Abstract: Trigeminal nerves are stimulated based upon pulse counting and chronobiology. A cutaneous electrode assembly is applied to the forehead to stimulate the ophthalmic nerves. A method may include determining a number of pulses to be administered to a patient based upon the disorder being treated, and pulsing current through an electrode assembly to stimulate the patient's supraorbital and supratrochlear nerves with the determined number of pulses. Another method may include determining a pulse repetition frequency for pulses to be administered to a patient based upon the disorder being treated, and pulsing current through an electrode assembly to stimulate the patient's supraorbital and supratrochlear nerves at the pulse repetition frequency.

Abstract: A spiral-based thin-film mesh for medical devices and related methods is provided. The spiral-based thin-film mesh may be used as a stent cover for a stent device. The thin-film mesh may include a plurality of spirals. The spirals allow the thin-film mesh to expand omni-directionally. In one or more embodiments, the spirals may be logarithmic spirals, golden spirals, approximated golden spirals, box Phi spirals, or Fibonacci spirals. The thin-film mesh may be formed from thin-film Nitinol (TFN), and may be fabricated via sputter deposition on a micropattemed wafer.

Abstract: A septal occlusion device for closing an abnormal opening in the heart includes a wire mesh support structure with a first disk, a second disk, and a waist portion joining the first and second disk; and a thin-film micromesh coupled to the wire mesh and configured to extend across the abnormal opening. A left arterial appendage (LAA) occlusion device for sealing an LAA in the heart includes a support structure having a plurality of struts extending radially from a center to a distal portion to form a substantially hemisphere or dome shape, the distal portion of each strut being configured to engage an interior wall of the left arterial appendage, and a thin-film micromesh cover attached to the support structure and configured to extend across the opening of the left arterial appendage.

Abstract: A method of manufacturing three-dimensional thin-film nitinol (NiTi) devices includes: depositing multiple layers of nitinol and sacrificial material on a substrate. A three-dimensional thin-film nitinol device may include a first layer of nitinol and a second layer of nitinol bonded to the first layer at an area masked and not covered by the sacrificial material during deposition of the second layer.

Abstract: A device includes an elastic tubular stent including struts forming closed cells arranged in rows along a circumferential direction of the stent, with each cell having a first obtuse-angled corner on one end of the cell along a longitudinal direction of the stent and a second obtuse-angled corner on an opposing end of the cell along the longitudinal direction. The stent may be fabricated by cutting an array of quadrilateral cells in a nitinol hypotube to form a stent, with each cell having four corners with approximately equal angles. The stent may then be expanded radially such that each cell has a first obtuse-angled corner on one end of the cell along a longitudinal direction of the stent and a second obtuse-angled corner on an opposing end of the cell along the longitudinal direction, and heat treated to fix the shape of the stent.

Abstract: An intrasaccular flow diverter includes a wire structure (e.g., a braided wire or a laser-cut hypotube), a thin-film mesh placed over the wire structure, and crimps fixing the thin-film mesh to the wire structure at each crimp. The wire structure and the thin-film mesh between adjacent crimps are expanded radially to form thin-film covered spheroid structures. When deployed in an aneurysm, the spheroid structures may volumetrically fill the aneurysm sac. An intrasaccular flow diverter with an umbrella structure includes a wire structure with a plurality of crimps along the wire structure, and a thin-film covered umbrella structure at one end of the wire structure. The wire structure between adjacent crimps is expanded radially to form a spheroid structure. When deployed in an aneurysm, the thin-film covered umbrella structure may cover the aneurysm neck.

Abstract: An implantable subcutaneous electrode system is disclosed. The implantable subcutaneous electrode system may include an electrode body with electrical contacts disposed thereon or integrally formed therein. The electrode body also may include an insulation region defined between the electrical contacts and an aperture defined in the electrode body for receiving an anchoring device. A minimally invasive delivery device and methods for delivery of an implantable electrode system is also provided. The methods may include steps of introducing a needle comprising a cannula and a stylet through a patient's skin, removing the stylet while leaving the cannula in place, introducing an electrode applicator through the cannula, the electrode applicator comprising a hollow driver which receives the electrode assembly, and anchoring the electrode assembly to a bone by driving the hollow driver such that a self-tapping screw within the electrode assembly screws into the bone.

Abstract: A system for trigeminal nerve stimulation includes a pulse generator, which includes a user control configured to receive a user adjustment and a microcontroller configured to receive electric stimulation parameters and operate the pulse generator to produce electrical pulses according to the electric stimulation parameters during a treatment session. A method for nerve stimulation includes receiving, by a pulse generator, electric stimulation parameters, and producing, by the pulse generator, electrical pulses according to electric stimulation parameters during a treatment session. The electric stimulation parameters include at least one user-set parameter, which includes a current amplitude that is responsive to the user adjustment of the user control, and at least one physician-set parameter, which includes an upper bound and a lower bound for the current amplitude.

Abstract: A thin-film covered stent device may include a thin-film mesh and a stent backbone covered by the thin-film mesh, thereby forming a dual-layer stent structure. The thin-film covered stent device may have smaller pores and a high pore density compared to conventional stents. For example, the thin-film covered stent device may have a slit length of between 50 and 250 micrometers and a pore density of between 134 and 227 pores per mm2. The thin-film covered stent device facilitates rapid healing of tissue defects such as those encountered during the endovascular treatment of an aneurysm.

