CN117918918A - Plugging device - Google Patents
Plugging device Download PDFInfo
- Publication number
- CN117918918A CN117918918A CN202211317591.6A CN202211317591A CN117918918A CN 117918918 A CN117918918 A CN 117918918A CN 202211317591 A CN202211317591 A CN 202211317591A CN 117918918 A CN117918918 A CN 117918918A
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- China
- Prior art keywords
- deformation
- main body
- occluder
- body part
- accommodating part
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- 230000004308 accommodation Effects 0.000 claims description 6
- 239000012528 membrane Substances 0.000 claims 2
- 210000004204 blood vessel Anatomy 0.000 abstract description 23
- 208000007536 Thrombosis Diseases 0.000 abstract description 3
- 230000015572 biosynthetic process Effects 0.000 abstract description 2
- 239000008280 blood Substances 0.000 abstract description 2
- 210000004369 blood Anatomy 0.000 abstract description 2
- 238000009940 knitting Methods 0.000 description 13
- 230000002792 vascular Effects 0.000 description 10
- NRTOMJZYCJJWKI-UHFFFAOYSA-N Titanium nitride Chemical compound [Ti]#N NRTOMJZYCJJWKI-UHFFFAOYSA-N 0.000 description 8
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- 208000002330 Congenital Heart Defects Diseases 0.000 description 3
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 3
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- 229910001285 shape-memory alloy Inorganic materials 0.000 description 3
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- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 3
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
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- 206010003226 Arteriovenous fistula Diseases 0.000 description 1
- 229920002101 Chitin Polymers 0.000 description 1
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- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 1
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- 206010016717 Fistula Diseases 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
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- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- SOQBVABWOPYFQZ-UHFFFAOYSA-N oxygen(2-);titanium(4+) Chemical group [O-2].[O-2].[Ti+4] SOQBVABWOPYFQZ-UHFFFAOYSA-N 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Public Health (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Reproductive Health (AREA)
- Vascular Medicine (AREA)
- Surgical Instruments (AREA)
- Prostheses (AREA)
Abstract
The invention relates to an occluder. The deformation containing part is at least partially radially protruded out of the main body part, and the furling piece is positioned in a groove formed by the recess of the far end of the deformation containing part facing the main body part and is positioned outside the deformation containing part. By arranging the main body part of the deformation accommodating part at least partially protruding radially, the part of the deformation accommodating part protruding radially outwards of the main body part is excessively extruded by the inner wall of the blood vessel, and the protruding part of the deformation accommodating part radially outwards of the main body part drives the deformation accommodating part to move towards the center direction of the main body part, so that the furling piece is accommodated by the deformation accommodating part, the contact area between the furling piece and blood is reduced, and the probability of thrombus formation is reduced.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to an occluder.
Background
This section provides merely background information related to the present disclosure and is not necessarily prior art.
Abnormal vascular access is abnormal vascular traffic in a non-physiological state in the body caused by factors such as congenital dysplasia, acquired compensation or trauma, and various clinical common diseases are accompanied with the existence of abnormal vascular access. Such as: complex cyanosis congenital heart disease is often accompanied by a coarse collateral of the aorta to pulmonary arteries; complicated arteriovenous tumor and arteriovenous fistula at different positions; coronary ventricular fistula, abnormal morphological endocardial defects of congenital heart disease, abnormal blood vessels existing in the body, blood vessels that need to be occluded due to surgical operations and the like, and the like.
In the prior art, a vascular occluder is generally implanted into a blood vessel to occlude an abnormal vascular channel, the two ends of the vascular occluder are generally fixed by a metal sealing head and a bolt head, and the two ends of the vascular occluder are protruded to the outside from the sealing heads, so that thrombus is easily generated at the ends of the vascular occluder, and the vascular occluder is not beneficial to human health.
Disclosure of Invention
Based on this, it is necessary to provide an occluder, which comprises a main body, a deformation accommodating portion disposed at a proximal end or a distal end of the main body, and a folding member, wherein one end of the deformation accommodating portion is connected with the main body, the other end of the deformation accommodating portion is constrained in the folding member, at least part of the deformation accommodating portion protrudes radially from the main body, and the folding member is disposed in a recess formed by recessing the distal end of the deformation accommodating portion toward the main body and is disposed outside the deformation accommodating portion.
Optionally, the deformation accommodating portion includes a protruding portion and a converging portion, and in an axial section of the plugging device, a left side contour line of the main body portion, a left side contour line of the protruding portion and a left side contour line of the converging portion are sequentially connected, and the converging portion is connected with the converging piece; the deformation accommodating part extends from a position connected with the main body part to the radial outer side of the main body part to form a protruding part, and then bends towards the center of the main body part to form a converging part, and the projection of the deformation accommodating part completely covers the projection of the main body part on the cross section perpendicular to the longitudinal center axis of the plugging device.
Optionally, the deformation resistance of the protruding portion is greater than the deformation resistance of the main body portion, and the converging portion is integrally connected with the main body portion.
Optionally, the raised portion is coated with a coating or provided with a support bar.
Optionally, the deformation accommodating portion comprises a wire mesh, and the diameter or wire width of the wire at the protruding portion is larger than the diameter or wire width of the wire at the converging portion.
