Ultrasound systems and methods for improved occlusion during cross-section and rotary excision procedures.

Abstract

An ultrasonic system includes an ultrasonic device having an ultrasonic transducer and a core wire having a proximal portion coupled to the ultrasonic transducer and a distal portion terminating at a distal tip. An ultrasonic energy source is electrically connected to the ultrasonic transducer. The ultrasonic energy source includes an ultrasonic signal generator circuit, a modulator circuit, and a controller. The ultrasonic signal generator circuit generates an ultrasonic electrical signal. The modulator circuit amplitude-modulates the ultrasonic electrical signal with a macroscopic motion electrical signal to generate a modulated ultrasonic electrical signal. The controller executes program instructions to select between an engagement mode and a transverse mode, wherein in the engagement mode, a first ultrasonic electrical signal is supplied from the ultrasonic energy source to the ultrasonic transducer, and in the transverse mode, a modulated ultrasonic electrical signal is supplied from the ultrasonic energy source to the ultrasonic transducer.

Description

[0001] Cross-reference to related applications

[0002] none Technical Field

[0003] This invention relates to ultrasound systems and methods, and more particularly to ultrasound systems and methods with improved occlusion engagement during cross and rotary excision procedures. Background Technology

[0004] Surgical procedures (such as crossing or thoracotomy) are used to restore patency and blood flow lost due to occlusion of one or more blood vessels. Crossing is a procedure that creates an opening through the occlusion. Throtomy may include crossing, but can also attempt to break up and remove the occlusion. Ultrasound systems with ultrasound catheters can be used to perform both crossing and thoracotomy procedures.

[0005] Intravascular occlusion can take the form of calcified vascular occlusion with rigid proximal and distal caps. During ultrasound cross-cutting or rotary excision procedures, the distal tip of the ultrasound catheter engages with the proximal cap of the calcified vascular occlusion. However, due to the rigidity of the proximal cap of the calcified vascular occlusion, the distal tip of the ultrasound catheter may inadvertently dislodge from the proximal cap and take a subintimal migration path into the lateral wall of the vascular system.

[0006] What is needed in this art is a system and method in which, at the beginning of a cross-cutting or rotary excision procedure, the distal tip of an ultrasound catheter is more reliably engaged and anchored into the proximal cap of the endovascular occlusion, thereby reducing the likelihood of the distal tip of the ultrasound catheter inadvertently entering the subintimal migration pathway. Other applications of ultrasound catheters, as well as other applications outside the human body, are also considered. Summary of the Invention

[0007] This invention provides a system and method in which, at the beginning of a cross-cutting or rotary excision procedure, the distal tip of an ultrasound catheter more reliably engages and anchors into the proximal cap of the endovascular occlusion, thereby reducing the likelihood of the distal tip of the ultrasound catheter inadvertently entering the subintimal migration pathway. Other applications of the ultrasound catheter outside the human body are also considered.

[0008] This invention relates to an ultrasonic system comprising an ultrasonic device having an ultrasonic transducer and a core wire having a proximal end and a distal end terminating at a distal tip. The proximal end is coupled to the ultrasonic transducer. An ultrasonic energy source is electrically connected to the ultrasonic transducer. The ultrasonic energy source includes an ultrasonic signal generator circuit, a modulator circuit, and a controller. The ultrasonic signal generator circuit is configured to generate a first ultrasonic electrical signal having a first ultrasonic frequency. The modulator circuit is configured to amplitude modulate the first ultrasonic electrical signal with a macroscopic motion electrical signal to generate a modulated ultrasonic electrical signal. The macroscopic motion electrical signal has a frequency at least 350 times smaller than the ultrasonic frequency of the first ultrasonic electrical signal. The controller is communicatively coupled to the ultrasonic energy source. The controller executes program instructions to select between an engagement mode and a transverse mode, wherein in the engagement mode, the first ultrasonic electrical signal is supplied from the ultrasonic energy source to the ultrasonic transducer, and in the transverse mode, the modulated ultrasonic electrical signal is supplied from the ultrasonic energy source to the ultrasonic transducer.

[0009] The present invention relates in another form to a method of operating an ultrasonic catheter coupled to an ultrasonic energy source, the ultrasonic catheter having a core wire coupled to an ultrasonic transducer, and the ultrasonic transducer being coupled to the ultrasonic energy source, the method comprising: providing an engagement mode wherein the ultrasonic energy source generates an ultrasonic electrical signal having a first frequency, the ultrasonic electrical signal being supplied to the ultrasonic transducer to establish a continuous wave at an ultrasonic vibration frequency in a distal portion of the core wire, wherein the continuous wave generates vibrational motion of the distal portion of the core wire having substantially only longitudinal vibrational motion; providing a transverse mode wherein the ultrasonic electrical signal is amplitude modulated with a macroscopic motion electrical signal having a second frequency at least 350 times smaller than the first frequency to establish a modulated continuous wave at the modulated ultrasonic vibration frequency in the distal portion of the core wire, wherein the modulated continuous wave generates vibrational motion of the distal portion of the core wire having a combination of longitudinal and transverse vibrational motion; operating the ultrasonic catheter in the engagement mode for a first duration; and operating the ultrasonic catheter in the transverse mode for a second duration after the first duration of the engagement mode.

