CN110141294A - medical coil - Google Patents
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- CN110141294A CN110141294A CN201910578891.1A CN201910578891A CN110141294A CN 110141294 A CN110141294 A CN 110141294A CN 201910578891 A CN201910578891 A CN 201910578891A CN 110141294 A CN110141294 A CN 110141294A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00778—Operations on blood vessels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00831—Material properties
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- A61B2017/00915—Material properties transparent or translucent for radioactive radiation
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Abstract
本发明提供一种医用弹簧圈,其包括弹簧和至少一个显影标记,所述显影标记套设在所述弹簧的外部和/或设置于所述弹簧的内部,由此,一方面,能够借助这些显影标记在植入过程中或植入后观察医用弹簧圈的具体位置和形态,有效解决了现有的弹簧圈显影性能不佳的问题;另一方面,由于显影标记套设在弹簧的外部和/或内部,因此,显影标记的设置不会影响弹簧本身的三维结构和刚度等物理性能,有效地实现颅内动脉瘤的栓塞治疗。
The present invention provides a medical coil, which includes a spring and at least one developing mark, and the developing mark is sleeved on the outside of the spring and/or arranged inside the spring, thus, on the one hand, it is possible to use these The specific position and shape of the medical coil can be observed during or after implantation of the developing mark, which effectively solves the problem of poor developing performance of the existing coil; on the other hand, since the developing mark is sleeved on the outside of the spring and Therefore, the setting of the developing marker will not affect the physical properties such as the three-dimensional structure and stiffness of the spring itself, and effectively realize the embolization treatment of intracranial aneurysms.
Description
技术领域technical field
本发明涉及医疗器械技术领域,尤其涉及一种医用弹簧圈。The invention relates to the technical field of medical instruments, in particular to a medical spring coil.
背景技术Background technique
颅内动脉瘤破裂出血具有极高的致残率和致死率。随着医疗技术提升、器械材料发展及神经介入医师经验积累,血管内治疗已成为降低破裂颅内动脉瘤再出血率和死亡率的首选治疗方法。在众多治疗方法中,应用最为广泛的是动脉瘤栓塞治疗,包括栓塞弹簧圈、液体栓塞剂、瘤腔内栓塞装置、球囊/支架辅助技术等。这其中,栓塞弹簧圈因其操作便捷、植入稳定、安全有效等优点,受到临床医生及科研人员越来越多的重视,逐渐成为临床治疗颅内动脉瘤的主流手段。Ruptured intracranial aneurysms have high morbidity and mortality. With the improvement of medical technology, the development of device materials and the accumulation of experience of neurointerventional physicians, endovascular therapy has become the preferred treatment method to reduce the rebleeding rate and mortality of ruptured intracranial aneurysms. Among the many treatment methods, aneurysm embolization is the most widely used, including embolic coils, liquid embolic agents, intratumoral embolization devices, and balloon/stent-assisted techniques. Among them, embolic coils have attracted more and more attention from clinicians and researchers due to their advantages of convenient operation, stable implantation, safety and effectiveness, and have gradually become the mainstream method for clinical treatment of intracranial aneurysms.
目前临床上使用的弹簧圈按材料与结构设计可分为金属裸弹簧圈(包括二维圈、三维成篮圈)与表面修饰弹簧圈。金属裸弹簧圈是目前使用最为广泛的弹簧圈,其对颅内破裂动脉瘤安全有效,可降低早期再出血率和远期致死率。典型的金属裸弹簧圈使用铂钨合金等金属材料制备,具有良好的生物兼容性,也具有较好的显影效果。表面修饰弹簧圈有水凝胶弹簧圈、生物活性涂层弹簧圈及带纤毛弹簧圈,这类弹簧圈通过对金属裸弹簧圈进行表面修饰处理,在临床上与单纯金属裸弹簧圈相比,表现出更好的瘤腔填塞率,更短的动脉瘤致栓及瘤颈内皮化周期,及更低的中远期复发率与再出血率。然而,颅内动脉瘤患者常表现为头疼、眼球运动障碍、肢体肿胀等,这是由于动脉瘤的占位效应,导致瘤体压迫周围神经、静脉及器官等产生的相应症状。目前临床上使用的弹簧圈(包括金属裸弹簧圈与表面修饰弹簧圈)均不具有可降解性,填塞后虽可以导致瘤内血栓及机化,但瘤体会保持固有大小,会持续对瘤外神经、血管及器官产生压迫,占位效应导致的临床症状无法消除。此外,金属裸弹簧圈与表面修饰弹簧圈的主体都为金属结构,在体内无法降解,因此其体内长期植入安全性与稳定性仍待考察。According to the material and structural design, the coils currently used clinically can be divided into bare metal coils (including two-dimensional coils and three-dimensional basket coils) and surface-modified coils. Bare metal coils are currently the most widely used coils, which are safe and effective for intracranial ruptured aneurysms, and can reduce early rebleeding rates and long-term mortality. Typical bare metal coils are made of platinum-tungsten alloy and other metal materials, which have good biocompatibility and good imaging effect. Surface-modified coils include hydrogel coils, bioactive coated coils and ciliated coils. This type of coils is clinically compared with bare metal coils by surface modification of bare metal coils. It showed better aneurysm cavity filling rate, shorter aneurysm thrombosis and aneurysm neck endothelialization cycle, and lower medium and long-term recurrence rate and rebleeding rate. However, patients with intracranial aneurysms often present with headaches, eye movement disorders, and limb swelling. The coils currently used clinically (including bare metal coils and surface-modified coils) are not degradable. Although they can lead to intratumoral thrombus and organization after packing, the tumor body maintains its inherent size and will continue to treat the tumor outside the tumor. Nerves, blood vessels and organs are compressed, and clinical symptoms caused by mass effect cannot be eliminated. In addition, the main bodies of bare metal coils and surface-modified coils are all metal structures, which cannot be degraded in vivo, so the safety and stability of long-term implantation in vivo remains to be investigated.
目前有专利提到可吸收(或可降解)弹簧圈,所用的制备材料有PLGA、PGA、镁合金等。但是这些材料在X射线下都无法显影,因此在设计可降解弹簧圈时,需要在弹簧上设计添加显影构件,以赋予可降解弹簧圈显影性。例如,将显影环粘接在可降解线圈的两端,或者将显影丝材制作的线圈与可降解金属丝材的线圈缠绕在一起,又或者由可降解材料与显影材料处理形成一体结构后绕制成三维弹簧等,以赋予弹簧圈显影性。但是,这几种弹簧圈在可吸收材料降解后,虽然体积有所减小,但依然保留了不可降解的三维结构,占位效应仍然存在。At present, there are patents mentioning absorbable (or degradable) spring coils, and the preparation materials used include PLGA, PGA, magnesium alloy, etc. However, none of these materials can be developed under X-rays. Therefore, when designing a degradable coil, it is necessary to design and add a developing component on the spring to endow the degradable coil with developing properties. For example, the developing ring is bonded to both ends of the degradable coil, or the coil made of developing wire and the coil of degradable metal wire are wound together, or the degradable material and the developing material are processed to form an integrated structure and then wound Make a three-dimensional spring, etc., to give the coil developability. However, although the volume of these spring coils has decreased after the degradation of the absorbable material, they still retain a non-degradable three-dimensional structure, and the occupying effect still exists.
