CN116077126B - Vascular occlusion device, manufacturing method and installation method thereof - Google Patents
Vascular occlusion device, manufacturing method and installation method thereof Download PDFInfo
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- CN116077126B CN116077126B CN202310116096.7A CN202310116096A CN116077126B CN 116077126 B CN116077126 B CN 116077126B CN 202310116096 A CN202310116096 A CN 202310116096A CN 116077126 B CN116077126 B CN 116077126B
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- 206010053648 Vascular occlusion Diseases 0.000 title claims abstract description 95
- 208000021331 vascular occlusion disease Diseases 0.000 title claims abstract description 95
- 238000000034 method Methods 0.000 title claims abstract description 27
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 15
- 238000009434 installation Methods 0.000 title abstract description 9
- 238000009954 braiding Methods 0.000 claims abstract description 63
- 229910052751 metal Inorganic materials 0.000 claims abstract description 28
- 239000002184 metal Substances 0.000 claims abstract description 28
- 230000000903 blocking effect Effects 0.000 claims abstract description 23
- 229910052755 nonmetal Inorganic materials 0.000 claims abstract description 5
- 229910000831 Steel Inorganic materials 0.000 claims description 44
- 239000010959 steel Substances 0.000 claims description 44
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 9
- -1 polytetrafluoroethylene Polymers 0.000 claims description 8
- 229910000566 Platinum-iridium alloy Inorganic materials 0.000 claims description 7
- HWLDNSXPUQTBOD-UHFFFAOYSA-N platinum-iridium alloy Chemical class [Ir].[Pt] HWLDNSXPUQTBOD-UHFFFAOYSA-N 0.000 claims description 7
- 239000002861 polymer material Substances 0.000 claims description 6
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 5
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 5
- 238000003825 pressing Methods 0.000 claims description 4
- 238000009941 weaving Methods 0.000 claims description 4
- 239000004698 Polyethylene Substances 0.000 claims description 3
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 claims description 3
- 238000009998 heat setting Methods 0.000 claims description 3
- 229920000573 polyethylene Polymers 0.000 claims description 3
- 238000007493 shaping process Methods 0.000 claims description 3
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 claims description 2
- 238000007789 sealing Methods 0.000 claims description 2
- 208000005189 Embolism Diseases 0.000 abstract description 11
- 239000010410 layer Substances 0.000 description 117
- 238000009940 knitting Methods 0.000 description 34
- 230000002792 vascular Effects 0.000 description 29
- 210000004204 blood vessel Anatomy 0.000 description 27
- 230000000694 effects Effects 0.000 description 12
- 230000017531 blood circulation Effects 0.000 description 8
- 239000000463 material Substances 0.000 description 8
- 230000008569 process Effects 0.000 description 7
- 208000007536 Thrombosis Diseases 0.000 description 4
- 238000004873 anchoring Methods 0.000 description 4
- 230000003073 embolic effect Effects 0.000 description 4
- 230000006386 memory function Effects 0.000 description 4
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 238000003745 diagnosis Methods 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 230000006870 function Effects 0.000 description 3
- 206010027439 Metal poisoning Diseases 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
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- 229910001285 shape-memory alloy Inorganic materials 0.000 description 2
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- 230000010108 arterial embolization Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000037237 body shape Effects 0.000 description 1
- 238000012512 characterization method Methods 0.000 description 1
- 230000010102 embolization Effects 0.000 description 1
- 238000002594 fluoroscopy Methods 0.000 description 1
- 201000011066 hemangioma Diseases 0.000 description 1
- 230000023597 hemostasis Effects 0.000 description 1
- 238000002697 interventional radiology Methods 0.000 description 1
- 238000010030 laminating Methods 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract
The invention belongs to the technical field of medical instruments, and particularly relates to a vascular occlusion device, a manufacturing method and an installation method thereof. The manufacturing method of the vascular occlusion device comprises the following steps: an outer layer braiding structure with a hollow inner cavity is adopted, and an undispersed plugging structure penetrates into the hollow inner cavity of the outer layer braiding structure along the axial direction of the outer layer braiding structure; the plugging structure comprises a plurality of nonmetal flexible strips with long strips, and each flexible strip extends along the axial direction of the outer layer braiding structure; fixing the first end of the outer braided structure and the first end of the plugging structure by using a fixing sleeve; the blocking structure is subjected to divergent treatment, so that the middle part of the blocking structure is mutually wound and divergently filled in the whole inner cavity of the outer layer woven structure; and fixing the second end of the outer layer woven structure and the second end of the plugging structure by using another fixing sleeve. According to the invention, the plugging structure comprises a plurality of nonmetallic flexible strips, so that the embolism efficiency can be remarkably improved on the basis of reducing the metal consumption.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a vascular occlusion device, a manufacturing method and an installation method thereof.
Background
Transcatheter vascular embolization (TRANSCATHETER ARTERIAL embolization) is one of the most important basic techniques for interventional radiology. To inject or send embolic material into a target vessel through a catheter under X-ray fluoroscopy, so as to occlude the vessel and achieve the intended therapeutic purpose. The technology has the advantages of minimally invasive property, whole-course image guidance and target blood vessel selectivity, so that the accuracy and controllability of embolism are greatly enhanced, and the technology becomes a revolutionary clinical treatment method.
Embolic material is injected into the blood vessel through the catheter, and the blood vessel is then occluded, thereby affecting the target blood vessel, the target organ and the local hydrodynamic forces to different extents.
The prior art vascular occluder generally adopts metal spring rings, and the embolic material can enter a human blood vessel through a small inner diameter of a catheter, and is expanded or coiled in the blood vessel after exiting the catheter, so that the vascular occluder is mostly used for embolizing a blood vessel or hemangioma cavity (3-15 mm) with a diameter which is much larger than that of the catheter. An implantable vascular occlusion device as disclosed in TW362007B, which discloses a vascular occlusion device woven from a super-elastic, self-expanding memory alloy wire multi-wire mesh design that increases wire density and increases interference with blood flow through a multi-layer wire mesh design; meanwhile, the size specification is more, and the device can be suitable for different blood vessels. However, the vascular occlusion device has a large metal content, and can cause metal poisoning of a human body after being placed in the human body for a long time. In addition, the grid gaps among the metal wires are larger, so that the blood stopping performance is insufficient.
For this reason, a new design is necessary to overcome the above-mentioned drawbacks.
Disclosure of Invention
Aiming at the technical problems of large grid gaps among metal wires, insufficient hemostasis and metal poisoning of a human body caused by excessive metal content of the vascular occluder in the prior art, the invention aims to provide the vascular occluder and a manufacturing method and an installation method thereof.
