A cutting balloon dilatation catheter

Abstract

The present invention relates to a cutting balloon dilatation catheter, comprising a balloon, a catheter, a cutting blade and a traction mechanism, wherein the cutting blade is connected to the balloon and has an outward opening, and the traction mechanism comprises a rotating tube with a distal end extending into the balloon and a flexible member that is windably arranged at the distal end of the rotating tube, the flexible member and the cutting blade being arranged in a one-to-one correspondence, one end of the flexible member being connected to the rotating tube, and the other end being connected to the inner wall of the balloon on the inner side of the cutting blade. The present invention can cause the balloon wall at the connection with the flexible member to deform and concave inward by the pulling action of the flexible member on the balloon, on the one hand pulling the cutting blade inward, thereby adjusting the exposed depth of the cutting blade; on the other hand, the deformation of the balloon wall squeezes the cutting blade, thereby adjusting the opening angle of the cutting blade. The pulling force of the flexible member can be controlled by rotating the rotating tube, thereby controlling the cutting depth and cutting range of the cutting blade, which is very convenient and has good cutting effect and safety.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a cutting balloon dilatation catheter. Background Art

[0002] With the advancement of interventional cardiology, balloon angioplasty has become a common treatment for arterial stenosis. However, traditional balloon angioplasty is often ineffective for lesions with severe fibrosis or calcification, often leading to incomplete dilation or elastic recoil, resulting in high restenosis rates. To address these issues, cutting balloon catheters have emerged.

[0003] Existing cutting balloon catheters typically incorporate fixed blades attached to the balloon surface, which mechanically expand and cut to reduce fibrous tissue and calcifications within the lesion. However, these designs have limitations, such as fixed blade position, difficulty controlling cutting depth and range, and potential damage to the vessel wall. Furthermore, due to limitations in the number and placement of blades, existing cutting balloon catheters are less than ideal for treating complex lesions. Summary of the Invention

[0004] The purpose of the present invention is to provide a cutting balloon dilatation catheter with controllable cutting depth and blade opening and closing angle.

[0005] In order to achieve the above object, the technical solution adopted by the present invention is:

[0006] A cutting balloon dilatation catheter comprises a balloon having an expanded state and a contracted state and a catheter, wherein the catheter comprises an inner tube and an outer tube sleeved outside the inner tube, wherein the distal end of the inner tube is inserted into the balloon and connected to the distal end of the balloon, and the distal end of the outer tube is inserted into the balloon and connected to the proximal end of the balloon. The cutting balloon dilatation catheter further comprises a cutting blade and a traction mechanism, wherein the cutting blade has a plurality of blades connected to the outer side wall of the balloon and has an outward opening; the traction mechanism comprises a rotating tube rotatably disposed between the inner tube and the outer tube and having a distal end extending into the balloon, and a flexible member windably disposed at the distal end of the rotating tube, wherein the flexible member has a plurality of blades arranged in a one-to-one correspondence with the cutting blades, one end of the flexible member is connected to the rotating tube, and the other end is connected to the inner wall of the balloon inside the cutting blade. When the balloon is in the expanded state and the rotating tube rotates along the winding direction, the flexible member is tensioned and gradually winds around the rotating tube and pulls the balloon, causing the cutting blade to gradually sink into the balloon, and the opening of the cutting blade has a tendency to shrink.

[0007] Preferably, the cutting blade is V-shaped and its narrow end (ie inner end) is connected to the balloon.

[0008] Preferably, the opening angle of the cutting blade in the fully opened state is 50° to 70°, more preferably 55° to 65°.

[0009] Preferably, the cutting blade is made of titanium alloy.

[0010] Preferably, there are 3 to 5 cutting blades.

[0011] Preferably, the cutting blade extends axially along the balloon.

[0012] Preferably, the balloon includes a main body and two variable diameter parts arranged on both sides of the main body. The balloon wall of the main body is recessed inward to form a groove. The groove has multiple grooves corresponding to the cutting blades. The inner end of the cutting blade is connected to the groove wall of the groove.

