CN117357316B - Tectorial membrane bracket and manufacturing method thereof - Google Patents
Tectorial membrane bracket and manufacturing method thereof Download PDFInfo
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- CN117357316B CN117357316B CN202311660529.1A CN202311660529A CN117357316B CN 117357316 B CN117357316 B CN 117357316B CN 202311660529 A CN202311660529 A CN 202311660529A CN 117357316 B CN117357316 B CN 117357316B
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- 210000002489 tectorial membrane Anatomy 0.000 title claims abstract description 32
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 19
- 230000006835 compression Effects 0.000 claims abstract description 22
- 238000007906 compression Methods 0.000 claims abstract description 22
- 210000002808 connective tissue Anatomy 0.000 claims abstract description 19
- 239000010408 film Substances 0.000 claims description 256
- 239000012528 membrane Substances 0.000 claims description 63
- 238000005245 sintering Methods 0.000 claims description 22
- 230000009471 action Effects 0.000 claims description 13
- 239000007888 film coating Substances 0.000 claims description 13
- 238000009501 film coating Methods 0.000 claims description 13
- 229920000295 expanded polytetrafluoroethylene Polymers 0.000 claims description 11
- 238000004804 winding Methods 0.000 claims description 11
- 238000001816 cooling Methods 0.000 claims description 9
- 230000007704 transition Effects 0.000 claims description 9
- 230000002093 peripheral effect Effects 0.000 claims description 8
- 239000010409 thin film Substances 0.000 claims description 8
- 238000010030 laminating Methods 0.000 claims description 5
- 238000007789 sealing Methods 0.000 claims description 4
- 238000009954 braiding Methods 0.000 claims description 3
- 238000000034 method Methods 0.000 claims description 3
- 239000011248 coating agent Substances 0.000 claims 2
- 238000000576 coating method Methods 0.000 claims 2
- 210000003240 portal vein Anatomy 0.000 abstract description 14
- 238000004033 diameter control Methods 0.000 abstract description 7
- 238000002324 minimally invasive surgery Methods 0.000 abstract description 6
- 239000010410 layer Substances 0.000 description 210
- 239000000463 material Substances 0.000 description 11
- 230000000452 restraining effect Effects 0.000 description 8
- 230000000694 effects Effects 0.000 description 7
- 239000000835 fiber Substances 0.000 description 5
- 238000006073 displacement reaction Methods 0.000 description 4
- 210000004185 liver Anatomy 0.000 description 4
- 230000000740 bleeding effect Effects 0.000 description 2
- 230000002440 hepatic effect Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000002356 single layer Substances 0.000 description 2
- 208000011580 syndromic disease Diseases 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- 206010003445 Ascites Diseases 0.000 description 1
- 206010016654 Fibrosis Diseases 0.000 description 1
- 206010067365 Hepatic hydrothorax Diseases 0.000 description 1
- 206010048612 Hydrothorax Diseases 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 206010056091 Varices oesophageal Diseases 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 208000019425 cirrhosis of liver Diseases 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 230000004761 fibrosis Effects 0.000 description 1
- 239000012943 hotmelt Substances 0.000 description 1
- 210000004731 jugular vein Anatomy 0.000 description 1
- 238000002690 local anesthesia Methods 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
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- 230000000087 stabilizing effect Effects 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/92—Stents in the form of a rolled-up sheet expanding after insertion into the vessel, e.g. with a spiral shape in cross-section
Abstract
The invention discloses a tectorial membrane bracket and a manufacturing method thereof, and relates to the field of medical appliances. The covered stent comprises a stent main body and a covered component, wherein the stent main body is provided with a covered section and a bare stent section; the film covering component comprises an inner film layer, a connecting film and an outer film layer; according to the invention, radial constraint force is provided for the tectorial membrane section through the adventitia layer, so that the tectorial membrane section is adjusted to be in a small-diameter-size posture, and therefore, when in minimally invasive surgery, the tectorial membrane bracket can be adjusted from a small-diameter state to a matched diameter suitable for reducing portal vein pressure under external driving. According to the covered stent provided by the invention, the compression constraint of the reinforced covered component on the covered section is improved, so that the covered stent has a small-diameter to-be-expanded posture, and the stability of diameter control of the covered stent in an expansion stage is improved.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a covered stent and a manufacturing method thereof.
