CN116077126B - Vascular occlusion device, manufacturing method and installation method thereof - Google Patents

Abstract

The present invention belongs to the technical field of medical devices, and specifically relates to a vascular occluder and a manufacturing method and installation method thereof. The manufacturing method of the vascular occluder includes: using an outer woven structure with a hollow inner cavity, inserting a non-divergent occluding structure into the hollow inner cavity of the outer woven structure along the axial direction of the outer woven structure; the occluding structure includes a plurality of non-metallic flexible strips in a strip shape, and each flexible strip extends along the axial direction of the outer woven structure; using a fixed sleeve to fix the first end of the outer woven structure and the first end of the occluding structure; diverging the occluding structure so that the middle part of the occluding structure is intertwined with each other and divergently filled in the entire inner cavity of the outer woven structure; using another fixed sleeve to fix the second end of the outer woven structure and the second end of the occluding structure. Since the occluding structure of the present invention includes a plurality of non-metallic flexible strips, the embolization efficiency can be significantly improved on the basis of reducing the amount of metal used.

Description

Vascular occluder and its manufacturing method and installation method

Technical Field

The present invention belongs to the technical field of medical devices, and in particular relates to a blood vessel occluder and a manufacturing method and an installation method thereof.

Background technique

Transcatheter arterial embolization is one of the most important basic techniques in interventional radiology. It is a technique that injects or delivers embolic material into the target blood vessel through a catheter under X-ray fluoroscopy to occlude the blood vessel and achieve the desired treatment purpose. This technique is minimally invasive, fully image-guided, and target vessel selective, which greatly enhances the accuracy and controllability of embolism and becomes a revolutionary clinical treatment method.

The embolic material is injected into the blood vessel through the catheter, and the blood vessel is then embolized, which in turn has varying degrees of impact on the target blood vessel, target organ and local flow dynamics.

The vascular occluders in the prior art generally use metal spring coils. Usually, such embolic substances can enter the human blood vessels through the small inner diameter of the catheter, expand or coil into shape in the blood vessels after leaving the catheter, and are mostly used to embolize blood vessels or hemangioma cavities (3 to 15 mm) that are much larger than the diameter of the catheter. For example, the vascular occluder type publication number TW362007B discloses an implantable vascular occlusion device, which discloses a vascular occlusion device woven from a multi-metal mesh design of superelastic, self-expanding memory alloy wire. The multi-layer metal mesh design increases the density of the metal wire and increases the interference with the blood flow; at the same time, a variety of sizes can be adapted to different blood vessels. However, this vascular occlusion device has a large metal content, and long-term placement in the human body will cause metal poisoning in the human body. In addition, due to the large mesh gaps between the metal wires, the hemostasis is insufficient.

Therefore, it is necessary to carry out a new design to overcome the above-mentioned shortcomings.

Summary of the invention

The present invention aims to provide a vascular occluder and a manufacturing method and an installation method thereof, in order to solve the technical problems that the mesh gaps between the metal wires of the prior art vascular occluder are large, the hemostasis is insufficient, and the metal content is too high, which may lead to metal poisoning in the human body.

The method for making a vascular occluder comprises the following steps:

S1, using an outer braided structure with a hollow inner cavity, inserting a non-divergent blocking structure into the hollow inner cavity of the outer braided structure along the axial direction of the outer braided structure;

The blocking structure comprises a plurality of long non-metallic flexible strips, each of which extends along the axis direction of the outer braided structure;

S2, fixing the first end of the outer braided structure and the first end of the blocking structure by using a fixing sleeve;

S3, performing a divergent treatment on the blocking structure, so that the middle parts of the blocking structure are mutually entangled and divergently filled in the entire inner cavity of the outer braided structure;

S4, using another fixing sleeve to fix the second end of the outer braided structure and the second end of the blocking structure.

In one embodiment, the outer braided structure is woven with memory metal wires, the outer braided structure is braided and formed with memory metal wires, and after the braiding is completed, the hollow inner cavity is formed in the outer braided structure by heat setting, and the inner diameter of the hollow inner cavity is greater than the inner diameters of the first end and the second end of the outer braided structure;

In step S3, when the blocking structure is subjected to a divergent treatment, the second end of the outer braided structure is pulled back and forth, so that the blocking structures are mutually entangled and divergently filled in the entire inner cavity of the outer braided structure.

In one embodiment, when the blocking structure is subjected to divergent treatment, the specific steps of pulling the second end of the outer braided structure back and forth so that the blocking structures are mutually entangled and divergently filled in the entire inner cavity of the outer braided structure are as follows:

Step V1: driving the distal end of the outer braided structure to move away from the proximal end of the outer braided structure, so that the outer braided structure covers more of the flexible strips, loosening the distal end of the outer braided structure, and causing the distal end of the outer braided structure to rebound, so that the flexible strips are divergently collected into the outer braided structure;

Repeat the above step V1 for multiple times until the flexible strips are intertwined and divergently filled in the entire inner cavity of the outer braided structure;

And\or, in step S3, when the blocking structure is subjected to divergence treatment, the flexible strips are spread out with a tool.

In one embodiment, in step S1, the proximal end of the outer braided structure has a proximal convergent segment of a preset length, and the distal end of the outer braided structure has a distal convergent segment of a preset length. After the blocking structure passes through the middle channel of the outer braided structure, at least the blocking structure of the preset length is located in the proximal convergent segment. Preferably, the blocking structure has a preset distance from the proximal end of the proximal convergent segment.