除此之外,采用上述显影结构的可降解弹簧圈还存在一些缺陷:1)可降解或可吸收材料本身不具备显影性,因而目前可降解弹簧圈的显影效果较差,或者,而为了达到必要的显影效果,所采用的可降解或可吸收材料占整个弹簧圈的体积比受到限制,一般不高于60%,因此仍然存在明显的占位效应;2)当弹簧圈中的可降解材料或可吸收材料被降解或吸收后,显影结构可能从弹簧圈上脱落甚至掉落至动脉瘤颈外,导致远端血管堵塞乃至危及生命。In addition, there are still some defects in the degradable coils using the above-mentioned development structure: 1) The degradable or absorbable materials themselves do not have developability, so the development effect of the degradable coils is poor at present, or, in order to achieve Necessary development effect, the volume ratio of the degradable or absorbable material used in the entire coil is limited, generally not higher than 60%, so there is still an obvious occupying effect; 2) When the degradable material in the coil Or after the absorbable material is degraded or absorbed, the imaging structure may fall off from the coil or even fall out of the neck of the aneurysm, resulting in distal vascular blockage and even life-threatening.
因此,需要改进现有的医用弹簧圈以解决上述问题。Therefore, it is necessary to improve the existing medical coils to solve the above problems.
发明内容Contents of the invention
本发明的目的在于提供一种医用弹簧圈,能有效解决现有的弹簧圈显影性能不佳的问题。The purpose of the present invention is to provide a medical coil, which can effectively solve the problem of poor developing performance of the existing coil.
为了实现上述目的,本发明提供一种医用弹簧圈,包括弹簧和至少一个显影标记,所述显影标记套设在所述弹簧的外部和/或设置于所述弹簧的内部。In order to achieve the above object, the present invention provides a medical coil, which includes a spring and at least one developing mark, and the developing mark is sleeved on the outside of the spring and/or arranged inside the spring.
可选地,至少部分所述弹簧的材料为生物可降解材料或生物可吸收材料。Optionally, at least part of the material of the spring is a biodegradable material or a bioabsorbable material.
可选地,所述生物可降解材料或生物可吸收材料的体积占所述弹簧圈的体积的百分比为70%~95%。Optionally, the biodegradable material or bioabsorbable material accounts for 70%-95% of the volume of the coil.
可选地,所述生物可降解材料或生物可吸收材料包括聚乳酸、聚羟基乙酸、聚氨酯、聚乳酸-羟基乙酸共聚物中的至少一种。Optionally, the biodegradable or bioabsorbable material includes at least one of polylactic acid, polyglycolic acid, polyurethane, and polylactic acid-glycolic acid copolymer.
可选地,至少两个所述显影标记沿所述弹簧的轴向间隔设置。Optionally, at least two of the developing marks are arranged at intervals along the axial direction of the spring.
可选地,所述显影标记通过过盈机械连接方式套设到所述弹簧的外壁上或嵌于所述弹簧的内壁上。Optionally, the developing mark is sleeved on the outer wall of the spring or embedded in the inner wall of the spring through an interference mechanical connection.
可选地,所述的弹簧圈还包括至少一个抗解旋部件,所述抗解旋部件穿设于所述弹簧的内部,且所述抗解旋部件的两端分别与所述弹簧的两端连接。Optionally, the spring coil further includes at least one anti-unrotation component, the anti-unrotation component is passed through the inside of the spring, and the two ends of the anti-unrotation component are respectively connected to the two ends of the spring. end connection.
可选地,所述显影标记设置于所述弹簧的内部,所述抗解旋部件穿设于所述显影标记的内部;所述抗解旋部件与所述显影标记通过胶黏剂粘接,或者,所述抗解旋部件在所述显影标记的两端分别形成结扣,且所述结扣的外径大于所述显影标记的内径。Optionally, the developing mark is arranged inside the spring, and the anti-unrotation component is penetrated inside the developing mark; the anti-unrotating component and the developing mark are bonded by an adhesive, Alternatively, the anti-untwisting component forms knots at both ends of the developing mark, and the outer diameter of the knot is larger than the inner diameter of the developing mark.
可选地,所述显影标记的数量为两个以上,相邻两个所述显影标记之间的间距的范围为3毫米~30毫米。Optionally, the number of the developed marks is more than two, and the distance between two adjacent developed marks ranges from 3 mm to 30 mm.
可选地,所述显影标记的数量为两个以上,至少一个所述显影标记位于所述弹簧的外部,且至少一个所述显影标记设置于所述弹簧的内部。Optionally, the number of the developing marks is more than two, at least one of the developing marks is located outside the spring, and at least one of the developing marks is arranged inside the spring.
可选地,所述显影标记沿所述弹簧圈的轴向延伸的尺寸的范围为0.005英寸~0.025英寸。Optionally, the size of the developing mark extending along the axial direction of the spring coil is in the range of 0.005 inches to 0.025 inches.
可选地,套设在所述弹簧的外部的所述显影标记的外径的范围为0.010英寸~0.0165英寸。Optionally, the outer diameter of the visible marker sleeved on the outside of the spring ranges from 0.010 inch to 0.0165 inch.
可选地,设置于所述弹簧内部的所述显影标记的外径的范围为0.002英寸~0.010英寸之间。Optionally, the outer diameter of the visible mark disposed inside the spring is in a range of 0.002 inches to 0.010 inches.
可选地,所述显影标记为环状、管状或弹簧状的结构。Optionally, the developing mark is a ring-shaped, tubular or spring-shaped structure.
可选地,所述显影标记的材料为不锈钢、铂、金、铑、铼、钯、铱和钨中的一种或多种组合。Optionally, the material of the developing mark is one or more combinations of stainless steel, platinum, gold, rhodium, rhenium, palladium, iridium and tungsten.
可选地,所述抗解旋部件的材料为不可降解的聚合物材料或不可降解的金属材料。Optionally, the material of the anti-unrotation component is a non-degradable polymer material or a non-degradable metal material.
可选地,所述聚合物材料包括聚丙烯、聚乙烯和聚异戊二烯中的至少一种;所述金属材料包括镍钛合金、铂钨合金、钛镍铜合金、钛镍铁合金、钛镍铬合金、铜镍合金、铜铝合金和铜锌合金中的至少一种。Optionally, the polymer material includes at least one of polypropylene, polyethylene, and polyisoprene; the metal material includes nickel-titanium alloy, platinum-tungsten alloy, titanium-nickel-copper alloy, titanium-nickel-iron alloy, titanium At least one of nickel-chromium alloy, copper-nickel alloy, copper-aluminum alloy and copper-zinc alloy.
可选地,所述的弹簧圈还包括设置在所述弹簧的两端的连接件,所述连接件将所述抗解旋部件的两端与所述弹簧的两端分别连接在一起。Optionally, the spring coil further includes connecting pieces arranged at both ends of the spring, and the connecting pieces respectively connect the two ends of the anti-unrotation component and the two ends of the spring together.
可选地,所述连接件为光滑曲面结构。Optionally, the connecting piece is a smooth curved structure.
可选地,所述连接件的材料为光固化或自然固化的粘性液体,所述粘性液体能在光照或自然环境条件下固化而形成所述光滑曲面结构。Optionally, the material of the connector is a light-cured or naturally cured viscous liquid, and the viscous liquid can be cured under light or natural environmental conditions to form the smooth curved surface structure.
可选地,所述粘性液体包括环氧树脂胶或丙烯酸化聚氨酯中的至少一种。Optionally, the viscous liquid includes at least one of epoxy glue or acrylated polyurethane.
可选地,所述连接件与所述弹簧和/或所述抗解旋部件的连接方式为粘接。Optionally, the connecting member is connected to the spring and/or the anti-unrotation component by bonding.
可选地,所述连接件的外径大于所述显影标记的内径。Optionally, the outer diameter of the connector is larger than the inner diameter of the visible mark.
