CN113995892A - Rubber-like shape memory recyclable esophageal stent and preparation method thereof - Google Patents
Rubber-like shape memory recyclable esophageal stent and preparation method thereof Download PDFInfo
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- CN113995892A CN113995892A CN202111317149.9A CN202111317149A CN113995892A CN 113995892 A CN113995892 A CN 113995892A CN 202111317149 A CN202111317149 A CN 202111317149A CN 113995892 A CN113995892 A CN 113995892A
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- 239000002861 polymer material Substances 0.000 claims abstract description 32
- 229920000431 shape-memory polymer Polymers 0.000 claims abstract description 31
- 238000011084 recovery Methods 0.000 claims abstract description 20
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- 229940126585 therapeutic drug Drugs 0.000 claims abstract description 6
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- 239000004814 polyurethane Substances 0.000 claims description 17
- 229920002635 polyurethane Polymers 0.000 claims description 14
- SZVJSHCCFOBDDC-UHFFFAOYSA-N iron(II,III) oxide Inorganic materials O=[Fe]O[Fe]O[Fe]=O SZVJSHCCFOBDDC-UHFFFAOYSA-N 0.000 claims description 11
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Images
Classifications
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L31/128—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
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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
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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- 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
- A61F2002/044—Oesophagi or esophagi or gullets
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- A—HUMAN NECESSITIES
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- 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
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/16—Materials with shape-memory or superelastic properties
Abstract
The invention relates to the technical field of medical appliances, in particular to a rubber-like shape memory recyclable esophageal stent and a preparation method thereof; is prepared from 70-85 parts by weight of super-elastic material, 13-20 parts by weight of shape memory polymer material and 2-8 parts by weight of biocompatible nano micro powder. When in use, the rubber-like shape memory recyclable esophageal stent is pressed and held in the catheter to be delivered to a lesion part in a human body; the crimped rubber-like shape memory retrievable esophageal stent recovers by super-elasticity after the catheter is removed. When in recovery, the rubber-like shape memory recoverable esophagus support is heated to the shape memory recovery temperature of the shape memory polymer material, and then the esophagus support can be recovered to the original structure, so that the esophagus support is convenient to take out. The stent prepared by the method has biocompatibility and small irritation to tissues; the automatic contraction of the stent can be realized through proper external stimulation; the therapeutic effect can be further enhanced by coating the therapeutic drug on the surface of the stent.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a rubber-like shape memory recyclable esophageal stent and a preparation method thereof.
Background
The in vivo implanted stent is widely applied in the process of treating diseases such as airway organic stenosis, esophagus cancer, bladder/prostate cancer and the like. In clinic, the implantation of the stent is temporary in many cases, and the stent needs to be recovered along with the treatment of primary focus and the reduction of the blockage degree of a narrow part.
The existing internal implanted stents are mainly made of stainless steel, NiTi alloy and other materials, and the stents basically utilize the super elasticity of stent materials or stent structures, and the stents can self-expand but cannot self-contract. The process of stent implantation is basically that the stent is first compressed in a catheter and delivered to the lesion in the body, and after the catheter is removed to release the stent, the stent begins to expand. In order to prevent the stent from moving, the stent must have sufficient rigidity so that it is in close contact with surrounding tissues after release and is not easily deformed. However, as a result of such design, in many disease treatment procedures (e.g., microcatheter intervention and treatment of benign colonic stenosis) where only temporary stents need to be implanted, it is difficult to remove the stents after the treatment is completed, i.e., stent retrieval is difficult. This has been a common drawback of existing implantable stents. Therefore, the clinical application of the in vivo implantable stent is limited to a certain extent. Especially for strictures of body ducts caused by benign lesions, the use is more limited.
In addition, most of the currently used in vivo implantable stents, whether metal stents or polymer stents, are of a braided structure, and have a high incidence rate in the aspect of tissue ingrowth.
