Boston Scientific Scimed, Inc.

Medtronic, Inc.

Medtronics, Inc.

Other

Boston Scientific Corporation

George Mamo

Michele Spinelli

Martin T Gerber

John Matthew Swoyer

Michael F Weiser

Keith Richard Carlton

Steven David Hartle

Michael S H Chu

Brett Nowlin

The invention provides, in various embodiments, aspects of soft tissue anchors, adjustable length/tension slings, interconnects between slings and soft tissue anchors, delivery devices and systems for implanting supportive slings, and methods relating to anchoring,adjusting and implanting supportive slings.

Systems, methods and devices relating to implantable supportive slings

The invention provides, in various embodiments, aspects of soft tissue anchors, adjustable length/tension slings, interconnects between slings and soft tissue anchors, delivery devices and systems for implanting supportive slings, and methods relating to anchoring, 5 adjusting and implanting supportive slings.

Disclosed are single-incision surgical procedures for treatment of urinary incontinence and/or pelvic floor disorders and related uses, devices, kits, and methods. Implants are also disclosed for use in the exemplary procedures. In certain embodiments, soft tissue anchors are used to anchor the surgical implants to obturator membranes of a patient.

Systems, devices, and methods for sub-urethral support

Systems, devices, and methods for treating pelvic floor disorders

The invention provides, in various embodiments, aspects of soft tissue anchors, adjustable length/tension slings, interconnects between slings and soft tissue anchors, delivery devices and systems for implanting supportive slings, and methods relating to anchoring, adjusting and implanting supportive slings.

An implantable medical electrical lead 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 plurality of tine elements arrayed in a tine element array along a segment of the lead.

Implantable medical lead including a plurality of tine elements

Methods and apparatus for implanting a stimulation lead in a patient's sacrum to deliver neurostimulation therapy that can reduce patient surgical complications, reduce patient recovery time, and reduce healthcare costs. A surgical instrumentation kit for minimally invasive implantation of a sacral stimulation lead through a foramen of the sacrum in a patient to electrically stimulate a sacral nerve comprises a needle and a dilator and optionally includes a guide wire. The needle is adapted to be inserted posterior to the sacrum through an entry point and guided into a foramen along an insertion path to a desired location. In one variation, a guide wire is inserted through a needle lumen, and the needle is withdrawn. The insertion path is dilated with a dilator inserted over the needle or over the guide wire to a diameter sufficient for inserting a stimulation lead, and the needle or guide wire is removed from the insertion path. The dilator optionally includes a dilator body and a dilator sheath fitted over the dilator body. The stimulation lead is inserted to the desired location through the dilator body lumen or the dilator sheath lumen after removal of the dilator body, and the dilator sheath or body is removed from the insertion path. If the clinician desires to separately anchor the stimulation lead, an incision is created through the entry point from an epidermis to a fascia layer, and the stimulation lead is anchored to the fascia layer. The stimulation lead can be connected to the neurostimulator to delivery therapies to treat pelvic floor disorders such as urinary control disorders, fecal control disorders, sexual dysfunction, and pelvic pain.

Minimally invasive apparatus for implanting a sacral stimulation lead

Systems, devices and methods for treating pelvic floor disorders

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.

Implantable medical electrical stimulation lead fixation method and apparatus

Implantable medical lead including tine markers

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&#xd7;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.

Method embodiments to implant a stimulation lead in a patient's sacrum to deliver neurostimulation therapy can reduce patient surgical complications, reduce patient recovery time, and reduce healthcare costs. A method embodiment begins by inserting a needle posterior to the sacrum through an entry point. The needle is guided into a foramen along an insertion path to a desired location. The insertion path is dilated with a dilator to a diameter sufficient for inserting a stimulation lead. The needle is removed from the insertion path. The stimulation lead is inserted to the desired location. The dilator is removed from the insertion path. Additionally if the clinician desires to separately anchor the stimulation lead, an incision is created through the entry point from an epidermis to a fascia layer. The stimulation lead is anchored to the fascia layer. After the stimulation lead has been anchored, the incision can be closed, or the stimulation lead proximal end can be tunneled to where an implantable neurostimulator is located and then the incision can be closed. A implanted sacral stimulation lead can be connected to the neurostimulator to delivery therapies to treat pelvic floor disorders such as urinary control disorders, fecal control disorders, sexual dysfunction, and pelvic pain.

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Ellicott City, MD, United States of America

George Mamo