Acoustic crushing system, method of operating the acoustic crushing system, and acoustic transducer

Abstract

To provide an acoustic lithotripsy system capable of delivering acoustic energy to a target located within a patient.SOLUTION: An acoustic transducer includes a first vibrator and a second vibrator. A system may include an impact member, coupled to the acoustic transducer, the impact member operable at a lower frequency than each of the first vibrator and the second vibrator. The system may further include controller circuitry, coupled to the acoustic transducer and the impact member, the controller circuitry including: an acoustic actuation control output, configured to selectively provide to at least one of the first vibrator or the second vibrator, an actuation control signal to control ablation of the target by the selected at least one of the first vibrator and the second vibrator. The first vibrator and / or or the second vibrator may be selected to operate with or without the impact member.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to Acoustic crushing system, acoustic crushing method, and acoustic a transducer, and more specifically to a lithotripsy using a transducer that includes a plurality of vibration devices each configured to vibrate at different frequencies and / or modes based on a target observation or detected characteristic acoustic of the transducer.

Background Art

[0002] Lithotripsy is a procedure used to destroy targets such as kidney stones that are too large (or cannot pass) to pass naturally through the body. Lithotripsy can use lasers or sound waves to break up the stones. Shock wave lithotripsy can use shock waves emitted from a lithotripter, acoustic waveguide, or acoustic probe connected to a transducer, and then these stones can be passed through the body (e.g., the urinary tract) or removed through the channel of a scope used to introduce the acoustic transducer. acoustic Shock wave lithotripsy can be either non-invasive or invasive. During an invasive procedure, a scope such as a probe or endoscope can be inserted into the patient's body. The sound wave can cause the impact member located at the end of the scope to impact the stone and break the stone into pieces.

[0003]

Summary of the Invention

Problems to be Solved by the Invention

[0004] The present invention It can provide the ability to fragment the target better and more efficiently, reduce the surgical complications while reducing or shortening the operation time, and bring about better patient outcomes. The objective is to provide an acoustic crushing system, an acoustic crushing method, and an acoustic transducer.

Means for Solving the Problems

[0005] This specification includes information for use in acoustic quarrying. acoustic stone crusher system , acoustic lithotripsy method , and acoustic transducer The following will be disclosed: For delivering acoustic energy to a target located inside the patient's body (such as a kidney stone or gallstone). acoustic stone crusher The system may include an acoustic transducer having a first vibrator and a second vibrator. The first and second vibrators may each include a piezoelectric material (or piezoelectric stack) to cause the vibrator to move, oscillate, etc., at a specific frequency and mode, such as in response to an applied electrical input signal. The first and second vibrators may each vibrate at frequencies within the ultrasonic range, and may vibrate at different frequencies within the ultrasonic range. For example, the first vibrator may vibrate at a frequency of 20 kilohertz (kHz), and the second vibrator may vibrate at a frequency of 100 kHz. Thus, the second vibrator may vibrate at a higher frequency than the first vibrator.

[0006] acoustic stone crusher The system may also include an impact member, such as a solenoid hammer or pneumatic actuator, capable of operating at frequencies lower than those of the first and second vibrators. For example, the impact member may operate at frequencies below ultrasonic, such as 20 hertz (Hz). In one example, the impact member may operate independently of the first and second vibrators, or it may operate in conjunction with or be driven by the first and / or second vibrators.

[0007] acoustic stone crusherThe system may include a controller circuit coupled to an acoustic transducer and / or an impact member. The controller circuit may include an acoustic actuation control output configured to selectively provide actuation control signals to the first and / or second vibrators, respectively, for causing the first and / or second vibrators to emit ultrasonic signals. For example, the actuation control signals may cause the first ultrasonic signal to be emitted from the first vibrator and the second ultrasonic signal to be emitted from the second vibrator. The ultrasonic signals emitted from the first and / or second vibrators can be used to control the ablation of a target by the selected first and / or second vibrators. The first and / or second vibrators may be selected to operate with or without an impact member, and may be selected to operate individually or simultaneously with each other. In other words, the first vibrator may be selected to operate by itself, the second vibrator may be selected to operate by itself, and the first and second vibrators may be selected to operate together simultaneously, thus acoustic The transducer can be operated in different modes.

[0008] The controller circuit may include a target characteristic signal input configured to receive a target characteristic signal. The target characteristic signal may provide an indicator of at least one of the following target characteristics: target composition (e.g., one or more substances constituting the target), size (e.g., length or width), or location (e.g., where the target is located in the patient's anatomical structure). The target composition or characteristics may be determined using spectral analysis or other analysis of the target by a spectrometer coupled to the controller circuit. Details of laser control using a spectrometer can be found in U.S. Patent Application No. 16 / 947.485, which incorporates its entirety. The activation control signal may be based at least in part on the received target characteristic signal. The activation control signal may be adjusted by either the physician user or the controller circuit in response to any change in the state of the target. For example, the activation control signal may be adjusted in response to a change in the composition of the target (e.g., in a situation where different layers of a stone are composed of different substances). In addition, or alternatively, the activation control signal may be adjusted based on the number of particles measured by a particle counter coupled to the controller circuit as the target is reduced or ablated.

[0009] For example, the first and second vibrators can be made at least partially separable. Or, to put it another way, acoustic A transducer can be a single solid component in which the vibrator is electrically coupled to a generator or sound waveguide, or acoustic A transducer can be separated into two or more pieces, with one piece containing one vibrator and another piece containing a second vibrator. acousticIn examples where the transducer is separated into two or more pieces, the first and second vibrators can be connected to each other by tubing and mechanical connections, etc. The mechanical connections may include at least one of screw connections, pneumatic connections, or over-center latches. The tubing can maintain a seal between the first and second vibrators and can be used to remove pieces of the target when the target is reduced or ablated.

[0010] The following acoustic stone crusher The use of dual-action systems, such as this one, can lead to better and more efficient fragmentation of targets, reducing or shortening surgical time while minimizing surgical complications, resulting in better patient outcomes.

[0011] In drawings that are not necessarily to scale, similar numbering may describe similar components in different drawings. Similar numbering with different suffixes may represent different instances of similar components. The drawings illustrate various embodiments discussed herein, not as limitations but as examples. [Brief explanation of the drawing]

[0012] [Figure 1] This figure shows an example of an acoustic transducer having a dual vibration stack configuration.

