Catheter, thrombolytic device, and fluid control method

Abstract

The application discloses a catheter, a thrombolytic device and a fluid control method, and belongs to the field of medical devices. The catheter comprises: an elongated tubular body for percutaneous placement in a body lumen of a target object; the inside of the elongated tubular body is used for arranging an energy source member; the elongated tubular body comprises a delivery lumen, a first lumen and a second lumen; the delivery lumen is used for conveying a first fluid; the elongated tubular body has a distal region provided with a delivery port; one end of the delivery port is in communication with the body lumen, and the other end is in communication with the delivery lumen to convey the first fluid into the body lumen; at least one of the first lumen and the second lumen is arranged around the outer periphery of the energy source member, and the first lumen and the second lumen are in fluid communication at the distal region to flow a second fluid for cooling the energy source member between the first lumen and the second lumen. The technical scheme provided by the application can control the temperature of the energy source and reduce the influence of heat generation of the energy source on the activity of the drug.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a catheter, a thrombolytic device, and a fluid control method. Background Technology

[0002] Thrombosis is a medical condition caused by the formation of a blood clot or thrombus within a blood vessel. Thrombi often form in valves, the legs, or other parts of the lower abdomen (i.e., deep vein thrombosis), but can also occur in other blood vessels. The formation of thrombi and the accumulation of plaque can lead to stroke or embolism, which can cause serious health problems, including death. For some thrombotic blockages, surgical intervention using a thrombolytic catheter may be necessary to remove the thrombus, plaque, or both from the blood vessel.

[0003] In related technologies, multiple drug delivery ports are created on the distal sidewall of the thrombolytic catheter within the body to achieve local drug release at the target site. To enhance the thrombolytic effect, the thrombolytic catheter also includes an ultrasound component configured to generate ultrasound energy. The ultrasound energy generated when the ultrasound component is in operation can enhance the therapeutic effect of the drug on the thrombus. However, the ultrasound component also generates a large amount of heat energy when in operation, which not only causes the temperature of the thrombolytic catheter to rise but also causes the ultrasound energy to decrease. Therefore, it is also necessary to deliver a fluid to the thrombolytic catheter to cool the ultrasound component. The coolant flows in from the proximal side of the catheter and can flow into the body from the distal opening of the catheter.

[0004] In the aforementioned related technologies, since the fluid used to cool the ultrasonic component flows directly into the human blood vessels from the distal opening of the catheter, its flow rate is limited, resulting in a limited cooling effect on the ultrasonic component. Furthermore, excessive flow of cooling fluid may have adverse effects on the human body.

[0005] In addition, the temperature of the drug solution in the thrombolytic catheter is affected by both the body temperature and the temperature of the ultrasound components, making it difficult to control the drug solution temperature within the ideal range that maximizes drug activity. Summary of the Invention

[0006] This application provides a catheter, a thrombolytic device, and a fluid control method that can improve the cooling efficiency of the energy source component, reduce the impact of heat generation from the energy source component on drug activity, and increase the energy emitted by the energy source component.

[0007] According to one aspect of the embodiments of this application, a catheter is provided, the catheter comprising:

[0008] A slender tubular body is used for percutaneous insertion into a target body cavity; the interior of the slender tubular body is used to insert an energy source component; the slender tubular body includes a delivery cavity, a first cavity, and a second cavity;

[0009] The delivery lumen is used to deliver the first fluid;

[0010] The elongated tubular body has a distal region, and the distal region is provided with a delivery port; one end of the delivery port is connected to the body lumen, and the other end is connected to the delivery lumen, so as to deliver the first fluid into the body lumen;

[0011] At least one of the first cavity and the second cavity is disposed around the outer periphery of the energy source component, and the first cavity and the second cavity are in fluid communication in the distal region to allow a second fluid for cooling the energy source component to flow between the first cavity and the second cavity.

[0012] In an exemplary embodiment, the number of delivery lumens is multiple, and the multiple delivery lumens include at least a first delivery lumen and a second delivery lumen;

[0013] The first delivery lumen and the second delivery lumen are in fluid communication in the distal region to allow the first fluid to flow between the first delivery lumen and the second delivery lumen; and / or,

[0014] A first tube wall is provided between the first delivery lumen and the second delivery lumen, and a first through hole is provided on the distal portion of the first tube wall; one end of the first through hole communicates with the first delivery lumen and the other end communicates with the second delivery lumen.

[0015] Wherein, one of the first delivery lumen and the second delivery lumen serves as the delivery channel for the first fluid to be delivered to the distal side of the catheter, and the other serves as the return channel for the first fluid to flow back from the distal side to the proximal side of the catheter.

[0016] In an exemplary embodiment, at least one of the first delivery lumen and the second delivery lumen is fluidly connected to a first temperature control component and / or a first temperature sensing component; the first temperature control component is used to control the first fluid within a first temperature range so that the drug in the first fluid remains at target activity; the first temperature sensing component is used to detect the temperature of the first fluid.

[0017] The first temperature control component includes a first temperature control element located inside the catheter and / or a second temperature control element located outside the catheter; the first temperature control element includes a temperature control element passing through the first delivery lumen and / or the second delivery lumen; the second temperature control element includes a temperature control element disposed in a first external conduit, wherein the first external conduit refers to an external fluid conduit communicating with the first delivery lumen and / or the second delivery lumen.

[0018] The first temperature measuring component includes a first temperature measuring element located inside the catheter and / or a second temperature measuring element located outside the catheter; the first temperature measuring element includes a temperature measuring element passing through the first delivery lumen and / or the second delivery lumen; the second temperature measuring element includes a temperature measuring element disposed in the first external pipeline.

[0019] In an exemplary embodiment, one of the first lumen and the second lumen serves as an infusion channel for the second fluid to be infused into the distal side of the catheter, and the other serves as a return channel for the second fluid to flow back from the distal side to the proximal side of the catheter.

[0020] Furthermore, a first tube wall is provided between the first tube lumen and the second tube lumen, and a first through hole is provided on the distal portion of the first tube wall; one end of the first through hole is connected to the first tube lumen, and the other end is connected to the second tube lumen.

[0021] In an exemplary embodiment, at least one of the first lumen and the second lumen is fluidly connected to a second temperature control component and / or a second temperature sensing component; the second temperature control component is used to control the energy source component to be within a second temperature range; the second temperature sensing component is used to detect the temperature of the second fluid and / or the energy source component.

[0022] The second temperature control component includes a third temperature control element located inside the conduit and / or a fourth temperature control element located outside the conduit; the third temperature control element includes a temperature control element passing through the first lumen and / or the second lumen; the fourth temperature control element includes a temperature control element disposed in a second external conduit, the second external conduit being a fluid conduit external to the conduit that communicates with the first lumen and / or the second lumen, and the fourth temperature control element is used to control at least one of the flow rate and temperature of the second fluid, so that the energy source component is within the second temperature range;

[0023] The second temperature measuring component includes a third temperature measuring element located inside the conduit and / or a fourth temperature measuring element located outside the conduit; the third temperature measuring element includes a temperature measuring element passing through the first lumen and / or the second lumen; the fourth temperature measuring element includes a temperature measuring element disposed in the second external conduit.

[0024] In an exemplary embodiment, the energy source component is disposed within the first cavity, and a fluid gap is provided between the outer wall of the energy source component and the inner wall of the first cavity. The fluid gap is used to provide a flow channel for the second fluid within the first cavity, and the fluid gap and the second cavity are in fluid communication in the distal region. A first region is formed between the inner wall of the first cavity and the outer wall of the elongated tubular body, and the second cavity and the delivery cavity are located in the first region.

[0025] Alternatively, the energy source component has a first annular region on its outer periphery, the first cavity and the second cavity are located within the first annular region, the cross-section of the first cavity is circular, fan-shaped, waist-shaped or crescent-shaped, and the cross-section of the second cavity is circular, fan-shaped, waist-shaped or crescent-shaped; the delivery cavity is located within the first annular region or within the second annular region, the second annular region being located between the first annular region and the outer wall of the elongated tubular body.

[0026] In an exemplary embodiment, the elongated tubular body is further provided with a guide wire cavity for threading a guide wire;

[0027] The guidewire lumen extends through the distal end of the elongated tubular body; the diameter of the distal end gradually decreases from the proximal side to the distal side along the axial direction, and the distal opening of the guidewire lumen is located in the axial region of the distal end or on the sidewall of the distal end.

[0028] Alternatively, one of the delivery lumen, the first lumen, and the second lumen may serve as the guidewire lumen, the distal end of which has a sealing structure; wherein the sealing structure has a first configuration in which the guidewire can slide axially through the sealing structure; after the guidewire is withdrawn from the sealing structure, the sealing structure has a second configuration in which the sealing structure is used to seal the first fluid and / or the second fluid.

[0029] In an exemplary embodiment, the energy source component includes an ultrasonic transducer and / or an ultrasonic guidewire;

[0030] The energy source component is fixedly connected to the interior of the elongated tubular body, or the energy source component can be axially slidably inserted into the interior of the elongated tubular body.

[0031] According to one aspect of the embodiments of this application, a thrombolytic device is provided, the thrombolytic device comprising:

[0032] The catheter as described in any of the embodiments above;

[0033] The energy source component is fixedly connected to the interior of the elongated tubular body, or the energy source component can be axially slidably inserted into the interior of the elongated tubular body;

[0034] A handle assembly for coupling to the proximal end of the catheter; the handle assembly is connected to a delivery tube, a first tube, and a second tube; wherein the delivery tube communicates with the lumen of the delivery tube, the first tube communicates with the first lumen, and the second tube communicates with the second lumen;

[0035] One of the first tube and the second tube is used to infuse the second fluid into the catheter, and the other is used to receive the second fluid flowing back from the distal to the proximal side of the catheter.

[0036] In an exemplary embodiment, the number of delivery lumens is multiple, and the multiple delivery lumens include at least a first delivery lumen and a second delivery lumen, wherein the first delivery lumen and the second delivery lumen are in fluid communication in the distal region;

[0037] The number of delivery tubes is multiple, and the multiple delivery tubes include at least a first delivery tube and a second delivery tube, wherein the first delivery tube is in communication with the first delivery lumen, and the second delivery tube is in communication with the second delivery lumen;

[0038] One of the first delivery tube and the second delivery tube is used to infuse the first fluid into the catheter, and the other is used to receive the first fluid flowing back from the distal to the proximal side of the catheter.

[0039] According to one aspect of the embodiments of this application, a fluid control method is provided, the method being applied to the above-mentioned thrombolytic device, the method comprising:

[0040] Obtain the first temperature information corresponding to the second fluid and / or the second temperature information corresponding to the energy source component;

[0041] Based on the first temperature information and / or the second temperature information, drive the second temperature control component to control the temperature of the second fluid and / or the flow rate of the second fluid, and / or control the output power of the energy source component, so as to control the working environment of the energy source component to meet the target temperature conditions;

[0042] The target temperature condition includes a first temperature condition and / or a second temperature condition. The first temperature condition refers to the target control condition that controls the temperature of the energy source component to be within a second temperature range, and the second temperature condition refers to the target control condition that controls the temperature of the second fluid to be within a third temperature range.

