CN115445059B - Automatic guiding balloon catheter and use method thereof - Google Patents

Abstract

The application relates to the technical field of medical instruments, in particular to an automatic guiding balloon catheter and a using method thereof. The application provides an automatic guiding balloon catheter, comprising: the device comprises an outer tube, a traction catheter and a balloon, wherein the traction catheter is telescopically arranged inside the outer tube and is connected to the balloon in a penetrating way, the distal end of the outer tube is connected with the proximal end of the balloon, the balloon is concavely wrapped in the outer tube, and the surface of a wrapping part is coated with a drug. The medicine sprayed on the surface of the saccule is tightly packed by the form of the automatic guiding packing saccule, and the medicine is effectively released at the lesion part, thereby reducing the medicine loss and improving the treatment effect.

Description

Automatically guided balloon catheter and method of use

Technical Field

The present application relates to the field of medical device technology, and in particular to an automatic guided balloon catheter and a method of use thereof.

Background Art

The drug-eluting balloon catheters currently on the market all have cylindrical balloon bodies, which are classified into different specifications according to the size and length of the balloon. The drug is evenly covered on the surface of the balloon through a spraying process.

The types of drugs sprayed on the balloon surface include paclitaxel and hydrophilic substances. After the drugs are sprayed, they need to be folded and then installed with a protective cover to protect the drugs on the balloon from falling off. However, during the operation, the protective cover needs to be removed, and the drugs on the balloon are completely exposed. When the protective cover is removed, a small amount of drugs will fall off.

In actual operation, it is necessary to use a guide catheter of specific specifications, establish a vascular access under the guidance of a guide guide wire, push the guide catheter to the coronary artery lesion under the guidance of the guide guide wire, and select the target vascular treatment position. Prepare the balloon catheter, evacuate the air in the catheter, and the catheter reaches the target vascular treatment position along the specific guide wire through the vascular access established by the guide catheter. When the balloon catheter is pushed to the lesion site in the guide catheter along the guide wire, there will be blood flushing, and touching the catheter wall during pushing will cause the loss of medicine on the balloon. Very little medicine actually reaches the lesion, and most of it is lost. The speed of the doctor's operation will also affect the amount of medicine reaching the lesion site.

In summary, a large amount of drug will be lost during the operation and delivery of the original drug balloon, and the amount of drug reaching the lesion is greatly reduced.

Summary of the invention

The purpose of the present application is to provide an automatically guided balloon catheter and a method of use, which can tightly wrap the drug sprayed on the surface of the balloon in the form of an automatically guided wrapped balloon and effectively release the drug at the lesion site, thereby reducing drug loss and improving the treatment effect.

In order to achieve the above-mentioned objectives, in a first aspect, the present invention provides an automatic guided balloon catheter, comprising: an outer tube, a traction catheter and a balloon, wherein the traction catheter is telescopically arranged inside the outer tube and is connected to the balloon, the distal end of the outer tube is connected to the proximal end of the balloon, and the balloon is wrapped in the outer tube in a concave shape and a drug is coated on the surface of the wrapped portion.

In an optional embodiment, the distal end of the traction catheter is connected to the distal end of the balloon by welding, and a catheter reinforcement is provided at the welding position.

In an optional embodiment, the distal end of the traction catheter and the distal end of the outer tube are respectively provided with a developing ring.

In an optional embodiment, the outer tube includes a pressure-filled cavity, which communicates with the interior of the balloon.

In an optional embodiment, the balloon comprises a double-layer structure, the outer layer material is polyether block polyamide, and the inner layer material comprises nylon, polysiloxane or polyurethane.

In an optional embodiment, the traction catheter includes an internal guidewire cavity, the guidewire cavity runs through the entire traction catheter, and communicates with the outside at the distal end of the balloon.

In an optional embodiment, a guide wire is further included, wherein the tail end of the guide wire extends from the distal end of the balloon, passes through the entire guide wire cavity, and then extends out from the traction catheter.

In an optional embodiment, a support ring is provided between the outer tube and the traction catheter, the support ring comprises a flexible support ring provided inside the outer tube, and the traction catheter can be movably connected to the support ring.

