Ultrasonic shear thrombolysis device

Abstract

The embodiment of the present invention provides an ultrasonic shearing thrombolytic device. The ultrasonic shearing thrombolytic device includes a thrombolytic catheter and an ultrasonic unit sleeved inside the thrombolytic catheter; the thrombolytic catheter is suitable for delivering thrombolytic agents to the thrombolytic site to ablate the thrombus; the ultrasonic unit includes at least two ultrasonic elements that vibrate independently of each other, and there is an ultrasonic emission phase difference between adjacent ultrasonic elements to produce an ultrasonic shearing effect when ablating the thrombus. By adopting the embodiment of the present invention, by increasing the shear force in the ultrasonic thrombolytic method, the destructive ability of ultrasonic thrombolysis on the target object can be improved, the efficiency of ultrasonic thrombolysis can be improved, the treatment time can be shortened, the dosage of thrombolytic agents can be reduced, the thrombolysis can be made more thorough, and the damage to blood vessels is less, which can greatly reduce the risk of complications such as tissue bleeding and nerve damage.

Description

Technical Field

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

[0002] Thrombosis is one of the common clinical diseases. The formation of thrombus often causes peripheral vascular occlusion. In severe cases, it can also cause dangerous diseases such as ischemic stroke, myocardial infarction, and pulmonary embolism, which seriously endangers human life and health. For the treatment of thrombus, traditional drug thrombolysis, balloon interventional angioplasty, and surgical thrombectomy all have obvious defects. For example, surgical thrombectomy can cause great damage to patients, while drug thrombolysis has a short time window and a low success rate. It can also cause complications such as nerve damage and intra-tissue bleeding.

[0003] Ultrasonic thrombolysis is a technique that applies ultrasound on the basis of catheter-directed thrombolysis (CDT). Through the mechanical effect and cavitation effect of ultrasound, it can increase the penetration of drugs into the thrombus, increase the contact area between drugs and thrombus, and accelerate thrombus dissolution.

[0004] However, current ultrasonic thrombolysis technology generally has problems such as low efficiency, long treatment time, and easy to cause bleeding symptoms. Summary of the invention

[0005] The purpose of an embodiment of the present invention is to provide an ultrasonic shearing thrombolytic device, which can increase the shear force in the ultrasonic thrombolytic method, thereby improving the destructive ability of ultrasonic thrombolysis on the target object, improving the efficiency of ultrasonic thrombolysis, shortening the treatment time, reducing the dose of thrombolytic agent, making thrombolysis more thorough, and causing less damage to blood vessels, which can greatly reduce the risk of complications such as tissue bleeding and nerve damage.

[0006] To achieve the above objectives, the embodiments of the present invention provide the following technical solutions:

[0007] An ultrasonic shearing thrombolytic device comprises a thrombolytic catheter and an ultrasonic unit sleeved in the thrombolytic catheter; the thrombolytic catheter is suitable for delivering thrombolytic agent to the thrombolytic site to ablate the thrombus; the ultrasonic unit comprises at least two ultrasonic elements that vibrate independently of each other, and there is an ultrasonic emission phase difference between adjacent ultrasonic elements to produce an ultrasonic shearing effect when ablating the thrombus; at least two of the ultrasonic elements are arranged in an ultrasonic array, and adjacent ultrasonic elements in the ultrasonic element array are connected by a decoupling medium so that each ultrasonic element vibrates independently of each other, and the ultrasonic array is also connected to a negative plate and is symmetrically distributed relative to the negative plate.

[0008] Optionally, the ultrasonic unit includes an ultrasonic catheter extending axially along the thrombolytic catheter, an ultrasonic core part arranged in the ultrasonic catheter, and an insulating sealing layer infused between the ultrasonic core part and the ultrasonic catheter; the ultrasonic core part includes the ultrasonic element.

[0009] Optionally, the ultrasound unit comprises at least two ultrasound element arrays connected in series along the axial direction of the thrombolytic catheter.

[0010] Optionally, the thrombolytic catheter comprises an inner chamber and an outer chamber which are arranged in sequence from the inside to the outside along its radial direction; the inner chamber extends along the axial direction of the thrombolytic catheter and is suitable for accommodating the ultrasonic unit; the outer chamber also extends along the axial direction of the thrombolytic catheter and is provided with at least one circumferentially around the inner chamber, which is suitable for delivering the thrombolytic agent.

[0011] Optionally, the ultrasound unit is adapted to move relative to the inner chamber along the axial direction of the thrombolytic catheter to reach the thrombolytic site.

