An ultrasonic thrombolytic catheter and an ultrasound module

Abstract

The utility model relates to a thrombolytic device technical field, especially disclose an ultrasonic thrombolytic catheter and ultrasonic module. The ultrasonic thrombolytic catheter, including single -cavity microcatheter, its characterized in that: the tube wall of single -cavity microcatheter includes outer sleeve and PTFE inner layer, and the waveguide is arranged in the cavity of single -cavity microcatheter, single -cavity microcatheter distal end's outer sleeve wall is provided with a section independent microchannel side by side, and the guide wire is threaded in the microchannel, and a plurality of developing rings are arranged on the guide wire, the ultrasonic module of application this ultrasonic thrombolytic catheter, the single -cavity microcatheter proximal end of ultrasonic thrombolytic catheter is connected with the swivel joint, and the proximal end of waveguide extends out of single -cavity microcatheter and passes through the swivel joint and connects the transducer. The utility model is simple to operate, and the treatment efficiency is high, and the required theoretical treatment time is short, reduces the potential treatment risk, and is helpful to reducing the labor intensity of doctor.

Description

Technical Field

[0001] This utility model relates to the field of thrombolytic device technology, and in particular to an ultrasonic thrombolytic catheter and ultrasonic module. Background Technology

[0002] Interventional catheterization and thrombolysis techniques are important minimally invasive methods in modern medicine for treating vascular diseases such as arterial and venous thrombosis, acute myocardial infarction, ischemic stroke, and pulmonary embolism. Modern catheter technology, combined with image guidance and materials science, enables minimally invasive and precise endovascular procedures. By inserting a catheter into the target vessel, diagnostic (e.g., angiography) or therapeutic (e.g., balloon angioplasty, stent implantation, thrombus removal) can be performed. This technique reduces trauma, shortens recovery time, and lowers the risk of complications.

[0003] Thrombolytic catheter technology, influenced by the development of endovascular interventional therapy, has gradually shifted from systemic thrombolysis (systemic drug administration) to precise local thrombolysis. Its core lies in delivering thrombolytic drugs directly to the thrombus site via catheter, or combining this with mechanical methods to rapidly remove the thrombus, significantly improving efficacy and reducing side effects. Technical requirements include: precise targeting to reduce the risk of systemic drug exposure and bleeding; rapid recanalization, as acute vascular occlusion (such as stroke and myocardial infarction) requires restoring blood flow within a "time window"; handling complex thrombi, addressing old, calcified, or high-burden thrombi in conjunction with mechanical intervention; and ensuring minimally invasiveness and safety, avoiding vascular damage and adapting to tortuous anatomical pathways.

[0004] Thrombolysis involves the local injection of fibrinolytic drugs via intravenous or catheter-directed administration. This activates plasminogen to convert into plasmin, thereby degrading fibrin in the thrombus, achieving the goal of dissolving the thrombus and restoring blood flow.

[0005] A rotary thrombolytic catheter is an interventional device that removes thrombi or atherosclerotic plaques from blood vessels through mechanical cutting or grinding. It is particularly suitable for the treatment of calcified, organized, or old thrombi / plaques. Its core principle is to physically break down thrombi or plaques using a high-speed rotating blade or rotary cutting head, and then remove the debris from the body using a suction or collection device.

[0006] Combining mechanical thrombus disruption with pharmacological thrombolysis can improve recanalization speed. Existing representative technologies include hydrodynamic thrombus removal systems, suitable for deep vein thrombosis and pulmonary embolism. These systems generate negative pressure through high-speed saline jets while simultaneously infusing thrombolytic drugs locally, rapidly clearing heavy thrombi and reducing drug dosage.

[0007] Current thrombolytic drug therapy has a high risk of bleeding, a narrow time window, and poor effectiveness in clearing old thrombi. Existing aspiration and rotary cutting thrombolytic catheters result in large surgical bleeding, and the high mechanical shearing force can damage red blood cells, leading to a high risk of hemolysis. Existing aspiration thrombolytic catheters may directly damage the vessel wall due to high-speed saline jets and negative pressure aspiration, increasing the probability of thrombus recurrence. Existing rotary cutting thrombectomy catheters may accidentally cut the vessel wall with high-speed rotating blades, especially in small vessels or tortuous anatomical sites, causing the risk of perforation and dissection. Existing aspiration and rotary cutting thrombolytic catheters have limited range of action, requiring precise control of the contact angle between the catheter and the thrombus, as well as the aspiration time and cutting speed. Improper operation can easily lead to vascular damage. Summary of the Invention

[0008] To overcome the shortcomings of the prior art, this utility model provides an ultrasonic thrombolysis catheter and ultrasonic module that are easy to operate, have high treatment efficiency, and reduce workload.

[0009] This utility model is achieved through the following technical solution: An ultrasonic thrombolytic catheter includes a single-lumen microcatheter, characterized in that: the wall of the single-lumen microcatheter includes an outer sheath and a PTFE inner layer, and a waveguide is inserted into the lumen of the single-lumen microcatheter; an independent microchannel is arranged side by side in the wall of the outer sheath at the distal end of the single-lumen microcatheter, a guide wire runs through the microchannel, and several imaging rings are arranged on the guide wire.