Optionally, the occluder further comprises a flow blocking film, and the circumferential edge of the flow blocking film is connected to the position with the largest diameter of the deformation accommodating part.
Optionally, the deformation accommodating portion includes a plurality of knitting wires, the knitting wires are knitted to form the deformation accommodating portion, and the choke film is stitched at the intersection point of the knitting wires.
Optionally, the occluder further comprises a connecting piece, one end of the connecting piece is connected with the flow blocking film, and the other end of the connecting piece is connected with the nearest end or the farthest end of the deformation accommodating part.
Optionally, the choke film completely covers the deformation accommodating portion and is attached to the inner wall of the deformation accommodating portion.
Optionally, the plugging device further comprises a fixing disc, wherein the fixing disc is connected with one end, far away from the deformation accommodating part, of the main body part, and the diameter of the fixing disc is larger than that of the main body part.
Optionally, the weave density of the retention tray is greater than the weave density of the body portion.
Compared with the prior art, the plugging device has the beneficial effects that:
After the occluder is implanted into a blood vessel, the deformation accommodating part is at least partially radially protruded from the main body part, so that the part of the deformation accommodating part protruding towards the radial outer side of the main body part is excessively extruded by the inner wall of the blood vessel (compared with the main body part), the part of the deformation accommodating part protruding towards the radial outer side of the main body part moves towards the radial center direction of the main body part (the arrow f direction), meanwhile, the extrusion force is transmitted to the tail end of the deformation accommodating part (namely, one end connected with the furling piece), and then the tail end of the deformation accommodating part moves towards the center direction of the main body part (namely, the arrow f direction) under the action of the extrusion force through the end surface of the furling piece positioned at the most distal end of the deformation accommodating part facing into a groove formed by recessing the main body part, so that the furling piece is accommodated by the deformation accommodating part, the contact area of the furling piece and blood is reduced, and the probability of thrombus formation is reduced.
Drawings
Fig. 1 is a schematic structural view of an occluder in accordance with a first embodiment of the present invention;
FIG. 2 is an enlarged schematic view of the structure A in FIG. 1 according to the present invention;
FIG. 3 is a schematic view of a gathering member according to a first embodiment of the present invention;
Fig. 4 is a schematic structural view of an occluder according to a first embodiment of the present invention after implantation in a blood vessel;
FIG. 5 is an enlarged schematic view of the structure at B in FIG. 1 according to the present invention;
FIG. 6 is a schematic view showing the structure of the coating layer attached to the occluder in the first embodiment of the present invention;
FIG. 7 is a schematic view of a structure of a covering film and a deformed accommodating portion according to an embodiment of the present invention;
FIG. 8 is an enlarged schematic view of the structure A in FIG. 7 according to the present invention;
fig. 9 is a schematic diagram of a connection structure between a support rod and a wire mesh in a second embodiment of the present invention;
Fig. 10 is a schematic view showing an expanded structure of a wire mesh and a support rod in a second embodiment of the present invention;
Fig. 11 is a schematic structural view of an occluder in a third embodiment of the present invention.
Detailed Description
In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit or scope of the invention, which is therefore not limited to the specific embodiments disclosed below.
In the field of interventional medical devices, "distal" is defined as the end of the procedure that is distal to the operator, and "proximal" is defined as the end of the procedure that is proximal to the operator. "axial" refers to a direction parallel to the line connecting the distal center and the proximal center of the medical device, and "radial" refers to a direction perpendicular to the axial direction.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
Example 1
The present embodiment provides an occluder 100, and the occluder 100 can be used for interventional intravascular occlusion of abnormal vascular passages, arteriovenous tumors, arteriovenous fistulae, coronary heart ventricular fistulae, congenital heart diseases and other abnormal endocardial defects.
As shown in fig. 1 to 4, the occluder 100 includes a main body 110, a deformation housing 120 provided at a proximal end or a distal end of the main body 110, and a folding member 130, one end of the deformation housing 120 is connected to the main body 110, and the other end of the deformation housing 120 is constrained in the folding member 130.
The occluding device 100 may be a mesh formed by braiding wires or by cutting a metallic member, the mesh having a certain elasticity. The material forming the occluding device 100 comprises a metallic material comprising any one of a nickel titanium based shape memory alloy, an iron based shape memory alloy, a copper based memory alloy, or a stainless steel wire, or a polymeric material comprising any one of absorbable polylactic acid wire, absorbable chitin fiber, or absorbable surgical suture.
The body 110 and the deformation receiving portion 120 may be integrally connected by laser cutting or integrally woven by a woven wire, which are made of a metal material, or welded together. The main body 110 has a substantially tubular structure, and the side wall of the main body 110 has a mesh structure to provide good adhesion. One end of the deformation housing portion 120 is connected to one axial end of the main body portion 110, the deformation housing portion 120 is located at one axial side of the main body portion 110, and one end of the deformation housing portion 120 away from the main body portion 110 is connected to the gather 130.
