Subcutaneous lead fixation mechanisms
First Claim
1. A medical device system to be subcutaneously placed at a target site posterior to a heart of a patient, comprising:
- an electrode;
a lead having a lead body extending from a proximal end to a distal end and defining a lead axis, the electrode being positioned along the lead;
a fixation mechanism positioned along the lead body proximal to the electrode; and
a plurality of fixation members extending from the fixation mechanism, each of the plurality of fixation members being pliant and forming a fixation member proximal end and a fixation member distal end, each of the plurality of fixation members having;
a first position corresponding to the fixation member distal end being positioned generally against the lead body during subcutaneous placement of the electrode;
a second position corresponding to the fixation member distal end being positioned away from the lead at an acute angle to the lead axis toward the proximal end of the lead to fixedly engage the electrode at the target site, each of said plurality of fixation members being resiliently biased toward the second position; and
a third position corresponding to the fixation member distal end being positioned away from the lead at an acute angle to the lead axis toward the distal end of the lead.
1 Assignment
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Accused Products
Abstract
A medical device that includes a lead having a lead body extending from a proximal end to a distal end, and a housing having a connector block for receiving the proximal end of the lead body. A fixation mechanism is positioned proximal to an electrode coil located at the distal end of the lead body, and a fixation member or a plurality of fixation members extend from the fixation mechanism from a fixation member proximal end to a fixation member distal end. The fixation members are advanceable from a first position corresponding to the fixation member distal end being positioned along the lead during subcutaneous placement of the lead, to a second position corresponding to the fixation member distal end being positioned away from the lead to fixedly engage the lead at a target site.
51 Citations
23 Claims
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1. A medical device system to be subcutaneously placed at a target site posterior to a heart of a patient, comprising:
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an electrode; a lead having a lead body extending from a proximal end to a distal end and defining a lead axis, the electrode being positioned along the lead; a fixation mechanism positioned along the lead body proximal to the electrode; and a plurality of fixation members extending from the fixation mechanism, each of the plurality of fixation members being pliant and forming a fixation member proximal end and a fixation member distal end, each of the plurality of fixation members having; a first position corresponding to the fixation member distal end being positioned generally against the lead body during subcutaneous placement of the electrode; a second position corresponding to the fixation member distal end being positioned away from the lead at an acute angle to the lead axis toward the proximal end of the lead to fixedly engage the electrode at the target site, each of said plurality of fixation members being resiliently biased toward the second position; and a third position corresponding to the fixation member distal end being positioned away from the lead at an acute angle to the lead axis toward the distal end of the lead. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A medical device system to be subcutaneously placed at a target site in a patient, comprising:
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a coil electrode; a lead having a lead body extending from a proximal end to a distal end and defining a lead axis, the coil electrode being positioned along the lead; a fixation mechanism positioned along the lead body proximal to the coil electrode, the fixation mechanism extending from a proximal end having a first diameter approximately equal to a diameter of the lead and a distal end having a second diameter greater than the first diameter; and a plurality of fixation members extending from the fixation mechanism being pliant and forming a fixation member proximal end and a fixation member distal end, each of the plurality of fixation members having; a first position corresponding to the fixation member distal end being positioned generally against the first diameter of the lead during subcutaneous placement of the electrode, a second position corresponding to the fixation member distal end being positioned away from the lead at an acute angle to the lead axis toward the proximal end of the lead to fixedly engage the coil electrode at the target site, each of said plurality of fixation members being resiliently biased toward the second position; and a third position corresponding to the fixation member distal end being positioned away from the lead at an acute angle to the lead axis toward the distal end of the lead. - View Dependent Claims (9, 10, 11, 12, 13, 14)
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15. A method of subcutaneously positioning a lead of a medical device system to a target site distinct from a heart of a patient, the lead having a lead axis and an electrode located along a distal end of the lead and a fixation mechanism positioned along the lead body proximal to the electrode, the fixation mechanism having a plurality of fixation members each being pliant and having a fixation member proximal end and a fixation member distal end, comprising:
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advancing a distal end of a first elongated member to the target site; inserting the lead within the first elongated member, the inserting advancing the plurality of fixation members from a first position corresponding to the fixation member distal end being resiliently biased to be positioned away from the lead at an acute angle to the lead axis toward the proximal end of the lead, to a second position corresponding to the fixation member distal end being positioned generally against the lead during subcutaneous placement of the electrode; and extending the electrode and the fixation mechanism outward from the distal end of the first elongated member proximate the target sit to advance the plurality of fixation members from second position to the first position to fixedly engage the electrode at the target site;
thenretracting the lead from proximate the target site to advance the plurality of fixation members from the first position to a third position corresponding to the fixation member distal end being positioned away from the lead at an acute angle to the lead axis toward the distal end of the lead. - View Dependent Claims (16, 17, 18)
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19. A medical device system comprising:
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a lead having a lead body extending from a proximal end to a distal end and defining a lead axis; an electrode positioned along the lead body; and a fixation mechanism positioned along the lead body including at least one fixation member extending from the fixation mechanism, being pliant and configured to maintain the lead in a fixed position relative to a body after subcutaneous placement, wherein the at least one fixation member is resiliently biased in a first position to extend in a first direction toward the proximal end of the lead at an acute angle relative to the lead axis, and change to a second position during lead retraction to extend in a second direction toward the distal end of the lead and at an acute angle relative to the lead axis. - View Dependent Claims (20, 21, 22, 23)
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Specification