CN109381779B

CN109381779B - Balloon catheter

Info

Publication number: CN109381779B
Application number: CN201710653518.9A
Authority: CN
Inventors: 张庭超; 李敬
Original assignee: Hangzhou Wei Qiang Medical Technology Co ltd
Current assignee: Hangzhou Wei Qiang Medical Technology Co ltd
Priority date: 2017-08-02
Filing date: 2017-08-02
Publication date: 2024-03-08
Anticipated expiration: 2037-08-02
Also published as: CN109381779A

Abstract

The invention discloses a balloon catheter, which comprises a pushing catheter and at least two expandable balloons positioned at the distal end of the pushing catheter. The pushing catheter comprises a catheter main body and a branch pipe body arranged at the far end of the catheter main body. The branch pipe body at least comprises a first branch and a second branch which extend towards different directions respectively. The balloon catheter of the invention can expand stenotic lesions of bifurcated vessels at one time, reduce the number of cannulation, enable full expansion, avoid vessel tearing, save operation time and reduce operation cost and complexity.

Description

Balloon catheter

Technical Field

The invention belongs to the technical field of medical instruments, and relates to a balloon catheter.

Background

Balloon catheters are a tool for angioplasty and have been widely used in clinical medicine for percutaneous transluminal angioplasty and percutaneous transluminal coronary angioplasty. Existing balloon catheter structures are typically single balloon catheters with an expandable balloon disposed at the distal end of the catheter. When using such single balloon catheters to treat bifurcated vascular lesions, there are two common treatments:

one way is to first expand the front and rear portions of the bifurcation with a single balloon catheter, and then expand the branch vessel with a single balloon catheter. The following disadvantages exist with this approach: incomplete expansion of the middle part of the bifurcation; multiple dilation results in excessive tearing of the vessel; the cost of using multiple balloon catheters is high; the patient is intubated for many times, and the pain is increased; repeated intubation and dilation, complex operation, long time and high working strength of doctors.

Alternatively, a single balloon catheter is used to simultaneously dilate the anterior, medial, and posterior bifurcation and then the branch is dilated with a separate balloon. The following disadvantages exist with this approach: the vascular tear at the rear section of the bifurcation is serious, which is very easy to cause vascular dissection, and then other means are needed to remedy (such as implantation of a bracket); and simultaneously, the vascular is extremely easy to be excessively torn, and the vascular is also easy to be proliferated to form secondary stenosis.

Disclosure of Invention

Aiming at the defects of the prior art, the invention provides the balloon catheter with the distal bifurcation, which can dilate the stenotic lesion part of the bifurcated vessel at one time, so that the middle part of the bifurcation is fully dilated, simultaneously, the intubation times can be reduced, the vessel tearing can be avoided, the operation time is saved, and the complexity and the cost of the operation are reduced.

The technical scheme adopted for solving the technical problems is as follows:

a balloon catheter comprising a push catheter and at least two expandable balloons at a distal end of the push catheter. The pushing catheter comprises a catheter main body and a branch pipe body arranged at the far end of the catheter main body. The branch pipe body at least comprises a first branch and a second branch which extend towards different directions respectively. The expandable balloon includes at least one first balloon disposed at a distal end of the first branch, at least one second balloon disposed at a distal end of the second branch, and a proximal diameter of a working segment of at least one of the first balloon and the second balloon is less than a diameter of a remaining portion of the working segment of the balloon.

In the balloon catheter, preferably, the diameter of the portion of the first balloon near the proximal end or/and the diameter of the portion of the second balloon near the proximal end gradually decreases from the distal end to the proximal end.

In the balloon catheter, preferably, the catheter body is a multi-lumen tube. The multi-cavity tube is internally provided with a first guide wire cavity, a second guide wire cavity, a first filling cavity and a second filling cavity which are not communicated with each other along the axial direction. The first guidewire lumen extends axially from the catheter body proximal end to the first branch distal end. The second guidewire lumen extends axially from the proximal end of the catheter body to the distal end of the second branch. The distal end of the first inflation lumen is in communication with the inner lumen of the first balloon. The distal end of the second inflation lumen is in communication with the lumen of the second balloon.

In the balloon catheter, preferably, the balloon catheter further comprises a handle arranged at the proximal end of the catheter body. The handle is provided with a first guide wire port, a second guide wire port, a first filling port and a second filling port. The first guidewire port communicates with the proximal end of the first guidewire lumen. The second guidewire port communicates with the proximal end of the second guidewire lumen. The first filling port communicates with a proximal end of the first filling lumen. The second filling port communicates with a proximal end of the second filling lumen.

