Ultrasonic probe assemblies and systems

Abstract

An ultrasonic probe assembly includes a handle configured for handheld use and a housing defining a chamber. A bracket is slidably coupled to the housing. The bracket has an operator arm configured for user operation to move the bracket between a first position and a second position. An ultrasonic catheter has a catheter sheath and an ultrasonic core wire. The ultrasonic catheter has a proximal end portion and a distal end portion. An ultrasonic transducer is located within the chamber of the housing. The ultrasonic transducer is connected to the proximal end portion of the ultrasonic catheter and to the bracket. The ultrasonic transducer is configured to move longitudinally within the chamber of the housing between a retracted position and an extended position in accordance with a corresponding longitudinal movement of the bracket.

Description

[0001] Cross-reference to related applications

[0002] none. Technical Field

[0003] This invention relates to an ultrasound system, and more particularly, to an ultrasound probe assembly and system for use in occlusion engagement during crossing and atherectomy procedures. Background Technology

[0004] Vascular surgeries, such as perforation procedures or plaque removal procedures, can be used to restore patency and blood flow lost due to one or more intravascular occlusions. A perforation procedure is a procedure that creates an opening by passing through the intravascular occlusion. Plaque removal procedures may include perforation but also attempt to break down and remove the intravascular occlusion. Ultrasound systems with ultrasound catheters can be used to perform both perforation and plaque removal procedures.

[0005] Intravascular occlusion can take the form of calcified vascular occlusion with rigid proximal and distal caps. During ultrasound perforation or plaque resection, the distal end of the ultrasound catheter engages the proximal cap of the calcified vascular occlusion. However, due to the rigidity of the proximal cap of the calcified vascular occlusion, the distal end of the ultrasound catheter may inadvertently bounce off the proximal cap and take a subintimal migration path into the sidewall of the vessel.

[0006] There is a need in the art for ultrasound probe assemblies and systems that can operate effectively in each of penetrating and plaque removal surgeries. Summary of the Invention

[0007] The present invention provides an ultrasound probe assembly and system that can operate effectively in each of penetrating and plaque removal surgeries.

[0008] This invention relates to an ultrasonic probe assembly and system comprising a handle configured for handheld use. The handle includes a housing defining a chamber. A bracket is slidably coupled to the housing within the chamber. The bracket is configured to move longitudinally along the housing between the first and second positions. The bracket has an operator arm configured to be operated by a user to move the bracket between the first and second positions. An ultrasonic catheter has a catheter sheath and an ultrasonic core wire. The ultrasonic catheter has a proximal end portion and a distal end portion. An ultrasonic transducer is located within the chamber of the housing. The ultrasonic transducer is connected to the proximal end portion of the ultrasonic catheter and to the bracket. The ultrasonic transducer is configured to move longitudinally within the chamber of the housing between a retracted position and an extended position in accordance with the corresponding longitudinal movement of the bracket.

[0009] The ultrasound catheter can be selectively operable in both a perforation mode and a plaque resection mode. In some embodiments, the system may further include a control mechanism configured such that, in the perforation mode, the control mechanism induces operation of the ultrasound transducer when the transducer moves proximally or distally between a retracted position and an extended position, and in the plaque resection mode, the control mechanism is configured to restrict operation of the ultrasound transducer if the transducer moves distally toward the extended position.

[0010] One advantage of this invention is that the junction of the ultrasonic catheter can move back and forth through the movement of the bracket and transducer, while the handle of the ultrasonic probe assembly is stationary relative to the patient, thereby providing more user control over the advancement and retraction of the junction of the ultrasonic catheter during surgery.

[0011] Another advantage of the present invention is that, based on the position of the bracket and transducer within the housing of the ultrasonic probe assembly, the through-mode and plaque removal modes can be functionally separated and distinguished. Attached Figure Description

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

[0013] Figure 1 This is a schematic diagram of the ultrasonic system of the present invention, wherein the sliding bracket and transducer of the ultrasonic probe assembly are in the retracted position.

[0014] Figure 2 It is along Figure 1 The line 2-2 cut Figure 1 A cross-sectional view of the distal portion of an ultrasonic catheter;

[0015] Figure 3 yes Figure 1 A schematic diagram of a portion of an ultrasonic system, in which the sliding bracket and transducer of the ultrasonic probe assembly are in an extended position.