The manufacturing method of the vascular occlusion device comprises the following steps:
s1, an outer layer braiding structure with a hollow inner cavity is adopted, and an undispersed plugging structure is penetrated into the hollow inner cavity of the outer layer braiding structure along the axial direction of the outer layer braiding structure;
the plugging structure comprises a plurality of nonmetal flexible strips with long strips, and each flexible strip extends along the axial direction of the outer layer braiding structure;
S2, fixing the first end of the outer layer woven structure and the first end of the plugging structure by using a fixing sleeve;
S3, performing divergent treatment on the blocking structure, so that the middle part of the blocking structure is mutually wound and divergently filled in the whole inner cavity of the outer layer woven structure;
And S4, fixing the second end of the outer layer woven structure and the second end of the plugging structure by using another fixing sleeve.
In an embodiment, the outer layer braiding structure is formed by braiding with memory metal wires, the outer layer braiding structure is formed by braiding with memory metal, and the hollow inner cavity is formed in the outer layer braiding structure in a heat setting mode after braiding is completed, 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 layer braiding structure;
In step S3, when the plugging structure is diverged, the second end of the outer layer woven structure is pulled back and forth, so that the plugging structure is intertwined and divergently filled in the whole inner cavity of the outer layer woven structure.
In one embodiment, when the plugging structure is divergently processed, the second end of the outer layer braided structure is pulled back and forth, so that the plugging structure is intertwined and divergently filled in the whole inner cavity of the outer layer braided structure, and the specific steps are as follows:
Step V1: driving the distal end of the outer layer braiding structure to move away from the proximal end of the outer layer braiding structure, wherein the outer layer braiding structure wraps more flexible strips, the distal end of the outer layer braiding structure is loosened, the distal end of the outer layer braiding structure rebounds, and then the flexible strips are divergently received in the outer layer braiding structure;
Repeating the step V1 for a plurality of times until each flexible strip is mutually wound and divergently filled in the whole inner cavity of the outer layer braiding structure;
and/or, in the step S3, when the plugging structure is subjected to the divergence treatment, a tool is used for poking and scattering the flexible strip.
In an embodiment, in step S1, the proximal end of the outer layer braided structure has a proximal end convergent section with a preset length, the distal end of the outer layer braided structure has a distal end convergent section with a preset length, and after the plugging structure passes through the middle channel of the outer layer braided structure, at least the plugging structure with a preset length is located in the proximal end convergent section, preferably the plugging structure has a preset distance from the proximal end of the proximal end convergent section;
In step S2, before the fixing sleeve is used for fixing, the outer layer woven structure and the plugging structure overlapped in the proximal end bundling section are bundled and bundled by a proximal end bundling piece, and are bundled and bundled to the proximal end part of the proximal end bundling section, and the fixing sleeve is sleeved outside the proximal end bundling piece, and the outer layer woven structure and the plugging structure at the proximal end side of the fixing sleeve are removed;
in step S1, the plugging structure passes through the middle channel of the outer layer braiding structure in a mode that one flexible strip is folded in half or back and forth in the middle channel;
And/or, in the step S2, after the fixing sleeve is used for fixing, the fixing sleeve is also placed into a proximal steel sleeve for pressing and fixing;
In step S3, after the blocking structure is diverged, it is ensured that at least the blocking structure with a preset length is located in the distal converging section, and preferably, the blocking structure has a preset distance from the distal end of the distal converging section;
In step S4, before the fixing sleeve is used for fixing, the outer layer woven structure and the plugging structure overlapped in the distal end bundling section are bundled and bundled by a distal end bundling piece, and are bundled and bundled to the distal end part of the distal end bundling section, and the fixing sleeve is sleeved outside the distal end bundling piece, and the outer layer woven structure and the plugging structure on the distal end side of the fixing sleeve are removed completely;
and/or, in the step S4, after the fixing sleeve is used for fixing, the fixing sleeve is further placed into a distal steel sleeve for pressing and fixing.
The invention also provides a vascular occluder comprising:
an outer braid structure having a hollow interior;
The sealing structure is provided with a plurality of strip-shaped flexible strips, each flexible strip extends along the length direction of the outer layer weaving structure, and the middle parts of the flexible strips are mutually wound and divergently filled in the inner cavity;
Two fixed sleeves, one fixed sleeve is fixed in the outer layer is woven the first end of structure and the first end of shutoff structure is outside, another fixed sleeve is fixed in the outer layer is woven the second end of structure and the second end of shutoff structure is outside.
In this embodiment, in the process of dispersing the blocking structure in the outer layer woven structure, the non-dispersed blocking structure may be first threaded into the hollow inner cavity of the outer layer woven structure along the axial direction of the outer layer woven structure;
Pulling back and forth the second end of the outer braided structure so that the plugging structure is intertwined and divergently filled in the whole inner cavity of the outer braided structure.
In this embodiment, the outer layer braiding structure is formed by braiding nickel titanium wires, and the hollow inner cavity is formed by thermal characterization, wherein 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 layer braiding structure;
the vascular occlusion device comprises N outer layer woven structures, wherein the first end of the outer layer woven structure of the ith section is connected with the second end of the outer layer woven 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 and second ends of the outer braid structure clamp each of the flexible strips.
In this embodiment, a proximal end constriction member is used for constricting a proximal end of the outer layer braided structure and a proximal end of the blocking structure, and one of the fixing sleeves is sleeved outside the proximal end constriction member;
The overlapping part of the distal end of the outer layer woven structure and the distal end of the plugging structure is bunched by a distal end bunching piece, and the other fixing sleeve is sleeved outside the distal end bunching piece;
And/or, the vascular occlusion device further comprises:
The proximal steel sleeve is provided with an internal thread at the proximal end and is pressed outside the proximal fixing sleeve;
the distal steel sleeve is pressed outside the distal fixing sleeve;
And/or the outer layer braiding structure is formed by braiding and shaping metal wires, wherein 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 0.02-0.15 mm;
And/or one or more of polytetrafluoroethylene, ultra-high molecular polyethylene and other high molecular polymer materials in the flexible strip, wherein the diameter of the flexible strip is 0.05-0.15 mm, and the number of the flexible strip is 10-24;
And/or the fixing sleeve, the proximal steel sleeve and the distal steel sleeve are made of one or more of nickel-titanium alloy, platinum-iridium alloy and high polymer materials, and the outer diameters of the fixing sleeve, the proximal steel sleeve and the distal steel sleeve are 0.9-1.4 mm;
And/or, the outer layer braiding structure is a hollow cylindrical disc or a hollow conical disc;
and/or the vascular occlusion device comprises one or more outer layer braiding structures, wherein the distal end face of the outer layer braiding structure positioned at the distal end is an arc-shaped face;
when the vascular occlusion device comprises at least two outer braided structures, the outer braided structures at the proximal end are hollow cylindrical discs.
