Abstract: Embodiments herein relate to systems and methods for intravascular lesion disruption. In an embodiment, a catheter system for imparting pressure to induce fractures upon a vascular lesion within or adjacent a blood vessel wall is included. The system includes a catheter configured to advance to a vascular lesion, the catheter including an elongate shaft that defines at least a first orifice for fluid flow; a balloon, coupled to the elongate shaft, that surrounds the first orifice where the balloon can expand from a collapsed configuration suitable for advancing the catheter through a patient's vasculature to a first expanded configuration suitable for anchoring the catheter in position relative to a treatment site; and a propulsion system configured to propel a fluid from the first orifice toward the balloon wall to create an inertial impulse in a vessel wall to transfer momentum to the vascular lesion. Other embodiments are also included herein.

Abstract: An atherectomy system includes a handle having a handle housing, with a drive member extending through the handle housing and operably coupled to an atherectomy burr. A drive mechanism is disposed within the handle housing and is adapted to rotatably engage the drive member. The drive mechanism may include an electric drive motor, a drive gear that is rotatably engaged with the electric drive motor and a driven gear that is coupled with the drive member and is engaged with the drive gear such that rotation of the driven gear causes rotation of the drive member. The drive mechanism may be configured to enable a rotation speed of the atherectomy burr of up to at least about 200,000 revolutions per minute (rpm).

Abstract: An atherectomy system includes a handle and a drive motor that is adapted to rotate a drive cable extending through the handle and operably coupled to an atherectomy burr. A control system is adapted to regulate operation of the drive motor, including providing the drive motor with a high frequency pulse width modulation (PWM) drive signal in order to operate the drive motor. The control system monitors a motor performance parameter such as motor speed or motor torque, and when the motor performance parameter approaches a limit of a performance range, the control system adds a low frequency PWM signal to the high frequency PWM drive signal, thereby causing the drive motor to produce a tactile signal that signals to the user that the motor performance parameter is approaching the limit of the performance range.

Abstract: A photoacoustic catheter adapted for placement within a blood vessel having a vessel wall includes an elongate shaft, a balloon and a photoacoustic transducer. The elongate shaft can extend from a proximal region to a distal region. The elongate shaft can include a light guide that is configured to be placed in optical communication with a light source. The balloon is coupled to the elongate shaft, and can be configured to expand from a collapsed configuration suitable for advancing the photoacoustic catheter through a patient's vasculature to a first expanded configuration suitable for anchoring the photoacoustic catheter in position relative to a treatment site. The photoacoustic transducer can be disposed on a surface of the balloon and in optical communication with the light guide. The photoacoustic transducer can include a light-absorbing material and a thermal expansion material.

Abstract: A catheter system for imparting pressure to induce fractures at a treatment site within or adjacent a blood vessel wall includes a catheter, a fortified balloon inflation fluid and a first light guide. The catheter includes an elongate shaft and a balloon that is coupled to the elongate shaft. The balloon has a balloon wall and can expand to a first expanded configuration to anchor the catheter in position relative. The fortified balloon inflation fluid can expand the balloon to the first expanded configuration. The fortified balloon inflation fluid includes a base inflation fluid and a fortification component. The fortification component reduces a threshold for inducing plasma formation in the fortified balloon inflation fluid compared to the base inflation fluid. The fortification component can include at least one of carbon and iron. The first light guide is disposed along the elongate shaft and is positioned at least partially within the balloon.

Abstract: A photoacoustic catheter adapted for placement within a blood vessel having a vessel wall includes an elongate shaft, a balloon and a photoacoustic transducer. The elongate shaft can extend from a proximal region to a distal region. The elongate shaft can include a light guide that is configured to be placed in optical communication with a light source. The balloon is coupled to the elongate shaft, and can be configured to expand from a collapsed configuration suitable for advancing the photoacoustic catheter through a patient's vasculature to a first expanded configuration suitable for anchoring the photoacoustic catheter in position relative to a treatment site. The photoacoustic transducer can be disposed on a surface of the balloon and in optical communication with the light guide. The photoacoustic transducer can include a light-absorbing material and a thermal expansion material.