Disclosure of Invention
In order to solve the above problems, the present invention provides a rubber-like shape memory recyclable esophageal stent and a method for manufacturing the same. Polyurethane is a shape memory polymer material with wide application prospect, and the shape memory temperature of the polyurethane can be adjusted within the range of-30 ℃ to 70 ℃ according to the requirement. Meanwhile, the material has better mechanical property and biocompatibility, so that the material can be used for manufacturing medical devices implanted in vivo.
The rubber-like shape memory recyclable esophageal stent is prepared from 70-85 parts by weight of super-elastic material, 13-20 parts by weight of shape memory polymer material and 2-8 parts by weight of biocompatible nano micro powder. The preparation method comprises the steps of firstly utilizing a star-shaped mold to prepare a star-shaped bracket from raw materials, and then expanding the bracket in a balloon expansion mode. The using method is that the rubber-like shape memory recyclable esophageal stent is firstly pressed and held in a catheter to be delivered to the lesion part in the body; the crimped rubber-like shape memory retrievable esophageal stent recovers by super-elasticity after the catheter is removed. When the rubber-like shape memory recyclable esophageal stent needs to be recycled, the rubber-like shape memory recyclable esophageal stent is heated to the shape memory recovery temperature, and can be recovered to be in a star-shaped structure, so that the size is reduced, and the rubber-like shape memory recyclable esophageal stent is convenient to take out. The rubber-like shape memory recyclable esophageal stent has the advantages that the manufacturing material of the rubber-like shape memory recyclable esophageal stent has biocompatibility and small irritation to tissues. After the rubber-like shape memory recyclable esophageal stent is implanted into a body, the esophageal stent can automatically contract through proper external stimulation, so that the size of the esophageal stent is reduced, and the esophageal stent is convenient to take out of the body. The therapeutic effect can be further enhanced by coating the therapeutic drug on the surface of the rubber-like shape memory recyclable esophageal stent.
The purpose of the invention can be realized by the following technical scheme:
the first purpose of the invention is to provide a rubber-like shape memory recoverable esophageal stent, which is prepared by 70-85 parts by weight of super-elastic material, 13-20 parts by weight of shape memory polymer material and 2-8 parts by weight of biocompatible nano-micro powder,
the rubber-like shape memory recyclable esophageal stent is hollow inside.
In one embodiment of the invention, the surface of the rubber-like shape memory recoverable esophageal stent is coated with a therapeutic drug that inhibits vascular endothelial cell proliferation.
In one embodiment of the present invention, the super-elastic material is silicone rubber, the shape memory polymer material is polyurethane, and the biocompatible nanopowder is Fe3O4And (4) nano micropowder.
In one embodiment of the invention, the rubber-like shape memory recoverable esophageal stent achieves automatic contraction under external stimulation, so that the size of the esophageal stent is reduced.
The second purpose of the invention is to provide a preparation method of the rubber-like shape memory recyclable esophageal stent, which comprises the following steps:
(1) heating the superelastic material and the shape memory polymer material to melt, resulting in a first mixture;
(2) adding the first mixture obtained in the step (1) into an organic solvent and biocompatible nano micro powder, and uniformly mixing to obtain a second mixture;
(3) placing the second mixture obtained in the step (2) in a star-shaped mold, and performing pressure forming after treatment to prepare a star-shaped support;
(4) and (4) expanding the star-shaped stent obtained in the step (3) into a tubular shape in a balloon expansion mode, and disinfecting to obtain the rubber-like shape memory recyclable esophageal stent.
In one embodiment of the present invention, in the step (2), the mixture is uniformly mixed by ultrasonic oscillation of an ultrasonic oscillator, and the organic solvent is volatilized.
In one embodiment of the present invention, in step (3), the temperature of the press molding is higher than the shape memory recovery temperature of the shape memory polymer material.
In one embodiment of the present invention, the shape memory temperature of the shape memory polymer material is the shape memory polymer material glass transition temperature.
In one embodiment of the invention, in step (4), the temperature during expansion is 15 ℃ above the shape memory recovery temperature of the shape memory polymer material.