[0010] The thrombolytic catheter of this invention has a single-lumen microcatheter structure. The distal end of the single-lumen microcatheter is provided with guidewire guide sections arranged side by side to form a distal double-lumen structure. The original single-lumen body has an operating window, which is formed by removing part of the material of the single-lumen microcatheter and can expose the waveguide inside. Several imaging rings are set on the guidewire guide section as needed for real-time monitoring.

[0011] The preferred technical solution of this utility model is as follows: The single-lumen microcatheter has a window on its side wall that exposes the internal cavity.

[0012] More preferably, the single-lumen microcatheter has a metal wire reinforcing intermediate layer located between the outer sheath and the inner PTFE layer, with the functional window as the boundary, to improve the connection strength of the single-lumen microcatheter.

[0013] More preferably, the microchannel through which the guide wire passes extends from the distal end of the single-lumen microcatheter to the relative position of the metal wire-reinforced intermediate layer.

[0014] The waveguide extends through a single-cavity microcatheter. A thickened structure is provided at the tip of the distal end of the waveguide to limit the movement of the waveguide and enhance its oscillation effect. A single-cavity microcatheter extends from the proximal end of the waveguide to facilitate the connection of an external transducer.

[0015] More preferably, the waveguide is made of titanium alloy or nickel-titanium alloy by grinding and is used for sound wave transmission.

[0016] The developing ring is a platinum-iridium alloy developing ring. There are three developing rings respectively set at the end of the guide wire and at both ends of the working window, which are used for developing mark positioning. The specific number is set as needed.

[0017] The ultrasonic module of the ultrasonic thrombolysis catheter described above is used, wherein the proximal end of the single-lumen microcatheter of the ultrasonic thrombolysis catheter is connected to a rotary joint, and the proximal end of the waveguide extends out of the single-lumen microcatheter and passes through the rotary joint to connect to the transducer.

[0018] The transducer outputs ultrasound waves of a specific frequency, which are transmitted along the waveguide. They cannot penetrate the microcatheter and only release ultrasound energy in the treatment window area, forming a cylindrical treatment area along the axis.

[0019] This invention utilizes the cavitation effect and mechanical oscillation of ultrasound to dissolve thrombi, achieving good results in clearing old thrombi. Drug-assisted thrombolysis can be used. The mechanical oscillation in the microcatheter's action area does not exert high mechanical shear force on the blood vessel wall, valves, or blood cells, reducing damage to normal tissues and the risk of hemolysis after treatment. The microcatheter applies specific frequency ultrasound energy to the action area, precisely breaking up thrombi and reducing damage to surrounding tissues and blood cells, thus lowering the risk of perforation and dissection after treatment.

[0020] This invention releases ultrasonic energy radially outward in 360° along the waveguide in the working window area, forming a cylindrical treatment area in the working area. Combined with a rotatable catheter, it can treat the target area in all directions without dead angles.

[0021] This invention is simple to operate, has high treatment efficiency, requires a short theoretical treatment time, reduces potential treatment risks, and helps reduce the workload of doctors. Attached Figure Description

[0022] The present invention will be further described below with reference to the accompanying drawings.

[0023] Figure 1 This is a schematic diagram of the structure of this utility model; Figure 2 for Figure 1 The diagram shows a cross-sectional view of plane AA. Figure 3 for Figure 1 The diagram shows a cross-sectional view of plane BB.

[0024] In the figure, 1 is the outer tube, 2 is the PTFE inner layer, 3 is the waveguide, 4 is the metal wire reinforced intermediate layer, 5 is the microchannel, 6 is the imaging ring, 7 is the infusion liquid, 8 is the working window, 9 is the rotary joint, and 10 is the transducer. Detailed Implementation

[0025] To make the above-mentioned objects, features, and advantages of this utility model more apparent and understandable, the specific embodiments of this utility model will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a full understanding of this utility model. However, this utility model can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this utility model. Therefore, this utility model is not limited to the specific embodiments disclosed below.

[0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0027] The present invention will now be described in detail with reference to the accompanying drawings.

[0028] Example 1: An ultrasonic thrombolysis catheter This embodiment includes a single-lumen microcatheter. The wall of the single-lumen microcatheter includes an outer sheath 1 and a PTFE inner layer 2. An effective window 8 for exposing the internal cavity is opened on the side wall of the single-lumen microcatheter body. A waveguide 3 is inserted through the cavity of the single-lumen microcatheter. An independent microchannel 5 is arranged side by side in the wall of the outer sheath 1 at the distal end of the single-lumen microcatheter. A guide wire runs through the microchannel 5, and several imaging rings 6 are arranged on the guide wire.

[0029] Waveguide 3 extends through a single-cavity microcatheter. A thickened structure is provided on the tip of the distal end of waveguide 3 to restrict the movement of the waveguide and enhance the oscillation effect. The proximal end of waveguide 3 extends out of the single-cavity microcatheter for external power components. Waveguide 3 is made of titanium alloy or nickel-titanium alloy by grinding to realize the transmission of the action signal, so as to facilitate thrombolysis operation.

