A double-layer balloon catheter guided by a guidewire for vascular chemical ablation

Abstract

The present invention discloses a guidewire-guided double-layer balloon catheter for vascular chemical ablation, comprising a catheter and a double-layer balloon axially arranged along the outer wall of the catheter, wherein the inner cavity of the catheter is radially divided into a guidewire guiding channel, a balloon filling channel and a drug administration channel which are independent of each other; the double-layer balloon comprises an inner balloon and an outer balloon which cover each other, wherein an outer cavity is formed between the inner balloon and the outer balloon after they are expanded, and the outer balloon is a loose porous structure, and is evenly and densely covered with micropores; after the balloon is expanded, the drug is delivered to the outer cavity through the drug administration channel, enters the balloon surface through the micropores and contacts with the target blood vessel endothelium, thereby accurately destroying the target blood vessel wall; under the condition of treating the same target blood vessel, compared with traditional chemical destruction or thermal ablation, the normal blood components may be greatly reduced, and the drug dosage may be reduced.

Description

Technical Field

[0001] The invention relates to medical equipment, in particular to a guidewire-guided double-layer balloon catheter for vascular chemical ablation. Background Art

[0002] Existing interventional catheters are divided into two categories according to their purpose: vascular recanalization and blood flow blocking. Vascular recanalization catheters are used to dilate narrowed blood vessels through mechanical dilation or micro-cutting. Drug-coated stents or balloons can release drugs after dilation to prevent restenosis of the blood vessels. Thrombolytic catheters are also vascular recanalization catheters, which play a recanalization role by introducing thrombolytic drugs. Blood flow blocking catheters are interventional catheters that block blood flow by balloon dilation and adhesion.

[0003] The most common interventional catheter is the balloon catheter, which has a double-lumen structure. The central channel is the guidewire channel, and the other channel at the tail is the balloon filling channel, which is connected to the balloon and expands the balloon by injecting gas or liquid. The two lumens are isolated from each other. Balloons are divided into non-compliant, semi-compliant, compliant and super-compliant.

[0004] At present, all kinds of balloon catheters are designed for the purpose of vascular recanalization or blood flow blocking, and the use of balloon drug delivery to achieve chemical ablation is not considered. In some diseases, blood vessels need to be destroyed to achieve the purpose of treatment. For example, severe varicose veins of the great saphenous vein need to be removed or destroyed, and KT syndrome needs to remove or destroy the marginal vein. The main methods are surgical resection, chemical destruction or physical thermal ablation. The corresponding existing catheter-based approaches to destroy blood vessels are divided into thermal ablation and catheter-based drug injection to destroy the blood vessel wall, both of which are non-precise. While thermally ablating or chemically destroying the blood vessel wall, a large amount of normal blood is also destroyed, posing a medical risk. In these diseases, the treatment purpose can be achieved by simply destroying the blood vessel wall.

[0005] There are currently no chemical ablation catheters that can achieve precise destruction, such as accurate ethanol ablation of the vessel wall via a balloon catheter. Summary of the invention

[0006] In order to overcome the deficiencies of the prior art, the present invention aims to provide a guidewire-guided double-layer balloon catheter for vascular chemical ablation that achieves precise chemical destruction of the vascular wall, thereby minimizing the damage to normal blood and reducing the amount of drugs used.

[0007] To achieve the above object, the technical solution adopted by the present invention is:

[0008] A guidewire-guided double-layer balloon catheter for vascular chemical ablation comprises a catheter and a double-layer balloon axially arranged along the outer wall of the catheter, the front end of the catheter is a guidewire traction head, and the rear end of the catheter is connected to a connector; the inner cavity of the catheter is radially divided into a guidewire guide channel, a balloon filling channel and a drug delivery channel that are independent of each other; the connector is provided with a first interface, a second interface and a third interface that are respectively connected to the guidewire guide channel, the balloon filling channel and the drug delivery channel; the double-layer balloon comprises an inner layer balloon and an outer layer balloon that cover each other, an outer cavity is formed between the inner layer balloon and the outer layer balloon after expansion, an inner cavity is formed in the inner layer balloon, the two cavities are isolated, the outer layer balloon is a loose porous structure, and micropores are evenly and densely distributed on the outer layer balloon, the inner cavity is connected to the balloon filling channel in the catheter, and the outer cavity is connected to the drug delivery channel in the catheter.