In the balloon catheter, preferably, the catheter body includes a first tube and a second tube. The distal end of the first tube body is connected to the proximal end of the first branch. The distal end of the second tube is connected to the proximal end of the second branch.

In the balloon catheter, it is preferable that the first tube body and the second tube body move relatively only along the axial direction, and the first branch and the second branch move relatively along the axial direction and the radial direction simultaneously.

In the balloon catheter, preferably, the second tube body is movably arranged in the first tube body in a penetrating manner, and a through hole is formed in the side wall, close to the distal end, of the first tube body. The distal end of the second tube body extends out of the through hole and is connected with the proximal end of the second branch.

In the balloon catheter, preferably, the first tube body and the second tube body are arranged in parallel, and the first tube body and the second tube body are jointly arranged in the hollow hoop in a penetrating manner.

In the balloon catheter, the preferred balloon catheter further comprises a first catheter seat arranged at the proximal end of the first catheter body and a second catheter seat arranged at the proximal end of the second catheter body, and the second catheter seat moves axially relative to the first catheter seat.

In the balloon catheter, preferably, a first wire guide cavity and a first filling cavity are arranged in the first catheter body. And a second guide wire cavity and a second filling cavity which are communicated are arranged in the second tube body. The proximal end of the first catheter hub is provided with a third guidewire port and a third filling port. The proximal end of the second catheter hub is provided with a fourth guidewire port and a fourth filling port. The third guidewire port is connected to the proximal end of the first guidewire lumen. The fourth guidewire port is connected to the proximal end of the second guidewire lumen. The third filling port is connected to the proximal end of the first filling chamber. The fourth filling port is connected to the proximal end of the second filling chamber.

Compared with the prior art, the invention has at least the following beneficial effects by arranging the branch pipe body at the distal end of the catheter main body and arranging at least one expandable saccule on the branch pipe body respectively:

the balloon catheter has the advantages that the far-end branch pipe can enter a plurality of branches of the bifurcated blood vessel at the same time, the stenotic lesion of the bifurcated blood vessel can be dilated at one time, the problems of vessel tearing and incomplete dilation in the middle of the bifurcation are avoided, meanwhile, the operation time can be saved, the operation complexity is reduced, and the pain caused by the repeated intubation of a patient is avoided.

Drawings

FIG. 1 is a schematic structural view of a balloon catheter according to a first embodiment, the balloon catheter including a push catheter and two expandable balloons at a distal end of the push catheter, the push catheter including a catheter body and a branch tube body at a distal end of the catheter body;

FIG. 2 is a cross-sectional view of the distal end of the catheter body, the lateral tube body, and two inflatable balloons of FIG. 1;

FIGS. 3-5 are schematic views of three embodiments of the inflatable balloon of FIG. 2;

fig. 6 to 10 are schematic structural views of different implementations of a catheter body in a balloon catheter of the second embodiment;

FIG. 11 is a schematic structural view of a balloon catheter according to a third embodiment, wherein the balloon catheter comprises a push catheter and two expandable balloons at the distal end of the push catheter, and the push catheter comprises a catheter body and a branch tube body at the distal end of the catheter body;

FIG. 12 is a cross-sectional view of the distal end of the catheter body, the branch tube body, and two inflatable balloons of FIG. 11;

fig. 13 is a cross-sectional view of another embodiment of the catheter body of fig. 11.

Detailed Description

For a clearer understanding of technical features, objects and effects of the present invention, a detailed description of embodiments of the present invention will be made with reference to the accompanying drawings.

In the interventional medical field, the end close to the operator is generally referred to as a proximal end, and the end far from the operator is generally referred to as a distal end.

Example 1

Referring to fig. 1, a balloon catheter according to a first embodiment of the present invention includes a push catheter and at least two expandable balloons at a distal end of the push catheter.