[0010] The present invention relates in yet another form to a method of operating an ultrasonic catheter coupled to an ultrasonic energy source, the ultrasonic catheter having a core wire coupled to an ultrasonic transducer, and the ultrasonic transducer being coupled to the ultrasonic energy source, the method comprising: providing an engagement mode wherein the ultrasonic energy source generates an ultrasonic electrical signal having an ultrasonic frequency, wherein the engagement mode is achieved by adjusting the output energy level of the ultrasonic energy source to a first output energy level to achieve substantially only longitudinal vibrational motion of the distal portion of the core wire; providing a transverse mode wherein the output energy level of the ultrasonic energy source increases from the first output energy level to a second output energy level above the first output energy level to achieve a combination of longitudinal vibrational motion and transverse vibrational motion of the distal portion of the core wire; operating the ultrasonic catheter in the engagement mode for a first duration; and operating the ultrasonic catheter in the transverse mode for a second duration after the first duration of the engagement mode.

[0011] The advantage of this invention is that, in the engagement mode, the distal tip of the ultrasound catheter engages and anchors more reliably to the proximal cap of the endovascular occlusion at the beginning of the cross or scalpel procedure, thereby reducing the likelihood that the distal tip of the ultrasound catheter may inadvertently take a subintimal migration path when the system transitions to lateral mode. Attached Figure Description

[0012] The above-mentioned and other features and advantages of the present invention, as well as the ways in which they are obtained, will become clearer and the invention will be better understood by referring to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:

[0013] Figure 1 This is an illustration of an ultrasound system for performing cross-and-rotation excision surgery according to an embodiment of the present invention;

[0014] Figure 2 According to one aspect of the invention Figure 1 A block diagram of a portion of an ultrasound system; and

[0015] Figure 3 It is a graph representing the output energy level of the ultrasonic energy source throughout the entire joint mode and transverse mode as a function of time.

[0016] Throughout the several views, corresponding reference numerals indicate the corresponding parts. The examples described herein illustrate at least one embodiment of the invention, and such examples should not be construed as limiting the scope of the invention in any way. Detailed Implementation

[0017] Now refer to the attached diagram, and more specifically to... Figure 1 An ultrasound system 10 for performing cross-cutting and rotary cutting surgery according to an embodiment of the present invention is shown.

[0018] The ultrasound system 10 may include a console 12 and an ultrasound device 14. The ultrasound device 14 includes a handheld component 16 and an ultrasound catheter 18. The ultrasound catheter 18 is detachably attached to the handheld component 16.

[0019] The console 12 includes a user interface 20, a controller 22, and an ultrasonic energy source 24. The console 12 may include multiple components in a single housing unit or in separate housing units. Optionally, the console 12 may also include a foot switch 26 and / or a saline injector 28.

[0020] In this embodiment, the handheld device 16 includes a housing body 16-1 and an ultrasonic transducer 16-2 internally mounted to the housing body 16-1. The housing body 16-1 has an external shape and size that facilitates gripping by the operator during cross-excision or rotary excision procedures.

[0021] The ultrasonic transducer 16-2 may be, for example, a piezoelectric transducer. The ultrasonic transducer 16-2 of the handheld device 16 is electrically connected to the ultrasonic energy source 24 via a cable 32 and is configured to receive the ultrasonic electrical signal generated by the ultrasonic energy source 24 and convert it into ultrasonic vibration energy, which may be in a frequency range corresponding to the frequency range of the ultrasonic electrical signal.

[0022] In this embodiment, the ultrasonic catheter 18 includes a housing 34, a sheath 36, and a core wire 38.

[0023] The housing 34 includes a Y-connector 34-1 that provides access to a flushing lumen (not shown) of the sheath 36. The Y-connector 34-1 is connected to the saline injector 28, for example, via a flexible hose 30. In this embodiment, the housing 34 also includes a retraction-extension mechanism 40 (such as a slider) connected to the sheath 36.

[0024] The sheath 36 is an elongated flexible tube, such as a polymer tube. The sheath 36 includes a proximal end 36-1, a distal end 36-2, and a sheath cavity 36-3. In this embodiment, the sheath cavity 36-3 is an elongated cavity extending longitudinally from the proximal end 36-1 to the distal end 36-2 within the sheath 36, and may be formed as a central cavity relative to the diameter of the sheath 36. The proximal end 36-1 of the sheath 36 is connected to the housing 34, and more specifically, in this embodiment, to the retraction-extension mechanism 40.