[0016] Figure 4 yes Figure 1 and Figure 3 A block diagram of the control mechanism of the ultrasonic system; and

[0017] Figure 5 This is a schematic diagram of a catheter slider that is attached to the catheter sheath to allow the catheter sheath of the ultrasonic catheter to move relative to the ultrasonic core wire.

[0018] The corresponding reference numerals in these views indicate the corresponding parts. The examples listed herein illustrate at least one embodiment of the invention, and these examples should not be construed as limiting the scope of the invention in any way. Detailed Implementation

[0019] Now refer to the attached diagram, and more specifically to... Figure 1 An ultrasound system 10 according to an embodiment of the present invention is shown. The ultrasound system 10 can be selectively operated in both a through-mode and a plaque resection mode.

[0020] The ultrasonic system 10 includes an ultrasonic signal generator 12 and an ultrasonic probe assembly 14. The ultrasonic signal generator 12 is communicatively coupled to the ultrasonic probe assembly 14 via a multi-core cable 16. As is known in the art, the ultrasonic signal generator 12 is configured to generate an electrical excitation signal for transmission to the ultrasonic probe assembly 14 via the multi-core cable 16. The electrical excitation signal may have an excitation frequency, for example, in the frequency range of 20 kHz to 40 kHz.

[0021] In this embodiment, the ultrasonic signal generator 12 is configured to generate, for example, an electrical excitation signal of 20 kHz, having a first output power when operating in a punch-through mode and a second output power when operating in a plaque excision mode, wherein the second output power is greater than the first output power. The ultrasonic signal generator 12 selectively supplies the electrical excitation signal (e.g., at one of the first and second output powers) to the ultrasonic probe assembly 14 to operate the ultrasonic probe assembly 14 in a selected one of the punch-through and plaque excision modes. The change in the output power of the electrical excitation signal can be achieved by changing one or more of the output current, voltage, duty cycle, waveform, and / or frequency of the electrical excitation signal.

[0022] The ultrasonic probe assembly 14 includes a handle 18 configured for handheld use by a user. The handle 18 includes a housing 20 defining a chamber 20-1. The ultrasonic probe assembly 14 also includes a bracket 22, an ultrasonic transducer 24, and an ultrasonic conduit 26.

[0023] The ultrasonic conduit 26 includes a conduit sheath 28 and an ultrasonic core wire 30. The ultrasonic conduit 26 has a proximal end portion 26-1 and a distal end portion 26-2. The conduit sheath 28 has a proximal sheath end 28-1 and a distal sheath end 28-2. The proximal sheath end 28-1 can, for example, be connected to the housing structure of the ultrasonic transducer 24.

[0024] refer to Figure 1 and Figure 2The ultrasonic core wire 30 has a proximal end 30-1 and a junction end 30-2. The ultrasonic core wire 30 is a long, flexible metallic wire, such as nitinol, which is located within and extends longitudinally within the conduit sheath 28. In this embodiment, the ultrasonic core wire 30 may have a length greater than 60 centimeters (cm), and in some embodiments, a length of 100 to 200 centimeters. The proximal end 30-1 of the ultrasonic core wire 30 is operatively connected, for example, via a horn 32 and / or an acoustic connector 34, to an ultrasonic transducer 24 to receive vibrational energy from the ultrasonic transducer 24, thereby generating vibrational motion of the ultrasonic core wire 30. The vibrational motion of the ultrasonic core wire 30 may be longitudinal vibration or a combination of longitudinal and transverse vibration, depending on the operating mode.