与现有技术相比,本发明的医用弹簧圈,具有以下有益效果:Compared with the prior art, the medical coil of the present invention has the following beneficial effects:
1、本发明的医用弹簧圈,包括弹簧和至少一个显影标记,所述显影标记套设在所述弹簧的外部和/或设置于所述弹簧的内部,由此,一方面,能够借助这些显影标记在植入过程中或植入后观察医用弹簧圈的具体位置和形态,有效解决了现有的弹簧圈显影性能不佳的问题;另一方面,由于显影标记套设在弹簧的外部和/或内部,因此,显影标记的设置不会影响弹簧本身的三维结构和刚度等物理性能,有效地实现颅内动脉瘤的栓塞治疗。1. The medical coil of the present invention comprises a spring and at least one developing mark, and the developing mark is sleeved on the outside of the spring and/or arranged inside the spring, thus, on the one hand, it is possible to use these developing marks to Marking observes the specific position and shape of the medical coil during or after implantation, effectively solving the problem of poor developing performance of the existing coil; on the other hand, since the developing marker is sleeved on the outside of the spring and/or Or internally, therefore, the setting of the developing 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.
2、进一步地,本发明的医用弹簧圈中的至少部分弹簧由生物可吸收和/或可降解材料制成,因而同时具备可降解性和显影性,一方面,在弹簧圈植入血管后可安全有效地栓塞颅内动脉瘤,使动脉瘤内血栓迅速纤维化,随着弹簧的可降解材料的被吸收和/或降解,瘤内纤维组织不断收缩,使动脉瘤不断缩小,从而可以极大程度上减小弹簧圈的占位效应,同时能避免金属圈植入后存在的长期安全性问题;另一方面,在弹簧圈降解或吸收之后,包括显影标记在内的剩余不可降解部分不再维持弹簧圈原有的三维结构,基本可以完全消除弹簧圈在动脉瘤中的长期占位效应,因此能同时有效解决占位效应的问题和对显影性能的需求。2. Furthermore, at least part of the springs in the medical coil of the present invention are made of bioabsorbable and/or degradable materials, so they have both degradability and imaging properties. On the one hand, after the coil is implanted in a blood vessel, it can Safe and effective embolization of intracranial aneurysm, rapid fibrosis of the thrombus in the aneurysm, as the degradable material of the spring is absorbed and/or degraded, the fibrous tissue in the aneurysm shrinks continuously, and the aneurysm shrinks continuously, so that the aneurysm can be greatly improved It can reduce the occupying effect of the spring coil to a certain extent, and at the same time avoid the long-term safety problems after the metal ring is implanted; Maintaining the original three-dimensional structure of the coil can basically completely eliminate the long-term occupying effect of the coil in the aneurysm, so it can effectively solve the problem of occupying effect and the demand for imaging performance at the same time.
3、进一步地,本发明的医用弹簧圈中,至少两个所述显影标记沿所述弹簧的轴向间隔设置,且这些显影标记间隔地套设在可降解弹簧的外部和/或设置在可降解弹簧的内部,这种显影标记和可降解的弹簧的配合设置方式,与现有的显影丝材与可降解材料缠绕或者两种材料一体成型的弹簧圈相比,显影效果更好,因而能够在获得同等显影效果的前提下,使用更少的显影材料,可以使得生物可吸收和/或可降解材料占整个弹簧圈的体积百分比更高,进而使得弹簧圈具有降解周期短、降级比例高的特点,对于解决占位效应和长期安全性问题带来更显著、更彻底的效果。3. Further, in the medical coil of the present invention, at least two of the developing marks are arranged at intervals along the axial direction of the spring, and these developing marks are sleeved on the outside of the degradable spring at intervals and/or arranged on a degradable spring. The inside of the degradable spring, the cooperating arrangement of the development mark and the degradable spring, compared with the existing development wire material and the degradable material winding or the spring coil formed by the two materials, the development effect is better, so it can Under the premise of obtaining the same developing effect, using less developing material can make the bioabsorbable and/or degradable material account for a higher volume percentage of the entire coil, which in turn makes the coil have a short degradation cycle and a high degradation ratio. Features, which bring more significant and thorough effects to solve the mass effect and long-term security problems.
4、进一步地,本发明的医用弹簧圈中,显影标记通过过盈机械连接方式套设在所述弹簧的外部和/或设置于所述弹簧的内部,即显影标记能被有效地固定在弹簧上,并且在医用弹簧圈被推送入血管内的过程中可以保持稳定,不会滑动,继而同时利用显影标记的显影性能来准确地定位和释放弹簧圈,以保证弹簧圈能准确地植入到病变位置。4. Further, in the medical coil of the present invention, the developing mark is sleeved on the outside of the spring and/or arranged inside the spring through an interference mechanical connection, that is, the developing mark can be effectively fixed on the spring On, and in the process of the medical coil being pushed into the blood vessel, it can keep stable without slipping, and then at the same time use the developing performance of the developing mark to accurately position and release the coil, so as to ensure that the coil can be accurately implanted into the blood vessel lesion location.
5、进一步地,本发明的医用弹簧圈还包括抗解旋部件,所述抗解旋部件穿设于所述显影标记的内部,或者,通过相应的方式与显影标记连接,由此,可以通过抗解旋部件来保持显影标记在轴向上的位置不变,以便在植入过程中和植入后准确定位和观察弹簧圈的具体位置和三维形态,同时也能够防止显影标记在弹簧降解后从弹簧圈上脱落,由此避免现有的显影标记容易脱落甚至掉落至动脉瘤颈外而导致远端血管堵塞乃至危及生命的问题。5. Further, the medical coil of the present invention also includes an anti-untwisting component, the anti-untwisting component is passed through the inside of the developing mark, or is connected with the developing mark in a corresponding way, thus, it can be passed through Anti-untwisting parts to keep the position of the visualization mark 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 implantation, and also prevent the visualization mark from degrading after the spring It falls off from the coil, thereby avoiding the problem that the existing developed markers are easy to fall off or even fall outside the neck of the aneurysm, resulting in blockage of distal blood vessels and even life-threatening problems.
6、进一步地,本发明的医用弹簧圈,包括设置在弹簧两端的光滑曲面结构,该光滑曲面结构能将抗解旋部件与弹簧的两端固定在一起,由此能够增加弹簧圈两端的光滑度,以在弹簧圈被推送入血管内的过程中减小弹簧圈推送阻力以及减少弹簧圈在填塞瘤内时对瘤壁可能产生的损伤,且在弹簧大部分降解或完全降解后,光滑曲面结构和抗解旋部件可以与显影标记保持有效的连接,以进一步防止显影标记在弹簧降解后从弹簧圈上脱落的风险。6. Further, the medical spring coil of the present invention includes a smooth curved surface structure arranged at both ends of the spring, and the smooth curved surface structure can fix the anti-unrotation component and the two ends of the spring together, thereby increasing the smoothness of the two ends of the spring coil. In order to reduce the coil push resistance and reduce the possible damage to the tumor wall when the coil is pushed into the blood vessel when the coil is pushed into the blood vessel, and after the spring is mostly degraded or completely degraded, the smooth surface The structure and the anti-untwisting member may remain operatively connected to the developer marker to further prevent the risk of the developer marker falling off the coil after the spring degrades.
附图说明Description of drawings
图1是本发明实施例一的医用弹簧圈的剖面结构示意图。Fig. 1 is a schematic cross-sectional structure diagram of a medical coil according to Embodiment 1 of the present invention.
图2是本发明实施例二的医用弹簧圈的剖面结构示意图。Fig. 2 is a schematic cross-sectional structure diagram of the medical coil according to the second embodiment of the present invention.
图3是本发明实施例三的医用弹簧圈的剖面结构示意图。Fig. 3 is a schematic cross-sectional structure diagram of the medical coil according to the third embodiment of the present invention.
