Neurosonic ablation

Abstract

An apparatus (22) comprising a tube (30) configured to be inserted into a blood vessel of a patient, a transducer housing (32) coupled to the tube at a distal end, a sheath cover (28) configured to enclose the transducer housing within the blood vessel, and at least one ablation ultrasound transducer (34) within the transducer housing, the transducer configured to emit ablation ultrasound waves through the sheath cover toward one or more nerves (90) surrounding the blood vessel. Other embodiments are also disclosed.

Description

[0001] Cross-reference with other patent applications This application claims priority to U.S. Provisional Application 63 / 533,711 entitled “Neuro-ultrasound Ablation”, filed August 21, 2023, the disclosure of which is incorporated herein by reference. Technical Field

[0002] This invention is generally related to ultrasound ablation therapy, especially to ultrasound ablation of nerves (such as the renal nerve). Background Technology

[0003] Refractory hypertension, which is hypertension that does not respond to medication, is a serious health problem.

[0004] In recent years, percutaneous renal denervation has become the preferred treatment for refractory hypertension. This procedure involves ablating the renal nerve within the renal artery using ablation media such as radiofrequency energy or ultrasound. This weakens the renal nerve activity, thereby lowering blood pressure. Summary of the Invention

[0005] Some embodiments of the present invention provide an apparatus configured to deliver ablation ultrasound waves to nerves surrounding a patient's blood vessel (e.g., a renal artery). The apparatus includes a tube configured for insertion into the blood vessel, a transducer housing distally coupled to the tube, a housing cover configured to surround the transducer housing within the blood vessel, and at least one ablation ultrasound transducer located within the transducer housing, the transducer being configured to emit ablation ultrasound waves through the housing cover to one or more nerves surrounding the blood vessel.

[0006] Typically, the location and direction of the ablation wave emission must be carefully chosen, taking into account the "non-target" anatomical structures surrounding the blood vessel (such as lymph nodes and other vessels). Similarly, the presence of these structures may necessitate precise control of the ablation energy delivery. If the ablation ultrasound is emitted uniformly in all directions along the entire length of the blood vessel during the procedure, it may be ineffective or even dangerous.

[0007] To address these challenges, in some embodiments, the device further includes at least one imaging ultrasound transducer located within a transducer housing. The imaging ultrasound transducer is configured to emit imaging ultrasound waves toward the perivascular area and transduces the reflected signals of the imaging ultrasound waves. The advantage is that the transduced reflected signals help construct an ultrasound image to guide the emission of ablation ultrasound waves, thereby enabling more effective and / or safer ablation. For example, a computer processor can construct an ultrasound image based on the transduced reflected signals and then process the image to identify anatomical structures such as nerves and / or non-target structures around the blood vessel.

[0008] In some embodiments, the ablation ultrasonic transducer includes an electroacoustic transducer element and one or more flexible elements (e.g., adhesive tape) for supporting the electroacoustic transducer element. Advantageously, these flexible elements can promote vibration of the electroacoustic transducer element.

[0009] In some embodiments, the device further includes a fluid conduit disposed within the transducer housing on a first side of the ablation ultrasound transducer, configured to deliver fluid to a distal end of the transducer housing such that the fluid flows from the distal end to the proximal end of the transducer housing, across a second side of the ablation ultrasound transducer from which the ablation wave is emitted. Therefore, it is advantageous that the fluid can carry away any air that might obstruct the ablation wave.

[0010] Therefore, according to some embodiments of the present invention, an apparatus is provided, the apparatus comprising: a tube configured to be inserted into a patient's blood vessel; a transducer housing distally coupled to the tube; an outer casing configured to surround the transducer housing within the blood vessel; and at least one ablation ultrasound transducer disposed within the transducer housing and configured to emit ablation ultrasound waves through the outer casing to one or more nerves surrounding the blood vessel.

[0011] In some embodiments, the transducer housing does not completely surround the ablation ultrasonic transducer.

[0012] In some embodiments, the tube is configured to transmit rolling torque and linear force to the transducer housing.

[0013] In some embodiments, the device further includes a quick-exchange tip, the distal end of which is coupled to the housing and configured to allow a guidewire to pass through.

[0014] In some embodiments, the apparatus further includes: A control handle configured to be coupled proximal to a tube body and including a gear system; and A motor unit is configured to be coupled to a gear system and to provide mechanical force to the gear system, thereby moving the tube.

[0015] In some embodiments, the transducer housing is configured to limit the angular range of the ablation ultrasound so that the ablation ultrasound does not ablate the entire circumference of the blood vessel simultaneously.

[0016] In some embodiments, the diameter of the outer casing is less than 10 Fr.

[0017] In some embodiments, the device further includes a conduit shaft that houses the tube body and is proximally coupled to a housing.

[0018] In some embodiments, the device further includes an inflatable element coupled to the outer wall of the catheter shaft or housing and configured to inflate within the blood vessel, thereby inhibiting contact between the outer wall and the vascular tissue.

[0019] In some embodiments, the acoustic impedance of the outer casing is lower than that of the duct shaft.

[0020] In some embodiments, the ablation ultrasound transducer includes: An electroacoustic transducer; and One or more flexible elements that support an electroacoustic transducer.

[0021] In some embodiments, the flexible element includes one or more flexible adhesive tapes.

[0022] In some embodiments, a flexible adhesive tape covers the periphery of the electroacoustic transducer element.

[0023] In some embodiments, the distal end of the outer casing is coupled to the tube body.

[0024] In some embodiments, the apparatus further includes: The conduit shaft, which houses the tube body; and An inflatable element is coupled to the outer wall of the catheter shaft or housing and configured to inflate within the blood vessel, thereby inhibiting contact between the outer wall of the blood vessel and the vascular tissue.

[0025] In some embodiments, the transducer housing includes a distal alignment element configured to align a guide wire passing through the transducer housing with the rolling axis of the transducer housing, such that the guide wire is aligned with the rolling axis at the distal end of the transducer housing.

[0026] In some embodiments, the shape of the alignment element defines a channel that is at least partially inclined relative to the rolling axis, and the alignment element is configured to align the guide wire by passing the guide wire through the channel.

[0027] In some embodiments, the device further includes a guidewire conduit passing through the transducer housing. The guidewire passes through the guidewire catheter, and The alignment element aligns the guidewire with the rolling axis by keeping the guidewire conduit aligned with the rolling axis.

[0028] In some embodiments, the apparatus further includes: A cover that surrounds at least a portion of the alignment element; and A fluid seal is disposed between the housing and the alignment element, or at the distal end of the alignment element within the housing.

[0029] In some embodiments, the transducer housing has an air pocket on the first side of the ablation ultrasonic transducer, so that the ablation ultrasonic waves are concentrated on the second side of the ablation ultrasonic transducer, the second side being opposite to and fluidly isolated from the first side.

[0030] In some embodiments, the ablation ultrasound transducer includes: Electroacoustic transducers; and One or more flexible elements are used to support the electroacoustic transducer and isolate the air cavity from the second side of the ablation ultrasonic transducer.

[0031] In some embodiments, the device further includes a fluid conduit disposed within a transducer housing on a first side of the ablation ultrasound transducer and configured to deliver fluid to a distal end of the transducer housing, such that the fluid flows from the distal end of the transducer housing to the proximal end, passing through a second side of the ablation ultrasound transducer.

[0032] In some embodiments, the device further includes a conduit shaft that houses the tube body; and The fluid conduit is configured such that the fluid flows proximally through the ablation ultrasound transducer and into the space between the conduit body and the conduit axis.

[0033] In some embodiments, fluid flows along the proximal end of the housing, and the housing is inflatable, so that the fluid can inflate the housing.

[0034] In some embodiments, the device further includes at least one imaging ultrasonic transducer disposed within a transducer housing and configured to: It emits imaging ultrasonic waves through the outer casing to the surrounding area, and This is converted into a reflected signal like ultrasound, which helps to construct an ultrasound image to guide the emission of ablation ultrasound waves.

[0035] In some embodiments, the imaging ultrasound transducer is located at the distal end of the ablation ultrasound transducer.

[0036] In some embodiments, the outer casing is cylindrical.

[0037] In some embodiments, the outer shell is inflatable, and the device further includes a fluid conduit for delivering fluid into the outer shell, such that the outer shell can be fluid-filled within the blood vessel.

[0038] According to some embodiments of the present invention, a system including the aforementioned device and a processor is also provided. The processor is configured to calculate the distance between the ablation ultrasound transducer and the inner wall of the blood vessel based on the converted reflected signal, and to control the emission of ablation ultrasound waves according to the distance.

[0039] In some embodiments, the processor is configured to calculate distance by processing ultrasound images.

[0040] According to some embodiments of the present invention, a system is also provided, the system including the device and the processor, the processor being configured to process ultrasound images to identify one or more surrounding anatomical structures.

[0041] In some embodiments, the processor is configured to process B-mode image time series, including the ultrasound images, in order to distinguish nerves from other blood vessels.

[0042] In some embodiments, The ultrasound image is a B-mode image, and The processor is also configured to process M-mode images in order to distinguish nerves from other blood vessels.

[0043] In some embodiments, the ultrasound images are three-dimensional.

[0044] In some embodiments, the anatomical structures include nerves.

[0045] In some embodiments, the anatomical structure includes one or more other blood vessels.

[0046] In some embodiments, the anatomical structures include one or more lymph nodes.

[0047] In some embodiments, the anatomical structures include arterial plaques.

[0048] In some embodiments, the processor is also configured to label anatomical structures in ultrasound images.

[0049] In some embodiments, the processor is also configured to control the emission of ablation ultrasound in response to the identification of the anatomical structure.

[0050] In some embodiments, the processor is configured to control the emission of the ablation ultrasonic transducer by controlling the pose of the ablation ultrasonic transducer when it emits ablation ultrasonic waves.

[0051] In some embodiments, the processor is configured to control the emission of ablation ultrasound by controlling the emission power.

[0052] In some embodiments, the processor is configured to control the emission of ablation ultrasound waves by controlling the emission duration in response to the pose of the ablation ultrasound transducer.

[0053] According to some embodiments of the present invention, a device system is also provided, the device further comprising a temperature sensor disposed within a transducer housing configured to detect a temperature within the transducer housing; and a processor configured to modulate the energy of the ablation ultrasound in response to the detected temperature.

[0054] According to some embodiments of the present invention, a method is also provided, comprising: inserting a transducer housing into a patient's blood vessel, the distal end of the transducer housing being coupled to a tube body and surrounded by an outer shell; and, as the transducer housing moves along the blood vessel, using at least one ablation ultrasound transducer located within the transducer housing, emitting ablation ultrasound waves through the outer shell to one or more nerves surrounding the blood vessel.

[0055] In some embodiments, the outer shell is inflatable, and the method further includes inflating the outer shell within the blood vessel prior to emitting ablation ultrasound.

[0056] In some embodiments, emitting ablation ultrasound includes emitting ablation ultrasound while varying the emission power.

[0057] In some embodiments, emitting ablation ultrasound includes emitting the ablation ultrasound while varying the emission duration for different orientations of the ablation ultrasound transducer.

[0058] In some embodiments, the blood vessel is a renal artery.

[0059] In some embodiments, moving the transducer housing includes moving the transducer housing downstream of a segment of the renal artery bifurcation.

[0060] In some embodiments, emitting ablation ultrasound includes emitting ablation ultrasound while controlling the orientation of the ablation ultrasound transducer.

[0061] In some embodiments, controlling the pose includes controlling the pose by rolling the transducer housing using the tube body.

[0062] In some embodiments, controlling the pose includes moving the transducer housing through the tube body, causing the ablation ultrasound transducer to move along a spiral path within the blood vessel, thereby controlling the pose.

[0063] In some embodiments, the method further includes: emitting imaging ultrasound waves toward the perivascular area using at least one imaging ultrasound transducer disposed within the transducer housing, such that the imaging ultrasound transducer can convert the reflected signal of the imaging ultrasound waves; and Emitting the ablation ultrasound includes emitting ablation ultrasound based on an ultrasound image constructed from the converted reflected signals.

[0064] In some embodiments, emitting ablation ultrasound includes emitting ablation ultrasound in response to the identification of one or more anatomical structures in the ultrasound image.

[0065] In some embodiments, the method further includes: rolling the transducer housing through the tube while moving the transducer housing along the blood vessel to control the angular range of the imaging ultrasound.

[0066] According to some embodiments of the present invention, a method is also provided, the method comprising: inserting a catheter shaft, a transducer housing (the distal end of which is coupled to a tube located within the catheter shaft and houses at least one ultrasound transducer), and an outer casing (the distal end of which is coupled to the catheter shaft and surrounds the transducer housing) into a patient's blood vessel. The method further comprises: moving the transducer housing through the outer casing using the tube without moving the catheter shaft, while the ultrasound transducer emits ultrasound waves toward the perivascular area.

[0067] In some embodiments, the outer shell is inflatable, and the method further includes inflating the outer shell within the blood vessel before emitting ultrasound.

[0068] In some embodiments, moving the transducer housing through the housing includes moving the transducer housing proximally through the housing.

[0069] In some embodiments, the method further includes: rolling the transducer housing through the tube while moving the transducer housing through the outer casing to control the angular range of the ultrasonic waves.

[0070] In some embodiments, the blood vessel is a renal artery.

[0071] In some embodiments, moving the transducer housing includes moving the transducer housing while the housing is located within a section downstream of the renal artery bifurcation.

[0072] In some embodiments, the ultrasound transducer is an ablation ultrasound transducer, the ultrasound waves are ablation ultrasound waves, and moving the transducer housing includes: moving the transducer housing while the ablation ultrasound transducer emits ablation ultrasound waves toward one or more nerves around the blood vessel.

[0073] In some embodiments, moving the transducer housing includes moving the transducer housing by initiating an automated process for moving the transducer housing.

[0074] In some embodiments, The ultrasonic transducer is an imaging ultrasonic transducer; Ultrasound is imaging ultrasound; The movable transducer housing includes: moving the transducer housing while the imaging ultrasonic transducer converts the reflected signal of the imaging ultrasonic wave; The transducer housing also houses at least one ablation ultrasonic transducer, and The method further includes using an ablation ultrasound transducer to emit ablation ultrasound waves onto one or more surrounding nerves based on an ultrasound image constructed from the converted reflected signals.

[0075] In some embodiments, moving the transducer housing includes moving the transducer housing along the direction of the motion path, and emitting ablation ultrasound includes emitting ablation ultrasound while the transducer housing is moving along the direction of the motion path.

[0076] In some embodiments, emitting ablation ultrasound includes emitting ablation ultrasound in response to identifying one or more anatomical structures in an ultrasound image.

[0077] In some embodiments, emitting ablation ultrasound includes emitting ablation ultrasound while controlling the orientation of the ablation ultrasound transducer.

[0078] In some embodiments, controlling the pose includes controlling the pose by rolling the transducer housing through the tube.

[0079] In some embodiments, controlling the pose includes moving the transducer housing through the tube body, causing the ablation ultrasound transducer to move along a spiral path within the blood vessel, thereby controlling the pose.

[0080] In some embodiments, emitting ablation ultrasound includes emitting the ablation ultrasound while changing the emission power.

[0081] In some embodiments, emitting ablation ultrasound includes emitting the ablation ultrasound while varying the emission duration for different orientations of the ablation ultrasound transducer.

[0082] According to some embodiments of the present invention, an apparatus is also provided, the apparatus comprising: a tube configured for insertion into a patient's blood vessel; a transducer housing distally coupled to the tube; one or more ultrasound transducers disposed within the transducer housing, the transducers being configured to emit ultrasound waves toward the perivascular space; and a fluid conduit disposed within the transducer housing, located on a first side of the ultrasound transducers, and configured to deliver fluid to a distal end of the transducer housing such that the fluid flows from the distal end of the transducer housing to the proximal end and through a second side of the ultrasound transducer (opposite to the first side).

[0083] In some embodiments, the ultrasound transducer includes an ablation ultrasound transducer configured to emit ablation ultrasound waves toward one or more nerves surrounding the blood vessel.

[0084] In some embodiments, the ultrasonic transducer further includes an imaging ultrasonic transducer configured as follows: It emits imaging ultrasonic waves to the surrounding area, and It is converted into a reflected signal like ultrasound to construct an ultrasound image, thereby guiding the emission of ablation ultrasound waves.

[0085] In some embodiments, the imaging ultrasound transducer is located at the distal end of the ablation ultrasound transducer.

[0086] In some embodiments, the device further includes damping material disposed within the transducer housing. The imaging ultrasonic transducer includes an imaging transducer element disposed within a damping material, and The fluid conduit passes through the damping material.

[0087] In some embodiments, the fluid conduit is configured to deliver fluid such that the fluid flows into the space between the damping material and the distal inner wall of the transducer housing, and flows from the space toward the proximal end through the transducer housing.

[0088] In some embodiments, The second side is fluidly isolated from the first side, and The transducer housing includes an air cavity on the first side of the ablation ultrasonic transducer, so that the ablation ultrasonic waves are concentrated on the second side of the ablation ultrasonic transducer.

[0089] In some embodiments, the device further includes an outer casing configured to surround a transducer housing, and the fluid conduit is configured to deliver fluid such that the fluid flows proximally between the ultrasonic transducer and the outer casing.

[0090] In some embodiments, the outer casing is cylindrical.

[0091] In some embodiments, the housing is inflatable, and the fluid inflates the housing as it flows toward the proximal end.

[0092] In some embodiments, the device further includes a conduit shaft that houses the tube body and has its proximal end coupled to a housing.

[0093] The construction of the fluid conduit allows fluid to flow proximally through the space between the conduit body and the conduit shaft.

[0094] In some embodiments, the outer casing is coupled distally to the tube body, and the fluid conduit is configured to deliver fluid such that the fluid flows proximally through the lumen of the tube body.

[0095] In some embodiments, the transducer housing includes a distal alignment element for aligning a guide wire passing through the transducer housing with the rolling axis of the transducer housing, such that the guide wire is aligned with the rolling axis at the distal end of the transducer housing.

[0096] In some embodiments, the apparatus further includes: A cover surrounding at least a portion of the alignment element; and A fluid seal is disposed between the housing and the alignment element, or at the distal end of the alignment element within the housing.

[0097] According to some embodiments of the present invention, an apparatus is also provided, the apparatus comprising: a tool configured for insertion into a patient via a guidewire, and a tube distally coupled to the tool, the tube being configured to transmit rolling torque to the tool to cause the tool to roll about a rolling axis. The tool includes a distal alignment element configured to align the guidewire with the rolling axis of the tool, thereby aligning the guidewire with the rolling axis at the distal end of the tool.

[0098] According to some embodiments of the present invention, an apparatus is also provided, the apparatus comprising: a tube configured for insertion into a patient's blood vessel; a transducer housing distally coupled to the tube; and an ablation ultrasound transducer located within the transducer housing, the transducer being configured to emit ablation ultrasound waves toward one or more nerves surrounding the blood vessel. The ablation ultrasound transducer includes an electroacoustic transducer element and one or more flexible elements supporting the electroacoustic transducer element.

[0099] In some embodiments, the transducer housing includes an air cavity on a first side of the ablation ultrasound transducer, and a flexible element isolates a second side of the ablation ultrasound transducer (opposite to the first side) from the air cavity.

[0100] In some embodiments, the flexible element is configured to promote the vibration of the electroacoustic transducer.

[0101] In some embodiments, the flexible element is configured to prevent short circuits between two opposing surfaces of the electroacoustic transducer.

[0102] In some embodiments, the flexible element includes one or more springs.

[0103] In some embodiments, the flexible element includes one or more flexible adhesive tapes.

[0104] In some embodiments, adhesive tape covers the periphery of the electroacoustic transducer element.

[0105] In some embodiments, the electroacoustic transducer is configured to vibrate along an axis perpendicular to the plane containing the outer periphery of the electroacoustic transducer.

[0106] In some embodiments, the adhesive tape comprises an adhesive selected from the group consisting of UV-curable adhesives, polyurethane adhesives, and silicone adhesives.

[0107] In some embodiments, the apparatus further includes: Damping material is disposed within the transducer housing, located at the distal end of the ablation ultrasonic transducer; and The imaging transducer element is housed within the damping material. The adhesive tape couples the electroacoustic transducer to the damping material.

[0108] In some embodiments, the device further includes an electrical interface located near and connected to the electroacoustic transducer via a wire, with an adhesive tape coupling the electroacoustic transducer to the electrical interface.

[0109] In some embodiments, adhesive tape couples the electroacoustic transducer element to the inner wall of the transducer housing.

[0110] A more complete understanding of the present invention will be achieved by referring to the detailed description of the embodiments of the present invention in conjunction with the accompanying drawings. Attached Figure Description

[0111] Figure 1 This is a schematic diagram of a neuroablation system according to some embodiments of the present invention; Figure 2 This is a schematic diagram of the distal portion of an in vivo ultrasound device according to some embodiments of the present invention; Figure 3 The imaging-ablation procedure according to some embodiments of the present invention is illustrated schematically with reference to example perspective images; Figure 4 A flowchart of an imaging-ablation procedure according to some embodiments of the present invention is shown; Figure 5A This is a schematic diagram of the distal end and cross-section of an in vivo ultrasound device according to some embodiments of the present invention; Figure 5B This is a schematic diagram of the distal end of an in vivo ultrasound device according to some embodiments of the present invention, the device including an inflatable outer shell; Figure 6 yes Figure 5A A partial exploded view of an in vivo ultrasound device according to some embodiments of the present invention is shown. Figure 7 yes Figure 5A A longitudinal cross-sectional view of an in vivo ultrasound device according to some embodiments of the present invention is shown. Figure 8A and Figure 8B These are partially exploded views of the distal end of an in vivo ultrasound device according to some embodiments of the present invention and corresponding views of the device in its assembled state. Figure 9 This is a schematic diagram of the distal end of an in vivo ultrasound device according to some embodiments of the present invention; Figure 10A and 10B This is a longitudinal cross-sectional view of the distal end of an in vivo ultrasound device according to some embodiments of the present invention; Figure 11 This is another longitudinal cross-sectional view of the distal end of an in vivo ultrasound device according to some embodiments of the present invention; Figure 12 This is a schematic diagram of an ultrasound image marked according to some embodiments of the present invention; Figure 13 This is a schematic diagram of the distal end of an in vivo ultrasound device according to some embodiments of the present invention. Detailed Implementation

[0112] Overview Some embodiments of the present invention provide an ultrasonic device, for example Figures 1-2 As shown by reference numeral 22 in the accompanying drawings, the device includes at least one therapeutic (ablation) transducer 34 comprising an electroacoustic transducing element, such as a piezoelectric ceramic. The device also includes a tube 30 for insertion into a blood vessel, a transducer housing 32 distally coupled to the tube 30, and an outer casing 28 surrounding the transducer housing 32 and serving as a low-impedance acoustic window. The transducer 34 is located within the transducer housing 32 and configured to deliver ablation ultrasound waves through the acoustic window to nerves surrounding a patient's blood vessel (e.g., a renal artery).

[0113] Typically, to avoid damaging "non-target" anatomical structures such as blood vessels and lymph nodes surrounding the renal artery, the location and direction of the ablation wave must be carefully selected. Similarly, due to the presence of these structures, it may be necessary to precisely control the amount of ablation energy delivered to the area surrounding the artery.

