CN114081570A

CN114081570A - Spring ring for embolism aneurysm and blood vessel

Info

Publication number: CN114081570A
Application number: CN202111492385.4A
Authority: CN
Inventors: 文世昌
Original assignee: Hangzhou Tuomai Medical Technology Co ltd
Current assignee: Hangzhou Tuomai Medical Technology Co ltd
Priority date: 2021-12-08
Filing date: 2021-12-08
Publication date: 2022-02-25
Anticipated expiration: 2041-12-08
Also published as: CN114081570B

Abstract

The application discloses a spring coil for embolizing aneurysm and blood vessel, include: the spiral main body adopts a spiral spring framework or a spiral twisted framework; an external mesh grid connected to the spiral body in a knot structure or locally shrunk onto the spiral body by heat treatment; during release of the coil in an aneurysm or vessel, the outer mesh fabric is expanded outwardly to increase the efficiency of filling in the aneurysm or vessel and prevent or slow the flow of blood in the aneurysm or vessel. The invention has the beneficial effects that: the external woven mesh is in a convex shape at intervals, so that the filling efficiency in aneurysms and blood vessels is improved, and the filling space of the spring ring in unit length is enlarged; outside woven mesh has multiple structural feature, can play the effect of abundant packing, and woven mesh disconnection point plays fixed action in aneurysm, blood vessel for it is higher to release in-process spring coil stability, and intertwine's efficiency is higher, increases the resistance between space and spring coil and aneurysm wall, the vascular wall, and the structure is more stable.

Description

Spring ring for embolism aneurysm and blood vessel

Technical Field

The application relates to the technical field of medical equipment, in particular to a spring ring for embolizing aneurysms and blood vessels.

Background

Intracranial aneurysms are a neoplastic protrusion of the arterial wall resulting from the localized abnormal enlargement of the internal cavity of the cerebral artery. The intracranial aneurysm is mainly caused by cystic bulging on the basis of congenital defects of local cerebral artery walls and increased pressure in cavities, and is the first cause of subarachnoid hemorrhage.

At present, a treatment scheme aiming at the aneurysm mainly adopts two means, one is craniotomy, the workload of the scheme is large, the operation difficulty is higher, generally, the first pushing is not performed, and the other is that the spring ring is used for carrying out aneurysm interventional embolization treatment. When the spring ring is stable in the aneurysm cavity, the connection between the push rod and the spring ring is released, when blood flows into the aneurysm, a plurality of small vortexes are formed at the edge of the aneurysm wall, so that the blood flow speed is reduced, the blood stops in a short time, and thrombus is formed, so that the pressure in the aneurysm is obviously reduced, and the rupture probability is very low.

Currently, there are a lot of spring coils produced by companies and the price varies greatly. The spring ring is mainly seen by the operator as the price and the use effect, the price of the spring ring is very high due to materials such as platinum-tungsten alloy, the weight of the spring ring made of platinum-tungsten alloy is relatively large, and the spring ring is high in stability, but the packing efficiency of the spring ring is generally high and the recurrence probability is high. The use of coils is more of a concern regarding packing rate and stability, especially the prevention of displacement and escape of the coil during release, is a problem that must be addressed.

Disclosure of Invention

In order to solve the technical problems, the embodiment of the application provides a coil for embolization aneurysms and blood vessels, which has high packing rate and extremely low escape rate.

The embodiment of the application provides a spring coil for embolizing aneurysm and blood vessel, which comprises:

the spiral main body adopts a spiral spring framework or a spiral twisted framework, and the outer surface of the spiral main body forms a spiral shape;

an outer mesh grid woven from woven filaments; the external woven net is connected with the spiral main body in a knot structure; or one part of the external woven mesh is shrunk to the outer surface of the spiral framework of the spiral main body through heat treatment, and the other part of the external woven mesh surrounds the outer surface of the spiral framework and is in an open state.

In the conveying process, the external braided net is compressed in the conveying guide pipe by applying acting force in the radial direction; when the coil is delivered to the aneurysm and released from the blood vessel, the external woven mesh is expanded outwards to improve the filling efficiency in the aneurysm and the blood vessel, prevent or slow down the blood flow in the aneurysm and the blood vessel, and enlarge the filling space of the coil with unit length.

