Spiral configurations for intravascular lead stability

• US 8,244,378 B2
• Filed: 01/30/2007
• Issued: 08/14/2012
• Est. Priority Date: 01/30/2007
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bly, Mark J., Westlund, Randy W., Heil, Ronald W. Jr., Koop, Brendan E., Zarembo, Paul E.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US11/668,926
• Publication Number:
  US 20080183259A1
• Time in Patent Office: 2,023 Days
• Field of Search: 607/115, 607/127, 607/131
• US Class Current: 607/127
• 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 medical electrical lead for transvascularly stimulating a nerve, muscle or other tissue from an adjacent vessel is described. The lead includes an expandable distal portion having one or more spirals for securing and stabilizing the lead within the vessel.

Claims

1. A medical electrical lead for stimulating a vagus nerve, wherein the lead is adapted to be delivered to a stimulation site within an internal jugular vein having a vessel wall adjacent to the vagus nerve, the lead comprising;

a proximal end adapted to be connected to a pulse generator;

a lead body including a distal portion comprising a first continuous spiral, a second continuous spiral, and a generally straight portion occurring between the first spiral and the second spiral, wherein the first and second spirals are adapted to transition between a collapsed configuration and an expanded configuration sized and shaped for securing and stabilizing the lead at the stimulation site in the internal jugular vein, and wherein in the expanded configuration the spirals are generally aligned with one another and have a predetermined effective outer diameter ranging from about 5 to about 50% greater than an inner diameter of the internal jugular vein such that the spirals are adapted to impart a lateral force on the vessel wall to urge the vessel wall in an outward direction towards the vagus nerve and wherein the generally straight portion is configured to extend generally parallel to a longitudinal axis of the lead body and to the vagus nerve when the lead is implanted in the internal jugular vein;

one or more conductors extending within the lead body including the distal portion; and

one or more electrodes adapted to deliver an electrical pulse transvascularly to the nerve to be stimulated located on the distal portion and operatively coupled to the one or more conductors, each of the one or more electrodes comprising a masked portion and an unmasked portion, wherein when the distal portion is in the expanded configuration, the unmasked portion of at least one electrode is located on an outer circumference of the first spiral or the second spiral such that the unmasked portion of the at least one electrode is adapted to be oriented in a direction towards the vagus nerve and to be placed in contact with the vessel wall adjacent to the vagus nerve and the masked portion is located on an inner circumference of the spiral and is adapted to be oriented away from the vagus nerve.

2. The medical electrical lead according to claim 1, wherein a distance between the electrode and the vagus nerve is less than 2 mm.

3. The medical electrical lead according to claim 1, wherein the first spiral winds in a first direction and the second spiral winds in an opposite second direction.

4. The medical electrical lead according to claim 1, wherein the distal portion is sized and shaped so that the unmasked portions of at least two electrodes are located on the outer circumference of the first spiral and/or the second spiral and oriented in a direction towards the vagus nerve when the distal portion is in the expanded configuration.

5. The medical electrical lead according to claim 1, wherein the distal portion comprises a superelastic material selected from the group consisting of Nitinol and MP35N.

6. The medical electrical lead according to claim 1, further comprising at least one electrode located on the generally straight portion.

7. The medial electrical lead according to claim 1, wherein the distal portion comprises one or more electrodes in parallel alignment with the nerve to be stimulated when the lead is implanted.