[0012] Optionally, the thrombolytic catheter includes a thrombolytic agent inlet and a thrombolytic agent outlet; the thrombolytic agent inlet is located at one end of the outer chamber to receive the thrombolytic agent; the thrombolytic agent outlet is arranged on the outer peripheral side of the outer chamber to output the thrombolytic agent.

[0013] Optionally, at least two bosses are provided in the inner chamber; the at least two bosses are arranged at circumferential intervals around the inner chamber between the inner wall of the inner chamber and the outer wall of the ultrasonic unit to form a coolant channel between the inner wall of the inner chamber and the outer wall of the ultrasonic unit; the coolant channel extends along the axial direction of the thrombolytic catheter and is suitable for receiving coolant to cool the ultrasonic unit.

[0014] Optionally, there is a certain distance difference between the adjacent ultrasonic elements; the distance difference causes a phase difference to be generated between the adjacent ultrasonic elements.

[0015] Compared with the prior art, the technical solution of the embodiment of the present invention has beneficial effects.

[0016] For example, by increasing shear force in the ultrasonic thrombolysis method, the destructive ability of ultrasonic thrombolysis on the target object can be enhanced, the efficiency of ultrasonic thrombolysis can be improved, the treatment time can be shortened, the dose of thrombolytic agent can be reduced, the thrombolysis can be made more thorough, and the damage to blood vessels can be less, which can greatly reduce the risk of complications such as tissue bleeding and nerve damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a connection diagram of an ultrasonic shearing thrombolytic device according to an embodiment of the present invention;

[0018] Figure 2 is a cross-sectional schematic diagram of a thrombolytic catheter in an embodiment of the present invention;

[0019] Figure 3 is a cross-sectional schematic diagram of an ultrasonic unit in an embodiment of the present invention;

[0020] Figure 4 is a schematic diagram of an ultrasonic core part in an embodiment of the present invention;

[0021] Figure 5 It is a cross-sectional schematic diagram of the combination of a thrombolytic catheter and an ultrasonic unit in an embodiment of the present invention.

[0022] Description of reference numerals:

[0023] 1 ultrasonic shearing thrombolytic device, 10 thrombolytic catheter, 11 inner chamber, 12 outer chamber, 121 thrombolytic agent inlet, 122 thrombolytic agent outlet, 13 boss, 14 coolant channel, 141 coolant inlet, 20 ultrasonic unit, 21 ultrasonic core part, 211 ultrasonic element, 212 negative electrode plate, 213 decoupling medium, 22 ultrasonic catheter, 23 insulating sealing layer, 30 host. DETAILED DESCRIPTION

[0024] In order to make the purpose, features and beneficial effects of the present invention more obvious and understandable, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. It is understood that the specific embodiments described below are only used to explain the present invention, rather than to limit the present invention. In addition, the same or similar reference numerals may be used in the figures to refer to the same or similar elements in different embodiments, and the description of the same or similar elements in different embodiments and the description of the prior art elements, features, effects, etc. may be omitted.

[0025] Figure 1 is a connection diagram of an ultrasonic shearing thrombolytic device according to an embodiment of the present invention; Figure 2 is a cross-sectional schematic diagram of a thrombolytic catheter in an embodiment of the present invention; Figure 3 is a cross-sectional schematic diagram of an ultrasonic unit in an embodiment of the present invention; Figure 4 is a schematic diagram of an ultrasonic core part in an embodiment of the present invention; Figure 5 It is a cross-sectional schematic diagram of the combination of a thrombolytic catheter and an ultrasonic unit in an embodiment of the present invention.

[0026] Reference Figures 1 to 5 , an embodiment of the present invention provides an ultrasonic shearing thrombolytic device 1.

[0027] Specifically, the ultrasonic shearing thrombolytic device 1 may include a thrombolytic catheter 10 and an ultrasonic unit 20 sleeved in the thrombolytic catheter 10. The thrombolytic catheter 10 is suitable for delivering a thrombolytic agent to a thrombolytic site to ablate a thrombus; the ultrasonic unit 20 includes at least two ultrasonic elements 211 that vibrate independently of each other, and there is an ultrasonic emission phase difference between adjacent ultrasonic elements 211 to generate an ultrasonic shearing effect when ablating a thrombus.

[0028] By adopting the above technical scheme, by increasing the shear force in the ultrasonic thrombolysis method, the destructive ability of ultrasonic thrombolysis on the target object can be improved, the efficiency of ultrasonic thrombolysis can be improved, the treatment time can be shortened, the dose of thrombolytic agent can be reduced, the thrombolysis can be made more thorough, and the damage to blood vessels can be less, which can greatly reduce the risk of complications such as tissue bleeding and nerve damage.

