Ultrasonic ablation device and ultrasonic ablation equipment
Patent Information
- Application Number
- CN202420589013.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-03-25
- Publication Date
- 2025-02-11
- Estimated Expiration
- 2034-03-25
Smart Images
Figure CN222444251U_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the technical field of medical devices, and in particular to an ultrasonic ablation device. The present application also relates to an ultrasonic ablation device having the ultrasonic ablation device. Background Art
[0002] At present, ultrasound ablation, as an emerging ablation technology, can achieve ablation without damaging tissues. Its safety and effectiveness are better than radiofrequency ablation and cryoablation technologies.
[0003] In the existing system, the distal end of the ultrasonic ablation device can be delivered to the target location in the subject's body, and the ultrasonic transducer in the balloon can emit acoustic energy radially outward to the subject's nerve tissue and other tissues, thereby heating the target nerve tissue through the used ultrasonic energy to intervene in the nerve tissue.
[0004] However, the inventors have found that the prior art has at least the following problems:
[0005] First, the current ultrasonic ablation device needs to replace balloons of different expansion specifications when dealing with blood vessels of different sizes. In addition, for patients with large changes in blood vessel diameter and physiological curvature, it takes a long time to replace the catheter, which is inconvenient to operate and affects work efficiency.
[0006] Second, the balloon cannot adhere well to the inner wall of the blood vessel within the coverage of ultrasound energy. The gap between the balloon and the blood vessel will cause thermal damage to the blood vessel and affect the safety of the ablation effect.
[0007] Third, the cooling cycle during the ablation process needs to rely on complex procedures to achieve, especially for the situation where multiple ablations are required during the operation, and the balloon needs to be expanded and deflated multiple times, and the operation procedures are more complicated.
[0008] Therefore, it is necessary for those skilled in the art to provide an ultrasonic ablation device that does not require frequent balloon replacement and can reduce thermal damage to blood vessels. Utility Model Content
[0009] In order to solve at least one of the technical problems mentioned in the background technology, the present application provides an ultrasonic ablation device and an ultrasonic ablation equipment having the ultrasonic ablation device, thereby eliminating the need for frequent replacement of balloons and reducing thermal damage to blood vessels.
[0010] To achieve the above-mentioned purpose, the present application provides an ultrasonic ablation device, comprising a catheter assembly, an ultrasonic transducer and a capsule;
[0011] The catheter assembly includes a guidewire channel, a water injection channel and a water return channel, and the catheter assembly is used to push the guidewire in the guidewire channel to a preset position;
[0012] The ultrasonic transducer is arranged at the distal end of the catheter assembly, and is used to emit an acoustic signal in the radial direction of the catheter assembly;
[0013] The sac is connected to the distal end of the catheter assembly and is arranged around the outside of the ultrasonic transducer. A flow area is formed between the sac and the catheter assembly. The flow area is respectively connected to the water injection channel and the water return channel so that the liquid medium can remove heat. The flow area can switch between a retracted structure and an inflated structure, and when the flow area is in the inflated structure, it can expand in stages in response to a positive pressure difference.
[0014] In some embodiments, the cross-sectional area of the water injection channel is greater than the cross-sectional area of the water return channel.
[0015] In some embodiments, the catheter assembly includes a first catheter and a second catheter;
[0016] The second catheter is arranged outside the first catheter, the first catheter has an emitting section extending relative to the distal end of the second catheter, the ultrasonic transducer is connected to the emitting section, and the capsule is arranged outside the emitting section and connected to the distal end of the second catheter;
[0017] The first catheter has a first guidewire lumen extending from the distal end of the emitting section to the proximal end of the emitting section.
[0018] In some embodiments, a gap is formed between the first conduit and the second conduit, and the gap forms a water injection channel;
[0019] The first catheter is provided with a first guide wire cavity and a water return channel, and the liquid medium in the flow area flows in from the gap and flows out through the water return channel.
[0020] In some embodiments, the second conduit is provided with a water injection channel, a water return channel and a cable channel, and the cable channel is used to set a cable of the ultrasonic transducer;
[0021] The second catheter is provided with a second guidewire cavity, and the first guidewire cavity is communicated with the second guidewire cavity to form a guidewire channel.
[0022] In some embodiments, the ultrasonic transducer includes a cylindrical piezoelectric layer and a cylindrical liner arranged on the inner surface of the cylindrical piezoelectric layer, the cylindrical liner is sleeved on the first catheter, and the cylindrical piezoelectric layer and the cylindrical liner are electrically connected to the cable of the ultrasonic transducer.
[0023] In some embodiments, the cross-sectional outer contour of the first conduit is circular or gourd-shaped.
[0024] In some embodiments, the shape of the balloon after expansion is one of an olive shape, a spherical shape, and a wavy cylindrical shape;
[0025] And / or, the bladder is made of rubber material.
