CN116807549A - Embolic device and embolic system - Google Patents
Embolic device and embolic system Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
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- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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Abstract
本发明涉及一种栓塞装置及栓塞系统，栓塞系统包括推送杆以及栓塞装置，推送杆的远端与栓塞装置的固定结构可解脱的连接，栓塞装置包括轴向依次连接的远端网格体、固定结构和近端网格体，远端网格体和近端网格体均由两端封闭的网管制成，且远端网格体和近端网格体之间能够相对扭转；其中：栓塞装置至少具有压缩状态和展开状态，并能够在压缩状态和展开状态之间切换；如此配置，能够降低对瘤壁的损伤，避免近端疝入载瘤血管的风险，并适用于不同规格的血管瘤，扩大应用范围。
The invention relates to an embolization device and an embolization system. The embolization system includes a push rod and an embolization device. The distal end of the push rod is detachably connected to the fixed structure of the embolization device. The embolization device includes a distal mesh body connected axially in sequence, The fixed structure and the proximal mesh body, the distal mesh body and the proximal mesh body are all made of mesh tubes with both ends closed, and the distal mesh body and the proximal mesh body can be relatively twisted; among them: The embolization device has at least a compressed state and an expanded state, and can switch between the compressed state and the expanded state; such a configuration can reduce damage to the tumor wall, avoid the risk of proximal herniation into the parent vessel, and is suitable for different specifications of Hemangiomas, expanding the scope of application.
Description
Technical Field
The application relates to the technical field of medical instruments, in particular to an embolism device and an embolism system.
Background
Intracranial aneurysms are pathological projections of the wall of the intracranial artery, the incidence rate is 5% -10%, and MRA researches show that the incidence rate of the unbroken aneurysms of 35-75-year-old adults in China is about 7.0%. Among them, saccular aneurysms are the most common type of aneurysm, accounting for 80% to 90% of all intracranial aneurysms, the most common cause of non-invasive subarachnoid hemorrhage (SAH), which, depending on the severity of the hemorrhage, can lead to permanent neurological deficit or death. Vascular interventional therapy has the characteristics of avoiding direct lesions of brain tissues, small surgical trauma and the like, and becomes a mainstream means for treating intracranial aneurysms in recent years. There are two main ways of vascular intervention, namely coil embolization and blood flow guiding devices.
Coil embolization relies on the release of a preformed coil from the catheter into the aneurysm for filling, resulting in a slow stasis of blood flow within the lumen of the aneurysm, thereby causing the formation of a clot and expelling further inflow of blood, thereby preventing further deployment of the aneurysm. When the embolism is successful, the thrombus may eventually become covered by a layer of endothelial cells, reforming the internal vessel wall. However, not all coil embolization procedures are successful, which may result in recanalization of the aneurysm, and may require implantation of additional devices, such as auxiliary stents and blood flow guides. The use of multiple devices increases the surgical time, the cost of treatment, and the likelihood of adverse events. The spring coil embolism efficiency is lower, requirements on doctor skill and experience are higher, and the risk of herniating the arterial tumor exists when the spring coil embolism is used alone, and the risk of generating ischemia complications can be increased when the spring coil embolism is used together with other instruments.
The application of the blood flow guiding device improves the long-term curative effect of large and huge aneurysms and greatly reduces the use of spring coils. The computer hemodynamic simulation analysis shows that when the metal coverage rate reaches 30% -50%, the blood flow in the aneurysm cavity can be obviously reduced. However, the use of blood flow guides has led patients to rely on dual antiplatelet therapy for long periods of time with the risk of post-operative bleeding complications; at the same time there is a risk of occluding the branch vessel with the blood flow guiding device for the bifurcation aneurysm. In addition, there is a certain risk of delayed rupture after treatment of a portion of a large aneurysm with a blood flow guiding device alone.