[0029] Reference Figure 2 In some embodiments, the thrombolytic catheter 10 may include an inner chamber 11 and an outer chamber 12 arranged in sequence from the inside to the outside along its radial direction. The inner chamber 11 extends along the axial direction of the thrombolytic catheter 10 and is suitable for accommodating the ultrasound unit 20; the outer chamber 12 also extends along the axial direction of the thrombolytic catheter 10 and is arranged around the circumference of the inner chamber 11. It is suitable for delivering thrombolytic agents.

[0030] In a specific implementation, the ultrasonic unit 20 is disposed in the inner chamber 11 and is adapted to move forward along the axial direction of the thrombolytic catheter 10 relative to the inner chamber 11 so as to reach the thrombolytic site to perform ultrasonic shear thrombolysis.

[0031] In some embodiments, the ultrasound unit 20 may be disposed in the inner chamber 11 and located at the front section of the thrombolytic catheter 10 so as to be disposed close to the thrombolytic site.

[0032] In a specific implementation, the outer chamber 12 is located outside the inner chamber 11 along the radial direction of the thrombolytic catheter 10 , and is suitable for serving as a thrombolytic agent channel to deliver the thrombolytic agent to the thrombolytic site.

[0033] In some embodiments, at least one outer chamber 12 may be provided around the circumference of the inner chamber 11. For example, four outer chambers 12 may be evenly arranged around the circumference of the inner chamber 11. In this way, the thrombolytic agent can be evenly delivered to the thrombolytic site.

[0034] In a specific implementation, the thrombolytic catheter 10 further includes a thrombolytic agent inlet 121 and a thrombolytic agent outlet 122. The thrombolytic agent inlet 121 may be located at one end of the outer chamber 12, i.e., the rear end, to receive the thrombolytic agent; the thrombolytic agent outlet 122 is disposed on the outer peripheral side of the outer chamber 12 and is only disposed at the catheter at the thrombolytic site.

[0035] In some embodiments, the thrombolytic agent outlet 122 may have different apertures according to the different pressures at different positions of the thrombolytic catheter 10 , thereby controlling the flow rate of the thrombolytic agent output at different positions of the thrombolytic catheter 10 .

[0036] In some embodiments, at least two bosses 13 are further provided in the inner chamber 11. The at least two bosses 13 are located between the inner side wall of the inner chamber 11 and the outer side wall of the ultrasonic unit 20, and are arranged at intervals around the circumference of the inner chamber 11. In this way, not only can a gap be formed between the inner side wall of the inner chamber 11 and the outer side wall of the ultrasonic unit 10 by the bosses 13, but the gap can also be divided into different gap chambers by adjacent bosses 13. The gap chamber is suitable for serving as a coolant channel 14.

[0037] In a specific implementation, the coolant channel 14 extends along the axial direction of the thrombolytic catheter 10 and is suitable for receiving and accommodating the coolant, so as to cool the ultrasonic unit 20 disposed in the inner chamber 11, thereby maintaining a constant temperature during the implementation process of ultrasonic shear thrombolysis.

[0038] In a specific implementation, the thrombolytic catheter 10 further includes a coolant inlet 141 and a coolant outlet. The coolant inlet 141 can be located at one end, i.e., the rear end, of the coolant channel 14 to receive the coolant; the coolant outlet can be located at the other end, i.e., the front end, of the coolant channel 14, close to the thrombolytic site.

[0039] In some embodiments, four bosses 13 may be provided around the circumference of the inner chamber 11 to form four coolant channels 14 evenly arranged on the outer circumference of the ultrasonic unit 20 , thereby evenly cooling the ultrasonic unit 20 .

[0040] In some embodiments, the thrombolytic agent inlet 121 and the coolant inlet 141 can be controlled to be delivered to the thrombolytic catheter 10 at a certain flow rate, so as to make the ultrasonic thrombolysis process more stable.

[0041] In a specific implementation, the thrombolytic catheter 10 can be made of a material with sufficient flexibility, kink resistance, and rigidity, and its structural strength can be sufficient to support its movement to the thrombolytic site.

[0042] In some embodiments, the thrombolytic catheter 10 may be made of materials such as polytetrafluoroethylene, polyethylene, or polyamide.

[0043] Reference Figure 3 In some embodiments, the ultrasound unit 20 may include an ultrasound catheter 22 extending along the axial direction of the thrombolytic catheter 10, an ultrasound core part 21 disposed in the ultrasound catheter 22, and an insulating sealing layer 23 infused between the ultrasound core part 21 and the ultrasound catheter 22. The ultrasound core part 21 includes an ultrasound element 211.