其中的附图标记如下:Wherein the reference signs are as follows:
1-显影标记;2-弹簧;3-抗解旋部件;4-光滑曲面结构;L1-显影标记的线宽;L2-相邻两个显影标记之间的间距。1-developed mark; 2-spring; 3-anti-untwisting component; 4-smooth surface structure; L1-line width of developed mark; L2-space between two adjacent developed marks.
具体实施方式Detailed ways
为使本发明的目的、特征更明显易懂,下面结合附图对本发明的技术方案作详细的说明,然而,本发明可以用不同的形式实现,不应只是局限在所述的实施例。此外,本文中的用语“和/或”表示二选一和二者兼具的情况;术语“连接”包括直接连接和间接连接。In order to make the purpose and features of the present invention more obvious and understandable, the technical solutions of the present invention will be described in detail below in conjunction with the accompanying drawings. However, the present invention can be implemented in different forms and should not be limited to the described embodiments. In addition, the term "and/or" in this article means an alternative or both; the term "connection" includes direct connection and indirect connection.
实施例一Embodiment one
请参考图1,本实施例提供一种医用弹簧圈,包括弹簧2、至少一个显影标记1、至少一个抗解旋部件3和两个光滑曲面结构4。Please refer to FIG. 1 , this embodiment provides a medical coil, including a spring 2 , at least one developing mark 1 , at least one anti-unrotation component 3 and two smooth curved surface structures 4 .
弹簧2为所述医用弹簧圈的主体结构,其可以是由相应的丝线在芯棒上绕制而成的形状均一的弹簧结构,整体上呈现为具有空腔的管状结构,以使得本实施例的医用弹簧圈形成栓塞弹簧圈。至少部分弹簧2的材料为生物可降解材料或生物可吸收材料,该生物可降解材料或生物可吸收材料的体积占医用弹簧圈的整个体积的百分比为70%~95%,由此使得本实施例的医用弹簧圈同时具备可降解性和显影性,一方面,在弹簧圈植入血管后可安全有效地栓塞颅内动脉瘤,使动脉瘤内血栓迅速纤维化,随着弹簧的可降解材料的被吸收和/或降解,瘤内纤维组织不断收缩,使动脉瘤不断缩小,从而可以极大程度上减小弹簧圈的占位效应,同时能避免金属圈植入后存在的长期安全性问题;另一方面,在弹簧圈降解或吸收之后,包括显影标记在内的剩余不可降解部分不再维持弹簧圈原有的三维结构,基本可以完全消除弹簧圈在动脉瘤中的长期占位效应,因此能同时有效解决占位效应的问题和对显影性能的需求。其中,所述生物可吸收/生物可降解材料包括但聚乳酸(PLA)、聚羟基乙酸(PGA)、聚氨酯(PU)、聚乳酸-羟基乙酸共聚物(PLGA/PGLA)中的至少一种。其中优选的是PLA、PGA、PGLA,使得医用弹簧圈的可降解/吸收的部分具有降解周期短、降解比例高的特点,利于在相对较短的时间内减小甚至是消除占位效应。The spring 2 is the main structure of the medical spring coil, which can be a spring structure with uniform shape formed by winding corresponding wires on the mandrel, and generally presents a tubular structure with a cavity, so that the present embodiment Medical coils form embolic coils. The material of at least part of the spring 2 is a biodegradable material or a bioabsorbable material, and the volume of the biodegradable material or bioabsorbable material accounts for 70% to 95% of the entire volume of the medical coil, thus making this implementation The medical coil of this example has both degradability and imaging properties. On the one hand, after the coil is implanted into the blood vessel, it can safely and effectively embolize the intracranial aneurysm, causing rapid fibrosis of the thrombus in the aneurysm. With the degradable material of the spring The fibrous tissue in the tumor shrinks continuously, making the aneurysm shrink continuously, which can greatly reduce the space occupation effect of the coil, and at the same time avoid the long-term safety problems after the implantation of the metal coil On the other hand, after the coil is degraded or absorbed, the remaining non-degradable part including the development mark no longer maintains the original three-dimensional structure of the coil, which can basically completely eliminate the long-term occupying effect of the coil in the aneurysm, Therefore, the problem of space occupation effect and the demand for developing performance can be effectively solved at the same time. Wherein, the bioabsorbable/biodegradable material includes at least one of polylactic acid (PLA), polyglycolic acid (PGA), polyurethane (PU), and polylactic-co-glycolic acid (PLGA/PGLA). Among them, PLA, PGA, and PGLA are preferred, so that the degradable/absorbable part of the medical coil has the characteristics of short degradation cycle and high degradation ratio, which is beneficial to reduce or even eliminate the occupying effect in a relatively short period of time.
至少一个显影标记1套设在弹簧2的外壁(即外部)上,由此,一方面,能够借助这些显影标记1在植入过程中或植入后观察医用弹簧圈的具体位置和形态,有效解决了现有的弹簧圈显影性能不佳的问题;另一方面,由于显影标记1套设在弹簧2的外部,因此,显影标记1的设置不会影响弹簧2本身的三维结构和刚度等物理性能,有效地实现颅内动脉瘤的栓塞治疗。At least one developing mark 1 is sleeved on the outer wall (i.e. the outside) of the spring 2, 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 developing marks 1, effectively It solves the problem of poor development performance of the existing spring coil; on the other hand, since the development mark 1 is sleeved outside the spring 2, the setting of the development mark 1 will not affect the physical properties such as the three-dimensional structure and stiffness of the spring 2 itself. Performance, effective embolization of intracranial aneurysms.
显影标记1可以为环状结构、管状结构或弹簧状结构,且显影标记1与弹簧2的连接方式为过盈机械连接,由此,在使得显影标记1的设置不会影响弹簧2本身的结构的前提下,能将显影标记1有效地固定在弹簧2上,并且在医用弹簧圈推送入人体血管的过程中可以使得显影标记1保持稳定,不会滑动。另外,显影标记1的选材需要满足在不影响医用弹簧圈在X射线下的显影效果的同时,对医用弹簧圈的柔软度及推送性也不会产生不良影响,因此,本实施例中,显影标记1的材料为X射线不可穿透材料,包括不锈钢、铂、金、铑、铼、钯、钨中的一种或多种组合(即合金)。而显影标记1的尺寸设计,需要根据所需植入动脉瘤尺寸的大小来确定,同时也需要满足在不影响医用弹簧圈在X射线下的显影效果的同时,对医用弹簧圈的柔软度及推送性也不会产生不良影响,因此,本实施例中,显影标记1的轴向尺寸L1(即显影标记1沿抗解旋部件3的长度方向x延伸的尺寸)的范围为0.005英寸~0.025英寸之间,优选的尺寸为0.01英寸~0.016英寸,各个显影标记1的外径(即沿垂直于抗解旋部件3的方向y上的尺寸)范围为0.010英寸~0.0165英寸之间,优选的尺寸为0.0135英寸~0.0145英寸,以在实现与弹簧2的过盈机械连接的同时,能够匹配所需植入动脉瘤尺寸的大小,防止在植入过程中损伤血管,因此,弹簧2的外径尺寸需要根据所需植入位置的空间尺寸来设计,弹簧2的外径尺寸需要匹配显影标记1的内径尺寸弹簧2。The development mark 1 can be a ring structure, a tubular structure or a spring structure, and the connection mode between the development mark 1 and the spring 2 is an interference mechanical connection, so that the setting of the development mark 1 will not affect the structure of the spring 2 itself Under the premise, the developing mark 1 can be effectively fixed on the spring 2, and the developing mark 1 can be kept stable and will not slip when the medical coil is pushed into the blood vessel of the human body. In addition, the material selection of the development mark 1 needs to meet the requirements of not affecting the development effect of the medical coil under X-rays, and at the same time, it will not adversely affect the softness and pushability of the medical coil. Therefore, in this embodiment, the development The material marked 1 is an X-ray impenetrable material, including one or more combinations (ie, alloys) of stainless steel, platinum, gold, rhodium, rhenium, palladium, and tungsten. The size design of the imaging mark 1 needs to be determined according to the size of the aneurysm to be implanted, and at the same time, it needs to meet the requirements for the softness and flexibility of the medical coil while not affecting the imaging effect of the medical coil under X-rays. Pushability will not be adversely affected, therefore, in this embodiment, the axial dimension L1 of the developed mark 1 (that is, the dimension that the developed mark 1 extends along the length direction x of the anti-unrotation member 3) ranges from 0.005 inches to 0.025 inches. Between inches, the preferred size is 0.01 inches to 0.016 inches, and the outer diameter of each developing mark 1 (that is, the dimension along the direction y perpendicular to the anti-unrotation component 3) ranges from 0.010 inches to 0.0165 inches, preferably The size is 0.0135 inches to 0.0145 inches, so as to achieve the interference mechanical connection with the spring 2, and at the same time match the size of the required implanted aneurysm to prevent damage to the blood vessel during the implantation process. Therefore, the outer diameter of the spring 2 The size needs to be designed according to the space size of the desired implantation site, and the outer diameter of the spring 2 needs to match the inner diameter of the spring 2 of the developing mark 1 .
