An ultrasonic microbubble thrombus fragmentation catheter

Abstract

This utility model discloses an ultrasonic microbubble thrombolysis catheter in the field of medical catheterization technology, comprising a catheter body and a catheter seat body. The catheter body includes a tip and a connecting end, and the catheter body is provided with an aspiration channel, an ultrasonic channel, and a microbubble channel. The aspiration channel, ultrasonic channel, and microbubble channel extend to the tip and the connecting end, and the connecting end is fixedly connected to the catheter seat body. The catheter seat body has three catheter connectors that are respectively connected to the aspiration channel, ultrasonic channel, and microbubble channel. The tip has a thrombolysis end face, and the aspiration channel, ultrasonic channel, and microbubble channel all extend to the thrombolysis end face. The ultrasonic microbubble thrombolysis catheter of this utility model can realize multiple operation modes such as negative pressure aspiration, microbubble activation, ultrasonic vibration, Bernoulli pressure difference, and drug thrombolysis. It has good thrombolysis and thrombolysis effects, facilitates aspiration and thrombectomy, and minimizes damage to venous valves.

Description

Technical Field

[0001] This utility model relates to the field of medical catheter devices, and in particular to an ultrasonic microbubble fragmentation catheter. Background Technology

[0002] Deep vein thrombosis (DVT) is a serious and common venous vascular disease characterized by abnormal blood clotting within the deep veins, belonging to the category of lower extremity venous return disorders. Thrombosis mostly occurs during periods of immobilization (especially after major orthopedic surgery). The three main contributing factors are slow blood flow, venous wall damage, and a hypercoagulable state. After thrombosis, except for a few cases that resolve spontaneously or remain localized to the site of origin, most spread to the main deep veins of the entire limb. When blood clots within the veins, if treatment is not timely, the thrombus may detach and travel to the lungs, causing a pulmonary embolism (PE), which carries a potentially fatal risk.

[0003] Current clinical treatment methods include anticoagulation, thrombolysis, or mechanical thrombus removal. However, these methods have drawbacks such as bleeding risk, poor clearance effect, and damage to venous valve function, resulting in less than ideal treatment outcomes.

[0004] Ultrasonic microbubbles possess both direct thrombolytic effects and the ability to enhance thrombolytic efficacy with the aid of thrombolytic drugs. Their primary thrombolytic mechanisms are ultrasonic cavitation and mechanical effects. When acting directly on the thrombus, they can inhibit excessive exposure of surrounding tissues and organs. Cavitation refers to the vaporization of a liquid when the local pressure drops below its saturated vapor pressure, forming bubbles. These bubbles may subsequently collapse in high-pressure areas, generating significant local pressure shocks and strong flow instability effects. The purpose of this application is to provide a catheter specifically designed for ultrasonic microwave thrombectomy. Utility Model Content

[0005] The purpose of this invention is to provide an ultrasonic microbubble embolization catheter to solve one or more technical problems existing in the prior art, and at least provide a beneficial option or create conditions.

[0006] The technical solution adopted to solve the above-mentioned technical problems is as follows: An ultrasonic microbubble thrombectomy catheter includes: a catheter body and a catheter seat body; The catheter body has a central axis and is a long strip extending along the central axis. The catheter body includes a head end and a connecting end, which are respectively located at the two ends of the axial direction of the catheter body. The catheter body is provided with an aspiration channel, an ultrasonic channel, and a microbubble channel. The aspiration channel, ultrasonic channel, and microbubble channel all extend along the central axis and pass through the head end and the connecting end. The connecting end is fixedly connected to the catheter seat body. The catheter seat body is provided with three catheter connectors, which are respectively connected to the aspiration channel, ultrasonic channel, and microbubble channel. The head end has a fragmented end face, and the aspiration channel, ultrasonic channel, and microbubble channel all extend to the fragmented end face.

