CARDIAC PACING LEAD AND DELIVERY SHEATH

• US 20100125281A1
• Filed: 11/17/2009
• Published: 05/20/2010
• Est. Priority Date: 11/17/2008
• Status: Abandoned Application

• Current Assignee: Northwestern University
• Original Assignee: Northwestern University
• Inventors: Jacobson, Jason, Kim, Michael, Rubenstein, Jason
• Application Number:
  US12/620,185
• Publication Number:
  US 20100125281A1
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

The present invention provides compositions and methods related to epicardial pacing systems. In particular, the present invention provides a novel delivery sheath and cardiac pacing lead to be deployed in the pericardial space via a percutaneous approach.

Claims

1. A system comprising:

(a) an epicardial pacing lead, wherein said epicardial pacing lead comprises a bipolar configuration with respect to the main lead axis, two or more electrodes, a mechanism for attaching the electrodes to a tissue surface, and a rotation shaft; and

(b) a delivery sheath, wherein said delivery sheath comprises a cylindrical cover, two or more mapping electrodes, and an orientation balloon;

wherein said epicardial pacing lead is configured to reside within said delivery sheath, and said delivery sheath is configured to be removed over said epicardial pacing lead.

2. The system of claim 1, wherein said electrodes are configured to extend orthogonally to said main lead axis.

3. The system of claim 1, wherein said electrodes are spaced 5-15 mm apart.

4. The system of claim 1, wherein said electrodes are spaced 10 mm apart.

5. The system of claim 1, wherein said mechanism is configured to advance said electrodes orthogonally to said main lead axis.

6. The system of claim 1, wherein said rotation shaft is configured to actuate said mechanism for attaching the electrodes to a tissue surface.

7. The system of claim 1, wherein said delivery sheath is steerable via controls at the sheath handle.

8. The system of claim 1, wherein said delivery sheath is bidirectionally steerable.

9. The system of claim 1, wherein said mapping electrodes sit above said lead electrodes and have the same spacing as said lead electrodes

10. The system of claim 1, wherein said orientation balloon comprises a flat pancake-shaped balloon at the sheath tip.

11. The system of claim 1, wherein said orientation balloon is configured to maintain the orientation of said sheath within the flat pericardial space.

12. The system of claim 1, wherein said delivery sheath is configured to be removed over said epicardial pacing lead after being split by a sheath cutter.

13. The system of claim 1, wherein said delivery sheath is configured to be larger than epicardial pacing lead, thereby allowing said sheath to be removed backwards over said epicardial pacing lead.

14. A method comprising:

a) inserting a delivery sheath containing an epicardial pacing lead into the pericardium;

b) positioning said delivery sheath in the proper position over the cardiac muscle;

c) testing for said proper position of said delivery sheath using mapping electrodes on the outer surface of said delivery sheath;

d) removing said delivery sheath from epicardial pacing lead; and

e) engaging said epicardial pacing lead with said cardiac muscle by two or more deployable electrodes positioned at the end of said epicardial pacing lead.

15. The method of claim 14, wherein said inserting comprises steering the delivery sheath through the pericardium via handles on the sheath handle.

16. The method of claim 14, further comprising a step between steps (a) and (b) comprising:

maintaining proper orientation of said delivery sheath within the flat pericardial space using a flat inflatable orientation balloon at the sheath tip.

17. The method of claim 14, wherein said testing for said proper position of said delivery sheath using mapping electrodes comprises testing pacing thresholds.

18. The method of claim 14, wherein said removing said delivery sheath from epicardial pacing lead comprises splitting said delivery sheath.

19. The method of claim 14, wherein said removing said delivery sheath from epicardial pacing lead comprises withdrawing said delivery backwards over said epicardial pacing lead.

20. The method of claim 14, wherein said engaging said epicardial pacing lead with said cardiac muscle comprises screwing two screw-in electrodes into said cardiac muscle.

21. The method of claim 20, wherein said screw-in electrodes are turned by a gearing mechanism within said epicardial pacing lead.

22. The method of claim 21, wherein said gearing mechanism is turned by a rotation shaft within said epicardial pacing lead.