In step S2, before the fixing sleeve is used for fixing, the outer braided structure and the blocking structure overlapped in the proximal bundling section are bundled and bundled using a proximal bundling piece, and the bundles are bundled and bundled to the proximal end of the proximal bundling section, the fixing sleeve is arranged outside the proximal bundling piece, and the outer braided structure and the blocking structure on the proximal side of the fixing sleeve are completely removed;

and\or, in step S1, the blocking structure passes through the middle channel of the outer woven structure by folding a flexible strip in half or back and forth in the middle channel;

and\or, in step S2, after the fixing sleeve is used for fixing, the fixing sleeve is also placed in the proximal steel sleeve for press-fitting and fixing;

and\or, in step S3, after the blocking structure is diverged, it is ensured that at least a preset length of the blocking structure is located within the distal convergence segment, preferably, the blocking structure has a preset distance from the distal end of the distal convergence segment;

In step S4, before the fixing sleeve is used for fixing, the outer braided structure and the blocking structure overlapped in the distal bundling section are bundled and bundled by a distal bundling piece, and the bundles are bundled and bundled to the distal end of the distal bundling section, the fixing sleeve is arranged outside the distal bundling piece, and the outer braided structure and the blocking structure on the distal side of the fixing sleeve are completely removed;

And\or, in step S4, after the fixing sleeve is used for fixing, the fixing sleeve is also placed in the distal steel sleeve for press-fitting and fixing.

The present invention also provides a blood vessel occluder, comprising:

an outer braided structure having a hollow inner cavity;

A blocking structure, a plurality of long flexible strips, each of which extends along the length direction of the outer braided structure, and the middle parts of each of which are intertwined and divergently filled in the inner cavity;

Two fixing sleeves, one fixing sleeve is fixed to the first end of the outer braided structure and the outside of the first end of the blocking structure, and the other fixing sleeve is fixed to the second end of the outer braided structure and the outside of the second end of the blocking structure.

In this embodiment, in the process of dispersing the blocking structure in the outer braided structure, the undispersed blocking structure may first be passed through the hollow inner cavity of the outer braided structure along the axial direction of the outer braided structure;

The second end of the outer braided structure is pulled back and forth, so that the blocking structures are entangled with each other and divergently filled in the entire inner cavity of the outer braided structure.

In this embodiment, the outer braided structure is braided and formed by nickel-titanium wire, and the hollow inner cavity is formed by heat setting, and the inner diameter of the hollow inner cavity is larger than the inner diameters of the first end and the second end of the outer braided structure;

The vascular occluder includes N outer braided structures, the first end of the outer braided structure of the i-th section is connected to the second end of the outer braided structure of the i+1-th section, N is a natural number greater than or equal to 2, and i is a natural number greater than or equal to 1.

In this embodiment, the first end and the second end of the outer braided structure clamp each of the flexible strips.

In this embodiment, the overlapping part of the proximal end of the outer braided structure and the proximal end of the blocking structure is restrained by a proximal restraining member, and a fixing sleeve is arranged outside the proximal restraining member;

The overlapping portion between the distal end of the outer braided structure and the distal end of the blocking structure is restrained by a distal restraining member, and another fixing sleeve is disposed outside the distal restraining member;

And\or, the vascular occluder further comprises:

A proximal steel sleeve, with an internal thread at the proximal end, the proximal steel sleeve is pressed onto the outside of the proximal fixed sleeve;

A distal steel sleeve, pressed onto the outside of the distal fixed sleeve;

And\or, the outer braided structure is braided and shaped by metal wires, the metal wires are one or more of nickel-titanium alloy, cobalt-chromium alloy and platinum-iridium alloy, and the diameter of the metal wires is 0.02 mm to 0.15 mm;

And\or, the flexible strip is one or more of polytetrafluoroethylene, ultra-high molecular polyethylene and other high molecular polymer materials, the diameter of the flexible strip is 0.05mm to 0.15mm, and the number of the flexible strips is 10 to 24;

And\or, the fixing sleeve, the proximal steel sleeve and the distal steel sleeve are all made of one or more of nickel-titanium alloy, platinum-iridium alloy and polymer materials, and the outer diameters of the fixing sleeve, the proximal steel sleeve and the distal steel sleeve are all 0.9 mm to 1.4 mm;

And\or, the outer braided structure is a hollow cylindrical disk or a hollow conical disk;

And\or, the vascular occluder comprises one or more outer braided structures, and the distal end surface of the outer braided structure located at the distal end is an arc-shaped surface;

When the vascular occluder includes at least two outer braided structures, the outer braided structure located at the proximal end is a hollow cylindrical disk.

The present invention also provides a method for installing the above-mentioned vascular occluder, characterized in that the distal end surface of the outer braided structure of the vascular occluder is an arc-shaped surface, and the method for installing the vascular occluder includes:

After the vascular occluder is compressed and delivered to the target position through the delivery device, when the vascular occluder is released from the catheter sheath of the delivery device into the blood vessel in the human body, the distal end of the vascular occluder is released first;

After the distal end of the vascular occluder is released, the size of the vascular occluder is diagnosed. When the distal end of the vascular occluder has the same outer contour as the vascular occluder before being compressed outside the human body, it is considered that the vascular occluder is smaller than the blood vessel. When the distal end of the vascular occluder is compressed into a long strip or a long strip, it is considered that the vascular occluder is larger than the blood vessel.

The vascular occluder that is too small or too large is recovered through the delivery device, and a vascular occluder of another model is replaced and released to the target position and diagnosed until it is no longer too small or too large. It is considered that the current vascular occluder is suitable, and the vascular occluder is separated from the delivery device and withdrawn from the human body to complete the installation of the vascular occluder.

The positive and progressive effects of the present invention are: the vascular occluder of the present invention has the following beneficial effects:

1. The outer braided structure and the blocking structure are combined to make the vascular occluder have a better effect. The outer braided structure has a certain effect of blood vessel blocking. In addition, the internal blocking structure completely fills the inner cavity of the outer braided structure, so that the vascular occluder forms a solid-like blocking material in the released state, which is more conducive to the formation of thrombus and improves the embolization efficiency, thereby achieving the purpose of vascular embolism.

Furthermore, since the blocking structure includes a plurality of non-metallic flexible strips, the embolization efficiency can be significantly improved on the basis of reducing the amount of metal used.

2. The proximal and distal ends of the outer braided structure and the blocking structure are fixed by a fixing sleeve, which is firm and reliable, and can prevent some flexible strips of the blocking structure from falling off from the mesh of the outer braided structure.

3. The design of wrapping the occluding structure with an outer braided structure makes it possible for the vascular occluder to achieve the purpose of embolization without using several devices. The braided wire of the outer braided structure has a memory function, and its own expansion force enables the vascular occluder to fit tightly with the inside of the blood vessel, thereby improving the stability of the embolism.

