Ultrasonic perfusion thrombolysis device

Abstract

The present invention provides an ultrasonic perfusion thrombolysis device. It includes: a perfusion support, at least one ultrasonic module for outputting ultrasonic waves, and a control component; the perfusion support includes a plurality of perfusion tubes for constructing the perfusion support, and the plurality of perfusion tubes extend along the circumference and axial direction of the perfusion support, and any perfusion tube has a perfusion tube section with a plurality of perfusion holes; at least one ultrasonic module is respectively arranged in the perfusion tube and extends along the perfusion tube section, and the ultrasonic module can expand and contract together with the perfusion support; the control component is connected to the perfusion support at the far end, and is used to accommodate the perfusion support in a contracted state and release the perfusion support, and is also used to control the expansion and contraction state of the perfusion support; the control component is also electrically connected to the ultrasonic module, and is used to provide a driving signal for the ultrasonic module. The perfusion tube of the perfusion support is used to perfuse the thrombolytic agent while providing ultrasonic waves to accelerate thrombolysis, which can effectively improve the thrombolysis efficiency, greatly reduce the dosage of the agent, and reduce the risk of bleeding.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an ultrasonic perfusion thrombolysis device. Background Art

[0002] Pulmonary embolism (PE) is a general term for a group of diseases or clinical syndromes caused by various emboli blocking the pulmonary artery or its branches, including pulmonary thromboembolism (PTE), fat embolism syndrome, amniotic fluid embolism, air embolism, tumor embolism, etc., among which PTE is the most common type of pulmonary embolism.

[0003] Interventional therapy is different from traditional pulmonary artery in that it can reduce the damage of open surgery to the patient's body and effectively remove blood clots. It is a good treatment for patients who do not respond well to drug therapy and have contraindications to thoracotomy. Interventional therapy has the characteristics of high safety and good short-term efficacy, but compared with other treatment methods, interventional therapy for pulmonary embolism is still in the development stage. Interventional treatment methods include catheter fragmentation and aspiration of blood clots, or local low-dose thrombolysis at the same time. At present, the large dosage of thrombolytic drugs, high risk of bleeding, and difficulty in operation in pulmonary artery interventional therapy are still research hotspots.

[0004] It should be noted that the information disclosed in the above background technology section is only used to enhance the understanding of the background of the present disclosure, and therefore may include information that does not constitute the prior art known to those skilled in the art. Summary of the invention

[0005] The purpose of the embodiment of the present invention is to provide an ultrasonic perfusion thrombolytic device, in which a perfusion stent is made of a perfusion tube with an opening, and an ultrasonic energy output structure is arranged in the perfusion tube, so that the drug can fully act on the thrombus, and the ultrasonic energy can better accelerate the thrombolysis, thereby improving the thrombolytic effect and significantly reducing the dosage of the thrombolytic drug, thereby reducing the risk of bleeding.

[0006] In order to solve the above technical problems, an embodiment of the present invention provides an ultrasonic perfusion thrombolysis device, comprising:

[0007] A perfusion stent, comprising a plurality of perfusion tubes for constructing the perfusion stent, wherein the plurality of perfusion tubes extend along the circumference and axial direction of the perfusion stent, and any of the perfusion tubes has a perfusion tube section with a plurality of perfusion holes;

[0008] At least one ultrasonic module for outputting ultrasonic waves, which is respectively disposed in the perfusion tube and extends along the perfusion tube section, and the ultrasonic module can expand and contract together with the perfusion support;

[0009] A control component, whose distal end is connected to the perfusion support, is used to accommodate the perfusion support in a contracted state and release the perfusion support, and is also used to control the expansion and contraction state of the perfusion support; the control component is also electrically connected to the ultrasound module and is used to provide a driving signal for the ultrasound module.