In one embodiment of the present invention, in the step (4), the stent expanded into a tubular shape is cooled to room temperature to maintain the tubular state before sterilization.
The third purpose of the invention is to provide a using method of the above rubber-like shape memory recyclable esophageal stent, which comprises the following steps:
(1) compressing the rubber-like shape memory recoverable esophageal stent in a catheter and delivering the stent to a lesion part in a body;
(2) removing the catheter, and recovering the rubber-like shape memory recoverable esophageal stent through elastic deformation to prop open the lesion part;
(3) when the rubber-like shape memory recyclable esophageal stent needs to be taken out, the rubber-like shape memory recyclable esophageal stent is heated to the shape memory recovery temperature of the shape memory polymer material, and the rubber-like shape memory recyclable esophageal stent is shrunk and recovered into a star-shaped stent through the shape memory effect;
(4) the contracted rubber-like shape memory can be taken out to recover the esophagus stent.
In one embodiment of the present invention, in step (3), the rubber-like shape memory recoverable esophageal stent is heated to the shape memory recovery temperature of the shape memory polymer material by saline.
In one embodiment of the present invention, in step (3), the rubber-like shape memory recyclable esophageal stent is heated to the shape memory recovery temperature of the shape memory polymer material by applying an oscillating magnetic field outside the patient's body using magnetic induction.
Compared with the prior art, the invention has the following beneficial effects:
(1) for benign stenotic lesions of certain ducts in the body, the rubber-like shape memory recyclable esophageal stent convenient to implant is taken out after lesion treatment is completed.
(2) The invention relates to a rubber-like shape memory recyclable esophageal stent which is made of materials such as silica gel, polyurethane and Fe3O4The nanometer micro powder is widely applied clinically, has good biocompatibility and small irritation to tissues.
(3) After the rubber-like shape memory recyclable esophageal stent is implanted into a body, when the disease is relieved or the esophageal stent needs to be taken out after treatment is finished, the stent can be automatically contracted through proper external stimulation, so that the size of the stent is reduced, and the stent is convenient to take out from the body.
(4) The rubber-like shape memory recyclable esophageal stent is tubular during working, and the defect of tissue ingrowth caused by a braided structure adopted by a common stent is overcome.
(5) The invention can further strengthen the treatment effect by coating the therapeutic drug on the surface of the rubber-like shape memory recyclable esophageal stent.
(6) The rubber-like shape memory recyclable esophageal stent is made of polymer materials, and compared with a metal stent, the rubber-like shape memory recyclable esophageal stent is simple in manufacturing process and low in cost, and can greatly reduce the medical burden of patients.
Drawings
FIG. 1 is a schematic diagram of the star-shaped shape of a rubber-like shape memory recyclable esophageal stent of the present invention;
FIG. 2 is a schematic diagram of the shape of an uninflated balloon placed inside a rubber-like shape memory recyclable esophageal stent of the present invention;
FIG. 3 is a schematic diagram of a rubber-like shape memory recyclable esophageal stent of the present invention expanded into a tubular shape by balloon expansion;
FIG. 4 is a schematic diagram showing the expanded shape of a rubber-like shape memory recoverable esophageal stent of the present invention;
FIG. 5 is a schematic diagram of a rubber-like shape memory recyclable esophageal stent of the present invention implanted in a body;
FIG. 6 is a schematic diagram illustrating the recoverable shape memory rubber-like esophageal stent of the present invention returning to the original shape of the star-shaped stent after being heated to the shape memory temperature;
reference numbers in the figures: 1. a star-shaped support; 2. a balloon; 3. the inner wall of the esophagus.
Detailed Description
The first purpose of the invention is to provide a rubber-like shape memory recoverable esophageal stent, which is prepared by 70-85 parts by weight of super-elastic material, 13-20 parts by weight of shape memory polymer material and 2-8 parts by weight of biocompatible nano-micro powder,
the rubber-like shape memory recyclable esophageal stent is hollow inside.
