Single-use intracranial drug balloon

Abstract

This invention discloses a disposable intracranial drug-eluting balloon comprising a catheter, one end of which is connected to a catheter hub, and a balloon assembly disposed at the end of the catheter away from the catheter hub. A hypotube is connected to the catheter, and a side opening is also provided on the catheter. A hydrophilic coating section is provided on the catheter, and the end of the hydrophilic coating section away from the catheter hub is connected to the balloon assembly. In this invention, by using a balloon assembly in conjunction with a catheter, medical personnel can easily move the balloon assembly to the narrowed area of ​​the patient's blood vessel. Then, diluted contrast fluid is injected into the balloon assembly through the catheter, causing the balloon assembly to inflate. At this time, after the inner sleeve is filled with contrast fluid, it first unfolds its folds, causing the outer layer to expand. It then expands through its own elastic deformation, causing the outer layer to continue to expand. The pressure required for the two expansions is different, allowing medical personnel to more accurately control the expansion speed of the drug-eluting balloon.

Description

Technical Field

[0001] This utility model relates to the field of medical equipment technology, and in particular to a disposable intracranial drug-eluting balloon. Background Technology

[0002] Drug-eluting balloon angioplasty is an interventional procedure used to treat cerebral vascular stenosis. Its effectiveness and duration vary from person to person. Typically, vascular patency can be maintained for several years after surgery, but the specific duration depends on multiple factors. Drug-eluting balloon angioplasty has a high success rate in cerebrovascular treatment, generally achieving immediate results in over 90% of cases. This means that most patients experience immediate symptom relief.

[0003] In existing technologies, when using intracranial drug-eluting balloons, if the force applied is too small, acute retraction of the blood vessel wall may occur, resulting in a decrease in the vasodilation effect. On the other hand, if the force is too large, dissecting hematoma may be easily created. Controlling the expansion of the drug-eluting balloon in the blood vessel relies too much on the on-the-spot performance of medical personnel during surgery, which is not conducive to controlling the surgical efficacy. Therefore, we propose to use disposable intracranial drug-eluting balloons to solve the above problems. Utility Model Content

[0004] The purpose of this invention is to solve the problems existing in the prior art by proposing a disposable intracranial drug-eluting balloon.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: A disposable intracranial drug-eluting balloon includes a catheter, one end of which is connected to a catheter hub, and a balloon assembly is disposed at the end of the catheter away from the catheter hub; The catheter is connected to a sodium hypochlorite tube and has a side opening. The catheter is provided with a hydrophilic coating section, and the end of the hydrophilic coating section away from the catheter seat is connected to the balloon assembly. The end of the balloon assembly away from the hydrophilic coating section is provided with a guide head. The catheter has a dual-lumen structure design. One lumen of the catheter is closed at the end near the guide head, and the other lumen is connected to the outside and extends to the side opening.

[0006] Preferably, the balloon assembly includes an outer layer fixedly connected to the catheter, an inner sleeve disposed inside the outer layer and abutting against the outer layer, the inner sleeve communicating with the catheter, the inner sleeve having multiple pleats, a contrast ring on the outer wall of the inner sleeve, and a drug coating on the inner sleeve.

[0007] Preferably, the guide head includes a guide tube fixedly connected to the balloon assembly, a protective sleeve is fixedly connected to the guide tube, and an extension sleeve is provided between the protective sleeve and the guide tube.

[0008] Preferably, there are two developing rings, which are respectively located near both ends of the inner sleeve.

[0009] Preferably, the drug contained in the drug coating is paclitaxel or rapamycin, and the drug-loaded matrix is ​​iodofol.

[0010] Compared with the prior art, the beneficial effects of this utility model are: 1. This utility model, by setting up a balloon assembly in conjunction with a catheter, allows medical personnel to easily move the balloon assembly to the narrow part of the patient's blood vessels. Then, the catheter is used to inject diluted contrast fluid into the balloon assembly, causing the balloon assembly to expand. At this time, after the inner sleeve is filled with contrast fluid, it first unfolds its folds and causes the outer layer to expand. It expands by its own elastic deformation, causing the outer layer to continue to expand. The pressure required for the two expansions is different, which allows medical personnel to more accurately control the expansion speed of the drug-eluting balloon and improve the surgical efficacy. 2. This utility model, by setting a contrast ring, allows medical personnel to more accurately locate the balloon component, ensuring that it moves to the narrow part of the blood vessel. In addition, with the help of a drug coating to treat the inner wall of the blood vessel, it can still limit the proliferation of the inner wall of the blood vessel after the operation, and prevent the blood vessel from becoming blocked again. Attached Figure Description

[0011] Figure 1 This is a side view of the disposable intracranial drug delivery balloon proposed in this utility model. Figure 2 This is a cross-sectional view of the balloon assembly of the disposable intracranial drug delivery balloon proposed in this utility model; Figure 3 This is a cross-sectional schematic diagram of the balloon assembly of the disposable intracranial drug delivery balloon proposed in this utility model.

