Intratumoral occlusion device

Abstract

An intratumoral occlusion device (10) switchable between a collapsed configuration and an expanded configuration. It comprises a mesh-like body structure (11) and a proximal attachment structure (12). The mesh-like body structure (11) comprises an inner support structure (111) and an outer occlusion structure (112) and is formed from a braided mesh tube. The inner support structure (111) is formed by folding a portion of the braided mesh tube into the interior of another portion of the braided mesh tube, and the outer occlusion structure (112) is formed by the unfolded portion of the braided mesh tube. A proximal end of the outer occlusion structure (112) is connected to the proximal attachment structure (12). The inner support structure (111) extends proximally toward the proximal attachment structure (12) and is connected thereto.This single-anchor design of the intratumoral occlusion device (10), achieved by folding the braided mesh tube, can reduce the risk of aneurysm rupture, provide improved axial support to the intratumoral occlusion device (10), and ensure long-term stability of the intratumoral occlusion device (10) during aneurysm filling.

Description

Intratumoral occlusion devices Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an intra-tumor occlusion device for aneurysm packing. Background Art

[0002] Intracranial aneurysms are a common clinical cerebrovascular disease with high mortality and disability rates. A noninvasive imaging study showed that the prevalence of intracranial aneurysms in Chinese patients is 7%. Subarachnoid hemorrhage caused by ruptured intracranial aneurysms has a 30-day mortality rate of up to 45%, and approximately 30% of survivors experience varying degrees of neurological deficits.

[0003] Vascular interventional therapy has become the mainstream method for treating intracranial aneurysms in recent years due to its ability to bypass brain tissue and reach the lesion directly, and its minimal surgical trauma. Vascular interventional therapy for intracranial aneurysms mainly includes coil embolization and blood flow diversion devices. Coil embolization relies on pre-formed coils released from a catheter into the aneurysm to fill it, causing the blood flow in the aneurysm cavity to slow down and stagnate, thereby causing clot formation and excluding further blood inflow, thereby preventing further expansion of the aneurysm. Blood flow diversion devices treat aneurysms through vascular reconstruction, and their use has improved the long-term efficacy of large and giant aneurysms. In addition, there is a certain risk of delayed rupture after using blood flow diversion devices alone to treat some large aneurysms. There are also some new types of intra-aneurysm embolization devices (such as WEB devices, Artisse devices, and Contour devices), which are usually made of shape memory alloy materials, pre-shaped, delivered through a catheter, and pushed out of the sheath after reaching a specific position. It self-expands and returns to the pre-formed shape, thereby achieving the purpose of blocking the aneurysm. However, the above treatment methods still have the following problems:

[0004] 1) However, for wide-necked and bifurcated aneurysms, additional devices (such as auxiliary stents or blood flow diversion devices) need to be implanted during coil embolization to prevent coil herniation. However, the use of multiple devices increases surgical time, treatment costs, and the possibility of adverse events. Coil embolization is less efficient and requires higher physician skills and experience. When used alone, there is a risk of aneurysm herniation. When used in combination with other devices, the risk of ischemic complications is increased.

[0005] 2) Blood flow diversion devices are not suitable for aneurysms at bifurcated sites or for parent arteries with perforating vessels, as they carry the risk of vascular occlusion. Furthermore, implantation of a blood flow diversion device causes patients to rely on dual antiplatelet therapy for a long time, and there is a risk of hemorrhagic complications after surgery.

[0006] 3) Regarding new intra-aneurysm embolization devices: The WEB device is mainly suitable for treating wide-diameter aneurysms at bifurcations, and is particularly suitable for regular aneurysms. The device has a long release length, and the distal rivet point has an impact on the aneurysm wall. In addition, the single spherical or cylindrical structure has a limited degree of fit with the inner wall of the aneurysm. After long-term implantation, it is easily squeezed and displaced, resulting in the risk of aneurysm recurrence. The working principle of the Artisse device is basically similar to that of the WEB device. Although it does not have a distal rivet point, its spherical structure also needs to completely fit the aneurysm wall to exert a better embolization effect. The Contour device is disc-shaped and suitable for bifurcated or apical aneurysms. The position needs to be repeatedly adjusted to ensure that the device can completely cover the aneurysm neck, otherwise it will affect the stability of the device in the aneurysm.

[0007] It should be noted that the information disclosed in the background technology section of the invention is only intended to deepen the understanding of the general background technology of the invention, and should not be regarded as an admission or any form of implication that the information constitutes prior art already known to those skilled in the art.

[0008] Summary of the Invention

[0009] The purpose of the present invention is to provide an intra-tumor occlusion device to solve at least one technical problem existing in the prior art vascular treatment methods for aneurysms.

[0010] To achieve the above-mentioned objectives, the present invention provides an intratumor occlusion device, which can switch between a compressed state and an expanded state, and includes a mesh main structure and a proximal fixing structure. The mesh main structure includes an internal support structure and an external occlusion structure. The mesh main structure is made of a braided mesh tube, and a part of the braided mesh tube is flipped inwardly to form the internal support structure, and the other part of the braided mesh tube that is not flipped forms the external occlusion structure. The proximal end of the external occlusion structure is connected to the proximal fixing structure, and the proximal end of the internal support structure extends toward the proximal fixing structure and is connected to the proximal fixing structure.

