CN109893311B - Degradable bracket and manufacturing method thereof - Google Patents
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- CN109893311B CN109893311B CN201811496884.9A CN201811496884A CN109893311B CN 109893311 B CN109893311 B CN 109893311B CN 201811496884 A CN201811496884 A CN 201811496884A CN 109893311 B CN109893311 B CN 109893311B
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Abstract
The invention discloses a novel degradable support and a manufacturing method thereof, and relates to the field of implanted medical instruments. The metal wires are twisted and woven into a hollow twist-type structure. The invention combines two base materials and provides the bracket which has good shaping, good radial supporting strength and can be completely developed. The invention also provides a manufacturing method of the novel degradable bracket.
Description
Technical Field
The invention relates to the field of implanted medical instruments, in particular to a novel degradable bracket and a manufacturing method thereof.
Background
Stents have found increasingly wide application in the field of cardiovascular diseases as an important instrument for treating vascular stenosis. For the metal stent widely applied to clinic at present, the metal stent permanently remains in a human body after completing a treatment task, so the metal stent has the defects of weakening MRI or CT images of coronary arteries, interfering surgical blood circulation reconstruction, preventing collateral circulation from forming, inhibiting positive vascular remodeling and the like. Based on these problems, biodegradable stents have attracted considerable attention as a possible alternative solution. Biodegradable stents are made of degradable polymeric or metallic materials. After being implanted into a lesion site, the biodegradable stent can play a role in supporting blood vessels in a short period of time, and realize the reconstruction of blood circulation. After the treatment is completed, the biodegradable stent can be degraded into organic matters which can be absorbed and metabolized by human body in the human body environment, and finally the stent can disappear. In addition, the short shelf life of the stent also affects the stent application because the stent must undergo a period of storage after preparation is complete.
The degradable stent generally comprises absorbable metal and polymer, the polymer material has very small density, the X-ray impermeability of the material is poor, the vascular stent prepared by the polymer is almost invisible under the assistance of medical imaging equipment and digital subtraction technique, so that a doctor cannot accurately position the stent in the operation process, and therefore, the polymer stent needs to be additionally provided with a developing mechanism, so that the developing mechanism can be identified by the doctor under DSA. Namely, the defect of the visibility of the stent matrix is overcome by a developing structure with good visibility.
In order to solve the problem of degradation of the stent, chinese patent 2014108566258 proposes a degradable iron-based alloy stent, but the iron-based stent itself has too slow degradation speed, and at least one of C, N, O, S, P, mn, pd, si, W, ti, co, cr, cu, re needs to be doped, and the iron-based stent can be doped into pure iron to form the medical iron-based alloy. And various polymers are added to accelerate the complete degradation of the polymer, and degradation products are complex and easily react with the generation of rejection of blood vessels.
In order to improve the radial support strength of the stent, chinese patent 2017112132378 proposes a polylactic acid and its copolymer stent, which is highly oriented in the radial direction, so as to improve the radial support strength, but at the same time, the toughness of the stent is greatly lost, so that the stent is easy to break after passing through a tortuous blood vessel.
In order to improve the development performance of the stent, chinese patent 2015103951018 proposes a vascular stent, in which the surface or structure of the stent is filled with a developer, but the complete development of the whole stent cannot be achieved
Accordingly, those skilled in the art have focused their efforts on developing a stent that has good shape, good radial support strength, and is capable of complete development.
Disclosure of Invention
In view of the above-mentioned drawbacks of the prior art, the present invention aims to develop a stent with good shape, good radial support strength and complete development, and compared with the conventional degradable stent using a single substrate, the present invention combines two substrates, and ensures that restenosis of the stent does not occur by utilizing good radial support of the polymer; the good shaping of the metal wire is utilized, so that the stent is ensured not to break after reaching lesion expansion through tortuous vessels, and the aim of completely developing the whole stent is fulfilled.
In order to achieve the above object, the present invention provides a novel degradable stent, which comprises an inner rib, a polymer substrate layer and a drug layer, wherein the inner rib comprises four or more metal wires with a developing function under an X-ray machine, the polymer substrate layer is formed by mixing polymer solutions and is wrapped around the metal wires, so as to form the polymer substrate layer with a supporting effect.
Further, the metal wire is one of an iron-based alloy, a magnesium-based alloy, a zinc-based alloy and an aluminum-based alloy.
Further, the cross section of the metal wire is cross-shaped.
Further, the metal wire is a single-cavity metal tube, so that the junction of the first substrate and the second substrate is internally of a hollow structure.
Further, the cross-sectional area of the polymer substrate layer is greater than 10 times the cross-sectional area of the wire.