[0114] To address these challenges, in some embodiments, the device further includes at least one imaging transducer 36, which comprises an electroacoustic transducing element, such as a piezoelectric ceramic. During the procedure, the imaging transducer is used to acquire images of the anatomical structures surrounding the patient's renal artery (the images may be two-dimensional images or three-dimensional images constructed from an array of two-dimensional images). The images are analyzed by a medical professional and / or by a computer processor 24. Figure 1 The system automatically analyzes and identifies renal nerves and / or non-target structures. Based on these identifications, medical professionals or processors use a therapeutic transducer to perform ablation procedures appropriate to the patient's anatomy.

[0115] For example, ablation ultrasound can be directed at any renal nerve identified in the image. Alternatively, ablation ultrasound can be emitted in multiple directions as the device moves along the artery, but the ablation power can be changed or emission can be stopped when the treatment transducer is directed toward a non-target structure. As another example, the speed at which the device moves along the artery can be varied depending on whether a nerve or a non-target structure is identified.

[0116] Typically, to improve ablation accuracy, the transducer housing is configured to limit the angular range of the ablation ultrasound waves, preventing simultaneous ablation across the entire circumference of the blood vessel. For example, in some embodiments, one side of the treatment transducer faces the air cavity, while the other faces the acoustic window. Advantageously, the ablation ultrasound waves can be concentrated and emitted through the acoustic window. Furthermore, it is advantageous that the tube 30 is configured to transmit torque to the transducer housing, allowing the treatment transducer to rotate and thus enabling ablation in any direction.

[0117] In some cases, to reach parts of the renal nerve, it may be necessary to position the therapeutic transducer after the bifurcation of the renal artery. Therefore, in some embodiments, the device is small enough to be inserted even into the thinner branches of the renal artery. In some embodiments, to facilitate miniaturization (and reduce manufacturing costs), the device comprises only a single therapeutic transducer and may optionally be equipped with a single imaging transducer.

[0118] In some embodiments, the therapeutic transducer element is supported within the transducer housing by a flexible element 50 (e.g., flexible adhesive tape 52). Figure 2 In addition to facilitating the vibration of the transducer element, the flexible element can also isolate the aforementioned air cavity from the other side of the transducer element (where the ablation wave is emitted), and / or prevent short circuits between the two sides of the transducer element.

[0119] In some embodiments, the distal end of the acoustic window is aligned with the duct axis 26 ( Figure 1Coupled with the transducer housing, the catheter shaft and acoustic window remain stationary during the imaging phase, while the transducer housing moves within the acoustic window. This technique offers the advantage of improved precision in subsequent ablation compared to moving the catheter shaft and acoustic window together with the transducer housing. For example, if the acoustic window is pulled back across an artery (i.e., moved upstream) during the imaging phase, and ablation is subsequently decided along that artery, it may be necessary to reposition the acoustic window downstream of that artery. However, accurately performing such repositioning can be difficult. In contrast, since the acoustic window remains in a fixed position during the imaging phase, such repositioning is unnecessary.

[0120] In some embodiments, the fluid circulates within the device. Advantageously, the fluid can reach the distal end of the device before flowing proximally through the transducer, thereby removing any air, including any air cavities at the distal end of the device, which might otherwise obstruct ablation and / or imaging ultrasound. Some embodiments provide a fluid seal 132 ( Figure 7 It is configured to prevent fluid from escaping into the patient's bloodstream.

[0121] Typically, the device uses guide wire 146 ( Figure 9 Guided by a guide wire. In some embodiments, the guide wire passes through a torque-transmitting tube and through an alignment element 126 at the distal end of the device. Figure 7 The alignment element aligns the guidewire with the axis of rotation of the device, thereby reducing the risk of arterial injury when the device is rotated (the alignment element may be integrated with the fluid seal described above). In other embodiments, the guidewire extends laterally along the device and passes through the quick-change tip 144 at the distal end of the device. Figure 9 ).

[0122] In addition to its application in the kidneys, the devices and methods described herein can also be used to ablate other nerves within other blood vessels. For example, in the treatment of type II diabetes, hepatic nerves can be ablated within the hepatic artery. Similarly, in the treatment of chronic upper abdominal pain (e.g., a complication of diseases such as pancreatic cancer or chronic pancreatitis), celiac plexus nerves can be ablated within the celiac artery. Furthermore, in the treatment of heart failure, greater visceral nerves can be ablated within the intercostal veins or arteries.

[0123] System Description Please refer to the following first. Figure 1 This is a schematic diagram of a neuroablation system 20 according to some embodiments of the present invention.

[0124] System 20 includes an in vivo ultrasound device 22. As described in detail below with reference to the accompanying drawings, device 22 is configured to ablate nerves (e.g., renal nerves) surrounding a patient's blood vessel (e.g., renal artery). In some embodiments, device 22 is also used to image the perivascular region prior to ablation.

[0125] Please see also Figure 2 This is a schematic diagram of the distal portion of an in vivo ultrasound device 22 according to some embodiments of the present invention.

[0126] Device 22 includes a tube body 30 and a transducer housing 32. The tube body 30 is configured for insertion into a blood vessel, and the distal end of the transducer housing 32 is coupled to the tube. In some embodiments, the length of the transducer housing 32 is 4 to 15 mm, for example, 8 to 12 mm. (It should be noted that...) Figure 2 Several features of device 22 have been omitted, such as the distal end of device 22, including the distal end of transducer housing 32. The device 22 also includes at least one ablation ultrasound transducer 34 disposed within the transducer housing 32 and configured to emit ablation ultrasound waves toward the nerve. The ablation ultrasound transducer 34 includes an electroacoustic transducer element 34e, which is typically made of a piezoelectric material.

[0127] In some embodiments, the device 22 further includes at least one imaging ultrasound transducer 36 disposed within the transducer housing 32. The transducer 36 is configured to emit imaging ultrasound waves toward the perivascular area and convert them into reflected signals resembling ultrasound waves to construct an ultrasound image, thereby guiding the emission of ablation ultrasound waves. The imaging ultrasound transducer 36 includes an electroacoustic transducer element 36e, which is typically made of a piezoelectric material.

[0128] Typically, the imaging transducer should be located as far distal as possible in the transducer housing 32 to reduce the advance distance required for imaging within the blood vessel. Therefore, the imaging ultrasound transducer is usually located distal to the ablation ultrasound transducer.

[0129] Typically, due to the different functions of each transducer, the physical properties of ultrasound transducers also vary. For example, the imaging transducer 36e may be made of soft piezoelectric ceramic, while the ablation transducer 34e may be made of hard piezoelectric ceramic. Furthermore, the surface area of ​​the ablation transducer may be larger than that of the imaging transducer. For example, the surface area A0 of the ablation transducer may be between 2 and 12 mm², while the surface area A1 of the imaging transducer may be between 0.25 and 1.5 mm², for example, 0.5 to 1 mm². Generally, the relatively smaller surface area A1 provides higher lateral and longitudinal resolution, which helps in identifying nerves in ultrasound images, as discussed below. Figure 3 Further description.

[0130] In some embodiments, the transducer elements are configured to vibrate at the same frequency, such as between 5 and 15 MHz, for example, 10 MHz. In other embodiments, the transducer elements are configured to vibrate at their respective different frequencies. For example, the imaging transducer element may vibrate at a higher frequency (e.g., 20 to 60 MHz) to achieve higher axial resolution, which helps in identifying nerves in ultrasound images.

[0131] Typically, the driving power of an ablation transducer is higher than that of an imaging transducer, resulting in higher energy of ablation ultrasound compared to imaging ultrasound. For example, the driving power of an ablation transducer can be between 1 and 10 W, while the driving power of an imaging transducer can be between 0.1 and 1 W.

[0132] Typically, the tube body 30 is configured to transmit rolling torque to the transducer housing 32. Therefore, during the imaging and / or ablation phases of the procedure, the transducer housing 32 can be rolled, i.e., about its rolling axis 42 ( Figure 2 Rotation. In addition, the tube body 30 is also configured to transmit a linear force to the transducer housing to cause the transducer housing to translate (e.g., advance or retract).

[0133] Typically, to reduce manufacturing costs and decrease the overall size of the transducer housing 32, the device 22 includes a relatively small number of transducers. For example, the device 22 may include a single ablation transducer and a single imaging transducer. Nevertheless, it is advantageous that imaging and / or ablation ultrasound waves can be emitted from the blood vessel in any direction perpendicular to the blood vessel by rolling the transducer housing.

[0134] Generally, each transducer element can have any suitable shape, such as rectangular or circular.

[0135] Typically, the imaging transducer element 36e is disposed within a damping material 38, which is used to suppress vibrations of the element in order to convert ultrasonic reflected signals. In some embodiments, the damping material 38 comprises a combination of tungsten and a binder.

[0136] Typically, to reduce acoustic impedance, the transducer housing 32 does not completely enclose the transducer, such as... Figure 2 As shown. Alternatively, the transducer housing can be completely enclosed.

[0137] Typically, device 22 also includes an electrical interface 44 disposed within the transducer housing and configured to connect transducer elements to corresponding conductors of a cable 48 passing through tube 30 via respective wires 46. In some embodiments, electrical interface 44 includes a printed circuit board (PCB) comprising two connection pads 45, each connection pad connecting a transducer element, and another connection pad (in...) Figure 2(Hidden in the middle), the connecting pads connect the other conductors of the cable 48 to the grounding terminal (typically the wall of the transducer housing 32).

[0138] In some embodiments, the device 22 further includes one or more flexible (e.g., elastic or compressible) elements 50 for supporting the ablation transducer element 34e. The flexible elements 50 facilitate the reduction of vibrations in the ablation transducer element, thereby improving ablation efficiency. In some embodiments, the flexible elements 50 also isolate the two opposing surfaces of the transducer element from each other, thereby preventing short circuits between the two surfaces.

[0139] In some embodiments, the flexible element 50 includes one or more springs. In other embodiments, the flexible element 50 includes one or more flexible adhesive strips 52 that may cover the periphery of the ablation transducer element. The adhesive strips 52 may comprise, for example, UV-curable adhesives, polyurethane adhesives, or silicone adhesives. Typically, the transducer element 34e vibrates along an axis perpendicular to the plane containing the element periphery, such as... Figure 2 The vibration indicator is shown in label 51.

[0140] For example, in some embodiments, such as Figure 2 As shown, the ablation transducer 34 is positioned close to the imaging transducer 36, and the damping material 38 is located between the two transducers. In some such embodiments (not shown), adhesive tape 52 supports the ablation transducer element by coupling it to the damping material 38. Alternatively or additionally, the electrical interface 44 may be positioned close to the ablation transducer, and the adhesive tape 52 may couple the ablation transducer element to the electrical interface 44. Alternatively or additionally, the ablation transducer element may also be coupled to the inner wall of the transducer housing.

[0141] like Figure 7 As shown, in some embodiments, the device 22 further includes a temperature sensor 154 disposed within the transducer housing 32, the temperature sensor 154 being used to sense the temperature within the transducer housing. For example, the temperature sensor 154 may include a coaxial thermocouple located at the distal end of a coaxial cable passing through the tube 30.

[0142] In some embodiments, system 10 also includes a pump (not shown) configured to pump fluid into device 22, as described below. Figure 5A , 5B Further described. Device 22 may also include a fluid conduit 54 configured to deliver fluid to a distal end of the transducer housing.

[0143] like Figure 1As shown, device 22 typically also includes an outer casing 28 for enclosing the transducer housing within the blood vessel, thereby isolating the transducer housing from the surrounding blood. Because the outer casing 28 encloses the transducer housing, any emitted ultrasound waves pass through it. Typically, the outer casing 28 has relatively low acoustic attenuation, for example, less than 3.5 dB / cm at a frequency of 1 MHz, to increase the propagation range of the ultrasound waves. Due to this characteristic, the outer casing 28 may also be referred to as an "acoustic window." In some embodiments, the outer casing 28 is cylindrical.