[0010] As an embodiment, the control assembly includes a handle, an outer sheath tube, an inner tube and a transmission tube;

[0011] The proximal end of the outer sheath is connected to the handle, and the handle is provided with a first driving member, and the first driving member is used to drive the outer sheath to move axially relative to the handle to accommodate or release the perfusion stent;

[0012] The inner tube is movably inserted into the outer sheath tube, the proximal end of the perfusion support is connected to the distal end of the inner tube, the inner tube has a perfusion cavity connected to the perfusion tube, the proximal end of the inner tube passes through the proximal end of the outer sheath tube and is connected to the handle, and the proximal end of the inner tube is connected to the injection joint extending from the handle;

[0013] The transmission tube is movably inserted into the perfusion support and the inner tube, the distal end of the transmission tube is connected to the distal end of the perfusion support, and the proximal end of the transmission tube extends out of the proximal end of the inner tube. The handle is provided with a second driving member, and the second driving member is used to drive the transmission tube to move axially relative to the inner tube to adjust the expansion and contraction state of the perfusion support.

[0014] As an embodiment, the distal end of the perfusion bracket is connected to the proximal end of the conical head, and a developing ring is provided at the distal end of the perfusion bracket; the handle is provided with a first slide groove and a second slide groove, the first slide groove is located at the distal end side of the second slide groove, the inner end of the first driving member extends into the first slide groove and is connected to the outer sheath tube, and the second driving member extends into the second slide groove and is connected to the transmission tube.

[0015] As an embodiment, the outer sheath tube and the handle are slidably sealed together, and the transmission tube and the handle are slidably sealed together; the handle is also provided with an injection joint connected to the outer sheath tube and used to evacuate the air in the outer sheath tube.

[0016] As an embodiment, the control assembly also includes a cooling tube whose distal end is connected to the proximal end of the transmission tube, the cooling tube extends out of the proximal end of the handle, a cooling joint is provided on one side of the proximal end of the cooling tube, a first cable joint is coaxially provided at the proximal end of the cooling tube, and the first cable joint is electrically connected to the ultrasonic module.

[0017] As an embodiment, the thrombolytic device also includes a temperature sensing assembly, which includes a plurality of temperature probes for monitoring the temperature around the ultrasonic module and a second cable connector electrically connected to the temperature probes, the plurality of temperature probes are fixed outside the transmission tube, and the second cable connector extends out of the handle.

[0018] As an embodiment, the temperature probe is a thermocouple, and a plurality of the thermocouples are fixed outside the transmission tube via a heat shrink tube.

[0019] As an embodiment, the perfusion stent is formed by a plurality of the perfusion tubes being woven in a forward and reverse spiral pattern, the number of the perfusion tubes is the same as the number of the ultrasonic modules, and the ultrasonic modules are arranged in the perfusion tubes in a one-to-one correspondence.

[0020] As an embodiment, the ultrasound module includes a strip-shaped flexible substrate and a plurality of piezoelectric ceramic sheets, and the plurality of piezoelectric ceramic sheets are axially spaced apart from each other along the flexible substrate.

[0021] As an embodiment, the multiple perfusion holes on the perfusion tube are distributed in an array along the circumferential direction and the axial direction.

[0022] It can be seen from the above technical solutions that the embodiments of the present invention have at least the following advantages and positive effects:

[0023] The perfusion stent can quickly open the blood vessel after expansion. The perfusion stent includes multiple perfusion tubes extending along its circumferential and axial directions. After the perfusion stent is expanded, the perfusion tube is embedded in the thrombus. The thrombolytic agent is perfused through the perfusion holes on the perfusion tube, so that the agent can act on the thrombus more fully. Since an ultrasonic module for outputting ultrasonic waves is provided in the perfusion tube section, the ultrasonic module can output ultrasonic waves to break up the thrombus while the thrombolytic agent is perfused to accelerate thrombolysis. The expansion state of the perfusion stent can also be adjusted through the control component to make the thrombolytic agent better contact the thrombus. Compared with traditional anticoagulant therapy and catheter thrombolysis, the thrombolytic efficiency can be improved and the dosage of thrombolytic agent can be significantly reduced, the risk of bleeding can be reduced, and the treatment cost can be saved. At the same time, it is easy to operate and can quickly meet the needs of clinical applications. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. It can be understood that the drawings in the following description are only embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying creative work.