Abstract: Cutaneous and subcutaneous TNS embodiments are disclosed for addressing autonomic nervous system imbalances. A cutaneous electrode assembly is applied to a patient's forehead, and a current is pulsed through the electrode assembly to stimulate the supraorbital and supratrochlear nerves on the patient to increase activity for the patient's parasympathetic nervous system. Pulsing the current increases the power spectral density for the patient's heart rate variability in a 0.1 to 0.15 Hz frequency band.

Abstract: Thin-film mesh for medical devices, including stent and scaffold devices, and related methods are provided. Micropatterned thin-film mesh, such as thin-film Nitinol (TFN) mesh, may be fabricated via sputter deposition on a micropatterned wafer. The thin-film mesh may include slits to be expanded into pores, and the expanded thin-film mesh used as a cover for a stent device. The stent device may include two stent modules that may be implanted at a bifurcated aneurysm such that one module passes through a medial surface of the other module. The thin-film mesh may include pores with complex, fractal, or fractal-like shapes. The thin-film mesh may be used as a scaffold for a scaffold device. The thin-film scaffold may be placed in a solution including structural protein such as fibrin, seeded with cells, and placed in the body to replace or repair tissue.

Abstract: Methods and devices are provided for the use of thin-film cuffs on endovascular grafts. A method includes forming a fenestrated thin-film Nitinol sheet, expanding the fenestrated thin-film Nitinol sheet to expand the fenestrations, and attaching the expanded thin-film Nitinol sheet to a longitudinal end of a cover for an endovascular graft to form a cuff for the endovascular graft. The method may further include implanting the endovascular graft into a blood vessel. An endovascular graft may include a cover having a proximal and distal end, a proximal thin-film mesh cuff extending from the proximal end, and a distal thin-film mesh cuff extending form the distal end.

Abstract: Trigeminal nerves are stimulated based upon pulse counting and chronobiology. A cutaneous electrode assembly is applied to the forehead to stimulate the ophthalmic nerves. A method may include determining a number of pulses to be administered to a patient based upon the disorder being treated, and pulsing current through an electrode assembly to stimulate the patient's supraorbital and supratrochlear nerves with the determined number of pulses. Another method may include determining a pulse repetition frequency for pulses to be administered to a patient based upon the disorder being treated, and pulsing current through an electrode assembly to stimulate the patient's supraorbital and supratrochlear nerves at the pulse repetition frequency.

Abstract: Cutaneous and subcutaneous TNS embodiments are disclosed for addressing autonomic nervous system imbalances. A cutaneous electrode assembly is applied to a patient's forehead, and a current is pulsed through the electrode assembly to stimulate the supraorbital and supratrochlear nerves on the patient to increase activity for the patient's parasympathetic nervous system. Pulsing the current increases the power spectral density for the patient's heart rate variability in a 0.1 to 0.15 Hz frequency band.

Abstract: A system for trigeminal nerve stimulation includes a pulse generator, which includes a user control configured to receive a user adjustment and a microcontroller configured to receive electric stimulation parameters and operate the pulse generator to produce electrical pulses according to the electric stimulation parameters during a treatment session. A method for nerve stimulation includes receiving, by a pulse generator, electric stimulation parameters, and producing, by the pulse generator, electrical pulses according to electric stimulation parameters during a treatment session. The electric stimulation parameters include at least one user-set parameter, which includes a current amplitude that is responsive to the user adjustment of the user control, and at least one physician-set parameter, which includes an upper bound and a lower bound for the current amplitude.

Abstract: A method of manufacturing three-dimensional thin-film nitinol (NiTi) devices includes: depositing multiple layers of nitinol and sacrificial material on a substrate. A three-dimensional thin-film nitinol device may include a first layer of nitinol and a second layer of nitinol bonded to the first layer at an area masked and not covered by the sacrificial material during deposition of the second layer.

Abstract: Cutaneous and subcutaneous TNS embodiments are disclosed for addressing autonomic nervous system imbalances. A cutaneous electrode assembly is applied to a patient's forehead, and a current is pulsed through the electrode assembly to stimulate the supraorbital and supratrochlear nerves on the patient to increase activity for the patient's parasympathetic nervous system. Pulsing the current increases the power spectral density for the patient's heart rate variability in a 0.1 to 0.15 Hz frequency band.

Abstract: A system for trigeminal nerve stimulation includes a storage medium, a pulse generator in communication with the storage medium, a power source coupled to the pulse generator, and at least one electrode communicatively coupled to the pulse generator. The pulse generator includes a microcontroller which executes instructions from the storage medium and the microcontroller is configured to perform at least one of the following operations: produce electrical pulses having defined characteristics, record a log of use and anomalous events, restrict use to a specified individual, interface with electrodes, provide a signal to the specified individual indicating operational conditions and trouble conditions, and provide a signal to the specified individual indicating an end of a treatment period.

Abstract: An implantable subcutaneous electrode system is disclosed. A minimally invasive delivery device and methods for delivery of an implantable electrode system is also provided.

Abstract: Disclosed herein is a system for trigeminal nerve stimulation. In one embodiment, the system includes a storage medium, a pulse generator in communication with the storage medium, a power source coupled to the pulse generator, and at least one electrode communicatively coupled to the pulse generator. The pulse generator includes a microcontroller which executes instructions from the storage medium and the microcontroller is configured to perform at least one of the following operations: produce electrical pulses having defined characteristics, record a log of use and anomalous events, restrict use to a specified individual, interface with electrodes, provide a signal to the specified individual indicating operational conditions and trouble conditions, and provide a signal to the specified individual indicating an end of a treatment period.