Abstract: The present disclosure provides apparatus and methods to both infer stent expansion (vessel expansion or compliance) and probability of procedural success (vessel patency) from pretreatment diagnostic imaging at the point-of-care and also train an inference model to generate such an inference, thus allowing a physician to choose with greater certainty an optimal treatment tool and treatment protocol for treating a vessel of a patient.

Abstract: A catheter system for pressure wave and inertial impulse generation for intravascular lesion disruption includes a balloon coupled to an elongate shaft, and a first and second light guide disposed along the elongate shaft. The first and second light guides each include a diverting feature in optical communication with at least one light window to direct light to exit each light guide toward a side surface portion thereof and toward the balloon. A method includes expanding the balloon from a collapsed configuration to a first expanded configuration, and activating a light source in optical communication with each light guide to provide sub-millisecond pulses of light to the diverting features, thereby inducing plasma formation in a balloon fluid, causing rapid bubble formation, and imparting pressure waves upon the treatment site.

Abstract: An atherectomy system includes a drive mechanism that is adapted to rotatably actuate an atherectomy burr and a controller that is adapted to regulate operation of the drive mechanism. In some cases, the drive mechanism includes a drive cable that is coupled with the atherectomy burr and an electric drive motor that is adapted to rotate the drive cable. The controller is adapted to regulate operation of the electric drive motor such that the drive mechanism emulates one or more performance parameters of an air turbine.

Abstract: An atherectomy system is adapted for both anterograde ablation and retrograde ablation, and includes a drive coil and an atherectomy tool coupled to the drive coil, the atherectomy tool including a distal region adapted for anterograde ablation and a proximal region adapted for retrograde ablation. A proximal handle includes an actuation member adapted to be movable in a first direction to urge the atherectomy tool in an anterograde ablation direction and to be movable in a second direction to urge the atherectomy tool in a retrograde ablation direction. The atherectomy system is adapted such that the actuation member provides a similar feedback to a user regardless of whether the atherectomy tool is ablating in the anterograde ablation direction or in the retrograde ablation direction.

Abstract: Medical systems and methods for making and using medical systems are disclosed. Example medical systems may include an atherectomy system configured to engage and remove plaque from walls in vessels of a vascular system. The atherectomy system may include a drive shaft, a rotational member coupled to an end of the drive shaft, a motor coupled to the drive shaft to rotate the rotational tip, and a control unit configured to control a motor state of the motor. The motor may be an electric motor. The control unit may adjust the motor state to decelerate the motor in response to detecting a jam or a stall condition. The jam or stall condition may be detected when a speed of the motor or other motor state reaches or goes beyond a threshold value as prescribed by a reference schedule.

Abstract: A catheter system for imparting pressure to induce fractures in a vascular lesion within or adjacent a vessel wall, includes a catheter and a superheating system. The catheter can advance to the vascular lesion. The catheter includes an elongate shaft and a balloon coupled to the elongate shaft. The balloon includes a balloon wall. The balloon moves between a collapsed configuration and a first expanded configuration suitable for anchoring the catheter in position relative to a treatment site. The superheating system can heat a balloon fluid within the balloon rapidly enough to achieve spontaneous vaporization of the balloon fluid and to generate inertial bubbles and acoustic pressure waves. The superheating system can include a first light guide extending along the elongate shaft. The first light guide is in optical communication with a light source at a proximal portion of the first light guide.

Abstract: An atherectomy system includes a user interface that an operator engages with in order to indicate requested movement of a drive assembly. One or more sensors are adapted to ascertain one or more conditions of the drive assembly and to output one or more condition signals to a controller that is operably coupled with the operator assembly and the drive assembly. The controller is adapted to receive the request signal from the operator assembly and the one or more condition signals, to determine a command signal in response to the received request signal and the received one or more condition signals, and provide the command signal to the drive assembly. The drive assembly is adapted to move relative to the advancer assembly in accordance with the command signal.

