Ultrasound-assisted thrombolysis device

Abstract

An ultrasound-assisted thrombolysis device is provided. The ultrasound-assisted thrombolysis device 100 includes a catheter 110, a first ultrasonic module 120, a second ultrasonic module 130, and a control device 140. The first ultrasonic module 120 and the second ultrasonic module 130 are installed in the catheter 110 and electrically connected to the control device 140. The first ultrasonic module 120 is used to emit ultrasonic waves toward the thrombus to dissolve the thrombus, and the second ultrasonic module 130 is used to emit ultrasonic waves toward the thrombus and measure the distance between the catheter 110 and the thrombus. The control device 140 controls the first ultrasonic module 120 and the second ultrasonic module 130 based on the measured distance.

Description

[Technical field]

[0001] The present invention relates to a device for ultrasound assisted thrombolysis, and more particularly to an ultrasound assisted thrombolysis device capable of monitoring the lysis state of a thrombus in real time. [Background technology]

[0002] Methods for treating thrombus include systemic thrombolysis, mechanical thrombectomy, and ultrasound assisted thrombolysis. Summary of the Invention [Problem to be solved by the invention]

[0003] Acute patients have no choice but to undergo systemic thrombolysis by administering high doses of thrombolytic agents via intravenous injection, but this is prone to causing internal bleeding. Mechanical thrombectomy requires patients to be exposed to X-rays for a long time. Compared with systemic thrombolysis, ultrasound-assisted thrombolysis can reduce the dose of thrombolytic agents, but it carries the risk of bleeding. In addition, all of the above thrombolysis methods cannot monitor the lysis status of the thrombus in real time.

[0004] Therefore, the present inventors believed that the above-mentioned drawbacks could be improved, and as a result of extensive research, they came to propose the present invention, which effectively improves the above-mentioned problems through rational design.

[0005] The present invention has been made in view of the above circumstances, and an object of the present invention is to provide an ultrasound-assisted thrombolysis device, which dissolves a thrombus using a first ultrasound wave, measures the distance between the thrombus and a catheter in real time using a second ultrasound wave, and monitors the dissolution state of the thrombus. This reduces the dose of the thrombolytic agent and reduces the bleeding risk of the patient. [Means for solving the problem]

[0006] In order to solve the above problems, an ultrasound-assisted thrombolysis device according to one aspect of the present invention includes a catheter, a first ultrasonic module, a second ultrasonic module, and a control device. The catheter has a wall and an accommodation space, and the wall surrounds the accommodation space. The first ultrasonic module and the second ultrasonic module are installed in the accommodation space. The first ultrasonic module emits a first ultrasonic wave. The first ultrasonic wave is used to dissolve a thrombus outside the catheter. The second ultrasonic module emits a second ultrasonic wave. The second ultrasonic wave acts on the thrombus and is used to reflect a third ultrasonic wave. The frequency of the second ultrasonic wave is higher than the frequency of the first ultrasonic wave. The control device is electrically connected to the first ultrasonic module and the second ultrasonic module. The control device measures a distance between the catheter and the thrombus based on a time difference between the emission time of the second ultrasonic wave and the reception time of the third ultrasonic wave, and determines whether to continuously activate or stop the first ultrasonic module and the second ultrasonic module based on the distance between the catheter and the thrombus. [Brief description of the drawings]

[0007] [Figure 1] 1 is a schematic diagram showing an ultrasound-assisted thrombolysis device according to one embodiment of the present invention; [Diagram 2] 1 is a schematic diagram showing an ultrasound-assisted thrombolysis device according to one embodiment of the present invention; [Figure 3a] 1 is a longitudinal sectional view showing a catheter according to a first embodiment of the present invention. [Figure 3b] 1 is a cross-sectional view showing a catheter according to a first embodiment of the present invention. [Figure 4a] FIG. 4 is a longitudinal sectional view showing a catheter according to a second embodiment of the present invention. [Figure 4b] FIG. 4 is a cross-sectional view showing a catheter according to a second embodiment of the present invention. [Diagram 5]FIG. 11 is a longitudinal sectional view showing a catheter according to a third embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Hereinafter, the embodiments of the present invention will be described in detail. However, the present invention is not limited to these, and various modifications are possible within the scope of the description. The technical scope of the present invention also includes embodiments obtained by appropriately combining the technical means disclosed in the different embodiments.

[0009] First, an ultrasound-assisted thrombolysis device 100 according to the present invention will be described with reference to FIGS.

