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. Embodiments of methods according to the present invention provide the ability to intra-operatively simulate post-operative physiologic function of a body part. Such methods may be used during various surgical procedures, including tendon transfer procedures. Included are one or more steps of confirming paralysis or a weakened condition of a body part, confirming responsivity or operability of transfer tissue to supplement the functionality of the paralyzed or weakened part, and intra-operatively simulating post-operative functionality of the transfer tissue to enhance and/or predict the outcome of the surgical procedure.

Abstract: Systems and methods according to the present invention provide a means for determining, as an example, the health or location of nerves. A determination according to the present invention may include semi-quantitative threshold testing using intra-operative electrical stimulation to determine whether one or more nerves are functioning as expected. A determination according to the present invention may also be utilized to determine or predict the success of a surgical procedure that may affect the functioning of one or more nerves. Semi-quantitative analysis may be performed by comparing electrical stimulation intensity, or an approximation thereof, at which a threshold neural response is observed to an expected or previously applied electrical stimulation intensity, or an approximation thereof.

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 use an external and/or implantable pulse generator system for neuromodulation stimulation to treat sexual dysfunction by the unilateral or bilateral stimulation of a target nerve A and/or a target nerve B using one or more leads and electrodes implanted in tissue in the pelvic region. The electrical stimulation waveform may be conveyed to the target nerve A electrode for a first predetermined amount of time, and conveyed to the target nerve B electrode for a second predetermined amount of time.

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: 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.

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 elastic body of the cuff. The elastic body of the cuff is formed from a substantially homogeneous material, and the electrically conductive surface and the body assume a coiled configuration in the natural state of the cuff. An applicator tool having a body and a slider are used to implant the cuff electrode about a nerve.

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: Systems and Methods treat bladder dysfunctions using neuromodulation stimulation. Bladder emptying through stimulation of urethral afferents, and continence through stimulation of the dorsal genital nerve, is provided with one or more implanted pulse generators and one or more leads. A simple surgical procedure preserves all existing functions. A stimulating catheter is provided to be used as a clinical screening tool. The stimulating catheter is used to measure bladder pressures and stimulate the urethra at the same time.

Abstract: An implantable pulse generator for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination is sized and configured to be implanted in subcutaneous tissue. 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, non-inductive wireless telemetry circuitry, and a microcontroller for control of the implantable pulse generator. A stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination comprises at least one electrically conductive surface, a lead connected to the electrically conductive surface, and an implantable pulse generator electrically connected to the lead.

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 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: 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: Neurostimulation assemblies, systems, and methods make possible the providing of short-term therapy or diagnostic testing by providing electrical connections between muscles and/or nerves inside the body and stimulus generators and/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 an electronics pod, the electronics pod including stimulation generation circuitry and user interface components. A power source and/or flash memory may be incorporated in neurostimulation assembly and/or the return electrode. The assemblies, systems, and methods are adapted to provide coordinated neurostimulation to multiple regions of the body.

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: 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 screen and/or treat disorders of the body using neurostimulation. A trial system implants a temporary or permanent percutaneous lead and couples the lead to an external pulse generator. The external pulse generator supplies a prescribed stimulation regime through the lead to a targeted tissue region. If an improvement in the treated disorder is achieved, use of the trial system may be continued, or an implantable system may be implanted.

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. Neuromuscular stimulation assemblies, systems, and methods may include a steerable introducer that defines an interior lumen sized and configured to shield a percutaneous electrode from contact with tissue during advancement to a desired position within tissue.