[0011] Optionally, the radial diameter of the internal support structure in the expanded state increases from the proximal end and the distal end to the middle part, respectively, or the radial diameter of the internal support structure in the expanded state decreases from the distal end to the proximal end.

[0012] Optionally, the outer contour of the internal support structure in the expanded state is spindle-shaped or inverted cone-shaped.

[0013] Optionally, the maximum radial diameter of the internal support structure in the expanded state is not greater than 1 / 2 of the radial diameter of the external blocking structure in the expanded state.

[0014] Optionally, the axial height of the external sealing structure in the expanded state is not greater than the radial diameter of the external sealing structure in the expanded state, and is not less than 1 / 2 of the radial diameter of the external sealing structure in the expanded state.

[0015] Optionally, an axial height of the external sealing structure in the expanded state is smaller than a radial diameter of the external sealing structure in the expanded state.

[0016] Optionally, the outer contour of the external sealing structure in the expanded state is spherical or cylindrical.

[0017] Optionally, the axial height of the external sealing structure in the expanded state is 0.6 to 0.8 times the radial diameter of the external sealing structure in the expanded state.

[0018] Optionally, the axial height of the internal support structure in the expanded state is not greater than the axial height of the external sealing structure in the expanded state, and / or the axial height of the internal support structure in the expanded state is not greater than the radial diameter of the external sealing structure in the expanded state.

[0019] Optionally, the axial height of the internal support structure in the expanded state is not less than 2 / 3 of the axial height of the external sealing structure in the expanded state, and / or the axial height of the internal support structure in the expanded state is not less than 2 / 3 of the radial diameter of the external sealing structure in the expanded state.

[0020] Optionally, the mesh area of ​​the proximal surface of the external blocking structure does not exceed 0.1 mm 2 .

[0021] Optionally, the intratumor occlusion device includes a proximal end and a distal end, and at the distal end, the braided mesh tube smoothly transitions at the inverted fold to form a distal opening.

[0022] Optionally, in the expanded state, the diameter of the distal opening is not less than 1 / 3 of the radial diameter of the external blocking structure.

[0023] The intratumor occlusion device provided by the present invention comprises: a mesh main structure and a proximal fixing structure, the mesh main structure comprising an internal support structure and an external occlusion structure, the mesh main structure being made of a braided mesh tube, a portion of the braided mesh tube being turned inwardly to form the internal support structure, the other portion of the braided mesh tube not turned inwardly forming the external occlusion structure, the proximal end of the external occlusion structure being connected to the proximal fixing structure, the proximal end of the internal support structure extending toward the proximal fixing structure and being connected to the proximal fixing structure. With such a configuration, the single rivet point design of the intratumor occlusion device can be achieved through the inversion of the braided mesh tube, thereby shortening the axial release length of the intratumor occlusion device and making the distal end more flexible and smooth, reducing the impact of the initial release of the intratumor occlusion device on the aneurysm top, thereby reducing the risk of aneurysm rupture, and at the same time, the inverted internal support structure enhances the axial support of the intratumor occlusion device, ensuring the long-term stability of the intratumor occlusion device during intratumoral filling. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The drawings provided herein are not necessarily drawn to scale, and some components and structures are exaggerated for clarity. Variations of the illustrated embodiments are contemplated. Therefore, the description of various aspects and elements of the embodiments in the drawings is not intended to limit the scope of the present invention. In the drawings:

[0025] FIG1 is a schematic diagram of the front view of the structure of the intratumor occlusion device in the expanded state according to the first embodiment of the present invention;

[0026] FIG2 is a schematic diagram of the intratumor occlusion device according to the first embodiment of the present invention when released;

[0027] FIG3 is a schematic diagram of the intra-aneurysm occlusion device according to the first embodiment of the present invention when it is completely released into the aneurysm;

[0028] FIG4 is a schematic diagram of the front view of the structure of the intratumor occlusion device in the expanded state according to the second embodiment of the present invention;

[0029] FIG5 is a schematic diagram of the front view of the structure of the intratumor occlusion device in the expanded state according to the third embodiment of the present invention.

[0030] The description of the accompanying numbers is as follows: 10, 20, 30 - intratumor occlusion device; 11 - mesh main structure; 111 - internal support structure; 112 - external occlusion structure; 12 - proximal fixing structure; 10A - proximal end of the intratumor occlusion device; 10B - distal end of the intratumor occlusion device; 10C - distal opening; D1 - radial diameter of the internal support structure; H1 - axial height of the internal support structure; D2 - radial diameter of the external occlusion structure; H2 - axial height of the external occlusion structure; 1 - microcatheter; 2 - aneurysm; 21 - aneurysm neck; 3 - push rod. DETAILED DESCRIPTION

[0031] Various exemplary embodiments will be described below. These examples are non-limiting and should be understood to illustrate the broader application of the apparatus, system, and method. These embodiments may be varied and replaced by equivalents without departing from the true spirit and scope of the present invention. In addition, various variations may be made to adapt to special circumstances, materials, material compositions, processes, processing actions, or steps to the purpose, spirit, or scope of the present invention. All of these variations are within the scope of protection of the present invention.