4. The selection of flexible strips of the sealing structure, especially polytetrafluoroethylene, has low adhesion. After multiple flexible strips are filled in the inner cavity of the outer woven structure, the adhesion or adhesion between the flexible strips can be greatly reduced.

5. The diameter of the metal wire used in the outer braided structure is 0.02mm-0.15mm, so that the diameter of the vascular occluder after compression reaches 0.5mm-0.9mm. The outer diameter of the steel sleeve is 0.9mm-1.4mm, so that the vascular occluder can be delivered through a small diameter catheter and can be easily loaded into a 5F catheter.

6. In the outer braided structure, the proximal hollow cylindrical disk plays the role of anchoring and slowing down the blood flow, and the distal hollow conical disk plays a diagnostic role. The specific shape and structural design of the outer braided structure can increase the anchoring ability, increase the ability to block blood flow, and reduce the probability of blood vessel damage.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic structural diagram of a vascular occluder provided in Embodiment 1 of the present invention;

FIG. 2( a) to FIG. 2( j) are schematic diagrams of a manufacturing process of a vascular occluder provided in Embodiment 1 of the present invention, wherein:

FIG2( a ) is a schematic diagram of an outer braided structure with relatively long contraction sections retained at both ends provided in Example 1;

FIG2( b ) is a schematic diagram of the blocking structure provided in Example 1 after passing through the central channel of the outer braided structure;

FIG2(c) is a schematic diagram of a proximal end constricting member used to constrict the proximal end of a blood vessel occluder provided in the first embodiment;

FIG2( d ) is a schematic diagram of the fixing sleeve provided in the first embodiment when it is arranged outside the proximal end constricting member;

FIG2(e) is a schematic diagram of the fixing sleeve provided in the first embodiment after being sleeved outside the proximal constricting member and after removing the redundant outer braided structure and the blocking structure;

FIG2( f ) is a schematic diagram of the proximal steel sleeve after being pressed together with the fixing sleeve provided in the first embodiment;

FIG2(g) is a schematic diagram of the plugging structure provided in Example 1 after the divergence treatment is completed;

FIG2(h) is a schematic diagram of the distal end of the vascular occluder after being tied and constricted by the distal constricting member provided in the first embodiment;

FIG2(i) is a schematic diagram of the fixing sleeve provided in the first embodiment when it is arranged outside the distal binding member;

FIG2(j) is a schematic diagram of the fixing sleeve provided in the first embodiment after being sleeved outside the distal constricting member and after removing the redundant outer braided structure and the blocking structure;

FIG3( a ) is a schematic diagram of delivering a vascular occluder to a target location of a blood vessel provided in Example 1;

FIG3( b ) is a schematic diagram of the vascular occluder at the target position of the blood vessel after exiting the delivery device provided in Example 1;

FIG. 4 is a schematic structural diagram of a blood vessel occluder provided in Embodiment 2 of the present invention.

Detailed ways

In order to make the technical means, creative features, objectives and effects achieved by the present invention easy to understand, the present invention is further described below with reference to specific illustrations.

In the present invention, when describing a vascular occluder, "distal end", "proximal end", "distal segment" and "proximal segment" are used as directional words, which are commonly used terms in the field of interventional medical devices, wherein "distal end" and "distal segment" refer to the end or segment away from the operator during the operation, and "proximal end" and "proximal segment" refer to the end or segment close to the operator during the operation.

Embodiment 1

The present embodiment provides a vascular occluder 6. Referring to FIG. 1 , the vascular occluder 6 includes an outer braided structure 1, a blocking structure 2, and two fixed sleeves. The two fixed sleeves may be circular steel sleeves, and the two fixed sleeves are respectively a proximal fixed sleeve 31 and a distal fixed sleeve 32. The outer braided structure 1 has a hollow inner cavity 16. The blocking structure 2 has a plurality of long non-metallic flexible strips 21. The flexible strips 21 are made of flexible material. Each flexible strip 21 extends along the length direction of the outer braided structure 1. Each flexible strip 21 is filled in the hollow inner cavity 16 in a divergent manner. Specifically, the middle part of each flexible strip 21 in the axial direction (i.e., the middle part in the axial direction of the blocking structure 2) is intertwined with each other and divergently filled in the entire hollow inner cavity 16 of the outer braided structure 1.

The first end of the outer braided structure 1 and the first end of the blocking structure 2 are fixed by a fixing sleeve 31 , and the second end of the outer braided structure 1 and the second end of the blocking structure 2 are fixed by a fixing sleeve 32 .

In some embodiments, the first end of the outer braided structure 1 is the proximal end of the outer braided structure 1, the first end of the blocking structure 2 is the proximal end of the blocking structure 2, the second end of the outer braided structure 1 is the distal end of the outer braided structure 1, and the second end of the blocking structure 2 is the distal end of the blocking structure 2. Of course, in some embodiments, it can also be the other way around, that is, the first end of the outer braided structure 1 is the distal end of the outer braided structure 1, the first end of the blocking structure 2 is the distal end of the blocking structure 2, the second end of the outer braided structure 1 is the proximal end of the outer braided structure 1, and the second end of the blocking structure 2 is the proximal end of the blocking structure 2.

The vascular occluder of this embodiment has compressibility and self-expandability, or refers to that the outer braided structure 1 has compressibility and self-expandability; compressibility means that the vascular occluder can be compressed to put it in a compressed state, and its main purpose is to enable the vascular occluder to be better transported through the delivery device, and can be transported and implanted in a thinner blood vessel; self-expandability means that after the vascular occluder enters the blood vessel and is released through the delivery device, it has a memory function and can expand by itself, so that it can fit closely with the blood vessel wall, improve the stability of the embolism, and thus achieve the effect of preventing blood flow and blocking the blood vessel.