[0013] Further preferably, the groove is consistent with the extending direction of the cutting blade.

[0014] More preferably, the groove is an arc-shaped groove.

[0015] Preferably, the flexible member includes a winding portion and a connecting portion roughly perpendicular to the winding portion, one end of the winding portion is connected to the rotating tube and the other end is connected to the middle area of ​​the connecting portion, and the connecting portion is connected to the inner wall of the balloon inside the cutting blade.

[0016] Preferably, the flexible member is made of a diaphragm made of a polymer material.

[0017] Further preferably, the flexible member is made of polyparaxylene.

[0018] Preferably, the cutting balloon dilatation catheter also includes a handle, which includes a catheter seat having an injection cavity and a guide wire cavity, a drive assembly provided on the catheter seat and configured to control the movement of the rotating tube, the proximal ends of the inner tube, outer tube, and rotating tube are connected to the catheter seat, a medium channel connected to the injection cavity is formed between the inner tube and the outer tube, and the rotating tube is connected to the drive assembly.

[0019] Further preferably, the proximal ends of the rotating tube and the inner tube extend out of the outer tube respectively, and the proximal end of the inner tube extends out of the rotating tube.

[0020] Preferably, the driving assembly includes a gear sleeved on the proximal end of the rotating tube, a first transmission wheel engaged with the gear, a transmission rod connected to the first transmission wheel, and an operating part connected to the transmission rod. By rotating the operating part, the operating part drives the transmission rod to rotate with the first transmission wheel, thereby driving the gear to rotate with the rotating tube.

[0021] Further preferably, the drive assembly further includes a housing connected to the catheter seat and a second transmission wheel engaged between the operating part and the transmission rod, the second transmission wheel having a plurality of wheels evenly distributed around the axis of the transmission rod, and the rotation axis lines of the second transmission wheel, the operating part, and the transmission rod are parallel.

[0022] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art:

[0023] The balloon of the present invention is connected to multiple cutting blades, and the cutting blades have outward openings. The flexible member pulls the balloon so that the balloon wall connected to the flexible member is deformed and concave inward, which on the one hand pulls the cutting blade inward, thereby adjusting the exposed depth of the cutting blade; on the other hand, the balloon wall deforms and squeezes the cutting blade, thereby adjusting the opening angle of the cutting blade. The pulling force of the flexible member can be controlled by rotating the rotating tube, and then the cutting depth and cutting range of the cutting blade can be controlled, which can effectively improve the cutting effect and safety and is very convenient to operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0025] Figure 1 This is a schematic structural diagram of the cutting balloon dilatation catheter of Example 1;

[0026] Figure 2 This is a half-section schematic diagram of the distal end portion of the cutting balloon dilatation catheter in Example 1;

[0027] Figure 3 This is an exploded view of the distal end of the cutting balloon dilatation catheter in Example 1;

[0028] Figure 4 This is a structural exploded view of another angle of the distal end of the cutting balloon dilatation catheter in Example 1;

[0029] Figure 5 This is a schematic structural diagram of the balloon in Example 1;

[0030] Figure 6 This is a schematic structural diagram of the balloon in Example 1 from another angle;

[0031] Figure 7 This is a structural diagram of the traction mechanism of Example 1;

[0032] Figure 8is a cross-sectional view of the handle of Example 1;

[0033] Figure 9 This is a half-section schematic diagram of the handle of Example 1;

[0034] Wherein: 1, balloon; 11, distal reducing portion; 12, main body; 121, groove; 13, proximal reducing portion;

[0035] 2. Cutting blade; 21. Opening;

[0036] 3. Traction mechanism; 31. Flexible member; 311. Connecting portion; 312. Winding portion; 32. Rotating tube;

[0037] 4. catheter; 41. inner tube; 42. outer tube;