The invention also provides a method for installing the vascular occlusion device, which is characterized in that the distal end face of the outer layer woven structure of the vascular occlusion device is an arc-shaped face, and the method for installing the vascular occlusion device comprises the following steps:
after the vascular occlusion device is compressed and conveyed to a target position through a conveying device, when the vascular occlusion device is released into a blood vessel in a human body from a catheter sheath of the conveying device, the distal end side of the vascular occlusion device is released first;
Diagnosing the size of the vascular occlusion device after the distal side of the vascular occlusion device is released, considering that the vascular occlusion device is smaller than a blood vessel when the distal side of the vascular occlusion device has the same outer contour as the vascular occlusion device before the vascular occlusion device is not compressed outside a human body, and considering that the vascular occlusion device is larger than the blood vessel when the distal side of the vascular occlusion device is compressed into a long or long strip shape;
and recovering the smaller or larger vascular occluder through a conveying device, continuing to release and diagnose the vascular occluder with the same model until the smaller or larger vascular occluder is not matched, separating the vascular occluder from the conveying device, and withdrawing the conveying device from the human body to finish the installation of the vascular occluder.
The invention has the positive progress effects that: the vascular occluder has the following beneficial effects:
1. Through the mutual combination of outer braided structure and the plugging structure for this vascular plugging device has better effect, and outer braided structure has the effect of certain vascular jam, and the inner chamber of outer braided structure is fully filled to inside plugging structure in addition, makes this vascular plugging device form the shutoff thing of a kind entity under the release condition, does benefit to the formation of thrombus more and improves embolism efficiency, realizes the purpose of vascular embolism.
And because the plugging structure comprises a plurality of nonmetallic flexible strips, the embolism efficiency can be obviously improved on the basis of reducing the metal consumption.
2. The outer layer braiding structure is fixed with the proximal end and the distal end of the plugging structure through the fixing sleeve, the fixation is firm and reliable, and the phenomenon that part of flexible strips of the plugging structure fall off from meshes of the outer layer braiding structure can be avoided.
3. Through the design of outer braided structure parcel plugging structure for this vascular plugging device need not use the purpose that the embolism just can be realized to the device of several, and the braided wire of outer braided structure has memory function, and its own expansion force makes its vascular plugging device can be inseparable with the inside laminating of blood vessel, has improved embolic stability.
4. The flexible strip material of the plugging structure, in particular to the polytetrafluoroethylene material, has lower adhesiveness, and can greatly reduce the adhesion or the adhesion before the flexible strip after a plurality of flexible strips are filled in the inner cavity of the outer layer woven structure.
5. The diameter of the metal wire used by the outer layer braiding structure is 0.02 mm-0.15 mm, so that the diameter of the compressed vascular occlusion device reaches 0.5 mm-0.9 mm, the outer diameter of the steel sleeve is 0.9 mm-1.4 mm, the vascular occlusion device can be conveyed through a small-diameter catheter, and the vascular occlusion device can be easily loaded into a 5F catheter.
6. In the outer layer braided structure, the hollow cylindrical disk at the proximal end plays a role in anchoring and slowing down blood flow velocity, the hollow conical disk at the distal end plays a role in diagnosis, the specific shape structural design of the outer layer braided structure can increase anchoring capacity, increase blocking capacity for blocking blood flow and reduce the damage probability of blood vessels.
Drawings
Fig. 1 is a schematic structural view of a vascular occlusion device according to a first embodiment of the present invention;
fig. 2 (a) to fig. 2 (j) are schematic views illustrating a manufacturing process of a vascular occlusion device according to a first embodiment of the present invention, wherein:
FIG. 2 (a) is a schematic view of an outer layer weave structure with both ends retaining longer converging sections provided in accordance with the first embodiment;
FIG. 2 (b) is a schematic view of the plugging structure according to the first embodiment after passing through the central channel of the outer braid structure;
FIG. 2 (c) is a schematic view of the embodiment of the invention after the proximal ends of the device are tied up with a proximal end tying device;
FIG. 2 (d) is a schematic view of the fixing sleeve according to the first embodiment sleeved outside the proximal end constriction;
FIG. 2 (e) is a schematic view of the fixing sleeve according to the first embodiment after the fixing sleeve is sleeved outside the proximal end constriction member and the redundant outer layer knitting structure and blocking structure are removed;
FIG. 2 (f) is a schematic view of the proximal steel jacket after press-fitting the fixing jacket according to the first embodiment;
FIG. 2 (g) is a schematic diagram of a completed diverging treatment of the plugging structure according to the first embodiment;
FIG. 2 (h) is a schematic diagram of the embodiment of the invention after the distal end of the device is tied up with a distal end tying device;
FIG. 2 (i) is a schematic view of the fixing sleeve according to the first embodiment sleeved outside the distal end constriction;
FIG. 2 (j) is a schematic view of the fixing sleeve according to the first embodiment after the fixing sleeve is sleeved outside the distal end constriction member and the redundant outer layer knitting structure and blocking structure are removed;
FIG. 3 (a) is a schematic diagram of a first embodiment of delivering a vascular occlusion device to a target site of a blood vessel;
FIG. 3 (b) is a schematic view of a vascular occlusion device at a vascular target site after withdrawal of a delivery device according to the first embodiment;
fig. 4 is a schematic structural view of a vascular occlusion device according to a second embodiment of the present invention.
Detailed Description
In order that the manner in which the invention is practiced, as well as the features and objects and functions thereof, will be readily understood and appreciated, the invention will be further described in connection with the accompanying drawings.
In the present invention, when describing a vascular occluder, "distal", "proximal", "distal section", "proximal section" are used as azimuth terms which are conventional terms in the field of interventional medical devices, wherein "distal", "distal section" means the end or section of the procedure that is remote from the operator and "proximal", "proximal section" means the end or section of the procedure that is proximal to the operator.
