CN102310034A

CN102310034A - Method for implementing process of ensuring vascular drug stent to have thick outer coating and thin inner coating

Info

Publication number: CN102310034A
Application number: CN2010102175337A
Authority: CN
Inventors: 钟民
Original assignee: SHENZHEN KINHELY BIO-TECH Co Ltd
Current assignee: SHENZHEN KINHELY BIO-TECH Co Ltd
Priority date: 2010-07-01
Filing date: 2010-07-01
Publication date: 2012-01-11
Anticipated expiration: 2030-07-01
Also published as: CN102310034B

Abstract

The invention relates to a method for implementing a process of ensuring a vascular drug stent to have a thick outer coating and a thin inner coating, which mainly comprises the following steps of: aligning a spray nozzle of an ultrasonic coating machine with the center of a spindle; mounting a stent with the length of 8mm to 40mm, which is to be coated, on a corresponding tool rotating shaft; setting the outer diameter of the tool rotating shaft to be in the range of 10 percent to 99 percent of the inner diameter of the stent, setting the advancing speed of a coated region to be in the range of 0.1 to 0.5 inch per minute and keeping a tool rotating; and setting the stent to ensure the inner surface part of the stent to be shaded by the tool rotating shaft, so that the dosage of liquor sprayed on the outer surface of the stent is larger than the dosage of the liquor sprayed on the inner surface of the stent. The method has the beneficial effects that by adopting a mode that the drug coating is provided with the thick outer surface and the thin inner surface to combine the special tool to fix the stent, the inner surface of the stent can be partly shaded by the tool, so that the dosage of the liquor sprayed on the outer surface of the stent is larger than the dosage of the liquor sprayed on the inner surface of the stent; the thickness of the drug coating of the outer surface of the stent is greater than the thickness of the drug coating on the inner surface of the stent, so the drug ingredients inside the stent cannot generate side effects on a human body.

Description

The implementation method of the outer thick interior thin technology of a kind of blood vessel drug eluting stent coating

Technical field

The present invention relates to medical technical field, the implementation method of the outer thick interior thin technology of specifically a kind of blood vessel drug eluting stent coating.

Background technology

After coronary stent is implanted coronary artery at present; The outer surface and the coronary endometrium of coronary artery bracket are close to, and inner surface then contacts with blood flow towards intravascular space, after drug stent is implanted coronary artery; It mainly is that the medication coat that contacts with endangium discharges medicine to endangium; Thereby play and suppress the endometrial hyperplasia effect and prevent reangiostenosis down, and may be released into blood at the implantation initial stage, can't play the endometrial hyperplasia effect that suppresses on the one hand towards the medicine of the medication coat of blood flow face; Possibly the underwent coronary blood flow flow to whole body more on the other hand through microcirculation; To body tissue's organ generation effect, might cause unnecessary side effect, thin outer thick technology outbalance in therefore adopting in process of production; Can make the more part of medication coat be positioned at the endangium face, thereby make the medicine orientation be released into endangium.In addition, existing medicine spraying coating process need to require rack surface dense medicine to be arranged reaching desirable result of treatment, but its inside tries not to be sprayed onto; Otherwise the drug ingedient of internal stent has side effects to people's cognition; Existing this type of device generally puts in the rotating shaft of its structure 1/5th place's swinging mountings of support, and rotating shaft is the fixed standard formula, can't satisfy dissimilar support sprayings; All be sprayed onto inside and outside the support like this, can't reach predetermined effect and harmful health.

Summary of the invention

To above defective; The present invention provides a kind of and guarantees that the stent drug coating approaches, helps health in thick outward, can improve the implementation method of the outer thick interior thin technology of blood vessel drug eluting stent coating of result of treatment, thereby can guarantee behind implant into body, can not have side effects to human body for the drug ingedient of internal stent admittedly.

