CN211583324U

CN211583324U - Medical spring ring

Info

Publication number: CN211583324U
Application number: CN201920996863.7U
Authority: CN
Inventors: 查序; 郭远益; 常孟琪; 陈冰
Original assignee: Microport Neurotech Shanghai Co Ltd
Current assignee: Microport Neurotech Shanghai Co Ltd
Priority date: 2019-06-28
Filing date: 2019-06-28
Publication date: 2020-09-29
Anticipated expiration: 2029-06-28

Abstract

The utility model provides a medical spring coil, at least part the spring coil is made by the changeable material of rigidity under the trigger condition of settlement, can be from this in the art and/or the postoperative through applying to the spring coil the trigger condition of settlement changes the rigidity of the material of this part, and then changes the rigidity of medical spring coil to effectively satisfy the requirement to spring coil compliance and fill the requirement to spring coil rigidity after accomplishing among the nerve intervention operation process.

Description

Medical spring ring

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to a medical spring coil.

Background

Intracranial aneurysms have very high disabling and lethal rates. With the development of medical technology, development of device materials and experience accumulation of neuro-interventionalists, intravascular treatment has become the first treatment method for reducing the reoccurrence rate and mortality rate of ruptured intracranial aneurysms. Of the many treatments, the most widely used are aneurysm embolization, including embolic coils, liquid embolization agents, intraluminal embolization devices, balloon/stent-assisted techniques, and the like. The embolic coil is gradually a mainstream means for clinically treating intracranial aneurysm due to the advantages of convenient operation, stable implantation, safety, effectiveness and the like, and more attention is paid to clinicians and researchers.

Generally, the preparation of the embolic coil is to wind a platinum-tungsten alloy wire on a core rod to form a coil with uniform shape, which is also called a primary coil; and then winding the primary coil on a die according to a preset shape for shaping treatment, thereby forming the secondary coil with a three-dimensional shape. The purpose of forming the three-dimensional shape is to make the coil more compliant with the shape of the aneurysm, reducing pressure on the wall of the aneurysm, and thus reducing the risk of rupture of the aneurysm during surgery. The mainstream plunger spring ring products in the current market are all the plug spring ring products manufactured by the method.

Both the primary and secondary coils of such embolic coils are pre-fabricated. During packaging, the coil is retained within an elongated introducer sheath of relatively small diameter, which is now constrained by the tube wall, and the shape of the secondary coil of the embolic coil is altered to assume a second three-dimensional shape, but the primary coil does not change significantly. During operation, the embolic coil will retain the second three-dimensional shape after it has been advanced out of the introducer sheath and into the microcatheter. When the coil exits the microcatheter and enters the aneurysm, the coil returns to the pre-shaped first three-dimensional shape due to disengagement from the wall constraint and the elasticity of the material itself. It can be seen that the softness of such embolic coils remains constant during use because the primary and secondary coils are pre-formed. For the treatment of aneurysms, however, the coil is required to be softer and more easily deformed during the packing process, thereby conforming to the wall of the aneurysm and increasing packing density. When the packing is completed, the spring ring is required to be harder and more stable in shape, so that the spring ring resists the impact of blood flow and is not easily compressed. Therefore, the current mainstream spring coil products have a defect that the flexibility of the spring coil cannot be changed, and the requirements on the performance of the spring coil in the filling process and after the filling process cannot be met at the same time.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a medical spring coil can overcome the problem that current spring coil compliance is unable to change with the postoperative in the art, and then can effectively satisfy the requirement of nerve intervention operation to spring coil compliance and fill the requirement to spring coil rigidity after accomplishing.

To achieve the above objects, the present invention provides a medical spring coil, at least a portion of which is made of a material having a variable stiffness under a set triggering condition.

Optionally, the spring ring comprises a first coil, at least part of the first coil being made of the material.

Optionally, the spring ring comprises a first coil and an anti-unscrewing part, the anti-unscrewing part is arranged inside the first coil in a penetrating manner, and two ends of the anti-unscrewing part are respectively connected with two ends of the first coil; at least part of the first coil and/or at least part of the anti-unscrewing member is made of the material.

Optionally, the spring coil comprises a first coil and a second coil; the second coil is sleeved outside the first coil, or the first coil is sleeved outside the second coil; two ends of the second coil are respectively connected with two ends of the first coil; at least part of the first coil and/or at least part of the second coil is made of the material.

Optionally, the spring ring comprises a first coil, an anti-unwinding member, and a second coil; the second coil is sleeved outside the first coil, or the first coil is sleeved outside the second coil; the anti-unwinding component is arranged in the first coil and the second coil in a penetrating mode, and two ends of the anti-unwinding component and two ends of the second coil are respectively connected with two ends of the first coil; a portion or all of at least one of the first coil, the anti-unwinding member, and the second coil is made of the material.

Optionally, the connection manner includes at least one of connection by a connection mechanism, bonding by an adhesive, and knotting connection.

Optionally, the anti-unwinding member is at least one strand of anti-unwinding filaments, each strand of anti-unwinding filaments having a diameter of 0.0003 inches to 0.003 inches.

