A tapered balloon dilatation catheter

Abstract

The application relates to a tapered balloon dilatation catheter, which comprises a balloon, an inner tube, a transmission tube, an outer tube and a winding mechanism, the winding mechanism is connected between the corresponding distal tapered body and / or proximal tapered body of the balloon and the transmission tube, and the winding mechanism has a fully open state, a winding state and a winding transition state; when the winding mechanism is in the fully open state, the shape of the winding mechanism matches the shape of the corresponding distal tapered body and / or proximal tapered body of the balloon in the inflated state; when the transmission tube is operated to switch the winding mechanism from the fully open state to the winding transition state or the winding state, the winding mechanism can be inwards retracted to drive the distal tapered body and / or the proximal tapered body to be retracted. The tapered body is retracted through the inwards retraction of the winding mechanism, so that the taper of the tapered body of the balloon can be adjusted, more flexible and accurate operation options can be provided, and the treatment effect is better.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a balloon dilatation catheter with adjustable taper. BACKGROUND

[0002] Percutaneous transluminal angioplasty (PTA) is a common minimally invasive treatment method for treating lumen stenosis or occlusion, and has the advantages of small trauma, fast effect, safety and reliability, short operation time and hospitalization time, simple operation, and wide clinical application. Balloon catheter is the main instrument of PTA, and can be used alone or in combination with stents to treat lumen stenosis or occlusion.

[0003] The balloon is usually composed of a middle section and two tapered sections arranged on both sides of the middle section, and the inflation of the balloon can be realized by stamping into the balloon. The taper of the existing balloon tapered section is usually not adjustable, which is not conducive to the treatment of difficult lesions; for some blood vessels with large changes in the inner diameter of the proximal and distal ends of the human body, poor adhesion is easily caused. SUMMARY

[0004] The purpose of the present application is to provide a balloon dilatation catheter with adjustable taper.

[0005] To achieve the above-mentioned purpose, the technical scheme adopted by the present application is:

[0006] A balloon dilatation catheter with adjustable taper, comprising a balloon having an inflated state and a deflated state, the balloon comprising an inflation part capable of being radially inflated or deflated, a distal tapered part and a proximal tapered part arranged on both ends of the inflation part, the distal tapered part comprising a distal connecting section, a distal tapered main body connected between the distal connecting section and the inflation part, the diameter of the distal tapered main body gradually increasing from distal to proximal in the inflated state; the proximal tapered part comprises a proximal connecting section, a proximal tapered main body connected between the proximal connecting section and the inflation part, the diameter of the proximal tapered main body gradually decreasing from distal to proximal in the inflated state, the balloon dilatation catheter further comprising:

[0007] A tube assembly, the tube assembly comprising an inner tube, a transmission tube and an outer tube sequentially sleeved from inside to outside, the inner tube distal end being inserted into the balloon and connected with the distal connecting section, the outer tube distal end being inserted into the balloon and connected with the proximal connecting section, the transmission tube distal end being inserted into the balloon and configured to be capable of rotating around its axis;

[0008] a plurality of winding mechanisms corresponding to the distal tapered body and the proximal tapered body are arranged, the winding mechanisms are connected between the corresponding distal tapered body and / or proximal tapered body and the transmission tube, the winding mechanisms have a fully open state, a winding state of being wound on the transmission tube, and a winding transition state between the fully open state and the winding state, when the winding mechanism is in the fully open state, the shape of the winding mechanism matches the shape of the corresponding distal tapered body and / or proximal tapered body in the inflated state,

[0009] When the transmission tube is operated to switch the winding mechanism from the fully open state to the winding transition state or the winding state, the winding mechanism can be inducted to shrink the distal tapered body and / or the proximal tapered body.

[0010] Preferably, the winding mechanism comprises a plurality of blades arranged around the outer periphery of the transmission tube and connected to the transmission tube at one end, and the blades can be wound on the transmission tube.

[0011] Further preferably, when the winding mechanism is in the fully open state, the blades are straightened.

[0012] Preferably, the blades are made of flexible material.

[0013] In some embodiments, the blades are made of nylon material.