[0038] 5. Handle; 51. Catheter seat; 511. Infusion chamber; 512. Guidewire chamber; 52. Gear; 53. First transmission wheel; 54. Transmission rod; 55. Housing; 56. Second transmission wheel; 57. Operating unit; 58. Rotating shaft; 59. Blocking member;

[0039] 6. Guide wire;

[0040] a. Opening angle. DETAILED DESCRIPTION

[0041] Hereinafter, only certain exemplary embodiments are briefly described. As will be appreciated by those skilled in the art, the described embodiments may be modified in various ways without departing from the spirit or scope of the embodiments of the present invention. Therefore, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0042] In describing the embodiments of the present invention, it should be understood that the terms "distal" and "proximal" and the like, indicating positions or relationships, are defined based on the orientation of the cutting balloon dilatation catheter during use, with the side closest to the operator being the proximal end and the side away from the operator being the distal end. These terms are used solely for the purpose of facilitating the description of the embodiments of the present invention and simplifying the description. They do not indicate or imply that the device or component referred to must have, be constructed, or operate in a specific orientation, and are therefore not to be construed as limiting the embodiments of the present invention.

[0043] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of the technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the embodiments of the present invention, "plurality" means two or more, unless otherwise specifically defined.

[0044] In the embodiments of the present invention, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Moreover, a first feature being "above," "above," and "above" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature includes the first feature being directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0045] The disclosure below provides many different embodiments or examples for implementing different structures of the embodiments of the present invention. In order to simplify the disclosure of the embodiments of the present invention, the components and configurations of specific examples are described below. Of course, these are merely examples and are not intended to limit the embodiments of the present invention. In addition, the embodiments of the present invention may repeat reference numerals and / or reference letters in different examples. Such repetition is for the purpose of simplicity and clarity and does not in itself indicate the relationship between the various embodiments and / or configurations discussed.

[0046] The embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0047] Example 1

[0048] A cutting balloon dilatation catheter, such as Figures 1 to 9 As shown, it includes a balloon 1, a catheter 4, a cutting blade 2, a traction mechanism 3 and a handle 5.

[0049] The balloon 1 can expand or contract along its radial direction. Figure 2 、 Figure 3 、 Figure 5 and Figure 6 , which includes a distal reducing portion 11, a main body 12 and a proximal reducing portion 13 arranged in sequence from far to near. Among them, the distal reducing portion 11 includes a distal connecting section and a distal cone located at the proximal end of the distal connecting section, and the diameter of the distal cone gradually expands from far to near in the expanded state. The main body 12 is roughly cylindrical in the expanded state, and its balloon wall is concave inward to form a groove 121. The groove 121 extends along the axial direction of the balloon 1. There are multiple grooves 121 evenly distributed along the circumference of the main body 12. In this embodiment, there are four grooves 121. The shape of the groove 121 is not specifically limited, and it is preferably an arc-shaped groove 121. The proximal reducing portion 13 includes a proximal connecting section and a proximal cone located at the distal end of the proximal connecting section, and the diameter of the proximal cone gradually decreases from far to near in the expanded state.

[0050] Preferably, the distal reducing portion 11, the main body 12, and the proximal reducing portion 13 are integrally formed. For example, the balloon 1 with the above structure can be formed by injection molding or blow molding, and the injection molding or blow molding process is based on existing technologies. The balloon 1 can be made of a polymer material with good moldability and flexibility, such as nylon 12.

[0051] There are multiple cutting blades 2 arranged in a one-to-one correspondence with the grooves 121. The following is a detailed description of one of the cutting blades 2 as an example. Figure 3 and Figure 4 The cutting blade 2 is V-shaped and its opening 21 faces outward. Preferably, the opening angle a is 50° to 70°. In this embodiment, the opening angle a of the cutting blade 2 is 60°. The center line of the cutting blade 2 preferably intersects with the axis of the balloon 1, thereby ensuring that the blades on both sides of the cutting blade 2 are symmetrical during use, thereby ensuring that the cutting depths of the blades on both sides of the opening 21 are consistent. The extension direction of the cutting blade 2 is consistent with the groove 121 of the balloon 1, and its narrow end (i.e., the inner end) is connected to the groove wall of the groove 121. Specifically, the two can be connected and fixed by spraying a biocompatible adhesive between the cutting blade 2 and the groove 121. The adhesive refers to the prior art and is not specifically limited by the present invention. The cutting blade 2 is preferably made of high-strength and light-weight titanium alloy. The titanium alloy blade can optionally be surface-coated, such as hard-coated, to improve the wear resistance and cutting performance of the blade.

