A novel rapid exchange balloon catheter

Abstract

The utility model discloses a novel quick exchange balloon catheter, which comprises a double-cavity tube, the double-cavity tube comprises a round through hole for guiding a wire and a crescent-shaped through hole located at the lower part of the round through hole, the front end of the double-cavity tube is communicated with a guide tip, a front wire guide hole is arranged in the guide tip, the rear end of the double-cavity tube is connected with an inflation cavity, the lower part of the inflation cavity is communicated with the crescent-shaped through hole, the rear end of the inflation cavity is connected with a silica gel block and a blocking block, the silica gel block and the blocking block are both provided with a central through hole communicated with the inflation cavity, the double-cavity tube is provided with a rear wire guide hole, a developing ring is clamped on the inner wall surface of the double-cavity tube, the developing ring is used for displaying the specific position of the balloon catheter entering a blood vessel, and a balloon is arranged on the outer wall surface of the double-cavity tube opposite to the developing ring. The scheme is convenient for operation, reduces operation time and reduces operation risk, avoids the use of multiple products, has good compatibility, and the quick connector can be used in cooperation with various medical consumables.

Description

Technical Field

[0001] This utility model relates to the field of surgical instruments for interventional treatment in the cardiovascular medicine field of clinical medicine, and specifically to a novel rapid exchange balloon catheter. Background Technology

[0002] Modern surgical procedures often utilize specialized medical kits or other medical instruments. This is especially true in confined spaces where multiple instruments are used in combination. Typically, the guiding and measuring instruments used earlier need to be removed during the procedure, and these same guiding and measuring instruments are required again in subsequent operations. This process is repeated multiple times during the surgery. Furthermore, airway surgery requires the closure of multiple airways before surgery can be performed on the affected airway.

[0003] In the prior art, Chinese utility model patent application number CN202122211440.X discloses a balloon catheter system. The balloon catheter system includes a balloon body, on which a restrictive device is provided. The restrictive device includes multiple sets of metal frame rods discontinuously distributed along the axial direction on the surface of the balloon body and balloon groove rings radially distributed on the surface of the balloon body. The metal frame rods and balloon groove rings are non-perpendicularly movable connected. The size of the restrictive device after being expanded is smaller than the maximum size of the balloon body when inflated. The metal frame rods are curved.

[0004] For example, Chinese Utility Model Patent Publication No. CN213552662U discloses a novel guiding catheter device for dilating the left upper lobe pulmonary artery. This guiding catheter device consists of a flexible tip, an anti-bending section, and a support section, arranged sequentially from proximal to distal. The outer layer of the flexible tip is made of polyethylene polymer material, and the inner layer is coated with polytetrafluoroethylene material. In addition to the inner and outer layers, the anti-bending and support sections also have a steel wire mesh woven in between. The flexible tip transitions through the anti-bending section and is oriented in the same direction as the support section. The guiding catheter has a U-shaped structure. This utility model can establish a channel to the target pulmonary vascular lesion site during interventional treatment and facilitates the delivery of interventional stents or devices. Its length and structure are suitable for the left upper lobe pulmonary artery, which was previously difficult to reach. This utility model lacks a structure that supports a balloon capable of contraction and expansion during interventional treatment, making it difficult to smoothly deliver the balloon into the pulmonary vessel for subsequent surgical treatment of the blocked pulmonary vessel.

[0005] For example, Chinese patent application publication number CN112102267A discloses a device for acquiring a pulmonary artery vascular tree. The device includes: a segmentation module for segmenting a CTPA image to obtain a binary image of the lung parenchyma, the binary image of the lung parenchyma indicating the position of the lung parenchyma in the CTPA image, the CTPA image being a three-dimensional image; a determination module for determining a binary image of pulmonary vessels based on the binary image of the lung parenchyma, the binary image of pulmonary vessels indicating the position of pulmonary vessels in the CTPA image; the segmentation module is also used to segment a three-dimensional image of aortic vessels to obtain a binary image of aortic vessels, the binary image of aortic vessels indicating the position of aortic vessels in the three-dimensional image of aortic vessels, the three-dimensional image of aortic vessels being the image corresponding to the aortic vessels in the CTPA image; a combination module for stitching the binary image of pulmonary vessels and the binary image of aortic vessels into a combined binary image; and an extraction module for extracting the pulmonary artery vascular tree from the CTPA image using the connected component with the largest number of voxels in the combined binary image, the pulmonary artery vascular tree being a three-dimensional image.

