A headless compliant balloon catheter device

Abstract

The utility model discloses an end -to -end compliance balloon catheter device, including guide tube, developing mark, seal pipe, transition pipe, base and compliance balloon, compliance balloon sets up at the outer surface of the far end of guide tube, in compliance balloon is not full state, compliance balloon is attached to the outer surface of the far end of guide tube, and the head end of guide tube is located in the far end of compliance balloon, in compliance balloon complete full state, compliance balloon inflation, and the head end of guide tube is wrapped, and the head end of guide tube is concave in the far end of compliance balloon, and the application is with the attribute of compliance balloon material high elasticity, makes balloon in full full state, just the head end of guide tube is concave or wrapped to the far end of balloon, makes the far end of balloon and will not produce the dead angle of containing thrombus or embolus, when again the liquid in balloon interior is carried out and draws back, and balloon can restore to initial state.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to a headless compliant balloon catheter device. Background Technology

[0002] In recent years, with advancements in imaging equipment and the emergence of new interventional devices, interventional vascular physicians can handle increasingly complex lesions, leading to a growing number of clinical cases and a wider range of diseases covered. However, one of the most challenging problems currently facing us is the potential for fragmented emboli to travel to the distal end of the vessel and cause occlusion during catheter manipulation or the delivery of balloons, stents, or occluders used in interventional procedures. In mechanical thrombectomy, balloon dilation allows the balloon to adhere to the vessel wall, temporarily blocking blood flow to protect the distal end of the vessel. Simultaneously, balloon contraction retracts the catheter to restore blood flow.

[0003] Intravascular thrombectomy, which involves delivering interventional thrombectomy instruments via a compliant balloon catheter for mechanical thrombectomy or aspiration of thrombi using a balloon catheter, offers advantages such as less bleeding, less trauma, fewer complications, safety, reliability, and rapid postoperative recovery. It has become a highlight in the treatment of acute ischemic stroke, with a higher revascularization rate and a wider treatment time window than intravenous or arterial thrombolysis.

[0004] However, traditional compliant balloon guiding catheters have a significant limitation or deficiency: the balloon, when fully inflated, usually has a protruding tip. When the balloon guiding catheter is completely aligned with the vessel wall proximal to the blood vessel, a thrombectomy stent or aspiration catheter containing a thrombus is withdrawn from the body through the lumen of the balloon guiding catheter. When the thrombus enters the lumen of the balloon guiding catheter, there is a significant gap or cavity between the protruding tip and the vessel wall. Even under negative pressure aspiration, there is still a risk of residual thrombus or emboli. Once the balloon portion of the guiding catheter contracts, the residual thrombus can travel with the blood flow towards the distal end of the vessel, causing stroke or cerebral infarction in the patient, posing a high risk. Utility Model Content

[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing a tipless compliant balloon catheter device. This device overcomes the limitations of existing technologies, allowing the balloon catheter to fully conform to the inner wall of the blood vessel without a noticeable tip when fully inflated, thereby reducing the risk of intraoperative thrombus residue or escape and further improving the safety of the procedure.

[0006] To achieve the above objectives, this utility model provides a headless compliant balloon catheter device, which includes a catheter, a contrast marker, a sealing tube, a transition tube, a base, and a compliant balloon.

[0007] The imaging marker is set at the tip of the catheter to indicate the position of the catheter tip;

[0008] The two ends of the sealing tube are respectively connected to the proximal end of the conduit and the distal end of the transition tube.

[0009] The base is fixed and connected to the proximal end of the transition tube, thereby fixing the conduit, sealing tube, and transition tube.

[0010] The compliant balloon is positioned on the distal outer surface of the catheter; when the compliant balloon is not inflated, it adheres to the distal outer surface of the catheter, with the distal end of the catheter located at the distal end of the compliant balloon; when the compliant balloon is fully inflated, it expands to enclose the distal end of the catheter, causing the distal end of the catheter to be recessed into the distal end of the compliant balloon.

[0011] Preferably, the base is Y-shaped and has a first interface and a second interface; wherein, the first interface communicates with the inflation cavity of the compliant balloon; and the second interface communicates with the cavity of the catheter.

