Balloon catheter

Abstract

The utility model aims to provide a balloon catheter which is high in measurement precision and low in assembly difficulty, and the balloon catheter comprises an inner tube and an outer tube which are used for supporting a balloon and forming a channel for inflating and deflating the balloon; the optical fiber sensor comprises a connected optical fiber sensor and is used for measuring blood pressure; the tip is arranged at the far end of the catheter, and a first through hole and a second through hole for mounting the catheter and the optical fiber sensor are formed in an inner cavity of the tip; a wire pipe is arranged in the annular cavity between the inner pipe and the outer pipe, and the optical fiber penetrates through the wire pipe and extends into the second through hole in the tip end to be connected with the sensor. That is to say, a spool is directly and additionally arranged outside the inner tube for mounting the optical fiber, so that how to fix the optical fiber on the inner tube does not need to be considered, the mounting and fixing difficulty of the optical fiber is greatly reduced, and particularly, the overall routing of the optical fiber is smooth, so that the measurement precision of the whole optical fiber sensor is high.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a balloon catheter. Background Technology

[0002] The working principle of the intra-aortic balloon counterpulsation (IABP) system is to place a balloon counterpulsation catheter in the patient's aorta via arterial puncture. An external counterpulsation pump inflates or deflates the balloon counterpulsation catheter according to the patient's electrocardiogram data. When the aortic valve closes during diastole, the counterpulsation pump inflates the balloon, generating positive pressure, increasing diastolic pressure, and increasing blood perfusion to the whole body and coronary arteries. At the beginning of systole, when the aortic valve opens, the balloon is rapidly deflated, generating negative pressure, causing a momentary drop in aortic pressure, reducing left ventricular ejection resistance (i.e., cardiac afterload), increasing cardiac output, and thus improving left ventricular ejection.

[0003] Sensors are typically mounted on intra-aortic blood pressure (IABP) devices to monitor and measure various parameters related to cardiac function, such as blood pressure, in real time. This provides doctors with accurate data to better assess patients' cardiac function and the effectiveness of IABP treatment. However, due to the small size of IABPs, how to set up the sensors and simplify their installation remains a pressing challenge for the industry. Utility Model Content

[0004] The purpose of this invention is to provide a balloon catheter with high measurement accuracy and low assembly difficulty.

[0005] To achieve the above objectives, the specific solution adopted by this utility model is as follows: a balloon catheter, comprising:

[0006] The catheter, including an inner tube and an outer tube, is used to support the balloon and to form a channel for inflating and deflating the balloon;

[0007] Fiber optic sensor, including connected fiber optic sensors, for measuring blood pressure;

[0008] The tip is located at the distal end of the catheter, and its inner cavity has a first through hole and a second through hole for mounting the catheter and the fiber optic sensor.

[0009] A conduit is installed in the annular cavity between the inner tube and the outer tube. The optical fiber passes through the conduit and extends to the second through hole at the tip to connect with the sensor.

[0010] Furthermore, the tubing extends from the proximal end of the inner tube to the proximal end of the tip, the lumen of the tubing is connected to the second through hole in the tip, the distal end face of the tubing abuts against the proximal end face of the tip to form an axial limiting fit, and the film covers the outer periphery of the inner tube and the tubing and fixes their positions.

[0011] Furthermore, the conduit is made of PTFE material with an inner diameter of 0.2mm-0.6mm, and the film is a PU film.

[0012] Furthermore, the outer wall of the tip is provided with a first filling hole and a second filling hole that communicate with the second through hole. The first filling hole and the second through hole are located at the middle position, and the second filling hole is located at the position corresponding to the sensor mounting position at the far end of the second through hole. Gel is filled into the second through hole from the first filling hole and the second through hole.

[0013] Furthermore, the distal end of the tip extends toward the distal end of the second through hole with an oblique hole, the core of the oblique hole being arranged at an angle to the axis of the tip, the angle α being 15° to 45°.

[0014] Furthermore, the first through hole and the second through hole are connected as an integral structure, and the connection between the far ends of the first through hole and the second through hole forms a stepped part, with the far end of the inner tube abutting against the step to form an axial limiting fit.

[0015] Furthermore, the core of the first through hole is eccentrically arranged with respect to the axis of the end, and the geometric center lines of the first and second through holes are collinear with the axes of the core and the end.

[0016] Furthermore, the outer tube extends to the proximal end of the balloon, while the inner tube and the suture tube protrude into the balloon cavity.