[0032] To the extent that any dimensions are described in the Summary or Detailed Description, they are intended to be examples only and are not intended to limit the present subject matter, except as set forth in the various exemplary embodiments. Furthermore, the various configurations of the embodiments described herein are intended to complement one another, rather than to be purely interchangeable, unless otherwise indicated. In other words, configurations from one embodiment can be freely combined with configurations from other embodiments, as readily understood by those skilled in the art, unless such configurations are indicated as being solely interchangeable.

[0033] In this application document, "proximal" and "distal" refer to the relative orientation, position, and direction of components or actions relative to each other from the perspective of an operator using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the medical device closest to the operator during normal operation, while "distal" generally refers to the end that first enters the patient's body. "Distal" and "proximal" in this application document do not refer to the ends of structures, but rather relative positions. For example, the distal end of a mesh structure is not the end of the mesh structure, but a position relatively close to the end of the mesh structure.

[0034] In this application document, "axial" generally refers to the height direction from the aneurysm neck to the aneurysm top when the intratumor occlusion device is filled in the aneurysm; "radial" generally refers to the diameter direction along the aneurysm neck when the intratumor occlusion device is filled in the aneurysm; "expanded state" includes the "free expansion state" when there is no external force, and the "filling state" when the device is constrained by the aneurysm wall when filled in the aneurysm; "radial diameter" refers to the outer diameter of the projection surface formed by projecting the outer contour onto the cross section, and the cross section is perpendicular to the axial direction.

[0035] First of all, it is necessary to understand that the traditional aneurysm occlusion device is a single-layer dense mesh, which mainly fills the aneurysm cavity in a spherical or cylindrical shape. There is no axial support inside the single-layer dense mesh. When filling the aneurysm for a long time, it is easy to be impacted by blood flow, causing the occlusion device to be axially compressed in the aneurysm cavity, which in turn causes the aneurysm neck to remain or recur. To this end, the core idea of ​​the present application is to provide an intratumor occlusion device, which is mainly used for the filling of aneurysms, especially the filling of intracranial aneurysms, and is particularly suitable for the treatment of saccular wide-necked aneurysms. The intratumor occlusion device described in the present application is a continuous double-layer mesh structure, and an internal support structure is provided inside the external occlusion structure, which can greatly improve the axial support of the intratumor occlusion device and ensure the stability of the intratumor occlusion device during long-term filling. In particular, when the internal support structure is spindle-shaped and inverted cone-shaped, the axial support is better.

[0036] Next, the present application will be further described in conjunction with preferred embodiments, and in the absence of conflict, the following implementation modes and features in the implementation modes may complement or be combined with each other.

[0037] [Example 1]

[0038] Please refer to Figures 1 to 3. Embodiment 1 of the present application provides an intra-tumor occlusion device 10, which includes a mesh main structure 11 and a proximal fixing structure 12. The mesh main structure 11 includes an internal support structure 111 and an external occlusion structure 112. The mesh main structure 11 is made of a braided mesh tube, which is a continuous double-layer mesh structure. Specifically, one part of the braided mesh tube is flipped inwardly to form the internal support structure 111, and the other part of the braided mesh tube that is not flipped forms the external occlusion structure 112. The external occlusion structure 112 provides complete contact with the inner wall of the aneurysm, basically completely filling the entire aneurysm cavity.

[0039] The intratumor occlusion device 10 includes a proximal end 10A and a distal end 10B. At the distal end 10B, the braided mesh tube is folded inward to form a distal opening 10C. It can be understood that the braided mesh tube does not form a clear crease when it is turned inward and folded. The folded portion is basically a circular arc. Therefore, the inward folded portion is basically a smooth transition to form a larger distal opening 10C. In this way, the flexibility is good, and even if the distal end of the intratumor occlusion device 10 contacts the tumor top, the damage to the tumor top can be reduced. Therefore, the external occlusion structure 112 and the internal support structure 111 are relatively smooth at the distal turning point, while ensuring the axial support force, the flexibility of the device itself is also taken into account without affecting the sheathing and delivery of the intratumor occlusion device 10. Furthermore, in the expanded state, the diameter of the distal opening 10C is not less than 1 / 3 of the radial diameter D2 of the external occlusion structure 112.

[0040] The proximal end of the external blocking structure 112 is connected to the proximal fixing structure 12. The proximal end of the internal support structure 111 extends toward the proximal fixing structure 12 and is connected to the proximal fixing structure 12. The proximal end of the internal support structure 111 and the proximal end of the external blocking structure 112 are the two ends of the braided mesh tube when it is not flipped over. The braided wire heads at the proximal end of the internal support structure 111 and the braided wire heads at the proximal end of the external blocking structure 112 are bound and fixed by the proximal fixing structure 12. The proximal fixing structure 12 can be a developing structure or a non-developing structure. The developing structure can be a developing sleeve. The developing structure can be made of platinum, gold, tantalum or any alloy of these or other non-radiopaque materials.

