Medical coil

Abstract

The present invention provides a medical coil, which comprises a spring and at least one radiopaque marker. The radiopaque marker is sleeved outside the spring and / or disposed inside the spring. Thus, on the one hand, the specific position and shape of the medical coil can be observed during or after implantation by means of these radiopaque markers, effectively solving the problem of poor radiopacity of the existing coils. On the other hand, since the radiopaque marker is sleeved outside and / or inside the spring, the setting of the radiopaque marker will not affect the physical properties such as the three-dimensional structure and stiffness of the spring itself, effectively realizing the embolization treatment of intracranial aneurysms.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a medical coil Background Art

[0002] The rupture and bleeding of intracranial aneurysms have extremely high disability and fatality rates. With the improvement of medical technology, the development of device materials, and the accumulation of experience of neurointerventional physicians, endovascular treatment has become the preferred treatment method for reducing the rebleeding rate and mortality of ruptured intracranial aneurysms. Among many treatment methods, the most widely used is aneurysm embolization treatment, including embolization coils, liquid embolization agents, intratumoral embolization devices, balloon / stent-assisted techniques, etc. Among these, embolization coils have received more and more attention from clinicians and researchers due to their advantages such as convenient operation, stable implantation, safety and effectiveness, and have gradually become the mainstream means for clinical treatment of intracranial aneurysms.

[0003] At present, the coils used clinically can be classified into bare metal coils (including two-dimensional coils and three-dimensional basket-forming coils) and surface-modified coils according to materials and structural designs. Bare metal coils are the most widely used coils at present, which are safe and effective for intracranial ruptured aneurysms and can reduce the early rebleeding rate and long-term fatality rate. Typical bare metal coils are prepared from metal materials such as platinum-tungsten alloy, have good biocompatibility, and also have good imaging effects. Surface-modified coils include hydrogel coils, bioactive coating coils, and ciliated coils. By surface-modifying the bare metal coils, these coils show better tumor cavity filling rates, shorter aneurysm embolization and tumor neck endothelialization cycles, and lower medium- and long-term recurrence and rebleeding rates compared with pure bare metal coils in clinical applications. However, patients with intracranial aneurysms often present symptoms such as headache, eye movement disorders, and limb swelling. This is due to the mass effect of the aneurysm, resulting in corresponding symptoms caused by the compression of the tumor body on surrounding nerves, veins, and organs. At present, the coils used clinically (including bare metal coils and surface-modified coils) are not biodegradable. Although thrombosis and organization in the tumor can be caused after packing, the tumor body will maintain its original size and will continuously compress the nerves, blood vessels, and organs outside the tumor, and the clinical symptoms caused by the mass effect cannot be eliminated. In addition, the main bodies of bare metal coils and surface-modified coils are metal structures and cannot be degraded in the body, so their long-term implantation safety and stability in the body still need to be investigated.

[0004] At present, there are patents that mention absorbable (or degradable) spring coils, and the materials used for their preparation include PLGA, PGA, magnesium alloys, etc. However, these materials cannot be developed under X-rays. Therefore, when designing degradable spring coils, it is necessary to design and add developing components to the springs to give the degradable spring coils developability. For example, the developing ring is bonded to the two ends of the degradable coil, or the coil made of developing wire is wound together with the coil of degradable metal wire, or the degradable material and the developing material are processed to form an integral structure and then wound into a three-dimensional spring, etc., to give the spring coil developability. However, after the absorbable material degrades, although the volume of these spring coils is reduced, the non-degradable three-dimensional structure is still retained, and the space occupying effect still exists.

[0005] In addition, the degradable spring coil using the above-mentioned development structure still has some defects: 1) The degradable or absorbable material itself does not have development properties, so the current development effect of the degradable spring coil is poor, or, in order to achieve the necessary development effect, the volume ratio of the degradable or absorbable material used in the entire spring coil is limited, generally not more than 60%, so there is still a significant space-occupying effect; 2) When the degradable material or absorbable material in the spring coil is degraded or absorbed, the development structure may fall off the spring coil or even fall outside the aneurysm neck, causing distal vascular blockage and even life-threatening.

[0006] Therefore, it is necessary to improve the existing medical spring coils to solve the above problems. Summary of the invention

[0007] The purpose of the present invention is to provide a medical spring coil which can effectively solve the problem of poor development performance of existing spring coils.

[0008] In order to achieve the above object, the present invention provides a medical spring coil, comprising a spring and at least one developing mark, wherein the developing mark is sleeved on the outside of the spring and / or arranged inside the spring.

[0009] Optionally, at least part of the spring is made of a biodegradable material or a bioabsorbable material.