Further, when the spiral main body adopts a spiral spring framework, the external woven mesh is connected with the spiral spring framework in a rope knot structure, a rope knot node is exposed out of the spring framework or hidden in a spring hole of the spring framework, and the structure of the rope bundle can be a woven mesh or a parallel binding or twisting binding shape of a plurality of strands of wires.

Further, when the spiral main body adopts a spiral spring framework, a core wire is arranged inside the spiral spring framework, the core wire is made of plastic wires or metal wires, the outer woven mesh is connected with the core wire in a rope knot structure, rope knot nodes are exposed out of the spring framework or hidden in spring holes of the spring framework, and the rope knot is sleeved on the spring wire or the core wire of the spiral spring framework or the rope knot sleeves the spring wire and the core wire together.

Further, the knot structure is formed by weaving a net shape or a parallel binding of a plurality of strands of wires or a twisting binding of a plurality of strands of wires.

Further, when the spiral main body adopts the spiral twisted framework, after the external woven mesh penetrates through the spiral main body, at least one region is locally shrunk into the spiral groove on the outer surface of the spiral main body through heat treatment, the spiral structure of the spiral main body is held tightly, and acting force for preventing the external woven mesh from sliding relative to the spiral main body is generated.

Further, the spirally twisted skeleton is twisted by one strand of wire to form a single-strand spirally twisted skeleton or is twisted by at least two strands of wire to form a multi-strand spirally twisted skeleton.

Further, the wire adopted by the single-stranded spirally twisted framework is flat and strip-shaped in the original state, the cross section of the wire is oval or polygonal, and the wire is twisted to form the single-stranded spirally twisted framework;

the multi-strand spiral twisted skeleton adopts wire materials which are in a strip shape in an original state and have circular or elliptical or polygonal sections, and the wire materials are parallelly overlapped into a bundle shape and then are twisted to form the multi-strand spiral twisted skeleton.

Furthermore, the outward-opening part of the external mesh grid can be partially cut off or completely cut off, and the weaving structure of the external mesh grid at the cut-off part after cutting off is broken, so that a plurality of disorderly mesh grid breaking points are formed; the woven mesh disconnection points prevent or slow the flow of blood in the aneurysm, blood vessel.

Further, the material of the outer woven mesh is a plastic material, including polypropylene or polyethylene or nylon or a degradable material.

Further, the spring ring still includes:

a developing part located at a distal end of the spiral body and made of a developing material; the outer diameter of the spirally twisted bobbin is not larger than the outer diameter of the developing portion.

Further, the spring ring still includes:

the releasing mechanism is positioned at the proximal end of the spiral main body and is used for connecting the conveying mechanism; the release mechanism and the conveying mechanism form a release mechanism, and when the spring ring is conveyed to the lesion position of the aneurysm and the blood vessel, the release mechanism is separated from the conveying mechanism, so that the spring ring is released.

Further, the release mechanism is integrally formed or welded with the proximal end of the spiral body through a bracket rib.

The invention has the beneficial effects that:

1: the external woven mesh is in a convex shape at intervals, so that the filling efficiency in aneurysms and blood vessels is improved, and the filling space of the spring ring in unit length is enlarged;

2: the external woven mesh has various structural characteristics and can play a role in full filling, and the disconnection points of the woven mesh play a role in fixing the aneurysm and the blood vessel, so that the stability of the spring rings is higher in the releasing process, the mutual winding efficiency is higher, the filling space is increased, the resistance among the spring rings and between the spring rings and the aneurysm wall and the blood vessel wall is increased, and the structure is more stable;

3: on the basis of the structure of the spring ring, the plastic wire is adopted as the material, so that the overall quality is reduced, but the stability of the spring ring is guaranteed due to the structural characteristics, the efficiency of the spring ring in operation is guaranteed, and the input cost of the whole spring ring is reduced.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

FIG. 1 is a schematic view of a coil of the present application inside an aneurysm;