[0013] [Figure 2] This figure shows an example of a separable dual vibration stack configuration for acoustic transducers.

[0014] [Figure 3] This is an illustrative flowchart of an acoustic lithotripsy method for acoustic lithotripsy of a target located within a patient.

[0015] [Figure 4] Block diagram showing an example of a machine in which one or more embodiments may be implemented.

[0016] [Figure 5] FIG. 1 is a diagram showing an example of a schematic view of an exemplary computer-based clinical decision support system (CDSS). DETAILED DESCRIPTION OF THE INVENTION

[0017] Acoustic or shock wave lithotripsy is used to destroy one or more targets, such as kidney stones (also referred to as "stones") that are too large to pass naturally through the body, acoustic using ultrasonic or other sound waves emitted from a lithotripter, acoustic waveguide, or acoustic probe connected to a transducer. Waves such as ultrasonic or other sound waves can be used to destroy or fragment the target, such as to enable the fragmented pieces to pass naturally through the body (e.g., the urinary tract) and exit therefrom, or can be removed through a scope and tube system that includes or into which an acoustic transducer is introduced. transformation Targets such as stones can have different compositions or can be composed of different substances. The composition of the stone generally determines the hardness level of the stone (e.g., how hard the stone is). The hardness level of the stone affects the fragmentation of the stone

[0018] of the stone. transformationDetermine the acoustic frequency required to fragment or break the stone. For example, harder stones, such as those formed from calcium oxalate, require more force, and thus lower frequency waves, to break the stone. On the other hand, softer stones, such as those formed from uric acid, require less force, and thus higher frequency waves, to break the stone. Often, a stone can have a heterogeneous or non-uniform composition such that the stone is composed of different materials. For example, a kidney stone can have an outer portion shell formed from calcium oxalate and an inner portion formed from uric acid. Thus, the outer portion of the stone can be harder than the inner portion, or vice versa. Alternatively, the entire stone may be a mixture of hard and soft materials. In such cases, different frequency waves can be used for different portions of the stone to more efficiently fragment the stone. Low frequency waves can be used to break the harder outer shell, and high frequency waves can be used to break the softer inner portion.

[0019] Ultrasound or other acoustic lithotripsy can benefit from dual-action or other multi-action vibrations. This can include using separate vibration stacks or members (or oscillators) within an acoustic transducer that can operate at different frequencies. This can result in greater fragmentation ability and, in turn, lower operative times and better patient outcomes. The inventors have identified the need to establish or adjust the sound waves emitted by the transducer during treatment based on, for example, how the stone breaks down or decomposes (e.g., the amount of fragmentation) depending on the composition of the stone or the changing composition of the stone.

[0020] FIG. 1 shows an example of an acoustic Hibiki transducer 100 having a dual vibration stack configuration. In FIG. 1, acoustic the transducer 100This may include a first vibrating part (vibrating stack or vibrating member; hereinafter referred to as the first vibrator 102) and a second vibrating part, stack, or member (hereinafter referred to as the second vibrator 104). For example, the first vibrator 102 and / or the second vibrator 104 are sound Hibiki Sound Hibiki It can be placed inside the Lanceducer 100. For example, sound Hibiki The Lance Deuce 100 is sound Hibiki The lanceducer 100 may include an impact member assembly 108 located at its proximal end (for example, an assembly that can include a solenoid, a projectile, a pneumatic actuator, a spring, or a free mass that is impacted by a projectile). For example, the impact member assembly 108 may include sound Hibiki It can be included in or form part of the handle of the Lanceduce 100. Hibiki The LanceDuce 100 can also be used as an acoustic waveguide or acoustic probe, or for sound Hibiki The distal end of the lance reducer 100 may include any suitable elements such as a solenoid, spring, pneumatic actuator, free mass, ring, sleeve, etc. The impact member assembly 108 will sound Hibiki In one example, located at the proximal end of the lanceducer 100, a mass and projectile-type impact member can be moved through the impact member assembly 108 to generate acoustic energy that can be transmitted to the acoustic probe 110, in addition to the energy provided by the ultrasonic signals from the first vibrator 102 and / or the second vibrator 104 to contact the target 112. In another exemplary embodiment (for example, where the impact member is a solenoid), the impact member assembly 108 is positioned close to the acoustic probe 110 to transmit sound. Hibiki It can be positioned at the distal end of the lanceducer 100. In one example, an acoustic signal, such as an ultrasonic signal, can be emitted by a first vibrator 102 and / or a second vibrator 104 (which are themselves driven by an electrical signal) and transmitted to the impact member assembly 108 and / or the acoustic probe 110. HibikiThe lanceducer 100 may optionally include a central portion or central block 106 that separates the first vibrator 102 from the second vibrator 104. The second vibrator 104 is sound Hibiki The first vibrator 102 can be positioned at or toward the proximal end of the lanceducer 100, and the first vibrator 102 is sound Hibiki It can be positioned at or toward the distal end of the Lanceduce 100.

[0021] In one example, the first vibrator 102 uses a first ultrasonic frequency such as 20 kHz. numerous The first vibrator 102 can be configured to operate at a first frequency, and the second vibrator 104 can be configured to operate at a substantially different or higher frequency, such as 100 kHz. Thus, the second vibrator 104 can be configured to vibrate at a higher or greater frequency than the first vibrator 102.

[0022] The first vibrator 102 and / or the second vibrator 104 strike a target such as a stone that should be fragmented by the impact member. 112 To make contact with, or target 112 To transfer energy to the impact member assembly 108, energy can be transmitted to the impact member assembly 108 via acoustic or ultrasonic signals, etc. Alternatively, the impact member assembly 108 may be the first vibrator 102 and / or a second vibrator 104 It can be driven by a separate actuator that is different from the sound. Hibiki Lanceduce 100 optionally targets the impact member. 112 Shock and target 112The impact member assembly 108 may include an elongated member that can be at least partially inserted into the patient's body so as to destroy or fragment it. The impact member assembly 108 may include a solenoid hammer or solenoid driver. The impact member assembly 108 may include at least one of a spring and a free mass. In one example, the impact member assembly 108 may include a cylindrical rod or tube, which may be formed from a metal such as surgical steel or aluminum.