[0026] The present application provides an ultrasonic ablation device, including a water injection interface, a water return interface, a signal interface, a water circulation device and a main unit, and also includes the above-mentioned ultrasonic ablation device, the water circulation device is connected to the water injection channel through the water injection interface, the water circulation device is connected to the water return channel through the water return interface, and the main unit is connected to the cable of the ultrasonic transducer through the signal interface.
[0027] In some embodiments, the host includes a controller;
[0028] Ultrasonic ablation equipment also includes:
[0029] A temperature sensor is provided at the water return interface and is used to detect the temperature of the liquid medium at the water return interface;
[0030] A pressure sensor, used to detect the pressure inside the bladder;
[0031] The controller is configured to communicate with the temperature sensor, the pressure sensor and the water circulation device. The controller is used to receive temperature data detected by the temperature sensor and pressure data detected by the pressure sensor and send instructions to the water circulation device.
[0032] Relative to the above-mentioned background technology, the ultrasonic ablation device provided in the embodiment of the present application includes a catheter assembly, an ultrasonic transducer and a capsule. Among them, the catheter assembly includes a guidewire channel, a water injection channel and a water return channel; the catheter assembly is used to push the guidewire in the guidewire channel to a preset position, and the ultrasonic transducer is arranged at the distal end of the catheter assembly, and the ultrasonic transducer is used to emit an acoustic signal in the radial direction of the catheter assembly; the capsule is connected to the distal end of the catheter assembly and is arranged around the outside of the ultrasonic transducer, and a flow area connected to the water injection channel and the water return channel is formed between the capsule and the catheter assembly, and the flow area can switch between a retracted structure and an inflated structure, and when the flow area is in an inflated structure, it can expand in stages in response to a positive pressure difference. The ultrasonic ablation device and ultrasonic ablation equipment thus arranged have the following beneficial effects:
[0033] First, when the liquid medium is injected into the balloon through the water injection channel and discharged from the balloon through the water return channel, the liquid medium can be circulated in the catheter assembly, thereby taking out the heat generated by the ultrasonic transducer when it is working. At the same time, while maintaining the circulation of the liquid medium, the state presented by the balloon after expansion can better fit the inner wall of the blood vessel, thereby preventing the gap between the balloon and the blood vessel from affecting the heat transfer, which is conducive to preventing the inside of the blood vessel from being thermally damaged;
[0034] Secondly, the flow area formed between the balloon and the catheter assembly can respond to the positive pressure difference and achieve graded expansion when in the inflated structure. That is to say, corresponding to different positive pressure differences, the balloon can expand to different sizes for adaptation. In this way, there is no need to frequently replace the balloon when dealing with blood vessels of different sizes, which is conducive to improving work efficiency and reducing costs. BRIEF DESCRIPTION OF THE DRAWINGS
[0035] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying any creative work.
[0036] Figure 1 This is a schematic structural diagram of an ultrasonic ablation device in the first embodiment of the present application;
[0037] Figure 2 for Figure 1 A magnified schematic diagram of part A;
[0038] Figure 3 for Figure 1 An assembly diagram of a first catheter and a second catheter in the ultrasonic ablation device shown;
[0039] Figure 4 for Figure 2 a cross-sectional view of the ultrasonic transducer, the first catheter and the cable assembly;
[0040] FIG5( a ) is a schematic diagram of the structure of the first capsule;
[0041] FIG5( b ) is a schematic diagram of the structure of the second capsule;
[0042] FIG5( c ) is a schematic diagram of the structure of the third capsule;
[0043] FIG5( d ) is a schematic diagram of the first capsule in a multi-stage expansion state;
[0044] Figure 6 This is a schematic diagram of the first type of capsule adhering to the inner wall of the blood vessel;
[0045] Figure 7 This is a schematic structural diagram of an ultrasonic ablation device in a second embodiment of the present application;
[0046] Figure 8 for Figure 7 A magnified schematic diagram of part B;
[0047] Fig. 9 for Figure 7 An assembly diagram of a first catheter and a second catheter in the ultrasonic ablation device shown;
[0048] Fig.10 for Figure 8 Cross-sectional view of the ultrasonic transducer, first catheter and cable assembly.
[0049] in:
[0050] 1-catheter assembly, 101-first catheter, 1011-tip, 1012-guidewire inlet, 1013-first guidewire lumen, 102-second catheter, 1021-guidewire outlet, 1022-second guidewire lumen;
[0051] 2-capsule;
[0052] 3- Water injection interface;
[0053] 4-Water return interface;
[0054] 5- water injection channel;
[0055] 6-water return channel, 601-water return port;
[0056] 7- Cable channel;
[0057] 8-Guidewire channel;
[0058] 9-ultrasonic transducer, 901-cylindrical piezoelectric layer, 902-cylindrical lining;
[0059] 10-Signal interface;
[0060] 11- Cable;
[0061] 12-developing ring;
[0062] 13-handle;
[0063] 14-Guidewire interface. DETAILED DESCRIPTION
[0064] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.