Example 1
The present embodiment provides a vascular occlusion device 6, referring to fig. 1, the vascular occlusion device 6 includes an outer braided structure 1, an occlusion structure 2, and two fixing sleeves, which may be annular steel sleeves, respectively a proximal fixing sleeve 31 and a distal fixing sleeve 32. The outer braided structure 1 has a hollow lumen 16. The plugging structure 2 is provided with a plurality of strip-shaped nonmetal flexible strips 21, the flexible strips 21 are made of flexible materials, and each flexible strip 21 extends along the length direction of the outer layer knitting structure 1. Each of the flexible strips 21 is filled in the hollow inner cavity 16 in a divergent manner, and specifically, the central portion in the axial direction of each of the flexible strips 21 (i.e., the central portion in the axial direction of the plugging structure 2) is intertwined 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 plugging 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 plugging 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 plugging structure 2 is the proximal end of the plugging 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 plugging structure 2 is the distal end of the plugging structure 2. Of course, in some embodiments, the reverse may be true, i.e., the first end of the outer braid structure 1 is the distal end of the outer braid structure 1, the first end of the plugging structure 2 is the distal end of the plugging structure 2, the second end of the outer braid structure 1 is the proximal end of the outer braid structure 1, and the second end of the plugging structure 2 is the proximal end of the plugging structure 2.
The vascular occlusion device of the present embodiment has compressibility and self-expansion, or the outer layer woven structure 1 has compressibility and self-expansion; the compressibility means that the vascular occlusion device can be compressed to be in a compressed state, and the main purpose of the vascular occlusion device is that the vascular occlusion device can be better conveyed through a conveying device and can be conveyed and implanted into a thinner vascular position, the self-expansion means that the vascular occlusion device has a memory function after being released through the conveying device, and can be automatically expanded, so that the vascular occlusion device can be closely attached to a vascular wall, the stability of embolism is improved, and the effects of preventing blood flow and blocking a blood vessel are achieved.
The flexible strip 21 of the plugging structure 2 of the embodiment is soft and is bent at will, and the length of the flexible strip 21 does not influence the loading and releasing of products in a certain interval, but only influences the filling condition of the inner cavity of the outer layer knitting structure 1, the flexible strip 21 is slightly shorter, and the divergence degree of the flexible strip 21 in the inner cavity of the outer layer knitting structure 1 is simpler; the flexible strip 21 is somewhat longer and the degree of divergence is more complex; the number or length of the flexible strips 21 will also change correspondingly according to the change in the size of the outer woven structure 1, the larger the outer diameter of the outer woven structure 1, the greater or longer the number of flexible strips 21. The plugging structure 2 can be adapted to the outer braided structure 1 by changing the length and the number, so that the effect of fully filling and filling the inner cavity is achieved. The plugging structure 2 is filled in the inner cavity of the outer layer woven structure 1, so that the vascular plugging device forms a solid-like plugging substance in a release state, blood flow can be blocked, the effects of blocking early blood flow and causing thrombus are achieved, thrombus formation is facilitated, and the embolism efficiency is improved, so that the purpose of vascular embolism is achieved.
The flexible strip 21 in this embodiment is a nonmetallic flexible structure, so that thrombus can be better intertwined and adsorbed, and the embolism effect can be achieved. And because of non-metal, the metal consumption of the vascular occlusion device can be reduced as much as possible, and the embolism effect can be obviously improved.
The outer layer knitting structure 1 and the proximal ends and distal ends of the plurality of elongated flexible strips 21 of the present embodiment are reliably fixed by the fixing sleeve, so that the flexible strips 21 can be prevented from falling off from the meshes of the outer layer knitting structure 1 to enter the blood. After the two ends of the long flexible strip 21 of this embodiment are reliably fixed, they can be always located in the inner cavity of the outer layer woven structure 1 to block the blood vessel.
Referring to fig. 1 and 2 (a), the outer braided structure 1 includes a proximal hollow cylindrical disk 11 and a distal hollow conical disk 12. The proximal hollow cylindrical disk 11 serves as an anchor for slowing down blood flow. For safer release of the vascular occlusion device from the catheter into the human body, the distal end of the embodiment adopts a hollow conical disc 12, and the distal end surface of the hollow conical disc 12 is an arc-shaped surface. When the distal end of the hollow conical disk 12 is released from the catheter sheath and is similar in shape to the external conical disk, the product is smaller than the blood vessel; when the release is severely compressed into long or slender strips, the product is larger than the blood vessel and can play a diagnostic role. However, the distal end face is described herein as including a hemispherical structure, a spherical structure, a bullet-shaped structure, a parabolic shape rotating around a symmetry axis, or the like, having a structure with an inclined end face for controlling the self-expansion rate during the release of the vascular occlusion device from the catheter into the human body.
The outer layer braiding structure 1 is of a single-layer or multi-layer reticular structure, preferably a single-layer reticular structure, so that the metal reaction in a human body is reduced, and the biocompatibility is better.
As shown in fig. 2 (a), the outer layer knitting structure 1 is formed by knitting a memory metal, and the hollow cavity 16 is formed in the outer layer knitting structure 1 by heat setting after knitting, and the inner diameter of the hollow cavity 16 is larger than the inner diameters of the first end and the second end of the outer layer knitting structure.
The outer layer braiding structure 1 is formed by braiding and shaping metal wires, wherein the metal wires are one or more of nickel-titanium alloy, cobalt-chromium alloy and platinum-iridium alloy. The diameter of the metal wires is 0.02 mm-0.15 mm, and the number of the metal wires can be 12/24/36/72, so that the diameter of the compressed vascular occlusion device can be controlled to be 0.5mm-0.9mm, and the vascular occlusion device can be well loaded into a 5F catheter. Wherein, the nickel-titanium alloy and the platinum-iridium alloy are memory metals.
The outer braided structure 1 of this embodiment is braided and shaped using wires so that the vascular occlusion device can be delivered through a small diameter catheter. The outer layer braided structure 1 of this embodiment is preferably braided by 36 wires, the ends of both ends have heads of 36 wires, when the plugging structure 2 is installed in the middle channel of the outer layer braided structure 1, the ends of the outer layer braided structure 1 need to be spread, which can lead to the scattering of the wire braided net at the head end, and the braided net cannot be maintained, so that the plugging structure 2 has the possibility of being unable to be placed in the middle channel, therefore, when the outer layer braided structure 1 is heat-set, it is necessary to ensure the longer braided net at both ends of the outer layer braided structure 1, that is, as shown in fig. 2 (a), it is preferable to keep the proximal end constriction section 13 and the distal end constriction section 14 with certain lengths.