[0023] The impact member is the target 112 The impact member can be of any suitable or desirable shape and can be made from any suitable or desirable material so that it can be driven by a first vibrator 102 and / or a second vibrator 104 and / or a separate different actuator to fragment it. In such an example, the frequency of the impact member may be less than ultrasonic (e.g., 20 Hz or less) and may be due to the ultrasonic vibrations of the first vibrator 102 and / or the second vibrator 104. In other words, vibrations from the first vibrator 102 and / or the second vibrator 104 can cause motion of the impact member at frequencies less than ultrasonic.

[0024] In another example, the impact member can be operated at acoustic frequencies below ultrasonic levels, but can be driven by a signal independently of either the first vibrator 102 and / or the second vibrator 104. For example, the impact member can be driven by a signal from a separate actuator different from the first vibrator 102 and / or the second vibrator 104.

[0025] The first vibrator 102 and / or the second vibrator 104 may include a piezoelectric material or a stack of piezoelectric materials (or any similar material) and may generate different types of vibration modes or waves. For example, the first vibrator 102 may be configured to emit longitudinal waves and the second vibrator 104 may be configured to emit transverse waves. Alternatively, the first vibrator 102 may be configured to emit transverse waves and the second vibrator 104 may be configured to emit longitudinal waves. In another example, each of the first vibrator 102 and the second vibrator 104 may be a target 112 Location, target 112 It may be possible to selectively emit either longitudinal or transverse waves, based on user selection or determination by a controller circuit, based on one or more of the characteristics of the device (e.g., composition, compositional profile, size, shape, etc.).

[0026] The first vibrator 102 and the second vibrator 104 can be electrically controlled by any electrical energy source and can operate independently of each other or simultaneously. In other words, the first vibrator 102 can operate on its own, the second vibrator 104 can operate on its own, and the first vibrator 102 and the second vibrator 104 can operate simultaneously. The ability to use the vibrators independently of each other and to transmit different types of waves through the vibrators allows a physician to... Hibiki The LanceDuce 100 offers flexibility in changing its operating mode (e.g., vertical and horizontal modes), which can be useful in various lithotripsy scenarios. For example, it can reduce compression (sound) (due to factors such as the location of the kidney stone within the kidney, or the composition or hardness level of the kidney stone). Hibiki Targeting those moving away from Lanceduce 100 112When it is determined that pressing (a certain object) is desirable, a single vibrator operating at a high frequency and / or emitting transverse waves may be desirable. In other cases, such as when kidney stones are very hard, it may be desirable to radiate energy from the first vibrator 102 and the second vibrator 104 simultaneously so that the frequencies from the first vibrator 102 and the frequencies from the second vibrator 104 can be superimposed, for example, to allow the stones to be fragmented more easily and quickly.

[0027] Figure 2 shows an acoustic transducer 200 This figure shows an example of a separable double vibration stack configuration. Figure 2 shows a cross-sectional view of an acoustic transducer 200 in which the first vibrator 202 is at least partially separable from the second vibrator 204. In such an example, the first vibrator 202 and the second vibrator 204 are the sound discussed above. Hibiki Similar to the central block 106 within the lanceducer 100, it can be configured to be separable in the central part, etc. The first vibrator 202 is the first separable part 212 It may include the second vibrator 204, and the second separation part 210 It can include (collectively referred to as the "separated portion"). The separated portion is the first separated portion 212 and the second separation part 210 They can be shaped to interlock with each other in order to form a bond. For example, one of the separating parts may include an extended or raised portion, and the other separating part may include a cavity so that the separating parts can be brought together by force (as indicated by the directional arrows) in such a way that the extended portion interlocks with the cavity.

[0028] In one example, the force holding the separated parts together can be a mechanical force. The mechanical force can be implemented via a mechanical connection. The mechanical connection can include two or more threaded members that can be fastened, twisted, or otherwise assembled by screwing, twisting, or other means, which can mate the separated parts together and maintain energy transfer to the first vibrator 202 and / or the second vibrator 204, a pneumatic connection (such as one or more pneumatic actuators), an overcenter latch or lever, or a combination thereof. An acoustic waveguide 214 (e.g., an ultrasonic waveguide or probe) can be connected to the acoustic transducer 200. One or more electrical signals can drive the first vibrator 202 and / or the second vibrator 204 to vibrate at a frequency such as an ultrasonic frequency in a vibration mode (e.g., a longitudinal mode or a transverse mode). The ultrasonic signals from the first vibrator 202 and / or the second vibrator 204 can be transmitted to the acoustic waveguide 214 to transfer energy to the target 224. In the example of the acoustic transducer 200 shown in Figure 2, the first vibrator 202 can always be active or "on," or in other words, the first vibrator 202 can always be "on." The second vibrator 204 is separated portion The second vibrator 204 can be activated when it is connected to the first vibrator 202 via a mechanical connection. Thus, in some examples, the second vibrator 204 can only be activated or "turned on" when it is connected to the first vibrator 202 via a mechanical connection. This makes it possible to enable dual-action lithography, where the activation control signals sent to the first vibrator 202 and the activation control signals sent to the second vibrator 204 can be superimposed. As described above with respect to Figure 1, the second vibrator 204 can be configured to vibrate at a different (e.g., higher) frequency than the first vibrator 202. Thus, the activation control signal sent to the first vibrator 202 can be at a lower frequency than the activation control signal sent to the second vibrator 204.

[0029] For example, sound HibikiEither the lanced transducer 100 or the acoustic transducer 200 may include a tube, such as a tube 206, for connecting the vibrators. The tube 206 (e.g., a floating lumen tube) can connect the first vibrator 202 and the second vibrator 204 even when the first vibrator 202 and the second vibrator 204 are separated from each other. In such an example, the tube 206 can maintain a seal between the first vibrator 202 and the second vibrator 204 so that a fluid (e.g., water, saline solution, etc.) can flow through the tube 206 (as indicated by the arrow) during the procedure. Furthermore, the tube 206 can allow fragmented pieces of a target, such as kidney stones, to pass through the tube 206, for example, when the acoustic transducer 200 is connected to a vacuum pump or vacuum source to aspirate fragmented pieces of the target from the patient's body. The tube 206 can be fixed relative to the first vibrator 202 and movable (e.g., sliding) relative to the second vibrator 204. For example, tube 206 can retract into the second vibrator 204 when the first vibrator 202 and the second vibrator 204 are connected to each other via a mechanical connection, and in this state, tube 206 maintains a seal between the first vibrator 202 and the second vibrator 204.

