Rubber-like shape memory recyclable esophageal stent and preparation method thereof

Abstract

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. The esophageal stent is prepared from 70-85 parts by weight of a superelastic material, 13-20 parts by weight of a shape memory polymer material and 2-8 parts by weight of biocompatible nano micro powder. When being in use, the rubber-like shape memory recyclable esophageal stent is pressed and held in a catheter and is conveyed to a diseased region in a body; and after the catheter is removed, the pressed and held rubber-like shape memory recoverable esophageal stent recovers by means of hyperelasticity. The rubber-like shape memory recyclable esophageal stent is heated to the shape memory recovery temperature of the shape memory polymer material to recover to the initial structure during recycling, so that the esophageal stent is convenient to take out. The manufacturing material of the stent obtained by the invention has biocompatibility and small stimulation to tissues; automatic contraction of the stent can be realized through proper external stimulation; and by coating the surface of the stent with a therapeutic drug, the therapeutic effect can be further enhanced.

Description

technical field

[0001] The invention relates to the technical field of medical devices, in particular to a recyclable esophageal stent with rubber-like shape memory and a preparation method thereof. Background technique

[0002] Implantable stents are widely used in the treatment of airway organic stenosis, esophageal cancer, bladder / prostate cancer and other diseases. In many clinical cases, the implantation of stents is temporary. With the treatment of the primary lesion and the degree of blockage in the stenosis is alleviated, the stent needs to be recovered.

[0003] Existing implantable stents in the body are mainly made of stainless steel, NiTi alloy and other materials. These stents basically utilize the superelasticity of the stent material or stent structure, and the stent itself can self-expand, but cannot self-contract. The process of stent implantation is basically to compress it in a catheter and deliver it to the lesion in the body. After the catheter is remov...

Examples

preparation example Construction

[0049] The second object of the present invention is to provide a method for preparing the above-mentioned recyclable esophageal stent with rubber-like shape memory, comprising the following steps:

[0050] (1) heating the superelastic material and the shape memory polymer material to melt to obtain the first mixture;

[0051] (2) adding the first mixture obtained in step (1) to an organic solvent and biocompatible nanopowder, and mixing uniformly to obtain a second mixture;

[0052] (3) placing the second mixture obtained in step (2) in a star-shaped mold, and pressurizing it after processing to prepare a star-shaped stent;

[0053] (4) expanding the star-shaped stent obtained in step (3) into a tubular shape by means of balloon inflation, and obtaining a rubber-like shape memory retrievable esophageal stent after sterilization.

[0054] In one embodiment of the present invention, in step (2), the mixture is homogeneously oscillated by an ultrasonic oscillator, and the organ...

Embodiment 1

[0068] This embodiment provides a recyclable esophageal stent with rubber-like shape memory.

[0069] Take 75 parts by weight of silicone rubber and 20 parts by weight of polyurethane (the glass transition temperature of polyurethane, that is, the recovery temperature of shape memory is 41° C.), and heat to melt.

[0070] Pour the melted mixture into a beaker filled with ethanol, and add 5 parts by weight of magnetic Fe 3 o 4 nano powder.

[0071] After the beaker was placed in an ultrasonic oscillator for 2 hours of ultrasonic vibration, the ethanol was volatilized by heating.

[0072] Make a star-shaped mold, pour the above mixture into the mold, heat it to 80°C to make it solidify and shape, and make the Fe-containing 3 o 4 Star-shaped scaffolds for nanopowders, such as figure 1 shown;

[0073] At a temperature higher than the glass transition temperature of polyurethane by 15°C (ie 56°C), through balloon inflation (such as figure 2 Shown) to contain Fe 3 o 4 The ...

Embodiment 2

[0076] This embodiment provides a recyclable esophageal stent with rubber-like shape memory.

[0077] Take 70 parts by weight of silicone rubber and 13 parts by weight of polyurethane (the glass transition temperature of polyurethane, that is, the recovery temperature of shape memory is 41° C.), and heat to melt.

[0078] Pour the melted mixture into a beaker filled with ethanol, and add 2 wt. parts of magnetic Fe to it 3 o 4 nano powder.