[0144] In some embodiments, the length of the housing 28 is less than 15 mm. Alternatively, the diameter of the housing may be less than 10 Fr, for example less than 7 Fr. These dimensions are advantageous for improving the maneuverability of the housing.

[0145] Typically, device 22 also includes a conduit shaft 26, in which a tube body 30 is housed.

[0146] In some embodiments, the proximal end of the conduit shaft 26 is coupled to the housing shroud 28, i.e., the housing shroud is coupled to the distal end of the conduit shaft. In such embodiments, the housing shroud 28 and the conduit shaft 26 typically do not roll with the transducer housing.

[0147] Typically, the outer casing 28 is made of a different material and / or has a thinner wall thickness, with an acoustic impedance lower than that of the conduit shaft 26. For example, the conduit shaft may be made of opaque polyether block amide (PEBA), such as opaque PEBAX®, while the outer casing may be made of optically transparent PEBA, such as optically transparent PEBAX®, with an acoustic impedance lower than that of opaque PEBA.

[0148] In other embodiments, as described below Figure 10A , 10B To further describe, the outer casing 28 is coupled at its distal end to the tube body 30 (i.e., the outer casing is connected to the distal end of the tube body), rather than to the conduit shaft 26.

[0149] Typically, system 20 also includes a control handle 56 configured to be proximal-coupled to tube 30 and including a gear system. During the imaging and / or ablation phase of the procedure, medical professionals (e.g., doctors, nurses, or technicians) can use the gear system to advance, retract, and / or (as indicated by roll indicator 58) roll the tube, thereby rolling the transducer housing.

[0150] In some embodiments, the control handle also includes one or more additional input interfaces, such as buttons. In such embodiments, healthcare professionals can use these additional input interfaces to control the emission of imaging and / or ablation ultrasound waves. Alternatively, healthcare professionals can use a separate input interface (e.g., a foot pedal) to control the emission of ultrasound waves.

[0151] Typically, the control handle 56 can also be configured to be proximal-coupled to the catheter shaft 26. Healthcare professionals use the control handle 56 to advance the catheter shaft, along with the catheter body 30, into the patient's blood vessel until the catheter shaft reaches the appropriate position within the vessel. This is typically done in conjunction with the following... Figure 3 The catheter axis is advanced via a guide sheath.

[0152] Typically, the control handle 56 includes an electrical interface 68 configured to be coupled to a cable 48 for exchanging signals over the cable. These signals may include signals received from and transmitted with the imaging transducer 36, signals received from the temperature sensor 154, etc. Figure 7 (and signals transmitted to the ablation transducer 34).

[0153] Typically, the control handle 56 also includes an accelerometer configured to track the position and roll angle of the transducer housing.

[0154] In some embodiments, the control handle 56 also includes a memory (not shown), such as an erasable programmable read-only memory (EPROM), configured to store identifiers of the device 22 (e.g., serial number), calibration information (e.g., the exact frequency of transducer element vibration), information recorded during previous use of the device 22, and / or any other relevant information.

[0155] Typically, system 20 also includes processor 24.

[0156] In some embodiments, processor 24 is configured to construct an ultrasound image based on signals from imaging transducer 36, which are derived from the conversion of ultrasound reflection signals. In some such embodiments, processor 24 is also configured to process the ultrasound image to identify one or more anatomical structures surrounding a blood vessel. Alternatively, the processor may identify these anatomical structures by processing the raw signals received from imaging transducer 36 without first constructing an image.

[0157] In some embodiments, processor 24 is implemented as a group of multiple processors that are networked cooperatively with each other via any suitable wired or wireless communication interface. This group of processors can cooperate in performing the processing functions described herein in any suitable manner. For example, one processor may construct an ultrasound image, while another processor may process said image. However, for simplicity, Figure 1 The following description assumes the use of a single processor.

[0158] In some embodiments, system 20 also includes a display 70. In such embodiments, processor 24 may display the acquired ultrasound images on display 70. Optionally, the processor may label any identified anatomical structures in the ultrasound images, as described below. Figure 12 Further description.

[0159] Alternatively, in combination with the following text Figure 3 Further described, processor 24 is configured to control the emission of ablation ultrasound waves, including optionally controlling the position and direction of these wave emissions. For example, the processor may execute an automated process to move the transducer housing to the desired position and direction.

[0160] In some embodiments, the control function described above is automatically initiated by the processor after recognizing anatomical structures in the ultrasound image. Alternatively, the control function may also be initiated by a user (e.g., a healthcare professional or assistant technician). In particular, the user may input instructions to the processor via any suitable input interface (e.g., the touchscreen of the display 70).

[0161] Alternatively or additionally, in addition to controlling the emission of ablation ultrasound, the processor can also control the emission of imaging ultrasound, including controlling the emission position and direction of these waves.

[0162] Typically, processor 24 is connected to interface circuitry 62, which is configured to establish a connection between processor 24 and device 22. For example, interface circuitry 62 may be connected (e.g., via cable 66 or wirelessly) to electrical interface 68 to transmit signals from imaging transducer 36 to interface circuitry 62. Alternatively or additionally, interface circuitry 62 may also be connected (e.g., via cable 66 or wirelessly) to the aforementioned memory in control handle 56 so that the processor can read data from and write data to the memory. Interface circuitry 62 and processor 24 may be housed within console 64.

[0163] In some embodiments, interface circuitry 62 includes a signal generator, an analog noise filter, a signal amplifier, and an analog-to-digital (A / D) converter. Thus, for example, in response to instructions from processor 24, interface circuitry 62 can generate a signal from the ultrasonic transducer at the distal end of drive device 22. Furthermore, after denoising and amplifying the analog signal from the imaging transducer, interface circuitry 62 can digitize the signal and transmit the digitized signal to processor 24. Similarly, signals from temperature sensors and accelerometers can also be selectively denoised, digitized, and transmitted to processor 24. (Alternatively or additionally, processor 24 can perform digital denoising on any of the aforementioned signals.) In addition to being connected to circuit 62, electrical interface 68 can also perform the aforementioned noise reduction, amplification, and / or digitization functions. In such embodiments, electrical interface 68 can be directly connected to processor 24.

[0164] In some embodiments, system 20 further includes a motor unit 60. In some such embodiments, the motor unit 60 is coupled to a gear system in the control handle 56 via a drive shaft 74. The motor unit 60 is configured to provide mechanical force to the gear system, thereby enabling the tube body 30 (and the transducer housing) to perform linear and rotational movements independently of the guide shaft 26. In other such embodiments, the motor unit 60 is mounted within a mating seat and directly coupled to the guide shaft 26 and the tube body 30. The motor unit slides within the mating seat, thereby moving the guide shaft and the tube body together and providing rotational force to rotate the tube body.

[0165] Typically, the motor unit 60 is connected to the interface circuit 62 via a cable 72, which can be used to power and communicate with the motor unit. For example, the processor 24 can control the motor unit via the cable 72, thereby driving the movement of the device 22.

[0166] Optionally, the motor unit 60 may include one or more input interfaces, such as joysticks, switches, or buttons. Healthcare professionals can use these input interfaces to drive the motor unit, providing mechanical force to the device 22 to move it. Alternatively or additionally, healthcare professionals can also use these input interfaces to issue commands regarding ultrasound emission. These commands can be transmitted from the motor unit to the processor 24 via cable 72 and interface circuitry 62. In response to these commands, the processor can control the emission of ultrasound; for example, the processor can control the emission of ultrasound by transmitting control signals via cable 66.

[0167] The functionality of any processor in System 20 can be implemented entirely in hardware, for example, using one or more fixed-function or general-purpose integrated circuits, application-specific integrated circuits (ASICs), and / or field-programmable gate arrays (FPGAs). Alternatively, the functionality can also be implemented at least partially in software. For example, the processor can be designed as a programmable processor, such as including a central processing unit (CPU) and / or a graphics processing unit (GPU). Program code (including software programs) and / or data can be loaded into the CPU and / or GPU for execution and processing. Program code and / or data can be downloaded to the processor in electronic form (e.g., via a network). Alternatively or additionally, program code and / or data can also be provided and / or stored on a non-transitory tangible storage medium, such as magnetic memory, optical memory, or electronic memory. When such program code and / or data are provided to the processor, a machine or special-purpose computer configured to perform the tasks described herein can be generated.

[0168] Surgical procedure Please see also Figure 3 Combined with fluorescent example perspective image 76, it schematically illustrates imaging and ablation procedures according to some embodiments of the present invention.

[0169] Image 76 shows the renal artery 78 branching from the aorta 80. The main branch 82 of artery 78 branches into several secondary branches 86 at the first bifurcation 84. These secondary branches 86 (which may include the superior and / or inferior segments of the artery) supply blood to the patient's kidneys. For ease of illustration, Figure 3 Other structures not visible in image 76, such as the renal nerve at 90, are superimposed. (Although) Figure 3 Specific anatomical details are shown, but it should be noted that the following text refers to... Figure 3 The described techniques can also be used for imaging and ablation within other blood vessels, as outlined in the overview section above. Typically, at the start of the procedure, medical staff will guide the guide sheath through the aorta 80 to the opening of the renal artery 78. (Optionally, medical staff may insert the guide sheath into the renal artery.) The guide sheath will typically be guided along guidewire 146 (… Figure 9 )navigation.

[0170] This navigation can be guided by any suitable imaging method, such as fluoroscopic images (as shown in Figure 76). To facilitate navigation under fluoroscopy, the guide sheath may be made of a radiopaque material and / or coupled to one or more radiopaque markers.

[0171] Subsequently, medical personnel typically insert the distal portion of the in vivo ultrasound device 22 (including the transducer housing 32) into the renal artery 78 (particularly the main branch 82) through a guide sheath and along a guidewire. Any part of the device 22, such as the transducer housing 32, may include a radiopaque material and / or be coupled with one or more radiopaque markers to facilitate insertion of the device into the artery and subsequent navigation within it.

[0172] Next, the imaging phase of the surgery is performed. Specifically, the medical staff (or processor 24) moves the transducer housing along the renal artery 78 while the imaging transducer 36 emits imaging ultrasound waves toward the periphery of the artery and converts the reflected signals of these imaging ultrasound waves. Based on these converted reflected signals, processor 24 constructs a two-dimensional or three-dimensional image (including a series of two-dimensional images) of the region. In some embodiments, the processor constructs a three-dimensional anatomical model based on the three-dimensional images.

[0173] In some embodiments, during the imaging phase, the transducer housing moves downstream of the arterial bifurcation 84, for example, along a smaller branch 86. For instance, the transducer housing may reach a position at least 2 cm downstream of the bifurcation. (Refer to the above text.) Figure 1 The relatively small size of the outer casing 28 facilitates the access of the transducer housing to this location.

[0174] Alternatively or additionally, while moving the transducer housing along the artery, a medical professional or processor 24 can roll the transducer housing via the tube 30 to control the angular range of the imaging ultrasound. Specifically, the transducer housing can be continuously rolled so that the ultrasound image covers the entire 360-degree range around the artery.

[0175] Typically, for any arterial segment requiring imaging, the transducer housing moves upstream along that segment during imaging. In other words, healthcare professionals first advance the transducer housing to the downstream end of the segment, and then retract it (manually or automatically) while emitting imaging ultrasound.

[0176] Alternatively, the transducer housing can be moved downstream along the segment while emitting imaging ultrasonic waves.

[0177] In some embodiments, the ultrasound image is registered with an image (e.g., a fluoroscopic image) used for navigation of the guiding device 22. The ultrasound image can then guide subsequent navigation of the device.