[0065] In order to enable those skilled in the art to better understand the present application, the present application is further described in detail below in conjunction with the accompanying drawings and specific implementation methods.
[0066] It should be noted that the directional words such as "upper end, lower end, left side, right side" described below are all defined based on the drawings in the specification.
[0067] It should be noted that in all specific embodiments of the present application, the end closer to the operator (such as medical staff) is defined as the proximal end, and the end for inserting into the patient's body is defined as the distal end. For a single component, the end closer to the operator is the proximal end, and the end farther from the operator is the distal end.
[0068] For example, in actual use, although the transmitting section is arranged as a whole in the patient's body, the proximal end of the transmitting section refers to the end or side closer to the operator along the path of catheter pushing intervention, and the distinction between the distal and proximal ends of other components is similar to the above description unless explicitly excluded.
[0069] It should also be noted that the directions or positional relationships indicated by "far" and the like in the present invention are based on the directions or positional relationships shown in the drawings, and are only for the purpose of simplifying the description and facilitating understanding, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as limiting the present invention. For the convenience of description, only the parts related to the relevant invention are shown in the drawings.
[0070] In the absence of conflict, the embodiments of the present invention and the features therein can be combined with each other. As used in the present invention, "installed", "connected", "connected", and one element "set" on another element should be understood in a broad sense, usually only indicating that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the two elements can be directly or indirectly connected, coupled, cooperated or transmitted through an intermediate element, or the two elements can be connected by energy or signal response, but cannot be understood as indicating or implying the spatial position relationship or direct contact relationship between the two elements, that is, one element can be in any orientation such as inside, outside, above, below or one side of another element, unless the content clearly indicates otherwise. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.
[0071] In this specification, each embodiment is described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the embodiments can be referred to each other. Any combination of all embodiments provided by the present invention is within the protection scope of this invention and will not be described in detail here.
[0072] See also Figure 1 and Figure 2 The ultrasonic ablation device provided in the embodiment of the present application includes a catheter assembly 1, an ultrasonic transducer 9 and a capsule 2.
[0073] Please also read Figure 3 The catheter assembly 1 includes a water injection channel 5, a water return channel 6 and a guide wire channel 8. The water injection channel 5, the water return channel 6 and the guide wire channel 8 are separated from each other. The water injection channel 5 is connected to the inner cavity of the capsule 2 and is used to inject liquid medium into the capsule 2. The water return channel 6 is connected to the inner cavity of the capsule 2 and is used to output the liquid medium in the capsule 2. The catheter assembly 1 is used to be pushed to a preset position by an operator along the guide wire in the guide wire channel 8.
[0074] In addition, the catheter assembly 1 further comprises a cable channel 7 , which can also be separated from the water injection channel 5 and the water return channel 6 . The cable channel 7 is used to set the cable 11 of the ultrasonic transducer 9 .
[0075] The ultrasonic transducer 9 is disposed at the distal end of the catheter assembly 1, and the cable 11 of the ultrasonic transducer 9 is disposed in the cable channel 7. The ultrasonic transducer 9 is used to transmit an acoustic signal in the radial direction of the catheter assembly 1. In some embodiments, the ultrasonic transducer 9 is also used to receive an acoustic signal to evaluate whether an ablation effect is achieved for the expected emission area. The ultrasonic transducer 9 can transmit acoustic energy radially outward to the neural tissue and other parts of the subject, thereby heating the target neural tissue through the used ultrasonic energy to intervene in the neural tissue.
[0076] Please also read Figure 4 The ultrasonic transducer 9 includes a cylindrical piezoelectric layer 901 and a cylindrical liner 902 disposed on the inner surface of the cylindrical piezoelectric layer 901. The cylindrical liner 902 is connected to the first catheter 101 of the catheter assembly 1 (in some embodiments, when the outer contour of the first catheter 101 is circular, the cylindrical liner 902 is sleeved on the first catheter 101). The cylindrical piezoelectric layer 901 and the cylindrical liner 902 are electrically connected to the cable 11. The cylindrical piezoelectric layer 901 is metallized inside and outside, and electrodes are respectively led out to connect the conductive layer and the shielding layer in the cable 11. The cylindrical liner 902 is added to the inner surface of the cylindrical piezoelectric layer 901. The cylindrical liner 902 has rigid and conductive properties, can form support and protection for the cylindrical piezoelectric layer 901, and can also limit the mechanical energy transmitted from the inner surface of the cylindrical piezoelectric layer 901, and reduce the heat generated by ultrasonic wave propagation on the inner surface.