[0052] The traction mechanism 3 includes a rotating tube 32 whose distal end extends into the balloon 1 and a flexible member 31 that can be rolled up at the distal end of the rotating tube 32. The flexible member 31 has a plurality of grooves 121 (or cutting blades 2) that are arranged one-to-one correspondingly. One end of the flexible member 31 is connected to the rotating tube 32, and the other end is connected to the inner wall of the balloon 1 on the inner side of the cutting blade 2. When the balloon 1 is in an expanded state and the rotating tube 32 rotates along the winding direction, the flexible member 31 is tensioned and gradually rolled up on the rotating tube 32 and pulls the balloon 1, so that the cutting blade 2 gradually sinks into the balloon 1, and the opening 21 of the cutting blade 2 tends to shrink.

[0053] Specifically, if Figure 4 and Figure 7As shown, the flexible member 31 includes a winding portion 312 and a connecting portion 311 that is roughly perpendicular to the winding portion 312. One end of the winding portion 312 is fixedly connected to the rotating tube 32 and the other end is fixedly connected to the middle area of ​​the connecting portion 311. When the winding portion 312 is wound, the middle area of ​​the connecting portion 311 can be pulled to ensure that the connecting portion 311 is evenly stressed. The connecting portion 311 is fixedly connected to the inner wall of the balloon 1 on the inner side of the cutting blade 2 (i.e., the side wall of the groove 121). The shape of the connecting portion 311 matches the side wall of the groove 121 to ensure a stable connection between the connecting portion 311 and the balloon 1. Furthermore, the flexible member 31 is made of a membrane made of a polymer material, specifically, high-strength and low-ductility polyparaxylene.

[0054] Catheter 4 comprises an inner tube 41 and an outer tube 42 sheathed and coaxially disposed outside inner tube 41. The distal end of inner tube 41 is inserted into and connected to the distal end of balloon 1, namely, to the distal connecting section of balloon 1. The distal end of outer tube 42 is inserted into and connected to the proximal end of balloon 1, namely, to the proximal connecting section of balloon 1. Rotating tube 32 is coaxial with inner tube 41 and rotatably disposed between inner and outer tubes 41, 42.

[0055] The handle 5 includes a catheter seat 51 having an injection cavity 511 and a guidewire cavity 512, and a drive assembly disposed on the catheter seat 51 and configured to control the movement of the rotating tube 32. The inner tube 41, outer tube 42, and proximal ends of the rotating tube 32 are connected to the catheter seat 51. A medium channel connected to the injection cavity 511 is formed between the inner tube 41 and the outer tube 42. By introducing an expansion medium into the injection cavity 511, the expansion medium can enter the balloon 1 through the medium channel. Under the action of the expansion medium, the balloon 1 can be expanded to an expanded state. Of course, the expansion medium can also be discharged through the medium channel and the injection cavity 511 in sequence, thereby switching the balloon 1 from an expanded state to a contracted state. The proximal ends of the rotating tube 32 and the inner tube 41 respectively extend out of the outer tube 42, and the proximal end of the inner tube 41 extends out of the rotating tube 32. The rotating tube 32 is connected to the drive assembly, and the drive assembly enables the rotating tube 32 to be controlled and rotated.