The flexible strip 21 is made of one or more of polytetrafluoroethylene, ultra-high molecular polyethylene and other high molecular polymer materials. The flexible strip material of the plugging structure, in particular to the polytetrafluoroethylene material, has lower adhesiveness, and can greatly reduce the adhesion or the adhesion before the flexible strip after a plurality of flexible strips are filled in the inner cavity of the outer layer woven structure. The diameter of the flexible strip 21 is 0.05 mm-0.15 mm, and the number of the flexible strips 21 is 10-24.
Referring to fig. 1,2 (c) and 2 (h), the overlapping portion of the proximal end of the outer layer braided structure 1 and the proximal end of the plugging structure 2 is narrowed by a proximal narrowing member 41, and the fixing sleeve 31 is sleeved outside the proximal narrowing member 41. The overlapping part of the distal end of the outer layer knitting structure 1 and the distal end of the plugging structure 2 is converged by a distal converging piece 42, and the fixing sleeve 32 is sleeved outside the distal converging piece 42. The proximal and distal constrictions 41 and 42 are preferably copper wire.
Referring to fig. 1,2 (f) and 2 (g), the vascular occlusion device further comprises a proximal steel sheath 51 and a distal steel sheath 52. The proximal end of the proximal steel sleeve 51 is provided with an internal thread, and the proximal steel sleeve 51 is press-fitted outside the fixed sleeve 31. The distal end of the distal steel sleeve 52 is of a distally convex conical configuration such that the distal steel sleeve 52 is a tapered steel sleeve, and the distal steel sleeve 52 is pressed against the outside of the fixed sleeve 32.
The proximal steel sheath 51 may be used to detachably connect with a delivery device, through which the delivery device delivers the vascular occlusion device to a target site, and through which the delivery device exits the body after complete release of the vascular occlusion device, the vascular occlusion device remains at the target site for vascular occlusion purposes. The distal steel sleeve 52 is a tapered steel sleeve. In the actual use process, a certain gap exists between the head of the loader of the conveying device and the tail of the sheath tube, the distal steel sleeve 52 of the vascular plugging device is provided with taper, so that products can enter the sheath tube more smoothly, the steel sleeve with taper cannot be sharp, and the damage to blood vessels in the conveying process is reduced.
The fixed sleeve 31, the fixed sleeve 32, the proximal steel sleeve 51 and the distal steel sleeve 52 are made of one or more of nickel-titanium alloy, platinum-iridium alloy and high 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 0.9 mm-1.4 mm.
Referring to fig. 3 (a) and 3 (b), a delivery device is connected to the internal thread of the proximal steel sheath 51, and then the vascular occlusion device is delivered to a target site by the delivery device, and finally the purpose of vascular occlusion is achieved through a subsequent operation.
Example two
The difference between the vascular occluder provided in this embodiment and the first embodiment is that:
Referring to fig. 4, the outer braid structure 1 of the present embodiment has three disks, namely, the outer braid structure 1 includes a proximal hollow cylindrical disk 11, a middle hollow cylindrical disk 15 and a distal hollow conical disk 12. The proximal ends of the outer braided structure 1 and the blocking structure 2 are fixed by a fixing sleeve 31 and a proximal steel sleeve 51. The distal end of the outer braided structure 1 and the distal end of the plugging structure 2 are fixed by the fixing sleeve 32 and the distal end steel sleeve 52.
The distal hollow conical disk 12 still serves as a diagnostic decision. Hollow cylindrical disk 11 and hollow cylindrical disk 15 provide greater anchoring capacity and provide better occlusion in vessels with large blood flow rates and long anchoring spaces than a single cylindrical disk.
In the plugging structure of this embodiment, according to the size of the inner cavity of the outer layer woven structure 1 and the plugging requirement, the diameter of the flexible strip is designed to be larger than that of the first embodiment, that is, each flexible strip in fig. 4 is thicker than that of the flexible strip in fig. 1 in the first embodiment.
It should be noted that, in this embodiment, the shape and thickness of the outer layer woven structure are similar to those of the first embodiment, and the description thereof will be omitted.
Example III
The present embodiment provides a method for manufacturing a vascular occlusion device, which can manufacture the vascular occlusion device of the first embodiment and the second embodiment. Taking the vascular occlusion device of the first embodiment as an example, the manufacturing method comprises the following specific steps:
s1, passing the undispersed plugging structure 2 through the middle channel of the outer layer braiding structure 1.
Referring to fig. 2 (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 layer braiding structure 1 is selected from the outer layer braiding structures 1 with two ends reserved with longer braiding net structures. I.e. the proximal end of the outer braided structure 1 has a proximal convergent section 13 of a preset length and the distal end of the outer braided structure 1 has a distal convergent section 14 of a preset length. The outer braided structure 1 comprises a proximal hollow cylindrical disc 11, a distal hollow conical disc 12, a proximal convergent section 13 and a distal convergent section 14.
Referring to fig. 2 (b), after the plugging structure 2 passes through the intermediate channel of the outer braided structure 1, at least a preset length of the plugging structure 2 is located in the proximal convergent section 13, preferably the plugging structure 2 is at a preset distance from the proximal end of the proximal convergent section 13.
The vascular occlusion device designed in the above way is provided with a section of only one end proximal end convergent section of the outer layer braiding structure 1 between the proximal end of the occlusion structure 2 and the proximal end of the proximal end convergent section 13, and is provided with a gradient for restraining the outer diameter of the braiding wires, so that the subsequent fixing sleeve 31 can be conveniently installed.
In this step, the plugging structure 2 may be passed through the middle channel of the outer woven structure 1 by folding a flexible strip 21 in half or back and forth in the middle channel. The non-divergent plugging structure 2 can generate the required number of flexible strips in a mode that one flexible strip is folded in half or folded back and forth in the middle channel of the outer layer weaving structure 1, after the plugging structure is worn, two ends of the flexible strip reaching the required number are sheared, and the purpose that one flexible strip is changed into a plurality of flexible strips 21 can be achieved.
A plurality of short flexible strips may have the possibility of the flexible strips penetrating out of the outer woven structure during the process of being placed in the intermediate channel, while a long flexible strip may greatly reduce this risk. The undispersed occluding structure 2 may be passed completely through the intermediate passage of the outer braided structure 1 and then the undispersed occluding structure 2 may be pulled back distally to achieve the effect shown in figure 2 (b). In fig. 2 (b), the effect that one flexible strip is folded back and forth for multiple layers to form seven flexible strips 21 is achieved, and the plugging structure 2 reserves a section of the plugging structure located in the proximal end converging section 13 of the outer layer knitting structure 1 to form a proximal overlapping section with the outer layer knitting structure 1 for subsequent fixation.
