Magnetic control self-adaptive coil system for aneurysm embolism and application method of magnetic control self-adaptive coil system

Abstract

The invention belongs to the field of biomedical engineering, and discloses a magnetic control self-adaptive coil system for aneurysm embolism and an application method thereof, and the magnetic control self-adaptive coil system comprises a magnetic control self-adaptive coil, a magnetic navigation module and a pushing module; the magnetic control self-adaptive coil is used for self-adaptively filling regular and irregular internal space of the aneurysm; the magnetic navigation module is used for performing magnetic navigation on the magnetic control self-adaptive coil, so that the magnetic control self-adaptive coil reaches a specified position; the pushing module is used for conveying the magnetic control self-adaptive coil into the guide pipe; the magnetic control self-adaptive coil is pushed through the matched micro guide wire, or normal saline is filled into an injector, bubbles are fully discharged, and the magnetic control self-adaptive coil is pushed to move in the catheter at a constant speed; the device has good self-adaptability and can be uniformly distributed in all aneurysms to form compact filling, and the position of the catheter does not need to be adjusted; and moreover, the filling material has adjustable mechanical properties and swelling properties, and can be matched with different coils according to application scenes, so that the filling rate is improved.

Description

Technical Field

[0001] This invention relates to the field of biomedical engineering, and more particularly to a magnetically controlled adaptive coil system for aneurysm embolization and its application method. Background Technology

[0002] The core principle of current minimally invasive embolization therapy is to insert embolic material into the aneurysm cavity through an interventional catheter, blocking blood flow and thus inducing intra-aneurysmal thrombosis. However, its effectiveness is highly dependent on the performance of the embolic material and the morphological characteristics of the aneurysm. For aneurysms, which account for approximately 30% of all aneurysms (such as cystic and lobulated aneurysms), existing embolic materials face significant challenges: the sac wall thickness of cystic aneurysms is only 1 / 3 to 1 / 2 that of the mother sac, making direct catheter contact prone to intraoperative rupture; lobulated aneurysms, due to the presence of multiple compartments, make it difficult for existing coils to be evenly distributed. Currently reported coils include metal coils, liquid embolization coils, hydrogel-based coils, and magnetic embolization media. Platinum coils, as the earliest commercially available embolization material, suffer from poor mechanical compatibility and structural rigidity; liquid embolization agents present challenges such as operational complexity and severe postoperative inflammatory reactions. To overcome the shortcomings of metal and liquid coils, hydrogel coils have been developed as a new generation of biocompatible materials. However, shear-thinned hydrogels exhibit weak tissue adhesion, high migration rate under physiological pressure, and require external activation for stimulus-responsive hydrogels, which can easily cause tissue damage. Magnetic embolization media have drawbacks such as simple structure and low filling rate.

[0003] Therefore, existing coils cannot adaptively fill aneurysms such as sacs, lobes, and ruptures, and this technology still needs improvement. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a magnetically controlled adaptive coil system for aneurysm embolization and its application method, in order to solve the problem that existing coils cannot adaptively fill aneurysms such as sacs, lobes, and ruptures.

[0005] The technical solution adopted by this invention to solve the technical problem is as follows: In a first aspect, the present invention provides a magnetically controlled adaptive coil system for aneurysm embolization, comprising: Magnetic adaptive coil, magnetic navigation module, and push module; The magnetically controlled adaptive coil is used to adaptively fill the internal space of the aneurysm; the internal space of the aneurysm includes: a regular internal space of the aneurysm and an irregular internal space of the aneurysm; The magnetic navigation module is used to perform magnetic navigation on the magnetically controlled adaptive coil so that the magnetically controlled adaptive coil reaches the designated position; The pushing module is used to deliver the magnetically controlled adaptive coil into the catheter; the magnetically controlled adaptive coil is pushed by a matching microguidewire, or by filling a syringe with saline solution and fully removing air bubbles, and then pushing the magnetically controlled adaptive coil at a uniform speed within the catheter.

[0006] In one implementation, the magnetic navigation module includes: a cylindrical permanent magnet loaded by a robotic arm; The diameter of the permanent magnet is 30-50 mm; the length of the permanent magnet is 30-60 mm; and the magnetic field strength on the surface of the permanent magnet is 100-600 mT.

[0007] In one implementation, the delivery module includes: a microcatheter, a microwire, a syringe, and saline solution.

[0008] In one implementation, the magnetically controlled adaptive coil is obtained by injecting a precursor solution into a transparent EP tube with a diameter of 0.3-0.6 mm and curing it with ultraviolet light to obtain magnetically controlled adaptive coils of various sizes; the magnetically controlled adaptive coil is used in an aneurysm embolization system to adaptively fill the internal space of the aneurysm.

[0009] In one implementation, the raw materials for preparing the magnetically controlled adaptive coil include: N-acryloylglycine, crosslinking agent, ultraviolet photoinitiator, neodymium iron boron magnetic powder, sodium alginate, and tantalum powder; The precursor solution is a solution composed of N-acryloylglycine amide, the crosslinking agent, the ultraviolet photoinitiator, the neodymium iron boron magnetic powder, the sodium alginate, and the tantalum powder dissolved or dispersed in deionized water.