At present, some novel disposable embolism apparatuses are generally prepared from shape memory materials and are prefabricated and shaped, and are pushed out of a sheath tube after reaching a specific position through catheter transmission, and self-expanding is restored to a prefabricated shape, so that the purpose of sealing an aneurysm is achieved. For example, a first embolic apparatus is provided, which is a spherical or cylindrical dense net device with riveted points at two ends, the whole device is expanded in a tumor cavity, and the treatment of the aneurysm is realized by covering the tumor neck by a proximal dense net. The second embolism apparatus is provided, a three-dimensional net structure is formed by a developing wire and a peripheral self-expanding memory alloy, and the three-dimensional net structure can be released and recovered through a catheter like a spring ring, can be spherical when being stuffed in a tumor, and further plays a role of turbulence. A third embolic device is also provided, woven from a double layer nickel titanium alloy, similar to the first embolic device in principle, but without a rivet point at the distal end of the device. The fourth embolic device is formed by weaving double-layer memory alloy, is disc-shaped without limitation, can be limited by tumor walls to be tulip-shaped when released in a tumor body, can be stably arranged at the lower part of the tumor body and cover the tumor neck, and further plays a role in reconstructing hemodynamics.
However, the design of the riveting point at the far end and the near end of the first embolic device enables the device to be in an axisymmetric structure, so that the device has orientation on covering of a tumor neck, is mainly used for treating bifurcation wide-diameter aneurysms, and is particularly suitable for regular aneurysms. If the first embolic device is designed in a single sphere, the release length of the device is longer, the friction extrusion to the tumor wall is large in the release process, the distal riveting point has an impact effect on the tumor wall, the tumor wall is easy to crack, the aneurysm bleeds, and in some cases, the proximal riveting point is extruded by the tumor wall to herniate into the carrying tumor artery, so that the endothelialization process of the tumor neck is influenced. In addition, the first embolic device is typically in the form of a single sphere or cylinder, with a large contact area, but insufficient support, poor long-term stability within the lumen of the tumor, and easy displacement of the device. The second type of embolism apparatus is shaped into a three-dimensional net structure by a plurality of sheet-shaped nets, and is similar to a sphere, and because the friction force between the three-dimensional net structures and the tumor wall is large, the molding stability of the apparatus in the tumor is poor, the apparatus is not easy to recover into a preset shape, the filling effect is affected, and the apparatus is complex to operate due to the fact that the apparatus is matched with a spring ring. The third embolic device works basically similar to the first embolic device, so that the same problem exists, and although the distal riveting point does not exist, the proximal riveting point covers the tumor neck with orientation, and the tumor wall is extruded by the tumor neck to squeeze the herniated parent artery, thereby affecting the endothelialization process. The proximal rivet point of the fourth embolic device is also easily extruded by the tumor wall to herniate into the parent artery, so that the device is suitable for the apical aneurysm, and the position of the device needs to be adjusted and placed repeatedly, otherwise, the stability of the device in the tumor is affected, and therefore, the efficiency is low. In addition, the internal cavity of the embolism apparatus is larger, the stability of the embolism apparatus is influenced under the action of a water hammer of blood, and meanwhile, the resistance of the internal cavity to the blood flow in the aneurysm is smaller, so that the embolism apparatus is not beneficial to the formation of thrombus in the aneurysm.
Disclosure of Invention
The application aims to provide an embolism device and an embolism system, which can reduce the damage to a tumor wall, avoid the risk of proximal herniation into a tumor-carrying vessel, are suitable for hemangioma with more specifications and expand the application range.
In order to achieve the above object, the present application provides an embolization device for plugging hemangioma, which comprises a distal mesh body, a fixed structure and a proximal mesh body which are axially connected in sequence, wherein the distal mesh body and the proximal mesh body are both made of a mesh tube with two closed ends, and the distal mesh body and the proximal mesh body can be twisted relatively; wherein: the embolic device has at least a compressed state and an expanded state, and is switchable between the compressed state and the expanded state.
Optionally, after the embolic device is deployed, the distal mesh body is in an ellipsoidal structure or a cylindrical structure, the proximal mesh body is in an ellipsoidal structure or a cylindrical structure, and the long axis of the distal mesh body and the long axis of the proximal mesh body are both intersected with the longitudinal axis of the embolic device.
Optionally, after deployment of the embolic device, the maximum outer diameter of the proximal mesh body is greater than or equal to the total longitudinal height of the embolic device.
