Substernal leadless electrical stimulation system

• US 10,668,270 B2
• Filed: 04/25/2014
• Issued: 06/02/2020
• 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., DeGroot, Paul J., McVenes, Rick D.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US14/261,488
• Publication Number:
  US 20140330331A1
• Time in Patent Office: 2,230 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 leadless cardiac pacing systems and methods for providing substernal pacing using the leadless cardiac pacing systems are described. In one embodiment, an implantable leadless cardiac pacing system includes a housing, a first electrode on the housing, a second electrode on the housing, and a pulse generator within the housing and electrically coupled to the first electrode and the second electrode. The housing is implanted substantially within an anterior mediastinum of a patient and the pulse generator is configured to deliver pacing pulses to a heart of the patient via a therapy vector formed between the first and second electrodes.

Claims

1. An implantable cardiac pacing system comprising:

a housing configured to be implanted substantially within an anterior mediastinum of a patient, wherein the anterior mediastinum represents a non-vascular, extra-pericardial location;

one or more anchoring mechanisms positioned along a length of the housing, wherein the one or more anchoring mechanisms are configured to anchor the housing within the anterior mediastinum of the patient such that the housing is physically isolated from a pericardium of the patient, wherein the one or more anchoring mechanisms comprises one or more tines extending from the housing, and wherein the one or more anchoring mechanisms are configured to affix the housing to loose connective tissue or other structures of the anterior mediastinum;

a first electrode on the housing;

a second electrode on the housing; and

a pulse generator within the housing and electrically coupled to the first electrode and the second electrode, wherein the pulse generator is configured to deliver pacing pulses to a heart of the patient via a therapy vector formed between the first and second electrodes.

2. The system of claim 1, wherein the pulse generator is configured to provide one of bradycardia pacing, antitachycardia (ATP) pacing, and post-shock pacing to the patient via the lead.

3. The system of claim 1, wherein the housing is configured to be implanted substantially within the anterior mediastinum such that the first and second electrodes are located over one of a cardiac silhouette of a ventricle of the heart as observed via an anterior-posterior (AP) fluoroscopic view of the heart.

4. The system of claim 3, further comprising:

a third electrode on the housing; and

a fourth electrode on the housing,

wherein the housing is configured to be implanted substantially within the anterior mediastinum such that the third and fourth electrodes are located over a cardiac silhouette of an atrium of the heart as observed via the AP fluoroscopic view of the heart.

5. The system of claim 1, further comprising:

a third electrode on the housing; and

a fourth electrode on the housing,

wherein the housing is configured to be implanted substantially within the anterior mediastinum such that the pulse generator provides pacing pulses to a ventricle of the heart via the first and second electrode and provides pacing pulses to an atrium of the heart via the third and fourth electrodes.

6. The system of claim 1, wherein the housing comprises a first housing and the pulse generator comprises a first pulse generator and the one or more anchoring mechanisms comprise one or more first anchoring mechanisms, the system further comprising:

a second housing separate from the first housing;

one or more second anchoring mechanisms positioned along a length of the second housing, wherein the one or more second anchoring mechanisms are configured to anchor the second housing within the anterior mediastinum of the patient such that the second housing is physically isolated from the pericardium of the patient;

a third electrode on the second housing;

a fourth electrode on the second housing; and

a second pulse generator within the second housing,

wherein the first and second housings are configured to be implanted substantially within the anterior mediastinum of the patient such that pacing pulses are delivered to a first chamber of the heart via the first and second electrodes of the first housing and pacing pulses are delivered to a second chamber of the heart via the third and fourth electrodes of the second housing.

7. The system of claim 6, further comprising:

a first communication module within the first housing; and

a second communication module within the second housing,

wherein the first communication module transmits a telemetry communication to the second communication module to coordinate the pacing pulses delivered to the first and second chambers of the heart.

8. The system of claim 1, wherein the housing comprises a first housing and the pulse generator comprises a first pulse generator, and the one or more anchoring mechanisms comprise one or more first anchoring mechanisms, the system further comprising:

a second housing separate from the first housing;

one or more second anchoring mechanisms positioned along a length of the second housing, wherein the one or more second anchoring mechanisms are configured to anchor the second housing within the anterior mediastinum of the patient such that the second housing is physically isolated from the pericardium of the patient;

a third electrode on the second housing;

a fourth electrode on the second housing; and

wherein the first and second housings are configured to be implanted substantially within the anterior mediastinum of the patient such that the first and second electrodes of the first housing sense electrical signals of a first chamber of the heart and the third and fourth electrodes of the second housing sense electrical signals of a second chamber of the heart.