[0056] Specifically, if Figure 8 and Figure 9As shown, the drive assembly includes a gear 52 mounted on the proximal end of the rotating tube 32, a first transmission wheel 53 meshed with the gear 52, a transmission rod 54 connected to and coaxial with the first transmission wheel 53, and an operating portion 57 connected to the transmission rod 54. Rotating the operating portion 57 drives the transmission rod 54 to rotate the first transmission wheel 53, thereby driving the gear 52 to rotate the rotating tube 32. More specifically, the drive assembly also includes a housing 55 connected to the catheter hub 51 and located outside the transmission rod 54, and a second transmission wheel 56 meshed between the operating portion 57 and the transmission rod 54. The second transmission wheel 56 has a plurality of evenly distributed second transmission wheels 56 around the axis of the transmission rod 54. The second transmission wheel 56 is rotatably connected to the housing 55 via a rotating shaft 58. The rotational axes of the second transmission wheel 56, the transmission rod 54, and the operating portion 57 are parallel.

[0057] The handle 5 further includes a blocking member 59 , which has at least two blocking members 59 located at the proximal end of the inner tube 41 and on the transmission rod 54 , and is used to form a blockage to prevent the expansion medium from leaking. The blocking member 59 may be a sealing rubber ring.

[0058] Working principle:

[0059] The catheter 4 is inserted into the patient's arterial stenosis site to ensure that the balloon 1 is located in the stenotic area. An expansion medium (such as saline or contrast agent) is introduced into the balloon 1 through the injection chamber 511 to expand the balloon 1 and compress the arterial stenosis site. During the expansion process of the balloon 1, the operating part 57 is rotated, and the operating part 57 drives the second transmission wheel 56 to rotate. When the second transmission wheel 56 rotates, the driving transmission rod 54 drives the first transmission wheel 53 to rotate, thereby driving the gear 52 to rotate the rotating tube 32. When the rotating tube 32 rotates in the winding direction, the flexible member 31 is gradually wound around the rotating tube 32 by the force of the rotating tube 32. On, the outer end of the flexible member 31 pulls the balloon 1. Under the pulling of the flexible member 31, the balloon 1 gradually deforms and concaves inward and moves inward with the cutting blade 2. The exposed depth of the cutting blade 2 gradually decreases. At the same time, the balloon 1 squeezes the cutting blade 2, causing the opening 21 of the cutting blade 2 to gradually decrease until it closes. When the operating part 57 is operated to rotate the rotating tube 32 in the opposite direction, the flexible member 31 gradually loosens the winding. Under the action of the expansion medium, the balloon 1 expands outward and moves outward with the cutting blade 2. The exposed depth of the cutting blade 2 gradually increases and the opening 21 gradually increases until it is fully opened. Adjust the exposed depth and / or opening angle a of the cutting blade 2 according to the thickness and area of ​​the fibrous tissue and calcification in the narrow area, and then cut. After the cutting is completed, the expansion medium is passed through the injection cavity 511 to shrink the balloon 1 and gently withdraw the catheter 4.

[0060] The above embodiments are intended only to illustrate the technical concepts and features of the present invention. Their purpose is to enable those skilled in the art to understand the contents of the present invention and implement them accordingly. They are not intended to limit the scope of protection of the present invention. Any equivalent changes or modifications made in accordance with the spirit of the present invention are intended to be covered by the scope of protection of the present invention.

Claims

1. A cutting balloon dilatation catheter, comprising a balloon (1) having an expanded state and a contracted state and a catheter (4), wherein the catheter (4) comprises an inner tube (41) and an outer tube (42) sleeved on the outer side of the inner tube (41), wherein the distal end of the inner tube (41) is inserted into the balloon (1) and connected to the distal end of the balloon (1), and the distal end of the outer tube (42) is inserted into the balloon (1) and connected to the proximal end of the balloon (1). Its characteristics are: The cutting balloon dilatation catheter further comprises a cutting blade (2) and a traction mechanism (3), wherein the cutting blade (2) has a plurality of blades connected to the outer side wall of the balloon (1), and the cutting blade (2) has an outward opening (21); the traction mechanism (3) comprises a rotating tube (32) rotatably arranged between the inner tube (41) and the outer tube (42) and the distal end of which extends into the balloon (1), and a flexible member (31) windably arranged at the distal end of the rotating tube (32), wherein the flexible member (31) has a plurality of blades arranged in a one-to-one correspondence with the cutting blades (2), one end of the flexible member (31) is connected to the rotating tube (32), and the other end is connected to the inner wall of the balloon (1) inside the cutting blade (2). When the balloon (1) is in an expanded state and the rotating tube (32) rotates in a winding direction, the flexible member (31) is tightened and gradually wound around the rotating tube (32) and pulls the balloon (1), so that the cutting blade (2) gradually sinks into the balloon (1), and the opening (21) of the cutting blade (2) tends to shrink.