In one embodiment of the invention, the surface of the rubber-like shape memory recoverable esophageal stent is coated with a therapeutic drug that inhibits vascular endothelial cell proliferation.
In one embodiment of the present invention, the super-elastic material is silicone rubber, the shape memory polymer material is polyurethane, and the biocompatible nanopowder is Fe3O4And (4) nano micropowder.
In one embodiment of the invention, the rubber-like shape memory recoverable esophageal stent achieves automatic contraction under external stimulation, so that the size of the esophageal stent is reduced.
The second purpose of the invention is to provide a preparation method of the rubber-like shape memory recyclable esophageal stent, which comprises the following steps:
(1) heating the superelastic material and the shape memory polymer material to melt, resulting in a first mixture;
(2) adding the first mixture obtained in the step (1) into an organic solvent and biocompatible nano micro powder, and uniformly mixing to obtain a second mixture;
(3) placing the second mixture obtained in the step (2) in a star-shaped mold, and performing pressure forming after treatment to prepare a star-shaped support;
(4) and (4) expanding the star-shaped stent obtained in the step (3) into a tubular shape in a balloon expansion mode, and disinfecting to obtain the rubber-like shape memory recyclable esophageal stent.
In one embodiment of the present invention, in the step (2), the mixture is uniformly mixed by ultrasonic oscillation of an ultrasonic oscillator, and the organic solvent is volatilized.
In one embodiment of the present invention, in step (3), the temperature of the press molding is higher than the shape memory recovery temperature of the shape memory polymer material.
In one embodiment of the present invention, the shape memory temperature of the shape memory polymer material is the shape memory polymer material glass transition temperature.
In one embodiment of the invention, in step (4), the temperature during expansion is 15 ℃ above the shape memory recovery temperature of the shape memory polymer material.
In one embodiment of the present invention, in the step (4), the stent expanded into a tubular shape is cooled to room temperature to maintain the tubular state before sterilization.
The invention provides a use method of the rubber-like shape memory recyclable esophageal stent, which comprises the following steps:
(1) compressing the rubber-like shape memory recoverable esophageal stent in a catheter and delivering the stent to a lesion part in a body;
(2) removing the catheter, and recovering the rubber-like shape memory recoverable esophageal stent through elastic deformation to prop open the lesion part;
(3) when the rubber-like shape memory recyclable esophageal stent needs to be taken out, the rubber-like shape memory recyclable esophageal stent is heated to the shape memory recovery temperature of the shape memory polymer material, and the rubber-like shape memory recyclable esophageal stent is shrunk to be restored to the original state through the shape memory effect;
(4) the contracted rubber-like shape memory can be taken out to recover the esophagus stent.
In one embodiment of the present invention, in step (3), the rubber-like shape memory recoverable esophageal stent is heated to the shape memory recovery temperature of the shape memory polymer material by saline.
In one embodiment of the present invention, in step (3), the rubber-like shape memory recyclable esophageal stent is heated to the shape memory recovery temperature of the shape memory polymer material by applying an oscillating magnetic field outside the patient's body using magnetic induction.
The invention will be described in detail with reference to the accompanying drawings and specific embodiments, in which reference numeral 1 denotes a star-shaped stent; 2 is a sacculus; 3 is the inner wall of esophagus.
Example 1
The present embodiment provides a rubber-like shape memory recyclable esophageal stent.
75 parts by weight of silicone rubber and 20 parts by weight of polyurethane (the glass transition temperature, i.e., the shape memory recovery temperature, of polyurethane is 41 ℃) were taken and heated to be melted.
The melted mixture was poured into a beaker containing ethanol, and 5 parts by weight of magnetic Fe was added thereto3O4And (4) nano micropowder.
And (3) putting the beaker into an ultrasonic oscillator for ultrasonic oscillation for 2 hours, and volatilizing the ethanol in a heating mode.
