Implantable medical electrical stimulation lead fixation method and apparatus
First Claim
1. An implantable medical electrical lead for electrical stimulation of body tissue adapted to be introduced through and released into body tissue employing an introducer having an introducer lumen, comprising:
- a lead body extending between lead proximal and distal ends;
P proximal connector elements formed in a connector array in a proximal segment of the lead body;
P stimulation electrodes arranged in an electrode array extending proximally from the lead distal end through a distal segment of the lead body;
P lead conductors extending between the P connector elements and the P stimulation electrodes; and
a plurality of M tine elements formed of a flexible biocompatible plastic, formed in a tine element array extending through a segment of the lead proximal to the electrode array, each tine element comprising N flexible, pliant, tines, each tine having a tine width and thickness and extending through a tine length from an attached tine end to a free tine end, the attached tine end attached to the lead body from a tine attachment site and supporting the tine extending outwardly of the lead body and proximally toward the lead proximal end, whereby the M×
N tines are adapted to be folded inward against the lead body when fitted into and constrained by the lumen of an introducer without overlapping one another and deploy outward to engage body tissue when the introducer is withdrawn proximally and release the tines to inhibit axial dislodgement of the P stimulation electrodes.
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Accused Products
Abstract
An implantable medical electrical lead particularly for stimulation of the sacral nerves comprises a lead body extending between a distal end and a proximal end, and the distal end having at least one electrode of an electrode array extending longitudinally from the distal end toward the proximal end. The lead body at its proximal end may be coupled to a pulse generator, additional intermediate wiring, or other stimulation device. A fixation mechanism is formed on or integrally with the lead body proximal to the electrode array that is adapted to be implanted in and engage subcutaneous tissue, particularly muscle tissue, to inhibit axial movement of the lead body and dislodgement of the stimulation electrodes. The fixation mechanism comprises a M tine elements arrayed in a tine element array along a segment of the lead proximal to the stimulation electrode array. Each tine element comprises at least N flexible, pliant, tines, each tine having a tine width and thickness and extending through a tine length from an attached tine end to a free tine end. The attached tine end is attached to the lead body from a tine attachment site and supports the tine extending outwardly of the lead body and proximally toward the lead proximal end. The M×N tines are adapted to be folded inward against the lead body when fitted into and constrained by the lumen of an introducer such that the tine free ends of more distal tines of more distal tine elements are urged toward or alongside the attached tine ends of the adjacent more proximal tines of more proximal tine elements, and the folded tines do not overlap one another.
416 Citations
22 Claims
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1. An implantable medical electrical lead for electrical stimulation of body tissue adapted to be introduced through and released into body tissue employing an introducer having an introducer lumen, comprising:
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a lead body extending between lead proximal and distal ends; P proximal connector elements formed in a connector array in a proximal segment of the lead body; P stimulation electrodes arranged in an electrode array extending proximally from the lead distal end through a distal segment of the lead body; P lead conductors extending between the P connector elements and the P stimulation electrodes; and a plurality of M tine elements formed of a flexible biocompatible plastic, formed in a tine element array extending through a segment of the lead proximal to the electrode array, each tine element comprising N flexible, pliant, tines, each tine having a tine width and thickness and extending through a tine length from an attached tine end to a free tine end, the attached tine end attached to the lead body from a tine attachment site and supporting the tine extending outwardly of the lead body and proximally toward the lead proximal end, whereby the M×
N tines are adapted to be folded inward against the lead body when fitted into and constrained by the lumen of an introducer without overlapping one another and deploy outward to engage body tissue when the introducer is withdrawn proximally and release the tines to inhibit axial dislodgement of the P stimulation electrodes. - View Dependent Claims (2, 3, 4, 5, 7, 8, 9)
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6. The implantable medical lead of claim 6, wherein N tines of the M tine elements are equal in number.
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10. A medical electrical stimulation system comprising:
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an implantable pulse generator for providing medical electrical stimulation; and a medical electrical lead coupled to the implantable pulse generator for electrical stimulation of body tissue and adapted to be introduced through and released into body tissue employing an introducer having an introducer lumen, the medical electrical lead further comprising; a lead body extending between lead proximal and distal ends; P proximal connector elements formed in a connector ray in a proximal segment of the lead body a coupled with the implantable pulse generator; P stimulation electrodes arranged in an electrode array extending proximally from the lead distal end through a distal segment of the lead body; P lead conductors extending between the P connector elements and the P stimulation electrodes; and a plurality of M tine elements formed of a flexible bio-compatible plastic, formed in a tine element array extending through a segment of the lead proximal to the electrode array, each tine element comprising N flexible, pliant, tines, each tine having a tine width and thickness and extending through a tine length from an attached tine end to a free tine end, the attached tine end attached to the lead body from a tine attachment site and supporting the tine extending outwardly of the lead body and proximally toward the lead proximal end, whereby the M×
N tines are adapted to be folded inward against the lead body when fitted into and constrained by the lumen of an introducer without overlapping one another and deploy outward to engage body tissue when the introducer is withdrawn proximally and release the tines to inhibit axial dislodgement of the P stimulation electrodes.- View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18)
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19. An implantable medical electrical lead for non-direct contact electrical stimulation of the sacral nerves comprising:
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a lead body extending between lead proximal and distal ends, the lead body comprising a first proximal connector element, an elongated distal wire coil electrode, and a first lead conductor extending between the first proximal connector element and the wire coil electrode, whereby the wire coil electrode is capable of being inserted through a foramen of the sacrum into operative relation with a sacral nerve to provide stimulation to the sacral nerve without necessarily being in direct contact with the sacral nerve, the lead body further comprising; a plurality of M tine elements formed of a flexible bio-compatible plastic, formed in a tine element array extending trough a segment of the lead proximal to the distal wire coil electrode, each tine element comprising N flexible, pliant, tines, each tine having a tine width and thickness and extending through a tine length from an attached tine end to a free tine end, the attached tine end attached to the lead body from a tine attachment site and supporting the tine extending outwardly of the lead body and proximally toward the lead proximal end, whereby the M×
N tines are adapted to be folded inward against the lead body when fitted into and constrained by the lumen of an introducer without overlapping one another and deploy outward to engage body tissue when the introducer is withdrawn proximally and release the tines to inhibit axial dislodgement of the distal electrode.- View Dependent Claims (20)
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21. An implantable medical electrical lead for non-direct contact electrical stimulation of the sacral nerves comprising:
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a lead body extending between lead proximal and distal ends, the lead body comprising a first proximal connector element, at least one distal electrode, and a first lead conductor extending between the first proximal connector element and the wire coil electrode, whereby the wire coil electrode is capable of being inserted through a foramen of the sacrum into operative relation with a sacral nerve to provide stimulation to the sacral nerve without necessarily being in direct contact with the sacral nerve, the lead body further comprising; a plurality of M tine elements formed of a flexible bio-compatible plastic, formed in a tine element array extending through a segment of the lead proximal to the distal electrode, each tine element comprising N flexible, pliant, tines, each tine having a tine width and thickness and extending through a tine length from an attached tine end to a free tine end, the attached tine end attached to the lead body from a tine attachment site and supporting the tine extending outwardly of the lead body and proximally toward the lead proximal end, whereby the M×
N tines are adapted to be folded inward against the lead body when fitted into and constrained by the lumen of an introducer without overlapping one another and deploy outward to engage body muscle tissue when the introducer is withdrawn proximally and release the tines to inhibit axial dislodgement of a distal electrode.- View Dependent Claims (22)
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Specification