[0010] In the example of Fig. 1, the ultrasound-assisted thrombolysis device 100 according to the present invention is applied to ultrasound assisted thrombolysis (USAT) treatment, and is used to destroy fibrin (not shown) in a thrombus 200, help a thrombolytic agent to penetrate into the inside of the thrombus 200, and accelerate the dissolution rate of the thrombus. In addition, during the treatment process, the ultrasound-assisted thrombolysis device 100 monitors the dissolution state of the thrombus 200 in real time, thereby significantly reducing the dosage of the thrombolytic agent and preventing internal bleeding in the patient.

[0011] In the example of Fig. 2, the ultrasound-assisted thrombolysis device 100 includes a catheter 110, at least one first ultrasonic module 120, at least one second ultrasonic module 130, and a control device 140. The catheter 110 has a wall 111 and an accommodating space 112, and the wall 111 surrounds the accommodating space 112. The first ultrasonic module 120 and the second ultrasonic module 130 are installed in the accommodating space 112 and located at the front end of the catheter 110. The first ultrasonic module 120 emits a first ultrasonic wave W1, and the second ultrasonic module 130 emits a second ultrasonic wave W2. The control device 140 is electrically connected to the first ultrasonic module 120 and the second ultrasonic module 130, and controls the first ultrasonic module 120 and the second ultrasonic module 130. The first ultrasonic module 120 emits a first ultrasonic wave W 1 toward the outside of the catheter 110 , and the second ultrasonic module 130 emits a second ultrasonic wave W 2 toward the outside of the catheter 110 .

[0012] Preferably, the ultrasound-assisted thrombolysis device 100 includes a plurality of first ultrasonic modules 120 and a plurality of second ultrasonic modules 130. The first ultrasonic modules 120 and the second ultrasonic modules 130 are arranged in a cross-shaped manner in the receiving space 112 along the axial direction X of the catheter 110, and each of the first ultrasonic modules 120 is located between two adjacent second ultrasonic modules 130. Along a direction Y intersecting the axial direction X, each of the first ultrasonic modules 120 emits a first ultrasonic wave W1 toward the outside of the catheter 110, and each of the second ultrasonic modules 130 emits a second ultrasonic wave W2 toward the outside of the catheter 110. In this embodiment, the direction Y is perpendicular to the axial direction X.

[0013] As shown in FIG. 1 and FIG. 2, the catheter 110 is placed in a blood vessel adjacent to the thrombus 200, and then the catheter 110 is moved so that its front end comes into contact with the thrombus 200. Next, the control device 140 activates the second ultrasonic module 130 to emit a second ultrasonic wave W2 toward the thrombus 200 outside the catheter 110. The second ultrasonic wave W2 acts on the thrombus 200 and is used to reflect a third ultrasonic wave W3, which is reflected from the thrombus 200 back to the second ultrasonic module 130. The control device 140 measures the initial distance between the catheter 110 and the thrombus 200 based on the time difference between the emission time of the second ultrasonic wave W2 and the reception time of the third ultrasonic wave W3. After obtaining the initial distance, the control device 140 activates the first ultrasonic module 120 to emit a first ultrasonic wave W1 toward the thrombus 200 outside the catheter 110, and the first ultrasonic wave W1 is used to assist in dissolving the thrombus 200. The positive and negative pressure of the first ultrasonic wave W1 destroys the fibrin in the thrombus 200, disperses or tears the fibrin, and helps the thrombolytic agent penetrate into the inside of the thrombus 200, thereby increasing the efficiency of dissolving the thrombus. Preferably, the first ultrasonic wave W1 is a low-frequency pulsed ultrasonic wave, the frequency of which is in the range of 1.5 to 2.5 MHz, to prevent burns to the blood vessel tissue. The frequency of the second ultrasonic wave W2 is higher than that of the first ultrasonic wave W1, to increase the resolution of distance measurement within the radial range of the blood vessel. The frequency of the second ultrasonic wave W2 is in the range of 15 to 25 MHz.

[0014] During the treatment process, the control device 140 activates the second ultrasonic module 130 at a fixed time to measure the distance, and the control device 140 automatically adjusts the output frequency and power of the first ultrasonic module 120 and the second ultrasonic module 130 according to the distance between the catheter 110 and the thrombus 200, and determines whether to continuously activate or stop the first ultrasonic module 120 and the second ultrasonic module 130 according to the distance between the catheter 110 and the thrombus 200. The present invention monitors and displays the change in distance in real time using the second ultrasonic module 130, so that medical staff can know the dissolution state of the thrombus 200 in real time and help them decide whether to continue the treatment. Preferably, the control device 140 does not activate the first ultrasonic module 120 and the second ultrasonic module 130 at the same time to prevent the first ultrasonic wave W1 from affecting the measurement of the distance.

