Ultrasound-based neuromodulation system

• US 10,350,440 B2
• Filed: 03/13/2014
• Issued: 07/16/2019
• 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, Jaime, Chandler, Paul E., Raquet, Jacob
• Primary Examiner(s): Della, Jaymi E
• Application Number:
  US14/209,948
• Publication Number:
  US 20140277033A1
• Time in Patent Office: 1,951 Days
• Field of Search: None
• 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 having a balloon along its distal end is disclosed in several embodiments. An ultrasound transducer positioned within an interior of the balloon can be selectively activated to emit acoustic energy radially outwardly in order to target nerve tissue and other portions of the subject anatomy. In some embodiments, the system is configured to be delivered over a guidewire.

Claims

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

a catheter comprising a guidewire lumen, at least one cable lumen and 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, the tip comprising an internal guidewire passage;

an ultrasound transducer positioned within the balloon, the ultrasound transducer comprising a cylindrical tube having proximal and distal ends, an outer surface and a lumen defining an inner surface, an inner electrode disposed on the inner surface and an outer electrode disposed on the outer surface;

at least one electrical cable positioned within the at least one cable lumen of the catheter, the at least one electrical cable comprising a first connector and a second connector, the first connector being electrically coupled to the outer electrode and physically attached to a portion of the outer surface of the ultrasound transducer not having the outer electrode, and the second connector being electrically coupled to the inner electrode; and

a transducer support structure consisting of;

a backing member disposed within the lumen and inner electrode, the backing member extending from the proximal end to the distal end of the cylindrical tube and defining an interior lumen;

an electrically insulating material disposed along the interior lumen of the backing member; and

a plurality of attachment points extending from the backing member, the plurality of attachment points configured to engage the inner electrode, spacings between the plurality of attachment points defining a plurality of openings;

wherein the plurality of attachment points define an internal space between the backing member and the inner electrode, the internal space being in fluid communication with the interior of the balloon via the plurality of openings so that, when in use, fluid entering the balloon passes along the outer electrode and into the internal space between the backing member and the inner electrode through the plurality of openings to transfer heat away from the ultrasound transducer, the backing member is generally aligned with the guidewire lumen of the catheter and the internal guidewire passage of the tip to permit the system to be delivered to a desired vascular position over a guidewire, and the backing member serves as a fluid barrier between fluid circulated within the balloon interior and the interior lumen.

2. The system of claim 1,

wherein the electrically insulating material comprises polyimide;

and

wherein the guidewire lumen extends from a proximal end of the catheter to the balloon.

3. The system of claim 1, wherein the electrically insulating material prevents electrical conduction between a guidewire and the backing member.

4. The system of claim 3, wherein the electrically insulating material comprises polyimide.

5. The system of claim 1, wherein the guidewire lumen extends from a proximal end of the catheter to the balloon.

6. The system of claim 1, wherein 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 1, wherein the backing member and plurality of attachment points are integrally formed.

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

a catheter comprising at least one cable lumen and 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;

a tip extending distally from a distal end of the balloon, the tip comprising an internal guidewire passage;

an ultrasound transducer positioned within the balloon, the ultrasound transducer comprising a cylindrical tube having a proximal end and a distal end, an inner surface, an outer surface, an inner electrode disposed on the inner surface and an outer electrode disposed on the outer surface;

the proximal end of the cylindrical tube comprising a stepped portion, wherein a portion of an outer diameter of the cylindrical tube is smaller than a portion of the outer diameter of the cylindrical tube located distal to the stepped portion such that the outer electrode is not disposed on the stepped portion;

at least one electrical cable positioned within the at least one cable lumen of the catheter, the at least one electrical cable comprising a first connector and a second connector, the first connector being electrically coupled to the outer electrode and physically attached to a portion of the outer surface of the ultrasound transducer not having the outer electrode, and the second connector being electrically coupled to the inner electrode;

a transducer support structure disposed within the lumen of the cylindrical tube, the transducer support structure having a plurality of attachment points configured to engage the inner electrode, the plurality of attachment points defining a plurality of openings; and