Background
Transjugular intrahepatic portosystemic shunt (Transjugular Intrahepatic Portosystemic Shunt (TIPS)) is an interventional radiological technique that integrates flow and flow interruption. The TIPS is punctured by the right jugular vein under local anesthesia, a special catheter sheath is arranged, a puncture needle is used for puncturing liver parenchyma to branches of intrahepatic portal veins, a balloon is used for expanding, a stent is implanted through a conveying system, a hepatic vein-portal vein shunt is established, the pressure of the whole extrahepatic portal vein area is reduced, and a treatment means for preventing gastroesophageal varices from rupture and bleeding, treating refractory or recurrent hydrothorax or hepatic hydrothorax, liver cirrhosis, buddha syndrome, liver sinus blocking syndrome and other portal vein complications is achieved.
When the minimally invasive stent is placed in an operation, a main tool is a stent and a matched stent conveying system, in general, a doctor judges and selects a stent with proper specification under an image device, the stent is preloaded into the stent conveying system, is placed at a corresponding part of a puncture channel under the guidance of an image, and after the conveying system is retracted, the stent is released and self-expands, a portal vein bypass channel is established, and the portal vein pressure is reduced so as to reduce or improve portal vein hypertension and complications thereof, such as varicose bleeding, stomach illness, refractory ascites and/or hepatic chest.
In a specific minimally invasive procedure, TIPS surgery currently requires clinically intraoperative precise control of portal vein pressure in a patient, and when a balloon is used for gradual expansion during the operation, the stent is required to be in a small diameter state to a suitable diameter for reducing portal vein pressure. The current apparatus can not meet the use requirement of gradually expanding and adjusting the stent from a small diameter, has insufficient diameter control capability, is not suitable for the peripheral vascular cavity of the liver device, and can not accurately and stably control the intraoperative portal vein pressure when implanting the stent with a large compressed diameter.
Disclosure of Invention
The technical problems to be solved or at least partially solved by the invention are that in the related art, the current apparatus cannot meet the use requirement of expanding and adjusting the stent gradually from a small diameter, the diameter control capability is insufficient, the apparatus is not suitable for the vascular cavity around the liver device, and the portal vein pressure in the operation cannot be accurately and stably controlled when the stent with a large compressed diameter is implanted.
The invention provides a covered stent, comprising:
a stent body having a covered section and a bare stent section;
a film covering assembly configured to fixedly connect the film covering sections;
the tectorial membrane component comprises an inner membrane layer, a connecting membrane and an outer membrane layer,
the film covering section is fixedly combined between the inner film layer and the connecting film, and the outer film layer is fixedly combined on the outer peripheral side of the connecting film;
the inner film layer is set to be an eptfe film layer structure with the number of 2N layers, and N is a positive integer greater than or equal to 1;
the connecting film is arranged as a fep-eptfe film layer;
the outer film layer is arranged as a combined structure of a plurality of eptfe film layers and a plurality of fep-eptfe film layers.
The outer membrane layer is arranged to be of a sleeve structure or a sleeve structure, the outer membrane layer has a constraint force acting towards the membrane covering section, the membrane covering section has a constraint state of being compressed under the action of the constraint force of the outer membrane layer, and the working state of being expanded outwards under the action of an external force and overcoming the constraint force of the outer membrane layer is overcome.
As a preferable scheme, the fep-eptfe film layer in the outer film layer is a film layer formed by sequentially laminating a fep film layer and an eptfe film layer which are coaxially arranged, the fep film layer is arranged on the inner peripheral side of the eptfe film layer, the outer film layer has anisotropy, and the elastic capacity of the outer film layer along the circumferential direction of the outer film layer is larger than that of the outer film layer along the axial direction of the outer film layer.
Optionally, the outer film layer is configured as a combined structure of 5-8 eptfe film layers and 5-8 fep-eptfe film layers.
Optionally, the outer diameter of the film covering section is set to be 6mm-10mm.
Optionally, the stent body has a self-expanding expansion force, and a resultant force of constraint forces of the outer membrane layer acting toward the compression of the covered segment is larger than the expansion force.
Optionally, an angle formed between the acting force direction of the outer membrane layer for restraining the tectorial membrane section and the axial direction of the bracket main body ranges from 30 degrees to 150 degrees.
