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: A surgical tool configured to facilitate delivery of a neurostimulator to a craniofacial region of a subject includes a handle portion, an elongate shaft having a contoured distal portion, and an insertion groove on the elongate shaft. The elongate shaft is configured to be advanced under a zygomatic bone along a maxillary tuberosity towards a pterygopalatine fossa. The distal portion includes a distal dissecting tip. The insertion groove is configured to receive, support, and guide a medical device or instrument.

Abstract: A leadless implantable medical device (IMD) may include an electrode, a housing, and an energy transfer component. The housing retains a pulse generator configured to provide stimulation energy for delivery to a tissue of interest, a power supply, a memory storing programmable instructions, and a processor communicatively coupled to the memory. The processor is responsive to the programmable instructions to control operation of the leadless IMD. The electrode is securely affixed to the tissue of interest. The housing includes first and second body portions mated to one another at a detachable interface. The electrode is coupled to the second body portion. The energy transfer component is distributed between the first and second body portions and is configured to convey at least one of stimulation energy or sensed signals across the detachable interface when the first and second body portions are mated to one another.

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: 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 and apparatus for molding a medical device utilizes a rigid outer stiffener and a flexible inner mold that nests with the outer stiffener. The medical device can be a stimulating apparatus used to deliver electrical stimulation to a peripheral, central or autonomic neural structure. More specifically, the medical device can be a neurostimulator apparatus designed to delivery electrical stimulation to the sphenopalatine ganglion (SPG) to treat primary headaches, such as migraines, cluster headaches and/or many other neurological disorders, such as atypical facial pain and/or trigeminal neuralgias.

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: 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: In some embodiments, the power generator for converting mechanical energy to electrical energy may include a compressible element adapted and configured to be placed in an environment having a variable compressive force such as varying ambient pressures. The compressible element may be compressed by a force applied by the variable pressure to the compressible element. The power generator may further include a transducer that may be coupled to the compressible element and that may convert mechanical energy from the compression of the compressible element to electrical energy. In some embodiments, the power generator may be adapted to be an implantable power generator for converting mechanical energy from a patient to electrical energy, such that the compressible element adapted and configured to be placed between two adjacent tissue layers of the patient and to be compressed by a force applied from the two adjacent tissue layers to the compressible element.

Abstract: One aspect of the present disclosure includes a neurostimulator delivery apparatus. The apparatus includes a handle portion, an elongate shaft extending from the handle portion, and a distal deployment portion. The distal deployment portion is configured to releasably mate with a neurostimulator. The neurostimulator is sized and configured for implantation into a craniofacial region of a subject.

Abstract: In some embodiments, the power generator for converting mechanical energy to electrical energy is described may include a compressible element adapted and configured to be placed in an environment having a variable compressive force such as varying ambient pressures. The compressible element may be compressed by a force applied by the variable pressure to the compressible element. The power generator may further include a transducer that may be coupled to the compressible element and that may convert mechanical energy from the compression of the compressible element to electrical energy. In some embodiments, the power generator may be adapted to be an implantable power generator for converting mechanical energy from a patient to electrical energy, such that the compressible element adapted and configured to be placed between two adjacent tissue layers of the patient and to be compressed by a force applied from the two adjacent tissue layers to the compressible element.

Abstract: A surgical tool configured to facilitate delivery of a neurostimulator to a craniofacial region of a subject includes a handle portion, an elongate shaft having a contoured distal portion, and an insertion groove on the elongate shaft. The elongate shaft is configured to be advanced under a zygomatic bone along a maxillary tuberosity towards a pterygopalatine fossa. The distal portion includes a distal dissecting tip. The insertion groove is configured to receive, support, and guide a medical device or instrument.

Abstract: A surgical guide to facilitate delivery of a therapy delivery device into the pterygopalatine fossa of a subject includes a curvilinear body having a distal end portion, a proximal end portion, and an intermediate portion extending between the distal and proximal end portions. The proximal end portion is defined by oppositely disposed first and second surfaces. The proximal end portion and the intermediate portion define a longitudinal plane that extends between the proximal and distal end portions. The distal end portion has an arcuate configuration relative to the longitudinal plane and is defined by oppositely disposed third and fourth surfaces.

Abstract: Medical electrical lead systems and related methods are described. The medical electrical lead systems may be configured to be at least partially implanted in a body of a subject. Some variations of the medical electrical lead systems may comprise a lead body comprising a proximal end and a distal end and a lumen extending at least partially therebetween, at least one electrode in the proximity of the distal end of the lead body, and a reservoir in fluid communication with the lumen, where the reservoir is located at a position removed from the distal end of the lead body. Certain variations of the medical electrical lead systems may comprise a lead body comprising a proximal end and a distal end and first and second lumens extending at least partially therebetween, and at least one electrode in the proximity of the distal end of the lead body.

Abstract: Medical electrical lead systems and related methods are described. The medical electrical lead systems may be configured to be at least partially implanted in a body of a subject. Some variations of the medical electrical lead systems may comprise a lead body comprising a proximal end and a distal end and a lumen extending at least partially therebetween, at least one electrode in the proximity of the distal end of the lead body, and a reservoir in fluid communication with the lumen, where the reservoir is located at a position removed from the distal end of the lead body. Certain variations of the medical electrical lead systems may comprise a lead body comprising a proximal end and a distal end and first and second lumens extending at least partially therebetween, and at least one electrode in the proximity of the distal end of the lead body.