CN118217459A - Plugging device and preparation method thereof - Google Patents
Plugging device and preparation method thereof Download PDFInfo
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- CN118217459A CN118217459A CN202211631013.XA CN202211631013A CN118217459A CN 118217459 A CN118217459 A CN 118217459A CN 202211631013 A CN202211631013 A CN 202211631013A CN 118217459 A CN118217459 A CN 118217459A
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- occluder
- endo
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- promoting substance
- filaments
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Landscapes
- Materials For Medical Uses (AREA)
Abstract
The invention relates to an occluder and a preparation method thereof. The occluder comprises an endo-membranization promoting substance which can accelerate the generation speed of an endo-membrane after the occluder is implanted, is beneficial to improving the safety performance of the occluder, and particularly for a degradable occluder, can prevent or reduce the possibility of the occluder losing efficacy due to degradation and loss of mechanical properties before the endo-membrane is not generated.
Description
Technical Field
The invention relates to the field of interventional medical instruments, in particular to an occluder and a preparation method thereof.
Background
This section provides merely background information related to the present disclosure and is not necessarily prior art.
The plugging device can be used for minimally invasive treatment of congenital heart diseases such as atrial septal defect, ventricular septal defect, patent arterial duct, patent foramen ovale and the like. The ideal occluder can effectively occlude the defect after implantation, the occluder firstly causes thrombus on the surface after implantation, and then the fibrocyte and endothelial cells grow into the thrombus to be gradually organized, and the process is called intimation. The current occluder is implanted with a slower endomembrane process, which is easy to cause the problem of thrombus falling off, so that the occluder has poor safety performance.
Disclosure of Invention
Based on this, it is necessary to provide an occluder with a high internalization rate.
An occluder comprising a functional filament which is one or more of a metal monofilament, a polymeric monofilament and a strand comprising an endotrophic substance, one of the strands being formed by a plurality of polymeric fiber strands.
An occluder comprising an endo-promoting substance which is one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide, chloroform, adenosine diphosphate, collagen.
In one embodiment, the internalization promoting substance is one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide, chloroform, adenosine diphosphate, and collagen.
In one embodiment, when the endo-membrane material is one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide and chloroform, the endo-membrane material accounts for 0.07% -3% of the mass of the occluder.
In one embodiment, the functional filaments are at least partially located on the outer surface of the occluding device.
In one embodiment, the interfacial expansion area ratio of the part or all of the surface of at least one of the metal monofilament, the polymer monofilament and the polymer fiber is 0.15 to 0.8.
In one embodiment, at least one of the polymeric monofilaments and/or polymeric fiber strands is hollow having at least one cavity.
In one embodiment, the hollow rate of the hollow structure is 1% -30%.
In one embodiment, at least one functional yarn is made of a polymer material and is covered with a protective layer, the protective layer comprises a degradable polymer material, and the degradation rate of the polymer material of the functional yarn is lower than that of the degradable polymer material of the protective layer.
In one embodiment, when the endo-membrane promoting substance is one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide and chloroform, the endo-membrane promoting substance accounts for 0.07-3% of the mass of the occluder, and at least one section of functional yarn exists in the endo-membrane promoting substance with the mass of 3-10%.
In one embodiment, the occluder comprises a mesh structure comprising at least one occluding disk and a waist connected to the occluding disk; or the plugging device comprises an anchoring part and a plugging part, wherein the anchoring part comprises a plurality of supporting rods, and the plugging part comprises a net structure formed by braiding; or the plugging device comprises an anchoring disc and a plugging disc, wherein the anchoring disc and the plugging disc both comprise a net structure formed by braiding.
A method for preparing an occluder, comprising the following steps:
Providing an occluder preform comprising one or more portions to be treated;
and (3) soaking and/or spraying the part to be treated to obtain the occluder containing the intimation promoting substance.
An occluder, comprising a functional filament, wherein the functional filament is one or more of a polymer monofilament and a strand, and one strand is formed by gathering a plurality of polymer fiber wires; wherein at least one of the polymer monofilaments and/or polymer fiber yarns has a sheath-core structure, and the sheath-core structure comprises a core layer and a skin layer wrapping the outer surface of the core layer; and/or at least one of the polymeric monofilaments and/or polymeric fiber yarns has a hollow structure having at least one cavity extending along a length of the hollow structure.
In one embodiment, the skin layer and the core layer each comprise a degradable polymeric material, the degradable polymeric material of the core layer having a molecular weight that is less than the molecular weight of the degradable polymeric material of the skin layer.
In one embodiment, the weight average molecular weight of the degradable high molecular material of the skin layer is 5-50 ten thousand Da, and the weight average molecular weight of the degradable high molecular material of the core layer is 2-20 ten thousand Da.
In one embodiment, the ratio of the cross-sectional area of the core layer to the total cross-sectional area of the sheath-core structure is between 5% and 90%.
In one embodiment, the core layer is any one of a porous structure, a hollow structure, and a solid structure.
In one embodiment, the cross-sectional shape of the skin layer includes, but is not limited to, one or more of a circle, an ellipse, a triangle, a square, an X-shape, and a Y-shape, and the cross-sectional shape of the core layer includes, but is not limited to, one or more of a circle, an ellipse, a triangle, a square, an X-shape, and a Y-shape, and in the same skin-core structure, the cross-sectional shape of the skin layer and the cross-sectional shape of the core layer are the same or different.
In one embodiment, the hollow rate of the hollow structure is 1% -30%.
In one embodiment, the cross-sectional area of the hollow structure has an outer contour shape including, but not limited to, one or more of a circle, an ellipse, a triangle, a square, an X-shape, and a Y-shape, and an inner contour shape including, but not limited to, one or more of a circle, an ellipse, a triangle, a square, an X-shape, and a Y-shape, the outer contour shape and the inner contour shape being the same or different in the same hollow structure.
In one embodiment, the functional filament comprises a functional material comprising one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide, chloroform, adenosine diphosphate, collagen, a growth factor, a polypeptide, and a phospholipid.
The occluder comprises an endo-membranization promoting substance which can accelerate the generation speed of an endo-membrane after the occluder is implanted, is beneficial to improving the safety performance of the occluder, and particularly can prevent or reduce the possibility of the occluder losing the blocking performance caused by degradation loss of mechanical property before the endo-membrane is not generated for the degradable occluder.
Drawings
FIG. 1 is a schematic structural view of an occluder in accordance with a first embodiment of the present invention;
FIG. 2 is a schematic illustration of the structure of the braided filaments and braided strands of FIG. 1;
FIG. 3 is a schematic view of a method for manufacturing an occluder in accordance with a first embodiment of the present invention;
fig. 4 is a schematic structural diagram of an occluder in a second embodiment of the present invention;
FIG. 5 is a schematic view of a hollow structure according to a fifth embodiment of the present invention;
fig. 6 is a schematic diagram of a sheath-core structure according to a sixth 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.
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.
For purposes of more clarity in describing the structure of the present invention, the terms "distal" and "proximal" are used as terms of orientation which are conventional in the art of interventional medical devices, wherein "distal" refers to the end of the procedure that is remote from the operator and "proximal" refers to the end of the procedure that is proximal to the operator.