Optionally, the material comprises an alloy having shape memory properties and/or a polymeric material having shape memory properties.

Optionally, the alloy includes at least one of a nickel-titanium-based alloy, a copper-nickel-based alloy, a copper-aluminum-based alloy, a copper-zinc-based alloy, and an iron-based alloy.

Optionally, the polymeric material comprises at least one of polyethylene, polyisoprene, polyester, copolyester, polyamide, copolyamide and polyurethane.

Optionally, the set trigger condition comprises at least one of a temperature change, a current change, a light change and a chemical change.

Optionally, the temperature change is a temperature change from a natural environment temperature, a refrigerating temperature or a freezing temperature to a human body temperature, or a temperature change after directly or indirectly contacting a heat source.

Optionally, the illumination change comprises applying at least one of laser, ultraviolet light, X-ray illumination to the shape memory material.

Optionally, the chemical change comprises the shape memory material contacting a body fluid of a human, and/or the shape memory material contacting a chemical liquid.

Optionally, the spring ring has a first state and a second state, the first state transitioning to the second state under the set trigger condition, and the second state having a stiffness greater than the stiffness of the first state.

Optionally, the material is a material subjected to a specific process including at least one of a heat treatment, a cold treatment, an electrical treatment, an optical treatment, and a chemical treatment.

Optionally, the set trigger condition is applied to the coil during or after the coil is formed into a basket.

Compared with the prior art, the technical scheme of the utility model, following beneficial effect has:

the utility model discloses a medical spring coil is at least partly made by the changeable material of rigidity under the trigger condition who sets for, for example the first coil of medical spring coil, second coil and anti part or the whole this material preparation of adopting of at least one structure in the part of unscrewing, can be from this in the art and/or the postoperative through applying to the spring coil the trigger condition who sets for changes the rigidity of the material of this part, and then changes medical spring coil's rigidity to effectively satisfy the requirement to spring coil compliance and fill the requirement to spring coil rigidity after accomplishing among the nerve intervention operation process. The material enables the medical spring ring to be in a softer state when the set triggering condition is not applied (such as before and during tamping), so that the pressure on the aneurysm wall when the medical spring ring is tamped is reduced, and the risk of rupture of the aneurysm is reduced; after the completion of the filling of the medical spring coil, the rigidity of the part made of the material is enhanced by applying the set triggering condition (such as temperature change, illumination change, current change or chemical change), so that the softness of the medical spring coil is reduced, the rigidity is improved, and finally the shape of the filled medical spring coil after being formed into a basket is more stable, so that the medical spring coil can resist blood flow impact and is not easy to be compressed, and the safety and the treatment effect of aneurysm embolism are further improved.

Drawings

Fig. 1 is a schematic sectional view of a medical spring coil according to a first embodiment of the present invention.

Fig. 2 is a schematic sectional view of a medical spring coil according to the second embodiment of the present invention.

Fig. 3 is a schematic sectional view of a medical spring coil according to a third embodiment of the present invention.

Fig. 4 is a schematic sectional view of a medical spring coil according to a fourth embodiment of the present invention.

Fig. 5 is a schematic sectional view of a medical spring coil according to the fifth embodiment of the present invention.

Fig. 6 is a schematic sectional view of a medical spring coil according to the sixth embodiment of the present invention

Wherein the reference numerals are as follows:

1-a first coil; 2-an anti-unwinding member; 3-connecting mechanism-; 4-second coil.

Detailed Description

In order to make the objects and features of the present invention more comprehensible, the technical solution of the present invention is described in detail below with reference to the accompanying drawings, however, the present invention may be realized in different forms, and should not be limited to the embodiments described. Further, the term "and/or" herein refers to either or both.

Example one

Referring to fig. 1, the present embodiment provides a medical coil for embolizing a lumen lesion, such as an aneurysm, including not only a first coil 1, but also an anti-unscrewing member 2. The first coil 1 may be wound from a metal wire, which may not have the ability to change stiffness under a set trigger condition. The first coil 1 may be a primary coil, for example, a tubular spring structure, and the anti-unwinding member 2 may be one or more than two strands of wire-like structures and is disposed in the first coil 1 along the axial direction of the first coil 1, or the anti-unwinding member 2 may be disposed in a cavity of the tubular spring structure of the first coil 1. Two ends (namely, a near end and a far end) of the anti-unscrewing part 2 are fixedly connected with two ends (namely, a near end and a far end) of the first coil 1 respectively, namely, the near end of the anti-unscrewing part 2 is fixedly connected with the near end of the first coil 1, and the far end of the anti-unscrewing part 2 is fixedly connected with the far end of the first coil 1. Wherein, the fixed connection mode includes but not limited to: 1) the anti-unscrewing part 2 and the first coil 1 can be fixedly connected by welding, using a connecting mechanism 3, the connecting mechanism 3 being, for example, a tubular, cap-shaped or hook-shaped fastener; 2) two ends of the anti-unscrewing part 2 are respectively tied on the corresponding ends of the first coil 1; 3) the coil 1 is bonded by using an adhesive, wherein the material of the adhesive is, for example, a photo-curing or naturally-curing viscous liquid which can be cured under illumination or a set natural environment condition, so that the anti-unwinding member 2 and the first coil 1 can be adhesively connected together by using the principle that the viscous liquid can be cured under illumination or a specific natural environment, wherein the adhesive includes, but is not limited to, epoxy resin glue or acrylated polyurethane.