[0025] Based on the power level of the electrically excited signal generated by the ultrasonic signal generator 12 and supplied to the ultrasonic transducer 24 via the multi-core cable 16, the ultrasonic transducer 24 can selectively operate in both a pass-through mode and a patch removal mode. In this embodiment, the ultrasonic signal generator 12 is configured to selectively supply one of a first electrically excited signal and a second electrically excited signal to the ultrasonic transducer 24. In the pass-through mode, the electrically excited signal supplied by the ultrasonic signal generator 12 is at a first output power, and consequently, the ultrasonic transducer 24 supplies vibrational energy to the ultrasonic core wire 30 at a first ultrasonic energy level, resulting in the ultrasonic core wire 30 undergoing substantially only longitudinal vibrational motion. In the patch removal mode, the electrically excited signal supplied by the ultrasonic signal generator 12 is at a second output power, and consequently, the ultrasonic transducer 24 supplies vibrational energy to the ultrasonic core wire 30 at a second ultrasonic energy level greater than the first ultrasonic energy level, resulting in the ultrasonic core wire 30 undergoing both lateral and longitudinal vibrational motion.

[0026] refer to Figure 1 and Figure 3 The bracket 22 is slidably coupled to the housing 20, for example, via a linear guide device (e.g., a track guide or channel guide formed in the housing 20), to receive a corresponding slidable element (e.g., a pin or roller) of the bracket 22. The bracket 22 is configured to move longitudinally within the chamber 20-1 along the housing 20 between a first position 36 and a second position 38 in a proximal direction 40 or a distal direction 42. The bracket 22 has an operator arm 22-1 configured to be operable by a user to move the bracket 22 between the first position 36 and the second position 38. More specifically, the operator arm 22-1 can extend through a slot 20-2 in the housing 20, such that a portion of the operator arm 22-1 is exposed outside the handle 18.

[0027] The ultrasonic transducer 24 is located in the chamber 20-1 of the housing 20 and is connected to the bracket 22 such that the bracket 22 and the ultrasonic transducer 24 move longitudinally in unison within the chamber 20-1 of the housing 20. In other words, the ultrasonic transducer 24 is configured to be in a retracted position 44 relative to the housing 20 within the chamber 20-1 in unison with respect to the housing 20, in accordance with the corresponding longitudinal movement of the bracket 22. Figure 1 ) and stretch position 46 ( Figure 3 The longitudinal movement between the bracket 22 and the ultrasonic transducer 24 is thus accommodated. Therefore, a buffer portion is provided within the housing 20 in the multi-core cable 16 to accommodate the movement of the bracket 22 and the ultrasonic transducer 24. Note that the retracted position 44 of the ultrasonic transducer 24 corresponds to the first position 36 of the bracket 22, and the extended position 46 of the ultrasonic transducer 24 corresponds to the second position 38 of the bracket 22.

[0028] Since the ultrasonic transducer 24 is connected to the proximal end portion 26-1 of the ultrasonic conduit 26, the ultrasonic conduit 26 moves in unison with the longitudinal movement of the ultrasonic transducer 24. In other words, according to one aspect of the invention, the combination of the bracket 22, the ultrasonic transducer 24, and the ultrasonic conduit 26 can be longitudinally moved relative to the housing 20 of the handle 18 by the longitudinal displacement of the operator arm 22-1 relative to the housing 20.

[0029] During operation, the operator arm 22-1 of the bracket 22 can be slidably operated, for example, by the user's thumb or forefinger, to allow movement of the bracket 22 and the ultrasonic transducer 24 within the chamber 20-1 of the housing 20 of the ultrasonic probe assembly 14. This movement of the bracket 22 and the ultrasonic transducer 24 translates into corresponding movement of the engagement end 30-2 of the ultrasonic core wire 30 of the ultrasonic catheter 26. Therefore, the catheter sheath 28 of the ultrasonic catheter 26 and the engagement end 30-2 of the ultrasonic core wire 30 can move back and forth via the movement of the bracket 22 and the ultrasonic transducer 24, while the handle 18 of the ultrasonic probe assembly 14 remains stationary relative to the patient, thus providing greater user control over the advance and retraction of the engagement end 30-2 of the ultrasonic core wire 30 of the ultrasonic catheter 26 during the procedure.