[0178] After the imaging phase, the ablation phase of the surgery is performed. Specifically, based on the ultrasound images constructed in the imaging phase, ablation ultrasound transducers 34 are used to emit ablation ultrasound waves toward one or more nerves 90 surrounding the artery.

[0179] More specifically, in some embodiments, healthcare personnel and / or processor 24 identify target anatomical structures in ultrasound images, and then the healthcare personnel perform the ablation phase accordingly. (Further details regarding processor 24's automatic identification of target anatomical structures will be referenced below.) Figure 12 Provided. ) Or, as mentioned above, in combination with... Figure 1 The processor 24 can execute the ablation phase via the control device 22. As the ablation transducer performs linear and rotational movements within the artery, the power of the ablation wave can be adjusted (or "tuned") based on the distance between the ablation ultrasound transducer and the arterial wall. (Typically, for smaller distances, the power can be reduced to decrease the risk of overheating of the inner wall.) Additionally or alternatively, as further described below, the power can be adjusted based on the proximity of the ablation transducer to nerves or non-target anatomical structures (such as heat sinks), and / or based on the temperature sensed by the temperature sensor 154. Figure 7 (To adjust the power.)

[0180] Typically, the processor calculates the distance between the ablation transducer and the inner wall of the artery based on the ultrasound reflection signal received by the transducer. For example, the processor can process the raw, converted signal to calculate the distance. (For example, the calculation can be based on the amplitude of the signal and the known velocity of ultrasound.) Alternatively, the processor can use any suitable image processing technique (e.g., image segmentation) to process the ultrasound image to calculate the distance.

[0181] Typically, ablation begins downstream of the artery and ends upstream. Alternatively, ablation can also begin upstream and end downstream.

[0182] In some embodiments, the identified anatomical structures include the nerve to be ablated. Additionally or alternatively, these anatomical structures may include non-target structures, i.e., structures other than the nerve. Non-target structures may include heat sinks such as blood vessels or lymph nodes, which inhibit the thermal effects required for nerve ablation. Other non-target structures include arterial plaques or other structures with high acoustic impedance, as well as sensitive structures such as the ureter.

[0183] Identifying anatomical structures in ultrasound images and / or calculating their distances to the arterial wall helps control the pose—i.e., position and angular direction—of the ablation ultrasound transducer. (As mentioned above, the angular direction can be controlled by rolling the transducer housing.) Additionally or alternatively, identifying anatomical structures and / or calculating their distances to the arterial wall also helps control the transmission power and / or transmission duration based on the ablation transducer's pose.

[0184] For example, after identifying the nerve at 90, "precise" ablation can be performed. In other words, the ablation transducer can be moved to a position 92 opposite the nerve, the transducer housing can be rotated to face the nerve, and then an ablation wave can be emitted.

[0185] Alternatively, for example, even if one or more nerves are identified, an ablation wave can be emitted while the transducer housing 32 passes through the artery, but the emission parameters can be adjusted accordingly based on the pose of the ablation transducer relative to the identified anatomical structure.

[0186] For example, when the ablation transducer is facing an identified non-target structure and / or within a threshold distance of the structure, the transmission power can be reduced (e.g., reduced to zero, i.e., transmission stops). Additionally or alternatively, when the ablation transducer is facing an identified heat sink or a structure with higher acoustic impedance and / or within its threshold distance, the transmission power can be increased to compensate for the effects of these structures. Additionally or alternatively, when the ablation transducer is facing a nerve and / or within its threshold distance, the transmission power can be increased.

[0187] Additionally or alternatively, when the ablation transducer is facing an identified non-target structure and / or within a threshold distance of that structure, the motion rate of the transducer housing (including linear motion and / or rolling) can be increased to reduce the ablation energy applied to the non-target structure. Alternatively, when the ablation transducer is facing an identified heat sink or a structure with high acoustic impedance and / or within a threshold distance of that structure, the motion rate of the transducer housing can be reduced to compensate for the effects of these structures. Alternatively, when the ablation transducer is facing a nerve and / or within its threshold distance, the motion rate of the transducer housing can be reduced (e.g., reduced to zero, i.e., the transducer housing remains stationary for a predetermined duration).

[0188] Additionally or alternatively, when the ablation transducer is within a threshold distance of the arterial wall, the emission power may be reduced (e.g., reduced to zero, i.e., emission is stopped).

[0189] In some such embodiments, the transducer housing 32 can be linearly moved (i.e., moved upstream or downstream) and rolled using the tube 30, such that the ablation ultrasound transducer 34 moves along a spiral path 94 within the artery 78, as... Figure 3 As shown. Compared to other paths, the helical path 94 helps to achieve a greater coverage area with ablation ultrasound. The pitch of the helical path 94 can vary in response to the identified anatomical structures.

[0190] During the imaging and ablation phases, linear movement of the transducer housing within the artery may be accompanied by linear movement of the catheter axis 26. Alternatively, the transducer housing may move linearly without any movement of the catheter axis.

[0191] In some embodiments, during the imaging and / or ablation phases, the transducer housing rolls at a rate of 0.1 to 6 rpm, and / or the transducer housing moves linearly at a rate of 0.1 to 5 mm / s.

[0192] Further details regarding this procedure can be found here. Figure 4 This is an example flowchart of an imaging and ablation procedure 96 according to some embodiments of the present invention.

[0193] Procedure 96 begins with positioning step 98, in which device 22 is moved along the guidewire to the downstream end of the vascular segment (e.g., the renal artery). For example, the device may be advanced along the guidewire to a location within a small branch 86. Figure 3 ).

[0194] Subsequently, in imaging step 100, the transducer housing is retracted and rolled while collecting imaging data. (Any function in imaging step 100 can be automatically executed by processor 24.) For example, for arterial applications, in imaging step 100, the transducer housing can be retracted all the way to the aortic inlet, as previously described, which is the location of the distal end of the guide sheath. Thus, for example, imaging of blood vessels within a range of 5–80 mm around the vessel can be performed.

[0195] In some embodiments, the conduit shaft (and corresponding outer casing) is retracted simultaneously with the retraction of the transducer housing. In other embodiments, the conduit shaft remains stationary while the transducer housing is retracted. The advantage of keeping the conduit shaft stationary is that, in the subsequent ablation phase, the transducer housing can be moved more easily along the same path and direction as in the imaging phase. For example, after retracting the transducer housing (i.e., moving the proximal end of the transducer housing) through the outer casing during the imaging phase, in the ablation phase, it is only necessary to advance the transducer housing distally through the outer casing and then retract it.

[0196] Next, in image construction step 102, an image is constructed based on the imaging data, and optionally a three-dimensional anatomical model is constructed, thus marking the end of the imaging phase of surgery 96. (In some embodiments, image construction step 102 is performed incrementally or in real-time and in parallel with the acquisition of imaging data.) Following the imaging phase of surgery 96, in decision step 103, the medical staff determines, based on the images and / or model, whether to ablate at least a portion of the segment, such as along the entire segment, a specific cross-section of the segment, or discrete locations along the segment or cross-section. If ablation is not required, the medical staff proceeds to another decision step 110, as described below. Otherwise, in planning step 104, the medical staff plans the ablation by selecting ablation locations and parameters. As mentioned above, ablation parameters may include, for example, the location and power of the ablation emission, or the speed of linear or rotational movement of the transducer housing.

[0197] Ablation sites are typically selected based on images and / or models. In some embodiments, ablation parameters are also selected based on images and / or models. For example, as described above, planning step 104 may include identifying the anatomical structures of the target in the image and selecting parameters accordingly.

[0198] Subsequently, in advancement step 106, the transducer housing is advanced to the downstream end of the segment. (If the catheter shaft has been retracted in imaging step 100, the catheter shaft must also be advanced.) Next, in ablation step 108, the transducer housing is retracted, and an ablation wave is emitted according to preset parameters. For example, as described above, the ablation wave may be emitted only at a specific location or continuously (e.g., when the ablation transducer moves along a spiral path), unless a non-target structure is within range.

[0199] For imaging step 100, in ablation step 108, the catheter shaft may be retracted together with the transducer housing, or it may remain stationary while the transducer housing is retracted. For example, in some embodiments, when the outer casing is coupled to the catheter shaft, the transducer housing moves through the outer casing without moving the outer casing. One advantage of the transducer housing moving independently of the outer casing is that the processor can more easily configure the system to achieve automated ablation compared to the case where the outer casing moves together with the transducer housing.

[0200] In some embodiments, planning step 104 and ablation step 108 are performed manually. In other embodiments, one or more functions of planning step 104 and / or ablation step 108 are performed automatically by processor 24. For example, in planning step 104, the processor may display an image on display 70 and selectively mark target structures. Next, medical personnel can select target areas around the blood vessels by marking the image shown (and / or confirming the markings placed by the processor). Subsequently, in ablation step 108, the processor may automatically guide ablation ultrasound to these areas.

[0201] Following ablation step 108, in decision step 110, medical personnel decide whether to image along another segment, such as an adjacent segment upstream of the current vessel or a segment of another branch of the vessel. If imaging is selected, the procedure continues to the positioning step 98 of step 96, moving the device to the downstream end of the new vessel segment. Otherwise, the procedure 96 ends, and the device is removed from the patient in device removal step 112.

[0202] Typically, the vast majority of nerve tissue lies within 6 mm of the blood vessel being imaged and ablated. Therefore, the imaging range around the blood vessel is usually less than 10 mm from the vessel, for example, less than 7 mm, and most (e.g., more than 80%) of the ablation energy is concentrated within this range.

[0203] In some embodiments, the processor 24 is configured to: when the temperature sensor 154 ( Figure 7 An alarm is triggered when the detected temperature exceeds a predefined threshold (e.g., 50 °C). Typically, if the outer sheath is too close to the vessel wall, restricting blood flow between the sheath and the vessel wall, the temperature may exceed the threshold (i.e., the sheath may overheat). Additionally, the temperature may also exceed the threshold if there are problems with the circulation of fluid through the sheath, or if the efficiency of the ablation transducer in converting power into acoustic energy is reduced.

[0204] Alternatively or additionally, the processor may also adjust the energy (i.e., power and / or duration) of the ablation wave based on the temperature detected by the temperature sensor 154, thereby reducing any clinical or technical risks. For example, the processor may cut off the power to the ablation transducer 34 when the temperature exceeds a preset threshold. Alternatively or additionally, the processor may also continuously adjust the energy to keep the temperature within a preset range.

[0205] Fluid and guidewire catheters For reference Figure 5A This is a schematic diagram of the distal end of the device 22 and its cross-section AA according to some embodiments of the present invention. See also... Figure 5B This is a schematic diagram of the distal end of a device 22 including an inflatable housing 28 according to some embodiments of the present invention. Also see... Figure 6 The diagram illustrates, for example... Figure 5A Partial exploded view of the device 22 shown.

[0206] As mentioned above Figures 1-2 The transducer housing 32 is coupled proximal to the tube body 30. As further described above, in some embodiments, the outer casing 28 is coupled proximal to the guide shaft 26. The transducer housing 32 is configured to move and roll linearly within the outer casing 28, which is achieved by mechanical forces transmitted through the tube body.

[0207] Typically, in order to improve the accuracy of directional emission of ablation ultrasound waves 118 from device 22, transducer housing 32 is configured to limit the angular range of ablation ultrasound waves so that the ablation ultrasound waves do not simultaneously ablate the entire circumference of the blood vessel.