[0015] As shown in FIG. 2, preferably, the ultrasound-assisted thrombolysis device 100 further includes a temperature sensor 150, which is installed in the receiving space 112 of the catheter 110 and electrically connected to the control device 140. During the treatment process, the temperature sensor 150 detects the temperature of either the inside or the outside of the catheter 110 or both. The control device 140 adjusts the output frequency and power of the first ultrasonic module 120 and the second ultrasonic module 130 according to the temperature detected by the temperature sensor 150 to prevent the vascular tissue from being destroyed by high temperature. In this embodiment, the temperature sensor 150 is installed at the very front end of the catheter 110, but the present invention does not limit the installation position of the temperature sensor 150, and it can be installed at any position adjacent to the first ultrasonic module 120 and the second ultrasonic module 130.

[0016] Thrombolysis is performed in combination with a labeled ultrasound contrast agent. In one embodiment, microbubbles are generated by an ultrasound contrast agent, polyfluoroethylene gas is injected into the microbubbles, and a receptor for identifiable glycoprotein GP Iib / IIIa is embedded on the surface, which helps the receptor to specifically identify the thrombus and increase the concentration of the contrast agent around the thrombus. The positive and negative pressure generated by the first ultrasound W1 vibrates the ultrasound contrast agent, which disperses the thrombus structure and forms a cavity, which helps the thrombolytic agent to enter the inside of the thrombus and increases the dissolution rate of the thrombus. In another embodiment, the thrombolytic effect is achieved only by the ultrasound-assisted thrombolysis device 100 and the labeled ultrasound contrast agent without using a thrombolytic agent.

[0017] Preferably, the catheter 110 further includes an inner core 113 (see FIG. 3a) disposed in the receiving space 112. The inner core 113 is made of a soft material, and the inner core 113 assists in the movement of the catheter 110 when the medical staff guides the catheter 110 to be positioned.

[0018] <First Example> 3a and 3b are longitudinal and transverse cross-sectional views, respectively, of a catheter 110 according to a first embodiment of the present invention. In the first embodiment, the first ultrasonic module 120 has a plurality of ultrasonic transducers 121. The ultrasonic transducers 121 are arranged in a ring shape in the receiving space 112 to form an array transducer. In this way, the first ultrasonic module 120 emits a first ultrasonic wave W1 360 degrees outside the catheter 110 to perform thrombolysis therapy. Similarly, the second ultrasonic module 130 has a plurality of ultrasonic transducers 131. By arranging the ultrasonic transducers 131 in a ring shape in the receiving space 112, the second ultrasonic module 130 emits a second ultrasonic wave W2 360 degrees outside the catheter 110 to comprehensively monitor the distance between the catheter 110 and the thrombus.

[0019] As shown in Figures 3a and 3b, in this embodiment, the ultrasonic transducers 121 / 131 are arranged in a ring shape on the surface of the inner core 113 at the same angle, so that the ultrasonic transducers 121 / 131 are positioned between the wall portion 111 and the inner core 113, and adjacent ultrasonic transducers 121 / 131 are arranged side by side on the surface of the inner core 113.

[0020] <Second Example> 4a and 4b, the difference between the first embodiment and the second embodiment is that the ultrasonic transducers 121 / 131 in the second embodiment are arranged in a ring shape at different angles on the surface of the inner core 113. The adjacent ultrasonic transducers 121 / 131 are arranged so as to intersect (alternately) on the surface of the inner core 113.

[0021] <Third Example> FIG. 5 shows a third embodiment of the present invention. The first ultrasonic module 120 has an annular ultrasonic transducer 122. The annular ultrasonic transducer 122 is installed in the receiving space 112 along the wall 111 and emits a first ultrasonic wave W1 360 degrees outside the catheter 110. No matter where the thrombus is located outside the catheter 110, the first ultrasonic wave W1 is emitted toward the thrombus. The second ultrasonic module 130 has an annular ultrasonic transducer 132. The annular ultrasonic transducer 132 is installed in the receiving space 112 along the wall 111 and emits a second ultrasonic wave W2 360 degrees outside the catheter 110 to comprehensively monitor the distance between the catheter 110 and the thrombus. Preferably, the annular ultrasonic transducer 122 / 132 is covered on the surface of the inner core 113, so that the annular ultrasonic transducer 122 / 132 is located between the wall 111 and the inner core 113.