In an optional embodiment, the distal end of the traction catheter is connected to the center of the distal end of the balloon, and the outer tube, the support ring and the traction catheter are concentrically arranged.

In a second aspect, the present invention provides a method for using the automatic guiding balloon catheter according to any one of the aforementioned embodiments, comprising the following steps:

Vascular access was constructed via a guide wire;

Delivering the distal end of the outer tube to the proximal side of the lesion site in the blood vessel;

Inflate the balloon so that the balloon wrapped in the outer tube moves in a rolling outward manner;

After the balloon is inflated and expanded, it fits tightly to the lesion, exposing the drug in the wrapped area and continuously releasing it to the lesion.

After the drug release is completed, the balloon is depressurized, and the traction catheter is withdrawn to drag the depressurized balloon into the outer tube;

Withdraw the outer tube to remove the automatic guided balloon catheter as a whole.

In the present application, by connecting the distal end of the outer tube with the proximal end of the balloon, and telescopically arranging the traction catheter inside the outer tube, and combining the connection form of the traction catheter being threaded onto the balloon, the balloon can be made to use the proximal end of the balloon as a deformation reference when pressurized and expanded, thereby driving the traction catheter to automatically move forward, thereby realizing automatically guided pressurized expansion deformation.

The balloon is wrapped in an outer tube in a concave shape, and the surface of the wrapped part is coated with drugs, so that the drugs coated on the surface of the balloon can be tightly wrapped, and the balloon catheter is pushed to the lesion under the guidance of the guide wire. At the lesion, the pressurized balloon moves forward in the form of rolling and everting, and the balloon is expanded at the lesion, so that the exposed drugs are continuously released at the lesion position. The continuous release time can be controlled according to specific requirements, which greatly reduces the loss of drugs, increases the drug release at the lesion position, and can better achieve the treatment effect.

Other features and advantages of the present application will be described in detail in the subsequent specific implementation section.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

FIG1 is a schematic diagram of the structure of the automatic guiding balloon catheter in the present application before being deformed by inflation;

FIG2 is a schematic diagram of the structure of the automatic guiding balloon catheter in the present application during the deformation process;

FIG3 is a schematic diagram of the structure of the automatic guiding balloon catheter in the present application after being deformed by inflation.

icon:

1-outer tube; 2-traction catheter; 3-balloon; 4-catheter reinforcement; 5-development ring; 6-guide wire; 7-support ring; 8-blood vessel; 9-lesion site.

DETAILED DESCRIPTION

In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

In the description of this application, it should be noted that the terms "inside", "outside", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the application is usually placed when in use, which is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application. In addition, the terms "first", "second", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

In the description of this application, it should also be noted that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

1-3 , the automatic guided balloon catheter in the present application can effectively wrap the drug coated on the surface of the balloon 3 by mainly changing the pressing form of the balloon 3 in the catheter, thereby preventing the drug from being washed away during the balloon 3 catheter delivery process.

Combined with the connection between the traction catheter 2 and the balloon 3, and connecting the distal end of the outer tube 1 with the proximal end of the balloon 3, the balloon 3 can be deformed within a controllable range, and the balloon 3 after pressure relief can be easily withdrawn into the outer tube 1 through the traction catheter 2, which is conducive to achieving automatic guided expansion and removal of the entire balloon 3 catheter.

The automatic guided balloon catheter in the present invention has a main structure including an outer tube 1, a traction catheter 2 and a balloon 3. Specifically, the traction catheter 2 can be freely and telescopically arranged in the outer tube 1, and is connected to the balloon 3 in the form of being threaded on the balloon 3. Through the connection between the traction catheter 2 and the balloon 3, combined with the guide wire 6 in the traction catheter 2, the balloon 3 can be expanded and deformed in an automatic guided manner under the guidance of the guide wire 6.

The distal end of the outer tube 1 is connected to the proximal end of the balloon 3, and the balloon 3 is wrapped in the outer tube 1 in a concave shape. Specifically, before being pressurized and deformed, the distal end of the traction catheter 2 is located in the outer tube 1 and is at least a certain distance from the distal end of the outer tube 1, so that the balloon body of the balloon 3 itself is wrapped in the outer tube 1 in a concave shape. By coating the surface of the wrapped part with drugs, effective protection can be formed for the coated drugs to prevent them from being washed away during transportation.

