of other parts, and the material diameter of the far-end part is smaller than that of other parts, so that the occupied space and the volume of the far-end part are correspondingly reduced in the release state after the crimping and shaping, and the far-end part of the stent body can be smoothly recycled into the thrombus taking microcatheter under the action of the push-pull guide wire in the release state of the far-end part of the stent body in the working process after the whole crimping and shaping treatment, so that the structural design is more reasonable.
In addition, the mesh size of the distal end part of the stent body is larger than that of other parts, and the material diameter of the distal end part is smaller than that of other parts, so that the radial supporting force of the surface of the stent body at different longitudinal positions can be adjusted, thereby adapting to the specific requirements of different diameter vessels and different anatomical positions in the cerebral vascular system, and further smoothly taking out the embolus. Simultaneously, the radial supporting force of the distal end part of the stent body can be weakened, so that the damage to the vascular wall is avoided as much as possible, and the clinical prognosis effect is good.
Embodiment III:
referring to fig. 1-2, the present embodiment is similar to the first embodiment in structure, and like numerals in the drawings represent like meanings, and are not repeated here, except that: in this embodiment, a plurality of developing marks 200 are sequentially arranged along each mesh 104 from the proximal end to the distal end of the stent body, so that the stent body has developing property as a whole. Further, each developing mark is continuously distributed along each mesh. Of course, the components may be distributed at intervals or offset as needed.
Compared with the first embodiment, the method has the advantages that a certain number of developing mark points are integrally arranged on the thrombus taking support from the near end to the far end, so that the technical problems that the contact condition of a thrombus taking device and thrombus cannot be clearly observed and the position and the form of the thrombus cannot be clearly seen in the thrombus taking process are effectively solved, the operation of the thrombus taking process is facilitated, and the thrombus capturing rate is further improved.
Examples four to six:
referring to fig. 5-6, there are shown four to six thrombus removal devices according to this embodiment, which comprise the mechanical thrombus removal stent, push-pull wire 300, and thrombus removal microcatheter 400 described in the first to third embodiments, respectively. A push-pull guide wire 300 is connected to the proximal end of the stent body 100, a thrombus taking micro-catheter 400 is sleeved on the surface of the push-pull guide wire, and the stent body can be recycled into the thrombus taking micro-catheter under the action of the push-pull guide wire. The specific structure of the mechanical thrombus-removing stent included in the fourth to sixth embodiments is shown in the first to third embodiments, respectively, and will not be repeated here.
In particular, and referring to fig. 7, a thrombi removal microcatheter is delivered along a vessel 500 to a location of a thrombus 600 by a microcatheter wire, the microcatheter tip being distal to the thrombus, and the device is operative to deliver a thrombi removal stent to the location of the thrombus by the microcatheter wire. Referring to fig. 8, the thrombus-taking stent is delivered to its distal end by the microcatheter, after which the microcatheter is retracted and prevented from being retracted with the microcatheter by the means of the external operating end of the thrombus-taking stent, so that the thrombus-taking stent is released and deployed just at the thrombus site, thereby fully seizing the thrombus. And then recovering a part of the stent, so that the stent can firmly fix thrombus, and combining with a cylindrical screen structure of the distal end part, filtering the thrombus and preventing the thrombus from escaping, and then taking out the thrombus taking stent together with the microcatheter under negative pressure suction.
In the present specification, each embodiment is described in a progressive manner, and each embodiment focuses on the difference from other embodiments, and identical and similar parts between the embodiments are referred to each other.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (7)

1. The utility model provides a mechanical thrombus taking support, includes the net tubular support body that forms by a plurality of mesh connection, and this support body includes integrated into one piece and smooth connection transition's proximal end part, middle main part and distal end part, and the support body is received under the exogenic action and is closed, release after the exogenic elimination resumes, characterized by: the bracket comprises a bracket body, a middle main body part and a far end part, wherein the bracket body is approximately triangular after being tiled and unfolded, the middle main body part is approximately rectangular after being tiled and unfolded, the far end part is approximately right trapezoid after being tiled and unfolded, the bracket body is formed by taking a corner of the tail part inclined waist side of the far end part as a starting point, integrally curling along the longitudinal horizontal direction, and then shaping, wherein the near end part of the bracket body is of a conical structure which is nearly small and far, the middle main body part is of a cylindrical structure, and the far end part is of a cylindrical screen structure under a release state.
2. The mechanical thrombolytic stent of claim 1, wherein: the mesh of the distal portion of the stent body is larger than the mesh size of the proximal portion and the intermediate main portion; the distal portion of the stent body has a material diameter that is thinner than the material diameters of the proximal portion and the intermediate main portion.
3. The mechanical thrombolytic stent of claim 1, wherein: along the mesh, a plurality of developing marks are sequentially distributed from the proximal end to the distal end of the bracket body.
4. A mechanical thrombolytic stent as claimed in claim 3 and characterized in that: the developing marks are distributed along the mesh in a continuous or interval staggered way.
5. The mechanical thrombolytic stent of claim 1, wherein: the bracket body is formed by heat treatment and shaping of a metal material with a shape memory effect or a high-elasticity polymer material.
6. The mechanical thrombolytic stent of claim 1, wherein: the proximal opening of the bracket body is fusiform.
7. A thrombus removal device comprising a mechanical thrombus removal stent according to any one of claims 1 to 6 wherein the proximal end of the stent body is connected to a push-pull guidewire and the stent body is operable to be retrieved into a thrombus removal microcatheter by the push-pull guidewire.
CN201810310960.6A 2018-04-09 2018-04-09 Mechanical thrombus taking support and thrombus taking device Active CN108742778B (en)

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CN112842434B (en) * 2020-12-30 2022-07-22 杭州唯强医疗科技有限公司 Intra-cavity blocking device

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CN107137125A (en) * 2017-06-20 2017-09-08 微创神通医疗科技(上海)有限公司 Take bolt support and take pin device
CN208864415U (en) * 2018-04-09 2019-05-17 宋朝阳 Machinery takes bolt bracket and thrombus withdrawing device

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CN103547224A (en) * 2011-05-13 2014-01-29 菲诺克斯有限公司 Thrombectomy device
EP3205296A1 (en) * 2016-02-12 2017-08-16 Covidien LP Vascular device marker attachment
CN106236341A (en) * 2016-08-19 2016-12-21 江苏大学 A kind of stepped scaffold being applicable to tapered blood vessel
CN107049420A (en) * 2017-05-09 2017-08-18 心凯诺医疗科技(上海)有限公司 One kind takes bolt support and thrombus withdrawing device
CN107137125A (en) * 2017-06-20 2017-09-08 微创神通医疗科技(上海)有限公司 Take bolt support and take pin device
CN208864415U (en) * 2018-04-09 2019-05-17 宋朝阳 Machinery takes bolt bracket and thrombus withdrawing device

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