[0010] In one implementation, the particle size of the neodymium iron boron magnetic powder is 0.5-5 μm; the particle size of the tantalum powder is 0.1-5 μm.

[0011] Secondly, the present invention provides an application method for a magnetically controlled adaptive coil system for aneurysm embolization, characterized in that it includes: It is compatible with existing interventional delivery devices, fills the weak parts of the aneurysm in a zero-contact manner, and adaptively adjusts the filling rate through a dynamic adjustment mechanism to adaptively fill the internal space of the aneurysm.

[0012] In one implementation, filling the weak portion of the aneurysm in a zero-contact manner includes: When the catheter fails to enter the ovarian sac, it is automatically filled using a magnetically controlled adaptive coil. When a single catheter is placed in the center of a lobulated aneurysm, the two lobes are adaptively and uniformly filled by the magnetically controlled adaptive coil. When the catheter does not contact the weak part of the ruptured aneurysm, it is quickly and adaptively blocked by the magnetically controlled adaptive coil.

[0013] In one implementation, the method of filling the weak portion of the aneurysm with zero contact further includes: The magnetic field is used to adjust the pose of the magnetically controlled adaptive coil; wherein the pose includes: the position of the coil head, the distribution position of the coil within the aneurysm, and the coil retrieval position.

[0014] In one implementation, the adaptive adjustment of the fill rate via a dynamic adjustment mechanism includes: The filling rate is further improved by using the magnetically controlled adaptive coil for dynamic self-expansion.

[0015] In one implementation, the application method further includes: By combining magnetically controlled adaptive coils with different mechanical properties, the filling rate of the embolization can be improved.

[0016] In one implementation, the compatible existing intervention push device includes: The magnetized adaptive coil is delivered via a standard microcatheter to prevent migration.

[0017] The present invention, by employing the above technical solution, has the following effects: 1) The magnetically controlled adaptive coil of the present invention has good adaptability and can be uniformly distributed in all aneurysms (especially challenging cystic and lobulated aneurysms) to form dense filling without adjusting the position of the catheter; moreover, the magnetically controlled adaptive coil has adjustable mechanical properties and swelling properties, and different coils can be matched according to the application scenario to improve the filling rate.

[0018] 2) The magnetically controlled adaptive coil of the present invention can be delivered via a conduit without the risk of migration, effectively avoiding biological barriers; moreover, the magnetically controlled adaptive coil has magnetic field responsiveness, and can use the magnetic field to adjust the position of the coil head to prevent coil leakage, and can also use the magnetic field to adjust the position of the coil to prevent escape, thus solving the major challenge of poor controllability of existing spring coil filling. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram of the magnetically controlled adaptive coil system for aneurysm embolization in this invention.

[0021] Figure 2 This is a schematic diagram illustrating the composition, preparation method, and performance of the magnetically controlled adaptive coil in this invention.

[0022] Figure 3 This is a schematic diagram comparing the morphology of coils with and without sodium alginate in this invention.

[0023] Figure 4 This is a schematic diagram of the self-expansion filling of the magnetically controlled adaptive coil during the embolization process in this invention.

[0024] Figure 5 This is a schematic diagram of the adaptive filling of the sub-sac, lobes, and ruptured aneurysm model by the magnetically controlled adaptive coil in this invention.

[0025] Figure 6 This is a schematic diagram of a lobulated aneurysm within the adaptive filling model of a magnetically controlled adaptive coil in this invention.

[0026] Figure 7 This is a schematic diagram of the magnetic response performance of the magnetically controlled adaptive coil in the model of this invention.

[0027] The objectives, features, and advantages of this invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of this invention clearer and more explicit, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0029] Exemplary System The core principle of current minimally invasive embolization therapy is to insert embolic material into the aneurysm cavity through an interventional catheter, blocking blood flow and thus inducing intra-aneurysmal thrombosis. However, its effectiveness is highly dependent on the performance of the embolic material and the morphological characteristics of the aneurysm. For aneurysms, which account for approximately 30% of all aneurysms (such as cystic and lobulated aneurysms), existing embolic materials face significant challenges: the sac wall thickness of cystic aneurysms is only 1 / 3 to 1 / 2 that of the mother sac, making direct catheter contact prone to intraoperative rupture; lobulated aneurysms, due to the presence of multiple compartments, make it difficult for existing coils to be evenly distributed. Currently reported coils include metal coils, liquid embolization coils, hydrogel-based coils, and magnetic embolization media. Platinum coils, as the earliest commercially available embolization material, suffer from poor mechanical compatibility and structural rigidity; liquid embolization agents present challenges such as operational complexity and severe postoperative inflammatory reactions. To overcome the shortcomings of metal and liquid coils, hydrogel coils have been developed as a new generation of biocompatible materials. However, shear-thinned hydrogels exhibit weak tissue adhesion, high migration rate under physiological pressure, and require external activation for stimulus-responsive hydrogels, which can easily cause tissue damage. Magnetic embolization media have drawbacks such as simple structure and low filling rate.