2. The cutting balloon dilatation catheter according to claim 1, characterized in that: The cutting blade (2) is V-shaped, and the narrow end of the cutting blade (2) is connected to the balloon (1).

3. The cutting balloon dilatation catheter according to claim 2, characterized in that: The opening angle (a) of the cutting blade (2) in the fully opened state is 50° to 70°; and / or, The cutting blade (2) is made of titanium alloy; and / or, The number of the cutting blades (2) is 3 to 5; and / or, The cutting blade (2) extends axially along the balloon (1).

4. The cutting balloon dilatation catheter according to claim 1, characterized in that: The balloon (1) comprises a main body (12) and two diameter-reducing parts arranged on both sides of the main body (12); the wall of the main body (12) is recessed inward to form a groove (121); the groove (121) has a plurality of grooves arranged in a one-to-one correspondence with the cutting blades (2); the inner end of the cutting blade (2) is connected to the groove wall of the groove (121).

5. The cutting balloon dilatation catheter according to claim 4, characterized in that: The groove (121) is consistent with the extending direction of the cutting blade (2).

6. The cutting balloon dilatation catheter according to claim 1, characterized in that: The flexible member (31) comprises a winding portion (312) and a connecting portion (311) substantially perpendicular to the winding portion (312), one end of the winding portion (312) being connected to the rotating tube (32) and the other end being connected to the middle area of ​​the connecting portion (311), and the connecting portion (311) being connected to the inner wall of the balloon (1) on the inner side of the cutting blade (2).

7. The cutting balloon dilatation catheter according to claim 1, characterized in that: The flexible member (31) is made of a diaphragm made of a polymer material; and / or, The material of the flexible member (31) is polyparaxylene.

8. The cutting balloon dilatation catheter according to claim 1, characterized in that: The cutting balloon dilatation catheter also includes a handle (5), the handle (5) includes a catheter seat (51) having an injection cavity (511) and a guide wire cavity (512), and a drive assembly provided on the catheter seat (51) and configured to control the movement of the rotating tube (32), the inner tube (41), the outer tube (42), and the proximal ends of the rotating tube (32) are connected to the catheter seat (51), a medium channel connected to the injection cavity (511) is formed between the inner tube (41) and the outer tube (42), and the rotating tube (32) is connected to the drive assembly.

9. The cutting balloon dilatation catheter according to claim 8, characterized in that: The driving assembly includes a gear (52) sleeved on the proximal end of the rotating tube (32), a first transmission wheel (53) meshed with the gear (52), a transmission rod (54) connected to the first transmission wheel (53), and an operating portion (57) connected to the transmission rod (54). The operating part (57) is rotated, and the operating part (57) drives the transmission rod (54) to rotate with the first transmission wheel (53), thereby driving the gear (52) to rotate with the rotating tube (32).

10. The cutting balloon dilatation catheter according to claim 9, characterized in that: The drive assembly further comprises a housing (55) connected to the catheter seat (51) and arranged outside the transmission rod (54), and a second transmission wheel (56) meshed between the operating portion (57) and the transmission rod (54), wherein the second transmission wheel (56) has a plurality of wheels evenly distributed along the circumference of the transmission rod (54), and the rotation axis lines of the second transmission wheel (56), the operating portion (57), and the transmission rod (54) are parallel.

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