Balloon dilatation catheter for carotid artery

Abstract

The balloon dilatation catheter for the carotid artery comprises a catheter assembly and a composite balloon arranged on the catheter assembly, and the composite balloon comprises a cylindrical main balloon body and at least three auxiliary balloon bodies arranged at intervals. The auxiliary balloon body is connected to a long-strip-shaped opening which is formed in the outer wall of the main balloon body and extends in the axial direction of the main balloon body, and when the composite balloon is expanded to the limit position, the auxiliary balloon body protrudes outwards and abuts against the inner wall of a blood vessel, so that the outer wall of the main balloon body and the inner wall of the blood vessel are connected in a sealed mode. The auxiliary sacculus bodies and the channels for blood circulation are defined between the outer walls of the adjacent auxiliary sacculus bodies, the auxiliary sacculus bodies can abut against the inner walls of the blood vessels to open the narrow positions, a good supporting effect is achieved, blood supply of the brain can be guaranteed through the defined channels, the blood vessels are not blocked, brain cell death is avoided, and the risk is reduced.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a balloon dilation catheter for the carotid artery. Background Technology

[0002] Carotid artery stenosis refers to the narrowing of the carotid artery lumen caused by atherosclerotic plaques. In severe cases, it can lead to stroke. The common preventive measure is to first dilate the blood vessel wall with a balloon to widen the narrowed area of ​​the carotid artery, and then implant a stent to restore the narrowed area of ​​the carotid artery to near normal.

[0003] Currently, the balloons used in clinical treatment of carotid artery stenosis are usually cylindrical, just like those used for peripheral arteries, meaning that the diameter of the head and tail ends are the same. This type of balloon provides good support after expansion, but it blocks the blood vessel after inflation, preventing blood from flowing through it. For peripheral arteries, the side effects of this blockage are manageable, but the carotid artery supplies blood to the brain, and brain cells are different from other cells in the body; once they die, they will not regenerate. Therefore, this type of balloon carries a greater risk when used for stroke prevention. Utility Model Content

[0004] The purpose of this invention is to overcome one or more drawbacks in the prior art and provide a balloon dilation catheter for the carotid artery.

[0005] To achieve the above objectives, the present invention employs a balloon dilation catheter for the carotid artery, comprising a catheter assembly and a composite balloon disposed on the catheter assembly. The composite balloon comprises a cylindrical main balloon body and at least three spaced auxiliary balloon bodies. The auxiliary balloon bodies are connected to an elongated opening extending axially along the outer wall of the main balloon body. When the composite balloon is dilated to its limit position, the auxiliary balloon bodies bulge outward and press against the inner wall of the blood vessel, thereby forming a channel for blood flow between the outer wall of the main balloon body, the inner wall of the blood vessel, and the outer walls of the adjacent auxiliary balloon bodies.

[0006] Preferably, during the expansion of the composite balloon, the auxiliary balloon expands before the main balloon.

[0007] More preferably, the auxiliary balloon body is made of the same material as the main balloon body and is integrally formed, and the wall thickness of the auxiliary balloon body is less than the wall thickness of the main balloon body.

[0008] Preferably, when the composite balloon is expanded to its limit position, the height of the auxiliary balloon bulging outward is less than or equal to the diameter of the main balloon.

[0009] Preferably, all the auxiliary balloons are evenly distributed around the axis of the main balloon.

[0010] Preferably, the length of the elongated opening is greater than or equal to 60% and less than or equal to 90% of the axial length of the main balloon body.

[0011] Preferably, the catheter assembly is a coaxial catheter assembly or a quick-exchange catheter assembly, with one end of the catheter assembly passing through the composite balloon and the other end connected to a catheter hub.

[0012] More preferably, the balloon dilation catheter further includes a tip tube, a flow sensor, and an inflation device. The tip tube is wrapped around the end of the catheter assembly that passes through the composite balloon. The flow sensor is located at the junction of the tip tube and the composite balloon and aligned with the channel. The inflation device is connected to the composite balloon through the catheter seat and is used to adjust the pressure inside the composite balloon.

[0013] More preferably, there are multiple flow sensors, and the flow sensors are signal-connected to the pressurization device. When the flow detected by the flow sensor is less than a set value, the pressurization device reduces the pressure inside the composite balloon.

[0014] More preferably, the catheter assembly includes an inner tube and an outer tube sleeved on the inner tube. The inner tube has a contrast ring located inside the composite balloon. The guidewire size that the inner tube can be adapted to is 0.014 inches, 0.018 inches, or 0.035 inches. One end of the outer tube is connected to the catheter hub, and the other end is connected to the end of the composite balloon away from the tip tube.