The push catheter includes a catheter body 100 and a branch tube 200 disposed at the distal end of the catheter body 100. The branch pipe body 200 includes at least two branches. Specifically, in the present embodiment, the branch pipe body 200 has a Y-shaped structure, and has a first branch 210 and a second branch 220 extending in different directions. The expandable balloon includes at least one first balloon 300 disposed distal to first branch 210, at least one second balloon 400 disposed distal to second branch 220. Specifically, in this embodiment, a first balloon 300 is disposed at the distal end of the first branch 210, and a second balloon 400 is disposed at the distal end of the second branch 220. Thus, the first balloon 300 and the second balloon 400 are pushed into the two branch vessels of the bifurcated vessel by the branch vessel 200, respectively, so that the anterior, middle and posterior portions of the bifurcated vessel can be simultaneously expanded. It is understood that in other embodiments, the number of the first balloons 300 and the second balloons 400 may be plural, and the plural first balloons 300 are sequentially connected with each other at a certain axial distance or without a certain interval, and the plural second balloons 400 are sequentially connected with each other at a certain axial distance or without a certain interval. Thus, simultaneous dilation of a plurality of stenotic lesion sites for each branch vessel can be achieved. For each of the first balloon 300 and the second balloon 400, a filling cavity corresponding thereto is provided in the catheter body 100 for filling the balloon.

The first branch 210 has an angle α between the axial direction and the axial direction of the second branch 220. The range of α is (0 °,180 ° ], i.e., 0 ° < α+.ltoreq.180°, since the angle between the two branch vessels of the bifurcated vessel is generally less than or equal to 180 °, α is in this range, facilitating the first and second branches 210 and 220 to deliver the first and second balloons 300 and 400, respectively, into the two branch vessels of the bifurcated vessel, it will be understood that the branch vessel 200 may have more than two branches, depending on the anatomy of the lesion to be dilated, as long as the expandable balloons are provided on each branch, respectively.

Referring also to fig. 2, the proximal diameter of the working segment of the second balloon 400 is smaller than the diameter of the remainder of the working segment of the second balloon 400. The working segment of the expandable balloon refers to: after inflation and expansion of the inflatable balloon, the generally cylindrical portion of the balloon may conform to the inner wall of the vessel for expanding the vessel. The reason for this is that, after the branch vessel body 200 pushes the first balloon 300 and the second balloon 400 into the two branch vessels of the bifurcated vessel at the same time, the proximal ends of the working sections of the first balloon 300 and the second balloon 400 are simultaneously located at the bifurcation position of the bifurcated vessel, and the vessel diameter at the bifurcation position is necessarily smaller than the sum of the diameters of the two branch vessels. Therefore, in order to avoid tearing of the blood vessel at the bifurcation after the proximal end of the working section of the first balloon 300 and the proximal end of the working section of the second balloon 400 are simultaneously inflated, the sum of the diameters of the proximal end of the working section of the first balloon 300 and the proximal end of the working section of the second balloon 400 needs to be smaller than the sum of the diameters of the rest of the working sections of the first balloon 300 and the second balloon 400. Meanwhile, for an expandable balloon, the effective length of the balloon, i.e., the length of the working section, refers to the length of the balloon which is in a generally cylindrical shape after filling, is attached to the vessel wall during the operation, and has the functions of supporting and expanding the vessel, so that the length of the working section determines the expansion performance of the balloon. The proximal diameter of the working segment of the second balloon 400 of this embodiment is smaller than the diameter of the remainder of the working segment of the balloon, and the second balloon 400 still has a longer effective length than a conventional tapered balloon, and therefore has a higher distensibility to the vessel wall of the branch vessel after filling. In addition to the embodiments described above, it is also possible that the proximal diameter of the working section of the first balloon 300 is smaller than the diameter of the remainder of the working section of the first balloon 300. Or the proximal diameters of the working segments of both the first balloon 300 and the second balloon 400 are smaller than the diameters of the remaining portions of the working segments of both balloons, respectively.

The proximal portion of the first balloon 300 or/and the proximal portion of the second balloon 400 may taper in diameter from distal to proximal. Thus, when first balloon 300 and second balloon 400 are inflated simultaneously, vascular tearing at the bifurcation site can be further prevented. The specific structure of the first balloon 300 and the second balloon 400 is as follows:

referring to fig. 3, in particular, a first balloon 300 is secured to the distal end of first branch 120. The fixing method is a common technical means in the field such as welding, bonding and the like, and is not described herein. The first balloon 300 is comprised of a proximal portion, a distal portion, and a working section therebetween. The proximal and distal portions of the first balloon 300 are each generally conical structures 310, with the intermediate working section 320 being cylindrical in configuration ranging from 2-15mm in diameter. The length of first balloon 300 ranges from 30-320mm. The effective length of first balloon 300, i.e., the length of working section 320, ranges from 20-300mm. The surface of first balloon 300 may be coated with at least one drug coating 330. Drug coating 330 may cover all or a portion of the surface of first balloon 300. In this embodiment, the drug coating 330 is disposed primarily on the outer surface of the working segment. The drug coating 330 may contain active drugs such as paclitaxel, rapamycin, etc. that inhibit smooth muscle cell proliferation. The diameter and effective length of the first balloon 300 may be selected according to the diameter of the blood vessel. The application of the drug coating 330 is prior art and will not be described in detail herein. The working section 320 of the first balloon 300 is substantially cylindrical, so that the first balloon 300 after filling has good adhesion, and can be adhered to the inner wall of a blood vessel for a certain length, and the medicine is ensured to be effectively transferred to the inner wall of the blood vessel.

The second balloon 400 is welded to the distal end of the second leg 220. The diameter of the proximal portion of the second balloon 400 decreases gradually from the distal end to the proximal end. There are various embodiments of such tapered structures, such as: the remainder of the second balloon 400, except for the distal portion, is generally tapered with a diameter that gradually decreases from the distal end to the proximal end (as shown in fig. 3). Or the proximal portion 403 and the distal portion 401 of the second balloon 400 are respectively generally tapered in opposite directions, the middle portion 402 is cylindrical, and a smooth transition between the cylindrical and tapered shapes is shown in fig. 4. Or the proximal end 403 and the distal end 401 of the second balloon 400 are respectively in opposite directions and are approximately conical, the middle 402 is in a cylindrical shape, and the diameters between the cylindrical shape and the conical shape form a step structure (as shown in fig. 5). The tapered configuration of the proximal portion 403 of the second balloon 400 is generally a long taper with little change in taper to form a taper of longer length and less change in diameter, with the diameter of the partial taper being much smaller than the cylindrical portion. The tapered, long tapered structure can increase the spacing between the first balloon 300 and the second balloon 400, avoid the problems of excessive vasodilation, vessel tearing or interlayer formation caused by the bonding or too small spacing between the two after inflation, and increase the effective length (i.e., working segment length) of the balloon after inflation.

Referring to fig. 4, the surface of the second balloon 400 is coated with at least one drug coating 330. A drug coating 330 is disposed on the outer surface of the cylindrical portion of the second balloon 400. In other embodiments, the surface of the second balloon 400 may not be provided with the drug coating 330.

The dimensions of the first balloon 300 and the second balloon 400 are determined according to the diameter of the blood vessel to be dilated, and are not particularly limited. The diameter of the first balloon 300 may be slightly larger than the diameter of the second balloon 400, or the first balloon 300 may have the same diameter as the second balloon 400.

Referring to fig. 1 again, developing and positioning devices 13 and 23 for balloon positioning are respectively disposed on the corresponding first and second branches 210 and 220 within the effective length ranges of the first and second balloons 300 and 400. The effective length range refers to the length range of the working segment of the first balloon 300 or the second balloon 400. The developing and positioning device 13 and 23 may be rings, bands, sheets, etc. made of an X-ray developing material, and the positions thereof may be displayed under the detection of the instrument to indicate the balloon position. The number of the developing position determining devices 13 and the developing position determining devices 23 on each branch may be one or more. The connection manner between the developing and positioning device 13 and 23 and each branch may be welding, bonding, hot pressing, press riveting, and other common technical means in the art, which are not described herein.

Referring also to fig. 2, the catheter body 100 is a multi-lumen tube. A branch pipe body 200 is provided at the distal end of the catheter main body 100. The catheter body 100 and the branch pipe body 200 may be integrally formed; the catheter body 100 and the branch pipe body 200 may be of separate structures, that is, the catheter body 100 and the branch pipe body 200 may be assembled and fixed together after being molded separately. The assembling and fixing manner can be bonding, welding, hot melting, threaded connection or interference fit and other technical means common in the art, and will not be described herein.

The multi-lumen tube is provided with a first guidewire lumen 130, a second guidewire lumen 230, a first filling lumen 140 and a second filling lumen 240 which are not communicated with each other along the axial direction. The first guidewire lumen 130 extends axially from the proximal end of the catheter body 100 to the distal end of the first branch 210. The second guidewire lumen 230 extends axially from the proximal end of the catheter body 100 to the distal end of the second branch 220. The distal end of first inflation lumen 130 communicates with the lumen of first balloon 300. The distal end of the second inflation lumen 230 communicates with the lumen of the second balloon 400.