[0030] To address the above-mentioned technical problems, this invention provides a magnetically controlled adaptive coil system and its application method for aneurysm embolization, comprising: a magnetically controlled adaptive coil, a magnetic navigation module, and a pushing module; the magnetically controlled adaptive coil is used to adaptively fill the internal space of the aneurysm; the internal space of the aneurysm includes: a regular aneurysm internal space and an irregular aneurysm internal space; the magnetic navigation module is used to magnetically navigate the magnetically controlled adaptive coil to a designated position; the pushing module is used to deliver the magnetically controlled adaptive coil into the catheter; the magnetically controlled adaptive coil is pushed by a matched microguidewire, or by filling a syringe with physiological saline and fully removing air bubbles, and uniformly pushing the magnetically controlled adaptive coil to move in the catheter; the magnetically controlled adaptive coil of this invention has good adaptability and can be uniformly distributed in all aneurysms (especially challenging cystic and lobulated aneurysms) to form dense filling without adjusting the position of the catheter; moreover, the magnetically controlled adaptive coil has adjustable mechanical properties and swelling properties, and different coils can be matched according to the application scenario to improve the filling rate.

[0031] like Figure 1 As shown, this embodiment of the invention provides a magnetically controlled adaptive coil system for aneurysm embolization, comprising: a magnetic navigation module 100, a pushing module 200, and a magnetically controlled adaptive coil 300; the magnetic navigation module 100 is used to magnetically navigate the magnetically controlled adaptive coil 300 to a designated position; the pushing module 200 is used to deliver the magnetically controlled adaptive coil 300 into a catheter; the magnetically controlled adaptive coil 300 is pushed by a matching microguidewire, or by filling a syringe with physiological saline and fully removing air bubbles, and uniformly pushing the magnetically controlled adaptive coil 300 to move within the catheter; the magnetically controlled adaptive coil 300 is used to adaptively fill the internal space of the aneurysm.

[0032] In this embodiment, the magnetically controlled adaptive coil system for aneurysm embolization can be used in all aneurysm model scenarios, including: regular aneurysm model scenarios and irregular aneurysm model scenarios; correspondingly, the internal space of the aneurysm includes the internal space of a regular aneurysm model and the internal space of an irregular aneurysm model.

[0033] Specifically, the magnetic navigation module 100 includes: a cylindrical permanent magnet loaded by a robotic arm; the diameter of the permanent magnet is 30-50 mm; the length of the permanent magnet is 30-60 mm; and the surface magnetic field strength of the permanent magnet is 100-600 mT. The pushing module 200 includes: a microcatheter, a microwire, a syringe, and physiological saline.

[0034] Specifically, the magnetically controlled adaptive coil 300 is obtained by injecting a precursor solution into a transparent EP tube with a diameter of 0.3-0.6 mm, followed by UV curing to obtain magnetically controlled adaptive coils 300 of various sizes. The magnetically controlled adaptive coil 300 is used in an aneurysm embolization system to adaptively fill the internal space of the aneurysm. The raw materials for preparing the magnetically controlled adaptive coil 300 include: N-acryloylglycine, a crosslinking agent, a UV photoinitiator, neodymium iron boron magnetic powder, sodium alginate, and tantalum powder. The precursor solution is a solution composed of N-acryloylglycine, the crosslinking agent, the UV photoinitiator, the neodymium iron boron magnetic powder, the sodium alginate, and the tantalum powder dissolved or dispersed in deionized water. The particle size of the neodymium iron boron magnetic powder is 0.5-5 μm; the particle size of the tantalum powder is 0.1-5 μm.

[0035] In this embodiment, the magnetically controlled adaptive coil has the following advantages in the application scenario of aneurysm embolization system: 1) The magnetically controlled adaptive coil can be delivered via a conduit, making it easy to operate and eliminating the risk of migration, thus effectively avoiding biological barriers; 2) The magnetically controlled adaptive coil has good adaptability and can be evenly distributed and densely filled in all aneurysms (especially challenging cystic and lobulated aneurysms) without adjusting the position of the catheter; in addition, the magnetically controlled adaptive coil has adjustable mechanical properties and can be matched with different coils according to the application scenario, or used in combination to improve the filling rate. 3) The magnetically controlled adaptive coil has good swelling properties and can expand at body temperature, thereby further improving the filling rate; 4) The magnetically controlled adaptive coil has good magnetic field responsiveness. It can use the magnetic field to adjust the position of the coil head to prevent coil leakage; it can also use the magnetic field to adjust the position of the coil to prevent escape, thus solving the major challenge of poor controllability of existing spring coil filling. 5) The magnetically controlled adaptive coil is a soft material swelling coil, which is softer than medical coils and can avoid damage to aneurysms.

