CN115501460A - Waveform balloon catheter and drug loading method thereof - Google Patents

Abstract

The invention relates to a waveform balloon catheter and a drug loading method thereof, the waveform balloon catheter comprises a waveform balloon, a catheter body and a catheter seat, wherein the outer surface of the waveform balloon is provided with a plurality of wave crests and wave troughs; a medicine carrying method for a waveform balloon catheter is to spray, dip or drip a liquid medicine on the surface of a waveform balloon to carry a plurality of medicines. The wave form sacculus both can avoid the excessive expansion to lead to the damage to the vascular wall, and the multiplicable medicine carrying space of trough department reduces droing of sacculus transportation process medicine, can also realize that different troughs carry different medicines. The waveform balloon catheter can be used for expanding the narrow part of a blood vessel or a cavity channel after carrying medicine, and can also be used for expanding the stenosis of a heart valve.

Description

Waveform balloon catheter and drug loading method thereof

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a waveform balloon catheter and a drug loading method thereof.

Background

Interventional therapy has become one of the major methods of treating cardiovascular disease worldwide. The balloon catheter is one of main instruments for intracavity interventional therapy, can be used for pre-expansion of blood vessels, can be used for expansion and shaping after the stent is placed, and can be used as a delivery platform of the stent and a drug-loaded balloon for targeted drug delivery. The prior art balloons are mostly cylindrical with smooth surfaces. Expansion of a conventional cylindrical balloon expands the vessel all the way, resulting in compression, rupture of plaque and elastic expansion of the vessel, with the susceptibility to intimal tears and even acute occlusions.

Compared with the traditional naked balloon, the drug-loaded balloon has the following advantages: the medicine in the specific vessel and cavity tube wall area is uniformly distributed; the concentration of local drugs is high; short-term effects within one week do not affect the long-term healing process; no polymer carrier, and reduced chronic inflammatory reaction and late thrombosis. Therefore, drug-loaded balloons have been applied to the treatment of cardiovascular stenosis. The medicine carrying sacculus that sells on the market adopts various carriers or adhesion technique to carry the medicine on the sacculus surface mostly, and when present conventional cylindrical sacculus is as medicine carrying sacculus, lacks the medicine carrying space, has following problem: in the process of conveying and releasing, the drug coating on the surface of the balloon can partially fall off under the action of blood flow impact and expansion pressure and flow into blood, and the drug loss in the process of pushing and expanding through blood vessels is nearly 40 percent, so that the treatment effect is influenced; the coating of the drug which is shed, especially some carriers, are not soluble in blood, will be present in the form of large particles and with the blood flow to the distal small vessels, there is a great risk of occluding the distal vessels, as has been reported in the literature.

Percutaneous balloon mitral valve dilatation percutaneous mitral valve balloon dilatation (PBMV) has become the first treatment method for selective rheumatic mitral valve stenosis, the immediate curative effect is satisfactory, but the medium-long term still has higher restenosis rate, and the 2-year follow-up restenosis rate after the operation is reported to be close to 20 percent in the literature. Therefore, the balloon-only expansion does not achieve the desired therapeutic effect.

Disclosure of Invention

The invention aims to provide a waveform balloon catheter and a drug loading method thereof, and aims to solve the problems in the background technology.

In order to achieve the purpose, the invention provides the following technical scheme:

a waveform sacculus pipe comprises a waveform sacculus, a pipe body and a pipe seat, wherein the outer surface of the waveform sacculus is provided with a plurality of wave crests and wave troughs, a wire guide pipe is arranged inside the sacculus, X-ray developable marks are arranged on the wire guide pipe corresponding to the positions of the wave troughs, and the pipe seat is communicated with the waveform sacculus through the pipe body and used for conveying pressurized and expanded liquid.

Preferably, the outer surface of the wave-shaped balloon is provided with a plurality of wave crests and wave troughs.

Preferably, the wave number of the outer surface of the wave-shaped balloon is 2-100.

Preferably, the wave-shaped balloon has a diameter of 1-40mm without a peak height.

Preferably, the wave crest height of the outer surface of the wave-shaped capsule is 0.1-4mm.

Preferably, the wave width of the outer surface of the wave-shaped balloon is 0.4-20mm.

Preferably, the inner diameter of the guide wire tube in the waveform balloon is 0.3-1mm.

Preferably, the marker ring comprises a noble metal material.

Preferably, the tube body is a single-component or multi-component mixed basic single-layer or multi-layer tube made of polyamide, polyether block polyamide, polyurethane, polyethylene glycol terephthalate, polytetrafluoroethylene, high-density or low-density polyethylene high polymer materials, or a metal tube made of stainless steel or nickel-titanium alloy, or a combination of the materials.