[0010] Optionally, the volume of the biodegradable material or bioabsorbable material accounts for 70% to 95% of the volume of the spring coil.

[0011] Optionally, the biodegradable material or bioabsorbable material includes at least one of polylactic acid, polyglycolic acid, polyurethane, and polylactic acid-glycolic acid copolymer.

[0012] Optionally, at least two of the development marks are arranged at intervals along the axial direction of the spring.

[0013] Optionally, the development mark is sleeved on the outer wall of the spring or embedded in the inner wall of the spring by an interference mechanical connection method.

[0014] Optionally, the spring coil further includes at least one anti-unwinding component, the anti-unwinding component penetrates through the inside of the spring, and both ends of the anti-unwinding component are respectively connected to both ends of the spring.

[0015] Optionally, the development mark is arranged inside the spring, and the anti-unwinding component penetrates through the inside of the development mark; the anti-unwinding component is bonded to the development mark by an adhesive, or the anti-unwinding component forms knots at both ends of the development mark, and the outer diameter of the knot is greater than the inner diameter of the development mark.

[0016] Optionally, the number of the development marks is more than two, and the range of the distance between two adjacent development marks is 3 mm to 30 mm.

[0017] Optionally, the number of the development marks is more than two, at least one of the development marks is located outside the spring, and at least one of the development marks is arranged inside the spring.

[0018] Optionally, the range of the dimension of the development mark extending along the axial direction of the spring coil is 0.005 inches to 0.025 inches.

[0019] Optionally, the range of the outer diameter of the development mark sleeved on the outside of the spring is 0.010 inches to 0.0165 inches.

[0020] Optionally, the range of the outer diameter of the development mark arranged inside the spring is between 0.002 inches and 0.010 inches.

[0021] Optionally, the development mark is in a ring-shaped, tubular or spring-shaped structure.

[0022] Optionally, the material of the development mark is one or a combination of stainless steel, platinum, gold, rhodium, rhenium, palladium, iridium and tungsten.

[0023] Optionally, the material of the anti-unwinding component is a non-degradable polymer material or a non-degradable metal material.

[0024] Optionally, the polymer material includes at least one of polypropylene, polyethylene and polyisoprene; the metal material includes at least one of nickel-titanium alloy, platinum-tungsten alloy, titanium-nickel-copper alloy, titanium-nickel-iron alloy, titanium-nickel-chromium alloy, copper-nickel alloy, copper-aluminum alloy and copper-zinc alloy.

[0025] Optionally, the spring coil further comprises connecting pieces arranged at both ends of the spring, and the connecting pieces respectively connect the two ends of the anti-untwisting component and the two ends of the spring together.

[0026] Optionally, the connecting piece is a smooth curved structure.

[0027] Optionally, the material of the connecting piece is a light-cured or naturally-cured viscous liquid, and the viscous liquid can be cured under light or natural environment conditions to form the smooth curved surface structure.

[0028] Optionally, the viscous liquid includes at least one of epoxy resin glue or acrylic polyurethane.

[0029] Optionally, the connection between the connecting member and the spring and / or the anti-unrotation component is by bonding.

[0030] Optionally, the outer diameter of the connecting member is larger than the inner diameter of the development mark.

[0031] Compared with the prior art, the medical spring coil of the present invention has the following beneficial effects:

[0032] 1. The medical spring coil of the present invention comprises a spring and at least one developing mark, wherein the developing mark is sleeved on the outside of the spring and / or arranged inside the spring. Thus, on the one hand, the specific position and shape of the medical spring coil can be observed during or after implantation with the help of these developing marks, which effectively solves the problem of poor developing performance of the existing spring coil; on the other hand, since the developing mark is sleeved on the outside and / or inside of the spring, the setting of the developing mark will not affect the physical properties such as the three-dimensional structure and stiffness of the spring itself, thereby effectively realizing the embolization treatment of intracranial aneurysms.

[0033] 2. Furthermore, at least part of the spring in the medical spring coil of the present invention is made of bioabsorbable and / or degradable materials, and thus has both degradability and developability. On the one hand, after the spring coil is implanted in the blood vessel, it can safely and effectively embolize the intracranial aneurysm, causing the thrombus in the aneurysm to rapidly fibrosize. As the degradable material of the spring is absorbed and / or degraded, the fibrous tissue in the aneurysm continues to shrink, causing the aneurysm to shrink continuously, thereby greatly reducing the space-occupying effect of the spring coil and avoiding the long-term safety problem after the implantation of the metal coil. On the other hand, after the spring coil is degraded or absorbed, the remaining non-degradable part including the developable mark no longer maintains the original three-dimensional structure of the spring coil, and the long-term space-occupying effect of the spring coil in the aneurysm can be basically completely eliminated, thereby effectively solving the space-occupying effect problem and the demand for developable performance at the same time.

