Intravascular flexible conveying channel device and using method thereof

Abstract

The invention provides an intravascular flexible delivery channel device, and relates to the technical field of medical instruments, the intravascular flexible delivery channel device comprises: a connecting rod, one end of which is connected with a pressure pump; the flexible pipeline is of a double-layer structure and comprises an outer film and an inner film, one end of the flexible pipeline is formed by connecting the outer film and the inner film in a sealed mode, the other end of the flexible pipeline is formed by connecting the outer film and the inner film, a filling opening is reserved, and the filling opening is connected with the other end of the connecting rod. The flexible pipeline is composed of the double-layer film and has a shape variable function, when the double-layer film is not pressurized, the flexible pipeline shrinks to be of a flexible strip-shaped structure, the hardness is small, the diameter is small, and the flexible pipeline can smoothly reach the positions where blood vessel stenosis and the like are difficult to pass; after a target position is reached, the space between the two layers of films is pressurized, the flexible pipeline is opened and has certain tension, the flexible pipeline can be attached to the inner wall of the blood vessel, the blood vessel is supported, the tubular channel shape is kept, instruments such as a balloon and a support can smoothly pass through the flexible pipeline to reach the diseased region, and the flexible pipeline can also be used for rapidly blocking the rupture position of the blood vessel.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an intravascular flexible delivery channel device and a method for using the same. Background Art

[0002] During intravascular treatment, sometimes the balloon or stent cannot successfully reach the target lesion area. In severe cases, the stent may even be destroyed or unloaded. The reasons may be:

[0003] The narrowed blood vessels will quickly return to their original shape due to elastic retraction;

[0004] After balloon dilation, the local tube wall is torn and the intima affects the stent path;

[0005] There are local calcified plaques, which affect the stent path.

[0006] The existing 5-into-6 double-catheter technology (Guidezilla TM extension catheter) can be used as an intravascular channel, but the Guidezilla TM extension catheter is relatively hard and has a large diameter, and its application is greatly limited. Summary of the invention

[0007] The purpose of the present invention is to provide an intravascular flexible delivery channel device and a method of using the same to improve the above problems. In order to achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0008] In a first aspect, the present application provides an intravascular flexible delivery channel device, comprising:

[0009] A connecting rod, one end of which is connected to a pressure pump;

[0010] The flexible pipe is a double-layer structure, including an outer membrane and an inner membrane, one end of which is closed and connected to the outer membrane and the other end is connected to the outer membrane and has a filling port, and the filling port is connected to the other end of the connecting rod.

[0011] Optionally, the gap between the outer film and the inner film of the flexible pipe is 0.2-0.3 mm.

[0012] Optionally, the inner wall surface of the inner membrane of the flexible pipe is coated with a hydrophilic coating.

[0013] Optionally, an arc-shaped transition section is provided at one end of the flexible pipe connected to the connecting rod, and a port section of the arc-shaped transition section is arc-shaped.

[0014] Optionally, the pressure pump is used to pressurize the space between the outer membrane and the inner membrane of the flexible pipe. After pressurization, the inner diameter of the flexible pipe is 2-5 mm.

[0015] Optionally, a guidewire cavity is provided in the connecting rod, a guidewire is provided in the guidewire cavity, a guidewire external connection hole is provided at a position of the connecting rod close to the flexible pipe, and the guidewire passes through the guidewire external connection hole.

[0016] Optionally, at least one developing mark is provided on the flexible pipe.

[0017] Optionally, a three-way connector is also included, one end of which is connected to the connecting rod; and the other end is provided with a pressure pump port for connecting a pressure pump.

[0018] In a second aspect, the present application also provides a method for using the above-mentioned intravascular flexible delivery channel device, comprising:

[0019] Perform negative pressure pumping operation on the flexible pipe to keep the flexible pipe in a flexible strip structure;

[0020] The flexible tube is delivered to the obstructed part in the blood vessel by pushing the connecting rod;

[0021] Pressurizing the flexible pipe to keep the flexible pipe in a tubular channel structure;

[0022] The device is delivered to the lesion through the tubular channel of the flexible tube.