Example 1
Referring to fig. 1 and 2, the present embodiment provides an occluder, which includes an occluding frame 110. The plugging frame 110 includes a plurality of braided wires 202 and a plurality of braided strands 204, and the plurality of braided wires 202 and the plurality of braided strands 204 are mixed to form a three-dimensional mesh structure, and the mesh structure has meshes. Wherein, the braiding wires 202 are monofilaments, and the wire diameter of each braiding wire 202 ranges from 0.1 mm to 0.5 mm. Braided strand 204 comprises a plurality of polymeric fiber strands that are gathered into one strand, which may be one or more of a twin strand, a triple strand, or a multiple strand. Each braided strand 204 has a gauge in the range of 50D/18F-600D/144F to compromise mechanical properties and softness requirements. The meaning of 50D/18F is that each braided strand 204 comprises 18 polymeric fiber threads, the total mass of the 18 polymeric fiber threads being 50 denier (D). 600D/144F has the same meaning and is not described in detail herein. In other embodiments, each braided strand 204 may have a gauge in the range of 30D/72F-100D/72F or 50D/72F-100D/72F with a twist of 1 twist to 30 twist/10 cm. The mechanical property and the softness are required, so that the occluder has weaker clamping and pressing on tissues and weaker abrasion on the tissues, but is not fallen from the defect part. The sum of the numbers of the braided wires 202 and the braided strands 204 ranges from 36 to 72, and the ratio of the numbers of the braided wires 202 to the numbers of the braided strands 204 ranges from 2:1 to 1:2, so that the stopper has smaller radial dimension after stretching while meeting the requirements of mechanical property and flexibility, and can be conveyed by using a conveying sheath pipe with smaller diameter.
The material of the braided filaments 202 and the braided strands 204 is a material with good biocompatibility. For example, in this embodiment, the braided filaments 202 and the braided strands 204 are made of polylactic acid, and in other embodiments, the braided filaments 202 and the braided strands 204 may be made of a metal material such as nickel-titanium alloy, other degradable polymer materials such as polydioxanone, or non-degradable polymer materials such as polyethylene terephthalate. In other embodiments, the braided strands 204 may be omitted and the occlusion frame 110 may be braided from a plurality of braided filaments 202. Alternatively, in other embodiments, the braided filaments 202 may be omitted and the occlusion frame 110 may be braided from a plurality of braided strands 204. Alternatively, in other embodiments, the plugging frame 110 may be formed by cutting a tube, injection molding, or the like.
In this embodiment, the occlusion frame 110 includes an occlusion disk 112 and a waist 114 connected to the occlusion disk 112. As shown, the number of occlusion discs 112 is 2, and the width of both occlusion discs 112 is greater than the width of waist 114. The two sealing discs 112 are respectively positioned at two opposite ends of the waist 114 to form a two-disc-waist structure with two large ends and a small middle. In other embodiments, the number of the sealing discs 112 may be only one, and one sealing disc 112 is connected to one end of the waist 114 to form a structure with a T-shaped cross section. In other embodiments, the number of the sealing discs 112 is greater than 2, and every two adjacent sealing discs 112 are connected by a waist 114. The structure of the plugging frame 110 is not limited to the above-described two-plate-one-waist structure or the structure having a T-shaped cross section, and may be any three-dimensional network shape capable of meeting the requirements for plugging a heart defect.
The occluding device further includes a proximal plug 120 and a distal closure 130. The proximal plug 120 is disposed on the proximal occlusion disk 112 for securing the free ends of the braided filaments 202 and braided strands 204 of the proximal occlusion disk 112. The distal closure head 130 is disposed on the distally located occlusion disk 112 for securing the free ends of the braided filaments 202 and braided strands 204 of the distally located occlusion disk 112.
The occluder comprises an endo-membranizing substance. The intimation promoting substance can accelerate the generation speed of the intima after the occluder is implanted, is beneficial to improving the safety performance of the occluder, and particularly for degradable occluder, can prevent or reduce the possibility of failure of the occluder due to degradation and loss of mechanical property before the intima is generated.
In this embodiment, the occluder comprises one or more functional filaments, wherein the functional filaments are one or more of metal filaments, polymeric filaments, and strands comprising an intimating promoting substance, and wherein one strand is formed by a plurality of polymeric fiber strands as described above. The term "comprising an endo-substance" as used herein means that the surface of the object is covered with or attached to an endo-substance and/or that the endo-substance is dispersed or attached within the object. Note that the "coating or adhering an endo-promoting substance on the surface of the object" may be coating or adhering an endo-promoting substance on the entire surface of the object, or coating or adhering an endo-promoting substance on a part of the surface of the object. For example, in this embodiment, the endo-promoting substance may be attached to or cover the entire surface of one or more functional filaments, or may be attached to or cover a portion of the surface of a functional filament, or the endo-promoting substance may be dispersed or attached within the functional filament. In other embodiments, the proximal plug 120 and the distal plug 130 may also contain an intimating promoting substance.
In this embodiment, all of the braided filaments 202 contain an endo-promoting substance, i.e., all of the braided filaments 202 are functional filaments, and all of the braided strands 204 contain an endo-promoting substance, i.e., all of the braided strands 204 are functional filaments. The arrangement is that the endo-promoting substance can be released from each part of the occluder after the occluder is implanted, and the released endo-promoting substance can stimulate the biological tissue contacted with the occluder in the maximum range and with uniform intensity so as to accelerate the endo-membranization process of the biological tissue. It will be appreciated that in other embodiments, only a portion of the braided filaments 202 and/or a portion of the braided strands 204 may be selected as functional filaments, or only a segment of the braided filaments 202 and/or a segment of the braided strands 204 may be selected as functional filaments (the term "segment" of filaments or strands herein refers to a portion of a filament or strand along the length). For example, in other embodiments, the functional filaments are located only where the occluding device is in contact with the site of the defect to be occluded, such as the waist 114, or the functional filaments are located only on the side of the occluding disk 112 adjacent to the waist 114. The functional filaments are at least partially positioned on the outer surface of the plugging device, so that the endo-promoting substances after implantation can be ensured to be better contacted with biological tissues, and a better endo-promoting effect can be obtained.
The endo-membrane promoting substance can be one or more selected from ethyl acetate, acetone, dimethylformamide, dimethylacetamide, chloroform, adenosine diphosphate, and collagen. Wherein, after the ethyl acetate, the acetone, the dimethylformamide, the dimethylacetamide and the chloroform are contacted with biological tissues, the organism can be stimulated to cause foreign body reaction, and a certain foreign body reaction is beneficial to accelerating the endomembranization process of the organism. Adenosine diphosphate has the effect of promoting platelet aggregation and adhesion, and promotes the process of intimation of living body by promoting thrombosis. For collagen, thrombus formation is triggered when it is exposed to flowing blood, thereby promoting the progression of intimation. The above-mentioned endo-membranization promoting substance has a good endo-membranization promoting effect, and in other embodiments, any other substance capable of promoting the in-vivo membranization process can be selected as the endo-membranization promoting substance.