[0030] Reference Figure 4The ultrasonic probe assembly 14 further includes, wholly or partially, a control mechanism 48, such as control circuitry, configured to control the operation of the ultrasonic transducer 24 based on the position, such as direction of movement, of the bracket 22 and the ultrasonic transducer 24 in each of the through-path mode and the plaque removal mode. More specifically, in the through-path mode, the control mechanism 48 causes the operation of the ultrasonic transducer 24, and consequently the operation of the ultrasonic catheter 26, when the ultrasonic transducer 24 moves along the proximal direction 40 or the distal direction 42 between the retracted position 44 and the extended position 46. Furthermore, in the plaque removal mode, if the ultrasonic transducer 24 (and the bracket 22) attempts to move along the distal direction 42 toward the extended position 46, the control mechanism 48 is configured to restrict the operation of the ultrasonic transducer 24.

[0031] For example, to limit the operation of the ultrasonic transducer 24 in plaque removal mode, if an attempt is made to move in the distal direction 42, an electrical solution could be, for example, reducing or cutting off the power supply to the ultrasonic transducer 24. Alternatively, a mechanical solution to limit the operation of the ultrasonic transducer 24 in plaque removal mode could be providing a mechanical stop in the housing 20 that allows the bracket 22 and the ultrasonic transducer 24 to move only in the proximal direction 40 when operating in plaque removal mode.

[0032] Combination Figure 1 and Figure 3 refer to Figure 4 In one embodiment of the electrical solution for limiting the operation of the ultrasonic transducer 24, the control mechanism 48 includes a first button 50, a second button 52, a sensor 54, and a control circuit 56.

[0033] The first button 50 and the second button 52 can be included within and attached to the housing 20 of the ultrasonic probe assembly 14. The first button 50 and the second button 52 can be, for example, corresponding buttons, selector switches, slide switches, or input icons on the ultrasonic probe assembly 14. Alternatively, or as a supplement to the above, the first button 50 and the second button 52 can be integrated into the user interface display 60 (see...). Figure 1 In this configuration, the user interface display is separate from the ultrasonic probe assembly 14, but is communicatively connected to the ultrasonic probe assembly.

[0034] A first button 50 is actuated by the user to select a pass-through mode, and a second button 52 is actuated by the user to select a plaque removal mode. An ultrasonic signal generator 12 is communicatively connected to each of the first button 50 and the second button 52, for example, via a multi-core cable 16. When the first button 50 is actuated, in association with the pass-through mode, the ultrasonic signal generator 12 generates an electrical excitation signal with a first output power. When the second button 52 is actuated, in association with the plaque removal mode, the ultrasonic signal generator 12 generates an electrical excitation signal with a second output power.

[0035] Sensor 54 is configured to detect the direction of movement of ultrasonic transducer 24 within chamber 20-1 of housing 20. Sensor 54 may be, for example, a proximity sensor or a sliding rheostat. More specifically, in this embodiment, sensor 54 is located within housing 20 to detect the direction of movement of bracket 22, and consequently, the direction of movement of ultrasonic transducer 24.

[0036] Control circuitry 56 is communicatively connected to sensor 54 and ultrasonic signal generator 12. If, in plaque removal mode (second button 52 is actuated), sensor 54 detects distal movement of ultrasonic transducer 24, control circuitry 56 can be configured to cut off the electrical excitation signal from ultrasonic transducer 24. Figure 4 In the example of the second button 52 of the control mechanism 48 shown, the sensor output of the sensor 54 and the button output of the second button 52 serve as inputs to an AND gate 58, the output of which is connected to a control circuit 56, such as a normally closed switch. Therefore, if the second button 52 is actuated and the sensor 54 detects movement of the ultrasonic transducer 24 in the distal direction 42, the output of the AND gate 58 changes the operating state of the control circuit 56 to the open state, thereby removing the electrical excitation signal from the ultrasonic transducer 24. Alternatively, it is conceivable that the AND gate 58 and the normally closed switch of the control circuit 56 can be replaced by a NAND gate and a normally closed switch.

[0037] In one embodiment, control circuitry 56 may be configured as a cut-off switch located within ultrasonic transducer 12, which disables operation of ultrasonic transducer 12 in plaque removal mode (when second button 52 is actuated) if sensor 54 detects distal movement 42 of ultrasonic transducer 24 within chamber 20-1 of housing 20. In an alternative embodiment, control circuitry 56 may be configured as a cut-off switch located at the electrical input of ultrasonic transducer 24, which disables operation of ultrasonic transducer 24 in plaque removal mode (when second button 52 is actuated) if sensor 54 detects distal movement 42 of ultrasonic transducer 24 within chamber 20-1 of housing 20.