[0015] Due to the application of the above technical solution, this utility model has the following advantages compared with the prior art:

[0016] The present invention provides a balloon dilation catheter for the carotid artery, comprising a catheter assembly and a composite balloon disposed on the catheter assembly. The composite balloon includes a cylindrical main balloon and at least three spaced auxiliary balloons. The auxiliary balloons are connected to an elongated opening extending axially along the outer wall of the main balloon. When the composite balloon is dilated to its maximum position, the auxiliary balloons bulge outward and press against the inner wall of the blood vessel. This creates a blood flow channel between the outer wall of the main balloon, the inner wall of the blood vessel, and the outer walls of adjacent auxiliary balloons. This allows for better support by using the auxiliary balloons to press against the inner wall of the blood vessel to open narrowed areas, while ensuring blood supply to the brain through the formed channel without blocking blood vessels, thereby preventing brain cell death and reducing risk. Attached Figure Description

[0017] Figure 1 This is a front view schematic diagram of a preferred embodiment of the present invention, with a partial cross-sectional view.

[0018] Figure 2 yes Figure 1 Cross-sectional view along the AA direction.

[0019] Figure 3 yes Figure 1 The 3D schematic diagram omits the flow sensor and pressurization device.

[0020] The components are: 10. Catheter assembly; 11. Inner tube; 12. Outer tube; 13. Contrast ring; 20. Composite balloon; 21. Main balloon body; 211. Long strip opening; 22. Secondary balloon body; 23. Channel; 30. Catheter seat; 40. Tip tube; 50. Flow sensor; 60. Inflation device. Detailed Implementation

[0021] like Figures 1 to 3 As shown, the balloon dilation catheter for the carotid artery provided by this utility model includes a catheter assembly 10 and a composite balloon 20 disposed on the catheter assembly 10. The composite balloon 20 includes a cylindrical main balloon body 21 and six spaced auxiliary balloon bodies 22. The auxiliary balloon bodies 22 are connected to an elongated opening 211 extending along the axial direction of the main balloon body 21 on the outer wall of the main balloon body 21. All the auxiliary balloon bodies 22 are evenly distributed around the axis of the main balloon body 21. When the composite balloon 20 is expanded to its limit position, the auxiliary balloon bodies 22 bulge outward and press against the inner wall of the blood vessel, so that the outer wall of the main balloon body 21, the inner wall of the blood vessel, and the outer wall of the adjacent auxiliary balloon bodies 22 form a channel 23 for blood flow.

[0022] The advantage of this design is that it can both provide better support by pressing the auxiliary balloon 22 against the inner wall of the blood vessel to open up the narrowed area, and ensure blood supply to the brain through the enclosed channel 23 without blocking the blood vessel, thereby avoiding brain cell death and reducing the risk.

[0023] During the expansion of the composite balloon 20, the auxiliary balloon body 22 expands before the main balloon body 21. Specifically, the auxiliary balloon body 22 and the main balloon body 21 are made of the same material, nylon 12, and the main balloon body 21 and the auxiliary balloon body 22 are integrally formed. The wall thickness of the auxiliary balloon body 22 is less than the wall thickness of the main balloon body 21. Preferably, when the composite balloon 20 expands to its limit position, the outward bulge height of the auxiliary balloon body 22 is less than or equal to the diameter of the main balloon body 21. Specifically, in this embodiment, when the composite balloon 20 expands to its limit position, the outward bulge height of the auxiliary balloon body 22 is 16.7% of the diameter of the main balloon body 21.

[0024] When the composite balloon 20 contracts, the auxiliary balloon body 22 contracts before the main balloon body 21. After contraction, the auxiliary balloon body 22 adheres to the outer wall of the main balloon body 21 to facilitate penetration into the blood vessel.

[0025] In this embodiment, the length of the elongated opening 211 is greater than or equal to 60% and less than or equal to 90% of the axial length of the main balloon body 21, so as to balance the support effect of the composite balloon 20 and the flow effect of the channel 23.

[0026] In this embodiment, one end of the catheter assembly 10 passes through the composite balloon 20, and the other end is connected to the catheter seat 30. The balloon dilation catheter also includes a tip tube 40, a flow sensor 50, and a pressurization device 60. The tip tube 40 is wrapped around the end of the catheter assembly 10 that passes through the composite balloon 20. The flow sensor 50 is located at the junction of the tip tube 10 and the composite balloon 20 and aligned with the channel 23. The pressurization device 60 is connected to the composite balloon 20 through the catheter seat 30 and is used to adjust the pressure inside the composite balloon 20.

