Ultrasonic ablation device and ultrasonic ablation equipment

Abstract

The invention discloses an ultrasonic ablation device and ultrasonic ablation equipment, and relates to the technical field of medical instruments, and the ultrasonic ablation device comprises a catheter assembly, an ultrasonic transducer and a bag body. The catheter assembly comprises a water injection channel, a water return channel and a guide wire channel. The ultrasonic transducer is arranged at the far end of the catheter assembly, and the ultrasonic transducer is used for emitting an acoustic signal to the radial direction of the catheter assembly; the balloon body is connected to the far end of the catheter assembly and arranged on the outer side of the ultrasonic transducer in a surrounding mode, a circulation area communicated with the water injection channel and the water return channel is formed between the balloon body and the catheter assembly, the circulation area can be switched between a retraction structure and an inflation structure, and when the circulation area is in the inflation structure, the circulation area can respond to the forward pressure difference to expand in a grading mode. By the adoption of the ultrasonic ablation device, the balloon does not need to be replaced frequently, and heat damage to blood vessels can be reduced.

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 apparatus 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 superior to radiofrequency ablation and cryoablation technologies.

[0003] In existing systems, the distal end of the ultrasonic ablation device can be delivered to a target location in a subject's body, and the ultrasonic transducer in the balloon can emit acoustic energy radially outward toward the subject's neural tissue and other tissues, thereby heating the target neural tissue through the ultrasonic energy used to intervene in the neural tissue.

[0004] However, the inventors have discovered that the prior art has at least the following problems:

[0005] First, current ultrasonic ablation devices require replacement of balloons with different inflation specifications when treating vessels of varying sizes. Furthermore, for patients with large variations in vessel diameter and physiological curvature, catheter replacement takes considerable time, making operation inconvenient and impacting work efficiency.

[0006] Second, the balloon cannot adhere well to the inner wall of the blood vessel within the coverage area of ​​ultrasound energy. The gap between the balloon and the blood vessel can 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 implement, especially when multiple ablations are required during the operation. In order to achieve multiple expansion and contraction of the balloon, 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. Summary of the Invention

[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 object, 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. 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 transmit 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 circulation area is formed between the sac and the catheter assembly. The circulation area is respectively connected to the water injection channel and the return water channel so that the liquid medium can remove 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.

[0014] In some embodiments, the cross-sectional area of ​​the water injection channel is larger 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 disposed outside the first catheter, the first catheter having an emitting section extending relative to a distal end of the second catheter, the ultrasonic transducer being connected to the emitting section, and the capsule being disposed 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, wherein the cable channel is used to arrange 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 balloon after expansion has an olive-shaped, spherical, and wavy cylindrical shape;

[0025] And / or, the bladder is made of rubber.

[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 host, 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 host is connected to the cable of the ultrasonic transducer through the signal interface.

[0027] In some embodiments, the host includes a controller;

[0028] Ultrasound 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] Compared with 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 return water 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. A flow area connected to the water injection channel and the return water channel is formed between the capsule and the catheter assembly. 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 respond to a positive pressure difference and expand in stages. 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 within the catheter assembly, thereby removing the heat generated by the ultrasonic transducer during operation. At the same time, while the liquid medium is circulating, the state presented by the expanded balloon can better conform to the inner wall of the blood vessel, thereby preventing the gap between the balloon and the blood vessel from affecting heat transfer, which helps to prevent thermal damage inside the blood vessel.

[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, 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 following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are merely embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without 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 the first catheter and the second catheter in the ultrasonic ablation device;

[0039] Figure 4 for Figure 2 a cross-sectional view of the ultrasound transducer, the first catheter, and the cable assembly;

[0040] Figure 5(a) is a schematic structural diagram of the first capsule;

[0041] Figure 5(b) is a schematic structural diagram of the second capsule;

[0042] Figure 5(c) is a schematic structural diagram of the third type of capsule;

[0043] FIG5( d ) is a schematic diagram of the first type of capsule in a multi-stage expansion state;

[0044] Figure 6 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 the second embodiment of the present application;

[0046] Figure 8 for Figure 7 An enlarged schematic diagram of part B;

[0047] Figure 9 for Figure 7 An assembly diagram of the first catheter and the second catheter in the ultrasonic ablation device;

[0048] Figure 10 for Figure 8 Cross-sectional view of the ultrasound 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-cyst;

[0052] 3- Water injection interface;

[0053] 4- Return water 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 this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts 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 with reference to the accompanying drawings and specific implementation methods.