[0041] As can be understood, the intratumoral occlusion device 10 of this embodiment has only one proximal rivet point, which can be understood as the location where the braided wire ends at the braided mesh tube are bound and fixed. That is, the ends of all the braided wires converge at the proximal end 10A of the intratumoral occlusion device 10 and are bound and fixed by the proximal fixing structure 12. The distal end 10B of the intratumoral occlusion device 10 is recessed inward and has no protruding rivet point. Compared to a dual proximal and distal rivet point structure, this single proximal rivet point structure shortens the axial release length of the intratumoral occlusion device 10 and makes the distal end more flexible and smooth. Upon being pushed out of the microcatheter 1, the device self-expands, minimizing the impact of the initial release of the intratumoral occlusion device 10 on the aneurysm dome and reducing the risk of aneurysm rupture. Furthermore, the release difficulty of the intratumoral occlusion device 10 is reduced, simplifying the entire surgical procedure, reducing the operator's reliance on personal aneurysm embolization experience, shortening surgical time, and improving surgical efficiency.

[0042] In order to achieve a single proximal rivet point, the applicant has attempted to cross-weave the wires and converge them proximally to form a proximal rivet point. Except for the proximal rivet point, the rest of the structure is a woven mesh. Although this simple woven structure has good flexibility, it lacks support and is easily compressed axially when filling the aneurysm. It cannot stably cover the aneurysm neck 21. In addition, the weaving process is complex and the manufacturing difficulty is high. To address this problem, the present invention uses a woven mesh tube. It only needs to be flipped inward. After flipping, the woven wire heads at both ends of the woven mesh tube are bound and fixed by the proximal fixing structure 12. Finally, after heat setting treatment, the intratumor occlusion device 10 with an internal support structure 111 and an external occlusion structure 112 can be obtained. It is relatively easier to achieve from a manufacturing process perspective. In addition to considering the difficulty of the process, the present invention also takes into account the flexibility and support of the entire intra-tumor occlusion device 10 while designing a single proximal rivet point, so that the intra-tumor occlusion device 10 can fit well with the inner wall of the aneurysm and can stably cover the aneurysm neck 21 for a long time, thereby reducing the risk of aneurysm recurrence.

[0043] The applicant has also attempted to flip one portion of the braided mesh tube outward from the other, but this can easily affect the performance of the braided mesh tube itself, particularly the material coverage. To address this issue, the present invention proposes flipping a portion of the braided mesh tube inward to form an internal support structure 111. This approach minimizes the impact on the braided mesh tube itself, making the entire flipping process controllable and virtually ensuring that the mesh size after flipping is consistent with the mesh size before flipping, thus ensuring the dense mesh performance of the mesh main structure 11.

[0044] The intratumoral occlusion device 10 generally has an expanded state and a compressed state, and can switch between the expanded and compressed states. As shown in FIG2 , the intratumoral occlusion device 10 can be delivered through a microcatheter 1 in a compressed state within the microcatheter 1. After being released from the microcatheter 1, it returns to a freely expanded state. As shown in FIG3 , the intratumoral occlusion device 10 can further transform from the freely expanded state to a packed state for packing within an aneurysm 2.

[0045] As shown in Figures 1 and 2 , the intratumor occlusion device 10 is releasably connected to the distal end of the push rod 3 via a proximal fixing structure 12. The push rod 3 propels the intratumor occlusion device 10 axially within the microcatheter 1. The connection method between the distal end of the push rod 3 and the proximal fixing structure 12 is not limited, as long as the two can be smoothly disconnected after connection. For example, the disconnection method may include electrochemical disconnection, thermal melt disconnection, mechanical disconnection, or hydrolytic disconnection.

[0046] The intratumoral occlusion device 10 can be implanted at the lesion site through an interventional procedure. During the procedure, the microcatheter 1 is inserted into the aneurysm lesion of the affected vessel. The entire intratumoral occlusion device 10 is then advanced within the microcatheter 1 until its distal end reaches the neck 21 of the aneurysm 2. While the microcatheter 1 is held stationary, the push rod 3 is pushed forward, gradually moving the intratumoral occlusion device 10 into the aneurysm 2. During this process, the intratumoral occlusion device 10 continuously and automatically expands. As shown in Figure 2, during the release process, the distal end of the external occlusion structure 112 is first pushed out of the microcatheter 1, forming a flexible and large semi-release state, which minimizes damage to the aneurysm tip. Furthermore, compared to the proximal and distal dual-rivet structure, the single-rivet structure has a shorter release distance, making it easier to operate. As the entire intratumoral occlusion device 10 is pushed out of the microcatheter 1, it is completely released within the aneurysm 2. Since the intratumoral occlusion device 10 is completely within the aneurysm 2, the long-term use of dual antiplatelet medication is eliminated, reducing the risk of bleeding complications.