The flexible strips 21 of the blocking structure 2 of this embodiment are soft and can be bent arbitrarily. Moreover, the length of the flexible strips 21 will not affect the loading and release of the product within a certain range, but will only affect the filling of the inner cavity of the outer braided structure 1. If the flexible strips 21 are slightly shorter, the divergence of the flexible strips 21 in the inner cavity of the outer braided structure 1 will be simpler; if the flexible strips 21 are slightly longer, the divergence will be more complicated; according to the change of the size of the outer braided structure 1, the number or length of the flexible strips 21 will also change accordingly. The larger the outer diameter of the outer braided structure 1, the more or longer the flexible strips 21. Therefore, the blocking structure 2 can adapt to the outer braided structure 1 by changing the length and number, so as to achieve the effect of fully filling and filling the inner cavity. Since the blocking structure 2 is filled in the inner cavity of the outer braided structure 1, the vascular occluder forms a quasi-entity blocking material in the released state, which can hinder blood flow, play the role of early blood flow blocking and thrombosis, and is more conducive to the formation of thrombus and improves the embolism efficiency, thereby achieving the purpose of vascular embolism.

The flexible strips 21 in this embodiment are non-metallic flexible structures, so they can better entangle with each other and absorb blood clots to achieve embolization effects. Moreover, since they are non-metallic, the metal content of the vascular occluder can be reduced as much as possible, and the embolization effect can be significantly improved.

The outer braided structure 1 and the proximal and distal ends of the plurality of long flexible strips 21 of this embodiment are reliably fixed by the fixing sleeve, so that the flexible strips 21 can be prevented from being too short and falling off from the mesh of the outer braided structure 1 and entering the blood. After the two ends of the long flexible strips 21 of this embodiment are reliably fixed, they can always be located in the inner cavity of the outer braided structure 1 to block the blood vessels.

Referring to Figures 1 and 2 (a), the outer braided structure 1 includes a hollow cylindrical disk 11 at the proximal end and a hollow conical disk 12 at the distal end. The hollow cylindrical disk 11 at the proximal end plays the role of anchoring and slowing down the blood flow rate. In order to make the vascular occluder safer when it is released from the catheter into the human body, the distal end of this embodiment adopts a hollow conical disk 12, and the distal end surface of the hollow conical disk 12 is an arc surface. When the distal end of the hollow conical disk 12 is released from the catheter sheath and is similar in shape to the conical disk outside the body, the product is smaller than the blood vessel; when it is released and severely compressed into a long strip or a long strip, the product is larger than the blood vessel, which can play a diagnostic role. However, it should be explained here that the distal end surface, including a hemispherical structure, a spherical structure, a bullet-shaped structure or a parabola rotating around the axis of symmetry, has a structure with an inclined end surface that controls the self-expansion speed during the release of the vascular occluder from the catheter into the human body.

The outer braided structure 1 is a single-layer or multi-layer mesh structure, preferably a single-layer mesh structure, so as to reduce the metal reaction in the human body and have better biocompatibility.

As shown in Figure 2(a), the outer layer braided structure 1 is formed by braiding with memory metal, and after weaving, the hollow inner cavity 16 is formed in the outer layer braided structure 1 by heat setting. The inner diameter of the hollow inner cavity 16 is larger than the inner diameters of the first end and the second end of the outer layer braided structure.

The outer braided structure 1 is formed by braiding metal wires, and the metal wires are one or more of nickel-titanium alloy, cobalt-chromium alloy and platinum-iridium alloy. The diameter of the metal wire is 0.02mm-0.15mm, and the number of metal wires can be 12/24/36/72, so that the diameter of the vascular occluder after compression can be controlled to 0.5mm-0.9mm, and it can be better loaded into a 5F catheter. Among them, nickel-titanium alloy and platinum-iridium alloy are memory metals.

The outer braided structure 1 of this embodiment is braided and shaped with metal wires, so that the vascular occluder can be delivered through a small diameter catheter. The outer braided structure 1 of this embodiment is preferably woven from 36 metal wires, and there are 36 metal wire heads at both ends. When the blocking structure 2 is installed into the middle channel of the outer braided structure 1, the two ends of the outer braided structure 1 need to be spread apart, which will cause the metal wire braided mesh at the head end to spread out and fail to maintain the braided mesh shape. There is a possibility that the blocking structure 2 cannot be placed in the middle channel. Therefore, when the outer braided structure 1 is heat-set, it is necessary to ensure that the braided mesh at both ends of the outer braided structure 1 is longer, that is, as shown in Figure 2 (a), it is better to retain a certain length of the proximal converging section 13 and the distal converging section 14.

The flexible strip 21 is made of one or more of polytetrafluoroethylene, ultra-high molecular polyethylene and other high molecular polymer materials. The selection of the flexible strip of the plugging structure, especially the selection of polytetrafluoroethylene, has low adhesion. After multiple flexible strips are filled in the inner cavity of the outer braided structure, the adhesion or adhesion between the flexible strips can be greatly reduced. The diameter of the flexible strip 21 is 0.05mm to 0.15mm, and the number of the flexible strips 21 is 10 to 24.

1, 2(c) and 2(h), the overlapping part of the proximal end of the outer braided structure 1 and the proximal end of the blocking structure 2 is bounded by a proximal end binding member 41, and the fixing sleeve 31 is sleeved outside the proximal end binding member 41. The overlapping part of the distal end of the outer braided structure 1 and the distal end of the blocking structure 2 is bounded by a distal end binding member 42, and the fixing sleeve 32 is sleeved outside the distal end binding member 42. The proximal end binding member 41 and the distal end binding member 42 are preferably made of copper wire.

1, 2(f) and 2(g), the vascular occluder further comprises a proximal steel sleeve 51 and a distal steel sleeve 52. The proximal end of the proximal steel sleeve 51 is provided with an internal thread, and the proximal steel sleeve 51 is pressed onto the outside of the fixing sleeve 31. The distal end of the distal steel sleeve 52 is a conical structure protruding toward the distal end, so that the distal steel sleeve 52 is a tapered steel sleeve, and the distal steel sleeve 52 is pressed onto the outside of the fixing sleeve 32.