[0038] Optionally, the control circuit 56 may be further configured to send a warning, for example, to publish the following message on the user interface display 60, namely, that the electrical excitation signal has been cut off from the ultrasonic transducer 24 during plaque removal mode due to the distal advancement of the junction 30-2 of the ultrasonic catheter 26, and the control circuit may further provide instructions for corrective action.

[0039] refer to Figure 5 As a supplementary feature, it is conceivable that the ultrasound system 10 may include a catheter slider 62 slidably coupled to the housing 20. The catheter slider 62 is connected to the catheter sheath 28 to allow movement of the catheter sheath 28 relative to the ultrasound core wire 30. In a through-mode, the catheter slider 62 may be positioned such that the junction end 30-2 of the ultrasound core wire 30 is a first distance 64 from the distal sheath end 28-2 of the catheter sheath 28 (e.g., fully retracted). In a plaque resection mode, the catheter slider 62 may be positioned such that the junction end 30-2 of the ultrasound core wire 30 is a second distance 66 from the distal sheath end 28-2 of the catheter sheath 28, for example, in a fully extended position, to expose more of the distal portion of the ultrasound core wire 30.

[0040] The following matters are also related to this invention:

[0041] In one embodiment, the present invention relates to an ultrasonic probe assembly for use in an ultrasonic system, which may include a handle, a bracket, an ultrasonic conduit, and an ultrasonic transducer. The handle is configured for handheld use and includes a housing defining a chamber. The bracket is slidably coupled to the housing within the chamber. The bracket is configured to move longitudinally along the housing between a first position and a second position. The bracket may have an operator arm configured to be operated by a user to move the bracket between the first and second positions. The ultrasonic conduit has a conduit sheath and an ultrasonic core wire. The ultrasonic conduit has a proximal end portion and a distal end portion. The ultrasonic transducer is located within the chamber of the housing. The ultrasonic transducer is connected to the proximal end portion of the ultrasonic conduit and to the bracket. The ultrasonic transducer is configured to move longitudinally within the chamber of the housing between a retracted position and an extended position in accordance with a corresponding longitudinal movement of the bracket.

[0042] According to any embodiment, the ultrasonic conduit can be configured to move in sync with the longitudinal movement of the ultrasonic transducer.

[0043] In some embodiments, the ultrasound catheter may be selectively operable in both a perforation mode and a plaque resection mode. Optionally, such embodiments may further include a control mechanism configured such that, in the perforation mode, the control mechanism induces operation of the ultrasound transducer when the transducer moves proximally or distally between a retracted position and an extended position, and in the plaque resection mode, the control mechanism is configured to restrict operation of the ultrasound transducer if the transducer moves distally toward the extended position.

[0044] In an embodiment that can selectively operate in both a punch-through mode and a plaque removal mode, the ultrasonic transducer / ultrasonic probe assembly can be configured to supply vibrational energy to the ultrasonic core wire at a first ultrasonic energy level in the punch-through mode and to supply vibrational energy to the ultrasonic core wire at a second ultrasonic energy level greater than the first ultrasonic energy level in the plaque removal mode.

[0045] In the embodiments described in the preceding paragraph, the ultrasonic transducer / ultrasonic probe assembly can be configured such that the vibrational energy supplied to the ultrasonic core wire at the second ultrasonic energy level can cause both longitudinal and transverse vibrations of the ultrasonic core wire.

[0046] In embodiments including a control mechanism, the control mechanism may include a sensor and control circuitry. The sensor may be located within the housing of the handle. The sensor is configured to detect the direction of motion of the ultrasonic transducer within the chamber of the housing. The control circuitry is communicatively coupled to the sensor and an ultrasonic signal generator. The control circuitry is configured to, in plaque removal mode, disable operation of the ultrasonic catheter if the sensor detects distal movement of the ultrasonic transducer within the chamber of the housing.

[0047] In embodiments that include sensors, the sensors may optionally be located within the housing to detect the direction of movement of the bracket.