[0025] The core wire 38 is a long, flexible metal wire, such as nitinol, which is located within and extends longitudinally within the sheath cavity 36-3 of the sheath 36. In this embodiment, the core wire 38 may have a length greater than 60 centimeters (cm), and in some embodiments, the length is 100 to 200 cm. The core wire 38 has a proximal end 38-1, a distal tip 38-2, and a distal portion 38-3.

[0026] The proximal end 38-1 of the core wire 38 is operably connected to the ultrasonic transducer 16-2, for example, via an acoustic connector, to receive vibrational energy from the ultrasonic transducer 16-2, thereby generating vibrational motion of the core wire 38. According to the invention, depending on the operating mode, the vibrational motion of the core wire 38 can be longitudinal or a combination of longitudinal and transverse vibrations.

[0027] For example, if the frequency of the ultrasonic electrical signal generated by the ultrasonic energy source 24 and supplied to the ultrasonic transducer 16-2 is 20 kHz, then the vibration frequency of the longitudinal vibration of the distal portion 38-3 of the core wire 38 can be 20 kHz accordingly, and when the ultrasonic electrical signal is amplitude modulated by a low-frequency modulation signal (e.g., 1 Hz-50 Hz), the transverse vibration is accompanied by the longitudinal vibration of the distal portion 38-3 of the core wire 38.

[0028] The distal tip 38-2 of the core wire 38 can be, for example, a blunt tip, or a rounded tip without a sharp point. In practice, the core wire 38 is advanced into a blood vessel of a vascular system with vascular occlusion, wherein the distal tip 38-2 of the core wire 38 engages with the vascular occlusion.

[0029] The distal portion 38-3 extends proximally from the distal tip 38-2 and terminates distally at the distal tip 38-2. In this embodiment, the distal portion 38-3 may have a portion with a decreasing diameter that is close to and spaced apart from the distal tip 38-2.

[0030] In this embodiment, the retraction-extension mechanism 40 of the housing 34 is configured to extend from the first, fully extended position of the sheath 36 (e.g., Figure 1 As shown in the diagram, the sheath 36 is retracted to its fully retracted position, wherein in the first, fully extended position of the sheath 36, the distal portion 38-3 of the core wire 38 (e.g., 5 cm to 8 cm) extends distally from the distal end 36-2 of the sheath 36, wherein in the fully retracted position of the sheath 36, the core wire 38 is fully deployed within the sheath cavity 36-3 of the sheath 36. Alternatively, it is conceivable that the core wire 38 can be slidably moved relative to the sheath 36 to fully extend the core wire 38 to expose the distal portion 38-3 of the core wire 38 distally from the distal end 36-2 of the sheath 36, and to fully retract the core wire 38 to cover the distal portion 38-3 of the core wire 38 with the sheath 36.

[0031] Foot switch 26 is connected to controller 22 via cable 26-1. Foot switch 26 can provide an auxiliary input signal to controller 22, which controller 22 can then use to activate and deactivate system components (e.g., the ultrasonic energy source 24 of ultrasonic system 10 and / or saline injector 28).

[0032] The saline injector 28 is connected to the controller 22 via cable 28-1. Figure 1As depicted, the saline injector 28 is in fluid communication with the ultrasound catheter 18 via a flexible tubing 30. The saline injector 28 can selectively deliver sterile saline to the ultrasound catheter 18, which can then be used to flush the anatomical area for endovascular occlusion modification surgery and / or to cool the moving parts of the ultrasound catheter 18 (e.g., the core wire 38).

[0033] Also refer to Figure 2 User interface 20 is connected to controller 22 via cable 20-1 (e.g., multi-cable or USB) to provide electrical and communication interconnection. Alternatively, user interface 20 may be a wireless link, such as Bluetooth, which is communicatively coupled to controller 22. User interface 20 may include, for example, a touchscreen display 20-2 (see...). Figure 1 The touchscreen display 20-2 may include, for example, a liquid crystal display (LCD) or a light-emitting diode (LED) display. Alternatively, the user interface 20 may be in the form of a laptop computer or tablet computer. The user interface 20 is configured to generate control signals based on user input received by the touchscreen display 20-2. For example, a user can operate the touchscreen display 20-2 of the user interface 20 to provide control signals to the controller 22 to initiate and / or terminate the operation of the ultrasonic energy source 24, and selectively start or stop the saline injector 28.

[0034] Special Reference Figure 2 The controller 22 is electrically connected to and communicatively coupled to each of the user interface 20 and the ultrasonic energy source 24. The controller 22 includes processor circuitry 42, interface circuitry system 44, and electronic memory circuitry 46.

[0035] Processor circuitry 42 may include one or more programmable microprocessors and associated circuitry, such as input / output interfaces, clocks, buffers, and memory. Processor circuitry 42 may be programmed, for example, by software or firmware stored in memory circuitry 46, to execute program instructions that process received input data and generate and send output data.