[0043] The thrombolytic device includes a second temperature control component, or the thrombolytic device is connected to the second temperature control component; the second temperature control component includes at least one of a cooling element, a heating element, and a flow control element.

[0044] In an exemplary embodiment, the method further includes:

[0045] Obtain the third temperature information corresponding to the first fluid;

[0046] Based on the third temperature information, the first temperature control component is driven to control the temperature and / or flow rate of the first fluid, and / or the output power of the energy source component is controlled to ensure that the drug in the first fluid meets the target infusion conditions.

[0047] The target infusion conditions include a first infusion condition and / or a second infusion condition. The first infusion condition refers to the target control condition that controls the first fluid within a first temperature range, and the drug maintains its target activity within the first temperature range. The second infusion condition refers to the target control condition that controls the first fluid at a target infusion flow rate.

[0048] The thrombolytic device includes the first temperature control component, or the thrombolytic device is connected to the first temperature control component; the first temperature control component includes at least one of the cooling element, the heating element, and the flow control element.

[0049] In an exemplary embodiment, the flow rate of the first fluid includes at least one of a first infusion flow rate, a second infusion flow rate, and a return flow rate;

[0050] When the first fluid is flowing unidirectionally inside the delivery cavity, the first infusion flow rate is used to characterize the flow rate of the first fluid being infused outside the delivery cavity when it is flowing unidirectionally.

[0051] When the first fluid is in a backflow flow inside the delivery lumen, the second infusion flow rate is used to characterize the flow rate of the first fluid being infused outside the delivery lumen during the backflow flow, and the backflow flow rate is used to characterize the flow rate of the portion of the first fluid that flows back from the distal side to the proximal side of the delivery lumen.

[0052] In an exemplary embodiment, driving the first temperature control component to control the temperature and / or flow rate of the first fluid based on the third temperature information includes:

[0053] If the third temperature information indicates that the temperature of the first fluid exceeds the first temperature range, the first temperature control component is driven to adjust the temperature of the first fluid toward the direction closer to the first temperature range, and / or the infusion flow rate of the first fluid is increased, wherein the infusion flow rate refers to the flow rate of the first fluid infused outside the delivery lumen.

[0054] According to one aspect of the embodiments of this application, a fluid control device is provided, the device comprising:

[0055] A temperature acquisition module is used to acquire first temperature information corresponding to the second fluid and / or second temperature information corresponding to the energy source component;

[0056] The fluid control module is used to drive the second temperature control component to control the temperature and / or flow rate of the second fluid based on the first temperature information and / or the second temperature information, and / or to control the output power of the energy source component so as to control the working environment of the energy source component to meet the target temperature conditions.

[0057] The target temperature condition includes a first temperature condition and / or a second temperature condition. The first temperature condition refers to the target control condition that controls the temperature of the energy source component to be within a second temperature range, and the second temperature condition refers to the target control condition that controls the temperature of the second fluid to be within a third temperature range.

[0058] The thrombolytic device includes a second temperature control component, or the thrombolytic device is connected to the second temperature control component; the second temperature control component includes at least one of a cooling element, a heating element, and a flow control element.

[0059] According to one aspect of the embodiments of this application, a computer device is provided, the computer device including a processor and a memory, the memory storing at least one instruction, at least one program, code set or instruction set, the at least one instruction, the at least one program, the code set or instruction set being loaded and executed by the processor to implement the above-described fluid control method.

[0060] According to one aspect of the embodiments of this application, a computer-readable storage medium is provided, the storage medium storing at least one instruction, at least one program, code set or instruction set, wherein the at least one instruction, the at least one program, the code set or instruction set is loaded and executed by a processor to implement the above-described fluid control method.

[0061] According to one aspect of the embodiments of this application, a computer program product is provided, the computer program product including computer instructions stored in a computer-readable storage medium. A processor of a computer device reads the computer instructions from the computer-readable storage medium, and the processor executes the computer instructions, causing the computer device to perform to implement the above-described fluid control method.

[0062] The technical solution provided in this application can bring the following beneficial effects:

[0063] By incorporating a separate delivery lumen within the catheter body to deliver the first fluid, the first fluid can be delivered into the body's lumen through the distal delivery port of the catheter, thereby treating any blockage within the lumen. Separate first and second lumens, independent of the delivery lumen, are also incorporated within the catheter body to allow for the flow of a second fluid used to cool the energy source component. At least one of the first and second lumens is positioned around the periphery of the energy source component. The second fluid effectively removes heat generated by the energy source component and flows proximally from one of the first and second lumens. This effectively cools the energy source component, maintaining it at optimal energy emission efficiency, while also reducing the temperature impact of the energy source component's heat on the first fluid. This helps maintain the first fluid within its set range to preserve its drug activity, thereby shortening thrombolysis time and comprehensively improving thrombolysis efficiency and effect. Furthermore, the second fluid used to cool the energy source component flows between the first and second lumens, preventing it from flowing out of the catheter in the distal region, thus reducing the amount of fluid entering the body, making it safer, and preventing a decrease in drug concentration in the first fluid, effectively preventing a decline in thrombolysis effect due to reduced drug concentration. Attached Figure Description

[0064] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0065] Figure 1 This is a schematic diagram of a first thrombolytic device provided in one embodiment of this application;

[0066] Figure 2 This is a schematic cross-sectional view of a first conduit provided in one embodiment of this application;

[0067] Figure 3 This is a schematic diagram of the working principle of an ultrasonic transducer conduit provided in one embodiment of this application;

[0068] Figure 4 This is a first schematic diagram of a split-type thrombolytic device provided in one embodiment of this application;

[0069] Figure 5 This is a second schematic diagram of a split-type thrombolytic device provided in one embodiment of this application;

[0070] Figure 6 This is a cross-sectional schematic diagram of a second conduit provided in one embodiment of this application;

[0071] Figure 7This is a cross-sectional schematic diagram of a third conduit provided in one embodiment of this application;

[0072] Figure 8 This is a cross-sectional schematic diagram of a fourth catheter provided in one embodiment of this application;

[0073] Figure 9 This is a schematic cross-sectional view of an ultrasonic guidewire catheter provided in one embodiment of this application;

[0074] Figure 10 This is a schematic diagram illustrating the working principle of an ultrasonic guidewire catheter provided in one embodiment of this application;

[0075] Figure 11 This is a cross-sectional schematic diagram of the fifth catheter provided in one embodiment of this application;

[0076] Figure 12 This is a cross-sectional schematic diagram of the sixth catheter provided in one embodiment of this application;

[0077] Figure 13 This is a schematic diagram of a second thrombolytic device provided in one embodiment of this application;

[0078] Figure 14 This is a cross-sectional schematic diagram of a seventh catheter provided in one embodiment of this application;

[0079] Figure 15 This is a flowchart of a fluid control method provided in one embodiment of this application. Figure 1 ;

[0080] Figure 16 This is a flow chart of a fluid control method provided in another embodiment of this application. Figure 2 ;

[0081] Figure 17 A block diagram of a fluid control device according to one embodiment of this application is shown;

[0082] Figure 18 A schematic diagram of the system structure of a thrombolysis system provided in one embodiment of this application is shown. Figure 1 ;

[0083] Figure 19 A schematic diagram of the system structure of a thrombolysis system provided in one embodiment of this application is shown. Figure 2 ;

[0084] Figure 20 A schematic diagram of the system structure of a thrombolysis system provided in one embodiment of this application is shown. Figure 3 ;

[0085] Figure 21 This application illustrates a schematic diagram of the control logic of a thrombolysis system provided in one embodiment. Figure 1 ;

[0086] Figure 22 A schematic diagram of the system structure of a thrombolysis system provided in one embodiment of this application is shown. Figure 4 ;

[0087] Figure 23 This application illustrates a schematic diagram of the control logic of a thrombolysis system provided in one embodiment. Figure 2 ;

[0088] Figure 24 A schematic diagram of the system structure of a thrombolysis system provided in one embodiment of this application is shown. Figure 5 ;

[0089] Figure 25 This application illustrates a schematic diagram of the control logic of a thrombolysis system provided in one embodiment. Figure 3 ;

[0090] Figure 26 This is a structural block diagram of a computer device provided in one embodiment of this application. Detailed Implementation

[0091] To make the objectives, technical solutions, and advantages of this application clearer, the embodiments of this application will be described in further detail below with reference to the accompanying drawings.

[0092] The thrombolytic device disclosed in this application is designed to deliver a therapeutic compound and transmit therapeutic energy within a body lumen to dissolve blockages, such as thrombi, located in obstructed areas within the body lumen. As used herein, the term "therapeutic compound" broadly refers to, but is not limited to, drugs, pharmaceuticals, dissolving compounds, genetic material, anticancer drugs, or any other substance capable of influencing physiological function. Furthermore, any mixture of any such substances and any substance falling within the general meaning of these terms is included within this definition of "therapeutic compound."

[0093] In an exemplary embodiment, please refer to Figure 1 , Figure 1 This is a schematic diagram of a thrombolytic device provided in one embodiment of this application. Figure 1 As shown, the thrombolytic device 100 includes a catheter 110, an energy source component (not shown in the figure), and a handle assembly 120.

[0094] The catheter 110 is designed as an elongated member to be inserted into the location of an obstruction within a body lumen. In an exemplary embodiment, as... Figure 2As shown, catheter 110 includes an elongated tubular body 111 having a proximal region 112 and a distal region 113. This elongated tubular body 111 is percutaneously inserted into a target body lumen so that the distal region 113 reaches the obstruction site within the body lumen. The distal region 113 is provided with a delivery port 114. A therapeutic compound within catheter 110 can flow out from the delivery port 114 and act on the obstruction site within the body lumen.

[0095] The interior of the aforementioned elongated tubular body 111 is used to house the energy source component 130. For example... Figure 3 As shown, when the catheter 110 reaches the thrombus region 210 within the body lumen 200, the therapeutic compound 300 can flow from the delivery port 114 into the thrombus region 210 to dissolve the thrombus in the thrombus region 210. Simultaneously, an energy source component 130 is inserted into the lumen of the catheter 110, and its transducer 131 can emit therapeutic energy, such as ultrasonic wave energy, to enhance the therapeutic effect of the therapeutic compound 300 at the thrombus region 210.

[0096] Optionally, the energy source component 130 may include an ultrasonic transducer and / or an ultrasonic guidewire.

