Abstract: Various aspects describe a lead delivery system for percutaneous introduction of a lead to a stimulation site near a neural target, such as the vagus nerve for nerve stimulation. The lead delivery system may include a needle assembly having a needle adapted to cut through tissue and provide initial access into the carotid sheath. The needle may be retracted into the lead delivery system to prevent cutting structures in the carotid sheath. The lead delivery system may also include a dilator assembly having one or more dilators to dilate a path to the stimulation site. The lead delivery system may further comprise a dilator assembly including a retractable needle adapted to cut through tissue. One or more locating elements, alternatively or in addition to one or more imaging elements, may be used on individual components of the lead delivery system for enhanced trackability and locatability within the body.

Abstract: The disclosure relates to a needle assembly for delivering a lead and methods of use. The needle assembly is configured to cut tissue and reduce the potential for cutting vulnerable bodily structures. The needle assembly includes an outer needle with a blunt tip and an inner needle with a sharp tip. The outer needle may be curved, and the inner needle may be curved. When the inner needle is rotated with respect to the outer needle, the inner needle protracts or retracts with respect to the outer needle. A stopping feature on the needle assembly may be included to resist over-rotation or over-extension. The needle assembly provides an initial path that may be further dilated for delivering a lead, such as a vagus nerve stimulation lead to a target site. The target site may be electrically tested with some embodiments.

Abstract: The present disclosure presents methods and apparatuses for mapping a target physiological region, for example, during baroreceptor stimulation therapy. In an aspect, such an example apparatus of the present disclosure may include a surgical instrument configured to be securely coupled to a patient and to allow access to a target physiological region. Furthermore, the example apparatus may include an attachment element coupled to the surgical instrument and configured to releasably engage a lead, stabilize the lead during mapping of the target physiological region, and allow the lead to be repositioned relative to the target physiological region.

Abstract: The disclosure relates to a needle assembly for delivering a lead and methods of use. The needle assembly is configured to cut tissue and reduce the potential for cutting vulnerable bodily structures. The needle assembly includes an outer needle with a blunt tip and an inner needle with a sharp tip. The outer needle may be curved, and the inner needle may be curved. When the inner needle is rotated with respect to the outer needle, the inner needle protracts or retracts with respect to the outer needle. A stopping feature on the needle assembly may be included to resist over-rotation or over-extension. The needle assembly provides an initial path that may be further dilated for delivering a lead, such as a vagus nerve stimulation lead to a target site. The target site may be electrically tested with some embodiments.

Abstract: Various aspects describe a lead delivery system for percutaneous introduction of a lead to a stimulation site near a neural target, such as the vagus nerve for nerve stimulation. The lead delivery system may include a needle assembly having a needle adapted to cut through tissue and provide initial access into the carotid sheath. The needle may be retracted into the lead delivery system to prevent cutting structures in the carotid sheath. The lead delivery system may also include a dilator assembly having one or more dilators to dilate a path to the stimulation site. The lead delivery system may further comprise a dilator assembly including a retractable needle adapted to cut through tissue. One or more locating elements, alternatively or in addition to one or more imaging elements, may be used on individual components of the lead delivery system for enhanced trackability and locatability within the body.

Abstract: The present disclosure presents methods and apparatuses for mapping a target physiological region, for example, during baroreceptor stimulation therapy. In an aspect, such an example apparatus of the present disclosure may include a surgical instrument configured to be securely coupled to a patient and to allow access to a target physiological region. Furthermore, the example apparatus may include an attachment element coupled to the surgical instrument and configured to releasably engage a lead, stabilize the lead during mapping of the target physiological region, and allow the lead to be repositioned relative to the target physiological region.

Abstract: Described is a system for stimulating a target region of a vagus nerve from a location within an internal jugular vein. The system comprises a medical lead and an insulating element. The insulating element is formed from a flexible sheet of electrically insulative material, and is to be implanted within the internal jugular vein to insulate nerve structures proximate the vagus nerve from stimulation. The insulating sheath includes at least one window through which the electrical stimuli can be delivered to the target region of the vagus nerve.

Abstract: A lead system has an elongate body, an active fixation assembly movable relative to the elongate lead body, including a non-stationary electrode. The lead system further includes a non-stationary electrode member and an electrical interconnect electrically connected between the non-stationary electrode member and the stationary electrode member. The electrical interconnect provides a reliable electrical interconnection between the stationary electrode and the non-stationary electrode, while allowing the non-stationary electrode to move relative to the stationary electrode.

Abstract: Described is a system for stimulating a target region of a vagus nerve from a location within an internal jugular vein. The system comprises a medical lead and an insulating element. The insulating element is formed from a flexible sheet of electrically insulative material, and is to be implanted within the internal jugular vein to insulate nerve structures proximate the vagus nerve from stimulation. The insulating sheath includes at least one window through which the electrical stimuli can be delivered to the target region of the vagus nerve.

Abstract: Described is a stimulation electrode assembly for stimulation of a vagus nerve within a carotid sheath. The stimulation electrode assembly comprises an insulating sheath and at least one energy delivery element. The insulating sheath includes a flexible sheet of electrically insulative material configured to assume a generally tubular shape to at least partially surround the carotid sheath when implanted, and having a first side and a second side, wherein the first side is positionable toward the carotid sheath when implanted. The at least one energy delivery element is located on the first side of the insulating sheath and is configured to deliver energy to the vagus nerve when implanted.