CN213030946U - Degradable drug stent delivery system - Google Patents
Degradable drug stent delivery system Download PDFInfo
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- CN213030946U CN213030946U CN202020211746.8U CN202020211746U CN213030946U CN 213030946 U CN213030946 U CN 213030946U CN 202020211746 U CN202020211746 U CN 202020211746U CN 213030946 U CN213030946 U CN 213030946U
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Abstract
The utility model discloses a degradable drug stent delivery system belonging to the technical field of three types of implantable medical devices. Specifically, a drug coating (2) is attached to the surface of a degradable stent (1), and the degradable stent (1) attached with the drug coating (2) is pressed and held on a balloon (7) of a balloon conveying system (3); the balloon conveying system (3) comprises a handle (4), a support rod (5), a near-end tube (6), a balloon (7) and a tip (8), wherein the near-end tube (6) is an annular catheter; the near-end tube (6) is provided with more than 1 self-filling holes (9) with the aperture of 0.005 mm-1 mm, and more than 1 developing ring (10) capable of developing under x-ray is arranged around the self-filling holes (9) or on the saccule (7). The utility model provides a degradable drug stent delivery system can guarantee that there is the blood flow that lasts in the blood vessel to exist, and then is showing and improving degradable stent expansion time.
Description
Technical Field
The utility model belongs to the technical field of three types of implantation nature medical instrument, in particular to degradable medicine support conveying system.
Background
The human fight against coronary heart disease has been continuous for many years, and the coronary heart disease has been well treated and controlled through the balloon era, the metal bare stent era and the drug metal stent stage. However, in the current medical metal stent stage, chest pain of patients caused by transient ischemia of blood vessels during operation and permanent administration of antiplatelet drugs due to vascular stimulation caused by permanent implantation of non-degradable materials still cannot be reduced.
Degradable stents, also called bioabsorbable stents, are known as the latest revolution in the field of percutaneous coronary intervention. Unlike permanently implanted and existing drug-metal non-degradable stents, degradable stents can be completely degraded after 1 to 3 years after being implanted into the human body, and no material remains in the site of the lesion. Such a therapeutic effect greatly reduces thrombosis associated with late stent-related adverse events associated with metallic stents, and because the stent material is degradable, the patient's drug delivery cycle can be reduced rather than lifelong.
With the intensive research on degradable stents, it has been gradually found that many medical polymers can be used for preparing degradable stents, and many medical polymers have been successfully applied to orthopedics or dentistry. The medical high molecular polymers for preparing the degradable stent are prepared into different stent forms, including an open-loop structure and a closed-loop structure, and various mechanical analyses are carried out on the stent forms. However, no matter what form the degradable material is made, due to the properties of the material, the mechanical properties of the degradable stent are inferior to those of the metal stent, and the elastic modulus and the yield strength of the degradable stent are lower than those of the metal stent, so that the degradable stent inevitably rebounds in a large area in the blood vessel. However, the long-term vascular foreign-body-free performance of the degradable stent is certainly excellent due to the complete degradation performance of the degradable stent. Therefore, in the near future, as long as the problem of the retraction rate after expansion is reduced, the degradable stent can completely replace a metal stent, and becomes a preferred method for treating coronary heart disease.
The method is characterized in that the degradable stent is firstly coated with a drug coating on the surface in a brushing, dip-coating or spraying manner, and then is pressed and held on a balloon conveying system. At the moment, due to the lower elastic modulus of the material, the inflated state of the degradable stent must be kept for a period of time, the degradable stent can obtain enough time to be shaped in the blood vessel by utilizing the stable pressure when the balloon is propped, then the balloon is gradually released and is drawn out of the body, and the whole process of the installation of the degradable stent is completed.
In the whole installation process, the degradable stent has enough time to be shaped in the blood vessel, and is particularly important, if the shaping time is short, the blood vessel inevitably brings circumferential pressing force to the degradable stent, and therefore, the degradable stent has higher retraction rate. In addition, because the lesion part has thrombus, the blood vessel is irregular, so that the blood flow can be completely blocked before the stent is not completely opened, thereby causing blood vessel far-end ischemia and chest pain in the operation of a patient.