[0017] In the above scheme, a conduit is installed in the annular cavity between the inner and outer tubes. The optical fiber passes through the conduit and extends to the second through-hole at its tip to connect with the sensor. In other words, an additional conduit is directly installed outside the inner tube for the installation of the optical fiber. This eliminates the need to consider how to fix the optical fiber to the inner tube, greatly reducing the difficulty of installing and fixing the optical fiber. In particular, the overall optical fiber routing is smooth, ensuring high measurement accuracy of the entire optical fiber sensor. Attached Figure Description

[0018] Figure 1 This is a cross-sectional view of the balloon catheter;

[0019] Figure 2 for Figure 1 Schematic diagram of the structure after gel injection;

[0020] Figure 3 for Figure 2 Sectional view along line AA;

[0021] Figure 4 for Figure 2 Sectional view along the BB direction;

[0022] Figure 5 for Figure 2 Sectional view along the CC direction. Detailed Implementation

[0023] To facilitate understanding, we will first define the terms "proximal" and "proximal side" as used below: "proximal" refers to the side closer to the operator / doctor, while "distal" and "distal side" refers to the side farther from the operator / doctor, i.e., the side closer to the heart. The following will combine... Figures 1-5 This utility model will be discussed in further detail.

[0024] A balloon catheter having:

[0025] The catheter 10, including an inner tube 11 and an outer tube 12, is used to support the balloon (not shown in the figure) and to form a channel for inflation and deflation of the balloon. Generally, the lumen of the inner tube 11 is used for guidewire insertion during balloon catheter intervention and for periodically infusing the inner tube with flushing fluid to prevent thrombus formation when the balloon catheter is working normally; while the annular chamber between the inner tube 11 and the outer tube 12 forms the inflation and deflation channel for the balloon.

[0026] The fiber optic sensor 20, including the connected optical fiber 21 and sensor 22, is used to measure blood pressure. The fiber optic sensor 20 uses optical signals as the carrier for transformation and transmission, and has the characteristics of high precision and high sensitivity, while avoiding the influence of electromagnetic interference on patients and medical equipment.

[0027] The tip 30 is located at the distal end of the catheter 10, and its inner cavity has a first through hole 31 and a second through hole 32 for mounting the catheter 10 and the fiber optic sensor 20. During installation, the distal end of the balloon is wrapped around the outer periphery of the tip 30, the proximal end of the balloon is wrapped around the distal periphery of the outer tube 12, and the inner tube 11 is located inside the balloon. The inner tube 11 extends into the first through hole 31 of the tip 30, and the fiber optic 21 also extends into the second through hole 32 of the tip 30 and is connected to the sensor 22.

[0028] Considering the installation of the optical fiber 21, a conduit 13 is installed in the annular cavity between the inner tube 11 and the outer tube 12. The optical fiber 21 passes through the conduit 13 and extends to the second through hole 32 at the tip 30 to connect with the sensor 22. In other words, an additional conduit 13 is directly installed outside the inner tube 11 for the installation of the optical fiber 21. This eliminates the need to consider how to fix the optical fiber 21 to the inner tube 11, greatly reducing the difficulty of installing and fixing the optical fiber 21. At the same time, the overall routing of the optical fiber 21 is smooth, ensuring high measurement accuracy of the entire optical fiber sensor.

[0029] To prevent the tubing 13 from twisting within the annular cavity between the inner and outer tubes, we preferably fix the tubing 13 to the inner tube 11. The tubing 13 extends from the proximal end of the inner tube 11 to the proximal end of the tip 30. The lumen of the tubing 13 is connected to the second through hole 22 in the tip 30. The distal end face of the tubing 13 abuts against the proximal end face of the tip 30 to form an axial limiting fit. The membrane 14 covers the outer periphery of the inner tube 11 and the tubing 13 and fixes their positions. The membrane 14 tightly wraps around the outer periphery of the inner tube 11 and the tubing 13, fixing their positions. The thickness of the membrane 14 is negligible, minimizing the cross-sectional area of ​​the inner tube 11 and the tubing 13, and ensuring that the cross-section of the inflation / deflation channel between the inner tube 11 and the outer tube 12 is as large as possible, thereby ensuring timely inflation / deflation response of the balloon and improving the counterpulsation effect.

[0030] Furthermore, the conduit 13 is made of PTFE material with an inner diameter of 0.2mm-0.6mm, and the film 14 is a PU film. The PU film has excellent elasticity and high strength, and can adapt to the shape and size of the inner tube 11 and the conduit 13, providing effective protection.

[0031] To fix the relative position of the fiber optic sensor 20 and its tip, a first filling hole 33 and a second filling hole 34 communicating with the second through hole 32 are provided on the outer wall of the tip 30. The first filling hole 33 corresponds to the middle position of the second through hole 32, and the second filling hole 34 is located at the position corresponding to the mounting position of the sensor 22 at the distal end of the second through hole 32. Gel 40 is filled into the second through hole 32 from the first filling hole 33 and the second through hole 32. During the installation of the fiber optic sensor 20, it can be observed through the second filling hole 34 whether the sensor 22 has reached the installation position. When the sensor 22 can be seen from the second filling hole 34, the pushing of the fiber optic sensor 20 can be stopped, and then gel 40 is injected into the second through hole 32 from the first filling hole 33 and the second filling hole 34 to fix the position.