此外,为了匹配所需植入的动脉瘤尺寸大小并保证弹簧圈在全部植入后显影标记能够均匀地分布在瘤体内,便于术中及术后疗效诊断,本实施例中设置的显影标记1的数量不少于2个,且这些显影标记1沿所述弹簧2的轴向间隔设置,并均套设在弹簧2的外部,这种显影标记1和弹簧2的配合设置方式,与现有的显影丝材与可降解材料缠绕或者两种材料一体成型的弹簧圈相比,显影效果更好,因而能够在获得同等显影效果的前提下,使用更少的显影材料,可以使得弹簧2中的生物可吸收和/或可降解材料占整个弹簧圈的体积百分比更高,达到70%~95%,进而使得弹簧圈具有降解周期短、降级比例高的特点,对于解决占位效应和长期安全性问题带来更显著、更彻底的效果。在具体实施时,可以沿所述弹簧2的轴向等间隔地均匀布设这些显影标记1,具体地,以每两个相邻的显影标记1之间的间距L2为相同值来均匀布设这些显影标记1,间距L2的范围例如为3毫米~30毫米,优选的尺寸为5毫米~10毫米。弹簧2的整体长度可以等于或者大于所有显影标记1的轴向尺寸L1的总和与所有间距L2的总和之和。在其它实施例中,多个所述显影标记1也可以是沿x方向非等间距的布设,例如在靠近弹簧圈两端的位置设置得较密、在靠近中间的位置设置得较疏。In addition, in order to match the size of the aneurysm to be implanted and to ensure that the imaging markers can be evenly distributed in the aneurysm after all the coils are implanted, so as to facilitate the diagnosis of the curative effect during and after the operation, the imaging marker 1 set in this embodiment The number of these development marks 1 is not less than two, and these development marks 1 are arranged at intervals along the axial direction of the spring 2, and are all sleeved on the outside of the spring 2. Compared with the spring coil wound by degradable material or integrally formed by two materials, the developing wire material has better developing effect, so it can use less developing material under the premise of obtaining the same developing effect, which can make the spring in spring 2 Bioabsorbable and/or degradable materials account for a higher volume percentage of the entire coil, reaching 70% to 95%, which in turn makes the coil have the characteristics of short degradation cycle and high degradation ratio, which is helpful for solving the occupation effect and long-term safety. Questions bring about a more pronounced and thorough effect. In a specific implementation, these developing marks 1 can be evenly arranged at equal intervals along the axial direction of the spring 2, specifically, these developing marks 1 can be evenly arranged with the distance L2 between every two adjacent developing marks 1 being the same value. Mark 1, the distance L2 ranges, for example, from 3 mm to 30 mm, and preferably ranges from 5 mm to 10 mm. The overall length of the spring 2 may be equal to or greater than the sum of the sum of the axial dimensions L1 of all the developed marks 1 and the sum of all the distances L2. In other embodiments, the plurality of developing marks 1 may also be arranged at unequal intervals along the x direction, for example, they are arranged densely near the two ends of the spring coil and sparsely arranged near the middle.
抗解旋部件3为丝线状结构,穿设在弹簧2的内部,并沿所述弹簧2的轴向延伸,所述抗解旋部件3的两端分别与所述弹簧2的两端连接。抗解旋部件3由不可降解的材料制成,所述不可降解的材料例如为不可降解的聚合物材料或包含合金在内的不可降解的金属材料,所述聚合物材料包括但不限于聚丙烯PP、聚乙烯和聚异戊二烯等;所述金属材料包括但不限于镍钛合金、铂钨合金、钛镍铜合金、钛镍铁合金、钛镍铬合金、铜镍合金、铜铝合金和铜锌合金等。其中,抗解旋部件3设置目的包括:一是实现弹簧2的抗解旋;二是保持显影标记1在轴向上的位置不变,以便在植入弹簧圈过程中和植入弹簧圈后准确定位和观察弹簧圈的具体位置和三维形态,同时也防止显影标记1在弹簧2的可降解部分降解后从弹簧圈上脱落的问题,由此避免现有的显影标记容易脱落甚至掉落至动脉瘤颈外而导致远端血管堵塞乃至危及生命的问题。The anti-unrotation component 3 is a thread-like structure, pierced inside the spring 2 , and extends along the axial direction of the spring 2 , and the two ends of the anti-unrotation component 3 are respectively connected to the two ends of the spring 2 . The anti-unrotation component 3 is made of non-degradable materials, such as non-degradable polymer materials or non-degradable metal materials including alloys, and the polymer materials include but not limited to polypropylene PP, polyethylene and polyisoprene; the metal materials include but not limited to 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, etc. Among them, the purpose of anti-unrotation component 3 includes: first, to realize the anti-unrotation of spring 2; Accurately locate and observe the specific position and three-dimensional shape of the spring coil, and at the same time prevent the problem that the developed mark 1 falls off from the coil after the degradable part of the spring 2 is degraded, thereby avoiding the existing developed mark from easily falling off or even falling to the Aneurysm outside the neck can lead to distal blood vessel blockage and even life-threatening problems.