Therefore, it is very important to maintain a sufficient time to expand the stent during the installation of the degradable stent, and at present, there is no good way to increase the expansion time of the degradable stent.
SUMMERY OF THE UTILITY MODEL
The utility model aims to provide a degradable drug stent delivery system aiming at the defects of the prior art, which comprises a degradable stent 1, a drug coating 2 and a balloon delivery system 3; the drug coating 2 is attached to the surface of the degradable stent 1, and the degradable stent 1 attached with the drug coating 2 is pressed and held on a balloon 7 of the balloon conveying system 3;
the degradable bracket 1 is of a hollow structure. The wall thickness of the degradable stent 1 is 0.05 mm-0.2 mm, the material is degradable material, such as non-metallic degradable material, preferably block copolymer of more than one or more corresponding monomers of levorotatory polylactic acid (PLLA), dextrorotatory polylactic acid (PDLA), racemic polylactic acid (PDLLA), Polyglycolide (PGA), polyethylene glycol (PEG) and polyglutamic acid (PLG), and the molecular weight is 30 ten thousand-100 ten thousand.
The utility model discloses degradable support 1 becomes tubular product through extrusion process by the degradable aggregate, and the mode that degradable tubular product corrodes and (or) 3d prints through laser sculpture and (or) corrosive agent obtains.
The drug coating 2 is a drug coating for treating hyperplasia or thrombus on the inner wall of the blood vessel. The drug coating 2 can control the release of the drug and comprises a polymer and an effective drug; wherein the ratio of the polymer to the effective drug is 1: 0.05-1: 10. The effective medicament in the medicament coating 2 comprises one or more of paclitaxel, paclitaxel derivatives, rapamycin and rapamycin derivatives; the release of effective medicine is controlled by using block copolymer of more than one or more corresponding monomers of levorotatory polylactic acid, dextrorotatory polylactic acid, racemic polylactic acid, polyglycolide, polyethylene glycol and polyglutamic acid, and the molecular weight of the polymer is 3-15 ten thousand.
The utility model discloses polymer molecular weight and polymer can control the release time of effective medicine with the proportion of medicine in the medicine coating 2, make the medicine release time of medicine coating 2 is 14 ~ 45 days. The effective drug and the polymer for controlling the drug release are mixed by adopting a solvent dissolving mode, wherein the solvent comprises tetrahydrofuran, chlorobenzene, dimethylbenzene, methylbenzene, acetonitrile, methanol, ethanol, chloroform, ethyl acetate, cyclohexane, butanone, acetone, petroleum ether and the like. And after the mixing is finished, the mixture is endowed on the surface of the degradable stent in a spraying, dip-coating or brush coating mode, and the degradable stent 1 with the drug coating 2 is obtained.
The balloon conveying system 3 comprises a handle 4, a support rod 5, a proximal tube 6, a balloon 7 and a tip 8, wherein the proximal tube 6 is an annular catheter; the near-end tube 6 is provided with more than 1 self-filling hole 9 with the aperture of 0.005 mm-1 mm, and the self-filling hole 9 is arranged at the welding position of the near-end inner tube and the near-end outer tube on the near-end tube 6. More than 1 developing rings 10 which can develop under x-ray are arranged around the self-perfusion hole 9 or on the saccule 7; wherein a visualization ring 10 around the self-priming hole 9 is provided on the proximal inner tube of the proximal tube 6. Wherein the development ring 10 is a metallic and/or non-metallic ring that is developed under x-rays.
Further, the developing ring 10 around the self-priming hole 9 is not more than 5cm away from the self-priming hole 9.
The utility model discloses degradable support 1 with medicine coating 2 is given at sacculus 7 coverage area of sacculus conveying system 3 through the mode of automatic pressure grip or manual pressure grip, and the time of pressure grip is 1min ~ 30 min.