The drug on the balloon 3 may be paclitaxel, a mixture of paclitaxel and rapamycin, or a mixture of rapamycin and a drug-carrying matrix.

During the inflation and deformation process, the connection part between the balloon 3 and the distal end of the outer tube 1 can be used as a reference point. More specifically, with the proximal end of the balloon 3 as the deformation reference point, the balloon 3 drives the traction catheter 2 to roll and unfold in the form of eversion and blooming, while the wrapped part of the balloon 3 protrudes from the outer tube 1, and the drug coated on the wrapped part is exposed. Furthermore, through pressurized expansion, the rolled and exposed surface of the balloon 3 is closely fitted with the diseased part 9 in the blood vessel 8, and the exposed drug is continuously released in the diseased part 9, effectively improving the treatment effect of the hardened and narrowed diseased part 9 in the blood vessel 8.

A guide wire 6 is inserted into the traction catheter 2. Based on the connection between the traction catheter 2 and the balloon 3, the balloon 3 drives the traction catheter 2 to continuously extend toward the distal end of the outer tube 1 along the guide wire 6 during deformation, thereby realizing automatic guided expansion, and the traction catheter 2 moves forward along with the balloon 3 in the form of a rolling expansion of a long balloon.

In order to prevent the balloon 3 from over-expanding, and further to prevent the balloon 3 from stretching only in the axial direction while weakening the expansion in the radial direction, the distal end of the traction catheter 2 is welded to the distal end of the balloon 3, which can control the expansion length of the balloon 3. On the one hand, it can make the deformation of the balloon 3 controllable and prevent the balloon 3 from moving forward excessively, effectively play a restraining role, and ensure that the balloon 3 is fully expanded in the radial direction, so that the medicine on the surface of the balloon 3 can be reliably attached to the diseased site 9; on the other hand, after the balloon 3 is depressurized, the balloon 3 can be withdrawn into the outer tube 1 by pulling back the traction catheter 2, so that the entire balloon 3 catheter can be reliably removed from the blood vessel 8.

Based on the welding between the distal end of the balloon 3 and the distal end of the traction catheter 2, and the distance between the distal end of the traction catheter 2 and the distal end of the outer tube 1, the balloon 3 in the present invention lies in the outer tube 1 in the form of a hollow cone before inflation, the tip of the hollow cone is the connection point between the distal end of the balloon 3 and the distal end of the traction catheter 2, the bottom of the hollow cone is the distal end of the outer tube 1, and the inner wall and the outer wall of the balloon 3 respectively constitute the inner and outer surfaces of the hollow cone.

With this arrangement, the outer side wall of the balloon 3 can be accommodated in the outer tube 1 in a concave shape, and at the same time, the surface of the balloon 3 in the concave portion can be effectively wrapped to effectively prevent the coating drug from being exposed.

A catheter reinforcement 4 is provided at the welding position between the distal end of the balloon 3 and the distal end of the traction catheter 2, which can enhance the connection strength between the balloon 3 and the traction catheter 2 and prevent damage to the structure of the balloon 3 itself when pulling back the balloon 3 or controlling the expansion degree of the balloon 3.

In one embodiment, the distal end of the traction catheter 2 and the distal end of the outer tube 1 are respectively provided with a developing ring 5, which can facilitate positioning and judgment. Specifically, based on the connection between the proximal end of the balloon 3 and the distal end of the outer tube 1, according to the positioning of the developing ring 5 at the distal end of the outer tube 1 and the size of the balloon 3, the distance of the balloon 3 to the lesion site 9 can be determined, thereby ensuring that the concave part of the balloon 3 before inflation accurately acts on the lesion site 9 after inflation and eversion expansion.

Combined with the developing ring 5 provided at the distal end of the traction catheter 2 , the length of the balloon 3 after inflation can be determined more accurately, the positioning accuracy can be further improved, and the telescopic movement of the traction catheter 2 can be conveniently controlled through the relative position relationship of the two developing rings 5 .

The outer tube 1 in the present invention is provided with a pressure-charging chamber inside, and the pressure-charging chamber is communicated with the inside of the balloon 3, so that the inflation and depressurization operations of the balloon 3 can be performed normally.

