Balloon catheter

Abstract

The application discloses a balloon catheter and belongs to the technical field of medical devices. The balloon catheter comprises an outer tube, an inner tube, a balloon and a fluid channel. The inner tube is arranged in the outer tube and is movably connected with the outer tube to adjust the length of the inner tube exposed at the distal end of the outer tube. The inner tube has a delivery channel arranged along the axial direction of the inner tube, and the delivery channel is used for passing medical devices. The balloon is arranged at the distal end of the outer tube. The distal end of the fluid channel is connected with the balloon, and the proximal end of the fluid channel extends towards the proximal end of the outer tube. The proximal end of the fluid channel is used for receiving fluid to make the balloon expand in the direction away from the inner tube. The inner tube is movably connected with the outer tube, the position of the inner tube can be adjusted in the inner tube, the inner tube can be extended out of the distal end of the outer tube and the length of the inner tube extended out of the distal end of the outer tube can be adjusted, so that the stent guide wire extended out of the stent can be covered, the stent guide wire is prevented from being exposed to the balloon catheter, and the stent guide wire is prevented from stimulating the blood vessel and causing damage to the blood vessel.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a balloon catheter. Background Technology

[0002] A balloon catheter is a flexible medical catheter with an inflatable or water-filled balloon at its tip, used in catheterization procedures to widen narrow openings or passages within the body. Conventional delivery balloon catheters can both achieve balloon dilation via their built-in balloon and deliver stents through the internal lumen, eliminating the need for instrument exchanges.

[0003] When a balloon catheter is used in conjunction with a stent, the stent is delivered into the catheter, visualized, and located at the affected site. The stent is then withdrawn from the catheter to achieve in-situ release. Commercially available intravascular stent delivery systems typically also include a guidewire for advancing the stent. The guidewire and stent are delivered together into the catheter, and the guidewire's position is controlled for stability. Withdrawal of the catheter then achieves in-situ stent release.

[0004] When a guidewire is used in conjunction with a stent, the guidewire passes through the stent, with its tip either inside or outside the stent. If the distal end of the catheter cannot cover the guidewire when the tip extends outside the stent, the guidewire will protrude from the catheter, potentially irritating the blood vessel and causing damage. Summary of the Invention

[0005] The purpose of this application is to provide a balloon catheter that solves the aforementioned technical problems existing in the prior art.

[0006] This application is implemented as follows: This application provides a balloon catheter, including an outer tube, an inner tube, a balloon, and a fluid channel. The outer tube is hollow, and the inner tube is inserted inside the outer tube and movably cooperates with the outer tube to adjust the length of the inner tube exposed at the distal end of the outer tube. The inner tube has a delivery cavity arranged along its axial direction for the passage of medical devices. The balloon is installed at the distal end of the outer tube, and the distal end of the fluid channel communicates with the balloon, with its proximal end extending toward the proximal end of the outer tube. The proximal end of the fluid channel is used to receive fluid to inflate the balloon away from the inner tube.

[0007] The technical solution provided in this application can achieve the following beneficial effects: In this application, the inner and outer tubes are movable together, allowing the position of the inner tube to be adjusted inside the outer tube. This enables the inner tube to extend beyond the distal end of the outer tube, and the length of the inner tube extending beyond the distal end of the outer tube can be adjusted to cover the stent guidewire extending from the stent, preventing the stent guidewire from being exposed outside the balloon catheter and thus preventing the stent guidewire from irritating or damaging the blood vessel. At the same time, the length of the inner tube extending beyond the distal end of the outer tube can be adjusted according to the stent guidewire of different brands and specifications, thereby adapting to different brands and specifications of stents and improving the flexibility of balloon catheter use. Attached Figure Description

[0008] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0009] Figure 1 This is a schematic diagram of the overall structure of the balloon catheter provided in some embodiments of this application. Figure 1 ; Figure 2 This application is about Figure 1 Detailed view of point A; Figure 3 This application is about Figure 2 BB section view; Figure 4 This is a schematic diagram of the overall structure of the balloon catheter provided in some embodiments of this application. Figure 2 ; Figure 5 This application is about Figure 4 Detailed image of point C; Figure 6 This is a partial structural diagram of the balloon catheter provided in some embodiments of this application. Figure 1 ; Figure 7 This is a partial structural diagram of the balloon catheter provided in some embodiments of this application. Figure 2 ; Figure 8 This is a schematic diagram of the combination of balloon catheter and stent provided in some embodiments of this application.