Making a star-shaped mold, pouring the mixture into the mold, addingHeating to 80 deg.C for solidification, demoulding to obtain Fe-containing material3O4A star-shaped support of nanopowder, as shown in FIG. 1;
the Fe content was achieved by balloon inflation (as shown in FIG. 2) at a temperature 15 deg.C (i.e., 56 deg.C) above the glass transition temperature of the polyurethane3O4The star-shaped scaffold of nanopowder expands into a tubular shape and then cools to room temperature, it will remain as a tubular shape.
Will contain Fe3O4Sterilizing the tubular support of the nanometer micropowder, and vacuum drying and sealing for later use; the resulting product is shown in fig. 4.
Example 2
The present embodiment provides a rubber-like shape memory recyclable esophageal stent.
70 parts by weight of silicone rubber and 13 parts by weight of polyurethane (the glass transition temperature, i.e., the shape memory recovery temperature, of polyurethane is 41 ℃) were taken and heated to be melted.
The melted mixture was poured into a beaker containing ethanol, and 2 parts by weight of magnetic Fe was added thereto3O4And (4) nano micropowder.
And (3) putting the beaker into an ultrasonic oscillator for ultrasonic oscillation for 2 hours, and volatilizing the ethanol in a heating mode.
Making a star-shaped mold, pouring the mixture into the mold, heating to 80 deg.C for solidification, and demolding to obtain the final product containing Fe3O4A star-shaped support of nanopowder, as shown in FIG. 1;
the Fe content was achieved by balloon inflation (as shown in FIG. 2) at a temperature 15 deg.C (i.e., 56 deg.C) above the glass transition temperature of the polyurethane3O4The star-shaped scaffold of nanopowder expands into a tubular shape and then cools to room temperature, it will remain as a tubular shape.
Will contain Fe3O4Sterilizing the tubular support of the nanometer micropowder, and vacuum drying and sealing for later use; the resulting product is shown in fig. 4.
Example 3
The present embodiment provides a rubber-like shape memory recyclable esophageal stent.
85 parts by weight of silicone rubber and 17 parts by weight of polyurethane (the glass transition temperature, i.e., the shape memory recovery temperature, of polyurethane is 41 ℃) were taken and heated to be melted.
The melted mixture was poured into a beaker containing ethanol, and 8 parts by weight of magnetic Fe was added thereto3O4And (4) nano micropowder.
And (3) putting the beaker into an ultrasonic oscillator for ultrasonic oscillation for 2 hours, and volatilizing the ethanol in a heating mode.
Making a star-shaped mold, pouring the mixture into the mold, heating to 80 deg.C for solidification, and demolding to obtain the final product containing Fe3O4A star-shaped support of nanopowder, as shown in FIG. 1;
the Fe content was achieved by balloon inflation (as shown in FIG. 2) at a temperature 15 deg.C (i.e., 56 deg.C) above the glass transition temperature of the polyurethane3O4The star-shaped scaffold of nanopowder expands into a tubular shape and then cools to room temperature, it will remain as a tubular shape.
Will contain Fe3O4Sterilizing the tubular support of the nanometer micropowder, and vacuum drying and sealing for later use; the resulting product is shown in fig. 4.
Example 4
The present embodiment provides a method for using a rubber-like shape memory recyclable esophageal stent.
Using the super elasticity of silicon rubber to contain Fe3O4The nano-micro powder rubber-like shape memory recoverable esophageal stent is compressed in a catheter and delivered to a lesion site in the body (as shown in fig. 3), and the stent is expanded in a tubular form at the lesion site through elastic deformation recovery (as shown in fig. 5) after the catheter is removed. Due to the presence of Fe3O4The enhancement effect of the nanometer micro powder can ensure that the esophageal stent keeps better radial supporting force.
