Direct delivery system for transvascular lead

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.

1 . A lead delivery system for delivering a neurostimulation lead to a patient's internal jugular vein using a percutaneous stick, the system comprising:
 a neurostimulation lead adapted to stimulate a vagus nerve from the internal jugular vein, the lead including 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 providing access to a lumen extending from the distal end to the side port;   a guidewire 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; and   a catheter having 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.   
   
   
       2 . The lead delivery system of  claim 1  wherein the distance between the side port and the generally spiral shaped retaining structure is a maximum of approximately 5 centimeters. 
   
   
       3 . The lead delivery system of  claim 1  wherein the lumen extends beyond the side port. 
   
   
       4 . The lead of  claim 1  wherein the generally spiral shaped retaining structure has a diameter of between approximately 5 and approximately 50 millimeters. 
   
   
       5 . The lead of  claim 1  wherein the generally spiral shaped retaining structure has a length of between approximately 30 and approximately 200 millimeters. 
   
   
       6 . The lead of  claim 1  wherein the generally spiral shaped retaining structure has a pitch of between approximately 0 centimeters and approximately 5 centimeters. 
   
   
       7 . The lead delivery system of  claim 1  wherein the neurostimulation lead has a diameter of between approximately 3 and approximately 8 French. 
   
   
       8 . The lead delivery system of  claim 1  wherein the lumen has a diameter of between approximately 0.014 and approximately 0.042 inch. 
   
   
       9 . The lead delivery system of  claim 1  wherein the catheter has a length of between approximately 10 and approximately 20 centimeters. 
   
   
       10 . The lead delivery system of  claim 1  wherein the guidewire has a diameter of between approximately 0.012 and approximately 0.040 inch and a length of between approximately 10 and approximately 40 centimeters. 
   
   
       11 . A lead delivery system for delivering a neurostimulation lead to a patient's internal jugular vein using a percutaneous stick, the system comprising:
 a neurostimulation lead adapted to stimulate a vagus nerve from the internal jugular vein, the lead including a proximal end, a distal end, a retaining structure configured to retain the lead in the internal jugular vein interposed between the proximal and distal ends, and a side port interposed between the retaining structure and the proximal end, the side port providing access to a lumen extending from the distal end to the side port;   a guidewire sized to fit within the side port and lumen and reduce a force exerted by the retaining structure against a surface external to the retaining structure, thereby facilitating advancement and orientation of the lead; and   a catheter having 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.   
   
   
       12 . The lead delivery system of  claim 11  wherein the surface external to the retaining structure is the catheter. 
   
   
       13 . The lead delivery system of  claim 11  wherein the surface external to the retaining structure is the internal jugular vein. 
   
   
       14 . The lead delivery system of  claim 11  wherein the retaining structure has a spiral, dual spiral, or stent-like structure. 
   
   
       15 . A method of directly delivering a neurostimulation lead to a patient's internal jugular vein, the method comprising:
 inserting a catheter into the internal jugular vein using a percutaneous stick;   inserting a guidewire into a side port 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, wherein the side port is interposed between the retaining structure and the proximal end and the lumen extends from the distal end to the side port;   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 catheter and the guidewire.   
   
   
       16 . The method of  claim 15  wherein advancing a portion of the neurostimulation lead comprises retaining a portion of the retaining structure in the catheter and orienting the lead comprises turning the catheter. 
   
   
       17 . The method of  claim 15  wherein advancing a portion of the neurostimulation lead comprises retaining all of the retaining structure in the catheter and orienting the lead comprises turning the catheter. 
   
   
       18 . The method of  claim 15  wherein advancing a portion of the neurostimulation lead comprises advancing the retaining structure beyond a distal end of the catheter and orienting the lead comprises turning the lead. 
   
   
       19 . The method of  claim 15  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. 
   
   
       20 . The method of  claim 15  wherein orienting the lead comprises orienting the electrode so the electrode is adjacent to a vagus nerve.