[0010] In the diagram: 100-outer tube, 200-inner tube, 210-delivery cavity, 220-limiting structure, 300-balloon, 400-fluid channel, 500-locking structure, 600-stent, 700-stent guidewire, 710-illuminating structure. Detailed Implementation

[0011] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be described in detail below. Obviously, the described embodiments are merely some embodiments of this invention, and not all embodiments. Based on the embodiments of this invention, all other implementation methods obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0012] In the various embodiments of this application, "proximal" and "distal" refer to the balloon catheter and its accessories, relative to the user's position in the usage environment. The end closer to the user is designated as the "proximal" end, and the end farther from the user is designated as the "distal" end. Furthermore, in the specification and claims, "and / or" indicates at least one of the connected objects, and the character " / " generally indicates that the preceding and following objects are in an "or" relationship.

[0013] This application provides a balloon catheter, including an outer tube 100, an inner tube 200, a balloon 300, and a fluid channel 400. See also... Figures 1 to 4 As shown, the outer tube 100 is a tubular structure with a hollow interior. The inner tube 200 passes through the outer tube 100 and is movably fitted with it. The inner tube 200 can move within the outer tube 100 to adjust the length of the inner tube 200 protruding from the distal end of the outer tube 100. The inner tube 200 has a delivery channel 210 arranged along its axial direction for the passage of medical devices. The medical devices are generally those used in conjunction with the balloon 300 catheter, such as guidewires and stents 600.

[0014] The balloon 300 is installed at the distal end of the outer tube 100. The balloon 300 is generally made of elastic material and is hollow inside. The balloon 300 can receive gas or liquid from the outside and thus inflate. The balloon 300 is located at the distal end of the outer tube 100 and moves synchronously with the outer tube 100 to the preset target position to expand at the target position.

[0015] The distal end of the fluid channel 400 communicates with the balloon 300, and the proximal end extends towards the proximal end of the outer tube 100. The proximal end of the fluid channel 400 is used to receive fluid to inflate the balloon 300 away from the inner tube 200. The fluid channel 400 is used to deliver fluid to the balloon 300 to inflate the balloon 300, and the fluid channel 400 is not inflatable. The fluid channel 400 can deliver either gas or liquid.

[0016] When using the catheter, it is first advanced to the target location, and fluid is introduced into the balloon 300 to inflate the balloon and dilate the blood vessel at the target location. After dilation, the balloon 300 is depressurized, and then the stent 600 is advanced to the appropriate position within the catheter. The stent 600 is typically paired with a stent guidewire 700, which has a contrast-enhancing structure 710, as shown in the reference. Figure 8 As shown, under X-ray or other surgical conditions, the operator can determine the position of the stent guidewire 700 by using the imaging structure 710.

[0017] It is important to note that when delivering the stent 600, the position of the inner tube 200 needs to be adjusted according to the length of the stent guide wire 700 extending from the stent 600. This ensures that when the stent 600 and stent guide wire 700 are delivered to the preset position in the catheter, the inner tube 200 can cover the stent guide wire 700. The fit between the catheter and the stent 600 can be found in [reference needed]. Figure 8 As shown. After the stent 600 is delivered to the preset position, the position of the stent guidewire 700 is stabilized, and the catheter is withdrawn to release the stent 600 in the preset position in the blood vessel. When withdrawing the catheter, the outer tube 100 connected to the balloon 300 can be withdrawn first, or the outer tube 100 and the inner tube 200 can be withdrawn simultaneously to ensure the smooth release of the stent 600.

[0018] The inner tube 200 can move within the outer tube 100, and the distal end of the inner tube 200 can extend beyond the outer tube 100. Furthermore, the length of the inner tube 200 protruding from the outer tube 100 is adjustable. This allows the inner tube 200 to cover the stent guidewire 700 when it extends beyond the stent 600, preventing direct contact and damage to the blood vessel. Different sizes and brands of stents 600 have different lengths of the stent guidewire 700 extending beyond the stent 600. Using the catheter provided in this embodiment, the relative positions of the inner tube 200 and the outer tube 100 are adjustable. The position of the inner tube 200 and the length of its distal end extending beyond the outer tube 100 can be adjusted to accommodate different brands and sizes of stents 600, resulting in a wider range of applications and greater flexibility.