光滑曲面结构4能够将抗解旋部件3的两端与弹簧2的两端固定在一起。光滑曲面结构4设置的目的包括:一是,增加弹簧圈两端的光滑度,以在弹簧圈被推送入血管内的过程中减少弹簧圈的的推送阻力,以及,减少弹簧圈在填塞瘤内的过程中对瘤壁可能产生的损伤;二是在弹簧2大部分降解或完全降解后,和抗解旋部件3一起与显影标记1保持有效的连接,以保持显影标记1在轴向上的位置不变,以便在植入弹簧圈过程中和植入弹簧圈后准确定位和观察弹簧圈的具体位置和三维形态,并防止显影标记在弹簧2的可降解部分降解后从弹簧圈上脱落的风险。本实施例中,光滑曲面结构4与弹簧2的连接方式为粘接,光滑曲面结构4的材料优选为光固化或自然固化的粘性液体,由此能够借助粘性液体在光照或特定的自然环境下可以固化的原理来形成光滑曲面结构4并使光滑曲面结构4与弹簧2粘接,其中,所述粘性液体的材料包括但不限于环氧树脂胶,丙烯酸化聚氨酯等。优选地,光滑曲面结构4的外径(即垂直于所述抗解旋部件长度的方向y上的尺寸)稍大于显影标记1的内径,光滑曲面结构4的轴向尺寸(即沿所述抗解旋部件长度的方向x上的尺寸)稍大于显影标记1的轴向尺寸,进而以在弹簧2完全降解后,抗解旋部件3与两端的光滑曲面结构4对显影标记1保持有效地连接,可阻止弹簧2的可降解部分降解后显影标记1移位以及从弹簧圈的两端掉落出来。The smooth curved surface structure 4 can fix the two ends of the anti-unrotation component 3 and the two ends of the spring 2 together. The purpose of setting the smooth surface structure 4 includes: firstly, to increase the smoothness of both ends of the coil, so as to reduce the pushing resistance of the coil when the coil is pushed into the blood vessel; The possible damage to the aneurysm wall during the process; the second is to maintain an effective connection with the development mark 1 together with the anti-unrotation component 3 after the spring 2 is mostly degraded or completely degraded, so as to maintain the position of the development mark 1 in the axial direction Invariant to allow accurate positioning and observation of the specific position and three-dimensional shape of the coil during and after coil implantation and to prevent the risk of the visible marker falling off the coil after degradation of the degradable part of the spring 2 . In this embodiment, the connection method between the smooth curved structure 4 and the spring 2 is bonding, and the material of the smooth curved structure 4 is preferably a light-cured or naturally cured viscous liquid, so that the viscous liquid can be used under light or a specific natural environment. The principle of curing can be used to form the smooth curved surface structure 4 and bond the smooth curved surface structure 4 to the spring 2, wherein the material of the viscous liquid includes but not limited to epoxy resin glue, acrylated polyurethane and the like. Preferably, the outer diameter of the smooth curved structure 4 (that is, the dimension in the direction y perpendicular to the length of the anti-untwisting component) is slightly larger than the inner diameter of the developing mark 1, and the axial dimension of the smooth curved structure 4 (that is, along the anti-unrotation component) The size in the direction x of the length of the unrotating part) is slightly larger than the axial dimension of the developing mark 1, so that after the spring 2 is completely degraded, the anti-unrotating part 3 and the smooth curved surface structure 4 at both ends remain effectively connected to the developing mark 1 , which can prevent the degradable part of the spring 2 from being displaced and falling out from both ends of the spring coil after the degradable part of the spring 2 is degraded.
综上所述,本实施例的医用弹簧圈包括弹簧和至少一个显影标记,所述显影标记套设在所述弹簧的外部,由此,一方面,能够借助这些显影标记在植入过程中或植入后观察医用弹簧圈的具体位置和形态,有效解决了现有的弹簧圈显影性能不佳的问题;另一方面,由于显影标记套设在弹簧的外部,因此,显影标记的设置不会影响弹簧本身的三维结构和刚度等物理性能,有效地实现颅内动脉瘤的栓塞治疗。此外,本实施例的医用弹簧圈,因至少部分弹簧可降解和设置有至少一个显影标记而同时具备可降解性和显影性,在弹簧圈植入血管后可安全有效地栓塞颅内动脉瘤,使动脉瘤内血栓的纤维化,且随着弹簧的可降解材料的被吸收和/或降解,瘤内纤维组织不断收缩,使动脉瘤不断缩小,从而可以极大程度上减小甚至消除弹簧圈的占位效应,同时能避免金属圈植入后存在的安全性问题。此外,至少两个所述显影标记沿所述弹簧的轴向间隔设置,各个显影标记套设在在弹簧的外部,不会影响弹簧本身的结构,且显影标记能通过过盈机械连接方式有效地固定在弹簧上,在弹簧圈被推送入血管内的过程中可以保持稳定,不会滑动,同时利用显影标记的显影性能来准确地定位和释放可降解弹簧圈,以保证弹簧圈能准确地植入到病变位置,且在手术后的长期植入过程中,可以通过显影标记来随访检查弹簧圈中的抗解旋部件、光滑曲面结构、弹簧剩余的不可被降解材料等不被降解的部分是否移位或掉落,保证弹簧圈长期植入的安全性与稳定性。进一步地,光滑曲面结构能将抗解旋部件与弹簧的两端固定在一起,由此能够增加弹簧圈两端的光滑度,以在弹簧圈被推送入血管内的过程中减小弹簧圈推送阻力以及减少弹簧圈在填塞动脉瘤时对瘤壁可能产生的损伤,且在弹簧大部分降解或完全降解后,光滑曲面结构和抗解旋部件可以与显影标记保持有效的连接,进而阻止显影标记在弹簧的可降解材料被降解后掉落与移位。To sum up, the medical coil of this embodiment includes a spring and at least one developing mark, and the developing mark is sheathed on the outside of the spring, so that, on the one hand, it is possible to use these developing marks during implantation or Observing the specific position and shape of the medical coil after implantation effectively solves the problem of poor developing performance of the existing coil; on the other hand, since the developing mark is sleeved outside the spring, the setting of the developing mark will not It affects the physical properties such as the three-dimensional structure and stiffness of the spring itself, and effectively realizes the embolization treatment of intracranial aneurysms. In addition, the medical coil of this embodiment has both degradability and visualization because at least part of the spring is degradable and is provided with at least one imaging mark, so it can embolize intracranial aneurysms safely and effectively after the coil is implanted in a blood vessel. 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 aneurysm shrinks continuously, so that the aneurysm shrinks continuously, so that the coil can be greatly reduced or even eliminated Occupation effect, and at the same time, it can avoid the safety problems after the metal ring is implanted. In addition, at least two developing marks are arranged at intervals along the axial direction of the spring, and each developing mark is sleeved outside the spring without affecting the structure of the spring itself, and the developing marks can be effectively connected through interference mechanical connection. Fixed on the spring, it can keep stable and will not slip when the coil is pushed into the blood vessel. At the same time, the development performance of the developed mark is used to accurately position and release the degradable coil to ensure that the coil can be accurately implanted. Into the lesion position, and in the long-term implantation process after surgery, it is possible to follow up and check whether the non-degradable parts such as the anti-untwisting parts in the coil, smooth curved surface structure, and the remaining non-degradable materials of the spring are Shifting or falling off ensures the safety and stability of the long-term implantation of the coil. Further, the smooth curved surface structure can fix the anti-unrotation component and the two ends of the spring together, thereby increasing the smoothness of the two ends of the coil to reduce the push resistance of the coil when the coil is pushed into the blood vessel As well as reducing the possible damage to the aneurysm wall caused by the coil when filling the aneurysm, and after the spring is mostly degraded or completely degraded, the smooth surface structure and the anti-unrotation component can maintain an effective connection with the developing mark, thereby preventing the developing mark from being The degradable material of the spring is degraded and falls and shifts.
实施例二Embodiment two
请参考图2,本实施例提供一种医用弹簧圈,包括弹簧2、至少一个显影标记1、至少一个抗解旋部件3和两个光滑曲面结构4。本实施例的可降解弹簧圈与实施例一的医用弹簧圈的主要区别在于:各个显影标记1套设在弹簧2的内部(可以称为内腔)中。由于显影标记1内嵌在弹簧2的内部,且弹簧2的外径大小需要根据所需植入的动脉瘤尺寸的大小来确定,因此,显影标记1的外径大小需要根据弹簧2的内径的大小来确定,同时也需要满足不影响可降解弹簧圈在X射线下的显影效果以及弹簧圈的柔软度的条件,由此,本实施例中的显影标记1的外径范围为0.002英寸~0.010英寸之间,优选的尺寸为0.004英寸~0.0065英寸。Please refer to FIG. 2 , this embodiment provides a medical coil, including a spring 2 , at least one developing mark 1 , at least one anti-unrotation component 3 and two smooth curved surface structures 4 . The main difference between the degradable coil of this embodiment and the medical coil of Embodiment 1 is that each developing mark 1 is sheathed in the interior of the spring 2 (which may be referred to as an inner cavity). Since the developing 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, the outer diameter of the developing marker 1 needs to be determined according to the inner diameter of the spring 2 size, and also need to meet the conditions that do not affect the developing effect of the degradable coil under X-rays and the softness of the coil. Therefore, the outer diameter of the developing mark 1 in this embodiment ranges from 0.002 inches to 0.010 inches. inches, with a preferred size of 0.004 inches to 0.0065 inches.
