CN114047296A - Method for evaluating in-vitro transferring efficiency of balloon drug coating - Google Patents

Method for evaluating in-vitro transferring efficiency of balloon drug coating Download PDF

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Publication number
CN114047296A
CN114047296A CN202111347834.6A CN202111347834A CN114047296A CN 114047296 A CN114047296 A CN 114047296A CN 202111347834 A CN202111347834 A CN 202111347834A CN 114047296 A CN114047296 A CN 114047296A
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China
Prior art keywords
blood vessel
balloon
drug
evaluating
tested
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Pending
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CN202111347834.6A
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Chinese (zh)
Inventor
吕露
王德军
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B Braun Medical Suzhou Co Ltd
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B Braun Medical Suzhou Co Ltd
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Priority to CN202111347834.6A priority Critical patent/CN114047296A/en
Publication of CN114047296A publication Critical patent/CN114047296A/en
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N13/00—Investigating surface or boundary effects, e.g. wetting power; Investigating diffusion effects; Analysing materials by determining surface, boundary, or diffusion effects
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/40—ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage

Abstract

The invention relates to an in vitro release evaluation method for a balloon drug coating, and belongs to the technical field of medical treatment. According to the evaluation method, the drug to be detected is released from the drug balloon according to actual use operation, and then the actual balloon drug coating external transfer efficiency of the drug balloon is obtained by measuring the drug content at the target blood vessel and calculating the drug content with the standard drug content of the drug to be detected. The method for evaluating the in-vitro transferring efficiency of the balloon drug coating provided by the application tracks the transferring condition of the balloon drug coating in the using process by utilizing an in-vitro simulation system, and establishes the evaluation method of the in-vitro delivery efficiency.