9. The system of claim 8, wherein the one or more second anchoring mechanisms comprise a plurality of anchoring mechanisms.

10. The system of claim 1, wherein the pulse generator is configured to deliver pacing pulses having pulse widths greater than or equal to two (2) milliseconds.

11. The system of claim 1, wherein the pulse generator is configured to deliver pacing pulses having pulse widths between approximately one and a half (1.5) milliseconds and twenty (20) milliseconds.

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

13. The system of claim 1, wherein the pulse generator is configured to deliver pacing pulses having pulse amplitudes between approximately one (1) and twenty (20) volts.

14. The system of claim 1, wherein the pulse generator is configured to deliver pacing pulses having pulse amplitudes less than five (5) volts.

15. The system of claim 1, wherein the pulse generator is configured to deliver pacing pulses having pulse amplitudes between approximately one (1) volt and two and a half (2.5) volts.

16. The system of claim 1, wherein the one or more anchoring mechanisms comprise a plurality of anchoring mechanisms.

17. The system of claim 1, wherein each anchoring mechanism of one or more anchoring mechanisms is configured to anchor the housing 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.

18. The system of claim 1, wherein the housing includes a first housing portion comprising a conductive material, wherein the housing includes a second housing portion comprising a conductive material, and wherein the system further comprises:

a spacer that separates the first housing portion and the second housing portion, wherein the spacer comprises a non-conductive material.

19. A method comprising:

providing a leadless implantable pulse generator (IPG) substantially within an anterior mediastinum of a patient, the leadless IPG including a housing configured to be implanted substantially within the anterior mediastinum, wherein the anterior mediastinum represents a non-vascular, extra-pericardial location, one or more anchoring mechanisms positioned along a length of the housing, wherein the one or more anchoring mechanisms are configured to anchor the housing within the anterior mediastinum of the patient such that the housing is physically isolated from a pericardium of the patient, wherein the one or more anchoring mechanisms comprises one or more tines extending from the housing, and wherein the one or more anchoring mechanisms are configured to affix the housing to loose connective tissue or other structures of the anterior mediastinum, a first electrode on the housing, a second electrode on the housing, and a pulse generator within the housing and electrically coupled to the first electrode and the second electrode;

generating one or more stimulation pulses with the implantable pulse generator; and

delivering the one or more stimulation pulses to a heart of the patient via the first and second electrode of the leadless IPG implanted substantially within the anterior mediastinum.

20. The method of claim 19, wherein delivering the one or more stimulation pulses comprises delivering one or more bradycardia pacing pulses, antitachycardia (ATP) pulses, and post-shock pacing pulses.

21. The method of claim 19, wherein the leadless IPG further includes a third electrode on the housing and a fourth electrode on the housing and delivering the one or more stimulation pulses comprises delivering stimulation pulses to a ventricle of the heart via the first and second electrodes on the housing and delivering one or more stimulation pulses to an atrium of the heart via the third and fourth electrodes on the housing.

22. The method of claim 21, wherein the housing of the leadless IPG is configured to be implanted substantially within the anterior mediastinum such that the first and second electrodes are located over a cardiac silhouette of a ventricle of the heart as observed via an anterior-posterior (AP) fluoroscopic view of the heart and the third and fourth electrodes are located over a cardiac silhouette of an atrium of the heart as observed via the AP fluoroscopic view of the heart.

23. The method of claim 19, wherein the leadless IPG comprises a first leadless IPG and the one or more anchoring mechanisms comprise one or more first anchoring mechanisms, the method further comprising:

providing a second leadless implantable pulse generator (IPG) substantially within the anterior mediastinum of the patient, the second leadless IPG including a second housing configured to be implanted substantially within the anterior mediastinum, one or more second anchoring mechanisms positioned along a length of the second housing, wherein the one or more second anchoring mechanisms are configured to anchor the second housing within the anterior mediastinum of the patient such that the second housing is physically isolated from the pericardium of the patient, a third electrode on the second housing, a fourth electrode on the second housing, and a second pulse generator within the second housing and electrically coupled to the third electrode and the fourth electrode;

generating one or more stimulation pulses with the second implantable pulse generator; and

delivering the one or more stimulation pulses, via the third and fourth electrode of the second leadless IPG, to a different chamber of the heart than the stimulation pulses delivered by the first leadless IPG.

24. The method of claim 23, further comprising transmitting a communication from the first leadless IPG to the second leadless IPG to coordinate the stimulation pulses delivered to the different chambers of the heart.

25. The method of claim 19, wherein generating and delivering the one or more stimulation pulses comprises generating and delivering one or more stimulation pulses having pulse widths between approximately one and a half (1.5) milliseconds and twenty (20) milliseconds.