When the endo-membrane promoting substance is one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide and trichloromethane, the mass percentage of the endo-membrane promoting substance in the plugging device (which can be also called as a first preset mass ratio) is 0.07% -3%, so that the endo-membrane promoting substance can be released continuously to have a good endo-membrane promoting effect, and excessive foreign body reaction caused by excessive content can be avoided.
In this embodiment, the endo-membranization promoting substances in the functional yarn are uniformly distributed, i.e. the mass percentages of the endo-membranization promoting substances in the sections of the functional yarn in each length direction are uniform, so that the endo-membranization process of biological tissues around the occluder is uniformly promoted. In other embodiments, the mass percent of the endotrophic substance in each of the lengthwise segments of the functional filament may be different. For example, the mass percent of the endo-membranization promoting substance in a certain section or a plurality of sections of functional wires can be properly increased to 3-10%, but the mass percent of the endo-membranization promoting substance accounting for 0.07-3% of the total mass of the occluder still needs to be maintained, so that the efficiency of promoting endo-membranization in the local position of the occluder can be improved.
When the endo-membrane promoting substance is one or more of adenosine diphosphate and collagen, the endo-membrane promoting substance accounts for 0.07-10% of the mass of the plugging device, and can be ensured to be released continuously so as to have a good endo-membrane promoting effect.
Referring to fig. 3, the occluder may be prepared by the following method:
Step S10: an occluder preform is provided, the occluder preform comprising one or more portions to be treated.
The occluder preform includes a plurality of braided filaments 202 and a plurality of braided strands 204, the plurality of braided filaments 202 and the plurality of braided strands 204 being braided to form the occluding frame 110. In this embodiment, all of the braided filaments 202 and braided strands 204 are used as the portion to be treated. In other embodiments, portions of the braided filaments 202 and/or braided strands 204 may be selected as the treatment, and only all of the braided filaments 202 may be selected as the treatment, or only all of the braided filaments 202 may be selected as the treatment.
Step S20: and (3) soaking and/or spraying the part to be treated to obtain the occluder containing the intimation promoting substance.
Illustratively, the portion to be treated is immersed in the solution of the intimating promoting substance at a predetermined treatment temperature for a predetermined treatment period, then removed, and dried at a predetermined drying temperature for a predetermined drying period to obtain the intimating promoting portion.
The solvent of the solution of the internalization promoting substance such as ethyl acetate, acetone, dimethylformamide, dimethylacetamide, and chloroform is ethanol, any other suitable solvent such as water may be used in other embodiments, the solvent of the solution of the internalization promoting substance such as adenosine diphosphate, collagen, and the like is water, and any other suitable solution may be used in other embodiments. The mass concentration range of the intimation promoting substance solution is 5% -99.5%. The preset treatment time ranges from 15 minutes to 30 hours, the preset treatment temperature ranges from 20 degrees to 45 degrees, the preset drying temperature ranges from 20 degrees to 45 degrees, and the preset drying time ranges from 2 hours to 30 hours. In other embodiments, the above-mentioned predetermined treatment period, predetermined treatment temperature, predetermined drying temperature, and predetermined drying period may be different from those of the present embodiment, and a person skilled in the art may set appropriate parameters as required, so long as the mass percentage of the intimating promoting substance in the occluder after treatment reaches a predetermined value range (also referred to as a second preset mass ratio).
In other embodiments, the solution of the intimating promoting substance may be sprayed on the portion to be treated by a spraying method, and after the drying treatment is completed, the mass percentage of the intimating promoting substance in the occluder reaches a predetermined value range. In other embodiments, the solution of the intimating promoting substance may be applied to the portion to be treated by a mixed treatment method of soaking and spraying, and after the drying treatment is completed, the mass percentage of the intimating promoting substance in the occluder reaches a predetermined value range. In addition, if the metal material to be treated has a weak adsorption ability to the internalization promoting substance, a degradable polymer such as polylactic acid may be added to the internalization promoting substance solution and applied to the to-be-treated portion, and after the drying treatment, a film layer containing the internalization promoting substance may be formed on the surface of the to-be-treated portion.
It will be appreciated that in step S10 of this embodiment, the plurality of braided filaments 202 and the plurality of braided strands 204 of the occluder preform have been braided to form the occluding frame 110. In other embodiments, the braided filaments 202 and braided strands 204 of the occluder preform in step S10 may not be formed into the occluding frame 110 at the moment, but are braided to form the occluding frame 110 after step S20.
Further, considering the situation that the degradation of the intimation promoting substance may exist in the subsequent processes, transportation, storage and the like, the stopper can be vacuum packed after sterilization is completed, so that the possibility of the degradation of the intimation promoting substance in the stopper is reduced. In addition, the processing parameters of step S20 may be controlled, so that the second preset mass ratio processed in step S20 is appropriately higher than the first preset mass ratio (for example, 0.07% -3%), and a certain loss is reserved, so that the mass percentage of the endo-membranization-promoting substance in the occluder is ensured to be within a preset mass percentage range when the occluder is implanted. In order to more accurately determine the loss amount of the intimation promoting substances in the plugging device in the subsequent processes, transportation, storage and the like, the loss amount of various intimation promoting substances can be counted through experiments in advance, and a better value of the second preset mass ratio after the treatment in the step S20 is determined based on the counted value.
A plurality of stopper samples A1 to A9 were prepared by the above preparation method, and a stopper having the same structure and specification as the stopper sample and containing no endo-membrane promoting substance was prepared as a comparative sample B1, and each sample was implanted into the room septum of panama pig, and the endo-membrane degree of the stopper was observed by dissection for 2 months, and the results are shown in the following table:
Example 2
In this embodiment, the braided strands 204 are omitted and the choke is added in addition to embodiment 1.
Referring to fig. 4, the present embodiment provides an occluder, which includes an occluding frame 110 and a flow blocking portion connected to the occluding frame 110. Wherein, the plugging frame 110 comprises a plurality of braiding wires 202, and the braiding wires 202 are braided to form a three-dimensional net structure. The material of the braiding wire 202 may be described with reference to embodiment 1, and will not be described in detail herein.
In this embodiment, the occlusion frame 110 includes an occlusion disk 112 and a waist 114 connected to the occlusion disk 112. As shown, the number of occlusion discs 112 is 2, and the width of both occlusion discs 112 is greater than the width of waist 114. The two sealing discs 112 are respectively positioned at two opposite ends of the waist 114 to form a two-disc-waist structure with two large ends and a small middle. In other embodiments, the number of the sealing discs 112 may be only one, and one sealing disc 112 is connected to one end of the waist 114 to form a structure with a T-shaped cross section. In other embodiments, the number of the sealing discs 112 is greater than 2, and every two adjacent sealing discs 112 are connected by a waist 114. The structure of the plugging frame 110 is not limited to the above-described two-plate-one-waist structure or the structure having a T-shaped cross section, and may be any three-dimensional network shape capable of meeting the requirements for plugging a heart defect.
The occluding device further includes a proximal plug 120 and a distal closure 130. The proximal plug 120 is disposed on the proximally located occlusion disk 112 for securing the free ends of the braided filaments 202 of the proximally located occlusion disk 112. The distal closure head 130 is disposed on the distally located occlusion disk 112 for securing the free ends of the braided filaments 202 of the distally located occlusion disk 112.