[0006] The shortcomings of the aforementioned patent applications are that the design of the balloon catheter guidewire channel leads to high guidewire passage resistance and slow exchange speed. The inflation chamber and guidewire chamber in the catheter are often independently separated, resulting in an increase in catheter diameter (affecting the ability to enter narrowed blood vessels) or a decrease in inflation efficiency. The imaging marker is too large or the material has poor imaging effect, resulting in unclear display of its position in the blood vessel. Inappropriate design of the tip angle or material of conventional catheters can easily cause mucosal damage when entering the diseased airway or blood vessel. Therefore, there is an urgent need to propose a new type of rapid exchange balloon catheter to make up for the problems of insufficient exchange efficiency, insufficient integration of the cavity, poor imaging accuracy, and high risk of tissue damage of traditional guidewires. Utility Model Content

[0007] This invention provides a novel rapid exchange balloon catheter to solve the problems mentioned above.

[0008] A novel rapid exchange balloon catheter includes: a balloon catheter, a double-lumen tube, the double-lumen tube including a round through-hole through which a guidewire passes, and a crescent-shaped through-hole located below the round through-hole; The front end of the dual-lumen tube is connected to the guide tip, which has a guide wire guide hole. The rear end of the dual-lumen tube is connected to an inflation chamber, the lower part of which is connected to the crescent-shaped through hole. The rear end of the inflation chamber is connected to a silicone block and a sealing block. Both the silicone block and the sealing block have a central through hole connected to the inflation chamber for inflation. The dual-lumen tube has a guide wire guide hole through which the guide wire is inserted into the round through hole. A contrast ring is fitted on the inner wall of the dual-lumen tube to show the specific position of the balloon catheter entering the blood vessel. A balloon is placed on the outer wall of the dual-lumen tube opposite to the contrast ring. Gas is supplied to the balloon cavity through the inflation chamber to inflate the balloon and expand the inner wall of the blood vessel to explore the lesion site.

[0009] Furthermore, the central through-hole is connected to a micro-inflation pump to inflate the balloon cavity.

[0010] Furthermore, the diameters of both the front guide wire guide hole and the rear guide wire guide hole are greater than or equal to 0.36 mm.

[0011] Furthermore, the length of the guide tip is 3mm to 5mm, and the angle between the bevel of the guide tip and the centerline of the dual-lumen tube is 15 degrees to 25 degrees.

[0012] Furthermore, the end face of the guide tip is arc-shaped to avoid damaging the diseased airway when it is inserted into the airway of the diseased trachea.

[0013] Furthermore, the material of the through hole is one of TPE, nylon, or polyether block amide, and the diameter is 0.36mm~1.2mm.

[0014] Furthermore, the radius of the lower concave arc surface of the crescent-shaped through hole is 1.2 mm, the radius of the upper concave arc surface is 0.6 mm, and the distance between the center point of the lower concave arc surface and the center point of the upper concave arc surface is 0.6 mm. The cross-sectional area of ​​the crescent-shaped through hole is 30% to 50% of the cross-sectional area of ​​the round through hole.

[0015] Furthermore, the balloon catheter has a diameter of 1.2mm to 2.0mm, a length of 1200mm to 1400mm, and is made of natural latex or silicone rubber.

[0016] Furthermore, the developing ring has an inner diameter of 1.2mm to 3.0mm and an outer diameter of 1.3mm to 3.2mm, and is made of platinum-iridium alloy or platinum-tungsten alloy.

[0017] Furthermore, the wall thickness of the balloon is 0.05mm~0.1mm, and the material is silicone rubber or polyurethane.

[0018] Compared with the prior art in this field, the novel rapid exchange balloon catheter provided by this utility model has the following advantages: 1. This utility model, by making a bevel in the double-lumen tube and then processing the cut with multi-tube welding technology, has strong toughness and unobstructed flow. The bevel in the double-lumen tube and the multi-tube welding process make the connection between the guidewire channel and the inflation channel smoother, avoiding burrs or deformation caused by traditional cutting, improving the flexural strength of the catheter, and ensuring the unobstructed flow of the guidewire and inflation medium. The guidewire channel and the inflation channel are integrated into a single double-lumen tube, resulting in a compact structure.