[0048] In some embodiments, the catheter sheath has a distal sheath end and the ultrasonic core wire has a mating end, wherein optionally, the mating end is movable relative to the distal sheath end.

[0049] In the embodiments described in the preceding paragraph, the ultrasound probe assembly may optionally include a catheter slider attached to the catheter sheath. The catheter slider may be configured to move the catheter sheath from its original position, wherein the junction end of the ultrasound core is positioned at a first distance from the distal sheath end of the catheter sheath in a through-mode, and the catheter slider may be configured to position the junction end of the ultrasound core at a second distance from the distal sheath end of the catheter sheath in a plaque resection mode, wherein the second distance is greater than the first distance.

[0050] In any of the foregoing embodiments, the ultrasonic transducer may be configured to receive an electrical excitation signal from an ultrasonic signal generator.

[0051] In another form, the invention relates to an ultrasonic system that may include an ultrasonic signal generator and an ultrasonic probe assembly, the ultrasonic probe assembly optionally being any of the ultrasonic probe assemblies described in any of the preceding paragraphs

[0040] to

[0049] . The ultrasonic probe assembly is communicatively coupled to the ultrasonic signal generator. The ultrasonic probe assembly may include a handle, a bracket, an ultrasonic conduit, and an ultrasonic transducer. The handle is configured for handheld use. The handle includes a housing defining a chamber. The bracket is slidably coupled to the housing within the chamber. The bracket is configured to move longitudinally along the housing between a first position and a second position. The bracket may have an operator arm configured to be operable by a user to move the bracket between the first and second positions. The ultrasonic conduit has a conduit sheath and an ultrasonic core wire. The ultrasonic conduit has a proximal end portion and a distal end portion. The ultrasonic transducer is located within the chamber of the housing. The ultrasonic transducer is connected to the proximal end portion of the ultrasonic conduit and to the bracket. The ultrasonic transducer is configured to move longitudinally within the cavity of the housing between a retracted position and an extended position in accordance with the corresponding longitudinal movement of the bracket.

[0052] According to any embodiment, the ultrasonic system can be configured such that the longitudinal movement of the ultrasonic duct and the ultrasonic transducer are synchronized.

[0053] In some embodiments, the ultrasound system may be selectively operable in both a through-mode and a plaque excision mode. In such embodiments, the ultrasound system may further include a control mechanism configured such that, in the through-mode, the control mechanism induces operation of the ultrasound transducer when the transducer moves between a retracted position and an extended position in a proximal or distal direction, and in the plaque excision mode, the control mechanism is configured to restrict operation of the ultrasound transducer if the transducer moves toward the extended position in a distal direction.

[0054] In an embodiment that can selectively operate in both a punch-through mode and a plaque removal mode, the ultrasonic system can be configured such that, in the punch-through mode, the ultrasonic transducer supplies vibrational energy to the ultrasonic core wire at a first ultrasonic energy level, and in the plaque removal mode, the ultrasonic transducer supplies vibrational energy to the ultrasonic core wire at a second ultrasonic energy level greater than the first ultrasonic energy level.

[0055] In an embodiment where operation is selectively possible in both a through-mode and a plaque excision mode, the handle may include a first button for selecting the through-mode and a second button for selecting the plaque excision mode. An ultrasonic signal generator may be communicatively coupled to each of the first and second buttons. The ultrasonic signal generator may be configured to generate an electrical excitation signal having a first output power when the through-mode is selected by actuation of the first button, and to have a second output power greater than the first output power when the plaque excision mode is selected by actuation of the second button. The ultrasonic signal generator is electrically connected to an ultrasonic transducer. The ultrasonic signal generator is configured to selectively supply an electrical excitation signal to the ultrasonic transducer. A control mechanism may include a sensor and control circuitry. The sensor may be located within the housing of the handle, wherein the sensor is configured to detect the direction of motion of the ultrasonic transducer within a cavity of the housing. The control circuitry is communicatively coupled to the sensor and the ultrasonic signal generator. The control circuitry is configured to disable operation of the ultrasonic signal generator in the plaque excision mode if the sensor detects distal motion of the ultrasonic transducer within the cavity of the housing.

