Abstract: An integrated physiological monitoring and tissue anchoring device is provided. The device includes a detachable clamp at the distal portion that includes a sensor configured to sense a physiological parameter from the gastrointestinal tract. A handle at the proximal portion of the device is configured to actuate the clamp into a closed configuration in which gastrointestinal tissue is grasped by the clamp. A cable connects the handle to the clamp and has a frangible section near the clamp such that the clamp is detachable from the cable at the frangible section.

Abstract: Endoscopic and self-deploying gastrointestinal suture retention systems are provided herein. Such systems provide prolonged residency in the gastrointestinal tract for chronic physiological monitoring or controlled drug release in the gastrointestinal tract. A self-deploying system includes a substrate, sensor and torsion springs and an endoscopic system includes a tubular device that includes detachable components at the distal portion thereof.

Abstract: A swallowable device to detect sleep apnea in a patient in need thereof. The swallowable device includes an ingestible capsule. An accelerometer is contained within the ingestible capsule and is configured to reside within the stomach to detect a respiration parameter(s) indicative of sleep apnea and generate a sensing signal based thereon. The ingestible capsule also includes a radio contained within the ingestible capsule and a micro-controller unit (MCU) in electrical communication with the accelerometer and the radio and configured and programmed to receive the sensing signal. The ingestible capsule can also include a microphone to detect a respiration parameter(s) indicative of sleep apnea and/or snoring.

Abstract: One aspect of the present disclosure relates to a system that can facilitate delivery of a medical device in proximity to a target region within a patient's body. Data representing an image of a portion of the patient's body can be received. Based on the data representing the image, a first three dimensional (3D) model of the medical device can be generated. A second 3D model of the medical device can be fitted within the first 3D model at a location in proximity to the target region to create a combined 3D model. A two dimensional (2D) projection of the combined 3D model can be created. In some instances, the 2D projection can be used to facilitate delivery of a medical device in proximity to the target region within a patient's body.

Abstract: Various methods for laser welding biocompatible material for use in implantable medical devices are disclosed. A method for laser processing includes applying a laser beam to a biocompatible material comprising at least 85% by weight zirconium oxide (ZrO2) or “zirconia” in an oxygen-free environment and depleting the material of oxygen. The depletion of oxygen converts the zirconium oxide to elemental zirconium at an interface where the material is applied to the elemental zirconium. In one embodiment, the present invention provides for an implantable medical device or component thereof made of a biocompatible material comprising zirconium oxide. The device includes a substrate that has an intrinsic conductive pathway comprising elemental zirconium that extends from a first surface to a second surface of the substrate.

Abstract: An implantable medical device is provided for the suppression or prevention of pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient. The implantable medical device can be a neurostimulator configured to be implanted on or near a cranial nerve to treat headache or other neurological disorders. One aspect of the implantable medical device is that it includes an electronics enclosure, a substrate integral to the electronics enclosure, and a monolithic feed-through integral to the electronics enclosure and the substrate. In some embodiments, the implantable medical device can include a fixation apparatus for attaching the device to a patient.

Abstract: Methods and apparatus for delivering a neurostimulator to a target tissue are provided which may include any number of features. One feature is a delivery tool comprising a handle portion, an elongate shaft comprising a contoured distal portion, a visualization system embedded in the elongate shaft, and an insertion groove on the elongate shaft configured to deploy the neurostimulator. The contoured distal portion can be shaped and configured to maintain contact with a posterior maxilla and elevate a periosteum off of the posterior maxilla to avoid soft tissue dissection. In some embodiments, the neurostimulator is implanted in close proximity to or touching the sphenopalatine ganglion.

Abstract: Methods and apparatus for delivering therapy from an implanted neurostimulator to a patient are provided. One feature is an external controller that acts as a gateway for therapy. The external controller can be a handheld controller that communicates wirelessly with the implanted neurostimulator. In some embodiments, the controller communicates with a database to determine a therapy approval status of the neurostimulator. Therapy can be approved by a physician prescription, or by prepayment, for example. In some embodiments, the neurostimulator is deactivated when no approved therapies remain.

Abstract: An implantable medical device is provided for the suppression or prevention of pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient. The implantable medical device can be a neurostimulator configured to be implanted on or near a cranial nerve to treat headache or other neurological disorders. One aspect of the implantable medical device is that it includes an electronics enclosure, a substrate integral to the electronics enclosure, and a monolithic feed-through integral to the electronics enclosure and the substrate. In some embodiments, the implantable medical device can include a fixation apparatus for attaching the device to a patient.

Abstract: Methods and apparatus for delivering therapy from an implanted neurostimulator to a patient are provided. One feature is an external controller that acts as a gateway for therapy. The external controller can be a handheld controller that communicates wirelessly with the implanted neurostimulator. In some embodiments, the controller communicates with a database to determine a therapy approval status of the neurostimulator. Therapy can be approved by a physician prescription, or by prepayment, for example. In some embodiments, the neurostimulator is deactivated when no approved therapies remain.

Abstract: Various methods for laser welding biocompatible material for use in implantable medical devices are disclosed. A method for laser processing includes applying a laser beam to a biocompatible material comprising at least 85% by weight zirconium oxide (ZrO2) or “zirconia” in an oxygen-free environment and depleting the material of oxygen. The depletion of oxygen converts the zirconium oxide to elemental zirconium at an interface where the material is applied to the elemental zirconium. In one embodiment, the present invention provides for an implantable medical device or component thereof made of a biocompatible material comprising zirconium oxide. The device includes a substrate that has an intrinsic conductive pathway comprising elemental zirconium that extends from a first surface to a second surface of the substrate.

Abstract: One aspect of the present disclosure relates to a system that can facilitate delivery of a medical device in proximity to a target region within a patient's body. Data representing an image of a portion of the patient's body can be received. Based on the data representing the image, a first three dimensional (3D) model of the medical device can be generated. A second 3D model of the medical device can be fitted within the first 3D model at a location in proximity to the target region to create a combined 3D model. A two dimensional (2D) projection of the combined 3D model can be created.

Abstract: An implantable medical device is provided for the suppression or prevention of pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient. The implantable medical device can be a neurostimulator configured to be implanted on or near a cranial nerve to treat headache or other neurological disorders. One aspect of the implantable medical device is that it includes an electronics enclosure, a substrate integral to the electronics enclosure, and a monolithic feed-through integral to the electronics enclosure and the substrate. In some embodiments, the implantable medical device can include a fixation apparatus for attaching the device to a patient.

Abstract: Methods and apparatus for delivering a neurostimulator to a target tissue are provided which may include any number of features. One feature is a delivery tool comprising a handle portion, an elongate shaft comprising a contoured distal portion, a visualization system embedded in the elongate shaft, and an insertion groove on the elongate shaft configured to deploy the neurostimulator. The contoured distal portion can be shaped and configured to maintain contact with a posterior maxilla and elevate a periosteum off of the posterior maxilla to avoid soft tissue dissection. In some embodiments, the neurostimulator is implanted in close proximity to or touching the sphenopalatine ganglion.

Abstract: An implantable medical device is provided for the suppression or prevention of pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient. The implantable medical device can be a neurostimulator configured to be implanted on or near a cranial nerve to treat headache or other neurological disorders. One aspect of the implantable medical device is that it includes an electronics enclosure, a substrate integral to the electronics enclosure, and a monolithic feed-through integral to the electronics enclosure and the substrate. In some embodiments, the implantable medical device can include a fixation apparatus for attaching the device to a patient.

Abstract: Methods and apparatus for delivering a neurostimulator to a target tissue are provided which may include any number of features. One feature is a delivery tool comprising a handle portion, an elongate shaft comprising a contoured distal portion, a visualization system embedded in the elongate shaft, and an insertion groove on the elongate shaft configured to deploy the neurostimulator. The contoured distal portion can be shaped and configured to maintain contact with a posterior maxilla and elevate a periosteum off of the posterior maxilla to avoid soft tissue dissection. In some embodiments, the neurostimulator is implanted in close proximity to or touching the sphenopalatine ganglion.

Abstract: An implantable medical device is provided for the suppression or prevention of pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient. The implantable medical device can be a neurostimulator configured to be implanted on or near a cranial nerve to treat headache or other neurological disorders. One aspect of the implantable medical device is that it includes an electronics enclosure, a substrate integral to the electronics enclosure, and a monolithic feed-through integral to the electronics enclosure and the substrate. In some embodiments, the implantable medical device can include a fixation apparatus for attaching the device to a patient.

Abstract: An implantable medical device is provided for the suppression or prevention of pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient. The implantable medical device can be a neurostimulator configured to be implanted on or near a cranial nerve to treat headache or other neurological disorders. One aspect of the implantable medical device is that it includes an electronics enclosure, a substrate integral to the electronics enclosure, and a monolithic feed-through integral to the electronics enclosure and the substrate. In some embodiments, the implantable medical device can include a fixation apparatus for attaching the device to a patient.

Abstract: Methods and apparatus for delivering a neurostimulator to a target tissue are provided which may include any number of features. One feature is a delivery tool comprising a handle portion, an elongate shaft comprising a contoured distal portion, a visualization system embedded in the elongate shaft, and an insertion groove on the elongate shaft configured to deploy the neurostimulator. The contoured distal portion can be shaped and configured to maintain contact with a posterior maxilla and elevate a periosteum off of the posterior maxilla to avoid soft tissue dissection. In some embodiments, the neurostimulator is implanted in close proximity to or touching the sphenopalatine ganglion.

Abstract: A method is provided for the suppression or prevention of pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient. The method comprises inserting an electrode into a patient. The electrode can be positioned on or proximate to a neural structure, and the electrode can detect an ENG signal. In some embodiments, the neural structure can be the patient's sphenopalatine ganglia (“SPG”), sphenopalatine nerves (“SPN”), or vidian nerves (“VN”). Placement of the electrode can be tested by detecting a characteristic ENG. If the characteristic ENG indicates that the electrode is not positioned on the target neural structure, the electrode can be repositioned.