In addition, when the structure of the connecting mechanism 3 that the both ends of the anti-unscrewing part 2 are connected with the both ends of the first coil 1 respectively is a smooth curved surface structure, the smoothness at both ends of the medical spring coil can be increased to reduce the spring coil pushing resistance in the process that the spring coil is pushed into the blood vessel and reduce the possible damage to the tumor wall when the spring coil is filled in the tumor and the possible damage to the tumor wall when the medical spring coil is filled in the tumor.

Wherein the diameter of the anti-unscrewing part 2 is between 0.0003 inch and 0.003 inch, and all or part of the anti-unscrewing part 2 is made of a material with variable rigidity under a set triggering condition. The material whose rigidity is changeable under the set trigger condition may be an alloy having a shape memory property, such as at least one of nickel-titanium-based alloy, copper-nickel-based alloy, copper-aluminum-based alloy, copper-zinc-based alloy, and iron-based alloy, wherein the nickel-titanium-based shape memory alloy is an alloy mainly containing nickel and titanium, such as titanium nickel, titanium nickel copper, titanium nickel iron, titanium nickel chromium, and the like. The shape memory material may be a polymer material having a shape memory property, for example, a polymer material such as polyethylene, polyisoprene, polyester, copolyester, polyamide, copolyamide, or polyurethane, or a polymer material having a shape memory effect obtained by molecularly combining and modifying two or more of these polymer materials. In other embodiments of the present invention, the material with variable stiffness under the set triggering condition is a combination of an alloy with shape memory properties and a polymer material with shape memory properties. In addition, the material with variable rigidity under the set triggering condition can be a material processed by a specific process, so that the material has the capacity or property of variable rigidity under the set triggering condition compared with the material without the specific process, and the specific process comprises at least one of heat treatment, cold treatment, electrical treatment, optical treatment and chemical treatment; the material with variable stiffness under a set triggering condition may also be a known material but with variable stiffness properties or capabilities under a set triggering condition being discovered for the first time or the material with variable stiffness properties under a set triggering condition being known but applied to medical products for the first time.

The rigidity of the material with variable rigidity under the set triggering condition can be changed, and the method is characterized in that: in the process of conveying and filling the medical spring ring, the rigidity of the anti-unwinding part 2 is lower; after the completion of the packing, the stiffness of the anti-unscrewing member 2 is changed under the influence of the set triggering conditions applied to the spring ring, achieving a higher stiffness. The set trigger conditions include, but are not limited to, temperature changes, current changes, illumination changes, and chemical changes. The temperature change is, for example, a change of a human body temperature (36.0-37.8 ℃), a temperature change from a natural environment temperature (0-30 ℃), a refrigerating temperature (0-10 ℃) or a freezing temperature (-40-0 ℃) to the human body temperature, or a change after directly or indirectly contacting an external heat source (or a temperature change caused by heating of the external heat source). The change in current, such as applying an external current to the medical coil, or applying an affordable current to the body, causes the shape memory material to become stiffer, which in turn causes the medical coil to become less flexible, stiffer, and more stable in shape. The illumination change includes, for example, at least one of laser, ultraviolet light, and X-ray illumination applied to the shape memory material, and once the shape memory material receives enough illumination, the rigidity of the shape memory material is increased, thereby reducing the softness, increasing the rigidity, and stabilizing the shape of the medical spring coil. The shape memory material is contacted with human body fluid through chemical change, chemical liquid is infused into the human body from the outside through intravenous injection, the shape memory material is contacted with the chemical liquid, once the shape memory material is contacted with the human body fluid or the infused chemical liquid, the rigidity of the shape memory material is improved, and further the softness of the medical spring ring is reduced, the rigidity is improved, and the shape is more stable.

The medical spring coil of the embodiment comprises a first coil 1 with unchangeable rigidity and an anti-unwinding part 2 with the rigidity changeable under the set triggering condition, part or all of the anti-unwinding part 2 is made of a shape memory material with the rigidity changeable under the set triggering condition, the shape memory material can have smaller rigidity under the natural environment or the low-temperature environment, the softness of the medical spring coil is higher before and during the packing, the medical spring coil is in a softer state, the pressure on the tumor wall when the medical spring coil is packed can be reduced, the risk of aneurysm rupture is reduced, after the packing of the medical spring coil is finished, and when the set triggering condition (such as temperature change, illumination change, current change or chemical change) is applied to the medical spring coil, the shape memory material can be under the influence of the set triggering condition, the rigidity is enhanced, so that the softness of the medical spring ring is reduced, and the rigidity is improved, so that the shape of the packed medical spring ring is more stable, the blood flow impact is resisted, and the medical spring ring is not easy to compress. That is to say, the softness degree of the medical spring coil of this embodiment can change in the art and postoperative, can effectively satisfy the requirement of nerve intervention operation to the softness degree of spring coil and fill the requirement to spring coil rigidity after accomplishing.