Optionally, the film covering section comprises a deformation part, a transition part and a connection part;
when the tectorial membrane section is in the constraint state, the deformation part has a minimum diameter posture;
the transition part is arranged between the deformation part and the connecting part, and is in the constraint state in the laminating section, and the transition part is arranged in a flaring way in the direction of the deformation part towards the connecting part;
the connecting part is arranged at the edge area of the covering film section adjacent to the bare bracket section.
A manufacturing method of a covered stent comprises the following steps:
and (3) manufacturing an inner membrane layer:
the two layers of the eptfe film layers are placed in a crossed and vertical mode and are wound on a mandrel with the diameter of 10mm to obtain a mandrel with the outer side wound with a 2N layer of the eptfe film layer structure, the mandrel is placed into an oven, and after film coating, sintering and cooling are carried out, an inner film layer is prepared, and then the inner film layer is separated from the mandrel with the diameter of 10 mm; wherein N is a positive integer greater than or equal to 1;
manufacturing an outer film layer:
winding an ePTFE film layer on a mandrel with the diameter of 6mm for multiple layers, putting the covered mandrel into an oven for film covering sintering, cooling to obtain a semi-finished film layer, winding a plurality of fep-ePTFE film layers on the semi-finished film layer, putting the film layer and the 6mm mandrel in the semi-finished film layer into the oven together for film covering sintering to obtain the film layer, and separating the film layer from the 6mm mandrel;
manufacturing a bracket main body combined with a connecting film and an inner film layer:
sleeving a bare stent section of a stent main body on a mandrel with the diameter of 10mm, and adjusting the position of the stent main body to enable the braiding end of the stent main body to be positioned outside an inner membranous layer; sleeving and fixing a layer of fep-eptfe film layer on the outer side of a film covering section of the bracket main body, fixing an inner film layer in an inner cavity of the film covering section, putting the three layers into an oven, sintering and heat sealing to fix the film covering section between the connecting film and the inner film layer, and after cooling, preparing the bracket main body combining the connecting film and the inner film layer;
manufacturing an integral covered stent:
compressing the bracket main body combined with the connecting film and the inner film layer into a state that the outer diameter is smaller than 6mm through a compression tool, sleeving the outer film layer outside the film covering section of the bracket main body, releasing the compression of the compression tool on the bracket main body, enabling the film covering section to be in a constraint state through the compression action of the outer film layer towards the film covering section, winding the fep film layers at two ends of the film covering section of the bracket main body, placing the fep film layers in an oven for sintering, enabling the fep film layers to fixedly connect the film and the outer film layer, and finally obtaining the film covering bracket.
The technical scheme provided by the invention has the following advantages:
1. the invention provides a covered stent, which comprises a stent main body and a covered membrane component, wherein the stent main body is provided with a covered membrane section and a bare stent section; the film covering assembly is configured to be fixedly connected with the film covering section; the film covering assembly comprises an inner film layer, a connecting film and an outer film layer, wherein the film covering section is fixedly combined between the inner film layer and the connecting film, and the outer film layer is fixedly combined on the outer peripheral side of the connecting film; the inner film layer is set to be an eptfe film layer structure with the number of 2N layers, and N is a positive integer greater than or equal to 1; the connecting film is arranged as a layer of fep-eptfe film layer, and the outer film layer is arranged as a combined structure of a plurality of layers of eptfe film layers and a plurality of layers of fep-eptfe film layers. The outer membrane layer is arranged to be of a sleeve structure or a sleeve structure, the outer membrane layer has a constraint force acting towards the membrane covering section, the membrane covering section has a constraint state of being compressed under the action of the constraint force of the outer membrane layer, and the working state of being expanded outwards under the action of an external force and overcoming the constraint force of the outer membrane layer is overcome.
The tectorial membrane support of this structure provides radial restraining force to tectorial membrane section through the adventitia layer, makes the tectorial membrane section adjust to the gesture of minor diameter size to when minimally invasive surgery, the tectorial membrane support can be adjusted to the matching diameter that is fit for reducing portal vein pressure from minor diameter state under external drive. Through the compression effect of the adventitia layer on the tectorial membrane section, the whole tectorial membrane support structure is promoted closely, the joint strength between the support main part and the tectorial membrane subassembly is improved, the interference influence of external pressure environment can be reduced, and intervention and expansion use are stable. According to the covered stent provided by the invention, the compression constraint of the reinforced covered component on the covered section is improved, so that the covered stent has a small-diameter to-be-expanded posture, and the stability of diameter control of the covered stent in an expansion stage is improved.