[0034] 3. Further, in the medical coil of the present invention, at least two of the radiopaque markers are arranged at intervals along the axial direction of the coil, and these radiopaque markers are sleeved outside the biodegradable coil at intervals and / or arranged inside the biodegradable coil. This cooperation setting mode of the radiopaque markers and the biodegradable coil has a better imaging effect compared with the existing radiopaque wire material wound around the biodegradable material or the coil formed by integrally molding the two materials. Therefore, on the premise of obtaining the same imaging effect, less radiopaque material can be used, which can make the volume percentage of the bioabsorbable and / or biodegradable material in the whole coil higher. Furthermore, the coil has the characteristics of a short degradation period and a high degradation ratio, bringing more significant and thorough effects for solving the mass effect and long-term safety problems.

[0035] 4. Further, in the medical coil of the present invention, the radiopaque markers are sleeved outside the coil and / or arranged inside the coil by an interference mechanical connection method, that is, the radiopaque markers can be effectively fixed on the coil and can remain stable during the process of pushing the medical coil into the blood vessel without sliding. Then, the imaging performance of the radiopaque markers is used to accurately position and release the coil to ensure that the coil can be accurately implanted into the lesion site.

[0036] 5. Further, the medical coil of the present invention further includes an anti-unwinding component. The anti-unwinding component penetrates through the inside of the radiopaque marker or is connected to the radiopaque marker by a corresponding method. Thus, the axial position of the radiopaque marker can be kept unchanged by the anti-unwinding component, so as to accurately position and observe the specific position and three-dimensional shape of the coil during and after implantation. At the same time, it can also prevent the radiopaque marker from falling off the coil after the coil degrades, thus avoiding the problem that the existing radiopaque marker is easy to fall off or even fall outside the aneurysm neck, resulting in distal vascular occlusion and even life-threatening.

[0037] 6. Further, the medical coil of the present invention includes smooth curved surface structures arranged at both ends of the coil. The smooth curved surface structures can fix the anti-unwinding component and both ends of the coil together, thereby increasing the smoothness of both ends of the coil, reducing the pushing resistance of the coil during the process of pushing the coil into the blood vessel and reducing the possible damage to the aneurysm wall when the coil fills the aneurysm. And after most or all of the coil degrades, the smooth curved surface structures and the anti-unwinding component can maintain an effective connection with the radiopaque marker to further prevent the risk of the radiopaque marker falling off the coil after the coil degrades. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 is a schematic cross-sectional structure view of the medical coil according to Embodiment 1 of the present invention.

[0039] Figure 2It is a schematic cross-sectional structure diagram of the medical coil in the second embodiment of the present invention.

[0040] Figure 3 It is a schematic cross-sectional structure diagram of the medical coil in the third embodiment of the present invention.

[0041] The reference numerals therein are as follows:

[0042] 1 - Radiopaque marker; 2 - Spring; 3 - Anti-uncoiling component; 4 - Smooth surface structure; L1 - Line width of the radiopaque marker; L2 - Spacing between two adjacent radiopaque markers. Detailed implementation manners

[0043] To make the objectives and features of the present invention more obvious and understandable, the technical solutions of the present invention will be described in detail below with reference to the accompanying drawings. However, the present invention can be implemented in different forms and should not be limited only to the described embodiments. In addition, the term "and / or" herein represents the situation of either one or both; the term "connection" includes direct connection and indirect connection.

[0044] Embodiment 1

[0045] Please refer to Figure 1 , this embodiment provides a medical coil, including a spring 2, at least one radiopaque marker 1, at least one anti-uncoiling component 3, and two smooth surface structures 4.

[0046] The spring 2 is the main structure of the medical coil. It can be a spring structure with a uniform shape wound by corresponding filaments on a mandrel, presenting as a tubular structure with a cavity as a whole, so that the medical coil in this embodiment forms an embolization coil. At least part of the material of the spring 2 is a biodegradable material or a bioabsorbable material, and the percentage of the volume of the biodegradable material or the bioabsorbable material in the whole volume of the medical coil is 70% - 95%. Thus, the medical coil in this embodiment has both degradability and radiopacity. On the one hand, after the coil is implanted into the blood vessel, it can safely and effectively embolize the intracranial aneurysm, causing the thrombus in the aneurysm to quickly fibrosis. As the biodegradable material of the spring is absorbed and / or degraded, the fibrous tissue in the aneurysm continuously shrinks, causing the aneurysm to continuously shrink, thereby greatly reducing the mass effect of the coil and avoiding the long-term safety problems existing after the implantation of the metal coil. On the other hand, after the coil degrades or is absorbed, the remaining non-degradable part, including the radiopaque marker, no longer maintains the original three-dimensional structure of the coil, and can basically completely eliminate the long-term mass effect of the coil in the aneurysm. Therefore, it can effectively solve the problems of the mass effect and the requirement for radiopacity performance at the same time. Among them, the bioabsorbable / biodegradable material includes at least one of polylactic acid (PLA), polyglycolic acid (PGA), polyurethane (PU), and poly(lactic-co-glycolic acid) (PLGA / PGLA). Preferably, PLA, PGA, and PGLA are used, so that the degradable / absorbable part of the medical coil has the characteristics of a short degradation period and a high degradation ratio, which is beneficial to reducing or even eliminating the mass effect in a relatively short time.

