Balloon dilatation catheter with reinforcing umbrella

Abstract

The utility model relates to a balloon dilatation catheter with a reinforcing umbrella, which comprises a balloon dilatation catheter component and a telescopic protective umbrella component, and the telescopic protective umbrella component comprises a tube component, a support wire component and a plurality of nickel-titanium alloy wires. The supporting wire assembly penetrates through the pipe assembly, the nickel-titanium alloy wires are located at the front end of the pipe assembly and distributed in the circumferential direction around the supporting wire assembly, the front ends of the nickel-titanium alloy wires are fixedly connected with the front end of the supporting wire assembly, and the rear ends of the nickel-titanium alloy wires are fixedly connected with the front end of the pipe assembly. When the supporting wire assembly is moved to the front position, all the nickel-titanium alloy wires are straightened, and when the supporting wire assembly is moved to the rear position, all the nickel-titanium alloy wires are deformed and shrunk into an umbrella shape. According to the balloon dilatation catheter with the reinforcing umbrella, efficient pressure focusing can be achieved under low dilatation pressure, tearing can be achieved on a severely-calcified vascular intima, and meanwhile the balloon can play a role in blocking, compressing and stopping bleeding.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, specifically to a balloon dilation catheter with a reinforcing umbrella. Background Technology

[0002] With social development and the continuous improvement of people's living standards, the number of people suffering from smoking, hypertension, and hyperlipidemia is increasing. These factors lead to damage to the vascular endothelium, the introduction of inflammatory substances, and the deposition of lipids, resulting in atherosclerotic plaques. If these plaques gradually increase, they can cause narrowing or even occlusion of blood vessels. In interventional treatment of cardiovascular diseases, the use of balloon dilation catheters to dilate blood vessels is a common treatment method. However, ordinary balloon dilation catheters may not achieve ideal therapeutic effects when treating some special and complex lesions alone.

[0003] Balloon dilation catheters primarily work by inflating the distal balloon to compress plaque in the blood vessel, stretching the vessel wall and reducing vascular stenosis. However, this can also lead to complications such as intimal tearing and elastic recoil. For hard, stenotic lesions (such as calcified lesions), it is usually necessary to increase the balloon inflation pressure to reduce the degree of stenosis and obtain sufficient lumen volume. However, increased inflation pressure increases the stretching of the vessel wall, leading to a greater likelihood of vascular injury-related complications (such as severe dissection and rebound). For particularly stubborn and hard lesions, even inflating the balloon to near burst pressure may not compress the plaque. To address this, various devices have emerged on the market, such as notched balloon dilation catheters, cut balloon dilation catheters, and braided balloon dilation catheters. These devices primarily dilate the stenosis by cutting the plaque or increasing balloon pressure to tear the lesion. However, these devices have complex manufacturing processes and low production efficiency. Utility Model Content

[0004] The technical problem to be solved by this utility model is to overcome the shortcomings of the prior art and provide a balloon dilation catheter with a reinforcing umbrella, thereby solving the technical problems of complex structure, simple function and high manufacturing cost of the balloon dilation catheters currently used to treat hard plaques on the blood vessel wall.

[0005] The technical solution adopted by this utility model to solve its technical problem is:

[0006] First aspect:

[0007] A balloon dilation catheter with a reinforcing umbrella is provided, comprising:

[0008] Balloon dilation catheter assembly, and

[0009] A retractable protective umbrella assembly, comprising a tube assembly, a support wire assembly, and multiple nickel-titanium alloy wires;

[0010] The support wire assembly passes through the tube assembly. Each nickel-titanium alloy wire is located at the front end of the tube assembly and is circumferentially distributed around the support wire assembly. The front end of each nickel-titanium alloy wire is fixedly connected to the front end of the support wire assembly, and the rear end of each nickel-titanium alloy wire is fixedly connected to the front end of the tube assembly. When the support wire assembly moves to the front position, each nickel-titanium alloy wire is straightened. When the support wire assembly moves to the rear position, each nickel-titanium alloy wire is deformed and contracted into an umbrella shape.

[0011] The retractable protective umbrella assembly is inserted into the guidewire lumen of the balloon dilation catheter assembly, which is adapted to clamp and position the retractable protective umbrella assembly that has passed through it.

[0012] Move the rear end of the retractable protective umbrella assembly, which is in a straightened state, to the rear end of the balloon dilation catheter assembly. At this time, each nickel-titanium alloy wire extends fully from the front end of the balloon dilation catheter assembly. As each nickel-titanium alloy wire opens into an umbrella shape, each nickel-titanium alloy wire is suitable for attaching to the balloon of the balloon dilation catheter assembly.