[0208] For example, in some embodiments, the transducer housing 32 has an air cavity 120 on one side of the ablation ultrasound transducer 34. Because air has a higher acoustic impedance, the ablation ultrasound waves 118 are concentrated on the other side of the ablation ultrasound transducer, which is fluidly isolated from the first side (e.g., via a flexible element 50). In such embodiments, a fluid conduit 54 is typically disposed within the transducer housing on the first side of the ablation ultrasound transducer. Figure 5A As indicated by fluid flow indicator 122, fluid conduit 54 is used to deliver fluid (e.g., distilled water) to the distal end of the transducer housing, allowing the fluid to flow proximally from the distal end of the transducer housing, passing over the second side of the ablation transducer 34. Specifically, the fluid can flow proximally across the outer casing 28, where it flows between the ablation transducer and the outer casing due to direct contact between the ablation transducer 34 and the outer casing. Therefore, the fluid can effectively remove air from the transducer housing, thereby reducing the acoustic impedance sensed by the ablation transducer. Similarly, the fluid can also flow between the imaging transducer 36 and the outer casing, thereby reducing the acoustic impedance sensed by the imaging transducer.

[0209] For example, in an embodiment where the imaging transducer 36 is located at the distal end of the ablation transducer 34, the fluid conduit 54 may pass through the damping material 38 and terminate at its distal end. Fluid may thus flow from the fluid conduit into the space 124 between the damping material 38 and the inner wall of the distal end of the transducer housing, and from the space 124 proximally through the transducer housing 32 and through the outer casing 28.

[0210] Normally, liquid flows from the outer casing 28 into the space between the tube body 30 and the guide shaft. The liquid can then continue to flow through this space to the proximal end of the device 22, where it can be collected in a container or circulated by a pump.

[0211] In other embodiments, fluid flows distally into the transducer housing through the lumen of the tube 30, rather than through the fluid conduit 54.

[0212] In some embodiments, fluid continuously circulates within the transducer housing during imaging and / or ablation.

[0213] In some embodiments, such as Figure 5B As shown, the outer casing 28 is inflatable. When inflated, the outer casing can have any suitable shape, such as cylindrical or elliptical.

[0214] Before emitting ablation ultrasound (e.g., before emitting any ultrasound), the outer shell is inflated within the blood vessel, for example, to a diameter of 3–10 mm. In some embodiments, the outer shell is inflated to contact the vessel wall. In some such embodiments, the outer shell may be designed with multiple valve-like structures that contact the vessel wall, with blood flowing between these valve-like structures. In other embodiments, the outer shell is inflated to a diameter smaller than the blood vessel diameter, allowing blood to flow between the outer shell and the vessel wall.

[0215] Typically, the fluid delivered by fluid conduit 54 inflates the housing as it flows proximally through it, as indicated by filling symbol 123. To deflate the housing, the fluid flow rate can be reduced, or the fluid can be pumped into the fluid conduit. Alternatively, a separate fluid conduit can be used to deliver the fluid used to inflate the housing.

[0216] The advantage of an inflatable sheath is that it helps to fix the ablation transducer in a central position within the blood vessel, thus keeping the delivered ablation energy approximately constant around the vessel. Furthermore, compared to a non-inflatable sheath, the increased fluid flow through an inflatable sheath removes more heat, potentially eliminating the need to regulate the ablation wave energy to avoid overheating.

[0217] In some embodiments, as described above Figure 3The guidewire used to guide the device passes through the transducer housing 32, for example, within the guidewire catheter 114. However, due to design limitations, the guidewire may not be radially centered relative to the transducer housing, i.e., it may not be aligned with the rolling axis of the transducer housing. If the guidewire extends distally into the blood vessel in such an off-center position, it may cause damage to the blood vessel as the transducer housing rolls.

[0218] Therefore, in such embodiments, the transducer housing 32 may include a distal alignment element 126 (such as...). Figure 6 As shown, this element, also known as a "centering element," is configured to radially center the guidewire relative to the transducer housing, i.e., to align the guidewire with the rolling axis of the transducer housing. Therefore, the guidewire can be radially centered at the distal end of the transducer housing, i.e., aligned with the rolling axis of the transducer housing.

[0219] In some embodiments, the alignment element 126 is integrally formed with a more proximal portion of the transducer housing. In other embodiments, the alignment element 126 is manufactured separately from the more proximal portion of the transducer housing and then coupled to that more proximal portion (e.g., bonded).

[0220] Optionally, device 22 may further include a housing 128 surrounding at least a portion of alignment element 126. In some such embodiments, device 22 may further include a non-invasive distal cap 130 fitted over housing 128. Housing 28 may be fitted over housing 128 and coupled to distal cap 130. Or (e.g., as described below) Figure 8A , 8B As shown), the housing 128 itself may include a non-invasive distal end, and the outer casing 28 may be coupled to the housing 128. Due to this coupling, the housing 128 and the cap 130 typically do not roll together with the transducer housing.

[0221] To facilitate rotation of the alignment element 126 within the housing 128, a small gap may be necessary between the alignment element and the housing. Therefore, a fluid seal 132 may be provided between the housing 128 and the alignment element 126, or at a location where the distal end of the alignment element is within the housing, to prevent fluid flowing through the device 22 from escaping through this gap into the patient's bloodstream (since the fluid seal 132 can withstand higher fluid pressures, it may be referred to as a "dynamic seal"). For further details, please see [link / reference]. Figure 7 It shows, as Figure 5A The diagram shows a longitudinal cross-sectional view of the device 22 according to some embodiments of the present invention.

[0222] In some embodiments, the alignment element 126 is shaped to define a channel 136 that is at least partially inclined relative to the rolling axis 42 (i.e., at least partially not parallel to the rolling axis 42). The alignment element is configured to align a guide wire by guiding the guide wire through the channel 136.

[0223] For example, such as Figure 7 As shown, the channel 136 may include a proximal straight section 136p (parallel to but not aligned with the rolling axis 42), a middle inclined section 136m, and a distal straight section 136d aligned with the rolling axis. Optionally, the guidewire catheter 114 may also terminate within the proximal straight section 136p, for example, at its distal end.

[0224] In embodiments including a distal cap 130, the shape of the cap defines a through-hole 138 that is aligned with the distal end of the channel 136 (and the rolling axis 42).

[0225] In some embodiments, the fluid seal 132 includes one or more O-rings that surround the alignment element 126 to seal the gap between the alignment element and the housing 128. Alternatively, the alignment element 126 may be shaped to define one or more annular recesses 140, and the O-rings may be located within the recesses 140.

[0226] For alternative embodiments, see now. Figure 8A It shows a partially exploded view of the distal end of the device 22 according to some embodiments of the present invention, and Figure 8B It shows a corresponding view of the device in an assembled state.

[0227] In some embodiments, the alignment element 126 is shaped to define a straight channel 142 aligned with the rolling axis 42, through which the guidewire conduit 114 passes. Thus, the alignment element 126 aligns the guidewire with the rolling axis 42 by holding the guidewire conduit aligned with the rolling axis. To allow for a more proximal portion 114p of the guidewire conduit to be off-center (due to relevant design constraints), the portion 114o of the guidewire conduit near the alignment element 126 obliquely passes through the transducer housing.

[0228] The fluid seal 132 may be disposed between the alignment element 126 and the housing 128, or as follows: Figure 8A As shown, it is positioned at the far end of the alignment element.

[0229] More generally, alignment element 126 can be used to align the guidewire with the rolling axis of any tool configured for insertion along the guidewire into the patient's body. Such tools may include, for example, an ultrasound transducer housing (see below), an optical mirror, a laser beam emitter, or a bone drill, each of which can be rotated within the body about its rolling axis.

[0230] For another alternative embodiment, see now. Figure 9 This is a schematic diagram of the distal end of the device 22 according to some embodiments of the present invention.

[0231] In some embodiments, device 22 includes a quick-change tip 144, the distal end of which is coupled to housing 28 and configured to guide guidewire 146 through. Optionally, quick-change tip 144 may be coupled to one or more radiopaque markers, or may be made of radiopaque material, to facilitate radiographic imaging of the device.

[0232] In such embodiments, the guidewire 146 does not need to pass through the tube body and transducer housing, but can instead travel along the tube body (e.g., along the outer wall of the guide tube shaft 26). Figure 1 The guide wire extends to the side of the transducer housing, and the transducer housing can roll independently of the guide wire. Therefore, it may be unnecessary to provide the guide wire conduit 114 or the alignment element 126. Figures 7-8B (For example, guidewire catheter 114 is not shown) Figure 2 This can correspond to an embodiment using a quick-change tip 144.

[0233] Other device designs See now Figure 10A This is a schematic diagram of the distal end of device 22 according to some embodiments of the present invention. See also... Figure 10B It shows, as Figure 10A The diagram shows a longitudinal cross-sectional view of the device 22 according to some embodiments of the present invention.

[0234] In some embodiments, the distal end of the outer casing 28 is coupled to the tube body 30. In other words, the distal end of the tube body 30 is coupled to both the transducer housing and the outer casing. During the imaging and ablation phases of the procedure, the transducer housing 32 can be moved (linearly or rotationally) together with the outer casing 28 using the tube body 30.

[0235] In such embodiments, the transducer always faces the same portion of the housing 28, which may have a lower acoustic impedance than other portions of the housing.

[0236] Any of the above methods (see Figure 5-9) facilitates the passage of fluid and guidewire. For example, as... Figure 10A As shown in -B, a portion of the guidewire conduit 114 may be angled, typically due to its passage through the alignment element 126. Figure 7 This is due to the fact that, in this case, the housing 128 rotates together with the outer casing 28 and the alignment element 126, and the housing 128 can be coupled to the alignment element so that there is no gap between the two elements, thus the fluid seal 132 ( Figure 7(This part can be omitted.) Another difference compared to Figure 5-9 is that the fluid flows along the lumen of the tube body 30 towards the proximal end, rather than flowing through the space between the tube body 30 and the guide shaft 26.

[0237] For reference Figure 11 This shows another longitudinal section of the distal end of position 22 according to some embodiments of the present invention.

[0238] Figure 11 and Figure 10B Similarly, the difference lies in the addition of an inflatable element 150 coupled to the outer wall of the catheter shaft 26. The inflatable element 150 is configured to inflate within the blood vessel, thereby inhibiting contact between the outer wall and the vascular tissue (and thus improving surgical safety). For example, the inflatable element 150 may include a balloon that is inflated via an inflation tube 152 located within the wall of the catheter shaft 26. The cross-sectional shape of the balloon may include one or more gaps so that the balloon does not obstruct blood flow within the blood vessel; for example, the balloon may include four radially spaced fins. Alternatively, the inflatable element 150 may include a stent or another inflatable mechanical structure.

[0239] As an alternative, the inflatable element 150 can be coupled to the housing 28.

[0240] For embodiments where the housing 28 is coupled to the conduit shaft 26 (e.g., as...) Figure 5A (As shown in -B), the inflatable element 150 can also be coupled to the outer wall of the conduit shaft 26 or the housing 28.

[0241] As described above, in some embodiments, device 22 includes at least one ablation transducer but not any imaging transducer. In such embodiments, the device can be used for ablation, for example, as referenced above. Figure 3-4 Alternatively, ablation can be selectively performed after imaging the perivascular area using a separate device. For example, after inserting the outer shell and transducer housing into the blood vessel, a healthcare professional or operator can move the transducer housing along the vessel (e.g., through the stationary outer shell) while the ablation transducer emits ablation ultrasound waves through the outer shell toward one or more nerves around the vessel.

[0242] The fluid and / or guidewire passage scheme described herein is also applicable to embodiments where the device includes at least one ablation transducer but does not include any imaging transducer. For example, a fluid conduit located on a first side of the ultrasonic transducer housing can deliver fluid to the distal end of the transducer housing, such that the fluid flows from the distal end of the transducer housing along the proximal end across a second side of the ultrasonic transducer. In this way, the fluid can effectively expel air from within the transducer housing.

[0243] Similarly, even in embodiments where device 22 does not include any imaging transducer, flexible element 50 can be used. Figure 2 ).

[0244] user interface For reference Figure 12 This is a schematic diagram of an ultrasound image 158 according to some embodiments of the present invention.