The proximal steel sleeve 51 can be used to be detachably connected with the delivery device. After the two are connected, the delivery device delivers the vascular occluder to the target position. After the vascular occluder is completely released, the delivery device is withdrawn from the body by separation of the two, and the vascular occluder remains at the target position to achieve the purpose of vascular embolism. The distal steel sleeve 52 is a tapered steel sleeve. In actual use, no matter how tightly the head of the loader of the delivery device and the tail of the sheath are matched, there will be a certain gap. The distal steel sleeve 52 of the vascular occluder has a taper, which can make the product enter the sheath more smoothly, and the tapered steel sleeve will not be sharp, reducing the damage to the blood vessel during the delivery process.

The fixing sleeve 31, the fixing sleeve 32, the proximal steel sleeve 51 and the distal steel sleeve 52 are all made of one or more of nickel-titanium alloy, platinum-iridium alloy and polymer materials; the outer diameters of the fixing sleeve 31, the fixing sleeve 32, the proximal steel sleeve 51 and the distal steel sleeve 52 are all 0.9mm to 1.4mm.

3(a) and 3(b), the delivery device is connected to the internal thread of the proximal steel sleeve 51, and then the vascular occluder is delivered to the target position through the delivery device, and finally the purpose of vascular embolization is achieved through subsequent operations.

Embodiment 2

The difference between the vascular occluder provided in this embodiment and the embodiment 1 is that:

4 , the outer braided structure 1 of this embodiment has three discs, that is, the outer braided structure 1 includes a proximal hollow cylindrical disc 11, a middle hollow cylindrical disc 15, and a distal hollow conical disc 12. The proximal end of the outer braided structure 1 is fixed to the proximal end of the blocking structure 2 by a fixing sleeve 31 and a proximal steel sleeve 51. The distal end of the outer braided structure 1 is fixed to the distal end of the blocking structure 2 by a fixing sleeve 32 and a distal steel sleeve 52.

The hollow conical disc 12 at the distal end still plays a role in diagnosis and judgment. Compared with a single cylindrical disc, the hollow cylindrical disc 11 and the hollow cylindrical disc 15 can provide greater anchoring ability and better blocking effect in blood vessels with high blood flow rate and long anchoring space.

In the blocking structure of this embodiment, according to the inner cavity size and blocking requirements of the outer braided structure 1, the diameter of the flexible strips is designed to be larger than that of the first embodiment, that is, each flexible strip in Figure 4 is thicker than the flexible strip in Figure 1 of the first embodiment.

It should be noted that, except for the shape of the outer woven structure and the thickness of the flexible strips, the other structures of this embodiment are similar to those of the first embodiment, and will not be described in detail here.

Embodiment 3

This embodiment provides a method for manufacturing a vascular occluder, which can be used to manufacture the vascular occluders of Embodiment 1 and Embodiment 2. Taking the vascular occluder of Embodiment 1 as an example, the manufacturing method includes the following specific steps:

S1 , passing the undiverged blocking structure 2 through the middle channel of the outer braided structure 1 .

Referring to FIG2(a), in this step, the outer braided structure 1 includes a proximal hollow cylindrical disk 11 and a distal hollow conical disk 12. The outer braided structure 1 uses an outer braided structure 1 with a relatively long braided mesh structure at both ends. That is, the proximal end of the outer braided structure 1 has a proximal convergence section 13 of a preset length, and the distal end of the outer braided structure 1 has a distal convergence section 14 of a preset length. Then the outer braided structure 1 includes a proximal hollow cylindrical disk 11, a distal hollow conical disk 12, a proximal convergence section 13, and a distal convergence section 14.

2( b ), after the blocking structure 2 passes through the middle channel of the outer braided structure 1 , at least a preset length of the blocking structure 2 is located within the proximal converging section 13 , and preferably, the blocking structure 2 has a preset distance from the proximal end of the proximal converging section 13 .

The vascular occluder of the above design has a proximal constriction section with only one end of the outer braided structure 1 between the proximal end of the occluding structure 2 and the proximal end of the proximal constriction section 13, giving the outer diameter of the constrained braided wire a gradient to facilitate the subsequent installation of the fixing sleeve 31.

In this step, the blocking structure 2 can be passed through the middle channel of the outer braided structure 1 by folding a flexible strip 21 in half or folding it back and forth in the middle channel. The non-divergent blocking structure 2 can generate the required number of flexible strips by folding a flexible strip in half or folding it back and forth in the middle channel of the outer braided structure 1. After the strips are inserted, the ends of the flexible strips that have reached the required number are cut off, so that the purpose of converting one flexible strip into multiple flexible strips 21 can be achieved.

When multiple short flexible strips are placed in the middle channel, there is a possibility that the flexible strips will pass through the outer braided structure, while a long flexible strip will greatly reduce this risk. The non-divergent blocking structure 2 can first completely pass through the middle channel of the outer braided structure 1, and then pull back the non-divergent blocking structure 2 from the distal end to achieve the effect shown in Figure 2(b). In Figure 2(b), the effect of a flexible strip folded back and forth in multiple layers to form seven flexible strips 21 is achieved, and the blocking structure 2 reserves a section located in the proximal converging section 13 of the outer braided structure 1 to form a proximal overlapping section with the outer braided structure 1 for subsequent fixation.

S2, fix the proximal end of the outer braided structure 1 and the proximal end of the blocking structure 2 by using the fixing sleeve 31.

Referring to Figure 2(c), before the fixing sleeve 31 is used for fixing, the overlapping outer braided structure 1 and the blocking structure 2 in the proximal binding section 13 are bundled and bundled using a proximal binding member 41, and the bundles are bundled and bundled to the proximal end of the proximal binding section 13. The bundling and bundling is to make the fixing sleeve 31 and the proximal end of the outer braided structure 1 and the proximal end of the blocking structure 2 more stably fixed. The proximal binding member 41 is preferably a copper wire, which is used to bundle and bundle from the proximal overlap of the outer braided structure 1 and the non-divergent blocking structure 2 to the proximal end of the outer braided structure 1, wherein there is only the outer braided structure 1 from the proximal end to the middle of the proximal end, giving a gradient to the outer diameter of the constrained braided wire, which facilitates the installation of the fixing sleeve 31.

2( d ), the fixing sleeve 31 is sleeved outside the proximal constricting member 41. When the fixing sleeve 31 is sleeved, it is as close to the proximal hollow cylindrical disk 11 as possible.

