Double-cavity balloon catheter structure with non-coaxial double cavities

Abstract

The utility model discloses a double-cavity balloon catheter structure with non-coaxial double cavities, which comprises a catheter body with double cavities and a balloon arranged at the far end of the catheter body, the catheter body comprises an inner tube and an outer tube, the inner tube is arranged in the inner cavity of the outer tube, the tube cavity of the inner tube forms a guide wire cavity, a pressure-resistant balloon charging and discharging tube is arranged between the inner tube and the outer tube, and the balloon charging and discharging tube is arranged in the outer tube. The balloon charging and discharging pipe is provided with a balloon charging and discharging cavity, the far end of the balloon charging and discharging pipe is connected with an inner cavity of the balloon, so that the balloon charging and discharging cavity is communicated with the inner cavity of the balloon, the balloon is charged and discharged, and the inner wall of the outer pipe is tightly attached to the outer wall of the inner pipe. Compared with the prior art, when the balloon is filled, the filling pressure of the balloon does not affect the guide wire cavity, it is guaranteed that the guide wire cavity is not deformed due to extrusion of peripheral pressure, passing of a guide wire and other instruments in the guide wire cavity is not affected, the use risk is reduced, the success rate of an operation is improved, and the probability of occurrence of operative complications is reduced.

Description

Technical Field

[0001] This utility model relates to a medical device, and more particularly to a non-coaxial dual-lumen dual-lumen balloon catheter structure. Background Technology

[0002] Balloon catheters, as the most common interventional medical devices, have been widely used in coronary angioplasty, assistive procedures for heart valve repair and replacement, intracranial arteriosclerosis treatment, and assisted embolization. Based on their lumen structure, balloon catheters are currently mainly divided into single-lumen catheters, double-lumen catheters, and multi-lumen catheters. Among them, double-lumen catheters primarily feature a coaxial double-lumen structure, meaning the two lumens are arranged concentrically. Figure 1 As shown in the diagram, the central guidewire lumen is typically smooth to reduce friction between the device and the lumen wall. This lumen is used to pass the guidewire or other embolic agents, medications, and devices that need to be delivered. The outer balloon inflation / deflation lumen 300 (between the outer tube 100 and the inner tube 200) surrounds the guidewire lumen 400 and is used for balloon inflation and depressurization fluid passage. The disadvantage of this structure is:

[0003] The guidewire lumen 400 and the balloon inflation / deflation lumen 300 are independent of each other and have no connection points. This makes the catheter prone to bending and damage during product delivery, leading to product failure. Because there is no connection between the two lumens, the overall integrity is poor, resulting in poor delivery and torsion performance, making it difficult for the product to reach the tortuous target blood vessel.

[0004] When the balloon is inflated under high pressure, the inflation pressure will compress the guidewire lumen 400, causing the guidewire lumen 400 to deform under external pressure, affecting the passage of the guidewire or other instruments in the guidewire lumen 400.

[0005] Coaxial double-lumen balloon catheters have a relatively large outer diameter. For some lesions with smaller blood vessel diameters, the large outer diameter of the catheter can restrict its ability to reach the target vessel. Large outer diameter catheters can also cause surgical complications such as vasospasm, larger incisions, and insufficient flexibility leading to poor delivery performance and difficulty in navigating tortuous blood vessels. Utility Model Content

[0006] The purpose of this invention is to provide a non-coaxial dual-lumen dual-lumen balloon catheter structure, and the technical problem to be solved is to improve the product's delivery capability.

[0007] To solve the above problems, the present invention adopts the following technical solution: a non-coaxial double-lumen double-lumen balloon catheter structure, including a catheter body with double lumens and a balloon disposed at the distal end of the catheter body. The catheter body includes an inner tube and an outer tube. The inner tube is disposed in the inner lumen of the outer tube, and the lumen of the inner tube forms a guidewire lumen. A pressure-resistant balloon inflation / discharging tube is provided between the inner tube and the outer tube. The balloon inflation / discharging tube has a balloon inflation / discharging cavity. The distal end of the balloon inflation / discharging tube is connected to the inner lumen of the balloon so that the balloon inflation / discharging cavity communicates with the inner lumen of the balloon to realize the inflation / discharging of the balloon. The inner wall of the outer tube is tightly fitted with the outer wall of the inner tube so that the balloon inflation / discharging tube is fixed between the outer tube and the inner tube and cannot be moved. The distal end of the inner tube extends from the distal end of the outer tube. The distal end of the balloon is sealed to the distal end of the inner tube, and the proximal end of the balloon is sealed to the distal end of the outer tube.