Optionally, after deployment of the embolic device, the maximum outer diameter of the distal mesh body is less than or equal to the maximum outer diameter of the proximal mesh body.
Optionally, after deployment of the embolic device, the maximum outer diameter of the distal mesh body is greater than or equal to 1/2 of the maximum outer diameter of the proximal mesh body.
Optionally, after the embolic device is deployed, the maximum outer diameter of the proximal mesh body is 3mm to 25mm.
Optionally, each mesh tube is a woven body, the wire diameter of the woven wires in the woven body is 0.0008-i n-0.002 i n, and the number of the woven wires is 48-144.
Optionally, after the embolic device is deployed, the longitudinal height of the distal mesh body is 1/3 to 1/2 of the total longitudinal height of the embolic device.
Optionally, one end of the fixing structure is fixedly connected with the net surface of the proximal end net body, and the other end of the fixing structure is fixedly connected with the net surface of the distal end net body.
Optionally, the fixing structure is capable of developing and/or the fixing structure is an elastic structure.
To achieve the above object, the present application also provides an embolic system comprising a push rod and an embolic device according to any one of the preceding claims, the distal end of the push rod being releasably connected to the fixation structure of the embolic device.
Compared with the prior art, the embolic device and the embolic system disclosed by the application have at least one of the following advantages:
the first, the embolic device disclosed by the application has the advantages that due to the existence of the middle fixing structure, in the release process, the far-end grid body can be restored to the unfolding state before the near-end grid body, and the influence of the unreleased near-end grid body is avoided, so that the release length of the whole embolic device can be effectively shortened; the configuration reduces the extrusion friction of the embolism device to the hemangioma in the release process, improves the operation safety, reduces the limit of the length-diameter ratio of the hemangioma to the selection of the embolism device, ensures that the embolism device can be suitable for larger hemangioma size and hemangiomas in different positions, and ensures that the proximal grid body and the distal grid body can generate relative torsion, so that the embolism device can be suitable for hemangiomas in different forms;
secondly, the embolic device disclosed by the application is characterized in that the distal mesh body consists of the network pipes with two closed ends, so that the whole distal mesh body has no riveting points protruding out of the mesh surface, and the whole distal end is a uniform dense mesh surface, so that the acting force on the tumor wall can be effectively dispersed after the distal mesh body contacts the tumor wall, the injury of the embolic device on the hemangioma is reduced, the rupture risk of the hemangioma is reduced, and in the release process of the proximal mesh body, the acting force of the whole embolic device on the hemangioma can be buffered by the distal mesh body, and the rupture risk of the hemangioma is further reduced;
thirdly, the embolic device disclosed by the application is characterized in that the proximal mesh body is also composed of the network pipes with two closed ends, so that the whole proximal mesh body is free of riveting points protruding out of the mesh surface, the whole proximal end is also a uniform dense mesh surface, the tumor neck can be effectively covered by the proximal dense mesh surface, the blood flow flowing into or out of the hemangioma is reduced, the thrombosis is promoted, the healing of the hemangioma is further promoted, and the endothelialization process at the tumor neck is promoted;
fourthly, the embolism device disclosed by the application is simpler to release, so that the dependence on the individual hemangioma embolism experience of a doctor in the operation process can be reduced, and the operation time is shortened; in addition, the proximal and distal mesh bodies form a multi-layer dense mesh structure in the tumor cavity, so that the embolic density can be improved, the number of instruments required by an operation can be reduced, the internal turbulence effect can be increased while the tumor neck coverage is improved, the formation of thrombus in the tumor can be promoted, and the embolism of hemangioma can be accelerated; in addition, the embolic device is fully located within the hemangioma, avoiding the use of dual antiplatelet drugs.