[0044] In a specific implementation, at least two ultrasonic elements 211 are provided, and the at least two ultrasonic elements 211 can be randomly combined in any number.

[0045] In a specific implementation, each of the at least two ultrasonic elements 211 may be in any shape, such as a concentric cylinder, a circular tube, a thin plate, or a triangle.

[0046] In some embodiments, the ultrasonic elements 211 may also be arranged into an ultrasonic element array.

[0047] When the ultrasonic elements 211 are arranged into an ultrasonic element array, ultrasonic elements 211 with a smaller volume may be selected for implementation to save space.

[0048] Reference Figure 4 In some embodiments, the ultrasonic element 211 may be a piezoelectric ceramic thin plate, and the piezoelectric ceramic thin plates may be arranged into a three-dimensional ultrasonic element array. For example, a 2x2x2 three-dimensional ultrasonic element array may be arranged. In this way, it is beneficial to radiate ultrasonic waves to all sides, so as to improve the ability of ultrasonic thrombolysis to destroy the target object.

[0049] In some embodiments, the ultrasonic core part 21 may include at least two ultrasonic element arrays connected in series along the axial direction of the thrombolytic catheter 10. For example, the ultrasonic core part 21 may include four three-dimensional ultrasonic element arrays connected in series along the axial direction of the thrombolytic catheter 10. In this way, the destructive ability of ultrasonic thrombolysis on the target object can also be improved.

[0050] In a specific implementation, the ultrasonic core part 21 further includes a negative electrode plate 212. The negative electrode plate 212 is suitable for being connected to each ultrasonic element 211 respectively.

[0051] As mentioned above, the ultrasonic elements 211 can be arranged into a three-dimensional ultrasonic element array. In this case, the negative electrode plate 212 is suitable for being arranged in the middle of the three-dimensional ultrasonic element array along the axial direction and connected to each ultrasonic element 211 on both sides thereof.

[0052] In a specific implementation, the ultrasonic core part 21 further includes a soft decoupling medium 213 to connect the ultrasonic elements 211 and enable the connected ultrasonic elements 211 to vibrate independently of each other, thereby radiating ultrasonic waves to the surroundings respectively.

[0053] In the embodiment of the present invention, there is an ultrasonic emission phase difference between adjacent ultrasonic elements 211 of at least two independently vibrating ultrasonic elements 211. In this way, an ultrasonic shearing effect can be generated during thrombus ablation, that is, the shearing effect can be increased while ultrasonic thrombolysis is performed.

[0054] When there is an ultrasonic emission phase difference between adjacent ultrasonic elements 211 (ie, adjacent ultrasonic elements 211 have different phase angles), shear force will be formed in the sound field area generated by adjacent ultrasonic elements 211. The formation of shear force during ultrasonic thrombolysis can greatly improve the destructive ability of the target object.

[0055] In some embodiments, the ultrasonic emission phase difference between adjacent ultrasonic elements 211 may be a value corresponding to a half wavelength or a quarter wavelength, so as to enhance the shear effect.

[0056] In a specific implementation, the ultrasonic shearing thrombolytic device 10 may further include a host 30. The host 30 is connected to the ultrasonic core part 21 in the ultrasonic unit 20, and is adapted to allow adjacent ultrasonic elements 211 to have an ultrasonic emission phase difference.

[0057] In a specific implementation, the phase control technology for enabling the adjacent ultrasonic elements 211 to have an ultrasonic emission phase difference through the host 30 can be implemented by any known and applicable technical means in the art, which is not limited here.

[0058] In some embodiments, the host 30 may further include a frequency and power amplifier control module to drive the ultrasonic unit 20 to generate ultrasonic waves of a certain frequency and power.

[0059] In some embodiments, the host 30 may further include a software module connected to the frequency and power amplifier control module to achieve adaptive power output of the ultrasound unit 20, thereby making the implementation process of ultrasonic shear thrombolysis safer and more stable.

[0060] In some embodiments, there may be a certain distance difference between adjacent ultrasonic elements 211 , and the distance difference causes a phase difference to occur between the adjacent ultrasonic elements 211 .

[0061] The ultrasonic shearing thrombolysis device 1 provided in the embodiment of the present invention is suitable for performing ultrasonic shearing thrombolysis on various types of thrombi.

[0062] The following is an explanation of the implementation process of the intravascular thrombolysis operation by the ultrasonic shearing thrombolysis device 1 proposed in the embodiment of the present invention. Specifically, the following steps are included:

[0063] Step S1: first insert a guidewire through the blood vessel to reach the thrombus location; then guide and insert the thrombolytic catheter 10 through the guidewire; and then remove the guidewire.