[0013] Furthermore, the tube assembly includes a spring tube and an umbrella handle;

[0014] The front end of the umbrella handle is fixedly connected to the rear end of the spring tube, and the rear end of the umbrella handle is provided with an external thread for engaging with the umbrella nut.

[0015] Furthermore, the support wire assembly includes a support wire, a guide head, and a bevel nut;

[0016] The front end of the support wire is fixedly connected to the guide head, and the rear end is fixedly connected to the umbrella nut.

[0017] Furthermore, the balloon dilation catheter assembly includes

[0018] Outer tube, core tube, balloon, tee handle, threaded cap, sealing tube, and white nut;

[0019] The core tube is inserted inside the outer tube, with its front end extending out of the outer tube. The front end of the balloon is connected to the core tube, and the rear end of the balloon is connected to the outer tube. The rear end of the outer tube is fixedly connected to the handle assembly.

[0020] The threaded cap is fixedly connected to the rear end of the three-way handle, the white nut is connected to the threaded cap, and the sealing tube is placed between the white nut and the threaded cap. When the white nut is tightened, the sealing tube locks the retractable protective umbrella assembly that passes through it.

[0021] Furthermore, the threaded cap includes

[0022] The cap body has a front cap hole and a rear cap hole. The front cap hole is adapted to be connected to the rear end of the handle assembly, and the sealing tube is disposed in the rear cap hole.

[0023] The white nut is threaded to the rear end of the cap body, and the front end of the white nut is inserted into the rear cap hole and axially abuts against the sealing tube.

[0024] The second aspect:

[0025] A method of using the aforementioned balloon dilation catheter with a reinforcing umbrella is provided, including...

[0026] Step S01: Insert the retractable protective umbrella assembly, which is in the straightened state, into the balloon dilation catheter assembly, ensuring that the head of the retractable protective umbrella assembly is aligned with the head of the balloon dilation catheter assembly. Rotate the white nut to lock the retractable protective umbrella assembly into the balloon dilation catheter assembly.

[0027] Step S02: Under X-ray monitoring, insert the assembled balloon dilation catheter with the reinforcing umbrella to the narrowed area and leave it in place. Confirm that the two radiopaque markers of the balloon dilation catheter are located at both ends of the narrowed area. Loosen the white nut and push the retractable protective umbrella assembly forward until the umbrella handle abuts the white nut. Observe the guide head and confirm that each nickel-titanium alloy wire protrudes from the head of the balloon dilation catheter. Use a pressure pump with a gauge connected to the injection chamber of the three-way handle side branch to slowly inject fluid into the balloon to pre-inflate it. Once the balloon has inflated, stop pressurizing and then rotate counterclockwise. Loosen the nut, pull the support wire assembly backward while pushing the umbrella handle forward. The umbrella handle can push the balloon dilation catheter forward. Confirm the movement of the retractable protective umbrella assembly backward through the guide head imaging. Slowly, each nickel-titanium alloy wire will attach to the balloon of the balloon dilation catheter. Continue to pressurize to the working pressure. During the pressurization process, the nickel-titanium alloy wires attached to the balloon will tear the lesion site, which can achieve efficient pressure focusing at a lower dilation pressure, tearing the vascular intima and reducing the risk of vascular elastic rebound and dissection.

[0028] Step S03: By observing the tearing effect, when the requirements are met, the pressure of the balloon is released, the support wire assembly in the retractable protective umbrella assembly is pushed forward and tightened on the umbrella handle. At this time, each nickel-titanium alloy wire is in a straight state, and the retractable protective umbrella assembly is withdrawn backward through the guide wire cavity.

[0029] The beneficial effects of this utility model are:

[0030] The balloon dilation catheter with a reinforcing umbrella of this invention can achieve efficient pressure focusing at a low dilation pressure, tearing the severely calcified vascular intima, while the balloon can also play a role in occlusion and hemostasis.

[0031] The balloon dilation catheter with a reinforcing umbrella has a simple structure and manufacturing process, and high production efficiency. Attached Figure Description

[0032] The present invention will be further described below with reference to the accompanying drawings.

[0033] Figure 1 This is a schematic diagram of a balloon dilation catheter with a reinforcing umbrella;

[0034] Figure 2 It is a balloon dilation catheter assembly

[0035] Figure 3 It is a retractable protective umbrella component (nickel-titanium alloy wire in straightened state).