Drawings
The features, nature, and advantages of the present application, as well as the related embodiments, will be described in conjunction with the following drawings, in which:
FIG. 1 is a front view of an embolic device of a first preferred embodiment of the present application;
FIG. 2 is a top view of an embolic device according to a first preferred embodiment of the present application, looking distally in a proximal direction;
FIG. 3 is a state diagram of an embolic device during release of a first preferred embodiment of the present application;
FIG. 4 is a state diagram showing the complete release of the embolic device of the first preferred embodiment of the present application within an aneurysm;
FIG. 5 is a cross-sectional view of a proximal mesh covering a tumor neck of an embolic device according to a preferred embodiment of the application;
FIG. 6 is a front view of an embolic device of a second preferred embodiment of the present application;
fig. 7 is a front view of an embolic device of a third preferred embodiment of the application.
Reference numerals are described as follows:
10-embolic devices; 11-a proximal mesh body; 12-a distal mesh body; 13-a fixed structure; 21-pushing rod; 31-microcatheter; 40-aneurysms; 41-tumor neck; 50-parent artery; longitudinal height of the L-embolic device; d1—maximum outer diameter of the distal mesh body; d2—maximum outer diameter of proximal mesh body.
Detailed Description
The application will be further described in detail with reference to the accompanying drawings, in order to make the objects, advantages and features of the application more apparent. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the application.
As used in this specification, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. As used in this specification, the term "plurality" is generally employed in its sense including two or more, unless the content clearly dictates otherwise. As used in this specification, the term "plurality" is generally employed in its sense including the indefinite number unless the content clearly dictates otherwise. As used in this specification, the terms "proximal" and "distal" refer to the location of the embolic device and/or portions of the embolic device relative to the operator along the longitudinal axis of the embolic device, unless otherwise indicated. In general, "proximal" refers to an end proximal to an operator and "distal" generally refers to an end distal from the operator. Herein, "longitudinal" refers to a direction perpendicular to the cross-section of the tumor neck, i.e., perpendicular to the cross-section of the tumor cavity; by "transverse" is meant a direction parallel to the cross-section of the tumor neck, i.e. parallel to the cross-section of the tumor cavity.
The core of the application is to disclose an embolic device, which is mainly used for treating intracranial saccular aneurysms, including bifurcation aneurysms and lateral aneurysms. It should be understood that the embolic device disclosed herein is not limited to aneurysms, but may also be hemangiomas that occur in other blood vessels.
The embolism device disclosed by the application is of a multi-layer dense-net structure, can realize the plugging of a neck of hemangioma in hemangioma, does not enter a tumor-carrying vessel, and does not need to take double antibodies for a long time. The proximal end of the embolism device disclosed by the application has no riveting point, can cover the uniform dense net surface of the tumor neck, plays a role in turbulent flow, reduces the impact of blood flow on the tumor inside the tumor sac, promotes the formation of thrombus inside the tumor, and further realizes the purpose of hemangioma embolism. The embolic device disclosed by the application can effectively shorten the release length, reduce friction extrusion on the tumor wall in the release process, improve the safety of operation, and simultaneously has no riveting point on the side of the distal end contacted with the tumor cavity, thereby further reducing the damage to hemangioma.
The embolic devices disclosed herein are deliverable through a microcatheter, having at least a compressed state and an expanded state, and being switchable between the compressed state and the expanded state. Typically, the embolic device is in a compressed state within the microcatheter and returns to an expanded state after being pushed out of the microcatheter.
The application will be described in more detail below with reference to the drawings and the preferred embodiments. The following embodiments and features of the embodiments may be complemented or combined with each other without conflict. For simplicity, it is assumed in the following description that the hemangioma is an intracranial aneurysm, and a person skilled in the art should be able to modify the following description, with appropriate modifications in detail, for cases other than an intracranial aneurysm.
Example 1
A preferred embodiment of the present application provides an embolic device 10, as shown in fig. 1-5. The embolic device 10 comprises a proximal mesh body 11, a fixed structure 13 and a distal mesh body 12 which are axially connected in sequence; the distal mesh body 12 and the proximal mesh body 11 are both composed (made) of mesh tubes with both ends closed, so that the whole embolic device 10 has no rivet points at the distal end and no rivet points at the proximal end, and various problems caused by the existence of the rivet points at the distal end and the proximal end are avoided. The rivet point is generally understood herein as the tie-down end of the plurality of braided filaments. In the prior art, the mesh-shaped braiding body generally has a proximal end and a distal end binding part, wherein the binding part is an end structure formed by binding together braided wires, and the binding part of the braided wires generally protrudes towards the outer part of the braiding body to form a pointed end (namely a riveting point), so that the braided wires are easy to impact and press the wall of an aneurysm, and the rupture of the aneurysm is caused.