[0245] In some embodiments, to assist medical staff in planning ablation procedures, the processor 24 displays on the monitor 70 ( Figure 1 The constructed ultrasound image 158 is displayed on the screen. In some such embodiments, healthcare professionals can switch between displaying a three-dimensional image and two-dimensional slices of the image. Alternatively or additionally, a three-dimensional image and one or more two-dimensional images may be displayed simultaneously.

[0246] In some embodiments—for example, such as Figure 12 As shown in image 158a (Type B), the processor overlays markers 160 onto the image to label one or more identified target anatomical structures, such as nerves or non-target structures. For example, the processor may draw an ellipse around each structure. Typically, healthcare professionals can modify, remove, or add markers to any target structure.

[0247] To identify anatomical structures in B-mode images, the processor may first use edge detection, segmentation, and / or other suitable image processing techniques to identify target regions in the image. Subsequently, the processor may identify the anatomical structure based on the shape and / or grayscale values ​​of the target region. For example, relatively rounded and darker areas may be identified as nerves or blood vessels. Areas that are brighter near the transducer and gradually darken further away from the transducer may be identified as lymph nodes or fibrous sheaths. Alternatively, the processor may also identify the anatomical structure based on its three-dimensional shape, which can be calculated based on the spatial relationships between target regions within a B-mode image sequence belonging to a three-dimensional model.

[0248] In some embodiments, the processor constructs an M-mode image based on the ultrasound reflection signal converted by the imaging transducer and processes the M-mode image to distinguish nerves and blood vessels, because nerves and blood vessels may look similar in a B-mode image. For example, Figure 12 The M-shaped image 158b includes a blood flow indicator 162 that indicates blood flow through the blood vessels.

[0249] For example, the processor can initially label all target structures in a B-mode image 158a. Subsequently (e.g., as instructed by a medical professional), the processor can construct an M-mode image 158b for the same anatomical slice imaged in B-mode image 158a. Based on identified blood flow indicator markers 162, the processor can remove markers 160 from the blood vessels.

[0250] Additionally or alternatively, the processor may construct a time series of B-mode images of the same anatomical slice, including B-mode image 158a, based on the converted ultrasound reflection signal. The processor may then process this time series to distinguish between nerves and blood vessels. For example, the processor may identify blood vessels based on the pulsation of the vessel wall shown in the time series. Specifically, the processor may identify blood vessels based on the amplitude of vessel wall movement exceeding a predefined threshold.

[0251] In other embodiments, all marking is performed manually by medical professionals.

[0252] In some embodiments, after a medical professional confirms the displayed markings, the processor displays suggested ablation parameters and / or automatically performs ablation.

[0253] During the ablation process, the processor can overlay wave indicator 164 onto the image to indicate the direction of ultrasound transmission.

[0254] In addition to image 158, the processor can also display images used to guide the surgery, such as image 76. Figure 3 Healthcare professionals can label images as needed to indicate ablation sites within the blood vessels. Ablation sites and parameters (such as power and duration), along with (optionally) subsequent blood pressure measurements of the patient, can be stored in a database. This database can then be consulted to better plan procedures should the same patient require additional nerve ablation. Furthermore, once sufficient data from multiple patients has accumulated in the database, it can be analyzed to determine the most suitable ablation sites.

[0255] Using optically pumped magnetometer For reference Figure 13 This is a schematic diagram of the distal end of the device 22 according to some embodiments of the present invention.

[0256] In some embodiments, the transducer housing 32 includes a vapor cell 166 containing alkali metal atoms (e.g., cesium) 168. An optical fiber cable 170 passes through the tube 30. Figure 2 The beam 172 (e.g., a circularly polarized laser) extends through the steam pool via an optical fiber cable 170, and the reflected light from the beam 172 is transmitted to a photodetector located near the end of the cable 170. The frequency of the light corresponds to the energy difference between the two atomic states of atom 168.

[0257] Because an electric current flows through the nerve 90, a magnetic field is generated near the nerve. Therefore, when the transducer housing approaches the nerve 90, under the Zeeman effect, atoms 168 absorb more light from the beam 172, resulting in a reduction in the reflection detected by the photodetector. (The magnetic field strength can be determined based on the degree of reflection attenuation.) Medical personnel can perform ablation operations based on the attenuation signal of the reflected light, for example, by rolling the transducer housing while the ablation transducer 34 emits ablation ultrasound waves.

[0258] Therefore, imaging transducer 36 ( Figure 2 () can be omitted.

[0259] Those skilled in the art should understand that this invention is not limited to the content specifically shown and described above. Rather, the scope of this invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications that would occur to those skilled in the art after reading the foregoing description and not found in the prior art. Except where any definition of any term in these incorporated documents is incorporated herein by reference, it shall be considered an integral part of this application: if any definition of a term in these incorporated documents conflicts with the express or implied definitions in this specification, then only the definitions in this specification shall be considered.

Claims

1. An apparatus, comprising: The tube is configured for insertion into the patient's blood vessels; The transducer housing, the distal end of which is coupled to the tube body; A housing, configured to surround the transducer housing within the blood vessel; and At least one ablation ultrasound transducer is disposed within the transducer housing and configured to emit ablation ultrasound waves through the housing toward one or more nerves surrounding the blood vessel.

2. The apparatus of claim 1, wherein the transducer housing does not completely surround the ablation ultrasonic transducer.

3. The apparatus according to claim 1, wherein, The tube is configured to transmit rolling torque and linear force to the transducer housing.

4. The device of claim 1 further includes a quick-exchange tip, the distal end of which is coupled to the housing and configured to allow a guidewire to pass through it.

5. The apparatus according to claim 1, further comprising: A control handle, configured to be coupled to the tube body at its proximal end, and including a gear system; and A motor unit is configured to be coupled to the gear system and to provide mechanical force to the gear system to move the tube.

6. The apparatus according to claim 1, wherein, The transducer housing is configured to limit the angular range of the ablation ultrasound waves, so that the ablation ultrasound waves do not ablate the entire circumference of the blood vessel simultaneously.

7. The device according to claim 1, wherein the diameter of the outer casing is less than 10 Fr.

8. The device according to any one of claims 1-7 further includes a conduit shaft, the conduit shaft housing the tube body and coupled to the outer casing at its proximal end.

9. The apparatus of claim 8 further includes an inflatable element coupled to an outer wall of the catheter shaft or the outer casing and configured to inflate within the blood vessel, thereby inhibiting contact between the outer wall and the tissue of the blood vessel.

10. The apparatus according to claim 8, wherein, The acoustic impedance of the outer casing is lower than that of the duct shaft.

11. The apparatus according to any one of claims 1-7, wherein the ablation ultrasonic transducer comprises: Electroacoustic transducer; and One or more flexible elements are used to support the electroacoustic transducer.

12. The apparatus according to claim 11, wherein, The flexible element includes one or more flexible adhesive tapes.

13. The apparatus according to claim 12, wherein, The flexible adhesive tape covers the periphery of the electroacoustic transducer.

14. The apparatus according to any one of claims 1-7, wherein, The outer casing is coupled to the tube body at its distal end.

15. The apparatus of claim 14, further comprising: A guide shaft, which houses the tube body; and An inflatable element coupled to the outer wall of the catheter shaft or the outer casing and configured to inflate within the blood vessel, thereby inhibiting contact between the outer wall and the tissue of the blood vessel.

16. The apparatus according to any one of claims 1-7, wherein, The transducer housing includes a distal alignment element configured to align a guide wire passing through the transducer housing with the rolling axis of the transducer housing, such that the guide wire is aligned with the rolling axis at the distal end of the transducer housing.

17. The apparatus according to claim 16, wherein, The alignment element is shaped to define a channel that is at least partially inclined relative to the rolling axis, and the alignment element is configured to align the guidewire by passing the guidewire through the channel.

18. The apparatus of claim 16, further comprising a guidewire conduit passing through the transducer housing. The guidewire passes through the guidewire catheter, and in, The alignment element aligns the guidewire with the rolling axis by holding the guidewire conduit aligned with the rolling axis.

19. The apparatus of claim 16, further comprising: A cover that surrounds at least a portion of the alignment element; as well as A fluid seal is disposed between the housing and the alignment element or at the distal end of the alignment element within the housing.

20. The apparatus according to any one of claims 1-7, wherein, The transducer housing includes an air cavity on the first side of the ablation ultrasonic transducer, such that the ablation ultrasonic waves are concentrated on the second side of the ablation ultrasonic transducer, the second side being opposite to the first side and fluidly isolated from the first side.

21. The apparatus of claim 20, wherein the ablation ultrasonic transducer comprises: Electroacoustic transducer; as well as One or more flexible elements are used to support the electroacoustic transducer and isolate the air cavity from the second side of the ablation ultrasonic transducer.

22. The apparatus of claim 20, further comprising a fluid conduit disposed within the transducer housing and located on the first side of the ablation ultrasonic transducer, the fluid conduit being configured to deliver the fluid to a distal end of the transducer housing such that the fluid flows from the distal end of the transducer housing to the proximal end and through the second side of the ablation ultrasonic transducer.

23. The apparatus of claim 22 further includes a conduit shaft, the conduit shaft housing the tube body. in, The fluid conduit is configured to deliver the fluid such that the fluid flows proximally through the ablation ultrasound transducer and into the space between the tube body and the conduit shaft.

24. The apparatus according to claim 22, wherein, The fluid flows proximally through the housing, wherein the housing is inflatable, and the fluid inflates the housing.

25. The apparatus according to any one of claims 1-7, further comprising at least one imaging ultrasonic transducer, said imaging ultrasonic transducer being disposed within the transducer housing and configured as follows: Imaging ultrasonic waves are emitted into the surrounding area through the outer casing, and The reflected signal of the imaging ultrasound is converted to construct an ultrasound image, thereby guiding the emission of the ablation ultrasound.

26. The apparatus of claim 25, wherein the imaging ultrasound transducer is located at the distal end of the ablation ultrasound transducer.

27. The apparatus according to any one of claims 1-7, wherein, The outer casing is cylindrical.

28. The apparatus according to any one of claims 1-7, wherein, The outer casing is inflatable, and the device further includes a fluid conduit configured to deliver fluid into the outer casing such that the fluid inflates the outer casing within the blood vessel.

29. The system includes: The apparatus according to claim 24, and The processor, configured as follows: Based on the converted reflected signal, the distance between the ablation ultrasound transducer and the inner wall of the blood vessel is calculated; and The emission of the ablation ultrasound is controlled according to the distance.

30. The system of claim 29, wherein the processor is configured to calculate distance by processing ultrasound images.

31. The system, comprising: The apparatus according to claim 24; as well as The processor is configured to process ultrasound images to identify one or more anatomical structures in the surrounding area.

32. The system of claim 31, wherein the processor is configured to process a B-mode image time series, including the ultrasound image, to distinguish nerves from other blood vessels.

33. The system according to claim 31, in, The ultrasound image is a B-mode image, and The processor is also configured to process M-shaped images in order to distinguish nerves from other blood vessels.

34. The system according to claim 31, wherein, The ultrasound image is three-dimensional.

35. The system according to claim 31, wherein, The anatomical structures include nerves.

36. The system according to claim 31, wherein, The anatomical structure includes one or more other blood vessels.

37. The system according to claim 31, wherein, The anatomical structures include one or more lymph nodes.

38. The system according to claim 31, wherein, The anatomical structures include arterial plaques.

39. The system according to claim 31, wherein, The processor is also configured to label the anatomical structures in the ultrasound images.

40. The system according to claim 31, wherein, The processor is also configured to control the emission of the ablation ultrasound in response to recognizing the anatomical structure.

41. The system according to claim 40, wherein, The processor is configured to control the emission of the ablation ultrasonic transducer by controlling the pose of the transducer when it emits the ablation ultrasonic waves.

42. The system according to claim 40, wherein, The processor is configured to control the emission of the ablation ultrasound by controlling the emission power.

