Bolt Medical, Inc.

Boston Scientific Scimed, Inc.

Eric A Schultheis

Christopher A Cook

Alvin Salinas

Gerald David Bacher

Alan Duong

Jeffrey S Lindquist

Eugene J Jung

Roger W McGowan

Daniel Frank Massimini

Ben Morris

Xiaoyu Yu

Yu Liu

Jeffrey Steven Fuller

Mina Mossayebi

Jesse Flores

Dave Parsons

Wenjie Xie

Nelson Lim

Thanh Tran

Rachel Lynn Troutman

James Dee Swift

Peter Dahl

A catheter system for treating a treatment site includes an energy source, a balloon, an energy guide, and a pressure sensor. The balloon is positionable substantially adjacent to the treatment site. The balloon has a balloon wall that defines a balloon interior that receives a balloon fluid. The energy source generates energy that is received by the energy guide so that the energy guide can guide the light energy into the balloon interior. The pressure sensor senses a balloon pressure of the balloon fluid. A method for disrupting calcification at the treatment site includes the steps of generating energy with an energy source, positioning a balloon substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon interior being configured to receive a balloon fluid, receiving energy from the energy source with an energy guide, guiding the energy from the energy source into the balloon interior with the energy guide; and sensing a balloon pressure of the balloon fluid with a pressure sensor.

System and method for pressure monitoring within a catheter system

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 method for treating a treatment site () within or adjacent to a heart valve () within a body of a patient includes the steps of generating energy with an energy source (); receiving energy from the energy source () with an energy guide (A); positioning a balloon assembly () adjacent to the treatment site (), the balloon assembly () including an outer balloon (B) and an inner balloon (A) that is positioned within and at least partially spaced-apart from the outer balloon (B) to define an interstitial space (A) therebetween that is configured to retain a balloon fluid (); and positioning a portion of the energy guide (A) that receives the energy from the energy source () within the interstitial space (A) between the balloons (A,B) so that a plasma-induced bubble () is formed in the balloon fluid () within the interstitial space (A).

Balloon assembly for valvuloplasty catheter system

A catheter system for treating a vascular lesion within or adjacent to a vessel wall within a body of a patient includes a single light source that generates light energy, a first light guide and a second light guide, and a multiplexer. The first light guide and the second light guide are each configured to selectively receive light energy from the light source. The multiplexer receives the light energy from the light source in the form of a source beam and selectively directs the light energy from the light source in the form of individual guide beams to each of the first light guide and the second light guide.

Multiplexer for laser-driven intravascular lithotripsy device

A catheter system () for treating a treatment site () includes an energy source (), a catheter fluid (), and an emitter assembly (). The emitter assembly () includes (i) at least a portion of an energy guide (A) having a guide distal end (D) that is positioned near the treatment site (), (ii) a plasma generator (), and (iii) an emitter housing () that is secured to the energy guide (A) and the plasma generator (). The emitter housing () includes (a) a first housing section () that is secured to the energy guide (A) at or near the guide distal end (D), (b) a second housing section () that is one of secured to and integrally formed with the plasma generator (), and (c) a connector section () that is coupled to and extends between the first housing section () and the second housing section (). The first housing section () includes a housing gap () that extends substantially along a length of the first housing section (), the first housing section () being configured to expand and contract due to changes in environmental conditions.

Optical emitter housing assembly for intravascular lithotripsy device

A catheter system for treating a treatment site within or adjacent to a blood vessel within a body of a patient, the treatment site having a proximal region and a distal region, includes an energy source, a guide shaft, and an energy guide. The energy source generates energy. The guide shaft is positionable adjacent to the treatment site. The energy guide receives energy from the energy source. The energy guide is movably coupled to the guide shaft. The energy guide includes a guide distal end that is configured to be positioned adjacent to the treatment site. The guide distal end of the energy guide is selectively movable relative to the guide shaft and adjacent to and between the proximal region and the distal region of the treatment site while the energy guide receives energy from the energy source.

Dynamic intravascular lithotripsy device with movable energy guide

A catheter system () for treating one or more treatment sites () within or adjacent to the heart valve () includes an energy source (), a plurality of energy guides (A), and a balloon assembly (). The energy source () generates energy. The plurality of energy guides (A) are configured to receive energy from the energy source (). The balloon assembly () includes a plurality of balloons (A) that are each positionable substantially adjacent to one or more treatment site(s) (). Each of the plurality of balloons (A) has a balloon wall () that defines a balloon interior (). Each of the plurality of balloons (A) is configured to retain a balloon fluid () within the balloon interior (). A portion of at least one of the plurality of energy guides (A) that receive the energy from the energy source () is positioned within the balloon interior () of each of the plurality of balloons (A) so that plasma is formed in the balloon fluid () within the balloon interior ().