[0019] In addition, when the catheter provided in this application is used in conjunction with the stent 600, only the position of the inner tube 200 needs to be adjusted, while the positions of the outer tube 100 and the balloon 300 can remain stable, making adjustment more convenient.

[0020] The inner tube 200 is generally made of a flexible material, allowing it to deform adaptively under external force. The inner tube 200 is more flexible, so even if it extends beyond the outer tube 100 and directly contacts the inner wall of the blood vessel, it is less likely to cause damage. Preferably, the distal end face of the inner tube 200 is designed with a curved structure to reduce the sharp edges at the distal end of the inner tube 200, further reducing the risk of damage to the blood vessel.

[0021] The fluid channel 400 is generally made of a material with high structural strength to prevent deformation of the fluid channel 400 under the impact of the fluid, which would affect the fluid transport.

[0022] In some preferred embodiments, the fluid channel 400 is disposed on the wall of the outer tube 100. The fluid channel 400 is connected to the wall of the outer tube 100 and moves synchronously with the outer tube 100. In some optional embodiments, the fluid channel 400 is formed by the wall of the outer tube 100, as can be referred to... Figure 5As shown, the fluid channel 400 is part of the outer tube 100. The hollow wall of the outer tube 100 forms the fluid channel 400, which can ensure that the outer wall of the outer tube 100 is smooth and without attachments, and can effectively avoid the influence of the fluid channel 400 on the insertion of the outer tube 100.

[0023] In some alternative embodiments, the fluid channel 400 can be provided separately. The fluid channel 400 is a tubular structure and is directly fixed to the outer tube 100. The fluid channel 400 can be fixed to the outer side wall or the inner side wall of the outer tube 100.

[0024] In some alternative embodiments, the fluid channel 400 may also be formed by a groove structure and a seal disposed on the side wall of the outer tube 100, the seal sealing the groove structure, the groove structure being used to transport fluid.

[0025] When the fluid channel 400 is formed by the wall of the outer tube 100, the fluid channel 400 is an annular cavity, and the fluid channel 400 is arranged around the inner tube 200. Correspondingly, the balloon 300 is also arranged around the inner tube 200. The fluid channel 400 communicates with the balloon 300, and both are arranged around the inner tube 200. The fluid channel 400 delivers fluid to the balloon 300 at a higher rate, and the fluid distribution in the balloon 300 is more uniform. The balloon 300 inflates more uniformly in the circumferential direction of the inner tube 200.

[0026] The proximal end of the fluid channel 400 is the fluid inlet, and fluid is injected into the fluid channel 400 from the proximal end. In some embodiments, the fluid inlet is located on the outer wall of the outer tube 100 for easier operation.

[0027] The balloon 300 and the outer tube 100 are made of different materials. In some embodiments, the balloon 300 and the outer tube 100 are two independent components, manufactured separately and then fixed together. In other embodiments, the balloon 300 and the outer tube 100 can also be integrally molded. The overall structure formed by the two has better structural strength and stability. Furthermore, when the fluid channel 400 is formed by the wall of the outer tube 100, the fluid channel 400 is directly connected to the balloon 300, effectively preventing air leakage in the fluid channel 400 and avoiding poor sealing at the connection between the fluid channel 400 and the balloon 300.

[0028] The balloon 300 is installed at the distal end of the outer tube 100. In some optional embodiments, the balloon 300 is fixed to the distal end face of the outer tube 100. When inflated, the balloon 300 can expand either away from or towards the inner tube 200, clamping the inner tube 200, stabilizing its position, and reducing the possibility of the inner tube 200 moving freely within the vascular lumen. In other optional embodiments, the balloon 300 is fixed to the outer wall of the outer tube 100, and the inner side of the balloon 300 is limited by the outer wall of the outer tube 100. When inflated, the balloon 300 expands away from the inner tube 200, avoiding direct contact between the balloon 300 and the inner tube 200, and preventing the inflation of the balloon 300 from affecting the movement of the inner tube 200.

