CN112168445A - Y-shaped integrated corrugated netted braided tracheal stent and manufacturing method thereof - Google Patents
Y-shaped integrated corrugated netted braided tracheal stent and manufacturing method thereof Download PDFInfo
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- CN112168445A CN112168445A CN202010993302.9A CN202010993302A CN112168445A CN 112168445 A CN112168445 A CN 112168445A CN 202010993302 A CN202010993302 A CN 202010993302A CN 112168445 A CN112168445 A CN 112168445A
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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
- A61F2/82—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
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Abstract
The invention discloses a Y-shaped integrated corrugated mesh woven tracheal stent and a manufacturing method thereof. The tracheal stent is woven into a rhombic net shape by a single nickel-titanium alloy wire and comprises a stent main body, a left branch and a right branch, wherein the stent main body, the left branch and the right branch are of an integrated structure, and the tracheal stent is characterized in that the connecting parts of the stent main body, the left branch and the right branch are provided with evenly distributed ripples. The manufacturing method comprises the following steps: and winding the bracket on a weaving die by using a nickel-titanium alloy wire, putting the woven bracket tube into a heat setting die for heat setting after winding, and then demoulding. The Y-shaped integrally corrugated netted braided tracheal stent prepared by the invention increases the compliance and the bendability of the stent tube, particularly the corrugation of the joint of the main stem and the 2 branches, so that the Y-shaped stent tube can be matched with the anatomical forms of the pipelines of different patients, the angle between the main stem and the 2 branches is changed, the Y-shaped stent tube conforms to the pathological changes of different conditions, and the Y-shaped integrally corrugated netted braided tracheal stent is tightly attached to the tracheal wall of a human body.
Description
Technical Field
The invention relates to a prosthesis in the technical field of medical engineering and a manufacturing method thereof, in particular to a Y-shaped integrated corrugated mesh woven tracheal stent and a manufacturing method thereof, belonging to the technical field of medical instruments.
Background
The intraluminal stent is a minimally invasive interventional therapy prosthesis which is made of metal or high molecular material and can be left in a human body for a long time or temporarily. At present, for patients who have narrow pressure outside the lumen and are old and bad in the whole body condition and cannot tolerate the operation due to tracheal stenosis and mediastinum, a tracheal stent is usually required to be placed, a conventional stent is generally in a straight cylinder split structure, when the lesion occurs at the body cavity bifurcation, such as the bifurcation structures of trachea, bronchus and the like, three stents are required to be placed, the operation frequency is high, the operation time is long, the probability of injury is high, the stent displacement, the cross overlapping of a plurality of stents, infection and granulation tissue hyperplasia are easy to occur, and the curative effect is affected. Moreover, the implantation of multiple stents is difficult to adapt well to the anatomy and stenosis at each carina, and thus, a Y-shaped stent is clinically needed. The branch angle of the existing Y-shaped stent cannot be changed once being determined, and the existing Y-shaped stent cannot adapt to tissue lesions of various degrees. At present, no Y-shaped stent which can conform to the trachea with different sizes and different degrees of pathological changes is reported.
The invention aims to prepare a Y-shaped integrated corrugated reticular braided tracheal stent. The patents that are currently relevant to the present disclosure, but with substantial differences, are: patent CN201524156U describes a Y-shaped tracheal stent and its introducer, which can effectively expand the lower periphery of the carina, and avoid the phenomena of stent displacement, multiple stents cross-overlapping, etc. after the conventional stent is inserted. However, the tectorial membrane stent has loose structure and uneven supporting force, is easy to deform when being subjected to external force, so that the lumen is narrowed again, and one stent can not adapt to the trachea with pathological changes of various degrees. Patent CN100496434C describes a Y-shaped stent, which solves the problems of mold making and weaving of the Y-shaped stent, and avoids the problem that multiple stents need to be implanted simultaneously in the carina. When the device is used for treatment, different specifications are required to be set according to different conditions, the tracheal stenosis part of a patient is scanned to obtain a CT or MRI sectional image, then a three-dimensional model of the tracheal stenosis part is reconstructed, the length and the inner diameter of the stenosis part are measured and analyzed, the angle between a main body and two branches is measured, and finally a mould is designed for manual weaving. The method can integrate the main body and the left and right branches, provide enough supporting force at the bifurcation part, and ensure that the stent is tightly attached to the tissues. However, the method is time-consuming and labor-consuming, has complex steps and higher cost, and once the branch angle is determined, the branch angle is not easy to adjust, so that the method cannot adapt to the anatomical morphology of different human body pipelines, cannot adapt to the adjustment of the stent angle after the tumor is enlarged after the stent is implanted, and cannot be quickly and conveniently applied to different patients.
