Methods and apparatuses for remodeling tissue of or adjacent to a body passage

• US 9,827,039 B2
• Filed: 03/11/2014
• Issued: 11/28/2017
• Est. Priority Date: 03/15/2013
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Dandler, Andres, Mathur, Prabodh
• Primary Examiner(s): Fowler, Daniel
• Application Number:
  US14/204,821
• Publication Number:
  US 20140276789A1
• Time in Patent Office: 1,358 Days
• 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 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves

Abstract

Medical devices and methods for making and using the same are disclosed. An medical device may include a medical device for renal nerve ablation. The medical device may include a catheter shaft having a distal region. An expandable balloon may be coupled to the distal region. An electrode assembly may be coupled to the balloon. The electrode assembly may include a first electrode pad including one or more electrodes. The first electrode pad may have a first lead-in edge, a first protruding edge, and a first transition region with a continuously changing curvature disposed between the first lead-in edge and the first protruding edge.

Claims

1. A medical device for renal nerve ablation, comprising:

a catheter shaft having a distal region;

an expandable balloon coupled to the distal region;

an electrode assembly coupled to the balloon, the electrode assembly including a first electrode pad including one or more electrodes and a first tail positioned proximal to the first electrode pad;

wherein the first electrode pad comprises a base layer and a sensor is positioned within an opening in the base layer;

wherein the electrode is positioned over the base layer;

wherein the electrode assembly has a first edge comprising a first lead-in edge on the first tail, a first protruding edge on the first electrode pad, and a first transition region disposed between the first lead-in edge and the first protruding edge; and

wherein there is a first continuously changing curvature along said first edge within the first transition region.

2. The medical device of claim 1, wherein the electrode assembly includes a second electrode pad positioned proximal to the first tail and second tail positioned proximal to the second electrode pad.

3. The medical device of claim 2, wherein the second electrode pad is circumferentially offset from the first electrode pad.

4. The medical device of claim 3, wherein the electrode assembly comprise a central axis, wherein the first electrode pad is asymmetrically disposed to one side of the central axis, and wherein the second electrode pad is asymmetrically disposed to an opposite side of the central axis.

5. The medical device of claim 2,

wherein the electrode assembly has a second edge comprising a second lead-in edge on the second tail, a second protruding edge on the second electrode pad, and a second transition region disposed between the second lead-in edge and the second protruding edge;

and

wherein there is a second continuously changing curvature along said second edge within the second transition region.

6. The medical device of claim 1, wherein the first electrode pad includes one or more pairs of bipolar electrodes.

7. The medical device of claim 1, further comprising one or more additional electrode assemblies coupled to the balloon.

8. The medical device of claim 1, wherein the first continuously changing curvature has a second derivative that is constant along the first transition region.

9. The medical device of claim 1, wherein the first transition region has a first curvature transition point where the first continuously changing curvature changes directions, and wherein the first continuously changing curvature has a second derivative that is a mathematically continuous function at the first curvature transition point.

10. The medical device of claim 1, wherein the first continuously changing curvature is defined by a mathematically continuous function.

11. The medical device of claim 10, wherein the mathematically continuous function includes a parabolic function.

12. A medical device for renal nerve ablation, comprising:

a catheter shaft having a distal region;

an expandable balloon coupled to the distal region;

a first electrode assembly attached to an outer surface of the balloon, the first electrode assembly including a first distal electrode pad including a first pair of bipolar electrodes and a first proximal electrode pad having a second pair of bipolar electrodes, the first proximal electrode pad being circumferentially offset from the first distal electrode pad;

a second electrode assembly attached to an outer surface of the balloon, the second electrode assembly including a second distal electrode pad including a third pair of bipolar electrodes, and a second proximal electrode pad having a fourth pair of bipolar electrodes, the second proximal electrode pad being circumferentially offset from the second distal electrode pad

wherein the first distal electrode pad comprises a first base layer and a first sensor is positioned within an opening in the first base layer, and wherein the first pair of bipolar electrodes is positioned over the first base layer;

wherein the first proximal electrode pad comprises a second base layer and a second sensor is positioned within an opening in the second base layer, and wherein the second pair of bipolar electrodes is positioned over the first base layer;

wherein the second distal electrode pad comprises a third base layer and a third sensor is positioned within an opening in the third base layer, and wherein the third pair of bipolar electrodes is positioned over the third base layer;

wherein the second proximal electrode pad comprises a fourth base layer and a fourth sensor is positioned within an opening in the fourth base layer, and wherein the fourth pair of bipolar electrodes is positioned over the first base layer;

wherein the first and second electrode assemblies key into one another;

wherein a proximal tail extends proximally from the first proximal electrode pad; and

wherein the first proximal electrode pad is centered with the proximal tail.

13. The medical device of claim 12, wherein the proximal electrode pad is longitudinally spaced from the distal electrode pad.

14. The medical device of claim 12, wherein the proximal electrode pad, the distal electrode pad, or both have a first edge comprising a first lead-in edge, a first protruding edge, and a first transition region disposed between the first lead-in edge and the first protruding edge;

and

wherein there is a first continuously changing curvature along said first edge within the first transition region.

15. The medical device of claim 14, wherein first continuously changing curvature is defined by a mathematically continuous function.

16. The medical device of claim 15, wherein the mathematically continuous function includes a parabolic function.

17. A medical device for renal nerve ablation, comprising:

a catheter shaft having a distal region;

an expandable balloon coupled to the distal region;

an electrode assembly attached to an outer surface of the balloon, the electrode assembly including a first electrode pad including a first pair of bipolar electrodes, a first tail positioned proximal to the first electrode pad, a second electrode pad having a second pair of bipolar electrodes positioned proximal to the first tail, and a second tail positioned proximal to the second electrode pad;

wherein the first electrode pad comprises a first base layer and a first sensor is positioned within an opening in the base first layer, and wherein the first pair of bipolar electrodes is positioned over the first base layer;

wherein the second electrode pad comprises a second base layer and a second sensor is positioned within an opening in the second base layer, and wherein the second pair of bipolar electrodes is positioned over the second base layer;

wherein the electrode assembly has a first edge comprising a first lead-in edge on the first tail, a first protruding edge on the first electrode pad, and a first transition region disposed between the first lead-in edge and the first protruding edge;

wherein there is a first continuously changing curvature along said first edge within the first transition region;

wherein the first continuously changing curvature is defined by a first mathematically continuous function;

wherein the electrode assembly has a second edge comprising a second lead-in edge on the second tail, a second protruding edge on the second electrode pad, and a second transition region disposed between the second lead-in edge and the second protruding edge;

wherein there is a second continuously changing curvature along said second edge within the second transition region; and

wherein the second continuously changing curvature is defined by a second mathematically continuous function.

18. The medical device of claim 17, wherein the first mathematically continuous function is the same as the second mathematically continuous function.

19. The medical device of claim 17, wherein the first mathematically continuous function is different from the second mathematically continuous function.