[0012] More preferably, liquid is injected into the compliant balloon through the first interface, causing the volume of the compliant balloon to expand synchronously; when the liquid inside the compliant balloon is aspirated, the volume of the compliant balloon shrinks synchronously until it returns to its initial state.

[0013] Preferably, a microcatheter or guidewire is delivered into the catheter through a second interface.

[0014] Preferably, the length of the compliant balloon in its initial state is 5-40 mm; and the length of the tip of the catheter is 0.3-2 mm.

[0015] Preferably, the compliant balloon has a diameter of 3-15 mm and a length of 5-40 mm when fully inflated.

[0016] Preferably, the catheter body diameter ranges from 0.038 to 0.098 inches, and the catheter length ranges from 80 to 150 cm.

[0017] Preferably, the length of the developing mark is 0.5-2 mm.

[0018] Preferably, the filling medium within the compliant balloon is a mixture of contrast agent and sterile saline.

[0019] Preferably, when the compliant balloon is fully inflated, the compliant balloon is spherical, apple-shaped, ellipsoidal, or cylindrical.

[0020] This utility model provides a tipless compliant balloon catheter device. By utilizing the highly elastic properties of the compliant balloon material, the balloon, when fully inflated, precisely concaves or wraps around the distal end of the catheter, preventing the distal end of the balloon from creating a dead zone that could accommodate thrombi or emboli. When the fluid inside the balloon is aspirated again, the balloon can return to its initial state. Attached Figure Description

[0021] Figure 1 A schematic diagram of the structure of a headless compliant balloon catheter device in its initial state, provided for an embodiment of this utility model;

[0022] Figure 2 A schematic diagram of the structure of a headless compliant balloon catheter device in a fully inflated state, provided for an embodiment of this utility model;

[0023] In the diagram: 1. Catheter; 11. Tip; 2. Imaging marker; 3. Sealing tube; 4. Transition tube; 5. Base; 51. First interface; 52. Second interface; 6. Compliant balloon. Detailed Implementation

[0024] The technical solution of this utility model will be further described in detail below with reference to the accompanying drawings and embodiments.

[0025] Figure 1 This is a schematic diagram of the structure of a tipless compliant balloon catheter device in its initial state, as provided in an embodiment of the present invention. Figure 2 A schematic diagram of a tipless compliant balloon catheter device in a fully inflated state, provided as an embodiment of this utility model, is shown below. Figure 1 and Figure 2 As shown, the headless compliant balloon 6 catheter 1 device provided in this embodiment of the present invention includes a catheter 1, a radiopaque marker 2, a sealing tube 3, a transition tube 4, a base 5, and a compliant balloon 6. Its structure will be described in detail below. It should be noted that the distal and proximal ends of each component are defined according to their distance from the operator; the end furthest from the operator is the "distal end," and vice versa.

[0026] Catheter 1 is the main structure of the device and serves as the core channel for delivering microcatheters, guidewires, or other interventional devices within blood vessels. Preferably, the diameter of catheter 1 is in the range of 0.038-0.098 inches, and the length of catheter 1 is in the range of 80-150 cm.

[0027] The imaging marker 2 is set at the tip 11 of the catheter 1, where the tip 11 refers to the distal beginning of the catheter 1, and is used to show the position of the tip 11 of the catheter 1 in the blood vessel. The material of the imaging marker 2 is preferably platinum alloy or precious metals such as tungsten or tantalum, and the length is preferably 0.5-2mm.

[0028] The sealing tube 3 is connected at both ends to the proximal end of the conduit 1 and the distal end of the transition tube 4, respectively, to connect the conduit 1 and the base 5, so as to ensure good sealing between the base 5 and the tube body.

[0029] The transition tube 4, located between the sealing tube 3 and the base 5, has a mechanical buffering effect and can prevent the proximal end of the catheter 1 from bending or being damaged during clinical use.

[0030] The base 5 is fixed and connected to the proximal end of the transition tube 4, and fixes the conduit 1, sealing tube 3 and transition tube 4 to ensure the overall structural stability.

