Spinous process balloon dilatation catheter

Abstract

The present invention relates to a spinous process balloon dilatation catheter, comprising a balloon, an inner tube, an outer tube, a spinous process assembly having tensioned and untensioned states, an elastic member that causes the spinous process assembly to always maintain a tensioned state, the spinous process assembly comprising multiple spinous processes and a ligating member, the spinous process comprising a spinous process body, and a blade having a hidden state and an exposed state, wherein the blade is hidden when the spinous process assembly is in the tensioned state and exposed when the spinous process assembly is in the untensioned state, and when a filling medium is introduced into the filling cavity, the balloon expands and drives the spinous process assembly to overcome the elastic force of the elastic member and switch from the tensioned state to the untensioned state. The spinous process balloon dilatation catheter is provided with a blade that can automatically switch between the hidden state and the exposed state according to the expansion or contraction of the balloon, thereby avoiding accidental cutting of the blood vessel when entering or removing the blood vessel, and effectively cutting calcification, plaque, and thrombus in the blood vessel.

Description

Technical Field

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

[0002] Balloon dilatation catheters are effective medical devices for treating vascular stenosis. To treat vascular stenosis caused by various factors and in different locations, current approaches primarily involve adding components to the balloon to enhance its effectiveness and reach. For example, blades bonded to the balloon surface can effectively cut calcifications, plaques, and thrombi.

[0003] Although gluing a blade on the surface of the balloon has a good effect on removing calcification, plaque, etc., the blade can also easily damage the blood vessels, especially when entering and removing the blood vessels, it is easy to cut the blood vessels and cause medical accidents. Summary of the Invention

[0004] The purpose of the present invention is to provide a spinous process balloon dilatation catheter with good cutting effect and good safety.

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

[0006] A spinous process balloon dilatation catheter comprises a balloon capable of expanding or contracting in its radial direction, an inner tube whose distal end is inserted into the balloon and connected to the distal end of the balloon, and an outer tube sheathed outside the inner tube and whose distal end is inserted into the balloon and connected to the proximal end of the balloon, wherein a filling lumen is formed between the inner tube and the outer tube to allow the flow of a filling medium, the filling lumen being in communication with the balloon, and the spinous process balloon dilatation catheter further comprising:

[0007] A spinous process assembly having a tensioned state and a non-tensioned state, the spinous process assembly comprising a plurality of spinous processes formed on the outer peripheral side of the balloon, two ligating members provided at both ends of the spinous process and used to movably bind the two ends of the spinous process to the two ends of the balloon, the spinous process comprising a spinous process body and a blade provided on the spinous process body, the blade having a hidden state and an exposed state, when the spinous process assembly is in a tensioned state, the blade is in a hidden state, and when the spinous process assembly is in a non-tensioned state, the blade is in an exposed state;

[0008] An elastic member connected between the outer tube and the proximal end of the spinous process assembly, so that the spinous process assembly has a tendency to always remain in a tensioned state,

[0009] When a filling medium is introduced into the filling cavity, the balloon expands and drives the spinous process assembly to overcome the elastic force of the elastic member and switch from the tensioned state to the non-tensioned state.

[0010] Preferably, the spinous process body includes a connecting portion and a spinous process portion.

[0011] Further preferably, the connecting portion has a certain elastic deformation capability, and can be stretched to tighten the spinous process assembly or can be shortened to relax the spinous process assembly.

[0012] Further preferably, the spinous process has a plurality of blades arranged on the connecting portion along the extension direction of the connecting portion, the spinous process includes two hinged links, and the blade is provided on one or both of the two links. When one or both of the two links rotate, the blade is hidden or exposed.

[0013] Preferably, the blade is arranged at the end of the link adjacent to another link. When the spinous process assembly is in a tensioned state, the two links are parallel and the blade is hidden between the two links. When the spinous process assembly is switched from a tensioned state to a non-tensioned state, the connecting portion shortens and drives the two links to rotate and arch outward to expose the blade.

[0014] In some embodiments, one of the two links has a hidden chamber, and the other link is provided with the blade at the end. The hidden chamber has an opening, and when the spinous process assembly switches from a tensioned state to a non-tensioned state, the blade is exposed through the opening.

[0015] Preferably, the plurality of spinous processes are connected end to end.

[0016] Preferably, the connecting portion is made of rubber.

[0017] Further preferably, the connecting portion includes a base arranged on the inner side of the spinous process, and the base is provided with multiple protrusions corresponding to the spinous process, one end of the spinous process is connected to the protrusion corresponding to it, and the other end is connected to another protrusion adjacent to the protrusion or another spinous process.