[0030] For example, sound Hibiki Either the lance transducer 100 or the acoustic transducer 200 includes a control unit such as the control unit 216. acoustic stone crusherIt can be included as part of a system. The control unit 216 may include or be part of a computer or other similar machine, such as the machine shown in Figure 4 below, and may include a controller circuit 218, a spectrometer 220, and / or a particle counter 222. The control unit 216 may include more or fewer components as needed, such as those shown and / or described in Figure 4. The controller circuit 218 may include a target characteristic signal input configured to receive a target characteristic signal that provides indicators related to the target. The indicators may include the composition of the target, such as material composition, the size of the target, or any other similar target characteristics. The controller circuit 218 may be configured to emit an activation control signal based at least partially on the received target characteristic signal.

[0031] The controller circuit 218 can be included as part of the control unit 216 or coupled to a spectrometer 220 that can be coupled to or connected to the control unit 216, so that spectral analysis can be performed on the target characteristic signal to determine target characteristics such as the composition of the target. The controller circuit 218 may further include an acoustic actuation control output configured to selectively supply actuation control or driver control signals to the first vibrator 202 or the second vibrator 204. In one example, the actuation control signal can be any electrical signal that drives the vibrator and causes the vibrator to emit an acoustic or ultrasonic signal, which can be focused and transmitted to the impact member. The actuation control signal transmitted to the first vibrator 202 may differ from the actuation control signal transmitted to the second vibrator 204, for example, the actuation control signal transmitted to the first vibrator 202 may differ from the actuation control signal transmitted to the second vibrator 204, for example, the actuation control signal transmitted to the first vibrator 202 may be based on one or more factors such as the frequency to which the first vibrator 202 and the second vibrator 204 are configured to vibrate. The actuation control signal may also control the type of wave (e.g., longitudinal or transverse) transmitted to the vibrator. The control unit 216 may also include or be coupled to a particle counter 222. The particle counter 222 can be configured to measure the number of particles generated by the target as the target is fragmented. The particle counter 222 can be located within the control unit 216, or it can include a part that can be physically located on some other part of the acoustic transducer 200, such as a handle or handpiece, where it can measure the number of particles being removed from the patient's body through the tube 206.

[0032] The control unit 216 and / or controller circuit 218 are controlled by the controller circuit 218, which is a particle counter. 222 It can be coupled to an artificial intelligence (AI) or machine learning (ML) system that allows for the adjustment of the operating control signal based on the number of particles, target characteristics, and / or target composition measured by the particle counter. In addition, or instead, the operating control signal can be linked to the target composition, target characteristics, or particle counter. 222 This can be adjusted by a determined change in the number of particles measured by [the method]. For example, acoustic stone crusher The system can determine that the kidney stone is formed of calcium oxalate and adjust the control signal to emit low-frequency waves from the first oscillator 202. The system can then determine that the stone's composition has changed to uric acid and adjust the control signal to emit high-frequency waves from the second oscillator 204. Similarly, the system can determine that the target is not fragmenting or breaking down at the same rate (for example, because the number of particles measured by the particle counter 222 is slowing down) and adjust the control signal accordingly.

[0033] Figure 3 shows the acoustic lithotripsy of a target located within the patient. acoustic stone crusher This is an example of a flowchart for Method 300. acoustic stone crusher Method 300 is, acoustic stone crusher Method 300 may include a series of actions or steps that can be used to carry it out. In 302, the composition or properties of the target can be determined. The composition may be the material composition determined by spectral analysis or by visual inspection by a physician. For example, this may include determining whether a target such as a kidney stone is made of uric acid or calcium oxalate. The composition of the target may help determine other properties of the target, such as hardness level, thickness, etc. In 304, a driver control signal may be generated based on the determined composition or properties of the target, and in 306, sound HibikiA driver control signal can be sent to at least one of the first or second vibrators included in the lanceducer. In 308, an impact member coupled to the first and / or second vibrators can use the vibrations from the first and / or second vibrators to deliver energy to the target. In 310, a spectrometer can be used to analyze the target signal from the target (e.g., light reflected from the target) in order to determine the target properties. For example, the spectrometer can determine the composition of the target and then the hardness level of the target. In 312, changes in target properties can be determined. In 314, the driver control signal can be adjusted in response to changes in target properties. Changes in target properties, such as changes in target composition, can be determined by analysis using a spectrometer or by changes in the number of particles fragmented from the target as determined by a particle counter. For example, if the hardness of the target increases, the driver control signal can be increased. Alternatively, if the hardness of the target decreases, the driver control signal can be decreased or reduced. Similarly, if the target's position changes during ablation, such as being pushed out from an impact member, the type of radiated wave can be adjusted (for example, from longitudinal waves to transverse waves).

[0034] For example, spectral analysis of a target can be performed continuously, repeatedly, at predetermined intervals, or periodically. Therefore, spectral analysis can be updated throughout the entire medical procedure, such as lithotripsy, to monitor the stone or target to determine whether any changes have occurred with respect to the target. In response to these changes, the driver control signals can be adjusted accordingly. This adjustment can be performed by pressing a foot switch or foot pedal, or by engaging some operating mechanism, such as through a touchscreen graphical user interface (GUI) or any similar activation mode. acoustic Transducer or acoustic By pressing a button or flipping a switch on the handpiece connected to the transducer, acousticThis can be done by the transducer user. In addition, or instead, the adjustment can be done by the controller without user intervention, such as the controller circuit 218 described above with respect to Figure 2. In such an example, the controller circuit can automatically make adjustments to the driver control signals, or it can suggest to the user that changes be made and allow the user to accept or reject the changes.