Abstract: A photoacoustic catheter can include an elongate shaft and a first photoacoustic transducer. The elongate shaft can extend from a proximal region to a distal region and can include a first light guide that is in optical communication with a light source. The first photoacoustic transducer can be disposed within the distal region of the elongate shaft and can be in optical communication with the first light guide. The first photoacoustic transducer can impart acoustic pressure waves upon a calcified lesion to induce fractures. The first photoacoustic transducer can include a light-absorbing material and a thermal expansion material that can be in contact with one another.

Abstract: An atherectomy system includes an advancer assembly and a drive assembly that is adapted to translate relative to the advancer assembly. A control knob extends from the drive assembly such that translating the control knob results in the drive assembly translating relative to the advancer assembly. A drive shaft is operably coupled with the drive assembly, the drive shaft translating relative to the advancer assembly as the drive assembly translates relative to the advancer assembly. A feedback modifier is operably coupled between the drive assembly and the advancer assembly and is adapted to provide a user of the atherectomy system with similar feedback via the control knob regardless of whether the user is moving the drive assembly in an anterograde ablation direction or a retrograde ablation direction.

Abstract: An atherectomy system includes a drive mechanism that is adapted to rotatably actuate an atherectomy burr and a controller that is adapted to regulate operation of the drive mechanism. In some cases, the drive mechanism includes a drive cable that is coupled with the atherectomy burr and a drive motor that is adapted to rotate the drive cable. The controller is adapted to receive an indication of an increase in torque experienced at the atherectomy burr and is further adapted to, in response, regulate operation of the drive mechanism such that the increase in torque results in a noticeable reduction in speed of the drive mechanism such that a user of the atherectomy system notices the reduction in speed and is alerted to the increase in torque.

Abstract: An atherectomy system includes a drive assembly and an advancer assembly. The drive assembly, which may be reusable, includes a drive motor having an output shaft and a first coupler segment that is secured relative to the output shaft. A controller may be adapted to regulate operation of the drive motor. The advancer assembly, which may be single use, includes a flexible drive cable that is adapted to be releasably securable to the first coupler segment. The advancer assembly includes gearing that is secured within the advancer assembly and is operably coupled with the flexible drive cable. A burr catheter is coupled with and extends distally of the gearing. The advancer assembly is adapted to enable relative translation of the burr catheter in order to advance and withdraw an atherectomy burr rotatably secured to a distal end of the burr catheter.

Abstract: A catheter system includes a catheter having an elongate shaft, a balloon and a light guide. The balloon expands from a collapsed configuration to a first expanded configuration. The light guide is disposed along the elongate shaft and is in optical communication with a light source and a balloon fluid. A first portion of the light guide extends into a recess defined by the elongate shaft. A protection structure is disposed within the recess and is in contact with the first portion of the light guide. The light source provides pulses of light to the balloon fluid, thereby initiating plasma formation and rapid bubble formation within the balloon, thereby imparting pressure waves upon a vascular lesion. The protection structure can provide structural protection from the pressure waves to the first portion of the light guide.

Abstract: An atherectomy system includes a drive mechanism adapted to rotatably actuate an atherectomy burr and a controller that is adapted to regulate operation of the drive mechanism. A guidewire motion detector is adapted to detect movement of the guidewire. The controller is further adapted to take action when the guidewire motion detector detects movement of the guidewire relative to the drive mechanism while the drive mechanism is operating.

Abstract: A catheter system includes a catheter having an elongate shaft, a balloon and a light guide. The balloon expands from a collapsed configuration to a first expanded configuration. The light guide is disposed along the elongate shaft and is in optical communication with a light source and a balloon fluid. A first portion of the light guide extends into a recess defined by the elongate shaft. A protection structure is disposed within the recess and is in contact with the first portion of the light guide. The light source provides pulses of light to the balloon fluid, thereby initiating plasma formation and rapid bubble formation within the balloon, thereby imparting pressure waves upon a treatment site. The protection structure can provide structural protection from the pressure waves to the first portion of the light guide.