[0036] The interface circuit system 44 includes input and output circuits to facilitate electrical connection and data transmission with the user interface 20 and the ultrasonic energy source 24.

[0037] Memory circuit 46 is an electronic non-transitory memory with multiple data storage locations, as is well known in the art. Memory circuit 46 may include one or more of volatile memory circuits (such as random access memory (RAM)) and non-volatile memory circuits (such as read-only memory (ROM), electrically erasable programmable ROM (EEPROM), NOR flash memory, NAND flash memory, etc.). Memory circuit 46 may be used, for example, to store program instructions that will be executed by processor circuit 42.

[0038] Controller 22 performs processing from the touchscreen display 20-2 of user interface 20 (see...) Figure 1 The program instructions received from the signals will be executed, and the output control signals C1, C2, and C3 will be output (see...). Figure 2 )Provide program instructions to the ultrasonic energy source 24 to control the operation of the ultrasonic energy source 24.

[0039] The ultrasonic energy source 24 is connected to the controller 22 via cable 48. Cable 48 includes electrical conductors 48-1, 48-2, and 48-3, each configured to carry a corresponding output control signal C1, C2, and C3. The ultrasonic energy source 24 includes an ultrasonic signal generator circuit 50, a modulator circuit 52, and an electrically actuated selector circuit 54 (e.g., an electronic switch circuit). While each of circuits 50, 52, and 54 can be implemented as an electrical / electronic component circuit, alternatively, it is contemplated that one or more of the circuits can be implemented in software / firmware.

[0040] The ultrasonic signal generator circuit 50 is configured to generate an ultrasonic electrical signal S1, for example, a high-frequency current, in a frequency range of 20 kHz to 150 kHz. More preferably, for example, the frequency of the ultrasonic electrical signal S1 can be in the range of 20 kHz to 40 kHz. In some applications, the ultrasonic frequency of the ultrasonic electrical signal S1 can be, or can be initially, 20 kHz.

[0041] Modulator circuit 52 is an amplitude modulation circuit configured to receive ultrasonic electrical signal S1 and modulate the amplitude of ultrasonic electrical signal S1 with macroscopic motion electrical signal S2 to generate modulated ultrasonic electrical signal S3. Macroscopic motion electrical signal S2 is a low-frequency modulation signal, defined herein as an electrical signal with a frequency at least 350 times lower than the frequency of ultrasonic electrical signal S1. For example, the frequency of macroscopic motion electrical signal S2 can be in the range of 1Hz-50Hz.

[0042] The selector circuit 54 is operated by the controller 22 to select one of the ultrasonic electrical signal S1 and the modulated ultrasonic electrical signal S3 as the excitation signal ES to be supplied to the ultrasonic transducer 16-2.

[0043] According to one aspect of the invention, the ultrasound system 10 performs cross-excision or rotary excision surgery by automatically transitioning from an engagement mode to a transverse mode. Specifically, the controller 22 executes program instructions to select between the engagement mode and the transverse mode, and this selection is achieved through the operation of the selector circuit 54, wherein in the engagement mode, an ultrasonic electrical signal S1 is supplied from the ultrasonic energy source 24 to the ultrasonic transducer 16-2, while in the transverse mode, a modulated ultrasonic electrical signal S3 is supplied from the ultrasonic energy source 24 to the ultrasonic transducer 16-2.

[0044] The engagement mode is used to initially engage and anchor the distal tip 38-2 of the core wire 38 into the proximal cap of a vascular occlusion (such as a calcified vascular occlusion) based on the excitation of the ultrasonic electrical signal S1 from the ultrasonic transducer 16-2. In this context, the term "anchoring" means that the distal tip 38-2 of the core wire 38 has been inserted into the proximal cap to restrict lateral movement of the distal tip 38-2, but the distal tip 38-2 does not necessarily need to be attached to the proximal cap of the vessel. The proximal cap of a calcified vascular occlusion is often irregular in shape but may have a generally or partially convex or concave surface. Thus, when the proximal cap has a convex shape, anchoring is particularly helpful in preventing subintimal migration of the distal tip 38-2. Therefore, by anchoring the distal tip 38-2 of the core wire 38 into the proximal cap of a calcified vascular occlusion, the distal tip 38-2 of the core wire 38 has a higher probability of remaining in the true lumen of the vessel during occlusion crossing or excision procedures without entering the subintimal region.

