Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

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.

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.

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. 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.

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.

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.