As shown in fig. 2, the deformation accommodation portion 120 protrudes radially at least partially from the main body portion 110. The main body 110 may extend in the axial direction of the main body 110, then extend toward the radial outside of the main body 110, and then bend to extend toward the radial center of the main body 110 to connect with the gathering member 130 to form the deformation receiving portion 120. The main body 110 may also extend directly along the radial outer side of the main body 110, and then bend toward the radial center of the main body 110 and extend near one side of the main body 110 to connect with the gathering member 130 to form the deformation receiving portion 120. It will be appreciated that the axial projection of the deformation housing 120 completely covers the body portion 110 in a cross section perpendicular to the longitudinal center axis of the occluding device 100, i.e. the deformation housing 120 completely covers one axial end of the body portion 110. It will be appreciated that the diameter of the portion of the deformation accommodation 120 extending radially toward the main body 110 is greater than the maximum diameter of the main body 110.
As shown in fig. 2, the gathering member 130 is located in a recess formed by recessing an end surface of the distal-most end 125 of the deformation accommodating portion 120 toward the main body portion 110, where the distal-most end 125 of the deformation accommodating portion 120 refers to an end point of the deformation accommodating portion 120 farthest from the main body portion 110 in the axial direction. The position where the folding member 130 is connected to the deformation housing portion 120 is referred to as a position where the folding member 130 folds the deformation housing portion 120, or a position where one end of the folding member 130 is attached to the deformation housing portion 120. It will be appreciated that the location where the gathering member 130 connects with the deformation housing 120 is spaced from the distal-most end 125 of the deformation housing 120. That is, the position where the gather 130 is connected to the deformation housing portion 120 is spaced apart from the distal-most end 125 of the deformation housing portion 120 by a distance x1.
As shown in fig. 3, one end of the folding member 130 is sealed, and the other end is provided with a receiving hole 131. One end of the deformation housing portion 120 is folded in the housing hole 131 and then fixedly connected to the folding member 130. The sealing end of the gathering member 130 faces the side of the deformation housing 120 away from the main body 110. It is understood that in other embodiments, one end of the deformation receiving portion 120 may be directly welded or adhered to the gathering member 130.
Thus, as shown in fig. 4, after the occluder 100 is implanted in a blood vessel, by the deformation housing portion 120 being at least partially radially protruding from the main body portion 110, the portion of the deformation housing portion 120 protruding radially outward from the main body portion 110 is excessively pressed by the inner wall of the blood vessel (compared to the main body portion 110), the portion of the deformation housing portion 120 protruding radially outward from the main body portion 110 moves toward the radial center direction (arrow f1 direction) of the main body portion 110, and at the same time, the pressing force is transmitted to the distal end of the deformation housing portion 120 (i.e., the end connected to the gathering member 130), and then the distal end of the deformation housing portion 120 moves toward the center direction (arrow f2 direction) of the main body portion 110 under the pressing force by the gathering member 130 being located in the recess formed by the end surface of the distal end 125 of the deformation housing portion 120 facing the main body portion 110.
Referring back to fig. 2, the deformation accommodating portion 120 includes a protruding portion 123 and a converging portion 124, in an axial cross section of the stopper, a left side contour line a1 of the main body portion 110, a left side contour line a2 of the protruding portion 123 and a left side contour line a3 of the converging portion 124 are sequentially connected, and one end of the converging portion 124 away from the protruding portion 123 is connected to the converging member 130; the deformation accommodation portion 120 extends from a position connected to the main body 110 to the outside in the radial direction of the main body 110 to form a convex portion 123, and is bent toward the center of the main body 110 to form a converging portion 124.
In this embodiment, the main body 110, the protruding portion 123 and the converging portion 124 are integrally connected, the protruding portion 123 may be formed by extending the main body 110 toward the radial outside, the converging portion 124 may be formed by bending the protruding portion 123 toward the center of the main body 110 and connecting the converging member 130, the maximum diameter d2 of the converging portion 124 is smaller than the diameter d1 of the main body 110, the maximum diameter d3 of the protruding portion 123 is larger than the diameter d1 of the main body, that is, d3> d1> d2, and the converging portion 124 is located radially inside the main body 110.
As shown in fig. 4, after the occluder 100 is implanted into a blood vessel, the protrusion 123 is excessively pressed by the inner wall of the blood vessel, and then pushes the bunching portion 124 to move towards a side close to the main body 110 (in the direction of arrow f 1), and the bunching portion 124 drives the bunching member 130 to move towards the main body 110 (in the direction of arrow f 2), so that the side wall of the bunching member 130 is attached to the side wall of the bunching portion 124, and the bunching member 130 is accommodated.
In this embodiment, the deformation accommodating portion 120 includes a first deformation accommodating portion 121, where the first deformation accommodating portion 121 is located at a distal end side of the main body 110, and the main body 110 extends radially outward toward the distal end side to form a distal protruding portion 1211, and then extends radially toward a radial center of the proximal end side to form a distal converging portion 1212. The projection of the first deformation receiving portion 121 completely covers the projection of the body portion 110 on a cross section perpendicular to the longitudinal center axis of the occluder.
It will be appreciated that in some embodiments, as shown in fig. 5, the deformation housing 120 further includes a second deformation housing 120, the second deformation housing 120 being located on the proximal side of the body 110.