The utility model discloses well sacculus conveying system 3 is degradable support 1's carrier, can be so that at the degradable support expansion in-process from irritating hole 9, blood from vascular near-end flow to distal end, guarantees slowly expand at degradable support and when pathological change position keeps pressure, has the blood flow existence that lasts in the blood vessel. The visualization ring 10 is able to mark not only the position of the balloon 7 but also the position of the self-irrigation hole 9.
The utility model provides a degradable drug stent delivery system implants human back with degradable support 1, and the mode through the degradation becomes middle and small molecule from high molecular polymer usually, and it is external to advance human metabolism discharge again, and the degradation cycle is generally 1 year to 3 years.
The utility model provides a degradable support expansion time of degradable drug stent delivery system has improved more than 1 times.
The utility model has the advantages that:
(1) the utility model provides a degradable drug stent delivery system, when the degradable stent expands in patient target pathological changes blood vessel, the doctor can withdraw operation accessory-seal wire according to the development loopback who marks from the hole of irritating, blood can get into and flow out from the distal end from the hole of irritating, thereby make the distal end blood vessel have the existence of blood flow, can guarantee when the degradable stent slowly expands and keeps pressure at the pathological changes position, there is continuous blood flow in the blood vessel, and then improve degradable stent expansion time, increase the pressurize time of degradable stent at patient target pathological changes position, give the abundant opening and deformation and the fixing in the blood vessel of degradable stent, thereby reduce the chest pain that the patient produced because of the distal end ischemia in the art, make patient can support longer degradable stent expansion time, increase the type-forming time of degradable stent, improve the operation security, the success rate of the operation is increased.
(2) The utility model provides a degradable drug stent delivery system not only provides the nonmetal degradable support that can degrade completely to and can treat the vascular thrombus of target pathological change through accurate medicine release, still solved because the not enough problem of holding power under comparing with metal support, degradable support expansion time is longer, and long-term vasoconstriction is littleer, and vascular late lumen loss rate is lower.
Drawings
FIG. 1 is a degradable drug stent delivery system provided by the present invention;
FIG. 2 is a partially enlarged view of the degradable drug stent delivery system provided by the present invention;
description of reference numerals: 1-degradable scaffold; 2-drug coating; 3-a balloon delivery system; 4-a handle; 5-support rod, 6-proximal tube, 7-sacculus; 8-tip; 9-self-priming holes; 10-developing ring.
Detailed Description
The utility model provides a degradable drug stent delivery system, which is further explained by combining the embodiment and the attached drawings.
The degradable drug stent delivery system shown in fig. 1 is composed of a degradable stent 1, a drug coating 2 and a balloon delivery system 3. The balloon delivery system 3 includes a handle 4, a support rod 5, a proximal tube 6, a balloon 7, and a tip 8.
As shown in FIG. 2, the drug coating 2 is attached to the surface of the degradable stent 1, and the degradable stent 1 attached with the drug coating 2 is crimped on the balloon 7 of the balloon delivery system 3. The balloon conveying system 3 is provided with more than 1 self-perfusion hole 9 with the aperture of 0.005 mm-1 mm on the near-end tube 6, and more than 1 developing ring 10 which can develop under x-ray is arranged around the self-perfusion hole 9 or on the balloon 7.
The degradable drug stent delivery system is implanted into the heart of an animal through conventional percutaneous transluminal coronary angioplasty, the balloon 7 is expanded at a target lesion part, the guide wire is withdrawn after the degradable stent 1 is propped up, blood flows from the near end to the far end of the blood vessel through the self-perfusion hole 9, and continuous blood flow in the blood vessel of the target lesion part is ensured while the degradable stent is slowly expanded and the pressure of the lesion part is kept.
Example 1
(1) Preparing left-handed polylactic acid (PLLA) granules with the molecular weight of 60 ten thousand into a pipe with the wall thickness of 0.15mm in a melt extrusion mode;
(2) the tube is made into a hollow bracket shape by a laser engraving mode.
