Developing degradable polymer stent and preparation method thereof

A technology for degrading polymers and developers, which is applied in the field of medical devices, can solve the problems of easy peeling of coatings, low grafting rate of iodine atoms, and disappearance, so as to improve surface hydrophilicity, reduce material surface energy, and improve binding force Effect

Active Publication Date: 2014-09-24
SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this method also has its disadvantages: the bonding strength with the main body of the stent is weak, and it is easy to fall off during the subsequent stent crimping and opening, resulting in poor developing effect; secondly, the dipping / spraying of the stent takes a long time to dry. Remove the solvent; moreover, the developer layer coated on the outer layer of the stent will disappear prematurely with the degradation of the material, which will cause inconvenience to the late follow-up of the stent
There is also a method of grafting iodine atoms to develop the stent, but the grafting rate of iodine atoms is very low, making the development efficiency very low
[0006] In view of the problems of poor biocompatibility and possible side effects of indwelling metal developers in the prior art; and the complex preparation of the developing coating, the coating is easy to fall off, cracks and other instability problems during the preparation and implantation process, further research is needed Discovery-stable, biocompatible X-ray-opaque stents

Method used

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  • Developing degradable polymer stent and preparation method thereof
  • Developing degradable polymer stent and preparation method thereof
  • Developing degradable polymer stent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Refer to attached figure 1 As shown, raw materials: PLLA degradable cardiovascular stent (BVS), developing coating (PLGA9%wt, iopromide1%wt, 90%wt alcohol)

[0041] Production process: First, use a plasma cleaning machine to treat the surface of the bracket with oxygen plasma (plasma treatment requirements: at 25°C, the power is 70KHz, the pressure in the working cabin is 0.01atm-0.3atm during cleaning, and the processing time Then put it into the plasma coating equipment, the temperature in the plasma coating cabin must be controlled at 20°C (process requirements: the power is 40KHz, nitrogen is used as the carrier gas, and the pressure in the working cabin is 0.01atm- 0.3atm, the processing time is 20min), and the developing coating (thickness is 0.5μm) is prepared.

[0042] After oxygen plasma treatment on the surface 4 of the stent substrate, the hydrophilic ability is greatly improved, and the affinity with the developing coating achieves a good effect.

Embodiment 2

[0044] Refer to attached figure 1 As shown, production raw materials: PLLA degradable cardiovascular stent (BVS), developing coating (collagen 9% wt, diatrizoate meglumine 1% wt, 75% wt alcohol)

[0045] Production process: First, use anodic pulse equipment to anodize the surface of the BVS stent (hydrochloric acid solution with an electrolyte mass fraction of 35%, time 10min, current 0.05A, frequency 1000Hz); then put it into the plasma coating equipment, The temperature in the plasma coating cabin must be controlled at 50°C (process requirements: the power is 40KHz, nitrogen is used as the carrier gas, the pressure in the working cabin is 0.01atm -0.3atm during cleaning, and the processing time is 20min), and the developing coating is prepared. (thickness is 2 μm).

[0046] After the surface 4 of the stent substrate is anodized, the hydrophilic ability is greatly improved, and the affinity with the developing coating is better. The prepared developing coating 3 has good af...

Embodiment 3

[0048] Refer to attached figure 2 As shown, production raw materials: PLLA degradable cardiovascular stent (BVS), developing coating (PLLA9%wt, iohexol 1%wt, 50%wt alcohol), protective coating (PDLA0.5%wt, dichloromethane 99.5%), drug coating (PLGA 1%, rapamycin 1%, dichloromethane 98%)

[0049] Production process: First, use a plasma cleaning machine to treat the surface of the bracket with oxygen plasma (plasma treatment requirements: at 45°C, the power is 30KHz, the pressure in the working cabin is 0.01atm -0.3atm during cleaning, and the processing time Then put it into the plasma coating equipment, the temperature inside the plasma coating chamber must be controlled at 30°C (process requirements: the power is 40KHz, argon is used as the carrier gas, and the pressure in the working chamber is 0.01atm during cleaning -0.3atm, treatment time is 20min), prepare developing coating (thickness is 0.5μm); after the developing coating is dry, use coating machine to apply protect...

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Abstract

The invention provides a developing degradable polymer stent and a preparation method thereof. A plasma vapor deposition method is adopted to deposit a degradable developing material on the surface of a bracket; the prepared developing coating is not transmitted under X ray, so that the stent can be clearly seen under X ray, and therefore, some interferences of a metal developing material on MRI (magnetic resonance imaging) and CT (computed tomography) images are avoided, and problems that side effects are easily produced as biocompatibility of the metal developing material is poor, and the metal developing material cannot be degraded and left in a blood vessel cavity after the stent is degraded are solved; according to the method, activation hydrophilic treatment is carried out on the surface of the polymer bracket, so as to improve affinity between the polymer base body and the developing coating and effectively solve the coating dropping problem; besides, a protective coating which is slow in degradation rate is coated on the surface of the developing coating, so that too quick degradation of the developing coating is prevented, and therefore, follow-up can be still carried out in the later stage of implanting.

Description

technical field [0001] The invention belongs to the technical field of medical devices, in particular to a fully degradable polymer bracket that can be developed and a preparation method thereof. Background technique [0002] Traditionally used stents for the treatment of vascular stenosis are all made of metal materials, which can be clearly seen under X-rays, but because the materials cannot be degraded and absorbed by the human body, they will permanently stay in the human body after implantation, like a metal "vest" "It also restricts the normal contraction and pulsation of blood vessels, and in severe cases, it will cause late thrombosis of the stent and cause the death of the patient. Furthermore, the existence of metal implants will affect the subsequent MRI or CT images of blood vessels and interfere with the doctor's judgment. [0003] In view of the existence of such problems, degradable stents that can be degraded and absorbed by the human body have emerged as th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/10A61L31/18A61L31/16A61F2/915
Inventor 程克奇常恩泽高康荣袁新袁玲
Owner SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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