Subcutaneous lead with tined fixation
First Claim
1. An implantable lead configured for placement within a tunnel formed in subcutaneous non-intrathoracic tissue, comprising:
- a lead body;
a cardiac electrode supported by the lead body, the cardiac electrode configured for one or both of sensing cardiac activity and delivering cardiac stimulation energy from a location within the tunnel; and
a plurality of fixation elements disposed longitudinally along at least an electrically insulative portion of the lead body in a spaced relationship, the fixation elements configured to passively secure one or both of the cardiac electrode and the lead body in subcutaneous non-intrathoracic tissue at a plurality of longitudinally spaced fixation sites of the tunnel, the plurality of fixation elements comprising;
a first set of curved tines, each curved tine of the first set comprising a first end attached to the lead body on the electrically insulative portion and a free end opposite the first end, each curved tine of the first set biased out of plane with respect to a longitudinal axis of the lead body in a first orientation to curve around some of the circumference of the lead body such that the free end points in a clockwise direction with respect to the circumference of the lead body at which the first end is attached to the lead body to resist rotation of the lead in the clockwise direction; and
a second set of curved tines, each curved tine of the second set comprising a first end attached to the leady body on the electrically insulative portion and a free end opposite the first end, each curved tine of the second set biased out of plane with respect to the longitudinal axis of the lead body in a second orientation to curve around some of the circumference of the lead body such that the free end points in a counterclockwise direction with respect to the circumference of the lead body at which the first end is attached to the lead body to resist rotation of the lead in the counterclockwise direction.
1 Assignment
0 Petitions
Accused Products
Abstract
Implantable subcutaneous devices and methods employ a lead and/or electrode for cardiac monitoring and/or intervention. The devices and methods may employ one or more fixation elements including, for example, tines, tines with barbs, spring-loaded tines, flexible or collapsible tines, and other tined fixation mechanisms configured to passively secure one or both of the electrode or body of the lead in subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads according to the present invention involves providing a lead comprising a lead body, an electrode, and one or more fixation elements, and passively securing one or both of the lead body and the electrode to subcutaneous non-intrathoracic tissue at one or more fixation sites using the fixation elements. The method may involve use of a delivery device, such as a sheath, for lead delivery to a subcutaneous non-intrathoracic implant site.
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Citations
29 Claims
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1. An implantable lead configured for placement within a tunnel formed in subcutaneous non-intrathoracic tissue, comprising:
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a lead body; a cardiac electrode supported by the lead body, the cardiac electrode configured for one or both of sensing cardiac activity and delivering cardiac stimulation energy from a location within the tunnel; and a plurality of fixation elements disposed longitudinally along at least an electrically insulative portion of the lead body in a spaced relationship, the fixation elements configured to passively secure one or both of the cardiac electrode and the lead body in subcutaneous non-intrathoracic tissue at a plurality of longitudinally spaced fixation sites of the tunnel, the plurality of fixation elements comprising; a first set of curved tines, each curved tine of the first set comprising a first end attached to the lead body on the electrically insulative portion and a free end opposite the first end, each curved tine of the first set biased out of plane with respect to a longitudinal axis of the lead body in a first orientation to curve around some of the circumference of the lead body such that the free end points in a clockwise direction with respect to the circumference of the lead body at which the first end is attached to the lead body to resist rotation of the lead in the clockwise direction; and a second set of curved tines, each curved tine of the second set comprising a first end attached to the leady body on the electrically insulative portion and a free end opposite the first end, each curved tine of the second set biased out of plane with respect to the longitudinal axis of the lead body in a second orientation to curve around some of the circumference of the lead body such that the free end points in a counterclockwise direction with respect to the circumference of the lead body at which the first end is attached to the lead body to resist rotation of the lead in the counterclockwise direction. - View Dependent Claims (2, 3, 4, 5, 6)
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7. An implantable lead system configured for placement within a tunnel formed in subcutaneous non-intrathoracic tissue, comprising:
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a lead comprising a lead body and a cardiac electrode configured for one or both of sensing cardiac activity and delivering cardiac stimulation energy from a location within the tunnel, the lead configured for placement within the tunnel; a plurality of fixation elements comprising a plurality of tines disposed longitudinally along at least an electrically insulative portion of the lead body in a spaced relationship, the plurality of tines comprising; at least one first type of tine having a first end attached to the electrically insulative portion of the lead body and a free end distal with respect to the first end, each of the first type of tine orientated along the lead body to extend from the lead body in a distal direction to passively secure one or both of the cardiac electrode and the lead body in subcutaneous non-intrathoracic tissue of the tunnel and resist axial displacement of the lead in the distal direction; and at least one second type of tine having a first end attached to the electrically insulative portion of the lead body and a free end proximal with respect to the first end, each of the second type of tine orientated along the lead body to extend from the lead body in a proximal direction to passively secure one or both of the cardiac electrode and the lead body in subcutaneous non-intrathoracic tissue of the tunnel and resist axial displacement of the lead in the proximal direction; and a delivery apparatus configured to introduce the lead to a desired location within the tunnel, the delivery apparatus comprising a sheath, a lumen of the sheath dimensioned to at least partially collapse the tines while permitting axial displacement of the lead within the lumen, wherein removal of the sheath from the lead body allows the tines to engage the subcutaneous non-intrathoracic tissue. - View Dependent Claims (8, 9)
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10. A method of stabilizing a lead within a tunnel formed in subcutaneous non-intrathoracic tissue, comprising:
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providing a lead comprising a lead body, a cardiac electrode, and a plurality of fixation elements comprising a plurality of tines disposed longitudinally along at least an electrically insulative portion of the lead body in a spaced relationship, the cardiac electrode configured for one or both of sensing cardiac activity and delivering cardiac stimulation energy from a location within the tunnel; and passively securing one or both of the lead body and the cardiac electrode to subcutaneous non-intrathoracic tissue defining the tunnel at a plurality of longitudinally spaced fixation sites using the fixation elements to resist rotation of the lead body in at least one of clockwise and counter-clockwise directions using a first set of curved tines of the plurality of tines, each curved tine of the first set comprising a first end attached to the lead body on the electrically insulative portion and a free end opposite the first end, each curved tine of the first set biased out of plane with respect to a longitudinal axis of the lead body in a first orientation to curve around some of the lead body circumference such that the free end points in a clockwise or counterclockwise direction with respect to the circumference of the lead body at which the first end is attached to the lead body to resist rotation of the lead in the clockwise or counterclockwise direction. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17)
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18. An implantable lead configured for placement within a tunnel formed in subcutaneous non-intrathoracic tissue, comprising:
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a lead body; a cardiac electrode supported by the lead body, the cardiac electrode configured for one or both of sensing cardiac activity and delivering cardiac stimulation energy from a location within the tunnel; and means, disposed longitudinally along at least an electrically insulative portion of the lead body in a spaced relationship, for passively fixing one or both of the lead body and cardiac electrode at a plurality of longitudinally spaced fixation sites of the tunnel using a plurality of tines to resist rotation of the lead body in both clockwise and counter-clockwise directions using a first set of curved tines of the plurality of tines curved around some of the circumference of the lead body in a clockwise orientation and a second set of curved tines of the plurality of tines curved around some of the circumference of the lead body in a counterclockwise orientation. - View Dependent Claims (19, 20, 21)
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22. A method of lead delivery, comprising:
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introducing a sheath into a tunnel formed in subcutaneous non-intrathoracic tissue; providing a lead comprising a lead body and a cardiac electrode, the lead body comprising a plurality of tines and the cardiac electrode configured for one or both of sensing cardiac activity and delivering cardiac stimulation energy from a location within the tunnel; advancing the lead through the sheath and to a location within the tunnel, the sheath at least partially collapsing the plurality of tines; passively fixing the lead body to subcutaneous non-intrathoracic tissue defining the tunnel at a plurality of longitudinally spaced fixation sites located along at least an electrically insulative portion of the lead body using the plurality of tines distributed at the plurality of fixation sites, the plurality of tines comprising; at least one first type of tine having a first end attached to the lead body and a free end distal with respect to the first end, each of the first type of tine orientated along the lead body to extend from the lead body in a distal direction to resist axial displacement of the lead in the distal direction; and at least one second type of tine having a first end attached to the lead body and a free end proximal with respect to the first end, each of the second type of tine orientated along the lead body to extend from the lead body in a proximal direction to resist axial displacement of the lead body in the proximal direction; and removing the sheath from the patient to allow the plurality of tines to engage subcutaneous non-intrathoracic tissue. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29)
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Specification