Therefore, the Y-shaped stent proposed in the above patent solves the problem of clinical lack of Y-shaped stents, but cannot adapt to various tissue lesions of different degrees, and the manufacturing method is time-consuming and labor-consuming, complex in steps and high in cost.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: the Y-shaped integrated corrugated netted braided tracheal stent can change the length and the bifurcation angle according to tissues, conform to pathological changes of different conditions and be tightly attached to the tissues.
In order to solve the technical problem, the invention provides a Y-shaped integrated corrugated mesh woven tracheal stent which is woven into a diamond mesh shape by a single nickel-titanium alloy wire and comprises a stent main body, a left branch and a right branch, wherein the stent main body, the left branch and the right branch are integrated into a whole.
Preferably, the length of the stent main body is 55-65mm, and the diameter is 15-20 mm; the length of the left branch and the right branch is 25-35mm, and the diameter is 10-15 mm; the included angle between the left branch and the right branch is 60-90 degrees; the distribution length of the corrugations on the main body of the bracket is 20-40mm, and the distribution length of the corrugations on the left branch and the right branch is 10-20 mm; the depth of the corrugation is 2-3 mm.
The invention also provides a manufacturing method of the Y-shaped integrated corrugated netted braided tracheal stent, which is characterized by comprising the following steps of:
step 1): designing a support weaving mold and a heat setting mold: the weaving mold comprises a mold main body, a mold left branch and a mold right branch which respectively correspond to the support main body, the left branch and the right branch, detachable structures are arranged among the mold main body, the mold left branch and the mold right branch, and bulges used for forming corrugations on the support are arranged on the weaving mold; the heat setting mould is matched with the weaving mould;
step 2): fixing the weaving die, then winding a support on the weaving die by using nickel-titanium alloy wires, and after the winding is finished, putting the woven support tube into a heat setting die for heat setting;
step 3): and (4) removing the metal support and demolding.
Preferably, a plurality of metal struts are uniformly arranged at the upper end of the mould main body, the lower end of the left branch of the mould, the lower end of the right branch of the mould and the joint of the mould main body and the left branch and the right branch of the mould in the step 1).
Preferably, the protrusion in step 1) is a spiral structure with two open ends or is composed of a plurality of annular closed structures arranged in sequence.
Preferably, the heat setting mold in step 1) is provided with a groove matched with the protrusion on the weaving mold.
Preferably, the heat setting mold in step 1) is divided into two parts along the Y-shaped surface, and the two parts are wrapped outside the weaving mold and pressed against each other during heat setting.
Preferably, the diameter of the nickel titanium alloy wire in the step 2) is 0.035-0.2 mm.
Preferably, the temperature for heat setting in the step 2) is 500-600 ℃, and the time is 8-60 min.
Compared with the prior art, the corrugating of the stent tube increases the compliance and the bendability of the stent tube, particularly the corrugating of the joint of the main part and the branch, so that the Y-shaped stent tube can conform to the angles of different carina parts, adapts to pathological changes of different degrees, is more tightly attached to a tissue, and can provide enough supporting force.
