Methods and apparatus for lead placement on a surface of the heart

• US 7,610,104 B2
• Filed: 05/10/2002
• Issued: 10/27/2009
• Est. Priority Date: 05/10/2002
• Status: Active Grant

• Current Assignee: SentreHeart, LLC (Atricure, Inc.)
• Original Assignee: Cerebral Vascular Applications, Inc.
• Inventors: Kaplan, Aaron V., Hahnen, Kevin F.
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Heller; Tammie K.
• Application Number:
  US10/144,205
• Publication Number:
  US 20030212446A1
• Time in Patent Office: 2,727 Days
• Field of Search: 606/129, 607/129, 607/115, 607/122
• US Class Current: 607/122
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

The methods and apparatus for lead placement on a surface of the heart are employed using an elongated body having proximal and distal end portions. The body defines a lead receiving passageway extending between a proximal inlet and a distal outlet for receiving a lead therethrough for contact with the heart surface. The elongated body is adapted for insertion between a pericardium and an epicardial surface. At least a portion of the body may have a non-circular cross-sectional shape adapted to retain the body orientation between the pericardium and the epicardial surface.

Claims

1. An apparatus adapted for placing a lead at a target site on an epicardial surface of a heart using a minimally-invasive delivery procedure, the epicardial surface of the heart having a generally convex shape and being surrounded by a pericardial sac, an inner surface of the pericardial sac generally conforming to the epicardial surface and defining a generally concave shape, the apparatus comprising:

an elongated body including a longitudinal axis, a proximal end portion and a distal end portion and defining a lead receiving passageway extending between a proximal inlet and a distal lead outlet for receiving a lead therethrough for contact with the epicardial surface of the heart, the elongated body being sufficiently flexible along the longitudinal axis to conform to the epicardial surface and sufficiently stiff to allow movement of the distal end in at least one plane upon application of a force to the proximal end of the lead body, the elongated body having a length sufficient to enable access to the target site using a sub-xyphoid approach,

wherein the distal end portion includes an upper surface and a lower surface opposed to the upper surface and configured to contact and generally conform to the epicardial surface, the distal lead outlet being located on the lower surface, the distal end portion having a cross-section with a width and a thickness, the width being greater than the thickness, the width and thickness tapering distally along the distal end portion such that the distal end portion has a tapered leading end,

wherein the tapered leading end is adapted to facilitate advancement of the distal end portion through a pericardial space located between the convex epicardial surface and the concave pericardial inner surface, and

wherein the distal end portion further defines a guidewire outlet, the guidewire outlet being smaller than the distal lead outlet, the guidewire outlet providing a pathway from the distal lead outlet to a distal end of the elongated body and being adapted to track the distal end portion on a guidewire along a pathway between the epicardial and pericardial surfaces to the target site.

2. The apparatus of claim 1 wherein the elongated body between the proximal inlet and the distal outlet of the lead receiving passageway has a length in the range of 10 cm to 40 cm.

3. The apparatus of claim 1 wherein the elongated body defines a plurality of lumens extending between the proximal inlet and the distal outlet.

4. The apparatus of claim 1 wherein the distal end portion of the elongated body is thinner than a more proximal portion of the elongated body.

5. The apparatus of claim 1 further comprising an elongated guide wire having a proximal end and a distal end and being received within the lead receiving passageway to facilitate lead placement.

6. The apparatus of claim 1 wherein the elongated body further defines a dedicated guide wire lumen extending between a guide wire inlet and the guide wire outlet, and an elongated guide wire having a proximal end and a distal end and being received within the guide wire lumen.

7. The apparatus of claim 1 wherein the proximal inlet of the lead receiving passageway is located between the proximal end portion and distal end portion of the elongated body.

8. The apparatus of claim 1 wherein the proximal inlet of the lead receiving passageway is located at the proximal end portion of the elongated body.