[0047] In the embodiment shown in FIG3 , after the intratumoral occlusion device 10 is fully released within the aneurysm 2, it can substantially fill the entire aneurysm cavity. At this point, the proximal surface of the external occlusion structure 112 effectively covers the aneurysm neck 21, reducing the impact of blood on the aneurysm cavity and providing a scaffold for the healing of the aneurysm neck, promoting its healing. The remaining portion of the external occlusion structure 112 conforms to the inner wall of the aneurysm cavity. The interaction between the external occlusion structure 112 and the aneurysm wall ensures stable packing of the intratumoral occlusion device 10. Simultaneously, the internal support structure 111 maintains the long-term axial stability of the intratumoral occlusion device 10, preventing postoperative aneurysm recurrence. In particular, the internal support structure 111 significantly enhances the axial support strength of the intratumoral occlusion device 10 with a single proximal rivet point, reduces the axial compression of the intratumoral occlusion device 10, effectively mitigates the impact of the blood flow "water hammer effect" on the intratumoral occlusion device 10, and effectively resists the compression effect caused by long-term blood impact, ultimately ensuring the long-term stability of the intratumoral occlusion device 10 during intratumoral packing.

[0048] As shown in FIG1 , the axial height H2 of the external occluding structure 112 in the expanded state is no greater than its radial diameter D2, resulting in a short release length and less likely to impact the aneurysm top. Furthermore, the axial height H2 of the external occluding structure 112 in the expanded state is no less than 1 / 2 of its radial diameter D2, i.e., the axial height H2 of the external occluding structure 112 in the expanded state is 50% to 100% of the radial diameter D2, ensuring that the intra-tumor occlusion device 10 can substantially fill the entire aneurysm cavity. When the intra-tumor occlusion device 10 fills the aneurysm cavity, it provides support for the internal aneurysm wall and can be used to treat ruptured aneurysms. If the aneurysm cavity is not filled, there is a risk of subsequent bleeding or rebleeding. Furthermore, when the intra-tumor occlusion device 10 fills the aneurysm cavity, the internal support structure 111 can better exert its axial support function, effectively improving the axial support of the intra-tumor occlusion device 10.

[0049] Preferably, the axial height H2 of the external occluding structure 112 in the expanded state is less than its radial diameter D2. This reduces the axial height of the intra-tumor occlusion device 10, shortening the deployment length of the intra-tumor occlusion device 10. This further reduces the difficulty of operation for the operator while minimizing the impact on the easily ruptured aneurysm dome and reducing the risk of rupture during the perioperative period. Furthermore, when the axial height H2 of the external occluding structure 112 in the expanded state is less than its radial diameter D2, the intra-tumor occlusion device 10 no longer needs to conform to the entire shape of the aneurysm cavity, making it applicable to a wider range of aneurysms, such as regular aneurysms and irregular aneurysms.

[0050] 1 and 3 , in this embodiment, the outer contour of the external blocking structure 112 in the expanded state is spherical. At this time, the axial height H2 of the external blocking structure 112 is substantially equal to the radial diameter D2 , almost filling the entire tumor cavity.

[0051] The radial diameter D2 of the expanded outer sealing structure 112 is primarily determined by the size of the aneurysm. Generally, the expanded radial diameter D2 of the outer sealing structure 112 can be set based on common aneurysm sizes. Optionally, the expanded radial diameter D2 of the outer sealing structure 112 is between 3 mm and 25 mm, which generally covers most common aneurysms.

[0052] The dense mesh of the external blocking structure 112 plays a major role in disturbing the flow. To this end, the external blocking structure 112 should provide a suitable mesh, which should not be too large. Preferably, the mesh area of ​​the proximal surface of the external blocking structure 112 does not exceed 0.1 mm. 2 While reducing the impact of blood flow on the tumor cavity, it can serve as a scaffold for endothelial cells to climb and promote the healing of the tumor neck.

[0053] This application does not make any special requirements on the materials used to prepare the above-mentioned braided mesh tube. It can be either a metal elastic material or a polymer material with good elasticity. Preferably, the braided mesh tube is woven from a wire material with shape memory properties and has good flexibility. Materials with shape memory properties include shape memory alloy materials, such as nickel titanium (Ni-Ti) alloy, nickel titanium cobalt alloy (Ni-Ti-Co), double-layer composite metal wire (Ni-Ti@Pt), etc. The wire material used to prepare the braided mesh tube can also be selected from polymer materials with certain shape recovery capabilities, such as polydioxanone (PDO), (lactide-ε-caprolactone) copolymer (PLC), polyurethane (PU), polynorbornene amorphous polymer, etc. Alternatively, the wire material used to prepare the braided mesh tube can be mixed with a shape memory alloy material and a metal wire with good developability (Pt, Pt-Ir, etc.), or it can be woven from a composite wire (DFT) of a shape memory alloy material and a developable material. The braided mesh tube can be woven from wire materials made of the same material, or woven from wire materials made of different materials.

[0054] Furthermore, the wire diameter of the wire in the braided mesh tube is 0.0005 in to 0.002 in, and the number of braided wires is 48 to 144, so that the braided mesh tube has good flexibility and support.