[0077] The balloon 2 is connected to the distal end of the catheter assembly 1 and is arranged around the outside of the ultrasonic transducer 9. A circulation area (that is, the inner cavity of the balloon 2 mentioned above) is formed between the balloon 2 and the catheter assembly 1. The circulation area is connected to the water injection channel 5 and the water return channel 6 so that the liquid medium can take out heat. The circulation area can switch between a retracted structure and an inflated structure, and when the circulation area is in the inflated structure, it can expand in stages in response to a positive pressure difference.
[0078] That is to say, the shape of the balloon 2 can be switched between a contracted state and an expanded state. When the inside of the balloon 2 is evacuated to a negative pressure, the balloon 2 contracts and can be folded on the tube body, thereby reducing the outer diameter of the balloon 2, which is beneficial for product pushing. When the inside of the balloon 2 is pressurized, the balloon 2 expands.
[0079] In this way, when the liquid medium is injected into the balloon 2 through the water injection channel 5 at a preset water injection pressure and discharged from the balloon 2 through the water return channel 6 at a preset water return pressure, the liquid medium can circulate in the catheter assembly 1 and the balloon 2 can be in an expanded or filled state.
[0080] It should be noted that the so-called positive pressure difference is the difference between the pressure formed by the injection of liquid medium and the pressure discharged by the liquid medium. This positive pressure difference determines the degree of expansion of the balloon and is a key factor in achieving the therapeutic effect. Because the balloon is inflated with liquid medium, the pressure at the connection point between the balloon and the water injection channel and the pressure at the connection point between the balloon and the water return channel are basically similar. In addition to being affected by the initial pressure of the water inlet, the positive pressure difference is also mainly affected by the difference in cross-sectional areas between the water injection channel 5 and the water return channel 6. The formula is roughly obtained, the positive pressure difference ΔF = F1 (S3-S1) + C, F1 is the pressure formed by the injection of liquid medium, S3 is the cross-sectional area of the water injection channel 5, S1 is the cross-sectional area of the water return channel 6, and C is a compensation parameter affected by environmental factors. The present application can achieve the purpose of more convenient control of the positive pressure difference by setting the difference in cross-sectional areas of the water injection channel 5 and the water return channel 6.
[0081] With the above-mentioned arrangement, the heat generated by the ultrasonic transducer 9 during operation is removed by circulating the liquid medium in the catheter assembly 1. At the same time, while maintaining the circulation of the liquid medium, the state presented by the expanded balloon 2 can better adhere to the inner wall of the blood vessel, thereby preventing the gap between the balloon 2 and the blood vessel from affecting the heat transfer, which is beneficial to preventing the inside of the blood vessel from being thermally damaged.
[0082] Please refer to Figure 5(d) as well. The flow area formed between the balloon 2 and the catheter assembly 1 can respond to the positive pressure difference and achieve graded expansion when in the inflated structure. That is to say, corresponding to different positive pressure differences, the balloon 2 can expand to different sizes for adaptation. In this way, there is no need to frequently replace the balloon 2 when dealing with blood vessels of different sizes, which is conducive to improving work efficiency and reducing costs.
[0083] In some embodiments, the size of the flow-through area in the inflated configuration increases with increasing positive pressure differential.
[0084] In this way, by adjusting the positive pressure difference between the preset water injection pressure and the preset water return pressure, the bladder 2 can be expanded to different diameters. As the positive pressure difference gradually increases, the diameter of the bladder 2 can gradually increase from the minimum 4mm to 12mm. For example, when the positive pressure difference is 2atm, the diameter of the bladder 2 is 4mm; when the positive pressure difference is 3atm, the diameter of the bladder 2 is 6mm; when the positive pressure difference is 4atm, the diameter of the bladder 2 is 8mm; when the positive pressure difference is 5atm, the diameter of the bladder 2 is 10mm; when the positive pressure difference is 6atm, the diameter of the bladder 2 is 12mm.
[0085] The above is only an example of the expansion of the balloon 2. The data may deviate from the actual situation. When a softer material is selected, the balloon 2 diameter will expand more under the same pressure. Conversely, when a harder material is selected, the balloon 2 diameter will expand less.
[0086] In some embodiments, the bladder 2 is made of rubber material, such as natural latex, nylon elastomer, silicone rubber, polyurethane elastomer, etc., and its hardness generally ranges from 30A to 70A on the Shore A scale.
[0087] During the expansion of the balloon 2, since the rubber balloon 2 is elastic and its surface has the adsorption properties of rubber, after the balloon 2 expands, the balloon 2 can be more closely attached to the inner wall of the blood vessel, thereby preventing the gap between the balloon 2 and the blood vessel from affecting heat transfer. At the same time, the balloon 2 will form a relatively good adsorption with the inner wall of the blood vessel, thereby forming a certain static friction force in the axial direction, so that during the ablation process, the position of the balloon 2 is relatively fixed without obvious slippage.
[0088] Please refer to FIG. 5( a ), FIG. 5( b ) and FIG. 5( c ) together. The shape of the balloon 2 after expansion is one of an olive shape, a spherical shape and a wavy cylindrical shape.