[0025] Figure 1 This is a schematic diagram of the overall structure of the perfusion stent of the ultrasonic perfusion thrombolytic device in the first embodiment of the present invention in an expanded state;

[0026] Figure 2 for Figure 1 The schematic diagram of the structure of the perfusion stent of the ultrasonic perfusion thrombolytic device is shown in a receiving state;

[0027] Figure 3 for Figure 1 The schematic diagram of the structure of the perfusion stent of the ultrasonic perfusion thrombolytic device is shown in a contracted state after release;

[0028] Figure 4 for Figure 1 A schematic diagram of the installation structure of the perfusion tube and the ultrasonic module of the ultrasonic perfusion thrombolysis device shown;

[0029] Figure 5 for Figure 1 The schematic diagram of the structure of the perfusion tube of the ultrasonic perfusion thrombolysis device shown;

[0030] Figure 6 for Figure 1 A schematic cross-sectional view of the installation structure of the perfusion tube and the ultrasonic module of the ultrasonic perfusion thrombolysis device shown;

[0031] Figure 7 for Figure 1 The schematic diagram of the installation structure of the thermocouple of the ultrasonic perfusion thrombolysis device is shown;

[0032] Figure 8 for Figure 1 The enlarged structural schematic diagram of the perfusion stent of the ultrasonic perfusion thrombolytic device is shown;

[0033] Fig. 9 for Figure 1 An enlarged structural schematic diagram of the control component of the ultrasonic perfusion thrombolysis device is shown;

[0034] Fig.10 for Figure 1 Schematic diagram of the thrombolytic state of the ultrasonic perfusion thrombolytic device.

[0035] In the figure: 1. conical head; 2. perfusion bracket; 21. perfusion tube; 22. perfusion hole; 23. developing ring; 3. ultrasonic module; 31. substrate; 32. piezoelectric ceramic sheet; 4. outer sheath; 5. inner tube; 6. transmission tube; 7. handle; 71. first slide groove; 72. second slide groove; 8. injection joint; 9. first drive member; 10. second drive member; 11. cooling joint; 12. first cable joint; 13. thermocouple; 14. injection tube; 15. injection joint; 16. signal line; 17. second cable joint; 18. blood vessel; 19. thrombus. DETAILED DESCRIPTION

[0036] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, it can be understood by those skilled in the art that in the embodiments of the present invention, many technical details are provided to enable readers to better understand the present invention. However, even without these technical details and various changes and modifications based on the following embodiments, the technical scheme claimed in the present invention can be implemented.

[0037] In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", etc., are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0038] It should be noted that, unless otherwise expressly specified, the terms "connected", "connected", etc. should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal connection of two elements.

[0039] In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator. The above definition is only for the convenience of expression and cannot be understood as a limitation of the present invention.

[0040] See also Figure 1 to Figure 6 As shown, the first embodiment of the present invention provides an ultrasonic perfusion thrombolysis device, which can be used for ultrasonic thrombolysis treatment of pulmonary embolism. The ultrasonic perfusion thrombolysis device of the embodiment of the present invention comprises: a perfusion support 2, at least one ultrasonic module 3 for outputting ultrasonic waves, and a control component.

