Boston Scientific Scimed, Inc.

Bolt Medical, Inc.

Daniel Frank Massimini

Roger W McGowan

Laszlo Trent Farago

David Gordon Spangler

Corydon Carlson

Haiping Shao

Mark Alfred Hilse

Christopher Smuk

Daniel Lee Krautkremer

Binh C Tran

Christopher A Cook

Jeffrey S Lindquist

Douglas Dean Pagoria

Eric A Schultheis

Jeffrey Steven Fuller

Robert Rawson

Dave Parsons

Darrin Dale Beekman

Roger Mcgowan

A catheter system () for treating a treatment site () within or adjacent to a blood vessel () includes a power source (), a light guide () and a plasma target (). In various embodiments, the light guide () receives power from the power source (). The light guide () has a distal tip (), and the light guide () emits light energy () in a direction away from the distal tip (). The plasma target () is spaced apart from the distal tip () of the light guide () by a target gap distance (). The plasma target () is configured to receive light energy () from the light guide () so that a plasma bubble () is generated at the plasma target (). The power source () can be a laser and the light guide () can be an optical fiber. The catheter system () can also an inflatable balloon () that encircles the distal tip () of the light guide (). The plasma target () can be positioned within the inflatable balloon (). The plasma target () can have a target face () that receives the light energy () from the light guide (). The plasma target () can be formed from one or more of tungsten, tantalum, platinum, molybdenum, niobium, iridium, magnesium oxide, beryllium oxide, tungsten carbide, titanium nitride, titanium carbonitride and titanium carbide.

Breakdown of laser pulse energy for breakup of vascular calcium

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.

Atherectomy system with guidewire detection

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. The first light guide is in optical communication with a light source and the fortified balloon inflation fluid. The light source provides sub-millisecond pulses of a light to the first light guide so that plasma formation and rapid bubble formation occur in the fortified balloon inflation fluid, thereby imparting pressure waves upon the treatment site.

Fortified balloon inflation fluid for plasma system to disrupt vascular lesions

A catheter system () for treating a treatment site () within or adjacent to the vessel wall of a blood vessel (), or the heart valve, includes an energy source (), a balloon (), an energy guide (A), and a balloon integrity protection system (). The energy source () generates energy. The balloon () is positionable substantially adjacent to the treatment site (). The balloon () has a balloon wall () that defines a balloon interior (). The balloon () is configured to retain a balloon fluid () within the balloon interior (). The energy guide (A) is configured to receive energy from the energy source () and guide the energy into the balloon interior () so that plasma is formed in the balloon fluid () within the balloon interior (). The balloon integrity protection system () is operatively coupled to the balloon (). The balloon integrity protection system () is configured to inhibit rupture of the balloon () due to the plasma formed in the balloon fluid () within the balloon interior () during use of the catheter system ().

System and method for maintaining balloon integrity within intravascular lithotripsy device with plasma generator

A catheter system for pressure wave and inertial impulse generation for intravascular lesion disruption at a treatment site includes a catheter including an elongate shaft and balloon coupled to the elongate shaft. The catheter system includes a light guide disposed along the elongate shaft and at least partially within the balloon, where the light guide is in optical communication with a light source and a balloon fluid. The catheter can include a first focusing element located at a distal portion of the light guide and in optical communication with the light source. The first focusing element can direct light from within the light guide to a first location at a first distance away from the distal portion of the light guide to initiate plasma formation in the balloon fluid away from the distal portion and to cause rapid bubble formation, thereby imparting pressure waves at the treatment site.

Focusing element for plasma system to disrupt vascular lesions

An atherectomy system includes a drive mechanism adapted to rotatably actuate an atherectomy burr and a controller that is adapted to operate the drive mechanism in a first operating mode in which the atherectomy burr is operated at a speed reference and with a predetermined torque limit. The controller is adapted to determine when the atherectomy burr becomes stuck while in the first operating mode and is further adapted to, when the atherectomy burr becomes stuck, operate the drive mechanism in a second operating mode that is different from the first operating mode.

Atherectomy system adapted to free a stuck atherectomy burr

A catheter system () for placement within a treatment site () at a vessel wall (A) or a heart valve includes an energy source (), a balloon (), an energy guide (A), and a tissue identification system (). The energy source () generates energy. The balloon () is positionable substantially adjacent to the treatment site (). The balloon () has a balloon wall () that defines a balloon interior (). The balloon () is configured to retain a balloon fluid () within the balloon interior (). The energy guide (A) is configured to receive energy from the energy source () and guide the energy into the balloon interior () so that plasma is formed in the balloon fluid () within the balloon interior (). The tissue identification system () is configured to spectroscopically analyze tissue within the treatment site (). A method for treating a treatment site () within or adjacent to a vessel wall (A) or a heart valve can utilize any of the catheter systems () described herein.

Spectroscopic tissue identification for balloon intravascular lithotripsy guidance

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.

Light guide protection structures for plasma system to disrupt vascular lesions

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).

Gearbox for atherectomy system

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.

Propulsion system for inertial energy transfer to disrupt vascular lesions

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.

Atherectomy motor control system with tactile feedback

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.

Balloon surface photoacoustic pressure wave generation to disrupt vascular lesions

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.

Atherectomy motor control system

A catheter system for treating a treatment site within or adjacent to a blood vessel includes a power source, a light guide and a plasma target. In various embodiments, the light guide receives power from the power source. The light guide has a distal tip, and the light guide emits light energy in a direction away from the distal tip. The plasma target is spaced apart from the distal tip of the light guide by a target gap distance. The plasma target is configured to receive light energy from the light guide so that a plasma bubble is generated at the plasma target. The power source can be a laser and the light guide can be an optical fiber. In certain embodiments, the catheter system can also an inflatable balloon that encircles the distal tip of the light guide. The plasma target can be positioned within the inflatable balloon. The target gap distance can be greater than 1 &#x3bc;m. The plasma target can have a target face that receives the light energy from the light guide. The target face can be angled relative to a direction the light energy is emitted to the plasma target. The plasma target can be formed from one or more of tungsten, tantalum, platinum, molybdenum, niobium, iridium, magnesium oxide, beryllium oxide, tungsten carbide, titanium nitride, titanium carbonitride and titanium carbide.

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Brooklyn Park, MN, United States of America

Daniel Frank Massimini