[0031] The compliant balloon 6 is used during mechanical thrombectomy interventional treatment. By expanding the balloon, it adheres to the inner wall of the blood vessel to temporarily block blood flow and protect the distal end of the vessel. Simultaneously, by contracting the balloon, the catheter 1 is withdrawn to restore blood flow. Specifically, the compliant balloon 6 is placed on the distal outer surface of the catheter 1. The distal sidewall of the catheter 1 has micropores through which filling fluid is injected into the compliant balloon 6. In the uninflated state (initial state), the compliant balloon 6 adheres to the distal outer surface of the catheter 1, and there is no significant increase in the outer diameter of the balloon. At this time, the tip 11 of the catheter 1 is located distal to the compliant balloon 6. When a liquid filling agent is injected into the balloon, the compliant balloon 6 responds immediately and expands rapidly. The final size of the balloon is positively correlated with the volume of the filling liquid. When the compliant balloon 6 is fully inflated, it is in an expanded state, wrapping around the tip 11 of the catheter 1, forming a wrap around the tip 11 of the catheter 1, so that the tip 11 of the catheter 1 is concave in the distal end of the compliant balloon 6. Preferably, when the compliant balloon 6 is fully inflated, the compliant balloon 6 can be spherical, apple-shaped, ellipsoidal, or cylindrical.

[0032] Understandably, to achieve intraballoon fluid injection, catheter 1 has a dual-lumen design: a balloon inflation lumen and a catheter body lumen. The balloon inflation lumen surrounds the outer side of the catheter body lumen, forming a thin-walled annular channel that extends only to the balloon-covered section (distal end of the catheter), used for inflating and aspirating fluid to control the balloon. The catheter body lumen is located on the central axis of the catheter and runs the entire length of the catheter. Correspondingly, the base 5 is preferably Y-shaped and made of polymer materials such as PC or PA. The base 5 has a first interface 51 and a second interface 52, which are inlets. The first interface 51 communicates with the inflation lumen of the compliant balloon 6; the second interface 52 communicates with the lumen of catheter 1. Specifically, the inflation fluid enters the lumen of catheter 1 through the first interface 51 and enters the compliant balloon 6 through micropores on the distal sidewall of catheter 1, causing the compliant balloon 6 to expand synchronously. When the fluid in the compliant balloon 6 is aspirated, the volume of the compliant balloon 6 shrinks synchronously until it returns to its initial state. Microcatheter 1 or guidewire is delivered into catheter 1 through the second interface 52.

[0033] In some embodiments, the compliant balloon 6 may be made of elastomeric polymer materials such as TPU or silicone. During simulated or clinical use, the compliant balloon 6 is inflated through the balloon inflation cavity built into the catheter 1. The inflation medium is a mixture of clinically commonly used contrast agent and sterile saline (the mixing ratio is usually 1:1). During the procedure, the balloon portion is guaranteed to have good imaging performance throughout the entire body under contrast conditions.

[0034] It should be noted that those skilled in the art can set the size of the balloon as needed. In this embodiment, the length of the compliant balloon 6 in the initial state is L, ranging from 5 to 40 mm; the length of the tip 11 of the catheter 1 is 0.3 to 2 mm. Furthermore, the diameter of the compliant balloon 6 in the fully inflated state is 3 to 15 mm, and the length is 5 to 40 mm.

[0035] Based on the understanding of the structure of the headless 11 compliant balloon 6 catheter 1 device provided in this embodiment, its application process is described below.

[0036] The headless compliant balloon 6 catheter 1 device (inner diameter 0.088 inches) is inserted into the simulated blood vessel. The compliant balloon 6 is positioned above the aortic arch at the common carotid artery, where the inner diameter of the vessel is approximately 8 mm. After the balloon catheter 1 device reaches the predetermined position, a mixture of contrast agent and normal saline (1:1) is injected into the balloon inflation channel through a syringe (the syringe is connected to the first interface 51). To make the observation clearer, a red staining agent is added to the contrast agent solution.

[0037] As the contrast agent continues to fill, the volume of the compliant balloon 6 gradually increases. At this point, the balloon is not completely attached to the inner wall of the blood vessel, and part of the distal tip 11 of the compliant balloon 6 still protrudes. When the compliant balloon 6 is fully inflated, it completely attaches to the inner wall of the blood vessel. At this point, the compliant balloon 6 completely wraps around the tip 11 of the catheter 1, presenting an overall state without the tip 11 (the distal end of the balloon appears concave). At this time, the compliant balloon 6 is approximately cylindrical, and the blood flow at the distal end of the compliant balloon 6 is temporarily blocked.