[0056] In embodiments that include control circuitry, the control circuitry may optionally be configured to cut off the electrical excitation signal from the ultrasonic transducer if the sensor detects that the ultrasonic transducer is moving in a distal direction.

[0057] In embodiments that include sensors, the sensors may optionally be located within the housing to detect the direction of movement of the bracket.

[0058] In any embodiment, the catheter sheath may have a distal sheath end and the ultrasound core may have a junction end. Optionally, the ultrasound system may further include a catheter slider attached to the catheter sheath, wherein the catheter slider is configured to position the junction end of the ultrasound core at a first distance from the distal sheath end of the catheter sheath in a through-mode, and the catheter slider is configured to position the junction end of the ultrasound core at a second distance from the distal sheath end of the catheter sheath in a plaque resection mode, wherein the second distance is greater than the first distance.

[0059] As used herein, the term “substantially” and any other degree words are relative modifiers intended to indicate permissible variations from a feature so modified. Such terms are not intended to limit the absolute value of the feature they modify, but rather to have more physical or functional characteristics than the reverse, and to be close to or approximate such physical or functional characteristics.

[0060] Although 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 are known or customary in the field to which this invention pertains and fall within the limitations of the appended claims.

Claims

1. An ultrasonic probe assembly for an ultrasonic system, comprising: A handle configured for handheld use, the handle including a housing defining a chamber; A bracket slidably coupled to the housing in the chamber, the bracket being configured to move longitudinally along the housing between a first position and a second position, the bracket having an operator arm configured to be operated by a user to move the bracket between the first position and the second position; An ultrasonic catheter having a catheter sheath and an ultrasonic core wire, the ultrasonic catheter having a proximal end portion and a distal end portion; An ultrasonic transducer is located in a chamber of the housing, the ultrasonic transducer is connected to the proximal end portion of the ultrasonic conduit, and the ultrasonic transducer is connected to the bracket, wherein the ultrasonic transducer is configured to move longitudinally within the chamber of the housing between a retracted position and an extended position in accordance with a corresponding longitudinal movement of the bracket. The ultrasound catheter is selectively operable in both a perforation mode and a plaque resection mode, and the ultrasound probe assembly further includes a control mechanism configured such that, in the perforation mode, the control mechanism causes operation of the ultrasound transducer when the ultrasound transducer moves proximally or distally between the retracted position and the extended position, and in the plaque resection mode, the control mechanism is configured to restrict operation of the ultrasound transducer if the ultrasound transducer moves distally toward the extended position.

2. The ultrasonic probe assembly according to claim 1, wherein, The ultrasonic conduit moves in unison with the longitudinal movement of the ultrasonic transducer.

3. The ultrasonic probe assembly according to claim 1, wherein, The ultrasonic transducer is configured to supply vibrational energy to the ultrasonic core wire at a first ultrasonic energy level in the pass-through mode, and to supply vibrational energy to the ultrasonic core wire at a second ultrasonic energy level greater than the first ultrasonic energy level in the patch removal mode.

4. The ultrasonic probe assembly according to claim 3, wherein, The vibrational energy supplied to the ultrasonic core wire by the second ultrasonic energy level causes both longitudinal and transverse vibrations of the ultrasonic core wire.

5. The ultrasonic probe assembly according to any one of claims 1 to 4, wherein the control mechanism comprises: A sensor located within the housing of the handle, wherein the sensor is configured to detect the direction of movement of the ultrasonic transducer within the chamber of the housing; and A control circuit communicatively connected to the sensor and the ultrasonic signal generator is configured to disable operation of the ultrasonic catheter in the plaque removal mode if the sensor detects distal movement of the ultrasonic transducer within the chamber of the housing.

6. The ultrasonic probe assembly according to claim 5, wherein, The sensor is located in the housing to detect the direction of movement of the bracket.

7. The ultrasonic probe assembly according to claim 1, wherein, The catheter sheath has a distal sheath end and the ultrasonic core wire has a mating end, wherein the mating end is movable relative to the distal sheath end.