[0019] 2. This utility model utilizes the shaping and sealing structure of silicone. The proximal end uses a hollow metal tube with silicone, and the rear end of the inflation chamber uses a combination of silicone block and sealing block. The elasticity of silicone achieves dynamic sealing to prevent gas leakage during inflation, and the flexibility of silicone reduces frictional damage to the inner wall of the blood vessel.

[0020] 3. This utility model uses a proximal connector that is the same size as the dual-lumen tube itself, which facilitates the use of matching structural components such as three-way plates, Y-valve, two-way valves, and quick connectors, and can be quickly removed. The proximal size of the inflation chamber matches the universal medical interface, allowing direct connection to a miniature inflation pump that is compatible with existing interventional consumables without the need for additional adapters.

[0021] 4. Using this utility model makes surgery safe and convenient, reduces surgery time and risks, avoids the use of multiple products, has good compatibility, and the quick connector can be used with a variety of medical consumables. Attached Figure Description

[0022] Figure 1 This is a schematic cross-sectional view of the novel rapid exchange balloon catheter described in this utility model; Figure 2 for Figure 1 The diagram shows a cross-sectional structure of AA.

[0023] Reference numerals: 10, through hole; 10.1, posterior guidewire guide hole; 20, crescent-shaped through hole; 30, guide tip; 30.1, anterior guidewire guide hole; 40, inflation chamber; 50, balloon; 55, silicone block; 60, occlusion block; 70, central through hole; 80, contrast ring; 90, balloon cavity; 100, double-lumen tube; 200, balloon catheter. Detailed Implementation

[0024] The following describes in detail, with reference to the accompanying drawings, specific embodiments of the novel rapid exchange balloon catheter of this utility model. Example

[0025] like Figures 1 to 2As shown, a novel rapid exchange balloon catheter includes: a balloon catheter 200 and a double-lumen tube 100. The double-lumen tube 100 includes a round through hole 10 through which a guidewire passes and a crescent-shaped through hole 20 located below the round through hole 10. The front end of the dual-lumen tube 100 is connected to the guide tip 30, and the guide tip 30 is provided with a front guide wire guide hole 30.1. The rear end of the dual-lumen tube 100 is connected to an inflation chamber 40, the lower part of which is connected to the crescent-shaped through hole 20. The rear end of the inflation chamber 40 is connected to a silicone block 55 and a sealing block 60. Both the silicone block 55 and the sealing block 60 are provided with a central through hole 70 communicating with the inflation chamber to inflate the inflation chamber 40. The dual-lumen tube 100 is provided with a rear guide wire. The guide hole 10.1 is used to insert the guide wire into the through hole 10. The outer wall of the double lumen tube 100 is fitted with a contrast ring 80, which is used to show the specific position of the balloon catheter 200 entering the blood vessel. The outer wall of the double lumen tube 100 opposite to the contrast ring 80 is provided with a balloon 50. Gas is supplied to the balloon cavity 90 through the inflation cavity 40 to inflate the balloon 50, thereby expanding the inner wall of the blood vessel to explore the lesion site.

[0026] Preferably, a single-mode optical fiber with a diameter of 0.3 mm is embedded in the dual-lumen tube 100 to achieve 10 μm resolution imaging of the blood vessel wall, which is performed synchronously with the expansion of the balloon 50 to better assess vascular lesions.

[0027] Preferably, the crescent-shaped through-hole 20 is designed using bionics. Based on the laminar flow characteristics of the blood vessel wall, the radius of the downward concave arc surface at the bottom of the crescent-shaped through-hole 20 is set to 1.2 mm, the radius of the downward concave arc surface at the top is set to 0.6 mm, and the distance between the center point of the downward concave arc surface at the bottom and the center point of the downward concave arc surface at the top is set to 0.6 mm. It is designed as an asymmetrical streamlined shape, so that the airflow forms a vortex effect in the crescent-shaped cavity, thereby improving the gas transmission efficiency.