Drawings
FIG. 1 is a schematic structural view of a Y-shaped integrally corrugated net-shaped woven tracheal stent provided by the invention;
FIG. 2 is a schematic structural view of a closed type braiding mold;
FIG. 3 is a schematic structural view of a closed heat-setting mold;
FIG. 4 is a schematic view of a spiral braiding mold configuration;
fig. 5 is a schematic structural view of a screw type heat setting die.
Detailed Description
In order to make the invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings.
As shown in figure 1, the Y-shaped integrally corrugated net-shaped woven tracheal stent prepared in the embodiment 1-3 is woven into a diamond net shape by a single nickel-titanium alloy wire, and comprises a stent main body 1, a left branch 2 and a right branch 3. The left branch and the right branch are separated in a crotch shape relative to the bracket main body 1 to form a Y-shaped bracket, and the bracket main body 1, the left branch 2 and the right branch 3 are of an integral structure.
As shown in fig. 2 and 4, the assembled stent braiding molds (fig. 2 is a closed braiding mold, and fig. 4 is a spiral braiding mold) include a mold main body, a mold left branch, and a mold right branch corresponding to the stent main body 1, the left branch 2, and the right branch 3, respectively. The two branches can be detached, so that the demolding work after heat setting is facilitated. The upper end of the die main body is provided with evenly distributed holes I4 so as to install n1 metal struts, the lower end of the left branch of the die is provided with evenly distributed holes II 5 to install n2 metal struts, the lower end of the right branch of the die is provided with evenly distributed holes III 6 to install n3 metal struts, the joint of the left branch of the die and the die main body, namely the left branch of the die is provided with evenly distributed holes IV 7 to install n4 metal struts, and the joint of the right branch of the die and the die main body, namely the right branch of the die is provided with evenly distributed holes V8 to install n5 metal struts. In order to ensure the consistency of the supporting force of the bracket, the distance between the supporting columns is required to be uniform, and the number of the supporting columns is required to be adjusted accordingly. For ease of weaving, the mould body is engraved with grooves 9. In order to form the corrugation effect, the mould main body, the left branch of the mould and the right branch of the mould are provided with a plurality of bulges 10. An included angle alpha is arranged between the left branch of the die and the right branch of the die.
As shown in fig. 3 and 5, the heat setting mold for the stent (fig. 3 is a closed type braiding mold, fig. 5 is a spiral type braiding mold), the groove part in the heat setting mold is divided into an upper part and a lower part corresponding to the convex part of the braiding mold, and the upper part and the lower part are pressed during heat setting.
Example 1
A manufacturing method of a Y-shaped integrated corrugated netted braided tracheal stent comprises the following specific steps:
the method comprises the following steps: and designing the size of the bracket and quickly manufacturing a prototype. The length of the main body of the bracket is determined to be 55mm, the diameter of the main body of the bracket is determined to be 15mm, the length of the branch is determined to be 25mm, the diameter of the branch is determined to be 10mm, and the included angle between the left branch and the right branch is 60 degrees. The length of the corrugation distribution on the main body of the bracket is 20mm, and the length of the corrugation distribution on the branch is 10 mm. The depth of the corrugations is 2 mm.
Step two: the number of pillars is determined according to the required density. The number of the supporting pillars at the upper end of the main body is determined to be 16, and the number of the pillars at the lower ends of the left branch and the right branch is determined to be 12. The number of the mounting pillars at the left branch and the right branch is 8.
Step three: the metal support is well installed, and a nickel-titanium alloy wire is used for weaving the support, wherein the diameter of the nickel-titanium wire is 0.035 mm.
Step four: after weaving, the fabric is put into a heat setting die for corrugation setting, the heat setting temperature is 500 ℃, and the heat setting time is 60 min.