[0097] Optionally, the energy source component 130 is fixedly connected to the interior of the elongated tubular body 111, or the energy source component can be axially slidably inserted into the interior of the elongated tubular body.

[0098] In one possible implementation, the energy source component 130 can be fixedly connected to the internal cavity of the elongated tubular body 111, for example, as... Figure 2 As shown, the energy source component 130 can be fixedly connected to the first lumen 102 described below. A fixed connection structure can exist between the energy source component 130 and the first lumen 102 to fix the energy source component 130 inside the elongated tubular body 111. The energy source component 130 is inserted into the body lumen of the target object synchronously with the conduit 110.

[0099] In another possible implementation, the energy source component 130 is axially slidable within the interior of the elongated tubular body 111. In one example, such as Figure 4 As shown, in addition to the catheter 100 and handle assembly 120, the thrombolysis device 100 also includes a separate power source component 130. Figure 4In this embodiment, the energy source component 130 is an ultrasonic tube that can be inserted into the conduit 110 from the outside. The proximal end of the aforementioned handle assembly includes a first interface 124 that mates with the energy source component 130. The proximal end of the energy source component 130 can be inserted into the lumen of the conduit 110 through the first interface 124. After the energy source component 130 is inserted into place, it can lock the first interface 124. For example, the first interface 124 may be equipped with a locking structure, which could be a Luer structure or other locking structures; this embodiment does not limit this. Figure 5 As shown, the energy source component 130 is inserted into the conduit 110 through the first interface 124 and locked with the first interface 124.

[0100] Optionally, the aforementioned elongated tubular body 111 includes a delivery lumen 101, a first lumen 102, and a second lumen 103. The delivery lumen 101 is used to deliver a first fluid, which includes a therapeutic compound. The first fluid within the delivery lumen 101 flows out of the catheter 110 through a delivery port 114. Figure 4 As shown, one end of the delivery port 114 is connected to the body lumen, and the other end is connected to the delivery lumen 101 to deliver the first fluid into the body lumen.

[0101] To cool the heat-generating energy source component 130, a second fluid flows in the first cavity 102 and the second cavity 103, such as... Figure 6 or Figure 7 As shown, at least one of the first cavity 102 and the second cavity 103 is arranged around the outer periphery of the energy source component 130. The first cavity 102 and the second cavity 103 are in fluid communication in the distal region, so that a second fluid for cooling the energy source component flows between the first cavity and the second cavity, thereby cooling the energy source component 130 on the outer periphery of the energy source component 130, removing excess heat generated by the energy source component 130 during operation, and keeping it at a better operating temperature.

[0102] Optionally, a second tube wall 115 is provided between the first tube 102 and the second tube 103, and a second through hole 116 is provided on the distal part of the second tube wall 115; one end of the second through hole 116 is connected to the first tube 102 and the other end is connected to the second tube 103.

[0103] The handle assembly 120 is used for proximal coupling with the catheter 110; the handle assembly 120 is connected to a delivery tube 121, a first tube 122, and a second tube 123; wherein, the delivery tube 121 is connected to the delivery lumen 101, the first tube 122 is connected to the first lumen 102, and the second tube 123 is connected to the second lumen 103.

[0104] One of the first tube 122 and the second tube 123 is used to inject the second fluid into the conduit 110, and the other is used to receive the second fluid flowing back from the distal side to the proximal side of the conduit 110.

[0105] Accordingly, one of the first lumen 102 and the second lumen 103 serves as an infusion channel for the second fluid to be infused to the distal side of the catheter 110, and the other serves as a return channel for the second fluid to flow back from the distal side to the proximal side of the catheter 110. Figure 2 Arrow 1a in the diagram exemplarily illustrates a flow path of a second fluid, wherein the first cavity 102 serves as an injection channel for the second fluid to be injected into the distal side of the conduit 110, and the second cavity 103 serves as a return channel for the second fluid to flow back from the distal side to the proximal side of the conduit 110. The second fluid flows from the proximal side to the distal side in the first cavity 102, and when it flows through the second through hole 116, it enters the second cavity 103 through the second through hole 116 and flows back to the proximal side in the second cavity 103, thereby achieving cooling of the energy source component 130 and completely removing heat from the distal region 113 and returning it to the proximal region 112.

[0106] In the technical solution provided in this application embodiment, by setting an independent delivery lumen in the catheter body to deliver the first fluid, the first fluid in the catheter can be delivered into the body lumen through the delivery port on the distal side of the catheter to achieve treatment of the blockage location in the body lumen; by setting a first lumen and a second lumen independent of the delivery lumen in the catheter body, a second fluid for cooling the energy source component can flow, and at least one of the first lumen and the second lumen is arranged around the outer periphery of the energy source component, the second fluid can effectively remove the heat energy generated by the energy source component and flow proximally from one of the first lumen and the second lumen, so as to effectively cool the energy source component and maintain it at the optimal energy emission efficiency, while also reducing the temperature impact of the heat generated by the energy source component on the first fluid, making it easier for the first fluid to be maintained within its set range to maintain good drug activity, thereby reducing the thrombolysis time and comprehensively improving the thrombolysis efficiency and thrombolysis effect. Furthermore, the second fluid used to cool the energy source components flows between the first and second lumens, without flowing out of the catheter in the distal region, reducing the amount of fluid entering the human body, making it safer for the human body, and does not reduce the drug concentration in the first fluid, effectively preventing the thrombolytic effect from decreasing due to the reduced drug concentration.

[0107] The first cavity 102 or the second cavity 103 mentioned above can be an independent cavity separate from the energy source component 130, or it can be a cavity used to pass through the energy source component. This application does not limit the configuration relationship between the energy source component 130 and the cavity of the second fluid.

[0108] In one possible implementation, the energy source component 130 is disposed through the first cavity 102 or the second cavity 103. For example... Figure 2 As shown, the energy source component 130 is disposed within the first cavity 102. A fluid gap 117 is provided between the outer wall of the energy source component 130 and the inner wall of the first cavity 102. The fluid gap 117 is used to provide a flow channel for the second fluid within the first cavity 102. The fluid gap 117 is in fluid communication with the second cavity 103 in the distal region. Specifically, the fluid gap 117 is in fluid communication with the second cavity 103 in the distal region through the second through hole 116.

[0109] In this case, such as Figure 6 As shown, a first region 118 is formed between the inner wall of the first lumen 102 and the outer wall 111 of the elongated tubular body, and the second lumen 103 and the delivery lumen 101 are located in the first region. Optionally, the second lumen 103 and the delivery lumen 101 are circumferentially spaced within the first region 118.

[0110] In another possible implementation, the first cavity 102 and the second cavity 103 are independent cavities separate from the energy source component 130 and are arranged around the outer periphery of the energy source component 130.

[0111] In one example, such as Figure 7 As shown, the energy source component 130 has a first annular region 119 on its outer periphery, and the first cavity 102 and the second cavity 103 are located within the first annular region 119.

[0112] Optionally, the cross-section of the first lumen is circular, fan-shaped, waist-shaped, or crescent-shaped, and the cross-section of the second lumen is circular, fan-shaped, waist-shaped, or crescent-shaped. Figure 7 In the example shown, the cross-sections of the first lumen 102 and the second lumen 103 are fan-shaped, dividing the first annular region 119 in two. Of course, there can be multiple pairs of first lumens 102 and second lumens 103, such as... Figure 8 As shown, the first annular region 119 includes two pairs of interconnected first lumens 102 and second lumens 103.

[0113] Optionally, the delivery lumen 101 is located within a first annular region 119 or within a second annular region 1110, the second annular region 1110 being situated between the first annular region 119 and the outer wall of the elongated tubular body 111. Figure 7 , Figure 8 In the example shown, the delivery lumen 101 is located within the second annular region 1110 and is crescent-shaped, curving inward toward the axis. Multiple delivery lumens 101 are distributed circumferentially within the second annular region 1110.

[0114] In another example, such as Figure 9 , Figure 10 As shown, the energy source component 130 is an ultrasonic guidewire inserted into the inner cavity of the elongated tubular body 111. With the energy source component 130 configured as an ultrasonic guidewire, the first annular region 119 between the energy source component 130 and the elongated tubular body 111, besides the first lumen 102 and the second lumen 103, can contain a delivery lumen 101 for transporting the first fluid. In this case, the delivery lumen 101 is located within the first annular region 119. The energy generating device of the ultrasonic guidewire is typically externally located. The ultrasonic guidewire primarily transmits the energy generated by the energy generating device through mechanical vibration. The vibration of the ultrasonic guidewire produces both transverse and longitudinal waves, thereby applying energy to the first fluid and improving drug delivery efficiency. During the vibration of the ultrasonic guidewire, there may not be significant heating; it mainly transmits mechanical vibration. At this time, the second fluid circulating in the first lumen 102 and the second lumen 103 can also be used to control the temperature of the first fluid, assisting in enhancing drug activity and achieving a better thrombolytic effect.

[0115] Optionally, a segmented drug delivery structure is provided in the distal region of the slender tubular body 111. The segmented drug delivery structure includes multiple drug delivery segments 81, each of which has a mesh-like porous structure, including multiple delivery ports 114 with pore sizes up to the micrometer level. To achieve micrometer-level port pore sizes, drug delivery ports need to be placed at intervals along the axial spatial distribution range to realize the segmented drug delivery structure. The intervals can be equidistant or gradually increasing according to the pressure relief law. Alternatively, laser drilling can be performed on a catheter with a certain strength, such as a hypotube, to achieve a micrometer-level microporous structure. In this case, the drug delivery ports are small enough to achieve a high drug delivery port injection pressure. Combined with ultrasonic energy, such as ultrasonic guide wires or transducers, even ultrasonic atomization drug delivery can be achieved.

[0116] To further enable temperature monitoring and / or temperature control of the second fluid, the aforementioned conduit device 100 may also include a temperature control component and a temperature measurement component. The temperature measurement component measures the fluid temperature, while the temperature control component controls the fluid temperature and / or flow rate.

[0117] In an exemplary embodiment, at least one of the first cavity 102 and the second cavity 103 is fluidly connected to the second temperature control component and / or the second temperature measuring component.

[0118] The second temperature control component is used to control the energy source component within a second temperature range. This second temperature range can be the desired operating temperature range for the ultrasonic transducer within the energy source component, within which the ultrasonic transducer exhibits better energy output. This application does not limit the second temperature range corresponding to the energy source component.

[0119] Optionally, the second temperature sensing element is used to detect the temperature of the second fluid and / or the energy source component. The second temperature sensing element can directly measure the temperature of the energy source component 130, or it can characterize the temperature of the energy source component 130 by measuring the temperature of the second fluid, or it can use the temperature of the second fluid as a reference for judging the energy source component 130.

