DIRECT DELIVERY SYSTEM FOR TRANSVASCULAR LEAD

• US 20110178530A1
• Filed: 04/04/2011
• Published: 07/21/2011
• Est. Priority Date: 01/30/2007
• Status: Active Grant

• Current Assignee: Mark J. Bly
• Original Assignee: Mark J. Bly
• Inventors: Bly, Mark J.
• Granted Patent: US 8,311,647 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

A lead delivery system for delivering a neurostimulation lead to a patient'"'"'s internal jugular vein using a percutaneous stick. The system comprises a neurostimulation lead adapted to stimulate a vagus nerve from the internal jugular vein. The lead includes a proximal end, a distal end, a generally spiral shaped retaining structure interposed between the proximal and distal ends and configured to retain the lead in the internal jugular vein, an electrode coupled to the retaining structure, and a side port interposed between the retaining structure and the proximal end. The side port provides access to a lumen extending from the distal end to the side port. A guidewire is sized to fit within the side port and lumen and reduce a force exerted by the retaining structure against the internal jugular vein, thereby allowing rotation of the lead and orientation of the electrode by applying a torque to the lead. A catheter has a lumen sized to slideably receive the medical electrical lead and configured to provide access to the internal jugular vein from the percutaneous stick site. A method of delivering a medical electrical lead to a patient'"'"'s internal jugular vein.

Claims

1. A method of directly delivering a neurostimulation lead to a patient'"'"'s internal jugular vein, the method comprising:

inserting an introducer into the internal jugular vein using a percutaneous stick;

inserting a guidewire into and through a lumen of a neurostimulation lead, the neurostimulation lead including a proximal end, a distal end, a retaining structure interposed between the proximal and distal ends, and an electrode coupled to the retaining structure;

advancing a portion of the neurostimulation lead through the introducer and orienting the lead to a desired position in the internal jugular vein; and

removing the introducer and the guidewire.

2. The method of claim 1 wherein the neurostimulation lead includes a side port interposed between the retaining structure and the proximal end, the lumen extends from the distal end to the side port, and wherein inserting the guidewire into and through the lumen of the neurostimulation lead comprises inserting the guidewire into the side port.

3. The method of claim 2 wherein a distance between the side port and the retaining structure is a maximum of about 5 centimeters.

4. The method of claim 1 wherein advancing a portion of the neurostimulation lead comprises advancing the retaining structure beyond a distal end of the introducer and orienting the lead comprises turning the lead.

5. The method of claim 1 further comprising reducing a force exerted by the retaining structure against a surface external to the retaining structure by inserting the guidewire through the lumen.

6. The method of claim 1 wherein orienting the lead comprises orienting the electrode so the electrode is adjacent to a vagus nerve.

7. The method of claim 1 wherein the retaining structure comprises a generally spiral shaped retaining structure.

8. The method of claim 6 wherein the generally spiral shaped retaining structure has a diameter of between about 5 millimeters and about 50 millimeters.

9. The method of claim 6 wherein the generally spiral shaped retaining structure has a pitch of between about 0 centimeters and about 5 centimeters.

11. The method of claim 9 wherein inserting a stylet into and through a lumen of the neurostimulation lead comprises inserting the stylet into a side port disposed within the neurostimulation lead.

12. The method of claim 9 wherein advancing a portion of the neurostimulation lead comprises advancing the retaining structure beyond a distal end of the introducer and orienting the lead comprises turning the lead.

13. The method of claim 9 further comprising reducing a force exerted by the retaining structure against a surface external to the retaining structure by inserting the guidewire through the lumen.

14. The method of claim 9 wherein orienting the lead comprises orienting the electrode so the electrode is adjacent to a vagus nerve.

15. The method of claim 9 wherein the neurostimulation lead has a diameter of between about 3 and about 8 French.

16. The method of claim 9 wherein the introducer has a length of between about 10 and about 20 centimeters.

10. A method of directly delivering a neurostimulation lead to a patient'"'"'s internal jugular vein, the method comprising:

inserting an introducer into the internal jugular vein;

inserting a stylet into and through a lumen of a neurostimulation lead, the neurostimulation lead including a proximal end, a distal end, a retaining structure interposed between the proximal and distal ends, and an electrode coupled to the retaining structure;

advancing a portion of the neurostimulation lead through the catheter and orienting the lead to a desired position in the internal jugular vein; and

removing the introducer and the stylet.

17. A method of directly delivering a neurostimulation lead to a patient'"'"'s internal jugular vein, the method comprising:

inserting an introducer into the internal jugular vein;

inserting a straightening member into a lumen of a neurostimulation lead, the neurostimulation lead including a proximal end, a distal end, a retaining structure interposed between the proximal and distal ends, and an electrode coupled to the retaining structure;

advancing a portion of the neurostimulation lead through the introducer and orienting the lead to a desired position in the internal jugular vein; and

removing the introducer and the straightening member.

18. The method of claim 17 wherein inserting a straightening member into a lumen of the neurostimulation lead comprises inserting the straightening member into a side port of the neurostimulation lead.

19. The method of claim 17 wherein advancing a portion of the neurostimulation lead comprises advancing the retaining structure beyond a distal end of the introducer and orienting the lead comprises turning the lead.

20. The method of claim 17 wherein orienting the lead comprises orienting the electrode so the electrode is adjacent to a vagus nerve.