[0089] Please also read Figure 6 Taking the olive-shaped shape after expansion as an example, as the internal pressure of the balloon 2 increases, the balloon 2 can present a multi-stage expansion state, so that the outer diameter of the balloon 2 continues to increase. In addition, due to the elastic texture of the balloon 2, the expanded balloon 2 can be well attached to the inner wall of the blood vessel.
[0090] In some embodiments, the cross-sectional area of the water injection channel 5 is greater than the cross-sectional area of the water return channel 6 .
[0091] In order to better maintain the balloon 2 in an expanded state while keeping the liquid medium circulating and to make the balloon 2 form a good adhesion with the inner wall of the blood vessel, in this embodiment, the cross-sectional area S3 of the water injection channel 5 is set to be larger than the cross-sectional area S1 of the water return channel 6.
[0092] The relationship between the critical pressure F0 of the balloon 2 in the expanded state and S3 / S1 can be calculated by in vitro experiments: F0 is positively correlated with 1 / (S3 / S1), that is, the larger the S3 / S1 ratio, the smaller the critical pressure F0 required for the balloon 2 to be in the expanded state.
[0093] In other words, in this embodiment, the cross-sectional area S3 of the water injection channel 5 is set to be larger than the cross-sectional area S1 of the water return channel 6, which is more conducive to keeping the bladder 2 in an expanded state.
[0094] The structure of the catheter assembly 1 is described in detail below:
[0095] The catheter assembly 1 includes a first catheter 101 and a second catheter 102. The second catheter 102 can be arranged outside the first catheter 101, the first catheter 101 has an emission section extending relative to the distal end of the second catheter 102, the distal end of the emission section has a tip 1011, the ultrasonic transducer 9 is connected to the emission section, and the capsule 2 is arranged outside the emission section and connected to the distal end of the second catheter 102.
[0096] At the same time, the first catheter 101 has a first guidewire cavity 1013, which extends from the distal end of the emission section to the proximal end of the emission section. The first guidewire cavity 1013 serves as a part of the guidewire channel 8 for allowing the guidewire to extend from the distal end of the emission section to the proximal end of the emission section.
[0097] The cross-sectional outer contour of the first catheter 101 can be circular or gourd-shaped. The circular first catheter 101 can facilitate the cylindrical liner 902 to be sleeved on the first catheter 101; the gourd-shaped first catheter 101 can form a gap with the second catheter 102 while providing certain support to the second catheter 102, which can facilitate the setting of the guidewire channel 8 and the cable channel 7. The gourd-shaped appearance of the launch section can also better adapt to blood vessels of different diameters, and can maintain good adaptability and effect whether in a wider blood vessel part or in a narrow area.
[0098] In order to facilitate the realization of the functions of the catheter assembly 1, the first catheter 101 can be a double-lumen structure or a single-lumen structure.
[0099] In some embodiments, the first catheter 101 is of double lumen construction.
[0100] Please also read Figure 1 , Figure 2 and Figure 3 A gap is formed between the first conduit 101 and the second conduit 102, and the gap penetrates the second conduit 102 to form a water injection channel 5. At the same time, the first conduit 101 is provided with a return water channel 6 and a return water port 601. The liquid medium in the circulation area flows into the gap and flows out through the return water port 601 and the return water channel 6.
[0101] In addition, the first catheter 101 is further provided with a first guidewire cavity 1013, and the tip 1011 is provided with a guidewire inlet 1012, the distal end of the first guidewire cavity 1013 is connected to the guidewire inlet 1012, the proximal end of the first guidewire cavity 1013 is connected to the guidewire cavity within the coverage of the second catheter 102, and the guidewire cavity within the coverage of the second catheter 102 is connected to the guidewire outlet 1021 on the side of the second catheter 102, so as to form a guidewire port (RX structure) that can be quickly exchanged, such as Figure 3 In this way, the guidewire entering from the guidewire inlet 1012 can extend out of the catheter assembly 1 from the guidewire outlet 1021 through the guidewire channel 8.
[0102] Of course, it is also possible not to add a guidewire outlet 1021 on the side of the second catheter 102, but to directly set a guidewire interface 14 that communicates with the guidewire channel 8 at the proximal end of the catheter assembly 1 to form an all-through guidewire port (OTW structure), such as Figure 7 .
[0103] It can be understood that in other embodiments, the cable channel 7 can be set in the gap or set as an independent channel in the first conduit 101 connected to the ultrasonic transducer 9. Of course, if the cable 11 is a cable with an insulating and waterproof outer layer, a cable channel may not be specially set.