[0014] Preferably, the thickness of the blades is 0.08-0.1 mm.

[0015] Preferably, the winding mechanism further comprises a support assembly arranged outside the blades, the support assembly comprises a mesh and a film fixedly connected to the inner side of the mesh, the outer end of the blade is fixedly connected to the film, and the mesh is fixedly connected to the inner side wall of the distal tapered body and / or the proximal tapered body.

[0016] Preferably, the balloon has one or a plurality of balloons arranged in the axial direction, and when the balloon is a plurality of balloons, the two adjacent balloons are connected end to end and communicate with each other.

[0017] Further preferably, when the balloon is a plurality of balloons, the two adjacent balloons share one winding mechanism, and the shape of the winding mechanism in the fully open state matches the shape of the distal tapered body and the proximal tapered body connected to the two adjacent balloons in the inflated state.

[0018] In some embodiments, the balloon is two.

[0019] Preferably, the balloon dilation catheter further comprises a braided layer arranged on the outer periphery of the balloon.

[0020] Preferably, the balloon dilatation catheter further comprises a handle, the handle comprising a catheter seat having a liquid injection cavity, a drive assembly arranged on the catheter seat and configured to control the movement of the transmission tube, the proximal ends of the inner tube and the outer tube being connected to the catheter seat and forming a liquid injection channel in communication with the liquid injection cavity, the proximal ends of the transmission tube and the inner tube extending out of the outer tube and the inner tube respectively, a sealing member arranged between the proximal ends of the transmission tube and the inner tube and the catheter seat to prevent liquid from flowing out, and the transmission tube being connected to the drive assembly.

[0021] In some embodiments, the drive assembly comprises an operation part coaxial with the transmission tube and arranged on the catheter seat to rotate around the axis of the transmission tube, and a transmission wheel assembly comprising a first transmission wheel fixedly connected to the transmission tube, a second transmission wheel engaged between the first transmission wheel and the operation part,

[0022] When the operation part is rotated, the operation part drives the second transmission wheel to rotate the first transmission wheel, and the transmission tube rotates synchronously with the first transmission wheel.

[0023] Further, the transmission wheel assembly is specifically arranged in two groups on both sides of the operation part.

[0024] Further, the second transmission wheel has a plurality of second transmission wheels uniformly arranged on the outer periphery of the first transmission wheel.

[0025] Thanks to the above technical solution, the present application has the following advantages compared with the prior art:

[0026] The present application can provide more flexible and accurate operation options and better treatment effect by setting the winding mechanism on the distal tapered body and the proximal tapered body, and driving the distal tapered body and the proximal tapered body to shrink inwardly through the winding mechanism, so as to adjust the taper of the balloon distal tapered body and the proximal tapered body. BRIEF DESCRIPTION OF DRAWINGS

[0027] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0028] Figure 1 The structure schematic diagram of the balloon dilatation catheter of Example 1, wherein the balloon is in the inflated state;

[0029] Figure 2 The structure schematic diagram of the balloon of Example 1 in the inflated state;

[0030] Figure 3 Figure 6 is a cross-sectional view of the balloon catheter of Figure 1, wherein the winding mechanism is in a winding state (for ease of illustration, the winding mechanism is not connected to the balloon in this figure); Figure 2

[0031] Figure 4 Figure 7 is a cross-sectional view of the balloon catheter of Figure 1, wherein the winding mechanism is in a fully wound state; Figure 2

[0032] Figure 5 Figure 8 is a structural schematic diagram of the winding mechanism of Example 1;

[0033] Figure 6 Figure 9 is an exploded structural schematic diagram of a winding mechanism of Example 1;

[0034] Figure 7 Figure 10 is an exploded structural schematic diagram of another winding mechanism of Example 1 (the film is not shown);

[0035] Figure 8 Figure 11 is a cross-sectional view of the balloon catheter of Example 1;

[0036] Figure 9 Figure 12 is an enlarged schematic diagram of part A of Figure 11; Figure 8

[0037] Figure 13 is a structural schematic diagram of a balloon blank being placed into a mold; Figure 10

