Systems and methods for implanting tissue stimulation electrodes in the pelvic region
First Claim
1. A stimulation lead assembly for placement in the pelvic floor and adapted to be coupled to an implantable pulse generator to deliver stimulation to selected stimulation sites comprising:
- a first stimulation lead comprising;
a first elongated lead body extending between a first lead body proximal end and a first lead body distal end comprising a first insulating sheath and at least one electrical conductor within the first insulating sheath;
a first proximal connector assembly having at least one lead connector element at the first lead body proximal end coupled to a proximal end of the electrical conductor;
a first stimulation electrode at the first lead body distal end coupled to a distal end of the electrical conductor; and
a first fixation mechanism extending along a portion of the lead body coupled to the first insulating sheath and extending laterally away from the lead body, the fixation mechanism formed of a material encouraging tissue ingrowth along the length of the portion of the lead body to stabilize the stimulation electrode at the stimulation site; and
a second stimulation lead comprising;
a second elongated lead body extending between a second lead body proximal end and a second lead body distal end comprising a second insulating sheath and at least one electrical conductor within the second insulating sheath;
a second proximal connector assembly having at least one lead connector element at the second lead body proximal end coupled to a proximal end of the electrical conductor;
a second stimulation electrode at the second lead body distal end coupled to a distal end of the electrical conductor; and
a second fixation mechanism extending along a portion of the second lead body coupled to the second insulating sheath and extending laterally away from the second lead body, the second fixation mechanism formed of a material encouraging tissue ingrowth along the length of the portion of the second lead body to stabilize the stimulation electrode at the stimulation site; and
an interconnecting portion coupled to the first and second lead body distal ends.
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Accused Products
Abstract
Implantable medical devices to relieve problems associated with incontinence and related pelvic disorders and methods of implanting same are disclosed. Stimulation leads for placement in the pelvic floor have fixation mechanisms for stabilization of the stimulation electrodes to inhibit dislodgement from a selected stimulation site. In certain embodiments, the fixation mechanisms encourage fibrosis about the lead to chronically stabilize the position of the stimulation lead and/or stimulation electrode(s). In certain embodiments, the fixation mechanisms are isolated from body tissue during routing of the stimulation lead through a tissue pathway and then exposed to body tissue to encourage fibrosis.
230 Citations
8 Claims
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1. A stimulation lead assembly for placement in the pelvic floor and adapted to be coupled to an implantable pulse generator to deliver stimulation to selected stimulation sites comprising:
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a first stimulation lead comprising; a first elongated lead body extending between a first lead body proximal end and a first lead body distal end comprising a first insulating sheath and at least one electrical conductor within the first insulating sheath; a first proximal connector assembly having at least one lead connector element at the first lead body proximal end coupled to a proximal end of the electrical conductor; a first stimulation electrode at the first lead body distal end coupled to a distal end of the electrical conductor; and a first fixation mechanism extending along a portion of the lead body coupled to the first insulating sheath and extending laterally away from the lead body, the fixation mechanism formed of a material encouraging tissue ingrowth along the length of the portion of the lead body to stabilize the stimulation electrode at the stimulation site; and a second stimulation lead comprising; a second elongated lead body extending between a second lead body proximal end and a second lead body distal end comprising a second insulating sheath and at least one electrical conductor within the second insulating sheath; a second proximal connector assembly having at least one lead connector element at the second lead body proximal end coupled to a proximal end of the electrical conductor; a second stimulation electrode at the second lead body distal end coupled to a distal end of the electrical conductor; and a second fixation mechanism extending along a portion of the second lead body coupled to the second insulating sheath and extending laterally away from the second lead body, the second fixation mechanism formed of a material encouraging tissue ingrowth along the length of the portion of the second lead body to stabilize the stimulation electrode at the stimulation site; and an interconnecting portion coupled to the first and second lead body distal ends. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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Specification