S2, the proximal end of the outer braided structure 1 and the proximal end of the plugging structure 2 are fixed by the fixing sleeve 31.
Referring to fig. 2 (c), the outer braided structure 1 and the plugging structure 2 overlapped in the proximal end closing section 13 are bundled by the proximal closing element 41 to the proximal end of the proximal end closing section 13 before being fixed by the fixing sleeve 31. The strapping is done to make the fixation sleeve 31 more stable with the proximal end of the outer braided structure 1 and the proximal end of the plugging structure 2. The proximal end constriction 41 is preferably a copper wire which is strapped from the overlapping of the proximal ends of the outer braided structure 1 and the non-diverging plugging structure 2 to the proximal end of the outer braided structure 1, wherein only the outer braided structure 1 is present in the middle of the proximal end to the proximal end, giving a gradient to the outer diameter of the constraining braided wire, facilitating the loading of the fixation sleeve 31.
Referring to fig. 2 (d), the fixing sleeve 31 is sleeved outside the proximal end constricting element 41. The retaining sleeve 31 is fitted over the hollow cylindrical disk 11 as close to the proximal end as possible.
The inner diameter of the fixing sleeve 31 is slightly larger than the outer diameter of the outer layer knitting structure 1 after all knitting wires are gathered, i.e. the inner diameter of the fixing sleeve 31 is slightly larger than the outer diameter of the proximal end closing section 13. The outer braided structure 1 and the undispersed plugging structure 2 are gathered to have an outer diameter very similar to the inner diameter of the fixed sleeve 31, and even in a state of not gathering in place, the outer braided structure is larger than the inner diameter of the fixed sleeve 31. So the longer mesh at the proximal end of the outer layer of the braided structure 1 prevents the braided filaments from unraveling and makes the installation of the retaining sleeve 31 less difficult, providing a transition for the installation of the retaining sleeve 31. Under the limit size, the flexible strip with the limit number is put in, so that the effects of conveying in the sheath tube as small as possible and filling the inside of the vascular occluder as full as possible are achieved.
Referring to fig. 2 (e), the outer braided structure 1 and the occlusion structure 2 on the proximal side of the fixation sheath 31 are removed entirely. The fixing sleeve 31 is arranged in the section of the proximal steel sleeve 51 without burrs, the threaded connection between the product and the pushing rod in the later period is not affected, the plugging structure 2 is changed from one flexible strip to a plurality of flexible strips 21, and the later dispersing treatment is facilitated.
Referring to fig. 2 (f), after the fixation with the fixation sleeve 31, the fixation sleeve 31 is also press-fitted into the proximal steel sleeve 51.
S3, performing divergent treatment on the plugging structure 2 to enable the plugging structure 2 to be filled in the inner cavity of the outer layer woven structure 1.
In addition, the inventors have found during development that how the non-metallic flexible strips 21 are sufficiently filled within the outer braided structure 1 is currently the most difficult problem to solve. Since the two ends of the flexible strip 21 in the length direction are fixed to the two ends of the outer woven structure 1 in order to prevent the flexible strip 21 from escaping from the outer woven structure 1. This is very difficult to achieve by keeping the ends of the flexible strip 21 fixed and by having the intermediate portion of the flexible strip 21 spread sufficiently within the hollow cavity 16 of the outer braided structure 1.
In order to solve the above problems, referring to fig. 2 (g), after the proximal end of the outer braided structure 1 is fixed by the fixing sleeve 31, the distal end of the outer braided structure 1 is pulled back and forth, the blocking structure 2 is relatively soft, has no memory function, the outer braided structure 1 is made of a memory alloy, has a memory function, and the outer braided structure 1 is heat-set into a structure having a hollow cavity therein, and the blocking structure 2 moves relative to the outer braided structure 1 and is retracted in the outer braided structure 1 every time it is pulled.
The specific steps may be as follows, after the plugging structure 2 penetrates into the outer layer knitting structure 1 along the axial direction, as shown in fig. 2 (e), the plugging structure 2 and the proximal end of the outer layer knitting structure 1 are fixed by a fixing sleeve 31, and then the distal end of the outer layer knitting structure 1 is pulled to drive the distal end of the outer layer knitting structure 1 to move towards the proximal direction far away from the outer layer knitting structure 1, and since the outer layer knitting structure 1 is formed by knitting with memory metal, the elasticity is very high and the plugging structure can be easily pulled. When the distal end of the outer layer knitting structure 1 is pulled to a state incapable of being pulled, the outer layer knitting structure 1 wraps more flexible strips 21, at this time, the distal end of the outer layer knitting structure 1 is loosened, the flexible strips are retracted into the outer layer knitting structure, and at the same time, vibration force generated by the rebound can stretch out the flexible strips 21, so that the flexible strips 21 are loosely and intertwined and filled in the hollow inner cavity 16 of the outer layer knitting structure 1.
The above procedure may be performed several times until each flexible strip 21 is loaded into the outer braided structure 1, whereby each flexible strip 21 is divergently filled in the hollow lumen 16 of the outer braided structure 1.
The filling method makes full use of the elastic properties of the outer layer woven structure 1 which is formed by knitting a memory metal, and fills the hollow cavity 16 of the outer layer woven structure 1 with the flexible strips 21 so as to be very skillfully dispersed.
Of course, it should be noted that in some embodiments, the outer braided structure 1 may also be secured 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 occlusion device is placed into the external tool and pulled and released, etc.
Meanwhile, more preferably, during the pulling process, the plugging structure 2 can be manually intervened and scattered by a needle, forceps or other tiny tools, so as to ensure that the plugging structure 2 is fully filled.
In addition, the vascular occlusion device comprises N outer layer braiding structures 1, wherein a first end of the outer layer braiding structure 1 of an ith section is connected with a second end of the outer layer braiding 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 layer knitting structure 1 clamp the flexible strips 21, so that when the outer layer knitting structure 1 is pulled back and forth, the first end and the second end of the outer layer knitting structure 1 play a clamping role on the flexible strips 21, and when rebound, the flexible strips 21 can be more conveniently bounced away.
Of course, in actual process, the distal end of the outer layer woven structure 1 of the (i+1) th section can be directly pulled to rebound when rebounding. Of course, the distal rebound of the ith node and the (i+1) th outer layer braid structure 1 may also be pulled, respectively.