As an example, the shape memory material in the present embodiment may be a nickel-titanium based shape memory alloy such as titanium-nickel, titanium-nickel-copper, titanium-nickel-iron, titanium-nickel-chromium, and the like. The initial transition temperature (i.e., the trigger temperature at which the stiffness can be significantly changed) of the shape memory alloy is low, typically between-10 ℃ and 10 ℃, and after heat treatment, the transition temperature of the shape memory alloy will rise to any point between 20 ℃ and 50 ℃, thereby obtaining the material with variable stiffness under the set trigger conditions in this embodiment. By selecting a particular combination of heat treatment parameters, a particular value of the final transition temperature of the shape memory alloy can be set, i.e., the heat-treated shape memory material can be used to make the corresponding portion of the anti-unwinding member of the spring coil capable of changing stiffness at the set transition temperature (i.e., the trigger condition), whereby the stiffness of the shape memory alloy transitions when the temperature of the environment in which the spring coil is located increases to greater than or equal to the transition temperature, as shown in: in the process of conveying and filling the medical spring ring, because the room temperature or the temperature in the micro catheter is lower, the rigidity of the anti-unwinding part 2 is in the range of 10 GPa-25 GPa, so that the rigidity (the softness is higher) of the medical spring ring is lower; after the packing is finished, when the temperature of the environment where the medical spring coil is located is increased to be greater than or equal to the transition temperature of the shape memory alloy (namely the temperature of the environment where the medical spring coil is located is changed from room temperature or the temperature in the micro catheter to the body temperature of a human body), the rigidity of the anti-unwinding part 2 is increased to 30 GPa-70 GPa, so that the medical spring coil achieves higher rigidity and more stable shape, and can resist blood flow impact and is not easy to compress.

It should be noted that in other embodiments of the present invention, the first coil 1 of the medical spring coil in fig. 1 may be replaced by a first coil made of a material with variable rigidity under the set triggering condition, and the anti-unscrewing member 2 may be made of a metal wire or a polymer wire, and may not have the capability of changing rigidity under the set triggering condition. So that the softness of the first coil 1 is changed under the above-mentioned set triggering conditions, thereby increasing the rigidity of the medical spring coil.

In other embodiments of the present invention, the first coil 1 of the medical spring coil in fig. 1 may be replaced by a first coil made of a material with a variable rigidity under the set triggering condition, so that the softness of the first coil 1 and the softness of the anti-unscrewing member 2 are changed under the set triggering condition, thereby changing the softness of the medical spring coil more significantly during and after the operation, for example, further improving the rigidity of the spring coil.

In addition, in other embodiments of the present invention, the material with variable rigidity under the set triggering condition in the first coil 1 and the material with variable rigidity under the set triggering condition in the anti-unscrewing part 2 are different, and the corresponding set triggering condition is also different, so that the first coil 1 and the anti-unscrewing part 2 can respectively change softness under different set triggering conditions, and further when the softness changing capability of the material with variable rigidity of one of the first coil 1 and the anti-unscrewing part 2 fails or cannot sufficiently realize the change of softness due to environmental restrictions, the softness changing capability of the material with variable rigidity is triggered to change the rigidity of the medical spring ring, thereby ensuring the embolotherapy effect of the medical spring ring and expanding the application range of the medical spring ring.

In addition, the present embodiments also provide a method for using a medical spring coil, comprising the steps of:

first, the medical coil is delivered to a designated location (not shown, typically a luminal lesion of the body, such as an aneurysm) by a delivery system (not shown) and released;

then, the medical spring ring is gradually formed into a basket at the designated position to form a three-dimensional structure; and the number of the first and second groups,

applying the set trigger condition to the medical spring coil during or after the formation of the basket of medical spring coils to increase the stiffness of the medical spring coil.

It should be noted that in this embodiment, the medical spring coil is in the first state (i.e., the less rigid state) when the set triggering condition is not applied, and the medical spring coil transitions to the second state when the set triggering condition is applied to the medical spring coil during or after the medical spring coil is in the basket, and the second state has a stiffness greater than the stiffness of the first state. Particularly, after the medical spring coil is formed into the basket, the medical spring coil already has a certain three-dimensional shape and structure, but the rigidity of the three-dimensional shape and structure is low, and some unnecessary deformation occurs after the medical spring coil is pressed by tissues and impacted by blood flow at the position of the aneurysm, at the moment, after the set triggering condition is applied to the medical spring coil formed into the basket, the three-dimensional shape and structure of the medical spring coil can not be changed, but the rigidity is increased, so that the unnecessary deformation caused by low rigidity can be avoided, and the spring coil can be enabled to conform to the shape of the aneurysm more stably. As used herein, a medical coil basket means that the medical coil forms a secondary coil structure having a three-dimensional shape during release of the medical coil at a desired location.