[0018] Preferably, the spinous process extends along the length direction of the balloon.

[0019] Preferably, the spinous processes are evenly arranged along the circumference of the balloon.

[0020] Preferably, the elastic member is a spring bellows.

[0021] Preferably, both ends of the spinous process are connected to the corresponding ligatures through metal wires.

[0022] Preferably, the spinous process balloon dilatation catheter further comprises a handle, the inner tube and the outer tube are both connected to the handle, and the handle has an injection cavity connected to the filling cavity and a guidewire cavity connected to the inner tube.

[0023] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art:

[0024] The spinous process balloon dilatation catheter of the present invention is provided with a blade, which can automatically switch between a hidden state and an exposed state according to the expansion or contraction of the balloon. On the one hand, it can avoid accidentally cutting the blood vessel when entering or removing the blood vessel, and has good safety; on the other hand, it can effectively cut calcification, plaque and thrombus in the blood vessel, and has a good cutting effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] 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.

[0026] Figure 1 Schematic diagram of the structure of the spinous process balloon dilatation catheter in Example 1, wherein the balloon is in an expanded state;

[0027] Figure 2 Schematic diagram of the structure of the spinous process assembly and the balloon in Example 1, wherein the balloon is half-cut and in an expanded state;

[0028] Figure 3 Schematic diagram of the structure of the spinous process assembly and the balloon in Example 1, wherein the balloon is in a deflated state;

[0029] Figure 4 Schematic diagram of the structure of the distal end portion of the spinous process assembly of Example 1, wherein the spinous process assembly is in a non-tensioned state;

[0030] Figure 5 Schematic diagram of the structure of the proximal portion of the spinous process assembly of Example 1, wherein the spinous process assembly is in a non-tensioned state;

[0031] Figure 6 This is a schematic structural diagram of the spinous process in Example 1 in a tensioned state;

[0032] Figure 7 for Figure 6 An enlarged schematic diagram of the spinous process of

[0033] Figure 8 This is a schematic structural diagram of the spinous process in Example 1 in a non-tensioned state;

[0034] Figure 9 for Figure 8 An enlarged schematic diagram of the spinous process of

[0035] Figure 10 This is a schematic structural diagram of the first chain link and the second chain link of Example 1;

[0036] Figure 11 This is a schematic structural diagram of the base of Example 1;

[0037] Among them: 1. Balloon; 2. Inner tube; 3. Outer tube; 4. Spinous process assembly; 41. Spinous process; 411. Spinous process; 4111. First link; 41111. Hidden chamber; 41112. Opening; 4112. Second link; 4113. Blade; 412. Base; 4121. Protrusion; 42. Ligating piece; 43. Metal wire; 5. Elastic piece; 6. Handle; 7. Guide wire. DETAILED DESCRIPTION

[0038] 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.

[0039] In describing the embodiments of the present invention, it should be understood that the terms "distal" and "proximal" and other terms indicating positions or locations are defined based on the orientation of the balloon dilation catheter 1 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 devices or components 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] The embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0044] Example 1

[0045] A spinous process balloon dilatation catheter, such as Figures 1 to 5 As shown, it includes a balloon 1, an inner tube 2, an outer tube 3, a spinous process assembly 4, an elastic member 5 and a handle 6. The balloon 1 can expand or contract along its radial direction, and the balloon 1 has a proximal pin and a distal pin. The distal end of the inner tube 2 is inserted into the balloon 1 and fixedly connected to the distal pin of the balloon 1. The outer tube 3 is sleeved on the outside of the inner tube 2, and the distal end of the outer tube 3 is inserted into the balloon 1 and fixedly connected to the proximal pin of the balloon 1. A filling cavity (not shown in the figure) that allows the circulation of a filling medium is formed between the inner tube 2 and the outer tube 3, and the filling cavity is connected to the balloon 1. The filling cavity can be used to introduce a filling medium into the balloon 1 or extract the filling medium of the balloon 1, thereby causing the balloon 1 to expand or contract. The filling medium includes but is not limited to physiological saline.

[0046] For some fibrotic or calcified lesions, it is difficult for the ordinary balloon 1 to fully expand. By arranging the spinous process assembly 4 on the peripheral side of the balloon 1, the removal effect of such lesions can be improved. Further, a blade 4113 is provided on the spinous process assembly 4, and the removal effect is even better. However, in addition to having a better removal effect on such lesions, the blade 4113 is also very easy to damage the inner wall of the blood vessel, especially in the process of entering and removing the blood vessel, it is inevitable that it will come into contact with the blood vessel wall, and the blood vessel may be cut if not careful. The inventor designed the spinous process assembly 4 so that the blade 4113 thereon can be hidden or exposed as needed, which can avoid accidentally cutting the blood vessel when entering or removing the blood vessel, while effectively cutting fibrotic or calcified lesions. The spinous process assembly 4 is further described below.