FIG. 2 is a schematic view of the spring coil of the present application in a straightened condition;

FIG. 3 is another angle schematic view of the spring coil of the present application in a straightened condition;

FIG. 4 is a schematic view of a proximal ball and helical body integrally formed version;

FIG. 5 is a schematic view of a proximal ball and helical body weld forming scheme;

FIG. 6 is a schematic view of a partial connection of an outer woven mesh to a helical body;

FIG. 7 is a schematic view of the partial connection of the spiral body to the developing section in region I of FIG. 4;

FIG. 8 is a schematic view of a spiral body and development section integrated scheme;

FIG. 9 is a schematic structural diagram of a region II of FIG. 8;

FIG. 10 is a schematic structural view of a single-stranded helically twisted scaffold;

FIG. 11 is a partial structural view of region III of FIG. 10;

FIG. 12 is a schematic structural view of a multi-stranded helically twisted scaffold;

FIG. 13 is a partial structural view of the region IV in FIG. 12;

FIG. 14 is a partial schematic structural view of an outer woven mesh;

FIG. 15 is another angular schematic of FIG. 14;

FIG. 16 is a partial structural view of the region V in FIG. 14;

FIG. 17 is a schematic view of the construction of the outer netting in a non-cutting configuration;

FIG. 18 is a schematic view of another angular configuration of the outer netting in a non-cutting configuration;

FIG. 19 is a schematic structural diagram of the spiral body of FIG. 17 employing a single-strand spiral twisted backbone design;

FIG. 20 is a schematic view of another angular configuration of the spiral body of FIG. 17 employing a single-strand spiral twisted backbone design;

FIG. 21 is a schematic view of an outer mesh grid connected to a spiral body in a knotted configuration;

FIG. 22 is a schematic view of a portion of the structure of region II of FIG. 21;

FIG. 23 is a schematic structural view of a knotting scheme of an outer woven mesh and a core wire;

FIG. 24 is a schematic view of a knotted construction of the outer netting alone;

fig. 25 is a partial structural view of the region IV in fig. 24.

The meaning of the reference symbols in the figures:

001-helix body, 002-outer woven mesh, 003-development part, 004-proximal ball, 005-rib, 006-constriction part, 007-bulge, 008-break point, 009-core wire, 010-spring, 011-wire, a-distal end, b-proximal end, L1-outer diameter of helix body, L2-outer diameter of development part.

Detailed Description

In order to make the purpose, features and advantages of the present application more obvious and understandable, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the embodiments described below are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

The invention is further elucidated with reference to the drawings and the embodiments.

In the description of the present application, it is to be understood that the terms "upper", "lower", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, are only for convenience in describing the present application and simplifying the description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present application.

The near-far in the present application is based on an operator, the near-near end is a direction close to the operator, and the far-far end is a direction far from the operator.

As shown in fig. 1-3, the coil for embolizing an aneurysm or blood vessel according to the present application comprises a helical body 001, a visualization portion 003, a proximal ball 004, and an outer braided mesh 002.

Whole spiral body 001 adopts coil spring skeleton or spiral distortion skeleton, and the surface forms spiral helicine scheme to go to cooperate with outside mesh grid 002. The external mesh grid 002 is connected with the spiral main body 001 in a knot structure or a part of the external mesh grid is locally shrunk to the outer surface of the spiral skeleton of the spiral main body through heat treatment, and the other part of the external mesh grid is in an open state around the outer surface of the spiral skeleton. The external woven mesh 002 is stretched outwards to play a role in stopping the flow of blood in an aneurysm and a blood vessel or slowing down the flow of blood, and the external woven mesh 002 can be contracted in both the axial direction and the radial direction so as to be contracted in the outer sleeve.

No matter what connection method the external mesh (002) is connected with the spiral body (001), the part extending to the outside can be cut off, the knitting structure of the mesh at the cut-off part is broken after cutting off, the knitting silk at the cut-off part forms a plurality of disorderly mesh break points, and the mesh break points have the function of stopping blood flow or slowing down blood flow in aneurysms and blood vessels.