[0036] In summary, the new generation of adaptive magnetic response swelling coil in this embodiment can achieve high filling efficiency in clinically challenging irregular aneurysms such as cystic, lobulated, and ruptured aneurysms, providing new options and directions for aneurysm embolization.

[0037] It is understood that the magnetically controlled adaptive coil is not only used in aneurysm embolization systems, but can also be applied to other systems and related fields, such as systems for arteriovenous malformations, heart valve diseases, thrombotic diseases, and MRI examinations.

[0038] As an example, in this embodiment, the preparation method of the magnetically controlled adaptive coil mainly includes the following steps: taking the aneurysm embolization system as an example, the magnetically controlled adaptive coil is prepared by ultraviolet light curing using a carefully designed precursor solution and a specific mold (transparent EP tube), as follows; First, N-acryloylglycine, crosslinking agent, ultraviolet photoinitiator, neodymium iron boron magnetic powder, sodium alginate, and tantalum powder are dissolved in deionized water to form a precursor solution.

[0039] In this embodiment, the liquid to solid ratio in the mixture is as follows: the mass-to-volume ratio of the N-acryloylglycamide, the crosslinking agent, the ultraviolet photoinitiator, the neodymium iron boron magnetic powder, the sodium alginate, the tantalum powder, and the deionized water is (25~350) mg : (0.2~12) mg : (1~20) μL : (10~450) mg : (1~45) mg : (50~500) mg : (0.5-2) mL. When selecting the solid components in the mixture, the particle size of the neodymium iron boron magnetic powder is 0.5-5 μm; the particle size of the tantalum powder is 0.1-5 μm.

[0040] In the preparation of the precursor solution, the neodymium iron boron magnetic powder and the sodium alginate are added in 3-4 portions. The sodium alginate is added after each addition of the neodymium iron boron magnetic powder. After each addition of the sodium alginate, the mixture is stirred for 15 minutes using a mixer.

[0041] It is worth mentioning that the N-acryloylglycamide used in this embodiment is the monomer N-acryloylglycamide; the crosslinking agent is N,N'-methylenebisacrylamide; and the ultraviolet photoinitiator is 2-hydroxy-2-methylphenylacetone. In the preparation scheme described in this embodiment, a strategy of adding small amounts of sodium alginate in multiple batches to coat the magnetic powder was adopted, which solved the problem of uneven distribution of magnetic powder in the magnetically controlled adaptive coil. Furthermore, the introduction of sodium alginate significantly improved the swelling performance of the magnetically controlled adaptive coil.

[0042] In this embodiment, by changing the ratio of N-acryloylglycine, neodymium iron boron magnetic powder, and sodium alginate, the mechanical strength of the magnetically controlled adaptive coil can be flexibly adjusted, thereby preparing different types of adaptive coils to match different application scenarios.

[0043] After preparing the aforementioned precursor solution, it is injected into a transparent EP tube with a diameter of 0.3-0.6 mm, and then cured under ultraviolet light to obtain magnetron adaptive coils of various sizes. Specifically, the precursor solution is injected into a mold, and after ultraviolet light curing, the magnetron adaptive coil is obtained. During the ultraviolet light curing process, the ultraviolet light wavelength is 365-405 nm, and the illumination time is 1-15 min.

[0044] like Figure 2 As shown, Figure 2 This is a schematic diagram illustrating the composition, fabrication method, and performance of the magnetically controlled adaptive coil in this embodiment. Figure 2 (a) shows the composition of the magnetically controlled adaptive coil. Figure 2 (b) shows the fabrication method of the magnetically controlled adaptive coil. Figure 2 (c) describes the mechanism of action of the thickener (SA). Figure 2 Image (d) shows the swelling properties of the magnetically controlled adaptive coil. Figure 2 Image (e) is a schematic diagram of an adaptively filled sac aneurysm using a magnetically controlled adaptive coil; combined with Figure 2 The process shown below, illustrated by an example, describes the synthesis steps of a magnetically controlled adaptive coil (PNAGA-S) for in-model aneurysm embolization: Dissolve 200 mg of N-acryloylglycine, 2.4 mg of N,N'-methylenebisacrylamide (crosslinking agent), 5 μL of 1173 initiator (2-hydroxy-2-methylphenylacetone, i.e., UV initiator), and 400 mg of tantalum powder in 1 mL of deionized water; add neodymium iron boron magnetic powder (400 mg) and sodium alginate (40 mg) in four portions.

[0045] During the process of adding the neodymium iron boron magnetic powder and the sodium alginate in portions, 100 mg of neodymium iron boron magnetic powder was added first, followed by 10 mg of sodium alginate. Each addition was mixed for 15 minutes to complete one addition process. This process was repeated three times to complete the entire addition process and obtain the precursor solution.

[0046] After the precursor solution is prepared, it is injected into a 0.5 mm diameter catheter (EP tube) using a syringe, and then irradiated with UV light for 5 minutes, followed by irradiation for another 5 minutes on the other side. After preparation, the resulting magnetized adaptive coil is wound into a circle and radially magnetized using a magnetizer.