[0120] Optionally, the second temperature control assembly includes a third temperature control element located inside the conduit and / or a fourth temperature control element located outside the conduit. The second fluid enters the first cavity 102 or the second cavity 103 from an external fluid supply device. For ease of explanation, this is illustrated by taking the example of the second fluid from the fluid supply device entering the first cavity 102 through the first pipe 122. After entering the first cavity 102 through the first pipe 122, the second fluid flows to the distal region and flows into the second cavity 103 through the second through hole 116 in the distal region, thereby flowing back to the proximal end through the second cavity 103 and being output externally from the third pipe 123, forming a flow path for the second fluid. This flow path has a portion located outside the conduit and a portion located inside the conduit; therefore, if the temperature of the second fluid is to be controlled, it can be controlled from outside and / or inside the conduit. At least one of the aforementioned third and fourth temperature control elements is required, and this embodiment of the application does not limit this.

[0121] A second external conduit connects the first pipe 122 and the third pipe 123. If the second external conduit is a closed loop, the flow path of the second fluid is a closed-loop path. If the second external conduit is a non-closed loop, for example, if the second fluid output from the third pipe 123 does not flow back to the first pipe 122 but enters the waste liquid tank, then the flow path of the second fluid is a remote return path. Both the closed-loop path and the remote return path can achieve the return of the second fluid in the region distal to the conduit, facilitating the control of the temperature of the energy source components.

[0122] Optionally, the third temperature control element includes a temperature control element that passes through the first lumen and / or the second lumen. If it is necessary to control the temperature of the second fluid within the conduit, then a temperature control element can be provided in at least one of the first lumen and / or the second lumen. Optionally, the aforementioned third temperature control element can be a heating element, a cooling element, or a combination of both; this application embodiment does not impose any limitations on this. Optionally, if the flow path of the second fluid is a closed-loop path, temperature control of the second fluid can be achieved by providing a temperature control element in at least one of the first lumen and the second lumen. If the flow path of the second fluid is a distal return path, it is preferable to provide a temperature control element in the infusion channel; it is also possible to provide a temperature control element in the distal portion of the return channel; this application embodiment does not impose any limitations on this.

[0123] Optionally, the fourth temperature control element includes a temperature control element disposed in the second external conduit. Optionally, the second external conduit refers to an external fluid conduit communicating with the first cavity and / or the second cavity. If the second fluid is controlled externally to cool the energy source component 130, in addition to directly controlling the temperature of the second fluid, the flow rate of the second fluid can also be controlled. A higher flow rate allows the second fluid to carry away more heat. Therefore, the fourth temperature control element is used to control at least one of the flow rate and temperature of the second fluid to keep the energy source component within a second temperature range. The fourth temperature control element can be a heating element, a cooling element, a flow control element, or any combination of the three; this application embodiment does not limit this.

[0124] Optionally, the second temperature sensing component includes a third temperature sensing element located inside the conduit and / or a fourth temperature sensing element located outside the conduit. Similar to temperature control, if it is desired to measure the temperature of the second fluid, it can also be measured from outside and / or inside the conduit.

[0125] Optionally, the third temperature sensing element includes a temperature sensing element that passes through the first lumen and / or the second lumen. In one example, such as Figure 7 As shown, temperature sensing elements 71 are provided in both the first cavity 102 and the second cavity 103. In another example, as... Figure 8 As shown, a temperature sensing element 71 is provided in the first cavity 102.

[0126] Optionally, the fourth temperature sensing element includes a temperature sensing element disposed in the second external pipeline.

[0127] The temperature sensing element mentioned above can be a thermocouple, and the embodiments of this application do not limit the type of temperature sensing element.

[0128] If the temperature control and sensing elements are installed in the external piping outside the conduit, the complexity of the conduit structure can be effectively reduced, thereby lowering consumable costs. If the temperature control and sensing elements are installed inside the conduit, the temperature of internal fluids and components, such as secondary fluids and energy source components, can be better controlled, ensuring they are in optimal working condition.

[0129] In an exemplary embodiment, the catheter described above needs to be inserted into the blocked area of ​​a body lumen under the guidance of a guidewire; therefore, as Figure 2 and Figure 11 As shown, the aforementioned elongated tubular body 111 is also provided with a guide wire cavity 140, which is used for threading a guide wire. Alternatively, as... Figure 6 , Figure 12 , Figure 14 As shown, cavity 61 can be used as an independent guidewire cavity.

[0130] Accordingly, such as Figure 1 , Figure 4 , Figure 5 As shown, the handle assembly 120 also includes a guide wire interface 125, through which the guide wire can be inserted into the guide wire cavity 140.

[0131] In one possible implementation, such as Figure 2 and Figure 11 As shown, the guidewire lumen 140 extends through the distal end 150 of the elongated tubular body 111. Optionally, the diameter of the distal end 150 gradually decreases axially from the proximal side to the distal side.

[0132] like Figure 2 As shown, the distal opening 141 of the guidewire cavity 140 is located in the axial region of the distal end 150, or, as... Figure 11 As shown, the distal opening 141 of the guidewire cavity 140 is formed on the sidewall 151 of the distal end 150.

[0133] In another possible implementation, one of the delivery lumen 101, the first lumen 102, and the second lumen 103 serves as a guidewire lumen, the distal end of which has a sealing structure; wherein the sealing structure has a first configuration in which the guidewire can slide axially through the sealing structure; after the guidewire is withdrawn from the sealing structure, the sealing structure has a second configuration in which the sealing structure is used to seal the first fluid and / or the second fluid.

[0134] For example, such as Figure 10As shown, the delivery lumen 101 can be used as a guidewire lumen. During the insertion of the catheter 110 into the body lumen under the guidance of the guidewire 9, the guidewire 9 passes through the delivery lumen 101. A sealing structure 91 is provided at the distal end of the delivery lumen 101. In a first configuration, the sealing structure 91 allows the guidewire 9 to pass through. After the guidewire 9 is withdrawn, the sealing structure 91 has a second configuration, in which it is used to seal the first fluid distally.

[0135] For example, the first cavity for inserting the energy source component serves as a guide wire cavity. The distal end of the first cavity has an opening to allow the guide wire to pass through the slender main component. The distal end of the energy source component and the distal opening of the first cavity form a sealing structure. In this first configuration, the energy source component is separated from the distal opening of the first cavity. The guide wire can pass through the distal opening of the first cavity, and the conduit, guided by the guide wire, can reach the blockage area. After the conduit reaches the blockage area, the guide wire can be withdrawn, and the energy source component can move distally and connect with the distal opening of the first cavity, thus forming a second configuration. In this second configuration, the distal opening of the first cavity is sealed by the distal end of the energy source component, for example, through a snap-fit ​​or magnetic adsorption. The second fluid flows back into the second cavity under this sealing to cool the energy source component. With this design, such as... Figure 6 , Figure 12 , Figure 14 As shown, cavity 61 may not be used as an independent guidewire cavity, but may be used as another second cavity for the return of the second fluid to improve the return efficiency of the second fluid, or as a delivery cavity. This application embodiment does not limit this.

[0136] For example, when one of the delivery lumen 101, the first lumen 102, and the second lumen 103 serves as the guidewire lumen, a slender sealing member is also inserted within the guidewire lumen. The distal end of the slender sealing member has a sealing portion. After the guidewire is withdrawn from the guidewire lumen, the slender sealing member can move to the distal end of the guidewire lumen. The sealing portion of the slender sealing member can engage with or magnetically attract the distal opening of the guidewire lumen to form the sealing structure of the second configuration described above. Optionally, the slender sealing member can be a guidewire with a sealing portion at its distal end.

[0137] In the aforementioned conduit, in addition to providing a first cavity 102 and a second cavity 103 capable of circulating and cooling the energy source component 130, the delivery cavity 101 can also be designed as a cavity with a circulation channel. In an exemplary embodiment, as... Figure 12 As shown, there are multiple delivery lumens 101, and the multiple delivery lumens 101 include at least a first delivery lumen 1011 and a second delivery lumen 1012.

[0138] The first delivery lumen 1011 and the second delivery lumen 1012 are in fluid communication in a distal region to allow the first fluid to flow between the first delivery lumen 1011 and the second delivery lumen 1012.

[0139] In one example, such as Figure 12 As shown, a first tube wall 160 is provided between the first delivery cavity 1011 and the second delivery cavity 1012, and a first through hole 170 is provided on the distal part of the first tube wall 160; one end of the first through hole 170 is connected to the first delivery cavity 1011, and the other end is connected to the second delivery cavity 1012.

[0140] One of the first delivery lumen 1011 and the second delivery lumen 1012 serves as an infusion channel for the first fluid to be infused into the distal side of the catheter 110, and the other serves as a return channel for the first fluid to flow back from the distal side to the proximal side of the catheter 110.

[0141] Correspondingly, such as Figure 13 As shown, the handle assembly 120 is connected to a plurality of delivery tubes 121, and the plurality of delivery tubes 121 include at least a first delivery tube 1211 and a second delivery tube 1212. The first delivery tube 1211 is connected to a first delivery lumen, and the second delivery tube 1212 is connected to a second delivery lumen.

[0142] One of the first delivery tube 1211 and the second delivery tube 1212 is used to deliver a first fluid into the catheter 110, and the other is used to receive the first fluid flowing back from the distal side to the proximal side of the catheter 110.

[0143] To further enable temperature monitoring and / or temperature control of the first fluid, the aforementioned conduit device 100 may also include a temperature control component and a temperature measurement component.

[0144] In an exemplary embodiment, at least one of the first delivery cavity 1011 and the second delivery cavity 1012 is fluidly connected to the first temperature control component and / or the first temperature measuring component.

[0145] The first temperature control component is used to control the first fluid within a first temperature range so that the drug in the first fluid remains at the target activity; the first temperature sensing component is used to detect the temperature of the first fluid.

[0146] Optionally, the first temperature control assembly includes a first temperature control element located inside the catheter and / or a second temperature control element located outside the catheter.

[0147] Similar to the second fluid, the first fluid also enters the first delivery lumen 1011 or the second delivery lumen 1012 from an external fluid supply device (which could be another fluid supply device). For ease of explanation, this will be described as an example where the first fluid from the fluid supply device enters the first delivery lumen 1011 through the first delivery tube 1211. After entering the first delivery lumen 1011 through the first delivery tube 1211, the first fluid flows towards the distal region. Upon entering the distal region, a portion of the first fluid flows into the body lumen from the delivery port 114 at the distal end of the first delivery lumen 1011 to treat the blocked area; another portion flows into the second delivery lumen 1012 through the first through hole 170. A portion of the first fluid entering the second delivery lumen 1012 flows into the body lumen from the delivery port 114 at the distal end of the second delivery lumen 1012 to treat the blocked area, while the other portion continues to flow back proximally and is output from the second delivery tube 1212, forming the flow path of the first fluid. This return path has a portion located outside the conduit and a portion located inside the conduit, so if you want to control the temperature of the first fluid, you can control it from outside the conduit and / or inside the conduit.