2. According to the tectorial membrane bracket provided by the invention, the fep-eptfe film layer in the outer membrane layer is a film layer formed by sequentially laminating a fep film layer and an eptfe film layer which are coaxially arranged, the fep film layer is arranged on the inner peripheral side of the eptfe film layer, the outer membrane layer has anisotropy, and the elastic capacity of the outer membrane layer along the circumferential direction of the outer membrane layer is larger than that of the outer membrane layer along the axial direction of the outer membrane layer.
In the expansion stage of the tectorial membrane bracket, when the external force acts on the fep-eptfe film layer to expand and deform, the eptfe film layer in the fep-eptfe film layer is compressed along the circumferential direction and stretched along the axial direction, and the elastic capacity of the adventitia layer along the circumferential direction is larger than that of the adventitia layer along the axial direction, so that the axial tensile displacement is converted into circumferential compression displacement, the fep-eptfe film layer can obtain a compact working posture, the adventitia layer has stronger circumferential constraint force on the tectorial membrane section, and the circumferential constraint force gradually increases along with the expansion action of the external force, so that the adventitia layer has a limiting and stable action effect on the diameter control of the tectorial membrane bracket.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic structural view of a stent graft provided by the present invention;
FIG. 2 is a schematic cross-sectional view of a stent graft according to the present invention;
FIG. 3 is a schematic front view of a stent graft according to the present invention;
reference numerals illustrate:
1-a stent body; 11-a film coating section; 111-deformation; 112-transition; 113-a connection; 12-bare stent sections;
2-a film-coating component; 21-an inner membrane layer; 22-a tie film; 23-adventitia layer.
Detailed Description
The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "connected," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
In addition, the technical features of the different embodiments of the present invention described below may be combined with each other as long as they do not collide with each other.
Example 1
The present embodiment provides a stent graft, see fig. 1 and 2, comprising a stent main body 1 and a stent graft assembly 2, the stent main body 1 having a stent graft segment 11 and a bare stent segment 12;
the film covering assembly 2 is configured to fixedly connect the film covering sections 11; the film covering assembly 2 comprises an inner film layer 21, a connecting film 22 and an outer film layer 23, wherein the film covering section 11 is fixedly combined between the inner film layer 21 and the connecting film 22, and the outer film layer 23 is fixedly combined on the outer peripheral side of the connecting film 22.
The outer membrane layer 23 has a restraining force acting towards the membrane covering section 11, the membrane covering section 11 has a restrained state of being compressed under the restraining force of the outer membrane layer 23, and an operating state of being expanded outwards under the action of an external force against the restraining force of the outer membrane layer 23.
In this embodiment, the outer diameter of the film coating section 11 is set to 6mm-10mm.
In this embodiment, the inner film layer 21 is configured as an eptfe film layer structure with 2N layers, where N is a positive integer greater than or equal to 1; the coupling film 22 is provided as a fep-eptfe film layer, and the outer film layer 23 is provided as a combination of a plurality of eptfe film layers and a plurality of fep-eptfe film layers.
In one embodiment, the adventitia layer 23 is provided as a sleeve structure.
In one embodiment, the outer membrane layer 23 is provided in a sleeve configuration.
Preferably, the above-mentioned fep-eptfe thin film layer in the above-mentioned outer film layer 23 is a thin film layer formed by sequentially laminating a fep thin film layer and an eptfe thin film layer, which are coaxially arranged, and the above-mentioned fep thin film layer is arranged on the inner peripheral side of the above-mentioned eptfe thin film layer.
The outer film layer 23 has anisotropy, and the elastic ability of the outer film layer 23 in its circumferential direction is greater than that of the outer film layer 23 in its axial direction.