Description

Method for evaluating in-vitro transferring efficiency of balloon drug coating
Technical Field
The invention relates to an evaluation method of in-vitro transfer efficiency of a balloon drug coating, belonging to the technical field of medical treatment.
Background
Aiming at the product standard and the guiding principle of the drug stent, the product standard, the guiding principle and the guidance of the drug balloon are relatively perfect and mature, but at present, no product standard, the guiding principle and the guidance of the drug balloon exist, and researchers mainly develop new products according to the general standard of drug-instrument combination products or refer to the relevant standard and the guiding principle of the drug stent. However, general standards are general and relate to few details, and for the relevant standards of the drug stent, due to the differences of balloon product characteristics, action modes and the like, the method related to in vitro evaluation of drug coatings is not always suitable, so that the research on the drug balloon is not based on the general standards.
At present, a plurality of researchers have some defects in the in-vitro test research of the drug balloon. The performance is as follows: firstly, a research and test model of drug release behavior selects a model of ASTM standard more, which is different from the actual action part and path of the product; secondly, the physiological characteristics of the blood vessel wall in the body cannot be well simulated by using glass, resin or self-made tubular gel and the like as the simulated blood vessel.
Disclosure of Invention
The invention aims to provide an evaluation method of in-vitro transfer efficiency of a drug coating of a balloon, which is used for evaluating the transfer condition of the drug balloon in the using process.
In order to achieve the purpose, the invention provides the following technical scheme: an in vitro release evaluation method of a saccule drug coating comprises the following steps:
s1, assembling the blood vessel model, and injecting a medium into the blood vessel model;
s2, starting an in-vivo environment simulation device, and setting the temperature and the pH value of the medium;
s3, setting the position of a target blood vessel in the blood vessel model, enabling a guide wire to reach the far end of the target blood vessel, and penetrating a guide catheter into the blood vessel model through the guide wire to reach the near end of the target blood vessel;
s4, inserting a balloon catheter to be tested into a guide catheter, and enabling the balloon catheter to be tested to reach the target blood vessel through the guide catheter;
s5, slowly pressurizing the balloon catheter to be tested to a preset pressure by using a pressurizing device, keeping the preset pressure in a preset time period so as to enable the medicine carried by the balloon catheter to be tested to reach the inner wall of the target blood vessel, and releasing pressure and vacuumizing the medical instrument to be tested after the preset time is reached;
and S6, measuring the content of the drug positioned in the target blood vessel, and calculating the in vitro delivery efficiency.
Further, the blood vessel model comprises at least two detachably connected blood vessel sections.
Furthermore, the blood vessel model is a simulated blood vessel model with the physiological characteristics of blood vessels and is made of silica gel, hydrogel or nano materials.
Further, the blood vessel model in the step S1 is constructed by using the human blood vessel data.
Further, the medium in the step S1 is simulated blood.
Further, in the step S1, the inner wall of the blood vessel model is further provided with a film sensor for testing the pressure of the target blood vessel wall.
Further, the in-vivo environment simulation device in step S2 includes a temperature control component, a medium flow rate control component, and a medium flow rate control component.
Further, in step S5, the balloon catheter to be tested may be slowly pressurized to a predetermined pressure by using a pressurizing device, the predetermined pressure is maintained within a predetermined time period, the medical device to be tested is depressurized and vacuumized after a predetermined time is reached, and then the balloon catheter to be tested is withdrawn along the guide wire.
Further, the in-vitro delivery efficiency calculation method in step S7 is that the in-vitro delivery efficiency is (the target blood vessel drug content/nominal drug content) × 100%, and the nominal drug content is the drug content carried by the balloon catheter to be tested.
The invention has the beneficial effects that: the method for evaluating the in-vitro transferring efficiency of the balloon drug coating provided by the application tracks the transferring condition of the balloon drug coating in the using process by utilizing an in-vitro simulation system, and establishes the evaluation method of the in-vitro delivery efficiency.
The foregoing description is only an overview of the technical solutions of the present invention, and in order to make the technical solutions of the present invention more clearly understood and to implement them in accordance with the contents of the description, the following detailed description is given with reference to the preferred embodiments of the present invention and the accompanying drawings.
Drawings
Fig. 1 is a flowchart of an evaluation method of balloon drug coating in-vitro transfer efficiency.
Detailed Description
The following detailed description of embodiments of the present invention is provided in connection with the accompanying drawings and examples. The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.
The invention provides an in vitro release evaluation method of a balloon drug coating, which comprises the following steps:
s1, assembling the blood vessel model, and injecting a medium into the blood vessel model;
s2, starting an in-vivo environment simulation device, and setting the temperature and the pH value of a medium;
s3, setting the position of a target blood vessel in the blood vessel model, leading a guide wire to reach the far end of the target blood vessel, and leading a guide catheter to penetrate into the blood vessel model through the guide wire to reach the near end of the target blood vessel;
s4, inserting the balloon catheter to be tested into the guide catheter, and enabling the balloon catheter to be tested to reach the target blood vessel through the guide catheter;
s5, slowly pressurizing the balloon catheter to be tested to a preset pressure by using a pressurizing device, keeping the preset pressure in a preset time period, and releasing pressure and vacuumizing the medical instrument to be tested after the preset time is reached;
and S6, testing the content of the target blood vessel drug, and calculating the in vitro delivery efficiency.