The cross-sectional shape of the multi-lumen tube is not limited, and only four functional lumens are required to be separated from each other. The first guidewire lumen 130 and the second guidewire lumen 230 are each configured to receive and pass over a guidewire. Thus, the first guidewire lumen 130 and the second guidewire lumen 230 need to take the form of lumens that are smooth in shape and facilitate guidewire movement. For example, referring to fig. 6, the cross-sections of the first guidewire lumen 130 and the second guidewire lumen 230 are generally selected from circular, oval, and the like. The cross-sectional shapes of first filling chamber 140 and second filling chamber 240 are not limited and may be any shape, such as circular (as shown in fig. 6) or crescent (as shown in fig. 7). One skilled in the art can arrange the first filling lumen 140 and the second filling lumen 240 to ensure a maximum cross-sectional area based on the cross-sectional shape of the push catheter, the location and shape of the first guidewire lumen 130 and the second guidewire lumen 230. It will be appreciated that in other embodiments, multiple first inflation lumens 140 or second inflation lumens 240 may be provided in the multi-lumen tube, as long as the distal end of each inflation lumen is in communication with the inner lumen of the inflatable balloon, respectively, to increase the flow of inflation fluid or gas and thereby increase the inflation and deflation rate of the inflatable balloon.

Referring again to fig. 1, the balloon catheter further includes a handle 500 disposed at the proximal end of the catheter body 100. The handle 500 is provided with a first guidewire port 510, a second guidewire port 520, a first filling port 530, and a second filling port 540. The first guidewire port 510 communicates with the proximal end of the first guidewire lumen 130. The second guidewire port 520 communicates with the proximal end of the second guidewire lumen 230. First filling port 530 communicates with the proximal end of first filling chamber 140. The second filling port 540 communicates with the proximal end of the second filling chamber 240.

In the present embodiment, the position between the first branch 210 and the second branch 220 in the branch pipe body 200 is fixed. That is, the position between the first balloon 300 disposed distal to the first branch 210 and the second balloon 400 disposed distal to the second branch 220 is fixed.

The implementation process of the balloon catheter for dilating a bifurcated vessel provided by the embodiment is as follows:

after the balloon catheter provided in this embodiment is inserted into the patient along the guide wire by percutaneous puncture, the push catheter is pushed distally by holding the handle 500, and the first branch 210 and the second branch 220 enter the two branch vessels at the bifurcation, respectively, under the guidance of the respective guide wires. At this time, the distal ends of the working sections of the first balloon 300 and the second balloon 400 respectively enter two branched blood vessels, and the proximal ends of the working sections of the first balloon 300 and the second balloon 400 are simultaneously positioned at the bifurcation positions of the blood vessels, and the two parts are overlapped. The first filling port 530 and the second filling port 540 at the proximal end of the handle 500 are respectively connected with an external balloon expansion pressure pump, and filling liquid enters the first balloon 30 and the second balloon 400 respectively through the first filling cavity 140 and the second filling cavity 240, and the first balloon 300 and the second balloon 400 are respectively inflated to simultaneously expand the stenotic lesion of two branch vessels. Since the working segment proximal end diameter of the second balloon 400 is smaller than the rest of the working segment diameter, the overlap between the proximal ends of the first balloon 300 and the second balloon 400 has a reduced overall outer diameter. Thus, not only can the diameters of the first balloon 300 and the second balloon 400 be adapted to the main branch and the branch after bifurcation, but the overlapping portion thereof can also be adapted to the diameter of the blood vessel at the bifurcation site, avoiding tearing of the blood vessel at the bifurcation site.

Compared with the prior art, the balloon catheter provided by the embodiment has at least the following beneficial effects:

(1) The distal branch pipe body can simultaneously enter a plurality of branches of the bifurcated vessel, can expand the stenotic lesion part of the bifurcated vessel at one time, avoid tearing the vessel and incomplete expansion of the bifurcated middle part, save operation time, reduce operation complexity and avoid pains caused by intubation of patients for many times.

(2) The balloon catheter of the embodiment can be provided with a plurality of expandable balloons on a plurality of branches, and can expand a multi-section lesion at one time.

