PACING LEAD AND METHOD FOR PACING IN THE PERICARDIAL SPACE

• US 20080065185A1
• Filed: 09/26/2006
• Published: 03/13/2008
• Est. Priority Date: 09/10/2006
• Status: Active Grant

• Current Assignee: Seth Worley
• Original Assignee: Seth Worley
• Inventors: Worley, Seth
• Granted Patent: US 8,036,757 B2
• Time in Patent Office: Days
• US Class Current: 607/119
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A pacing lead for implantation in the pericardial space includes an elongated lead body, a compression fixation element, and at least one electrode on either the lead body or the fixation element. The fixation element defines a resilient structure, and is positioned and dimensioned so that when the lead is disposed in the pericardial space, the resilient fixation element is compressed between the parietal and visceral pericardium, thereby biasing the electrode against the myocardium and providing positional stabilization to the lead. Further positional stability may be provided mechanically with structures enabling the application of adhesive or with fixation screw or tine elements.

Claims

1. A pacing lead for implantation in a pericardial space defined between an epicardial wall and a parietal pericardial wall, the epicardial wall and the parietal pericardial wall defining a height dimension of the pericardial space, the pacing lead comprising:

an elongated lead body presenting a longitudinal axis;

a generally helically shaped resilient fixation element extending from the elongated lead body along an axis oriented in a direction generally normal to the longitudinal axis, the resilient fixation element presenting a predetermined height dimension greater than the height dimension of the pericardial space; and

at least one electrode on either the lead body or the resilient fixation element, wherein when the resilient fixation element is emplaced within the pericardial space, the resilient fixation element is compressed between the epicardial wall and the parietal pericardial wall and thereby exerts a biasing force, biasing the at least one electrode against the epicardial wall.

2. The lead of claim 1, wherein the lead includes a pair of electrodes.

3. The lead of claim 1, wherein the lead body defines a first lumen for receiving a stylet or guidewire.

4. The lead of claim 3, wherein the first lumen extends through the lead body and the resilient fixation element.

5. The lead of claim 3, wherein the lead defines an aperture extending from the first lumen to an exterior surface of the lead.

6. The lead of claim 3, further comprising a stylet or guidewire.

7. The lead of claim 3, wherein the lead body defines a second lumen for transporting adhesive for fixing the lead.

8. The lead of claim 1, wherein the biasing force exerted by the resilient fixation element is between about 1 gram and about 30 grams.

9. The lead of claim 7, wherein the biasing force exerted by the resilient fixation element is between about 3 grams and about 10 grams.

10. The lead of claim 1, further comprising a fixation screw element or fixation tines.

33. The lead of claim 1, further comprising a fixation screw element or fixation tines.

11. A method of emplacing a pacing lead having a preformed shape into a pericardial space defined between an epicardial wall and a parietal pericardial wall, the method comprising:

providing a pacing lead including an elongated lead body presenting a longitudinal axis, a pre-formed generally helically shaped resilient fixation element extending from the elongated lead body along an axis oriented in a direction generally normal to the longitudinal axis, and at least one electrode on either the lead body or the resilient fixation element;

advancing a guidewire into the pericardial space through a coronary venous system;

advancing the pacing lead into the pericardial space over the guidewire, dilating at least a portion of the coronary venous system as the pacing lead is advanced over the guidewire; and

withdrawing the guidewire to enable the resilient fixation element to assume its pre-formed shape, the resilient fixation element being compressed within the pericardial space so as to bias the at least one electrode against the epicardial wall, the elongated lead body being frictionally engaged and stabilized within the dilated portion of the coronary venous system.

12. A pacing lead for implantation in a pericardial space defined between an epicardial wall and a parietal pericardial wall, the epicardial wall and the parietal pericardial wall defining a height dimension of the pericardial space, the pacing lead comprising:

an elongated lead body presenting a longitudinal axis;

resilient fixation means extending from the lead body; and

at least one electrode on either the lead body or the resilient fixation means, wherein when the resilient fixation element is emplaced within the pericardial space, the resilient fixation means is compressed between the epicardial wall and the parietal pericardial wall and thereby exerts a biasing force, biasing the at least one electrode against the epicardial wall.

13. The pacing lead of claim 12, wherein the resilient fixation means comprises a generally helically shaped fixation element.

14. The pacing lead of claim 13, wherein the generally helically shaped fixation element extends from the elongated lead body along an axis oriented in a direction generally normal to the longitudinal axis.

15. The pacing lead of claim 12, wherein the resilient fixation means comprises a loop structure.

16. The lead of claim 12, wherein the lead body defines a first lumen for receiving a stylet or guidewire.

17. The lead of claim 16, wherein the first lumen extends through the lead body and the resilient fixation element.

18. The lead of claim 16, wherein the lead defines an aperture extending from the first lumen to an exterior surface of the lead.

