Abstract: The present invention provides an external fixation device and method thereof. The device includes at least an insert for inserting into a patient's tissue such as a bone. The insert is fastened to a fastening assembly which comprises at least a RF heat source member during MRI scanning of the patient. At least a part of the RF heat source member's surface is covered with an absorption material to reduce the direct or indirect transfer of RF induced heat from the member to the insert. The absorption material has an electric conductivity greater than 10?4 S/m.

Abstract: A medical lead includes a lead body, a connector, an electrical conductor, and a sleeve. The lead body includes a distal end and a proximal end defining a longitudinal axis of the lead body. The connector is positioned near the proximal end of the lead body. The electrical conductor extends about the longitudinal axis of the lead body. The sleeve is coupled to an insulative material of the lead body and positioned around the electrical conductor. The electrical conductor is electrically coupled to the connector. The sleeve includes a fixed portion that is fixed to the electrical conductor and an unfixed portion that is not fixed to the electrical conductor. In response to bending of the medical lead, the conductor may move within the unfixed portion to relieve strain created by the bending.

Abstract: Provided herein relates to implantable devices and systems with dynamic silk coatings. In some embodiments, the dynamic silk coatings can be formed in situ or in vivo.

Abstract: Autonomic nervous system control via high frequency spinal cord modulation, and associated systems and methods. A method for treating a patient in accordance with a particular embodiment includes selecting a neural modulation site to include a neural population of the patient's spinal cord, and selecting parameters of a neural modulation signal to at least reduce an autonomic system deficit in the patient.

Abstract: A catheter configured to deliver therapeutic energy to a tissue can include can include an elongate shaft extending along a shaft longitudinal axis and comprising a shaft proximal end and a shaft distal end. The catheter can include a flexible tip assembly comprising a tip assembly outer surface, wherein the flexible tip assembly is connected to the shaft distal end and is configured to deliver therapeutic energy to the tissue, and wherein the flexible tip assembly further includes. The flexible tip assembly can include an insulative layer comprising an insulative layer outer surface, wherein the insulative layer is disposed on the tip assembly outer surface and a mapping electrode disposed on the insulative layer outer surface.

Abstract: A catheter apparatus for assessing denervation comprises: an elongated catheter body; a deployable structure coupled to the catheter body, the deployable structure being deployable outwardly from and contractible inwardly toward the longitudinal axis of the catheter body; one or more ablation elements disposed on the deployable structure to move outwardly and inwardly with the deployable structure; one or more stimulation elements spaced from each other and disposed on the deployable structure to move with the deployable structure, the stimulation elements being powered to supply nerve stimulating signals to the vessel; and one or more recording elements spaced from each other and from the stimulation elements, the recording elements being disposed on the deployable structure to move with the deployable structure, the recording elements configured to record response of the vessel to the nerve stimulating signals.

Abstract: Improved systems are disclosed for providing advantages during stimulation of peripheral nerves using transcutaneous, percutaneous, and implantable stimulators. Percutaneous stimulation is improved by accessories that guide the angel and depth of injection to allow for easy and controlled needle injection. Transcutaneous stimulation is improved using pressure to improve nerve recruitment. Systems and methods are disclosed for providing nerve stimulation of a patient to treat medical disorders and conditions within a single user or multiple user environments such as assisted living centers.

Abstract: An optical electrode having a plurality of electrodes, including a recording electrode having a roughened surface and an optical light source configured to emit light, wherein at least a portion of the light impinges on the recording electrode. Also disclosed are methods of producing an optical electrode and an opto-electronic neural interface system.

Abstract: A neural interface device that comprises an implantable microelectrode body. The implantable microelectrode body includes a neural interface probe, which includes a thin film metal trace connected to an interface pad and an amorphous silicon carbide insulation. The amorphous silicon carbide insulation surrounds the thin film metal trace to form an outside surface of the neural interface probe. The interface pad is exposed to an ambient environment of the neural interface probe through an opening in the amorphous silicon carbide insulation. Methods of manufacturing the neural interface device are disclosed.

Abstract: An implantable electrical stimulation lead includes at least three modular lead elements configured to couple together to form the lead, each of the modular lead elements including a proximal end portion, a distal end portion, and a male connector element or a female connector element disposed on at least one of the proximal end portion or the distal end portion of the modular lead element, The modular lead elements are coupleable together by insertion of a male connector element into a female connector element.