(3) In the balloon catheter of this embodiment, the diameter of the proximal end of the working section of the expandable balloon is smaller than the diameter of the rest of the balloon, which can not only better adapt to the anatomical features of the bifurcated vessel, avoid damaging the bifurcation site of the vessel, but also ensure that the working section has a longer effective length and improve the expansion capacity.

Example two

The balloon catheter provided in the second embodiment has substantially the same structure as the balloon catheter provided in the first embodiment. The difference is that, in the balloon catheter provided in the second embodiment, the structure of the catheter body is different from that of the balloon catheter of the first embodiment.

Specifically, in the present embodiment, the catheter main body includes an outer tube (i.e., a first tube body) and at least one inner tube (i.e., a second tube body) that is penetratingly installed in the outer tube. The first pipe body and the second pipe body are fixedly connected together and can not move relatively. The distal end of the inner tube or the distal end of the outer tube is connected to the proximal end of the first branch or the proximal end of the second branch, respectively. The outer tube or/and the inner tube are provided with a first guide wire cavity, a second guide wire cavity, a first filling cavity and a second filling cavity which are not communicated with each other. In this embodiment, the outer tube has a different structure according to the number of the inner tubes.

Referring to fig. 8, only one inner tube is inserted into the outer tube, and the inner lumen of the inner tube may be used as the first guide wire lumen 130 or the second guide wire lumen 230. The outer tube is a multi-lumen tube having at least three lumens, one of which serves as the first guidewire lumen 130 or the second guidewire lumen 230, and the other two of which serve as the first filling lumen 140 and the second filling lumen 240, respectively.

Referring to fig. 9, two inner tubes are disposed in the outer tube in a penetrating manner, and the two inner tubes are arranged in parallel. The lumens of the two inner tubes serve as a first guidewire lumen 130 and a second guidewire lumen 230, respectively. The two regions between the outer tube and the two inner tubes act as a first filling chamber 140 and a second filling chamber 240, respectively.

Referring to fig. 10, three inner tubes may be inserted into the outer tube, and two of the inner tubes are sleeved together. Of the two inner tubes that are sleeved together, the lumen of the inner tube that is located inside may serve as the first guidewire lumen 130 or the second guidewire lumen 230. The lumen of the other separate inner tube serves as either the second guidewire lumen 230 or the first guidewire lumen 130. The gap between the outer tube and the inner tube, and the gap between the two nested inner tubes, serve as a first filling chamber 140 and a second filling chamber 240, respectively.

It will be appreciated that in other embodiments, at least two lumens may be provided in each of two inner tubes arranged in parallel, with one lumen in each inner tube being the first guidewire lumen 130 or the second guidewire lumen 230 and the other lumen being the first filling lumen 140 or the second filling lumen 240.

It will be appreciated that in other embodiments, four inner tubes may be threaded into the outer tube, with at least two of the inner tubes being arranged substantially parallel (i.e., side-by-side) and the remaining inner tubes being nested with the two side-by-side inner tubes. The lumens of the two side-by-side inner tubes serve as the first guidewire lumen 130 and the second guidewire lumen 230, respectively, while the space between the outer tube and the inner tube, and the space between the inner tube and the inner tube serve as the first filling lumen and the second filling lumen, respectively.

It should be understood that the above positional relationship of the inner tube and the outer tube is merely exemplary, and that structures suitable for the present invention are within the scope of the present invention.

Compared with the prior art, the balloon catheter of the embodiment has at least the following beneficial effects:

the distal branch pipe body can simultaneously enter a plurality of branches of the bifurcated vessel, can expand the stenotic lesion part of the bifurcated vessel at one time, avoid tearing the vessel and incomplete expansion of the bifurcated middle part, save operation time, reduce operation complexity and avoid pains caused by intubation of patients for many times.

Example III

The balloon catheter provided in the third embodiment has substantially the same structure as the balloon catheter provided in the first embodiment. The difference is that, in the balloon catheter provided in the third embodiment, the structure of the catheter body is different from that of the balloon catheter of the first embodiment.