[0104] It is also necessary to explain that, in this embodiment, the first catheter 101 serves as an internal catheter of the second catheter 102, a part of which is disposed in the second catheter 102, and the other part extends out of the second catheter 102, and the first catheter 101 is provided with two channels, namely, the return channel 6 and the first guidewire cavity 1013, and the gap formed between the first catheter 101 and the second catheter 102 serves as a common channel for the water injection channel 5 and the cable channel 7. The first catheter 101 may be a catheter extending from the proximal end of the second catheter 102 and extending from the distal end of the second catheter 102, or may be fixedly connected only to the distal end of the second catheter 102 and extending a transmitting end to the distal end of the second catheter 102.
[0105] Specifically, the distal end of the return water channel 6 is closed by a heat shrink process, and the proximal end is connected to the return water interface 4. The first conduit 101 opens a return water port 601 at a position corresponding to the return water channel 6 to form a passage connecting the return water port 601, the return water channel 6 and the return water interface 4; the gap between the first conduit 101 and the second conduit 102 passes through the second conduit 102 and is connected to the water injection interface 3 at the proximal end, and is isolated from other channels by a sealant or sealing ring process to form a passage connecting the gap, the water injection interface 3 and the flow area in the capsule 2; the inner and outer electrodes of the ultrasonic transducer 9 are respectively connected to the inner conductor and the outer shield of the cable 11, and the cable 11 passes through the gap and is connected to the signal interface 10 at the proximal end, thereby forming a signal path between the ultrasonic transducer 9, the cable 11 and the signal interface 10.
[0106] In addition, in order to eliminate the pressure bottleneck, the cross-sectional area S2 of the water return port 601 is equal to the cross-sectional area S1 of the water return channel 6 to ensure that the liquid medium can smoothly enter the water return channel 6 from the water return port 601 .
[0107] During implementation, the guidewire enters from the guidewire inlet 1012 of the tip 1011 and passes out from the guidewire outlet 1021. The imaging catheter enters the target blood vessel along the guidewire. The position of the developing ring 12, which is sleeved on the first catheter 101 and located on both sides of the ultrasonic transducer 9, can be displayed through in vitro X-ray transmission, so as to locate the position of the capsule 2 in the blood vessel, inject the liquid medium from the water injection interface 3, and enter from the water injection channel 5 to fill the capsule 2. After the signal interface 10 is connected to the device host, the ultrasonic transducer 9 in the capsule 2 can output the acoustic signal, thereby achieving ablation of the lesion. At the same time, the return water port 601 on the first catheter 101 will bring out the liquid medium inside the capsule 2 through the return water interface 4. If the water injection interface 3 and the return water interface 4 are connected to the same water circulation device, the internal circulation of the liquid medium can be realized, and the heat brought by the acoustic signal generated by the ultrasonic transducer 9 can be brought out, so as to better protect the inside of the blood vessel from thermal damage.
[0108] In some embodiments, the first catheter 101 is of single lumen construction.
[0109] Please also read Figure 7 , Figure 8 and Fig. 9 The second catheter 102 is provided with a water injection channel 5, a water return channel 6 and a cable channel 7 which are separated from each other; the first catheter 101 has a first guidewire cavity 1013, and the second catheter 102 has a second guidewire cavity 1022. After the first catheter 101 and the second catheter 102 are connected, the first guidewire cavity 1013 and the second guidewire cavity 1022 are connected to form a guidewire channel 8. The tip 1011 is provided with a guidewire inlet 1012, and the guidewire entering from the guidewire inlet 1012 extends out of the catheter assembly 1 through the guidewire channel 8.
[0110] Specifically, the distal end of the guidewire channel 8 is communicated with the guidewire inlet 1012 in the tip 1011, and the proximal end is communicated with the guidewire interface 14 to form a passage connecting the guidewire inlet 1012, the guidewire channel 8 and the guidewire interface 14. Compared with the previous embodiment, the guidewire of this embodiment passes through the entire process from the guidewire inlet 1012 at the distal end to the guidewire interface 14 at the proximal end, which is an OTW structure, which is conducive to operation in relatively thick blood vessels without generating a bifurcation phenomenon between the guidewire and the catheter.
[0111] At the same time, the water injection channel 5 in the second conduit 102 is connected to the water injection interface 3 at the proximal end, and is isolated from other channels by sealant or insert injection molding process, thereby forming a passage connecting the water injection channel 5, the water injection interface 3 and the flow area inside the capsule 2; the return water channel 6 in the second conduit 102 is connected to the return water interface 4 at the proximal end, and is isolated from other channels by sealant or insert injection molding process, thereby forming a passage connecting the return water channel 6, the return water interface 4 and the flow area inside the capsule 2; the inner and outer electrodes of the ultrasonic transducer 9 are respectively connected to the inner conductor and the outer shield of the cable 11, and the cable 11 passes through the cable channel 7 and is connected to the signal interface 10 at the proximal end, thereby forming a signal path between the ultrasonic transducer 9, the cable 11 and the signal interface 10.