Furthermore, the balloon 3 in the present invention is a double-layer structure, specifically a hard outer and soft inner structure. Preferably, the inner and outer walls of the balloon 3 are designed as an integrated whole, and the outer wall is made of a harder polyether block polyamide material. The purpose of making the outer wall of the balloon 3 of the harder material is to prevent the balloon 3 from over-expanding during the pressurization process and deviating from the regular cylindrical shape, and to avoid the balloon 3 from being traction-controlled by the traction catheter 2 due to rapid movement during the pressurization process.

The inner wall of the balloon 3 is made of a softer elastic material such as nylon, polysiloxane or polyurethane. Compared with the existing ordinary balloon 3, it is easier to turn outward and act on the lesion site in a shorter time during the pressurization of the balloon 3, and the drug efficacy is maximized without being washed away by the blood.

It should be pointed out that the double-layer structure of the balloon 3, which is hard on the outside and soft on the inside, takes into account two factors: smoother inflation and deformation and control of the expansion and deformation of the balloon 3 during the deformation process. It can better expand and deform within a controllable range, thereby ensuring that the balloon 3 can be reliably everted and bloomed, and through regular deformation, the surface of the balloon 3 can fully fit the diseased area 9.

The traction catheter 2 includes a guidewire cavity (not shown in the figure) located inside. Specifically, the guidewire cavity runs through the entire traction catheter 2 and is arranged on the axis of the traction catheter 2, wherein the distal opening of the guidewire cavity is arranged in the middle of the distal end of the balloon 3 and is sealed and welded to the catheter reinforcement 4, which can enhance the automatic guiding function of the balloon 3 during the deformation process.

The distal end of the guidewire cavity is terminated at the distal end of the balloon 3, and the guidewire cavity is communicated with the outside at the distal end of the balloon 3, so that the guidewire can be extended from the distal end of the balloon 3. Specifically, before the balloon 3 catheter as a whole enters the blood vessel 8, the tail end of the guide wire 6 is extended from the distal end of the balloon 3, passes through the entire guidewire cavity, and then extends from the traction catheter 2. The entire balloon 3 catheter can enter the blood vessel 8 under the guidance of the guide wire 6 and accurately and reliably reach the lesion site 9.

In another preferred embodiment, a support ring 7 is provided between the outer tube 1 and the traction catheter 2, and the support ring 7 includes a flexible support ring 7 provided inside the outer tube 1, and the traction catheter 2 can be movably connected to the support ring 7. The flexible support ring 7 enables the outer tube 1 and the traction catheter 2 to be arranged concentrically, and the reliability of the telescopic movement of the traction catheter 2 inside the outer tube 1 is maintained.

The distal end of the traction catheter 2 is connected to the center of the distal end of the balloon 3. Furthermore, by concentrically arranging the outer tube 1, the support ring 7 and the traction catheter 2, the traction catheter 2 can drive the balloon 3 to move in the axial direction of the outer tube 1, and thus the traction catheter 2 can reliably withdraw the depressurized balloon 3 into the outer tube 1, which is beneficial to the overall removal of the balloon 3 catheter after drug release.

It is important to point out that, through the automatic balloon 3 catheter of the present invention, the drug sprayed on the balloon 3 can be wrapped in the outer tube 1, and the loss of the drug is completely avoided during the doctor's operation and transportation process. When the drug reaches the lesion site, the drug is released and most of the drug can act on the lesion site, thereby ensuring the treatment effect to the greatest extent.

The present invention also provides a method for using the above-mentioned automatic guiding balloon catheter, comprising the following steps:

Select a balloon 3 catheter of specific specifications, establish a blood vessel 8 access under the guidance of the guide wire 6, remove the protective cover on the distal end of the balloon 3 catheter, push the balloon 3 catheter to the coronary artery lesion under the guidance of the guide wire 6, and select the target blood vessel 8 treatment position.

The distal end of the outer tube 1 on the balloon 3 catheter is transported to the proximal side of the diseased site 9 in the blood vessel 8, and a space for the balloon 3 to be pressurized and deformed is reserved between the distal end of the outer tube 1 and the diseased site 9.