The flow blocking portion includes three flow blocking films 140. The two blocking films 140 are respectively connected with the two blocking plates 112, for example, the two blocking films 140 are respectively fixed in the two blocking plates 112 or outside the two blocking plates 112, and one blocking film 140 is arranged in the waist 114. In other embodiments, only one of the sealing discs 112 may be provided with one flow blocking film 140, and the other sealing disc 112 may not be provided with a flow blocking film 140; or two or more flow blocking films 140 are arranged in the same sealing disc 112, or another flow blocking film 140 can be arranged around the circumference of the waist 114 at the same time when the three flow blocking films 140 are arranged.
In this embodiment, the choke film 140 extends substantially radially, and the circumferential edge thereof is stitched to the plugging frame 110 by stitching strands, and in other embodiments, the choke film 140 may be fixed to the supporting net 110 by an adhesive. The material of the choke film 140 may be a degradable polymer material such as polycaprolactone, levorotatory polylactic acid, polyurethane, polydioxanone, racemic polylactic acid or polyamide, or a non-degradable polymer material such as polyethylene terephthalate. The choke film 140 may be a woven, knitted or non-woven structure. The maximum pore on the surface is not more than 3mm multiplied by 3mm, and the thickness is 10 micrometers to 150 micrometers. It should be noted that, in other embodiments, the blocking film 140 may be omitted when the stopper meets the blocking requirement in other manners.
The occluder comprises an endo-membranizing substance. The intimation promoting substance can accelerate the generation speed of the intima after the occluder is implanted, is beneficial to improving the safety performance of the occluder, and particularly for degradable occluder, can prevent or reduce the possibility of failure of the occluder due to degradation and loss of mechanical property before the intima is generated.
In this embodiment, the occluder comprises one or more functional filaments and one or more endo-membranization promoting films, wherein the functional filaments are one or more of metal filaments, polymer filaments and strands containing endo-membranization promoting substances, and the endo-membranization promoting films are the flow blocking films 140 containing the endo-membranization promoting substances.
In this embodiment, all the braided wires 202 contain an endo-membrane promoting substance, i.e., all the braided wires 202 are functional wires, all the suture strands contain an endo-membrane promoting substance, i.e., all the suture strands are functional wires, and all the choke films 140 contain an endo-membrane promoting substance, i.e., all the choke films 140 are endo-membrane promoting films. The arrangement is that the endo-promoting substance can be released from each part of the occluder after the occluder is implanted, and the released endo-promoting substance can stimulate the biological tissue contacted with the occluder in the maximum range and with uniform intensity so as to accelerate the endo-membranization process of the biological tissue. It will be appreciated that in other embodiments, only a portion of the braided filaments 202 and/or the stitched strands may be selected as functional filaments, only a portion of the blocker film 140 may be selected as an endo-film, or only a segment of the braided filaments 202 and/or only a segment of the stitched strands may be selected as functional filaments, and only a portion of the blocker film 140 may be selected as an endo-film. For example, in other embodiments, the functional filaments are located only in the portion of the occluding device that contacts the defect site to be occluded, such as the waist 114, or the functional filaments are located only on the side of the occluding disk 112 that is adjacent to the waist 114, or the barrier film 140 contains an intimating promoting substance only at its circumferential edge to form an annular intimating promoting film. As long as it is ensured that one or more of the functional filaments and the endo-membrane can at least partially contact the biological tissue after implantation, a better endo-membrane effect can be obtained when the endo-membrane promoting substance is better in contact with the biological tissue.
The optional materials of the endo-membranization promoting substance and the mass percentage of the endo-membranization promoting substance in the occluder can be described in example 1, and will not be described herein. In this embodiment, the endo-membranization promoting substances in the functional yarn and the endo-membranization promoting film are uniformly distributed, that is, the mass percentages of the endo-membranization promoting substances in the sections of the functional yarn in each length direction are uniform, and the mass percentages of the endo-membranization promoting substances in each area of the endo-membranization promoting film are uniform, so that the endo-membranization promoting process of biological tissues around the plugging device is uniformly promoted. In other embodiments, the mass percent of the internalization promoting substance may be different in each lengthwise segment of the functional filament and may be different in each region of the internalization promoting film. The arrangement is favorable for improving the efficiency of promoting the intimation of the local position of the plugging device.
The preparation method of the occluder can refer to the following steps:
Step S10: an occluder preform is provided, the occluder preform comprising one or more portions to be treated.
The occluder preform comprises a plurality of braided filaments 202 and at least one suture strand, the plurality of braided filaments 202 being braided to form the occluding frame 110. In this embodiment, all of the braided wires 202, the braided wires, and the choke film 140 are used as the portions to be treated. In other embodiments, portions of the braided wire 202, the suture strands, and the choke film 140 may be selected as the portions to be treated, and in other embodiments, only the braided wire 202 and the suture strands may be selected as the portions to be treated.
Step S20: and (3) soaking and/or spraying the part to be treated to obtain the occluder containing the intimation promoting substance.
Illustratively, the portion to be treated is immersed in the solution of the intimating promoting substance at a predetermined treatment temperature for a predetermined treatment period, then taken out, and then dried at a predetermined drying temperature for a predetermined drying period to obtain the intimating promoting portion, and this step is specifically described with reference to embodiment 1 and will not be repeated herein.
It will be appreciated that the invention is not limited to the configuration of the occluding device. In other embodiments, the configuration of the occluder may be different from that described in embodiments 1, 2, in other embodiments the occluder may be other configurations, for example, the occluder comprises an anchoring portion comprising a plurality of support rods and an occluding portion comprising a braided mesh structure; or the plugging device comprises an anchoring disc and a plugging disc, and the anchoring disc and the plugging disc comprise net structures formed by braiding.
Example 3
In this example, the ratio of the interfacial expansion area of the surface of at least one of the metal monofilament, the polymer monofilament, and the polymer fiber yarn of the functional yarn of the sealer of this example to the interfacial expansion area of the surface of at least one of the metal monofilament, the polymer monofilament, and the polymer fiber yarn of the sealer of this example was 0.15 to 0.8. By improving the surface roughness of the monofilaments and/or the polymer fiber wires, the deposition of platelets is facilitated, the adsorption capacity of the functional wires to the intimating substances is improved, the effect of accelerating the intimating process is achieved, and the loss of the intimating substances in the storage and transportation processes of the plugging device is reduced.
The preparation method of the occluder of this embodiment can be described with reference to embodiment 1 and embodiment 2. The rough surface of the metal monofilament, the polymer monofilament and the polymer fiber line can be obtained by one or more of grinding and laser etching before or after the step S20.
It is understood that the endo-membranization promoting substance of the occluder of the present embodiment may be omitted, and the endo-membranization process of the occluder may be promoted to some extent by making the interfacial expansion area ratio of at least one of the metal monofilament, the polymer monofilament, and the polymer fiber wire of the functional filaments to be 0.15 to 0.8.
Example 4
In this embodiment, the functional yarn is covered with a protective layer on the basis of any one of embodiments 1 to 3. The protective layer comprises degradable high polymer material, and the thickness of the protective layer is 0.01-0.02 mm. The protective layer covers the surface of the functional yarn, so that the pores on the surface of the functional yarn can be closed to a certain extent, the release speed of the intimating promoting substance through the pores on the surface of the functional yarn can be reduced, and the loss in the subsequent process, transportation and storage processes of the plugging device can be reduced.