(3) And blowing off surface impurities of the degradable support 1 which is made into the hollow shape by using an ion fan, and eliminating static electricity on the surface of the degradable support.
(4) Dissolving racemic polylactic acid (PDLLA) with the molecular weight of 15 ten thousand and paclitaxel in acetone according to the ratio of 2:1, taking the degradable stent 1, spraying a mixture of the paclitaxel and the racemic polylactic acid on the surface of the degradable stent 1 in a spraying mode, and obtaining a layer of compact drug coating 2 on the surface of the degradable stent 1 after chloroform is completely volatilized.
(5) The proximal end inner tube and the proximal end outer tube of the balloon delivery system 3 are welded together by heat, then 4 perfusion holes 9 with the aperture of 0.05mm are drilled on the proximal end tube 6 by a drilling mode, and a developing ring 10 which can develop under x-ray is assembled on the proximal end inner tube at the side, close to the handle, of the perfusion hole 9.
(6) The degradable stent 1 loaded with the drug coating 2 is pressed and held on the balloon 7 of the balloon delivery system 3 by an automatic press-and-grip machine.
Example 2
(1) Pellets of L-polylactic acid (PLLA) having a molecular weight of 60 ten thousand were melt-extruded to form a pipe having a wall thickness of 0.18 mm.
(2) The tube is made into a hollow bracket shape by a laser engraving mode.
(3) And blowing off surface impurities of the degradable support 1 which is made into the hollow shape by using an ion fan, and eliminating static electricity on the surface of the degradable support.
(4) Dissolving racemic polylactic acid (PDLLA) with the molecular weight of 15 ten thousand and paclitaxel in acetone according to the ratio of 2:1, taking the degradable stent 1, spraying a mixture of the paclitaxel and the racemic polylactic acid on the surface of the degradable stent 1 in a spraying mode, and obtaining a layer of compact drug coating 2 on the surface of the degradable stent 1 after chloroform is completely volatilized.
(5) The proximal end inner tube and the proximal end outer tube of the balloon delivery system 3 are welded together by heat, then 4 perfusion holes 9 with the aperture of 0.05mm are drilled on the proximal end tube 6 by a drilling mode, and a developing ring 10 which can develop under x-ray is assembled on the proximal end inner tube at the side, close to the handle, of the perfusion hole 9.
(6) The degradable stent 1 loaded with the drug coating 2 is pressed and held on the balloon 7 of the balloon delivery system 3 by an automatic press-and-grip machine.
Example 3
(1) Pellets of L-polylactic acid (PLLA) having a molecular weight of 60 ten thousand were melt-extruded to form a pipe having a wall thickness of 0.2 mm.
(2) The tube is made into a hollow bracket shape by a laser engraving mode.
(3) And blowing off surface impurities of the degradable support 1 which is made into the hollow shape by using an ion fan, and eliminating static electricity on the surface of the degradable support.
(4) Dissolving racemic polylactic acid (PDLLA) with the molecular weight of 15 ten thousand and paclitaxel in acetone according to the ratio of 2:1, taking the degradable stent 1, spraying a mixture of the paclitaxel and the racemic polylactic acid on the surface of the degradable stent 1 in a spraying mode, and obtaining a layer of compact drug coating 2 on the surface of the degradable stent 1 after chloroform is completely volatilized.
(5) The proximal end inner tube and the proximal end outer tube of the balloon delivery system 3 are welded together by heat, then 4 perfusion holes 9 with the aperture of 0.05mm are drilled on the proximal end tube 6 by a drilling mode, and a developing ring 10 which can develop under x-ray is assembled on the proximal end inner tube at the side, close to the handle, of the perfusion hole 9.
(6) The degradable stent 1 loaded with the drug coating 2 is pressed and held on the balloon 7 of the balloon delivery system 3 by an automatic press-and-grip machine.
Example 4
The degradable stent delivery systems prepared in examples 1-3 were used in vivo in animal experiments with conventional degradable stent delivery systems without self-perfusion holes.