For example, when the external mesh (002) is connected to the lower part of the spiral body (001) in a knot structure, the structure extending outwards forms a closed loop and expands towards the outside of the spiral spring skeleton to protrude out of the spiral spring skeleton, so that the effects of stopping blood flow or slowing down blood flow can be generated in an aneurysm and a blood vessel. In this way, the closed loop can be cut open to form braided mesh disconnection points in a disordered state, and the scattered braided mesh disconnection points can also play a role in stopping the blood flow in an aneurysm and a blood vessel or slowing down the blood flow.

In another embodiment, a portion of the outer braided mesh 002 is heat treated to locally contract to the outer surface of the helical backbone of the helical body 001, and the other portion of the outer braided mesh is in an open state around the outer surface of the helical backbone, which can generate a blood flow stopping or slowing effect in an aneurysm or blood vessel. In this manner, even if the part opened to the outside is cut open, and even if a part of the part is cut open to form an opening or the whole part is cut open to form two structures similar to a trumpet-shaped structure, the braided mesh break points in a disordered state can be formed, and the scattered braided mesh break points can also have the function of stopping or slowing down the blood flow in the aneurysm or the blood vessel.

The spiral body 001 in this application adopts three kinds of modes: a spiral spring skeleton, a single-strand spiral twisted skeleton and a multi-strand spiral twisted skeleton.

The first embodiment is as follows: as shown in fig. 21-22.

In this embodiment, the spiral body 001 is a spiral spring frame (a spiral rising structure mainly including a spring), and the outer mesh braid 002 is connected to the spiral body 001 in a knotted structure.

The whole framework is made of spring materials, the external woven mesh 002 is knotted on the spring wire 011, and the nodes are exposed out of the spring framework. Each knot of the outer mesh (002) extends outward with two mesh break points (008) to stop the flow of blood in the aneurysm and blood vessel or slow down the flow of blood.

Example two: as shown in fig. 23.

In this embodiment, the spiral main body 001 adopts a spiral spring skeleton (a spiral ascending structure using a spring as a main body), the core wire 009 is arranged inside the spiral spring skeleton, the core wire 009 is made of plastic wire or metal wire, the external mesh grid 002 is connected with the core wire 009 through a knot structure, and the knot nodes are sleeved on the core wire of the spring inner cavity of the spiral spring skeleton. Each knot of the outer mesh (002) extends outward with two mesh break points (008) to stop the flow of blood in the aneurysm and blood vessel or slow down the flow of blood.

In the first and second embodiments, the outer woven mesh 002 and the spiral body 001 are knotted in a multi-layer manner as shown in fig. 24-25, and the rope bundle can be in a woven mesh or a twisted binding manner with a plurality of wires. The knot point of the rope is exposed out of the spring framework or hidden in the spring hole of the spring framework, and the knot point of the rope can be one end or a plurality of ends. But is not limited to this, and any other knotting method that can maintain fixation may be substituted.

Example three: as shown in fig. 7, 10, 11.

In this embodiment, the spiral body 001 adopts a single-stranded spirally twisted skeleton, and the spiral body 001 adopts a strand of filament 011 to be twisted into a spiral twisted shape. The outer diameter L1 of the spiral twisted spiral body is not larger than the outer diameter L2 of the developing part. The wire 011 is in a flat strip shape in the original state. The cross section of the device can be rectangular or oval or polygonal.

As shown in FIGS. 10-11, when a single-stranded wire 011 is selected, the two ends of the helical body 001 are reversely twisted into a helical twisted shape to form a single-stranded helically twisted skeleton. The twisted structure that single strand silk material 011 formed, its side can form a top-down spiral groove, and when connecting portion shrunk, can laminate each other better, and the fastness is higher. After the external woven mesh 002 passes through the spiral main body, at least one region is locally contracted into the spiral groove on the outer surface of the spiral main body through heat treatment, and the spiral structure of the spiral main body 001 is held tightly, so that acting force for preventing the external woven mesh 002 from sliding relative to the spiral main body 001 is generated.

Example four: as shown in fig. 12-13.

