Ultrasound-based neuromodulation system
Inventors
Taylor, Kevin • Merino, Jaime • Chandler, Paul • Raquet, Jacob • Gandionco, Isidro M. • ROTH, Austin R.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12102845-B2
Publication Date
2024-10-01
Expiration Date
Abstract
A neuromodulation system including a catheter has a balloon along its distal end. An ultrasound transducer positioned within an interior of the balloon can be selectively activated to emit acoustic energy radially outwardly, targeting nerve tissue and other portions of the subject anatomy. Targeted nerve tissue can be heated by the application of ultrasonic energy to neuromodulate the tissue. The system may be delivered over a guidewire. A catheter enhances fluid delivery to a distal end of the catheter while reducing an overall diameter of the catheter. The catheter comprises a guidewire lumen that is eccentric relative to a center axis of the catheter.
Core Innovation
The invention provides an ultrasound-based ablation system for intraluminally ablating nerve tissue. A catheter is advanced within a blood vessel to a target anatomical location, and the system includes a balloon positioned at a distal end of the catheter. An interior of the balloon is defined by a balloon wall and is in fluid communication with at least one fluid delivery lumen and at least one fluid return lumen of the catheter.
An ultrasound transducer is positioned within the interior of the balloon and is constructed as a cylindrical tube having an inner surface and an outer surface. The cylindrical tube has a length and a circumference that is substantially uniform along the length, and the inner surface and the outer surface are substantially parallel with the balloon wall. During activation, the transducer simultaneously and uniformly emits acoustic energy radially around the circumference of the cylindrical tube and along the length of the cylindrical tube to target an annular region around the outer surface of the cylindrical tube.
Cooling is achieved by circulating cooling fluid through the interior of the balloon, transferred from a first syringe pump through the at least one fluid delivery lumen to the balloon interior and transferred away through the at least one fluid return lumen to a second syringe pump. The cooling fluid is circulated adjacent to the ultrasound transducer within the balloon when the ultrasound transducer is activated, while protecting an inner wall of the blood vessel lumen using the cooling fluid. The method targets nerve tissue in an annular region a specified distance from an inner lumen of the blood vessel while maintaining a desired temperature threshold along a wall while allowing a higher temperature profile at a particular distance radially away.
The described approach is further applied to renal nerves by advancing the catheter within a renal artery to an anatomical location, with the balloon and cylindrical-tube ultrasound transducer positioned at a distal end. The annular ablation region is defined relative to an inner lumen of the renal artery, and the cooling fluid circulation protects an inner arterial wall during ultrasound activation. The cooling fluid circulation is performed at a flowrate range by syringe-pump transfer through delivery and return lumens, with the first syringe pump including a reservoir and a movable member to transfer the cooling fluid.
Claims Coverage
The partial content includes four independent claims: one directed to intraluminally ablating nerve tissue in a blood vessel, two directed to renal nerve ablation in a renal artery, and one directed to ablating/neuromodulating nerve tissue using the same balloon-contained cylindrical ultrasound transducer concept. Across the independent claims, the main inventive features are the balloon-contained cylindrical-tube ultrasound transducer emitting radially and along its length while a syringe-pump-driven circulation of cooling fluid protects the vessel wall and targets an annular region at a defined distance.
Balloon-contained cylindrical tube ultrasound transducer for radially uniform acoustic emission
An ultrasound transducer positioned within a balloon interior and constructed as a cylindrical tube having an inner surface and an outer surface, with length and circumference substantially uniform along the length, wherein the transducer simultaneously and uniformly emits acoustic energy radially around the circumference of the cylindrical tube and along the length of the cylindrical tube to target an annular region that surrounds the outer surface of the cylindrical tube.
Cooling-fluid circulation through balloon interior using delivery and return lumens with syringe pumps
Circulating cooling fluid through the interior of the balloon at a flowrate in a range of 10-25 ml/min by transferring cooling fluid from a first syringe pump through at least one fluid delivery lumen to the interior of the balloon and transferring cooling fluid away through at least one fluid return lumen to a second syringe pump, wherein the cooling fluid is circulated adjacent to the ultrasound transducer within the balloon when the ultrasound transducer is activated.
Annular-region targeting at 1 mm to 6 mm from vessel inner lumen while protecting inner wall
Activating the ultrasound transducer to ablate or neuromodulate nerve tissue in an annular region about 1 mm to 6 mm from an inner lumen of the blood vessel or renal artery by simultaneously and uniformly emitting acoustic energy radially and along the length of the cylindrical tube to target the annular region surrounding the outer surface of the cylindrical tube while protecting an inner wall using the cooling fluid.
Syringe pump reservoir with movable member for transferring cooling fluid
The first syringe pump comprises a reservoir for storing a volume of the cooling fluid and a movable member configured to move within the reservoir in order to transfer the cooling fluid through the at least one fluid delivery lumen to the interior of the balloon.
Catheter size constraint (5 French or 6 French)
The catheter is 6 French or 5 French, wherein the method advances the catheter within a blood vessel lumen to a target anatomical location and uses a balloon positioned at a distal end of the catheter.
Functional thermal behavior using desired temperature threshold at wall
Circulating the cooling fluid through the interior of the balloon maintains a desired temperature threshold along a wall of the target anatomical location while allowing a higher temperature profile at a particular distance radially away from the wall of the target anatomical location.
Across the independent claims, the core coverage is a balloon-delivered cylindrical-tube ultrasound transducer that emits uniformly radially and along its length to treat nerve tissue in an annular region at about 1 mm to 6 mm from the vessel inner lumen, with syringe-pump-driven cooling-fluid circulation through balloon delivery/return lumens to protect the inner vessel/arterial wall.
Stated Advantages
Protecting an inner wall of the blood vessel lumen or an inner arterial wall using the cooling fluid while ablating or neuromodulating nerve tissue in an annular region.
Maintaining a desired temperature threshold along a wall of the target anatomical location while allowing a higher temperature profile at a particular distance radially away from the wall.
Providing annular-region targeting by simultaneously and uniformly emitting acoustic energy radially around the circumference of the cylindrical tube and along the length of the cylindrical tube.
Documented Applications
Intraluminally ablating nerve tissue in a subject using an ultrasound-based ablation system advanced within a blood vessel to a target anatomical location.
Ablating or neuromodulating nerve tissue in a blood vessel using an ultrasound-based ablation system with a distal balloon containing a cylindrical-tube ultrasound transducer and circulating cooling fluid.
Ablating renal nerves using an ultrasound-based ablation system advanced within a renal artery to an anatomical location.
The renal ablation method is associated with treating hypertension (patient outcome stated in the provided partial claim member).
Interested in licensing this patent?