[0045] For example, in the bonding mode, an ultrasonic electrical signal S1 is generated at an ultrasonic frequency (e.g., 20 kHz), and the ultrasonic electrical signal S1 is supplied to the ultrasonic transducer 16-2. The electrical power of the ultrasonic electrical signal S1 supplied to the ultrasonic transducer 16-2 is selected, for example, by the controller 22, to establish a continuous wave at the ultrasonic vibration frequency in the distal portion 38-3 of the core wire 38. The continuous wave generates vibrational motion of the distal portion 38-3 and the distal tip 38-2 of the core wire 38, which has essentially only longitudinal vibrational motion, so as to anchor the distal tip 38-2 of the core wire 38 to the proximal cap of the calcified vascular occlusion based on the ultrasonic electrical signal S1 excited by the ultrasonic transducer 16-2. In this embodiment, the longitudinal vibrational motion of the distal portion 38-3 of the core wire 38 is in the range of 20 micrometers to 40 micrometers.

[0046] As used herein, the term "substantially longitudinal vibrational motion" means longitudinal vibrational motion with substantially no accompanying lateral vibrational motion. The term "substantially no accompanying lateral vibrational motion" means lateral vibrational motion of less than 1 micrometer at any location along the distal portion 38-3 of the core wire 38.

[0047] The lateral mode follows the engagement mode. Based on the modulation of the ultrasonic electrical signal S3 excitation from the ultrasonic transducer 16-2, the lateral mode is used to more aggressively penetrate and destroy vascular lesions, causing the distal portion 38-3 of the core wire 38 to be subjected to a combination of longitudinal and lateral vibrational motions while remaining anchored in the calcified vascular occlusion until the crossing and / or destruction of the vascular occlusion is completed. In this embodiment, the longitudinal vibrational motion of the distal portion 38-3 of the core wire 38 is in the range of 20 micrometers to 40 micrometers, while the lateral vibrational motion of the distal portion 38-3 of the core wire 38 is in the range of 3 micrometers to 10 micrometers.

[0048] For example, in transverse mode, an ultrasound electrical signal S1 (e.g., having an ultrasound frequency of 20 kHz) is amplitude modulated by a macroscopic motion electrical signal S2 (e.g., an electrical signal S2 having a non-ultrasound frequency at least 350 times lower than the ultrasound electrical signal S1) to generate a modulated ultrasound electrical signal S3. The frequency of the macroscopic motion electrical signal S2 may, for example, be in the range of 1 Hz to 50 Hz, or more specifically in the range of 5 Hz to 15 Hz. The amplitude-modulated ultrasound electrical signal S3 is supplied to an ultrasound transducer 16-2, which in turn establishes a modulated continuous wave at the modulated ultrasound vibration frequency in the distal portion 38-3 of the core wire 38. The modulated continuous wave generates a vibrational motion of the distal portion 38-3 of the core wire 38 (including the distal tip 38-2) having a combination of longitudinal and transverse vibrational motions, which are excited by the modulated ultrasound electrical signal S3 from the ultrasound transducer 16-2 and transmitted to the calcified vascular occlusion. In this embodiment, the longitudinal vibration motion of the distal portion 38-3 of the core wire 38 is in the range of 20 micrometers to 40 micrometers, while the lateral vibration motion of the distal portion 38-3 of the core wire 38 is in the range of 3 micrometers to 10 micrometers.

[0049] Also refer to Figure 3 During operation, the controller 22 executes program instructions causing the ultrasound system 10 to operate in engagement mode for a first duration (t0-t1), and then in lateral mode for a second duration (t1-t3) after the first duration (t0-t1) of engagement mode. The first duration (t0-t1) begins at t0 when the distal tip 38-2 of the distal portion 38-3 of the core wire 38 contacts the proximal cap of the calcified vascular occlusion in the blood vessel and the excitation signal ES (S1) is delivered to the ultrasound transducer 16-2. During the first duration (t0-t1), the distal tip 38-2 of the core wire 38 penetrates the proximal cap of the calcified vascular occlusion to anchor the distal portion 38-3 of the core wire 38 within the calcified vascular occlusion.

[0050] For example, the first duration (t0-t1) can be from 1 second to 3 seconds and can vary within that range based on factors such as the expected stiffness / density of the proximal cap of the occluded vessel. In some procedures, a first duration (t0-t1) of 1.75 seconds can be selected as the initial setting. The second duration (t1-t3) is the time required for the distal tip 38-2 of the core suture 38 to leave the distal tip cap of the occluded vessel; that is, it is a time that can vary based on factors such as the length and density of the occluded vessel and whether the procedure is a cross-cutting or rotary cutting procedure. In a rotary cutting procedure, the distal portion 38-3 of the core suture 38 disrupts the calcified occluded vessel.

[0051] A transition from the adjoint mode to the transverse mode can occur when the output energy level (i.e., power, current and / or voltage) of the ultrasonic energy source 24 increases steadily during the transverse mode time period (t1-t2) (i.e., at the end of the adjoint mode).

[0052] For example, in engagement mode, controller 22 executes program instructions to adjust the output energy level (e.g., the amplitude or frequency of the ultrasound signal generator circuit 50) of the ultrasound energy source to a first output energy level OEL1 to achieve substantially only longitudinal vibrational movement of the distal portion 38-3 of the core wire 38, i.e., substantially no lateral vibrational movement of the distal portion 38-3 of the core wire 38. The longitudinal vibrational movement of the distal portion 38-3 of the core wire 38 is sustained at the first output energy level OEL1 for a first duration (t0-t1) to anchor the distal tip 38-2 of the core wire 38 into the proximal cap of the vascular occlusion.