For realizing above-mentioned purpose, the present invention adopts following technical scheme:

The implementation method of the outer thick interior thin technology of a kind of blood vessel drug eluting stent coating; Its key step comprises the nozzle alignment alignment of shafts that adopts the ultrasonic spray machine; The length of getting the desire spraying is that the support of 8mm-40mm is installed on the corresponding frock rotating shaft; It is the 10%-99% of shelf inner diameter that frock rotating shaft external diameter is got in setting, and frock is fixed on the fixed axis of spraying, and the fltting speed of spraying area is got 0.1-0.5 inch/min and kept the frock rotation; Said support be set to its inner surface portion by the frock rotating shaft block make the spraying soup in the dosage of rack outer surface greater than inner surface dosage, spraying comes and goes number of times and is set at 10; Its nozzle soup flow velocity is 0.1-1.0ml/min, and its frock speed of rotation is 100-300rad/min.

The beneficial effect of the implementation method of the outer thick interior thin technology of blood vessel drug eluting stent coating of the present invention is: thin outer thick mode combines special frock fixed support in the medication coat through adopting; The support inner surface portion is blocked by frock; The outer thick interior thin ratio of the proportionate relationship decision coating of frock external diameter and shelf inner diameter; Generally get the 10%-99% that the frock external diameter is equivalent to shelf inner diameter, that is to say that the frock external diameter is big more with respect to support external diameter ratio, the support undercoating is just thin more; Relatively external coating is also just thick more, so make the spraying soup in the dosage of rack outer surface greater than inner surface dosage; Because stent diameter is fixing with the flower type; The frock size is also constant, therefore under the condition of process stabilizing, can obtain the coating layer thickness uniformity of rack outer surface, and the thickness of inner surface is uniformity also; Simultaneously since the medicine that outer surface is sprayed greater than inner surface; Therefore the medication coat thickness of outer surface is greater than inner surface, so can human body do not had side effects because of the drug ingedient of internal stent behind the implant into body, helps guaranteeing health, improves result of treatment.

The specific embodiment

The implementation method of the outer thick interior thin technology of the described blood vessel drug eluting stent coating of the embodiment of the invention, its key step comprises:

(1) adopting model is the ultrasonic spray machine of JKMP005-01 and ultrasonic power is set is 1.1W; The nozzle alignment alignment of shafts with flush coater; Nozzle tip is that 10mm and feed liquor nozzle flush with ultrasonic nozzle with axle base; Adjustment soup flow velocity is 0.1-1.0ml/min, and the adjustment frock speed of rotation is 100-300rad/min;

The length of (2) getting desire spraying is that the support of 8mm-40mm is installed on the corresponding frock rotating shaft; It is the 10%-99% of shelf inner diameter that frock rotating shaft external diameter is got in setting; Frock is fixed on the fixed axis of spraying; This axle has motor control to move to the nozzle direction to keep 360 ° of rotations simultaneously, and the axle motor is through the spraying software control and manually move the frock key thus, confirms the starting point and the terminal point of support spraying; The edge of starting point nozzle alignment rack far end is amphi position slightly, the position that terminal point nozzle alignment proximal edge is slightly outer;

(3) fltting speed of spraying area is got 0.1-0.5 inch/min and is kept frock rotation, and this support inner surface portion is blocked by the frock rotating shaft, so make the spraying soup in the dosage of rack outer surface greater than inner surface dosage, promptly realize outer thin in thick; Spraying comes and goes number of times and is set at 10, and then is 725 μ g and evenly complete according to the bracket coating weight of weighing.

Claims

A blood vessel drug eluting stent coating outer thick in the implementation method of thin technology; Its key step comprises the nozzle alignment alignment of shafts that adopts the ultrasonic spray machine; The length of getting desire spraying is on the 8mm-40mm support the is installed in corresponding frock rotating shaft; Frock is fixed on the fixed axis of spraying, and the fltting speed of spraying area is got 0.1-0.5 inch/min and kept the frock rotation, and it is characterized in that: frock rotating shaft external diameter wherein is the 10%-99% of shelf inner diameter; Said support inner surface portion by the frock rotating shaft block make the spraying soup in the dosage of rack outer surface greater than inner surface dosage, spraying comes and goes number of times and is set at 10.
2. the implementation method of the outer thick interior thin technology of blood vessel drug eluting stent coating according to claim 1, it is characterized in that: its nozzle soup flow velocity is 0.1-1.0ml/min.
3. the implementation method of the outer thick interior thin technology of blood vessel drug eluting stent coating according to claim 1, it is characterized in that: its frock speed of rotation is 100-300rad/min.