CN115429484A - Braided superior vena cava tectorial membrane stent and manufacturing process thereof - Google Patents
Braided superior vena cava tectorial membrane stent and manufacturing process thereof Download PDFInfo
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- CN115429484A CN115429484A CN202210950083.5A CN202210950083A CN115429484A CN 115429484 A CN115429484 A CN 115429484A CN 202210950083 A CN202210950083 A CN 202210950083A CN 115429484 A CN115429484 A CN 115429484A
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- braided
- stent
- layer
- vena cava
- superior vena
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- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
Abstract
The invention provides a braided superior vena cava tectorial membrane stent and a manufacturing process thereof, the braided superior vena cava tectorial membrane stent comprises a braided stent and a membrane tube, the braided stent comprises an outer braided layer and an inner braided layer which are mutually sleeved, and the membrane tube is arranged between the outer braided layer and the inner braided layer; the parts of the two ends of the woven support extending out of the membrane tube are shaped into a horn mouth structure, and a developing ring installation station is arranged at the horn mouth. Adopt the closed loop formula support of two-layer weaving, the holding power and the radial force of increase support, the fashioned support of weaving has higher flexibility, also can provide better adherence at small-angle bending section blood vessel, prevents the emergence of support internal fistula. The membrane tube which is easy to be planted by living cells is arranged, so that the risk of tissue invasion can be prevented, tumors can be blocked, and the hemorrhagic lesion of the superior vena cava can be adapted to.
Description
Technical Field
The invention belongs to the technical field of medical equipment, and particularly relates to a woven superior vena cava tectorial membrane stent and a manufacturing process thereof.
Background
Among the apparatus that has gone on the market, do not have the tectorial membrane support of being exclusively used in superior vena cava, the support of superior vena cava will guarantee certain holding power and radial force in the blood vessel, in order to increase compliance characteristic and just can guarantee the laminating between support and the vascular wall better, prevent the emergence of internal fistula. The currently adopted covered stent has poor flexibility while having good supporting force and radial force, so that the application value in a bending section blood vessel is limited, and the wall-adhering effect is poor; the stent with better flexibility has smaller effective diameter, so that the application in a wider superior vena cava trunk is limited, and the condition of in-stent restenosis is easy to occur.
Therefore, there is a need to provide an improved solution to the above-mentioned deficiencies of the prior art.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and provides a braided superior vena cava tectorial membrane stent and a manufacturing process thereof. .
In order to achieve the above purpose, the invention provides the following technical scheme:
a braided superior vena cava tectorial membrane stent comprises a braided stent and a membrane tube, wherein the braided stent comprises an outer braided layer and an inner braided layer which are mutually sleeved, and the membrane tube is arranged between the outer braided layer and the inner braided layer;
the two ends of the woven support extend out of the part of the membrane tube and are shaped into a horn mouth structure, and a developing ring installation station is arranged at the horn mouth.
Preferably, the outer braided layer and the inner braided layer are both closed-loop type net tubular supports formed by circularly braiding an alloy wire, and the two ends of the alloy wire are respectively wound in a mutually crossed manner in the axial direction and the radial direction from one end to the other end.
Preferably, the mesh formed by weaving the outer woven layer and the inner woven layer is rhombic; the part of the woven support corresponding to the horn mouth does not exceed one mesh.
Preferably, the alloy wire is an alloy flat wire, and the parts of the alloy wire corresponding to the two end faces of the weaving bracket are arc-shaped faces.
Preferably, the outer and inner braided layers are heat fused with the membrane tube.
Preferably, the membrane tube is a biocompatible membrane tube, the outer diameter of which is adapted to the inner diameter of the outer braided layer.
Preferably, both ends of the braided stent are provided with 4 developing rings.
A manufacturing process of a woven superior vena cava tectorial membrane stent comprises the following steps:
weaving the support by using alloy wires, and after weaving is finished, nesting the support in a specific mould and placing the support in a muffle furnace for primary shaping; after preliminary shaping, the membrane tube is nested between the outer weaving layer and the inner weaving layer, and the weaving support nested with the membrane tube is placed into a muffle furnace for final shaping, so that the weaving support, the outer weaving layer and the inner weaving layer are fused into a whole in a hot mode.
Preferably, the braided stent comprises an outer braided layer and an inner braided layer which are mutually sleeved, and the outer braided layer and the inner braided layer are closed-loop type mesh tubular stents which are formed by respectively starting from one end to the other end of an alloy wire, mutually crossing and surrounding the two ends in the axial direction and the radial direction and being braided in a circulating mode.
