Method for reducing arterial restenosis in the presence of an intravascular stent

• US 6,648,881 B2
• Filed: 08/27/2001
• Issued: 11/18/2003
• Est. Priority Date: 04/19/1999
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: KenKnight, Bruce H., Warren, Jay A., Hahn, Stephen John
• Primary Examiner(s): COHEN, LEE S
• Application Number:
  US09/940,337
• Publication Number:
  US 20020072743A1
• Time in Patent Office: 813 Days
• Field of Search: 606/192, 606/194, 606/196, 606/198, 606/41-50, 606/32, 606/33, 606/34, 600/372, 600/381
• US Class Current: 606/32
• 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 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG

Abstract

A first electrode is positioned within an artery proximate an implanted intravascular stent. A second electrode is positioned at a separate location relative the position of the first electrode. Electrical energy is then delivered between the first and the second electrodes to produce an electrical field adjacent the implanted intravascular stent. When a intravascular stent is implanted in a coronary artery, the delivery of the electrical energy is coordinated to cardiac cycles detected in sensed cardiac signals, where the delivery of the electrical energy between the first electrode and the second electrode occurs during a predetermined portion of the cardiac cycle.

Claims

1. A method, comprising:

sensing cardiac signals, where the cardiac signals include a cardiac cycle;

positioning a first electrode within an artery proximate an implanted intravascular stent;

positioning a second electrode at a remote position outside the lumen of the stent; and

delivering at least one pulse of electrical energy between the first electrode and the second electrode during a predetermined portion of the cardiac cycle, at a repetition rate that is less than or equal to the order of a frequency between heart depolarizations.

2. The method of claim 1, wherein positioning the second electrode at the remote position includes positioning the second electrode on a dermal surface of a patient.

3. The method of claim 1, wherein the first electrode is positioned on a catheter, and wherein positioning the first electrode within the artery includes positioning at least a portion of the catheter within the artery to position the first electrode proximate the implanted intravascular stent.

4. The method of claim 3, wherein at least a portion of the first electrode is positioned within a lumen of the implanted intravascular stent.

5. The method of claim 4, wherein the first electrode is positioned within the lumen of the implanted intravascular stent.

6. The method of claim 5, wherein the first electrode has first and second electrode ends and the implanted intravascular stent has first and second stent ends, where positioning the first electrode within the artery includes positioning the first electrode within a lumen of the implanted intravascular stent with the first and second electrode ends aligned with the first and second stent ends, respectively.

7. The method of claim 3, wherein the second electrode is positioned on the catheter proximal the first electrode, and wherein positioning the second electrode at the remote position includes positioning the catheter within the artery so the first electrode is positioned proximal the implanted intravascular stent and the second electrode is positioned proximal the first electrode along the catheter.

8. The method of claim 7, wherein the implanted intravascular stent has first and second stent ends, and positioning the first electrode and the second electrode includes positioning the first electrode and the second electrode within a lumen of the implanted intravascular stent.

9. The method of claim 1, including physically contacting the first electrode with the implanted intravascular stent.

10. The method of claim 1, wherein the predetermined portion of the cardiac cycle is a QRS-complex of the cardiac cycle.

11. A method, comprising:

positioning at least a portion of a first electrode within a lumen of an intravascularly implanted stent;

positioning a second electrode at a remote position outside the lumen of the stent; and

delivering at least one pulse of electrical energy between the first electrode and the second electrode, at a repetition rate that is less than or equal to the order of a frequency between heart depolarizations.

12. The method of claim 11, wherein the first electrode has first and second electrode ends and the stent has first and second stent ends, where positioning at least a portion of the first electrode within the lumen of the stent includes positioning the first electrode within the lumen of the stent with the first and second electrode ends aligned with the first and second stent ends, respectively.

13. A method comprising:

positioning at least a portion of a first electrode within a lumen of an intravascularly implanted stent;

positioning a second electrode at a remote position relative to the first electrode; and

delivering at least one sub-radio-frequency (sub-RF) pulse of electrical energy between the first electrode and the second electrode, at a repetition rate that is less than or equal to the order of a frequency between heart depolarizations.

14. The method of claim 13, in which the delivering at least one pulse includes discharging a capacitor.

15. The method of claim 13, in which the delivering at least one pulse includes delivering at least one substantially constant current pulse.

16. The method of claim 13, in which the delivering at least one pulse includes delivering at least one substantially direct current (DC) pulse.

17. The method of claim 13, in which the delivering at least one pulse includes delivering at least one pulse having a current density between about 1 ampere/cm² and about 4 amperes/cm².