[0055] Preferably, the internal support structure 111 also has a certain degree of flexibility, so that the internal support structure 111 has a certain compression margin in the axial direction, thereby improving the flexibility of the intratumor occlusion device 10. Therefore, the internal support structure 111 cannot be too soft or too hard. If the internal support structure 111 is too hard, the axial support is strong enough, but it will affect the flexibility of the entire intratumor occlusion device 10, resulting in the intratumor occlusion device 10 not being able to fit well with the inner wall of the aneurysm; if the internal support structure 111 is too soft, the axial support is too weak, which will affect the support of the entire intratumor occlusion device 10, resulting in the intratumor occlusion device 10 being easily compressed axially. In response to these problems, the present invention designs the internal support structure 111 as a mesh structure that can be compressed to a certain extent in the axial direction. To this end, the radial diameter D1 of the internal support structure 111 in the expanded state is different, that is, the internal support structure 111 in the expanded state has a variable radial diameter D1, which is different from a hollow mesh tube with a constant radial diameter.

[0056] Furthermore, the radial diameter D1 of the internal support structure 111 in the expanded state increases from the proximal and distal ends toward the middle portion, respectively, such that the internal support structure 111 in the expanded state has a spindle shape. Alternatively, the radial diameter D1 of the internal support structure 112 in the expanded state decreases from the distal end toward the proximal end, such that the internal support structure 111 in the expanded state has an inverted conical shape. Compared to a spherical shape, the spindle shape and the inverted conical shape can effectively improve axial support and provide a good support effect.

[0057] As shown in Figure 1, in this embodiment, the expanded internal support structure 111 has a spindle-shaped profile. In this case, the internal support structure 111 is a spindle-shaped mesh structure that expands in the middle and contracts at both ends. This spindle-shaped internal support structure 111 provides axial support while also maintaining a certain degree of flexibility. This allows for greater axial deformation margin when the external sealing structure 112 is radially compressed.

[0058] The axial height H1 of the internal support structure 111 in the expanded state is no greater than the axial height H2 of the external blocking structure 112 in the expanded state, and / or the axial height H1 of the internal support structure 111 in the expanded state is no greater than the radial diameter D2 of the external blocking structure 112 in the expanded state. More preferably, the axial height H1 of the internal support structure 111 in the expanded state is no less than 2 / 3, such as 2 / 3, 3 / 4, or 5 / 6, of the axial height H2 of the external blocking structure 112 in the expanded state, and / or the axial height H1 of the internal support structure 111 in the expanded state is no less than 2 / 3, such as 2 / 3, 3 / 4, or 5 / 6, of the radial diameter D2 of the external blocking structure 112 in the expanded state. By controlling the axial height H1 of the internal support structure 111 in the expanded state, excessive internal concavity that increases the delivery resistance of the intratumor occlusion device 10 can be avoided, while also minimizing the effect of the proximal and distal concavities of the external blocking structure 112 on the sheathing of the intratumor occlusion device 10.

[0059] Preferably, the maximum radial diameter of the internal support structure 111 in the expanded state is no greater than 1 / 2 of the radial diameter D2 of the external occluding structure 112 in the expanded state, such as 1 / 4, 1 / 3, or 1 / 2, to prevent excessive protrusion of the internal support structure 111, which would result in excessive axial compression of the intratumor occlusion device 10 and thus reduce the axial support force. It should be understood that the larger the radial diameter of the internal support structure 111, the better its axial compliance. However, if the radial diameter of the internal support structure 111 is too large, the axial support will be reduced.

[0060] As shown in Figures 1 to 3, as an example, the outer contour of the external occluding structure 112 in the expanded state is spherical, and the outer contour of the internal supporting structure 111 in the expanded state is spindle-shaped. The axial height H1 of the internal supporting structure 111 in the expanded state is ¾ of the radial diameter D2 of the external occluding structure 112 in the expanded state, and the maximum radial diameter of the internal supporting structure 111 in the expanded state is 1 / 3 of the radial diameter D2 of the external occluding structure 112 in the expanded state. This structure of the intra-aneurysm occlusion device 10 has minimal impact on the aneurysm apex during the initial release phase, and a short release length facilitates surgical operation. It also achieves stable occlusion and good long-term axial stability.

[0061] [Example 2]

[0062] As shown in FIG4 , a second embodiment of the present application provides an intratumor occlusion device 20 . The reference numerals for the corresponding components of the intratumor occlusion device 20 of this embodiment continue to use the reference numerals used in the first embodiment. The structure of the intratumor occlusion device 20 of this embodiment is substantially identical to that of the intratumor occlusion device 10 of the first embodiment. The similarities between the first and second embodiments will not be described in detail again. Those skilled in the art will be able to understand the differences between the second embodiment and the first embodiment based on the following description.

[0063] In the exemplary embodiment shown in FIG4 , the outer contour of the external occlusion structure 112 in the expanded state is spherical, and the outer contour of the internal support structure 111 in the expanded state is an inverted cone. "Inverted cone" can be understood as the radial diameter D1 of the internal support structure 111 after expansion decreases from the distal end to the proximal end, which can be gradually reduced or first gradually reduced and then remained unchanged. Compared with the spindle-shaped mesh structure, the inverted cone mesh structure can achieve a smaller recovery resistance of the intratumor occlusion device 20. Specifically, the resistance when the intratumor occlusion device 20 is retracted into the microcatheter 1 is less than the resistance when the internal support structure 111 is spindle-shaped, but the axial extension margin of the intratumor occlusion device 20 is less than the axial extension margin of the spindle-shaped internal support structure 111. Therefore, the axial support of the inverted cone is better.