The first deformation accommodating portion 121 and the second deformation accommodating portion 122 are disposed radially symmetrically at both axial ends of the main body 110, the second deformation accommodating portion 122 includes a proximal receiving portion 1222 and a proximal protruding portion 1221, the main body 110 extends radially outward toward the proximal side to form a proximal protruding portion 1211, and then extends radially center toward the distal side to form a proximal receiving portion 1222, and the axial projection of the second deformation accommodating portion 120 completely covers the main body 110. The second deformation accommodating portion 120 is provided with a conveying mating member 140, one end of the conveying mating member 140 is provided with a connecting hole, the proximal end folding portion 1222 is gathered in the connecting hole, the other end of the conveying mating member 140 is detachably connected with the conveyor, for example, the other end of the conveying mating member 140 is provided with a threaded hole for being mated with the conveyor, and the conveyor is in threaded fit with the threaded hole.
It will be appreciated that in some embodiments, as shown in FIG. 2, the ratio of the maximum diameter d2 of the raised portion 123 to the maximum diameter d1 of the body portion 110 to the convexity is between 1.05-1.3, e.g., the ratio of the maximum diameter d2 of the raised portion 123 to the d1 of the body portion 110 may be 1.05, 1.1, 1.2, 1.25, or 1.3. In this way, it is ensured that the protrusion 123 has a sufficient protrusion amount to be pressed by the inner wall of the blood vessel, that the deformation amount of the protrusion 123 after being pressed can push the constriction 124 to move toward the main body 110, and that the difficulty in sheathing caused by the excessive diameter of the protrusion 123 can be avoided.
It will be appreciated that in some embodiments, the protruding portion 123, the converging portion 124 may be disposed along the circumferential direction of the main body portion 110 to form a deformation receiving portion 120 that completely covers the protruding portion 123 and the converging portion 124 in one circumferential direction. In other embodiments, the protruding portion 123 and the converging portion 124 may be partially disposed in the circumferential direction of the deformation accommodating portion 120, for example, the protruding portion 123 and the converging portion 124 may be disposed only on one circumferential side of the deformation accommodating portion 120, the protruding portion 123 and the converging portion 124 may be disposed in a partial area in the circumferential direction, and the protruding portion 123 and the converging portion 124 may not be disposed in a partial area, so long as the protruding portion 123 may be pressed to drive the converging portion 124 to move toward the radial center of the main body 110, and the converging portion 124 may clamp or wrap the converging member 130.
It is understood that in some embodiments, the raised portion 123 and the converging portion 124 may be formed by heat setting. For example, a mold is provided in which the deformation receiving portion 120 is protruded, a woven tubular member or a cut tubular member is fitted over the mold, and then the tubular member is heat-set to obtain the protruding portion 123 and the converging portion 124.
In the present embodiment, the deformation resistance of the protruding portion 123 is greater than that of the main body portion 110, the converging portion 124 is integrally connected with the main body portion 110, and the area of a single mesh of the converging portion 124 is smaller than that of the main body portion 110.
The deformation resistance refers to the ability of the occluding device 100 to deform under the extrusion of an external force. The stronger the deformation resistance, the greater the force needed to squeeze the part to deform, and the deformation resistance can be measured by using a force measuring instrument. For example, in one embodiment, the deformation resistance of the boss 123 is tested in the following manner: the pressure head of the dynamometer is contacted with the outer side wall of the boss 123, at this time, the reading of the dynamometer display is adjusted to zero, then the measuring scale is adjusted, the pointer starts to apply pressure after pointing to zero, and when the displacement scale moves to 30% of the diameter of the boss 123, the force value displayed on the dynamometer is recorded. The deformation resistance of the body portion 110 is as follows: the pressure head of the dynamometer is contacted with the outer side wall of the main body 110, at the moment, the reading of the dynamometer display is adjusted to be zero, then the measuring scale is adjusted, the pointer points to zero and then begins to apply pressure, and when the displacement scale moves to 30% of the diameter of the main body 110, the force value displayed on the dynamometer is recorded. In the present embodiment, the main body portion 110 is integrally woven or integrally cut with the converging portion 124, and the main body portion 110 is identical to the woven or cut structure of the converging portion 124 except that the area of the single mesh on the converging portion 124 is smaller than the area of the single mesh on the main body portion 110 when the converging portion 124 is restrained by the converging member 130.
In this way, the deformation resistance of the convex portion 123 is made larger than that of the main body portion 110, and the deformation resistance of the main body portion 110 is made similar to that of the converging portion 124, so that the deformation resistance of the convex portion 123 is made larger than that of the main body portion 110.
In this embodiment, as shown in fig. 2 and 6, the protruding portion 123 and the converging portion 124 may be formed by integrally knitting the knitting wires, where the protruding portion 123 is located, the two intersecting knitting wires may be fixedly connected at the intersection point, for example, welded or stitched, where the converging portion 124 is located, the two intersecting knitting wires are movably connected at the intersection point, that is, the two intersecting knitting wires may move relatively, so that after the protruding portion 123 is stressed, the two intersecting knitting wires at the protruding portion 123 are difficult to generate adaptive slippage at the intersection point, and have a larger deformation resistance, and the two intersecting knitting wires at the converging portion 124 are movably connected, so that the knitting wires may generate adaptive slippage and be easier to deform, thereby making the deformation resistance of the protruding portion 123 greater than the deformation resistance of the converging portion 124.