Therefore, the embolic device 10 of the present embodiment does not have a concave structure for hiding the rivet points, not only can contact the tumor top through the close mesh surface at the distal end, increase the contact area, improve the stability, and reduce the impact on the tumor wall, but also can cover the tumor neck through the close mesh surface at the proximal end, increase the metal coverage rate of the tumor neck, and simultaneously avoid the problem of herniation of the existing proximal rivet points into the tumor-carrying vessel. It should be further understood that the mesh tube with two closed ends refers to a manner of centripetal braiding, so that the braided wires are in a central concentrated state, for example, the proximal mesh surface of the proximal mesh body 11 is formed by converging the braided wires at the closed end of the mesh tube toward the center, so as to form a uniform and compact mesh surface, for example, the distal mesh surface of the distal mesh body 12 is also formed by converging the braided wires at the closed end of the mesh tube toward the center, and the mesh surface is uniform and compact. More specifically, since the embolic device 10 has no anchor points at both the proximal and distal ends, injury to the aneurysm wall is reduced, impact of the distal anchor points to the aneurysm wall is prevented, risk of rupture of the aneurysm wall is reduced, and the problem that the proximal anchor points are easily herniated into the parent artery by extrusion of the aneurysm wall is avoided, the influence on the endothelialization process is avoided, and meanwhile, the device has no orientation problem for covering the neck of the aneurysm, and is applicable to both regular and irregular aneurysms, and is also applicable to apical aneurysms or lateral aneurysms.
In addition, due to the arrangement of the fixing structure 13, the distal grid body 12 and the proximal grid body 11 can be twisted relatively, so that the two can be coaxial or non-coaxial, and therefore, the application range is wider without being limited by the orientation of the tumor neck. It should also be understood that the fixation structure 13 does not overlap the proximal and distal mesh bodies 11, 12 in the longitudinal direction, i.e. the fixation structure 13 is arranged between the proximal and distal mesh bodies 11, 12, thereby fixing the two mesh bodies and enabling the two mesh bodies to twist relatively, the twist angle can be larger, and aneurysms of different shapes are suitable. The size of the fixing structure 13 is far smaller than that of any one of the mesh bodies, and certain connection strength is ensured while elasticity is provided, and the size of the fixing structure 13 can be set according to the need by a person skilled in the art, for example, the fixing structure 13 can be set to be about 0.5mm to 2.0mm in length.
The fixing structure 13 is usually adhered to and fixed with the mesh glue, one end of the fixing structure 13 is adhered to and fixed with the distal mesh glue of the proximal mesh 11, and the other end of the fixing structure 13 is adhered to and fixed with the proximal mesh glue of the distal mesh 12. The structure of the fixing structure 13 is not limited in the present application, and may be an elastic structure such as an elastic tube, a spring plate, or a spring. Further, the fixing structure 13 can be developed, such as a developing ring or a developing spring.
Further, the preferred embodiment of the present application also provides an embolic system comprising a push rod 21 and an embolic device 10, the distal end of the push rod 21 being releasably connected to the fixation structure 13. Thus, the embolic device 10 can be delivered through the microcatheter 31 and into the aneurysm by the pusher bar 21, thereby effecting the release and retrieval of the embolic device. The device can be released and recovered for multiple times, the operation difficulty is reduced, the aneurysm is effectively occluded, the occlusion of the aneurysm and the branch is avoided, the displacement of the device can be effectively avoided, the displacement risk after the filling in the tumor is reduced, and simultaneously, aneurysms with different positions, different forms and different sizes can be treated.
The push rod 21 can be released from the fixed structure 13. The distal end of the pushing rod 21 has a releasing area, and after the embolic device 10 reaches a specific position, releasing can be achieved, and the releasing manner between the pushing rod 21 and the fixed structure 13 can be thermal releasing, electrolytic releasing, mechanical releasing, hydrolytic releasing, etc. in the prior art, which is not limited. In the non-ideal release state of the device, the device can be repositioned and released after being recovered again.