[0029] In the embodiments provided in this application, the inner tube 200 can move relative to the outer tube 100. In some preferred embodiments, a limiting structure 220 is provided on the outer side wall of the inner tube 200, which can be referred to... Figure 5 As shown, the limiting structure 220 is located on the proximal side of the outer tube 100, outside the outer tube 100. The outer tube 100 is located on the movement path of the limiting structure 220, so as to limit and cooperate with the limiting structure 220. When the outer tube 100 and the limiting structure 220 are in a limiting cooperation, the distal end of the inner tube 200 is exposed outside the outer tube 100. The limiting structure 220 cooperates with the outer tube 100 to prevent the inner tube 200 from extending further beyond the distal end of the outer tube 100, limiting the maximum length that the inner tube 200 can extend beyond the distal end of the outer tube 100, and also preventing the proximal end of the inner tube 200 from being accidentally pushed into the outer tube 100.

[0030] The limiting structure 220 can be a protrusion located near the end of the inner tube 200, as shown in the reference. Figure 5 As shown, the inner tube 200 can be directly formed into the limiting structure 220 during injection molding. In other embodiments, the limiting structure 220 can also be subsequently processed and fixed to the outside of the inner tube 200. This application does not limit the specific shape of the limiting structure 220.

[0031] When adjusting the position of the inner tube 200, the starting point for adjustment is when the distal end of the inner tube 200 is flush with the distal end of the outer tube 100. The ending point is when the limiting structure 220 of the inner tube 200 and the limiting mechanism of the outer tube 100 are engaged, at which point the length of the inner tube 200 extending beyond the outer tube 100 reaches its maximum. When operating the inner tube 200, the operator must avoid the distal end of the inner tube 200 retracting into the outer tube 100, as this would create a step between the inner tube 200 and the outer tube 100, which could easily cause the support 600 to jam when it is being transported.

[0032] The inner tube 200 and the outer tube 100 are movably fitted together, and there is a gap between the outer wall of the inner tube 200 and the inner wall of the outer tube 100, which provides space for the inner tube 200 to move. When the inner tube 200 and the outer tube 100 are coaxial, the gap size is between 0.02 mm and 0.2 mm.

[0033] The size of the gap needs to take into account both the dimensions of the inner tube 200 and the outer tube 100. If the gap is too large, it will cause the outer tube 100 to accumulate. It will also result in either the outer tube 100 being too large or the inner tube 200 being too small. If the inner tube 200 is too large, it will cause difficulty in catheter insertion; if it is too small, it will cause difficulty in delivering the stent 600. If the gap is too small, it will cause the inner tube 200 to move unsmoothly within the outer tube 100, resulting in excessive resistance and preventing the inner tube 200 from moving smoothly to cover the stent guidewire 700. Therefore, in the embodiments provided in this application, the gap size is generally between 0.02 mm and 0.2 mm to avoid the outer tube 100 being too large, the inner tube 200 being too small, and the inner tube 200 being difficult to move relative to the outer tube 100. In some preferred embodiments, the gap size is set to 0.1 mm.

[0034] A locking structure 500 is provided at the proximal end of the inner tube 200 and / or the proximal end of the outer tube 100. The locking structure 500 is used to fix the relative position of the inner tube 200 and the outer tube 100, preventing the inner tube 200 from moving arbitrarily and affecting intraoperative operations. When it is necessary to adjust the relative position of the inner tube 200 and the outer tube 100, the locking structure 500 is opened, as shown in the reference... Figure 6 As shown, at this time, the locking structure 500 does not lock the inner tube 200 and the outer tube 100, and the inner tube 200 can move relative to the outer tube 100 to adjust its position. After the inner tube 200 is moved to the desired position, refer to... Figure 7 As shown, the locking structure 500 locks the relative positions of the inner tube 200 and the outer tube 100, facilitating the next step of the operation.

[0035] The locking structure 500 can be individually installed on the inner tube 200 or the outer tube 100. For example, the outer tube 100 is provided with a clamping structure to clamp and fix the inner tube 200. A detachable rubber ring is embedded in the inner tube 200, and the relative positions of the inner tube 200 and the outer tube 100 are fixed by clamping the rubber ring between them. The inner tube 200 is provided with multiple grooves for installing the rubber ring, and the position of the rubber ring is adjustable to adapt to changes in the relative positions of the inner tube 200 and the outer tube 100.