[0047] In practical manufacturing scenarios, the amounts of N-acryloylglycine, the crosslinking agent, the ultraviolet photoinitiator, the neodymium iron boron magnetic powder, the sodium alginate, the tantalum powder, and the deionized water can be adaptively modified to meet the requirements for the size, magnetism, and hardness of the magnetically controlled adaptive coil. Alternatively, the amount and frequency of addition of the neodymium iron boron magnetic powder and the sodium alginate can be adaptively adjusted according to the material hardness requirements of the magnetically controlled adaptive coil. For example, increasing the amount and frequency of addition of the neodymium iron boron magnetic powder and the sodium alginate can change the hardness of the magnetically controlled adaptive coil.

[0048] In this embodiment, sodium alginate is introduced as a thickener, and a strategy of adding it in small amounts multiple times is adopted to completely solve the problem of local magnetic powder deposition; such as Figure 3 As shown, Figure 3 This is a comparative morphological diagram of a magnetron adaptive coil with and without sodium alginate. The comparison reveals that the magnetron adaptive coil with sodium alginate significantly increases the amount of magnetic powder encapsulation. Furthermore, the addition of sodium alginate further enhances the swelling performance of the magnetron adaptive coil.

[0049] Therefore, in this embodiment, the addition of sodium alginate achieves the dual function of uniformly coating the magnetic powder and adjusting the swelling rate of the magnetically controlled adaptive coil.

[0050] Furthermore, in this embodiment, in order to ensure the navigation performance of the magnetic navigation module, the permanent magnet needs to be radially magnetized, and the N pole and S pole are marked after magnetization.

[0051] The delivery module includes: a microcatheter, a microguidewire, a syringe, and saline solution. The microcatheter has a diameter of 0.3-0.7 mm. The specific delivery and release methods of the delivery module are as follows: Align the EP tube containing the magnetically controlled adaptive coil with the delivery port of the microcatheter, and transmit the magnetically controlled adaptive coil into the microcatheter via the microguidewire. During this process, the magnetically controlled adaptive coil is pushed to move within the microcatheter by the matching microguidewire; alternatively, physiological saline is filled into the syringe, and air bubbles are fully expelled. The syringe control valve is then pushed at a constant speed to provide water pressure that propels the magnetically controlled adaptive coil to move within the microcatheter.

[0052] Based on the above-mentioned aneurysm embolization system, in the application method of the magnetically controlled adaptive coil, the weak part of the aneurysm can be filled in a "zero-contact" manner in this embodiment, and it can be made compatible with existing interventional push devices through a dynamic adjustment mechanism.

[0053] Specifically, there are several methods for filling the weak parts of an aneurysm using a "zero-contact" approach: 1) For the cyst portion that the microcatheter cannot enter, adaptive filling is performed using the aforementioned magnetically controlled adaptive coil; 2) When a single catheter is placed at the center of a lobulated aneurysm, the two lobes are adaptively and uniformly filled using the magnetically controlled adaptive coil; 3) For the weak part of the ruptured aneurysm that is not in contact with the microcatheter, adaptive and rapid occlusion is performed by the magnetically controlled adaptive coil.

[0054] In the above-mentioned application method of the magnetically controlled adaptive coil, the dynamic adjustment mechanism is as follows: During the use of the magnetically controlled adaptive coil, the coil's position is adjusted using a magnetic field throughout the process (especially the head position of the coil, its distribution within the aneurysm, and its retraction position). In this embodiment, based on the dynamic adjustment mechanism, the magnetically controlled adaptive coil can dynamically self-expand, thereby further improving the filling rate.

[0055] In the above-mentioned application method of the magnetically controlled adaptive coil, when compatible with existing interventional pushing devices, the magnetically controlled adaptive coil can be directly delivered through a standard microcatheter to prevent the magnetically controlled adaptive coil from migrating.

[0056] In the application method of the magnetically controlled adaptive coil in this embodiment, regarding the filling strategy of the magnetically controlled adaptive coil: The microcatheter is placed directly in the mother aneurysm portion of the ovary and in the center of the lobulated aneurysm, without contacting the weakest parts of the aneurysm, such as... Figure 5 As shown, Figure 5 In diagram (a), after being modulated by a magnetic field, the magnetically controlled adaptive coil achieves adaptive filling, and the microcatheter does not contact the weak part of the aneurysm. Figure 5 The part enclosed in the red box in (a) is a schematic diagram of how the magnetically controlled adaptive coil adjusts the direction of the coil head in response to the magnetic field during the filling process; Figure 5 (b) illustrates the specific adaptive filling process. During this process, for single / double sac aneurysm portions where the microcatheter cannot enter, adaptive filling is performed using the magnetically controlled adaptive coil. Furthermore, for the two lobes of a lobulated aneurysm, adaptive and uniform filling of both lobes is performed using the magnetically controlled adaptive coil. Figure 5 The parts enclosed by the red dashed boxes in (b) are the effects of adaptive filling for single and double sac aneurysms, double sac aneurysms, and lobulated aneurysms. Figure 5 (c) illustrates the effective closure process of a ruptured aneurysm. For the weak portion of the ruptured aneurysm that is not contacted by the microcatheter, adaptive and rapid closure is achieved through the magnetically controlled adaptive coil. Figure 5The part enclosed by the red box and the dashed box in (c) is: the jet-like water flow was successfully blocked, indicating that the embolization coil quickly sealed the ruptured aneurysm.