Referring to fig. 3, during delivery, first microcatheter 31 is advanced into parent artery 50 and distal end of microcatheter 31 is aligned with aneurysm 40, embolic device 10 is delivered through microcatheter 31 and embolic device 10 is advanced out of the distal end of microcatheter 31 using push rod 21, during release, distal mesh body 12 is advanced out of the lumen of the tumor first and then proximal mesh body 11 is advanced out of the lumen of the tumor and then released. After the embolic device 10 is completely released, the push rod 21 is separated from the fixed structure 13, and finally, the push rod 21 and the microcatheter 31 are withdrawn from the body to complete the embolization.
Fig. 4 and 5 show the embolic device 10 in a tamponaded state within an aneurysm 40. As shown in fig. 4 and 5, the entire embolic device 10 completely covers the tumor neck 41 with the proximal mesh surface of the proximal mesh body 11, providing continuous, high metal coverage and high mesh density coverage at the tumor neck 41, with good occlusion. And the proximal mesh body 11 and the distal mesh body 12 form a multi-layer dense mesh in the tumor cavity, so that the turbulent flow effect is good, thrombus formation in the tumor can be accelerated, and the endothelialization process is accelerated. In addition, the embolic device 10 has a smaller axial length after release, making the device adaptable to larger size aneurysms.
The shape of the expanded proximal mesh body 11 and distal mesh body 12 is not particularly limited in the present application, as long as the mesh surface is smooth and has no protrusions. It will be appreciated that the expanded shapes of the proximal mesh body 11 and the distal mesh body 12 include, but are not limited to, ellipsoids or cylinders. Preferably, the proximal mesh body 11 and the distal mesh body 12 are configured in an expanded shape having a lateral dimension greater than a longitudinal dimension to accommodate the tamponade of aneurysms of a larger size. As shown in this embodiment, after the embolic device 10 is deployed, the distal mesh body 12 and the proximal mesh body 11 are both ellipsoidal structures, and the major axis length of each ellipsoidal structure is the transverse dimension (i.e., the maximum outer diameter) and the minor axis length is the longitudinal dimension (i.e., the longitudinal height).
In some embodiments, the maximum outer diameter D1 of the distal mesh body 12 is equal to the maximum outer diameter D2 of the proximal mesh body 11 after deployment of the embolic device 10, or the maximum outer diameter D1 of the distal mesh body 12 is less than the maximum outer diameter D2 of the proximal mesh body 11, at which point a larger aneurysm may be applicable. Preferably, the maximum outer diameter D1 of the distal mesh body 12 is greater than or equal to 1/2 of the maximum outer diameter of the proximal mesh body 11, so as to ensure sufficient support and stability of the entire device. In this embodiment, as shown in fig. 1, the maximum outer diameter D1 of the distal mesh body 12 is equal to the maximum outer diameter D2 of the proximal mesh body 11, and the entire embolic device 10 is applicable to aneurysms of smaller size.
According to clinical requirements, the maximum outer diameter D2 of the proximal mesh body 11 can be generally set to 3 mm-25 mm after the embolic device 10 is deployed, so that the embolic device 10 can be applied to aneurysms of different sizes. In addition, each of the mesh tubes is usually woven by woven wires, preferably, the wire diameter of the woven wires is 0.0008-i n-0.002 i n, and the number of the woven wires is 48-144, so that a relatively dense mesh is formed, and the packing effect is better. Any one of the grid bodies can be formed by shaping a net pipe in a mould, and then the two grid bodies are fixedly connected by a fixing structure 13.
In some embodiments, after deployment of the embolic device 10, the overall longitudinal height L of the embolic device 10 is less than or equal to the maximum outer diameter D2 of the proximal mesh body 11. Preferably, the embolic device 10 has a longitudinal overall height L that is less than the maximum outer diameter D2 of the proximal mesh body 11 to accommodate aneurysms of greater aspect ratio. In this embodiment, as shown in fig. 1, the embolic device 10 has a longitudinal overall height L equal to the maximum outer diameter D2 of the proximal mesh body 11.