It will be appreciated that in other embodiments, the boss 123 and the constriction 124 may be integrally cut into a formed wire mesh having a larger wire diameter at the boss 123 than at the constriction 124, for example, a wire diameter or width at the boss 123 of between 0.1 and 0.2mm, and in particular may be 0.1, 0.12, 0.15 or 0.2mm. At the converging portion 124, the wire has a diameter or width of between 0.05 and 0.15mm, specifically, may be 0.05, 0.08, 0.1, 0.12 or 0.15mm, and the wire having a larger diameter or width has a stronger stiffness so that the deformation resistance at the convex portion 123 is greater than the deformation resistance at the converging portion 124.
Thus, after the occluder 100 is implanted into a blood vessel, the protrusion 123 is harder and is difficult to deform by the arrangement that the deformation resistance of the protrusion 123 is greater than that of the constriction 124, so that the extrusion force is promoted to be transmitted to the constriction 124, and then the protrusion 123 can push the constriction 124 to move, and the deformation resistance of the constriction 124 is smaller than that of the constriction 124, so that the constriction 124 is softer, thereby being convenient for the constriction 124 to wrap the constriction 130 and promoting the accommodation of the constriction 130.
As shown in fig. 6, in the present embodiment, the convex portion 123 is coated with a coating 160, the coating 160 being for enhancing the deformation resistance of the convex portion 123, the coating 160 including any one of a titanium oxide coating, a titanium nitride coating, or a titanium nitride ceramic coating.
The coating 160 comprises any one of a titanium oxide coating, a titanium nitride coating, or a titanium nitride ceramic coating, it being understood that in one embodiment, the titanium nitride coating 160 is applied to the inner or outer walls of the boss 123 using the following steps: (1) heat treatment: heat-treating the convex portion 123; (2) surface pretreatment: cleaning the oxide layer and pollutants on the surface of the protruding part 123; (3) ion sputtering cleaning: placing the pretreated protruding part 123 into a vacuum chamber, introducing argon, adding negative bias, and performing ion sputtering cleaning on the surface by utilizing glow discharge plasma; (4) deposition of a pseudo diffusion layer: after ion sputtering cleaning, one or more cold cathode vacuum arc ion sources with filtering devices are started; (5) coating a sublayer film: after the pseudo diffusion layer is completed, alternately coating pure titanium and titanium nitride; (6) cycle selection: repeating step (5); (7) plating of pure titanium nitride layer: and (3) starting one or more ion sources, plating a pure titanium nitride layer with the thickness of 200-400 nm, and closing the ion sources, gas and bias voltage after the thickness is reached. After the titanium oxide coating is coated on the position of the protruding part 123, on one hand, titanium oxide forms crystals on the surface of the wire of the protruding part 123, and the crystals increase the rigidity of the wire, so that the rigidity of the whole protruding part 123 is increased, and the transmission of extrusion force is promoted; on the other hand, the setting of the deformation resistance of the bulge 123 is increased by coating the coating 160, so that the difficulty of processing the bulge 123 for enhancing the deformation resistance is reduced, and the difficulty of manufacturing products is reduced. It will be appreciated that in some embodiments, the coating 160 may be disposed on the boss 123 alone, or may be disposed on both the boss 123 and the body 110.
As shown in fig. 2, the occluder 100 further comprises a choke film 150, and the circumferential edge of the choke film 150 is connected to the maximum diameter of the deformation accommodating portion 120.
The choke film 150 includes any one of a PTFE choke film, a PET choke film, and a PU choke film, where the circumferential profile of the choke film 150 corresponds to the circumferential profile of the deformation accommodating portion 120, the position of the deformation accommodating portion 120 where the diameter is largest refers to the position of the boss 123 where the diameter is largest, the position of the choke film 150 corresponds to the position of the boss 123 where the diameter is largest, the circumferential edge of the choke film 150 is attached to the inner wall of the boss 123 where the diameter is largest, and the choke film 150 may be sewn, bonded, or thermally pressed to the inner wall of the boss 123 where the diameter is largest.
It will be appreciated that in other embodiments, the blocker film 150 may also be coupled to the boss 123, to other locations on the inner wall of the constriction 124, or to a constraint, for example, in one embodiment, the blocker film 150 is coupled to the constriction 130 by a suture at the center of the blocker film 150. For another example, in other embodiments, the choke film 150 may also be connected to the inner wall of the constriction 124.
It should be appreciated that, in other embodiments, the choke film 150 may be further connected to the outer side wall of the deformation accommodating portion 120 and completely cover the deformation accommodating portion 120, and the choke film 150 and one end of the converging member away from the main body 110 are spaced apart, so that the bulge 123 pushes the converging portion 124 to move towards the main body 110, and the sealing end of the converging portion 130 is prevented from piercing the choke film 150 after the converging portion 124 wraps the converging member 130. On the other hand, sewing the choke film 150 on the outer side of the deformation accommodating portion 120 can also effectively reduce the sewing difficulty of the choke film 150.