[0007] The ultrasonic microbubble thrombolysis catheter provided by this invention has at least the following beneficial effects: The aspiration channel is connected to negative pressure via the catheter connector of the catheter seat body for thrombus aspiration. The microbubble channel is connected to a microbubble generator via a corresponding catheter connector, enabling microbubble infusion into the tip. The ultrasonic channel can accommodate ultrasonic guidewires or other ultrasonic generators to achieve ultrasonic conduction, allowing ultrasound waves to act on one side of the tip. Under the influence of ultrasound, the microbubbles vibrate and rupture, generating high shear force and small shock waves around the thrombus, making the thrombus looser and easier to dissolve or aspirate. Depending on clinical needs, the microbubble channel can also be used for thrombolytic drug infusion. Simultaneous microbubble infusion and negative pressure aspiration creates a pressure differential, providing additional shear force through Bernoulli's principle to assist in thrombolysis, allowing more fragmented thrombus particles to be extracted from the body. The ultrasonic microbubble thrombolysis catheter provided by this invention can realize multiple operation modes such as negative pressure aspiration, microbubble activation, ultrasonic vibration, Bernoulli pressure difference, and drug thrombolysis. It has good thrombolysis effect, facilitates aspiration and thrombus removal, and causes little damage to venous valves.

[0008] As a further improvement to the above technical solution, the ultrasonic microbubble embolization catheter also includes a stress relief tube, which is sealed and sleeved on the outside of the connecting end and connected to the catheter seat body.

[0009] As a further improvement to the above technical solution, the broken bolt end face is planar, the broken bolt end face is perpendicular to the central axis, or the broken bolt end face is inclined to the central axis.

[0010] As a further improvement to the above technical solution, the catheter body is provided with at least one bent portion near the head end, and the central axis of the bent portion extends in a bent manner.

[0011] As a further improvement to the above technical solution, the inner diameters of the ultrasonic channel and the microbubble channel are both smaller than the inner diameter of the suction channel. The suction channel is located in the middle of the catheter body, and the ultrasonic channel and the microbubble channel are located on one or both sides of the radial side of the suction channel.

[0012] As a further improvement to the above technical solution, the tube wall of the catheter body surrounds the suction channel. The tube wall includes, from the inside to the outside, an inner liner, an inner layer, an inner tube layer, and an outer tube layer. The inner liner forms the channel wall of the suction channel. The inner layer is used to maintain the strength performance of the catheter body. Both the ultrasonic channel and the microbubble channel are located between the inner tube layer and the outer tube layer.

[0013] As a further improvement to the above technical solution, the inner layer includes a spring-wound layer, which is formed by winding spring wire. The winding pitch of the spring wire is increased along the central axis from the connecting end to the head end, so that the strength of the catheter body on the side near the connecting end is higher than the strength on the side near the head end.

[0014] As a further improvement to the above technical solution, the inner layer also includes a braided layer, which is disposed on the outside of the wound spring layer. The braided layer is made of braided yarn, and the density setting method of the braided yarn is consistent with the winding pitch setting method of the spring yarn.

[0015] As a further improvement to the above technical solution, the outer tube layer is made of a developing material, the inner layer is provided with a developing ring made of a developing material, the developing material extends circumferentially around the tube body, and the developing ring is located near the head end.

[0016] As a further improvement to the above technical solution, the outer side of the catheter body is provided with a hydrophilic coating, which at least covers the outer side of the head end. Attached Figure Description

[0017] The present invention will be further described below with reference to the accompanying drawings and embodiments; Figure 1 This is a side view of an embodiment of the ultrasonic microbubble thrombectomy catheter provided by this utility model; Figure 2 This is a schematic diagram of the ultrasonic microbubble thrombectomy catheter provided by this utility model during its use. Figure 3 This is a schematic diagram of the bent portion of an embodiment of the ultrasonic microbubble thrombus fragmentation catheter provided by this utility model; Figure 4 This is a schematic diagram of the fragmentation end face structure of an embodiment of the ultrasonic microbubble fragmentation catheter provided by this utility model; Figure 5 This is a cross-sectional schematic diagram of an embodiment of the ultrasonic microbubble thrombectomy catheter provided by this utility model; Figure 6 This is a side sectional view of an embodiment of the head end provided by this utility model.

[0018] In the diagram: 100-Catheter body, 110-Head end, 111-Fragmented thrombus end face, 112-Iconic ring, 120-Connecting end, 130-Tube wall, 131-Inner liner, 132-Inner layer, 1321-Spring-wound layer, 1322-Braided layer, 133-Inner tube layer, 134-Outer tube layer, 140-Bending part, 150-Aspiration channel, 160-Ultrasound channel, 170-Microbubble channel, 200-Catheter seat body, 210-Catheter connector, 220-Stress relief tube. Detailed Implementation

[0019] This section will describe in detail the specific embodiments of the present utility model. The preferred embodiments of the present utility model are shown in the accompanying drawings. The purpose of the drawings is to supplement the textual description with graphics, so that people can intuitively and vividly understand each technical feature and the overall technical solution of the present utility model, but they should not be construed as limiting the scope of protection of the present utility model.