Preferably, the material of the balloon is one or a mixture of more of polyamide, polyether block polyamide, polyurethane, polyethylene glycol terephthalate, latex and silica gel.

Preferably, one end of the guide wire tube is positioned at the far end of the balloon, and the other end of the guide wire tube is positioned in the middle of the tube body or positioned at the catheter seat.

Preferably, the surface of the wave-shaped balloon can be loaded with medicines by liquid medicine spraying or dip coating or dripping, and the medicines comprise one or more of resveratrol, ligustrazine, ginkgo leaf extract, probucol, paclitaxel, everolimus, rapamycin, zotarolimus, tirofiban hydrochloride, vinblastine, topotecan hydrochloride, aminoglutethimide, nimustine, carmustine, 5-fluorouracil, floxuridine, heparin and growth factors.

Preferably, the drug loading method of the wave-shaped balloon catheter comprises the following steps:

spraying or dip-coating or instilling the single-component liquid medicine on the surface of the waveform balloon to carry the same medicine;

spraying or dip-coating or instilling the multi-component mixed liquid medicine on the surface of the wave-shaped saccule to load a plurality of medicines;

spraying or dip-coating or instilling multiple single-component liquid medicines on the surface of the wave-shaped saccule to load multiple medicines;

multiple times of single-component liquid medicine is accurately sprayed or instilled at each wave trough of the wave-shaped saccule to sequentially load different medicines.

Compared with the prior art, the invention has the beneficial effects that:

when the waveform balloon catheter is used for expanding a lumen in clinical application, the wave crest provides enough expansion, and a certain buffer space is reserved at the wave trough, so that the damage to the catheter wall caused by over expansion can be avoided; when the balloon is applied as a drug-carrying balloon, the drug-carrying space at the wave trough can be increased, and the falling of drugs in the balloon conveying process is reduced; when the expansion treatment device is used for the expansion treatment of the cardiac valve stenosis, the wave crests have the effect of fixed positioning, the medicine carrying at the wave troughs can realize the effect of accurately releasing the medicine, and the wave troughs carry different medicines, so that the expansion can be realized for multiple times to sequentially release different medicines, and the treatment effect is improved.

Drawings

FIG. 1 is a schematic structural view of a wave-shaped balloon catheter with one end of a guidewire tube positioned in the middle of a catheter body;

FIG. 2 is a schematic structural view of a waveform balloon catheter with one end of the guidewire tube located at the catheter hub;

FIG. 3 is a schematic view of a balloon with wavenumber 6;

in the figure: 1. the device comprises a waveform balloon, 11, wave crests, 12, wave troughs, 13, a marking ring, 14, a guide wire tube, 2, a tube body, 3, a catheter seat, 31, a liquid filling port, 32 and a guide wire port, wherein D is the diameter of the balloon, L is the width of the wave crest, and h is the height of the wave crest.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.

Example 1

The diameter of the wavy balloon made of polyether block polyamide is 2.0mm, the wave number is 11, the wave peak width is 2mm, the wave peak height is 0.1mm, the inner diameter of the guide wire tube is 0.40mm, one end of the guide wire tube is positioned in the middle of the tube body, as shown in figure 1, the marking ring is a PE tube containing tungsten and is positioned at the wave trough at two ends, the material of the tube body is a mixed tube of polyether block polyamide and high-density or low-density polyethylene close to the balloon section, the stainless steel tube is positioned close to the catheter seat section, and the wavy balloon catheter can be used for dilating the lesion with the blood vessel diameter of about 2.0mm and the stenosis length of about 20mm.

Example 2

The catheter is a corrugated balloon which is made of polyamide and has the diameter of 5.0mm, the wave number of 32, the wave peak width of 4mm and the wave peak height of 0.4mm, the inner diameter of a guide wire tube is 0.90mm, one end of the guide wire tube is positioned on a catheter base, as shown in figure 2, a marking ring is made of platinum-containing iridium alloy and positioned at the wave troughs at two ends, a catheter body is made of polyamide tube, and the corrugated balloon catheter can be used for dilating lesions with the diameter of 5.0mm and the stenosis length of 120 mm.

Example 3

The diameter of a corrugated balloon made of a polyamide and polyether block polyamide mixed tube is 4.0mm, the wave number is 8, the wave peak width is 5mm, the wave peak height is 0.2mm, the inner diameter of the guide wire tube is 0.40mm, one end of the guide wire tube is positioned in the middle of a tube body, as shown in figure 1, a marking ring is made of platinum-containing iridium alloy and positioned at the wave troughs at two ends, the section, close to the balloon, of the tube body is made of a polyether block polyamide and high-density or low-density polyethylene mixed tube, and the section, close to a catheter seat, of the tube body is a stainless steel tube. Dissolving paclitaxel in organic solvent, dripping medicinal liquid on the surface of the balloon, allowing the medicinal liquid to flow toward the wave trough, allowing paclitaxel to deposit on the surface of the balloon after the solvent is rapidly volatilized, and allowing the thickness of the medicinal coating at the wave trough to be higher than that at the wave crest to load more medicinal substances. The drug-loaded waveform balloon catheter can be used for dilating the lesion with the diameter of a blood vessel of about 4.0mm and the stenosis length of about 35 mm.