[0047] At least one radiopaque marker 1 is sleeved on the outer wall (i.e., the outside) of the spring 2. Thus, on the one hand, it is possible to observe the specific position and shape of the medical coil during or after implantation with the help of these radiopaque markers 1, effectively solving the problem of poor radiopacity performance of the existing coils. On the other hand, since the radiopaque marker 1 is sleeved on the outside of the spring 2, the setting of the radiopaque marker 1 will not affect the physical properties such as the three-dimensional structure and stiffness of the spring 2 itself, and effectively realizes the embolization treatment of intracranial aneurysms.

[0048] The developing marker 1 can be in a ring structure, a tubular structure or a spring-like structure, and the connection mode between the developing marker 1 and the spring 2 is an interference mechanical connection. Thus, on the premise that the setting of the developing marker 1 does not affect the structure of the spring 2 itself, the developing marker 1 can be effectively fixed on the spring 2, and the developing marker 1 can be kept stable and will not slide during the process of pushing the medical coil into the human blood vessel. In addition, the material selection of the developing marker 1 needs to meet the requirements that while not affecting the imaging effect of the medical coil under X-ray, it will not have an adverse impact on the softness and pushability of the medical coil. Therefore, in this embodiment, the material of the developing marker 1 is an X-ray non-penetrable material, including one or more combinations (i.e., alloys) of stainless steel, platinum, gold, rhodium, rhenium, palladium, tungsten. The size design of the developing marker 1 needs to be determined according to the size of the aneurysm to be implanted, and at the same time, it also needs to meet the requirements that while not affecting the imaging effect of the medical coil under X-ray, it will not have an adverse impact on the softness and pushability of the medical coil. Therefore, in this embodiment, the axial dimension L1 of the developing marker 1 (i.e., the dimension of the developing marker 1 extending along the length direction x of the anti-unwinding member 3) ranges from 0.005 inches to 0.025 inches, and the preferred dimension is from 0.01 inches to 0.016 inches. The outer diameter of each developing marker 1 (i.e., the dimension in the direction y perpendicular to the anti-unwinding member 3) ranges from 0.010 inches to 0.0165 inches, and the preferred dimension is from 0.0135 inches to 0.0145 inches. In order to achieve an interference mechanical connection with the spring 2 and be able to match the size of the aneurysm to be implanted, and prevent damage to the blood vessel during the implantation process, the outer diameter dimension of the spring 2 needs to be designed according to the spatial dimension of the implantation position, and the outer diameter dimension of the spring 2 needs to match the inner diameter dimension of the developing marker 1 of the spring 2.

[0049] In addition, in order to match the size of the aneurysm to be implanted and ensure that the imaging markers can be evenly distributed in the aneurysm after all the coils are implanted, facilitating the diagnosis of the efficacy during and after the operation, in this embodiment, the number of the imaging markers 1 is not less than 2, and these imaging markers 1 are arranged at intervals along the axial direction of the spring 2 and are all sleeved outside the spring 2. This cooperative arrangement of the imaging markers 1 and the spring 2 has a better imaging effect compared with the existing imaging filaments wound around the biodegradable material or the coils formed by integrally molding the two materials. Therefore, on the premise of obtaining the same imaging effect, less imaging material can be used, and the volume percentage of the bioabsorbable and / or biodegradable material in the spring 2 in the entire coil can be higher, reaching 70% to 95%. Furthermore, the coil has the characteristics of a short degradation period and a high degradation ratio, bringing more significant and thorough effects on solving the mass effect and long-term safety problems. During specific implementation, these imaging markers 1 can be evenly arranged at equal intervals along the axial direction of the spring 2. Specifically, these imaging markers 1 are evenly arranged with the same value for the distance L2 between every two adjacent imaging markers 1. The range of the distance L2 is, for example, 3 mm to 30 mm, and the preferred size is 5 mm to 10 mm. The overall length of the spring 2 can be equal to or greater than the sum of the axial dimensions L1 of all the imaging markers 1 and the sum of all the distances L2. In other embodiments, the multiple imaging markers 1 can also be arranged at unequal intervals in the x direction. For example, they are arranged more densely near both ends of the coil and more sparsely near the middle.