8. The ultrasonic probe assembly of claim 7, further comprising a catheter slider connected to the catheter sheath, wherein, The catheter slider is configured to move the catheter sheath from its original position, wherein the joint end of the ultrasonic core wire is positioned at a first distance from the distal sheath end of the catheter sheath in the through-through mode, and the catheter slider is configured to position the joint end of the ultrasonic core wire at a second distance from the distal sheath end of the catheter sheath in the plaque resection mode, the second distance being greater than the first distance.

9. The ultrasonic probe assembly according to claim 1, wherein, The ultrasonic transducer is configured to receive an electrical excitation signal from an ultrasonic signal generator.

10. An ultrasonic system, comprising: Ultrasonic signal generator; and An ultrasonic probe assembly communicatively connected to the ultrasonic signal generator, the ultrasonic probe assembly comprising: A handle configured for handheld use, the handle including a housing defining a chamber; A bracket slidably coupled to the housing within the chamber, the bracket being configured to move longitudinally along the housing between a first position and a second position, the bracket having an operator arm configured to be operated by a user to move the bracket between the first position and the second position; An ultrasonic catheter having a catheter sheath and an ultrasonic core wire, the ultrasonic catheter having a proximal end portion and a distal end portion; An ultrasonic transducer is located in a chamber of the housing, the ultrasonic transducer is connected to the proximal end portion of the ultrasonic conduit, and the ultrasonic transducer is connected to the bracket, wherein the ultrasonic transducer is configured to move longitudinally within the chamber of the housing between a retracted position and an extended position in accordance with a corresponding longitudinal movement of the bracket. The ultrasound system is selectively operable in both a penetration mode and a plaque excision mode, and the ultrasound system further includes a control mechanism configured such that, in the penetration mode, the control mechanism causes operation of the ultrasound transducer when the ultrasound transducer moves in a proximal or distal direction between the retracted position and the extended position, and in the plaque excision mode, the control mechanism is configured to restrict operation of the ultrasound transducer if the ultrasound transducer moves distally toward the extended position.

11. The ultrasonic system according to claim 10, wherein, The ultrasonic conduit moves in unison with the longitudinal movement of the ultrasonic transducer.

12. The ultrasonic system according to claim 10, wherein, In the pass-through mode, the ultrasonic transducer supplies vibrational energy to the ultrasonic core wire at a first ultrasonic energy level, and in the plaque removal mode, the ultrasonic transducer supplies vibrational energy to the ultrasonic core wire at a second ultrasonic energy level greater than the first ultrasonic energy level.

13. The ultrasonic system according to claim 10, wherein: The handle includes a first button for selecting the perforation mode and a second button for selecting the plaque excision mode; The ultrasonic signal generator is communicatively connected to each of the first and second buttons. The ultrasonic signal generator is configured to generate an electrical excitation signal with a first output power when the punch-through mode is selected by actuation of the first button, and to generate an electrical excitation signal with a second output power greater than the first output power when the plaque removal mode is selected by actuation of the second button. The ultrasonic signal generator is electrically connected to the ultrasonic transducer and is configured to selectively supply electrical excitation signals to the ultrasonic transducer. The control mechanism includes: A sensor located within the housing of the handle, wherein the sensor is configured to detect the direction of movement of the ultrasonic transducer within the chamber of the housing; and A control circuit communicatively connected to the sensor and the ultrasonic signal generator is configured to disable the operation of the ultrasonic signal generator in the plaque removal mode if the sensor detects distal movement of the ultrasonic transducer within the cavity of the housing.

14. The ultrasonic system according to claim 13, wherein, The control circuit is configured to cut off the electrical excitation signal from the ultrasonic transducer if the sensor detects movement of the ultrasonic transducer in the direction of the distal end.

15. The ultrasonic system according to claim 13, wherein, The sensor is located in the housing to detect the direction of movement of the bracket.

16. The ultrasonic system according to any one of claims 10 to 15, wherein, The catheter sheath has a distal sheath end and the ultrasonic core has a junction end. The ultrasonic system further includes a catheter slider connected to the catheter sheath, wherein the catheter slider is configured to position the junction end of the ultrasonic core at a first distance from the distal sheath end of the catheter sheath in the perforation mode, and the catheter slider is configured to position the junction end of the ultrasonic core at a second distance from the distal sheath end of the catheter sheath in the plaque resection mode, the second distance being greater than the first distance.

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