In this embodiment, the spiral body 001 adopts a multi-strand spiral twisted skeleton, and the filament 011 is in a strip shape in its original state, and its cross section may be circular, rectangular, elliptical or polygonal. When the spiral main body 001 is made of a plurality of strands of silk materials 011, the silk materials 011 are parallelly overlapped into a bunch shape, and then two ends of the bunch-shaped spiral main body 001 are reversely twisted to form a spiral twist shape. After the external woven mesh 002 penetrates through the spiral main body, at least one region is locally contracted into the spiral groove on the outer surface of the spiral main body through heat treatment, the spiral structure of the spiral main body 001 is tightly held, acting force for preventing the external woven mesh 002 and the spiral main body 001 from sliding relatively is generated, the twisted structure is formed by a plurality of strands of silk materials 011, and the rigidity of the spiral main body 001 per se is improved relative to a single strand.

The selection of the third embodiment and the fourth embodiment can be selected according to the aneurysm and the blood vessel to be filled.

In the spirally twisted skeleton structures of the third and fourth embodiments, the outer mesh braid 002 is not connected to the spiral body 001 in a knot manner but is woven by a plurality of woven filaments in a combined weaving manner of a combination of a left-hand weaving and a right-hand weaving, as shown in fig. 14 to 16, nodes form a distribution in a one-layer pattern, and in adjacent two layers, the filament length between the nodes of the left layer and the nodes of the right layer are the same so that no protrusion is generated when the constriction portion 006 is constricted.

The entire outer mesh (002) is first woven with filaments into a hollow tubular mesh structure. The constrictions 006 and projections 007 are separated on the outer woven mesh 002, wherein the constrictions 006 are locally constricted inwardly to the spiral body 001 upon heat treatment, and the projections 007 are other areas of projections formed upon constriction of the constrictions 006.

The boss 007 is compressible in the radial direction by the applied force in the free state. In the initial state, the protrusion 007 is contracted in the sleeve, and under the pushing of the conveying mechanism, the widest end of the diameter of the protrusion area forms a support area after protruding from the sleeve so as to exert acting force for preventing the spring coil from escaping in an aneurysm and a blood vessel, so that the stability of the spring coil in the releasing process is higher, the mutual winding efficiency is higher, and the filling space is increased.

In this application, there are two kinds of schemes for the projecting part 007 of the external mesh grid 002:

example five: as shown in fig. 17-18.

After constriction 006 has been constricted, protrusions 007 form a structure like that of fig. 17-18, similar to a gyroscope, and by virtue of the widest edge of protrusions 007 acting as a support region, protrusions 007 extend outwardly to act as a stop to, or slow down the flow of blood within, an aneurysm or vessel when released into the aneurysm or vessel.

Example six: as shown in fig. 2-3.

The middle region of the protrusion 007 is cut off to form a set of open structures. The opening edge thereof is formed with a plurality of mesh break points 008, and these mesh break points 008 may be distributed in a disordered manner. The broken areas have certain gaps to prevent the relative mesh break points 008 from interfering.

For embodiment five, the mesh grid disconnection point 008 that this embodiment produced can improve the abundant filling effect of whole spring coil, and mesh grid disconnection point plays fixed action in aneurysm, blood vessel for spring coil stability is higher in the release process, and intertwine's efficiency is higher, and increase filling space increases between the spring coil and the resistance between spring coil and aneurysm wall, the vascular wall, and the structure is more stable.

Of course, the entire middle area of the protrusion 007 may not be completely cut off, and the cut-off portion may also form some mesh-grid disconnection points 008 at the edge, which may also serve to prevent or slow the flow of blood in the aneurysm and blood vessel.

As a specific example, the position of the braided mesh disconnection point 008 protrudes from the contraction part 006 and extends outward, so that in the aneurysm and the blood vessel, the braided mesh disconnection point 008 generates a force with an external area as much as possible to prevent the blood flow in the aneurysm and the blood vessel or slow down the blood flow.

The material of the filament is plastic filament or PP or nylon or degradable material.