[0047] like Figures 2 to 11 As shown, the spinous process assembly 4 has a tensioned state (see Figure 3 、 Figure 6 and Figure 7 ) and non-tensioned state (see Figure 2 、 Figure 4 、 Figure 5 、 Figure 8 and Figure 9The spinous process assembly 4 includes a plurality of spinous processes 41 and a ligature 42, wherein the plurality of spinous processes 41 are evenly arranged on the periphery of the balloon 1, and each spinous process 41 extends along the length direction (i.e., axial direction) of the balloon 1. The ligature 42 has two ligatures 42, one at the distal end and the other at the proximal end of the spinous process 41, for movably restraining the two ends of the spinous process 41 to the two ends of the balloon 1. The ligature 42 is specifically a ligature ring, and the two ends of the spinous process 41 are respectively connected to the ligature ring by a metal wire 43.

[0048] The spinous process 41 includes a spinous process body and a plurality of blades 4113 provided on the spinous process body. The blades 4113 have a hidden state and an exposed state. When the spinous process assembly 4 is in a tensioned state, the blades 4113 are in a hidden state. When the spinous process assembly 4 is in a non-tensioned state, the blades 4113 are in an exposed state. The elastic member 5 is connected between the outer tube 3 and the proximal end of the spinous process assembly 4, so that the spinous process assembly 4 has a tendency to always remain in a tensioned state. Specifically, the elastic member 5 can be a spring or a spring bellows, one end of which is connected to the proximal ligation member 42, and the other end is connected to the outer tube 3 or the handle 6. When the filling medium is introduced into the filling cavity, the balloon 1 expands and drives the spinous process assembly 4 to overcome the elastic force of the elastic member 5 and switch from the tensioned state to the non-tensioned state. That is: in the initial state, the balloon 1 contracts, and the spinous process assembly 4 is tensioned under the action of the elastic member 5, so that the blade 4113 is hidden, and the balloon 1 can enter or move out of the blood vessel, and the blade 4113 does not contact the blood vessel wall. When the balloon 1 reaches the specified position in the blood vessel, the filling medium is introduced into the balloon 1, the balloon 1 expands, and the outside of the balloon 1 abuts against the spinous process assembly 4, so that the spinous process assembly 4 overcomes the elastic force of the elastic member 5 and switches to a non-tensioned state, thereby exposing the blade 4113 to cut the diseased tissue.

[0049] Specifically, the spinous process body includes a connecting portion and a spinous process portion 411, see Figures 6 to 9 .

[0050] The connecting portion has a certain elastic deformation capability and can be extended to tighten the spinous process assembly 4 or shortened to relax the spinous process assembly 4. In this embodiment, the connecting portion is a rubber base 412, which is provided with a plurality of protrusions 4121 corresponding to the spinous process 411. One end of the spinous process 411 can be fixedly connected to the corresponding protrusion 4121 by an adhesive, and the other end is connected to another spinous process 411 adjacent to the spinous process 411.

[0051] The spinous process 411 has multiple blades arranged along the extending direction of the connecting portion. Taking one of the spinous processes 411 as an example, the spinous process 411 includes two hinged links, namely a first link 4111 and a second link 4112. A blade 4113 is provided on one or both of the two links. When one or both of the two links rotate, the blade 4113 is hidden or exposed. In this embodiment, the blade 4113 is provided at the distal end of the second link 4112. The first link 4111 has a hidden chamber 41111 capable of concealing the blade 4113, and the hidden chamber 41111 has an opening 41112. When the spinous process assembly 4 is in a tensioned state, the distal end of the second link 4112, which has the blade 4113, is located in the hidden chamber 41111, and the first link 4111 and the second link 4112 are parallel. When the spinous process assembly 4 switches from the tensioned state to the untensioned state, the base 412 shortens and drives the first link 4111 and the second link 4112 to rotate and arch outward, so that the blade 4113 is exposed to the outside through the opening 41112 .

[0052] Furthermore, the multiple spinous processes 411 are connected end to end.

[0053] Handle 6 includes an injection lumen connected to the filling channel and a guidewire lumen connected to inner tube 2. Both inner tube 2 and outer tube 3 are connected to handle 6. During use, the user can inject filling medium into balloon 1 through the injection lumen to expand it, or withdraw the filling medium to deflate it. A guidewire 7 can be inserted through the guidewire lumen into inner tube 2, thereby guiding balloon 1 into the target location in the blood vessel.