In this way, the circumferential edge of the choke film 150 is connected to the position with the largest diameter of the deformation accommodating portion 120, so that on one hand, the choke film 150 can completely cover the deformation accommodating portion 120, the choke film 150 can form a barrier to blood flow at the deformation accommodating portion 120, and the plugging effect of the plugging device 100 is improved, on the other hand, the choke film 150 can form a constraint to the position with the largest diameter at the deformation accommodating portion 120, and the deformation resistance of the protruding portion 123 is further improved.
As shown in fig. 7, the occluder 100 further comprises a connector, one end of which is connected to the middle portion of the flow blocking film 150, and the other end of which is connected to the most distal end 125 of the deformation receiving portion 120.
The connecting member includes any one of a suture and a braided wire. One end of the connection member is sewn to a middle portion of the choke film 150, which refers to a portion between a circumferential edge of the choke film 150 and a center of the choke film 150, and specifically, a position where the connection member is sewn to the choke film 150 may be disposed corresponding to the distal-most end 125 of the deformation receiving portion 120. The most distal end 125 of the deformation receiving portion 120 refers to a position where the protruding portion 123 is connected to the converging portion 124, which is an inflection point where the protruding portion 123 is bent toward the center of the main body portion 110, and the other end of the connecting member is sewn to the most distal end 125 of the deformation receiving portion 120. In this embodiment, there are two connectors, and the two connectors are radially symmetrically disposed on both sides of the gathering member 130, it will be appreciated that in other embodiments there are a plurality of connectors, and the plurality of connectors are disposed in a central circumferential array of the flow blocking film 150.
After the occluder 100 is implanted into a blood vessel, the connection position of the protruding portion 123 and the converging portion 124 (i.e. the most distal end 125 of the deformation accommodating portion 120) is extruded by the inner wall of the blood vessel and moves towards the center of the main body portion 110, the most distal end 125 of the deformation accommodating portion 120 drives the flow blocking film 150 to protrude towards the inner wall close to the deformation accommodating portion 120 through the conveying matching piece 140, the flow blocking film 150 can cover the joint of the grid, and the occlusion effect of the flow blocking film 150 is increased.
As shown in fig. 8, the deformation receiving portion 120 includes a plurality of braided wires, all of which intersect to form a mesh structure, and the choke film 150 is sewn at the intersection points of the braided wires.
In this embodiment, the braided wires include a first braided wire 126 and a second braided wire 127, the first braided wire 126 and the second braided wire 127 intersect to form an intersection point a1, the choke film 150 is attached to the intersection point a1, the suture thread passes out of the inner side of the choke film 150 and is located at the outer side of the intersection point a1, then bypasses a1 to enter the inner side of the choke film 150, the suture thread is circulated for a plurality of times, the suture connection at the intersection point of the choke film 150 and the braided wires is realized, the suture thread is wound at the intersection point, the suture thread can form a constraint on the intersection point of the braided wires, the relative movement of the suture thread on the first braided wire 126 and the second braided wire 127 forms a constraint in the compression process of the protruding portion 123, and the deformation resistance of the protruding portion 123 is increased. It will be appreciated that the choke film 150 may be stitched to all of the intersections of the filaments of the weave at the maximum diameter of the boss 123, or may be stitched to some of the intersections of the filaments of the weave at the maximum diameter of the boss 123.
The advantage of this arrangement is that, through intersecting the braided wires to form the deformation accommodating portion 120, the choke film 150 is sewn at the intersecting point of the braided wires, so that the suture can restrict the intersecting point, and the difficulty of sliding caused by the pressed braided wires at the intersecting point is increased, so that the deformation resistance of the boss 123 is increased, and after the boss 123 is pressed, the force can be transmitted to the tail end of the boss 123 to press the converging portion 124 to move towards the main body 110.
Example two
The present embodiment differs from the first embodiment in that, as shown in fig. 9, the deformation housing portion 220 includes a screen 228 and a plurality of support rods 229, all of the support rods 229 are connected to the screen 228 and are disposed along the circumferential direction of the screen 228, and the support rods 229 extend from the main body portion 210 to the boss portion 223.
In this embodiment, the occluder 200 is formed by cutting a tubular metal member with laser, and at the deformation receiving portion 220, the tubular metal member is cut with laser to form a mesh structure, as shown in fig. 10, and in a partially expanded configuration of the mesh structure, a plurality of support rods 229 are arranged in an equidistant array along the width direction, and the diameter or the rod width of the support rods 229 is between 0.15 and 0.4, for example, the diameter or the rod width of the support rods 229 may be 0.15, 0.18, 0.25, 0.3 or 0.4. In the closed configuration of the mesh structure (i.e., the solid configuration of the occluding device 200), the support struts 229 are disposed along the axial direction of the occluding device 200 and a plurality of support struts 229 are disposed along a circumferential array of the occluding device 200. The support rods 229 form the main body support framework of the occluding device 200 and provide sufficient radial support for the occluding device 200. The support bar 229 extends from the main body portion 210 to the boss 223, i.e., the support bar 229 extends from the main body portion 210 to the distal-most end 225 of the deformation accommodation portion 220. The support bar 229 provides a certain resistance to deformation for the boss 223. It is understood that the support bar 229 may be provided only on the boss 223, or may be provided on both the boss 223 and the main body 210.