[0038] Figure 14 is a structural schematic diagram of the balloon blank being prepared for stretching; Figure 11

[0039] Figure 15 is a structural schematic diagram of the balloon blank during the shaping process; Figure 12

[0040] Figure 16 is a structural schematic diagram of the balloon after shaping; Figure 13 Figure 17 is a structural schematic diagram of the balloon catheter of Example 1, wherein: 1, balloon; 11, inflation portion; 12, distal tapered portion; 121, distal connecting section; 122, distal tapered body; 13, proximal tapered portion; 131, proximal connecting section; 132, proximal tapered body; 14, transition section;

[0041] 2, tube assembly; 21, inner tube; 22, transmission tube; 23, outer tube;

[0042] 3, winding mechanism; 31, blade; 32, mesh; 33, film;

[0043] 4, handle; 41, catheter seat; 411, liquid injection cavity; 42, drive assembly; 421, operation portion; 422, first transmission wheel; 423, second transmission wheel; 424, transmission wheel fixing seat; 43, first blocking member; 44, second blocking member;

[0044]

[0045] ​​​5. A molding die. DETAILED DESCRIPTION

[0046] In the following description, certain specific examples will be described in simple terms. As would be apparent to one of ordinary skill in the art, the described examples can be modified in various different ways without departing from the spirit or scope of embodiments of the application. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0047] In the description of embodiments of the application, it needs to be understood that the terms "far", "near" and the like indicate the position or location relationship defined in the position of the balloon dilatation catheter in use, wherein the side close to the operator is the proximal end and the side away from the operator is the distal end. It is only for the convenience of describing the embodiments of the application and simplifying the description, and does not indicate or imply that the indicated device or element must have a particular position, be constructed and operated in a particular position, and therefore cannot be understood as a limitation on the embodiments of the application.

[0048] In addition, the terms "first", "second" are only for the purpose of description, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first", "second" can explicitly or implicitly include one or more of the features. In the description of embodiments of the application, the meaning of "multiple" is two or more, unless otherwise specifically limited.

[0049] In embodiments of the application, unless otherwise specifically defined and limited, "on" or "under" of a first feature to a second feature can include that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, "on", "above" and "over" of the first feature to the second feature includes that the first feature is directly above and obliquely above the second feature, or only indicates that the first feature is higher in horizontal height than the second feature. "Below", "under" and "underneath" of the first feature to the second feature includes that the first feature is directly below and obliquely below the second feature, or only indicates that the first feature is lower in horizontal height than the second feature.

[0050] The following disclosure provides many different embodiments or examples for implementing different structures of embodiments of the application. For simplicity of the disclosure, the description of the specific examples below is described. Of course, they are only examples and the purpose is not to limit the embodiments of the application. In addition, the embodiments of the application can refer to the same reference numerals and / or reference letters in different examples, and such repetition is for the purpose of simplification and clarity, and does not indicate the relationship between the various embodiments and / or arrangements discussed.

[0051] The embodiments of the application will be described in detail below with reference to the accompanying drawings.

[0052] Embodiment 1

[0053] A tapered balloon dilatation catheter, as shown in the figure, comprises a balloon 1, a winding mechanism 3, a tube assembly 2 and a handle 4. Figures 1 to 9

[0054] The balloon 1 has an inflated state (as shown in the figure) and a deflated state (not shown in the figure). Figure 2

[0055] Specifically, the balloon 1 comprises an inflation part 11 capable of being radially inflated or deflated, a distal tapered part 12 and a proximal tapered part 13 arranged at both ends of the inflation part 11. The inflation part 11 is in a cylindrical shape and extends along an axial direction; the distal tapered part 12 comprises a distal connecting segment 121 and a distal tapered body 122 connected between the distal connecting segment 121 and the inflation part 11, and the diameter of the distal tapered body 122 gradually increases from the distal end to the proximal end in the inflated state; the proximal tapered part 13 comprises a proximal connecting segment 131 and a proximal tapered body 132 connected between the proximal connecting segment 131 and the inflation part 11, and the diameter of the proximal tapered body 132 gradually decreases from the distal end to the proximal end in the inflated state. The balloon 1 has one or multiple arranged along the axial direction, and when the balloon 1 has multiple, two adjacent balloons 1 are connected end to end and communicate with each other.