[0036] Figure 4 It is a retractable protective umbrella component (nickel-titanium alloy wire retracts into an umbrella shape).

[0037] Figure 5 This is a schematic diagram of a balloon dilation catheter (with the support wire assembly aligned with the front end of the balloon dilation catheter assembly);

[0038] Figure 6 This is a schematic diagram of a balloon dilation catheter (with the nickel-titanium alloy wire at the front end of the support wire assembly extending completely from the balloon);

[0039] Figure 7 This is a schematic diagram of a balloon dilation catheter (the rearward movement of the support wire assembly causes deformation of the nickel-titanium alloy wire);

[0040] Figure 8 This is a schematic diagram of a balloon dilation catheter (a nickel-titanium alloy wire attached to the balloon);

[0041] in,

[0042] 1. Tube assembly; 11. Spring tube; 12. Umbrella handle;

[0043] 2. Support wire assembly; 21. Support wire; 22. Guide head; 23. Umbrella nut;

[0044] 3. Nickel-titanium alloy wire;

[0045] 41. Outer tube; 42. Core tube; 43. Balloon; 44. Three-way handle;

[0046] 51. Threaded cap; 52. Sealing tube; 53. White nut. Detailed Implementation

[0047] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0048] This application provides a balloon dilation catheter with a reinforcing umbrella, which will be described in detail below. It should be noted that the order of description of the following embodiments is not intended to limit the preferred order of the embodiments of this application. Furthermore, the descriptions of each embodiment have their own emphasis; parts not described in detail in a certain embodiment can be referred to in the relevant descriptions of other embodiments.

[0049] To address the technical problems of existing balloon dilation catheters used to treat hard plaques on blood vessel walls, which are characterized by complex structure, simple function, and high manufacturing cost, an embodiment of this application provides a balloon dilation catheter with a reinforcing umbrella. This is described in detail below.

[0050] like Figures 1 to 8 As shown, a balloon dilation catheter with a reinforcing umbrella includes...

[0051] Balloon dilation catheter assembly, and

[0052] A retractable protective umbrella assembly, comprising a tube assembly 1, a support wire assembly 2, and multiple nickel-titanium alloy wires 3;

[0053] The support wire assembly 2 passes through the tube assembly 1. Each nickel-titanium alloy wire 3 is located at the front end of the tube assembly 1 and is circumferentially distributed around the support wire assembly 2. The front end of the nickel-titanium alloy wire 3 is fixedly connected to the front end of the support wire assembly 2, and the rear end of the nickel-titanium alloy wire 3 is fixedly connected to the front end of the tube assembly 1. When the support wire assembly 2 moves to the front position, each nickel-titanium alloy wire 3 is straightened. When the support wire assembly 2 moves to the rear position, each nickel-titanium alloy wire 3 is deformed and contracted into an umbrella shape.

[0054] The retractable protective umbrella assembly is inserted into the guidewire lumen of the balloon dilation catheter assembly, which is adapted to clamp and position the retractable protective umbrella assembly that has passed through it.

[0055] Move the rear end of the retractable protective umbrella assembly, which is in a straightened state, to the rear end of the balloon dilation catheter assembly. At this time, each nickel-titanium alloy wire 3 extends fully from the front end of the balloon dilation catheter assembly. As each nickel-titanium alloy wire 3 opens into an umbrella shape, each nickel-titanium alloy wire 3 is suitable for attaching to the balloon of the balloon dilation catheter assembly.

[0056] Specifically, as an optional implementation method in this embodiment, such as Figure 3 and Figure 4 As shown, the tube assembly 1 includes a spring tube 11 and an umbrella handle 12;

[0057] The front end of the umbrella handle 12 is fixedly connected to the rear end of the spring tube 11, and the rear end of the umbrella handle 12 is provided with an external thread for engaging with the umbrella nut 23.

[0058] Specifically, as an optional implementation method in this embodiment, such as Figure 3 and Figure 4 As shown, the support wire assembly 2 includes a support wire 21, a guide head 22, and a nut 23;

[0059] The front end of the support wire 21 is fixedly connected to the guide head 22, and the rear end is fixedly connected to the umbrella nut 23.

[0060] Specifically, as an optional implementation method in this embodiment, such as Figure 1 and Figure 2 As shown, the balloon dilation catheter assembly includes an outer tube 41, a core tube 43, a balloon 43, a three-way handle 44, a threaded cap 51, a sealing tube 52, and a white nut 53.