[0020] In the description of this utility model, it should be understood that the directional descriptions, such as up, down, front, back, left, right, etc., indicate the directional or positional relationship based on the directional 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 element 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.

[0021] In the description of this utility model, if there are words such as "several", they mean one or more, "multiple" means two or more, "greater than", "less than", "exceeding" etc. are understood to exclude the number itself, and "above", "below", "within" etc. are understood to include the number itself.

[0022] In the description of this utility model, unless otherwise explicitly defined, terms such as "setting," "installation," and "connection" should be interpreted broadly, and those skilled in the art can reasonably determine the specific meaning of the above terms in this utility model in conjunction with the specific content of the technical solution.

[0023] Reference Figures 1 to 6 The ultrasonic microbubble thrombectomy catheter of this utility model is illustrated in the following embodiments: An ultrasonic microbubble thrombus fragmentation catheter includes: a catheter body 100 and a catheter seat body 200.

[0024] The catheter body 100 has a central axis and is elongated along the central axis. The catheter body 100 includes a head end 110 and a connecting end 120, which are respectively located at the two axial ends of the catheter body 100.

[0025] The catheter body 100 is provided with an aspiration channel 150, an ultrasonic channel 160, and a microbubble channel 170. The aspiration channel 150, ultrasonic channel 160, and microbubble channel 170 all extend along the central axis and penetrate the tip 110 and the connecting end 120. The connecting end 120 is fixedly connected to the catheter seat body 200. The catheter seat body 200 has three catheter connectors 210, which are respectively connected to the aspiration channel 150, ultrasonic channel 160, and microbubble channel 170. The tip 110 has a fragmented end face 111, and the aspiration channel 150, ultrasonic channel 160, and microbubble channel 170 all extend to the fragmented end face 111.

[0026] In practical use, the aspiration channel 150 is connected to negative pressure via the catheter connector 210 of the catheter holder body 200 to aspirate the thrombus. The microbubble channel 170 is connected to a microbubble generator via a corresponding catheter connector 210, enabling the infusion of microbubbles into the tip 110. The ultrasound channel 160 can accommodate ultrasound generators such as ultrasound guide wires to achieve ultrasound conduction, allowing ultrasound waves to act on one side of the tip 110. Under the influence of ultrasound waves, the microbubbles vibrate and rupture, generating high shear forces and tiny shock waves around the thrombus, making the thrombus looser and easier to dissolve or aspirate. Depending on clinical needs, the microbubble channel 170 can also be used for the infusion of thrombolytic drugs. The simultaneous infusion of microbubbles and negative pressure aspiration creates a pressure differential, providing additional shear force through Bernoulli's principle to assist in thrombus fragmentation, allowing more fragmented thrombus particles to be removed from the body. The ultrasonic microbubble thrombolysis catheter provided by this invention can realize multiple operation modes such as negative pressure aspiration, microbubble activation, ultrasonic vibration, Bernoulli pressure difference, and drug thrombolysis. It has good thrombolysis effect, facilitates aspiration and thrombus removal, and causes little damage to venous valves.

[0027] In this embodiment, the ultrasonic microbubble embolization catheter further includes a stress relief tube 220, which is sealed and sleeved on the outside of the connecting end 120 and connected to the catheter seat body 200. By providing the stress relief tube 220, the catheter body 100 near the connecting end 120 can be wrapped and protected, facilitating the user's manipulation of the catheter during operation and preventing stress concentration and catheter breakage.

[0028] The broken bolt end face 111 in this embodiment is planar. (Refer to the attached diagram.) Figure 4 The head end 110 can adopt a flat or beveled structure. For example... Figure 4 As shown in (1), when the head end 110 adopts a flat structure, the end face 111 of the broken bolt is perpendicular to the central axis. Figure 4 (2) As shown, when the head end 110 adopts a beveled structure, the end face 111 of the broken bolt is inclined to the central axis.