In this embodiment, the protective layer completely covers the surface of each functional filament, and in other embodiments, the protective layer covers only a portion of the functional filaments. In other embodiments, the protective layer may also cover the mesh openings on the occlusion frame 110.
The protective layer and the functional yarn are made of degradable high polymer materials, and the degradation speed of the degradable high polymer materials in the protective layer is higher than that of the degradable high polymer materials in the functional yarn. In other embodiments, the protective layer is made of a degradable polymer material, and the functional yarn may be made of a non-degradable polymer material, so long as the degradation rate of the degradable polymer material in the protective layer is higher than the degradation rate of the polymer material in the functional yarn. The setting can make degradable polymer material in the protection layer degrade fast in early implantation stage to accelerate the rapid release of intimating promoting substance in the functional yarn, and then accelerate the early intimating speed of the occluder.
In this embodiment, the functional yarn is made of polylactic acid, and the protective layer is made of polylactic acid, and the weight average molecular weight of the polylactic acid in the protective layer is smaller than that of the polylactic acid in the functional yarn, for example, the ratio of the weight average molecular weight of the polylactic acid in the protective layer to the weight average molecular weight of the polylactic acid in the functional yarn is in the range of 1/6 to 1/3. In other embodiments, the material selected for the functional filament may be a metal material such as nickel-titanium alloy, or other degradable polymer materials such as polydioxanone, or non-degradable polymer materials such as polyethylene terephthalate. The degradable polymer material in the protective layer can be one or more selected from polyamide, polycaprolactone, polyurethane, polyglycolic acid, polylactic acid-glycolic acid copolymer, polydioxanone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate, polyglycolic acid, polydioxanone and polycarbonate. When the functional silk is made of high molecular materials, the weight average molecular weight of the high molecular materials is required to be larger than that of the degradable high molecular materials in the protective layer, and the arrangement has the advantages that the plugging device can obtain better mechanical properties, the degradable high molecular materials in the protective layer can be degraded faster in the early stage of implantation, and the early stage of intimation is accelerated.
The preparation method of the occluder of the present embodiment includes the steps S10 and S20, and further includes, after the step S20:
Step S30: and dissolving the degradable high polymer material in a solvent to prepare a protective layer solution.
Wherein, the solvent of the degradable polymer material can be one or more of chloroform, acetonitrile and tetrahydrofuran. The concentration of the protective layer solution ranges from 15mg/mL to 30mg/mL, for example, the concentration may be 20mg/mL.
Step S40: and (3) attaching the protective layer solution to all or part of the surfaces of the functional filaments by adopting a soaking or spraying method, and forming the protective layer after the solvent volatilizes.
Illustratively, the plugging device after completing step S20 is soaked in the protective layer solution for a preset soaking period, then taken out, and the plugging device is placed in a preset temperature environment to be dried for a preset drying period, so that a protective layer is formed on all or part of the surface of the functional yarn. Wherein the preset soaking time is 1-3 seconds, the preset temperature is 30-45 degrees, and the preset drying time is 20-30 hours.
In other embodiments, the protective layer may also be formed using a spray process. In addition, the above-mentioned preset soaking time period, preset temperature, preset drying time period may be different from the present embodiment, and a person skilled in the art may set appropriate parameters as required, so long as the functional yarn is covered with a protective layer after being treated.
Example 5
Referring to fig. 1,2 and 5, this embodiment provides an occluder similar to the occluder of embodiment 1 in structure and including an occluding frame 110 on the basis of any one of embodiments 1,3 and 4. The plugging frame 110 includes a plurality of braided wires 202 and a plurality of braided strands 204, and the plurality of braided wires 202 and the plurality of braided strands 204 are mixed to form a three-dimensional mesh structure, and the mesh structure has meshes. The braided filaments 202 and the braided strands 204 are made of a polymer material, for example, the braided filaments 202 and the braided strands 204 in this embodiment are made of polylactic acid, and in other embodiments, the polymer material may be other degradable polymer materials such as polydioxanone, or non-degradable polymer materials such as polyethylene terephthalate. Braided filaments 202 are monofilaments of a polymeric material and braided strands 204 comprise a plurality of polymeric fiber strands that are gathered into a strand, which may be one or more of a twin strand, a triple strand, or a multiple strand. The structure and dimensions of the braided filaments 202 and braided strands 204 are described with reference to embodiment 1 and are not described in detail herein.
In this embodiment, the plugging device includes a functional filament, the functional filament is one or more of a polymer monofilament and a strand, and one strand is formed by gathering a plurality of polymer fiber wires; wherein at least one polymeric monofilament and/or polymeric fiber strands has a hollow structure 160, the hollow structure 160 having at least one cavity extending along a length of the hollow structure 160. In this embodiment, all of the braided filaments 202 are functional filaments and all of the braided strands 204 are functional filaments. In other embodiments, only a portion of the braided filaments 202 and/or a portion of the braided strands 204 may be selected as functional filaments.
The hollow structure 160 has more excellent blood adsorption performance than the solid structure, and after the occluder of the embodiment is implanted into a living body, the hollow structure 160 has a wicking effect, so that blood can be accelerated to enter the cavity of the occluder, and the transmission rate of the blood in the cavity of the occluder can be accelerated, so that the interior of the occluder can be filled with the blood rapidly; when the inside of the occluder is filled with blood, the blood does not flow in the inner cavity of the occluder rapidly, so that thrombus can be formed more rapidly, and the process of membranization of the occluder is accelerated. In addition, the hollow structure 160 has better adherence performance than a solid structure, so that the occluder can be better tightly attached to the defect part, and the growth of fibroblasts and endothelial cells into thrombus is accelerated to improve the intimation process.
In this embodiment, all of the polymeric fiber strands in the braided strands 204 have a hollow structure 160. In other embodiments, only a portion of the polymeric fiber strands of the braided strands 204 may have the hollow structure 160; or a portion of the polymeric fiber strands present in all of the braided strands 204 have a hollow structure 160. In other embodiments, some or all of the braided wires 202 have a hollow structure 160. Regardless of the arrangement, the process of the endocardization of the occluder can be improved to a certain extent as long as at least one woven wire 202 and/or polymer fiber wire in the occluder has a hollow structure 160.
Further, the ratio of the number of the braided wires 202 with the hollow structure 160 to the total number of the braided wires 202 is not more than 30%, and the ratio of the number of the polymer fiber wires with the hollow structure 160 to the total number of the polymer fiber wires may be not more than 30%, so as to avoid the influence of the excessive hollow structure 160 on the supporting performance and the shape stability of the occluder.
The hollow rate of the hollow structure 160 affects the mechanical properties and blood adsorption properties of the hollow structure 160, and the hollow rate refers to the percentage of the cross-sectional area of the hollow portion (i.e., the cavity) to the total cross-sectional area in the cross-section of the hollow structure 160. The higher the hollow ratio, the better the blood adsorption performance of the hollow structure 160 and the softer, but the weaker the supporting force, so the hollow ratio of the hollow structure 160 may be set to 1% to 30% in order to make the hollow structure 160 give consideration to both superior blood adsorption performance and mechanical properties. When the hollow rate is within this range, the hollow structure 160 may have good blood adsorption performance, adherence performance and superior support, so as to avoid insufficient support force of the occluder after deployment due to too high hollow rate, and is too easy to deform when being extruded.