[0112] Please also read Fig.10 The ultrasonic transducer 9 includes a cylindrical piezoelectric layer 901 and a cylindrical liner 902 arranged on the inner surface of the cylindrical piezoelectric layer 901 . The cylindrical liner 902 is sleeved on the first catheter 101 . The cylindrical piezoelectric layer 901 and the cylindrical liner 902 are electrically connected to the cable 11 .
[0113] Specifically, the ultrasonic transducer 9 is a cylindrical tube of piezoelectric material as a whole, the inner and outer tube layers of which are metallized, and two electrodes are respectively led out to connect the inner conductor and the shielding layer of the cable 11. A cylindrical lining 902 is added to the inner surface of the cylindrical piezoelectric layer 901. The cylindrical lining 902 has rigid and conductive properties, which can form support and protection for the cylindrical piezoelectric layer 901. At the same time, it can limit the mechanical energy transmitted from the inner surface of the cylindrical piezoelectric layer 901, and reduce the heat generated by ultrasonic wave propagation on the inner surface of the cylindrical piezoelectric layer 901.
[0114] In addition, the proximal end of the second conduit 102 is connected to the handle 13 , and the proximal end of the handle 13 has a water injection interface 3 , a water return interface 4 and a signal interface 10 .
[0115] An ultrasonic ablation device provided in the present application includes a water injection interface 3, a water return interface 4, a signal interface 10, a water circulation device and a main unit, and also includes the ultrasonic ablation device described in the above embodiment. The water circulation device is connected to the water injection channel 5 through the water injection interface 3, the water circulation device is connected to the water return channel 6 through the water return interface 4, and the main unit is connected to the cable 11 through the signal interface 10.
[0116] In addition, the host includes a controller, and the ultrasonic ablation device also includes a temperature sensor and a pressure sensor.
[0117] The temperature sensor is disposed at the water return interface 4 , and is used to detect the temperature of the liquid medium at the water return interface 4 . The pressure sensor can be disposed in the capsule 2 , and is used to detect the pressure inside the capsule 2 .
[0118] It can be understood that the controller is configured to communicate with the temperature sensor, the pressure sensor and the water circulation device, and the controller is used to control the operation of the water circulation device according to the temperature data detected by the temperature sensor and the pressure data detected by the pressure sensor.
[0119] It should be noted that there is a certain temperature difference ΔT between the water temperature T2 of the water return interface 4 and the water temperature T1 inside the capsule 2 , and this temperature difference can be obtained through experimental testing.
[0120] After the water injection interface 3, the water return interface 4, and the signal interface 10 are connected to the host, the system display will show the pressure F1 formed by the injected liquid medium. At the same time, by directly testing the water temperature T2 of the water return interface and adding the temperature difference ΔT, the water temperature T1 inside the capsule 2 can be calculated.
[0121] The host will adjust the pressure F1 formed by the injected liquid medium according to the water temperature T1, and because the water temperature T1 inside the capsule 2 is positively correlated with 1 / F1, when the temperature is too high, the controller controls the water circulation device to increase the water circulation rate by increasing F1.
[0122] At the same time, in order to ensure that F1 is not too high, which will lead to excessive positive pressure difference ΔF and thus excessive expansion of the bladder 2, the controller controls the water circulation device to extract pressure through the return water interface 4. In this way, while increasing water circulation, the positive pressure difference ΔF of the bladder 2 is not increased.
[0123] It should be further explained that, based on the above-mentioned embodiment that "the cross-sectional area S3 of the water injection channel 5 is set to be larger than the cross-sectional area S1 of the water return channel 6", the water circulation device can be a circulating water pump, and the cross-sectional areas of the water injection channel 5 and the water return channel 6 are set to be different, that is, by setting the diameter difference, the operation state of a single circulating water pump can be set, and the channel diameter difference inherent in its own pipeline design can be used to cause more water injection and less water discharge, so that more liquid medium can be retained in the capsule 2, and the capsule 2 can be conveniently switched from the retracted structure to the inflated structure without the need for the host to send additional instructions to the circulating water pump. Accordingly, the switching of the capsule 2 to the inflated structure and achieving the desired graded expansion degree only requires adjusting the water circulation rate of the circulating water pump, so that the desired graded expansion degree can be achieved and the water circulation in the capsule 2 can be maintained, so as to reduce the temperature of the patient tissue directly contacted by the capsule 2 and avoid causing damage to the patient tissue that is not desired. The above description does not exclude the implementation scheme of setting two or more water circulation pumps to control the water injection channel 5 and the water outlet channel 6 separately, but wants to emphasize that the present application can adapt to the conventional multi-water circulation pump multi-program control mode as well as the channel single circulation water pump multi-mode control mode, or even the combination of the two modes. Compared with two independent circulation water pumps, each pump is responsible for one channel, which means that the controller needs to be able to independently adjust and control the operating state of the two pumps, which may increase the design and operation complexity of the controller because it is necessary to ensure the coordinated work of the two pumps and possible synchronization problems. Compared with other prior arts, the conduit structure of the present application can better meet the needs of a single circulation water pump for multi-stage water circulation rate adjustment. The conduit of the present application is used in conjunction with a single circulation water pump, and the water flow is controlled by the difference in pipe diameter through pipeline and fluid dynamics design, and the water circulation and temperature control are maintained by the natural pressure difference. Because only the operating state of one pump needs to be adjusted, the design of the control system is simpler, the corresponding structure is simpler and the operation is easier, and the possibility of system failure and maintenance cost can also be reduced.