[0029] The catheter body 100 can be of a straight tube type or a bent tube type. In a straight tube type, the central axis of the catheter body 100 extends in a straight line. In a bent tube type, the catheter body 100 has at least one bend 140 near the tip 110, and the central axis of the bend 140 extends in a bent direction. Figure 3 (1) and Figure 3 (2) As shown, the conduit body 100 is provided with a bending portion 140, which adopts a circular arc transition. The specific parameters such as the inclination angle and the radius of the circular arc transition of the bending portion 140 can be set as needed. Figure 3 (3) and Figure 3 As shown in (4), in some embodiments, the catheter body 100 is provided with two bending portions 140, and the two bending portions 140 may be in the same or opposite directions.

[0030] The inner diameters of the ultrasonic channel 160 and the microbubble channel 170 are both smaller than the inner diameter of the suction channel 150. The suction channel 150 is located in the middle of the catheter body 100, and the ultrasonic channel 160 and the microbubble channel 170 are located on one or both sides of the suction channel 150 in the radial direction.

[0031] Reference Figure 5 , Figure 5 (1) and Figure 5 (2) These are all cross-sectional schematic diagrams of the conduit body 100. For example... Figure 5 As shown in (2), in some embodiments, the ultrasonic channel 160 and the microbubble channel 170 may be disposed on the radial side of the suction channel 150. Figure 5 As shown in (1), in some other embodiments, the ultrasonic channel 160 and the microbubble channel 170 may be respectively disposed on the radial sides of the suction channel 150.

[0032] In this embodiment, the catheter body 100 includes a tube wall 130, which forms the suction channel 150. The tube wall 130 includes, from the inside to the outside, an inner liner 131, an inner layer 132, an inner tube layer 133, and an outer tube layer 134. The inner liner 131 forms the channel wall of the suction channel 150. The inner layer 132 is used to maintain the strength performance of the catheter body 100. The ultrasound channel 160 and the microbubble channel 170 are both located between the inner tube layer 133 and the outer tube layer 134.

[0033] The inner layer 132 in this embodiment includes a spring-wound layer 1321 and a braided layer 1322, wherein the braided layer 1322 is disposed on the outside of the spring-wound layer 1321.

[0034] The spring-wound layer 1321 is made of spring wire wound together. The winding pitch of the spring wire is increased along the central axis from the connecting end 120 to the head end 110, so that the strength of the catheter body 100 on the side closer to the connecting end 120 is higher than the strength on the side closer to the head end 110.

[0035] The braided layer 1322 is woven from braided yarns. The density setting method of the braided yarns is consistent with the winding pitch setting method of the spring yarns. That is, the braiding density of the braided layer 1322 is large on the side near the connecting end 120 and small on the side near the head end 110.

[0036] The structure of the catheter body is enhanced and its strength is improved by setting the spring-wound layer 1321 and the braided layer 1322. The spring-wound pitch and braiding density of the spring-wound layer 1321 and the braided layer 1322 are set to vary along the central axis, so that the catheter body 100 exhibits a strength variation from the connecting end 120 to the head end 110. This allows the catheter body 100 near the head end 110 to remain flexible and easy to bend, thus ensuring positioning performance; at the same time, it allows the catheter body 100 near the connecting end 120 to maintain strength, making it easier to handle and providing higher support performance.

[0037] Specifically, the spring wire can be made of stainless steel wire or other spirally extended metal wire with strong plasticity. The braided wire can be made of nickel-titanium alloy wire. The spring wire and braided wire can be divided into round wire, flat wire, or arranged in a mixed winding or braiding manner according to their cross-sectional shapes.

[0038] In some embodiments, the outer tube layer 134 is made of a radiopaque material so that the catheter body 100 can be guided along the guidewire to the target location of the blood vessel under DSA fluoroscopy.

[0039] In a further embodiment, the inner layer 132 is provided with a radiopaque ring 112, which extends circumferentially around the catheter body 100 and is located close to the tip 110. The radiopaque ring 112 is made of platinum-iridium alloy and can be developed under X-ray, thereby facilitating accurate determination of the specific location of the tip 110.

[0040] In a further embodiment, the outer side of the catheter body 100 is provided with a hydrophilic coating, which at least covers the outer side of the tip 110.

