Cobalt-chromium alloy artery stent with full-biodegradation medicine coating, stent system and preparation method thereof

A technology of drug coating and cobalt-chromium alloy, which is applied in stents, coatings, medical science, etc., can solve the problem of weak combination of coatings and stent metal platforms, affecting the effectiveness and safety of drug stents, and retention of stents and delivery systems To improve the radial support force and X-ray imaging performance, reduce the probability of surface coating peeling, and improve clinical indicators

Active Publication Date: 2010-06-23
万瑞飞鸿(北京)医疗器材有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In interventional therapy operations, when the stent is pressed until the diameter meets the requirements of the blood vessel, it is delivered to the thrombus lesion through a delivery system such as a balloon through a long blood vessel in the body. Due to technical problems, the stent and the delivery system are generally compressed. Grips are combined into a system for sales and use to facilitate clinical use. However, due to the fact that the coatings on the surface of traditional drug stents are mostly formed by unipolar coating technology, the adhesion is poor, which makes the combination between the coating and the metal platform of the stent weak and difficult. It is easy to cause coating damage during the crimping process, and it is easy to damage the coating when passing through narrow lesions, tortuous lesions or calcified lesions, resulting in uneven distribution of drugs, which directly affects the effectiveness and safety of drug stents; in addition, due to In the stent system, after the stent is sleeved on the balloon body of the delivery system, the tangential crimping technique is often used. In the tangential crimping scheme, the coating is inevitably damaged due to tangential friction on the surface, and due to the tangential pressure The limitation of gripping technology makes the indwelling force between the stent and the delivery system small, so that the stent is likely to be unloaded during the movement of the balloon with the balloon in the unexpanded state, and it is easy to cause the failure of the operation

Method used

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  • Cobalt-chromium alloy artery stent with full-biodegradation medicine coating, stent system and preparation method thereof
  • Cobalt-chromium alloy artery stent with full-biodegradation medicine coating, stent system and preparation method thereof
  • Cobalt-chromium alloy artery stent with full-biodegradation medicine coating, stent system and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Such as figure 1 As shown, a cobalt-chromium alloy arterial stent with a fully biodegradable drug coating, which includes a thin-walled hollow collar stent and a fully biodegradable drug coating coated on the stent, which is engraved and cut from a cobalt-chromium alloy L605 tube, The bracket includes a support rod 1 with six sine wave units in the circumferential direction and a connecting rod 2 connecting two adjacent support rods in the axial direction. Composition, the rib width of the circular arc connecting section 6 is less than or equal to the rib width of the straight rod 5; the crests 3 and troughs 4 of the sine wave units of the adjacent support rods 1 are respectively opposite, and the connecting rods 2 are arranged at intervals On the opposite two troughs 4 of two adjacent sine wave structures, and each trough 4 is provided with at most one connecting rod 2, the connecting rod 2 is composed of an "S"-shaped connecting section 7 and a straight rod connecting...

Embodiment 2

[0054] The difference between this embodiment and embodiment 1 is:

[0055] The rib width range of the arc connection section of the support rod is 0.0762mm, the rib width range of the straight rod is 0.0889mm, and the rib width range of the connecting rod is 0.07112mm.

[0056] The preparation method of the cobalt chromium alloy arterial stent with full biodegradable drug coating comprises the following steps:

[0057] (1) The cobalt-chromium alloy L605 pipe is electrochemically polished after laser engraving and cutting to prepare a thin-walled hollow collar bracket;

[0058] (2) carry out pretreatment to described support:

[0059] Carry out surface cleaning treatment: clean the surface of the bracket with purified water to remove fine particles and dust in the bracket processing process;

[0060] (3) Carry out secondary filtration and purification to radon, then input in the surface passivation treatment device, adjust the injection pressure to be 0.15 bar, the gas flow ...

Embodiment 3

[0065] The difference between this embodiment and embodiment 1 is:

[0066] The rib width range of the arc connection section of the support rod is 0.0762mm, the rib width range of the straight rod is 0.0762mm, and the rib width range of the connecting rod is 0.07mm.

[0067] The preparation method of the cobalt chromium alloy arterial stent with full biodegradable drug coating comprises the following steps:

[0068] (1) The cobalt-chromium alloy L605 pipe is electrochemically polished after laser engraving and cutting to prepare a thin-walled hollow collar bracket;

[0069] (2) carry out pretreatment to described support:

[0070] Carry out surface cleaning treatment: clean the surface of the bracket with purified water to remove fine particles and dust in the bracket processing process;

[0071] (3) Carry out secondary filtration and purification to nitrogen, then input in the surface passivation treatment device, adjust injection pressure to be 0.14 bar, gas flow rate is ...

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Abstract

The invention provides a cobalt-chromium alloy artery stent with full-biodegradation medicine coating; the full-biodegradation coating of the stent has good stent flexibility, pathological change permeability and radial bearing force; the invention further provides a preparation method of the stent; multi-level coating applying technology, metallic support surface inert gas processing process and the like are adopted, the firmness of the stent surface coating, the toughness and tensile strength thereof are greatly improved, thereby being beneficial to keeping the integrity of the coating; in addition, the invention provides a cobalt-chromium alloy artery stent with full-biodegradation medicine coating, which is prepared by radial grading squeezing process, the damage of the coating can be avoided to the greatest extent, the retention force between the stent and a conveying system is greatly improved, the possibility that the stent is migrated in the conveying process is avoided, the clinical using risk is reduced, and the problems of coronary artery stenosis and restenosis are effectively solved.

Description

technical field [0001] The invention relates to a cobalt-chromium alloy arterial stent with a fully biodegradable drug coating, a stent system and a preparation method thereof. Background technique [0002] Since the first bare metal stent Palmaz-Schatz in the United States was implanted into the human body in 1985, the restenosis rate of coronary vessels caused by simple balloon expansion is very high. Stent interventional therapy can successfully solve this problem and become the main method of clinical treatment. After that, the technology of interventional therapy experienced the era of development from bare metal stents to drug-eluting stents. Drug-eluting stents have been on the market for five years now. At home and abroad, the rapamycin drug-eluting stent with medical 316 stainless steel as the stent platform has become one of the main therapeutic products for coronary heart disease. At present, stainless steel rapamycin drug-eluting stents are widely used in PCI i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/10A61L31/02A61L31/16A61L31/14A61F2/90A61F2/84A61F2/915A61F2/958
Inventor 田飞王昊飞王海军
Owner 万瑞飞鸿(北京)医疗器材有限公司
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