[0064] As an example, the axial height H1 of the internal support structure 111 in the expanded state is 5 / 6 of the radial diameter D2 of the external occluding structure 112 in the expanded state, and the maximum radial diameter of the internal support structure 111 in the expanded state is 1 / 4 of the radial diameter D2 of the external occluding structure 112 in the expanded state. Compared with the first embodiment, the distal end of the external occluding structure 112 in this embodiment is more rounded and fuller, which can better conform to the shape of the aneurysm, reduce the impact of the intra-aneurysm occlusion device 20 on the aneurysm apex during release, and reduce the risk of intraoperative rupture and bleeding. At the same time, its stronger axial support can better resist the "water hammer" effect on the aneurysm neck during long-term occlusion, thereby reducing the recurrence rate of aneurysms.

[0065] [Example 3]

[0066] As shown in FIG5 , a third embodiment of the present application provides an intratumor occlusion device 30 . The reference numerals for the corresponding components of the intratumor occlusion device 30 of this embodiment continue to use the reference numerals used in the first embodiment. The structure of the intratumor occlusion device 30 of this embodiment is substantially identical to that of the intratumor occlusion device 10 of the first embodiment. The similarities between the first and third embodiments will not be described in detail again. Those skilled in the art will be able to understand the differences between the third embodiment and the first embodiment based on the following description.

[0067] In the exemplary embodiment shown in FIG5 , the outer occluding structure 112 has a cylindrical outer profile in the expanded state, while the inner supporting structure 111 has an inverted conical outer profile in the expanded state. Similarly, the inverted conical mesh structure can achieve lower retrieval resistance for the intratumor occlusion device 30. Specifically, the resistance when the intratumor occlusion device 30 is retracted into the microcatheter 1 is lower than when the inner supporting structure 111 is spindle-shaped.

[0068] In this embodiment, when the external sealing structure 112 has a cylindrical profile in the expanded state, its axial height H2 is less than its radial diameter D2, thus only partially filling the aneurysm cavity while still covering the aneurysm neck 21. Compared to a spherical external sealing structure 112, the proximal surface of the cylindrical external sealing structure 112 is flatter and has a larger area, better covering the aneurysm neck 21 and being suitable for aneurysms with wider necks.

[0069] Preferably, the axial height H2 of the external blocking structure 112 in the expanded state is 0.6 to 0.8 times the radial diameter D2, so as to avoid the axial height H2 of the external blocking structure 112 being too small to affect the support stability.

[0070] As shown in Figure 5, as an example, the axial height H1 of the internal support structure 111 in the expanded state is 5 / 6 of the radial diameter D2 of the external occluding structure 112 in the expanded state, so that the distal end of the external occluding structure 112 is more rounded and full, which can better conform to the shape of the aneurysm, reduce the impact of the intra-tumor occlusion device 30 on the top of the aneurysm during the release process, and reduce the risk of rupture and bleeding during surgery. At the same time, its axial support is stronger, which can better resist the "water hammer effect" on the aneurysm neck during long-term occlusion, thereby reducing the recurrence rate of aneurysms.

[0071] In this embodiment, the maximum radial diameter of the internal support structure 111 in the expanded state is 1 / 3 of the radial diameter D2 of the external blocking structure 112 in the expanded state, which can ensure axial support while having a certain degree of compliance.

[0072] Finally, it should be noted that the external contour of the internal support structure 111 after expansion may not be the spindle shape or inverted cone shape described above, as long as the radial diameter D1 of the internal support structure 111 is variable. Preferably, the internal support structure 111 is a structure that is large in the middle and small at both ends, or a structure that is large at the distal end and small at the proximal end. The external shape of the internal support structure 111 can be obtained through mold shaping, which is relatively easy to implement in terms of technology. Similarly, the external contour of the external blocking structure 112 after expansion may not be spherical or cylindrical, as long as the proximal surface of the external blocking structure 112 can cover the tumor neck and the remaining part can be attached to the tumor wall for anchoring. In addition, when the external contour of the external blocking structure 112 is cylindrical, the internal support structure 111 can also be spindle-shaped.

[0073] Compared with the prior art, the intratumoral occlusion device provided by the present application is simple to release, which can reduce the reliance on the doctor's personal aneurysm embolization experience during the operation and reduce the operation time; and there is only one rivet point at the proximal end, the release length is shortened, and the distal end is a flexible mesh, which can reduce the impact on the aneurysm top and reduce the risk of aneurysm rupture. In addition, the intratumoral occlusion device conforms to the aneurysm cavity filling through the external occlusion structure, and the radial size is excessive, which can ensure that the intratumoral occlusion device is stably placed in the aneurysm, and the internal support structure has good axial support. After blocking the aneurysm neck, it can ensure that the intratumoral occlusion device maintains long-term dimensional stability, reduce the axial compression of the device, and reduce the recurrence rate of aneurysms. In addition, the proximal surface of the external occlusion structure can effectively block the aneurysm neck and promote aneurysm healing, which is particularly suitable for wide-necked aneurysms. Moreover, the intratumoral occlusion device is completely located within the aneurysm, which can avoid the use of dual antiplatelet drugs and reduce the risk of bleeding and other complications.

