Substernal electrical stimulation system

• US 10,532,203 B2
• Filed: 04/25/2014
• Issued: 01/14/2020
• 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., McVenes, Rick D.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US14/261,479
• Publication Number:
  US 20140330329A1
• Time in Patent Office: 2,090 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 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Implantable cardiac pacing systems and methods for providing substernal pacing are described. In one example, a cardiac pacing system includes a pacemaker implanted in a patient and an implantable medical electrical lead. The implantable medical electrical lead includes an elongated lead body having a proximal end and a distal portion, a connector configured to couple to the pacemaker at the proximal end of the elongated lead body, and one or more electrodes along the distal portion of the elongated lead body, wherein the distal portion of the elongated lead body of the lead is implanted substantially within an anterior mediastinum of the patient and the pacemaker is configured to deliver pacing pulses to a heart of the patient.

Claims

1. A method comprising:

generating one or more pacing pulses with an implantable pulse generator, wherein the one or more pacing pulses have pulse amplitudes between approximately one (1) and twenty (20) volts; and

delivering the one or more pacing pulses via at least one electrode of an implantable medical electrical lead implanted at least partially within an anterior mediastinum of a patient such that the at least one electrode is physically isolated from a pericardium of the patient.

2. The method of claim 1, wherein delivering the one or more pacing pulses comprises delivering one of bradycardia pacing, anti-tachycardia (ATP) pacing, or post-shock pacing to a heart of patient via the implantable medical electrical lead.

3. The method of claim 1, wherein delivering the one or more pacing pulses comprises delivering the one or more pacing pulses via a therapy vector between an electrode of the at least one electrode of the implantable medical electrical lead and an electrode on a housing of the implantable pulse generator.

4. The method of claim 1, wherein the implantable medical electrical lead includes at least two electrodes and delivering the one or more pacing pulses comprises delivering the one or more pacing pulses via a therapy vector between two of the at least two electrodes of the implantable medical electrical lead.

5. The method of claim 1, wherein delivering the one or more pacing pulses comprises delivering one or more pacing pulses having pulse widths greater than two (2) milliseconds and less than or equal to twenty (20) milliseconds.

6. The method of claim 1, further comprising:

sensing electrical signals corresponding to cardiac activity of the heart of the patient via the at least one electrode of the implantable medical electrical lead,

wherein delivering the one or more pacing pulses comprises delivering the one or more pacing pulses based on the sensed electrical signals.

7. The method of claim 1, wherein the implantable medical electrical lead comprises a first implantable medical electrical lead, and wherein delivering the one or more pacing pulses comprises delivering pacing pulses to a ventricle of the heart via the at least one electrode of the first implantable medical electrical lead, and delivering pacing pulses to an atrium of the heart via at least one electrode of a second implantable medical electrical lead implanted at least partially within the anterior mediastinum of the patient such that the at least one electrode of the second implantable medical electrical lead is physically isolated from the pericardium of the patient.

8. The method of claim 1, wherein delivering the one or more pacing pulses via the at least one electrode of the implantable medical electrical lead comprises delivering pacing pulses to a ventricle of the heart of the patient via at least a first electrode of the at least one electrode of the implantable medical electrical lead and delivering pacing pulses to an atrium of the heart via at least a second electrode of the at least one electrode of the implantable medical electrical lead.

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

11. The method of claim 1, wherein the one or more pacing pulses have pulse amplitudes between one (1) and eight (8) volts, and pulse widths between one-half (0.5) and three (3) milliseconds.

12. The method of claim 1, wherein the one or more pacing pulses have pulse amplitudes between five (5) and ten (10) volts, and pulse widths between three (3) and ten (10) milliseconds.

13. The method of claim 1, wherein delivering the one or more pacing pulses comprises delivering one or more pacing pulses having pulse widths less than or equal to one and a half (1.5) milliseconds.

14. The method of claim 13, wherein delivering the one or more pacing pulses comprises delivering the one or more pacing pulses via the at least one electrode of the implantable medical electrical lead implanted at least partially within the anterior mediastinum of the patient such that the at least one electrode is physically isolated from the pericardium of the patient comprises delivering the one or more pacing pulses via the at least one electrode of the implantable medical electrical lead implanted such that the at least one electrode is located over one of a cardiac silhouette of a ventricle of a heart of the patient as observed via an anterior-posterior (AP) fluoroscopic view of the heart or a cardiac silhouette of an atrium of the heart as observed via the AP fluoroscopic view of the heart.

15. The method of claim 1, wherein delivering the one or more pacing pulses comprises delivering one or more pacing pulses having pulse amplitudes less than approximately five (5) volts.

16. The method of claim 1, wherein delivering the one or more pacing pulses comprises delivering one or more pacing pulses having pulse amplitudes less than approximately two (2) volts.

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

18. The method of claim 1, wherein delivering the one or more pacing pulses comprises delivering the one or more pacing pulses via the at least one electrode of the implantable medical electrical lead implanted at least partially within the anterior mediastinum of the patient such that the at least one electrode is physically isolated from the pericardium of the patient, and such that a proximal portion of the implantable medical electrical lead exits the anterior mediastinum of the patient at a xiphoid process of the patient to connect to the implantable pulse generator.