Further, the metal wires are twisted and woven to form a hollow twist structure, and the hollow structure of the hollow twist structure is formed by wrapping the metal wires around one prefabricated polymer wire for twisting and weaving, and degrading and removing the prefabricated polymer wire after weaving is completed.
In addition, the invention provides a novel manufacturing method of the degradable support, which is characterized by comprising the following steps:
step 4, wrapping polymer solution on the surface of the inner rib of the hollow fried dough twist structure, and forming a solid polymer substrate layer with a manufactured shape after solidification;
and 5, covering the surface of the polymer substrate layer with a drug solution to form a drug coating.
Further, in the step 1, the metal wire is one of an iron-based alloy, a magnesium-based alloy, a zinc-based alloy and an aluminum-based alloy.
Further, in step 1, the cross section of the metal wire is cross-shaped.
Further, in step 1, the metal wire is a single-lumen metal tube.
The invention has the beneficial effects that: the invention combines the advantages of good plasticity of the metal degradable stent and good supportability of the polymer degradable stent, and compared with the metal degradable stent, the invention improves the supportability and is not easy to cause restenosis in blood vessels; compared with a polymer degradable stent, the plastic is improved, the stent is not easy to break, and the full development can be realized. The hollow twist structure is adopted, so that part of polymers can be embedded into the twist structure in the process of wrapping the polymer substrate layer at the later stage, so as to increase the firmness of wrapping. Meanwhile, a part of gaps are reserved in the operation process, so that the plasticity and flexibility of the degradable stent are improved, and the passage of pathological tissues is facilitated.
The conception, specific structure, and technical effects of the present invention will be further described with reference to the accompanying drawings to fully understand the objects, features, and effects of the present invention.
Drawings
FIG. 1 is a top view of an internal rib of a hollow twist structure in accordance with a preferred embodiment of the present invention;
FIG. 2 is a side view of an inner rib of a hollow twist structure in accordance with a preferred embodiment of the present invention;
FIG. 3 is an oblique view of the internal ribs of a hollow twist structure in accordance with a preferred embodiment of the present invention;
fig. 4 is a schematic cross-sectional view of a degradable stent made up of four wires according to a preferred embodiment of the present invention.
Detailed Description
The following description of the preferred embodiments of the present invention refers to the accompanying drawings, which make the technical contents thereof more clear and easy to understand. The present invention may be embodied in many different forms of embodiments and the scope of the present invention is not limited to only the embodiments described herein.
In the drawings, like structural elements are referred to by like reference numerals and components having similar structure or function are referred to by like reference numerals. The dimensions and thickness of each component shown in the drawings are arbitrarily shown, and the present invention is not limited to the dimensions and thickness of each component. The thickness of the components is exaggerated in some places in the drawings for clarity of illustration.
In all the following embodiments, the material of the metal wire 1 forming the inner rib may be a material with a developing function under an X-ray machine, such as an iron-based alloy, a magnesium-based alloy, a zinc-based alloy, an aluminum-based alloy, or the like, or may be obtained by cutting a single-cavity metal tube by laser, and the metal wire 1 may be a single wire or may be arranged independently.
Example 1
Fig. 1 is a top view of a hollow twist-type combined arrangement structure of a plurality of metal ribs according to a preferred embodiment of the present invention, wherein the wires 21 and 22 are 2 out of four wires with the same cross section. The preformed polymer filaments 23 are wrapped in four wires (including wires 21, 22) to form a bundle. Fig. 2 is a side view of the hollow twist-type combined arrangement of the plurality of internal ribs, and fig. 3 is an oblique view of the hollow twist-type combined arrangement of the plurality of internal ribs, wherein the plurality of internal ribs are hollow twist-type combined arrangement, and the twist-type combined arrangement can greatly improve the toughness of the bracket to avoid the bracket from breaking, but has a defect in flexibility. The embodiment designs a hollow twist-type arrangement method, which makes each metal wire have independent movable space to make up for the defect of flexibility, and the specific implementation process is as follows:
step 4, wrapping polymer solution on the surface of the inner rib of the hollow fried dough twist structure, and forming a solid polymer substrate layer with a manufactured shape after solidification;
and 5, covering the surface of the polymer substrate layer with a drug solution to form a drug coating.
Example two
Fig. 4 shows a cross section of a straight frame with four wires independently arranged according to another preferred embodiment of the present invention, by which the manufacturing process of the present invention can be specifically described. The inner ribs are four metal wires with the same material model and are respectively and independently arranged, and the metal wires 1 are iron-based alloy, magnesium-based alloy, zinc-based alloy and aluminum-based alloy with developing function under an X-ray machine; the polymer substrate layer 2 formed by wrapping polymer solution around four metal wires, wherein the polymer solution is one or more of PLLA, PDLLA, PDLA, PLGA, PGLA, PLA, PDLGA, and the polymer substrate layer 2 with solid supporting effect is formed by wrapping polymer solution around the periphery, so that the metal wires 1 have good radial supporting property, and restenosis is prevented; the periphery of the polymer substrate layer 2 is covered with a drug layer 3 of a mixture of drug and polymer solution.
