Low profile electrodes for an angioplasty shock wave catheter

• US 8,747,416 B2
• Filed: 10/23/2013
• Issued: 06/10/2014
• Est. Priority Date: 08/06/2012
• Status: Active Grant

• Current Assignee: Shockwave Medical, Incorporated
• Original Assignee: Shockwave Medical, Incorporated
• Inventors: Hakala, Doug, Adams, John M., Le, Khoi T., Wu, Show-Mean Steve
• Primary Examiner(s): McEvoy, Thomas
• Assistant Examiner(s): Papeika, Rachel S
• Application Number:
  US14/061,554
• Publication Number:
  US 20140052147A1
• Time in Patent Office: 230 Days
• Field of Search: 606/48, 606/50, 606/127, 606/128, 606/159, 606/167, 606/170, 606/191, 606192-194, 606196-198, 601/2, 601/4, 604/22
• US Class Current: 606/128
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 17/22022 using electric discharge
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22021 electric leads passing through the catheter
• CPC Class Codes: A61B 2017/22025 applying a shock wave A61B2017/22091 takes precedence
• CPC Class Codes: A61B 2017/22028 arrays, e.g. phased arrays
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22062 to be filled with liquid

Abstract

Described herein are low-profile electrodes for use with an angioplasty shockwave catheter. A low-profile electrode assembly may have an inner electrode, an insulating layer disposed over the inner electrode such that an opening in the insulating layer is aligned with the inner electrode, and an outer electrode sheath disposed over the insulating layer such that an opening in the outer electrode sheath is coaxially aligned with the opening in the insulating layer. This layered configuration allows for the generation of shockwaves that propagate outward from the side of the catheter. In some variations, the electrode assembly has a second inner electrode, and the insulating layer and outer electrode may each have a second opening that are coaxially aligned with the second inner electrode. An angioplasty shockwave catheter may have a plurality of such low-profile electrode assemblies along its length to break up calcified plaques along a length of a vessel.

Claims

1. A device for generating shockwaves comprising:

an axially extending elongate member;

a balloon surrounding a portion of the elongate member, said balloon being fillable with a conductive fluid;

a first wire extending along an outside surface of the elongate member terminating in a first inner electrode at a first side location within the balloon;

a second wire extending along the outside surface of the elongate member terminating in a second inner electrode located at a second side location radially across the elongate member from the first inner electrode;

a cylindrically-shaped insulating sheath having a first aperture and a second aperture, the insulating sheath disposed around the first and second inner electrodes such that the first aperture of the insulating sheath is located over the first inner electrode and the second aperture of the insulating sheath is located over the second inner electrode; and

an outer electrode sheath having a first aperture and a second aperture, the outer electrode sheath disposed around the insulating sheath such that the first aperture of the outer electrode sheath is aligned with the first aperture of the insulating sheath and the second aperture of the outer electrode sheath is aligned with the second aperture of the insulating sheath, and arranged so that when the balloon is filled with the conductive fluid and a voltage is applied across the first and second inner electrodes, a current flows in series from the first inner electrode to the outer electrode sheath to the second inner electrode such that a first shockwave is initiated from the first side location and a second shockwave is initiated from the second side location.

2. The device of claim 1, wherein the outer surface of the elongate member has a first groove and a second groove that each extend along a length of the elongate member, wherein the first wire is slidably disposed within the first groove and the second wire is slidably disposed within the second groove.

3. The device of claim 1, wherein the first inner electrode is crimped over an electrically conductive portion of the first wire and the second inner electrode is crimped over an electrically conductive portion of the second wire.

4. The device of claim 3, wherein the first inner electrode is a first hypotube that is crimped over the first wire and the second inner electrode is a second hypotube that is crimped over the second wire.

5. The device of claim 1, wherein the elongate member has a guidewire lumen extending therethrough.

6. A system for generating shockwaves comprising:

an axially extending elongate member;

a balloon surrounding a portion of the elongate member, said balloon being fillable with a conductive fluid;

a first electrode assembly at a first location along the length of the elongate member, the first electrode assembly having a first inner electrode, a second inner electrode, and an outer electrode and configured to initiate shockwaves at two circumferentially opposite locations; and

a second electrode assembly at a second location along the length of the elongate member, the second electrode assembly having a first inner electrode, a second inner electrode, and an outer electrode and configured to initiate shockwaves at two circumferentially opposite locations wherein the second inner electrode of the first electrode assembly and the first inner electrode of the second electrode assembly are connected and wherein when the balloon is filled with the conductive fluid and a voltage is applied across the first inner electrode of the first electrode assembly and the second inner electrode of the second electrode assembly, a current flows in series from the first inner electrode to the outer electrode to the second inner electrode of the first electrode assembly to the first inner electrode to the outer electrode to the second inner electrode of the second electrode assembly such that a first pair of shockwaves is generated at the two circumferentially opposite locations of the first electrode assembly and a second pair of shockwaves is generated at the two circumferentially opposite locations of the second electrode assembly.