[0148] A first external conduit connects the first delivery tube 1211 and the second delivery tube 1212. If the first external conduit is a closed loop, the flow path of the first fluid is a closed-loop path. If the first external conduit is a non-closed loop, for example, if the first fluid output from the second delivery tube 1212 no longer flows back to the first delivery tube 1211 but enters the waste liquid tank, then the flow path of the first fluid is a remote return path. Both the closed-loop path and the remote return path can achieve the return of the first fluid in the distal region of the conduit, which facilitates the control of the first fluid temperature.

[0149] Optionally, the first temperature control element includes a temperature control element disposed in the first delivery lumen and / or the second delivery lumen.

[0150] If the temperature of the first fluid needs to be controlled within the conduit, a temperature control element can be provided in at least one of the first delivery lumen and / or the second delivery lumen. Optionally, the aforementioned first temperature control element can be a heating element, a cooling element, or a combination of both; this application embodiment does not impose any limitations on this. Optionally, if the flow path of the first fluid is a closed-loop path, temperature control of the first fluid can be achieved by providing a temperature control element in at least one of the first and second delivery lumens. If the flow path of the first fluid is a distal return path, it is preferable to provide a temperature control element in the infusion channel, or in the distal portion of the return channel; this application embodiment does not impose any limitations on this.

[0151] In one example, such as Figure 3As shown, a temperature control element 31 is provided in the inner lumen of the catheter 110. The temperature control element 31 can heat the first fluid in the inner lumen of the catheter 110 so that the drug in the first fluid has maximum activity, thereby achieving the best drug thrombolytic effect.

[0152] Optionally, the second temperature control element includes a temperature control element disposed in the first external conduit, which refers to an external fluid conduit communicating with the first delivery cavity and / or the second delivery cavity. The second temperature control element controls the temperature of the first fluid externally. The second temperature control element can be a heating element, a cooling element, or a combination of both, and the embodiments of this application do not limit this.

[0153] Optionally, the first temperature sensing component includes a first temperature sensing element located inside the conduit and / or a second temperature sensing element located outside the conduit. Similar to temperature control, if it is desired to measure the temperature of the first fluid, it can also be measured from outside and / or inside the conduit.

[0154] Optionally, the first temperature sensing element includes a temperature sensing element disposed in the first delivery lumen and / or the second delivery lumen.

[0155] Optionally, the second temperature sensing element includes a temperature sensing element disposed in the first external pipeline.

[0156] Optionally, the temperature sensing elements mentioned above include, but are not limited to, thermocouples and thermistors.

[0157] In one example, such as Figure 14 As shown, both the first delivery cavity 1011 and the second delivery cavity 1012 are equipped with thermocouples 90. Alternatively, as... Figure 6 As shown, a temperature sensing element 62 is provided inside the delivery tube 101. Alternatively, as... Figure 9 As shown, a temperature sensing element 93 is provided inside the delivery tube 101.

[0158] In the technical solution provided in this application embodiment, by setting a first delivery lumen and a second delivery lumen connected at their distal ends in the catheter body to deliver the first fluid, not only can the first fluid in the catheter be delivered into the body lumen through the delivery port on the distal side of the catheter to achieve treatment of the blockage in the body lumen, but the first fluid can also form a backflow in the catheter, thereby facilitating the control of the temperature of the first fluid in the backflow path, so as to maximize the activity of the drug in the first fluid and improve the thrombolytic effect of the drug; and, by backflowing the first fluid in the first delivery lumen and the second delivery lumen, the physical isolation between the first fluid and the energy source component can be increased, reducing the adverse effects of the heat generated by the energy source component on the temperature of the first fluid.

[0159] By incorporating a first lumen and a second lumen, independent of the delivery lumen, within the catheter body, a second fluid for cooling the energy source component can flow. At least one of the first and second lumens is positioned around the periphery of the energy source component. This second fluid effectively removes heat generated by the energy source component and flows proximally from one of the first and second lumens. This effectively cools the energy source component, maintaining it at optimal energy emission efficiency, while also reducing the temperature impact of the energy source component's heat on the first fluid. This helps maintain the first fluid within its set range to preserve drug activity, thereby shortening thrombolysis time and comprehensively improving thrombolysis efficiency and effect. Furthermore, the second fluid for cooling the energy source component flows between the first and second lumens, preventing it from flowing out of the catheter in the distal region, reducing the amount of fluid entering the body, making it safer, and does not reduce the drug concentration in the first fluid, effectively preventing a decrease in thrombolysis effect due to reduced drug concentration.

[0160] Furthermore, the aforementioned catheter body simultaneously has return channels corresponding to the first fluid and the second fluid, which can achieve separate control of the temperature of the first fluid and the operating temperature of the energy source component. This allows the first fluid to be controlled within a first temperature range that maximizes its drug activity, while the energy source component can be controlled within a second temperature range to achieve optimal energy emission efficiency. By separately controlling the temperature of the first fluid and the operating temperature of the energy source component, both thrombolysis efficiency and thrombolysis effect can be improved simultaneously.

[0161] In an exemplary example, the thrombolytic device described above is also connected to a control device, which can compare the actual temperature detected by the temperature control element with the desired target temperature range, thereby controlling the temperature control component to control the first fluid and the second fluid respectively, so that the first fluid is in the first temperature range and the energy source component is in the second temperature range.

[0162] Please refer to Figure 15 It illustrates the flow chart of a fluid control method provided in one embodiment of this application. Figure 1 This method can be applied to computer equipment, which refers to electronic devices with data calculation and processing capabilities. For example, the executing entity of each step can be a control device connected to the thrombolysis device, or it can be an electronic device within the thrombolysis device. This method may include the following steps (1510-1520).

[0163] Step 1510: Obtain the first temperature information corresponding to the second fluid and / or the second temperature information corresponding to the energy source component.

[0164] The aforementioned first temperature information refers to the temperature information of the second fluid. This first temperature information can be detected and obtained by the aforementioned second temperature measuring component. The second temperature measuring component includes a third temperature measuring element located inside the conduit and / or a fourth temperature measuring element located outside the conduit. The aforementioned first temperature information can be the temperature information of the second fluid inside the conduit, or the temperature information of the second fluid outside the conduit, or a fusion of both, such as an average value; this embodiment of the application does not limit this.

[0165] The aforementioned second temperature information refers to the temperature information of the energy source component. This second temperature information can also be obtained through detection by the second measuring component. Multiple third temperature sensing elements, such as multiple thermocouples, can be present inside the conduit to detect the temperature of the second fluid and the temperature of the energy source component, respectively. The specific method depends on the number and placement of the temperature sensing elements, and this embodiment does not limit this.

[0166] For catheters that can only detect the temperature of the second fluid, step 1510 can be performed by obtaining only the first temperature information; for catheters that can only detect the energy source component (such as an ultrasonic transducer), step 1510 can be performed by obtaining only the second temperature information; for catheters that can detect both, step 1510 can be performed by obtaining at least one of the two information. Those skilled in the art can choose according to the configuration of the temperature measuring element in the thrombolysis device, and this application embodiment does not limit this.

[0167] Step 1520: Based on the first temperature information and / or the second temperature information, drive the second temperature control component to control the temperature of the second fluid and / or the flow rate of the second fluid, and / or control the output power of the energy source component, so as to control the working environment of the energy source component to meet the target temperature conditions.

[0168] The aforementioned thrombolytic device includes a second temperature control component, or the thrombolytic device is connected to the second temperature control component. Therefore, the temperature and / or flow rate of the second fluid can be controlled by driving the second temperature control component. Optionally, the second temperature control component includes at least one of a cooling element, a heating element, and a flow control element.

[0169] Optionally, the target temperature conditions include a first temperature condition and / or a second temperature condition. The first temperature condition refers to the target control condition that controls the temperature of the energy source component to be within a second temperature range, and the second temperature condition refers to the target control condition that controls the temperature of the second fluid to be within a third temperature range.

[0170] For some thrombolytic devices that can detect the temperature of the energy source component, the temperature of the energy source component can be directly used as the control target. During the operation of the energy source component, the second temperature information and the second temperature range are compared, and the temperature and flow rate of the second fluid are controlled to keep the temperature of the energy source component within the second temperature range, thereby realizing the energy source component temperature feedback control based on the first temperature condition.

[0171] For example, if the second temperature information indicates that the temperature of the energy source component exceeds the second temperature range, the flow rate of the second fluid can be increased, allowing more of the second fluid to circulate around the energy source component. This removes excess heat generated during operation more quickly and effectively, achieving the goal of cooling the energy source component until its temperature returns to the second temperature range. Alternatively, the second fluid can be cooled by driving a cooling element, allowing the relatively cooler fluid to circulate around the energy source component, rapidly reducing its temperature to the second temperature range and improving its operating efficiency. Of course, adjusting the flow rate and temperature can occur simultaneously; either one can achieve cooling of the energy source component. Those skilled in the art can configure this according to actual needs, and this application does not limit this approach.

[0172] For thrombolytic devices where the temperature of the energy source component is difficult to detect, the temperature of the second fluid can also be used as a control target. This is because the second fluid flows back around the energy source component to cool it. Therefore, as the energy source component heats up, the temperature of the second fluid also changes accordingly. Thus, using the temperature of the second fluid as the control target and controlling its temperature within the third temperature range means controlling the temperature of the energy source component within the second temperature range. This allows for indirect control of the energy source component's temperature by controlling the temperature of the second fluid. Correspondingly, during the operation of the energy source component, the first temperature information and the third temperature range are compared, and by controlling at least one of the second fluid's temperature and flow rate, the temperature of the second fluid is controlled within the third temperature range, achieving energy source component temperature feedback control based on the second temperature condition.

[0173] For example, if the first temperature information indicates that the temperature of the second fluid exceeds the third temperature range, the flow rate of the second fluid can be increased, allowing more of the second fluid to circulate around the energy source component. This removes excess heat generated by the energy source component during operation more quickly and effectively, achieving the goal of cooling the energy source component until its temperature returns to the third temperature range. Alternatively, the second fluid can be cooled by driving a cooling element, lowering its temperature to the third temperature range. This allows the relatively cooler second fluid to circulate around the energy source component, rapidly cooling it and improving its operating efficiency. Similarly, adjusting the flow rate and temperature can occur simultaneously; either one can achieve cooling of both the second fluid and the energy source component. Those skilled in the art can configure this according to actual needs, and this application does not limit this specific configuration.

[0174] Cooling of the energy source component can be achieved by either temperature feedback control of the energy source component based on the first temperature condition or temperature feedback control of the energy source component based on the second temperature condition, or both can coexist. This application does not limit this.

[0175] The second and third temperature ranges mentioned above can be determined based on specific thrombolytic devices and related experiments. In this application, the specific numerical ranges of the second and third temperature ranges are not limited.