[0008] Furthermore, the outer tube is provided with a heat shrink tubing.

[0009] Furthermore, the cavity wall of the guidewire cavity is coated with a chemical coating to reduce the coefficient of friction.

[0010] Furthermore, the chemical coating is silicone oil or polyvinylpyrrolidone.

[0011] Furthermore, the diameter of the guidewire cavity is 0.406-0.4572 mm.

[0012] Furthermore, the wall thickness of the balloon inflation / deflation tube is 0.05-0.2 mm.

[0013] Compared with the prior art, this invention sets up a balloon inflation / deflation tube between the outer and inner tubes, tightly fitting the inner wall of the outer tube to the outer wall of the inner tube. The balloon inflation / deflation tube is fixed between the outer and inner tubes, forming a non-coaxial double-lumen structure. In this way, when the balloon is inflated, the inflation pressure will not affect the guidewire lumen, ensuring that the guidewire lumen is not deformed by external pressure. This allows the guidewire and other instruments to pass through the guidewire lumen without being affected, reducing the risk of use, improving the success of the operation, and reducing the probability of surgical complications. Attached Figure Description

[0014] Figure 1 This is a schematic diagram of the structure of a balloon catheter using existing technology.

[0015] Figure 2 yes Figure 1 A sectional view along the A-A direction.

[0016] Figure 3 This is a schematic diagram of the structure of this utility model.

[0017] Figure 4 yes Figure 3 A cross-sectional view along the B-B direction. Detailed Implementation

[0018] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments.

[0019] In this invention, the distal end refers to the end furthest from the surgeon; the proximal end refers to the end closest to the surgeon.

[0020] like Figure 3 and Figure 4 As shown, this utility model discloses a non-coaxial dual-lumen balloon catheter structure, including a catheter body 1 and a balloon 2. The catheter body 1 includes an inner tube 3 and an outer tube 4. The inner tube 3 is disposed in the inner lumen of the outer tube 4, and the lumen of the inner tube 3 forms a guidewire lumen 31. A pressure-resistant balloon inflation / deflation tube 5 is provided between the inner tube 3 and the outer tube 4. The balloon inflation / deflation tube 5 has a balloon inflation / deflation cavity. The distal end of the balloon inflation / deflation tube 5 is sealed to the inner lumen of the balloon 2 so that the balloon inflation / deflation cavity communicates with the inner lumen of the balloon 2, thereby realizing the inflation and deflation of the balloon 2. The inner wall of the outer tube 4 is tightly fitted to the outer wall of the inner tube 3 to fix the balloon inflation / deflation tube 5 between the outer tube 4 and the inner tube 3. The tubes 3 are immovable. The distal end of the inner tube 3 extends from the distal end of the outer tube 4. The distal end of the balloon 2 is sealed to the distal end of the inner tube 3. The proximal end of the balloon 3 is sealed to the distal end of the outer tube 4. The sealing connection between the balloon 2 and the catheter body 1 is existing technology and will not be described in detail here. In this utility model, the outer tube 4 is not used as the balloon inflation / deflation chamber, but is used to fix the balloon inflation / deflation tube 5, which is used for balloon inflation / deflation, between the outer tube 4 and the inner tube 3, so that the balloon inflation / deflation tube 5 and the inner tube 3, which is the guidewire chamber 31, are non-coaxial. Since the outer tube 4 and the inner tube 3 are tightly fitted together, the overall diameter of the catheter body 1 is reduced.

[0021] like Figure 3 and Figure 4 As shown, a heat shrink tube 6 is provided outside the outer tube 4. When heated on the rheological device, the heat shrink tube 6 is squeezed inward by the heat, which welds the inner wall of the outer tube 4 and the outer wall of the inner tube 3 together by the heating and the inward squeezing force of the heat shrink tube, and makes the balloon filling and unloading tube 5 firmly "clamped" between the outer tube and the inner tube.

[0022] In this invention, to reduce friction with the guidewire or other instruments, the inner tube 3 is made of a smooth material with a low coefficient of friction, optionally at least one of polytetrafluoroethylene and high-density polyethylene. A biocompatible chemical coating is applied to the wall of the guidewire lumen 31 of the inner tube 3; optionally, the chemical coating is silicone oil or polyvinylpyrrolidone. The diameter of the guidewire lumen 31 is typically matched to the size of the guidewire or other instruments. For example, for a 0.014-inch guidewire commonly used in cardiovascular interventional therapy, the diameter of the guidewire lumen is optionally 0.406-0.4572 mm.