After the divergence treatment of the plugging structure 2, the distal end of the plugging structure 2 can be sheared off to ensure that the plugging structure 2 is completely in the distal end convergent section 14 of the outer woven structure 1, and preferably, the distal end of the plugging structure 2 is a certain distance away from the distal end of the distal end convergent section 14. So that the plugging structure 2 is reserved with a section which is positioned in the distal convergent section 14 to form a distal overlapped section with the outer layer knitting structure 1 for subsequent fixation.
And S4, fixing the distal end of the outer braided structure 1 and the distal end of the plugging structure 2 by using the fixing sleeve 32.
Referring to fig. 2 (h), the outer braided structure 1 and the plugging structure 2 overlapped in the distal end convergent section 14 are strapped and convergent by the distal convergent member 42 to the distal end of the distal convergent section 14 before being fixed by the fixing sleeve 32. The distal constriction 42 is preferably a copper wire which is strapped from the overlapping distal ends of the outer braided structure 1 and the non-diverging plugging structure 2 to the distal end of the outer braided structure 1, wherein the distal end to the distal middle has only the outer braided structure 1, giving the braided wire a gradient in outer diameter, facilitating the loading of the retaining sleeve 32.
Referring to fig. 2 (i), the retaining sleeve 32 is positioned over the distal constriction 42. The retaining sleeve 32 is positioned as close to the distal hollow conical disk 12 as possible.
The inner diameter of the fixing sleeve 32 is slightly larger than the outer diameter of the outer layer braided structure 1 after all braided wires are gathered, i.e. the inner diameter of the fixing sleeve 32 is slightly larger than the outer diameter of the distal convergent section 14. The outer braided structure 1 and the undispersed plugging structure 2 are gathered to have an outer diameter very similar to the inner diameter of the fixed sleeve 32, and even in a state of not gathering in place, the outer braided structure is larger than the inner diameter of the fixed sleeve 32. The longer mesh at the proximal end of the outer braid structure 1 prevents the braid from unraveling and makes it less difficult to load the retaining sleeve 32, providing a transition for the loading of the retaining sleeve 32.
Referring to fig. 2 (j), the outer braided structure 1 and the occlusion structure 2 on the distal end side of the anchor sheath 32 are removed entirely. Not only ensures that the fixing sleeve 32 is arranged in the section of the distal steel sleeve 52 without burrs, but also enables the plugging structure 2 to be changed into an independent flexible strip from the distal folding flexible strip, so that the plugging structure 2 is thoroughly decomposed into short flexible strips 21 with required quantity from a long flexible strip, and each flexible strip is independently stressed, so that the influence of each flexible strip on each other is minimized.
After securing with the securing sleeve 32, the securing sleeve 32 is also placed into the distal steel sleeve 52 for press fit securing. Referring to fig. 1, a schematic view of the vascular occlusion device after the distal steel sheath 52 is assembled with the retaining sheath 32 and then compressed is also shown.
Example IV
The embodiment provides a method for installing a vascular occlusion device, wherein the distal end face of an outer layer woven structure 1 of the vascular occlusion device is an arc-shaped face, and the method comprises the following specific steps:
After the vascular occlusion device is compressed and delivered to the target site by the delivery device, the distal side of the vascular occlusion device is first released when the vascular occlusion device is released from the catheter sheath of the delivery device into a blood vessel within the body. Diagnosing the size of the vascular occlusion device after the distal end side of the vascular occlusion device is released, considering that the vascular occlusion device is smaller than a blood vessel when the distal end side of the vascular occlusion device has the same outer contour as the vascular occlusion device before the vascular occlusion device is not compressed outside a human body, and considering that the vascular occlusion device is larger than the blood vessel when the distal end side of the vascular occlusion device is compressed into a long strip shape or a strip shape; the smaller or larger vessel occluder is recovered by the delivery device, the vessel occluder of the other model is continued to the target position for release and diagnosis until no smaller or larger phenomenon occurs, and the current vessel occluder is considered to be adapted, as shown by vessel occluder 6 in fig. 3 (a). The vascular occluder is separated from the conveying device, and the conveying device is withdrawn from the human body to complete the installation of the vascular occluder. The vascular occlusion device 6 shown in fig. 3 (b) is left in the blood vessel 7 for the purpose of vascular occlusion.
In the embodiment, the diagnosis effect is realized by adopting the arc-shaped surface as the distal end surface of the outer layer woven structure 1, whether the model of the blood vessel occluder is matched with the size of the blood vessel or not is diagnosed, if not, the blood vessel occluder is recovered, and the next model is replaced. Without the diagnostic function of this embodiment, the vascular occlusion device would not be fully occluded when it is small, and would be stretched too long when it is too large, potentially affecting other blood vessels. Once the vascular occlusion device is completely released, the device is more cumbersome to recycle, so that the diagnostic function is adopted before the complete release, and a prognosis can be made before the vascular occlusion device is completely released.
The distal end face of the present embodiment includes a hemispherical structure, a spherical structure, a bullet-shaped structure, a parabolic rotation body shape around a symmetry axis, or the like, and has a structure having an inclined end face for controlling the self-expansion rate in the process of releasing the vascular occlusion device from the catheter into the human body.
It should be emphasized that the above-described embodiments may be used in combination with each other, and that some details mentioned in one embodiment may be equally effective in another embodiment, so that many details are not repeated in each embodiment to avoid repetition.
The foregoing has shown and described the basic principles, principal features and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, and that the above embodiments and descriptions are merely illustrative of the principles of the present invention, and various changes and modifications may be made without departing from the spirit and scope of the invention, which is defined in the appended claims. The scope of the invention is defined by the appended claims and equivalents thereof.
Claims (11)
1. A method for manufacturing a vascular occlusion device, which is characterized by comprising the following steps:
s1, an outer layer braiding structure with a hollow inner cavity is adopted, and an undispersed plugging structure is penetrated into the hollow inner cavity of the outer layer braiding structure along the axial direction of the outer layer braiding structure;
the plugging structure comprises a plurality of nonmetal flexible strips with long strips, and each flexible strip extends along the axial direction of the outer layer braiding structure;
S2, fixing the first end of the outer layer woven structure and the first end of the plugging structure by using a fixing sleeve;
S3, performing divergent treatment on the blocking structure, so that the middle parts of the blocking structure are mutually wound and divergently filled in the whole inner cavity of the outer layer woven structure, and particularly, the middle parts of the flexible strip in the axial direction are mutually wound and divergently filled in the whole hollow inner cavity of the outer layer woven structure;
And S4, fixing the second end of the outer layer woven structure and the second end of the plugging structure by using another fixing sleeve.