[0041] The perfusion stent 2 includes a plurality of perfusion tubes 21 for constructing the perfusion stent. The plurality of perfusion tubes 21 extend along the circumference and axial direction of the perfusion stent 2. Each perfusion tube 21 has a perfusion tube section with a plurality of perfusion holes 22. Each perfusion hole 22 serves as a drug injection point and is evenly dispersed along the circumference and axial direction of the perfusion stent 2, so that the thrombolytic agent can reach the thrombus more evenly, and can significantly increase the direct action area of ​​the agent on the thrombus and improve the thrombolytic efficiency. The perfusion stent 2 can expand and contract. The perfusion stent 2 is housed in the control component. After being delivered to the target thrombus position by the control component, it can be released and its expansion state can be controlled. After the perfusion stent 2 expands, the blood vessel can be quickly opened.

[0042] The ultrasonic modules 3 are respectively arranged in the perfusion tube 21 and extend along the perfusion tube section, and the ultrasonic modules 3 can expand and contract together with the perfusion stent 2, that is, the ultrasonic module 3 placed in the perfusion tube 21 has the elastic deformation ability to follow the expansion and contraction of the perfusion stent 2, and will not hinder the expansion and contraction of the perfusion stent 2. The ultrasonic module 3 extends along the perfusion tube section, so that the perfusion tube can output ultrasonic energy along its perfusion tube section, so that the drug can be directly injected and ultrasonic waves can be output uniformly and densely along each perfusion tube section to the thrombus, which can significantly improve the thrombolytic efficiency and greatly reduce the amount of thrombolytic drugs.

[0043] The control component is electrically connected to the ultrasonic module 3 and is used to provide a driving signal to the ultrasonic module 3 so that the ultrasonic module 3 can output ultrasonic energy to assist thrombolysis. The distal end of the control component is connected to the perfusion support 2 and is used to accommodate the perfusion support 2 in a contracted state and release the perfusion support 2. The control component is also used to control the expansion and contraction state of the perfusion support 2. The perfusion support 2 is delivered to the target thrombus position through the control component, and the perfusion support 2 is released, and then the perfusion support 2 is controlled to expand to open the blood vessel and perform ultrasound-assisted thrombolysis. During the treatment, the expansion state of the perfusion support 2 can be adjusted according to the distribution of the thrombus, so that the perfusion support 2 maintains a thrombolysis state in full contact with the thrombus. After the thrombolysis is completed, the perfusion support 2 is contracted and accommodated in the control component by the control component to withdraw the thrombolytic device from the body.

[0044] See also Figure 8 As shown, the perfusion stent 2 is formed by a plurality of perfusion tubes 21 that are woven in a spiral manner in both forward and reverse directions. The perfusion tube 21 can be a nickel-titanium tube. It is understandable that the perfusion tube can also be made of a cobalt-based alloy, such as a cobalt-chromium alloy, as long as the perfusion stent meets the use requirements such as flexibility, elastic deformation ability and biocompatibility. This embodiment does not impose excessive restrictions on the material of the perfusion tube. Please refer to Figure 4~Figure 6As shown, the multiple perfusion holes 22 on the perfusion tube 21 are distributed in an array along the circumference and the axial direction. For example, the perfusion tube section is provided with multiple perfusion holes at equal intervals along its circumference, and multiple perfusion holes are provided at equal intervals along its axial direction. The perfusion holes 22 can be a self-sealing hole structure, that is, when the pressure in the perfusion tube is greater than a threshold value, the medicine can be ejected from the perfusion hole, and when the pressure is less than or equal to the threshold value, the perfusion hole is in a closed state, which is beneficial to reduce the amount of medicine used. This embodiment does not impose excessive restrictions on the structure of the perfusion holes 22, and the perfusion holes may not be self-sealing holes. The perfusion tube 21 has densely distributed injection points in the circumference and axial directions, which is beneficial to suspend the perfusion stent in the blood vessel during perfusion, and avoid the perfusion stent from being close to one side of the blood vessel wall. This embodiment does not impose specific restrictions on the shape, number and distribution of the perfusion holes. The distal end of the perfusion stent 2 is connected to the proximal end of the conical head 1. The distal end of the conical head 1 is conical, which facilitates the advancement of the thrombolytic device in the blood vessel. The distal end of each perfusion tube 21 can be welded to the proximal end of the conical head 1. A developing ring 23 is provided at the distal end of the perfusion stent 2 to assist in locating the position of the perfusion stent 2 in the blood vessel.