[0064] Step S2 : sleeve the ultrasonic unit 20 into the inner chamber 11 of the thrombolytic catheter 10 along the axial direction of the thrombolytic catheter 10 until reaching the front end of the thrombolytic catheter 10 .

[0065] Step S3: inject the thrombolytic agent into the outer chamber 12 from the thrombolytic agent inlet 121 at a certain flow rate, inject the coolant into the coolant channel 14 from the coolant inlet 141 at a certain flow rate, turn on the host 30 and drive the ultrasonic unit 20 to emit ultrasonic waves at a certain power.

[0066] Although specific embodiments have been described above, these embodiments are not intended to limit the scope of the present disclosure, even when only a single embodiment is described with respect to specific features. The feature examples provided in the present disclosure are intended to be illustrative rather than limiting, unless otherwise stated. In specific implementations, the technical features of one or more dependent claims may be combined with the technical features of the independent claims, based on actual needs and where technically feasible, and the technical features from the corresponding independent claims may be combined in any appropriate manner rather than just by the specific combinations listed in the claims.

[0067] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the scope defined by the claims.

Claims

1. An ultrasonic shearing thrombolysis device (1), characterized in that: The invention comprises a thrombolytic catheter (10) and an ultrasonic unit (20) sleeved in the thrombolytic catheter (10); the thrombolytic catheter (10) is suitable for delivering a thrombolytic agent to a thrombolytic site to ablate a thrombus; the ultrasonic unit (20) comprises at least two ultrasonic elements (211) that vibrate independently of each other, and there is a distance difference between adjacent ultrasonic elements (211), and the distance difference causes a phase difference between the adjacent ultrasonic elements (211) to generate an ultrasonic shearing effect when ablating a thrombus; at least two of the ultrasonic elements (211) are arranged in an ultrasonic array, and adjacent ultrasonic elements (211) in the ultrasonic element array are connected by a decoupling medium (213) so that each ultrasonic element (211) vibrates independently of each other, and the ultrasonic array is also connected to a negative plate (212) and is symmetrically distributed relative to the negative plate (212).

2. The ultrasonic shearing thrombolysis device (1) according to claim 1, characterized in that: The ultrasonic unit (20) comprises an ultrasonic catheter (22) extending along the axial direction of the thrombolytic catheter (10), an ultrasonic core part (21) arranged in the ultrasonic catheter (22), and an insulating sealing layer (23) infused between the ultrasonic core part (21) and the ultrasonic catheter (22); the ultrasonic core part (21) comprises the ultrasonic element (211).

3. The ultrasonic shearing thrombolytic device (1) according to claim 1, characterized in that: The ultrasonic unit (20) comprises at least two ultrasonic element arrays connected in series along the axial direction of the thrombolytic catheter (10).

4. The ultrasonic shearing thrombolysis device (1) according to claim 1, characterized in that: The thrombolytic catheter (10) comprises an inner chamber (11) and an outer chamber (12) which are arranged in sequence from the inside to the outside along its radial direction; the inner chamber (11) extends along the axial direction of the thrombolytic catheter (10) and is suitable for accommodating the ultrasonic unit (20); the outer chamber (12) also extends along the axial direction of the thrombolytic catheter (10) and is provided with at least one circumferentially around the inner chamber (11), which is suitable for delivering the thrombolytic agent.

5. The ultrasonic shearing thrombolytic device (1) according to claim 4, characterized in that: The ultrasonic unit (20) is adapted to move relative to the inner chamber (11) along the axial direction of the thrombolytic catheter (10) to reach the thrombolytic site.

6. The ultrasonic shearing thrombolytic device (1) according to claim 4, characterized in that: The thrombolytic catheter (10) comprises a thrombolytic agent inlet (121) and a thrombolytic agent outlet (122); the thrombolytic agent inlet (121) is located at one end of the outer chamber (12) to receive the thrombolytic agent; the thrombolytic agent outlet (122) is arranged on the outer peripheral side of the outer chamber (12) to output the thrombolytic agent.

7. The ultrasonic shearing thrombolytic device (1) according to claim 4, characterized in that: At least two bosses (13) are provided in the inner chamber (11); the at least two bosses (13) are arranged at intervals around the circumference of the inner chamber (11) between the inner wall of the inner chamber (11) and the outer wall of the ultrasonic unit (20), so that a coolant channel (14) is formed between the inner wall of the inner chamber (11) and the outer wall of the ultrasonic unit (20); the coolant channel (14) extends along the axial direction of the thrombolytic catheter (10) and is suitable for receiving a coolant to cool the ultrasonic unit (20).

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