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

• US 20020072743A1
• Filed: 08/27/2001
• Published: 06/13/2002
• Est. Priority Date: 04/19/1999
• Status: Active Grant

• 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
• Granted Patent: US 6,648,881 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• 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 relative to the first electrode; and

delivering electrical energy between the first electrode and the second electrode during a predetermined portion of the cardiac cycle.

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 a stent;

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

delivering electrical energy between the first electrode and the second electrode.

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.

14. The system of claim 13, including a catheter, where the catheter includes an elongate body having a peripheral surface, proximal end, and a distal end, where the first electrode is positioned on the peripheral surface of the catheter between the proximal end and the distal end, and where the first lead connector is located at the proximal end and a first lead conductor contained within the elongate body couples the first electrode to the first lead connector.

15. The system of claim 14, wherein a third electrode is positioned on the peripheral surface of the catheter, where the first electrode and the third electrode are spaced apart and spaced longitudinally along the peripheral surface, where the third electrode is coupled to the first lead conductor contained within the elongate body.

16. The system of claim 14, including an external lead, where the external lead includes an elongate body having a peripheral surface, proximal end, and a distal end, where the second electrode is positioned at the distal end of the external lead, and where the second lead connector is located at the proximal end and a second lead conductor contained within the elongate body couples the second electrode to the second lead connector.

17. The system of claim 13, wherein the intravascular stent has a predetermined length, and wherein the first electrode has a length between 80 and 120% of the predetermined length of the intravascular stent.

18. The system of claim 13, wherein the energy source supplies electrical energy and is coupled to a transducer which converts electrical energy to radio frequency energy, where the energy source produces a radio frequency energy pulse for the intravascular stent.

19. The system of claim 13, wherein the energy source produces an electrical energy pulse for the intravascular stent.

13. A system, comprising:

an intravascular stent, wherein the intravascular stent is electrically conductive;

a first electrode coupled to a first lead connector;

a second electrode coupled to a second lead connector;

a pulse generator, wherein the pulse generator includes a programming circuit, a display screen, a data input device, a first and a second input/output socket, an electrogram analysis circuit, a microprocessor, and an energy source;

wherein

the programming circuit is coupled to the display screen, where the programming circuit controls the display screen to request parameter values for an electrical energy pulse;

the data input device is coupled to the programming circuit and the display screen, where the programming circuit receives the parameter values provided through the data input device;

the first lead connector is releasably coupled to the first input/output socket and the second lead connector is releasably coupled to the second input/output socket;

the electrogram analysis circuit is coupled to the first electrode and the second electrode coupled through the first and second lead connectors, where the electrogram analysis circuit receives a cardiac signal sensed between the first and second electrode, and where the electrogram analysis circuit detects cardiac complexes in the sensed cardiac signal;

the microprocessor is coupled to the programming circuit, the electrogram analysis circuit and the energy source, where the microprocessor receives the parameter values from the programming circuit and the cardiac complexes in the sensed cardiac signal from the electrogram analysis circuit, and controls the energy source to generate the electrical energy pulse having the parameter values for the intravascular stent when a predetermined portion of a cardiac complex occurs in the cardiac signal.

20. A system, comprising:

an intravascular stent, the intravascular stent being electrically conductive;

a first electrode coupled to a first lead connector;

a second electrode coupled to a second lead connector;

two or more surface electrocardiogram electrodes, wherein each of the two or more surface electrocardiogram electrodes is coupled to a lead connector of two or more lead connectors;

a pulse generator, wherein the pulse generator includes a programming circuit, a display screen, a data input device, a first and a second input/output socket, an electrogram analysis circuit, a microprocessor, and an energy source;

wherein

the programming circuit is coupled to the display screen, where the programming circuit controls the display screen to request parameter values for an electrical energy pulse;

the data input device is coupled to the programming circuit and the display screen, where the programming circuit receives the parameter values provided through the data input device;

the first lead connector is releasably coupled to the first input/output socket and the second lead connector is releasably coupled to the second input/output socket;

the electrogram analysis circuit is coupled to the two or more surface electrocardiogram electrodes through the two or more lead connectors, where the electrogram analysis circuit receives a cardiac signal sensed between the two or more surface electrocardiogram electrodes, and where the electrogram analysis circuit detects cardiac complexes in the sensed cardiac signal;

the microprocessor is coupled to the programming circuit, the electrogram analysis circuit and the energy source, where the microprocessor receives the parameter values from the programming circuit and the cardiac complexes in the sensed cardiac signal from the electrogram analysis circuit, and controls the energy source to generate the electrical energy pulse having the parameter values for the intravascular stent when a predetermined portion of a cardiac complex occurs in the cardiac signal.

21. The system of claim 20, including a catheter, where the catheter includes an elongate body having a peripheral surface, proximal end, and a distal end, where the first electrode is positioned on the peripheral surface of the catheter between the proximal end and the distal end, and where the first lead connector is located at the proximal end and a first lead conductor contained within the elongate body couples the first electrode to the first lead connector.

22. The system of claim 21, including an external lead, where the external lead includes an elongate body having a peripheral surface, proximal end, and a distal end, where the second electrode is positioned at the distal end of the external lead, and where the second lead connector is located at the proximal end and a second lead conductor contained within the elongate body couples the second electrode to the second lead connector.

23. The system of claim 21, wherein a third electrode is positioned on the peripheral surface of the catheter, where the first electrode and the third electrode are spaced apart and spaced longitudinally along the peripheral surface, and wherein the third electrode is coupled to a third lead connector located at the proximal end and a third lead conductor contained within the elongate body couples the third electrode to the third lead connector.

24. The system of claim 20, wherein the intravascular stent has a predetermined length, and wherein the first electrode has a length between 80 and 120% of the predetermined length of the intravascular stent.

25. The system of claim 20, wherein the energy source supplies electrical energy and is coupled to a transducer which converts electrical energy to radio frequency energy, where the energy source produces a radio frequency energy pulse for the intravascular stent.

26. The system of claim 20, wherein the energy source produces an electrical energy pulse for the intravascular stent.