a backing member coupled to the transducer support structure and disposed within the lumen and the inner electrode, the transducer support structure defining an internal space between the backing member and the inner electrode, the internal space being in fluid communication with the interior of the balloon via the plurality of openings so that, when in use, fluid entering the balloon passes along the outer electrode and into the internal space between the backing member and the inner electrode through the plurality of openings to transfer heat away from the ultrasound transducer, the backing member further comprising an interior lumen that is generally aligned with the guidewire lumen of the catheter and the internal guidewire passage of the tip to permit the system to be delivered to a desired vascular position over a guidewire, wherein the backing member is electrically coupled to the second connector.

9. The system of claim 8, further comprising a ring surrounding the stepped portion, the ring being sized and shaped to surround the portion of the outer diameter of the cylindrical tube located distal to the stepped portion, the ring being electrically conductive so that the first connector is electrically coupled to the electrode along the outer surface of the cylindrical tube;

wherein the ring comprises a conductive machined ring that couples around the stepped portion of the cylindrical tube; and

wherein the stepped portion extends approximately 5% to 25% of a length of the cylindrical tube.

10. The system of claim 9, wherein the ring comprises conductive solder.

11. The system of claim 9, wherein the ring comprises a conductive machined ring that couples around the stepped portion of the cylindrical tube.

12. The system of claim 8, wherein the stepped portion extends approximately 5% to 25% of a length of the cylindrical tube.

13. The system of claim 8, wherein the stepped portion comprises a portion of the cylindrical tube that is removed using grinding or other removal techniques.

14. The system of claim 8, wherein an impedance of the at least one electrical cable substantially matches an impedance of the ultrasound transducer.

15. The system of claim 14, wherein the impedance of the electrical cable and the ultrasound transducer is approximately 40 to 60 ohms.

16. The system of claim 8, wherein the backing member and transducer support structure are integrally formed.

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

a catheter comprising a cable lumen extending from a proximal end to a distal end of the catheter;

a balloon positioned at a distal end of the catheter;

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

an ultrasound transducer positioned at or near a distal end of the catheter, the ultrasound transducer comprising a cylindrical tube having an inner surface and an outer surface, and an inner electrode disposed on the inner surface and an outer electrode disposed on the outer surface, a proximal portion of the cylindrical tube having a stepped portion such that the outer electrode is not disposed on the stepped portion;

a transducer support structure having a plurality of attachment points configured to engage the inner electrode, spacings between the plurality of attachment points defining a plurality of openings, the transducer support structure being electrically coupled to the inner electrode;

a backing member extending through the cylindrical tube, the transducer support structure defining an internal space between the backing member and the inner electrode, the internal space being in fluid communication with an interior of the balloon via the plurality of openings so that, when in use, fluid entering the balloon passes along the outer electrode and into the internal space between the backing member and the inner electrode through the plurality of openings; and

an electrical cable positioned within the cable lumen of the catheter and extending from the proximal end to the distal end of the catheter, wherein a proximal end of the electrical cable is configured to be coupled to a generator configured to selectively provide electrical power to the ultrasound transducer through the electrical cable, the electrical cable comprising a first connector and a second connector, the first connector being electrically coupled to the outer electrode and physically attached to a portion of the outer surface of the ultrasound transducer not having the outer electrode, and the second connector being electrically coupled to the backing member;

wherein an impedance of the electrical cable is substantially equal to an impedance of the ultrasound transducer, thereby providing a more efficient power transfer from the generator to the ultrasound transducer when the ablation system is in use.

18. The system of claim 17,

wherein the electrical cable comprises a coaxial cable;

and

wherein the impedance of the electrical cable and the ultrasound transducer is approximately 40 to 60 ohms.

19. The system of claim 17, wherein the electrical cable comprises a coaxial cable.

20. The system of claim 17, wherein the impedance of the electrical cable and the ultrasound transducer is approximately 40 to 60 ohms.

21. The system of claim 17, wherein the backing member and transducer support structure are integrally formed.