Nerve ablation devices and related methods of use and manufacture
A medical device for sympathetic nerve ablation includes a catheter shaft and an expandable member disposed on the catheter shaft. The balloon is configured to be able to shift between an unexpanded configuration and an expanded configuration. The medical device includes an elongate electrode assembly constructed as a flexible circuit and a protective bumper member. The elongate electrode assembly may have an outer edge and may be disposed on an outer surface of the balloon. The protective bumper member may cover at least a portion of the outer edge of the elongate electrode assembly.
1. A medical device configured for nerve ablation, comprising:
a catheter shaft;
an expandable balloon disposed on the catheter shaft, the balloon being capable of shifting between an unexpanded configuration and an expanded configuration;
an elongate electrode assembly constructed as a flexible circuit, the elongate electrode assembly disposed on an outer surface of the balloon and having an upper surface, an outer edge and a thickness R 4 at the outer edge; and
a protective bumper member comprising a polymeric material positioned in its entirety over the upper surface of the elongate electrode assembly and over the outer surface of the expandable balloon and covering at least a portion of the outer edge of the elongate electrode assembly, the protective bumper member extending laterally from the outer edge and onto the upper surface of the elongate electrode assembly by a first distance R 1 and extending laterally from the outer edge over the outer surface of the expandable balloon and away from the elongate electrode assembly by a second distance R 2 , wherein R 1 is 2 to 20 times R 4 and R 2 is 2 to 20 times R 4 , and wherein the protective bumper member is formed from a light curable adhesive.
2. The medical device of claim 1 , wherein the protective bumper member comprises a polymeric material.
3. The medical device of claim 1 , wherein the light curable adhesive has a viscosity greater than about 6000 centiPoise.
4. The medical device of claim 1 , wherein the light curable adhesive has a viscosity greater than about 10,000 centiPoise.
5. The medical device of claim 1 , wherein the protective bumper member covers all of the outer edge of the elongate electrode assembly.
6. The medical device of claim 1 , wherein at least a portion of a bottom side of the elongate electrode assembly is attached to the outer surface of the balloon.
7. The medical device of claim 1 , wherein the balloon is a non-compliant balloon and the elongate electrode assembly folds and unfolds with the balloon.
8. The medical device of claim 1 , wherein the balloon is a compliant balloon and the elongate electrode assembly folds and unfolds with the balloon.
9. The medical device of claim 1 , wherein the balloon comprises polyethyleneterephthalate (PET).
10. The medical device of claim 1 , comprising one or more voids formed in the outer edge of the electrode assembly.
11. The medical device of claim 10 , further comprising one or more additional voids formed in the electrode assembly that do not extend to the outer edge of the electrode assembly.
12. A medical device configured for nerve ablation, comprising:
a catheter shaft;
an expandable member coupled to the catheter shaft, the expandable member being capable of shifting between an unexpanded configuration and an expanded configuration; and
an elongate electrode assembly constructed as a flexible circuit having a plurality of layers, the elongate electrode assembly having an upper surface and an outer edge, the elongate electrode assembly disposed on an outer surface of the expandable member and having a thickness R 4 at the outer edge; and
a protective bumper member comprising a polymeric material positioned in its entirety over the upper surface of the elongate electrode assembly and over the outer surface of the expandable member and extending about the outer edge of the elongate electrode assembly, the protective bumper member extending laterally from the outer edge and onto the upper surface of the elongate electrode assembly by a first distance R 1 and extending laterally from the outer edge over the outer surface of the expandable member and away from the elongate electrode assembly by a second distance R 2 , wherein R 1 is 2 to 20 times R 4 and R 2 is 2 to 20 times R 4 , and wherein the protective bumper member is formed from a light curable adhesive.
13. The medical device of claim 12 , wherein the protective bumper member covers the outer edge and a portion of an outer periphery of the elongate electrode assembly.
14. The medical device of claim 12 , wherein the protective bumper member comprises a polymeric material.
15. The medical device of claim 12 , wherein the light curable adhesive has a viscosity greater than about 6000 centiPoise.
16. The medical device of claim 12 , wherein the light curable adhesive has a viscosity greater than about 10,000 centiPoise.
17. The medical device of claim 12 , wherein the balloon is a non-compliant balloon and the elongate electrode assembly folds and unfolds with the balloon.
18. A medical device configured for nerve ablation within a body passageway, comprising:
a catheter shaft;
an elongate balloon coupled to the catheter shaft, the balloon being capable of shifting between an unexpanded configuration and an expanded configuration;
a plurality of electrode assemblies each constructed as a flexible circuit having a plurality of layers and having an upper surface, the plurality of electrode assemblies being bonded to an outer surface of the balloon, each of the plurality of electrode assemblies including an outer edge and having a thickness R 4 at the outer edge; and
a plurality of protective polymeric bumper members, each of the plurality of protective polymeric bumper members comprising a polymeric material and positioned in its entirety over the upper surface of a corresponding one of the plurality of electrode assemblies and over the outer surface of the expandable balloon and surrounding the outer edge of the corresponding one of the plurality of electrode assemblies, and each of the plurality of protective polymeric bumper members extending laterally from the outer edge and onto the upper surface of the corresponding one of the plurality of electrode assemblies by a first distance R 1 and extending laterally from the outer edge over the outer surface of the expandable balloon and away from the corresponding one of the plurality of electrode assemblies by a second distance R 2 , wherein R 1 is 2 to 20 times R 4 and R 2 is 2 to 20 times R 4 , and wherein the protective bumper member is formed from a light curable adhesive.
19. The medical device of claim 18 , wherein the light curable adhesive has a viscosity greater than about 6000 centiPoise.
20. The medical device of claim 18 , wherein the balloon is a non-compliant balloon.