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Nano micropore structure capable of storing and releasing various kinds of medicament for medicament eluting instrument and preparation method

A microporous structure and nanoscale technology, applied in the field of medical implant devices and their preparation, can solve the problems of single drug therapeutic agent, adverse reactions of polymer dosage, incomplete stent endothelialization, etc.

Active Publication Date: 2009-07-08
BEIJING TARGET TECH
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  • Summary
  • Abstract
  • Description
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  • Application Information

AI Technical Summary

Problems solved by technology

Completed clinical trials have shown that this kind of stent carrying a single drug can effectively inhibit the occurrence of restenosis in the short term, but it is not perfect: some studies have shown that this kind of stent cannot complete the endothelialization process in a short period of time, This means that there is a higher chance of long-term thrombosis compared with bare stents. Recent studies have even shown that 2 years after implantation of single-drug polymer stents, the stent endothelialization is still incomplete
[0007] In addition, some studies have shown that polymer-carried single-drug stents have late restenosis catch-up after long-term implantation.
The analysis of related studies found that polymers may be the main reason for endothelial delay and late restenosis catch-up, but it also has a great relationship with the singleness of drugs. Stenotic drugs can inhibit the growth of endothelium while inhibiting the neointimal, and it is difficult for a single drug to resist restenosis caused by multiple complex factors
[0008] Recently, there are patents (US 2008 / 0241215 A1, US 2008 / 0172124 A1, etc.) in order to solve the problem of the singleness of the drug therapeutic agent in the drug stent, on the basis of the first-generation drug stent, antioxidant drugs are added to further resist restenosis. and some adverse reactions, but these types of patents use polymers to control the release of two drugs, and the two drugs can be mixed in the same polymer or in different polymers. Under the combined action of drugs, the effect of inhibiting restenosis will be more significant, but the increased amount of polymer will also bring more serious adverse reactions
[0009] Therefore, on the one hand, the existing polymer-carrying single drug-coated stents can only inhibit or even delay the occurrence of restenosis because they carry mostly anti-cell proliferation single drugs, and cannot simultaneously reduce the effects such as endothelialization. On the other hand, although the existence of the polymer can better control the release of the drug, the adverse consequences caused by the continuous inflammatory response it causes are indeed more fatal

Method used

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  • Nano micropore structure capable of storing and releasing various kinds of medicament for medicament eluting instrument and preparation method
  • Nano micropore structure capable of storing and releasing various kinds of medicament for medicament eluting instrument and preparation method
  • Nano micropore structure capable of storing and releasing various kinds of medicament for medicament eluting instrument and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0113] See process flow figure 1 , using the H-S stainless steel stent as the body to prepare a nanoscale hole dual drug release structure, including:

[0114] ①Preparation of holes on the surface of the instrument body: see patent 200610168125.0 for the specific method, and prepare holes with a size between 100nm and 1000nm;

[0115] refer to Figure 4 As shown, the nano-scale hole dual drug release structure mainly includes the device body 10, successively coating active drugs 20 and 30, and holes 40; the holes 40 are a large number of nano-scale holes, and the nano-scale holes 40 can be chemically Or physical methods, such as corrosion, anodic oxidation, micro-arc oxidation, micro-arc nitriding, etc., or these methods are directly prepared in the raw material of the device body 10 (see patent 200610168125.0 for specific methods), without any intermediate between the device body 10 In the interlayer, the nanoscale hole 40 can be a drug-loading groove or a hole structure (s...

Embodiment 2

[0120] See process flow figure 2 , using the AZ31B magnesium alloy stent as the body to prepare nano-scale porous multi-drug release structures, including:

[0121] ①Preparation of holes on the surface of the instrument body: For specific methods, refer to patent 200610168125.0 to prepare holes with a size between 10nm and 500nm;

[0122] refer to Figure 5 As shown, the nano-scale hole multi-drug release structure mainly includes the device body 10, active drugs 20 and 30, and holes 40; the holes 40 are a large number of nano-scale holes, and the nano-scale holes 40 can be obtained by chemical or physical methods. , such as corrosion, anodic oxidation, micro-arc oxidation, micro-arc nitriding and other methods or the combination of these methods are directly prepared and formed in the raw material of the device body 10 (see patent 200610168125.0 for specific methods), without any intermediate layer between the device body 10, The nanoscale hole 40 can be a drug-loading gro...

Embodiment 3

[0132] See process flow figure 2 , using the AZ31B magnesium alloy stent as the main body, according to the preparation process of Example 2 to prepare a nanoscale hole dual drug release structure, including:

[0133] Prepare the mixture of paclitaxel and probucol:

[0134] Dissolve 10 mg of paclitaxel and 5 mg of probucol in 100 ml of acetone respectively, shake well and place in the refrigerator for later use after the drugs are fully dissolved.

[0135] ③Apply two kinds of drugs on the surface of the device first, but after drying, apply a layer of paclitaxel:

[0136] Apply to the surface of the instrument by dipping method.

[0137] ④Apply a layer of polysaccharide controlled release layer:

[0138] After the mixed drug coating is dry, apply a layer of polysaccharide (1mg polysaccharide dissolved in 10ml physiological saline to form a solution) on the surface of the device by spraying, which can play a role in controlling the release of the mixed drug. Loss of drug d...

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Abstract

The invention relates to a nanometer medicinal elution apparatus in microcellular structure for storing and releasing multiple medicines and a preparation method thereof. The multiple medicines in the invention are selected from medicine therapeutic agents, carrier therapeutic genes and bioactive substances, wherein one or two of the medicine therapeutic agents is / are taxol and / or probucol. The preparation method of the medicinal elution apparatus in the invention mainly comprises the followings: 1) nanometer holes are prepared on the surface of the apparatus body; 2) multiple medicines are coated in the nanometer holes and on the surface of the apparatus body. The apparatus body in the invention does not contain polymers, thereby reducing the risk of long-term thrombus possibly caused by polymers; the nanometer holes on the surface of the apparatus body do not have any influence for mechanical property of the body, thereby being capable of efficiently controlling the releasing rate of medicines and obviously reducing the restenosis rate after surgical operations. The invention can be applied to various medicinal elution implanting apparatuses, particularly having good effects for curing vascular lesion and preventing blood vessel restenosis in vascular stents.

Description

technical field [0001] The invention relates to a medical implant device and a preparation method thereof, in particular to a drug eluting device with a nanoscale microporous structure capable of storing and releasing various drugs and a preparation method thereof. Background technique [0002] Drug-eluting devices are a category of implanted medical devices, including vascular stents, catheters, guide wires, cardiac pacemakers, heart valves, surgical implant materials, hard tissue implants, and other medical implants that need to release drugs instrument. Taking vascular stents as an example, the vascular stents used in the early stage were bare stents, including stainless steel, titanium alloy, cobalt alloy and nickel-titanium memory alloy stents, etc., but the restenosis rate was relatively high, above 30%. The first generation of drug-coated stents (polymer drug-loaded stents) has greatly reduced the incidence of restenosis, and its coating drugs include heparin, cortic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M31/00A61F2/91
CPCA61L2400/12A61L2300/416A61L2300/422A61F2/91A61L2300/60A61F2250/0068A61L2300/45A61L2300/42A61L31/16
Inventor 张昱昕王玲张正才范霈蒲忠杰
Owner BEIJING TARGET TECH
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