[0056] In this embodiment, as shown in the figure, the balloon 1 has two, and the proximal tapered body 132 of the distal balloon 1 is connected with the distal tapered body 122 of the proximal balloon 1 through a transition segment 14. The double balloon is more suitable for complex lesions such as difficult bending, bifurcation and stenosis. The preparation method of the structure balloon 1 is as follows: the balloon blank is made of nylon material, two balloon blanks are connected in series, and the length of a single balloon blank is 25-35% of the total length of the balloon 1. As shown in the figure, the double balloon blank is placed in the inside of the forming mold 5 (made of profiled beryllium copper material, half mold forming) according to the middle position, the double balloon blank is inflated with nitrogen to maintain a pressure of 6-10 atm, the mold is heated to 75-85℃ for 40-60 min, then the length of the double balloon blank is slowly stretched to 40%-60% of the length of the two ends of the double balloon, then the temperature is raised to 110℃ for 60-100 min, and then the pressure is raised to 28-35 atm, the two ends start to stretch, and the length is 100%-150% of the length of the two ends of the double balloon, and the double balloon starts to form. Figures 1 to 4 Figures 10 to 13

[0057] ​​​​The tube assembly 2 comprises an inner tube 21, a transmission tube 22 and an outer tube 23 which are coaxially arranged from inside to outside. The inner tube 21 is used for passing a guide wire, and its distal end is fixedly connected to the distal connecting section 121 of the balloon 1. The outer tube 23 is connected to the handle 4, and its distal end is fixedly connected to the proximal connecting section 131 of the balloon 1. The transmission tube 22 is inserted into the balloon 1 and is configured to rotate around the axis of the balloon 1.

[0058] The winding mechanism 3 has a plurality of groups corresponding to the distal tapered body 122 and the proximal tapered body 132. That is, when the balloon 1 is one, the winding mechanism 3 has two groups corresponding to the distal tapered body 122 and the proximal tapered body 132 of the balloon 1 respectively; when the balloon 1 is multiple, the winding mechanism 3 has a plurality of groups corresponding to the distal tapered body 122 of the distal-most balloon 1, the proximal tapered body 132 of the proximal-most balloon 1 and the proximal tapered body 132 and the distal tapered body 122 connecting adjacent two balloons 1 respectively. In the embodiment, as shown in FIG. 1, the winding mechanism 3 has three groups, wherein the first group corresponds to the distal tapered body 122 of the distal balloon 1, the second group corresponds to the proximal tapered body 132 and the distal tapered body 122 of the adjacent two balloons 1 in the middle region, and the third group corresponds to the proximal tapered body 132 of the proximal balloon 1. Figure 5

[0059] The winding mechanism 3 is connected to the distal tapered body 122 and / or the proximal tapered body 132 corresponding thereto and the transmission tube 22, and has a fully expanded state, a winding state and a winding transition state between the fully expanded state and the winding state. When the winding mechanism 3 is in the fully expanded state, the shape of the winding mechanism 3 matches the shape of the distal tapered body 122 and / or the proximal tapered body 132 corresponding thereto in the inflated state; when the winding mechanism 3 is in the winding state, the winding mechanism 3 is wound on the transmission tube 22.

[0060] ​Specifically, the winding mechanism 3 includes a support assembly fixedly connected to the corresponding distal conical body 122 and / or proximal conical body 132, and a plurality of blades 31. Each blade 31 has one end connected to the inner sidewall of the support assembly and the other end connected to the transmission tube 22. When the winding mechanism 3 is in a fully extended state, the blades 31 are stretched straight. When the transmission tube 22 is operated to switch the winding mechanism 3 from the fully extended state to the winding transition state or the wound state, the blades 31 gradually wind around the transmission tube 22, driving the support assembly and the distal conical body 122 and / or proximal conical body 132 to retract inward. This allows the tapered angle of the conical body to be adjustable, allowing it to be adjusted according to intravascular conditions. Preferably, the blades 31 are made of nylon with a thickness of 0.08 to 0.1 mm. One end of the blades 31 can be glued to the transmission tube 22, and the other end can be welded to the support assembly. The support assembly includes a mesh 32 fixedly attached to the inner wall of the distal tapered body 122 and / or the proximal tapered body 132, and a film 33 fixedly attached to the inner side of the mesh 32. The mesh 32 can be made of 316L stainless steel and is soaked in developer, which solidifies on the surface of the mesh 32, thereby facilitating in-vivo adjustment of the taper. The film 33 is preferably made of nylon.

