Abstract: A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.

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: A leadless pulse generator is disclosed herein. The leadless pulse generator has a body, a helical anchor, an electrode, and a sleeve. The body includes a distal end and a proximal end opposite the distal end. The helical anchor distally extends from the distal end. The electrode is at the distal end. The sleeve distally extends from the distal end and has a proximal face and a distal face opposite the proximal face. The proximal face is adjacent the body. The sleeve coaxially extends about the helical anchor and further has a biased state wherein the distal face is near a distal tip of the helical anchor. The sleeve is configured to compress such that the distal face displaces proximally towards the proximal face upon the distal face being forced against the cardiac tissue in the course of the helical anchor screwing into the cardiac tissue.

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 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: 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: 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, a method includes releasably attaching an image capture assembly to a distal portion of a TEE device. Next, the TEE device coupled to the image capture assembly is inserted into an oral cavity of the patient. With the image capture assembly releasably attached to the distal portion of the TEE device, image data of an esophagus of the patient captured by the image capture assembly is displayed. While viewing the display of image data, the TEE device coupled to the image capture assembly can be moved within the esophagus. With both the TEE device and the image capture assembly disposed within the esophagus, the image capture assembly is detached from the TEE device. With the image capture assembly detached from the TEE device, and with the TEE device disposed at least in part within the esophagus, the image capture assembly is removed from the 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: 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: A reinforced medical electrical lead for neurological applications has a reinforced construction for resisting the detachment of electrodes and lead connection terminals, thereby improving the robustness of the lead and extending the life of the lead by reducing the likelihood that a further surgical procedure will be required to remove the lead for repair or replacement thereof. The present reinforced lead construction maintains the integrity of the electrical connection between the conductor and the respective electrode and lead connection terminal by incorporating several reinforcing features in the lead construction in contrast to conventional lead constructions where it is possible to pull the electrodes and lead connection terminals away from their contact points with relatively little force.

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: An implantable neurostimulation electrode assembly comprises a first electrode unit and a second electrode unit configured to be arranged in a side-by-side configuration. The first electrode unit includes a dielectric first paddle, a plurality of first electrodes carried by the first paddle, and a guideline. The guideline has a distal section affixed to the first paddle and a proximal section having a length configured to extend externally of a patient. The second electrode unit has a dielectric second paddle and a plurality of second electrodes carried by the second paddle. The second paddle is configured to travel along the guideline and contact the first paddle in the side-by-side configuration. As a result, the first and second electrode units of this embodiment can be passed percutaneously through the same percutaneous entry hole and assembled in vivo at the stimulation site to form a larger paddle-type electrode array without surgical implantation.

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.