Step five: and (5) demolding to obtain the Y-shaped integrally corrugated netted braided tracheal stent. The length of the main body of the bracket is 55mm, the diameter of the main body of the bracket is 15mm, the length of each branch is 25mm, the diameter of each branch is 10mm, and the included angle between the left branch and the right branch is 60 degrees. The length of the corrugation distribution on the main body of the bracket is 20mm, and the length of the corrugation distribution on the branch is 10 mm. The corrugation depths are all 2 mm.
Example 2
A manufacturing method of a Y-shaped integrated corrugated netted braided tracheal stent comprises the following specific steps:
the method comprises the following steps: and designing the size of the bracket and quickly manufacturing a prototype. The length of the main body of the bracket is determined to be 60mm, the diameter of the main body of the bracket is determined to be 18mm, the length of the branch is determined to be 30mm, the diameter of the branch is determined to be 15mm, and the included angle between the left branch and the right branch is determined to be 90 degrees. The length of the corrugation distribution on the main body of the bracket is 30mm, and the length of the corrugation distribution on the branch is 15 mm. The corrugation depths are all 2 mm.
Step two: the number of pillars is determined according to the required density. The number of the supporting pillars at the upper end of the main body is 20, and the number of the pillars at the lower ends of the left branch and the right branch is 14. The number of the mounting pillars at the left branch and the right branch is 12.
Step three: the metal support is well installed, and a nickel-titanium alloy wire is used for weaving the support, wherein the diameter of the nickel-titanium wire is 0.08 mm.
Step four: after weaving, the fabric is put into a heat setting die for corrugation setting, wherein the heat setting temperature is 550 ℃, and the heat setting time is 20 min.
Step five: and (5) demolding to obtain the Y-shaped integrally corrugated netted braided tracheal stent. The length of the main body of the bracket is 60mm, the diameter of the main body of the bracket is 18mm, the length of the branch is 30mm, the diameter of the branch is 15mm, and the included angle between the left branch and the right branch is 90 degrees. The length of the corrugation distribution on the main body of the bracket is 30mm, and the length of the corrugation distribution on the branch is 15 mm. The corrugation depths are all 2 mm.
Example 3
A manufacturing method of a Y-shaped integrated corrugated netted braided tracheal stent comprises the following specific steps:
the method comprises the following steps: and designing the size of the bracket and quickly manufacturing a prototype. The length of the main body of the bracket is determined to be 65mm, the diameter of the main body of the bracket is determined to be 20mm, the length of the branch is 35mm, the diameter of the branch is determined to be 15mm, and the included angle between the left branch and the right branch is 90 degrees. The corrugation length of the trunk is 40mm, and the corrugation length of the branches is 20 mm. The corrugation depths are all 2 mm.
Step two: the number of pillars is determined according to the required density. The number of the supporting pillars at the upper end of the main body is determined to be 24, and the number of the pillars at the lower ends of the left branch and the right branch is determined to be 16. The number of the mounting pillars at the left branch and the right branch is 12.
Step three: the metal support is well installed, and a nickel-titanium alloy wire is used for weaving the support, wherein the diameter of the nickel-titanium wire is 0.2 mm.
Step four: after weaving, the fabric is put into a heat setting die for corrugation setting, wherein the heat setting temperature is 590 ℃, and the heat setting time is 10 min.
Step five: and (5) demolding to obtain the Y-shaped integrally corrugated netted braided tracheal stent. The length of the main body of the bracket is 65mm, the diameter of the main body of the bracket is 20mm, the length of the branch is 35mm, the diameter of the branch is 15mm, and the included angle between the left branch and the right branch is 90 degrees. The corrugation length of the trunk is 40mm, and the corrugation length of the branches is 20 mm. The corrugation depths are all 2 mm.