[0176] In the technical solution provided in this application embodiment, by comparing the detected temperature information with the set temperature range, it is possible to determine the control operation of at least one of the flow rate and temperature of the second fluid, thereby controlling the temperature of the second fluid and / or the energy source component within the corresponding range, realizing feedback control of the temperature of the energy source component, and carrying away the excess heat generated by the energy source component through the reflux of the second fluid, reducing the influence of the energy source component on the temperature of the first fluid, and making it easier to maintain the drug in the first fluid at the target activity and maintain a good thrombolytic effect.

[0177] In another possible implementation, the heat generation of the energy source component can be controlled by controlling its output power. For example, if the second temperature information indicates that the temperature of the energy source component exceeds the second temperature range, or the first temperature information indicates that the temperature of the second fluid exceeds the third temperature range, the output efficiency of the energy source component can be controlled to bring the temperature of the energy source component closer to the second temperature range, or to bring the temperature of the second fluid closer to the third temperature range. For example, if the temperature of the energy source component is greater than the second temperature range or the temperature of the second fluid is greater than the third temperature range, the output power of the energy source component can be reduced, thereby lowering the operating ambient temperature of the energy source component.

[0178] In the technical solution provided in this application embodiment, in order to control the working environment of the energy source component to meet the target temperature conditions, at least one of the above three methods can be used for control, that is, at least one of the following operations can be performed: controlling the temperature of the second fluid, controlling the flow rate of the second fluid, and controlling the output power of the energy source component. Those skilled in the art can choose one or combine the configurations according to actual needs, and this application embodiment does not limit this.

[0179] In an exemplary embodiment, such as Figure 16 As shown, Figure 16 The flowchart of another embodiment of the fluid control method provided in this application is shown. Figure 2 The above method may also include the following steps (1530-1540):

[0180] Step 1530: Obtain the third temperature information corresponding to the first fluid.

[0181] The aforementioned third temperature information refers to the temperature information of the first fluid. The temperature of the first fluid can be detected by the aforementioned first temperature measuring component (such as a thermocouple). This application embodiment does not limit the method of obtaining the temperature of the first fluid.

[0182] Step 1540: Based on the third temperature information, drive the first temperature control component to control the temperature and / or flow rate of the first fluid, and / or control the output power of the energy source component to control the drug in the first fluid to meet the target infusion conditions.

[0183] The thrombolytic device includes a first temperature control component, or the thrombolytic device is connected to the first temperature control component, so that the temperature and / or flow rate of the first fluid can be controlled by driving the first temperature control component. The first temperature control component includes at least one of a cooling element, a heating element, and a flow control element.

[0184] The aforementioned target infusion conditions are target control conditions used to maintain the thrombolytic effect. Optionally, the target infusion conditions include a first infusion condition and / or a second infusion condition.

[0185] The first infusion condition refers to the target control condition that controls the first fluid to be within a first temperature range, and the drug maintains its target activity within the first temperature range; the second infusion condition refers to the target control condition that controls the first fluid to be within a target infusion flow rate.

[0186] The temperature of the first fluid may change due to various factors, such as body temperature and the heating effect of the energy source components. If the temperature of the first fluid changes due to any of these factors and the changed temperature exceeds the optimal temperature range for drug activity, the thrombolytic effect of the drug on thrombi and other blockages will be affected. In order to maintain the thrombolytic effect at a high level, the technical solution provided in this application can, on the one hand, adjust the temperature of the first fluid to keep it within the first temperature range, achieving feedback control based on the first infusion conditions, thereby maintaining the drug activity at the target activity level (such as the optimal activity level) and maintaining a good thrombolytic effect; on the other hand, the infusion flow rate of the first fluid can be adjusted to adjust the drug dosage, such as increasing the dosage within a safe range, achieving control based on the second infusion conditions, thereby maintaining a good thrombolytic effect.

[0187] The aforementioned target infusion flow rate refers to the desired flow rate for infusing the first fluid into the body lumen, i.e., outside the delivery lumen. Optionally, the target infusion flow rate is related to the temperature of the first fluid. Further, the target infusion flow rate can be determined based on the temperature difference between the temperature of the first fluid and a first temperature range. A larger temperature difference indicates lower drug activity and a poorer thrombolytic effect; therefore, the drug dosage can be increased by increasing the infusion flow rate. The aforementioned target infusion flow rate and the aforementioned temperature difference are positively correlated. This application does not limit the correspondence between the target infusion flow rate and the temperature difference; those skilled in the art can determine it based on actual thrombolytic devices and related experiments.

[0188] Optionally, the flow rate of the first fluid includes at least one of a first infusion flow rate, a second infusion flow rate, and a return flow rate.

[0189] When the first fluid is flowing unidirectionally inside the delivery cavity, the first delivery flow rate is used to characterize the flow rate of the first fluid being delivered to the outside of the delivery cavity when it is flowing unidirectionally.

[0190] When the first fluid is in a reflux flow inside the delivery cavity, the second delivery flow rate is used to characterize the flow rate of the first fluid being delivered to the outside of the delivery cavity during the reflux flow, and the reflux flow rate is used to characterize the flow rate of the portion of the first fluid that refluxes from the distal side to the proximal side of the delivery cavity.

[0191] When adjusting the flow rate of the first fluid, at least one of the first infusion flow rate, the second infusion flow rate, and the return flow rate can be adjusted.

[0192] For example, in one possible implementation, if the third temperature information indicates that the temperature of the first fluid exceeds a first temperature range, the first temperature control component is driven to adjust the temperature of the first fluid towards the direction closer to the first temperature range, and / or, the infusion flow rate of the first fluid is increased, where the infusion flow rate refers to the flow rate of the first fluid infused outside the delivery lumen. In the case of unidirectional flow of the first fluid, the infusion flow rate can be the aforementioned first infusion flow rate; in the case of reflux flow of the first fluid, the infusion flow rate can be the aforementioned second infusion flow rate. By increasing the infusion flow rate of the first fluid, the amount of drug infused into the body lumen can be increased, thereby maintaining a better thrombolytic effect even in environments with poor drug activity by increasing the dosage within a safe range.

[0193] In another possible implementation, the above can also increase the return flow rate of the first fluid and reduce the residence time of the first fluid in the heat radiation area of ​​the energy source component, thereby reducing the impact of the heat generated by the energy source component on the temperature of the first fluid.

[0194] In the technical solution provided in this application embodiment, by comparing the detected temperature information of the first fluid with the temperature range of optimal drug activity, it is possible to determine the control operation of at least one of the flow rate and temperature of the first fluid, thereby independently controlling the temperature of the first fluid within the temperature range of optimal drug activity, and / or dynamically adjusting the drug infusion rate. From at least one of the two perspectives of adjusting drug activity and adjusting drug dosage, the thrombolytic efficiency is maintained at a high level, further reducing the adverse effects of heat generation of the energy source component on the thrombolytic effect.

[0195] In another possible implementation, the temperature of the first fluid can be controlled by controlling the output power of the energy source component. For example, if the third temperature information indicates that the temperature of the first fluid exceeds the first temperature range, the output efficiency of the energy source component can be controlled to change the heat generation of the energy source component, thereby affecting the temperature of the first fluid to move closer to the first temperature range.

[0196] For example, if the temperature of the first fluid is greater than the first temperature range, the output power of the energy source component is reduced, thereby reducing the heat generated by the energy source component. The temperature of the first fluid is relatively reduced, and the temperature of the first fluid can thus approach the first temperature range, maintaining the drug activity.

[0197] For example, if the temperature of the first fluid is lower than the first temperature range, the output power of the energy source component can be increased, thereby increasing the heat generation of the energy source component within a safe range. The temperature of the first fluid will then rise, and the temperature of the first fluid can thus approach the first temperature range, maintaining the drug activity.

[0198] In the case of first fluid recirculation, the flow rate and / or temperature of the first fluid can be further controlled to accelerate the adjustment of the temperature of the first fluid and bring it closer to the first temperature range as soon as possible.

[0199] In the technical solution provided in this application embodiment, in order to control the drug in the first fluid to meet the target infusion conditions, at least one of the above three methods can be used for control, that is, at least one of the following operations can be performed: controlling the temperature of the first fluid, controlling the flow rate of the first fluid, and controlling the output power of the energy source component. Those skilled in the art can choose one or combine the configurations according to actual needs, and this application embodiment does not limit this.

[0200] The following are embodiments of the apparatus of this application, which can be used to execute embodiments of the method of this application. For details not disclosed in the apparatus embodiments of this application, please refer to the embodiments of the method of this application.

[0201] Please refer to Figure 17 This diagram illustrates a block diagram of a fluid control device according to an embodiment of this application. The device has the function of implementing the above-described fluid control method; this function can be implemented in hardware or by hardware executing corresponding software. The device can be a computer device or can be installed in a computer device or a thrombolysis device. The device 1700 may include:

[0202] Temperature acquisition module 1710 is used to acquire first temperature information corresponding to the second fluid and / or second temperature information corresponding to the energy source component;

[0203] The fluid control module 1720 is used to drive the second temperature control component to control the temperature and / or flow rate of the second fluid and / or control the output power of the energy source component according to the first temperature information and / or the second temperature information, so as to control the working environment of the energy source component to meet the target temperature conditions.

[0204] The target temperature condition includes a first temperature condition and / or a second temperature condition. The first temperature condition refers to the target control condition that controls the temperature of the energy source component to be within a second temperature range, and the second temperature condition refers to the target control condition that controls the temperature of the second fluid to be within a third temperature range.

[0205] The thrombolytic device includes a second temperature control component, or the thrombolytic device is connected to the second temperature control component; the second temperature control component includes at least one of a cooling element, a heating element, and a flow control element.

[0206] In summary, the technical solution provided by the embodiments of this application, by setting an independent delivery lumen in the catheter body for delivering the first fluid, can deliver the first fluid in the catheter into the body lumen through the delivery port on the distal side of the catheter to achieve treatment of the blockage location in the body lumen; by setting a first lumen and a second lumen independent of the delivery lumen in the catheter body, a second fluid for cooling the energy source component can flow, and at least one of the first lumen and the second lumen is arranged around the periphery of the energy source component, the second fluid can effectively remove the heat energy generated by the energy source component and flow proximally from one of the first lumen and the second lumen. In this way, the energy source component can be effectively cooled to maintain its optimal energy emission efficiency, while also reducing the temperature impact of the heat generated by the energy source component on the first fluid, making it easier for the first fluid to be maintained within its set range to maintain good drug activity, thereby reducing thrombolysis time and comprehensively improving thrombolysis efficiency and thrombolysis effect. Furthermore, the second fluid used to cool the energy source components flows between the first and second lumens, without flowing out of the catheter in the distal region, reducing the amount of fluid entering the human body, making it safer for the human body, and does not reduce the drug concentration in the first fluid, effectively preventing the thrombolytic effect from decreasing due to the reduced drug concentration.