Specifically, in the expansion stage of the covered stent, when the fep-eptfe film layer expands and deforms under the action of external force, the eptfe film layer in the fep-eptfe film layer is compressed along the circumferential direction and stretched along the axial direction, and as the elastic capacity of the eptfe film layer along the circumferential direction is greater than that of the eptfe film layer, the axial stretching displacement is converted into circumferential compression displacement, so that the fep-eptfe film layer can obtain a compact working posture, the outer film layer 23 has stronger circumferential constraint force on the covered section 11, and the circumferential constraint force gradually increases along with the expansion action of the external force, so that the outer film layer 23 has the effect of limiting and stabilizing the diameter control of the covered stent.
It should be noted that the material of the eptfe monolayer has anisotropy, and the ductile deformation force perpendicular to the fibrosis direction and other directions have differences, and the method is specifically expressed as follows: when stretching along the vertical fiber extension direction, the material is easy to extend and deform, but when stretching along the fiber direction again, the deformation along the vertical fiber direction can be recovered, and the stable state of each diameter after passive expansion can be realized by utilizing the anisotropic property of the extension force of the eptfe through different film layers.
In a specific embodiment, after the multiple eptfe film layers are sintered, the multiple eptfe film layers and the multiple fep-eptfe laminated film materials are sintered, and finally, an outer film layer 23 of a composite layer structure is formed, so that the diameter of the film coating section 11 is controllable within 6-10 mm.
In a preferred embodiment, the outer film layer 23 is provided as a combination of 5-8 eptfe film layers and 5-8 fep-eptfe film layers.
For the inner film layer 21, the sintering temperature of the multiple eptfe film layers (2N layers) is 370 ℃ or above, so as to reach the sintering temperature of the eptfe material, and the sintered film material does not have a fiberization structure and isotropy any more, so that the effects of preventing tearing and improving the tensile strength can be achieved.
For the outer film layer 23, the multi-layer fep-eptfe film layer is wound on the sintered multi-layer eptfe film and then sintered, the main sintering temperature is 285 ℃ or lower, the sintering temperature of the fep material is reached, the sintered fep material plays a role in middle hot melt adhesion, and the eptfe in the fep-eptfe material still has a fibrous structure because the sintering temperature of the fep-eptfe material does not reach 370 ℃, so that the effect of stability after passive expansion can be achieved.
In this embodiment, the stent body 1 has a self-expanding expansion force, and the resultant force of the constraining forces of the outer membrane layer 23 acting in compression toward the covered section 11 is larger than the expansion force. In the expansion stage of the minimally invasive surgery, the expansion is carried out through the external force action of the tectorial membrane stent, the external expansion diameter of the tectorial membrane section 11 is increased, the corresponding external expansion diameter of the adventitia layer 23 is increased, the restriction acting force of the adventitia layer 23 on the tectorial membrane section 11 is stronger, the connection is tighter, and when the tectorial membrane stent is expanded to the expected diameter size, the tectorial membrane stent can be in the stable expanded diameter size.
The angle formed between the acting force direction of the outer membrane layer 23 for restraining the covered membrane section 11 and the axial direction of the stent main body 1 is 30-150 degrees, so that the outer membrane layer 23 can expand along the radial direction of the stent main body 1 at least.
As an implementation manner of the basis of the embodiment, an included angle formed between the acting force direction of the adventitia layer 23 for restraining the tectorial membrane section 11 and the axial direction of the stent main body 1 is 90 degrees, that is, the adventitia layer 23 can expand along the radial direction of the stent main body 1.
In some alternative embodiments, the included angle formed between the acting force direction of the adventitia layer 23 for restraining the tectorial membrane section 11 and the axial direction of the stent body 1 is 45 ° or 135 °, and the unidirectional extension direction of the adventitia layer 23 is inclined relative to the axial direction of the stent body 1, so that the adventitia layer 23 can expand along the circumferential direction and the axial direction of the stent body 1.
In the exemplary embodiment of the present example, an ePTFE (expanded polytetrafluoroethylene) film layer is disposed in the outer film layer 23. The ePTFE material has a stronger extensibility in a single direction to allow the outer membrane layer 23 to acquire circumferential restraint to the covered segments 11 by its extensibility.
The orientation for stronger stretching is determined by the arrangement of the internal fibers, arrangement density, fineness of the fiber monomers, length, initial modulus, rebound resilience, bending property, etc. in the actually selected material, so that the outer film layer 23 acquires stronger resilience in a single direction.