[0053] In lateral mode, controller 22 can execute program instructions to increase the amplitude of the macroscopic motion electrical signal S2, which modulates the ultrasonic electrical signal S1, according to the ramp profile during the time period (t1-t2), so that the output energy level of the modulated ultrasonic electrical signal S3 of ultrasonic energy source 24 gradually increases from the first output energy level OEL1 to the second output energy level OEL2 according to the ramp profile. The ramp profile is defined by the first output energy level OEL1 and the second output energy level OEL2. The ramp profile can be linear, or alternatively, it can be a curve (such as a parabola, exponential curve, or "S" shape).

[0054] In the transverse mode, the amount of transverse vibrational motion of the distal portion 38-3 of the core wire 38 increases with the increase of the output energy level during the time period (t1-t2). The combination of longitudinal and transverse vibrational motion of the distal portion 38-3 of the core wire 38 continues at the second output energy level OEL2 for the remainder of the second duration (t1-t3) (t2-t3).

[0055] In other words, in this embodiment, by introducing a macroscopic motion electrical signal S2 (i.e., by using the macroscopic motion electrical signal S2 to modulate the amplitude of the ultrasonic electrical signal S1), the output energy level of the ultrasonic energy source 24 increases from the first output energy level OEL1 to the second output energy level OEL2 (higher than the first output energy level), wherein the amplitude of the macroscopic motion electrical signal S2 can be increased according to the slope profile during the time period (t1-t2) in order to smoothly increase the amount of lateral vibration motion of the distal portion 38-3 of the core wire 38.

[0056] Although Figure 1 and 2 The embodiment depicted shows a distal portion 38-3 of the core wire 38 extending from the distal end 36-2 of the sheath 36. However, it should be recognized that the invention can be practiced with an ultrasonic catheter configuration in which the distal portion 38-3 is wholly or partially contained within the sheath 36, and / or the distal portion 38-3 is connected to the distal end 36-2 of the sheath 36, such as, for example, those available from BD / CRBard. Branded ultrasound catheters.

[0057] The following items also relate to this invention:

[0058] In one form, the present invention relates to an ultrasonic system. The ultrasonic system may include an ultrasonic device having an ultrasonic transducer, and a core wire having a proximal end and a distal end terminating at a distal tip, the proximal end being coupled to the ultrasonic transducer. An ultrasonic energy source may be electrically connected to the ultrasonic transducer. The ultrasonic energy source may include an ultrasonic signal generator circuit and a modulator circuit. The ultrasonic signal generator circuit may be configured to generate a first ultrasonic electrical signal having a first ultrasonic frequency. The modulator circuit may be configured to amplitude modulate the first ultrasonic electrical signal, optionally using a macroscopic motion electrical signal, to generate a modulated ultrasonic electrical signal. The macroscopic motion electrical signal may have a frequency at least 350 times smaller than the ultrasonic frequency of the first ultrasonic electrical signal. A controller may be communicatively coupled to the ultrasonic energy source. The controller may be configured to execute program instructions selecting between an engagement mode and a transverse mode, wherein in the engagement mode, the first ultrasonic electrical signal is supplied from the ultrasonic energy source to the ultrasonic transducer, and in the transverse mode, the modulated ultrasonic electrical signal is supplied from the ultrasonic energy source to the ultrasonic transducer.

[0059] In any embodiment, the ultrasound system may include a sheath having a sheath cavity, wherein the core wire is located in the sheath cavity and extends longitudinally therein.

[0060] In some embodiments, the distal portion of the core wire can extend from the distal end of the sheath.

[0061] In any embodiment, in the engagement mode, the ultrasonic system can be controlled by a controller such that the ultrasonic transducer establishes a continuous wave at the ultrasonic vibration frequency in the distal portion of the core wire, wherein the continuous wave generates vibrational motion of the distal portion of the core wire, which is substantially only longitudinal vibrational motion.

[0062] In any embodiment, in transverse mode, the ultrasonic system can be controlled by a controller such that the ultrasonic transducer generates a modulated continuous wave that produces a vibrational motion of the distal portion of the core wire, the vibrational motion having both longitudinal and transverse vibrational motions, wherein the longitudinal vibrational motion can be in the range of 20 micrometers to 40 micrometers and the transverse vibrational motion can be in the range of 3 micrometers to 10 micrometers.

[0063] In any embodiment, the frequency of the first ultrasonic electrical signal can be in the range of 20 kHz to 40 kHz and the frequency of the macroscopic motion electrical signal can be in the range of 1 Hz to 50 Hz.