本实施例中,各个显影标记1套设在弹簧2的内部,可以具体采用以下三种方案:In this embodiment, each developing mark 1 is sleeved inside the spring 2, and the following three schemes can be specifically adopted:
1)各个显影标记1通过过盈机械连接方式嵌在弹簧2的内壁上,此情况下,抗解旋部件3穿设于各个显影标记1的内部,但各个显影标记1可以不与抗解旋部件3接触,也可以有接触,或者,其中一些显影标记1与抗解旋部件3接触,另一些显影标记1不与抗解旋部件3接触;1) Each developing mark 1 is embedded on the inner wall of the spring 2 through an interference mechanical connection. In this case, the anti-unrotation component 3 is penetrated inside each developing mark 1, but each developing mark 1 may not be connected with the anti-unrotating The parts 3 are in contact, or there may be contact, or some of the developed marks 1 are in contact with the anti-untwisting part 3, and some of the developed marks 1 are not in contact with the anti-untwisting part 3;
2)各个显影标记1的中心有个较小的孔供抗解旋部件4穿过,抗解旋部件3在每个显影标记1的两端分别打个结而形成结扣,这个结扣的外径大于显影标记1的中心的孔的内径,此情况下,抗解旋部件3穿设于各个显影标记1的内部,但各个显影标记1与弹簧2可以连接,也可以不连接;2) There is a smaller hole in the center of each developing mark 1 for the anti-untwisting component 4 to pass through, and the anti-untwisting component 3 is respectively tied with a knot at both ends of each developing mark 1 to form a knot. The outer diameter is greater than the inner diameter of the hole in the center of the developing mark 1. In this case, the anti-unrotation component 3 is penetrated inside each developing mark 1, but each developing mark 1 and the spring 2 may or may not be connected;
3)各个显影标记1的中心有个较小的孔供抗解旋部件3穿过,抗解旋部件3与显影标记1接触的位置通过胶黏剂粘接而固定在一起,此情况下,抗解旋部件3穿设于各个显影标记1的内部,各个显影标记1与弹簧2可以连接,也可以不连接。3) There is a small hole in the center of each developing mark 1 for the anti-unrotation component 3 to pass through, and the position where the anti-unrotation component 3 is in contact with the developing mark 1 is fixed together by adhesive bonding. In this case, The anti-unrotation component 3 is installed inside each developing mark 1 , and each developing mark 1 can be connected with the spring 2 or not.
本实施例的医用弹簧圈的各部件的选材以及其余尺寸的设计等均与实施例一的医用弹簧圈相同,在此不再赘述。The material selection of each component of the medical coil of this embodiment and the design of other dimensions are the same as those of the medical coil of Embodiment 1, and will not be repeated here.
本实施例的医用弹簧圈,相对实施例一的医用弹簧圈,外表面更平滑,有利于降低医用弹簧圈推送入人体血管的过程中的推送阻力,避免损伤组织,更重要的是,由于各个显影标记均套设在弹簧的内部,因此可以避免弹簧中的显影标记受外部阻力等环境因素的影响而滑动甚至脱落,增强显影标记在医用弹簧圈推送入人体血管的过程中的结构稳定性。Compared with the medical coil of Example 1, the medical coil of this embodiment has a smoother outer surface, which is beneficial to reduce the push resistance in the process of pushing the medical coil into the blood vessels of the human body, avoiding damage to tissues, and more importantly, due to various The developing marks are all sleeved inside the spring, so it can prevent the developing marks in the spring from sliding or even falling off due to external resistance and other environmental factors, and enhance the structural stability of the developing marks in the process of pushing the medical coil into the human blood vessel.
此外,本实施例的医用弹簧圈中,可以设置至少两个显影标记1,这些显影标记1沿所述弹簧2的轴向间隔设置,可以是等间隔设置,也可以是非等间隔设置,且这些显影标记1均设置在可降解的弹簧2的内部,由此使得本实施例的医用弹簧圈,与现有的显影丝材与可降解材料缠绕或者两种材料一体成型的弹簧圈相比,显影效果更好,因而能够在获得同等显影效果的前提下,使用更少的显影材料,可以使得生物可吸收和/或可降解材料占整个弹簧圈的体积百分比更高,进而使得弹簧圈具有降解周期短、降级比例高的特点,对于解决占位效应和长期安全性问题带来更显著、更彻底的效果。In addition, in the medical spring coil of this embodiment, at least two developing marks 1 can be provided, 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 The development marks 1 are all set inside the degradable spring 2, thus making the medical coil of this embodiment, compared with the existing coils in which the development wire is wound with the degradable material or the two materials are integrally formed, the development The effect is better, so it is possible to use less developing material under the premise of obtaining the same developing effect, which can make the bioabsorbable and/or degradable material account for a higher volume percentage of the entire coil, thereby enabling the coil to have a degradation cycle The characteristics of short duration and high downgrading ratio bring about more significant and thorough effects on solving mass effect and long-term security problems.
实施例三Embodiment three
请参考图3,本实施例提供一种医用弹簧圈,包括弹簧2、至少一个显影标记1、至少一个抗解旋部件3和两个光滑曲面结构4。本实施例的医用弹簧圈与实施例一的医用弹簧圈的主要区别在于:显影标记1分为两种,一种显影标记1a是内嵌在弹簧2的内部,另一种显影标记1b是套设在弹簧2的外部,且抗解旋部件3穿设于弹簧2各个显影标记1a的内部。由于显影标记1b套设在弹簧2的外部,而显影标记1a内嵌在弹簧2内部,因此,显影标记1b的外径尺寸需要根据所需植入的动脉瘤尺寸的大小来确定,显影标记1a的外径尺寸需要根据弹簧2的内径尺寸的大小来确定,同时显影标记1a和1b的设置也需要满足不影响医用弹簧圈在X射线下的显影效果以及医用弹簧圈的柔软度的条件,由此,本实施例中,各个显影标记1a的外径范围为0.002英寸~0.010英寸之间,优选的尺寸为0.004英寸~0.0065英寸,各个显影标记1b的外径范围为0.010英寸~0.0165英寸之间,优选的尺寸为0.0135英寸~0.0145英寸。Please refer to FIG. 3 , this embodiment provides a medical coil, including a spring 2 , at least one developing mark 1 , at least one anti-unrotation component 3 and two smooth curved surface structures 4 . The main difference between the medical coil of this embodiment and the medical coil of Embodiment 1 is that: the development mark 1 is divided into two types, one kind of development mark 1a is embedded inside the spring 2, and the other kind of development mark 1b is a sleeve It is arranged on the outside of the spring 2 , and the anti-unrotation component 3 is passed through the inside of each developing mark 1 a of the spring 2 . Since the developing mark 1b is sleeved on the outside of the spring 2, and the developing mark 1a is embedded inside the spring 2, the outer diameter of the developing mark 1b needs to be determined according to the size of the aneurysm to be implanted. The developing mark 1a The outer diameter of the spring 2 needs to be determined according to the size of the inner diameter of the spring 2. At the same time, the setting of the development marks 1a and 1b also needs to meet the conditions of not affecting the development effect of the medical coil under X-rays and the softness of the medical coil. Therefore, in this embodiment, the outer diameter range of each developed mark 1a is between 0.002 inch and 0.010 inch, and the preferred size is 0.004 inch to 0.0065 inch, and the outer diameter range of each developed mark 1b is between 0.010 inch and 0.0165 inch. , the preferred size is 0.0135 inches to 0.0145 inches.