Example two

Referring to fig. 2, the present embodiment provides a medical spring coil, which is used for embolizing a lumen lesion site such as an aneurysm, and includes a first coil 1, where the first coil 1 may be a primary coil, such as a tubular spring structure, two ends of the first coil 1 are respectively connected with a connecting mechanism 3, and the connecting mechanism 3 is a tubular, cap-shaped or hook-shaped fastener, and is welded to two ends of the first coil 1 by a welding method, so as to enhance the mechanical performance of the medical spring coil; the connecting mechanism 3 may also be a structure formed by an adhesive, and is adhered to both ends of the first coil 1.

The medical coil of this embodiment differs from the medical coil of the first embodiment in that: the anti-unwinding member is omitted and part or all of the first coil 1 is made of a material whose stiffness is variable under a set triggering condition. The material with variable stiffness under the set trigger condition may be the same as in the first embodiment, and is not described herein again.

As an example, the material with variable stiffness under the set trigger condition in this embodiment may be a light-triggered shape memory polymer material obtained by introducing a cinnamic acid group into a side chain of an acrylate copolymer network by a radical copolymerization method, or in other words, the material with variable stiffness under the set trigger condition is a chemically treated material, and the set trigger condition is a light change. When the material is irradiated by visible light with the wavelength of less than 260nm, the decrosslinking effect can occur, and the material has low rigidity and Young modulus of about 1 GPa-10 GPa. When the spring ring is completely filled, ultraviolet light with the wavelength of 260nm is used for irradiating the spring ring (namely, the set triggering condition of light change is applied to the spring ring), the material in the spring ring generates a crosslinking effect, and under the influence of the crosslinking effect, the rigidity of the part made of the material in the spring ring is improved, and the Young modulus is increased to 15 GPa-30 GPa, so that the rigidity of the medical spring ring of the embodiment can be changed after the ultraviolet light irradiation, the structure is simpler, and the manufacturing cost is lower.

In addition, the embodiment also provides a use method of the medical spring ring, and the specific process is basically the same as that of the embodiment, and is not repeated herein.

EXAMPLE III

Referring to fig. 3, the present embodiment provides a medical coil for embolizing a lumen lesion, such as an aneurysm, having not only a first coil 1 but also a second coil 4. The first coil 1 may be wound from a metal wire, which may not have the ability to change its stiffness under a set triggering condition. The first coil 1 and the second coil 4 are both primary coils, for example, both are tubular spring structures, the outer diameter of the second coil 4 is smaller than the inner diameter of the first coil 1, and the second coil 4 is disposed in the first coil 1 (i.e., the second coil 4 is nested in the inner cavity of the first coil 1), and both ends (i.e., the proximal end and the distal end) of the second coil 4 are respectively fixedly connected with both ends (i.e., the proximal end and the distal end) of the first coil 1, i.e., the proximal end of the second coil 4 is fixedly connected with the proximal end of the first coil 1, and the distal end of the second coil 4 is fixedly connected with the distal end of the first coil 1. Wherein, the fixed connection mode includes but not limited to: 1) the first coil 1 and the second coil 4 are connected by a connecting mechanism 3, the connecting mechanism 3 is a tubular, cap-shaped or hook-shaped fastener, for example, and can fix the corresponding ends of the first coil 1 and the second coil 4 together by welding; 2) bonding by using an adhesive; 3) connect through mechanical connection modes such as interference fit, transition fit or clearance fit, and first coil 1 and second coil 4 except both ends, other positions can be connected, also can not connect.

The second coil 4 is formed by winding a wire, and all or part of the second coil 4 is made of a material with variable rigidity under a set trigger condition. The material with variable rigidity under the set trigger condition may be the same as those in the first and second embodiments, and is not described herein again.

The second coil 4 has an outer diameter in the range of 0.002 inch to 0.010 inch. In addition, the winding density of the second coil 4 may be less than that of the first coil 1, may be equal to that of the first coil 1, or may be greater than that of the first coil 1, that is, the number of coils of the second coil 4 per unit length may be less than, equal to, or greater than that of the first coil 1.

The medical spring coil of this embodiment differs from the medical spring coil of the first embodiment in that the anti-unwinding member is replaced with a second coil 4. In the embodiment, in the operation and after the operation, the rigidity change of the corresponding material of the second coil 4 can be triggered through the set triggering condition, so that the softness of the medical spring coil in the embodiment is changed in the operation and after the operation, and the requirements of the nerve interventional operation on the softness of the spring coil and the requirements on the rigidity of the spring coil after the completion of filling can be effectively met.

It should be noted that, in other embodiments of the present invention, the first coil 1 of the medical spring coil in fig. 3 may be replaced by a first coil made of a material with variable rigidity under the set triggering condition, so that the softness of the first coil 1 and the softness of the second coil 4 are changed under the triggering condition, thereby changing the softness of the medical spring coil during and after the operation.