[0124] It should be noted that, in this specification, relational terms such as first and second are merely used to distinguish one entity from other entities, but do not necessarily require or imply any actual relationship or order between these entities.
[0125] The ultrasonic ablation device and ultrasonic ablation equipment provided by the present application are introduced in detail above. Specific examples are used herein to illustrate the principles and implementation methods of the present application. The description of the above embodiments is only used to help understand the scheme and core ideas of the present application. It should be pointed out that for ordinary technicians in this technical field, without departing from the principles of the present application, several improvements and modifications can be made to the present application, and these improvements and modifications also fall within the scope of protection of the present application.
Claims
1. An ultrasonic ablation device, characterized in that: Includes a catheter assembly, an ultrasound transducer, and a balloon; The catheter assembly comprises a guidewire channel, a water injection channel and a water return channel, and the catheter assembly is used to push the guidewire in the guidewire channel to a preset position; The ultrasonic transducer is arranged at the distal end of the catheter assembly, and the ultrasonic transducer is used to emit an acoustic signal in the radial direction of the catheter assembly; The sac is connected to the distal end of the catheter assembly and is arranged around the outside of the ultrasonic transducer. A flow area is formed between the sac and the catheter assembly. The flow area is respectively connected to the water injection channel and the water return channel so that the liquid medium can remove heat. The flow area can be switched between a retracted structure and an inflated structure, and when the flow area is in the inflated structure, it can expand in stages in response to a positive pressure difference.
2. The ultrasonic ablation device according to claim 1, characterized in that: The cross-sectional area of the water injection channel is greater than the cross-sectional area of the water return channel.
3. The ultrasonic ablation device according to claim 2, characterized in that: The catheter assembly includes a first catheter and a second catheter; The second catheter is arranged outside the first catheter, the first catheter has an emitting section extending relative to the distal end of the second catheter, the ultrasonic transducer is connected to the emitting section, and the capsule is arranged outside the emitting section and connected to the distal end of the second catheter; The first catheter has a first guidewire lumen extending from the distal end of the emitting section to the proximal end of the emitting section.
4. The ultrasonic ablation device according to claim 3, characterized in that: A gap is formed between the first conduit and the second conduit, and the gap forms the water injection channel; The first catheter is provided with the first guide wire cavity and the water return channel, and the liquid medium in the circulation area flows into the gap and flows out through the water return channel.
5. The ultrasonic ablation device according to claim 3, characterized in that: The second conduit is provided with the water injection channel, the water return channel and a cable channel, and the cable channel is used to set the cable of the ultrasonic transducer; The second catheter is provided with a second guidewire cavity, and the first guidewire cavity is communicated with the second guidewire cavity to form the guidewire channel.
6. The ultrasonic ablation device according to claim 3, characterized in that: The ultrasonic transducer includes a cylindrical piezoelectric layer and a cylindrical liner arranged on the inner surface of the cylindrical piezoelectric layer, the cylindrical liner is sleeved on the first catheter, and the cylindrical piezoelectric layer and the cylindrical liner are electrically connected to the cable of the ultrasonic transducer.
7. The ultrasonic ablation device according to any one of claims 3 to 6, characterized in that: The cross-sectional outer contour of the first conduit is circular or gourd-shaped.
8. The ultrasonic ablation device according to any one of claims 1 to 6, characterized in that: The shape of the balloon after expansion is one of an olive shape, a spherical shape and a wavy cylindrical shape; And / or, the bladder is made of rubber material.
9. An ultrasonic ablation device, comprising a water injection interface, a water return interface, a signal interface, a water circulation device and a host, characterized in that: It also includes the ultrasonic ablation device as described in any one of claims 1-8, the water circulation device is connected to the water injection channel through the water injection interface, the water circulation device is connected to the water return channel through the water return interface, and the host is connected to the cable of the ultrasonic transducer through the signal interface.
10. The ultrasonic ablation device according to claim 9, characterized in that: The host includes a controller; The ultrasonic ablation device also includes: A temperature sensor, provided at the water return interface, for detecting the temperature of the liquid medium at the water return interface; A pressure sensor, used to detect the pressure inside the capsule; The controller is configured to be in communication connection with the temperature sensor, the pressure sensor and the water circulation device, and is used to receive temperature data detected by the temperature sensor and pressure data detected by the pressure sensor and send instructions to the water circulation device.