The blood vessel model has physiological characteristics, is formed by one of silica gel, hydrogel or composite gel, is established by adopting general human blood vessel data, and has the physiological characteristics of elasticity and the like of human blood vessels. The blood vessel model includes that at least two sections can dismantle the blood vessel section of connecting, and at the in-process that washes the blood vessel model, because there is superfine blood vessel position in the blood vessel model, if use the blood vessel model of integral type, when washing tiny blood vessel position, difficult remaining particle of this position dashes totally, dismantles the blood vessel section and opens and wash, and the blood vessel part of each section is all shorter for wash the convenience, make particle quantity can all be collected.
The medium in step S1 is simulated blood. The simulated blood is plasma or the simulated blood prepared by adding salt and other viscous substances into normal saline, so that the detection result of the balloon catheter to be detected is more referential. In the preparation or use of the medium, the pH value of the medium can be adjusted by using an acid solution or an alkali solution, and the ion concentration of the medium is selected by adding a salt substance or a diluted solution. The medium used can regulate the ionic state therein.
In step S1, a thin film sensor is further disposed on the inner wall of the blood vessel model and used for testing the pressure of the target blood vessel wall, and the thin film sensor can feed back the pressure of the target blood vessel in real time.
The in-vivo environment simulation device in step S2 includes a temperature control unit, a medium flow rate control unit, and a medium flow rate control unit. The in-vivo environment simulation device controls the temperature of the medium through the medium temperature control assembly, and the temperature control assembly can increase the temperature of the medium and keep the temperature constant. The temperature control component can be a water bath, but is not limited to this, and can also be other temperature control devices. The medium flow rate control assembly and the medium flow control assembly can control the flow rate and the flow rate when the medium simulates the blood flow.
In step S3, the guide wire is used in cooperation with the guide catheter, and the guide wire assists the guide catheter to be inserted into the target blood vessel. The guide wire and guide catheter are prior art and therefore not described in detail herein. It should be noted that the medical device to be tested is a pressurized interventional catheter. The thin film sensor is arranged on the inner wall of a target blood vessel of the blood vessel model and used for monitoring the pressure of the wall of the target blood vessel.
Step S5 may also be that a pressurizing device is used to slowly pressurize the balloon catheter to be tested to a predetermined pressure, the predetermined pressure is maintained within a predetermined time period, the medical device to be tested is depressurized and vacuumized after the predetermined time is reached, and then the balloon catheter to be tested is withdrawn along the guide wire original path. In step S5, since the blood vessel model is a detachable model, the blood vessel model of the target blood vessel attachment can be directly detached, and the balloon catheter to be measured is directly led out therefrom. If the process of the balloon catheter to be tested in practical application is simulated, the balloon catheter is withdrawn along the guide wire.
And the pressurizing device is connected with the balloon catheter to be tested and is used for pressurizing the balloon catheter to be tested. The pressurizing device is connected with a multifunctional joint, and the multifunctional joint is connected with the balloon catheter to be tested. It should be noted that the multifunctional joint is a universal joint, and can connect different balloon catheters to be tested. The pressurizing device may use any one of hydraulic, pneumatic or mechanical screw pressurizing means, such as a pressurizing pump, but is not limited thereto, and the specific pressurizing device is not limited.
It should be noted that the predetermined pressure and the predetermined time are the use pressure and the constant pressure time of the balloon catheter to be tested, and the operation here follows the actual use requirement of the balloon catheter to be tested in detail so as to effectively detect the external transshipment of the balloon catheter to be tested.
The in vitro delivery efficiency calculation method in step S7 is that the in vitro delivery efficiency is (target blood vessel drug content/nominal drug content) × 100%, where the nominal drug content is the drug content carried by the balloon catheter to be tested.
The following is a detailed description of specific examples:
example one
(1) Assembling the detachable blood vessel model parts into a complete blood vessel model, injecting plasma into the blood vessel model by using a guide pipe, and setting the flow rate of the plasma to be 6 mL/s;
(2) starting an in-vitro environment simulation device, and setting the temperature of the blood plasma to be the common temperature of body fluid, namely 37 ℃ by using a water bath kettle, wherein the pH value is 7.0;
(3) setting the position of a target blood vessel in the blood vessel model, leading a guide wire to reach the far end of the target blood vessel, and leading a guide catheter to penetrate into the blood vessel model through the guide wire to reach the near end of the target blood vessel;
(4) inserting a balloon catheter to be tested containing 162 mu g of medicine into the guide catheter until the balloon catheter completely reaches the outside of the distal end of the guide catheter, namely, the balloon catheter enters the interior of the blood vessel model from the exterior of the blood vessel model by virtue of the guide wire and reaches the position of a target blood vessel after passing through the guide catheter;
(5) slowly pressurizing the saccule by using a PTCA pressurizing device, monitoring the pressure of a target vascular wall by using a film sensor, and maintaining the pressure of 12atm for 1min after the pressure suffered by the saccule to be detected reaches 12atm from 0 atm;
(6) releasing pressure after countdown is finished, vacuumizing, disassembling a blood vessel model close to a target blood vessel section, taking out the target blood vessel, and measuring the content of the medicine at the target blood vessel to obtain 120.6 mu g;
(7) and calculating the in-vitro delivery efficiency of the balloon catheter to be tested, wherein the in-vitro delivery efficiency is 120.6 mu g/162 mu g and 74.4%.
In conclusion, the method for evaluating the in-vitro transfer efficiency of the balloon drug coating provided by the application tracks the transfer condition of the balloon drug coating in the using process by using the in-vitro simulation system, and establishes the evaluation method of the in-vitro delivery efficiency.
The technical features and the detection items of the above-described embodiments may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the above-described embodiments are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (10)