Furthermore, in other embodiments of the present invention, the material of the first coil 1 with variable rigidity under the set triggering condition is different from the material of the second coil 4 with variable rigidity under the set triggering condition, and the corresponding set triggering condition is also different, so that the first coil 1 and the second coil 4 can change softness under different set triggering conditions, and further when the softness changing capability of the material of variable rigidity of one of the first coil 1 and the second coil 4 fails or cannot sufficiently change softness due to environmental restrictions, the softness changing capability of the other material with variable rigidity is triggered to change the rigidity of the medical spring ring, thereby ensuring the embolization treatment effect of the medical spring ring and expanding the application range of the medical spring ring.

In addition, the present embodiment further provides a method for using the medical spring coil, and the specific process is substantially the same as the method for using the medical spring coil in the first embodiment, and therefore, the detailed description thereof is omitted here.

Example four

Referring to fig. 4, the present embodiment provides a medical coil for embolizing a lumen lesion, such as an aneurysm, having not only a first coil 1 but also a second coil 4. The first coil 1 may be wound from a metal wire, which may not have the ability to change its stiffness under certain triggering conditions. The first coil 1 and the second coil 4 are both primary coils, for example, both are tubular spring structures, the inner diameter of the second coil 4 is larger than the outer diameter of the first coil 1, and the second coil 4 is sleeved outside the first coil 1, that is, the second coil 4 is arranged outside the first coil 1, and both ends (that is, the near end and the far end) of the second coil 4 are respectively fixedly connected with both ends (that is, the near end and the far end) of the first coil 1, that is, the near end of the second coil 4 is fixedly connected with the near end of the first coil 1, and the far end of the second coil 4 is fixedly connected with the far end of the first coil 1. Wherein, the fixed connection mode includes but not limited to: 1) the first coil 1 and the second coil 4 are connected by a connecting mechanism 3, the connecting mechanism 3 is a tubular, cap-shaped or hook-shaped fastener, for example, and can fix the corresponding ends of the first coil 1 and the second coil 4 together by welding; 2) bonding by using an adhesive; 3) the corresponding ends of the first coil 1 and the second coil 4 are connected together in a mechanical connection mode such as interference fit, transition fit or clearance fit, and the first coil 1 and the second coil 4 can be connected or not connected at other parts except two ends.

The second coil 4 has an outer diameter in the range of 0.010 inches to 0.0165 inches. In addition, the winding density of the second coil 4 may be less than that of the first coil 1, may be equal to that of the first coil 1, or may be greater than that of the first coil 1, that is, the number of coils of the second coil 4 per unit length may be less than, equal to, or greater than that of the first coil 1.

The medical coil of this embodiment differs from the medical coil of the third embodiment in that the second coil 4 is disposed outside the first coil 1. In the embodiment, in the operation and after the operation, the rigidity change of the corresponding material of the second coil 4 can be triggered through the set triggering condition, so that the softness of the medical spring coil in the embodiment is changed in the operation and after the operation, and the requirements of the nerve interventional operation on the softness of the spring coil and the requirements on the rigidity of the spring coil after the completion of filling can be effectively met.

It should be noted that, in other embodiments of the present invention, the first coil 1 of the medical spring coil in fig. 4 may be replaced by a first coil made of a material with variable rigidity under the set triggering condition, so that the softness of the first coil 1 and the softness of the second coil 4 are changed under the triggering condition, thereby changing the softness of the medical spring coil during and after the operation.

Furthermore, in other embodiments of the present invention, the material of the first coil 1 with variable rigidity under the set triggering condition is different from the material of the second coil 4 with variable rigidity under the set triggering condition, and the corresponding set triggering condition is also different, so that the first coil 1 and the second coil 4 can change softness under different set triggering conditions, and further when the softness changing capability of the material of variable rigidity of one of the first coil 1 and the second coil 4 fails or cannot sufficiently change softness due to environmental restrictions, the softness changing capability of the other material of variable rigidity is triggered to change the rigidity of the medical spring ring, thereby ensuring the embolization treatment effect of the medical spring ring and expanding the application range of the medical spring ring.

EXAMPLE five

Referring to fig. 5, the present embodiment provides a medical coil for embolization of a lumen lesion, such as an aneurysm, having not only a first coil 1 but also an anti-unwinding member 2 and a second coil 4. The first coil 1 may be wound from a metal wire, which may not have the ability to change its stiffness under certain triggering conditions. The first coil 1 and the second coil 4 are both primary coils, for example, both are tubular spring structures, the outer diameter of the second coil 4 is smaller than the inner diameter of the first coil 1, the second coil 4 is nested in the inner cavity of the first coil 1, the anti-unscrewing component 2 is arranged in the inner cavity of the second coil 4 along the axial direction of the second coil 4, and both ends (i.e., the proximal end and the distal end) of the second coil 4 and both ends (i.e., the proximal end and the distal end) of the anti-unscrewing component 2 are fixedly connected with both ends (i.e., the proximal end and the distal end) of the first coil 1 respectively. Wherein, the fixed connection mode includes but not limited to: 1) the first coil 1 and the second coil 4 are connected by a connecting mechanism 3, the connecting mechanism 3 is a tubular, cap-shaped or hook-shaped fastener, for example, and can fix the corresponding ends of the first coil 1 and the second coil 4 together by welding; 2) two ends of the anti-unwinding part 2 are respectively knotted at corresponding ends of the first coil 1 and the second coil 4; 3) bonding by using an adhesive; (4) through mode mechanical connection such as interference fit, transition fit or clearance fit, and first coil 1 and second coil 4 except both ends, other positions can be connected, also can not connect.