[0050] The anti-unwinding member 3 is in a filamentous structure, penetrates inside the spring 2, and extends along the axial direction of the spring 2. Both ends of the anti-unwinding member 3 are respectively connected to both ends of the spring 2. The anti-unwinding member 3 is made of a non-degradable material, and the non-degradable material is, for example, a non-degradable polymer material or a non-degradable metal material including an alloy. The polymer materials include, but are not limited to, polypropylene PP, polyethylene, polyisoprene, etc.; the metal materials include, but are not limited to, nitinol, platinum-tungsten alloy, titanium-nickel-copper alloy, titanium-nickel-iron alloy, titanium-nickel-chromium alloy, copper-nickel alloy, copper-aluminum alloy, copper-zinc alloy, etc. Among them, the purposes of setting the anti-unwinding member 3 include: one is to realize the anti-unwinding of the spring 2; the other is to keep the positions of the imaging markers 1 unchanged in the axial direction, so as to accurately locate and observe the specific position and three-dimensional shape of the coil during and after the implantation of the coil, and at the same time prevent the problem that the imaging markers 1 fall off from the coil after the biodegradable part of the spring 2 degrades, thereby avoiding the problem that the existing imaging markers are prone to falling off and even falling outside the aneurysm neck, resulting in distal vascular occlusion and even endangering life.

[0051] The smooth surface structure 4 can fix the two ends of the anti-unwinding component 3 and the two ends of the spring 2 together. The purposes of setting the smooth surface structure 4 include: First, to increase the smoothness of the two ends of the spring coil, so as to reduce the pushing resistance of the spring coil during the process of being pushed into the blood vessel, and to reduce the possible damage to the aneurysm wall during the process of packing the aneurysm with the spring coil; Second, after most or all of the spring 2 degrades, it remains effectively connected with the anti-unwinding component 3 and the imaging marker 1 to keep the position of the imaging marker 1 unchanged axially, so as to accurately position and observe the specific position and three-dimensional shape of the spring coil during and after the implantation of the spring coil, and prevent the risk of the imaging marker falling off from the spring coil after the degradable part of the spring 2 degrades. In this embodiment, the connection mode between the smooth surface structure 4 and the spring 2 is bonding, and the material of the smooth surface structure 4 is preferably a light-curing or naturally-curing viscous liquid. Thus, the smooth surface structure 4 can be formed and bonded to the spring 2 by means of the principle that the viscous liquid can be cured under light or a specific natural environment. Among them, the materials of the viscous liquid include but are not limited to epoxy resin glue, acrylated polyurethane, etc. Preferably, the outer diameter of the smooth surface structure 4 (i.e., the dimension in the direction y perpendicular to the length of the anti-unwinding component) is slightly larger than the inner diameter of the imaging marker 1, and the axial dimension of the smooth surface structure 4 (i.e., the dimension in the direction x along the length of the anti-unwinding component) is slightly larger than the axial dimension of the imaging marker 1. Furthermore, after the spring 2 is completely degraded, the anti-unwinding component 3 and the smooth surface structures 4 at both ends can effectively connect to the imaging marker 1, preventing the imaging marker 1 from shifting and falling out from both ends of the spring coil after the degradable part of the spring 2 degrades.

[0052] In summary, the medical coil of this embodiment includes a spring and at least one radiopaque marker. The radiopaque marker is sleeved outside the spring. Thus, on the one hand, the specific position and shape of the medical coil can be observed during or after implantation with the help of these radiopaque markers, effectively solving the problem of poor radiopacity performance of the existing coils. On the other hand, since the radiopaque marker is sleeved outside the spring, the setting of the radiopaque marker will not affect the physical properties such as the three-dimensional structure and stiffness of the spring itself, effectively realizing the embolization treatment of intracranial aneurysms. In addition, the medical coil of this embodiment has both degradability and radiopacity due to at least partial degradability of the spring and the setting of at least one radiopaque marker. After the coil is implanted into the blood vessel, it can safely and effectively embolize the intracranial aneurysm, cause fibrosis of the thrombus in the aneurysm, and as the degradable material of the spring is absorbed and / or degraded, the fibrous tissue in the tumor continuously shrinks, causing the aneurysm to continuously shrink, thereby greatly reducing or even eliminating the mass effect of the coil, and at the same time avoiding the safety problems existing after the implantation of the metal coil. In addition, at least two of the radiopaque markers are arranged at intervals along the axial direction of the spring. Each radiopaque marker is sleeved outside the spring, which will not affect the structure of the spring itself, and the radiopaque marker can be effectively fixed on the spring by an interference mechanical connection method, and can remain stable during the process of pushing the coil into the blood vessel without sliding. At the same time, the radiopacity performance of the radiopaque marker is used to accurately position and release the degradable coil to ensure that the coil can be accurately implanted into the lesion position, and during the long-term implantation after the operation, the non-degradable parts such as the anti-unwinding component, smooth surface structure, and the remaining non-degradable material of the spring in the coil can be followed up and checked through the radiopaque marker to ensure whether they are displaced or dropped, ensuring the safety and stability of the long-term implantation of the coil. Further, the smooth surface structure can fix the anti-unwinding component to both ends of the spring, thereby increasing the smoothness of both ends of the coil, reducing the pushing resistance of the coil during the process of pushing the coil into the blood vessel and reducing the possible damage to the aneurysm wall when the coil fills the aneurysm, and after most or all of the spring is degraded, the smooth surface structure and the anti-unwinding component can maintain an effective connection with the radiopaque marker, thereby preventing the radiopaque marker from falling off and shifting after the degradable material of the spring is degraded.