[0045] As an example but not a limitation, the number of perfusion tubes 21 and ultrasound modules 3 can be the same, and the ultrasound modules 3 are arranged in the perfusion tubes 21 in a one-to-one correspondence, that is, each perfusion tube 21 is placed with an ultrasound module 3, and the ultrasound module has multiple ultrasound output structures, so that different positions in the perfusion tube 21 can provide ultrasound energy densely. Figure 4~Figure 6 The ultrasonic module 3 may include a strip-shaped flexible substrate 31 and a plurality of piezoelectric ceramic sheets 32, and the plurality of piezoelectric ceramic sheets 32 are arranged at intervals along the axial direction of the substrate 31. The piezoelectric ceramic sheets 32 are used to convert electrical energy into ultrasonic energy. The ultrasonic module 3 outputs ultrasonic waves at different positions of the perfusion tube 21 through the plurality of piezoelectric ceramic sheets 32. The piezoelectric ceramic sheets 32 may be in the shape of a rectangular thin plate, and the length direction of the piezoelectric ceramic sheets 32 is parallel to the axial direction of the perfusion tube 21. The length, width, thickness of the piezoelectric ceramic sheets 32 and the spacing between adjacent piezoelectric ceramic sheets 32 may be designed according to the maximum bending degree of the perfusion tube 21 when the perfusion bracket 2 is expanded, so that the piezoelectric ceramic sheets 32 will not hinder the perfusion tube 21 from reaching the required bending degree when placed in the perfusion tube 21. This embodiment does not impose excessive restrictions on the shape of the piezoelectric ceramic sheets 32. After the multiple piezoelectric ceramic pieces 32 of any ultrasonic module 3 are connected in parallel, they are connected to the ultrasonic drive module through a wire to obtain an excitation signal to output ultrasonic waves. The multiple piezoelectric ceramic pieces 32 of each ultrasonic module 3 are connected in parallel so that each piezoelectric ceramic piece 32 works independently. It can be understood that the operating frequency and power range of the ultrasonic module 3 can be determined according to the required thrombolytic efficiency and safety, and no excessive restrictions are made here. By evenly arranging the multiple piezoelectric ceramic pieces 32 of the ultrasonic module 3 along the perfusion tube section, ultrasonic energy can be output closer to and more evenly to the target thrombus, significantly improving the thrombolytic and thrombus fragmentation efficiency, and accelerating thrombus ablation.

[0046] See also Figure 1~Figure 3 As shown, the control assembly may include a handle 7, an inner tube 5, a transmission tube 6, and an outer sheath tube 4. The proximal end of the perfusion stent 2 is connected to the distal end of the inner tube 5. The inner tube 5 has a perfusion cavity (not shown) connected to the perfusion tube 21. The inner tube 5 may be a multi-lumen tube. The distal end of the inner tube 5 is welded to the proximal end of each perfusion tube 21, so that the multiple cavities of the inner tube 5 can be connected to the lumen of the perfusion tube 21, and the perfusion stent 2 is fixed by the inner tube 5. The proximal end of the inner tube 5 is fixedly penetrated in the handle 7, and the proximal end of the inner tube 5 is connected to the injection connector 15 extending out of the handle 7. The proximal end of the inner tube 5 can be connected to the injection connector 15 through the injection tube 14, so that the thrombolytic agent is delivered to the perfusion stent 2 through the multiple cavities of the inner tube 5. The injection connector 15 can be screwed to the injector (not shown), and the thrombolytic agent is pushed to the perfusion stent 2 through the injector.