Preferably, the setting temperature of the primary setting is 400 ℃, and the setting time is 60min;
the final setting temperature is 500 deg.C, and the setting time is 20min.
Has the advantages that: adopt the closed loop formula support of two-layer weaving, the holding power and the radial force of increase support, the fashioned support of weaving has higher flexibility, also can provide better adherence at small-angle bending section blood vessel, prevents the emergence of support internal fistula. The membrane tube which is easy to be planted by living cells is arranged, so that the risk of tissue invasion can be prevented, tumors can be blocked, and the hemorrhagic lesion of the superior vena cava can be adapted to.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the invention and, together with the description, serve to explain the invention and not to limit the invention. Wherein:
FIG. 1 is a simplified front view of a stent graft according to one embodiment of the present invention;
FIG. 2 is a schematic perspective view of a bare stent according to an embodiment of the present invention;
FIG. 3 is a simplified structural diagram of a developer ring mounting in one embodiment of the invention.
In the figure: 1. a membrane tube; 2. an inner braid; 3. an outer braid layer; 4. installing a station; 5. alloy wires; 6. and a developing ring.
Detailed Description
The technical solutions in the embodiments of the present invention will be described clearly and completely below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments that can be derived by one of ordinary skill in the art from the embodiments given herein are intended to be within the scope of the present invention.
In the description of the present invention, the terms "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, which are for convenience of description of the present invention only and do not require that the present invention must be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. The terms "connected" and "connected" used herein should be interpreted broadly, and may include, for example, a fixed connection or a detachable connection; they may be directly connected or indirectly connected through intermediate members, and specific meanings of the above terms will be understood by those skilled in the art as appropriate.
The present invention will be described in detail below with reference to the embodiments with reference to the attached drawings. It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict.
As shown in fig. 1-3, a woven superior vena cava tectorial membrane stent comprises a woven stent and a membrane tube 1, the woven stent is a tube-shaped stent, the woven stent is of a double-layer structure, specifically, an inner layer is an inner woven layer 2, an outer layer is an outer woven layer 3, the outer woven layer 3 is correspondingly sleeved outside the inner woven layer 2, the structures of the outer woven layer 3 and the inner woven layer 2 are completely consistent except for different diameters, the weaving process of the outer woven layer 3 and the inner woven layer 2 is consistent, but the outer diameters of used specific molds are different, so that the gaps of Eptfe tube membranes are reserved on the inner and outer woven layers nested into a whole, meshes of the outer woven layer 3 and the inner woven layer 2 which are mutually sleeved are corresponding, a closed-loop type stent which is woven by two layers is adopted, the supporting force and the radial force of the stent are increased, the woven and molded stent has higher flexibility, a blood vessel at a bending section can also provide better adherence, and small angle in the stent is prevented from occurring.
A film tube 1 is arranged between the outer woven layer 3 and the inner woven layer 2, the weaving process of the outer woven layer 3 is consistent with that of the inner woven layer 2, but the outer diameters of the used specific molds are different, so that a gap of an Eptfe tube film is reserved between the inner woven layer and the outer woven layer which are nested into a whole; the membrane tube is easy to be planted by living cells, can prevent the risk of tissue invasion, block tumors and better adapt to hemorrhagic lesions of superior vena cava. The part that stretches out membrane tube 1 at the both ends of weaving the support is stereotyped for the horn mouth structure, makes and forms closed loop structure between the mesh and the mesh of weaving the support, has increased the radial holding power at both ends, is equipped with development ring installation station in horn mouth department, is used for confirming the support position through installation development ring 6 on this installation station, ensures the accurate release of support through development ring 6, prevents that support aversion and development ring 6 from droing.
In an optional embodiment, the outer weaving layer 3 and the inner weaving layer 2 are consistent in structure, and are closed-loop type net tubular supports formed by circularly weaving and encircling the two ends of an alloy wire 5 from one end to the other end in an axial and radial mutual crossing mode, flexibility of the supports is improved through weaving, adherence performance is guaranteed, and the characteristics of superior vena cava are adapted to. In this embodiment, the outer woven layer 3 and the inner woven layer 2 form a closed loop structure between the woven meshes to avoid puncturing blood vessels, wherein the mesh shape is preferably diamond-shaped, and has high resilience to avoid deformation of the woven stent. Wherein the horn mouth corresponds and weaves the support part and does not exceed a mesh to this is when guaranteeing the radial holding power at both ends, and furthest's assurance membrane tube 1's coverage area has improved the ability that prevents the risk of tissue invasion, prevents the interior restenosis of support.