Specifically, referring to fig. 11, the catheter body 100 of the push catheter includes a first tube 110 and a second tube 120. The first tube 110 and the second tube 120 can move relative to each other in the axial direction. The distal end of the first tube 110 is connected to the proximal end of the first branch 210. The distal end of the second tube 120 is connected to the proximal end of the second leg 220. Thus, the first branch 210 and the second branch 220 of the branch pipe body 200 can move in the axial direction and the radial direction at the same time. That is, the position between the first balloon 300 disposed distally of the first branch 210 and the second balloon 400 disposed distally of the second branch 220 may be adjustable. The adjusting directions are respectively as follows: the relative positions of the first balloon 300 and the second balloon 400 in the axial direction are adjusted to adapt to different distances between the narrow lesion part and the bifurcation in the bifurcation vessel; the relative positions of the first balloon 300 and the second balloon 400 in the radial direction are adjusted to adapt to different included angles between the bifurcation vessel branches.

Specifically, the positional relationship between the first tube body 110 and the second tube body 120 may have the following two embodiments:

referring to fig. 11, the first embodiment: the second tube 120 is movably disposed in the first tube 110, and a through hole 111 is formed on a distal side wall of the first tube 110, and the distal end of the second tube 120 extends out of the through hole 111 and is connected to the second branch 220. Therefore, when the second tube 120 moves axially along the first tube 110, the second branch 220 is driven to move towards the distal end or the proximal end of the second tube 120, so as to adjust the position of the second balloon 400 to adapt to the bifurcated vessels with different structures and different stenoses of the bifurcated vessels.

Second embodiment: the first pipe body 110 and the second pipe body 120 are arranged approximately in parallel (i.e. parallel), and are connected through a limiting piece, so that only axial mutual movement and no radial movement can occur between the first pipe body 110 and the second pipe body 120. The limiting member has various modes: for example, the limiting member may be a collar disposed between the first tube body 110 and the second tube body 120, or the first tube body 110 and the second tube body 120 may be movably disposed together in a hollow hoop member, so as to limit only axial movement therebetween. The specific shape and axial length of the hoop member are not limited and may be adjusted according to the lengths of the first and second tubes 110 and 120. For example, the hoop member may be a circular, oval or "8" shape, or may be a tubular body having a certain axial length, or a third tubular body, as shown in fig. 13, for sleeving the first tubular body 110 and the second tubular body 120 together, or the like. It will be appreciated that to reduce the overall diameter of the balloon catheter, the shapes of the first tube 110 and the second tube 120 should cooperate to form a complete, angular-free shape, such as a circle or oval.

Referring to fig. 12, the first guide wire lumen 130, the second guide wire lumen 230, the first filling lumen 140 and the second filling lumen 240 in the first tube body 110 and the second tube body 120 are respectively and independently disposed, that is, the first guide wire lumen 130 and the first filling lumen 140 are disposed in the first tube body 110, and the second guide wire lumen 230 and the second filling lumen 240 are disposed in the second tube body 120.

Referring to fig. 11 again, the balloon catheter provided in this embodiment further includes a first catheter hub 600 disposed at the proximal end of the first tube 110 and a second catheter hub 500 disposed at the proximal end of the second tube 120. The second catheter hub 500 is axially movable relative to the first catheter hub 600. When the first tube 110 and the second tube 120 are coaxially sleeved, the handle 600 is sleeved outside the first tube 110. When the first tube body 110 and the second tube body 120 are disposed in parallel, the first catheter holder 600 and the second catheter holder 500 are disposed independently of each other.

A first guidewire lumen 130 and a first filling lumen 140 are disposed therethrough within the first tube 110. A second guidewire lumen 230 and a second filling lumen 240 are disposed therethrough within the second tube 120. A third guidewire port 610 and a third filling port 620 are provided at the proximal end of the first catheter hub 600. A fourth guidewire port 510 and a fourth filling port 520 are provided at the proximal end of the second catheter hub 500. A third guidewire port 610 is connected to the proximal end of the first guidewire lumen 130. A fourth guidewire port 510 is connected to the proximal end of the second guidewire lumen 230. Third filling port 620 is connected to the proximal end of first filling chamber 140. Fourth filling port 520 is connected to the proximal end of second filling chamber 240.

In summary, the far-end branch pipe of the balloon catheter can enter a plurality of branches of the bifurcated vessel at the same time, can dilate the stenotic lesion of the bifurcated vessel at one time, avoids tearing of the vessel and incomplete dilation of the middle of the bifurcation, can save operation time, reduces operation complexity and avoids pains caused by repeated intubation of patients.

Meanwhile, the invention can expand the multi-segment lesion at one time by arranging a plurality of expandable saccules on a plurality of branches.