Catheter system for valvuloplasty procedure

A medical device including a catheter body, a first elongate body, and a service loop ring. The catheter body has a catheter shaft. The first elongate body extends through at least part of the catheter shaft and is configured to move longitudinally in the catheter shaft. The first elongate body is looped through the service loop ring to form a service loop configured to expand and contract as the first elongate body moves longitudinally in the catheter shaft.

Service loop ring

A method for treating a treatment site within or adjacent to a vessel wall or a heart valve, includes the steps of (i) generating light energy with a light source; (ii) positioning a balloon substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior that receives a balloon fluid; (iii) receiving the light energy from the light source with a light guide at a guide proximal end; (iv) guiding the light energy with the light guide in a first direction from the guide proximal end toward a guide distal end that is positioned within the balloon interior; and (v) optically analyzing with an optical analyzer assembly light energy from the light guide, wherein the light energy that is analyzed moves in a second direction that is opposite the first direction.

Optical analyzer assembly and method for intravascular lithotripsy device

A catheter system () for treating a treatment site () within or adjacent to a vessel wall (A) of a blood vessel () within a body () of a patient () includes an energy source (), a catheter fluid (), and an emitter assembly (). The energy source () generates energy. The emitter assembly () includes (i) at least a portion of an energy guide (A) having a guide distal end (D) that is selectively positioned near the treatment site (), (ii) a plasma generator (), and (iii) an emitter housing () that is secured to each of the energy guide (A) and the plasma generator () to maintain a relative position between the guide distal end (D) of the energy guide (A) and the plasma generator (). The energy guide (A) is configured to receive energy from the energy source () and direct the energy toward the plasma generator () to generate a plasma bubble () in the catheter fluid (). The plasma generator () directs energy from the plasma bubble () toward the treatment site ().

Intravascular lithotripsy catheter

A catheter system for treating a treatment site within or adjacent to a vessel wall or a heart valve includes an energy source, a balloon, an energy guide, and an electrical analyzer assembly. 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 that receives a balloon fluid. The energy guide is configured to receive energy from the energy source and guide the energy into the balloon interior. The electrical analyzer assembly is configured to monitor a balloon condition during use of the catheter system. The electrical analyzer assembly can include a first electrode, a second electrode, and an impedance detector that is electrically coupled to the first electrode and the second electrode. The impedance detector is configured to detect impedance between the first electrode and the second electrode.

Electrical analyzer assembly for intravascular lithotripsy device

A catheter system and method for treating a treatment site within or adjacent to a vessel wall or a heart valve within a body of a patient includes an energy source, an inflatable balloon, an energy guide, and an acoustic sensor. The inflatable balloon is positionable substantially adjacent to the treatment site. The inflatable balloon has a balloon wall that defines a balloon interior that receives a balloon fluid. The energy guide receives energy from the energy source and guides the energy into the balloon interior. The acoustic sensor is positioned outside the body of the patient. The acoustic sensor senses acoustic sound waves generated in the balloon fluid within the balloon interior. The acoustic sensor generates a sensor signal based at least in part on the sensed acoustic sound waves.

Acoustic performance monitoring system and method within intravascular lithotripsy device

A catheter system () used for treating a treatment site () within or adjacent to the heart valve () includes an energy source (), an energy guide (A), and a balloon assembly (). The energy source () generates energy. The energy guide (A) is configured to receive energy from the energy source (). The balloon assembly () is positionable substantially adjacent to the treatment site (). The balloon assembly () includes an outer balloon (B) and an inner balloon (A) that is positioned substantially within the outer balloon (B). Each of the balloons (A,B) has a balloon wall () that defines a balloon interior (). Each of the balloons (A,B) is configured to retain a balloon fluid () within the balloon interior (). The balloon wall () of the inner balloon (A) is positioned spaced apart from the balloon wall () of the outer balloon (B) to define an interstitial space (A) therebetween. A portion of the energy guide (A) that receives the energy from the energy source () is positioned within the interstitial space (A) between the balloons (A,B) so that a plasma-induced bubble () is formed in the balloon fluid () within the interstitial space (A).

A catheter system for treating a treatment site within or adjacent to a vessel wall or a heart valve, includes a light source, a balloon, a light guide and an optical analyzer assembly. The light source generates first light energy. The balloon is positionable substantially adjacent to the treatment site. The balloon has a balloon wall that defines a balloon interior that receives a balloon fluid. The light guide receives the first light energy and guides the first light energy in a first direction from a guide proximal end toward a guide distal end positioned within the balloon interior. The optical analyzer assembly optically analyzes a second light energy from the light guide that moves in a second direction that is opposite the first direction. The optical analyzer assembly includes a safety shutdown system to inhibit the first light energy from being received by the guide proximal end of the light guide.

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San Clemente, CA, United States of America

Eric A Schultheis