In an optional embodiment, the alloy wire 5 is an alloy flat wire made of nickel-titanium alloy wire, specifically, the alloy flat wire with the thickness less than or equal to 0.1 (0.06) mm is adopted, and when the weaving is carried out, the alloy flat wire can be mutually crossed, encircled and circularly woven on a mandrel with the thickness of 14/16/18mm to form a woven stent suitable for the superior vena cava. The parts of the alloy wires corresponding to the two end faces of the woven stent are arc-shaped faces, so that the smoothness of the two ends of the stent is increased, the stent can be prevented from puncturing blood vessels, and the protective capability of the stent on the blood vessels is enhanced.
In an alternative embodiment, the outer braid 3 and the inner braid 2 are heat fused with the membrane tube 1. The membrane tube 1 is specifically an ePTFE membrane tube 1, has biocompatibility, is easy to be planted by living cells, can prevent the risk of tissue invasion, blocks tumors, is more suitable for hemorrhagic lesions of superior vena cava, and effectively avoids restenosis in the stent.
In an optional embodiment, the membrane tube 1 is made of a biocompatible material, and the outer diameter of the membrane tube is matched with the inner diameter of the outer woven layer 3, specifically, the weaving process of the outer woven layer and the inner woven layer is consistent, but the outer diameters of the used specific molds are different, the inner diameter of the outer woven layer is larger than the outer diameter of the inner woven support matched with the outer woven layer, and the outer diameter of the outer woven layer is smaller than the inner diameter of the outer woven support, so that the inner and outer woven supports nested into a whole are provided with gaps of the Eptfe tube membrane.
In an optional embodiment, the both ends of weaving the support all are equipped with 4 development rings 6, four development rings 6 of each end are about weaving the circumference equipartition of support, in this embodiment, development ring installation station 4 includes neck form section and cyclic annular section, and neck form section diameter is greater than the cyclic annular section, and development ring 6 is cyclic annular and has the incision, and press the ring 6 through external force and hold at the cyclic annular section, with development ring 6 propelling movement to neck form section, prescribe a limit to development ring 6 through the neck form section, prevent to drop.
In an alternative embodiment, the present invention further provides a process for manufacturing a braided superior vena cava stent, comprising:
weaving the stent by using alloy wires, specifically, inserting two ends of a nickel-titanium alloy wire from one end along a specific mold respectively to enable the two ends to be mutually crossed and uniformly distributed in the axial direction and the radial direction, circularly weaving the nickel-titanium alloy wire into a closed-loop network tubular stent, and after weaving, placing the nickel-titanium alloy wire into a muffle furnace for preliminary shaping after being nested in the specific mold; after preliminary sizing, the membrane tube 1 is sleeved, the braided support is overturned, the membrane tube 1 is nested between the outer braided layer 3 and the inner braided layer 2, the braided support nested with the membrane tube 1 is placed into a muffle furnace for final sizing, and the braided support, the outer braided layer 3 and the inner braided layer 2 are fused into a whole through heat.
In an optional embodiment, weave the support including the outer weaving layer 3 and the interior weaving layer 2 that cup joint each other, outer weaving layer 3 and interior weaving layer 2 are a alloy silk both ends head respectively by one end play to the other end by axial and radial intercrossing encircle and circulate the closed loop formula net tubulose support that forms, adopt the closed loop formula support of two-layer weaving, the holding power and the radial power of increase support, it has higher flexibility to weave fashioned support, also can provide better adherence at the crooked section blood vessel of low-angle, prevent the emergence of internal fistula of support. Wherein, the meshes of the woven support are all rhombus, and the two ends of the woven support are provided with bellmouths so as to improve the radial supporting capability of the woven support. The inner layer weaving support is sleeved on the mandrel, the outer wall structure of the mandrel is matched with the structure of the weaving body to be supported, and the mandrel is placed into a muffle furnace for preliminary shaping; sleeving the outer layer braided support on the mandrel, and primarily shaping; the primarily-shaped braided stent is nested, the Eptfe membrane tube 1 is sleeved in the middle of the braided stent, then the braided stent is sleeved on the mandrel, certain pressure is given, the braided stent is placed in a muffle furnace for final shaping, the inner and outer layers of the braided stent are thermally fused into a whole through the fused Eptfe membrane tube 1, and the displacement and the deformation of the braided stent are prevented through the self tension of the Eptfe membrane tube 1. The outer diameter OD3 of the mandrel is less than the outer diameter OD1 of the mandrel is less than the outer diameter OD2 of the mandrel, OD1-OD3 are recommended to be more than or equal to 0.5mm, ID2-OD1 are recommended to be more than or equal to 0.2mm, in an optional embodiment, the setting temperature of primary setting is 400 ℃, and the setting time is 60min; the final setting temperature is 500 ℃, and the setting time is 20min. It should be understood that the above description is only exemplary, and the embodiments of the present application do not limit the present invention.