[0066] It should be noted that the directional terms 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 embodiments of the present application, the end closer to the operator (e.g., 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 defined as the proximal end, and the end farther from the operator is defined as 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 insertion. 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 other designations in the present invention are based on the directions or positional relationships shown in the accompanying drawings and are intended solely to simplify description and facilitate understanding. They do not indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. For ease of description, only the portions relevant to the invention are shown in the accompanying 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 through energy or signal response, but cannot be understood as indicating or implying a 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 on 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 the specific circumstances.

[0071] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other. Any combination of all the embodiments provided by the present invention is within the scope of protection 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 refer to Figure 3 The catheter assembly 1 includes a water injection channel 5, a water return channel 6, and a guidewire channel 8. The water injection channel 5, the water return channel 6, and the guidewire channel 8 are separated from each other. The water injection channel 5 is connected to the inner cavity of the bladder 2 and is used to inject liquid medium into the bladder 2. The water return channel 6 is connected to the inner cavity of the bladder 2 and is used to discharge the liquid medium in the bladder 2. The catheter assembly 1 is used to be pushed to a preset position by the operator along the guidewire in the guidewire channel 8.

[0074] In addition, the catheter assembly 1 further includes 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] Ultrasonic transducer 9 is disposed at the distal end of catheter assembly 1, and cable 11 of ultrasonic transducer 9 is disposed in cable channel 7. Ultrasonic transducer 9 is configured to transmit acoustic signals in a radial direction of catheter assembly 1. In some embodiments, ultrasonic transducer 9 is further configured to receive acoustic signals to assess whether ablation has been achieved within the intended emission region. Ultrasonic transducer 9 is capable of transmitting acoustic energy radially outward toward neural tissue and other parts of the subject, thereby heating the target neural tissue with the ultrasonic energy to thereby intervene in the neural tissue.

[0076] Please also refer to 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 conduit 101 of the conduit assembly 1 (in some embodiments, when the outer contour of the first conduit 101 is circular, the cylindrical liner 902 is sleeved on the first conduit 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 drawn out to connect to the conductive layer and shielding layer inside 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, which can provide 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, thereby reducing the heat generated by ultrasonic wave propagation on the inner surface.

[0077] The sac 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 sac 2 mentioned above) is formed between the sac 2 and the catheter assembly 1. The circulation area is connected to the water injection channel 5 and the return water 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 conducive to 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 sac 2 through the water injection channel 5 at a preset water injection pressure and discharged from the sac 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 sac 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 of the liquid medium discharged. This positive pressure difference determines the degree of expansion of the balloon and is a key factor in achieving therapeutic effects. Because the balloon is inflated with liquid medium, the pressure at the point where the balloon is connected to the water injection channel and the pressure at the point where the balloon is connected to the return water 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 of the water injection channel 5 and the return water channel 6. The formula is roughly derived as follows: positive pressure difference ΔF = F1 (S3-S1) + C, where 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 return water 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 return water channel 6.

[0081] By adopting the above-mentioned setting method, the heat generated by the ultrasonic transducer 9 during operation is brought out by the circulation of 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 prevent the interior of the blood vessel from being damaged by heat.

[0082] Please refer to Figure 5(d) as well. When the flow area formed between the balloon 2 and the catheter assembly 1 is in the inflated configuration, it can respond to the positive pressure difference and achieve graded expansion. That is, 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] Thus, by adjusting the positive pressure difference between the preset water injection pressure and the preset return water 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 a minimum of 4mm to 12mm. For example, when the positive pressure difference is made of Pebax3533 (nylon elastomer, Shore hardness of approximately 30A), the diameter of the bladder 2 is 4mm when the positive pressure difference is 2atm; 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; and 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 Shore hardness 30A to 70A.