19. The lead of claim 16, wherein the lead body defines a second lumen for transporting adhesive for fixing the lead.

20. The lead of claim 12, wherein the biasing force exerted by the resilient fixation means is between about 1 gram and about 30 grams.

21. The lead of claim 20, wherein the biasing force exerted by the resilient fixation means is between about 3 grams and about 10 grams.

22. The lead of claim 12, further comprising mechanical fixation means.

23. The lead of claim 22, wherein the mechanical fixation means includes adhesive, a fixation screw element, or fixation tines.

24. A pacing lead for implantation in a pericardial space defined between an epicardial wall and a parietal pericardial wall, the epicardial wall and the parietal pericardial wall defining a height dimension of the pericardial space, the pacing lead comprising:

an elongated lead body presenting a longitudinal axis;

a resilient compression fixation element extending from the elongated lead body about an axis oriented in a direction generally normal to the longitudinal axis, the resilient compression fixation element presenting a predetermined height dimension greater than the height dimension of the pericardial space; and

a first electrode on one of the lead body or the resilient fixation element, wherein when the resilient fixation element is emplaced within the pericardial space, the resilient fixation element is compressed between the epicardial wall and the parietal pericardial wall and thereby exerts a biasing force, biasing the first electrode against the epicardial wall.

25. The lead of claim 24, wherein the lead further comprises a second electrode, the second electrode spaced apart from the first electrode and disposed on the other of the lead body or the resilient fixation element, wherein when the resilient fixation element is emplaced within the pericardial space, the first electrode is biased against the epicardial wall while the second electrode is biased against the parietal pericardial wall.

26. The lead of claim 24, wherein the lead body defines a first lumen.

27. The lead of claim 26, wherein the lead defines at least one aperture extending from the first lumen to an exterior surface of the lead.

28. The lead of claim 27, wherein the lead further includes absorbent material for distributing adhesive disposed proximate the at least one aperture.

29. The lead of claim 28, wherein the absorbent material covers the at least one aperture.

30. The lead of claim 27, wherein the lead includes a plurality of apertures extending from the first lumen to the exterior of the lead.

31. The lead of claim 30, wherein the lead includes a plurality of electrodes and wherein each of the plurality of apertures is disposed proximate one of the plurality of electrodes.

32. The lead of claim 26, wherein the lead body defines a second lumen for transporting adhesive for fixing the lead.

34. A method of emplacing a pacing lead having a preformed shape into a pericardial space defined between an epicardial wall and a parietal pericardial wall, the method comprising:

providing a pacing lead including an elongated lead body presenting a longitudinal axis, a pre-formed resilient compression fixation element extending from the elongated lead body about an axis oriented in a direction generally normal to the longitudinal axis, the resilient compression fixation element presenting a predetermined height dimension greater than the height dimension of the pericardial space, and a first electrode on one of the lead body or the resilient fixation element;

straightening the pre-formed resilient compression fixation element with a guidewire or stylet;

advancing the pacing lead into the pericardial space; and

withdrawing the guidewire or stylet to enable the pre-formed resilient fixation element to assume its pre-formed shape, wherein the pre-formed resilient fixation element is compressed within the pericardial space so as to bias the at least one electrode against the epicardial wall.

35. The method of claim 34, wherein the lead body defines a first lumen and wherein the step of straightening the pre-formed resilient compression fixation element comprises disposing the guidewire or stylet in the first lumen.

36. The method of claim 35, wherein the lead defines at least one aperture extending from the first lumen to an exterior surface of the lead, and wherein the method further comprises applying adhesive through the at least one aperture to adhere the lead to the epicardial wall or the parietal pericardial wall.

37. The method of claim 36, further comprising introducing adhesive to a location proximate the at least one aperture by forcing the adhesive through the first lumen.

38. The method of claim 36, further comprising disposing a hollow stylet in the first lumen and disposing the adhesive proximate the at least one opening through the hollow stylet.

39. The method of claim 35, wherein the lead body defines a second lumen, wherein the lead body defines at least one aperture extending from the second lumen to an exterior surface of the lead, and wherein the method further comprises applying adhesive through the at least one aperture to adhere the lead to the epicardial wall or the parietal pericardial wall.

40. The method of claim 39, further comprising introducing adhesive to a location proximate the at least one aperture by forcing the adhesive through the second lumen.

41. The method of claim 39, further comprising disposing a hollow stylet in the second lumen and disposing the adhesive proximate the at least one opening through the hollow stylet.

42. The method of claim 34, wherein the lead includes a fixation screw element or fixation tines, and wherein the method includes engaging the fixation screw element or fixation tines with the epicardial wall or the parietal pericardial wall.