Implantable cardioverter-defibrillator (ICD) system including substernal lead

• US 10,471,267 B2
• Filed: 04/25/2014
• Issued: 11/12/2019
• Est. Priority Date: 05/06/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Thompson-Nauman, Amy E., Christie, Melissa G. T., DeGroot, Paul J., McVenes, Rick D., Dolan, Becky L.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US14/261,470
• Publication Number:
  US 20140330327A1
• Time in Patent Office: 2,027 Days
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

Substernal implantable cardioverter-defibrillator (ICD) systems and methods for providing substernal electrical stimulation therapy to treat malignant tachyarrhythmia, e.g., ventricular tachycardia (VT) and ventricular fibrillation (VF) are described. In one example, an implantable cardioverter-defibrillator (ICD) system includes an ICD implanted in a patient and an implantable medical electrical lead. The lead includes an elongated lead body having a proximal end and a distal portion, a connector at the proximal end of the lead body configured to couple to the ICD, and one or more electrodes along the distal portion of the elongated lead body. The distal portion of the elongated lead body of the lead is implanted substantially within an anterior mediastinum of the patient and the ICD is configured to deliver electrical stimulation to a heart of the patient using the one or more electrodes.

Claims

1. A method comprising:

detecting a tachycardia with the implantable cardioverter-defibrillator (ICD) system having an ICD and a medical electrical lead, the medical electrical lead having a proximal end coupled to the ICD and a distal portion including one or more electrodes implanted substantially within an anterior mediastinum of a patient such that the one or more electrodes are physically isolated from a pericardium of the patient, wherein the one or more electrodes comprise a defibrillation electrode;

generating an electrical stimulation comprising at least one of a cardioversion shock or a defibrillation shock with the ICD in response to detecting the tachycardia; and

delivering the at least one of the cardioversion shock or the defibrillation shock to a heart of the patient via the defibrillation electrode implanted substantially within the anterior mediastinum of the patient.

2. The method of claim 1, wherein the one or more electrodes further comprise one or more pacing electrodes, the method further comprising:

generating one or more anti-tachycardia pacing (ATP) pulses with the ICD in response to detecting the tachycardia; and

delivering the one or more ATP pulses to the heart via one or more pacing electrodes implanted substantially within the anterior mediastinum of the patient.

3. The method of claim 2, wherein each of the one or more ATP pulses has a pulse width between approximately one and a half (1.5) milliseconds and twenty (20) milliseconds.

4. The method of claim 1, wherein the at least one of the cardioversion shock or the defibrillation shock has an energy between 35-60 Joules (J).

5. The method of claim 1, wherein the distal portion of the lead is implanted substantially within the anterior mediastinum such that the defibrillation electrode is located over a cardiac silhouette of a ventricle of the heart as observed via an anterior-posterior (AP) fluoroscopic view of the heart.

6. The method of claim 1, wherein the one or more electrodes includes at least one pacing electrode and the ICD is configured to provide one of bradycardia pacing, antitachycardia (ATP) pacing, or post-shock pacing to the patient via the at least one pacing electrode.

7. The method of claim 1, wherein the ICD is configured to deliver pacing pulses having pulse widths greater than two (2) milliseconds.

8. The method of claim 1, wherein the ICD is configured to deliver pacing pulses having pulse widths between two (2) and three (3) milliseconds.

9. The method of claim 1, wherein the ICD is configured to deliver pacing pulses having pulse widths greater than two (2) milliseconds and less than eight (8) milliseconds.

10. The method of claim 1, wherein the ICD is configured to deliver pacing pulses having leading-edge pulse amplitudes between approximately one (1) and twenty (20) volts.

11. The method of claim 1, wherein the distal portion of the lead is implanted substantially within the anterior mediastinum such that a therapy vector from the defibrillation electrode to the ICD is substantially across the ventricles of the heart.

12. The method of claim 1, wherein the ICD is configured to deliver pacing pulses having pulse widths less than or equal to one and a half (1.5) milliseconds.

13. The method of claim 1, wherein the ICD is configured to deliver pacing pulses having leading-edge pulse amplitudes less than approximately five (5) volts.

14. The method of claim 1, wherein the ICD is configured to deliver pacing pulses having lead-edge pulse amplitudes less than approximately two (2) volts.

15. The method of claim 1, wherein the medical electrical lead comprises one or more anchoring mechanisms positioned along a length of the medical electrical lead, wherein the one or more anchoring mechanisms are configured to anchor the medical electrical lead within the anterior mediastinum of the patient.

16. The method of claim 15, wherein the one or more anchoring mechanisms comprise a plurality of anchoring mechanisms.

17. The method of claim 15, wherein each anchoring mechanism of one or more anchoring mechanisms is configured to anchor the medical electrical lead within the anterior mediastinum of the patient by anchoring the housing to at least one of loose connective tissue, bone, fascia, or muscle within the anterior mediastinum of the patient.