Abstract: A bipolar electrosurgical device including an outer shaft, an inner shaft, first and second electrode surfaces, and an irrigation channel. The outer shaft defines a lumen, a proximal end and a distal end forming a cutting window. The inner shaft is rotatably disposed within the outer shaft, and defines a distal portion forming a cutting tip. The cutting tip and the cutting window combine to define a cutting implement. The first and second electrode surfaces are electrically isolated, and are formed at the cutting implement. The irrigation channel extends parallel to the outer shaft, and terminates in at least one outlet port. The outlet port is proximally spaced from the cutting window and is located radially outside of the outer shaft. Fluid (e.g., saline) is emitted at the exterior surface of the device near the cutting window and is readily present for interacting with the electrode surfaces.

Abstract: In one example, a medical device includes a housing having a channel configured to receive an electrical lead. The medical device can further have a rotatable member having a longitudinal axis about which the rotatable member is configured to rotate. The rotatable member can have an outer surface having a first radius from the longitudinal axis. The rotatable member can also have a cam lobe extending farther from the longitudinal axis than the first radius of the outer surface. The cam lobe can have a substantially planar surface parallel to the longitudinal axis. The substantially planar surface of the cam lobe can be configured to retain the electrical lead within the channel. The medical device can further have a slider having a central portion substantially parallel with the cam lobe. The slider can further have a slider protrusion on the central portion of the slider.

Abstract: Methods for automatically programming a signal generator in a patient therapy system and associated systems are disclosed. A representative method comprises retrieving data including therapy program parameters, level of efficacy, and medication use corresponding to a plurality of time periods; identifying from the data a target time period having a corresponding level of efficacy; determining from the data if medication was used during the target time period; determining from the data if medication was used during a prior time period immediately before the target time period; calculating a lead position confidence factor; and programming the signal generator to repeat therapy with the therapy program parameters corresponding to the target time period if the confidence factor is greater than a threshold value and medication was used during the prior time period and not during the target time period.

Abstract: During charging of implantable devices via inductive coupling, heat may be produced within the implantable device, so control of the charging may be desirable to reduce or avoid the risk of undesirable tissue heating. Exchanging parameters relevant for charging may prevent undesirable heating, but typically increase the complexity of the devices used. An implantable device is provided, for wirelessly receiving energy pulses, monitoring the energy storage, and transmitting a first sufficient energy signal if the energy storage exceeds a first maximum value. An associated energy transmission device is provided, for wirelessly transmitting a plurality of successive energy pulses transmitted at a first power level, pausing energy transmission immediately after the first sufficient energy signal is received, and subsequently resuming energy pulse transmission at the first power level if no further sufficient energy signal is received.

Abstract: In some examples, a tool for, e.g., creating a sub-sternal tunnel in a patient or other use, is described. The tool may include a handle and a tunneling shaft coupled to the handle. The tunneling shaft extends from a proximal end to a distal end, and at least a portion of the tunneling shaft extends in a curved orientation between the first end to the distal end. The distal end of the tunneling shaft includes a cutting tool having a sharp edge. The cutting tool is moveable from a recessed position in which the sharp edge of the cutting tool is recessed into the distal end of the tunneling shaft to a deployed position in which the sharp edge of the cutting tool extends beyond the distal end of the tunneling shaft in the deployed position, e.g., to cut pericardium, scar tissue, and/or connective tissue with the sharp edge.

Abstract: Methods for treating polycystic kidney disease with therapeutic renal neuromodulation and associated systems and methods are disclosed herein. One aspect of the present technology is directed to methods that at least partially inhibit sympathetic neural activity in nerves proximate a renal artery of a kidney of a patient. One or more measurable physiological parameter corresponding to the polycystic kidney disease can thereby be reduced. Moreover, central sympathetic drive in the patient can be reduced in a manner that treats the patient for the polycystic kidney disease. Renal sympathetic nerve activity can be modulated along the afferent and/or efferent pathway. The modulation can be achieved, for example, using an intravascularly positioned catheter carrying a neuromodulation assembly, e.g., a neuromodulation assembly configured to cryotherapeutically cool the renal nerve or to deliver an energy field to the renal nerve.

Abstract: Methods and devices described herein facilitate improved treatment of body organs.