[0023] In this invention, the balloon inflation / deflation tube 5 is made of a pressure-resistant material, optionally at least one of polyimide, polyetheretherketone, polytetrafluoroethylene, fluorinated ethylene propylene, and high-density polyethylene. Considering that the balloon inflation / deflation tube is both pressure-resistant and does not compress the guidewire lumen, while also reducing the overall outer diameter of the product, the wall thickness of the balloon inflation / deflation tube 5 is 0.05-0.2 mm.

[0024] In this invention, the outer tube 4 is made of at least one of nylon, polyether block polyamide, and polyurethane.

[0025] In this invention, the assembly method between the inner tube, outer tube, and balloon inflation / unloading tube is as follows: A smooth mandrel is inserted into the inner cavity of the guidewire cavity as a support to prevent the guidewire cavity from collapsing or reducing its roundness. The balloon inflation / unloading tubes are arranged side by side and inserted into the inner cavity of the outer tube as a whole. The outer tube is then fitted into the inner cavity of the heat shrink tubing. The heat shrink tubing is heated on a rheological device, and the heat shrink tubing is pressed towards the center of the inner tube, thereby welding the inner layer of the outer tube to the outer layer of the inner tube. This ensures that the balloon inflation / unloading tube is firmly "clamped" between the inner layer of the outer tube and the outer layer of the inner tube. Finally, the smooth mandrel inside the guidewire cavity is removed, completing the assembly.

[0026] This utility model has the following beneficial effects:

[0027] Connecting the guidewire lumen to the balloon filling and unloading tube via an outer tube improves the overall integrity and delivery performance of the product.

[0028] The inflation pressure of the balloon inflation / deflation cannula will not affect the guidewire lumen, ensuring that the guidewire lumen is not deformed by external pressure. This ensures that the passage of the guidewire and other instruments in the guidewire lumen is not affected, reducing the risk of use and improving the success rate of the operation.

[0029] The outer diameter of the catheter body is smaller than that of the coaxial double-lumen catheter, which allows for more application scenarios and reduces the probability of surgical complications.

Claims

1. A non-coaxial dual-lumen balloon catheter structure comprising a catheter body (1) having dual lumens and a balloon (2) provided at the distal end of the catheter body (1), characterized in that: The catheter body (1) includes an inner tube (3) and an outer tube (4). The inner tube (3) is located in the inner cavity of the outer tube (4). The lumen of the inner tube (3) forms a guidewire lumen (31). A pressure-resistant balloon inflation / deflation tube (5) is provided between the inner tube (3) and the outer tube (4). The balloon inflation / deflation tube (5) has a balloon inflation / deflation cavity. The distal end of the balloon inflation / deflation tube (5) is connected to the inner cavity of the balloon (2) so that the balloon inflation / deflation cavity communicates with the inner cavity of the balloon (2) to realize the inflation / deflation of the balloon (2). The inner wall of the outer tube (4) is tightly fitted with the outer wall of the inner tube (3) so that the balloon inflation / deflation tube (5) is fixed between the outer tube (4) and the inner tube (3) and cannot be moved. The distal end of the inner tube (3) extends from the distal end of the outer tube (4). The distal end of the balloon (2) is sealed to the distal end of the inner tube (3). The proximal end of the balloon (2) is sealed to the distal end of the outer tube (4).

2. The non-coaxial dual-lumen balloon catheter structure of claim 1, wherein: The outer tube (4) is provided with a heat shrink tubing (6).

3. The non-coaxial dual-lumen balloon catheter structure of claim 1, wherein: The wall of the guide wire cavity (31) is coated with a chemical coating to reduce the coefficient of friction.

4. The non-coaxial dual-lumen balloon catheter structure of claim 3, wherein: The chemical coating is silicone oil or polyvinylpyrrolidone.

5. The non-coaxial dual-lumen balloon catheter structure of any of claims 1-4, wherein: The diameter of the guidewire cavity (31) is 0.406-0.4572 mm.

6. The non-coaxial dual-lumen balloon catheter structure of claim 5, wherein: The wall thickness of the balloon filling and unloading tube (5) is 0.05-0.2 mm.

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