[0047] See also Fig. 9 As shown, the handle 7 may be tubular, the proximal end of the outer sheath 4 is connected to the handle 7, the inner tube 5 is movably inserted into the outer sheath 4, and the handle 7 is provided with a first driving member 9, which is used to drive the outer sheath 4 to move axially relative to the handle 7 to accommodate or release the perfusion stent 2. The first driving member 9 may be annular and sleeved on the handle 7, and the handle 7 is provided with a first slide groove 71, and the length of the first slide groove 71 is related to the axial retraction distance of the outer sheath 4 when the perfusion stent 2 is released. The inner end of the first driving member 9 extends into the first slide groove and is connected to the outer sheath 4, and the first driving member 9 and the handle 7 can be positioned by friction, and no specific limitation is made here. Figure 1 , Figure 3 As shown, when the first driving member 9 is moved from the distal end to the proximal end of the handle 7 to the proximal end of the first slide groove 71, the first driving member 9 drives the outer sheath 4 to retract into the handle 7, and the perfusion stent 2 is completely released. Figure 2 As shown, when the first driving member 9 is located Figure 2 In the position shown, the perfusion support 2 is completely contained in the outer sheath 4. The handle 7 is also provided with a liquid injection joint 8 connected to the outer sheath 4 and used to evacuate the air in the outer sheath 4. The outer sheath 4 and the handle 7 are slidably sealed to prevent blood from seeping out of the handle.

[0048] The transmission tube 6 is movably arranged in the perfusion support 2 and the inner tube 5, the distal end of the transmission tube 6 is connected to the distal end of the perfusion support 2, and the proximal end of the transmission tube 6 is connected to the handle 7. The handle 7 is provided with a second driving member 10, and the second driving member 10 is used to drive the transmission tube 6 to move axially relative to the inner tube 5 to adjust the expansion and contraction of the perfusion support 2. The handle 7 is provided with a second slide groove 72, the first slide groove 71 is located at the distal end side of the second slide groove 72, the second driving member 10 extends into the second slide groove 72 and is connected to the transmission tube 6, and the distal end of the transmission tube 6 can be welded to the proximal end of the conical head 1. The transmission tube 6 penetrates the perfusion support 2, the inner tube 5 and the handle 7 in sequence from far to near, and the proximal end of the transmission tube 6 is transmission-connected with the second driving member 10, which can be a traction key. The handle 7 is provided with a second slide groove 72, and the inner end of the traction key is fixedly connected with the transmission tube 6, for example, the inner end of the traction key can be welded to the transmission tube 6 or connected to the transmission tube 6 through a fixed ring, and the outer end of the traction key is exposed from the handle 7. When the traction key is driven to move along the second slide groove 72, the transmission tube 6 can be driven to move axially relative to the inner tube 5, and the length of the second slide groove 72 limits the axial movement range of the transmission tube 6. The second slide groove 72 is provided with saw teeth axially along the inner side, and the second driving member 10 is provided with a saw tooth structure cooperating with the saw teeth, so that the second driving member 10 can be slidably positioned, so that the second driving member 10 is positioned at the end position of sliding, so that the perfusion support 2 maintains its current expansion or contraction state. When the distal end of the transmission tube 6 moves axially toward the distal end of the inner tube 5, the perfusion support 2 can be gradually expanded, and vice versa, when the distal end of the transmission tube 6 moves axially away from the distal end of the inner tube 5, the perfusion support 2 can be gradually contracted. The transmission tube 6 and the handle 7 are slidably sealed to prevent blood from seeping out of the handle 7.

[0049] The control assembly may also include a cooling tube whose distal end is connected to the proximal end of the transmission tube 6, the cooling tube extends out of the proximal end of the handle 7, and a cooling joint 11 is provided on one side of the proximal end of the cooling tube. A cooling medium is injected through the cooling joint 11 to absorb excessive heat generated by ultrasonic thrombolysis and avoid damage to the human body caused by excessive local temperature. A first cable connector 12 is coaxially provided at the proximal end of the cooling tube, and the first cable connector 12 is electrically connected to the ultrasonic module 3.