[0057] Based on the above filling strategy, this embodiment further improves the filling rate by swelling the magnetically controlled adaptive coil; such as Figure 4 As shown, Figure 4 The process of self-expansion filling of the magnetically controlled adaptive coil during embolization is illustrated in the figure, specifically, as follows: Figure 4 As shown in the red circle, the magnetically controlled adaptive coil fills the unfilled portion of the aneurysm through self-expansion, thereby further improving the filling rate and achieving dense filling.

[0058] In the application method of the magnetically controlled adaptive coil in this embodiment, the control of the magnetically controlled adaptive coil mainly involves using a magnetic field to guide the coil embolization process throughout, thereby achieving real-time adjustment of the coil head position and recovery of the externally leaking coil, which improves the embolization success rate.

[0059] Compared to existing coil embolization systems, the magnetically controlled adaptive coil prepared in this embodiment has significant advantages in filling sac-like, lobulated, and ruptured aneurysms, solving the problem of rupture risk caused by the need for deep catheter insertion in traditional coil-based sac-like aneurysms; it also solves the problem of uneven filling in lobulated aneurysms; the magnetically controlled adaptive coil in this embodiment does not require dual-catheter operation, reducing surgical complexity. Furthermore, its volume expands after implantation (adjustable from 10% to 450%), sealing the junction area and blocking blood flow flushing; Figure 6 As shown, Figure 6 The process of adaptively filling a lobulated aneurysm within the model using the magnetically controlled adaptive coil is shown. After filling, the coils are evenly distributed and the blood flow is blocked.

[0060] The magnetically controlled adaptive coil prepared in this embodiment can be directly assembled in an EP tube and used directly in embolization model experiments. The embolization experiment can be performed by delivering the coil into a microcatheter via a delivery port. Depending on the coil's stiffness, a guidewire or water injection can be flexibly selected for delivery.

[0061] In this embodiment, a high surface magnetic strength magnet is customized by simulating the influence of magnet length and diameter on magnetic field strength. The content and dispersion of magnetic powder are improved by adjusting the feeding sequence and strategy of sodium alginate / magnetic powder. Furthermore, the coil is radially magnetized, and the coil head position is dynamically adjusted by rotating the magnetic field to achieve coil tail recovery. Figure 7 As shown, Figure 7 The paper demonstrates that the magnetically controlled adaptive coil prepared in this embodiment has good magnetic response performance within the model. By precisely adjusting the position of the coil head through the magnetic navigation module and recovering the exposed part of the coil, the fill rate of the magnetically controlled adaptive coil is improved.

[0062] This embodiment achieves the following technical effects through the above technical solution: 1) The magnetically controlled adaptive coil of this embodiment has good adaptability and can be evenly distributed in all aneurysms (especially challenging cystic and lobulated aneurysms) to form dense filling without adjusting the position of the catheter; moreover, the magnetically controlled adaptive coil has adjustable mechanical properties and swelling properties, and different coils can be matched according to the application scenario to improve the filling rate.

[0063] 2) The magnetically controlled adaptive coil of this embodiment can be delivered via a conduit without the risk of migration, effectively avoiding biological barriers; moreover, the magnetically controlled adaptive coil has magnetic field responsiveness, and can use the magnetic field to adjust the position of the coil head to prevent coil leakage, and can also use the magnetic field to adjust the position of the coil to prevent escape, thus solving the major challenge of poor controllability of existing spring coil filling.

[0064] Exemplary methods Based on the above-described magnetically controlled adaptive coil system for aneurysm embolization, the present invention also provides an application method, comprising: It is compatible with existing interventional delivery devices, fills the weak parts of the aneurysm in a zero-contact manner, and adaptively adjusts the filling rate through a dynamic adjustment mechanism to adaptively fill the internal space of the aneurysm.

[0065] The method of filling the weak part of the aneurysm in a zero-contact manner includes: when the catheter does not enter the ovary portion, adaptive filling is performed by a magnetically controlled adaptive coil; when a single catheter is placed in the center of the lobed aneurysm, the magnetically controlled adaptive coil adaptively and evenly fills both lobes; and when the catheter does not contact the weak part of the ruptured aneurysm, adaptive and rapid occlusion is performed by the magnetically controlled adaptive coil.

[0066] The method of filling the weak part of the aneurysm in a zero-contact manner further includes: using a magnetic field to adjust the pose of the magnetically controlled adaptive coil; wherein the pose includes: the position of the coil head, the distribution position of the coil within the aneurysm, and the coil retrieval position.