The above description is only exemplary of the invention and should not be taken as limiting the invention, as any modification, equivalent replacement, or improvement made within the spirit and principle of the invention is intended to be covered by the appended claims.
Claims (10)
1. A braided superior vena cava tectorial membrane stent is characterized by comprising a braided stent and a membrane tube, wherein the braided stent comprises an outer braided layer and an inner braided layer which are mutually sleeved, and the membrane tube is arranged between the outer braided layer and the inner braided layer;
the two ends of the woven support extend out of the parts of the membrane tubes and are shaped into a horn mouth structure, and a developing ring installation station is arranged at the horn mouth.
2. The braided superior vena cava stent as defined in claim 1, wherein the outer braid and the inner braid are both closed-loop mesh tubular stents formed by circularly braiding a single alloy wire with its ends respectively looped and crossed from one end to the other end in axial and radial directions.
3. The braided superior vena cava stent of claim 2, wherein the outer braid and the inner braid are braided to form diamond-shaped mesh openings; the part of the woven support corresponding to the horn mouth does not exceed one mesh.
4. The braided superior vena cava stent according to claim 2, wherein the alloy wires are flat alloy wires, and the portions of the alloy wires corresponding to the two end faces of the braided stent are arc-shaped surfaces.
5. The braided superior vena cava stent of claim 1, wherein the outer and inner braids are thermally fused to the membrane tube.
6. The braided superior vena cava stent of claim 5, wherein the membrane tube is a biocompatible membrane tube having an outer diameter that is compatible with an inner diameter of the outer braided layer.
7. The braided superior vena cava stent of claim 1, wherein 4 visualization rings are provided at each end of the braided stent.
8. A manufacturing process of a woven superior vena cava tectorial membrane stent is characterized by comprising the following steps:
weaving the support by using alloy wires, and after weaving is finished, nesting the support in a specific mould and placing the support in a muffle furnace for primary shaping; after preliminary shaping, the membrane tube is nested between the outer weaving layer and the inner weaving layer, and the weaving support nested with the membrane tube is placed into a muffle furnace for final shaping, so that the weaving support, the outer weaving layer and the inner weaving layer are fused into a whole in a hot mode.
9. The manufacturing process of the braided superior vena cava tectorial membrane stent of claim 8, wherein the braided stent comprises an outer braided layer and an inner braided layer which are sleeved with each other, the outer braided layer and the inner braided layer are both closed-loop type mesh tubular stents which are formed by circularly braiding two end heads of an alloy wire from one end to the other end in a way of being crossed and encircled axially and radially.
10. The manufacturing process of the braided superior vena cava tectorial membrane stent according to claim 8, wherein the setting temperature of the initial setting is 400 ℃ and the setting time is 60min;
the final setting temperature is 500 deg.C, and the setting time is 20min.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210950083.5A CN115429484A (en) | 2022-08-09 | 2022-08-09 | Braided superior vena cava tectorial membrane stent and manufacturing process thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202210950083.5A CN115429484A (en) | 2022-08-09 | 2022-08-09 | Braided superior vena cava tectorial membrane stent and manufacturing process thereof |
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| CN115429484A true CN115429484A (en) | 2022-12-06 |
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| CN202210950083.5A Pending CN115429484A (en) | 2022-08-09 | 2022-08-09 | Braided superior vena cava tectorial membrane stent and manufacturing process thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117717656A (en) * | 2024-02-18 | 2024-03-19 | 北京阿迈特医疗器械有限公司 | Support with developing structure and preparation method thereof |
| CN117717656B (en) * | 2024-02-18 | 2024-04-26 | 北京阿迈特医疗器械有限公司 | Support with developing structure and preparation method thereof |
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