In some embodiments, the longitudinal height of the distal mesh body 12 after deployment of the embolic device 10 is 1/3 to 1/2 of the total longitudinal height L of the embolic device 10, i.e., the distal mesh body 12 cannot be too high, otherwise the release length would be increased, the surgical safety would be reduced, and the adaptation to wide carotid aneurysms of greater aspect ratio would be detrimental. And so arranged, it is also advantageous to increase the lateral dimension of the proximal mesh body 12 to increase coverage of the tumor neck.
As shown in FIG. 1, in this embodiment, the longitudinal height of the distal mesh body 12 after deployment of the embolic device 10 is 1/2 of the total longitudinal height L of the embolic device 10.
Further, the mesh tube may be woven from woven filaments of an elastic material or a superelastic material. For example, the material can be woven from wires with shape memory performance, and comprises one or more metal materials with shape memory performance, such as nickel-titanium (Ni-T i) alloy, nickel-titanium-cobalt alloy (Ni-Ti-Co), double-layer composite metal wires (Ni-Ti@Pt) and the like; polymeric materials having a shape recovery capability such as one or more combinations of Polydioxanone (PDO), (lactide-epsilon-caprolactone) copolymers (PLC), polyurethane (PU), polynorbornene amorphous polymers, and the like may also be selected; the material can also be made by braiding shape memory material and metal wire (Pt, pt-I r, etc.) with good developing property, or by braiding composite wire (DFT) of shape memory material and developing material. The composite wire (DFT) herein refers to a sleeve comprising a core wire and a cladding core wire, the material of the core wire including but not limited to one of platinum, iridium, gold, silver, tantalum and tungsten or alloys thereof, and the material of the sleeve including but not limited to one or more combinations of nitinol, stainless steel, cobalt chrome, nickel cobalt alloy. Thus, the material of the dense mesh allows the device deformation to be constrained within the microcatheter in a low profile configuration and then to revert to a pre-set deployed configuration upon release from the microcatheter. In other embodiments, the dense mesh may be formed of other suitable self-forming materials that are capable of returning to a desired shape upon release of the microcatheter 31.
< example two >
In this embodiment, as shown in fig. 6, after the embolic device 10 is deployed, the distal mesh body 12 has a cylindrical structure, and the proximal mesh body 11 has a still ellipsoidal structure. The following description will be mainly directed to the difference from the first embodiment, and for the same point, reference is made to the first embodiment.
In this embodiment, after the embolic device 10 is deployed, the maximum outer diameter D1 of the distal mesh body 12 is 2/3 of the maximum outer diameter D2 of the proximal mesh body 11, and the maximum outer diameter D1 of the distal mesh body 12 in the first embodiment is equal to the maximum outer diameter D2 of the proximal mesh body 11. Further, the axial overall height L of the embolic device 10 of the present embodiment is equal to the maximum outer diameter D2 of the proximal mesh body 11, as in the first embodiment. In addition, the longitudinal height of the distal mesh body 12 after the embolic device 10 of the present embodiment is deployed is 2/5 of the total longitudinal height L of the embolic device, while the longitudinal height of the distal mesh body 12 in the first embodiment is 1/2 of the total longitudinal height L of the embolic device 10.
It should be appreciated that the embolic device 10 of the present embodiment can effectively shorten the axial release length of the device while ensuring that the proximal mesh covers the neck of the tumor, and the proximal mesh has a larger lateral dimension, which can better cover the neck of the tumor, maintain the stability of the device, and is more suitable for wide carotid aneurysms.
Example III
In this embodiment, as shown in fig. 7, after the embolic device 10 is deployed, the distal mesh body 12 is still in an ellipsoidal structure, and the proximal mesh body 11 is in a cylindrical structure. The following description will be mainly directed to the difference from the first embodiment, and for the same point, reference is made to the first embodiment.