The cross-sectional area of the hollow structure 160 has an outer contour shape, i.e., the cross-sectional shape of the outer surface of the hollow structure 160, and an inner contour shape, i.e., the cross-sectional shape of the cavity. The outer contoured shape includes, but is not limited to, one or more of a circle, oval, triangle, square, X-shape, Y-shape, and the inner contoured shape includes, but is not limited to, one or more of a circle, oval, triangle, square, X-shape, Y-shape. In the same hollow structure 160, the outer contour shape and the inner contour shape are the same or different. In this embodiment, the outer contour shape and the inner contour shape of the hollow structure 160 are substantially circular, and in other embodiments, the outer contour shape and the inner contour shape of the hollow structure 160 may be selected from the non-circular shapes described above. Compared with a round shape, the above-mentioned other non-round shape can make the hollow structure 160 obtain a larger blood contact area, so that the hollow structure 160 has more excellent blood adsorption performance, especially when the cavity of the hollow structure 160 has a non-round cross-sectional profile, a narrow space is easily formed in the cavity, so that blood is more likely to coagulate to form thrombus, and further the intimation process of the occluder is further accelerated. In addition, when the outer profile shape is non-circular, the cohesion between the interwoven hollow structures 160 can be increased, the slippage between the interwoven hollow structures 160 can be prevented, the dimensional stability of the occluder is improved, and meanwhile, the porosity is increased, so that the mechanical property of the occluder can be improved, the blood adsorption property can be further improved, and the intimation process of the occluder can be accelerated.
It is understood that in other embodiments, the outer contour shape of the cross-section of the braided filaments 202 and/or braided strands 204 may include one or more of circular, oval, triangular, square, X-shaped, Y-shaped, even without the hollow structure 160.
Further, at least one functional filament contains a functional substance. The functional substances include endo-membranization promoting substances, and the mass percentages and specific material selection of the endo-membranization promoting substances can be referred to the descriptions in any of the above embodiments, and are not repeated herein. The functional yarn of the embodiment has the hollow structure 160, so that the functional material can be quickly adsorbed in the process of step S20, and the solvent can be quickly released in the drying process, thereby improving the treatment efficiency. In addition, after step S20 is completed, the hollow structure 160 can increase the contact area with the functional substance, which is beneficial to increasing the adsorption strength of the functional substance, and reducing the loss of the functional substance in the subsequent processes, storage and transportation. Particularly, when the endo-membranization promoting substance is one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide and chloroform, the endo-membranization promoting substance is absorbed into the hollow structure 160 in the treatment process of the step S20, and the endo-membranization promoting substance can dissolve the surface of the treated functional filament to a certain extent, so that the original partial pores on the surface of the functional filament are gradually closed, and the loss of the functional substance in the subsequent process, storage and transportation processes can be reduced.
In other embodiments, the functional substance may be an endothelialization-promoting substance, or a combination of an endothelialization-promoting substance and an endo-internalization-promoting substance, wherein the endothelialization-promoting substance is at least one selected from the group consisting of a growth factor, a polypeptide, and a phospholipid. Wherein the growth factor is at least one selected from the group consisting of Epidermal Growth Factor (EGF), fibroblast Growth Factor (FGF) and platelet derived factor (PDGF). The polypeptide is at least one selected from tyrosine-isoleucine-glycine-serine-arginine pentapeptide (YIGSR), cyclo (arginine-glycine-aspartic acid-tyrosine-lysine) (Tyr-RGD) and polypeptide containing arginine-glycine-aspartic acid (RGD) sequence. The phospholipid is at least one selected from phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine and phosphatidylinositol. Among these, the polypeptide comprising an arginine-glycine-aspartic acid (RGD) sequence may be an arginine-glycine-aspartic acid (RGD) polypeptide, an arginine-glycine-aspartic acid-serine (RGDS) polypeptide, or the like. The endothelialization promoting substance has good endothelialization promoting effect and is beneficial to the endothelium to climb and attach to the occluder quickly. The endothelialization promoting substance accounts for 0.07 to 10 percent of the mass of the plugging device, and can ensure the sustained release of the endothelialization promoting substance so as to have better endothelialization promoting effect. In other embodiments, the functional substance may be other substances such as drugs.
It will be appreciated that the invention is not limited to the configuration of the occluding device. In other embodiments, the occluder may have a different configuration from that described in this embodiment, for example, the occluder may have a structure as in embodiment 2, where the braided strands 204 are omitted and a flow blocking portion is added, the flow blocking portion includes at least one flow blocking film 140, and the circumferential edge of the flow blocking film is sutured to the occlusion frame 110 by suturing strands, where the suturing strands include polymer fiber yarns, and the flow blocking film 140 may include polymer fiber yarns therein. At least one of the braided filaments 202 and/or polymeric fiber strands has a hollow structure 160 as described above, and specific hollow ratios and contour shapes are described above. Further, at least one of the braided filaments 202 and/or polymeric fiber strands has the hollow structure 160 and contains the functional material described above, and the functional material may be selected by reference to the above. In other embodiments, the occluder may be of other configurations, for example, the occluder comprises an anchor portion comprising a plurality of support rods and an occluding portion comprising a braided mesh structure; or the plugging device comprises an anchoring disc and a plugging disc, and the anchoring disc and the plugging disc comprise net structures formed by braiding.
The endo-membranization promoting substance of the occluder of the present embodiment can be omitted, and the endo-membranization process of the occluder can be promoted to a certain extent by making the hollow structure 160 of the functional filaments.
Example 6
Referring to fig. 1,2 and 6, this embodiment provides an occluder similar to the occluder of embodiment 1 in structure and comprising an occluding frame 110 on the basis of any of embodiments 1, 3-5. The plugging frame 110 includes a plurality of braided wires 202 and a plurality of braided strands 204, and the plurality of braided wires 202 and the plurality of braided strands 204 are mixed to form a three-dimensional mesh structure, and the mesh structure has meshes. The braided filaments 202 and the braided strands 204 are made of a polymer material, for example, the braided filaments 202 and the braided strands 204 in this embodiment are made of polylactic acid, and in other embodiments, the polymer material may be other degradable polymer materials such as polydioxanone, or non-degradable polymer materials such as polyethylene terephthalate. Braided filaments 202 are monofilaments of a polymeric material and braided strands 204 comprise a plurality of polymeric fiber strands that are gathered into a strand, which may be one or more of a twin strand, a triple strand, or a multiple strand. The structure and dimensions of the braided filaments 202 and braided strands 204 are described with reference to embodiment 1 and are not described in detail herein.
In this embodiment, the plugging device includes a functional filament, the functional filament is one or more of a polymer monofilament and a strand, and one strand is formed by gathering a plurality of polymer fiber wires; the at least one polymer monofilament and/or polymer fiber has a sheath-core structure 170, and the sheath-core structure 170 includes a core layer 171 and a sheath layer 172 wrapping an outer surface of the core layer 171. In this embodiment, all of the braided filaments 202 are functional filaments and all of the braided strands 204 are functional filaments. In other embodiments, only a portion of the braided filaments 202 and/or a portion of the braided strands 204 may be selected as functional filaments.