Example 4

The diameter of the wavy balloon made of latex is 30mm, the wave number is 3, the wave peak width is 20mm, the wave peak height is 4mm, the inner diameter of the guide wire tube is 0.90mm, one end of the guide wire tube is positioned on the catheter base, as shown in figure 2, the marking ring is made of platinum-iridium-containing alloy material and positioned at two wave troughs in the middle, and the tube body is made of polyamide tube. Respectively dissolving probucol and rapamycin in an organic solvent, spraying probucol liquid medicine on a first trough at the far end of the catheter by ultrasonic spraying, and after the surface of the coating is dried, coating rapamycin liquid medicine on a second trough, wherein the two troughs are respectively loaded with different medicines. The drug-loaded waveform balloon catheter can be used for dilation of mitral valve stenosis, when the first wave trough is clamped at the mitral valve stenosis to be dilated once, probucol drug is released, the balloon retracts and then is pushed forward, and the second wave trough is clamped at the mitral valve stenosis to be dilated once again to release rapamycin drug.

Example 5

A method for loading medicine on a waveform balloon catheter comprises the step of spraying or dip-coating or instilling a single-component liquid medicine on the surface of a waveform balloon to load the same medicine.

Example 6

A method for loading medicine on a waveform balloon catheter comprises spraying or dip-coating or instilling multi-component mixed liquid medicine on the surface of a waveform balloon to load multiple medicines.

Example 7

A method for loading medicine on a waveform balloon catheter comprises spraying or dip-coating or instilling multiple single-component liquid medicines on the surface of a waveform balloon to load multiple medicines.

Example 8

A method for loading medicine on a waveform balloon catheter comprises the step of accurately spraying or instilling multiple single-component liquid medicines on each wave trough of the waveform balloon to sequentially load different medicines.

Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims (10)

1. The utility model provides a wave form sacculus pipe, includes wave form sacculus, shaft of a tube and pipe seat, its characterized in that: the outer surface of the waveform sacculus is provided with a plurality of wave crests and wave troughs, the sacculus is internally provided with a silk guide tube, the silk guide tube at the position corresponding to the wave trough is provided with a mark which can be developed by X rays, and the catheter seat is communicated with the waveform sacculus through a catheter body to convey pressurized and expanded liquid.

2. The wave balloon catheter of claim 1, wherein: the wave number of the outer surface of the wave-shaped balloon is 2-100.

3. The wave balloon catheter of claim 1, wherein: the diameter of the wave-shaped balloon without the peak height is 1-40mm.

4. The wave balloon catheter of claim 1, wherein: the height of the wave crest on the outer surface of the wave-shaped saccule is 0.1-4mm.

5. The wave balloon catheter of claim 1, wherein: the wave width of the outer surface of the wave-shaped saccule is 0.4-20mm.

6. The wave balloon catheter of claim 1, wherein: the inner diameter of the guide wire tube in the wave-shaped saccule is 0.3-1mm.

7. The waveform balloon catheter as claimed in claim 1, wherein: the marker ring comprises a noble metal material.

8. The wave balloon catheter of claim 1, wherein: one end of the guide wire tube is positioned at the far end of the wave-shaped saccule, and the other end of the guide wire tube is positioned in the middle of the tube body or positioned in the catheter seat.

9. The wave balloon catheter of claim 1, wherein: the surface of the wave-shaped saccule can be coated with a medicine by liquid medicine spraying or dip coating or instillation, and the medicine is one or more of resveratrol, ligustrazine, ginkgo leaf extract, probucol, paclitaxel, everolimus, rapamycin, zotarolimus, tirofiban hydrochloride, vinblastine, topotecan hydrochloride, aminoglutethimide, nimustine, carmustine, 5-fluorouracil, floxuridine, heparin and growth factors.

10. A drug loading method of a waveform balloon catheter is characterized in that: a method of loading a drug in a wave balloon, comprising:

the surface of the waveform saccule is loaded with the same medicine by spraying, dip-coating or instilling the single-component liquid medicine;

spraying or dip-coating or instilling the multi-component mixed liquid medicine on the surface of the wave-shaped saccule to load a plurality of medicines;

spraying or dip-coating or instilling multiple single-component liquid medicines on the surface of the wave-shaped saccule to load multiple medicines;

spraying or dripping the single-component liquid medicine on each wave trough of the wave-shaped saccule for multiple times, and sequentially loading different medicines.

Images