Animal experiments two kinds of stent delivery systems were implanted into the animal's heart by conventional percutaneous transluminal coronary angioplasty, and the initial value of the vessel diameter was measured by coronary angiography before implantation. The expansion time of the two degradable stent delivery systems is recorded in the implantation process respectively, an electrocardiogram is observed, and when the electrocardiogram has bad changes, the expansion is finished and the expansion time is recorded. After the degradable stent is implanted, measuring the diameter of a blood vessel in a coronary angiography mode in 10 minutes, 30 minutes and 1 hour respectively, and calculating and recording the retraction amount by comparing the initial value of the diameter of the blood vessel; data as shown in table 1 were obtained:
TABLE 1
From table 1, can see that compare in ordinary, not have from the degradable stent delivery system who fills the function, the utility model provides a degradable stent delivery system is vascular in the same time and is retracted volume little, and degradable support expansion time has improved more than 1 times.
Claims (6)
1. A degradable drug stent delivery system is characterized by comprising a degradable stent (1), a drug coating (2) and a balloon delivery system (3); the drug coating (2) is attached to the surface of the degradable stent (1), and the degradable stent (1) attached with the drug coating (2) is pressed and held on a balloon (7) of the balloon conveying system (3);
the degradable bracket (1) is of a hollow structure;
the balloon conveying system (3) comprises a handle (4), a support rod (5), a near-end tube (6), a balloon (7) and a tip (8), wherein the near-end tube (6) is an annular catheter; the near-end pipe (6) is provided with more than 1 self-filling hole (9) with the aperture of 0.005 mm-1 mm, and the self-filling hole (9) is arranged at the welding position of the near-end inner pipe and the near-end outer pipe on the near-end pipe (6);
more than 1 developing ring (10) capable of developing under x-ray is arranged around the self-perfusion hole (9) or on the saccule (7), and the developing ring (10) around the self-perfusion hole (9) is arranged on the near-end inner tube of the near-end tube (6).
2. The degradable drug stent delivery system of claim 1 wherein the wall thickness of the degradable stent (1) is 0.05mm to 0.2mm and the material is non-metallic degradable material.
3. The degradable drug stent delivery system of claim 2 wherein the degradable stent (1) is made of L-polylactic acid, D-polylactic acid, racemic polylactic acid, polyglycolide, polyethylene glycol or polyglutamic acid with molecular weight of 30-100 ten thousand.
4. The degradable drug stent delivery system of claim 1 wherein the drug coating (2) is a drug coating for the treatment of hyperplasia or thrombosis of the inner wall of a blood vessel.
5. The degradable drug stent delivery system of claim 4, wherein the effective drug in the drug coating layer (2) is paclitaxel, a paclitaxel derivative, rapamycin or a rapamycin derivative; the release of effective drugs is controlled by utilizing levorotatory polylactic acid, dextrorotatory polylactic acid, racemic polylactic acid, polyglycolide, polyethylene glycol or polyglutamic acid, and the molecular weight of the polymer is 3-15 ten thousand.
6. The degradable drug stent delivery system of claim 1, wherein the development ring (10) around the self-perfusion hole (9) is no more than 5cm away from the self-perfusion hole (9).
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| CN202020211746.8U CN213030946U (en) | 2020-02-26 | 2020-02-26 | Degradable drug stent delivery system |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113057772A (en) * | 2021-05-06 | 2021-07-02 | 哈尔滨医科大学 | Stent system |
| CN113288533A (en) * | 2021-05-11 | 2021-08-24 | 天津市胸科医院 | Absorbable stent control system and control method |
-
2020
- 2020-02-26 CN CN202020211746.8U patent/CN213030946U/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113057772A (en) * | 2021-05-06 | 2021-07-02 | 哈尔滨医科大学 | Stent system |
| CN113288533A (en) * | 2021-05-11 | 2021-08-24 | 天津市胸科医院 | Absorbable stent control system and control method |
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