[0023] Optionally, the method of use further includes:

[0024] When a blood vessel ruptures, a flexible tube (2) having a size corresponding to the blood vessel is used to block the ruptured blood vessel.

[0025] The beneficial effects of the present invention are:

[0026] The flexible pipe of the present invention is composed of a double-layer film and has the function of changeable shape. When the double-layer film is not pressurized, the flexible pipe shrinks to a flexible strip structure with low hardness and small diameter, and can smoothly reach difficult-to-pass parts such as stenotic blood vessels; after reaching the target position, pressure is applied between the double-layer films, the flexible pipe is opened and has a certain tension, can fit with the inner wall of the blood vessel, prop up the blood vessel and maintain the tubular channel shape, and balloons, stents and other instruments can smoothly pass through the flexible pipe and be transported to the lesion site.

[0027] Other features and advantages of the present invention will be set forth in the following description, and in part will become apparent from the description, or may be understood by practicing embodiments of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0029] Figure 1 This is a schematic diagram of the structure of the flexible intravascular delivery channel device according to an embodiment of the present application;

[0030] Figure 2 This is a schematic diagram of the flexible intravascular delivery channel device in an unpressurized state according to an embodiment of the present application;

[0031] Figure 3 This is a schematic diagram of the arc-shaped transition section of the flexible intravascular delivery channel device according to an embodiment of the present application.

[0032] Markings in the figure: 1-connecting rod; 2-flexible pipe; 201-development mark; 202-arc transition section; 3-guide wire; 4-triplet three-way connector; 401-pressure pump port. DETAILED DESCRIPTION

[0033] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. The components of the embodiments of the present invention generally described and shown in the drawings here can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0034] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0035] Coronary heart disease is a major disease that endangers human health. Percutaneous coronary intervention is currently the main treatment method. When there are complex lesions such as calcification, twisting or dissection in the coronary artery, the balloon or stent may not be able to successfully reach the target lesion area. In severe cases, the stent may even be destroyed or unloaded. The existing 5-into-6 double catheter technology (Guidezilla TM extension catheter) can be used as an intravascular channel. The guide catheter section of the Guidezilla TM extension catheter is 25 cm long and is composed of a special steel wire braided mesh and polymer structure. Its advantage is that it provides greater flexibility and a smooth surface, so that it can reach areas that are difficult for instruments to pass through and create a passage. However, the Guidezilla TM extension catheter is made of metal, has a higher hardness and a larger diameter, and its application is greatly limited.

[0036] Example 1

[0037] See also Figure 1 In order to solve the problems of the prior art, the present invention provides an intravascular flexible delivery channel device, comprising:

[0038] A connecting rod (1), one end of which is connected to a pressure pump;

[0039] A flexible pipe (2) is a double-layer structure, comprising an outer membrane and an inner membrane, one end of which is a closed connection between the outer membrane and the inner membrane, and the other end is a connection between the outer membrane and the inner membrane and has a filling port, wherein the filling port is connected to the other end of the connecting rod (1).

[0040] The flexible pipe (2) of the present invention is composed of a double-layer film and has the function of changing its shape. Figure 2 When the double-layer film is not pressurized, the flexible pipe (2) shrinks to a flexible strip structure with low hardness and small diameter, and can smoothly reach difficult-to-pass locations such as stenotic blood vessels; after reaching the target location, pressure is applied between the double-layer film, see Figure 1 and Figure 3 The flexible tube (2) is opened and has a certain tension, and can fit with the inner wall of the blood vessel, prop up the blood vessel and maintain the tubular channel shape, so that balloons, stents and other devices can pass through the flexible tube (2) smoothly to reach the lesion site. After pressurization, the diameter of the flexible tube (2) increases appropriately as the pressure increases.

[0041] As an optional embodiment, the gap between the outer membrane and the inner membrane of the flexible pipe (2) is 0.2-0.3 mm, preferably set to 0.25 mm; the gap is used only to pressurize the flexible pipe (2), and in order to ensure that the flexible pipe (2) has a smaller outer diameter and a larger inner diameter as much as possible, the gap should not be set too large.