[0028] Preferably, coating the inner wall of the through hole 10 with a polytetrafluoroethylene (PTFE) nano-coating reduces the coefficient of friction to 0.04 and the resistance of the guide wire to pass through to 35%, which can further improve the hydrodynamic performance of the dual-lumen tube 100.

[0029] Furthermore, the central through-hole 70 is connected to a micro-inflation pump to inflate the balloon cavity 90. The micro-inflation pump integrates a pressure sensor and a PID controller to adjust the inflation pressure in real time according to the elastic modulus of the blood vessel, with an error of ±0.1 atm, to avoid over-expansion.

[0030] Furthermore, the diameters of the front guide wire guide hole 30.1 and the rear guide wire guide hole 10.1 are both greater than or equal to 0.36 mm.

[0031] Furthermore, the length of the guide tip 30 is 3mm to 5mm, and the angle between the inclined surface of the guide tip 30 and the center line of the dual-lumen tube 100 is 15 degrees to 25 degrees.

[0032] Preferably, the guide tip 30 is made of nickel-titanium alloy (NiTi) with a preset bending angle of 15°~25°. It automatically recovers its shape at body temperature to adapt to the curvature of blood vessels. An integrated micro fiber optic pressure sensor with a diameter of 0.1mm is set inside the guide tip 30 (not shown in the figure) to provide real-time feedback on the contact pressure of the blood vessel wall with an accuracy of ±0.1N, thus avoiding excessive compression.

[0033] Furthermore, the end face of the guide tip 30 is arc-shaped to avoid damaging the diseased airway when it is inserted into the airway of the diseased trachea.

[0034] Furthermore, the material of the through hole 10 is one of TPE, nylon, or polyether block amide, and the diameter is 0.36mm~1.2mm.

[0035] Furthermore, the radius of the lower concave arc surface of the crescent-shaped through hole 20 is 1.2 mm, the radius of the upper concave arc surface is 0.6 mm, and the distance between the center point of the lower concave arc surface and the center point of the upper concave arc surface is 0.6 mm. The cross-sectional area of ​​the crescent-shaped through hole 20 is 30% to 50% of the cross-sectional area of ​​the round through hole 10.

[0036] Furthermore, the balloon catheter 200 has a diameter of 1.2 mm to 2.0 mm and a length of 1200 mm to 1400 mm, and is made of natural latex or silicone rubber.

[0037] Furthermore, the developing ring 80 has an inner diameter of 1.2mm to 3.0mm and an outer diameter of 1.3mm to 3.2mm, and is made of platinum-iridium alloy or platinum-tungsten alloy.

[0038] Preferably, 5% gadolinium is added to the imaging ring 80, so that it can be visualized with high signal under both X-ray and MRI (T1-weighted images). For temporary implantation needs, the magnesium alloy imaging ring 80 has a degradation cycle of only 30 days and does not need to be removed after the operation.

[0039] Furthermore, the wall thickness of the balloon 50 is 0.05mm~0.1mm, and the material is silicone rubber or polyurethane.

[0040] Preferably, the wall thickness of the balloon 50 gradually decreases from 0.1 mm proximally to 0.05 mm distally to match the stress distribution during vasodilation. The inner polyurethane material is leak-proof, the middle woven polyester fiber mesh has a burst pressure resistance of ≥12 atm, and the outer layer is coated with a heparinized coating to prevent thrombosis.

[0041] Furthermore, the guide tip 30 is connected to the balloon catheter 200 by heat fusion, and the balloon 50 is connected to the balloon catheter 200 by adhesive bonding. Preferably, the guide tip 30 and the balloon catheter 200 can be welded by femtosecond laser with a pulse width of 200 fs and an energy density of 5 J / cm², so as to achieve a heat-free connection between the guide tip 30 and the double lumen tube 100 (the tensile strength of the joint is ≥ 95% of the original material).

[0042] Furthermore, the sealing block 60 is made of stainless steel, and the sealing block 60 is connected to the inner wall of the balloon catheter 200 by adhesive bonding. The length of the sealing block 60 is 1mm~3.5mm, and there are two sealing blocks 60, which are symmetrically arranged on the inner wall of the balloon catheter 200. The following is a brief description of how the novel rapid exchange balloon catheter described in this invention is used to partially occlude the trachea during lung surgery: First, guided by the zebra guidewire, it is inserted from the guide tip 30 tube and extends through the rear guidewire guide hole 10.1; Inflate the balloon 50 by injecting air into the end of the occlusion block 60 with a syringe with a needle. After inflation, remove the syringe and seal the central through hole 70 with a silicone block 55 to keep the balloon 50 inflated for tracheal occlusion. After the operation, withdraw the air from the balloon 50 with a syringe to restore the balloon 50 to its original shape.