[0035] Figure 4 is a block diagram showing an example of a machine in which one or more embodiments may be implemented. In some examples, machine 400 can operate as a standalone device or can be connected to other machines (e.g., network connection). For example, machine 400 can include, be combined with, or be connected to any or all of the following components: control unit 216, controller circuit 218, particle counter 222, and / or spectrometer 220 (or any other components included in or combined with control unit 216 perform one or more of their operations described above). In a network deployment, machine 400 can operate as a server machine, a client machine, or both in a server-client network environment. In one example, machine 400 can function as a peer machine in a peer-to-peer (P2P) (or other discrete) network environment. Machine 400 can be a personal computer (PC), tablet PC, set-top box (STB), personal digital assistant (PDA), mobile phone, web appliance, network router, switch or bridge, or any machine capable of executing (sequentially or otherwise) instructions that specify the operations that the machine should perform. Furthermore, although only one machine is shown, the term “machine” should also be interpreted to include any set of machines that individually or collectively execute an instruction set (or more instruction sets) to perform one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), and other computer cluster configurations.

[0036] The examples described herein may include or be operated by logic or several components or mechanisms. A circuit set is a collection of circuits implemented in a tangible entity, including hardware (e.g., simple circuits, gates, logic, etc.). Circuit set membership may be flexible over time and may be the basis for hardware variability. A circuit set includes components that, individually or in combination, can perform specified operations when operating. In one example, the hardware of a circuit set may be designed immutably to perform a particular operation (e.g., hardwired). In another example, the hardware of a circuit set may include variable-connected physical components (e.g., execution units, transistors, simple circuits, etc.), including a computer-readable medium that is physically modified to encode instructions for a particular operation (e.g., a magnetically or electrically movable arrangement of invariant mass particles). When connecting physical components, the underlying electrical properties of the hardware components are changed, for example, from an insulator to a conductor, or vice versa. The instructions allow embedded hardware (e.g., an execution unit or loading mechanism) to fabricate components of the circuit set within the hardware via variable connections to perform a portion of a particular operation while operating. Therefore, the computer-readable medium is communicatively connected to other components of the circuit set members while the device is operating. In one example, any of the physical components can be used by two or more members of two or more circuit sets. For example, during operation, the execution unit can be used by a first circuit of a first circuit set at one point, and at a different point in time by a second circuit of the first circuit set, or by a third circuit of a second circuit set.

[0037] The machine (e.g., a computer system) 400 may include a hardware processor 402 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, a field-programmable gate array (FPGA), or any combination thereof), main memory 404, and static memory 406, some or all of which can communicate with each other via an interconnect (e.g., a bus) 430. The machine 400 may also include a display device 410 may further include an alphanumeric input device 412 (e.g., a keyboard) and a user interface (UI) navigation device 414 (e.g., a mouse). In one example, a display device 410, input device 412, and UI navigation device 414 can be touchscreen displays. Machine 400 is mass storage device The machine 400 may also include a drive unit (for example) 408, a signal generating device 418 (for example, a speaker), a network interface device 420, and one or more sensors 416 such as a Global Positioning System (GPS) sensor, compass, accelerometer, or other sensor. The machine 400 may also include an output controller 428, such as a serial (for example, Universal Serial Bus (USB)), parallel, or wired or wireless (for example, infrared (IR), near-field communication (NFC)) connection, to communicate with or control one or more peripheral devices (for example, a printer, a card reader, etc.).

[0038] mass storage device 408 may include a machine-readable medium 422 in which one or more sets of data structures or instructions 424 (e.g., software) that embody or are used by any one or more of the technologies or functions described herein are stored. Instructions 424 may also reside, fully or at least partially, in main memory 404, static memory 406, or hardware processor 402 during execution by machine 400. For example, hardware processor 402, main memory 404, static memory 406, or mass storage device One or any combination of 408 is a machine-readable medium. 422 It can be constructed.

[0039] Although the machine-readable medium 422 is shown as a single medium, the term “machine-readable medium” may include a single or multiple mediums configured to store one or more instructions 424 (e.g., a centralized or distributed database, and / or associated caches and servers).

[0040] The term “machine-readable medium” can include any medium that can store, encode, or carry instructions for execution by machine 400, cause machine 400 to execute one or more of the technologies of this disclosure, or store, encode, or carry data structures used or associated with such instructions. Examples of non-limiting machine-readable mediums can include solid-state memory, as well as optical and magnetic media. In one example, a mass machine-readable medium includes a machine-readable medium having a plurality of particles having an immutable (e.g., stationary) mass. Thus, a mass machine-readable medium is not a transient propagating signal. Specific examples of mass machine-readable mediums can include non-volatile memory such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)) and flash memory devices, magnetic disks such as internal hard disks and removable disks, as well as CD-ROM and DVD-ROM disks.

[0041] Instruction 424 can be further transmitted or received through a communication network 426 using a transmission medium via a network interface device 420 that utilizes one of several transport protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP), etc.). Illustrative communication networks may include, among others, local area networks (LANs), wide area networks (WANs), packet data networks (e.g., the Internet), mobile phone networks (e.g., cellular networks), basic telephone (POTS) networks, and wireless data networks (e.g., the IEEE 802.11 and IEEE 802.16 families of standards, known as Wi-Fi®), the IEEE 802.15.4 family of standards, and peer-to-peer (P2P) networks. For example, the network interface device 420 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas to connect to the communication network 426. For example, the network interface device 420 may include multiple antennas to wirelessly transmit signals using at least one of the following technologies: single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO). The term “transmission medium” should be interpreted to include any intangible medium on which instructions to be executed by the machine 400 can be stored, encoded, or carried, and to include digital or analog communication signals or other intangible medium to facilitate the communication of such software.

[0042] Figure 5 shows a schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 500 configured to determine information or characteristics of a target, such as size, composition, hardness, density, or similar properties or information, based on a spectral analysis of the signal from the target. CDSS 500 is specific to the patient's treatment. acousticTransducer type, acoustic An input interface 502 provides parameters such as components connected to a transducer and the location of a target within the patient's body as input features to the artificial intelligence (AI) model 504. acoustic The system may include a processor that performs inference operations to provide an AI model with parameters to generate a determination of target characteristics and optimal settings for reducing or ablating a target, such as the frequency or amplitude of the ablation control signal and the type of wave to be emitted (e.g., longitudinal or transverse), and an output interface 508 that can communicate the determined target characteristics and settings to a user, such as a clinician.