The polymer substrate layer 2 can be obtained by spraying on the surface of the metal wire 1, and the specific implementation process is as follows: dissolving the polymer solution in one or more organic solvents selected from methanol, ethanol, isopropanol, acetone, tetrahydrofuran, acetonitrile and chloroform to form a spraying solution, fully oscillating and uniformly mixing, covering a layer of spraying solution with the thickness of 10-15um on the surface of the metal wire 1 at the spraying rate of 0.01-0.06mm/min, and airing for 10min at the temperature of 20-25 ℃ and the RH of 40-60%; spraying again on the surface, and repeating the steps until the polymer solution covers more than 10 times of the cross-sectional area of the metal wire 1; and feeding the metal wire 1 sprayed with the spraying solution into an oven, and drying the metal wire at a temperature lower than the glass transition temperature of the polymer solution material by 10-20 ℃ to form the polymer substrate layer 2.
The medicine layer 3 can be obtained by spraying medicine solution on the surface of the polymer substrate layer 2, and the specific implementation process is as follows: dissolving the medicine and the polymer solution in one or more organic solvents selected from methanol, ethanol, isopropanol, acetone, tetrahydrofuran, acetonitrile and chloroform to form a medicine solution, fully oscillating and uniformly mixing, covering a layer of medicine solution with the thickness of 5-10um on the surface of the polymer substrate layer at the spraying rate of 0.01-0.03mm/min, sending the sprayed polymer substrate into a baking oven, and drying at the temperature of 10-20 ℃ lower than the glass transition temperature of the medicine solution material to form the medicine layer 3.
Example III
In this embodiment, the polymer substrate layer 2 may also be obtained by dip-coating the metal wire 1, and the specific implementation process is as follows: dissolving the polymer solution in one or more organic solvents selected from methanol, ethanol, isopropanol, acetone, tetrahydrofuran, acetonitrile and chloroform to form a dip-coating solution, and fully oscillating and uniformly mixing; immersing the metal wire 1 in the dip-coating solution, taking out the metal wire 1 after 1min, airing, overturning the metal wire 1180 degrees after airing, immersing the metal wire in the dip-coating solution again, taking out the metal wire after 1min, airing, and ensuring that the dip-coating solutions at two ends of the metal wire 1 are uniformly coated; the coating thickness is 15-25um, and the positive and negative two times are recorded as one cycle; then airing for 10min at 20-25 ℃ and 40-60% RH; repeating the above steps until the cross-sectional area of the wire 1 covered with the dip-coating solution is 0.01mm 2 To 0.04mm 2 Between them; and (3) feeding the metal wire 1 dip-coated with the dip-coating solution into an oven, and drying the metal wire at a temperature lower than the glass transition temperature of the polymer solution material by 10-20 ℃ to form the polymer substrate layer 2. Furthermore, the polymer substrate layer 2 may also be obtained by 3D printing of the wires 1.
The drug layer 3 can also be obtained by dip-coating the polymer substrate layer 2 by the following specific implementation processes: dissolving the medicine and the polymer solution in one or more organic solvents selected from methanol, ethanol, isopropanol, acetone, tetrahydrofuran, acetonitrile and chloroform to form a medicine solution, and fully oscillating and uniformly mixing; immersing the polymer substrate layer in the drug solution, taking out after 1min, and airing; after the polymer substrate layer is dried in the air, the polymer substrate layer is turned over by 180 degrees and is immersed in the drug solution again, the polymer substrate layer is taken out after 1min and dried in the air, the drug solution at two ends of the polymer substrate layer is ensured to be coated uniformly, the thickness of dip coating is regulated by controlling the concentration of the drug solution, and the thicker the concentration is, the thinner the coating is on the contrary; and (3) feeding the metal wire 1 which is dip-coated with the drug solution into an oven, and drying the metal wire at a temperature lower than the glass transition temperature of the drug solution material by 10-20 ℃ to form the drug layer 3. In addition, the drug layer 3 may also be obtained by 3D printing the polymer substrate layer 2.
Example IV
The metal wire 1 can also be selected from metal hollow pipes. The metal wire 1 formed by the metal hollow coffin can cut the spiral line in the axial direction or cut the hollow line in the radial direction (the hollow shape can be round, directional, polygonal or various special shapes) on the surface of the tubular material in a 3D laser cutting mode, so that the purpose of reducing the bending moment of the metal tube is achieved. Compared with the metal wire, the overall bending moment of the metal wire is greatly reduced, the flexibility of the whole bracket structure is greatly improved, the polymer in the coating process of the polymer base material in the subsequent coating process of the polymer base material enters the hollow tube through a processing gap of laser cutting on the hollow tube, and the cohesive strength between the polymer base material and the metal base material after curing is greatly improved.