[0061] Since the performance of the balloon 1 is reduced after being connected to the support assembly, the performance of the balloon 1 can be enhanced by covering the balloon 1 with a braided layer (not shown in the figure). The braided layer can be specifically made of polyurethane.

[0062] like Figure 8 and Figure 9 As shown, the handle 4 includes a catheter adapter 41 having an injection cavity 411, and a drive assembly 42 disposed on the catheter adapter 41 and configured to control the movement of the transmission tube 22. The proximal ends of the inner tube 21 and outer tube 23 are connected to the catheter adapter 41, forming an injection channel therebetween that communicates with the injection cavity 411. The proximal ends of the transmission tube 22 and inner tube 21 extend out of the outer tube 23, respectively, while the proximal end of the inner tube 21 extends out of the transmission tube 22. A blocking member (i.e., a first blocking member 43 and a second blocking member 44) is disposed between the proximal ends of the transmission tube 22 and inner tube 21 and the catheter adapter 41 to prevent the outflow of liquid. The transmission tube 22 is connected to the drive assembly 42.

[0063] The driving assembly 42 comprises an operation part 421 coaxial with the transmission pipe 22 and arranged on the catheter seat 41 to rotate around the axis of the transmission pipe 22, and a transmission wheel assembly arranged between the operation part 421 and the handle 4. The transmission wheel assembly comprises a first transmission wheel 422 fixedly connected to the transmission pipe 22, a plurality of second transmission wheels 423 engaged between the first transmission wheel 422 and the operation part 421 and uniformly arranged on the outer circumferential side of the first transmission wheel 422, and a transmission wheel fixing seat 424 fixedly connected to the handle 4, the second transmission wheels 423 being rotatably arranged on the transmission wheel fixing seat 424. When the operation part 421 is rotated, the operation part 421 drives the second transmission wheels 423 to rotate the first transmission wheel 422, and the transmission pipe 22 rotates synchronously with the first transmission wheel 422. In the embodiment, the transmission wheel assembly is specifically arranged in two groups on both sides of the operation part 421.

[0064] The use steps of the balloon dilatation catheter are as follows:

[0065] The balloon 1 is introduced into the target blood vessel along the guide wire, and the balloon 1 is filled with liquid through the liquid injection cavity 411 to reach the inflated state. During the process, the operation part 421 can be synchronously rotated to rotate the transmission pipe 22, so as to drive the winding mechanism 3 to convert from the winding state to the winding transition state or the fully open state. The operation part 421 is positively or negatively rotated according to the inner wall condition of the target blood vessel to adjust the taper of the tapered body of the balloon 1.

[0066] The above embodiments are only for illustrating the technical concept and characteristics of the present application, and the purpose is to enable those skilled in the art to understand the content of the present application and to implement it, and cannot limit the protection scope of the present application. Any equivalent changes or modifications made according to the spirit and essence of the present application shall be covered within the protection scope of the present application.