The inner diameter of the fixed sleeve 31 is slightly larger than the outer diameter of all the braided wires of the outer braided structure 1 after being gathered together, that is, the inner diameter of the fixed sleeve 31 is slightly larger than the outer diameter of the proximal contraction section 13. The outer diameter of the outer braided structure 1 and the non-divergent occluding structure 2 after being gathered together is very close to the inner diameter of the fixed sleeve 31, and even larger than the inner diameter of the fixed sleeve 31 when not gathered in place. Therefore, retaining a longer braided mesh at the proximal end of the outer braided structure 1 can prevent the braided wires from spreading and make it less difficult to install the fixed sleeve 31, providing a transition for the installation of the fixed sleeve 31. The maximum number of flexible strips can be placed under the maximum size to achieve the effect of transporting in the smallest possible sheath and filling the inside of the vascular occluder as fully as possible.

Referring to Fig. 2(e), the outer braided structure 1 and the blocking structure 2 on the proximal side of the fixing sleeve 31 are completely removed. This ensures that there are no burrs when the fixing sleeve 31 is inserted into the proximal steel sleeve 51, which will not affect the threaded connection between the product and the push rod in the later stage, and the blocking structure 2 can be changed from one flexible strip to multiple flexible strips 21, which is convenient for the subsequent unbundling process.

2( f ), after being fixed by the fixing sleeve 31 , the fixing sleeve 31 is also placed in the proximal steel sleeve 51 for press-fitting and fixing.

S3 , performing a divergent process on the blocking structure 2 , so that the blocking structure 2 is filled in the inner cavity of the outer braided structure 1 .

In addition, the inventors found during the research and development process that how to fully fill the non-metallic flexible strip 21 in the outer braided structure 1 is the most difficult problem to solve at present. Because in order to prevent the flexible strip 21 from escaping from the outer braided structure 1, the two ends of the flexible strip 21 in the length direction must be fixed to the two ends of the outer braided structure 1 in the length direction. While keeping the two ends of the flexible strip 21 fixed, the middle part of the flexible strip 21 must be fully dispersed in the hollow inner cavity 16 of the outer braided structure 1, which is very difficult to achieve.

In order to solve the above problem, referring to Figure 2(g), after the proximal end of the outer layer braided structure 1 is fixed with a fixing sleeve 31, the distal end of the outer layer braided structure 1 is pulled back and forth. The blocking structure 2 is relatively soft and has no memory function. The outer layer braided structure 1 is a memory alloy and has a memory function, and the outer layer braided structure 1 is heat-formed into a structure with a hollow cavity inside. Each time it is pulled, the blocking structure 2 moves relative to the outer layer braided structure 1 and shrinks inside the outer layer braided structure 1.

The specific steps are as follows: after the blocking structure 2 is inserted into the outer braided structure 1 along the axial direction, as shown in FIG2(e), a fixing sleeve 31 is used to fix the blocking structure 2 and the proximal end of the outer braided structure 1, and then the distal end of the outer braided structure 1 is pulled to drive the distal end of the outer braided structure 1 to move away from the proximal end of the outer braided structure 1. Since the outer braided structure 1 is formed by braiding with memory metal, it has great elasticity and can be easily pulled apart. When the distal end of the outer braided structure 1 is pulled to a state where it cannot be pulled, the outer braided structure 1 covers more flexible strips 21. At this time, if the hand is released, the distal end of the outer braided structure 1 rebounds, and each flexible strip is received in the outer braided structure. At the same time, the vibration force generated by the rebound can disperse each flexible strip 21, and each flexible strip 21 is loosely and intertwined to fill the hollow inner cavity 16 of the outer braided structure 1.

The above process can be performed several times until each flexible strip 21 is loaded into the outer braided structure 1 , and each flexible strip 21 is then diffusely filled in the hollow inner cavity 16 of the outer braided structure 1 .

The above filling method fully utilizes the elastic properties of the outer braided structure 1 which is a memory metal braided molding, and very cleverly fills the flexible strips 21 divergently in the hollow inner cavity 16 of the outer braided structure 1.

Of course, it should be noted that in some embodiments, the outer braided structure 1 can be fixed and pulled by an external tool so that each flexible strip 21 is loaded into the outer braided structure 1, for example, the entire vascular occluder is placed in the external tool and pulled and released.

At the same time, more preferably, during the pulling process, the blocking structure 2 can be manually intervened and dispersed by means of a needle, tweezers or other small tools to ensure that the blocking structure 2 is fully filled.

In addition, the vascular occluder includes N outer braided structures 1, the first end of the outer braided structure 1 of the i-th section is connected to the second end of the outer braided structure 1 of the i+1-th section, N is a natural number greater than or equal to 2, and i is a natural number greater than or equal to 1. In this embodiment, N is 2, and i is 1.

The first end and the second end of the outer braided structure 1 clamp each flexible strip 21, so that when the outer braided structure 1 is pulled back and forth, the first end and the second end of the outer braided structure 1 clamp the flexible strips 21, and when rebounding, the flexible strips 21 can be more conveniently spread out.

Of course, in the actual process, when rebounding, the distal end of the outer braided structure 1 of the i+1th section can be directly pulled to rebound. Of course, the distal ends of the i-th section and the i+1th outer braided structure 1 can also be pulled to rebound separately.

After the blocking structure 2 is diverged, the distal end of the blocking structure 2 can be cut off to ensure that the blocking structure 2 is completely in the distal convergence section 14 of the outer braided structure 1. Preferably, the distal end of the blocking structure 2 is at a certain distance from the distal end of the distal convergence section 14. This allows the blocking structure 2 to reserve a section in the distal convergence section 14 to form a distal overlap section with the outer braided structure 1 for subsequent fixation.

S4, fix the distal end of the outer braided structure 1 and the distal end of the blocking structure 2 by using the fixing sleeve 32.