[0061] The core tube 43 is inserted inside the outer tube 41, with its front end extending out of the outer tube 41. The front end of the balloon 43 is connected to the core tube 43, and the rear end of the balloon 43 is connected to the outer tube 41. The rear end of the outer tube 41 is fixedly connected to the handle assembly.

[0062] The threaded cap 51 is fixedly connected to the rear end of the three-way handle 44, the white nut 53 is connected to the threaded cap 51, and the sealing tube 52 is disposed between the white nut 53 and the threaded cap 51. When the white nut 53 is tightened, the sealing tube 52 is driven to lock the retractable protective umbrella assembly that passes through it.

[0063] Specifically, a soft tip is provided at the front end of the core tube 43, and a radiopaque marker is provided on the core tube 43, which is located inside the balloon 43.

[0064] Specifically, as an optional implementation method in this embodiment, such as Figure 2 As shown, the threaded cap 51 includes a cap body, a front cap hole and a rear cap hole are provided in the cap body, the front cap hole is adapted to be connected to the rear end of the handle assembly, and the sealing tube 52 is disposed in the rear cap hole;

[0065] The white nut 53 is threaded to the rear end of the cap body, and the front end of the white nut 53 is inserted into the rear cap hole and axially abuts against the sealing tube 52.

[0066] In this embodiment, the sealing tube 52 is a rubber part with a central opening for the spring tube 11 to pass through. As the white nut 53 is tightened, the sealing tube 52 undergoes radial deformation to clamp the spring tube 11.

[0067] In this embodiment, the nickel-titanium alloy wire 3, the guide head 22, and the support wire 21 are fixed together by welding and pressing. The rear end of the nickel-titanium alloy wire 3 is fixed to the spring tube 11 by welding, and the tail end of the support wire 21 is fixed to the umbrella nut 23 by glue. When the umbrella nut 23 is tightened on the handle (e.g., ... Figure 3As shown, when the three nickel-titanium alloy wires 3 are straightened, and the umbrella nut 23 is loosened and moved to the rear position, the support wire assembly 2 moves backward and is pulled backward, which can deform and shrink the nickel-titanium alloy wires 3 to form an umbrella shape, as shown. Figure 4 As shown.

[0068] This application provides a method for using the aforementioned balloon dilation catheter with a reinforcing umbrella, including...

[0069] Step S01: Insert the retractable protective umbrella assembly (in its straightened state) into the balloon dilation catheter assembly, ensuring that the head of the retractable protective umbrella assembly is aligned with the head of the balloon dilation catheter assembly. Figure 5 As shown, rotate the white nut 53 to lock the retractable protective umbrella assembly inside the balloon dilation catheter assembly;

[0070] Step S02: Under X-ray monitoring, the assembled balloon dilation catheter with reinforcing umbrella is delivered to the narrowed area and left in place. Confirm that the two radiopaque markers of the balloon dilation catheter are located at both ends of the narrowed area. Loosen the white nut 53 and push the retractable protective umbrella assembly forward until the umbrella handle 12 abuts against the white nut 53. Figure 6 As shown, observe the guide head 22 and confirm that each nickel-titanium alloy wire 3 protrudes from the head of the balloon dilation catheter. Use a pressure pump with a gauge connected to the injection chamber of the side branch of the three-way handle 44 to slowly inject liquid into the balloon 43 to pre-inflate it. Once the balloon 43 has inflated, stop pressurizing. Next, loosen the nut counterclockwise, pull the support wire assembly 2 backward while simultaneously pushing the umbrella handle 12 forward. The umbrella handle 12 can move forward against the balloon dilation catheter. Figure 7 As shown, the retractable protective umbrella assembly moves backward as confirmed by imaging with the guide head 22. Slowly, the nickel-titanium alloy wires 3 attach to the balloon 43 of the balloon dilation catheter, as... Figure 8 As shown, the pressure is continued to be increased to the working pressure. During the pressurization process, the nickel-titanium alloy wire 3 attached to the balloon 43 will tear the lesion site, which can achieve efficient pressure focusing at a lower expansion pressure, tear the vascular intima, and reduce the risk of vascular elastic rebound and dissection.

[0071] Step S03: By observing the tearing effect, when the requirements are met, the pressure of the balloon 43 is released, the support wire assembly 2 in the retractable protective umbrella assembly is pushed forward and tightened on the umbrella handle 12. At this time, each nickel-titanium alloy wire 3 is in a straightened state, and the retractable protective umbrella assembly is withdrawn backward through the guide wire cavity.

[0072] When bleeding occurs at the tear site, the balloon 43 can be expanded to compress and stop the bleeding. It can also be used to block blood vessels, block them when injecting medication, or block body fluids that pose a risk of infection, thereby blocking the target blood vessel segment.