[0038] In acute thrombectomy, negative pressure aspiration is used simultaneously. Although the traditional guiding catheter 1 temporarily blocks blood flow, there is a high possibility that residual thrombi or emboli will form in the cavity between the tip 11 of the catheter 1 and the blood vessel wall. When the balloon retracts, the residual thrombi or emboli will further escape to the distal end of the blood vessel along the blood flow, causing serious adverse clinical events. This patented technology can successfully solve the above problems.

[0039] This utility model provides a tipless compliant balloon catheter device. By utilizing the highly elastic properties of the compliant balloon material, the balloon, when fully inflated, precisely concaves or wraps around the distal end of the catheter, preventing the distal end of the balloon from creating a dead zone that could accommodate thrombi or emboli. When the fluid inside the balloon is aspirated again, the balloon can return to its initial state.

[0040] In this utility model, the term "multiple" refers to two or more unless otherwise explicitly defined. The terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; "linking" can be a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0041] In the description of this utility model, it should be understood that the terms "upper", "lower", "left", "right", "front", "rear", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or unit referred to must have a specific orientation or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0042] In the description herein, the terms "a specific embodiment," "some embodiments," "one embodiment," etc., refer to a specific feature, structure, material, or characteristic described in connection with that embodiment or example, which is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0043] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of this utility model. It should be understood that the above description is only a specific embodiment of this utility model and is not intended to limit the scope of protection of this utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the scope of protection of this utility model.

Claims

1. A tipless compliant balloon catheter device, characterized in that, The headless compliant balloon catheter device includes a catheter, a radiopaque marker, a sealing tube, a transition tube, a base, and a compliant balloon; The imaging marker is set at the tip of the catheter to indicate the position of the catheter tip; The two ends of the sealing tube are respectively connected to the proximal end of the conduit and the distal end of the transition tube. The base is fixed and connected to the proximal end of the transition tube, thereby fixing the conduit, sealing tube, and transition tube. The compliant balloon is positioned on the distal outer surface of the catheter; when the compliant balloon is not inflated, it adheres to the distal outer surface of the catheter, with the distal end of the catheter located at the distal end of the compliant balloon; when the compliant balloon is fully inflated, it expands to enclose the distal end of the catheter, causing the distal end of the catheter to be recessed into the distal end of the compliant balloon.

2. The tipless compliant balloon catheter device according to claim 1, characterized in that, The base is Y-shaped and has a first interface and a second interface; wherein, the first interface communicates with the inflation cavity of the compliant balloon; and the second interface communicates with the cavity of the catheter.

3. The tipless compliant balloon catheter device according to claim 2, characterized in that, Liquid is injected into the compliant balloon through the first interface, causing the volume of the compliant balloon to expand synchronously; when the liquid inside the compliant balloon is aspirated, the volume of the compliant balloon shrinks synchronously until it returns to its initial state.

4. The tipless compliant balloon catheter device according to claim 1, characterized in that, Microcatheters or guidewires are delivered into the catheter through the second interface.

5. The tipless compliant balloon catheter device according to claim 1, characterized in that, The compliant balloon has a length of 5-40 mm in its initial state; the tip length of the catheter is 0.3-2 mm.

6. The tipless compliant balloon catheter device according to claim 1, characterized in that, The compliant balloon has a diameter of 3-15 mm and a length of 5-40 mm when fully inflated.

7. The tipless compliant balloon catheter device according to claim 1, characterized in that, The catheter body diameter ranges from 0.038 to 0.098 inches, and the catheter length ranges from 80 to 150 cm.

8. The tipless compliant balloon catheter device according to claim 1, characterized in that, The length of the developing mark is 0.5-2 mm.

9. The tipless compliant balloon catheter device according to claim 1, characterized in that, The compliant balloon is filled with a mixture of contrast agent and sterile saline.

10. The tipless compliant balloon catheter device according to claim 1, characterized in that, When the compliant balloon is fully inflated, the compliant balloon is spherical, apple-shaped, ellipsoidal, or cylindrical.

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