[0087] During the expansion of the balloon 2, since the balloon 2 made of rubber 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 and no obvious slippage will occur.

[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 refer to 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 exhibit multiple expansion states, causing the outer diameter of the balloon 2 to continuously increase. In addition, the elastic texture of the balloon 2 allows the expanded balloon 2 to adhere well to the inner wall of the blood vessel.

[0090] In some embodiments, the cross-sectional area of ​​the water injection channel 5 is larger 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 ensure good adhesion between the balloon 2 and 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 return water channel 6.

[0092] The relationship between the critical pressure F0 of the balloon 2 in the expanded state and S3 / S1 can be calculated using in vitro tests: 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 disposed outside the first catheter 101. The first catheter 101 has an emitting section extending distally from the second catheter 102. The distal end of the emitting section has a tip 1011. The ultrasonic transducer 9 is connected to the emitting section. The capsule 2 is disposed outside the emitting 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 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. A circular first catheter 101 facilitates the fitting of the cylindrical liner 902 onto the first catheter 101. The gourd-shaped first catheter 101 can create a gap with the second catheter 102 while providing some support for the second catheter 102, facilitating the installation of the guidewire channel 8 and the cable channel 7. The gourd-shaped launch section can also better adapt to vessels of varying diameters, maintaining good adaptability and effectiveness in both wider and narrower areas of the vessel.

[0098] In order to facilitate the realization of the functions of the catheter assembly 1 , the first catheter 101 may be a double-lumen structure or a single-lumen structure.

[0099] In some embodiments, the first catheter 101 is of a double-lumen configuration.

[0100] Please also refer to 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, and the proximal end of the first guidewire cavity 1013 is connected to the guidewire cavity within the coverage range of the second catheter 102. The guidewire cavity within the coverage range of the second catheter 102 is connected to the guidewire outlet 1021 on the side of the second catheter 102 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 pass through the guidewire channel 8 and extend out of the catheter assembly 1 from the guidewire outlet 1021.

[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 that is 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 should also be explained that in this embodiment, the first conduit 101 serves as the inner conduit of the second conduit 102, with a portion disposed within the second conduit 102 and the other portion extending from the second conduit 102. Furthermore, the first conduit 101 is provided with two channels, namely the return channel 6 and the first guidewire lumen 1013. The gap formed between the first conduit 101 and the second conduit 102 serves as a shared channel for the water injection channel 5 and the cable channel 7. The first conduit 101 may be a conduit that extends from the proximal end of the second conduit 102 and extends from the distal end of the second conduit 102, or it may be fixedly connected only to the distal end of the second conduit 102 and have a transmitting end extending toward the distal end of the second conduit 102.

[0105] Specifically, the distal end of the return water channel 6 is sealed by a heat shrinkage 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 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 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 exits from the guidewire outlet 1021. The imaging catheter follows the guidewire into the target blood vessel. 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-rays, thereby locating the position of the capsule 2 in the blood vessel. The liquid medium is injected from the water injection interface 3 and enters 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 an acoustic signal, thereby achieving ablation of the lesion. At the same time, the return water port 601 on the first catheter 101 will bring the liquid medium inside the capsule 2 out 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 achieved, and the heat generated by the acoustic signal generated by the ultrasonic transducer 9 can be brought out, thereby better protecting the interior of the blood vessel from thermal damage.

[0108] In some embodiments, the first catheter 101 is of single lumen construction.