Referring to fig. 3, the covering section includes a deformation portion 111, a transition portion 112, and a connection portion 113, where the deformation portion has a minimum diameter posture in the constrained state; specifically, the deformation part 111 of the film covering section 11 is compressed by the film covering assembly 2, so that the deformation part 111 obtains the minimum diameter posture to match the diameter size required by the minimally invasive surgery; the transition part 112 is arranged between the deformation part 111 and the connecting part 113, and in the constrained state of the film covering section 11, the transition part 112 is arranged in a flaring manner in the direction of the deformation part 111 towards the connecting part 113; the connecting part 113 is arranged in the edge area of the covering film section 11 adjacent to the bare bracket section 12, and the flaring modeling on the transitional part 112 can enable the covering film component 2 to form an end part binding opening on the bracket main body 1, so that the bracket main body 1 forms a limit on the covering film component 2 in the length direction, the circumferential synchronous expansion of the covering film component 2 is promoted in the expansion stage, and the diameter size control capability of the covering film bracket is improved.
According to the covered stent assembly provided by the invention, the circumferential constraint force is provided for the covered section 11 through the adventitia layer 23, so that the covered section 11 is adjusted to be in a small-diameter-size posture, and the covered stent can be adjusted to a matched diameter suitable for reducing the portal vein pressure from a small-diameter state under external driving during minimally invasive surgery. Through the compression effect of the adventitia layer 23 on the tectorial membrane section 11, the compactness of the whole tectorial membrane bracket structure is promoted, the connection strength between the bracket main body 1 and the tectorial membrane component 2 is improved, the interference influence of the external pressure environment can be reduced, and the intervention and the expansion are stable in use.
According to the covered stent provided by the invention, the compression constraint of the reinforced covered component 2 on the covered section 11 is improved, so that the covered stent has a small-diameter posture to be expanded, and the stability of diameter control of the covered stent in the expansion stage is improved.
Example 2
The embodiment provides a manufacturing method of a covered stent, which comprises the following steps:
and (3) manufacturing an inner film layer 21:
placing the two eptfe film layers in a crossed and perpendicular way, winding the two layers on a mandrel with the diameter of 10mm, curling the two layers for a plurality of layers to obtain a mandrel with the outer side wound with a 2N-layer eptfe film layer structure, putting the mandrel into an oven, performing film-coating sintering cooling to obtain an inner film layer 21, and separating the inner film layer 21 from the mandrel with the diameter of 10 mm; wherein N is a positive integer greater than or equal to 1;
preparing an outer film layer 23:
winding a single-layer ePTFE film layer on a mandrel with the diameter of 6mm for winding a plurality of layers, putting the covered mandrel into a baking oven for film covering sintering, cooling to obtain a semi-finished outer film layer 23, winding a plurality of fep-ePTFE film layers on the semi-finished outer film layer 23, putting the multi-layer fep-ePTFE film layers and the 6mm mandrel in the semi-finished outer film layer 23 into the baking oven together for film covering sintering to obtain an outer film layer 23, and separating the outer film layer 23 from the 6mm mandrel;
manufacturing a bracket main body 1 combined with a connecting film 22 and an inner film layer 21:
the bare stent section 12 of the stent main body 1 is sleeved on a mandrel with the diameter of 10mm, and the position of the stent main body 1 is adjusted so that the braiding end of the bare stent section is positioned outside the inner membranous layer 21; sleeving and fixing a layer of fep-eptfe film layer on the outer side of a film covering section 11 of a bracket main body 1, fixing an inner film layer 21 in an inner cavity of the film covering section 11, putting the three layers into an oven, sintering and heat sealing to fix the film covering section 11 between a connecting film 22 and the inner film layer 21, and cooling to obtain the bracket main body 1 combining the connecting film 22 and the inner film layer 21;
manufacturing an integral covered stent:
the stent main body 1 combined with the connecting membrane 22 and the inner membrane layer 21 is compressed into a state that the outer diameter is smaller than 6mm by a compression tool, the outer membrane layer 23 is sleeved outside the membrane covering section 11 of the stent main body 1, the compression tool is released to compress the stent main body 1, the membrane covering section 11 is in a constraint state by the compression action of the outer membrane layer 23 towards the membrane covering section 11, the fep membrane layers are wound at two ends of the membrane covering section 11 of the stent main body 1, and the fep membrane layers are sintered in an oven, so that the connecting membrane 22 and the outer membrane layer 23 are fixedly connected with the fep membrane layers, and finally the coated stent is manufactured.