Claims

1. A tapered balloon dilatation catheter comprising a balloon having an inflated state and a deflated state, the balloon comprising an inflatable portion capable of being radially inflated or deflated, a distal tapered portion and a proximal tapered portion disposed at opposite ends of the inflatable portion, the distal tapered portion comprising a distal connecting segment, a distal tapered body connected between the distal connecting segment and the inflatable portion, the distal tapered body gradually increasing in diameter from a distal end to a proximal end in the inflated state; the proximal tapered portion comprising a proximal connecting segment, a proximal tapered body connected between the proximal connecting segment and the inflatable portion, the proximal tapered body gradually decreasing in diameter from a distal end to a proximal end in the inflated state, characterized in that: The balloon expansion catheter further comprises: a tube assembly comprising an inner tube, a transmission tube and an outer tube, which are sequentially sleeved from inside to outside, the distal end of the inner tube is inserted into the balloon and connected with the distal connecting segment, the distal end of the outer tube is inserted into the balloon and connected with the proximal connecting segment, and the distal end of the transmission tube is inserted into the balloon and is configured to rotate around the axis thereof; a plurality of winding mechanisms corresponding to the distal tapered body and the proximal tapered body are arranged, the winding mechanism is connected between the corresponding distal tapered body and / or proximal tapered body and the transmission tube, the winding mechanism has a fully open state, a winding state of being wound on the transmission tube and a winding transition state between the fully open state and the winding state, when the winding mechanism is in the fully open state, the shape of the winding mechanism matches the shape of the corresponding distal tapered body and / or proximal tapered body in the inflated state, when the transmission tube is operated to switch the winding mechanism from the fully open state to the winding transition state or the winding state, the winding mechanism can be inwards retracted and drive the corresponding distal tapered body and / or proximal tapered body to be retracted.

2. The tapered balloon dilation catheter of claim 1, wherein: The winding mechanism comprises a plurality of blades arranged around the outer periphery of the transmission tube and connected at one end to the transmission tube, and the blades can be wound on the transmission tube.

3. The tapered balloon dilation catheter of claim 2, wherein: The blades are made of nylon material; and / or The thickness of the blades is 0.08-0.1 mm.

4. The tapered balloon dilation catheter of claim 2, wherein: The winding mechanism further comprises a support assembly arranged outside the blades, the support assembly comprises a net and a film fixedly connected to the inside of the net, the outer end of the blade is fixedly connected to the film, and the net is fixedly connected to the inner side wall of the distal tapered body and / or the proximal tapered body.

5. The tapered balloon dilation catheter of claim 1, wherein: The balloon has one or a plurality of balloons arranged in the axial direction, when the balloon is a plurality of balloons, two adjacent balloons are connected end to end and communicate with each other.

6. The tapered balloon dilation catheter of claim 5, wherein: When the balloon is a plurality of balloons, the two adjacent balloons share one winding mechanism, and the shape of the winding mechanism in the fully open state matches the shape of the distal tapered body and the proximal tapered body connected to the two adjacent balloons in the inflated state.

7. The tapered balloon dilation catheter of claim 1, wherein: The balloon expansion catheter further comprises a braided layer arranged outside the periphery of the balloon.

8. The tapered balloon dilation catheter of claim 1, wherein: The balloon expansion catheter further comprises a handle, the handle comprises a catheter seat having a liquid injection cavity, a drive assembly arranged in the catheter seat and configured to control the movement of the transmission tube, the proximal ends of the inner tube and the outer tube are connected to the catheter seat and form a liquid injection channel communicating with the liquid injection cavity between them, the proximal ends of the transmission tube and the inner tube respectively protrude from the outer tube and the proximal end of the inner tube protrudes from the transmission tube, a blocking member is arranged between the proximal ends of the transmission tube and the inner tube and the catheter seat to prevent liquid from flowing out, and the transmission tube is connected to the drive assembly.

9. The tapered balloon dilation catheter of claim 8, wherein: The drive assembly comprises an operation part coaxial with the transmission tube and arranged on the catheter seat to rotate around the axis thereof, and a transmission wheel assembly, the transmission wheel assembly comprises a first transmission wheel fixedly connected to the transmission tube, a second transmission wheel engaged between the first transmission wheel and the operation part, Rotating the operation part, the operation part drives the second transmission wheel to drive the first transmission wheel to rotate, and the transmission pipe rotates synchronously with the first transmission wheel.

10. The tapered balloon dilation catheter of claim 9, wherein: The transmission wheel assembly is specifically divided into two groups on both sides of the operation part; and / or, The second transmission wheel has multiple wheels uniformly arranged on the outer circumferential side of the first transmission wheel.

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