The foregoing describes in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations can be made in accordance with the concepts of the invention without requiring creative effort by one of ordinary skill in the art. Therefore, all technical solutions which can be obtained by logic analysis, reasoning or limited experiments based on the prior art by the person skilled in the art according to the inventive concept shall be within the scope of protection defined by the claims.
Claims (6)
1. The degradable support comprises inner ribs, a polymer substrate layer and a drug layer, and is characterized in that the inner ribs comprise metal wires with a developing function under an X-ray machine, the number of the metal wires is four or more, the polymer substrate layer is formed by mixing polymer solutions and is wrapped on the periphery of the metal wires to form the polymer substrate layer with a supporting effect, the cross section area of the polymer substrate layer is 10 times of the cross section area of the metal wires, the metal wires are one of iron-based alloy, magnesium-based alloy, zinc-based alloy and aluminum-based alloy, the metal wires are twisted and woven into a hollow fibrilia structure, the hollow structure of the hollow fibrilia structure is formed by wrapping a plurality of metal wires around one prefabricated polymer wire for twisting and weaving, and after weaving is completed, the prefabricated polymer wires are degraded and removed.
2. The degradable stent of claim 1, wherein the wire is cross-shaped in cross-section.
3. The degradable stent of claim 1, wherein the wire is a single lumen metal tube.
4. A method of manufacturing a degradable stent, the method comprising the steps of:
step 1, selecting four or more metal wires with a developing function under an X-ray machine as inner ribs, wrapping a plurality of metal wires around a prefabricated polymer wire to form a bundle, wherein the metal wires are one of iron-based alloy, magnesium-based alloy, zinc-based alloy and aluminum-based alloy;
step 2, twisting the metal wires and the prefabricated polymer wires together, and weaving the twisted metal wires and the prefabricated polymer wires into a twist-type structure;
step 3, degrading the prefabricated polymer filaments, and forming a hollow structure in the middle of the twist-shaped structure after removing the prefabricated polymer filaments to obtain a hollow twist-shaped structure inner rib;
step 4, wrapping polymer solution on the surface of the inner rib of the hollow fried dough twist structure, and forming a solid polymer base material layer with a manufactured shape after solidification, wherein the cross section area of the polymer base material layer is more than 10 times of the cross section area of the metal wire;
and 5, covering the surface of the polymer substrate layer with a drug solution to form a drug coating.
5. The method of claim 4, wherein in step 1, the wire has a cross-shaped cross-section.
6. The method of claim 5, wherein in step 1, the wire is a single lumen metal tube.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201811496884.9A CN109893311B (en) | 2018-12-07 | 2018-12-07 | Degradable bracket and manufacturing method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201811496884.9A CN109893311B (en) | 2018-12-07 | 2018-12-07 | Degradable bracket and manufacturing method thereof |
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| CN109893311B true CN109893311B (en) | 2023-06-30 |
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Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6241691B1 (en) * | 1997-12-05 | 2001-06-05 | Micrus Corporation | Coated superelastic stent |
| US6494907B1 (en) * | 1998-04-28 | 2002-12-17 | Intratherapeutics, Inc. | Braided stent |
| US20030153971A1 (en) * | 2002-02-14 | 2003-08-14 | Chandru Chandrasekaran | Metal reinforced biodegradable intraluminal stents |
| EP2117463B1 (en) * | 2007-03-07 | 2018-11-14 | Boston Scientific Limited | Radiopaque polymeric stent |
| US8623071B2 (en) * | 2008-01-07 | 2014-01-07 | DePuy Synthes Products, LLC | Radiopaque super-elastic intravascular stent |
| CN102440856A (en) * | 2011-12-09 | 2012-05-09 | 微创医疗器械(上海)有限公司 | Biodegradable stent visible under X-ray and preparation method thereof |
| US9119736B2 (en) * | 2012-01-27 | 2015-09-01 | Medtronic Vascular, Inc. | Hollow drug-filled stent and method of forming hollow drug-filled stent |
| CN104271170A (en) * | 2012-04-26 | 2015-01-07 | 美敦力瓦斯科尔勒公司 | Radiopaque enhanced cobalt alloy for stents |
| CN203953885U (en) * | 2014-05-27 | 2014-11-26 | 微创神通医疗科技（上海）有限公司 | A kind of intravascular stent |
| CN210228409U (en) * | 2018-12-07 | 2020-04-03 | 上海百心安生物技术有限公司 | A new type of degradable stent |
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