The second coil 4 is formed by winding a wire, and all or part of the second coil 4 is made of a material with variable rigidity under a set trigger condition. The second coil 4 has an outer diameter in the range of 0.002 inch to 0.010 inch. In addition, the winding density of the second coil 4 may be less than that of the first coil 1, may be equal to that of the first coil 1, or may be greater than that of the first coil 1, that is, the number of coils of the second coil 4 per unit length may be less than, equal to, or greater than that of the first coil 1.

The medical spring coil of the present embodiment is different from the medical spring coil of the third embodiment in that the anti-unscrewing member 2 is additionally arranged inside the second coil 4, so that the medical spring coil can maintain the tubular spring structure of the primary coil during the process of delivery or filling through the anti-unscrewing member, and further, the medical spring coil is helpful for forming and maintaining the three-dimensional shape of the secondary coil, and the embolization treatment effect is improved.

In the embodiment, in the operation and after the operation, the rigidity change of the corresponding material of the second coil 4 can be triggered through the set triggering condition, so that the softness of the medical spring coil in the embodiment is changed in the operation and after the operation, and the requirements of the nerve interventional operation on the softness of the spring coil and the requirements on the rigidity of the spring coil after the completion of filling can be effectively met.

It should be noted that, in other embodiments of the present invention, the first coil 1 and the anti-unscrewing member 2 of the medical spring coil in fig. 5 may be made of materials with variable rigidity under the set triggering condition alternatively or simultaneously to make a part or all of the structure, so that the first coil 1 and the anti-unscrewing member 2 change the flexibility alternately or simultaneously with the second coil 4 under the set triggering condition, thereby changing the flexibility of the medical spring coil during and after the operation.

In addition, in other embodiments of the present invention, two or more of the first coil 1, the anti-unscrewing part 2 and the second coil 4 are made of different materials with variable stiffness under the set triggering conditions, and the corresponding set triggering conditions are also different, so that the medical spring ring can change the flexibility under different set triggering conditions, and further when the flexibility of one of the first coil 1, the anti-unscrewing part 2 and the second coil 4 fails to change the flexibility or cannot sufficiently change the flexibility due to environmental restrictions, the flexibility of the other one or two other materials with variable stiffness is triggered to change the stiffness of the medical spring ring, thereby ensuring the embolotherapy effect of the medical spring ring and expanding the application range of the medical spring ring.

In addition, in other embodiments of the present invention, only one of the anti-unscrewing members 2 in fig. 5 may be replaced by a member made of a material whose rigidity is variable under the set triggering condition, and the second coil 4 may be replaced by a material which does not have the ability to change the rigidity under the set triggering condition, so that the softness of the anti-unscrewing member 2 is changed under the set triggering condition, and the rigidity of the medical spring coil is increased.

EXAMPLE six

Referring to fig. 6, the present embodiment provides a medical coil for embolization of a lumen lesion, such as an aneurysm, having not only a first coil 1 but also an anti-unwinding member 2 and a second coil 4. The first coil 1 may be wound from a metal wire, which may not have the ability to change its stiffness under certain triggering conditions. The first coil 1 and the second coil 4 are primary coils, for example, both are tubular spring structures, the inner diameter of the second coil 4 is larger than the outer diameter of the first coil 1, the second coil 4 is sleeved outside the first coil 1, the anti-unscrewing part 2 is arranged in the first coil 1 along the axial direction of the first coil 1, and both ends (namely, the near end and the far end) of the second coil 4 and both ends (namely, the near end and the far end) of the anti-unscrewing part 2 are fixedly connected with both ends (namely, the near end and the far end) of the first coil 1 respectively. Wherein, the fixed connection mode includes but not limited to: 1) the first coil 1 and the second coil 4 are connected by a connecting mechanism 3, the connecting mechanism 3 is a tubular, cap-shaped or hook-shaped fastener, for example, and can fix the corresponding ends of the first coil 1 and the second coil 4 together by welding; 2) two ends of the anti-unwinding part 2 are respectively knotted at corresponding ends of the first coil 1 and the second coil 4; 3) bonding by using an adhesive; (4) through mode mechanical connection such as interference fit, transition fit or clearance fit, and first coil 1 and second coil 4 except both ends, other positions can be connected, also can not connect.