1. The method for evaluating the in-vitro release of the balloon drug coating is characterized by comprising the following steps of:
s1, assembling the blood vessel model, and injecting a medium into the blood vessel model;
s2, starting an in-vivo environment simulation device, and setting the temperature and the pH value of the medium;
s3, setting the position of a target blood vessel in the blood vessel model, enabling a guide wire to reach the far end of the target blood vessel, and penetrating a guide catheter into the blood vessel model through the guide wire to reach the near end of the target blood vessel;
s4, inserting a balloon catheter to be tested into a guide catheter, and enabling the balloon catheter to be tested to reach the target blood vessel through the guide catheter;
s5, slowly pressurizing the balloon catheter to be tested to a preset pressure by using a pressurizing device, keeping the preset pressure in a preset time period so as to enable the medicine carried by the balloon catheter to be tested to reach the inner wall of the target blood vessel, and releasing pressure and vacuumizing the medical instrument to be tested after the preset time is reached;
and S6, measuring the content of the drug positioned in the target blood vessel, and calculating the in vitro delivery efficiency.
2. The method for evaluating the in vitro release of the balloon drug coating according to claim 1, wherein the blood vessel model is a simulated blood vessel model with physiological characteristics of blood vessels and is composed of silica gel, hydrogel or nano-materials.
3. The method for evaluating the in vitro release of the balloon drug coating according to claim 1, wherein the blood vessel model in the step S1 is constructed by using human blood vessel data.
4. The method for evaluating the in vitro release of a balloon drug coating according to claim 1, wherein the blood vessel model comprises at least two detachably connected blood vessel segments.
5. The method for evaluating in vitro release of a balloon drug coating according to claim 4, wherein the step S6 is to disassemble the blood vessel model, take out the target blood vessel, and test the drug content of the target blood vessel.
6. The method for evaluating the in vitro release of a balloon drug coating according to claim 1, wherein the medium in the step S1 is simulated blood.
7. The method for evaluating the in-vitro release of the balloon drug coating according to claim 1, wherein a thin film sensor is further arranged on the inner wall of the blood vessel model in the step S1 for testing the pressure of the target blood vessel wall.
8. The method for evaluating the in vitro release of the drug coating on the balloon according to claim 1, wherein the in vivo environment simulation device in the step S2 comprises a temperature control module, a medium flow rate control module and a medium flow control module.
9. The method for evaluating in-vitro release of a balloon drug coating according to claim 1, wherein step S5 further includes slowly pressurizing the balloon catheter to be tested to a predetermined pressure by using a pressurizing device, maintaining the predetermined pressure for a predetermined period of time, releasing pressure and vacuumizing the medical device to be tested after a predetermined time is reached, and then withdrawing the balloon catheter to be tested along the guide wire.
10. The method for evaluating in-vitro release of a balloon drug coating according to claim 1, wherein the in-vitro delivery efficiency of step S7 is calculated as in-vitro delivery efficiency (target blood vessel drug content/nominal drug content) × 100%, and the nominal drug content is the drug content carried by the balloon catheter to be tested.
CN202111347834.6A 2021-11-15 2021-11-15 Method for evaluating in-vitro transferring efficiency of balloon drug coating Pending CN114047296A (en)

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CN202111347834.6A CN114047296A (en) 2021-11-15 2021-11-15 Method for evaluating in-vitro transferring efficiency of balloon drug coating

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Application Number Priority Date Filing Date Title
CN202111347834.6A CN114047296A (en) 2021-11-15 2021-11-15 Method for evaluating in-vitro transferring efficiency of balloon drug coating

Publications (1)

Publication Number Publication Date
CN114047296A true CN114047296A (en) 2022-02-15

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