Internal lumen inner bracket with bilateral medicine-releasing performance and preparation method thereof

Abstract

The invention discloses an internal lumen inner bracket with bilateral medicine-releasing performance and a preparation method thereof, relating to the technical field of medical equipment. The bracket consists of a naked metal bracket and an enveloped film, wherein the enveloped film comprises an outer layer medicine-releasing layer, an insulating layer and an inner layer medicine-releasing layer; the outer layer medicine-releasing layer is positioned at the outermost side of the bracket; and the bracket is inwards sequentially provided with the insulating layer and the inner layer medicine-releasing layer. The preparation method of the bracket adopts a solution dipping method or a molten press film packing method, wherein the dissolvent method comprises the following steps of dissolvingmedicine and high polymer material in the dissolvent, and sequentially dipping the naked metal bracket in a coating film in solution with different components; and the molten press film packing method comprises the following steps of mixing the high polymer material with the medicine under high temperature, hot pressing the mixture into a film, and packing the film on the naked metal bracket. After being implanted into human body, the bracket can enlarge a narrow pipeline, outward releases anti-tumor drug and inward releases antibiotic drug, realizes long-term local anti-tumor treatment, and avoids infection and salts sedimentation.

Description

technical field [0001] The invention relates to a stent in the technical field of medical devices and a preparation method thereof, in particular to an in vivo intraluminal stent with bilateral drug release performance and a preparation method thereof. Background technique [0002] Benign and malignant strictures or obstructions of the urethra, prostatic tract, and biliary tract are common and serious clinical conditions. In addition to surgical resection, radiotherapy, and chemotherapy, the mainstay of treatment is stenting. In this method, the tubular stent is implanted into the diseased official cavity in the body through surgery or endoscopy, and the narrow or closed lumen is stretched to the required opening diameter by using the mechanical support ability of the stent to ensure the normal physiological state of the human lumen. function, thereby effectively improving the quality of life of patients and prolonging their survival time. The urethra, prostatic tract and ...

AI Technical Summary

Problems solved by technology

These physiological characteristics often pose a huge threat to traditional stents, such as: bacteria tend to adhere to the inner wall of the stent to form a layer of biofilm, which will further adsorb various salts, thereby forming a layer of bacteria and The mineralized crust layer composed of salts, so that the inner diameter of the original stent will be greatly reduced and lose its function of opening the lumen; at the same time, excessively adhered bacteria often lead to local infection

[0003] Traditional metal stents and coated metal stents used in the urethra, prostatic tract and biliary tract still have at least the following deficiencies: (1) They do not have a real active therapeutic effect, and only play a palliative role in mechanical support and short-term maintenance of lumen opening , can do nothing to prevent the occurrence of restenosis caused by the continued growth of the tumor into the lumen; although the covered metal stent can prevent the in-growth of the tumor to a certain extent, it still cannot prevent the longitudinal excessive growth of the tumor and the resulting Stent compressive restenosis; (2) The traditional mesh bare stent cannot solve the problem of cavity wall perforation and fistula, which leads to the leakage of cavity fluid (such as bile, urine or prostatic fluid). To a certain extent, it can prevent the inward growth of the tumor through the mesh of the stent, but it still cannot prevent the longitudinal overgrowth of the tumor and compressive restenosis; (3) After the traditional palliative stent is implanted into the human body, it still needs to cooperate with systemic drug therapy, but the systemic drug The blood drug concentration in tumor tissue is low, and it is difficult to achieve an effective therapeutic concentration; if the therapeutic effect is to be achieved, long-term high-dose drug treatment is necessary, but most anticancer drugs have serious side effects. (4) The urethra, prostatic tract and biliary tract are lumen sites where a large number of bacteria parasitize, which can easily cause bacterial infection; at the same time, the salt concentration in urine, prostatic fluid and bile is very high After the stent is implanted, it is easy to induce the mineralization and deposition of these salts on the surface of the stent to form a shell. Therefore, clinically, after the stent is implanted, bacterial adhesion frequently occurs on the inner wall, thereby further absorbing and depositing inorganic salts, and finally on the inner wall of the stent. A biomineralized shell composed of inorganic salts and bacteria is formed, resulting in bacterial infection of the human cavity and blockage of the stent; (5) Bacterial infection and the biological shell composed of bacteria and inorganic salts force the stent to be replaced frequently to ensure the smooth flow of the lumen. This greatly increases the cost of treatment and prevents the long-term application of traditional stents in the urethra, prostatic tract and biliary tract

Its shortcoming is that the stent is a metal-covered stent, which has no function of releasing drugs, and cannot play an active role in treating pipeline diseases or anti-restenosis

The disadvantage of this stent is that it is only suitable for the vascular field and is not suitable for the urethra, prostatic tract and biliary tract

In addition, the multi-layer drug-loaded layers used in the stent only contain one drug, which cannot better prevent and treat luminal diseases that require a combination of multiple drugs.

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