Ultrasound-based neuromodulation system

• US 10,456,605 B2
• Filed: 03/10/2014
• Issued: 10/29/2019
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Inventors: Taylor, Kevin, Merino, Jamie, Chandler, Paul, Raquet, Jacob, Gandionco, Isidro M., Roth, Austin R.
• Primary Examiner(s): Hupczey, Jr., Ronald
• Assistant Examiner(s): Blaise, Bradford C.
• Application Number:
  US14/773,285
• Publication Number:
  US 20160016016A1
• Time in Patent Office: 2,059 Days
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61N 2007/0021 Neural system treatment
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: A61N 7/022 intracavitary

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.

Claims

1. An intravascular, ultrasound-based ablation system comprising:

a catheter comprising at least one fluid lumen;

a balloon positioned at a distal end of the catheter, an interior of the balloon being in fluid communication with the at least one fluid lumen of the catheter, wherein the balloon is configured to inflate when fluid is delivered into the interior through the at least one fluid lumen of the catheter;

a tip extending distally from a distal end of the balloon;

an ultrasound transducer positioned within the balloon, the ultrasound transducer comprising a cylindrical tube extending a first length and comprising inner and outer surfaces, each of the inner and outer surfaces comprising an electrode, wherein the ultrasound transducer defines an internal space adjacent the inner surface, the internal space being in fluid communication with the interior of the balloon so that, when in use, fluid entering the balloon passes along both the inner and outer surfaces to transfer heat away from the ultrasound transducer;

a backing member extending a second length that is longer than the first length, the backing member extending entirely through the ultrasound transducer; and

an insulating member extending a third length that is longer than the second length, the insulating member extending from the catheter to the tip and connecting the catheter with the tip, the insulting member positioned within the backing member and extending entirely through the backing member such that the backing member is offset from the distal end of the catheter.

2. The system of claim 1, wherein the catheter further comprises a guidewire lumen.

3. The system of claim 2, wherein the insulating member comprises a central opening configured to receive a guidewire, wherein the insulating member serves as a fluid barrier between fluid circulated within the interior of the balloon and the central opening, and, optionally, wherein the central opening of the insulating member is offset relative to the guidewire lumen of the catheter.

4. The system of claim 3, wherein the central opening of the insulating member is generally aligned with the guidewire lumen of the catheter and an internal guidewire passage of the tip to permit the system to be delivered to a desired vascular position over a guidewire.

5. The system of claim 3, wherein the insulating member comprises an electrically insulating material along an interior surface of the central opening of the insulating member so as to prevent electrical conduction between a guidewire and the insulating member and, optionally, wherein the electrically insulating material comprises polyimide.

6. The system of claim 2, wherein the catheter further comprises a proximal end and the guidewire lumen extends from a location between the proximal and distal ends of the catheter to the distal end of the catheter, such that the catheter comprises a rapid exchange design.

7. The system of claim 2, wherein the guidewire lumen is oriented along an axis that is eccentric relative to a center axis of the catheter.

8. The system of claim 7, further comprising at least one centering assembly located at or near the distal end of the catheter, wherein the at least one centering assembly comprises a passage that is positioned along the center axis of the catheter, wherein a guidewire is configured to be positioned through the passage of the at least one centering assembly so that the guidewire is radially centered at or the distal end of the catheter, while the guidewire is configured to be eccentrically located within the guidewire lumen of the catheter.

9. The system of claim 8, wherein the at least one fluid lumen includes an axis that is eccentric to a central axis of the catheter, and wherein the at least one fluid lumen comprises a non-circular shape to increase the cross-sectional area of the at least one fluid lumen.

10. The system of claim 8, wherein the centering assembly comprises a plurality of wings extending radially outwardly from g center opening, the wings configured to engage an inner surface of the balloon.

11. The system of claim 1, wherein the catheter further comprises at least one cable lumen, the system further comprising at least one electrical cable positioned within the at least one cable lumen of the catheter, the at least one electrical cable being electrically coupled to the inner and outer surfaces of the ultrasound transducer.

12. The system of claim 11, wherein an impedance of the at least one electrical cable substantially matches an impedance of the ultrasound transducer.

13. The system of claim 12, wherein the backing member is electrically coupled to the inner surface of the cylindrical tube of the ultrasound transducer, and, optionally, wherein the first connector of the electrical cable is electrically coupled to the outer surface of the ultrasound transducer while not physically attached to the outer surface of the ultrasound transducer.

14. The system of claim 1, wherein the cylindrical tube of the ultrasound transducer comprises a proximal end and a distal end, wherein the proximal end of the cylindrical tube comprises a stepped portion, wherein a portion of the outer diameter formed by the outer surface of the cylindrical tube is smaller than a portion of the outer diameter of the cylindrical tube located distal to the stepped portion, the system further comprising:

at least one electrical cable configured to supply electrical power to the ultrasound transducer, wherein the at least one electrical cable comprises a first conductor and a second conductor;

the backing member being electrically conductive and in contact with, at least intermittently, the inner surface of the cylindrical tube of the ultrasound transducer;

wherein the first conductor is connected to an exterior of the cylindrical tube along the stepped portion, and wherein the second conductor is connected to the backing member so that the second conductor is electrically coupled to the inner surface of the cylindrical tube; and

a ring surrounding the stepped portion of the cylindrical tube, the ring being sized and shaped to surround the portion of the outer diameter of the cylindrical tube located distal to the stepped portion, wherein the ring is electrically conductive so that the first connector is electrically coupled to the outer surface of the cylindrical tube, and wherein the ring allows for uniform electrical loading of the ultrasound transducer when the ultrasound transducer is energized.

15. The system of claim 14, wherein the ring comprises conductive solder.

16. The system of claim 14, wherein the ring comprises a conductive machined ring that couples around the stepped portion of the cylindrical tube and, optionally, wherein the stepped portion extends approximately 5% to 25% of a length of the cylindrical tube.

17. The system of claim 1, further comprising a fluid transfer device configured to selectively deliver a cooling fluid within the balloon when the ultrasound transducer is activated in order to transfer heat away from the ultrasound transducer during use, wherein the fluid transfer device comprises a reservoir for storing a volume of cooling fluid and a movable member configured to move within an interior of the reservoir in order to transfer cooling fluid through the at least one fluid lumen of the catheter to the balloon, wherein the reservoir is sized to store sufficient cooling fluid for an entire ablation procedure.

18. The system of claim 17, wherein the fluid transfer device comprises a syringe pump, and wherein the movable member is coupled to a motor for selectively advancing the movable member relative to the reservoir.

19. The system of claim 17, wherein the at least one fluid lumen of the catheter comprises a fluid delivery lumen and a fluid return lumen, wherein cooling fluid is delivered to the balloon from the fluid transfer device via the fluid delivery lumen, and wherein cooling fluid is withdrawn from the balloon via the fluid return lumen.

20. The system of claim 19, wherein the fluid transfer device comprises a first and second fluid transfer device, wherein the fluid delivery lumen is in fluid communication with the first fluid transfer device, and wherein the fluid return lumen is in fluid communication with the second fluid transfer device, wherein both the first and the second fluid transfer devices are operated simultaneously to circulate cooling fluid through the balloon during an ablation procedure.

21. The system of claim 1, wherein the catheter further comprises a guidewire lumen and an electrical cable lumen, wherein each of the at least one fluid lumen, the guidewire lumen and the electrical cable lumen is not positioned along the cross-sectional centerline of the catheter.