Referring to FIG. 2(h), before the fixing sleeve 32 is used for fixing, the outer braided structure 1 and the blocking structure 2 overlapped in the distal binding section 14 are bundled and bundled by the distal binding member 42, and the bundles are bundled and bundled to the distal end of the distal binding section 14. The distal binding member 42 is preferably a copper wire, which is used to bundle and bundle from the distal overlap of the outer braided structure 1 and the non-divergent blocking structure 2 to the distal end of the outer braided structure 1, wherein only the outer braided structure 1 is present from the distal end to the middle of the distal end, giving a gradient to the outer diameter of the constrained braided wire, which facilitates the installation of the fixing sleeve 32.

2(i), the fixing sleeve 32 is sleeved on the outside of the distal constricting member 42. When the fixing sleeve 32 is sleeved, it is as close to the distal hollow conical disk 12 as possible.

The inner diameter of the fixed sleeve 32 is slightly larger than the outer diameter of all the braided wires of the outer braided structure 1 after being gathered together, that is, the inner diameter of the fixed sleeve 32 is slightly larger than the outer diameter of the distal convergence section 14. The outer diameter of the outer braided structure 1 and the non-divergent blocking structure 2 after being gathered together is very close to the inner diameter of the fixed sleeve 32, and even larger than the inner diameter of the fixed sleeve 32 when not gathered in place. Therefore, the proximal end of the outer braided structure 1 retains a relatively long braided mesh to prevent the braided wires from spreading and to make it less difficult to install the fixed sleeve 32, providing a transition for the installation of the fixed sleeve 32.

Referring to Fig. 2(j), the outer braided structure 1 and the blocking structure 2 on the distal side of the fixing sleeve 32 are completely removed. This ensures that the fixing sleeve 32 is installed in the distal steel sleeve 52 without burrs, and the blocking structure 2 can be transformed from a distal folded flexible strip into an independent flexible strip, so that the blocking structure 2 is completely decomposed from a long flexible strip into a required number of short flexible strips 21, each flexible strip is subjected to force independently, and the influence between them is minimized.

After being fixed by the fixing sleeve 32, the fixing sleeve 32 is also placed in the distal steel sleeve 52 for compression and fixing. Referring to Figure 1, it can also be seen as a schematic diagram of the vascular occluder after the fixing sleeve 32 is inserted into the distal steel sleeve 52 and the compression is completed.

Embodiment 4

This embodiment provides a method for installing a vascular occluder, wherein the distal end surface of the outer braided structure 1 of the vascular occluder is an arc-shaped surface, and the installation method includes the following specific steps:

After the vascular occluder is compressed and delivered to the target position through the delivery device, when the vascular occluder is released from the catheter sheath of the delivery device into the blood vessel in the human body, the distal side of the vascular occluder is released first. After the distal side of the vascular occluder is released, the size of the vascular occluder is diagnosed. When the distal side of the vascular occluder has the same outer contour as the vascular occluder before being compressed outside the human body, it is considered that the vascular occluder is smaller than the blood vessel. When the distal side of the vascular occluder is compressed into a long strip or a long strip, it is considered that the vascular occluder is larger than the blood vessel; the smaller or larger vascular occluder is recovered through the delivery device, and a vascular occluder of another model is replaced and released to the target position and diagnosed until there is no smaller or larger phenomenon, the current vascular occluder is considered to be adapted, and the vascular occluder 6 shown in Figure 3 (a) is considered to be adapted. The vascular occluder is separated from the delivery device, and the delivery device is withdrawn from the human body to complete the installation of the vascular occluder. As shown in Figure 3 (b), the vascular occluder 6 is left in the blood vessel 7 to achieve the purpose of vascular embolism.

This embodiment achieves a diagnostic function by making the distal end surface of the outer braided structure 1 an arc-shaped surface, and diagnoses whether the model of the vascular occluder is compatible with the size of the blood vessel. If it is not compatible, it is recycled and replaced with the next model. Without the diagnostic function of this embodiment, when the vascular occluder is small, it cannot be completely blocked. When the vascular occluder is too large, the vascular occluder will be stretched too long and may affect other blood vessels. Once the vascular occluder is completely released, it is troublesome to recycle it. Therefore, the diagnostic function is used before the complete release, so that a pre-judgment can be made before the vascular occluder is completely released.

The distal end surface of this embodiment includes a hemispherical structure, a spherical structure, a bullet-shaped structure or a parabola rotating around a symmetry axis, etc., which has an inclined end surface structure that controls the self-expansion speed of the vascular occluder during release from the catheter into the human body.

It should be emphasized that the above-mentioned embodiments can be used in conjunction with each other, and the details mentioned in one embodiment are also effective in another embodiment. However, in order to avoid repetition, many details will not be repeated in each embodiment.

The above shows and describes the basic principles, main features and advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited to the above embodiments. The above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims (11)