[0064] In any embodiment, the controller may be configured to execute program instructions to operate in engagement mode for a first duration and then in lateral mode for a second duration after the first duration of engagement mode.

[0065] In any embodiment, the ultrasonic energy source can be configured to increase the output energy level of the ultrasonic energy source from a first output energy level to a second output energy level higher than the first output energy level by introducing a macroscopic motion electrical signal.

[0066] In any embodiment, the ultrasonic energy source can be configured such that the amount of lateral vibrational motion increases with increasing output energy level, and wherein the transition from the first output energy level to the second output energy level can be based on a ramp profile.

[0067] In any embodiment, the amplitude of the macroscopic motion electrical signal can be increased based on the slope profile.

[0068] In another form, the present invention relates to a method of operating an ultrasonic conduit coupled to an ultrasonic energy source, the ultrasonic conduit having a core wire coupled to an ultrasonic transducer, and the ultrasonic transducer being coupled to an ultrasonic energy source, optionally an ultrasonic system of any of the preceding paragraphs

[0057] to

[0066] . The method may include providing an engagement mode in which an ultrasonic energy source generates an ultrasonic electrical signal having a first frequency, the ultrasonic electrical signal being supplied to an ultrasonic transducer to establish a continuous wave at an ultrasonic vibration frequency in a distal portion of the core wire, wherein the continuous wave generates vibrational motion of the distal portion of the core wire, the vibrational motion being substantially only longitudinal; providing a transverse mode in which the ultrasonic electrical signal is amplitude modulated with a second frequency having a frequency at least 350 times smaller than the first frequency to establish a modulated continuous wave at a modulated ultrasonic vibration frequency in the distal portion of the core wire, wherein the modulated continuous wave generates vibrational motion of the distal portion of the core wire having a combination of longitudinal and transverse vibrational motion; operating the ultrasonic catheter in the engagement mode for a first duration; and operating the ultrasonic catheter in the transverse mode for a second duration after the first duration of the engagement mode.

[0069] In any embodiment, the first frequency of the ultrasonic electrical signal may be in the range of 20 kHz to 40 kHz and the second frequency of the macroscopic motion electrical signal may be in the range of 1 Hz to 50 Hz.

[0070] In some embodiments, the first frequency of the ultrasonic electrical signal may be 20 kHz and the second frequency of the macroscopic motion electrical signal may be in the range of 5 Hz to 15 Hz.

[0071] In any embodiment, in the engagement mode, the longitudinal vibration motion can be in the range of 20 micrometers to 40 micrometers and the lateral vibration motion is less than 1 micrometer.

[0072] In any embodiment, in lateral mode, the longitudinal vibration motion can be in the range of 20 micrometers to 40 micrometers and the lateral vibration motion can be in the range of 3 micrometers to 10 micrometers.

[0073] In any embodiment, the first duration can be from 1 second to 3 seconds.

[0074] In any embodiment, the first duration may begin when the distal tip of the distal portion of the core wire contacts the proximal cap of the calcified vascular occlusion in the blood vessel and the excitation signal is delivered to the ultrasound transducer.

[0075] In any embodiment, during the first duration, the distal tip of the core wire can penetrate the calcified vascular occlusion.

[0076] In any embodiment, during the second duration, the distal portion of the core wire can disrupt the calcified vascular occlusion.

[0077] In some of these embodiments, the amplitude of the macroscopic motion electrical signal can be increased based on the slope profile.

[0078] In another form, the present invention relates to a method of operating an ultrasonic conduit coupled to an ultrasonic energy source, the ultrasonic conduit having a core wire coupled to an ultrasonic transducer, and the ultrasonic transducer being coupled to an ultrasonic energy source, optionally an ultrasonic system of any of the preceding paragraphs

[0057] to

[0066] . The method may include providing an engagement mode in which the ultrasonic energy source generates an ultrasonic electrical signal having an ultrasonic frequency, wherein the engagement mode can be achieved by adjusting the output energy level of the ultrasonic energy source to a first output energy level to achieve substantially only longitudinal vibrational motion of the distal portion of the core wire; providing a transverse mode in which the output energy level of the ultrasonic energy source increases from the first output energy level to a second output energy level above the first output energy level to achieve a combination of longitudinal vibrational motion and transverse vibrational motion of the distal portion of the core wire; operating the ultrasonic conduit in the engagement mode for a first duration; and operating the ultrasonic conduit in the transverse mode for a second duration after the first duration of the engagement mode.

[0079] In any embodiment, in transverse mode, the output energy level of the ultrasonic energy source is increased from a first output energy level to a second output energy level by amplitude modulation of the ultrasonic electrical signal using an optional macroscopic motion electrical signal, wherein the macroscopic motion electrical signal has a frequency at least 350 times smaller than the ultrasonic frequency of the ultrasonic electrical signal.