[0109] Please also refer to Figure 7 、 Figure 8 and Figure 9 The second catheter 102 is provided with a water injection channel 5, a return water channel 6 and a cable channel 7 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. 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 connected to the guidewire inlet 1012 in the tip 1011, and the proximal end is connected to the guidewire interface 14, thereby forming 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 length from the distal guidewire inlet 1012 to the proximal guidewire interface 14, forming an over-the-wire (OTW) structure, which is convenient for operation in relatively thick blood vessels without causing bifurcation 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 circulation 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 circulation area inside the capsule 2; the inner and outer electrodes of the ultrasonic transducer 9 are respectively connected to the inner conductor and 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 refer to Figure 10 The above-mentioned ultrasonic transducer 9 includes a cylindrical piezoelectric layer 901 and a cylindrical lining 902 arranged on the inner surface of the cylindrical piezoelectric layer 901. The cylindrical lining 902 is sleeved on the first catheter 101. The cylindrical piezoelectric layer 901 and the cylindrical lining 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 the propagation of ultrasonic waves 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 return water 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 return water channel 6 through the return water 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 provided at the water return interface 4 for detecting the temperature of the liquid medium at the water return interface 4 , and the pressure sensor can be provided in the capsule 2 for detecting 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 return water interface 4 and the water temperature T1 inside the capsule 2 , and this temperature difference can be obtained through experimental testing.

[0120] After connecting the water injection interface 3, the return water interface 4, and the signal interface 10 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 return water 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 since 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 an excessive positive pressure difference ΔF and thus excessive expansion of the bladder 2, the controller controls the water circulation device to pump 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 aforementioned embodiment where "the cross-sectional area S3 of the water injection channel 5 is set to be greater than the cross-sectional area S1 of the water return channel 6," the water circulation device can be a circulating water pump. 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 a diameter difference, the operating state of a single circulating water pump can be set to utilize the channel diameter difference inherent in the pipeline design to cause more water injection and less water discharge, thereby allowing more liquid medium to remain in the balloon 2. Without the host computer sending additional instructions to the circulating water pump, the balloon 2 can be conveniently switched from the retracted configuration to the inflated configuration. Accordingly, switching the balloon 2 to the inflated configuration and achieving the desired graded expansion degree only requires adjusting the water circulation rate of the circulating water pump to achieve the desired graded expansion degree and maintain water circulation within the balloon 2, thereby reducing the temperature of the patient tissue directly contacted by the balloon 2 and avoiding undesirable damage to the patient tissue. The above description does not exclude the implementation of setting up two or more water circulation pumps to control the water injection channel 5 and the water outlet channel 6 separately. Instead, it is intended to emphasize that the present application is adaptable to both conventional multi-water circulation pump multi-program control mode and single-channel circulation water pump multi-mode control mode, and even a combination of the two modes. Compared with two independent circulation water pumps, each pump is responsible for one channel. This means that the controller needs to be able to independently adjust and control the operating status of the two pumps. This may increase the design and operation complexity of the controller because it is necessary to ensure the coordinated operation of the two pumps and possible synchronization issues. Compared with other existing technologies, 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. Using the conduit of the present application in conjunction with a single circulation water pump, through the design of the pipe and fluid dynamics, the difference in pipe diameter is used to control the water flow, and the natural pressure difference is used to maintain water circulation and temperature control. Because only the operating status of one pump needs to be adjusted, the control system design is simpler, the corresponding structure is simpler and the operation is easier, and the possibility of system failure and maintenance costs 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: including a catheter assembly, an ultrasound transducer, and a balloon; 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; The ultrasonic transducer is arranged at the distal end of the catheter assembly, and is used to transmit 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 circulation area is formed between the sac and the catheter assembly. The circulation area is respectively connected to the water injection channel and the return water channel so that the liquid medium can remove 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.

2. The ultrasonic ablation device according to claim 1, wherein: The cross-sectional area of ​​the water injection channel is larger than the cross-sectional area of ​​the water return channel.

3. The ultrasonic ablation device according to claim 2, wherein: 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, wherein: 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 guidewire cavity and the water return channel. 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, wherein: 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 arrange the cable of the ultrasonic transducer; The second catheter is provided with a second guidewire lumen, and the first guidewire lumen is communicated with the second guidewire lumen to form the guidewire channel.

6. The ultrasonic ablation device according to claim 3, wherein: 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. 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, wherein: The cross-section 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, wherein: The shape of the balloon after expansion is one of an olive shape, a spherical shape and a wavy cylindrical shape; And / or, the capsule 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 return water channel through the return water 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, wherein: The host includes a controller; The ultrasonic ablation device further comprises: 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; A pressure sensor, used to detect the pressure inside the capsule; The controller is configured to be in communication 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.

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