Blood flow controllable perfusion type balloon catheter

Abstract

The invention provides a blood flow controllable perfusion type balloon catheter. The blood flow controllable perfusion type balloon catheter comprises a catheter base, a balloon and a perfusion catheter connected between the catheter base and the balloon. The perfusion catheter is of a double-cavity structure and is composed of a guide wire cavity and a filling cavity which are independent of each other, and a blood perfusion hole is formed in the guide wire cavity. The perfusion catheter of a double-cavity structure is adopted, the perfusion catheter is composed of a guide wire cavity and a filling cavity which are independent of each other, the guide wire cavity is provided with a blood perfusion hole and a developing mark, the blood flow is controlled in cooperation with withdrawing of a guide wire, and blood flow can be kept to pass to a certain extent while it is guaranteed that the narrow part of the blood vessel is expanded in the sacculus filling state; complications caused by blood interruption in the operation of using the balloon are effectively avoided, and the operability and safety of the operation are improved.

Description

Technical Field

[0001] This invention relates to a balloon catheter, specifically to a blood flow-controlled perfusion balloon catheter system for vascular occlusion, belonging to the field of vascular interventional therapy technology. Background Technology

[0002] For cardiovascular diseases, balloon angioplasty is one of the most commonly used treatments. However, traditional balloon dilation catheters completely interrupt blood flow within the vessel during dilation, causing insufficient blood supply to the myocardium. Consequently, the balloon cannot dilate for an extended period, leading to restenosis. Furthermore, during such interventional procedures, directly opening the occluded vessel after balloon withdrawal can cause further damage, known as ischemia-reperfusion injury, which can trigger a series of complications and potentially lead to serious and irreversible consequences for the patient. Summary of the Invention

[0003] To address the problems associated with traditional balloon dilation catheters, this invention aims to provide a blood flow-controlled perfusion balloon catheter. The blood flow rate is controlled by adjusting the guidewire retraction position and the number of open perfusion orifices, thus resolving complications caused by temporary ischemia and irreversible trauma resulting from reperfusion after ischemia. The specific technical solution is as follows: A blood flow controllable perfusion balloon catheter includes a catheter seat, a balloon, and an perfusion catheter connected between the catheter seat and the balloon. The perfusion catheter has a dual-lumen structure, consisting of an independent guidewire lumen and an filling lumen. The guidewire lumen is provided with blood perfusion holes, which are arranged in a radially staggered manner and axially parallel to the direction of the catheter.

[0004] The axial direction parallel to the catheter direction is designed to facilitate clearer and easier identification of the retraction position and the number of exposed perfusion holes during catheter retraction, thus determining the blood flow rate. The radially staggered arrangement allows for more precise blood flow control. Since the hole diameter on a product is fixed, retracting the guidewire between the first and second holes axially exposes a small portion of the first radial hole. At this point, the guidewire is positioned at the exposure point, meaning that even before the guidewire has traveled the entire exposed length, the blood flow rate can be 1.1, 1.2, 1.3, or more times the flow rate of a single hole. This allows for more precise flow control.

[0005] Optionally, the balloon is positioned at the distal end of the infusion catheter and communicates with the filling cavity.

[0006] Optionally, the diameter of the guidewire cavity is greater than or equal to 1.1 times the diameter of the guidewire to ensure that the guidewire can be easily retracted or advanced.

[0007] Optionally, the number of blood perfusion holes is 2-32.

[0008] The number of blood perfusion holes needs to be determined based on the diameter and mechanical properties of the tubing. Different tubing specifications require different numbers and arrangements of perfusion holes. For example, smaller diameter tubing will have fewer radially staggered perfusion holes. Meeting the mechanical performance requirements of the product is a prerequisite for the design.

[0009] Optionally, the opening area of ​​a single blood perfusion port is 0.01-4.0 mm. 2 The opening area primarily affects blood flow.

[0010] Optionally, imaging markers are provided between adjacent blood perfusion holes in the axial direction for positioning the retracted guidewire.

[0011] Optionally, the imaging markers are formed by fusing tungsten, barium sulfate, and bismuth hypochlorite into the perfusion catheter to achieve imaging.

[0012] Optionally, the axial length of the imaging marker is less than or equal to the axial distance between adjacent blood perfusion holes.

[0013] Alternatively, the blood perfusion hole may be formed by techniques such as physical drilling, chemical etching, laser or thermal puncture.

[0014] Compared with the prior art, the advantages of the present invention are as follows: This invention relates to a blood perfusion balloon catheter suitable for re-dilation of vascular stenosis. The invention allows for blood supply to the ischemic area through the blood perfusion port while minimizing ischemia-reperfusion injury. The catheter employs a dual-lumen structure, consisting of an independent guidewire lumen and an inflation lumen. The guidewire lumen is equipped with a blood perfusion port and contrast markers. Combined with the guidewire, the blood flow is controlled. When the balloon is inflated, it ensures dilation of the vascular stenosis while maintaining a certain level of blood flow, effectively avoiding complications caused by blood interruption during balloon-assisted surgery, thus improving surgical operability and safety. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the overall structure of the blood flow controllable perfusion balloon catheter of the present invention; Figure 2 This is a partial structural diagram of the balloon and blood perfusion port of the blood flow controllable perfusion balloon catheter of the present invention; Figure 3 This is a schematic diagram showing the blood perfusion port of the blood flow controllable perfusion balloon catheter of the present invention unfolded on the perfusion catheter; Figure 4 A schematic diagram of the blood flow controllable perfusion balloon catheter of the present invention in use; In the diagram: 1. Catheter seat, 2. Guidewire lumen, 3. Filling lumen, 4. Imaging marker, 5. Blood perfusion port, 6. Balloon, 7. Marker ring, 8. Guidewire, 9. Perfusion catheter, 10. Vessel wall. Detailed Implementation