2. The method of manufacturing a vascular occlusion device of claim 1, wherein said outer braided structure is braided from memory metal wires, said outer braided structure is braided from memory metal, and said hollow lumen is formed in said outer braided structure by heat setting after braiding is completed, said hollow lumen having an inner diameter greater than the inner diameters of said first and second ends of said outer braided structure;
In step S3, when the plugging structure is diverged, the second end of the outer layer woven structure is pulled back and forth, so that the plugging structure is intertwined and divergently filled in the whole inner cavity of the outer layer woven structure.
3. The method of manufacturing a vascular occlusion device of claim 2, wherein the step of pulling back and forth the second end of the outer braided structure while the occlusion structure is divergently treated so that the occlusion structure is intertwined with each other and divergently fills the entire lumen of the outer braided structure comprises the steps of:
Step V1: driving the distal end of the outer layer braiding structure to move away from the proximal end of the outer layer braiding structure, wherein the outer layer braiding structure wraps more flexible strips, the distal end of the outer layer braiding structure is loosened, the distal end of the outer layer braiding structure rebounds, and then the flexible strips are divergently received in the outer layer braiding structure;
repeating the step V1 for a plurality of times until each flexible strip is mutually wound and divergently filled in the whole inner cavity of the outer layer woven structure;
and/or, in the step S3, when the plugging structure is subjected to the divergence treatment, a tool is used for poking and scattering the flexible strip.
4. The method for manufacturing a vascular occlusion device according to claim 1, wherein in step S1, a proximal end of the outer layer braided structure has a proximal end convergent section of a preset length, a distal end of the outer layer braided structure has a distal end convergent section of a preset length, and after the occlusion structure passes through an intermediate channel of the outer layer braided structure, at least the occlusion structure of the preset length is located in the proximal end convergent section;
In step S2, before the fixing sleeve is used for fixing, the outer layer woven structure and the plugging structure overlapped in the proximal end bundling section are bundled and bundled by a proximal end bundling piece, and are bundled and bundled to the proximal end part of the proximal end bundling section, and the fixing sleeve is sleeved outside the proximal end bundling piece, and the outer layer woven structure and the plugging structure at the proximal end side of the fixing sleeve are removed;
in step S1, the plugging structure passes through the middle channel of the outer layer braiding structure in a mode that one flexible strip is folded in half or back and forth in the middle channel;
And/or, in the step S2, after the fixing sleeve is used for fixing, the fixing sleeve is also placed into a proximal steel sleeve for pressing and fixing;
In step S3, after the blocking structure is diverged, ensuring that at least the blocking structure with the preset length is located in the distal convergent section;
In step S4, before the fixing sleeve is used for fixing, the outer layer woven structure and the plugging structure overlapped in the distal end bundling section are bundled and bundled by a distal end bundling piece, and are bundled and bundled to the distal end part of the distal end bundling section, and the fixing sleeve is sleeved outside the distal end bundling piece, and the outer layer woven structure and the plugging structure on the distal end side of the fixing sleeve are removed completely;
and/or, in the step S4, after the fixing sleeve is used for fixing, the fixing sleeve is further placed into a distal steel sleeve for pressing and fixing.
5. The method of claim 4, wherein the occlusion structure is a predetermined distance from the proximal end of the proximal constriction.
6. The method of claim 4, wherein the occlusion structure is a predetermined distance from the distal end of the distal end constriction.
7. A vascular occlusion device, comprising:
an outer braid structure having a hollow interior;
The sealing structure comprises a plurality of strip-shaped flexible strips, wherein each flexible strip extends along the length direction of the outer layer weaving structure, the middle parts of the flexible strips are mutually wound and divergently filled in the inner cavity, and particularly, the middle parts of the flexible strips in the axial direction are mutually wound and divergently filled in the whole hollow inner cavity of the outer layer weaving structure;
Two fixed sleeves, one fixed sleeve is fixed in the outer layer is woven the first end of structure and the first end of shutoff structure is outside, another fixed sleeve is fixed in the outer layer is woven the second end of structure and the second end of shutoff structure is outside.
8. The vascular occlusion device of claim 7, wherein in diverging the occlusion structure from said outer braided structure, non-diverging occlusion structure is first threaded into said hollow lumen of said outer braided structure along an axial direction of said outer braided structure;
Pulling back and forth the second end of the outer braided structure so that the plugging structure is intertwined and divergently filled in the whole inner cavity of the outer braided structure.
9. The vascular occlusion device of claim 8, wherein said outer braided structure is braided from nickel titanium wire and is thermally qualitative to form said hollow lumen having an inner diameter greater than the inner diameters of the first and second ends of said outer braided structure;
the vascular occlusion device comprises N outer layer woven structures, wherein the first end of the outer layer woven structure of the ith section is connected with the second end of the outer layer woven 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 occlusion device of claim 9, wherein the first and second ends of the outer braided structure grip each of the flexible strips.
11. The vascular occlusion device of claim 7, wherein a proximal end of said outer braid structure is necked in with a proximal crimp at a proximal overlap of said occlusion structure, and wherein one of said retaining sleeves is disposed over said proximal crimp;
The overlapping part of the distal end of the outer layer woven structure and the distal end of the plugging structure is bunched by a distal end bunching piece, and the other fixing sleeve is sleeved outside the distal end bunching piece;
And/or, the vascular occlusion device further comprises:
The proximal steel sleeve is provided with an internal thread at the proximal end and is pressed outside the proximal fixing sleeve;
the distal steel sleeve is pressed outside the distal fixing sleeve;
And/or the outer layer braiding structure is formed by braiding and shaping metal wires, wherein 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 0.02-0.15 mm;
And/or one or more of polytetrafluoroethylene, ultra-high molecular polyethylene and high molecular polymer materials in the flexible strip, wherein the diameter of the flexible strip is 0.05-0.15 mm, and the number of the flexible strip is 10-24;
And/or the fixing sleeve, the proximal steel sleeve and the distal steel sleeve are made of one or more of nickel-titanium alloy, platinum-iridium alloy and high polymer materials, and the outer diameters of the fixing sleeve, the proximal steel sleeve and the distal steel sleeve are 0.9-1.4 mm;
And/or, the outer layer braiding structure is a hollow cylindrical disc or a hollow conical disc;
and/or the vascular occlusion device comprises one or more outer layer braiding structures, wherein the distal end face of the outer layer braiding structure positioned at the distal end is an arc-shaped face;
when the vascular occlusion device comprises at least two outer braided structures, the outer braided structures at the proximal end are hollow cylindrical discs.
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| CN116077126A (en) | 2023-05-09 |
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