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 In one variation, a guide wire is inserted through a needle lumen, and the needle is withdrawn.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 therapy delivery system has a therapy delivery element that is inserted or implanted into a human body and anchored or fixed to tissue to delivery a therapy to a patient. In one embodiment an implantable neurostimulator uses an electrical stimulation lead to delivery a therapy such as sacral nerve stimulation, peripheral nerve stimulation, and the like. In another embodiment the implantable therapeutic substance delivery device, also known as a drug pump, is connected to a catheter to deliver a therapy to treat conditions such as spasticity, cancer, pain, and the like. The therapy delivery element is anchored to tissue using an adjustable anchor having a therapy grip element, at least two extension elements connected to the therapy grip element, and a tissue fixation element connected to the extension elements.

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: 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 therapy delivery system has a therapy delivery element that is inserted or implanted into a human body and anchored or fixed to tissue to delivery a therapy to a patient. In one embodiment an implantable neurostimulator uses an electrical stimulation lead to delivery a therapy such as sacral nerve stimulation, peripheral nerve stimulation, and the like. In another embodiment the implantable therapeutic substance delivery device, also known as a drug pump, is connected to a catheter to deliver a therapy to treat conditions such as spasticity, cancer, pain, and the like. The therapy delivery element is anchored to tissue using an adjustable anchor having a therapy grip element, at least two extension elements connected to the therapy grip element, and a tissue fixation element connected to the extension elements.

Abstract: An implantable medical lead for stimulation of the sacral nerves comprises a lead body which includes a distal end and a proximal end, and the distal end having at least one electrode contact having a length of between 0.75 and 1.50 inches 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. The implantable lead is implanted by taking the lead and implanting near the sacral nerves and then connecting to a pulse generator.

Abstract: Devices are currently implanted in patients to treat pain and other conditions including incontinence by delivering stimulants to the nervous system. Surgical methods are improved for implanting the devices. The soft tissues of the body are dilated above the site of device implantation, for example, above the sacrum, to create an annulus of dilated soft tissues. The tissues are dilated by introducing into the soft tissue sequentially larger cannulated dilating devices. A tubular retractor is then passed over the largest introduced dilating device and at least a number of the dilating devices are retracted. This establishes a tubular device insertion corridor through the dilated soft tissues to the site of implantation, for example, the foramen of the sacrum. The device to be implanted, such as an electrical lead, is then inserted through the corridor. The device is tested in situ. Finally, such other method steps are performed, including closing the corridor, as implantation requires.

Abstract: An implantable medical lead for stimulation of the sacral nerves comprises a lead body which includes a distal end and a proximal end, and the distal end having at least one electrode contact having a length of between 0.10 and 1.50 inches 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. The implantable medical lead can comprise a first and second electrode contacts. The second electrode contact has a length of between 0.030 and 1.00 extending longitudinally from a point approximately 1.00 from the distal end toward the proximal end. The first and second electrode contacts do no overlap longitudinally. The implantable lead is implanted by taking the lead and implanting near the sacral nerves and then connecting to a pulse generator.