43. The system of claim 40, wherein the processor is configured to control the emission of the ablation ultrasound by controlling the emission duration in response to the pose of the ablation ultrasound transducer.

44. The system includes: The apparatus according to any one of claims 1-7 further includes a temperature sensor disposed within the transducer housing, the temperature sensor being configured to detect the temperature within the transducer housing; and The processor is configured to adjust the energy of the ablation ultrasound based on the detected temperature.

45. Methods, including: The transducer housing is inserted into the patient's blood vessel, wherein the distal end of the transducer housing is coupled to the tube body and is surrounded by an outer shell. and As the transducer housing is moved along the blood vessel, at least one ablation ultrasound transducer disposed within the transducer housing emits ablation ultrasound waves through the housing toward one or more nerves surrounding the blood vessel.

46. ​​The method according to claim 45, wherein, The outer shell is inflatable, and the method further includes inflating the outer shell within the blood vessel before emitting the ablation ultrasound.

47. The method of claim 45, wherein the step of emitting ablation ultrasound comprises: The ablation ultrasound is emitted while the emission power is changed.

48. The method of claim 45, wherein the step of emitting ablation ultrasound comprises: The ablation ultrasound waves are emitted while the emission duration is changed according to the different orientations of the ablation ultrasound transducer.

49. The method according to any one of claims 45-48, wherein the blood vessel is a renal artery.

50. The method of claim 49, wherein the step of moving the transducer housing comprises: The transducer housing is moved along a section downstream of the renal artery bifurcation.

51. The method according to any one of claims 45-48, wherein the step of emitting the ablation ultrasound comprises: While controlling the orientation of the ablation ultrasonic transducer, the ablation ultrasonic waves are emitted.

52. The method according to claim 51, wherein, The step of controlling the pose includes: controlling the pose by rolling the transducer housing using the tube body.

53. The method according to claim 51, wherein, The step of controlling the posture includes: moving the transducer housing by using the tube body, causing the ablation ultrasound transducer to move along a spiral path within the blood vessel, thereby controlling the posture.

54. The method according to any one of claims 45-48, further comprising: At least one imaging ultrasound transducer disposed within the transducer housing is used to emit imaging ultrasound waves toward the periphery of the blood vessel, such that the imaging ultrasound transducer converts the reflected signal of the imaging ultrasound waves. The step of emitting the ablation ultrasound includes emitting the ablation ultrasound based on an ultrasound image constructed from the converted reflected signals.

55. The method of claim 54, wherein the step of emitting the ablation ultrasound comprises: The ablation ultrasound is emitted in response to the identification of one or more anatomical structures in the ultrasound image.

56. The method of claim 54, further comprising: While moving the transducer housing along the blood vessel, the transducer housing is rolled by the tube to control the angular range of the imaging ultrasound.

57. Methods, including: Insert the following components into the patient's blood vessels: duct axis, A transducer housing, the distal end of which is coupled to a tube body disposed within the conduit shaft, and housing at least one ultrasonic transducer, and A housing, the distal end of which is coupled to the duct shaft and surrounds the transducer housing; and While the ultrasound transducer emits ultrasound waves toward the periphery of the blood vessel, the transducer housing is moved through the outer casing using the tube without moving the catheter shaft.

58. The method of claim 57, wherein, The outer casing is inflatable, and the method further includes inflating the outer casing within the blood vessel before emitting the ultrasound waves.

59. The method according to claim 57, wherein, The step of moving the transducer housing through the outer casing includes: moving the transducer housing proximally through the outer casing.

60. The method of claim 57, further comprising: While moving the transducer housing through the outer casing, the transducer housing is rolled by the tube to control the angular range of the ultrasonic waves.

61. The method according to any one of claims 57-60, wherein the blood vessel is a renal artery.

62. The method of claim 61, wherein the step of moving the transducer housing comprises: The transducer housing is moved while the outer casing is located within a section downstream of the renal artery bifurcation.

63. The method according to any one of claims 57-60, wherein the ultrasonic transducer is an ablation ultrasonic transducer, the ultrasonic wave is an ablation ultrasonic wave, and the step of moving the transducer housing comprises: While the ablation ultrasound transducer emits the ablation ultrasound waves toward one or more nerves surrounding the blood vessel, the transducer housing is moved.

64. The method of claim 63, wherein the step of moving the transducer housing comprises: The transducer housing is moved by initiating an automated process for moving the transducer housing.

65. The method according to any one of claims 57-60, in, The ultrasonic transducer is an imaging ultrasonic transducer. The ultrasound wave referred to here is an imaging ultrasound wave. The step of moving the transducer housing includes: moving the transducer housing while the imaging ultrasonic transducer converts the reflected signal of the imaging ultrasonic wave; The transducer housing further houses at least one ablation ultrasonic transducer, and The method further includes: based on an ultrasound image constructed from the converted reflected signal, using the ablation ultrasound transducer to emit ablation ultrasound waves to one or more surrounding nerves.

66. The method of claim 65, wherein the step of moving the transducer housing comprises: The step of moving the transducer housing along the direction of the motion path and emitting the ablation ultrasound includes: emitting the ablation ultrasound while moving the transducer housing along the direction of the motion path.

67. The method of claim 65, wherein the step of emitting the ablation ultrasound comprises: The ablation ultrasound is emitted in response to the identification of one or more anatomical structures in the ultrasound image.

68. The method of claim 65, wherein the step of emitting the ablation ultrasound comprises: The ablation ultrasound is emitted while controlling the orientation of the ablation ultrasound transducer.

69. The method according to claim 68, wherein, The step of controlling the pose includes controlling the pose by rolling the transducer housing using the tube.

70. The method according to claim 68, wherein, The step of controlling the pose includes moving the transducer housing through the tube body, causing the ablation ultrasound transducer to move along a spiral path within the blood vessel, thereby controlling the pose.

71. The method of claim 65, wherein the step of emitting the ablation ultrasound includes emitting the ablation ultrasound while changing the emission power.

72. The method of claim 65, wherein the step of emitting the ablation ultrasound includes emitting the ablation ultrasound while changing the emission duration for different orientations of the ablation ultrasound transducer.

73. An apparatus comprising: A tube configured for insertion into a patient's blood vessel; A transducer housing, the distal end of which is coupled to the tube body; One or more ultrasonic transducers are disposed within the transducer housing and configured to emit ultrasonic waves toward the periphery of the blood vessel; and A fluid conduit is disposed within the transducer housing and located on a first side of the ultrasonic transducer. The fluid conduit is configured to deliver fluid to a distal end of the transducer housing, such that the fluid flows from the distal end to the proximal end of the transducer housing and through a second side of the ultrasonic transducer opposite to the first side.

74. The apparatus according to claim 73, wherein, The ultrasound transducer includes an ablation ultrasound transducer configured to emit ablation ultrasound waves toward one or more nerves surrounding the blood vessel.

75. The apparatus of claim 74, wherein the ultrasonic transducer further comprises an imaging ultrasonic transducer configured as follows: Emitting imaging ultrasonic waves to the surrounding area, and The reflected signal of the imaging ultrasound is converted to construct an ultrasound image, thereby guiding the emission of the ablation ultrasound.

76. The apparatus of claim 75, wherein the imaging ultrasound transducer is located at the distal end of the ablation ultrasound transducer.

77. The apparatus of claim 76, further comprising a damping material disposed within the transducer housing. in, The imaging ultrasonic transducer includes an imaging transducer element disposed within the damping material, and The fluid conduit passes through the damping material.

78. The apparatus according to claim 77, wherein, The fluid conduit is configured to deliver the fluid such that the fluid flows into the space between the damping material and the distal inner wall of the transducer housing, and flows from the space to the proximal end through the transducer housing.

79. The apparatus according to claim 74, in, The second side is fluidly isolated from the first side, and The transducer housing has an air cavity on the first side of the ablation ultrasonic transducer, so that the ablation ultrasonic waves are concentrated on the second side of the ablation ultrasonic transducer.

80. The apparatus of any one of claims 73-79, further comprising a housing configured to surround the transducer housing, wherein the fluid conduit is configured to deliver the fluid such that the fluid flows proximally between the ultrasonic transducer and the housing.

81. The apparatus according to claim 80, wherein, The outer casing is cylindrical.

82. The apparatus according to claim 80, wherein, The outer casing is inflatable, so that when the fluid flows toward the proximal end, the fluid inflates the outer casing.

83. The apparatus of claim 80, further comprising a conduit shaft, the conduit shaft receiving the tube body and having its proximal end coupled to the outer casing. in, The fluid conduit is configured to deliver the fluid such that the fluid flows proximally between the tube body and the conduit shaft.

84. The apparatus according to claim 80, wherein, The outer casing is coupled at its distal end to the tube body, and the fluid conduit is configured to deliver the fluid such that the fluid flows proximally through the lumen of the tube body.

85. The apparatus according to any one of claims 73-79, wherein, The transducer housing includes a distal alignment element configured to align a guide wire passing through the transducer housing with the rolling axis of the transducer housing, such that the guide wire is aligned with the rolling axis at the distal end of the transducer housing.

86. The apparatus of claim 85, further comprising: A cover that surrounds at least a portion of the alignment element; as well as A fluid seal is disposed between the housing and the alignment element or at the distal end of the alignment element within the housing.

87. An apparatus comprising: The tool is configured to be inserted into the patient's body along the guidewire; and A tube body, the distal end of which is coupled to the tool and configured to transmit rolling torque to the tool, thereby causing the tool to roll about a rolling axis. The tool includes a distal alignment element configured to align the guidewire with the rolling axis of the tool, thereby aligning the guidewire with the rolling axis at the distal end of the tool.

88. An apparatus comprising: The tube is configured for insertion into the patient's blood vessels; The transducer housing is coupled at its distal end to the tube body; An ablation ultrasound transducer, disposed within the transducer housing and configured to emit ablation ultrasound waves toward one or more nerves surrounding the blood vessel, the ablation ultrasound transducer comprising: Electroacoustic transducer; and One or more flexible elements are used to support the electroacoustic transducer.

89. The apparatus according to claim 88, wherein, The transducer housing has an air cavity on the first side of the ablation ultrasonic transducer, and the flexible element isolates the second side of the ablation ultrasonic transducer from the air cavity, with the second side opposite to the first side.

90. The apparatus according to claim 88, wherein, The flexible element is configured to promote the vibration of the electroacoustic transducer.

91. The apparatus according to claim 88, wherein, The flexible element is configured to prevent short circuits between the two opposing surfaces of the electroacoustic transducer.

92. The apparatus according to claim 88, wherein, The flexible element includes one or more springs.

93. The apparatus according to any one of claims 88-92, wherein, The flexible element includes one or more flexible adhesive tapes.

94. The apparatus according to claim 93, wherein, The adhesive tape covers the periphery of the electroacoustic transducer.

95. The apparatus according to claim 94, wherein, The electroacoustic transducer is configured to vibrate along an axis perpendicular to the plane containing the perimeter of the electroacoustic transducer.

96. The apparatus according to claim 93, wherein, The adhesive tape contains an adhesive selected from the group consisting of UV-curable adhesives, polyurethane adhesives, and silicone adhesives.

97. The apparatus of claim 93, further comprising: Damping material is disposed within the transducer housing and located at the distal end of the ablation ultrasonic transducer; as well as An imaging transducer element is disposed within the damping material. The adhesive tape couples the electroacoustic transducer to the damping material.

98. The apparatus of claim 93 further includes an electrical interface, the proximal end of which is coupled to and connected to the electroacoustic transducer element and its wires, wherein the adhesive tape couples the electroacoustic transducer element to the electrical interface.

99. The apparatus according to claim 93, wherein, The adhesive tape couples the electroacoustic transducer element to the inner wall of the transducer housing.

Images