CN115445059A - Automatic guiding balloon catheter and using method - 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 invention provides an automatic guiding balloon catheter, comprising: the traction catheter is telescopically arranged inside the outer tube and connected to the balloon in a penetrating mode, the far end of the outer tube is connected with the near end of the balloon, and the balloon is wrapped in the outer tube in a concave mode and coated with medicine on the surface of the wrapping portion. Through the form of the automatic guide wrapping type saccule, the medicine sprayed on the surface of the saccule is tightly wrapped, and the medicine is effectively released at a diseased part, so that the treatment effect is improved while the medicine loss is reduced.

Description

Automatic guiding balloon catheter and using method

Technical Field

The application relates to the technical field of medical instruments, in particular to an automatic guiding balloon catheter and a using method thereof.

Background

In the existing medicine balloon catheters on the market, the balloon body part of the balloon is cylindrical, the medicine balloon is divided into different specifications according to the size and the length of the balloon, and the medicine is uniformly covered on the surface of the balloon through a spraying process.

The types of the medicines sprayed on the surface of the balloon comprise paclitaxel and hydrophilic substances, and the medicines are folded after being sprayed and then are protected by installing a protective sleeve to prevent the medicines on the balloon from falling off. However, in the process of surgical operation, the protective sleeve needs to be removed, the medicine on the balloon is completely exposed, and a small amount of medicine falls off when the balloon is removed.

In practical operation, a guide catheter with specific specification is required to be used, a blood vessel passage is established under the guidance of the guide wire, the guide catheter is pushed to the coronary lesion of the heart under the guidance of the guide wire, and a target blood vessel treatment position is selected. Preparing a balloon catheter, evacuating air in the catheter, and enabling the catheter to reach a target vascular treatment position along a specific guide wire through a vascular access established by the guide catheter. When the balloon catheter is pushed to the lesion position along the guide wire in the guide catheter, blood is flushed, and the drug on the balloon is lost due to the touch of the catheter wall during pushing. The medicine really reaching the pathological changes is little and most of the medicine is lost, and the amount of the medicine reaching the pathological changes can be influenced by the operating time of a doctor.

In conclusion, a large amount of medicaments are lost in the operation and conveying processes of the original medicament balloon, and the medicaments reaching the pathological changes are greatly reduced.

Disclosure of Invention

The application aims to provide an automatic guiding balloon catheter and a using method, which can tightly wrap the medicine sprayed on the surface of the balloon in an automatic guiding wrapping type balloon mode, effectively release the medicine at a pathological change part, and improve the treatment effect while reducing the medicine loss.

In order to achieve the above object, in a first aspect, the present invention provides an automatic guided balloon catheter comprising: the traction catheter is telescopically arranged inside the outer tube and connected on the balloon in a penetrating mode, the far end of the outer tube is connected with the near end of the balloon, the balloon is wrapped in the outer tube in a concave mode, and the surface of the wrapped portion is coated with medicine.

In an alternative embodiment, the distal end of the pull catheter is welded to the distal end of the balloon, and a catheter reinforcement is provided at the weld.

In an alternative embodiment, the distal end of the pull catheter and the distal end of the outer tube are provided with visualization rings, respectively.

In an alternative embodiment, the outer tube includes a plenum that communicates with the interior of the balloon.

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

In an alternative embodiment, the traction catheter includes an internal guidewire lumen that extends through the entire traction catheter and communicates with the exterior at the distal end of the balloon.

In an optional embodiment, the balloon catheter further comprises a guide wire, wherein the tail end of the guide wire extends from the distal end of the balloon and extends out of the traction catheter after penetrating through the whole guide wire cavity.

In an alternative embodiment, a support ring is arranged between the outer tube and the draft tube, the support ring comprising a flexible support ring arranged within the outer tube, the draft tube being movably threaded on the support ring.

In an alternative embodiment, the distal end of the pull catheter is attached to the center of the distal end of the balloon, and the outer tube, the support ring, and the pull catheter are concentrically disposed.

In a second aspect, the present invention provides a method of using the self-guiding balloon catheter according to any one of the preceding embodiments, comprising the steps of:

constructing a vascular access through a guide wire;

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

pressurizing the saccule to make the saccule wrapped in the outer tube move in a rolling type eversion way;

the saccule is tightly attached to the lesion part after being pressurized and expanded, so that the medicine at the wrapped part is exposed and continuously released at the lesion part;

after the medicine is released, the saccule is decompressed, the traction catheter is withdrawn, and the decompressed saccule is dragged into the outer tube;

and withdrawing the outer tube to integrally withdraw the automatic guide saccule catheter.

Through being connected the distal end of outer tube and the near-end of sacculus in this application to will pull the pipe telescopically and set up inside the outer tube, and combine to pull the connection form of pipe cross-under on the sacculus, can make the sacculus use the sacculus near-end as the deformation benchmark when pressurizing the expansion, drive and pull the automatic forward movement of pipe, realize the inflation deformation of automatic direction.

The combined balloon is wrapped in the outer tube in a concave manner, the surface of the wrapped part is coated with medicines, the medicines coated on the surface of the balloon can be tightly wrapped, the balloon catheter is pushed to a lesion under the guidance of a guide wire, the lesion is moved forwards in a rolling and eversion manner through the pressurized balloon, and the balloon is spread at the lesion, so that the exposed medicines are continuously released at the lesion position, the continuous release time can be controlled according to specific requirements, the medicine loss is greatly reduced, the medicine release at the lesion position is increased, and the treatment effect can be better achieved.

Additional features and advantages of the present application will be described in detail in the detailed description which follows.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained from the drawings without inventive effort.

FIG. 1 is a schematic structural view of an automatic guided balloon catheter according to the present application before being deformed by pressurization;

FIG. 2 is a schematic structural view of the self-guiding balloon catheter of the present application during deformation;

fig. 3 is a schematic structural view of the self-guiding balloon catheter after being deformed by pressurization.

Icon:

1-an outer tube; 2-a traction catheter; 3-a balloon; 4-a catheter reinforcement; 5-a developing ring; 6-guide wire; 7-a support ring; 8-blood vessels; 9-the diseased region.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. It should be apparent that the embodiments described are some, but not all embodiments of the present application. The components of the embodiments of the present application, generally described and illustrated in the figures herein, can be arranged and designed in a wide variety of different configurations.

In the description of the present application, it should be noted that the terms "inside", "outside", and the like indicate orientations or positional relationships based on orientations or positional relationships shown in the drawings or orientations or positional relationships that the product of the application is usually placed in when used, and are used only for convenience of description and simplification of the description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and operate, and thus, should not be construed as limiting the present application. Furthermore, the terms "first," "second," and the like are used merely to distinguish one description from another, and are not to be construed as indicating or implying relative importance.

In the description of the present application, it should also be noted that, unless expressly stated or limited otherwise, the terms "disposed" and "connected" are to be construed broadly, and may for example be fixedly connected, detachably connected, or integrally connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.

Referring to fig. 1-3, the automatic guiding balloon catheter in the present application can effectively wrap the drug coated on the surface of the balloon 3 by mainly changing the pressing and lying mode of the balloon 3 in the catheter, so as to prevent the drug from washing away and losing in the catheter delivery process of the balloon 3.

Combine to pull being connected between pipe 2 and the sacculus 3 to and make the distal end of outer tube 1 be connected with the near-end of sacculus 3, can make sacculus 3 carry out deformation at controllable within range, and make things convenient for sacculus 3 after the pressure release to withdraw through pulling pipe 2 and get into outer tube 1, do benefit to the removal that realizes automatic guide expansion and whole sacculus 3 pipe.

The main structure of the automatic guiding saccule conduit comprises an outer tube 1, a traction conduit 2 and a saccule 3, specifically, the traction conduit 2 is freely and telescopically arranged in the outer tube 1 and is connected with the saccule 3 in a mode of being connected on the saccule 3 in a penetrating way, and the saccule 3 can be expanded and deformed in an automatic guiding mode under the guiding of a guiding guide wire 6 by the connection between the traction conduit 2 and the saccule 3 and the combination of the guiding guide wire 6 in the traction conduit 2.

The far end of outer tube 1 is connected with the near-end of sacculus 3, and sacculus 3 wraps up in outer tube 1 with sunken form, specifically, before not inflating deformation, the distal end of traction catheter 2 is located outer tube 1, and has certain distance with the distal end of outer tube 1 at least, makes sacculus 3's utricule itself wrap up in outer tube 1 with sunken form, through the surface coating medicine at the parcel position, can form the effective protection to coating medicine, prevents that it from receiving to erode in transportation process and running off.

The medicine on the balloon 3 can be paclitaxel, a mixture of paclitaxel and rapamycin, and a mixture of rapamycin and a medicine-carrying matrix.

The balloon 3 can be connected with the far end of the outer tube 1 as a reference point in the pressurizing deformation process, and more specifically, the near end of the balloon 3 is used as a deformation reference point, so that the balloon 3 drives the traction catheter 2 to roll and unfold in an outward turning manner, meanwhile, the wrapping part of the balloon 3 protrudes out of the outer tube 1, and the medicine coated on the wrapping part is exposed, further, the surface of the balloon 3 which is exposed in a rolling manner is tightly attached to a lesion part 9 in a blood vessel 8 through pressurizing expansion, the exposed medicine is continuously released at the lesion part 9, and the treatment effect of the hardened and narrowed lesion part 9 in the blood vessel 8 is effectively improved.

A guide wire 6 penetrates through the traction catheter 2, and based on the connection between the traction catheter 2 and the balloon 3, the traction catheter 2 is driven to continuously extend out of the far end of the outer tube 1 along the guide wire 6 in the deformation process of the balloon 3, so that automatic guiding expansion is realized, and the traction catheter 2 moves forwards along with the balloon 3 in a rolling expansion mode of the expansion of the elongated balloon.

In order to prevent the balloon 3 from being over-expanded, and further in order to prevent the balloon 3 from being expanded only in the axial direction and weakening the expansion in the radial direction, the far end of the traction catheter 2 is welded with the far end of the balloon 3, so that the control on the expansion length of the balloon 3 can be formed, on one hand, the deformation of the balloon 3 can be controlled, the balloon 3 is prevented from moving forwards excessively, the traction effect is effectively achieved, the sufficient expansion of the balloon 3 in the radial direction is ensured, and the medicine on the surface of the balloon 3 can be reliably attached to the lesion part 9; on the other hand, after the balloon 3 is decompressed, the balloon 3 can be withdrawn into the outer tube 1 by pulling back the traction catheter 2, so that the whole balloon 3 catheter can be reliably withdrawn from the blood vessel 8.

Based on the welding of the far end of the balloon 3 and the far end of the traction catheter 2 and the distance between the far end of the traction catheter 2 and the far end of the outer tube 1, the balloon 3 is accommodated in the outer tube 1 in a hollow pointed cone form before pressurization, the tip of the hollow pointed cone is a connection point of the far end of the balloon 3 and the far end of the traction catheter 2, the bottom of the hollow pointed cone is the far end of the outer tube 1, and the inner side wall and the outer side wall of the balloon 3 respectively form the inner surface and the outer surface of the hollow pointed cone.

Through this kind of mode of setting up, can make the lateral wall of sacculus 3 with the form holding of sunken form in outer tube 1, make 3 faces of sacculus of depressed part obtain effective parcel simultaneously, effectively prevent exposing of coating medicine.

The catheter reinforcing part 4 is arranged at the welding part of the far end of the balloon 3 and the far end of the traction catheter 2, so that the connection strength between the balloon 3 and the traction catheter 2 can be enhanced, and the balloon 3 is prevented from being damaged when the balloon 3 is pulled back or the expansion degree of the balloon 3 is controlled.

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 visualization ring 5, which can facilitate the positioning judgment. Specifically, based on the connection between the near end of the balloon 3 and the far end of the outer tube 1, the distance from the balloon 3 to the lesion site 9 can be determined according to the positioning of the far-end developing ring 5 of the outer tube 1 and the size of the balloon 3, so that the balloon 3 at the concave part before being inflated is ensured to accurately act on the lesion site 9 after being inflated in an everted manner.

The length of sacculus 3 after pressurizing can be judged more accurately by combining the developing ring 5 arranged at the far end of the traction catheter 2, the positioning accuracy is further improved, and the telescopic movement of the traction catheter 2 can be controlled conveniently through the relative position relation of the two developing rings 5.

The inner part of the outer tube 1 is provided with a pressurizing cavity which is communicated with the inner part of the saccule 3, so that the pressurizing and depressurizing operation of the saccule 3 can be normally carried out.

Further, the balloon 3 in the present invention is a double-layer structure, specifically a structure with hard outer part and soft inner part, preferably, the inner and outer walls of the balloon 3 are integrally designed, the outer wall is made of hard polyether block polyamide, and the outer wall of the balloon 3 made of hard material is based on the principle that the balloon 3 can be prevented from excessively expanding in the pressurizing process to cause the shape deviation from the regular cylindrical shape, and the balloon 3 is prevented from being rapidly moved in the pressurizing process without being restricted by the traction of the traction catheter 2.

The inner wall of the saccule 3 is made of softer elastic materials such as nylon, polysiloxane or polyurethane, and compared with the existing common saccule 3, the saccule 3 is easier to be outwards turned out in a shorter time and acts on a lesion position in the pressurizing process, and the adherence drug effect is furthest ensured under the condition that the drug is not washed by blood.

It should be pointed out that the double-layer structure of the balloon 3 with hard outside and soft inside takes into account two factors of more smooth pressurizing deformation and restraining the expansion deformation in the deformation process of the balloon 3, and can better perform the expansion deformation in a controllable range, thereby ensuring that the balloon 3 is reliably everted and bloated, and ensuring that the surface of the balloon 3 is fully attached to the lesion part 9 through regular deformation.

The traction catheter 2 comprises a guide wire cavity (not shown in the figure) which is positioned inside, specifically, the guide wire cavity is communicated with the whole traction catheter 2 and is arranged on the shaft center of the traction catheter 2, wherein the far end opening of the guide wire cavity is arranged at the center of the far end of the balloon 3 and is welded with the catheter reinforcing piece 4 in a sealing way, and the automatic guiding function of the balloon 3 in the deformation process can be enhanced.

The distal end of the guide wire cavity is stopped at the distal end of the balloon 3, and the guide wire cavity is communicated with the outside at the distal end of the balloon 3, so that the guide wire can extend out of the distal end of the balloon 3. Specifically, before the balloon 3 catheter integrally runs on a blood vessel 8, the tail end of the guide wire 6 extends from the far end of the balloon 3, penetrates through the whole guide wire cavity and then extends out of the traction catheter 2. The integral balloon 3 catheter can enter the blood vessel 8 under the guiding action of the guide wire 6 and accurately and reliably reach the lesion site 9.

In another preferred embodiment, a support ring 7 is arranged between the outer tube 1 and the draft guide tube 2, the support ring 7 comprising a flexible support ring 7 arranged inside the outer tube 1, the draft guide tube 2 being movably threaded on the support ring 7. The outer tube 1 can be arranged concentrically with the draft tube 2 by means of the flexible support ring 7, maintaining the reliability of the telescopic movement of the draft tube 2 inside the outer tube 1.

The far end of the traction catheter 2 is connected with the center of the far end of the balloon 3, further, the outer tube 1, the support ring 7 and the traction catheter 2 are concentrically arranged, the traction catheter 2 can drive the balloon 3 to move in the axis direction of the outer tube 1, and then the traction catheter 2 can reliably withdraw the deflated balloon 3 into the outer tube 1, so that the balloon 3 catheter after drug release is favorably and integrally withdrawn.

It is important to point out that the automatic balloon 3 catheter of the invention can wrap the medicine sprayed on the balloon 3 in the outer tube 1, completely avoid the loss of the medicine in the operation and transportation process of a doctor, release the medicine when reaching the lesion position, and mostly act on the lesion position, thereby ensuring the treatment effect to the maximum extent.

The invention also provides a using method of the automatic guiding balloon catheter, which comprises the following steps:

selecting a balloon 3 catheter with specific specification, establishing a blood vessel 8 passage under the guidance of a guide wire 6, removing a protective sleeve on the distal end of the balloon 3 catheter, pushing the balloon 3 catheter to a coronary lesion under the guidance of the guide wire 6, and selecting a target blood vessel 8 treatment position.