As a specific example, the developing part 003 is provided at the distal end a of the spiral body 001, and the surface thereof is coated with a developing material or directly made of a developing material. The developing section 003 serves as the most initial end of the entire coil spring, and the head portion thereof has a spherical shape to reduce the advancing resistance. Specifically, a spring 010 is provided at the rear end of the developing section 003 for the purpose of making the conveyance more flexible.

As a specific example, the proximal end b of the spiral body 001 is provided with a proximal ball 004, which is connected to the proximal end of the spiral body 001 by a rib 005 for connection to a delivery mechanism. As shown in fig. 4, the rib 005 and the spiral body 001 are made of the same material and integrally formed. As shown in fig. 5, the proximal ball 004 is connected to the rib 005 by welding.

Although the preferred embodiments of the present invention have been described in detail, the present invention is not limited to the details of the foregoing embodiments, and various equivalent changes (such as number, shape, position, etc.) may be made to the technical solution of the present invention within the technical spirit of the present invention, and the equivalents are protected by the present invention.

Claims

1. A coil for embolizing an aneurysm and a blood vessel, comprising:

an outer mesh grid woven from woven filaments; the external woven net is connected with the spiral main body in a knot structure; or one part of the external woven mesh is locally shrunk to the outer surface of the spiral framework of the spiral main body through heat treatment, and the other part of the external woven mesh surrounds the outer surface of the spiral framework and is in an open state;

during the conveying process, the outer woven mesh is compressed in the conveying guide pipe by applying acting force in the radial direction; when the coil is delivered to the aneurysm and released from the blood vessel, the outer woven mesh is expanded outwards to improve the filling efficiency in the aneurysm and the blood vessel, prevent or slow down the blood flow in the aneurysm and the blood vessel, and enlarge the filling space of the coil per unit length.

2. The embolic aneurysm, vascular spring coil of claim 1, wherein the outer mesh is attached to the coil spring scaffold in a knot configuration when the coil body is a coil spring scaffold, the knot point being exposed from the spring scaffold or hidden within a spring hole of the spring scaffold.

3. The embolic aneurysm, vascular spring coil of claim 1, wherein when the helical body is a helical spring skeleton, a core wire is disposed inside the helical spring skeleton, the core wire is made of plastic wire or metal wire, the outer mesh grid is connected to the core wire in a knot structure, the knot point is exposed outside the spring skeleton or hidden in the spring hole of the spring skeleton, and the knot is sleeved on the spring wire or the core wire of the helical spring skeleton or the knot puts the spring wire and the core wire together.

4. The embolic aneurysm, vascular coil of claim 1, wherein said knotted structure is formed by braiding a mesh or parallel binding of multiple filaments or twist binding of multiple filaments.

5. The embolic aneurysm, vascular coil of claim 1, wherein the helical body comprises a helically twisted backbone, wherein after the outer woven mesh has passed through the helical body, at least one region is heat treated to partially shrink into the helical groove of the outer surface of the helical body, thereby gripping the helical structure of the helical body and generating a force that resists relative sliding movement of the outer woven mesh and the helical body.

6. The embolic aneurysm, vascular coil of claim 5, wherein the helically twisted scaffold is twisted from one strand of wire to form a single-strand helically twisted scaffold or from at least two strands of wire to form a multi-strand helically twisted scaffold.

7. The embolic aneurysm, vascular spring coil of claim 6, wherein said single-stranded helically-twisted scaffold is a wire that is flat, ribbon-like in its original state, and has an oval or polygonal cross-section, and is twisted to form the single-stranded helically-twisted scaffold;

8. The embolic aneurysm, vascular coil of any of claims 1-7, wherein the outwardly flaring portion of the outer mesh is partially or completely severed, and the braided structure of the outer mesh at the severed site is broken to form a plurality of disorganized mesh discontinuities; the woven mesh disconnection points prevent or slow blood flow within the aneurysm, vessel.

9. The embolic aneurysm, vascular coil of claim 8, wherein the material of the outer woven mesh is a plastic material comprising polypropylene or polyethylene or nylon or a degradable material.

10. The embolic aneurysm, vascular coil of claim 1, further comprising: