Abstract: Improved assemblies, systems, and methods provide safeguarding against tissue injury during surgical procedures and/or identify nerve damage occurring prior to surgery and/or verify range of motion or attributes of muscle contraction during reconstructive surgery. A stimulation control device may incorporate a range of low and high intensity stimulation to provide a stimulation and evaluation of both nerves and muscles. A stimulation control device is removably coupled to a surgical device or is imbedded within the medical device to provide a stimulation and treatment medical device. A disposable hand held stimulation system includes an operative element extending from the housing, the housing includes an operative element adjustment portion and a visual indication to provide feedback or status to the user.

Abstract: Neurostimulation assemblies, systems, and methods make possible the providing of short-term therapy or diagnostic testing by providing electrical connections between muscles or nerves inside the body and stimulus generators or recording instruments mounted on the surface of -the skin or carried outside the body. Neurostimulation assemblies, systems, and methods may include a carrier and a removable electronics pod, the electronics pod including stimulation generation circuitry, a power input bay to hold a disposable power source, and user interface components. The assemblies, systems, and methods are adapted to provide coordinated neurostimulation to multiple regions of the body.

Abstract: Systems and methods for programming and logging medical device and patient data are provided. The systems include a handheld device, which is capable of communicating with a medical device, and a base station, which provides connectivity for the handheld device to accomplish various functions such as recharging, programming, data back-up and data entry. The methods comprise the steps of detecting a medical device, obtaining and recording information from the medical device. Additionally, medical device parameters may be modified and the recorded information may be archived for future reference.

Abstract: Improved assemblies, systems, and methods provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The stimulation system includes a hermetically sealed implantable pulse generator and methods for assembly and programming.

Abstract: Improved assemblies, systems, and methods provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The stimulation system may include both external and internal components, with an implantable pulse generator sized and configured to be implanted subcutaneously in a tissue region. A lead having a proximal end and a distal end is coupled to the implantable pulse generator and is adapted for implantation in subcutaneous tissue. The distal end of the lead is adapted to be remote from the pulse generator and capable of extending up to an anatomical furthest distance from the pulse generator. The circuitry carried within the case is operable for generating electrical stimulation pulses and capable of electrically driving the generated electrical stimulation pulses from the pulse generator through the lead extending up to the anatomical furthest distance.

Abstract: Improved assemblies, systems, and methods provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The stimulation system may include both external and internal components, with an implantable pulse generator sized and configured to be implanted subcutaneously in a tissue region. The implantable pulse generator includes a welded titanium case. Circuitry and hardware adapted for wireless telemetry is located within the case, and includes a primary cell or rechargeable power source, a microcontroller for control of the implantable pulse generator, and a power receiving coil for receiving an RF magnetic field to recharge the rechargeable power source, the power receiving coil having a maximum outside dimension.

Abstract: Improved assemblies, systems, and methods provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The stimulation systems and methods include an implantable pulse generator adapted for wireless telemetry and having a unique signature to enable secure communications. An external controller includes circuitry adapted for wireless telemetry. The secure communications includes at least a first communication from the external controller to the pulse generator. The first communication includes the pulse generator's unique signature. A response communication from the pulse generator to the external controller includes data elements that indicate the response communication is a response, and not a command from an external controller.

Abstract: Improved assemblies, systems, and methods provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The stimulation system includes both implantable components and external components. The implantable components comprise a pulse generator including an operating system, a predefined set of stimulation parameters, a rechargeable battery, a power receiving coil, and a lead coupled to an electrode to provide electrical stimulation. An external clinical programmer system comprises a clinical programmer adapted for radio frequency wireless telemetry communication with the pulse generator, and a docking station, the docking station including a cradle to dock the hand held clinical programmer, the cradle adapted to provide access to a printer and/or non-volatile memory.

Abstract: Improved assemblies, systems, and methods provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The stimulation system includes an implantable pulse generator and a lead sized and configured to be implanted subcutaneously in a tissue region. An external controller includes circuitry adapted for wireless telemetry and a charging coil for generating the radio frequency magnetic field to transcutaneously recharge a rechargeable battery in the pulse generator. Using wireless telemetry, the pulse generator is adapted to transmit status information back to the external controller to allow the external controller to automatically adjust up or down the magnitude of the radio frequency magnetic field and/or to instruct a user to reposition the charging coil, the status information adapted to allow optimal recharging of the pulse generator rechargeable battery.

Abstract: Improved assemblies, systems, and methods provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The stimulation system includes a pulse generator including a housing sized and configured for implantation in subcutaneous tissue, circuitry carried within the housing, the circuitry operable for generating electrical stimulation pulses, and a rechargeable battery coupled to the circuitry and carried within the housing, the rechargeable battery including a battery capacity. The circuitry is adapted to suspend the generation of electrical stimulation pulses at a first remaining battery capacity, and the circuitry is adapted to enter a dormant mode at a second remaining battery capacity. The first battery remaining capacity may be greater than or equal to the second remaining battery capacity. At the second remaining battery capacity, only a safety margin battery capacity remains.

Abstract: Neuromuscular stimulation assemblies, systems, and methods make possible the providing of short-term therapy or diagnostic testing by providing electrical connections between muscles or nerves inside the body and stimulus generators or recording instruments mounted on the surface of the skin outside the body or worn or carried by the patient. The assemblies, systems, and methods include an electrode sized and configured for implantation in tissue, a percutaneous lead electrically coupled to the electrode, a carrier sized and configured to be carried by the patient and to hold a power source, an electronics pod removably carried on-board the carrier and including circuitry configured to generate a stimulation pulse, and an electrode connection element carried on-board the carrier that is electrically coupled to the electronics pod. Instructions furnished by a clinician or caregiver or physician prescribe the release and replacement of a disposable battery according to a prescribed battery replacement regime.

Abstract: Percutaneous electrode assemblies, systems, and methods make possible the providing of short-term therapy or diagnostic testing by providing electrical connections between muscles or nerves inside the body and stimulus generators or recording instruments carried outside the body. The percutaneous electrodes include a flexible body having an electrically conductive region, a tissue penetrating region, and a percutaneous lead electrically coupled to the electrically conductive region. An anchoring element is positioned on the flexible body to resist movement of the electrically conductive region within tissue. An introducer is sized and configured to receive the flexible body and shield the anchoring element from contact with tissue while the electrically conductive region is placed to a desired position within tissue, and accommodates advancement of the anchoring element beyond the interior lumen for contact with tissue to resist movement of the electrically conductive region placed in the desired position.

Abstract: Improved assemblies, systems, and methods provide safeguarding against nerve injury during surgical procedures and/or identify nerve damage occurring prior to surgery and/or verify range of motion or attributes of muscle contraction during reconstructive surgery. A stimulation control device may incorporate a range of low and high intensity stimulation to provide a stimulation and evaluation of both nerves and muscles. A stimulation control device is removably coupled to a surgical device or is imbedded within the medical device to provide a stimulation and treatment medical device.

Abstract: Systems and methods make possible the differentiation and identification of tissue regions locally innervated by targeted nerves. The systems and methods make it possible to access the nervous system at these localized regions for therapeutic benefit. For example, the systems and methods can be used to access parasympathetic nerves localized in fat pads on the surface of the heart.

Abstract: Systems provide a stimulation electrode assembly sized and configured for placement in an adipose tissue region to stimulate a nerve in the adipose tissue region comprising an elongated lead sized and configured to be implanted within the adipose tissue region, the lead including at least two electrically conductive portions to apply electrical stimulation to nerve tissue in the adipose tissue region, and at least two expandable anchoring structures deployable from the lead to engage adipose tissue and resist dislodgment and/or migration of the at least two electrically conductive portions within the adipose tissue region.

Abstract: Devices, systems, and methods for recording, and/or stimulation, and/or blocking of a nerve make use of a molded cuff electrode. An electrically conductive surface is coupled to an inside surface of the cuff's elastic body. The electrically conductive surface and the body assume a coiled configuration in its natural state. An applicator tool having a body and a slider are used to implant the cuff electrode about a nerve.

Abstract: Systems and methods treat urinary incontinence by the bilateral stimulation of the left and/or right branches of the dorsal genital nerves using a single lead implanted in adipose or other tissue in the region at or near the pubic symphysis.

Abstract: Systems and methods provide a stimulation electrode assembly comprising an elongated lead sized and configured to be implanted within an adipose tissue region. The lead includes an electrically conductive portion to apply electrical stimulation to nerve or muscle in the adipose tissue region and at least one expandable anchoring structure deployable from the lead to engage adipose tissue and resist dislodgment and/or migration of the electrically conductive portion within the adipose tissue region.

Abstract: Improved assemblies, systems, and methods provide an MES processor for acquisition and processing of myoelectric signals from muscles, nerves, or central nervous system tissue, or any combination. The MES processor is sized and configured to be implanted subcutaneous a tissue region. The MES processor includes an electrically conductive case of a laser welded titanium material. Control circuitry is located within the case, the control circuitry including a rechargeable power source, a receive coil for receiving an RF magnetic field to recharge the power source, and a microcontroller for control of the MES processor. Improved assemblies, systems, and methods also provide an acquisition and processing system for sensing myoelectric signals from muscles, nerves, or central nervous system tissue, or any combination.

Abstract: Improved assemblies, systems, and methods provide an implantable pulse generator for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The implantable pulse generator is sized and configured to be implanted subcutaneously in a tissue region. The implantable pulse generator includes an electrically conductive laser welded titanium case. Control circuitry is located within the case, and includes a primary cell or rechargeable power source, a receive coil for receiving an RF magnetic field to recharge the rechargeable power source, and a microcontroller for control of the implantable pulse generator. Improved assemblies, systems, and methods also provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination.