CN217854143U

CN217854143U - Balloon assembly and blood vessel dilation system

Info

Publication number: CN217854143U
Application number: CN202120580499.3U
Authority: CN
Inventors: 史冬梅
Original assignee: Beijing Yixin Medical Development Foundation; Beijing Anzhen Hospital
Current assignee: Beijing Yixin Medical Development Foundation; Beijing Anzhen Hospital
Priority date: 2021-03-22
Filing date: 2021-03-22
Publication date: 2022-11-22
Anticipated expiration: 2031-03-22

Abstract

The utility model discloses a sacculus subassembly and vasodilatation system, sacculus subassembly are including expanding the sacculus, cutting sacculus and propelling movement pipe, and the expansion sacculus is established in cutting sacculus the place ahead. The utility model discloses a sacculus subassembly has simplified the step of blood vessel intervention operation, has shortened the operation time, reduces patient's complication and produces the probability.

Description

Balloon assembly and blood vessel dilation system

Technical Field

The utility model relates to the technical field of medical equipment, in particular to vasodilation sacculus subassembly and vasodilation system.

Background

Endovascular intervention is the most common method of treatment in the prior art for coronary artery stenosis. In some cases, calcified lesions or fibrotic structures are produced on the inner wall of the coronary artery of a patient, and for such lesions, it is often segmented with a balloon having a cutting member. However, the balloons with cutting components have poor trafficability, and a common balloon must be used for expansion before the cutting balloon can enter a lesion. This results in prolonged surgery time, increased patient complications, and adverse patient recovery from surgery.

SUMMERY OF THE UTILITY MODEL

According to a first aspect of the present application, there is provided a balloon assembly comprising:

the expansion balloon comprises a balloon main body and connecting parts which are arranged at the two ends of the balloon main body and are connected with the pushing pipes, and a cavity is arranged in the expansion balloon and can be switched between a contraction state and an expansion state;

the cutting balloon is arranged on one side of the expansion balloon, and a cutting part is arranged on the surface of the cutting balloon;

the propelling movement pipe sets up and keeps away from the one end of expansion sacculus and expand between sacculus and the cutting sacculus at the cutting sacculus, with expansion sacculus and cutting sacculus sealing connection, propelling movement pipe and expansion sacculus, cutting sacculus syntropy removal.

According to another aspect of the present application, there is provided a vasodilation system comprising:

a guide wire is guided to enter a blood vessel in advance to provide a motion track for the balloon component;

the pressure pump is connected with the port of the catheter and controls the expansion degree of the expansion balloon and the cutting balloon; and:

any of the balloon assemblies described above.

Drawings

Other objects and advantages of the present application will become apparent from the following description of the present application with reference to the accompanying drawings, and may help to provide a thorough understanding of the present application. In the drawings:

FIG. 1 shows a schematic diagram according to an embodiment of the present application;

fig. 2 is a schematic view showing the balloon cutting of the lesion site in the present embodiment;

fig. 3 shows a schematic diagram according to another embodiment of the present application.

It should be noted that the figures are not drawn to scale and that elements of similar structure or function are generally represented by like reference numerals throughout the figures for illustrative purposes. It should also be noted that the drawings are only for the purpose of illustrating preferred embodiments and are not intended to limit the application itself. The drawings do not show every aspect of the described embodiments and do not limit the scope of the disclosure.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings of the embodiments of the present invention. It should be apparent that the described embodiment is one embodiment of the invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the described embodiments of the invention without any inventive step, are within the scope of protection of the invention.

It is to be noted that technical terms or scientific terms used herein should have the ordinary meaning as understood by those having ordinary skill in the art to which the present invention belongs, unless otherwise defined. If the description refers to "first", "second", etc. throughout this document, these descriptions are only used for distinguishing similar objects, and should not be understood as indicating or implying relative importance, order or implied number of indicated technical features, it should be understood that the data described in "first", "second", etc. may be interchanged where appropriate. Furthermore, spatially relative terms, such as "above," "below," "top," "bottom," and the like, may be used herein for ease of description to describe one element or feature's spatial relationship to another element or feature as illustrated in the figures, and should be understood to encompass different orientations in use or operation in addition to the orientation depicted in the figures.

Embodiments of the present application provide an ID expansion balloon assembly for expanding the ID of a blood vessel to remove obstructions and hardened plaque from the blood vessel.

In the prior art, the balloon is a common method for expanding the position of the endovascular obstruction, but when the endovascular obstruction is a calcified lesion or a fibrotic lesion, the common balloon cannot effectively expand the lesion. For such lesions, a common approach is to use a dilatation balloon with other devices. However, the balloon is difficult to enter the lesion of the blood vessel, and the lesion can be accessed only by cutting the balloon after the balloon is expanded by using a common balloon. This results in a greatly prolonged operation time, increases the probability of complications and is not favorable for the postoperative recovery of the patient.

According to the above thought, the present application improves on the existing balloon assembly. Specifically, both the dilation balloon 10 and the cutting balloon 20 are disposed at one end of one balloon assembly, during the procedure. The two balloons extend into the blood vessel in a contraction state, and when the expansion balloon 10 reaches a lesion, the first catheter cavity 31 is filled with gas or liquid to expand the expansion balloon 10 and extrude the obstruction 60; then, the dilatation balloon 10 is contracted, the propelling tube 30 is pushed to the cutting balloon to enter the lesion, the second catheter cavity 32 is filled with gas or liquid, the cutting balloon 20 is inflated, and the cutting device arranged on the cutting balloon 20 cuts the blockage 60, so that the inner diameter of the blood vessel is enlarged.

Some embodiments of the present application provide a balloon assembly comprising:

the expansion balloon 10 comprises a balloon main body and connecting parts which are arranged at two ends of the balloon main body and are connected with the pushing pipes, wherein a cavity is arranged in the expansion balloon, and the expansion balloon can be switched between a contraction state and an expansion state. The dilation balloon 10 is used to dilate the vascular lesion to the point where the cutting balloon 20 is able to pass.

And a cutting balloon 20 disposed on one side of the dilatation balloon 10, wherein a cutting member is disposed on the surface of the cutting balloon 20.

The pushing tube 30 is arranged at one end of the cutting balloon 20 far away from the expansion balloon 10 and between the expansion balloon 10 and the cutting balloon 20 and is connected with the expansion balloon 10 and the cutting balloon 20 in a sealing mode, and the pushing tube 30, the expansion balloon 10 and the cutting balloon 20 move in the same direction.

Through the arrangement, the balloon component can complete the expansion process of the vascular lesion at one time, and the follow-up problem caused by frequent replacement of the balloon catheter is avoided.

The push tube 30 is internally provided with a first catheter cavity 31 and a second catheter cavity 32 which are respectively and independently communicated with the inner cavity of the expansion balloon 10 and the inner cavity of the cutting balloon 20. In some embodiments, as shown in fig. 1 and 3, the first catheter lumen 31 and the second catheter lumen 32 are coaxial annular lumens disposed within the pusher tube 30, but this manner should not be construed as limiting the present application, and it should be understood by those skilled in the art that any arrangement of catheter lumens that can ensure that the catheter lumens are independently connected to the two balloons is within the scope of the present application.

In some embodiments, an opening 34 is formed in the side wall of the pusher tube 30, and a guide tube 40 is disposed within the pusher tube 30, the dilation balloon 10, and the cutting balloon 20, wherein one end of the guide tube 40 is sealingly connected to the opening 34 in the side wall of the pusher tube, and the other end is sealingly connected to the end of the dilation balloon 10 distal from the cutting balloon 20, forming a catheter tip 33. A guide wire 50 is disposed within the guide tube 40 to guide the direction of the balloon assembly.

In other embodiments, the pusher tube 30 does not have an opening in the sidewall thereof, and the guide tube 40 has one end sealingly connected to the end of the dilation balloon 10 distal to the cutting balloon 20 to form the catheter tip 33 and another end disposed at the end of the pusher tube 30 distal to the cutting balloon 20 to form a port. A guide wire is disposed within the guide tube 40.

In some embodiments, the end of the pushing tube 30 away from the cutting balloon 20 is provided with a catheter port 311 and a catheter port 321, which are respectively communicated with the first catheter lumen 31 and the second catheter lumen 32, and gas or liquid can enter the dilatation balloon 10 or the cutting balloon 20 through the catheter port 311 or the catheter port 321 and the catheter lumen 31 or the catheter lumen 32, so as to control the expansion state of the dilatation balloon 10 and the cutting balloon 20. Referring to fig. 2, when the cutting balloon 20 is inflated, the cutting member provided thereon has a cutting and squeezing effect on the obstruction 60 within the blood vessel.

In some embodiments, the cutting balloon 20 is folded into the interior with the cutting member disposed on the cutting balloon 20 in the collapsed state; in addition, the cutting balloon 20 is made of a memory shape material, and when the cutting balloon 20 is contracted after the blood vessel is expanded, the cutting member is still folded into the balloon.

Referring to fig. 1, in some embodiments, the cutting elements on the cutting balloon 20 are provided as blades 21, the cutting edges of the blades 21 facing the vessel wall for cutting the obstruction 60 within the vessel, thereby acting to expand the inner diameter of the vessel. The embodiment of the utility model does not limit the shape and arrangement mode of the blades, in some embodiments, the blades 21 are long blades extending along the axial direction of the cutting saccule and distributed on the surface of the cutting saccule, and the number of the long blades can be 2, 3, 4 or 5; in other embodiments, blades 21 are groups of small blades distributed around the surface of the cutting balloon in the axial direction of the cutting balloon.

In some embodiments, the cutting balloon is made of a hard material, and the surface of the cutting balloon is uniformly opened during the expansion process of the cutting balloon, so that the damage to the blood vessel at the non-pathological part caused by the weakened cutting effect of the blades 21 on the hard obstruction 60 or the deformation of the balloon is avoided.

In some embodiments, the opening 34 in the sidewall of the pusher tube 30 is disposed between the two catheter ports and the cutting balloon, and the guide wire 50 is disposed within the guide tube 40.

In some embodiments, the cutting balloon and the blades 21 disposed thereon are provided with a drug coating or microcapsules containing a drug for preventing intimal hyperplasia of the blood vessel or for preventing thrombopoiesis due to platelet coagulation, typically including paclitaxel or an anticoagulant drug.

In some embodiments, the cutting balloon 20 may also be a spinous process balloon with the surface cutting component being provided as a spinous process integrally formed with the spinous process balloon. The shape of the spinous process can be set arbitrarily, including but not limited to any polygon such as triangle, rectangle, etc. Through the arrangement, the blades 21 arranged on the cutting balloon can be prevented from falling off, but the cutting effect of the spinous process balloon is inferior to that of the cutting balloon.

In some embodiments, the cutting balloon 20 may also be a double guidewire balloon, see fig. 3, with the cutting elements being a guidewire 231 and a guide guidewire 50 secured to the surface of the double guidewire balloon, the guidewire 231 being disposed longitudinally on the surface of the double guidewire balloon. The guide wire 231 and the guide wire 50 are not in a fixed positional relationship, and preferably, the guide wire 231 and the guide wire 50 are disposed opposite to each other. The double guidewire balloon passes through vascular lesions more easily than the cutting balloon, but it has a weaker ability to cut the vascular obstruction 60.

In some embodiments, when the cutting balloon 20 is provided as a dual guidewire balloon, the opening 34 is provided on the side wall of the pusher tube between the dilation balloon 10 and the cutting balloon 20, and the guide wire 50 is provided within the guide tube 40. With the above arrangement, the guide wire 50 is positioned outside the dual wire balloon for cutting the endovascular obstruction 60.

In some embodiments, the two ends of the guide tube portions corresponding to the dilatation balloon 10 and the cutting balloon 20 are provided with the developing marks 41, and after the balloon assembly enters the body of the patient, the developing marks 41 are used for indicating the positions of the corresponding balloons, so that whether the balloons reach the lesion or not can be conveniently and accurately judged.

In some embodiments, the surface of the balloon assembly is provided with a hydrophilic layer for reducing frictional resistance when the balloon assembly enters the blood vessel.

Embodiments of the present application also provide a vasodilation system comprising:

a guide wire 50 providing a motion track for the balloon assembly;

a pressure pump connected to the two catheter ports for controlling the degree of inflation of the dilatation balloon 10 and the cutting balloon 20; and:

any of the balloon assemblies described above.

It should also be noted that, in case of conflict, the embodiments and features of the embodiments of the present invention may be combined with each other to obtain new embodiments.

The above description is only an embodiment of the present invention, but the scope of the present invention is not limited thereto, and the scope of the present invention is subject to the scope of the claims.

Claims

1. A balloon assembly, comprising:

the inflatable balloon (10) comprises a balloon main body and connecting parts which are arranged at two ends of the balloon main body and are connected with pushing pipes, wherein a cavity is arranged in the inflatable balloon (10) and can be switched between a contraction state and an expansion state;

a cutting balloon (20), wherein the cutting balloon (20) is arranged on one side of the expansion balloon (10), and a cutting part is arranged on the surface of the cutting balloon (20);

the pushing tube (30) is arranged at one end, far away from the expansion balloon (10), of the cutting balloon (20) and between the expansion balloon (10) and the cutting balloon (20), the expansion balloon (10) is connected with the cutting balloon (20) in a sealing mode, and the pushing tube (30) moves in the same direction as the expansion balloon (10) and the cutting balloon (20).

2. The balloon assembly according to claim 1, wherein the pushing tube (30) is internally provided with a first catheter lumen (31) and a second catheter lumen (32) which are respectively and independently communicated with the inner lumens of the dilatation balloon (10) and the cutting balloon (20).

3. The balloon assembly of claim 1 wherein the pusher tube sidewall is provided with at least one opening (34).

4. The balloon assembly of claim 1, wherein a guide tube (40) is disposed within the push tube (30), the dilation balloon (10) and the cutting balloon (20), wherein one end of the guide tube (40) is sealingly connected to an opening (34) in a sidewall of the push tube, and the other end is sealingly connected to an end of the dilation balloon (10) distal from the cutting balloon (20) to form a catheter tip (33), and wherein a guide wire (50) is disposed within the guide tube (40).

5. A balloon assembly according to claim 2, wherein the pushing tube (30) is provided with two catheter ports (311, 321) at its end remote from the cutting balloon (20), the catheter ports (311, 321) being in communication with the first and second catheter lumens (31, 32), respectively, and gas or liquid can enter the dilatation balloon (10) and the cutting balloon (20) through the catheter ports (311, 321) and the first and second catheter lumens (31, 32) to control the inflation state of the dilatation balloon (10) and the cutting balloon (20).

6. The balloon assembly according to claim 1, characterized in that the cutting member provided on the cutting balloon (20) is a blade (21), the blade (21) is uniformly or non-uniformly provided on the surface of the cutting balloon, facing the vessel wall, and the blade (21) can cut the obstruction (60) at the vessel obstruction.

7. A balloon assembly according to claim 6 wherein the cutting balloon is made of a hard material and is uniformly radially expanded during inflation.

8. The balloon assembly of claim 5, wherein the opening (34) in the push tube sidewall is provided between the catheter port (311, 321) and the cutting balloon (20).

9. The balloon assembly of claim 1, wherein the cutting balloon (20) is a dual-guidewire balloon and the cutting components are a guidewire (231) and a guide guidewire (50) disposed on a sidewall of the cutting balloon (20).

10. The balloon assembly of claim 9, wherein the opening in the sidewall of the pusher tube is disposed between the dilation balloon (10) and the cutting balloon (20).

11. The balloon assembly of claim 1 wherein the cutting balloon (20) is a spinous process balloon and the cutting member is a spinous process integrally formed with the spinous process balloon.

12. The balloon assembly according to claim 4, characterized in that the guide tube (40) is provided with visualization markings (41) at both ends of the portion of the dilation balloon (10) and the cutting balloon (20), the visualization markings being capable of indicating the position of the dilation balloon (10) and the cutting balloon (20) inside the patient's body.

13. A balloon assembly according to claim 1 wherein the surface of the balloon assembly is provided with a hydrophilic layer.

14. A vasodilation system, comprising:

the balloon assembly of any one of claims 1-13;

a guide wire (50) providing a motion track for the balloon assembly;

a pressure pump connected to the catheter ports (311, 321) to control the degree of inflation of the dilatation balloon (10) and the cutting balloon (20).