[0043] The input interface 502 may include a direct data link between the CDSS 500 and one or more medical devices that generate at least some of the input features. For example, the input interface 502 can transmit information from the spectrometer 220, information from the particle counter 222, and / or information about signals returned directly from the target to the CDSS 500 during therapeutic and / or diagnostic medical procedures. In one example, used during the procedure acoustic Information regarding transducers, vibration sources, etc., can be stored in the database 506. In addition, or instead, the input interface 502 can be a classic user interface that facilitates interaction between the user and the CDSS 500. For example, the input interface 502 is: acousticA user interface can be facilitated that allows the user to manually input information about transducers, vibration sources, scopes, optical components, signals to be blocked or allowed, etc. In addition, or instead, the input interface 502 can provide the CDSS 500 with access to an electronic patient record or components used during a procedure, from which one or more input features can be extracted. In either of these cases, the input interface 502 can provide information about a specific patient, type of medical procedure, type of scope, etc., at the time or before the CDSS 500 is used to access the input features. acoustic Transducer type, acoustic The system can be configured to collect one or more of the following input features in relation to one or more of the features of the transducer or its components.

[0044] An example of an input feature is used during medical procedures. acoustic The transducer type can be included.

[0045] An example of an input feature could include the location of a target within the patient's body.

[0046] An example of an input feature is: acoustic The transducer may include the types of components connected to it.

[0047] An example of an input feature may include signal information from the feedback signal 512 received by the spectrometer 510 from the target.

[0048] An example of an input feature could include spectral analysis of the target received from the spectrometer 510.

[0049] Based on one or more of the above input features, the processor uses the AI ​​model 504 to perform inference operations to generate determined properties of the target, such as the target's size, composition, hardness, density, or any similar properties. For example, the input interface 502 can deliver one or more of the above input features to the input layer of the AI ​​model 504, which propagates these input features to the output layer through the AI ​​model 504. The AI ​​model 504 can provide a computer system with the ability to perform tasks without being explicitly programmed by making inferences based on patterns found in the analysis of data. The AI ​​model 504 explores the study and construction of algorithms (e.g., machine learning algorithms) that can learn from existing data and make predictions about new data. Such algorithms work by building an AI model from exemplary training data to make data-driven predictions or decisions, which are expressed as outputs or evaluations.

[0050] Two modes of machine learning (ML) can be considered: supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., correlating inputs to outputs or results) to learn relationships between inputs and outputs. The goal of supervised ML is to learn a feature that, given some training data, best approximates the relationship between inputs and outputs to be trained, so that given inputs to produce corresponding outputs, the ML model can implement the same relationship. Unsupervised ML is the training of ML algorithms using unclassified and unlabeled information, allowing the algorithm to act on that information without guidance. Unsupervised ML is useful in exploratory analysis because it can automatically identify structures within the data.

[0051] Supervised ML tasks can include classification and regression problems. Classification problems, also known as categorical classification problems, aim to classify an item into one of several categorical values ​​(e.g., is this object an apple or an orange?). Regression algorithms aim to quantify several items (e.g., by assigning a score to some input value). Some examples of supervised ML algorithms include logistic regression (LR), naive Bayes, random forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and support vector machines (SVM).

[0052] Some possible tasks in unsupervised ML include clustering, representation learning, and density estimation. Some examples of unsupervised ML algorithms are K-means clustering, principal component analysis, and autoencoders.

[0053] Another type of machine learning is federative learning (also known as collaborative learning), which trains algorithms across multiple distributed devices that hold local data without exchanging data. This approach contrasts with traditional centralized machine learning techniques where all local datasets are uploaded to a single server, as well as more classical distributed approaches that often assume local data samples are uniformly distributed. Federative learning allows multiple actors to build a common, robust machine learning model without sharing data, thus enabling the addressing of critical issues such as data privacy, data security, data access rights, and access to heterogeneous data.

[0054] In some examples, the AI ​​model 504 can be trained continuously or periodically before the processor performs inference calculations. Then, during the inference calculations, patient-specific input features provided to the AI ​​model 504 can propagate from the input layer through one or more hidden layers to the output layer corresponding to information about the target. For example, when evaluating the spectral analysis of a signal from a target, the system can determine one or more characteristics of the target. During and / or after the inference calculations, information about the target can be communicated to the user via the output interface 508 (e.g., the user interface (UI)) and / or connected to the processor. acoustic The transducer can be made to automatically perform desired actions. For example, based on the target composition, the system can make the transducer activate one or both of the vibrators, select or adjust the frequency and / or amplitude of the vibration signal, select or adjust the type of wave emitted, etc. The actions can be performed automatically based on analysis by an AI model, or they can be presented to the user as recommended settings that the user can accept, reject, or adjust as needed.

[0055] Notes and Examples Embodiment 1 is a system for acoustic lithotripsy for delivering acoustic energy to a target located within a patient, the system comprising: an acoustic transducer, which includes a first vibrator and a second vibrator; and a controller circuit coupled to the acoustic transducer, the controller circuit including an acoustic actuation control output configured to selectively provide an actuation control signal to at least one of the first vibrator or the second vibrator for controlling the ablation of the target by at least one selected from the first vibrator or the second vibrator.

[0056] In Embodiment 2, the subject of Embodiment 1 is an impact member coupled to an acoustic transducer, the impact member optionally includes an impact member capable of operating at a frequency lower than each of the first vibrator and the second vibrator, and the controller circuit includes a target characteristic signal input configured to receive a target characteristic signal that provides an index of at least one of a target composition or other target characteristics, and the operation control signal includes the target characteristic signal input, which is at least partially based on the received target characteristic signal, and is selected so that at least one of the first vibrator or the second vibrator operates with or without the impact member.

[0057] In Example 3, one or more of the themes from Examples 1 to 2 optionally include the fact that the operating control signal is an electronic signal that causes a first vibrator to emit a first ultrasonic signal and a second vibrator to emit a second ultrasonic signal, and the second vibrator is configured to vibrate at a higher frequency than the first vibrator.