[0032] To prevent the sensor 22 from slipping out of the second through hole 32, an oblique hole 35 extends from the distal end of the tip 30 toward the distal end of the second through hole 32. The core of the oblique hole 35 is arranged at an angle to the axis of the tip 30, with the angle α ranging from 15° to 45°. The oblique hole 35 provides at least the following benefits: (1) The oblique hole 35 allows the sensor 22 to collect blood pressure data without being directly exposed to the blood, thus protecting the sensor 22 and making the output more stable and reliable; (2) The obliquely arranged oblique hole 35 can limit the position of the sensor 22, preventing the sensor 22 from slipping out of the tip 30; (3) When injecting gel 40 into the second through hole 32 from the first filling hole 33 and the second filling hole 34, excess air bubbles can be discharged from the oblique hole 35, reducing air bubbles in the gel 40 after curing. It should be emphasized that the gel 40 here is a pressure-permeable material that can transmit blood pressure to the sensor 22.

[0033] To ensure the reliability of the injected gel 40, the sequence of injecting gel 40 into the hole is as follows: first, inject gel 40 into the first filling hole 33 to fix the entire optical fiber 21 inside the tip 30. At this time, the gel 40 is about to fill the second through hole 32. Then, inject gel into the first filling hole 33. Finally, add gel through the oblique hole 35.

[0034] Because the tip 30 itself is very small, in order to facilitate processing, the first through hole 31 and the second through hole 32 are connected as an integral structure. The connection between the far ends of the first through hole 31 and the second through hole 32 forms a stepped part, and the far end of the inner tube 11 abuts against the step to form an axial limiting fit.

[0035] Furthermore, the core of the first through hole 31 is eccentrically arranged with respect to the axis of the end 30, and the geometric center lines of the first through hole 31 and the second through hole 32 are collinear with the axes of the core and the end 30. In other words, the geometric axes of the inner tube 11 and the line tube 13 are collinear with the axis of the end 30, so that the inner tube 11 and the line tube 13 are also located at the center of the balloon, which is beneficial for the folding of the balloon.

[0036] Furthermore, as shown in the figure, the outer tube 12 extends to the proximal end of the balloon, and the inner tube 11 and the liner 13 protrude into the inner cavity of the balloon. The inner tube 11, the liner 13, and the tip 30 are fixedly connected by heat fusion welding, and the connection is sealed to prevent gas leakage from the balloon.

Claims

1. A balloon catheter, characterized in that, have: The catheter (10), including an inner tube (11) and an outer tube (12), is used to support the balloon and to form a channel for inflating and deflating the balloon; A fiber optic sensor (20) includes a connecting fiber optic cable (21) and a sensor (22) for measuring blood pressure; The tip (30) is located at the distal end of the conduit (10), and its inner cavity is provided with a first through hole (31) and a second through hole (32) for mounting the conduit (10) and the fiber optic sensor (20). A wire tube (13) is provided in the annular cavity between the inner tube (11) and the outer tube (12). The optical fiber (21) passes through the wire tube (13) and extends to the second through hole (32) of the tip (30) and is connected to the sensor (22).

2. The balloon catheter according to claim 1, characterized in that: The tube (13) extends from the proximal end of the inner tube (11) to the proximal end of the tip (30). The lumen of the tube (13) is connected to the second through hole (32) in the tip (30). The distal end face of the tube (13) abuts against the proximal end face of the tip (30) to form an axial limiting fit. The film (14) covers the outer periphery of the inner tube (11) and the tube (13) and fixes their positions.

3. The balloon catheter according to claim 2, characterized in that: The conduit (13) is made of PTFE material with an inner diameter of 0.2mm-0.6mm, and the film (14) is a PU film.

4. The balloon catheter according to claim 2, characterized in that: The outer wall of the tip (30) is provided with a first filling hole (33) and a second filling hole (34) communicating with the second through hole (32). The first filling hole (33) corresponds to the middle position of the second through hole (32). The second filling hole (34) is provided with the position of the far end of the second through hole (32) corresponding to the mounting position of the sensor (22). Gel (40) is filled into the second through hole (32) from the first filling hole (33) and the second through hole (32).

5. The balloon catheter according to claim 2 or 4, characterized in that: The tip (30) extends toward the distal end of the second through hole (32) with an oblique hole (35). The core of the oblique hole (35) is arranged at an angle to the axis of the tip (30), and the angle α is 15° to 45°.

6. The balloon catheter according to claim 1, characterized in that: The first through hole (31) and the second through hole (32) are connected as an integral structure. The connection between the far ends of the first through hole (31) and the second through hole (32) forms a step. The far end of the inner tube (11) abuts against the step to form an axial limiting fit.

7. The balloon catheter according to claim 1, characterized in that: The core and tip (30) of the first through hole (31) are eccentrically arranged, and the geometric center lines of the first through hole (31) and the second through hole (32) are collinear with the axis of the core and tip (30).

8. The balloon catheter according to claim 1, characterized in that: The outer tube (12) extends to the proximal end of the balloon, while the inner tube (11) and the suture tube (13) protrude into the inner cavity of the balloon.

Images