CN109567990B - Degradable bracket and manufacturing method thereof - Google Patents
Degradable bracket and manufacturing method thereof Download PDFInfo
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- CN109567990B CN109567990B CN201811495358.0A CN201811495358A CN109567990B CN 109567990 B CN109567990 B CN 109567990B CN 201811495358 A CN201811495358 A CN 201811495358A CN 109567990 B CN109567990 B CN 109567990B
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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
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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
- A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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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
- 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
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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
- 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 discloses a novel degradable support and a manufacturing method thereof, and relates to the field of implanted medical instruments, the novel degradable support comprises an inner rib, a polymer substrate layer and a drug layer, wherein the inner rib is a metal substrate with a developing function under an X-ray machine, the polymer substrate layer is formed by mixing polymer solutions, the metal substrate is wrapped layer by layer and reinforced, the drug layer is formed by mixing drugs and the polymer solutions, and the drug layer covers the surface of the polymer substrate layer. Aiming at the problems that the existing metal alloy is too slow in degradation speed, complex in degradation products and easy to react with blood vessels in a rejection way, the polymer degradable stent is insufficient in toughness and easy to fracture, and the stent surface is not completely developed after being filled with a developer, the invention combines two base materials, and provides the stent 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 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 base material 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 purpose, the invention provides a degradable support, which is characterized by comprising an inner rib, a polymer substrate layer and a drug layer, wherein the inner rib is a metal substrate with a developing function under an X-ray machine, the polymer substrate layer is formed by mixing polymer solutions, and is wrapped on the periphery of the metal substrate to form a solid polymer substrate layer with a supporting effect, the polymer solution is formed by mixing one or more polymers in PLLA, PDLLA, PDLA, PLGA, PGLA, PLA, PDLGA, the drug layer is formed by mixing drugs and polymer solutions, the drug layer covers the surface of the polymer substrate layer, and the drugs are one or more of paclitaxel, sirolimus and everolimus.
Further, the metal base material is one of an iron-based alloy, a magnesium-based alloy, a zinc-based alloy and an aluminum-based alloy.
Further, the metal base material is single or multiple, and the cross section of the metal base material is rectangular or circular.
Further, the metal base material is a single-cavity metal tube, and the metal base material are independently arranged in parallel.
Further, the metal base material is a plurality of metal base materials which are arranged in a hollow twist type combination way.
Further, the cross-sectional area of the polymer substrate layer is greater than 10 times the cross-sectional area of the metal substrate.
In addition, the invention provides a manufacturing method of the degradable bracket, which is characterized by comprising the following steps:
step 1, selecting a metal substrate with a developing function under an X-ray machine, selecting one or more of PLLA, PDLLA, PDLA, PLGA, PGLA, PLA, PDLGA polymer solutions, and mixing one or more of paclitaxel, sirolimus and everolimus as a drug, wherein the drug solution is formed by mixing the drug and the polymer solutions;
step 2, wrapping polymer solution around the periphery of the metal substrate layer by layer, and repeating the process until the cross-sectional area of the peripheral protection wall of the metal substrate is 0.01mm 2 To 0.04mm 2 Obtaining a polymer substrate layer;
and step 3, covering the surface of the polymer substrate layer with the drug solution to form a drug layer.
Further, in step 2, the polymer substrate layer is obtained by spraying on the surface of the metal substrate, specifically: 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 substrate 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 this surface, repeating the above steps until the cross-sectional area of the polymer solution covering the metal substrate is 0.01mm 2 To 0.04mm 2 Between them; and (3) feeding the metal substrate sprayed with the spraying solution into a baking oven, and drying the metal substrate at a temperature lower than the glass transition temperature of the polymer solution material by 10-20 ℃ to form the polymer substrate layer.
Further, in step 3, the drug layer is obtained by spraying a drug solution on the surface of the polymer substrate layer, specifically: 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.
Further, in step 2, the polymer substrate layer is obtained by dip-coating the metal substrateThe method comprises the following specific steps: 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 substrate in the dip-coating solution, taking out the metal substrate after 1min, airing, turning over the metal substrate by 180 degrees after airing, immersing the metal substrate in the dip-coating solution again, taking out the metal substrate after 1min, airing, and ensuring that the dip-coating solutions at two ends of the metal substrate 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 metal substrate covered by the dip coating solution is 0.01. 0.01mm 2 To 0.04mm 2 Between them; and (3) feeding the metal substrate which is dip-coated with the dip-coating solution into a baking oven, and drying the metal substrate at a temperature lower than the glass transition temperature of the polymer solution material by 10-20 ℃ to form the polymer substrate layer.
Further, in step 3, the drug layer is obtained by dip-coating the polymer substrate layer, specifically: 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 substrate which is dip-coated with the drug solution into an oven, and drying the metal substrate at a temperature lower than the glass transition temperature of the drug solution material by 10-20 ℃ to form the drug layer.