During the delivery process, the drug coated on the surface of the balloon 3 is in a wrapped state, which reduces the loss due to blood flow erosion and contact with the inner wall of the blood vessel 8.

The balloon 3 is pressurized, so that the balloon 3 wrapped in the outer tube 1 in a concave shape moves forward in a rolling manner to protrude from the outer tube 1 and extend toward the distal end of the outer tube 1 .

By controlling the traction catheter 2 to restrain the excessive extension of the balloon 3 , the balloon 3 is expanded in the radial direction and fits tightly with the lesion site 9 , so that the medicine in the wrapped part is exposed and continuously released at the lesion site 9 .

By controlling the inflation time of the balloon 3, the release time of the drug is controlled, and the duration of the action time can be determined according to the specific situation. After the drug release is completed, the balloon 3 is depressurized, and the traction catheter 2 is withdrawn to drag the depressurized balloon 3 into the outer tube 1.

The outer tube 1 is withdrawn to completely remove the automatic guiding balloon catheter from the blood vessel 8 .

By using the automatic guiding balloon catheter in the present invention, the loss of the balloon 3 during the delivery process can be avoided to the greatest extent, and the treatment effect on the lesion site 9 can be effectively improved.

It should be noted that, in the absence of conflict, the features in the embodiments of this application may be combined with each other.

The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims (4)

1. An auto-guiding balloon catheter, comprising: the traction catheter is arranged inside the outer tube in a telescopic way and is connected to the balloon in a penetrating way, the distal end of the outer tube is connected with the proximal end of the balloon, the balloon is concavely wrapped in the outer tube, and the surface of a wrapping part is coated with a drug;

before the traction catheter is in non-pressurized deformation, the distal end of the traction catheter is positioned in the outer tube, at least a certain distance exists between the distal end of the traction catheter and the distal end of the outer tube, the balloon is accommodated in the outer tube in a hollow pointed cone mode, the tip end of the hollow pointed cone is a connection point between the distal end of the balloon and the distal end of the traction catheter, the bottom of the hollow pointed cone is the distal end of the outer tube, and the inner side wall and the outer side wall of the balloon respectively form the inner side and the outer side of the hollow pointed cone;

The balloon comprises a double-layer structure with hard outside and soft inside, the outer layer is made of polyether block polyamide, and the inner layer is made of nylon, polysiloxane or polyurethane;

a support ring is arranged between the outer tube and the traction catheter, the support ring comprises a flexible support ring arranged in the outer tube, and the traction catheter is movably connected on the support ring in a penetrating way;

the distal end of the traction catheter is welded with the distal end of the balloon, and a catheter reinforcement is arranged at the welding part;

the distal end of the traction catheter and the distal end of the outer tube are respectively provided with a developing ring;

the traction catheter comprises a guide wire cavity positioned inside, and the guide wire cavity penetrates through the whole traction catheter and is communicated with the outside at the distal end of the balloon;

the guide wire cavity is arranged on the axis of the traction catheter, and the distal end opening of the guide wire cavity is arranged at the center part of the distal end of the balloon and is welded with the catheter reinforcement in a sealing way;

The automatic guiding balloon catheter comprises the following steps in the use process:

constructing a vascular access through a guide wire;

delivering the distal end of the outer tube to the proximal side of the endovascular lesion;

Pressurizing the sacculus to enable the sacculus wrapped in the outer tube to roll and move outwards;

The balloon is tightly attached to the lesion part after being inflated, so that the medicine at the wrapping part is exposed and is continuously released at the lesion part;

after the medicine is released, the balloon is decompressed, the traction catheter is retracted, and the decompressed balloon is dragged into the outer tube;

And (5) retracting the outer tube to enable the automatic guiding balloon catheter to be wholly withdrawn.

2. The self-guiding balloon catheter of claim 1, wherein the outer tube comprises a plenum that communicates with the interior of the balloon.

3. The self-guiding balloon catheter of claim 1, further comprising a guide wire, a trailing end of the guide wire extending from a distal end of the balloon and extending from the traction catheter throughout the guide wire lumen.

4. The self-guiding balloon catheter of claim 1, wherein the distal end of the traction catheter is centered on the distal end of the balloon, and the outer tube, the support ring, and the traction catheter are concentrically disposed.