[0058] In Example 4, one or more subjects from Examples 1 to 3 optionally include a distal portion of a long member that can be at least partially inserted into a patient's body, and at least one of a sound waveguide or an acoustic probe.

[0059] In Example 5, one or more of the themes from Examples 1 to 4 optionally include the following: the first vibrator and the second vibrator comprise a piezoelectric material, one of the first or second vibrators is configured to radiate longitudinal waves, and the other of the first or second vibrator is configured to radiate transverse waves.

[0060] In Example 6, one or more of the themes from Examples 2 to 5 optionally include the inclusion of a solenoid hammer as the impact member.

[0061] In Example 7, one or more of the themes from Examples 2 to 6 optionally include the fact that the impact member includes at least one of a spring or a free mass.

[0062] In Example 8, one or more subjects from Examples 1 to 7 optionally include a spectrometer coupled to a controller circuit, configured to analyze the composition or characteristics of a target.

[0063] In Example 9, the subject matter of Example 8 optionally includes the configuration in which the controller circuit is configured to adjust the control signal in response to changes in the target composition based on information from the spectrometer.

[0064] In Example 10, one or more subjects from Examples 1 to 9 optionally include a particle counter coupled to a controller circuit configured to measure the number of particles as the target is reduced or ablated.

[0065] In Example 11, the subject matter of Example 10 optionally includes the configuration in which the controller circuit adjusts the control signal based on the number of particles measured by the particle counter.

[0066] In Example 12, one or more themes from Examples 1 to 11 optionally include the fact that the first vibrator and the second vibrator are at least partially separable and connectable to each other by tubes and mechanical connections.

[0067] In Example 13, the subject matter of Example 12 optionally includes the mechanical connection comprising at least one of a screw connection, a pneumatic connection, or an over-center latch.

[0068] In Example 14, one or more of the themes from Examples 12 to 13 optionally include a controller circuit that includes an operating mode in which the first vibrator is always activated, and the second vibrator is activated when connected to the first vibrator via a mechanical connection.

[0069] In Example 15, one or more of the themes from Examples 12 to 14 optionally include a tube that is fixed to a first vibrator and movable to a second vibrator, and that the tube retracts into the second vibrator when the first and second vibrators are connected to each other via a mechanical connection, and in that state the tube maintains a seal between the first and second vibrators.

[0070] Example 16 is a method for acoustic lithotripsy of a target located within a patient, the method comprising: determining the target composition or other target characteristics of the target; generating a driver control signal based on the determined target characteristics of the target; sending the driver control signal to at least one of a first vibrator or a second vibrator; and causing an impact member coupled to at least one of the first vibrator or the second vibrator to deliver energy to the target using vibrations from at least one of the first vibrator or the second vibrator.

[0071] In Example 17, the subject matter of Example 16 optionally includes the steps of analyzing a target signal from a target using a spectrometer to determine the target composition or other target characteristics, and adjusting a driver control signal in response to a change in the target composition of the target.

[0072] Example 18 optionally includes one or more subjects from Examples 16-17: measuring the number of particles generated by a target using a particle counter, and adjusting a driver control signal based on the number of particles measured by the particle counter.

[0073] Embodiment 19 is an acoustic transducer comprising: a first vibrator; a second vibrator that is at least partially separable from the first vibrator; an impact member coupled to at least one of the first or second vibrators; an acoustic waveguide coupled to the impact member or at least one of the first or second vibrators; a tube that partially connects the first vibrator to the second vibrator and maintains a seal between them; and a connecting member configured to engage the first vibrator with the second vibrator.

[0074] In Example 20, the subject of Example 19 is configured to include an operating state in which the first vibrator is always activated, and optionally includes the selective activation of the second vibrator when connected to the first vibrator via a connecting member.

[0075] In Example 21, one or more of the themes from Examples 19 to 20 optionally include a tube that is fixed to a first vibrator and slidable to a second vibrator, the tube retracts into the second vibrator when the first and second vibrators are connected to each other via a connecting member, and the tube maintains a seal between the first and second vibrators.

[0076] The above detailed description includes references to the accompanying drawings, which form part of the detailed description. The drawings illustrate, as examples, specific embodiments that can be put into practice. These embodiments are also referred to herein as “examples.” Such examples may include elements in addition to those illustrated or described. However, the inventors also intend examples in which only these illustrated or described elements are provided. Furthermore, the inventors also intend examples in which, with respect to a particular example (or one or more embodiments thereof), or in respect to other examples (or one or more embodiments thereof) illustrated or described herein, any combination or arrangement of these illustrated or described elements (or one or more embodiments thereof) is used.

[0077] All publications, patents, and patent documents referenced herein are incorporated herein by reference in their entirety, as if they were incorporated individually. In the event of any conflicting use between this specification and these incorporated references, the use in the incorporated references should be considered supplementary to the use herein, and in the event of any conflicting inconsistency, the use herein shall prevail.

[0078] The above description is intended to be illustrative, not restrictive. For example, the above examples (or one or more embodiments thereof) can be used in combination with each other. Other embodiments can be used by those skilled in the art, etc., based on the above description. The abstract is presented with the understanding that it is intended to allow readers to quickly confirm the nature of the technical disclosure and is not to be used to interpret or limit the scope or meaning of the claims. Furthermore, the above detailed description may consolidate various features to streamline the disclosure. This should not be interpreted as meaning that any disclosed features not claimed are essential to any claim. Rather, the subject matter of the invention does not need to be present in all of the particular disclosed embodiments. Therefore, the following claims are incorporated into the detailed description, with each claim independent as a separate embodiment. The scope of the embodiments should be determined by reference to the appended claims, along with the entire scope of the equivalents to which such claims are granted.