[0080] In any embodiment, in the transverse mode, the amount of transverse vibrational motion increases with the increase of the output energy level, and the transition from the first output energy level to the second output energy level can be based on the ramp profile.

[0081] In some of these embodiments, the amplitude of the macroscopic motion electrical signal can be increased based on the slope profile.

[0082] In some embodiments, the amplitude of the macroscopic motion electrical signal can be increased according to the ramp profile to increase the output energy level of the ultrasonic energy source from a first output energy level to a second output energy level.

[0083] In some embodiments, the method may include continuing longitudinal vibrational motion of the distal portion of the core wire at a first output energy level for a first duration to anchor the distal tip of the core wire in a closure proximal cap; increasing the output energy level according to a predetermined ramp profile during a second duration to generate a combination of longitudinal and lateral vibrational motion of the distal portion of the core wire, the amount of lateral vibrational motion increasing with the increase of the output energy level, and the ramp profile being defined by the first and second output energy levels; and continuing the combination of longitudinal and lateral vibrational motion of the distal portion of the core wire at a second output energy level for the remainder of the second duration, wherein the second duration may be a variable time.

[0084] In any embodiment, the first duration may be in the range of 1.0 to 3.0 seconds.

[0085] In some embodiments, the first duration may be 1.75 seconds.

[0086] As used herein, “substantially,” “generally speaking,” and other degree terms are relative modifiers intended to indicate permissible variations in the characteristic so modified. For example, unless otherwise stated, the term “substantially” refers to a physical or functional characteristic that is close to or approximates its modification. Moreover, as used herein, the specified range of “X to Y” includes the X and Y boundaries of that range.

[0087] While the invention has been described with respect to at least one embodiment, further modifications may be made to the invention within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or adaptations of the invention using its general principles. Furthermore, this application is intended to cover any deviations from this disclosure that fall within the known or conventional practices of the field to which this invention pertains and are limited by the appended claims.

Claims

1. An ultrasound system, comprising: An ultrasonic device having an ultrasonic transducer, and a core wire having a proximal end and a distal end terminating at a distal tip, the proximal end being coupled to the ultrasonic transducer; An ultrasonic energy source, electrically connected to an ultrasonic transducer, includes: An ultrasonic signal generator circuit is configured to generate a first ultrasonic electrical signal having a first ultrasonic frequency. as well as A modulator circuit is configured to amplitude modulate a first ultrasonic electrical signal with a macroscopic motion electrical signal to generate a modulated ultrasonic electrical signal, the macroscopic motion electrical signal having a frequency at least 350 times smaller than the ultrasonic frequency of the first ultrasonic electrical signal; and The controller is communicatively coupled to the ultrasound energy source and is configured to execute program instructions that select between an engagement mode that outputs a first ultrasound electrical signal to anchor the distal tip in a vascular occlusion and a transverse mode that outputs a modulated ultrasound electrical signal to disrupt the vascular occlusion.

2. The ultrasound system of claim 1, comprising a sheath having a sheath cavity, wherein the core wire is located in the sheath cavity of the sheath and extends longitudinally therein.

3. The ultrasound system of claim 2, wherein the distal portion of the core wire extends from the distal end of the sheath.

4. The ultrasonic system according to any one of claims 1 to 3, wherein in the engagement mode, the ultrasonic transducer establishes a continuous wave at the ultrasonic vibration frequency in the distal portion of the core wire, wherein the continuous wave generates a vibrational motion of the distal portion of the core wire that is substantially only longitudinal.

5. The ultrasonic system according to any one of claims 1 to 3, wherein in transverse mode, the ultrasonic transducer generates a modulated continuous wave that produces a vibrational motion of the distal portion of the core wire, the vibrational motion having both longitudinal and transverse vibrational motions, wherein the longitudinal vibrational motion is in the range of 20 micrometers to 40 micrometers and the transverse vibrational motion is in the range of 3 micrometers to 10 micrometers.

6. The ultrasonic system according to any one of claims 1 to 3, wherein the frequency of the first ultrasonic electrical signal is in the range of 20 kHz to 40 kHz and the frequency of the macroscopic motion electrical signal is in the range of 1 Hz to 50 Hz.

7. The ultrasound system according to any one of claims 1 to 3, wherein the controller executes program instructions to operate in an engagement mode for a first duration and, after the first duration of the engagement mode, to operate in a transverse mode for a second duration.

8. The ultrasonic system according to any one of claims 1 to 3, wherein the introduction of macroscopic motion electrical signals causes the output energy level of the ultrasonic energy source to increase from a first output energy level to a second output energy level higher than the first output energy level.

9. The ultrasonic system of claim 8, wherein the amount of lateral vibration motion increases with increasing output energy level, and wherein the transition from the first output energy level to the second output energy level is based on a ramp profile.

10. The ultrasonic system according to any one of claims 1 to 3, wherein the amplitude of the macroscopic motion electrical signal increases according to the slope profile.

Images