In this embodiment, after the embolic device 10 is deployed, the maximum outer diameter D1 of the distal mesh body 12 is 1/2 of the maximum outer diameter D2 of the proximal mesh body 11, and the maximum outer diameter D1 of the distal mesh body 12 in the first embodiment is equal to the maximum outer diameter D2 of the proximal mesh body 11. In addition, after the embolic device 10 of the present embodiment is deployed, the axial total length L is equal to the outer diameter D2 of the proximal mesh body 11, as in the first embodiment. In addition, after the embolic device 10 of the present embodiment is deployed, the longitudinal height of the distal mesh body 12 is 1/3 of the total longitudinal height L of the embolic device, while the longitudinal height of the distal mesh body 12 in the first embodiment is 1/2 of the total longitudinal height L of the embolic device 10.
It will be appreciated that the embolic device 10 of the present embodiment can effectively shorten the axial release length of the device while ensuring that the proximal surface covers the neck of the aneurysm, and the proximal mesh surface has a larger transverse dimension, can better cover the neck of the aneurysm, and maintains the stability of the device, thereby being more suitable for aneurysms with larger aspect ratios.
While in other embodiments, the proximal mesh body 11 and the distal mesh body 12 may also be cylindrical structures at the same time.
In summary, due to the existence of the intermediate fixing structure, the distal mesh body can be restored to the unfolded state in the release process, so that the release length of the whole embolic device is effectively shortened, the extrusion friction of the embolic device to the aneurysm is reduced, the limit of the length-diameter ratio of the aneurysm to the embolic device is reduced, the embolic device can be suitable for larger aneurysm size, and the acting force of the device to the aneurysm can be buffered by the distal mesh body in the proximal release process; meanwhile, the far end has no riveting point but is a uniform dense net surface, the center of the net surface is formed by centripetally arranging the closed ends of the net pipes, the acting force on the tumor wall can be effectively dispersed after the net surface contacts the tumor wall, the damage of the embolic device to the aneurysm is reduced, and the rupture risk of the aneurysm is reduced. The proximal end is also free of riveting points, so that the nearest end surface is a nearly horizontal uniform dense net surface, the tumor neck can be effectively covered, and the endothelialization process of the tumor neck can be promoted.
It will also be appreciated that shortening the release length of the embolic device allows the embolic device to be used not only in bifurcated aneurysms (i.e., apical aneurysms) but also in lateral aneurysms. In addition, it is to be understood that the push rod is connected with the middle fixing structure of the embolism device in a releasable way, so that the problem that the push rod is connected with the rivet point arranged at the proximal end of the existing embolism apparatus is solved, the protruding rivet point at the proximal end of the device is eliminated, and the influence of the device on blood flow in a tumor-carrying artery is reduced. It should also be appreciated that the proximal end of the embolic device may be of an ellipsoidal or cylindrical configuration, and the proximal end surface may be configured as a concentric arrangement of closed ends of the mesh tube, and the push rod may be connected through the central circular aperture to the fixation structure, thereby providing a near horizontal dense mesh surface on the proximal end surface, having no depressions or protrusions, being uniform and dense, effectively covering the neck of the aneurysm, reducing blood flow into or out of the aneurysm, promoting thrombosis, and thus promoting healing of the aneurysm.
In addition to the advantages described above, the embolic device disclosed by the application is simpler to release, can reduce the dependence on the personal aneurysm embolization experience of a doctor during the operation, and can reduce the operation time. In addition, the composite structure with an ellipsoidal structure and/or a cylindrical structure enables intratumoral molding to be more stable, the multilayer dense net structure can improve the embolic density, reduce the number of instruments required by an operation, improve the intratumoral coverage, increase the internal turbulence effect, promote the intratumoral thrombosis and accelerate the embolism of an aneurysm. In addition, the embolic device is fully positioned within the aneurysm, avoiding the use of dual antiplatelet agents. In addition, in the unfolded state, the far end is of an ellipsoidal or cylindrical structure, the furthest end can be contacted with the tumor top, the stable existence of the device in the tumor is ensured, the device is not shifted, and the stability is good.
The above description is only illustrative of the preferred embodiments of the present application and is not intended to limit the scope of the present application, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present application.
Claims (12)
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| CN202210289009.3A CN116807549B (en) | 2022-03-22 | 2022-03-22 | Embolic device and embolic system |
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