Claims

1. An acoustic lithotripsy system for acoustic lithotripsy to deliver acoustic energy to a target located within the patient, An acoustic transducer including a first vibrator that vibrates at a first frequency and radiates a wave of a first waveform type, and a second vibrator that vibrates at a second frequency different from the first frequency and radiates a wave of a second waveform type different from the first waveform type, A controller circuit coupled to the acoustic transducer, Equipped with, The controller circuit is A target characteristic signal input configured to receive a target characteristic signal indicating the composition of the target from at least one optical sensor, The system includes an acoustically operated control output configured to selectively provide an operational control signal to at least one of the first or second vibrators for controlling the ablation of the target by the selected at least one of the first or second vibrators, and to select at least one of vibration at a first frequency and emission of a wave of a first waveform type by the first vibrator, and vibration at a second frequency and emission of a wave of a second waveform type by the second vibrator, based on the composition of the target determined using the target characteristic signal. The first vibrator is, When the composition of the target satisfies the first target composition characteristics, a wave of the first waveform type is radiated toward the target. The second vibrator is, An acoustic crushing system that radiates waves of a second waveform type toward a target when the composition of the target satisfies the second target composition characteristics.

2. The acoustic transducer further comprises an impact member coupled to it, The impact member is capable of operating at a lower frequency than each of the first vibrator and the second vibrator. The acoustic crushing system according to claim 1, wherein at least one of the first vibrator or the second vibrator is selected to operate with or without the impact member.

3. The acoustic crushing system according to claim 1, wherein the operating control signal is an electronic signal that causes the first vibrator to emit a first ultrasonic signal and the second vibrator to emit a second ultrasonic signal, and the second vibrator is configured to vibrate at a higher frequency than the first vibrator.

4. A distal portion of a long member that can be inserted at least partially into the patient's body, At least one of an acoustic waveguide or an acoustic probe, The acoustic crushing system according to claim 1, further comprising:

5. The acoustic crushing system according to claim 1, wherein the first vibrator and the second vibrator each include a piezoelectric material, and one of the first vibrator or the second vibrator is configured to radiate longitudinal waves, and the other of the first vibrator or the second vibrator is configured to radiate transverse waves.

6. The acoustic crushing system according to claim 2, wherein the impact member includes a solenoid hammer.

7. The acoustic crushing system according to claim 2, wherein the impact member includes at least one of a spring or a free mass.

8. The controller circuit further comprises a spectrometer coupled to the controller circuit, The acoustic crushing system according to claim 1, wherein the spectrometer is configured to analyze the composition or properties of the target.

9. The acoustic crushing system according to claim 8, wherein the controller circuit is configured to adjust the operation control signal in response to a change in the composition of the target, based on information from the spectrometer.

10. The acoustic crushing system according to claim 1, further comprising a particle counter coupled to the controller circuit and configured to measure the number of particles when the target is reduced or ablated.

11. The acoustic crushing system according to claim 10, wherein the controller circuit is configured to adjust the operating control signal based on the number of particles measured by the particle counter.

12. The acoustic crushing system according to claim 1, wherein the first vibrator and the second vibrator are at least partially separable and connectable to each other by tubes and mechanical connections.

13. The acoustic crushing system according to claim 12, wherein the mechanical connection includes at least one of a screw connection, a pneumatic connection, or an over-center latch.

14. The acoustic crushing system according to claim 12, wherein the controller circuit includes an operating mode in which the first vibrator is always in an activated state, and the second vibrator is activated when connected to the first vibrator via the mechanical connection.

15. The acoustic crushing system according to claim 12, wherein the tube is fixed to the first vibrator and movable to the second vibrator, and when the first vibrator and the second vibrator are connected to each other via the mechanical connection, the tube retracts into the second vibrator, and in that state the tube maintains a seal between the first vibrator and the second vibrator.

16. A method for operating an acoustic lithotripsy system for acoustic lithotripsy of a target located within a patient, The controller circuit of the acoustic crushing system, The steps include receiving a target characteristic signal indicating the composition of the target from at least one optical sensor, The steps include selectively providing an operating control signal to at least one of the first or second vibrators to control the ablation of the target by the selected at least one of the first or second vibrators, and selecting at least one of the following based on the composition of the target determined using the target characteristic signal: vibration at a first frequency and emission of waves of a first waveform type by the first vibrator, and vibration at a second frequency and emission of waves of a second waveform type by the second vibrator. The first vibrator is, When the composition of the target satisfies the first target composition characteristics, a wave of the first waveform type is radiated toward the target. The second vibrator is, A method for operating an acoustic crushing system, which radiates a second waveform type of wave toward a target when the composition of the target satisfies a second target composition characteristic.

17. The controller circuit is The steps include: analyzing the target signal from the target using a spectrometer to determine the target composition or other target characteristics; The steps include adjusting the operating control signal in response to a change in the target composition of the target, A method for operating the acoustic crushing system according to claim 16, wherein the system is executed.

18. The controller circuit is The steps include: measuring the number of particles generated by the target using a particle counter; The steps include adjusting the operating control signal based on the number of particles measured by the particle counter, A method for operating the acoustic crushing system according to claim 16, wherein the system is executed.

19. A first vibrator that vibrates at a first frequency and radiates a wave of a first waveform type, A second vibrator that is at least partially separable from the first vibrator, vibrates at a second frequency different from the first frequency, and radiates a wave of a second waveform type different from the first waveform type, An impact member coupled to at least one of the first vibrator or the second vibrator, A sound waveguide coupled to at least one of the impact member or the first vibrator or the second vibrator, A tube that partially connects the first vibrator to the second vibrator and maintains a seal between them, A connecting member configured to engage the first vibrator with the second vibrator, Equipped with, The first vibrator and the second vibrator are, Based on the composition of the target determined using a target characteristic signal received from at least one optical sensor, at least one of the following is selected: vibration at a first frequency and emission of a wave of a first waveform type by the first vibrator, and vibration at a second frequency and emission of a wave of a second waveform type by the second vibrator. The first vibrator is, When the composition of the target satisfies the first target composition characteristics, a wave of the first waveform type is radiated toward the target. The second vibrator is, An acoustic transducer that radiates a wave of the second waveform type toward a target when the composition of the target satisfies the second target composition characteristics.

20. The acoustic transducer according to claim 19, wherein the first vibrator is configured to include an operating state in which it is always activated, and the second vibrator is selectively activated when connected to the first vibrator via the connecting member.

21. The acoustic transducer according to claim 19, wherein the tube is fixed to the first vibrator and slidable to the second vibrator, and when the first vibrator and the second vibrator are connected to each other via the connecting member, the tube retracts into the second vibrator, and the tube maintains a seal between the first vibrator and the second vibrator.

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