[0053] Embodiment 2

[0054] Please refer to Figure 2, this embodiment provides a medical coil, which includes a spring 2, at least one radiopaque marker 1, at least one anti-uncoiling component 3, and two smooth surface structures 4. The main difference between the degradable coil of this embodiment and the medical coil of Embodiment 1 is that each radiopaque marker 1 is sleeved inside the spring 2 (which can be called the inner cavity). Since the radiopaque marker 1 is embedded inside the spring 2, and the outer diameter of the spring 2 needs to be determined according to the size of the aneurysm to be implanted, therefore, the outer diameter of the radiopaque marker 1 needs to be determined according to the inner diameter of the spring 2, and at the same time, it also needs to meet the conditions of not affecting the imaging effect of the degradable coil under X-ray and the softness of the coil. Thus, the outer diameter range of the radiopaque marker 1 in this embodiment is between 0.002 inches and 0.010 inches, and the preferred size is 0.004 inches to 0.0065 inches.

[0055] In this embodiment, each radiopaque marker 1 is sleeved inside the spring 2, and the following three schemes can be specifically adopted:

[0056] 1) Each radiopaque marker 1 is embedded on the inner wall of the spring 2 by an interference mechanical connection method. In this case, the anti-uncoiling component 3 passes through the inside of each radiopaque marker 1. However, each radiopaque marker 1 may or may not be in contact with the anti-uncoiling component 3, or some of the radiopaque markers 1 are in contact with the anti-uncoiling component 3, while some are not.

[0057] 2) Each radiopaque marker 1 has a smaller hole in the center for the anti-uncoiling component 4 to pass through. The anti-uncoiling component 3 forms a knot at both ends of each radiopaque marker 1, and the outer diameter of this knot is larger than the inner diameter of the hole in the center of the radiopaque marker 1. In this case, the anti-uncoiling component 3 passes through the inside of each radiopaque marker 1, but each radiopaque marker 1 may or may not be connected to the spring 2.

[0058] 3) Each radiopaque marker 1 has a smaller hole in the center for the anti-uncoiling component 3 to pass through, and the position where the anti-uncoiling component 3 contacts the radiopaque marker 1 is fixed together by an adhesive. In this case, the anti-uncoiling component 3 passes through the inside of each radiopaque marker 1, and each radiopaque marker 1 may or may not be connected to the spring 2.

[0059] The material selection of each component of the medical coil in this embodiment and the design of the remaining dimensions are the same as those of the medical coil in Embodiment 1, and will not be elaborated here.

[0060] The medical spring coil of this embodiment has a smoother outer surface than the medical spring coil of the first embodiment, which is beneficial to reducing the pushing resistance of the medical spring coil in the process of pushing it into the human blood vessel and avoiding tissue damage. More importantly, since each developing mark is sleeved inside the spring, it can prevent the developing mark in the spring from sliding or even falling off due to environmental factors such as external resistance, thereby enhancing the structural stability of the developing mark in the process of pushing the medical spring coil into the human blood vessel.

[0061] In addition, in the medical spring coil of the present embodiment, at least two developing marks 1 can be set, and these developing marks 1 are arranged at intervals along the axial direction of the spring 2, and can be arranged at equal intervals or at unequal intervals, and these developing marks 1 are all arranged inside the degradable spring 2, so that the medical spring coil of the present embodiment has a better developing effect than the spring coil in which the existing developing wire material and the degradable material are wound or the two materials are integrally formed, so that less developing material can be used while obtaining the same developing effect, and the volume percentage of the bioabsorbable and / or degradable material in the entire spring coil can be higher, so that the spring coil has the characteristics of a short degradation cycle and a high degradation ratio, which brings more significant and thorough effects on solving the space occupancy effect and long-term safety problems.