[0207] It should be noted that the apparatus provided in the above embodiments is only illustrated by the division of the above functional modules when implementing its functions. In actual applications, the above functions can be assigned to different functional modules as needed, that is, the internal structure of the device can be divided into different functional modules to complete all or part of the functions described above. In addition, the apparatus and method embodiments provided in the above embodiments belong to the same concept, and the specific implementation process can be found in the method embodiments, which will not be repeated here.

[0208] Please refer to Figure 18 It illustrates a schematic diagram of the system structure of a thrombolysis system provided in one embodiment of this application. Figure 1 The thrombolytic device may include a control unit, an energy source (i.e., an energy source component), a power circuit, a heated water circulation device, a temperature sensor, a temperature measuring device, and a water circulation control module. The control unit may include a user interface and display, a control processing unit, and an analog-to-digital (A / D) converter. Temperature regulation of the heated water circulation device can be achieved through an external temperature control system, or through a heating element placed within the water circulation device in conjunction with an external temperature control system. In this case, a water circulation control device (such as a water pump) is also required to circulate the water in and out. The aforementioned heated water circulation device can be used to control the temperature of the primary fluid to achieve temperature control of the drug environment.

[0209] Please refer to Figure 19 It illustrates a schematic diagram of the system structure of a thrombolysis system provided in one embodiment of this application. Figure 2The thrombolytic system includes a heating element (such as a heating wire) and a related temperature control system to control the temperature of the drug environment. The heating wire can be directly placed in the first fluid for temperature control, or the energy can be indirectly transferred to the drug in the delivery lumen through water in the heating wire channel (in which case the heating wire and the drug are isolated).

[0210] Please refer to Figure 20 and Figure 21 , Figure 20 A schematic diagram of the system structure of a thrombolysis system provided in one embodiment of this application is shown. Figure 3 , Figure 21 This application illustrates a schematic diagram of the control logic of a thrombolysis system provided in one embodiment. Figure 1 The thrombolysis system includes an ultrasonic transducer and a corresponding water circulation and temperature control system to achieve unified temperature control of the transducer (energy source component) and the drug delivery chamber (delivery lumen). Because the ultrasonic transducer itself generates heat through energy conversion, a water circulation control system 1 is needed to drive the cooling water (secondary fluid) backflow to remove the heat from the ultrasonic transducer. The water circulation control system 1 can control the rate at which the cooling water removes heat. The temperature control of the cooling circulating water is achieved by another water temperature control system 1, which maintains the cooling water at a target temperature. This target temperature is the temperature range that maximizes drug activity within a safe range for the human body without affecting the performance of the ultrasonic transducer. When the monitored temperature exceeds a given threshold temperature (set temperature), the cooling water circulation rate needs to be controlled by adjusting the water circulation pump speed. When adjusting the flow rate fails to reach the expected target temperature, the transducer's energy needs to be adjusted, such as reducing the emission amplitude, energy duty cycle, emission period, and other energy parameters to achieve the desired temperature. The order in which the transducer parameters are adjusted and the circulating cooling water pump speed is regulated can also be reversed. The control equipment can control the water circulation control system 1 and the water temperature control system 1 by controlling the temperature-controlled water circulation control device 1.

[0211] Please refer to Figure 22 and Figure 23 , Figure 22 A schematic diagram of the system structure of a thrombolysis system provided in one embodiment of this application is shown. Figure 4 , Figure 23 This application illustrates a schematic diagram of the control logic of a thrombolysis system provided in one embodiment. Figure 2This thrombolytic system includes an ultrasonic transducer and a corresponding water circulation and temperature control system to separately control the fluid temperature of the transducer (energy source component) and the drug delivery chamber (delivery lumen). Because the ultrasonic transducer itself generates heat through energy conversion, a water circulation control system 1 is needed to drive the cooling water (secondary fluid) backflow to remove the heat from the ultrasonic transducer. The water circulation control system 1 can control the rate at which the cooling water removes heat. The temperature control of the cooling circulating water is achieved by another water temperature control system 1, which controls the temperature of the cooling water. The target temperature is maintained at a temperature that maximizes drug activity within a safe range for the human body without affecting the performance of the ultrasonic transducer.

[0212] Meanwhile, the drug's temperature is controlled by another drug temperature control and monitoring system, as shown in the diagram: the water circulation control system 2 and the water temperature control system 2. These two temperature control and monitoring systems operate independently. The water circulation control system 2 controls the flow rate of the drug solution, while the water temperature control system 2 controls the temperature of the drug solution to the desired temperature, which is the temperature range within the safe range for the human body that maximizes the drug's activity.

[0213] When the monitored temperature of the cooling water circulation exceeds a given threshold temperature, the cooling water flow rate needs to be adjusted by regulating the pump speed. When adjusting the flow rate fails to achieve the desired temperature, the transducer's energy needs to be adjusted, such as reducing the emission amplitude, energy duty cycle, and emission period, to achieve the desired temperature. The order of adjusting the transducer parameters and regulating the circulating cooling water pump speed can also be reversed.

[0214] The logic for drug temperature control is that when the monitored temperature is higher or lower than a given target temperature, the temperature of the heating system needs to be adjusted. This includes adjusting the temperature of the outside or inside of the drug circulation pipeline or the temperature of the built-in heating wire to directly or indirectly reflect the drug temperature. Heating can be stopped to achieve cooling or the heating intensity can be increased to reach the desired temperature.

[0215] The control equipment can control the water circulation control system 1 and the water temperature control system 1 by controlling the temperature-controlled water circulation control device 1. The control equipment can also control the water circulation control system 2 and the water temperature control system 2 by controlling the temperature-controlled water circulation control device 2.

[0216] Please refer to Figure 24 and Figure 25 , Figure 24 A schematic diagram of the system structure of a thrombolysis system provided in one embodiment of this application is shown. Figure 5 , Figure 25 This application illustrates a schematic diagram of the control logic of a thrombolysis system provided in one embodiment. Figure 3This thrombolysis system comprises an external ultrasonic transducer that drives the ultrasonic guidewire, a corresponding energy control system, a current and voltage detection system (impedance vs. frequency detection) module, the ultrasonic guidewire, and a corresponding water circulation and temperature control system or heating wire system. This allows for independent control of ultrasonic energy and drug temperature. Temperature control can be achieved through water circulation channels with a built-in heating wire or an external temperature control system. Alternatively, each channel may not have water circulation; instead, the built-in heating wire heats the aquatic environment while simultaneously transferring the temperature to the external drug (in this case, the heating wire and the drug environment are isolated). The heating wire can also directly heat the drug environment. The transducer control system primarily compensates for the ultrasonic guidewire's vibration mode by detecting its excitation information, impedance value, and vibration frequency, comparing these to the guidewire's expected resonant frequency and corresponding impedance value, thus maintaining sufficient energy transfer even in tortuous vascular environments.

[0217] Please refer to Figure 26 This diagram illustrates a structural block diagram of a computer device according to an embodiment of this application. The computer device may be a control device in a thrombolysis apparatus. This computer device is used to implement the fluid control method provided in the above embodiments.

[0218] Specifically:

[0219] Typically, computer device 900 includes a processor 901 and a memory 902.

[0220] Processor 901 may include one or more processing cores, such as a quad-core processor, an octa-core processor, etc. Processor 901 may be implemented using at least one hardware form selected from DSP (Digital Signal Processing), FPGA (Field Programmable Gate Array), and PLA (Programmable Logic Array). Processor 901 may also include a main processor and a coprocessor. The main processor, also known as a CPU (Central Processing Unit), is used to process data in the wake-up state; the coprocessor is a low-power processor used to process data in the standby state. In some embodiments, processor 901 may integrate a GPU (Graphics Processing Unit), which is responsible for rendering and drawing the content to be displayed on the screen. In some embodiments, processor 901 may also include an AI (Artificial Intelligence) processor, which is used to handle computational operations related to machine learning.

[0221] The memory 902 may include one or more computer-readable storage media, which may be non-transitory. The memory 902 may also include high-speed random access memory and non-volatile memory, such as one or more disk storage devices or flash memory devices. In some embodiments, the non-transitory computer-readable storage media in the memory 902 is used to store at least one instruction, at least one program, code set, or instruction set, configured to be executed by one or more processors to implement the fluid control method described above.

[0222] In some embodiments, the computer device 900 may optionally include a peripheral device interface 903 and at least one peripheral device. The processor 901, memory 902, and peripheral device interface 903 can be connected via a bus or signal line. Each peripheral device can be connected to the peripheral device interface 903 via a bus, signal line, or circuit board. Specifically, the peripheral device includes at least one of a power source drive module 904, a touch display screen 905, a temperature control component 906, an audio circuit 907, a pump component 908, and a power supply 909. The power source drive module 904 can be used to drive a power source component. The temperature control component 903 can be the first temperature control component and / or the second temperature control component described above. The temperature control component may include a flow rate control element, such as a pump unit.

[0223] The computer device 900 can receive user input to perform the steps or operations in the above method.

[0224] Those skilled in the art will understand that Figure 9 The structure shown does not constitute a limitation on the computer device 900, and may include more or fewer components than shown, or combine certain components, or use different component arrangements.

[0225] In an exemplary embodiment, a computer-readable storage medium is also provided, the storage medium storing at least one instruction, at least one program, code set, or instruction set, the at least one instruction, the at least one program, the code set, or the instruction set being executed by a processor to implement the fluid control method described above.

[0226] Optionally, the computer-readable storage medium may include: ROM (Read Only Memory), RAM (Random Access Memory), SSD (Solid State Drives), or optical disc, etc. The random access memory may include ReRAM (Resistance Random Access Memory) and DRAM (Dynamic Random Access Memory).

[0227] In an exemplary embodiment, a computer program product or computer program is also provided, which includes computer instructions stored in a computer-readable storage medium. A processor of a computer device reads the computer instructions from the computer-readable storage medium and executes the computer instructions, causing the computer device to perform the fluid control method described above.

[0228] It should be understood that "multiple" as used herein refers to two or more. "And / or" describes the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A alone, A and B simultaneously, or B alone. The character " / " generally indicates that the preceding and following related objects are in an "or" relationship. Furthermore, the step numbers described herein are merely illustrative of one possible execution order. In some other embodiments, the steps may not be executed in numerical order, such as two steps with different numbers being executed simultaneously, or two steps with different numbers being executed in the reverse order of the illustration. This application does not limit this.

[0229] In the description of this application, it should be noted that, in the embodiments of this application, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature.

[0230] In the description of the embodiments of this application, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, "linking" can be a detachable connection or a non-detachable connection; it can be a direct connection or an indirect connection through an intermediate medium. "Fixed connection" refers to a connection where the relative positional relationship remains unchanged after the connection.