The far end of the outer tube 1 on the balloon 3 catheter is conveyed to the near end side part of a lesion site 9 in the blood vessel 8, and a space for pressurizing and deforming the balloon 3 is reserved between the far end of the outer tube 1 and the lesion site 9.

The medicine coated on the surface of the balloon 3 is in a wrapping state in the conveying process, so that the blood flow scouring and the loss caused by touching with the inner wall of the blood vessel 8 are reduced.

And pressurizing the sacculus 3, so that the sacculus 3 which is wrapped in the outer tube 1 in a concave shape moves forwards in a rolling mode to protrude out of the outer tube 1 and extends towards the far end of the outer tube 1.

The excessive forward extension of the balloon 3 is controlled by controlling the traction catheter 2, so that the balloon 3 is expanded and expanded in the radial direction and is tightly attached to the lesion part 9, and the medicine wrapped on the lesion part is exposed and continuously released on the lesion part 9.

The release time of the medicine is controlled by controlling the pressurizing and expanding time of the balloon 3, and the length of the action time can be judged according to specific conditions. After the medicine is released, the saccule 3 is decompressed, the traction catheter 2 is withdrawn, and the decompressed saccule 3 is dragged into the outer tube 1.

And withdrawing the outer tube 1 to integrally withdraw the automatic guiding saccule catheter in the blood vessel 8.

By using the automatic guiding balloon catheter, the loss of the balloon 3 in the conveying process can be avoided to the greatest extent, and the treatment effect on the lesion part 9 is effectively improved.

It should be noted that the features of the embodiments in the present application may be combined with each other without conflict.

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

Claims (10)

1. An auto-guiding balloon catheter, comprising: the traction catheter is telescopically arranged inside the outer tube and connected to the balloon in a penetrating mode, the far end of the outer tube is connected with the near end of the balloon, and the balloon is wrapped in the outer tube in a concave mode and coated with medicine on the surface of the wrapping portion.

2. The self-guiding balloon catheter of claim 1, wherein a distal end of the pull catheter is welded to a distal end of the balloon, and a catheter reinforcement is provided at the weld.

3. The self-guiding balloon catheter according to claim 2, wherein the distal end of the traction catheter and the distal end of the outer tube are provided with visualization rings, respectively.

4. The self-guiding balloon catheter of claim 1, wherein the outer tube includes a inflation lumen in communication with an interior of the balloon.

5. The self-guiding balloon catheter of claim 1, wherein the balloon comprises a double layer structure, the outer layer is polyether block polyamide and the inner layer is nylon, silicone or polyurethane.

6. The self-guiding balloon catheter of claim 1, wherein the pull catheter includes an internal guidewire lumen that extends through the entire pull catheter and communicates with the exterior at the distal end of the balloon.

7. The self-guiding balloon catheter of claim 6, further comprising a guide wire having a trailing end that extends from the distal end of the balloon and extends from the pull catheter through the entire guide wire lumen.

8. The self-guiding balloon catheter according to claim 1, wherein a support ring is disposed between the outer tube and the pull catheter, the support ring comprising a flexible support ring disposed within the outer tube, the pull catheter being movably threaded onto the support ring.

9. The self-guiding balloon catheter of claim 8, wherein a distal end of the pull catheter is centered with respect to a distal end of the balloon, the outer tube, the support ring, and the pull catheter being concentrically disposed.

10. A method of using the self-guiding balloon catheter according to any one of claims 1-9, comprising the steps of:

constructing a vascular access through a guide wire;

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

pressurizing the sacculus to enable the sacculus wrapped in the outer tube to move in a rolling type outward turning manner;

the saccule is tightly attached to a lesion part after being pressurized and expanded, so that the medicine wrapped on the lesion part is exposed and continuously released on the lesion part;

after the medicine is released, the saccule is decompressed, the traction catheter is withdrawn, and the decompressed saccule is dragged into the outer tube;

and withdrawing the outer tube to integrally withdraw the automatic guide saccule catheter.

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