The method of making the sheath-core structure 170 may be: the spinning solution of the skin layer 172 and the spinning solution of the core layer 171 are respectively input into the two feeding channels, and are sprayed and formed through a composite spray head. For example, for the braided wire 202 having the sheath-core structure 170, the spinning solution of the sheath 172 and the spinning solution of the core layer 171 can be prepared by heating and melting the raw materials, respectively, then the two spinning solutions are conveyed through two feeding channels, respectively, extruded through a composite nozzle, and finally the wire with a certain size is prepared through a plurality of stretching and cooling processes. For the polymer fiber yarn, the fiber yarn with relatively smaller diameter can be prepared by dissolving the raw materials in the solvent to prepare the spinning solution of the sheath 172 and the spinning solution of the core 171 respectively, then conveying the two spinning solutions to the composite nozzle respectively through two feeding channels, and preparing the fiber yarn with the sheath-core structure 170 through processes such as melt spinning or solution spinning. The preparation method of the sheath-core structure is not limited to the above-described exemplary spinning process, and may be prepared by using, for example, electrostatic spinning or the like.
In the skin-core structure 170, the structure of the skin layer 172 is different from that of a common coating, the structure is more uniform, the molecular chain arrangement is more regular, the orientation degree is higher, and the crystallinity is also higher, for example, the crystallinity of the skin layer 172 in this embodiment may be 40% -70%, and in other embodiments, the crystallinity of the skin layer 172 may be different from that in this embodiment. The core layer 171 of the sheath-core structure 170 is more loosely structured and has a lower crystallinity than the sheath layer 172. After the occluder is implanted in a living body, due to the difference of the structures of the skin layer 172 and the core layer 171, after the core layer 171 is filled with blood, the blood does not flow rapidly in the blood, so that thrombus can be formed more quickly, and the process of the endomembranization of the occluder is accelerated. In addition, the skin layer 172 has better strength (e.g., breaking strength, fatigue resistance, supporting performance) than the core layer 171, and the core layer 171 is softer, so that the skin-core structure 170 has better mechanical strength and better adhesion performance, can be better closely attached to the defect part, and can accelerate the growth of the fibroblasts and endothelial cells into the thrombus to further accelerate the intimation process.
In this embodiment, all of the polymeric fiber strands in the braided strands 204 have a sheath-core structure 170. In other embodiments, only a portion of the polymeric fiber strands of the braided strands 204 may have the sheath-core structure 170; or a portion of the polymeric fiber strands present in all of the braided strands 204 have a sheath-core structure 170. In other embodiments, some or all of the braided filaments 202 may have a sheath-core structure 170. Regardless of the arrangement, the process of the endocinization of the occluder can be improved to a certain extent as long as at least one woven wire 202 and/or polymer fiber wire in the occluder has a sheath-core structure 170.
In addition, in this embodiment, the skin layer 172 and the core layer 171 are made of the same degradable polymer material, for example, polylactic acid is used for both the skin layer 172 and the core layer 171, and in other embodiments, different polymer materials may be used for the skin layer 172 and the core layer 171. The molecular weight of the polymer material of the skin layer 172 is greater than that of the polymer material of the core layer 171, for example, the weight average molecular weight of the degradable polymer material of the skin layer 172 is 5 to 50 Da, and the weight average molecular weight of the degradable polymer material of the core layer 171 is 2 to 20 Da. Therefore, the skin layer 172 outside the core layer 171 can protect the core layer 171 to a certain extent, and prevent premature breakage of the occluder before complete endocardization is not completed due to excessive rapid degradation of the core layer 171, thereby affecting self-repair of the defect.
The ratio R of the cross-sectional area of the core layer 171 in the skin-core structure 170 to the total cross-sectional area of the skin-core structure 170 affects the mechanical property and the blood adsorption property of the skin-core structure 170, and the R value in this embodiment is set to 5% -90%, so that the skin-core structure 170 has good blood adsorption property, adherence property and better supportability, and insufficient supporting force of the plugging device after being unfolded due to the excessively high R value is avoided, and the plugging device is excessively easy to deform and excessively fast to degrade when being extruded. In other embodiments, the R value may be limited to any of the following ranges: 5 to 20 percent, 20 to 40 percent, 40 to 60 percent and 60 to 90 percent.
Further, in the present embodiment, the core layer 171 has a porous structure, and the porous core layer 171 can be obtained by the following method: the spinning solution of the core layer 171 is made of a water-soluble polymer material and a water-insoluble polymer material, and for example, the spinning solution of the core layer 171 includes polylactic acid and polyvinylpyrrolidone (PVP), and after the core layer 171 is solidified and molded, the water-insoluble polymer material is removed by a treatment such as a hot water bath, thereby obtaining the porous core layer 171. The pores in the core layer 171 tend to clot blood within the core layer 171 to form a thrombus, further accelerating the intimation process of the occluder. In other embodiments, the core layer 171 may not be a porous structure, but may be a solid structure or a hollow structure.
In this embodiment, the cross-sectional shape of the skin 172 includes, but is not limited to, one or more of circular, oval, triangular, square, X-shaped, Y-shaped, and the cross-sectional shape of the core 171 includes, but is not limited to, one or more of circular, oval, triangular, square, X-shaped, Y-shaped. In the same sheath-core structure 170, the cross-sectional shape of the sheath 172 and the cross-sectional shape of the core 171 may be the same or different. In this embodiment, the cross-sectional shape of the skin layer 172 and the cross-sectional shape of the core layer 171 are substantially circular, and in other embodiments, the cross-sectional shape of the skin layer 172 and the cross-sectional shape of the core layer 171 may be selected from the non-circular shapes described above. Compared with a round shape, the non-round shape can enable the skin-core structure 170 to obtain a larger blood contact area, so that the skin-core structure has more excellent blood adsorption performance, and in addition, when the cross section of the skin layer 172 is non-round, the braiding strength between the skin-core structures 170 interweaved with each other can be increased, and meanwhile, the porosity is increased, so that the mechanical property of the plugging device can be improved, the blood adsorption performance can be further improved, and the endocardization process of the plugging device can be accelerated.
It is understood that in other embodiments, the outer contour shape of the cross-section of the braided filaments 202 and/or braided strands 204 may include one or more of circular, oval, triangular, square, X-shaped, Y-shaped, even without the sheath-core structure 170.
Further, at least one functional filament contains a functional substance. The functional substances include endo-membranization promoting substances, and the mass percentages and specific material selection of the endo-membranization promoting substances can be referred to the descriptions in any of the above embodiments, and are not repeated herein. The functional yarn of the present embodiment has the sheath-core structure 170, so that the core 171 adsorbs the functional substance during the processing of step S20, the sheath 172 reduces the loss of the functional substance during the subsequent processes, storage and transportation, and the sheath-core structure 170 can control the functional substance to be continuously released at a proper speed after being implanted into the living body. Particularly, when the internalization promoting substance is one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide and chloroform, the internalization promoting substance can be rapidly absorbed into the core layer 171 and is slightly dissolved in the core layer 171 in the process of step S20, and the internalization promoting substance can be dissolved on the surface of the treated skin layer 172 to a certain extent, so that the original partial pores on the surface of the skin layer 172 are gradually closed, thereby locking the internalization promoting substance in the core layer 171 to a greater extent and reducing the loss of functional substances in the subsequent processes, storage and transportation.
