CN112316282A - Drug-coated balloon dilatation catheter for intracranial blood vessels - Google Patents

Abstract

The invention discloses a drug-coated balloon dilatation catheter for intracranial blood vessels, belonging to the field of medical instruments. The drug coating balloon dilatation catheter consists of a tip, a developing ring, a drug coating, a balloon, an inner tube, an outer tube and a handle, wherein the surface of the outer tube is coated with a hydrophilic coating; the front end of the inner tube is provided with a tip; a saccule is fixed behind the tip, and a developing ring is arranged on an inner tube in the saccule; the balloon is connected with the outer tube, the inner tube penetrates through the balloon and the outer tube and is connected with the operation knob, and the outer tube is connected with the handle; the inner surface of the saccule outside the inner tube is coated with a drug coating layer which is coated on the periphery of the inner tube. The intracranial drug coating balloon dilatation catheter is loaded with the anti-cell proliferation drug, and the drug is firmly locked on the balloon by using a special balloon curling mode, so that a small amount of effective drug is lost in the catheter conveying process, and a large amount of effective drug is conveyed to the vessel wall when a lesion part is expanded, and the occurrence of restenosis is reduced. Meanwhile, the intervention is not implanted, the stimulation is reduced, and the safety is improved.

Description

Drug-coated balloon dilatation catheter for intracranial blood vessels

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a drug-coated balloon dilatation catheter for intracranial blood vessels.

Background

With the gradual improvement of living standard and life of people and the gradual rise of working pressure, the phenomenon of cerebral apoplexy is more and more common, and has the trend of youthfulness, which brings inconvenience to the daily life of people. Cerebral apoplexy is divided into cerebral arterial thrombosis and hemorrhagic stroke. The hemorrhagic stroke is mainly caused by cerebral vascular rupture, and is commonly seen in patients with hypertension, smoking history, aneurysm and cerebral artery malformation. Ischemic stroke is a chronic disease, and is caused by insufficient blood supply due to the stenosis of cerebral arteries or the blood embolism of cerebral arteries. Of all stroke patients, approximately 70% and above are caused by cerebral vascular ischemia, and it can be said that ischemic stroke has gradually become one of the biggest killers of human health.

Most of the early treatment means of ischemic stroke are medicines, and patients are treated in stages through thrombolytic drugs, defibrination drugs, anticoagulant drugs, platelet aggregation resistant drugs, nerve protection drugs and statins, so that a certain effect is achieved. However, the drug therapy is not targeted drug delivery at first, and after entering a human body, high-dose drugs have little effect on target blood vessels, so that the bioavailability is low, and the drug therapy does not conform to the current popular targeted engineering. In recent years, the cerebral ischemic stroke treatment is divided into Acute Ischemic Stroke (AIS) and intracranial atherosclerosis (ICAD), and in AIS treatment, in order to dredge the cerebral vessels blocked by thrombus as soon as possible, a thrombus suction system or a thrombus taking support is generally adopted to take out the thrombus. ICAD, however, differs from AIS in its pathogenesis, and is a chronic disease affecting large and medium-sized elasticity and muscular arteries of the whole body characterized by progressive lipid deposition, fibrous tissue proliferation and inflammatory cell infiltration, and has prominent manifestations in the cerebral blood supply arterial system. On ICAD interventional devices, there are naked balloons and naked stents on the market at present, and although brain interventional and implantation devices have taken on the stage, over several years of clinical application and summarizing the implantation interventional products in the coronary field, the treatment effect of the naked balloons and the naked stents on stenosis of cerebral vessels or cerebral artery thromboembolism is not obvious or even inferior to drug treatment. Therefore, there is a lack of a practical instrument for ICAD.

The concept of drug-coated balloon dilatation catheters has been proposed for some time and the current fields of application include coronary, peripheral, arteriovenous fistulas and the like, have shown good safety and efficacy. The medicine balloon is an interventional instrument, and is characterized in that the medicine for resisting cell proliferation is given on the balloon in a certain mode, in the operation, the medicine is directly acted on a target lesion blood vessel in a balloon expansion mode, and finally the medicine is absorbed by the target lesion blood vessel, so that the cell proliferation is prevented, and the blood vessel stenosis is prevented.

Although the drug balloon is a very efficient target drug delivery device, since the existing technology physically attaches the drug on the balloon, the current technical bottleneck is focused on how to deliver the drug to the lesion more effectively without being washed away by blood during the delivery process. Thereby leading the target blood vessel to obtain more efficient drug treatment and achieving more effective treatment effect.

Disclosure of Invention

The invention aims to provide a drug-coated balloon dilatation catheter for intracranial blood vessels, which is characterized by consisting of a tip, a developing ring, a drug coating, a balloon, an inner tube, an outer tube and a handle, wherein the surface of the outer tube is coated with a hydrophilic coating; the front end of theinner tube 5 is provided with a tip 1; asaccule 4 is fixed behind the tip 1, and a developingring 2 is arranged on aninner tube 5 in thesaccule 4; the right end of theballoon 4 is connected with the outer tube 6 and is connected with an operation knob; theinner tube 5 passes through theballoon 4 and the outer tube 6, and the outer tube 6 is connected with the handle 7; the inner surface of theballoon 4 outside theinner tube 5 is coated with adrug coating 3 around theinner tube 5.