[0012] In the diagram: 1. Catheter; 2. Catheter seat; 3. Hypophthalmic tube; 4. Hydrophilic coating section; 5. Guide head; 51. Guide tube; 52. Protective sleeve; 53. Extension sleeve; 6. Outer layer; 7. Inner sleeve; 8. Imaging ring. Detailed Implementation

[0013] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present utility model. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments.

[0014] Reference Figure 1-3 A disposable intracranial drug balloon includes a catheter 1, one end of which is connected to a catheter seat 2, and a balloon assembly is provided at the end of the catheter 1 away from the catheter seat 2; The catheter 1 is connected to a sodium hypochlorite tube 3. The catheter 1 also has a side opening. The catheter 1 is provided with a hydrophilic coating section 4, and the end of the hydrophilic coating section 4 away from the catheter 1 seat is connected to the balloon assembly. The end of the balloon assembly away from the hydrophilic coating section 4 is provided with a guide head 5. The catheter 1 has a dual-lumen structure design. One lumen of the catheter 1 is closed at the end near the guide head 5, and the other lumen is connected to the outside at the end near the guide head 5 and extends to the side opening.

[0015] In this design, before surgery, medical personnel first use a syringe filled with sterile heparinized saline to connect with the distal end of the balloon dilation catheter 1 to clean the guidewire lumen. Then, a pressure pump filled with diluted contrast solution (i.e., a mixture of 50% contrast agent and 50% saline) is connected to a three-way valve and then to the handle of catheter 1. The vascular puncture point is then prepared according to standard operating procedures. After the guidewire passes through the target lesion site, the rear end of the guidewire is threaded through catheter 1, and catheter 1 with the balloon assembly is pushed along the guidewire to the target lesion site. The contrast ring 8 on the balloon assembly is used to locate the balloon at the lesion site, and the position of the balloon is confirmed by angiography. Afterward, the guidewire is removed from the side opening. Next, connect the pressure pump partially filled with diluted contrast fluid to the three-way valve, evacuate the air by drawing back the negative pressure, and turn the interface between the three-way valve and catheter 1 to the closed position. Then, purge the air from the pressure pump and close the side interface of the three-way valve. To ensure the drug coating adheres to the lesion site on the arterial wall, inflate the balloon assembly with appropriate pressure. When the desired pressure value is reached, maintain the pressure for at least 30-60 seconds. After maintaining the pressure, aspirate the balloon assembly with the pressure pump to empty it. Do not allow catheter 1 to move while the balloon assembly is not completely emptied. Finally... The balloon assembly is withdrawn into the guiding catheter 1, and contrast fluid is injected through the guiding catheter 1 to observe the dilation effect. The entire surgical procedure is then completed. In this design, the hydrophilic coating section 4 is the external coating of the catheter 1, which is also the main body of the catheter 1. It is used to ensure that the catheter 1 moves smoothly within the patient's inner tube. The side opening is for connecting components such as the guide wire. It should be noted that the catheter 1 completely penetrates the balloon assembly and extends towards the guide head 5. The contrast fluid is injected into the balloon assembly through another lumen of the catheter 1 that is not connected to the side opening.