In addition, in the balloon catheter disclosed by the invention, the diameter of the proximal end of the working section of the expandable balloon is smaller than the diameter of the rest part of the balloon, so that the balloon catheter can be well adapted to the anatomical characteristics of bifurcated vessels, the bifurcation position of the vessels is prevented from being damaged, the working section can be ensured to have a longer effective length, and the expansion capacity is improved.

In addition, the second balloon and the first balloon can move relatively, so that the relative positions of the balloons can be adjusted, and the catheter is more flexible to use. After the second saccule enters the branch, the position of the second saccule can be reasonably adjusted according to the actual position of the lesion, so that the second saccule can be better attached to the lesion part.

The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.

Claims

1. A balloon catheter comprising a push catheter and at least two expandable balloons at the distal end of the push catheter, wherein the push catheter comprises a catheter main body and a branched pipe body arranged at the distal end of the catheter main body, the branched pipe body at least comprises a first branch and a second branch which respectively extend towards different directions, the range of an included angle between the axial direction of the first branch and the axial direction of the second branch is (0 degrees, 180 degrees) and the expandable balloons comprise at least one first balloon arranged at the distal end of the first branch and at least one second balloon arranged at the distal end of the second branch, the proximal diameter of a working section of at least one balloon of the first balloon and the second balloon is smaller than the diameter of the rest of the working section of the balloon, and the sum of the proximal diameters of the working section of the first balloon and the proximal diameter of the working section of the second balloon is smaller than the sum of the diameters of the rest of the working section of the first balloon and the second balloon;

the catheter body comprises a first tube body and a second tube body, wherein the distal end of the first tube body is connected with the proximal end of the first branch, and the distal end of the second tube body is connected with the proximal end of the second branch; the first tube body and the second tube body only move relatively along the axial direction, the first branch and the second branch move relatively along the axial direction and the radial direction simultaneously, and the relative positions of the first balloon arranged at the distal end of the first branch and the second balloon arranged at the distal end of the second branch are adjusted along the axial direction and the radial direction simultaneously; the second pipe body is movably arranged in the first pipe body in a penetrating mode, a through hole is formed in the side wall, close to the far end, of the first pipe body, and the far end of the second pipe body penetrates out of the through hole.

2. The balloon catheter of claim 1, wherein a proximal portion of the first balloon or/and a proximal portion of the second balloon gradually decreases in diameter from distal end to proximal end.

3. The balloon catheter of claim 1, wherein the catheter body is a multi-lumen tube, and wherein first, second, first and second inflation lumens are axially disposed within the multi-lumen tube that are not in communication with one another; the first guide wire cavity is axially communicated with the first branch distal end from the proximal end of the catheter body, and the second guide wire cavity is axially communicated with the second branch distal end from the proximal end of the catheter body; the distal end of the first filling cavity is communicated with the inner cavity of the first balloon, and the distal end of the second filling cavity is communicated with the inner cavity of the second balloon.

4. The balloon catheter of claim 3, further comprising a handle disposed at a proximal end of the catheter body, the proximal end of the handle having a first guidewire port, a second guidewire port, a first filling port, and a second filling port, the first guidewire port in communication with the proximal end of the first guidewire lumen, the second guidewire port in communication with the proximal end of the second guidewire lumen, the first filling port in communication with the proximal end of the first filling lumen, and the second filling port in communication with the proximal end of the second filling lumen.

5. The balloon catheter of claim 1, wherein the first tube is juxtaposed with the second tube and the first tube and the second tube are co-threaded into a hollow hoop.

6. The balloon catheter of claim 1, further comprising a first catheter hub disposed at a proximal end of the first tube and a second catheter hub disposed at a proximal end of the second tube, wherein the second catheter hub moves axially relative to the first catheter hub.

7. The balloon catheter of claim 6, wherein a first guidewire lumen and a first inflation lumen are provided therethrough in the first tube, and a second guidewire lumen and a second inflation lumen are provided therethrough in the second tube; the proximal end of the first catheter seat is provided with a third guide wire port and a third filling port, the proximal end of the second catheter seat is provided with a fourth guide wire port and a fourth filling port, the third guide wire port is connected with the proximal end of the first guide wire cavity, the fourth guide wire port is connected with the proximal end of the second guide wire cavity, the third filling port is connected with the proximal end of the first filling cavity, and the fourth filling port is connected with the proximal end of the second filling cavity.