Lead stabilizer and extension wire

A kit for implanting a cardiac lead of the type comprising an elongated lead body enclosing a lead body lumen, the lead body extending from a proximal connector assembly to a distal electrode, through a skin incision of a patient accessing the vasculature to dispose the distal electrode at an implantation site within a coronary vessel of the heart of the patient, the kit comprising:

• a guide catheter extending between a guide catheter proximal end and a guide catheter distal end adapted to be advanced through the incision and the vasculature until a distal end of the guide catheter is located in the coronary vessel and the proximal end of the guide catheter is outside the skin incision, the guide catheter having a guide catheter outer diameter sized to be advanced through the vasculature and at least a portion of the coronary vessel and a guide catheter lumen sized to receive the cardiac lead;
• a guide tool adapted to be advanced through the proximal lumen opening into the lead body lumen during insertion and advancement of the cardiac lead through the guide catheter lumen, manipulated to advance the distal electrode out of the guide catheter lumen and into contact with cardiac tissue to be stimulated, and retracted and withdrawn from the lead body lumen and through the proximal lumen opening leaving the lead body extending through the guide catheter lumen;
• and
• a lead stabilization and extension wire having a distal wire segment adapted to be inserted through the proximal lumen opening into the lead body lumen after withdrawal of the guide tool to facilitate retraction of the guide catheter over the lead body further comprising:
• a wire sheath having a sheath outer diameter dimensioned to be received within the lead body lumen and a sheath lumen within a sheath body extending between sheath body proximal and distal ends;
• and
• an elongated core wire having a core wire body extending between proximal and distal core wire body ends and a core wire body outer diameter sized to be received in the sheath lumen,
• wherein the elongated core wire is insertable into the sheath lumen to selectively adjust the length of the lead stabilization and extension wire between the core wire body proximal end and the sheath body distal end.

A method for installing an intravenous cardiac lead having a lead body lumen within a patient, comprising:

• advancing a guide catheter having a guide catheter lumen through a skin incision and the vasculature until a distal end of the guide catheter is located in a coronary vessel of the heart;
• advancing the cardiac lead through the guide catheter lumen to position a distal end of the cardiac lead at an implantation site, wherein at least a portion of the cardiac lead is maintained within the guide catheter lumen;
• providing a lead stabilization and extension wire comprising a wire sheath having a sheath outer diameter dimensioned to be received within the lead body lumen and a sheath lumen within a sheath body extending between sheath body proximal and distal ends and an elongated core wire having a core wire body extending between proximal and distal core wire body ends and a core wire body outer diameter sized to be received in the sheath lumen,
• moving the elongated core wire with respect to the sheath lumen to selectively adjust the length of the lead stabilization and extension wire between the core wire body proximal end and the sheath body distal end,
• inserting a distal wire segment of the lead stabilization and extension wire into the cardiac lead lumen to stabilize the cardiac lead;
• retracting the guide catheter from the cardiac lead lumen and onto a proximal wire segment of the lead stabilization and extension wire;
• and
• retracting the distal wire segment of the lead stabilization and extension wire from the lead lumen.

A method of implanting a cardiac lead of the type comprising an elongated lead body extending from a proximal connector assembly to a distal electrode enclosing a lead conductor and a lead body lumen having a proximal lumen opening through a skin incision of a patient accessing the vasculature to dispose the distal electrode at an implantation site within a coronary vessel of the heart of the patient, the method comprising:

• advancing a guide catheter through the incision and the vasculature until a distal end of the guide catheter is located in the coronary vessel and the proximal end of the guide catheter is outside the skin incision, the guide catheter having a guide catheter outer diameter sized to be advanced through the vasculature and at least a portion of a coronary vessel and a guide catheter lumen sized to receive the cardiac lead;
• advancing the cardiac lead through the guide catheter lumen to position the distal electrode of the cardiac lead at an implantation site, wherein at least a portion of the cardiac lead is maintained within the guide catheter lumen;
• providing a wire sheath having a sheath outer diameter dimensioned to be received within the lead body lumen, a lead clamp movable along the length of the wire sheath that can engage with the lead connector element, a sheath lumen, and a sheath hub incorporating a friction element surrounding the sheath lumen;
• providing an elongated core wire having a core wire outer diameter sized to be received in the sheath lumen in frictional engagement with the friction element;
• inserting the elongated core wire into the sheath lumen to form a lead stabilization and extension wire having an extension wire length corresponding to the length of the wire sheath and the length of the core wire extending outside the sheath lumen, whereby the frictional engagement of the core wire with the friction element maintains the extension wire length;
• inserting a distal portion of the extension wire through the proximal lumen opening to extend through a proximal portion of the lead body lumen and to dispose a proximal extension wire length, substantially corresponding to the length of the guide catheter body, outside the lead body lumen;
• affixing the lead clamp to the lead connector assembly to maintain the distal portion of the extension wire within the lead body lumen and the proximal extension wire length outside the lead body lumen;
• applying stabilization force to the core wire extending proximally from the guide catheter to stabilize the lead body;
• retracting the guide catheter over the lead body to dispose the guide catheter body substantially over the proximal extension wire length thereby exposing the lead connector assembly;
• detaching the lead clamp from the lead connector assembly;
• and
• withdrawing the distal portion of the lead stabilization and extension wire from the lead body lumen through the proximal lumen opening leaving the distal electrode at the implantation site.