[0074] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Reference can be made to the common and similar parts between the various embodiments. The systems disclosed in the embodiments are described briefly because they correspond to the methods disclosed in the embodiments. For relevant details, refer to the method description.

[0075] It should also be noted that although the present invention has been disclosed above with reference to preferred embodiments, the above embodiments are not intended to limit the present invention. For any person skilled in the art, without departing from the scope of the technical solution of the present invention, the technical content disclosed above can be used to make many possible changes and modifications to the technical solution of the present invention, or to modify it into an equivalent embodiment with equivalent changes. Therefore, any simple modification, equivalent change, and modification made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of protection of the technical solution of the present invention.

[0076] It should also be understood that, unless otherwise specified or indicated, the terms "first", "second", "third", etc. in the specification are only used to distinguish the various components, elements, steps, etc. in the specification, and are not used to indicate the logical relationship or sequential relationship between the various components, elements, steps, etc.

[0077] It should also be understood that the terms described herein are intended to describe particular embodiments only and are not intended to limit the scope of the invention. It should be noted that the singular forms "a" and "an" as used herein and in the appended claims include plural references unless the context clearly indicates otherwise. For example, a reference to "a step" or "a device" means a reference to one or more steps or devices, and may include secondary steps as well as secondary devices. All conjunctions used should be understood in their broadest sense. Also, the word "or" should be understood to have the definition of a logical "or" rather than a logical "exclusive or" unless the context clearly indicates otherwise. Furthermore, implementation of the methods and / or apparatus in embodiments of the present invention may include performing selected tasks manually, automatically, or in combination.

Claims

1. An intratumor occlusion device capable of switching between a compressed state and an expanded state, characterized in that: The invention comprises a mesh main structure and a proximal fixing structure, wherein the mesh main structure comprises an internal supporting structure and an external blocking structure, wherein the mesh main structure is made of a braided mesh tube, wherein a part of the braided mesh tube is flipped inwardly to form the internal supporting structure, and the other part of the braided mesh tube that is not flipped inward forms the external blocking structure, the proximal end of the external blocking structure is connected to the proximal fixing structure, and the proximal end of the internal supporting structure extends toward the proximal fixing structure and is connected to the proximal fixing structure.

2. The intratumor occlusion device according to claim 1, characterized in that: The radial diameter of the internal support structure in the expanded state increases from the proximal end and the distal end to the middle portion of the internal support structure.

3. The intratumor occlusion device according to claim 1, characterized in that: The radial diameter of the inner support structure in the expanded state decreases from the distal end to the proximal end of the inner support structure.

4. The intratumor occlusion device according to claim 1 or 2, characterized in that: The outer contour of the internal support structure in the expanded state is spindle-shaped.

5. The intratumor occlusion device according to claim 1 or 3, characterized in that: The outer contour of the internal support structure in the expanded state is an inverted cone.

6. The intratumor occlusion device according to claim 4 or 5, characterized in that: The maximum radial diameter of the internal support structure in the expanded state is no greater than 1 / 2 of the radial diameter of the external blocking structure in the expanded state.

7. The intratumor occlusion device according to any one of claims 1 to 3, characterized in that: An axial height of the external sealing structure in the expanded state is not greater than a radial diameter of the external sealing structure in the expanded state, and is not less than 1 / 2 of the radial diameter of the external sealing structure in the expanded state.

8. The intratumor occlusion device according to claim 7, characterized in that: An axial height of the external sealing structure in the expanded state is smaller than a radial diameter of the external sealing structure in the expanded state.

9. The intratumor occlusion device according to claim 7, characterized in that: The outer shape of the external sealing structure in the expanded state is spherical or cylindrical.

10. The intratumor occlusion device according to claim 8, characterized in that: The axial height of the external blocking structure in the expanded state is 0.6 to 0.8 times the radial diameter of the external blocking structure in the expanded state.

11. The intratumor occlusion device according to any one of claims 1 to 3, characterized in that: The axial height of the internal support structure in the expanded state is not greater than the axial height of the external blocking structure in the expanded state, and / or the axial height of the internal support structure in the expanded state is not greater than the radial diameter of the external blocking structure in the expanded state.

12. The intratumor occlusion device according to any one of claims 1 to 3, characterized in that: The axial height of the internal support structure in the expanded state is not less than 2 / 3 of the axial height of the external sealing structure in the expanded state, and / or the axial height of the internal support structure in the expanded state is not less than 2 / 3 of the radial diameter of the external sealing structure in the expanded state.

13. The intratumor occlusion device according to any one of claims 1 to 3, characterized in that: The mesh area of ​​the proximal surface of the external blocking structure does not exceed 0.1mm 2 .

14. The intratumor occlusion device according to any one of claims 1 to 3, characterized in that: The intratumor occlusion device comprises a proximal end and a distal end. At the distal end of the intratumor occlusion device, the braided mesh tube is folded inwardly and smoothly transitioned to form a distal opening.

15. The intratumor occlusion device according to claim 14, characterized in that: In the expanded state, the diameter of the distal opening is not less than 1 / 3 of the radial diameter of the external blocking structure.

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