[0030] The single-lumen microcatheter is bounded by the working window 8. A metal wire-reinforced intermediate layer 4 is located between the outer sheath 1 and the PTFE inner layer 2 within the single-lumen microcatheter near the working window 8. A microchannel 5 with a guide wire extends from the distal end of the single-lumen microcatheter to the relative position of the metal wire-reinforced intermediate layer 4.

[0031] The imaging ring 6 is a platinum-iridium alloy imaging ring. There are three imaging rings 6 distributed on the guide wire to mark and locate the imaging. The specific number can be set as needed. In this embodiment, one imaging ring 6 is set at the end of the guide wire, and one imaging ring is set at each end of the corresponding working window 8 to determine the position of the distal end of the microcatheter and the working window 8 in the blood vessel.

[0032] In this embodiment, the ultrasonic thrombolysis catheter penetrates the thrombus under the traction of the guide wire 5. The imaging ring 6 on the guide wire 5 is used to detect and locate the thrombus. Its working window 8 forms the microcatheter working area. The mechanical oscillation of the waveguide 3 will not exert high mechanical shear force on the blood vessel wall, valves and other tissues and blood cells, reducing damage to normal tissues and the risk of hemolysis after treatment.

[0033] Example 2: An ultrasonic module This embodiment uses the ultrasonic thrombolysis catheter described in Embodiment 1 to form an ultrasonic module, wherein the proximal end of the single-lumen microcatheter of the ultrasonic thrombolysis catheter is connected to the rotary joint 9, and the proximal end of the waveguide 3 extends out of the single-lumen microcatheter and passes through the rotary joint 9 to connect to the transducer 10.

[0034] The ultrasound module in this embodiment utilizes the cavitation effect and mechanical oscillation of ultrasound to dissolve thrombi, which is effective in clearing old thrombi and can be assisted by drugs. The transducer 10 generates ultrasound waves of a specific frequency, which are transmitted along the waveguide 3 and cannot penetrate the microcatheter. The microcatheter is positioned at the thrombus location under the action of the guide wire and releases ultrasound energy outward only through the action window 8, forming a cylindrical treatment area along the axis, which precisely breaks up the thrombus, reduces the damage to surrounding tissues and blood cells, and reduces the risk of perforation and dissection after treatment.

[0035] In addition, the cavity of the waveguide 3 placed in the microcatheter can be used for the flow of infusion fluid 7, which is achieved through an external supply channel to supply appropriate therapeutic drugs according to the patient's condition, in conjunction with physical thrombolysis. Under the monitoring of the imaging ring 6, the rotary joint 9 provides rotational power to the microcatheter, driving the action window 8 to rotate, achieving comprehensive and thorough treatment of the target area.

[0036] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and not to limit it. Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model, and they should all be covered within the scope of the claims and specification of this utility model.

Claims

1. An ultrasonic thrombolysis catheter, comprising a single-lumen microcatheter, characterized in that: The wall of the single-lumen microcatheter includes an outer tube (1) and a PTFE inner layer (2). A waveguide (3) is inserted into the cavity of the single-lumen microcatheter. An independent microchannel (5) is arranged side by side in the wall of the outer tube (1) at the distal end of the single-lumen microcatheter. A guide wire runs through the microchannel (5), and several imaging rings (6) are arranged on the guide wire.

2. The ultrasonic thrombolysis catheter as described in claim 1, characterized in that: The single-lumen microcatheter has an opening (8) on its side wall to expose the internal cavity.

3. The ultrasonic thrombolysis catheter as described in claim 2, characterized in that: The single-lumen microcatheter is bounded by the working window (8), and a metal wire reinforced intermediate layer (4) is provided in the single-lumen microcatheter near the working window (8) between the outer tube (1) and the PTFE inner layer (2).

4. The ultrasonic thrombolysis catheter as described in claim 1, characterized in that: The waveguide (3) extends through the single-cavity microcatheter, and a thickened structure is provided on the tip of the distal end of the waveguide (3). The single-cavity microcatheter extends from the proximal end of the waveguide (3).

5. The ultrasonic thrombolysis catheter as described in claim 1 or 4, characterized in that: The waveguide (3) is made of titanium alloy or nickel-titanium alloy by grinding.

6. The ultrasonic thrombolysis catheter as described in claim 3, characterized in that: The microchannel (5) through which the guide wire passes extends from the distal end of the single-lumen microcatheter to the relative position of the wire-reinforced intermediate layer (4).

7. The ultrasonic thrombolysis catheter as described in claim 1, characterized in that: The developing ring (6) is a platinum-iridium alloy developing ring, and there are three developing rings (6) respectively set at the end of the guide wire and at both ends of the working window (8).

8. The ultrasonic module of the ultrasonic thrombolysis catheter according to claim 1, characterized in that: The single-lumen microcatheter of the ultrasonic thrombolytic catheter is connected to a rotary joint (9) at its proximal end, and the waveguide (3) extends from the single-lumen microcatheter through the rotary joint (9) and is connected to the transducer (10).

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