9. The apparatus of claim 1 further including a handle located at the proximal end portion of the elongated body.

10. The apparatus of claim 1 wherein the elongated body further defines a fluid delivery lumen having a proximal opening and a distal opening which is located in proximity to the distal lead outlet, the fluid delivery lumen being in fluid communication with a fluid source at the proximal opening so as to introduce a fluid to a pericardial space.

11. The apparatus of claim 1 further including an endoscope carried by the elongated body having a proximal end and a distal end which is located in proximity to the distal lead outlet, the proximal end of the endoscope being connected to an operator-readable output device so as to view the surface of the heart in proximity to the distal end of the endoscope.

12. The apparatus of claim 1 further including an elongated flexible element having a proximal end and a distal end and being disposed in at least a portion of the elongated body which is configured to be inserted between the pericardial inner surface and the epicardial surface, the element being adapted to retain a desired shape corresponding to a surface of the heart.

13. The apparatus of claim 12 wherein the elongated flexible element is a wire carried by the elongated body.

14. The apparatus of claim 1 wherein the elongated body defines a longitudinal axis and at least a portion of the elongated body is curved relative to the longitudinal axis.

15. The apparatus of claim 14 wherein at least a portion of the elongated body is curved in the range of approximately 10 degrees to 80 degrees.

16. The apparatus of claim 1 further including an elongated sleeve disposed circumferentially relative to the elongated body, the sleeve being adapted to control a curvature of the elongated body relative to a longitudinal axis.

17. The apparatus of claim 1, wherein the guide wire outlet is a channel formed in the lower surface of the distal end portion.

18. The apparatus of claim 1, wherein the guide wire outlet is oriented in a direction parallel with a longitudinal axis of the elongated body and the lead outlet is generally oriented in a direction perpendicular with the lower surface.

19. An apparatus adapted for placing a lead at a target site on an epicardial surface of a heart using a minimally-invasive delivery procedure, the epicardial surface of the heart having a generally convex shape and being surrounded by a pericardial sac, an inner surface of the pericardial sac generally conforming to the epicardial surface and defining a generally concave shape, the apparatus comprising:

an elongated body including a longitudinal axis, a proximal end portion and a distal end portion and defining a passageway which includes at least one inlet adapted to receive an elongated guide wire and a lead, the distal end portion having a cross-section with a width and a thickness, the width being greater than the thickness, the width and thickness tapering distally along the distal end portion such that the distal end portion has a tapered leading end, the tapered leading end being adapted to facilitate advancement of the distal end portion through a pericardial space located between the convex epicardial surface and the concave pericardial inner surface, the passageway having a lead outlet and a guide wire outlet which is distally located on the elongated body in relation to the lead outlet and non-concentric with the lead outlet, the lead outlet being sufficiently sized to allow passage of the lead for contact with the surface of the heart, the guide wire outlet being sufficiently sized and oriented to allow passage of the guide wire forward of the distal end portion of the elongated body, the guide wire outlet being smaller than the lead outlet to avoid extension of the lead beyond of the distal end portion of the elongated body, wherein the distal end portion includes an upper surface and a lower surface opposed to the upper surface and configured to contact and generally conform to the epicardial surface, and the lead and guide wire outlets are located on the lower surface.

20. The apparatus of claim 19 wherein the lead outlet distally tapers to the guide wire outlet.

21. The apparatus of claim 19 wherein the portion of the elongated body at the guide wire outlet is thinner than a more proximal portion of the elongated body.

22. The apparatus of claim 19 wherein the elongated body in proximity to at least one of the lead outlet and guide wire outlet has a non-circular shape.

23. The apparatus of claim 19 wherein the elongated body is sufficiently flexible along the longitudinal axis to conform to the epicardial surface.

24. The apparatus of claim 19, wherein the guide wire outlet is a channel formed in the lower surface of the distal end portion.

25. The apparatus of claim 19, wherein the guide wire outlet is oriented in a direction parallel with the longitudinal axis of the elongated body and the lead outlet is generally oriented in a direction perpendicular with the lower surface.