[0067] The adaptive adjustment of the fill rate through a dynamic adjustment mechanism includes: dynamically self-expanding the magnetically controlled adaptive coil to further improve the fill rate.

[0068] The application method further includes: using magnetically controlled adaptive coils with different mechanical properties to improve the embolization rate. The compatibility with existing interventional delivery devices includes: delivering the magnetically controlled adaptive coils via a standard microcatheter to prevent migration.

[0069] As an example, in the application method of the magnetically controlled adaptive coil, the weak part of the aneurysm can be filled in a "zero-contact" manner in this embodiment, and it can be made compatible with existing interventional push devices through a dynamic adjustment mechanism.

[0070] Specifically, there are several methods for filling the weak parts of an aneurysm using a "zero-contact" approach: 1) For the cyst portion that the microcatheter cannot enter, adaptive filling is performed using the aforementioned magnetically controlled adaptive coil; 2) When a single catheter is placed at the center of a lobulated aneurysm, the two lobes are adaptively and uniformly filled using the magnetically controlled adaptive coil; 3) For the weak part of the ruptured aneurysm that is not in contact with the microcatheter, adaptive and rapid occlusion is performed by the magnetically controlled adaptive coil.

[0071] In the above-mentioned application method of the magnetically controlled adaptive coil, the dynamic adjustment mechanism is as follows: During the use of the magnetically controlled adaptive coil, the coil's position is adjusted using a magnetic field throughout the process (especially the head position of the coil, its distribution within the aneurysm, and its retraction position). In this embodiment, based on the dynamic adjustment mechanism, the magnetically controlled adaptive coil can dynamically self-expand, thereby further improving the filling rate.

[0072] In the above-mentioned application method of the magnetically controlled adaptive coil, when compatible with existing interventional pushing devices, the magnetically controlled adaptive coil can be directly delivered through a standard microcatheter to prevent the magnetically controlled adaptive coil from migrating.

[0073] In the application method of the magnetically controlled adaptive coil in this embodiment, regarding the filling strategy of the magnetically controlled adaptive coil: The microcatheter is placed directly in the mother aneurysm portion of the ovary and in the center of the lobulated aneurysm, without contacting the weakest parts of the aneurysm, such as... Figure 5 As shown, Figure 5 In diagram (a), after being modulated by a magnetic field, the magnetically controlled adaptive coil achieves adaptive filling, and the microcatheter does not contact the weak part of the aneurysm. Figure 5 The part enclosed in the red box in (a) is a schematic diagram of how the magnetically controlled adaptive coil adjusts the direction of the coil head in response to the magnetic field during the filling process; Figure 5 (b) illustrates the specific adaptive filling process. During this process, for single / double sac aneurysm portions where the microcatheter cannot enter, adaptive filling is performed using the magnetically controlled adaptive coil. Furthermore, for the two lobes of a lobulated aneurysm, adaptive and uniform filling of both lobes is performed using the magnetically controlled adaptive coil. Figure 5The parts enclosed by the red dashed boxes in (b) are the effects of adaptive filling for single and double sac aneurysms, double sac aneurysms, and lobulated aneurysms. Figure 5 (c) illustrates the effective closure process of a ruptured aneurysm. For the weak portion of the ruptured aneurysm that is not contacted by the microcatheter, adaptive and rapid closure is achieved through the magnetically controlled adaptive coil. Figure 5 The part enclosed by the red box and the dashed box in (c) is: the jet-like water flow was successfully blocked, indicating that the embolization coil quickly sealed the ruptured aneurysm.

[0074] Based on the above filling strategy, this embodiment further improves the filling rate by swelling the magnetically controlled adaptive coil; such as Figure 4 As shown, Figure 4 The process of self-expansion filling of the magnetically controlled adaptive coil during embolization is illustrated in the figure, specifically, as follows: Figure 4 As shown in the red circle, the magnetically controlled adaptive coil fills the unfilled portion of the aneurysm through self-expansion, thereby further improving the filling rate and achieving dense filling.

[0075] In the application method of the magnetically controlled adaptive coil in this embodiment, the control of the magnetically controlled adaptive coil mainly involves using a magnetic field to guide the coil embolization process throughout, thereby achieving real-time adjustment of the coil head position and recovery of the externally leaking coil, which improves the embolization success rate.

[0076] In summary, this invention provides a magnetically controlled adaptive coil system for aneurysm embolization and its application method, comprising: a magnetic navigation module, a pushing module, and a magnetically controlled adaptive coil; the magnetic navigation module is used to magnetically navigate the magnetically controlled adaptive coil to a designated position; the pushing module is used to deliver the magnetically controlled adaptive coil into the catheter; the magnetically controlled adaptive coil is pushed through a matched microguidewire, or by filling a syringe with physiological saline and fully removing air bubbles, and uniformly pushing the magnetically controlled adaptive coil to move within the catheter; the magnetically controlled adaptive coil is used to adaptively fill irregular internal spaces; the magnetically controlled adaptive coil of this invention has good adaptability and can be uniformly distributed in all aneurysms (especially challenging cystic and lobulated aneurysms) to form dense filling without adjusting the catheter position; moreover, the magnetically controlled adaptive coil has adjustable mechanical and swelling properties, and different coils can be matched according to the application scenario to improve the filling rate.