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 a metal material, the polymer substrate layer of the degradable stent is solid after solidification and can bear certain pressure, so that the metal substrate wrapped in the polymer substrate layer has good radial supportability and strength, and the restenosis in blood vessels is ensured not to occur. Compared with polymer materials, the degradable stent has the advantages that the plasticity is improved, the stent fracture is not easy to occur, and the full development can be realized.
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 schematic illustration of a single metal substrate structure in accordance with a preferred embodiment of the present invention;
FIG. 2 is a top view of a multiple metal inner rib structure in accordance with a preferred embodiment of the present invention;
FIG. 3 is a side view of a multi-metal inner rib structure in accordance with a preferred embodiment of the present invention;
FIG. 4 is an oblique view of the structure of a plurality of metal inner ribs according to a preferred embodiment of the present invention;
FIG. 5 is a cross section of two metal substrates independently aligned with a straight frame 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.
Example 1
As shown in FIG. 1, the invention provides a specific embodiment of a single metal substrate structure, wherein the selected metal substrate 1 can be iron-based alloy, magnesium-based alloy, zinc-based alloy, aluminum-based alloy and other materials with developing functions under an X-ray machine, can also be obtained by cutting a single-cavity metal tube through laser, and the metal substrate 1 can be single or multiple metal substrates which are independently arranged.
Fig. 2 is a plan view of a combined arrangement structure of a plurality of metal inner ribs and hollow twist patterns 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. 3 is a side view of the hollow twist-type combined arrangement of the plurality of inner ribs, and fig. 4 is an oblique view of the hollow twist-type combined arrangement of the plurality of inner ribs, wherein the plurality of inner 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 substrate have independent movable space to make up for the defect of flexibility, and the specific implementation process is as follows: the metal base material 21 and the metal base material 22 are crossed in a cross shape, the inside of the joint is designed into a hollow structure 23, the inside of the hollow structure 23 is filled with a polymer lining core which is soluble in dip-coating solution, after weaving is finished, the whole metal base material is wholly immersed in the dip-coating solution, and the polymer lining core is dissolved, so that a hollow twist-shaped structure is obtained.
Example two
Fig. 5 shows a cross section of two metal substrates independently arranged in a straight frame 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 two metal base materials with the same material model, and are respectively and independently arranged, and the metal base material 1 is an iron-based alloy, a magnesium-based alloy, a zinc-based alloy and an aluminum-based alloy with a developing function under an X-ray machine; a polymer substrate layer 2 formed by wrapping polymer solution around two metal substrates, wherein the polymer solution is one or more of PLLA, PDLLA, PDLA, PLGA, PGLA, PLA, PDLGA, and the polymer substrate layer 2 is formed by wrapping polymer solution around the periphery, and the polymer substrate layer 2 is solid after solidification and can bear a certain pressure, so that the metal substrates 1 wrapped in the polymer substrate layer 2 have good radial support and ensure that restenosis does not occur; 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 substrate 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 substrate 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 this surface, repeating the above steps until the cross-sectional area of the polymer solution covering the metal substrate 1 is 0.01mm 2 To 0.04mm 2 Between them; and (3) feeding the metal substrate 1 sprayed with the spraying solution into an oven, and drying the metal substrate 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 substrate 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 substrate 1 in the dip-coating solution, taking out the metal substrate after 1min, airing, overturning the metal substrate 1180 DEG after airing, immersing the metal substrate in the dip-coating solution again, taking out the metal substrate after 1min, airing, and protectingThe dip-coating solution at the two ends of the metal substrate 1 is 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 metal substrate 1 covered with the dip-coating solution is 0.01. 0.01mm 2 To 0.04mm 2 Between them; and (3) feeding the metal substrate 1 dip-coated with the dip-coating solution into an oven, and drying the metal substrate at a temperature lower than the glass transition temperature of the polymer solution material by 10-20 ℃ to form the polymer substrate layer 2. In addition, the polymer substrate layer 2 can also be obtained by 3D printing of the metal substrate 1. The polymer substrate layer 2 is finally obtained, and the polymer substrate layer 2 is solid after solidification and can bear a certain pressure, so that the metal substrate 1 wrapped in the polymer substrate layer 2 has good radial support.
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 substrate 1 which is dip-coated with the drug solution into an oven, and drying the metal substrate 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.
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 (8)
1. The degradable support is characterized by comprising an inner rib, a polymer substrate layer and a drug layer, wherein the inner rib is a metal substrate with a developing function under an X-ray machine, polymer solution is wrapped on the periphery of the metal substrate to form a solid polymer substrate layer with a supporting effect, the polymer solution is formed by mixing one or more polymers in PLLA, PDLLA, PDLA, PLGA, PGLA, PLA, PDLGA, the drug layer is formed by mixing a drug and the polymer solution and covers the surface of the polymer substrate layer, and the drug is one or more of paclitaxel, sirolimus and everolimus;
the number of the metal base materials is multiple, and the cross section of the metal base materials is rectangular or circular;
the metal substrates are in a hollow twist-shaped structure, the metal substrates and the metal substrates are crossed in a cross manner, the inside of the joint is designed to be in a hollow structure, and the hollow structure is formed by dissolving a polymer lining core which is filled in the hollow structure and can be dissolved in a dip-coating solution.