[0062] Embodiment 3

[0063] Please refer to Figure 3 The present embodiment provides a medical spring coil, comprising a spring 2, at least one developing mark 1, at least one anti-unwinding component 3 and two smooth curved surface structures 4. The main difference between the medical spring coil of the present embodiment and the medical spring coil of the first embodiment is that the developing mark 1 is divided into two types, one developing mark 1a is embedded in the spring 2, and the other developing mark 1b is sleeved on the outside of the spring 2, and the anti-unwinding component 3 is penetrated inside each developing mark 1a of the spring 2. Since the development mark 1b is sleeved on the outside of the spring 2, and the development mark 1a is embedded in the spring 2, the outer diameter of the development mark 1b needs to be determined according to the size of the aneurysm to be implanted, and the outer diameter of the development mark 1a needs to be determined according to the inner diameter of the spring 2. At the same time, the arrangement of the development marks 1a and 1b also needs to meet the conditions of not affecting the development effect of the medical spring coil under X-rays and the softness of the medical spring coil. Therefore, in this embodiment, the outer diameter of each development mark 1a ranges from 0.002 inches to 0.010 inches, and the preferred size is 0.004 inches to 0.0065 inches. The outer diameter of each development mark 1b ranges from 0.010 inches to 0.0165 inches, and the preferred size is 0.0135 inches to 0.0145 inches.

[0064] In this embodiment, each developing marker 1a is sleeved inside the spring 2, and the following three solutions can be specifically adopted:

[0065] 1) Each developing marker 1a is embedded on the inner wall of the spring 2 by an interference mechanical connection method. In this case, the anti-unwinding member 3 passes through the inside of each developing marker 1a. However, each developing marker 1a may not be in contact with the anti-unwinding member 3, may all be in contact, or some of the developing markers 1a are in contact with the anti-unwinding member 3 while the others are not.

[0066] 2) Each developing marker 1a has a smaller hole in the center for the anti-unwinding member 4 to pass through. The anti-unwinding member 3 forms a knot at both ends of each developing marker 1a, and the outer diameter of this knot is greater than the inner diameter of the hole in the center of the developing marker 1. In this case, the anti-unwinding member 3 passes through the inside of each developing marker 1a, but each developing marker 1a may or may not be connected to the spring 2.

[0067] 3) Each developing marker 1a has a smaller hole in the center for the anti-unwinding member 3 to pass through, and the position where the anti-unwinding member 3 contacts the developing marker 1a is fixed together by adhesive bonding. In this case, the anti-unwinding member 3 passes through the inside of each developing marker 1a, and each developing marker 1a may or may not be connected to the spring 2.

[0068] The material selection of each component of the medical coil in this embodiment and the design of the remaining dimensions are the same as those of the medical coil in Embodiment 1, and will not be elaborated here.

[0069] In addition, in the medical coil of this embodiment, the developing markers 1b sleeved outside the spring 2 and the developing markers 1a nested inside the spring 2 are arranged alternately along the axial direction of the spring 2, and there is a gap between the corresponding two developing markers 1. This gap can be uniform or non-uniform.

[0070] For the medical coil of this embodiment, compared with the medical coil of Embodiment 1, since the developing markers include the developing markers embedded inside the spring and the developing markers sleeved outside the spring, the structural stability of the medical coil can be enhanced by using the developing markers embedded inside the spring and the anti-unwinding members. During the process of pushing the medical coil into the human blood vessel, each developing marker can be made more stable and will not slide.

[0071] It should be noted that although in the medical coils in the above various embodiments, a smooth curved surface structure is used as a connecting member to connect the two ends of the anti-rotation member to the two ends of the spring, the technical solution of the present invention is not limited thereto. In other embodiments of the present invention, the smooth curved surface structure can be replaced with other connecting members having non-smooth curved surfaces, such as polyhedron-shaped connecting members, etc.

[0072] In addition, although in the medical coils in the above various embodiments, an anti-rotation member is provided, and by connecting the non-degradable anti-rotation member and the smooth curved surface structures at both ends, the problem that the imaging marker falls off the coil after the spring degrades is avoided, the technical solution of the present invention is not limited thereto. In other embodiments of the present invention, any suitable method and structure can be adopted to ensure that the provided imaging structure is not only located at both ends of the coil, but also can be located on the middle section between the two ends of the coil, and the imaging marker does not fall off the coil after the spring degrades. For example, in another embodiment, the medical coil omits the anti-rotation member, and its spring is a structure in which two spring bodies are nested together, and the two ends of these two spring bodies are respectively connected together, and the inner spring body is non-degradable, and the outer spring body is at least partially degradable. In this case, the non-degradable inner spring body can be used to keep the imaging marker unchanged in the axial position, so as to accurately position and observe the shape of the coil during and after implantation, and at the same time prevent the imaging marker from falling off the coil after the spring degrades or even falling outside the aneurysm neck, resulting in distal vascular occlusion and even life-threatening problems. At the same time, the degradability of the outer spring is used to reduce the overall occupancy effect of the coil.