[0016] Furthermore, the balloon assembly includes an outer layer 6 fixedly connected to the catheter 1, an inner sleeve 7 disposed inside the outer layer 6 and abutting against the outer layer 6, the inner sleeve 7 being connected to the catheter 1, the inner sleeve 7 having multiple folds, and the outer wall of the inner sleeve 7 having a contrast ring 8, and the inner sleeve 7 having a drug coating. In this design, the inner sheath 7 is connected to the internal tubing of the catheter 1 for injecting diluted contrast fluid for dilation. The inner sheath 7, with its multi-segmented folds, requires less pressure when the contrast fluid is injected via a pressure pump, and the pressure set by the pump is also relatively low at this time. After the inner sheath 7 expands to the unfolded state, it abuts against the inner wall of the outer layer 6. At this point, driving the expansion component to expand requires overcoming the elastic potential energy of the inner sheath 7 and the outer layer 6, as well as the elasticity of the vascular wall, requiring greater pressure. This allows medical personnel to perform more precise operations in conjunction with the angiography, which is beneficial for accurately controlling the balloon expansion pressure. This ensures effective vascular dilation while avoiding acute retraction of the vascular wall and the occurrence of dissecting hematoma, reducing the demand on the technical level and on-site performance of medical personnel, and improving the stability of the surgical procedure.

[0017] Furthermore, the guide head 5 includes a guide tube 51 fixedly connected to the balloon assembly, a protective sleeve 52 fixedly connected to the guide tube 51, and an extension sleeve 53 provided between the protective sleeve 52 and the guide tube 51, with the guide wire movably passing through the protective sleeve 52 and the extension sleeve 53. The guide tube 51 is also integrated with the catheter 1. The guide head 5, together with the extension sleeve 53, is used to slightly dilate blood vessels and guide the drug capsule assembly and the catheter 1 along the guide wire to move to the narrow part of the blood vessel.

[0018] Furthermore, there are two imaging rings 8, which are respectively located near the two ends of the inner sleeve 7. In this design, the imaging rings 8 can help medical personnel to more clearly understand the position of the balloon assembly and ensure that the middle of the balloon assembly is directly facing the narrow blood flow area.

[0019] Furthermore, the drug coating contains paclitaxel or rapamycin, and the drug-loaded matrix is ​​iodofol. Paclitaxel or rapamycin is used to inhibit cell proliferation by inducing cell cycle arrest and mitotic catastrophe, thus preventing re-blockage at narrow blood vessels. The drug-loaded matrix can also be prepared from one or more of iodofol, iopromide, iohexol, iodopyram, urea, shellac, sorbic acid, and fatty acids. The drug-loaded matrix is ​​used to assist in the better release of paclitaxel or rapamycin. The above description is only a preferred embodiment of the present utility model, but the protection scope of the present utility model is not limited thereto. Any equivalent substitutions or changes made by those skilled in the art within the technical scope disclosed in the present utility model, based on the technical solution and the inventive concept of the present utility model, should be included within the protection scope of the present utility model.

Claims

1. A disposable intracranial drug-eluting balloon, comprising a catheter (1), one end of which is connected to a catheter hub (2), characterized in that, A balloon assembly is provided at the end of the catheter (1) away from the catheter seat (2); The catheter (1) is connected to a sodium hypochlorite tube (3). The catheter (1) is also provided with a side opening. The catheter (1) is provided with a hydrophilic coating section (4). The end of the hydrophilic coating section (4) away from the catheter (1) seat is connected to the balloon assembly. The end of the balloon assembly away from the hydrophilic coating section (4) is provided with a guide head (5). The catheter (1) is a dual-lumen structure design. One lumen of the catheter (1) is closed at the end near the guide head (5), and the other lumen is connected to the outside at the end near the guide head (5) and extends to the side opening.

2. The disposable intracranial drug-eluting balloon according to claim 1, characterized in that, The balloon assembly includes an outer layer (6) fixedly connected to a catheter (1), an inner sleeve (7) is disposed inside the outer layer (6), and the inner sleeve (7) is disposed against the outer layer (6). The inner sleeve (7) is connected to the catheter (1). The inner sleeve (7) is provided with multiple folds, and the outer wall of the inner sleeve (7) is provided with a radiopaque ring (8). The inner sleeve (7) is provided with a drug coating.

3. The disposable intracranial drug-eluting balloon according to claim 2, characterized in that, The guide head (5) includes a guide tube (51) fixedly connected to the balloon assembly. A protective sleeve (52) is fixedly connected to the guide tube (51), and an extension sleeve (53) is provided between the protective sleeve (52) and the guide tube (51).

4. The disposable intracranial drug-eluting balloon according to claim 2, characterized in that, Two developing rings (8) are provided, respectively located near the two ends of the inner sleeve (7).

5. The disposable intracranial drug-eluting balloon according to claim 2, characterized in that, The drug coating contains either paclitaxel or rapamycin, and the drug-loaded matrix is ​​iodofol.

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