[0073] All the devices (parts whose specific structures are not specified) selected in this application are general standard parts or parts known to those skilled in the art. Their structures and principles can be learned by those skilled in the art through technical manuals or conventional experimental methods.

[0074] In the description of the embodiments of this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0075] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0076] In the several embodiments provided in this application, it should be understood that the disclosed systems, apparatuses, and methods can be implemented in other ways. The apparatus embodiments described above are merely illustrative. For example, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. Furthermore, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Additionally, the shown or discussed mutual couplings, direct couplings, or communication connections may be through some communication interfaces; indirect couplings or communication connections between devices or units may be electrical, mechanical, or other forms.

[0077] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0078] In addition, in the various embodiments of this utility model, each functional unit can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit.

[0079] Based on the above-described preferred embodiments of this utility model, and through the foregoing description, those skilled in the art can make various changes and modifications without departing from the technical concept of this utility model. The technical scope of this utility model is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. A balloon dilatation catheter with a reinforced umbrella, characterized by, The balloon dilatation catheter assembly comprises a balloon dilatation catheter assembly and a collapsible umbrella assembly; The collapsible umbrella assembly comprises a tube assembly (1), a support wire assembly (2) and a plurality of nitinol wires (3); The support wire assembly (2) passes through the tube assembly (1), each nitinol wire (3) is located at the front end of the tube assembly (1) and is distributed in a circumferential direction around the support wire assembly (2), the front end of the nitinol wire (3) is fixedly connected to the front end of the support wire assembly (2), and the rear end of the nitinol wire (3) is fixedly connected to the front end of the tube assembly (1); each nitinol wire (3) is straightened when the support wire assembly (2) moves to a forward position, and each nitinol wire (3) is deformed and shrunk into an umbrella shape when the support wire assembly (2) moves to a rearward position; The collapsible umbrella assembly is arranged in a guide wire lumen of the balloon dilatation catheter assembly, and the balloon dilatation catheter assembly is adapted to clamp and position the passing collapsible umbrella assembly; The rear end of the collapsible umbrella assembly in a straightened state is moved to the rear end of the balloon dilatation catheter assembly, at this time, each nitinol wire (3) is completely extended from the front end of the balloon dilatation catheter assembly, and each nitinol wire (3) is adapted to be attached to a balloon of the balloon dilatation catheter assembly as each nitinol wire (3) is opened into an umbrella shape.

2. The balloon dilatation catheter with a reinforced umbrella according to claim 1, characterized in that The tube assembly (1) comprises a spring tube (11) and an umbrella handle (12); The front end of the umbrella handle (12) is fixedly connected to the rear end of the spring tube (11), and the rear end of the umbrella handle (12) is provided with an external thread for cooperating with an umbrella nut (23).

3. The balloon dilatation catheter with a reinforced umbrella according to claim 1, characterized in that The support wire assembly (2) comprises a support wire (21), a guide head (22) and an umbrella nut (23); The front end of the support wire (21) is fixedly connected to the guide head (22), and the rear end of the support wire (21) is fixedly connected to the umbrella nut (23).

4. The balloon dilatation catheter with a reinforced umbrella according to claim 1, characterized in that The balloon dilatation catheter assembly comprises an outer tube (41), a core tube (42), a balloon (43), a three-way handle (44), a threaded cap (51), a sealing tube (52) and a white nut (53); The core tube (42) is arranged in the outer tube (41) and extends out of the outer tube (41) at the front end, the balloon (43) is connected to the core tube (42) at the front end and is connected to the outer tube (41) at the rear end, and the rear end of the outer tube (41) is fixedly connected to a handle assembly; The threaded cap (51) is fixedly connected to the rear end of the three-way handle (44), the white nut (53) is connected to the threaded cap (51), and the sealing tube (52) is arranged between the white nut (53) and the threaded cap (51), so that the passing collapsible umbrella assembly is locked when the white nut (53) is tightened.

5. The balloon dilatation catheter with a reinforced umbrella according to claim 4, characterized in that The threaded cap (51) comprises a cap body, a front cap hole and a rear cap hole are formed in the cap body, the front cap hole is adapted to be connected to the rear end of the handle assembly, and the sealing tube (52) is arranged in the rear cap hole. ​ The white screw cap (53) is screwed at the rear end of the cap body, and the front end of the white screw cap (53) is inserted into the rear cap hole and abuts against the sealing tube (52) in the axial direction.

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