Drug coating for large-size balloon and preparation method thereof

Abstract

The invention belongs to the technical field of medical instruments, and relates to interventional medical instruments, in particular to a drug coating for a large-size balloon and a preparation method thereof.The drug coating is formed by coating the surface of the balloon with a drug combination solution, and the drug combination solution comprises a drug solution and a conjugate solution; the conjugate solution comprises a solvent A and a solvent B, and the solvent A comprises any one or a combination of at least two of deionized water, methanol, ethanol, acetonitrile, dimethyl sulfoxide, isopropanol, acetone and tetrahydrofuran; the solvent B comprises any one or a combination of at least two of diethyl ether, dichloromethane, ethyl formate, methyl acetate and soybean oil. The method is suitable for the large-size balloon, the drug coating is uniform and compact, and the defects that the drug coating of the large-size balloon is not high in uniformity and firmness are overcome.

Description

technical field

[0001] The invention belongs to the technical field of medical devices and relates to interventional medical devices, in particular to a drug coating for a large-sized balloon and a preparation method thereof. Background technique

[0002] Angioplasty is a method to restore the narrowed blood vessel to its original shape, even if the blood vessel returns to its original shape when it was not narrowed, so that the blood flow can be smooth again, and the blood supply can return to or near normal. Commonly used methods for angioplasty include bare balloon dilation, implantation of bare stents, or drug stents. However, these treatment methods all have different defects.

[0003] Drug-coated balloon dilatation catheter refers to coating a layer of anti-angioproliferative drugs on the surface of the bare balloon, and then when the balloon reaches the lesion vessel wall and is expanded, the drug is quickly released and transferred to the vessel wall, playing a role...

Examples

Embodiment 1

[0054] In this embodiment, the drug balloon dilatation catheter is prepared by the following preparation method:

[0055] (1) Mix ethanol and dichloromethane to form a conjugated solution, including 10 mL of ethanol and 100 mL of dichloromethane. Separately take 5.5 g of paclitaxel and 0.5 mL of polyethylene glycol, form a drug combination at 30 kPa and raise the temperature to 50° C., mix them in the above conjugated solution, and obtain a supersaturated drug mixture by vortex oscillation.

[0056] (2) The diameter of the balloon dilatation catheter is 4.0 mm, and the effective length of the balloon is 40 mm. It is wiped with acetonitrile and dried with an infrared lamp.

[0057] (3) The power of the ultrasonic generator is 2.5W, the nozzle aperture is 20μm, the spray width is 3mm, and the spray flow rate is 0.02mL / min; the carrier gas is nitrogen, and the carrier gas flow rate is 3.0L / min, and the carrier gas passes through the heating jacket and humidifier , to control the...

Embodiment 2

[0060] In this embodiment, the drug balloon dilatation catheter is prepared by the following preparation method:

[0061] (1) Mix ethanol and dichloromethane to form a conjugated solution, including 10 mL of ethanol and 100 mL of dichloromethane. Separately take 5.5 g of paclitaxel and 0.5 mL of glycerol, form a drug combination at 30 kPa and raise the temperature to 50° C., mix them in the above conjugated solution, and obtain a supersaturated drug mixture by vortex oscillation.

[0062] (2) The diameter of the balloon dilatation catheter is 6.0 mm, and the effective length of the balloon is 300 mm. It is wiped with isopropanol and dried with an infrared lamp.

[0063] (3) The power of the ultrasonic generator is 2.5W, the nozzle aperture is 20μm, the spray width is 3mm, and the spray flow rate is 0.02mL / min; the carrier gas is nitrogen, and the carrier gas flow rate is 3.0L / min, and the carrier gas passes through the heating jacket and humidifier , to control the temperatur...

Embodiment 3

[0066] In this embodiment, the drug balloon dilatation catheter is prepared by the following preparation method:

[0067] (1) Mix deionized water and ethyl formate to form a conjugate solution, including 20 mL of deionized water and 100 mL of ethyl formate. Separately take 6.0 g of paclitaxel and 0.5 mL of glycerol, form a drug combination at 30 kPa and raise the temperature to 50° C., mix them in the above conjugated solution, and obtain a supersaturated drug mixture by vortex oscillation.