本实施例中,各个显影标记1a套设在弹簧2的内部,可以具体采用以下三种方案:In this embodiment, each development mark 1a is sleeved inside the spring 2, and the following three schemes can be specifically adopted:
1)各个显影标记1a通过过盈机械连接方式嵌在弹簧2的内壁上,此情况下,抗解旋部件3穿设于各个显影标记1a的内部,但各个显影标记1a可以均不与抗解旋部件3接触,也可以均有接触,或者,其中一些显影标记1a与抗解旋部件3接触,另一些显影标记1a不与抗解旋部件3接触;1) Each development mark 1a is embedded on the inner wall of the spring 2 through an interference mechanical connection. In this case, the anti-unrotation component 3 is penetrated inside each development mark 1a, but each development mark 1a may not be connected with the anti-unrotation Rotation part 3 contact, also can all be in contact, or, wherein some developing marks 1a are in contact with anti-unrotation part 3, other development marks 1a are not in contact with anti-unrotation part 3;
2)各个显影标记1a的中心有个较小的孔供抗解旋部件4穿过,抗解旋部件3在每个显影标记1a的两端分别打个结而形成结扣,这个结扣的外径大于显影标记1的中心的孔的内径,此情况下,抗解旋部件3穿设于各个显影标记1a的内部,但各个显影标记1a与弹簧2可以连接,也可以不连接;2) There is a smaller hole in the center of each developing mark 1a for the anti-untwisting component 4 to pass through, and the anti-untwisting component 3 is respectively tied with a knot at both ends of each developing mark 1a to form a knot. The outer diameter is larger than the inner diameter of the hole in the center of the developed mark 1. In this case, the anti-unrotation component 3 is penetrated inside each developed mark 1a, but each developed mark 1a can be connected to the spring 2 or not;
3)各个显影标记1a的中心有个较小的孔供抗解旋部件3穿过,抗解旋部件3与显影标记1a接触的位置通过胶黏剂粘接而固定在一起,此情况下,抗解旋部件3穿设于各个显影标记1a的内部,各个显影标记1a与弹簧2可以连接,也可以不连接。3) There is a small hole in the center of each developed mark 1a for the anti-unrotation component 3 to pass through, and the position where the anti-unrotation component 3 is in contact with the developed mark 1a is fixed together by adhesive bonding. In this case, The anti-unrotation component 3 is disposed inside each developing mark 1a, and each developing mark 1a can be connected to the spring 2 or not.
本实施例的医用弹簧圈的各部件的选材以及其余尺寸的设计等均与实施例一的医用弹簧圈相同,在此不再赘述。The material selection of each component of the medical coil of this embodiment and the design of other dimensions are the same as those of the medical coil of Embodiment 1, and will not be repeated here.
此外,本实施例的医用弹簧圈中,套设在弹簧2外部的显影标记1b和嵌套在弹簧2内部的显影标记1a沿弹簧2的轴向交替排布,且相应的两个显影标记1之间设有间隔,该间隔可以是均匀的,也可以是非均匀的。In addition, in the medical coil of this embodiment, the development marks 1b sleeved outside the spring 2 and the development marks 1a nested inside the spring 2 are alternately arranged along the axial direction of the spring 2, and the corresponding two development marks 1 There is an interval between them, and the interval can be uniform or non-uniform.
本实施例的医用弹簧圈,相对实施例一的医用弹簧圈,由于显影标记包括内嵌在弹簧的内部中的显影标记和套设在弹簧的外部的显影标记,因此,可以利用内嵌在弹簧的内部中的显影标记和抗解旋部件增强医用弹簧圈的结构稳定性,在医用弹簧圈推送入人体血管的过程中可以使得各个显影标记更加稳定,不会滑动。The medical coil of this embodiment, compared with the medical coil of Embodiment 1, since the development mark includes the development mark embedded in the spring and the development mark sleeved on the outside of the spring, therefore, it is possible to use the The developing marks and anti-untwisting parts in the interior of the medical coil enhance the structural stability of the medical coil, which can make each developing mark more stable and not slip when the medical coil is pushed into the human blood vessel.
需要说明的是,虽然上述的各个实施例中的医用弹簧圈中,均通过光滑曲面结构作为连接件,将抗解旋部件的两端与弹簧的两端连接在一起,但是本发明的技术方案并不仅仅限定于此,在本发明的其他实施例中,光滑曲面结构可以替换为其他具有非光滑曲面的连接件,例如,多面体状的连接件等。It should be noted that, although the medical spring coils in each of the above-mentioned embodiments use a smooth curved surface structure as a connector to connect the two ends of the anti-unrotation component and the two ends of the spring, the technical solution of the present invention It is not limited thereto, and in other embodiments of the present invention, the smooth curved surface structure may be replaced by other connectors with non-smooth curved surfaces, for example, polyhedral connectors and the like.
此外,虽然上述的各个实施例中的医用弹簧圈中,均设置有抗解旋部件,通过不可降解的抗解旋部件和两端的光滑曲面结构的连接,来避免显影标记在弹簧降解后从弹簧圈上脱落的问题,但是本发明的技术方案并不仅仅限定于此,在本发明的其他实施例中,可以采用任意合适的方式和结构,来保证设置的显影结构不仅位于弹簧圈的两端,还可以位于弹簧圈两端之间的中间段上,且显影标记在弹簧降解后不会从弹簧圈上脱落,例如,在一个其他实施例中,医用弹簧圈省去抗解旋部件,其弹簧为两个弹簧体嵌套在一起的结构,且这两个弹簧体的两端分别连接在一起,且其中内部的弹簧体为不可降解的,外部的弹簧体至少部分可降解,这种情况下,可以利用内部的这个不可降解的弹簧体,来保持显影标记在轴向上的位置不变,以便在植入过程中和植入后准确定位和观察弹簧圈的形态,同时也防止显影标记在弹簧降解后从弹簧圈上脱落甚至掉落至动脉瘤颈外而导致远端血管堵塞乃至危及生命的问题,同时利用外部的弹簧的可降解性,来减小弹簧圈整体的占位效应。In addition, although the medical coils in each of the above-mentioned embodiments are provided with anti-untwisting parts, the connection between the non-degradable anti-untwisting parts and the smooth curved surface structures at both ends prevents the development mark from detaching from the spring after the spring is degraded. However, 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 used to ensure that the set developing structure is not only located at both ends of the spring coil , can also be located on the middle section between the two ends of the coil, and the development mark will not fall off from the coil after the spring is degraded. The spring is a structure in which two spring bodies are nested together, and the two ends of the 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 Next, the internal non-degradable spring body can be used to keep the position of the development mark in the axial direction unchanged, so that the shape of the spring coil can be accurately positioned and observed during and after implantation, and at the same time, it can also prevent the development mark After the spring is degraded, it falls off from the coil or even falls outside the neck of the aneurysm, causing distal blood vessel blockage and even life-threatening problems. At the same time, the degradability of the external spring is used to reduce the overall occupying effect of the coil.
显然,本领域的技术人员可以对发明进行各种改动和变型而不脱离本发明的精神和范围。这样,倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内,则本发明也意图包含这些改动和变型在内。Obviously, those skilled in the art can make various changes and modifications to the invention without departing from the spirit and scope of the 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 modifications and variations.
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