[0231] The directional terms used in the embodiments of this application, such as "inner" and "outer," are merely for reference to the directions in the accompanying drawings. Therefore, the directional terms used are for better and clearer explanation and understanding of the embodiments of this application, and are not intended to 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 the embodiments of this application. Furthermore, unless otherwise stated in this application, "multiple" as used in this application refers to two or more.

[0232] In the description of embodiments of this application, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element.

[0233] In the field of interventional medical devices, "distal" and "proximal" are two important anatomical terms used to describe the orientation and position of a device. Their definitions are based on the relationship between the device and the operator's or patient's body; the distal end refers to the end of the device furthest from the operator's or patient's center of body, while the proximal end refers to the end of the device closest to the operator's or patient's center of body.

[0234] The above description is merely an exemplary embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A catheter, characterized in that, The catheter includes: A slender tubular body is used for percutaneous insertion into a target body cavity; the interior of the slender tubular body is used to insert an energy source component; the slender tubular body includes a delivery cavity, a first cavity, and a second cavity; The delivery lumen is used to deliver the first fluid; The elongated tubular body has a distal region, and the distal region is provided with a delivery port; one end of the delivery port is connected to the body lumen, and the other end is connected to the delivery lumen, so as to deliver the first fluid into the body lumen; At least one of the first cavity and the second cavity is disposed around the outer periphery of the energy source component, and the first cavity and the second cavity are in fluid communication in the distal region to allow a second fluid for cooling the energy source component to flow between the first cavity and the second cavity.

2. The catheter according to claim 1, characterized in that, The number of delivery lumens is multiple, and the multiple delivery lumens include at least a first delivery lumen and a second delivery lumen; The first delivery lumen and the second delivery lumen are in fluid communication in the distal region to allow the first fluid to flow between the first delivery lumen and the second delivery lumen; And / or, A first tube wall is provided between the first delivery lumen and the second delivery lumen, and a first through hole is provided on the distal portion of the first tube wall; one end of the first through hole communicates with the first delivery lumen and the other end communicates with the second delivery lumen. Wherein, one of the first delivery lumen and the second delivery lumen serves as the delivery channel for the first fluid to be delivered to the distal side of the catheter, and the other serves as the return channel for the first fluid to flow back from the distal side to the proximal side of the catheter.

3. The catheter according to claim 2, characterized in that, At least one of the first delivery lumen and the second delivery lumen is fluidly connected to a first temperature control component and / or a first temperature sensing component; the first temperature control component is used to control the first fluid within a first temperature range so that the drug in the first fluid remains at target activity; the first temperature sensing component is used to detect the temperature of the first fluid. The first temperature control component includes a first temperature control element located inside the catheter and / or a second temperature control element located outside the catheter; the first temperature control element includes a temperature control element passing through the first delivery lumen and / or the second delivery lumen; the second temperature control element includes a temperature control element disposed in a first external conduit, wherein the first external conduit refers to an external fluid conduit communicating with the first delivery lumen and / or the second delivery lumen. The first temperature measuring component includes a first temperature measuring element located inside the catheter and / or a second temperature measuring element located outside the catheter; the first temperature measuring element includes a temperature measuring element passing through the first delivery lumen and / or the second delivery lumen; the second temperature measuring element includes a temperature measuring element disposed in the first external pipeline.

4. The catheter according to claim 1, characterized in that, One of the first lumen and the second lumen serves as an infusion channel for the second fluid to be infused into the distal side of the catheter, and the other serves as a return channel for the second fluid to flow back from the distal side to the proximal side of the catheter. Furthermore, a second pipe wall is provided between the first lumen and the second lumen, and a second through hole is provided on the distal portion of the second pipe wall; one end of the second through hole is connected to the first lumen, and the other end is connected to the second lumen.

5. The catheter according to claim 1, characterized in that, At least one of the first lumen and the second lumen is fluidly connected to a second temperature control component and / or a second temperature sensing component; the second temperature control component is used to control the energy source component to be within a second temperature range; the second temperature sensing component is used to detect the temperature of the second fluid and / or the energy source component. The second temperature control component includes a third temperature control element located inside the conduit and / or a fourth temperature control element located outside the conduit; the third temperature control element includes a temperature control element passing through the first lumen and / or the second lumen; the fourth temperature control element includes a temperature control element disposed in a second external conduit, the second external conduit being a fluid conduit external to the conduit that communicates with the first lumen and / or the second lumen, and the fourth temperature control element is used to control at least one of the flow rate and temperature of the second fluid, so that the energy source component is within the second temperature range; The second temperature measuring component includes a third temperature measuring element located inside the conduit and / or a fourth temperature measuring element located outside the conduit; the third temperature measuring element includes a temperature measuring element passing through the first lumen and / or the second lumen; the fourth temperature measuring element includes a temperature measuring element disposed in the second external conduit.

6. The catheter according to claim 1, characterized in that, The energy source component is disposed within the first cavity, and there is a fluid gap between the outer wall of the energy source component and the inner wall of the first cavity. The fluid gap is used to provide a flow channel for the second fluid within the first cavity, and the fluid gap and the second cavity are in fluid communication in the distal region. There is a first region between the inner wall of the first cavity and the outer wall of the elongated tubular body, and the second cavity and the delivery cavity are located in the first region. Alternatively, the energy source component has a first annular region on its outer periphery, the first cavity and the second cavity are located within the first annular region, the cross-section of the first cavity is circular, fan-shaped, waist-shaped or crescent-shaped, and the cross-section of the second cavity is circular, fan-shaped, waist-shaped or crescent-shaped; the delivery cavity is located within the first annular region or within the second annular region, the second annular region being located between the first annular region and the outer wall of the elongated tubular body.

7. The catheter according to claim 6, characterized in that, The elongated tubular body is also provided with a guide wire cavity, which is used to insert a guide wire. The guidewire lumen extends through the distal end of the elongated tubular body; the diameter of the distal end gradually decreases from the proximal side to the distal side along the axial direction, and the distal opening of the guidewire lumen is located in the axial region of the distal end or on the sidewall of the distal end. Alternatively, one of the delivery lumen, the first lumen, and the second lumen may serve as the guidewire lumen, the distal end of which has a sealing structure; wherein the sealing structure has a first configuration in which the guidewire can slide axially through the sealing structure; after the guidewire is withdrawn from the sealing structure, the sealing structure has a second configuration in which the sealing structure is used to seal the first fluid and / or the second fluid.

8. The catheter according to claim 1, characterized in that, The energy source component includes an ultrasonic transducer and / or an ultrasonic guidewire; The energy source component is fixedly connected to the interior of the elongated tubular body, or the energy source component can be axially slidably inserted into the interior of the elongated tubular body.

9. A thrombolytic device, characterized in that, The thrombolytic device includes: The catheter as described in any one of claims 1 to 8; The energy source component is fixedly connected to the interior of the elongated tubular body, or the energy source component can be axially slidably inserted into the interior of the elongated tubular body; A handle assembly for coupling to the proximal end of the catheter; the handle assembly is connected to a delivery tube, a first tube, and a second tube; wherein the delivery tube communicates with the lumen of the delivery tube, the first tube communicates with the first lumen, and the second tube communicates with the second lumen; One of the first tube and the second tube is used to infuse the second fluid into the catheter, and the other is used to receive the second fluid flowing back from the distal to the proximal side of the catheter.

10. The catheter according to claim 9, characterized in that, The number of delivery lumens is multiple, and the multiple delivery lumens include at least a first delivery lumen and a second delivery lumen, wherein the first delivery lumen and the second delivery lumen are in fluid communication in the distal region; The number of delivery tubes is multiple, and the multiple delivery tubes include at least a first delivery tube and a second delivery tube, wherein the first delivery tube is in communication with the first delivery lumen, and the second delivery tube is in communication with the second delivery lumen; One of the first delivery tube and the second delivery tube is used to infuse the first fluid into the catheter, and the other is used to receive the first fluid flowing back from the distal to the proximal side of the catheter.

11. A fluid control method, characterized in that, The method is applied to the thrombolytic device as described in claim 9 or 10, and the method includes: Obtain the first temperature information corresponding to the second fluid and / or the second temperature information corresponding to the energy source component; Based on the first temperature information and / or the second temperature information, drive the second temperature control component to control the temperature of the second fluid and / or the flow rate of the second fluid, and / or control the output power of the energy source component, so as to control the working environment of the energy source component to meet the target temperature conditions; The target temperature condition includes a first temperature condition and / or a second temperature condition. The first temperature condition refers to the target control condition that controls the temperature of the energy source component to be within a second temperature range, and the second temperature condition refers to the target control condition that controls the temperature of the second fluid to be within a third temperature range. The thrombolytic device includes a second temperature control component, or the thrombolytic device is connected to the second temperature control component; the second temperature control component includes at least one of a cooling element, a heating element, and a flow control element.

12. The fluid control method according to claim 11, characterized in that, The method further includes: Obtain the third temperature information corresponding to the first fluid; Based on the third temperature information, the first temperature control component is driven to control the temperature and / or flow rate of the first fluid, and / or the output power of the energy source component is controlled to ensure that the drug in the first fluid meets the target infusion conditions. The target infusion conditions include a first infusion condition and / or a second infusion condition. The first infusion condition refers to the target control condition that controls the first fluid within a first temperature range, and the drug maintains its target activity within the first temperature range. The second infusion condition refers to the target control condition that controls the first fluid at a target infusion flow rate. The thrombolytic device includes the first temperature control component, or the thrombolytic device is connected to the first temperature control component; the first temperature control component includes at least one of the cooling element, the heating element, and the flow control element.

13. The fluid control method according to claim 12, characterized in that, The flow rate of the first fluid includes at least one of a first infusion flow rate, a second infusion flow rate, and a return flow rate; When the first fluid is flowing unidirectionally inside the delivery cavity, the first infusion flow rate is used to characterize the flow rate of the first fluid being infused outside the delivery cavity when it is flowing unidirectionally. When the first fluid is in a backflow flow inside the delivery lumen, the second infusion flow rate is used to characterize the flow rate of the first fluid being infused outside the delivery lumen during the backflow flow, and the backflow flow rate is used to characterize the flow rate of the portion of the first fluid that flows back from the distal side to the proximal side of the delivery lumen.

14. The fluid control method according to claim 12, characterized in that, The step of driving the first temperature control component to control the temperature of the first fluid and / or the flow rate of the first fluid based on the third temperature information includes: If the third temperature information indicates that the temperature of the first fluid exceeds the first temperature range, the first temperature control component is driven to adjust the temperature of the first fluid toward the direction closer to the first temperature range, and / or the infusion flow rate of the first fluid is increased, wherein the infusion flow rate refers to the flow rate of the first fluid infused outside the delivery lumen.

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