7. The system of claim 6, further comprising:

a third electrode assembly at a third location along the length of the elongate member, the third electrode assembly having a first inner electrode, a second inner electrode, and an outer electrode and configured to initiate shockwaves at two circumferentially opposite locations.

8. The system of claim 7, further comprising:

a fourth electrode assembly at a fourth location along the length of the elongate member, the fourth electrode assembly having a first inner electrode, a second inner electrode, and an outer electrode and configured to initiate shockwaves at two circumferentially opposite locations.

9. The system of claim 8, further comprising:

a fifth electrode assembly at a fifth location along the length of the elongate member, the fifth electrode assembly having a first inner electrode, a second inner electrode, and an outer electrode and configured to initiate shockwaves at two circumferentially opposite locations.

10. The system of claim 9, further comprising a voltage pulse generator having first, second, and third channels, and a return connector, and wherein the first channel is selectively connectable to the first electrode assembly, the second channel is selectively connectable to the third electrode assembly, the third channel is selectively connectable to the fourth electrode assembly, and the return connector is connected to the second, third, and fifth electrode assemblies.

11. The system of claim 9, wherein the second inner electrode of the first electrode assembly is connected to the first inner electrode of the second electrode assembly, the second inner electrode of the fourth electrode assembly is connected to the first inner electrode of the fifth electrode assembly, and the second inner electrodes of the second, third, and fifth electrode assemblies are connected.

12. The system of claim 11, wherein when the balloon is filled with the conductive fluid and a voltage is applied across the first and second inner electrodes of the third electrode assembly, a current flows from the first inner electrode to the outer electrode to the second inner electrode of the third electrode assembly such that a pair of shockwaves is generated at the two circumferentially opposite locations of the third electrode assembly.

13. The system of claim 11, wherein when the balloon is filled with the conductive fluid and a voltage is applied across the first inner electrode of the fourth electrode assembly and the second inner electrode of the fifth electrode assembly, a current flows from the first inner electrode to the outer electrode to the second inner electrode of the fourth electrode assembly to the first inner electrode to the outer electrode to the second inner electrode of the fifth electrode assembly such that a first pair of shockwaves is generated at the two circumferentially opposite locations of the fourth electrode assembly and second pair of shockwaves is generated at the two circumferentially opposite locations of the fifth electrode assembly.

14. A system for generating shockwaves comprising:

an axially extending elongate member;

a balloon surrounding a portion of the elongate member, said balloon being fillable with a conductive fluid;

a first electrode assembly at a first location along the length of the elongate member, the first electrode assembly having a first inner electrode, a second inner electrode, and an outer electrode and configured to initiate shockwaves at two different locations;

a second electrode assembly at a second location along the length of the elongate member, the second electrode assembly having a first inner electrode, a second inner electrode, and an outer electrode and configured to initiate shockwaves at two different locations, wherein said first and second electrode assemblies are connected in series;

a third electrode assembly at a third location along the length of the elongate member, the third electrode assembly having a first inner electrode, a second inner electrode, and an outer electrode and configured to initiate shockwaves at two different locations;

a fourth electrode assembly at a fourth location along the length of the elongate member, the fourth electrode assembly having a first inner electrode, a second inner electrode, and an outer electrode and configured to initiate shockwaves at two different locations, wherein said third and fourth electrode assemblies are connected in series; and

a voltage pulse generator having first and second channels and a return connector, and wherein the first channel is selectively connectable to the first electrode assembly and the second channel is selectively connectable to the third electrode assembly, and the return connector is connected to the second and fourth electrode assemblies and configured to selectively energize one of the first and second serially connected electrode assemblies and the third and fourth serially connected electrode assemblies.

15. The system of claim 14, wherein the second inner electrode of the first electrode assembly is connected to the first inner electrode of the second electrode assembly and the second inner electrode of the third electrode assembly is connected to the first inner electrode of the fourth electrode assembly, and the second inner electrodes of the second and fourth electrode assemblies are connected to the return connector.

16. The system of claim 15 further comprising:

a fifth electrode assembly at a fifth location along the length of the elongate member, the fifth electrode assembly having a first inner electrode, a second inner electrode, and an outer electrode and configured to initiate shockwaves at two different locations and wherein the voltage pulse generator includes a third channel selectively connectable to the fifth electrode assembly.