Myocardial lead attachment system

• US 20050113901A1
• Filed: 10/22/2004
• Published: 05/26/2005
• Est. Priority Date: 10/24/2003
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Westlund, Randy W., Heil, Ronald W. Jr., Kelley, Peter T., Shiroff, Jason Alan, Gresl, Charles, Coe, M. Sean, Palme, Donald F. II
• Application Number:
  US10/971,551
• Publication Number:
  US 20050113901A1
• Time in Patent Office: Days
• US Class Current: 607/130
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/0608 J-shaped
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61N 1/0568 with drug delivery
• 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
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

The present invention is a myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient'"'"'s heart. The system includes an anchor, a tether coupled to the anchor, and a delivery instrument for receiving and advancing the anchor through a tract in the heart from a proximal entrance site to a distal exit site in such a manner that the tether extends proximally from the anchor through the tract. The delivery instrument includes a needle having a distal tip and a nest. The nest is positioned proximal to the distal tip and is sized to receive the anchor. The delivery instrument further includes an ejection mechanism for ejecting the anchor from the nest.

Claims

1. A myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient'"'"'s heart, the system comprising:

an anchor;

a tether coupled to the anchor; and

a delivery instrument for receiving and advancing the anchor through a tract in the heart from a proximal entrance site to a distal exit site in such a manner that the tether extends proximally from the anchor through the tract, said delivery instrument comprising;

a needle having a distal tip and a nest positioned proximal to the distal tip and sized to receive the anchor, and

an ejection mechanism for ejecting the anchor from the nest.

2. The lead attachment system of claim 1 wherein the ejection mechanism further comprises an actuator for ejecting the anchor from the nest.

3. The lead attachment system of claim 1 wherein a distal portion of the needle is formed with a radial curvature.

4. The lead attachment system of claim 2 wherein the ejection mechanism further comprises an elongated member slidable from a retracted position to an extended position in response to actuation of the actuator to engage the anchor mechanism.

5. The lead attachment system of claim 4 further comprising:

a mechanical stop for limiting extension of the elongated member; and

a resilient member biasing the actuator to retract the elongated member.

6. The lead attachment system of claim 1 wherein the delivery instrument further comprises:

a distal electrically active area on the needle; and

a conductive member for connecting the electrically active area to an external electrical device.

7. The lead attachment system of claim 1 wherein the nest further includes a slot for receiving the tether.

8. The lead attachment system of claim 1 wherein the nest includes a ramp adapted to assist in ejection of the anchor.

9. The lead attachment system of claim 1 further comprising a lead body having a proximal end, a distal end, and at least a first electrode near the distal end, said lead body adapted to advance over the tether through the tract.

10. The lead attachment system of claim 9 wherein the lead body is a unipolar lead.

11. The lead attachment system of claim 10 wherein the lead body includes a second electrode spaced apart the first electrode apart by about at least 2 cm.

12. The lead attachment system of claim 9 wherein the lead body is a pseudo-unipolar lead.

13. The lead attachment system of claim 9 wherein the lead body is a bipolar lead.

14. A myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient'"'"'s heart, the system comprising:

an anchor having a longitudinal bore extending therethrough;

a tether coupled to the anchor; and

a delivery instrument for receiving and advancing the anchor through a tract in the heart from a proximal entrance site to a distal exit site in such a manner that the tether extends proximally from the anchor through the tract, said delivery instrument comprising;

a needle having a proximal end, a distal end formed with a nest for receiving the anchor and a central lumen extending therethrough;

a stylet slidably received in the needle lumen and the anchor bore, and

an ejector plug formed on the stylet for engaging the anchor.

15. The lead attachment system of claim 14 wherein the nest is an open sleeve at the distal end of the needle.

16. The lead attachment system of claim 15 wherein the nest has an internal stop for transmitting an axial force to the anchor.

17. The lead attachment system of claim 15 wherein the anchor has a proximal region sized to be received in the nest and a distal region sized to be retained outside of the nest.

18. The lead attachment system of claim 15 wherein the anchor has a tapered distal face shaped to dissect the tissue of the myocardium.

19. The lead attachment system of claim 14 wherein the stylet has a pointed distal end shaped to dissect the tissue of the myocardium.

20. A method for using a delivery instrument to implant a myocardial lead into the heart, said lead having at least a first electrode, the method comprising:

mating a myocardial anchor coupled to a tether to a distal end of the delivery instrument;

advancing the distal end of the delivery instrument through a tract in the heart;

deploying the anchor into the heart;

withdrawing the delivery instrument through the tract in such a manner that the tether extends through the tract;

threading a myocardial lead onto the tether; and

advancing the lead over the tether into the heart.

21. The method of claim 20 further comprising:

advancing the anchor through the epicardium, into the myocardium, and back through the epicardium; and

deploying the anchor mechanism on the epicardial surface.

22. The method of claim 20 further comprising:

advancing the anchor through the epicardium, into the myocardium and through the endocardium; and

deploying the anchor on the endocardial surface.

23. The method of claim 20 further comprising:

advancing the anchor through the epicardium and into the myocardium; and

deploying the anchor into the myocardium.

24. The method of claim 20 further comprising:

advancing the anchor into the pericardium and out of the pericardium without traversing the epicardium; and

deploying the anchor on the pericardial surface.

25. The method of claim 20 further comprising advancing the lead body until the first electrode is in contact with the heart.

26. The method of claim 20 further comprising advancing the lead body until the first electrode is in contact with the myocardium.

27. The method of claim 26 wherein the lead body includes a second electrode proximal to the first electrode and further comprising advancing the lead body until the second electrode is at least partially in contact with the heart.

28. The method of claim 27 further comprising advancing the lead body until the second electrode straddles the epicardium.

29. The method of claim 27 further comprising advancing the lead body until the second electrode is in contact with the myocardium.

30. The method of claim 20 further comprising:

forming a working channel and a visual channel to the heart with an endoscopic probe; and

advancing the anchor and delivery instrument to the heart through the working channel.