1. A method for manufacturing a vascular occluder, characterized in that it comprises the following steps: S1, using an outer braided structure with a hollow inner cavity, inserting a non-divergent blocking structure into the hollow inner cavity of the outer braided structure along the axial direction of the outer braided structure; The blocking structure comprises a plurality of long non-metallic flexible strips, each of which extends along the axis direction of the outer braided structure; S2, fixing the first end of the outer braided structure and the first end of the blocking structure by using a fixing sleeve; S3, performing a divergent treatment on the blocking structure, so that the middle parts of the blocking structure are mutually entangled and divergently filled in the entire inner cavity of the outer braided structure. Specifically, the middle parts of the axial directions of the flexible strips are mutually entangled and divergently filled in the entire hollow inner cavity of the outer braided structure; S4, using another fixing sleeve to fix the second end of the outer braided structure and the second end of the blocking structure. 2. The method for manufacturing a vascular occluder according to claim 1, characterized in that the outer braided structure is woven with memory metal wires, the outer braided structure is braided and formed by memory metal, and after the braiding is completed, the hollow inner cavity is formed in the outer braided structure by heat setting, and the inner diameter of the hollow inner cavity is larger than the inner diameters of the first end and the second end of the outer braided structure; In step S3, when the blocking structure is subjected to a divergent treatment, the second end of the outer braided structure is pulled back and forth, so that the blocking structures are mutually entangled and divergently filled in the entire inner cavity of the outer braided structure. 3. The method for manufacturing a vascular occluder according to claim 2, characterized in that when the occluding structure is subjected to divergent treatment, the second end of the outer braided structure is pulled back and forth so that the occluding structure is mutually entangled and divergently filled in the entire inner cavity of the outer braided structure. The specific steps are as follows: Step V1: driving the distal end of the outer braided structure to move away from the proximal end of the outer braided structure, so that the outer braided structure covers more of the flexible strips, loosening the distal end of the outer braided structure, and causing the distal end of the outer braided structure to rebound, so that the flexible strips are divergently collected into the outer braided structure; Repeat the above step V1 multiple times until the flexible strips are intertwined and divergently filled in the entire inner cavity of the outer braided structure; And\or, in step S3, when the blocking structure is subjected to divergence treatment, the flexible strips are spread out with a tool. 4. The method for manufacturing a vascular occluder according to claim 1, characterized in that, in step S1, the proximal end of the outer braided structure has a proximal converging section of a preset length, the distal end of the outer braided structure has a distal converging section of a preset length, and after the blocking structure passes through the middle channel of the outer braided structure, at least the blocking structure of the preset length is located in the proximal converging section; In step S2, before the fixing sleeve is used for fixing, the outer braided structure and the blocking structure overlapped in the proximal bundling section are bundled and bundled using a proximal bundling piece, and the bundles are bundled and bundled to the proximal end of the proximal bundling section, the fixing sleeve is arranged outside the proximal bundling piece, and the outer braided structure and the blocking structure on the proximal side of the fixing sleeve are completely removed; and\or, in step S1, the blocking structure passes through the middle channel of the outer woven structure by folding a flexible strip in half or back and forth in the middle channel; And\or, in step S2, after the fixing sleeve is used for fixing, the fixing sleeve is also placed in the proximal steel sleeve for pressing and fixing; and\or, in step S3, after the occluding structure is diverged, it is ensured that at least a preset length of the occluding structure is located within the distal convergence segment; In step S4, before the fixing sleeve is used for fixing, the outer braided structure and the blocking structure overlapped in the distal bundling section are bundled and bundled by a distal bundling piece, and the bundles are bundled and bundled to the distal end of the distal bundling section, the fixing sleeve is arranged outside the distal bundling piece, and the outer braided structure and the blocking structure on the distal side of the fixing sleeve are completely removed; And\or, in step S4, after the fixing sleeve is used for fixing, the fixing sleeve is also placed in the distal steel sleeve for press-fitting and fixing. 5 . The method for manufacturing a vascular occluder according to claim 4 , wherein the occluding structure has a preset distance from the proximal end of the proximal contracting section. 6 . The method for manufacturing a vascular occluder according to claim 4 , wherein the occluding structure has a preset distance from the distal end of the distal converging section. 7. A vascular occluder, comprising: an outer braided structure having a hollow inner cavity; A blocking structure, a plurality of long flexible strips, each of which extends along the length direction of the outer braided structure, and the middle parts of each of which are intertwined and divergently filled in the inner cavity. Specifically, the middle parts of each of the flexible strips in the axial direction are intertwined and divergently filled in the entire hollow inner cavity of the outer braided structure; Two fixing sleeves, one fixing sleeve is fixed to the first end of the outer braided structure and the outside of the first end of the blocking structure, and the other fixing sleeve is fixed to the second end of the outer braided structure and the outside of the second end of the blocking structure. 8. The vascular occluder according to claim 7, characterized in that, in the process of dispersing the occluding structure into the outer braided structure, the undispersed occluding structure can be firstly passed into the hollow inner cavity of the outer braided structure along the axial direction of the outer braided structure; The second end of the outer braided structure is pulled back and forth, so that the blocking structures are entangled with each other and divergently filled in the entire inner cavity of the outer braided structure. 9. The vascular occluder according to claim 8, characterized in that the outer braided structure is braided and formed by nickel-titanium wire, and the hollow inner cavity is formed by heat setting, and the inner diameter of the hollow inner cavity is larger than the inner diameters of the first end and the second end of the outer braided structure; The vascular occluder includes N outer braided structures, the first end of the outer braided structure of the i-th section is connected to the second end of the outer braided structure of the i+1-th section, N is a natural number greater than or equal to 2, and i is a natural number greater than or equal to 1. 10 . The vascular occluder according to claim 9 , wherein the first end and the second end of the outer braided structure clamp each of the flexible strips. 11. The vascular occluder according to claim 7, characterized in that the overlapping part of the proximal end of the outer braided structure and the proximal end of the occluding structure is tightened by a proximal tightening member, and one of the fixing sleeves is arranged outside the proximal tightening member; The overlapping portion between the distal end of the outer braided structure and the distal end of the blocking structure is restrained by a distal restraining member, and another fixing sleeve is disposed outside the distal restraining member; And\or, the vascular occluder further comprises: A proximal steel sleeve, with an internal thread at the proximal end, the proximal steel sleeve is pressed onto the outside of the proximal fixed sleeve; A distal steel sleeve, pressed onto the outside of the distal fixed sleeve; And\or, the outer braided structure is braided and shaped by metal wires, the metal wires are one or more of nickel-titanium alloy, cobalt-chromium alloy and platinum-iridium alloy, and the diameter of the metal wires is 0.02 mm to 0.15 mm; And\or, the flexible strip is one or more of polytetrafluoroethylene, ultra-high molecular polyethylene and high molecular polymer materials, the diameter of the flexible strip is 0.05mm to 0.15mm, and the number of the flexible strips is 10 to 24; And\or, the fixing sleeve, the proximal steel sleeve and the distal steel sleeve are all made of one or more of nickel-titanium alloy, platinum-iridium alloy and polymer materials, and the outer diameters of the fixing sleeve, the proximal steel sleeve and the distal steel sleeve are all 0.9 mm to 1.4 mm; And\or, the outer braided structure is a hollow cylindrical disk or a hollow conical disk; And\or, the vascular occluder comprises one or more outer braided structures, and the distal end surface of the outer braided structure located at the distal end is an arc-shaped surface; When the vascular occluder includes at least two outer braided structures, the outer braided structure located at the proximal end is a hollow cylindrical disk.