The fep film layers are wound at the two ends of the film covering section 11 of the bracket main body 1 and are sintered in an oven, so that the fep film layers are fixedly connected with the film 22 and the outer film layer 23; by means of the arrangement, the two ends of the covering film section 11 combined with the connecting film 22 are fixed through the heat sealing winding of the fep film layer, so that the fixing effect among the covering film section 11, the connecting film 22 and the outer film layer 23 is enhanced, and the structure is prevented from shifting in the axial direction in the expanding stage.
In the above description, the sintering temperature was set to 270 ℃ to 390 ℃.
The manufacturing method provides the manufactured covered stent, and the covered stent has a small-diameter to-be-expanded posture by improving the compression constraint of the reinforced covered stent assembly 2 on the covered section 11, so that the covered stent can be gradually adjusted from a small-diameter state to a matched diameter suitable for reducing the portal vein pressure under external driving.
It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the invention.
Claims (7)
1. A stent graft, comprising:
a stent main body (1) provided with a tectorial membrane section (11) and a bare stent section (12);
a membrane module (2) configured to fixedly connect the membrane segments (11);
the tectorial membrane component (2) comprises an inner membrane layer (21), a connecting membrane (22) and an outer membrane layer (23),
the film covering section (11) is fixedly combined between the inner film layer (21) and the connecting film (22), and the outer film layer (23) is fixedly combined on the outer periphery side of the connecting film (22);
the inner film layer (21) is of a sintered eptfe film layer structure with the number of 2N layers, and N is a positive integer greater than or equal to 1;
the connecting film (22) is arranged as a fep-eptfe film layer;
the outer film layer (23) is arranged into a combined structure of a plurality of eptfe film layers and a plurality of fep-eptfe film layers;
wherein the outer membrane layer (23) is arranged into a sleeve structure or a sleeve structure, the outer membrane layer (23) has a constraint force acting towards the membrane covering section (11), the membrane covering section (11) has a constraint state of being compressed under the constraint force of the outer membrane layer (23), and has an expanded working state of overcoming the constraint force of the outer membrane layer (23) under the action of an external force;
the fep-eptfe film layer in the outer film layer (23) is a film layer formed by sequentially laminating a fep film layer and an eptfe film layer which are coaxially arranged, the fep film layer is arranged on the inner peripheral side of the eptfe film layer, the fep-eptfe film layer is wound on the sintered multi-layer eptfe film and then sintered, and the sintering temperature of the fep-eptfe film layer is 285 ℃ or lower;
the outer film layer (23) has anisotropy, and the elastic capability of the outer film layer (23) along the circumferential direction thereof is greater than that of the outer film layer (23) along the axial direction thereof.
2. The stent graft according to claim 1, wherein the adventitia layer (23) is provided as a combined structure of 5-8 eptfe thin film layers and 5-8 fep-eptfe thin film layers.
3. A stent graft according to claim 1, characterised in that the outer diameter of the stent graft (11) is set to 6mm-10mm.
4. The stent graft according to claim 1, wherein the stent body (1) has a self-expanding expansion force, and the resultant of the constraining forces of the outer membrane layer (23) acting in compression towards the stent graft (11) is greater than the expansion force.
5. The stent graft according to claim 1, wherein the angle formed between the direction of the force of the adventitia layer (23) constraining the stent graft (11) and the axial direction of the stent body (1) is in the range of 30 ° -150 °.
6. The stent graft according to any one of claims 1-5, wherein the stent graft (11) comprises a deformation portion (111), a transition portion (112) and a connection portion (113);
in the constrained state of the film-covered section (11), the deformation (111) has a minimum diameter attitude;
the transition part (112) is arranged between the deformation part (111) and the connecting part (113), and in the constrained state of the film covering section (11), the transition part (112) is arranged in a flaring manner in the direction of the deformation part (111) towards the connecting part (113);
the connecting part (113) is arranged at the edge area of the covering film section (11) adjacent to the bare bracket section (12).