[0041] In the ultrasonic microbubble embolization catheter provided by this utility model, the effective length of the catheter body 100 is 50 to 170 cm, the coverage length of the hydrophilic coating is 50 to 100 cm from the tip 110, the inner diameter of the suction channel 150 is 1.0 to 2.5 mm, and the outer diameter of the catheter body 100 is 1.2 to 4.0 mm.

[0042] The inner liner 131 is made of PTFE, which creates a smooth and lubricated cavity wall, improving the transport of thrombi within the aspiration channel 150 and facilitating the passage of guidewires and other instruments. The outer tubing 134 can be made of polymer materials such as TPU, Pebax, PA, or PI, and contains barium sulfate material that can be visualized under X-ray. The inner tubing 133 is made of PTFE or PI. The catheter hub is made of PC material, and the catheter connector 210 is a standard Luer connector.

[0043] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example 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.

[0044] Although embodiments of the present invention have been shown and described, those skilled in the art can make various changes, modifications, substitutions and alterations to these embodiments without departing from the principles and spirit of the present invention. All such changes, modifications, equivalent alterations or substitutions are included within the scope defined by the claims of this application, and the scope of the present invention is defined by the claims and their equivalents.

Claims

1. An ultrasound microbubble embolization catheter, characterized by: include: The catheter body and catheter hub; The catheter body has a central axis and is a long strip extending along the central axis. The catheter body includes a head end and a connecting end, which are respectively located at the two ends of the axial direction of the catheter body. The catheter body is provided with an aspiration channel, an ultrasonic channel, and a microbubble channel. The aspiration channel, ultrasonic channel, and microbubble channel all extend along the central axis and pass through the head end and the connecting end. The connecting end is fixedly connected to the catheter seat body. The catheter seat body is provided with three catheter connectors, which are respectively connected to the aspiration channel, ultrasonic channel, and microbubble channel. The head end has a fragmented end face, and the aspiration channel, ultrasonic channel, and microbubble channel all extend to the fragmented end face.

2. The ultrasound microbubble embolization catheter of claim 1, wherein: The ultrasonic microbubble embolization catheter also includes a stress relief tube, which is sealed and sleeved on the outside of the connecting end and connected to the catheter seat body.

3. The ultrasonic microbubble thrombectomy catheter according to claim 1, characterized in that: The broken bolt end face is planar, perpendicular to the central axis, or inclined to the central axis.

4. The ultrasonic microbubble thrombectomy catheter according to claim 1, characterized in that: The catheter body has at least one bend near the head end, and the central axis of the bend extends in a bent manner.

5. The ultrasonic microbubble thrombectomy catheter according to claim 1, characterized in that: The inner diameters of the ultrasonic channel and the microbubble channel are both smaller than the inner diameter of the suction channel. The suction channel is located in the middle of the catheter body, and the ultrasonic channel and the microbubble channel are located on one or both sides of the suction channel in the radial direction.

6. The ultrasonic microbubble thrombectomy catheter according to claim 5, characterized in that: The tube wall of the catheter body forms the suction channel. The tube wall includes, from the inside to the outside, an inner liner, an inner layer, an inner tube layer, and an outer tube layer. The inner liner forms the channel wall of the suction channel. The inner layer is used to maintain the strength performance of the catheter body. Both the ultrasonic channel and the microbubble channel are located between the inner tube layer and the outer tube layer.

7. The ultrasonic microbubble thrombectomy catheter according to claim 6, characterized in that: The inner layer includes a spring-wound layer, which is made of spring wire wound together. The winding pitch of the spring wire is increased along the central axis from the connecting end to the head end, so that the strength of the catheter body on the side closer to the connecting end is higher than the strength on the side closer to the head end.

8. The ultrasonic microbubble thrombectomy catheter according to claim 7, characterized in that: The inner layer also includes a braided layer, which is located on the outside of the spring winding layer. The braided layer is made of braided yarn, and the density setting of the braided yarn is consistent with the winding pitch setting of the spring yarn.

9. The ultrasonic microbubble thrombectomy catheter according to claim 6, characterized in that: The outer tube layer is made of a developing material, and the inner layer is provided with a developing ring made of the developing material. The developing material extends circumferentially around the tube body, and the developing ring is located near the head end.

10. The ultrasonic microbubble thrombectomy catheter according to claim 1, characterized in that: The outer side of the catheter body is provided with a hydrophilic coating, which at least covers the outer side of the head end.

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