[0036] Alternatively, locking structures 500 can be provided on both the outer tube 100 and the inner tube 200. The locking structure 500 on the inner tube 200 and the locking structure 500 on the outer tube 100 cooperate with each other to fix the relative position of the inner tube 200 and the outer tube 100. For example, the locking structure 500 can be a Luer connector, a pin, a latch, or a keyway structure, etc.

[0037] In some preferred embodiments, the inner wall of the outer tube 100 and the outer wall of the inner tube 200 are both provided with a hydrophilic coating. The hydrophilic coating can reduce the friction between the inner tube 200 and the outer tube 100 in a liquid environment, making it easier to adjust the position of the inner tube 200 inside the outer tube 100 and enhancing the overall operability of the conduit.

[0038] In some preferred embodiments, both the distal end of the inner tube 200 and the balloon 300 are equipped with imaging positioning devices, allowing the operator to determine the relative positions of the inner tube 200 and the balloon 300 under X-ray or other surgical conditions. When used in conjunction with the stent 600, it further facilitates the operator in adjusting the relative positions of the stent 600 and the catheter.

[0039] It should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element.

[0040] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention.

Claims

1. A balloon catheter, characterized in that, include: Outer tube (100), the inner part of which is hollow; An inner tube (200) is inserted inside the outer tube (100) and is movably fitted with the outer tube (100) to adjust the length of the inner tube (200) protruding from the distal end of the outer tube (100) so as to ensure that when the stent (600) and stent guidewire (700) are delivered to a preset position in the catheter, the inner tube (200) can cover the stent guidewire (700); the inner tube (200) has a delivery cavity (210) arranged along its axial direction for the stent guidewire (700) and stent (600) to pass through; A balloon (300) is mounted at the distal end of the outer tube (100); A fluid channel (400) is provided, the distal end of which is connected to the balloon (300), and the proximal end of which extends toward the proximal end of the outer tube (100). The proximal end of the fluid channel (400) is used to receive fluid so that the balloon (300) expands away from the inner tube (200). The fluid channel (400) is disposed on the wall of the outer tube (100) and moves synchronously with the outer tube (100). There is a gap between the outer wall of the inner tube (200) and the inner wall of the outer tube (100), which provides space for the inner tube (200) to move.

2. The balloon catheter according to claim 1, characterized in that, The fluid channel (400) is formed by the wall of the outer tube (100); Alternatively, the fluid channel (400) is a tubular structure, and the fluid channel (400) is fixed to the outer tube (100).

3. A balloon catheter according to claim 2, characterized in that, When the fluid channel (400) is formed by the wall of the outer tube (100), the fluid channel (400) is an annular cavity, the fluid channel (400) surrounds the inner tube (200), and the balloon (300) is also arranged around the inner tube (200).

4. A balloon catheter according to claim 1, characterized in that, The balloon (300) and the outer tube (100) are integrally formed.

5. A balloon catheter according to claim 1, characterized in that, The balloon (300) is fixed to the distal end face of the outer tube (100); Alternatively, the balloon (300) is fixed to the outer wall of the outer tube (100).

6. A balloon catheter according to claim 1, characterized in that, The outer wall of the inner tube (200) is provided with a limiting structure (220), the limiting structure (220) is located on the proximal side of the outer tube (100), and the outer tube (100) is located on the movement path of the limiting structure (220) to limit and cooperate with the limiting structure (220). When the outer tube (100) is in a limiting engagement with the limiting structure (220), the distal end of the inner tube (200) is exposed outside the outer tube (100).

7. A balloon catheter according to claim 6, characterized in that, The limiting structure (220) is a protrusion located near the end of the inner tube (200).

8. A balloon catheter according to claim 1, characterized in that, When the inner tube (200) and the outer tube (100) are coaxial, the gap size is between 0.02 mm and 0.2 mm.

9. A balloon catheter according to claim 1, characterized in that, A locking structure (500) is provided at the proximal end of the inner tube (200) and / or the proximal end of the outer tube (100), the locking structure (500) being used to fix the relative position of the inner tube (200) and the outer tube (100); And / or, the inner wall of the outer tube (100) and the outer wall of the inner tube (200) are both provided with a hydrophilic coating; And / or, both the distal end of the inner tube (200) and the balloon (300) are provided with imaging positioning devices.

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