[0077] It should be understood that the application of the present invention is not limited to the examples above. Those skilled in the art can make improvements or modifications based on the above description, and all such improvements and modifications should fall within the protection scope of the appended claims.

Claims

1. A magnetically controlled adaptive coil system for aneurysm embolization, characterized in that, include: Magnetic adaptive coil, magnetic navigation module, and push module; The magnetically controlled adaptive coil is used to adaptively fill the internal space of the aneurysm; wherein, the internal space of the aneurysm includes: a regular internal space of the aneurysm and an irregular internal space of the aneurysm; The magnetic navigation module is used to perform magnetic navigation on the magnetically controlled adaptive coil so that the magnetically controlled adaptive coil reaches the designated position; The pushing module is used to deliver the magnetically controlled adaptive coil into the catheter; the magnetically controlled adaptive coil is pushed by a matching microguidewire, or by filling a syringe with saline solution and fully removing air bubbles, and then pushing the magnetically controlled adaptive coil at a uniform speed within the catheter.

2. The magnetically controlled adaptive coil system for aneurysm embolization according to claim 1, characterized in that, The magnetic navigation module includes: a cylindrical permanent magnet loaded by a robotic arm; The diameter of the permanent magnet is 30-50 mm; the length of the permanent magnet is 30-60 mm; and the magnetic field strength on the surface of the permanent magnet is 100-600 mT.

3. The magnetically controlled adaptive coil system for aneurysm embolization according to claim 1, characterized in that, The delivery module includes: a microcatheter, a microwire, a syringe, and saline solution.

4. The magnetically controlled adaptive coil system for aneurysm embolization according to claim 1, characterized in that, The magnetically controlled adaptive coil is obtained by injecting a precursor solution into a transparent EP tube with a diameter of 0.3-0.6 mm and curing it with ultraviolet light to obtain magnetically controlled adaptive coils of various sizes; the magnetically controlled adaptive coil is used in an aneurysm embolization system to adaptively fill the internal space of the aneurysm.

5. The magnetically controlled adaptive coil system for aneurysm embolization according to claim 4, characterized in that, The raw materials for preparing the magnetically controlled adaptive coil include: N-acryloylglycine, crosslinking agent, ultraviolet photoinitiator, neodymium iron boron magnetic powder, sodium alginate, and tantalum powder; The precursor solution is a solution composed of N-acryloylglycine amide, the crosslinking agent, the ultraviolet photoinitiator, the neodymium iron boron magnetic powder, the sodium alginate, and the tantalum powder dissolved or dispersed in deionized water.

6. The magnetically controlled adaptive coil system for aneurysm embolization according to claim 4, characterized in that, The particle size of the neodymium iron boron magnetic powder is 0.5-5 μm; the particle size of the tantalum powder is 0.1-5 μm.

7. An application method of a magnetically controlled adaptive coil system for aneurysm embolization, characterized in that, include: It is compatible with existing interventional delivery devices, fills the weak parts of the aneurysm in a zero-contact manner, and adaptively adjusts the filling rate through a dynamic adjustment mechanism to adaptively fill the internal space of the aneurysm.

8. The application method of the magnetically controlled adaptive coil system for aneurysm embolization according to claim 7, characterized in that, The method of filling the weak part of the aneurysm in a zero-contact manner includes: When the catheter fails to enter the ovarian sac, it is automatically filled using a magnetically controlled adaptive coil. When a single catheter is placed in the center of a lobulated aneurysm, the two lobes are adaptively and uniformly filled by the magnetically controlled adaptive coil. When the catheter does not contact the weak part of the ruptured aneurysm, it is quickly and adaptively blocked by the magnetically controlled adaptive coil.

9. The application method of the magnetically controlled adaptive coil system for aneurysm embolization according to claim 7, characterized in that, The method of filling the weak portion of the aneurysm in a zero-contact manner also includes: The magnetic field is used to adjust the pose of the magnetically controlled adaptive coil; wherein the pose includes: the position of the coil head, the distribution position of the coil within the aneurysm, and the coil retrieval position.

10. The application method of the magnetically controlled adaptive coil system for aneurysm embolization according to claim 7, characterized in that, The adaptive adjustment of the fill rate through a dynamic adjustment mechanism includes: The filling rate is further improved by using the magnetically controlled adaptive coil for dynamic self-expansion.

11. The application method of the magnetically controlled adaptive coil system for aneurysm embolization according to claim 7, characterized in that, The application method also includes: By combining magnetically controlled adaptive coils with different mechanical properties, the filling rate of the embolization can be improved.

12. The application method of the magnetically controlled adaptive coil system for aneurysm embolization according to claim 7, characterized in that, The compatible existing intervention push device includes: The magnetized adaptive coil is delivered via a standard microcatheter to prevent migration.

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