[0079] After the beaker was placed in an ultrasonic oscillator for 2 hours of ultrasonic vibration, the ethanol was volatilized by heating.

[0080] Make a star-shaped mold, pour the above mixture into the mold, heat it to 80°C to make it solidify and shape, and make the Fe-containing 3 o 4 Star-shaped scaffolds for nanopowders, such as figure 1 shown;

[0081] At a temperature higher than the glass transition temperature of polyurethane by 15°C (ie 56°C), through balloon inflation (such as figure 2 Shown) to contain Fe 3 o 4 The ...

technical field

[0001] The invention relates to the technical field of medical devices, in particular to a recyclable esophageal stent with rubber-like shape memory and a preparation method thereof. Background technique

[0002] Implantable stents are widely used in the treatment of airway organic stenosis, esophageal cancer, bladder / prostate cancer and other diseases. In many clinical cases, the implantation of stents is temporary. With the treatment of the primary lesion and the degree of blockage in the stenosis is alleviated, the stent needs to be recovered.

[0003] Existing implantable stents in the body are mainly made of stainless steel, NiTi alloy and other materials. These stents basically utilize the superelasticity of the stent material or stent structure, and the stent itself can self-expand, but cannot self-contract. The process of stent implantation is basically to compress it in a catheter and deliver it to the lesion in the body. After the catheter is remov...

Examples

preparation example Construction

[0049] The second object of the present invention is to provide a method for preparing the above-mentioned recyclable esophageal stent with rubber-like shape memory, comprising the following steps:

[0050] (1) heating the superelastic material and the shape memory polymer material to melt to obtain the first mixture;

[0051] (2) adding the first mixture obtained in step (1) to an organic solvent and biocompatible nanopowder, and mixing uniformly to obtain a second mixture;

[0052] (3) placing the second mixture obtained in step (2) in a star-shaped mold, and pressurizing it after processing to prepare a star-shaped stent;

[0053] (4) expanding the star-shaped stent obtained in step (3) into a tubular shape by means of balloon inflation, and obtaining a rubber-like shape memory retrievable esophageal stent after sterilization.

[0054] In one embodiment of the present invention, in step (2), the mixture is homogeneously oscillated by an ultrasonic oscillator, and the organ...

Embodiment 1

[0068] This embodiment provides a recyclable esophageal stent with rubber-like shape memory.

[0069] Take 75 parts by weight of silicone rubber and 20 parts by weight of polyurethane (the glass transition temperature of polyurethane, that is, the recovery temperature of shape memory is 41° C.), and heat to melt.

[0070] Pour the melted mixture into a beaker filled with ethanol, and add 5 parts by weight of magnetic Fe 3 o 4 nano powder.

[0071] After the beaker was placed in an ultrasonic oscillator for 2 hours of ultrasonic vibration, the ethanol was volatilized by heating.

[0072] Make a star-shaped mold, pour the above mixture into the mold, heat it to 80°C to make it solidify and shape, and make the Fe-containing 3 o 4 Star-shaped scaffolds for nanopowders, such as figure 1 shown;

[0073] At a temperature higher than the glass transition temperature of polyurethane by 15°C (ie 56°C), through balloon inflation (such as figure 2 Shown) to contain Fe 3 o 4 The ...

Embodiment 2

[0076] This embodiment provides a recyclable esophageal stent with rubber-like shape memory.

[0077] Take 70 parts by weight of silicone rubber and 13 parts by weight of polyurethane (the glass transition temperature of polyurethane, that is, the recovery temperature of shape memory is 41° C.), and heat to melt.

[0078] Pour the melted mixture into a beaker filled with ethanol, and add 2 wt. parts of magnetic Fe to it 3 o 4 nano powder.

[0079] After the beaker was placed in an ultrasonic oscillator for 2 hours of ultrasonic vibration, the ethanol was volatilized by heating.

[0080] Make a star-shaped mold, pour the above mixture into the mold, heat it to 80°C to make it solidify and shape, and make the Fe-containing 3 o 4 Star-shaped scaffolds for nanopowders, such as figure 1 shown;

[0081] At a temperature higher than the glass transition temperature of polyurethane by 15°C (ie 56°C), through balloon inflation (such as figure 2 Shown) to contain Fe 3 o 4 The ...

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