[0043] The above description is merely a preferred embodiment of this utility model and is not intended to limit the scope of this utility model. Various modifications and variations can be made to this utility model by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the protection scope of the claims of this utility model.

Claims

1. A novel rapid exchange balloon catheter, characterized in that, include: The balloon catheter (200) has a double-lumen tube (100), which includes a round through hole (10) through which a guidewire passes and a crescent-shaped through hole (20) located below the round through hole (10). The front end of the dual-lumen tube (100) is connected to the guide tip (30), and the guide tip (30) is provided with a guide wire guide hole (30.1). The rear end of the dual-lumen tube (100) is connected to an inflation chamber (40). The lower part of the inflation chamber (40) is connected to the crescent-shaped through hole (20). The rear end of the inflation chamber (40) is connected to a silicone block (55) and a sealing block (60). Both the silicone block (55) and the sealing block (60) are provided with a central through hole (70) connecting to the inflation chamber to inflate the inflation chamber (40). The dual-lumen tube (100) is provided with The device has a guide wire guide hole (10.1) through which the guide wire is inserted into the through hole (10). A contrast ring (80) is provided on the inner wall of the double lumen tube (100). The contrast ring (80) is used to show the specific position of the balloon catheter (200) entering the blood vessel. A balloon (50) is provided on the outer wall of the double lumen tube (100) opposite to the contrast ring (80). Gas is supplied to the balloon cavity (90) through the inflation cavity (40) to inflate the balloon (50) and expand the inner wall of the blood vessel to explore the lesion site.

2. The novel rapid exchange balloon catheter according to claim 1, characterized in that, The central through-hole (70) is connected to a micro-inflator to inflate the balloon cavity (90).

3. The novel rapid exchange balloon catheter according to claim 1, characterized in that, The diameters of the front guide wire guide hole (30.1) and the rear guide wire guide hole (10.1) are both greater than or equal to 0.36 mm.

4. The novel rapid exchange balloon catheter according to claim 1, characterized in that, The length of the guide tip (30) is 3mm to 5mm, and the angle between the inclined surface of the guide tip (30) and the center line of the double-lumen tube (100) is 15 degrees to 25 degrees.

5. The novel rapid exchange balloon catheter according to claim 1, characterized in that, The length of the guide tip (30) is 3mm to 5mm, and the angle between the inclined surface of the guide tip (30) and the center line of the double-lumen tube (100) is 15 degrees to 25 degrees.

6. The novel rapid exchange balloon catheter according to claim 1, characterized in that, The material of the through hole (10) is one of TPE, nylon, or polyether block amide, and the diameter is 0.36mm~1.2mm.

7. The novel rapid exchange balloon catheter according to claim 1, characterized in that, The radius of the lower concave arc surface of the crescent-shaped through hole (20) is 1.2 mm, the radius of the upper concave arc surface is 0.6 mm, and the distance between the center point of the lower concave arc surface and the center point of the upper concave arc surface is 0.6 mm. The cross-sectional area of ​​the crescent-shaped through hole (20) is 30% to 50% of the cross-sectional area of ​​the round through hole (10).

8. The novel rapid exchange balloon catheter according to claim 1, characterized in that, The balloon catheter (200) has a diameter of 1.2 mm to 2.0 mm and a length of 1200 mm to 1400 mm, and is made of natural latex or silicone rubber.

9. The novel rapid exchange balloon catheter according to claim 1, characterized in that, The developing ring (80) has an inner diameter of 1.2mm to 3.0mm and an outer diameter of 1.3mm to 3.2mm, and is made of platinum-iridium alloy or platinum-tungsten alloy.

10. The novel rapid exchange balloon catheter according to claim 1, characterized in that, The balloon (50) has a wall thickness of 0.05mm to 0.1mm and is made of silicone rubber or polyurethane.

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