[0022] In the present invention, the first ultrasonic wave W1 is used to increase the penetration rate of the thrombolytic agent, reduce the dosage of the thrombolytic agent, and prevent the patient from suffering from internal bleeding, and the second ultrasonic wave W2 is used to measure the distance between the catheter 110 and the thrombus, thereby monitoring the lysis state of the thrombus in real time during the treatment process. The control device 140 automatically adjusts the first ultrasonic module 120 and the second ultrasonic module 130 according to the lysis state of the thrombus, thereby allowing the medical staff to decide whether to terminate the treatment process early.

[0023] The present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the claims. Embodiments obtained by appropriately combining the technical means disclosed in different embodiments are also included in the technical scope of the present invention. [Explanation of symbols]

[0024] 100 Ultrasonic Assisted Thrombolysis Device 110 Catheter 111 Wall section 112 Containment Space 113 Inner Core 120 First ultrasonic module 121 Ultrasonic Transducer 122 Annular Ultrasonic Transducer 130 Second ultrasonic module 131 Ultrasonic Transducer 132 Annular Ultrasonic Transducer 140 Control device 150 Temperature Sensor 200 Blood clot W1 First Ultrasound W2 Second Ultrasound W3 3rd ultrasound X-axis direction Y Direction

Claims

1. a catheter having a wall and a receiving space, the wall surrounding the receiving space; At least one first ultrasonic module is installed in the receiving space and emits a first ultrasonic wave, the first ultrasonic wave being used to dissolve a thrombus on the outside of the catheter; At least one second ultrasonic module is installed in the receiving space and emits a second ultrasonic wave, the second ultrasonic wave is used to act on the thrombus and reflect a third ultrasonic wave, and the frequency of the second ultrasonic wave is higher than the frequency of the first ultrasonic wave; a control device electrically connected to the first ultrasonic module and the second ultrasonic module, for measuring a distance between the catheter and the thrombus based on a time difference between a transmission time of the second ultrasonic wave and a reception time of the third ultrasonic wave, and for determining whether to continuously activate or stop the first ultrasonic module and the second ultrasonic module based on the distance between the catheter and the thrombus; 1. An ultrasound-assisted thrombolysis device comprising:

2. 2. The ultrasound-assisted thrombolysis device according to claim 1, wherein the first ultrasonic module has a plurality of ultrasonic transducers arranged in an annular shape in the receiving space.

3. 3. The ultrasound-assisted thrombolysis device according to claim 1, wherein the second ultrasonic module has a plurality of ultrasonic transducers arranged in an annular shape in the receiving space.

4. The catheter further includes an inner core disposed in the accommodation space, 4. The ultrasound assisted thrombolysis device of claim 3, wherein said ultrasonic transducer is located between said inner core and said wall.

5. 2. The ultrasound-assisted thrombolysis device of claim 1, wherein the first ultrasonic module comprises an annular ultrasonic transducer disposed in the receiving space along the wall.

6. 6. The ultrasound-assisted thrombolysis device according to claim 1, wherein the second ultrasonic module has an annular ultrasonic transducer disposed in the receiving space along the wall.

7. The catheter further includes an inner core disposed in the accommodation space, 7. The ultrasound assisted thrombolysis device of claim 6, wherein said annular ultrasonic transducer is located between said inner core and said wall.

8. 2. The ultrasound-assisted thrombolysis device of claim 1, further comprising a plurality of the first ultrasonic modules and a plurality of the second ultrasonic modules arranged in a cross-shaped manner in the accommodating space along the axial direction of the catheter.

9. 2. The ultrasound-assisted thrombolysis device of claim 1, wherein the frequency of the first ultrasound wave ranges between 1.5 and 2.5 MHz.

10. 10. The ultrasound-assisted thrombolysis device of claim 1 or 9, wherein the frequency of the second ultrasound is in the range between 15 and 25 MHz.

11. A temperature sensor is provided in the accommodation space and detects a temperature of one or both of the inside and the outside of the catheter. The ultrasound-assisted thrombolysis device of claim 1, wherein the control device is electrically connected to the temperature sensor and controls the first ultrasonic module and the second ultrasonic module based on the temperature detected by the temperature sensor.

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