The medical spring coil of the present embodiment is different from the medical spring coil of the fourth embodiment in that an anti-unwinding member 2 is additionally arranged in the first coil 1, so that the medical spring coil can maintain the tubular spring structure of the primary coil during the process of delivery or filling through the anti-unwinding member, and further, the medical spring coil is helpful for forming and maintaining the three-dimensional shape of the secondary coil, and the embolization treatment effect is improved.

It should be noted that, in other embodiments of the present invention, the first coil 1 and the anti-unscrewing member 2 of the medical spring coil in fig. 6 may be made of materials with variable rigidity under the set triggering condition alternatively or simultaneously to make a part or all of the structure, so that the first coil 1 and the anti-unscrewing member 2 change the flexibility alternately or simultaneously with the second coil 4 under the set triggering condition, thereby changing the flexibility of the medical spring coil during and after the operation.

In addition, in other embodiments of the present invention, two or more of the first coil 1, the anti-unscrewing part 2 and the second coil 4 are made of different materials with variable stiffness under different set triggering conditions, and the corresponding set triggering conditions are different, so that the medical spring ring can change softness under different set triggering conditions, and further when the changing capability of the softness of one of the materials with variable stiffness of the first coil 1, the anti-unscrewing part 2 and the second coil 4 fails or cannot sufficiently change the softness due to environmental restrictions, the changing capability of the softness of the other material with variable stiffness is triggered to change the stiffness of the medical spring ring, thereby ensuring the embolotherapy effect of the medical spring ring and expanding the application range of the medical spring ring.

It should be noted that, the first coil 1 and the second coil 4 in the above embodiments are both exemplified by the structure of a primary coil, but the technical solution of the present invention is not limited thereto, and the first coil 1 or the second coil 4 may also be a secondary coil structure having a specific three-dimensional shape, for example, a hexahedral structure.

It will be apparent to those skilled in the art that various changes and modifications may be made to the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims and their equivalents, the present invention is also intended to include such modifications and variations.

Claims

1. A medical spring coil, wherein at least a portion of the coil is formed of a material having a variable stiffness under a set triggering condition, and wherein the medical spring coil has a pre-manufactured first state that transitions to a second state under the set triggering condition, the second state having a stiffness greater than the stiffness of the first state.

2. The medical spring coil of claim 1, wherein the spring coil comprises a first coil, at least a portion of the first coil being formed from the material.

3. The medical spring coil of claim 1, wherein the spring coil includes a first coil and an anti-unscrewing member, the anti-unscrewing member being disposed inside the first coil, and both ends of the anti-unscrewing member being connected to both ends of the first coil, respectively; at least part of the first coil and/or at least part of the anti-unscrewing member is made of the material.

4. The medical spring coil of claim 1, wherein the spring coil includes a first coil and a second coil; the second coil is sleeved outside the first coil, or the first coil is sleeved outside the second coil; two ends of the second coil are respectively connected with two ends of the first coil; at least part of the first coil and/or at least part of the second coil is made of the material.

5. The medical spring coil of claim 1, wherein the spring coil includes a first coil, an anti-unwinding member, and a second coil; the second coil is sleeved outside the first coil, or the first coil is sleeved outside the second coil; the anti-unwinding component is arranged in the first coil and the second coil in a penetrating mode, and two ends of the anti-unwinding component and two ends of the second coil are respectively connected with two ends of the first coil; a portion or all of at least one of the first coil, the anti-unwinding member, and the second coil is made of the material.

6. The medical spring coil of any of claims 3-5, wherein the means of attachment includes at least one of attachment with an attachment mechanism, bonding with an adhesive, and knotting.

7. The medical coil of claim 3 or 5 wherein said anti-unwinding member is at least one strand of anti-unwinding wire, each strand of said anti-unwinding wire having a diameter of 0.0003 inch to 0.003 inch.

8. The medical spring coil of any of claims 1-5, wherein the material includes an alloy having shape memory properties and/or a polymeric material having shape memory properties.

9. The medical spring coil of claim 8, wherein the alloy is a nickel-titanium-based alloy, a copper-nickel-based alloy, a copper-aluminum-based alloy, a copper-zinc-based alloy, or an iron-based alloy; the high polymer material is polyethylene, polyisoprene, polyester, copolyester, polyamide, copolyamide or polyurethane.

10. The medical spring coil of any of claims 1-5, wherein the set trigger condition includes at least one of a change in temperature, a change in current, a change in light, and a change in chemistry.

11. The medical coil of claim 10, wherein said temperature change is a change from a natural ambient temperature, a refrigerated temperature, or a frozen temperature to a human body temperature, or a change in temperature upon direct or indirect contact with a heat source; the illumination variation comprises applying at least one of laser, ultraviolet light, X-ray illumination to the material; the chemical change comprises the material contacting a body fluid of a human, and/or the material contacting a chemical liquid.

12. The medical spring coil of any of claims 1-5, wherein the material is treated by a particular process, the particular process including at least one of heat treatment, cold treatment, electrical treatment, optical treatment, and chemical treatment.

13. The medical spring coil of any of claims 1-5, wherein the set trigger condition is applied to the spring coil during or after the spring coil is formed into a basket.