[0054] 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 spinous process balloon dilatation catheter, comprising a balloon (1) capable of expanding or contracting along its radial direction, an inner tube (2) distally inserted into the balloon (1) and connected to the distal end of the balloon (1), an outer tube (3) sleeved on the outside of the inner tube (2) and distally inserted into the balloon (1) and connected to the proximal end of the balloon (1), a filling lumen allowing the flow of a filling medium is formed between the inner tube (2) and the outer tube (3), the filling lumen being in communication with the balloon (1), and characterized in that: The spinous process balloon dilatation catheter further comprises: A spinous process assembly (4) having a tensioned state and a non-tensioned state, wherein the spinous process assembly (4) includes a plurality of spinous processes (41) formed on the outer peripheral side of the balloon (1), two ligatures (42) respectively arranged at both ends of the spinous process (41) and used to movably bind the two ends of the spinous process (41) to the two ends of the balloon (1), the spinous process (41) includes a spinous process body and a blade (4113) arranged on the spinous process body, the blade (4113) has a hidden state and an exposed state, when the spinous process assembly (4) is in the tensioned state, the blade (4113) is in the hidden state, and when the spinous process assembly (4) is in the non-tensioned state, the blade (4113) is in the exposed state. In a non-tensioned state, the blade (4113) is in an exposed state, the spinous process body comprises a connecting portion and a spinous process portion (411), the connecting portion having a certain elastic deformation capability, which can be extended to tension the spinous process assembly (4) or shortened to relax the spinous process assembly (4); the spinous process portion (411) has a plurality of blades arranged on the connecting portion along an extension direction of the connecting portion, the spinous process portion (411) comprises two hinged links, the blade (4113) is provided on one or both of the two links, and when one or both of the two links rotate, the blade (4113) is hidden or exposed; An elastic member (5), the elastic member (5) being connected between the outer tube (3) and the proximal end of the spinous process assembly (4), so that the spinous process assembly (4) has a tendency to always remain in a tensioned state. When a filling medium is introduced into the filling cavity, the balloon (1) expands and drives the spinous process assembly (4) to overcome the elastic force of the elastic member (5) and switch from the tensioned state to the non-tensioned state.

2. The spinous process balloon dilatation catheter according to claim 1, characterized in that: The blade (4113) is arranged at the end of the chain link adjacent to another chain link. When the spinous process assembly (4) is in a tensioned state, the two chain links are parallel, and the blade (4113) is hidden between the two chain links. When the spinous process assembly (4) switches from a tensioned state to a non-tensioned state, the connecting portion shortens and drives the two chain links to rotate and arch outwards, exposing the blade (4113).

3. The spinous process balloon dilatation catheter according to claim 2, characterized in that: One of the two chain links has a hidden chamber (41111), and the other link is provided with the blade (4113) at its end. The hidden chamber (41111) has an opening (41112). When the spinous process assembly (4) switches from a tensioned state to a non-tensioned state, the blade (4113) is exposed through the opening (41112).

4. The spinous process balloon dilatation catheter according to claim 1, characterized in that: The plurality of spinous processes (411) are connected end to end.

5. The spinous process balloon dilatation catheter according to claim 1, characterized in that: The connecting portion is a base (412) made of rubber material and arranged on the inner side of the spinous process (411). The base (412) is provided with a plurality of protrusions (4121) corresponding to the spinous process (411). One end of the spinous process (411) is connected to the protrusion (4121) corresponding to it, and the other end is connected to another protrusion (4121) adjacent to the protrusion (4121) or another spinous process (411).

6. The spinous process balloon dilatation catheter according to claim 1, characterized in that: The spinous process (41) extends along the length direction of the balloon (1); and / or, The spinous processes (41) are evenly arranged along the periphery of the balloon (1).

7. The spinous process balloon dilatation catheter according to claim 1, characterized in that: The elastic member (5) is a spring bellows.

8. The spinous process balloon dilatation catheter according to claim 1, characterized in that: The two ends of the spinous process (41) are connected to the corresponding ligature (42) via metal wires (43).

9. The spinous process balloon dilatation catheter according to claim 1, characterized in that: The spinous process balloon dilatation catheter further comprises a handle (6), the inner tube (2) and the outer tube (3) are both connected to the handle (6), and the handle (6) has an injection cavity connected to the filling cavity and a guide wire cavity connected to the inner tube (2).

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