2. The degradable stent of claim 1, wherein the metal substrate is one of an iron-based alloy, a magnesium-based alloy, a zinc-based alloy, and an aluminum-based alloy.
3. The degradable stent of claim 1, wherein the polymeric substrate layer cross-sectional area is greater than 10 times the metal substrate cross-sectional area.
4. A method of manufacturing a degradable stent, the method comprising the steps of:
step 1, selecting a metal substrate with an inner rib as a developing function under an X-ray machine, selecting a polymer solution as a mixture of one or more polymers in PLLA, PDLLA, PDLA, PLGA, PGLA, PLA, PDLGA, selecting one or more drugs in paclitaxel, sirolimus and everolimus, and mixing the drug solution with the polymer solution;
the number of the metal base materials is multiple, and the cross section of the metal base materials is rectangular or circular;
the metal substrates are in a hollow twist-shaped structure, the metal substrates and the metal substrates are crossed in a cross shape, the inside of the joint is designed to be a hollow structure, and the hollow structure is formed by dissolving a polymer lining core which is filled in the hollow structure and can be dissolved in a dip-coating solution;
step 2, wrapping polymer solution around the periphery of the metal substrate layer by layer, and repeating the process until the cross-sectional area of the peripheral protection wall of the metal substrate is 0.01mm 2 To 0.04mm 2 Obtaining a polymer substrate layer;
and step 3, covering the surface of the polymer substrate layer with the drug solution to form a drug layer.
5. The method according to claim 4, wherein the polymer substrate layer of step 2 is obtained by spraying a solution on the surface of the metal substrate, specifically: 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 substrate 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; and (3) feeding the metal substrate sprayed with the spraying solution into a baking oven, and drying the metal substrate at a temperature lower than the glass transition temperature of the polymer solution material by 10-20 ℃ to form the polymer substrate layer.
6. The method of claim 4, wherein the drug layer of step 3 is obtained by spraying a drug solution on the surface of the polymer substrate layer, specifically: 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 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.
7. The method according to claim 4, wherein the polymer substrate layer of step 2 is obtained by dip coating the metal substrate, in particular: 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 substrate in the dip-coating solution, taking out the metal substrate after 1min, airing, turning over the metal substrate by 180 degrees after airing, immersing the metal substrate in the dip-coating solution again, taking out the metal substrate after 1min, airing, and ensuring that the dip-coating solutions at two ends of the metal substrate 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 steps; and (3) feeding the metal substrate which is dip-coated with the dip-coating solution into a baking oven, and drying the metal substrate at a temperature lower than the glass transition temperature of the polymer solution material by 10-20 ℃ to form the polymer substrate layer.
8. The method according to claim 4, wherein the drug layer of step 3 is obtained by dip coating, in particular: 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 metal substrate coated with the polymer substrate layer in the drug solution for 1min, taking out and airing; after the coating is dried, the metal substrate wrapped with the polymer substrate layer is turned over by 180 degrees and immersed in the drug solution again, and the coating is taken out and dried after 1min, so that the drug solution at two ends of the polymer substrate layer is ensured to be uniformly coated, the thickness of the dip coating is regulated by controlling the concentration of the drug solution, and the thicker the coating is, the thinner the coating is; and (3) feeding the metal substrate which is dip-coated with the drug solution into an oven, and drying the metal substrate at a temperature lower than the glass transition temperature of the drug solution material by 10-20 ℃ to form the drug layer.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811495358.0A CN109567990B (en) | 2018-12-07 | 2018-12-07 | Degradable bracket and manufacturing method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811495358.0A CN109567990B (en) | 2018-12-07 | 2018-12-07 | Degradable bracket and manufacturing method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN109567990A CN109567990A (en) | 2019-04-05 |
| CN109567990B true CN109567990B (en) | 2023-07-21 |
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| CN2197371Y (en) * | 1994-07-07 | 1995-05-17 | 薛玉龙 | Toughness weaving shreads |
| US6287335B1 (en) * | 1999-04-26 | 2001-09-11 | William J. Drasler | Intravascular folded tubular endoprosthesis |
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| CN103877624B (en) * | 2012-12-21 | 2016-05-25 | 上海微创医疗器械（集团）有限公司 | A kind of degradable polyester support and preparation method thereof |
| JP2015154921A (en) * | 2014-01-17 | 2015-08-27 | 株式会社日本ステントテクノロジー | drug sustained-release stent |
| JP6667758B2 (en) * | 2015-11-26 | 2020-03-18 | 株式会社 日本医療機器技研 | Bioabsorbable stent |
| CN107519539A (en) * | 2017-09-11 | 2017-12-29 | 乐普（北京）医疗器械股份有限公司 | A kind of medical degradable Zn-base alloy and its intravascular stent product |
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| CN2197371Y (en) * | 1994-07-07 | 1995-05-17 | 薛玉龙 | Toughness weaving shreads |
| US6287335B1 (en) * | 1999-04-26 | 2001-09-11 | William J. Drasler | Intravascular folded tubular endoprosthesis |
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