[0016] The present invention will be further described below with reference to the accompanying drawings and specific embodiments: Example

[0017] like Figure 1 The diagram shows a flow-controlled perfusion balloon catheter system, including a catheter hub 1, a balloon 6, and an perfusion catheter 9 connecting the catheter hub and the balloon. The perfusion catheter 9 has a dual-lumen structure, consisting of an independent guidewire lumen 2 and an filling lumen 3. The diameter of the guidewire lumen 2 is greater than or equal to 1.1 times the guidewire diameter. Multiple blood perfusion holes 5 are present on the guidewire lumen 2. The balloon 6 is located distal to the perfusion catheter 9 and communicates with the filling lumen, which is expanded by injecting a dilator. Example

[0018] like Figure 2 As shown: Blood perfusion port 5 is located on the guidewire lumen of the perfusion catheter. Example

[0019] like Figure 3 As shown, the blood perfusion holes 5 are arranged in a radially staggered pattern and axially parallel to the catheter system. Furthermore, a contrast marker 4 is placed between adjacent blood perfusion holes 5 in the axial direction to position the retracted guidewire. The distance between any two adjacent blood perfusion holes 5 should be greater than the length of the contrast marker 4. The blood perfusion holes 5 are formed by techniques such as physical drilling, chemical etching, laser, or thermal puncture. Example

[0020] like Figure 4 The diagram illustrates the use of the blood flow controllable perfusion balloon catheter of this invention. It shows that the effective working section of the balloon 6 is longer than the length of the vascular stenosis lesion, and the vessel wall 10 provides some support. The length of the vascular stenosis lesion accounts for 60%-80% of the effective working section of the balloon. Example

[0021] The method of using the blood flow controllable perfusion balloon catheter of the present invention is as follows: The catheter system is inserted into the blood vessel under the guidance of the guidewire, positioning the balloon at the target lesion site. The balloon is inflated to the appropriate size to support the narrowed lesion. At this point, the guidewire can be withdrawn; the operator determines the withdrawal position, which determines the number of exposed perfusion holes to determine the appropriate blood perfusion flow rate. After the procedure, the balloon is depressurized, the catheter system is withdrawn from the blood vessel, and finally, the guidewire is withdrawn. Example

[0022] The specific method for controlling blood flow is as follows: when the guidewire is withdrawn back to the first imaging marker, it indicates that only one blood perfusion port is connected to the blood. At this time, the blood flow is relatively small. Continue to withdraw the guidewire, that is, the more blood perfusion ports are exposed, the greater the blood flow. Example

[0023] Balloon 6 can be made of different materials and can be either compliant or non-compliant. After inflation, the diameter of balloon 6 ranges from 0.75 to 30 mm. The balloon diameter can be controlled by adjusting the inflation pressure and the volume of the injected dilator, thereby adapting to diseased blood vessels of different sizes and shapes. Example

[0024] The difference between this embodiment and the above embodiment is that the blood flow controllable perfusion balloon catheter provided in this embodiment has two blood perfusion holes 5, with an opening area of ​​0.01 mm. 2 . Example

[0025] The difference between this embodiment and the above embodiment is that the blood flow controllable perfusion balloon catheter provided in this embodiment has 32 blood perfusion holes 5, with an opening area of ​​4.0 mm. 2 . Example

[0026] The difference between this embodiment and the above embodiment is that the blood flow controllable perfusion balloon catheter provided in this embodiment has 16 blood perfusion holes 5, with an opening area of ​​2.0 mm. 2 . Example

[0027] The difference between this embodiment and the above embodiment is that the blood flow controllable perfusion balloon catheter provided in this embodiment has 20 blood perfusion holes 5, with an opening area of ​​0.04 mm. 2 .

[0028] 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 person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in the present invention, and these modifications or substitutions should all be covered within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A blood flow controllable perfusion balloon catheter, comprising a catheter seat (1), a balloon (6), and an perfusion catheter (9) connecting the catheter seat (1) and the balloon (6), characterized in that, The perfusion catheter (9) has a dual-lumen structure, consisting of an independent guidewire lumen (2) and a filling lumen (3). The guidewire lumen (2) is provided with blood perfusion holes (5), which are arranged in a radially staggered manner and axially parallel to the direction of the catheter.

2. The blood flow controllable perfusion balloon catheter according to claim 1, characterized in that, The balloon (6) is positioned at the distal end of the infusion catheter (9) and communicates with the filling cavity.

3. The blood flow controllable perfusion balloon catheter according to claim 1, characterized in that, The diameter of the guidewire cavity (2) is greater than or equal to 1.1 times the diameter of the guidewire.

4. The blood flow controllable perfusion balloon catheter according to claim 1, characterized in that, The number of blood perfusion holes (5) is 2-32.

5. The blood flow controllable perfusion balloon catheter according to claim 1, characterized in that, The opening area of ​​a single blood perfusion port (5) is 0.01-4.0 mm. 2 .

6. The blood flow controllable perfusion balloon catheter according to claim 1, characterized in that, Imaging markers (4) are provided between adjacent blood perfusion holes (5) in the axial direction.

7. The blood flow controllable perfusion balloon catheter according to claim 6, characterized in that, The imaging markers (4) are formed by fusing tungsten, barium sulfate and bismuth hypochlorite into the perfusion catheter (9).

8. The blood flow controllable perfusion balloon catheter according to claim 6, characterized in that, The axial length of the imaging marker (4) is less than or equal to the axial distance between the adjacent blood perfusion holes (5).

9. The blood flow controllable perfusion balloon catheter according to claim 1, characterized in that, The blood perfusion hole (5) is formed by perforation techniques such as physical drilling, chemical corrosion, laser or thermal puncture.

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