In other embodiments, the functional substance may be an endothelialization-promoting substance, or a combination of an endothelialization-promoting substance and an endo-internalization-promoting substance, wherein the endothelialization-promoting substance is at least one selected from the group consisting of a growth factor, a polypeptide, and a phospholipid. Wherein the growth factor is at least one selected from the group consisting of Epidermal Growth Factor (EGF), fibroblast Growth Factor (FGF) and platelet derived factor (PDGF). The polypeptide is at least one selected from tyrosine-isoleucine-glycine-serine-arginine pentapeptide (YIGSR), cyclo (arginine-glycine-aspartic acid-tyrosine-lysine) (Tyr-RGD) and polypeptide containing arginine-glycine-aspartic acid (RGD) sequence. The phospholipid is at least one selected from phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine and phosphatidylinositol. Among these, the polypeptide comprising an arginine-glycine-aspartic acid (RGD) sequence may be an arginine-glycine-aspartic acid (RGD) polypeptide, an arginine-glycine-aspartic acid-serine (RGDS) polypeptide, or the like. The endothelialization promoting substance has good endothelialization promoting effect and is beneficial to the endothelium to climb and attach to the occluder quickly. The endothelialization promoting substance accounts for 0.07 to 10 percent of the mass of the plugging device, and can ensure the sustained release of the endothelialization promoting substance so as to have better endothelialization promoting effect. In other embodiments, the functional substance may be other substances such as drugs.
It will be appreciated that the invention is not limited to the configuration of the occluding device. In other embodiments, the occluder may have a different configuration from that described in this embodiment, for example, the occluder may be configured as in embodiment 2, where the braided strands 204 are omitted and a flow blocking portion is added, the flow blocking portion includes at least one flow blocking film 140, and the circumferential edge of the flow blocking film is sutured to the occluding frame 110 by suturing strands, where the suturing strands include polymer fiber threads, and the flow blocking film 140 may also include polymer fiber threads therein. At least one of the braided filaments 202 and/or polymeric fiber strands has a sheath-core structure 170 as described above, and the characteristics of the sheath-core structure 170 may be as described above. Further, at least one of the braided filaments 202 and/or polymeric fiber strands has the sheath-core structure 170 and contains the functional materials described above, and the specific mass percentages and material selection of the functional materials are as described above. In other embodiments, the occluder may be of other configurations, for example, the occluder comprises an anchor portion comprising a plurality of support rods and an occluding portion comprising a braided mesh structure; or the plugging device comprises an anchoring disc and a plugging disc, and the anchoring disc and the plugging disc comprise net structures formed by braiding. Based on different configurations of the occluder, the occluder can be a atrial septum occluder, a ventricular septum occluder, an arterial catheter patent occluder, an oval foramen patent occluder, a left atrial appendage occluder and the like.
The endo-membranization promoting substance of the occluder of the present embodiment may be omitted, and the endo-membranization process of the occluder may be promoted to some extent by making the sheath-core structure 170 of the functional filaments.
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 (16)
1. An occluder, comprising a functional filament, wherein the functional filament is one or more of a metal monofilament, a polymer monofilament and a strand comprising an intimation promoting substance, and one strand is formed by gathering a plurality of polymer fiber wires.
2. An occluder, comprising an endo-membrane promoting substance, wherein the endo-membrane promoting substance is one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide, chloroform, adenosine diphosphate and collagen.
3. The occluder of claim 1, wherein the endo-promoting substance is one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide, chloroform, adenosine diphosphate, collagen.
4. The occluder of claim 2 or 3, wherein when the endo-membrane promoting substance is one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide and chloroform, the endo-membrane promoting substance accounts for 0.07-3% of the occluder by mass.
5. The occluder of claim 1, wherein the functional filaments are at least partially located on an outer surface of the occluder.
6. The occluder of claim 1, wherein the interfacial expansion area ratio of a part or all of the surface of at least one of the metal filaments, the polymer filaments, and the polymer fiber threads is 0.15 to 0.8.
7. The occluder of claim 1, wherein at least one of said polymeric monofilaments and/or polymeric fiber strands is hollow having at least one cavity.
8. The occluder of claim 7, wherein the hollow structure has a hollow rate of 1% to 30%.
9. The occluder of claim 1, wherein at least one functional filament is made of a polymeric material and the functional filament is covered with a protective layer, the protective layer comprising a degradable polymeric material, the polymeric material of the functional filament having a degradation rate that is lower than a degradation rate of the degradable polymeric material of the protective layer.
10. The occluder of claim 1, wherein when the endo-promoting substance is one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide, and chloroform, the endo-promoting substance comprises 0.07% to 3% by mass of the occluder, and the endo-promoting substance is present in at least one segment of functional filaments in an amount of 3% to 10% by mass.
11. A method for preparing an occluder, comprising the following steps:
Providing an occluder preform comprising one or more portions to be treated;
and (3) soaking and/or spraying the part to be treated to obtain the occluder containing the intimation promoting substance.
12. The plugging device is characterized by comprising functional filaments, wherein the functional filaments are one or more of polymer monofilaments and strands, and one strand is formed by gathering a plurality of polymer fiber wires; wherein at least one of the polymer monofilaments and/or polymer fiber yarns has a sheath-core structure, and the sheath-core structure comprises a core layer and a skin layer wrapping the outer surface of the core layer; and/or at least one of the polymeric monofilaments and/or polymeric fiber yarns has a hollow structure having at least one cavity extending along a length of the hollow structure.
13. The occluder of claim 12, wherein the skin layer and the core layer each comprise a degradable polymeric material, the degradable polymeric material of the core layer having a molecular weight that is less than the molecular weight of the degradable polymeric material of the skin layer.
14. The occluder of claim 12, wherein the core layer is any one of a porous structure, a hollow structure, a solid structure.
15. The occluder of claim 12, wherein the skin layer has a cross-sectional shape including, but not limited to, one or more of circular, oval, triangular, square, X-shaped, Y-shaped, and the core layer has a cross-sectional shape including, but not limited to, one or more of circular, oval, triangular, square, X-shaped, Y-shaped, and wherein the skin layer has a cross-sectional shape that is the same as or different from the core layer in the same skin-core structure.
16. The occlusion device of any of claims 12-15, wherein said functional filaments comprise a functional substance comprising one or more of ethyl acetate, acetone, dimethylformamide, dimethylacetamide, chloroform, adenosine diphosphate, collagen, growth factors, polypeptides, phospholipids.
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| CN202211631013.XA CN118217459A (en) | 2022-12-19 | 2022-12-19 | Plugging device and preparation method thereof |
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| CN202211631013.XA CN118217459A (en) | 2022-12-19 | 2022-12-19 | Plugging device and preparation method thereof |
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