The wire mesh 228 is positioned between two adjacent support rods 229 and integrally connected to the two adjacent support rods 229. The wire diameter or rod width in the wire mesh 228 is between 0.08 and 0.2, specifically the wire mesh 228 may have a diameter or rod width of 0.08, 0.1, 0.15, or 0.2. The wire rods in the wire mesh 228 have a smaller rod width or diameter than the support rods 229, and the wire mesh 228 has good deformability to better conform to the inner wall of the vessel. For the position of the converging portion 224, since only the wire mesh 228 is provided, the deformation performance of the wire mesh 228 is larger than that of the support rod 229, so that the converging portion 224 has better deformation performance than the convex portion 223.
After the occluder 200 is implanted into a blood vessel, the protruding portion 223 is pressed by the inner wall of the blood vessel, the supporting rod 229 has a larger rod diameter and is difficult to deform, so that the supporting rod 229 is pressed to drive the converging portion 224 to move towards the radial center of the main body 210, the converging piece moves towards the radial center of the main body 210 along with the converging portion 224, and the converging piece is wrapped by the converging portion 224.
The number of the support rods 229 is not limited in this embodiment, and the number of the support rods 229 may be two, and the two support rods 229 are radially symmetrically disposed on the deformation receiving portion 220. It will be appreciated that in other embodiments, the number of support rods 229 may be 3, 4, 5 or 6, with a plurality of support rods 229 being circumferentially arranged in an array on the screen 228.
It will be appreciated that in other embodiments, the screen 228 is formed from woven filaments, and the support rods 229 are provided through the screen 228. For example, in one embodiment, the woven wire on the wire mesh 228 has a plurality of intersecting points in the axial direction, and the support bar 229 is interwoven with the plurality of intersecting points up and down in order to connect the support bar 229 with the wire mesh 228. In other embodiments, the support rods 229 may also be welded to the intersection points to effect connection of the support rods 229 to the wire mesh 228.
The advantage of this arrangement is that by deforming the accommodating portion 220 to include the screen 228 and the plurality of support rods 229, all of the support rods 229 are connected to the screen 228 and arranged in the circumferential direction of the screen 228, so that the support rods 229 can strengthen the deformation resistance of the screen 228, the support rods 229 extend from the main body portion 210 to the boss 223, so that the support rods 229 can strengthen the deformation resistance at the boss 223, and the screen 228 is provided only at the converging portion 224, so that the deformation resistance of the boss 223 is greater than the deformation resistance of the converging portion 224, thereby facilitating the transfer of stress at the boss 223 to the converging portion 224.
As shown in fig. 9, the choke film 250 completely covers the deformation housing portion 220 and is attached to the inner wall of the deformation housing portion 220. In this embodiment, the choke film 250 is attached to the inner wall of the deformation accommodating portion 220, the choke film 250 is connected to the inner wall of the deformation accommodating portion 220, and the contour of the choke film 250 is set corresponding to the contour of the inner wall of the deformation accommodating portion 220. The choke film 250 may be sewn, adhered or thermocompression bonded to the inner wall of the deformation receiving portion 220. Thus, the choke film 250 completely covers the deformation housing portion 220 and is attached to the inner wall of the deformation housing portion 220, so that the area covered by the choke film 250 at the deformation housing portion 220 is maximized, and the plugging effect of the plugging device 200 is increased.
Example III
The difference between this embodiment and the first embodiment is that, as shown in fig. 11, the occluder 300 further includes a fixing plate 380, where the fixing plate 380 is connected to an end of the main body 310 away from the deformation receiving portion 320, and the diameter of the fixing plate 380 is larger than that of the main body 310.
The holding pan 380 comprises a wire mesh which may be woven from braided wires or laser cut from a metal tubular member. The fixing plate 380 is connected to the main body 310 by a fixing member. For example, in one embodiment, a first fixing hole is formed at one end of the fixing member, one end of the fixing portion adjacent to the fixing plate 380 is fixed in the first fixing hole, a second fixing hole is formed at the other end of the fixing member, and one end of the fixing plate 380 adjacent to the fixing portion is fixed in the fixing hole, thereby realizing connection of the fixing plate 380 and the main body portion 310. The diameter of the fixing disk 380 is larger than the diameter of the main body 310, meaning that the diameter d4 of the fixing disk 380 is larger than the diameter d1 of the main body 310.
After the occluder 300 is implanted into a blood vessel, the fixing disc 380 is attached to the inner wall of the blood vessel at the distal end side of the main body 310, and the side wall of the fixing disc 380 is in a net structure, so that the fixing disc 380 and the inner wall of the blood vessel have good attachment shape, the friction force between the fixing disc 380 and the inner wall of the blood vessel is increased, the displacement resistance of the occluder 300 is increased, and the occluder 300 is prevented from being displaced due to scouring of blood flow.
The braid density of the retainer disk 380 is greater than the braid density of the body portion 310.
The knitting density refers to the number of filament intersections per unit area. The number of intersecting points of filaments in the unit area (cm 2) after the fixing disk 380 is unfolded is greater than the number of intersecting points of filaments of the main body portion 310. For example, in other embodiments, the number of intersection points of filaments per unit area after deployment of the holding pan 380 is between 70-144, specifically the number of intersection points of filaments per unit area is: 70. 73, 81, 96, 124, or 144. The number of intersecting points of filaments per unit area of the body portion 310 is between 30 and 70, specifically, the number of intersecting points of filaments per unit area is 30, 32, 36, 43, 51, 64 or 70.