[0050] See also Figure 7The thrombolytic device may also include a temperature sensing component, which includes a plurality of temperature probes for monitoring the temperature around the ultrasonic module 3 and a second cable connector 17 electrically connected to the plurality of temperature probes, wherein the plurality of temperature probes are fixedly arranged outside the transmission tube 6. The second cable connector 17 extends out of the handle 7. The plurality of temperature probes are thermocouples, and the plurality of thermocouples 13 are fixedly arranged outside the transmission tube 6 through a heat shrink tube. It should be noted that the signal line of the ultrasonic module 3 can be routed through the gap between the inner tube 5 and the outer sheath tube 4 to the inside of the handle 7, and connected to the PCBA (Printed Circuit Board Assembly) arranged in the handle 7, and the first cable connector 12 is connected to the PCBA, so that the external ultrasonic device provides a driving signal to the ultrasonic module 3. The signal lines of the plurality of thermocouples 13 can be routed along the outer wall of the transmission tube 6 to the inside of the handle 7 and connected to the PCBA, and the PCBA is connected to the second cable connector 17, and the temperature information around the ultrasonic module 3 is provided to the external device through the second cable connector 17.

[0051] Combination Figure 1 , Fig.10 As shown, the method of using the ultrasonic perfusion thrombolytic device of the embodiment of the present invention is as follows:

[0052] The thrombolytic device of the embodiment of the present invention is inserted into the blood vessel 18 and delivered to the thrombus 19. The first driving member 9 is pulled to the proximal end of the first slide groove 71 to release the perfusion support 2. The second driving member 10 is pulled to the proximal end of the second slide groove 72 to expand the perfusion support 2 to the maximum outer diameter. The outer diameter of the perfusion support 2 can be adjusted as needed during use. The injection connector 15 at the tail end of the handle 7 is connected to the thrombolytic injector to perfuse the thrombolytic drug. The ultrasonic device is started to drive the ultrasonic module to output ultrasonic energy to enhance the thrombolytic effect. After the perfusion of the thrombolytic drug is completed, the treatment is terminated. First, the second driving member 10 is pushed back to the initial position to make the perfusion support 2 in a fully contracted state, and then the first driving member 9 is pushed back to the initial position to retract the perfusion support 2 into the outer sheath 4, and then the thrombolytic device is withdrawn from the human body.

[0053] Compared with the prior art, the embodiments of the present invention infuse thrombolytic agents through infusion holes that are evenly and densely distributed along the circumference and axial direction of the infusion stent, and output ultrasonic energy through the ultrasonic module in the infusion tube, so as to directly, evenly and densely inject drugs into the thrombus and perform ultrasound-assisted thrombolysis, thereby significantly improving the thrombolytic efficiency and greatly reducing the amount of agents used. While improving the treatment effect, it also reduces the risk of bleeding. At the same time, it is easy to operate and suitable for rapid promotion and application.

[0054] Those skilled in the art will appreciate that the above-mentioned embodiments are specific examples for implementing the present invention, and in actual applications, various changes may be made thereto in form and detail without departing from the spirit and scope of the present invention.

Claims

1. An ultrasonic perfusion thrombolytic device, characterized in that: include: A perfusion stent, comprising a plurality of perfusion tubes for constructing the perfusion stent, wherein the plurality of perfusion tubes extend along the circumference and axial direction of the perfusion stent, and any of the perfusion tubes has a perfusion tube section with a plurality of perfusion holes; At least one ultrasonic module for outputting ultrasonic waves, which is respectively disposed in the perfusion tube and extends along the perfusion tube section, and the ultrasonic module can expand and contract together with the perfusion support; A control component, whose distal end is connected to the perfusion support, is used to accommodate the perfusion support in a contracted state and release the perfusion support, and is also used to control the expansion and contraction state of the perfusion support; the control component is also electrically connected to the ultrasound module and is used to provide a driving signal for the ultrasound module.