[0042] As an optional embodiment, the inner wall surface of the inner membrane of the flexible pipe (2) is coated with a hydrophilic coating to improve the smoothness of the inner wall and ensure that the device can pass through the channel smoothly. The hydrophilic coating can specifically be made of polyvinyl pyrrolidone (PVP), polyethylene oxide, etc.

[0043] As an optional implementation, see Figure 3 The end of the flexible pipe (2) connected to the connecting rod (1) is provided with an arc-shaped transition section (202), and the end section of the arc-shaped transition section (202) is arc-shaped. The design of the arc-shaped transition section (202) can provide a guiding function for the instrument, so that the instrument can smoothly enter the flexible pipe (2).

[0044] As an optional embodiment, the pressure pump is used to pressurize the space between the outer membrane and the inner membrane of the flexible pipe (2). After pressurization, the inner diameter of the flexible pipe (2) is 2-5 mm. Specifically, the inner diameter and outer diameter of the flexible pipe (2) can be designed according to different blood vessels. For example, the inner diameter can generally be 5 mm, 4.5 mm, 4 mm, 3.75 mm, 3.5 mm, 3.0 mm, 2.75 mm, 2.5 mm, 2.25 mm and 2 mm. After pressurization, the gap between the two layers of the flexible pipe (2) remains relatively stable.

[0045] As an optional embodiment, a guidewire (3) cavity is provided in the connecting rod (1), a guidewire (3) is provided in the guidewire (3) cavity, and a guidewire (3) is provided in a position of the connecting rod (1) close to the flexible pipe (2). The guidewire (3) passes through the guidewire (3) external hole and pushes the flexible pipe (2) toward the distal end of the blood vessel along the guidewire (3); the tip design of the guidewire (3) usually has good flexibility and maneuverability, and can accurately navigate to the narrow or blocked blood vessel site and guide the instrument into the blood vessel. The guidewire (3) can also provide support for the instrument to prevent the instrument from being folded or shifted when passing through a narrow or curved blood vessel.

[0046] As an optional embodiment, at least one developing mark (201) is provided on the flexible pipe (2). For a flexible pipe (2) having a length greater than or equal to 10 mm, two developing marks (201) are preferably provided, respectively close to the two ends of the flexible pipe (2); for a flexible conveying pipe having a length less than 10 mm, one developing mark (201) is preferably provided, located at the far end of the flexible pipe (2) (the end away from the connecting rod (1)).

[0047] The position of the development mark (201) can be displayed by X-ray scanning, thereby visualizing the specific position of the flexible tube (2) in the blood vessel, making it easier to control it.

[0048] As an optional embodiment, a three-way connector (4) is further included, one end of which is connected to the connecting rod (1); and the other end is provided with a pressure pump port (401) for connecting a pressure pump. In the process of coronary angiography and treatment, cerebral angiography and treatment, peripheral angiography and treatment, etc., the three-way connector (4) is used to connect a catheter and a syringe, so as to facilitate multi-channel infusion and drug injection.

[0049] A filling cavity is also provided in the connecting rod (1), and the filling cavity and the guide wire (3) cavity are independent of each other; one end of the filling cavity is connected to the filling port of the flexible pipe (2), and the other end is connected to the pressure pump port (401) of the three-way connector (4), and the flexible pipe (2) is pressurized through the filling cavity.

[0050] Example 2

[0051] The present application also provides a method for using the above-mentioned intravascular flexible delivery channel device, including:

[0052] Adjusting the pressure pump to apply negative pressure to the flexible pipe (2) so that the flexible pipe (2) contracts and remains in a flexible strip structure;

[0053] The flexible tube (2) is delivered to the obstructed part in the blood vessel by pushing the connecting rod (1), and during the operation, the position of the flexible tube (2) can be assisted by the developing mark (201);

[0054] The pressure pump is adjusted to pressurize the flexible pipe (2) so that the flexible pipe (2) maintains a tubular channel structure; at this time, the flexible pipe (2) is closely attached to the inner wall of the blood vessel, ensuring that the interventional instrument can pass through the tubular channel smoothly;

[0055] The instrument is delivered to the lesion site through the tubular channel of the flexible pipe (2).