[0009] Furthermore, the micropores on the outer balloon are distributed at equal intervals.

[0010] Furthermore, a developing mark is arranged on the outside of the catheter, and two developing marks are located inside the double-layer balloon near the end of the double-layer balloon.

[0011] Furthermore, the double-layer balloon is a double-balloon structure arranged along the axial direction of the catheter, and the two balloons are independent of each other.

[0012] Furthermore, the diameter of the catheter is 5Fr-10Fr.

[0013] Furthermore, the double-layer balloon has a diameter of 0.5 cm-3.0 cm and a length of 3 cm-10 cm.

[0014] Furthermore, after the inner balloon and the outer balloon are expanded, the volume of the outer cavity formed between the two is 1.5-2.0 ml.

[0015] The present invention has the following beneficial effects:

[0016] The guidewire-guided double-layer balloon catheter for vascular chemical ablation of the present invention radially divides the inner cavity of the catheter into independent guidewire guidance channels, balloon filling channels and drug administration channels; one channel is used for guidewire guidance, another channel is used for balloon filling, and the third channel is connected to an outer cavity formed between the inner and outer balloons after the two are expanded. The outer balloon on the surface of the outer cavity has a loose porous structure, and micropores are evenly distributed on the outer balloon. After the balloon is expanded, the drug is delivered to the outer cavity through the drug administration channel, enters the balloon surface through the micropores and contacts the target blood vessel endothelium, thereby accurately destroying the target blood vessel wall; when treating the same target blood vessel, compared with traditional chemical destruction or thermal ablation, it may greatly reduce normal blood components and reduce drug dosage.

[0017] After the balloon is filled and expanded, it adheres to the blood vessel wall and squeezes out the blood. There is little or no blood between the balloon surface and the blood vessel wall. When the drug reaches the balloon surface, a local high-concentration environment is formed. The high-concentration drug directly contacts the blood vessel endothelium and achieves a destructive effect. At the same time, the destructive effect on normal blood is minimized, reducing the amount of drug used.

[0018] The connector is provided with three independent interfaces, and the catheter is divided into three-dimensional branches leading to the balloon surface. Each channel does not affect each other, thus improving the delivery efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 The overall structure diagram of the present invention is

[0020] Figure 2 Schematic diagram of the catheter cross section

[0021] Figure 3 Schematic diagram of the balloon structure

[0022] Figure 4 A partial enlarged view of the balloon

[0023] Figure 5 Schematic diagram of the double balloon structure

[0024] In the figure: 1-catheter, 2-double-layer balloon, 3-connector, 4-first interface, 5-second interface, 6-third interface, 7-development mark, 8-micropore, 9-inner balloon, 10-outer balloon, 11-guidewire guidance channel, 12-balloon filling channel, 13-drug administration channel. DETAILED DESCRIPTION

[0025] The present invention is further described in detail below with reference to specific embodiments, but is not intended to limit the present invention.

[0026] like Figure 1 As shown, the guidewire-guided double-layer balloon catheter for vascular chemical ablation of the present invention includes a catheter 1 and a double-layer balloon 2 axially arranged along the outer wall of the catheter. The balloon is coated on the outside of the catheter 1 and is a closed structure. After air or liquid is introduced, the balloon can expand and expand to open the narrow part of the blood vessel. The diameter of the catheter is 5Fr-10Fr, the diameter of the double-layer balloon 2 is 0.5cm-3.0cm, and the length is 3cm-10cm. The balloon can be made of non-compliant, semi-compliant, compliant and super-compliant materials as needed.

[0027] like Figure 2 and Figure 3As shown, the front end of the catheter 1 is a guidewire traction head, the end is small and the diameter gradually increases towards the rear end, the rear end of the catheter is connected to a connector 3, and the inner cavity of the catheter 1 is radially divided into independent guidewire guide channels 11, balloon filling channels 12 and drug administration channels 13; the connector 3 is provided with a first interface 4, a second interface 5 and a third interface 6 which are respectively connected to the guidewire guide channel 11, the balloon filling channel 12 and the drug administration channel 13; different materials are fed into the three channels through various structures, the second interface 5 is connected to the guidewire guide channel 11 and is kept in the same direction as the axial position of the catheter 1 to avoid bending of the guidewire, and the guidewire guide channel 11 is used for the guidewire to pass. The double-layer balloon 2 includes an inner balloon 9 and an outer balloon 10 that cover each other. After the inner balloon 9 and the outer balloon 10 are expanded, an outer cavity is formed between the two, and an inner cavity is formed inside the inner balloon 9. The two cavities are isolated. The balloon filling channel 12 is connected to the internal cavity of the double-layer balloon 2, and the outer cavity is connected to the drug delivery channel 13 in the catheter 1. After the balloon is delivered to the lesion site, air or liquid is filled into the balloon through the balloon filling channel 12 to inflate and expand the balloon.