In this way, by setting the knitting density of the fixing disc 380 to be greater than that of the main body 310, the number of the intersections of the filaments in the unit area of the fixing disc 380 is greater than that of the intersections of the filaments of the main body 310, so that the contact area between the fixing disc 380 and the inner wall of the blood vessel is increased, the static friction force between the fixing disc 380 and the inner wall of the blood vessel is increased, and the fixing effect of the occluder 300 is further increased.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.
Claims (11)
1. The plugging device is characterized by comprising a main body part, a deformation accommodating part and a furling piece, wherein the deformation accommodating part is arranged at the proximal end or the distal end of the main body part, one end of the deformation accommodating part is connected with the main body part, the other end of the deformation accommodating part is restrained in the furling piece, the deformation accommodating part protrudes out of the main body part at least partially in a radial direction, and the furling piece is positioned in a groove formed by the distal end of the deformation accommodating part facing towards the recess of the main body part and is positioned outside the deformation accommodating part.
2. The occluder of claim 1, wherein the deformation accommodation portion comprises a bulge portion and a constriction portion, the left side contour line of the main body portion, the left side contour line of the bulge portion and the left side contour line of the constriction portion being connected in sequence in an axial section of the occluder, the constriction portion being connected with the constriction member; the deformation accommodating part extends from a position connected with the main body part to the radial outer side of the main body part to form the protruding part, and bends towards the center of the main body part to form the converging part, and on a cross section perpendicular to the longitudinal center axis of the occluder, the projection of the deformation accommodating part completely covers the projection of the main body part.
3. The occluder of claim 2, wherein the protrusion has a resistance to deformation greater than the body, and wherein the constriction is integrally connected to the body.
4. The occluder of claim 2, wherein the raised portion is coated with a coating or is provided with a support rod.
5. The occluder of claim 2, wherein the deformation receptacle comprises a wire mesh, the diameter or wire width of the wire at the raised portion being greater than the diameter or wire width of the wire at the necked portion.
6. The occluder of claim 1, further comprising a flow blocking membrane having a circumferential edge connected to the deformation receptacle at a maximum diameter.
7. The occluder of claim 6, wherein the deformation receptacle comprises a plurality of braided filaments braided to form the deformation receptacle, the flow blocking film being stitched at intersections of the braided filaments.
8. The occluder of claim 7, further comprising a connector having one end connected to the flow blocking membrane and the other end connected to the proximal-most or distal-most end of the deformation receptacle.
9. The occluder of claim 6, wherein the flow blocking film completely covers the deformed receptacle and conforms to an inner wall of the deformed receptacle.
10. The occluder of claim 1, further comprising a retaining disk connected to an end of the body portion remote from the deformation receiving portion, the retaining disk having a diameter greater than the diameter of the body portion.
11. The occluder of claim 9, wherein the braid density of the fixation disc is greater than the braid density of the body portion.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211317591.6A CN117918918A (en) | 2022-10-26 | 2022-10-26 | Plugging device |
| PCT/CN2023/125896 WO2024088206A1 (en) | 2022-10-26 | 2023-10-23 | Occluder |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211317591.6A CN117918918A (en) | 2022-10-26 | 2022-10-26 | Plugging device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117918918A true CN117918918A (en) | 2024-04-26 |
Family
ID=90767188
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202211317591.6A Pending CN117918918A (en) | 2022-10-26 | 2022-10-26 | Plugging device |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN117918918A (en) |
| WO (1) | WO2024088206A1 (en) |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6168622B1 (en) * | 1996-01-24 | 2001-01-02 | Microvena Corporation | Method and apparatus for occluding aneurysms |
| CN200980741Y (en) * | 2006-11-13 | 2007-11-28 | 王震 | Vascular inner blocking device |
| CN105433991B (en) * | 2015-12-28 | 2018-12-07 | 先健科技(深圳)有限公司 | Plugging device |
| CN109381239A (en) * | 2018-10-08 | 2019-02-26 | 陈金凤 | A kind of patend ductus arteriosus occluder |
| EP3741312A1 (en) * | 2019-05-22 | 2020-11-25 | Occlutech Holding AG | Occluder with stretchable waist |
| CN211583282U (en) * | 2019-09-20 | 2020-09-29 | 先健科技(深圳)有限公司 | Absorbable occluder and occlusion system |
| CN114680956A (en) * | 2020-12-30 | 2022-07-01 | 先健科技(深圳)有限公司 | Occlusion device |
| CN112932561A (en) * | 2021-02-01 | 2021-06-11 | 上海锦葵医疗器械股份有限公司 | Heart ventricular septal defect occluder with flat two end surfaces and manufacturing method thereof |
| CN114246631A (en) * | 2022-02-28 | 2022-03-29 | 上海介入医疗器械有限公司 | Plugging device and plugging assembly |
-
2022
- 2022-10-26 CN CN202211317591.6A patent/CN117918918A/en active Pending
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2023
- 2023-10-23 WO PCT/CN2023/125896 patent/WO2024088206A1/en unknown
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| WO2024088206A1 (en) | 2024-05-02 |
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