[0068] (2) The diameter of the balloon dilatation catheter is 12.0mm, and the effective length of the balloon is 40mm. It is wiped with acetonitrile and dried with infrared light.

[0069] (3) The power of the ultrasonic generator is 2.5W, the nozzle aperture is 20μm, the spray width is 3mm, and the spray flow rate is 0.02mL / min; the carrier gas is nitrogen, and the carrier gas flow rate is 3.0L / min, and the carrier gas passes through the heating jacket and humidifier , to control the te...

technical field

[0001] The invention belongs to the technical field of medical devices and relates to interventional medical devices, in particular to a drug coating for a large-sized balloon and a preparation method thereof. Background technique

[0002] Angioplasty is a method to restore the narrowed blood vessel to its original shape, even if the blood vessel returns to its original shape when it was not narrowed, so that the blood flow can be smooth again, and the blood supply can return to or near normal. Commonly used methods for angioplasty include bare balloon dilation, implantation of bare stents, or drug stents. However, these treatment methods all have different defects.

[0003] Drug-coated balloon dilatation catheter refers to coating a layer of anti-angioproliferative drugs on the surface of the bare balloon, and then when the balloon reaches the lesion vessel wall and is expanded, the drug is quickly released and transferred to the vessel wall, playing a role...

Examples

Embodiment 1

[0054] In this embodiment, the drug balloon dilatation catheter is prepared by the following preparation method:

[0055] (1) Mix ethanol and dichloromethane to form a conjugated solution, including 10 mL of ethanol and 100 mL of dichloromethane. Separately take 5.5 g of paclitaxel and 0.5 mL of polyethylene glycol, form a drug combination at 30 kPa and raise the temperature to 50° C., mix them in the above conjugated solution, and obtain a supersaturated drug mixture by vortex oscillation.

[0056] (2) The diameter of the balloon dilatation catheter is 4.0 mm, and the effective length of the balloon is 40 mm. It is wiped with acetonitrile and dried with an infrared lamp.

[0057] (3) The power of the ultrasonic generator is 2.5W, the nozzle aperture is 20μm, the spray width is 3mm, and the spray flow rate is 0.02mL / min; the carrier gas is nitrogen, and the carrier gas flow rate is 3.0L / min, and the carrier gas passes through the heating jacket and humidifier , to control the...

Embodiment 2

[0060] In this embodiment, the drug balloon dilatation catheter is prepared by the following preparation method:

[0061] (1) Mix ethanol and dichloromethane to form a conjugated solution, including 10 mL of ethanol and 100 mL of dichloromethane. Separately take 5.5 g of paclitaxel and 0.5 mL of glycerol, form a drug combination at 30 kPa and raise the temperature to 50° C., mix them in the above conjugated solution, and obtain a supersaturated drug mixture by vortex oscillation.

[0062] (2) The diameter of the balloon dilatation catheter is 6.0 mm, and the effective length of the balloon is 300 mm. It is wiped with isopropanol and dried with an infrared lamp.

[0063] (3) The power of the ultrasonic generator is 2.5W, the nozzle aperture is 20μm, the spray width is 3mm, and the spray flow rate is 0.02mL / min; the carrier gas is nitrogen, and the carrier gas flow rate is 3.0L / min, and the carrier gas passes through the heating jacket and humidifier , to control the temperatur...

Embodiment 3

[0066] In this embodiment, the drug balloon dilatation catheter is prepared by the following preparation method:

[0067] (1) Mix deionized water and ethyl formate to form a conjugate solution, including 20 mL of deionized water and 100 mL of ethyl formate. Separately take 6.0 g of paclitaxel and 0.5 mL of glycerol, form a drug combination at 30 kPa and raise the temperature to 50° C., mix them in the above conjugated solution, and obtain a supersaturated drug mixture by vortex oscillation.

[0068] (2) The diameter of the balloon dilatation catheter is 12.0mm, and the effective length of the balloon is 40mm. It is wiped with acetonitrile and dried with infrared light.

[0069] (3) The power of the ultrasonic generator is 2.5W, the nozzle aperture is 20μm, the spray width is 3mm, and the spray flow rate is 0.02mL / min; the carrier gas is nitrogen, and the carrier gas flow rate is 3.0L / min, and the carrier gas passes through the heating jacket and humidifier , to control the te...

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