[0028] like Figure 3 and Figure 4 As shown, the outer balloon 10 is a loose porous structure, and the outer balloon 10 is evenly and densely covered with micropores 8. After the balloon is expanded, the micropores 8 expand and open to deliver the drug to the balloon surface.

[0029] When in use, the inner balloon 9 is filled first, and then the drug is filled into the drug delivery channel 13 through the third interface 6 to a certain pressure. The micropores 8 on the surface of the outer balloon 10 are opened, and the drug is released to the blood vessel wall. After the inner balloon 9 and the outer balloon 10 are expanded, the volume of the outer cavity formed between the two is 1.5-2.0 ml, which is sufficient to accommodate the required amount of medicine, thereby ensuring the drug supply.

[0030] like Figure 3 and Figure 4 As shown, a plurality of micropores 8 are evenly spaced around the circumference of the outer balloon 10. After the balloon is expanded, the micropores 8 are easily stretched and opened, and the drug can directly reach the balloon surface.

[0031] like Figure 3 and Figure 5 As shown, a developing mark 7 is arranged on the outside of the catheter, and two developing marks 7 are located inside the double-layer balloon 2 near the end of the double-layer balloon 2, which facilitates tracking of the position after the balloon enters the blood vessel.

[0032] like Figure 5 As shown, the double-layer balloon 2 may also be a double-balloon structure arranged along the axial direction of the catheter 1, and the two balloons are independent of each other and deliver drugs to the location of vascular lesions respectively.

[0033] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the above embodiments, a person skilled in the art should understand that the specific implementation modes of the present invention can still be modified or replaced by equivalents, and any modification or equivalent replacement that does not depart from the spirit and scope of the present invention should be included in the scope of the claims.

Claims

1. A guidewire-guided double-layer balloon catheter for vascular chemical ablation, characterized in that: The invention comprises a catheter (1) and a double-layer balloon (2) arranged axially along the outer wall of the catheter, wherein the double-layer balloon (2) is a double-balloon structure arranged axially along the catheter (1), the two balloons are independent of each other, the front end of the catheter (1) is a guidewire traction head, and the rear end of the catheter is connected to a connector (3); the inner cavity of the catheter (1) is radially divided into a guidewire guide channel (11), a balloon filling channel (12), and a drug delivery channel (13) which are independent of each other; the connector (3) is provided with a first connector which is connected to the guidewire guide channel (11), the balloon filling channel (12), and the drug delivery channel (13), respectively. A first interface (4), a second interface (5) and a third interface (6); the double-layer balloon (2) comprises an inner layer balloon (9) and an outer layer balloon (10) which cover each other, wherein an outer cavity is formed between the inner layer balloon (9) and the outer layer balloon (10) after expansion, an inner cavity is formed inside the inner layer balloon (9), and the two cavities are isolated from each other; the outer layer balloon (10) is a loose porous structure, and micropores (8) are uniformly distributed on the outer layer balloon (10); the inner cavity is connected to the balloon filling channel (12) in the catheter (1), and the outer cavity is connected to the drug delivery channel (13) in the catheter (1); The diameter of the catheter (1) is 5Fr-10Fr; The double-layer balloon (2) has a diameter of 0.5 cm to 3.0 cm and a length of 3 cm to 10 cm.

2. A guidewire-guided double-layer balloon catheter for vascular chemical ablation according to claim 1, characterized in that: The micropores (8) on the outer balloon (10) are distributed at equal intervals.

3. A guidewire-guided double-layer balloon catheter for vascular chemical ablation according to claim 2, characterized in that: A developing mark (7) is arranged on the outside of the catheter, and two developing marks (7) are located inside the double-layer balloon (2) and close to the end of the double-layer balloon (2).

4. The guidewire-guided double-layer balloon catheter for vascular chemical ablation according to claim 1, characterized in that: After the inner balloon (9) and the outer balloon (10) are expanded, the volume of the outer cavity formed between the two is 1.5-2.0 mL.

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