2. The ultrasonic perfusion thrombolytic device according to claim 1, characterized in that: The control assembly includes a handle, an outer sheath tube, an inner tube and a transmission tube; The proximal end of the outer sheath is connected to the handle, and the handle is provided with a first driving member, and the first driving member is used to drive the outer sheath to move axially relative to the handle to accommodate or release the perfusion stent; The inner tube is movably inserted into the outer sheath tube, the proximal end of the perfusion support is connected to the distal end of the inner tube, the inner tube has a perfusion cavity connected to the perfusion tube, the proximal end of the inner tube passes through the proximal end of the outer sheath tube and is connected to the handle, and the proximal end of the inner tube is connected to the injection joint extending from the handle; The transmission tube is movably inserted into the perfusion support and the inner tube, the distal end of the transmission tube is connected to the distal end of the perfusion support, and the proximal end of the transmission tube extends out of the proximal end of the inner tube. The handle is provided with a second driving member, and the second driving member is used to drive the transmission tube to move axially relative to the inner tube to adjust the expansion and contraction state of the perfusion support.

3. The ultrasonic perfusion thrombolytic device according to claim 2, characterized in that: The distal end of the perfusion bracket is connected to the proximal end of the conical head, and a developing ring is provided at the distal end of the perfusion bracket; the handle is provided with a first slide groove and a second slide groove, the first slide groove is located at the distal end side of the second slide groove, the inner end of the first driving member extends into the first slide groove and is connected to the outer sheath tube, and the second driving member extends into the second slide groove and is connected to the transmission tube.

4. The ultrasonic perfusion thrombolytic device according to claim 2, characterized in that: The outer sheath tube is in sliding sealing cooperation with the handle, and the transmission tube is in sliding sealing cooperation with the handle; the handle is also provided with a liquid injection joint which is connected with the outer sheath tube and is used to evacuate the air in the outer sheath tube.

5. The ultrasonic perfusion thrombolytic device according to claim 2, characterized in that: The control assembly also includes a cooling tube whose distal end is connected to the proximal end of the transmission tube, the cooling tube extends out of the proximal end of the handle, a cooling connector is provided on one side of the proximal end of the cooling tube, a first cable connector is coaxially provided at the proximal end of the cooling tube, and the first cable connector is electrically connected to the ultrasonic module.

6. The ultrasonic perfusion thrombolytic device according to claim 2, characterized in that: The thrombolytic device also includes a temperature sensing assembly, which includes a plurality of temperature probes for monitoring the temperature around the ultrasonic module and a second cable connector electrically connected to the temperature probes. The plurality of temperature probes are fixed outside the transmission tube, and the second cable connector extends out of the handle.

7. The ultrasonic perfusion thrombolytic device according to claim 6, characterized in that: The temperature probe is a thermocouple, and a plurality of the thermocouples are fixed outside the transmission tube through a heat shrink tube.

8. The ultrasonic perfusion thrombolytic device according to claim 1, characterized in that: The perfusion support is formed by a plurality of perfusion tubes that are woven in a forward and reverse spiral pattern. The number of the perfusion tubes is the same as that of the ultrasonic modules, and the ultrasonic modules are arranged in the perfusion tubes in a one-to-one correspondence.

9. The ultrasonic perfusion thrombolytic device according to claim 1, characterized in that: The ultrasonic module includes a strip-shaped flexible substrate and a plurality of piezoelectric ceramic sheets, wherein the plurality of piezoelectric ceramic sheets are arranged at intervals along the axial direction of the flexible substrate.

10. The ultrasonic perfusion thrombolytic device according to claim 1, characterized in that: The multiple perfusion holes on the perfusion tube are distributed in an array along the circumferential direction and the axial direction.

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