The saccule is divided into more than or equal to 3 petals and is wrapped on the periphery of theinner tube 5 to form a three-leaf fin saccule; spraying theliquid medicine 8 on the pits of the three-blade fins by using amedicine coating device 9 to form amedicine coating 3; the concave pit of the balloon valve can receive more effective medicines; the inner layer of thedrug coating 3, which is in contact with the surface of the balloon, is a crystallization layer and is called an 'ice layer', the outer layer is in one or more layers of micro-particle states and is called a 'snow layer', and the double-layer or multi-layer structure has the advantages that the dense 'snow layer' can protect effective drugs of the 'ice layer' to directly reach a lesion position and directly act on a blood vessel wall; and finally, rolling the saccule coated with the ice layer and the snow layer by adopting saccule curling equipment, and attaching the rolled saccule to the inner tube, wherein under the structure, more effective medicines are protected in the valve of the saccule so as to achieve the aim of reducing the medicine loss in the conveying process, and the medicine coating saccule dilatation catheter is obtained.

The drug coating balloon dilatation catheter is of a rapid exchange Rx structure or is of a coaxial double-cavity OTW structure; wherein the length range of the balloon effective area is 5 mm-40 mm, and the diameter range is 1.0 mm-4.5 mm;

the whole effective length range of the dilatation catheter is 1350 mm-1450 mm.

The drug coating covers the effective area of the balloon and is composed of drugs capable of resisting cell proliferation, and the drugs include one or a combination of more of paclitaxel, paclitaxel derivatives, rapamycin derivatives and arsenic trioxide.

The drug coating of the drug coating balloon is of a double-layer or multi-layer structure, and the mass ratio of the effective drug at the innermost layer to the effective drug at the outer layer of the drug coating is 1: 0.01-1: 1.

The hydrophilic coating is coated on the surface of the outer tube, and the hydrophilic coating is arranged on partial area of the outer tube, so that the catheter is smoother after entering the blood vessel and can pass through the blood vessel with intracranial tortuous lesion more easily.

Compared with the naked saccule and the naked stent which are on the market in the intracranial, the intracranial drug coating saccule dilatation catheter carries the anti-cell proliferation drug and uses a special saccule curling mode to firmly lock the drug on the saccule, so that a small amount of effective drug is lost in the catheter conveying process, and a large amount of effective drug is conveyed to the vessel wall when a lesion part is expanded, and the occurrence of restenosis is reduced. Meanwhile, the intervention is not implanted, the stimulation is reduced, and the safety is improved.

Drawings

Fig. 1 is a structural schematic diagram of a drug-coated balloon dilatation catheter.

Fig. 2 is a schematic structural view of a drug-coated balloon being segmented into 3 lobes.

FIG. 3 is a schematic diagram of a drug coating apparatus spraying a drug solution onto the dimples of a tri-lobe fin.

Fig. 4 is a schematic cross-sectional view of a crimped balloon.

Detailed Description

The invention provides a drug-coated balloon dilatation catheter for intracranial blood vessels, which is described below by combining the accompanying drawings.

A schematic structural diagram of a drug-coated balloon dilatation catheter as shown in figure 1. The balloon dilatation catheter for intracranial drug coating is shown in the figure, which consists of a tip, a developing ring, a drug coating, a balloon, an inner tube, an outer tube and a handle, wherein the surface of the outer tube 6 is coated with a hydrophilic coating; the front end of theinner tube 5 is provided with a tip 1; asaccule 4 is fixed behind the tip 1, and a developingring 2 is arranged on aninner tube 5 in thesaccule 4; the right end of theballoon 4 is connected with an outer tube 6, and aninner tube 5 penetrates through theballoon 4 and the outer tube 6 and is connected with an operation knob; the outer tube 6 is connected with a handle 7; the inner surface of theballoon 4 outside theinner tube 5 is coated with adrug coating 3 around theinner tube 5.

The drug-coated balloon is segmented into 3-segment structure as shown in fig. 2. The saccule is divided into more than or equal to 3 petals and is wrapped on the periphery of theinner tube 5 to form a three-leaf fin saccule; spraying aliquid medicine 8 on the pits of the three-blade fin by using amedicine coating device 9 to form a medicine coating 3 (shown in figure 3); the concave pit of the balloon valve can receive more effective medicines; the inner layer of the drug coating layer, which is in contact with the surface of the balloon, is a crystallization layer and is called an 'ice layer', the outer layer is in one or more layers of micro-particle states and is called a 'snow layer', and the double-layer or multi-layer structure has the advantages that the dense 'snow layer' can protect effective drugs of the 'ice layer' to directly reach a lesion position and directly act on a blood vessel wall; and finally, the saccule coated with the ice layer and the snow layer is rolled up by a saccule curling device and is attached to the inner tube (as shown in figure 4), and under the structure, more effective medicines are protected in the valve of the saccule so as to achieve the purpose of reducing the medicine loss in the conveying process, namely the medicine coating saccule dilatation catheter is obtained.

The drug coating balloon dilatation catheter is of a rapid exchange Rx structure or is of a coaxial double-cavity OTW structure; wherein the length range of the balloon effective area is 5 mm-40 mm, and the diameter range is 1.0 mm-4.5 mm; the whole effective length range of the dilatation catheter is 1350 mm-1450 mm. The effective area of the balloon covered by the drug coating is composed of drugs capable of resisting cell proliferation, and the drugs comprise one or more of paclitaxel, paclitaxel derivatives, rapamycin derivatives and arsenic trioxide. The mass ratio of the effective medicine at the innermost layer of the medicine coating to the effective medicine at the outer layer is 1: 0.01-1: 1.

And the hydrophilic coating is coated on the surface of the outer tube, namely the hydrophilic coating is arranged on part of the area of the outer tube, so that the catheter is smoother after entering the blood vessel and can more easily pass through the blood vessel with intracranial tortuous lesion.

The intracranial drug coating balloon dilatation catheter is loaded with the anti-cell proliferation drug, and the drug is firmly locked on the balloon by using a special balloon curling mode, so that a small amount of effective drug is lost in the catheter conveying process, and a large amount of effective drug is conveyed to the vessel wall when a lesion part is expanded, and the occurrence of restenosis is reduced. Meanwhile, the intervention is not implanted, the stimulation is reduced, and the safety is improved.

Claims (6)

1. A drug-coated balloon dilatation catheter for intracranial blood vessels, which is characterized by consisting of a tip, a developing ring, a drug coating, a balloon, an inner tube, an outer tube and a handle, wherein the surface of the outer tube is coated with a hydrophilic coating; the front end of the inner tube (5) is provided with a tip (1); a saccule (4) is fixed behind the tip (1), and a developing ring (2) is arranged on an inner tube (5) in the saccule (4); the right end of the balloon (4) is connected with the outer tube (6), and the inner tube (5) penetrates through the balloon (4) and the outer tube (6) and is connected with the operation knob; the outer tube (6) is connected with the handle (7), and the inner surface of the saccule (4) outside the inner tube (5) is coated with the drug coating (3) which is wrapped on the periphery of the inner tube (5).

2. The drug-coated balloon dilatation catheter for intracranial blood vessels as claimed in claim 1, wherein the balloon is segmented into 3 or more segments and wrapped around the inner tube (5) forming a tri-lobed-fin balloon; spraying a liquid medicine (8) on the pits of the three-blade fins by using a medicine coating device (9) to form a medicine coating (3); the concave pit of the balloon valve can receive more effective medicines; the inner layer of the drug coating (3) in contact with the surface of the balloon is a crystallization layer and is called an 'ice layer', the outer layer is in one or more layers of micro-particle states and is called a 'snow layer', and the double-layer or multi-layer structure has the advantages that the effective drugs of the 'ice layer' can be protected by the compact 'snow layer' to directly reach the lesion site and directly act on the blood vessel wall; and finally, rolling the saccule coated with the ice layer and the snow layer by adopting saccule curling equipment, and attaching the rolled saccule to the inner tube, wherein under the structure, more effective medicines are protected in the valve of the saccule so as to achieve the aim of reducing the medicine loss in the conveying process, and the medicine coating saccule dilatation catheter is obtained.

3. The drug-coated balloon dilatation catheter for intracranial blood vessels according to claim 1 wherein the drug-coated balloon dilatation catheter is a fast-exchange Rx structure or a coaxial dual-lumen OTW structure; wherein the length range of the balloon effective area is 5 mm-40 mm, and the diameter range is 1.0 mm-4.5 mm; the whole effective length range of the dilatation catheter is 1350 mm-1450 mm.

4. The drug-coated balloon dilatation catheter for intracranial vessels according to claim 1 wherein the drug-coated effective area covering the balloon consists of a drug capable of resisting cell proliferation including one or a combination of paclitaxel, paclitaxel derivatives, rapamycin derivatives and arsenic trioxide.

5. The drug-coated balloon dilatation catheter for intracranial blood vessels as claimed in claim 4, wherein the drug coating of the drug-coated balloon is of a double-layer or multi-layer structure, and the mass ratio of the effective drug at the innermost layer to the effective drug at the outer layer of the drug coating is 1: 0.01-1: 1.

6. The drug-coated balloon dilatation catheter for intracranial blood vessels as claimed in claim 1, wherein the hydrophilic coating on the outer tube surface is a hydrophilic coating on a partial area of the outer tube, so that the catheter is smoother after entering the blood vessels and easier to pass through the blood vessels with intracranial tortuous lesions.

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