The Y-shaped bracket can effectively expand the pathological changes at the carina of the trachea without displacement of the bracket, and simultaneously, the main part and the branch connecting part of the Y-shaped bracket are subjected to corrugating treatment, so that the bracket can adapt to the pathological changes of different conditions at the carina of the trachea, and the angle and the length of the bracket tube are more tightly attached to tissues. According to the weaving mold and the heat setting mold of the Y-shaped support, the left branch and the right branch of the weaving mold are detachable, demolding of the woven support is easy, grooves matched with the protrusions on the weaving mold are formed in the heat setting mold, the mold is divided into two parts along the Y-shaped surface, and the two parts are wrapped on the outer side of the weaving mold and are mutually compressed to generate corrugations during heat setting.
Claims (9)
1. The utility model provides a trachea support is woven to Y type integration corrugate netted rhombus is netted by single nickel titanium alloy silk, includes support main part (1), left branch (2), right branch (3), support main part (1) and left branch (2), right branch (3) structure as an organic whole, its characterized in that, the junction of support main part (1) and left branch (2), right branch (3) have evenly distributed's ripple.
2. The Y-shaped integrated corrugated netted braided tracheal stent as claimed in claim 1, wherein said stent body (1) has a length of 55-65mm and a diameter of 15-20 mm; the length of the left branch (2) and the right branch (3) is 25-35mm, and the diameter is 10-15 mm; the included angle between the left branch (2) and the right branch (3) is 60-90 degrees; the distribution length of the corrugations on the bracket main body (1) is 20-40mm, and the distribution length of the corrugations on the left branch (2) and the right branch (3) is 10-20 mm; the depth of the corrugation is 2-3 mm.
3. The method for manufacturing the Y-shaped integrally corrugated netted braided tracheal stent as claimed in claim 1 or 2, characterized by comprising the following steps:
step 1): designing a support weaving mold and a heat setting mold: the weaving mold comprises a mold main body, a mold left branch and a mold right branch which respectively correspond to the support main body (1), the left branch (2) and the right branch (3), detachable structures are arranged among the mold main body, the mold left branch and the mold right branch, and bulges (10) for forming corrugations on the support are arranged on the weaving mold; the heat setting mould is matched with the weaving mould;
step 2): fixing the weaving die, then winding a support on the weaving die by using nickel-titanium alloy wires, and after the winding is finished, putting the woven support tube into a heat setting die for heat setting;
step 3): and (4) removing the metal support and demolding.
4. The method for manufacturing a Y-shaped integrated corrugated netted braided tracheal stent as claimed in claim 3, wherein a plurality of metal struts are uniformly arranged at the upper end of the mold main body, the lower end of the left branch of the mold, the lower end of the right branch of the mold and the joint of the mold main body and the left branch of the mold and the right branch of the mold in step 1).
5. The method for manufacturing a Y-shaped integrated corrugated netted braided tracheal stent as claimed in claim 3, wherein the protrusions (10) in step 1) are in a spiral structure with two open ends or are composed of a plurality of annular closed structures arranged in sequence.
6. The method for manufacturing a Y-shaped integrated corrugated netted braided tracheal stent as claimed in claim 3, wherein the heat setting die in step 1) is provided with a groove matched with the protrusion (1) on the braiding die.
7. The method for manufacturing a Y-shaped integrated corrugated netted braided tracheal stent as claimed in claim 3, wherein said heat-setting die in step 1) is divided into two parts along the Y-shaped surface, and the two parts are wrapped outside the braided die and pressed against each other during heat-setting.
8. The method for manufacturing a Y-shaped integrated corrugated meshed braided tracheal stent as claimed in claim 3, wherein the diameter of the nickel-titanium alloy wire in the step 2) is 0.035-0.2 mm.
9. The method for manufacturing a Y-shaped integrated corrugated netted braided tracheal stent as claimed in claim 3, wherein the temperature for heat setting in step 2) is 500-600 ℃ and the time is 8-60 min.
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CN117653434A (en) * | 2023-12-12 | 2024-03-08 | 上海交通大学医学院附属瑞金医院卢湾分院 | Y-shaped tectorial membrane tracheal stent, imbedding device and manufacturing method |
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