[0073] Obviously, those skilled in the art can make various changes and modifications to the invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention also intends to include these changes and modifications.

Claims

1. A medical coil, characterized in that, It includes a spring, at least one anti-unwinding component, and at least two developing markers spaced axially along the spring. At least one of the developing markers is sleeved outside the spring, and at least another developing marker is arranged inside the spring. The anti-unwinding component passes through the inside of the spring and is respectively connected to both ends of the spring at both ends to achieve anti-unwinding of the spring; and the anti-unwinding component further passes through the inside of each developing marker arranged inside the spring; wherein, the anti-unwinding component is bonded to each developing marker arranged inside the spring by an adhesive; or the anti-unwinding component forms knots at both ends of each developing marker arranged inside the spring, and the outer diameter of the knot is greater than the inner diameter of each developing marker arranged inside the spring; or each developing marker arranged inside the spring is embedded on the inner wall of the spring by an interference mechanical connection method, and at least part of the developing markers arranged inside the spring is in contact with the anti-unwinding component; the anti-unwinding component is also used to keep the position of the developing markers arranged inside the spring unchanged axially, and prevent the developing markers arranged inside the spring from falling off the spring after the degradable part of the spring degrades.

2. The medical coil according to claim 1, wherein, At least part of the material of the spring is a biodegradable material.

3. The medical coil according to claim 2, wherein The percentage of the volume of the biodegradable material in the volume of the spring coil is 70% - 95%.

4. The medical coil according to claim 2, wherein The biodegradable material includes at least one of polylactic acid, polyglycolic acid, polyurethane, and poly(lactic acid - glycolic acid) copolymer.

5. The medical coil according to claim 1 or 2, characterized in that, At least one of the developing markers is sleeved on the outer wall of the spring by an interference mechanical connection method.

6. The medical coil according to claim 1 or 2, characterized in that, The number of the developing markers is more than two, and the range of the distance between adjacent two developing markers is 3 mm - 30 mm.

7. The medical coil according to claim 1 or 2, characterized in that, The range of the dimension of the developing marker extending along the axial direction of the spring coil is 0.005 inches - 0.025 inches.

8. The medical coil according to claim 1 or 2, characterized in that, The range of the outer diameter of the developing marker sleeved outside the spring is 0.010 inches - 0.0165 inches.

9. The medical coil according to claim 1 or 2, characterized in that, The range of the outer diameter of the developing marker arranged inside the spring is between 0.002 inches - 0.010 inches.

10. The medical coil according to claim 1 or 2, characterized in that, The developing marker is in a ring-shaped, tubular or spring-shaped structure.

11. The medical coil according to claim 1 or 2, characterized in that, The material of the developing marker is one or a combination of stainless steel, platinum, gold, rhodium, rhenium, palladium, iridium, and tungsten.

12. The medical coil according to claim 1, wherein The material of the anti-unwinding component is a non-degradable polymer material or a non-degradable metal material.

13. The medical coil according to claim 12, wherein, The polymer material includes at least one of polypropylene, polyethylene, and polyisoprene; the metal material includes at least one of nickel-titanium alloy, platinum-tungsten alloy, titanium-nickel-copper alloy, titanium-nickel-iron alloy, titanium-nickel-chromium alloy, copper-nickel alloy, copper-aluminum alloy, and copper-zinc alloy.

14. The medical coil as claimed in claim 1, wherein, It also includes connectors arranged at both ends of the spring, and the connectors connect the two ends of the anti-unwinding component with the two ends of the spring respectively.

15. The medical coil according to claim 14, wherein, The connector is in a smooth curved surface structure.

16. The medical coil according to claim 15, wherein, The material of the connecting member is a light-curing or naturally-curing viscous liquid, and the viscous liquid can be cured under light or natural environmental conditions to form the smooth curved surface structure.

17. The medical coil according to claim 16, wherein, The viscous liquid includes at least one of epoxy resin glue or acrylated polyurethane.

18. The medical coil according to claim 14, wherein The connection method between the connecting member and the spring and / or the anti-unwinding member is bonding.

19. The medical coil according to claim 14, wherein, The outer diameter of the connecting member is greater than the inner diameter of the developing mark.

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