[0056] The inner and outer membranes of the flexible tube (2) have a certain tension and can be made of the same material as the coronary intervention balloon, such as polyethylene terephthalate (PET) or nylon. Under a certain pressure, the degree of deformation can be controlled.

[0057] If the flexible tube (2) ruptures, it will return to a strip-shaped structure after the internal pressure drops, and can be smoothly evacuated from the blood vessel cavity.

[0058] As an optional embodiment, the obstructed area in the blood vessel includes at least one of a stenotic area, a vessel wall tear area, and a calcified plaque area.

[0059] The method for using the flexible conveying pipeline device of the present application may also include:

[0060] When a blood vessel ruptures, a flexible tube (2) having a size corresponding to the blood vessel is used to block the ruptured blood vessel.

[0061] During coronary intervention, arterial rupture may sometimes occur, which requires covering with a coated stent as soon as possible. However, coated stents are not often available in clinical practice and are difficult to adapt to blood vessels of various inner diameters. The flexible delivery conduit device provided in the present application can completely replace the coated stent, can quickly seal the vascular rupture, and can finely adjust the size of the flexible conduit (2) by adjusting the pressure, and has better adaptability than the coated stent.

[0062] Compared with the existing GuidezillaTM extension catheter, the flexible delivery conduit device of the present invention has the advantages of lower hardness, better flexibility, variable shape and size, and a wider range of applications; and the GuidezillaTM extension catheter is a metal wire braided structure, which is easy to get entangled or scratched with other instruments, while the flexible conduit (2) of the present invention does not have this disadvantage.

[0063] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. An intravascular flexible delivery channel device, characterized in that: include: A connecting rod (1), one end of which is connected to a pressure pump; A flexible pipe (2) is a double-layer structure, comprising an outer membrane and an inner membrane, one end of which is a closed connection between the outer membrane and the inner membrane, and the other end is a connection between the outer membrane and the inner membrane and has a filling port, wherein the filling port is connected to the other end of the connecting rod (1).

2. The flexible intravascular delivery channel device according to claim 1, characterized in that: The gap between the outer film and the inner film of the flexible pipe (2) is 0.2-0.3 mm.

3. The flexible intravascular delivery channel device according to claim 1, characterized in that: The inner wall surface of the inner membrane of the flexible pipe (2) is coated with a hydrophilic coating.

4. The flexible intravascular delivery channel device according to claim 1, characterized in that: An arc-shaped transition section (202) is provided at one end of the flexible pipe (2) connected to the connecting rod (1), and the end section of the arc-shaped transition section (202) is arc-shaped.

5. The flexible intravascular delivery channel device according to claim 1, characterized in that: The pressure pump is used to apply pressure between the outer membrane and the inner membrane of the flexible pipe (2). After the pressure is applied, the inner diameter of the flexible pipe (2) is 2-5 mm.

6. The flexible intravascular delivery channel device according to claim 1, characterized in that: A guidewire cavity is provided in the connecting rod (1), a guidewire (3) is provided in the guidewire cavity, and a guidewire external connection hole is provided at a position of the connecting rod (1) close to the flexible pipe (2), and the guidewire (3) passes through the guidewire external connection hole.

7. The flexible intravascular delivery channel device according to claim 1, characterized in that: At least one developing mark (201) is provided on the flexible pipe (2).

8. The flexible intravascular delivery channel device according to claim 1, characterized in that: It also comprises a three-way connector (4), one end of which is connected to the connecting rod (1); and the other end is provided with a pressure pump port (401) for connecting a pressure pump.

9. The method for using the flexible intravascular delivery channel device according to any one of claims 1 to 8, characterized in that: include: Applying negative pressure to the flexible pipe (2) to keep the flexible pipe (2) in a flexible strip structure; The flexible tube (2) is delivered to the obstructed part in the blood vessel by pushing the connecting rod (1); Pressurizing the flexible pipe (2) to keep the flexible pipe (2) in a tubular channel structure; The device is delivered to the lesion through the tubular channel of the flexible tube.

10. The method for using the intravascular flexible delivery channel device according to claim 9, characterized in that: The method of use also includes: When a blood vessel ruptures, a flexible tube (2) having a size corresponding to the blood vessel is used to block the ruptured blood vessel.

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