When the patient has reduced symptoms or the treatment is over, the Fe-containing composition needs to be taken out3O4When the nanometer micropowder is used as the stent, normal saline with the temperature of 41 ℃ can be introduced into the esophagus of a patient, under the condition of 41 ℃ (namely the shape memory recovery temperature of polyurethane),the tubular stent will return to its original star shape (as shown in fig. 6) by the shape memory effect of the polyurethane, facilitating removal due to the reduced volume.
The embodiments described above are described to facilitate an understanding and use of the invention by those skilled in the art. It will be readily apparent to those skilled in the art that various modifications to these embodiments may be made, and the generic principles described herein may be applied to other embodiments without the use of the inventive faculty. Therefore, the present invention is not limited to the above embodiments, and those skilled in the art should make improvements and modifications within the scope of the present invention based on the disclosure of the present invention.
Claims (10)
1. A rubber-like shape memory recoverable esophageal stent is characterized by being prepared from 70-85 parts by weight of super-elastic material, 13-20 parts by weight of shape memory polymer material and 2-8 parts by weight of biocompatible nano micro powder,
the rubber-like shape memory recyclable esophageal stent is hollow inside.
2. The rubber-like shape memory retrieval esophageal stent of claim 1, wherein the surface of the rubber-like shape memory retrieval esophageal stent is coated with a therapeutic drug that inhibits vascular endothelial cell proliferation.
3. The rubber-like shape memory recyclable esophageal stent of claim 1, wherein the super-elastic material is silicone rubber, the shape memory polymer material is polyurethane, and the biocompatible nanopowder is Fe3O4And (4) nano micropowder.
4. The rubber-like shape memory retrieval esophageal stent of claim 1, wherein the rubber-like shape memory retrieval esophageal stent is capable of self-contracting under an external stimulus, such that the volume of the stent is reduced.
5. A method for preparing the rubber-like shape memory recyclable esophageal stent of claim 1, comprising the steps of:
(1) heating the superelastic material and the shape memory polymer material to melt, resulting in a first mixture;
(2) adding the first mixture obtained in the step (1) into an organic solvent and biocompatible nano micro powder, and uniformly mixing to obtain a second mixture;
(3) placing the second mixture obtained in the step (2) in a star-shaped mold, and performing pressure forming after treatment to prepare a star-shaped support;
(4) and (4) expanding the star-shaped stent obtained in the step (3) into a tubular shape in a balloon expansion mode, and disinfecting to obtain the rubber-like shape memory recyclable esophageal stent.
6. The method for preparing the rubber-like shape memory recyclable esophageal stent as described in claim 5, wherein in the step (2), the mixture is uniformly mixed by ultrasonic oscillation of an ultrasonic oscillator, and the organic solvent is volatilized.
7. The method for preparing a rubber-like shape memory recyclable esophageal stent as described in claim 5, wherein in the step (3), the temperature of the compression molding is higher than the shape memory recovery temperature of the shape memory polymer material.
8. The method of claim 7, wherein the shape memory temperature of the shape memory polymer material is the glass transition temperature of the shape memory polymer material.
9. The method for preparing a rubber-like shape memory recyclable esophageal stent as described in claim 5, wherein in the step (4), the temperature during the swelling process is 15 ℃ higher than the shape memory recovery temperature of the shape memory polymer material.
10. The method for preparing a rubber-like shape memory recyclable esophageal stent according to claim 5, wherein in the step (4), the stent expanded into a tubular shape is cooled to room temperature to maintain the tubular shape before sterilization.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102764168A (en) * | 2011-05-03 | 2012-11-07 | 上海理工大学 | Elastic shape memory recyclable bracket and manufacturing method and using method thereof |
| CN104116578A (en) * | 2014-07-18 | 2014-10-29 | 西安交通大学 | Method for forming artificial vascular stent through 4D printing |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102764168A (en) * | 2011-05-03 | 2012-11-07 | 上海理工大学 | Elastic shape memory recyclable bracket and manufacturing method and using method thereof |
| CN104116578A (en) * | 2014-07-18 | 2014-10-29 | 西安交通大学 | Method for forming artificial vascular stent through 4D printing |
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