Medtronic, Inc.

Nuvectra Corporation

Medtronics, Inc.

Other

Michele Spinelli

John Matthew Swoyer

Martin T Gerber

George Mamo

Keith Richard Carlton

Steven David Hartle

Steven Siegel

Norbert F Kaula

Yohannes Iyassu

Scott F Drees

Giancarlo Barolat

George J Mano

Sylvia Malaguti

Gianluca Giardiello

Keith Carlson

An anal electrode device is configured to measure a response of a patient to a stimulation pulse. The anal electrode device includes an elongated shaft that is configured to be at least partially inserted into an anal canal of the patient. A first sensory electrode is disposed on a first region of the shaft. The first sensory electrode is configured to measure a compound motor action potential (CMAP) from an internal sphincter of the patient while the shaft is partially inserted into the anal canal of the patient. A second sensory electrode is disposed on a second region of the shaft. The second sensory electrode is configured to measure the CMAP from an external sphincter of the patient while the shaft is partially inserted into the anal canal of the patient.

Methods, systems and devices for determining optimal placement for pudendal nerve stimulation lead using patient feedback

In various examples, an apparatus includes a stimulation lead including an elongate body including a distal end and a proximal end. At least one first electrode is disposed proximate the distal end of the elongate body and is configured to stimulate a first target nerve. At least one second electrode is disposed between the at least one first electrode and the proximal end of the elongate body and is configured to stimulate a second target nerve. At least one first fixation structure is disposed between the at least one second electrode and the proximal end of the elongate body. The at least one first fixation structure is configured to anchor the stimulation lead proximate the sacrum, wherein the at least one first fixation structure is located on the elongate body and spaced a first distance proximally along the elongate body from the at least one first electrode.

Implantable medical lead for stimulation of multiple nerves

An implantable stimulation lead has electrode contacts that are configured to deliver an electrical stimulation therapy for a patient. A sheath extends along a longitudinal axis. The sheath defines a lumen into which the stimulation lead can be inserted. A distal end of the sheath includes a plurality of base segments that are separated from one another. A plurality of fixation structures are located on the base segments, respectively. In a first configuration, the fixation structures are each disposed proximate to the sheath. In a second configuration, the fixation structures each extend radially outward from the sheath. In a third configuration, the base segments deflect radially inward toward the longitudinal axis.

Implantable medical lead with collapsible fixation member

In various examples, a stimulation lead for at least partial implantation within a patient includes an elongate lead body and a sheath selectively attachable to the lead body. The sheath includes a fixation member. The fixation member includes a retracted configuration in which the fixation member is disposed proximate the sheath. In a deployed configuration, the fixation member extends radially outwardly from the sheath to anchor the stimulation lead within the patient. In a removal configuration, the fixation member is radially inwardly collapsible toward the longitudinal sheath axis with the lead body removed from within the sheath.

The present disclosure involves a method of measuring a physiological feedback from a patient in response to electrical stimulation. A stimulation parameter of a sacral nerve stimulation therapy is ramped up. The sacral nerve stimulation therapy includes electrical pulses generated by a pulse generator based on programming instructions received from an electronic programmer. The electrical pulses are delivered to a patient via a stimulation lead that is implanted in the patient. Via an anal electrode device that is at least partially inserted inside an anal canal of the patient, a compound motor action potential (CMAP) is measured from an anal sphincter of the patient while the stimulation parameter of the sacral nerve stimulation therapy is being ramped up. A stimulation threshold is determined based on the measured CMAP.

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

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. A fixation mechanism is formed on or integrally with the lead body proximal to the electrode array that is adapted to be implanted in an engage subcutaneous tissue, particularly muscle tissue, to inhibit axial movement of the lead body and dislodgement of the stimulation electrodes.

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.

Described are implantable devices and methods for treating various disorders of the pelvic floor by means of electrical stimulation of the pudendal or other nerves, and optional means for delivering drugs in association therewith. A method of precisely positioning and implanting a medical electrical lead so as to provide optimal stimulation of the pudendal nerve or a portion thereof is also described. Placement of a stimulation lead next to or on the pudendal nerve may be performed using conventional prior art techniques through gross anatomical positioning, but usually does not result in truly optimal lead placement. One method of the present invention utilizes neurophysiological monitoring to assess the evoked responses of the pudendal nerve, and thereby provide a method for determining the optimal stimulation site. Additionally, one or more electrical stimulation signals are applied, and optionally one or more drugs are infused, injected or otherwise administered, to appropriate portions of a patient's pelvic floor and pudendal nerve or portions thereof in an amount and manner effective to treat a number of disorders, including, but not limited to, urinary and/or fecal voiding dysfunctions such as constipation, incontinence disorders such as urge frequency and urinary retention disorders, sexual dysfunctions such as orgasmic and erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia.

Method, system and device for treating disorders of the pelvic floor by means of electrical stimulation of the pudendal and associated nerves, and the optional delivery of drugs in association therewith

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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Milan, Italy

Michele Spinelli