[0027] Preferably, there are three flow sensors 50, which are spaced apart and aligned with the channel 23. The flow sensors 50 are connected to the inflation device 60 via a signal connection, which can be wireless (such as Wi-Fi, Bluetooth, etc.) or wired (signal line connection). The inflation device 60 is preferably an automatic inflation device. When the flow detected by the flow sensor 50 is less than the set value, the inflation device 60 automatically reduces the pressure inside the composite balloon 20 to expand the channel 23 until the flow is greater than or equal to the set value. This structural design can automatically determine the relationship between inflation pressure and flow, ensuring the maximization of product functionality and reducing the difficulty of operation for users. It should be noted that the inflation device 60 has a manual mode to allow for active inflation in the early stages to preferentially dilate narrowed blood vessels.

[0028] In this embodiment, the catheter assembly 10 is a coaxial catheter assembly or a quick-exchange catheter assembly. The catheter assembly 10 includes an inner tube 11 and an outer tube 12 sleeved on the inner tube 11. The inner tube 11 is provided with a radiopaque ring 13 located inside the composite balloon 20. There are two radiopaque rings 13, which are respectively provided at the two ends of the composite balloon 20. The maximum guidewire size that the inner tube 11 can be adapted to is 0.018 inches. One end of the outer tube 12 is connected to the catheter seat 30, and the other end is connected to the end of the composite balloon 20 away from the tip tube 40.

[0029] The above embodiments are only for illustrating the technical concept and features of this utility model, and are intended to enable those skilled in the art to understand the content of this utility model and implement it accordingly. They should not be construed as limiting the scope of protection of this utility model. All equivalent changes or modifications made in accordance with the spirit and essence of this utility model should be included within the scope of protection of this utility model.

Claims

1. A balloon dilatation catheter for carotid artery, comprising a catheter assembly and a composite balloon arranged on the catheter assembly, characterized in that: the composite balloon comprises a main balloon body in a cylindrical shape and at least three auxiliary balloon bodies arranged at intervals, the auxiliary balloon bodies being connected to long strip-shaped openings formed on the outer wall of the main balloon body and extending along the axial direction of the main balloon body, when the composite balloon is dilated to the limit position, the auxiliary balloon bodies bulge outward and abut against the inner wall of the blood vessel, so as to form a channel for blood circulation between the outer wall of the main balloon body, the inner wall of the blood vessel and the outer wall of the adjacent auxiliary balloon body.

2. The balloon dilation catheter of claim 1, wherein: the auxiliary balloon bodies are dilated before the main balloon body when the composite balloon is dilated.

3. The balloon dilation catheter of claim 2, wherein: the auxiliary balloon bodies are made of the same material as the main balloon body and are integrally formed, and the wall thickness of the auxiliary balloon body is smaller than that of the main balloon body.

4. The balloon dilation catheter of claim 1, wherein: the height of the auxiliary balloon body bulging outward is less than or equal to the diameter of the main balloon body when the composite balloon is dilated to the limit position.

5. The balloon dilation catheter of claim 1, wherein: all the auxiliary balloon bodies are uniformly distributed around the axial line of the main balloon body.

6. The balloon dilation catheter of claim 1, wherein: the length of the long strip-shaped opening is greater than or equal to 60% of the axial length of the main balloon body and less than or equal to 90% of the axial length of the main balloon body.

7. The balloon dilation catheter of claim 1, wherein: the catheter assembly is a coaxial catheter assembly or a rapid exchange catheter assembly, one end of the catheter assembly penetrates the composite balloon, and the other end is connected with a catheter seat.

8. The balloon dilation catheter of claim 7, wherein: the balloon dilatation catheter further comprises a tip tube, a flow sensor and a pressure charging device, the tip tube is wrapped around the end of the catheter assembly penetrating the composite balloon, the flow sensor is arranged at the junction of the tip tube and the composite balloon and is aligned with the channel, and the pressure charging device is connected in communication with the composite balloon through the catheter seat for adjusting the pressure in the composite balloon.

9. The balloon dilation catheter of claim 8, wherein: the flow sensor is in signal connection with the pressure charging device, and when the flow detected by the flow sensor is less than a set value, the pressure charging device reduces the pressure in the composite balloon.

10. The balloon dilation catheter of claim 8, wherein: the catheter assembly comprises an inner tube and an outer tube sleeved on the inner tube, the inner tube is provided with a developing ring arranged in the composite balloon, the maximum compatible guide wire size of the inner tube is 0.014 inch, 0.018 inch or 0.035 inch, one end of the outer tube is connected with the catheter seat, and the other end is connected with the end of the composite balloon away from the tip tube.

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