7. The manufacturing method of the covered stent is characterized by comprising the following steps:
manufacturing an inner film layer (21):
the two layers of eptfe films are placed in a crossed and vertical mode, the two layers of eptfe films are wound on a mandrel with the diameter of 10mm to obtain a mandrel with the outer side wound with a 2N-layer eptfe film layer structure, the mandrel is placed into an oven, and after film coating sintering cooling is carried out, an inner film layer (21) is prepared, and then the inner film layer (21) is separated from the mandrel with the diameter of 10 mm; wherein N is a positive integer greater than or equal to 1;
manufacturing an outer film layer (23):
winding an ePTFE film layer on a mandrel with the diameter of 6mm for multiple layers, putting the coated mandrel into an oven for coating sintering, cooling to obtain a semi-finished outer film layer (23), winding a plurality of fep-ePTFE film layers on the semi-finished outer film layer (23), putting the semi-finished outer film layer and the 6mm mandrel in the semi-finished outer film layer (23) into the oven together, and performing coating sintering, wherein the sintering temperature of the fep-ePTFE film layer is 285 ℃ or lower, so as to obtain the outer film layer (23), and separating the outer film layer (23) from the 6mm mandrel;
manufacturing a bracket main body (1) combined with a connecting film (22) and an inner film layer (21):
the bare stent section (12) of the stent main body (1) is sleeved on a mandrel with the diameter of 10mm, and the position of the stent main body (1) is adjusted to enable the braiding end of the bare stent section to be positioned outside the inner membranous layer (21); sleeving and fixing a layer of fep-eptfe film layer on the outer side of a film covering section (11) of a bracket main body (1), fixing an inner film layer (21) in an inner cavity of the film covering section (11), putting the three layers into an oven, sintering and heat sealing to fix the film covering section (11) between a connecting film (22) and the inner film layer (21), and cooling to obtain the bracket main body (1) combined with the connecting film (22) and the inner film layer (21);
manufacturing an integral covered stent:
the method comprises the steps of compressing a bracket main body (1) combined with a connecting film (22) and an inner film layer (21) into a state that the outer diameter is smaller than 6mm through a compression tool, sleeving an outer film layer (23) outside a film coating section (11) of the bracket main body (1), releasing compression of the compression tool on the bracket main body (1), enabling the film coating section (11) to be in a constraint state through compression of the outer film layer (23) towards the film coating section (11), winding and arranging fep film layers at two ends of the film coating section (11) of the bracket main body (1), and sintering the film coating section in an oven to enable the fep film layers to be fixedly connected with the film (22) and the outer film layer (23) so as to finally obtain the film coating bracket.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202311660529.1A CN117357316B (en) | 2023-12-06 | 2023-12-06 | Tectorial membrane bracket and manufacturing method thereof |
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| CN202311660529.1A CN117357316B (en) | 2023-12-06 | 2023-12-06 | Tectorial membrane bracket and manufacturing method thereof |
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| CN117357316B true CN117357316B (en) | 2024-02-20 |
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| CN117045390A (en) * | 2023-10-12 | 2023-11-14 | 苏州美创医疗科技有限公司 | Expansion bracket |
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| US6336937B1 (en) * | 1998-12-09 | 2002-01-08 | Gore Enterprise Holdings, Inc. | Multi-stage expandable stent-graft |
| US8425584B2 (en) * | 2006-04-21 | 2013-04-23 | W. L. Gore & Associates, Inc. | Expandable covered stent with wide range of wrinkle-free deployed diameters |
| AU2016403450B2 (en) * | 2016-04-21 | 2019-10-03 | W. L. Gore & Associates, Inc. | Diametrically adjustable endoprostheses and associated systems and methods |
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|---|---|---|---|---|
| US4443657A (en) * | 1980-05-30 | 1984-04-17 | W. L. Gore & Associates, Inc. | Ribbon cable with a two-layer insulation |
| US5972441A (en) * | 1993-08-18 | 1999-10-26 | W. L. Gore & Associates, Inc. | Thin-wall polytetrafluoroethylene tube |
| US6673102B1 (en) * | 1999-01-22 | 2004-01-06 | Gore Enterprises Holdings, Inc. | Covered endoprosthesis and delivery system |
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| CN117045390A (en) * | 2023-10-12 | 2023-11-14 | 苏州美创医疗科技有限公司 | Expansion bracket |
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| Publication number | Publication date |
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| CN117357316A (en) | 2024-01-09 |
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