Abstract: A method for implanting a lead includes inserting a needle into the patient; inserting a lead blank through the needle; steering the lead blank to, or near, a lead implantation site; removing the needle from the patient and leaving the lead blank; advancing a flexible sheath over the lead blank after removing the needle; removing the lead blank from the patient and leaving the flexible sheath; inserting a lead through the flexible sheath, after removing the lead blank, and implanting the lead at the lead implantation site; and removing the flexible sheath. The flexible sheath can also be used for explanting a lead and, optionally, implanting a new lead.

Abstract: Diagnostic screening tests that can be used to identify if a patient is a good candidates for an implantable vagus nerve stimulation device. One or more analyte, such as a cytokine or inflammatory molecule, can be measured from a blood sample taken prior to implantation of a vagus nerve stimulator to determine the patient's responsiveness to VNS for treatment of an inflammatory disorder.

Abstract: A method of treating Alzheimer's Disease and/or Multiple Sclerosis and/or Minimally Conscious State and/or Mood Disorders and/or vascular brain disorders where there is small vessel compromise in a subject in need thereof, comprising applying a neuromodulation signal to the 1PAG or v1PAG of the subject.

Abstract: A deep treatment bioelectric device includes multiple electrodes joined with a planar substrate.

Abstract: Pill-sized pacemaker system including a pill-size pacemaker and a lead connector, the pacemaker having a distal end including a first screw hook and a proximal end including a first magnetic coupler, the lead connector having a distal end including a second screw hook and a proximal end including a second magnetic coupler, the first and second magnetic couplers being disc-shaped, each including at least one depth-wise electrode, wherein the first screw hook is for screwing the pacemaker to inner heart tissue and for sensing at least one signal from the inner heart tissue, the second screw hook is for screwing the lead connector to inner heart tissue and for sensing at least one signal from the inner heart tissue, and the pacemaker and the lead connector are electrically coupled via each depth-wise electrode of the first and second magnetic couplers when the first and second magnetic couplers are magnetically coupled.

Abstract: A neuromodulation catheter in accordance with a particular embodiment includes an elongate shaft and a neuromodulation element operably connected to the shaft. The shaft includes a proximal hypotube segment at its proximal end portion and a jacket disposed around at least a portion of an outer surface of the hypotube segment. The jacket may be made at least partially of a polymer blend including polyether block amide and polysiloxane. The neuromodulation element includes a distal hypotube segment and a tubular jacket disposed around at least a portion of an outer surface of the distal hypotube segment. The jacket has reduced-diameter segments spaced apart along its longitudinal axis. The neuromodulation element further includes band electrodes respectively seated in the reduced-diameter segments and respectively forming closed loops extending circumferentially around the jacket.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods for delivering therapy to an adrenal gland of a patient. The apparatuses, systems, and methods may include a plurality of stimulation elements arranged configured to deliver stimulation energy through at least one of the plurality of stimulation elements to modulate aldosterone levels within the patient.

Abstract: The invention provides a neural electrode, including a current generation device, a first and a second electrode. The current generation device is connected to the first and second electrodes through a conductive metal wire respectively. At least one of the first and second electrodes is a graphene electrode. The graphene electrode has soft texture and desirable stability to tolerate the repeated pressing and folding treatment, very high charge injection efficiency, and desirable in vivo stability, and is configured to electrically stimulate tissues and organs such as hearts and nerves to promote electrical stimulation and repair of neurons, to further promote regeneration of neural functions. The invention further provides use of a mineralized three-dimensional porous graphene foam material to prepare a bone defect filler. The bone defect filler has desirable biological compatibility, promotes cell proliferation, and accelerates and induces osteogenic differentiation of bone marrow mesenchymal stem cells.

Abstract: A method for fabricating electrodes sized and dimensioned to record, measure, and/or stimulate very fine nerve structures (e.g., microscale or less) is described herein. The method can include securing a tip of an electrode, comprising a conductor substantially encased by an insulator, to a proximal portion of an inserter. The electrode can be wound around a proximal portion of the inserter and a portion of the electrode can be secured to a distal portion of the inserter. A tension in the electrode can be maintained during the winding to keep the electrode in place during the winding.

Abstract: The invention provides a body-worn patch sensor for simultaneously measuring a blood pressure (BP), pulse oximetry (SpO2), and other vital signs and hemodynamic parameters from a patient. The patch sensor features a sensing portion having a flexible housing that is worn entirely on the patient's chest and encloses a battery, wireless transmitter, and all the sensor's sensing and electronic components. It measures electrocardiogram (ECG), impedance plethysmogram (IPG), photoplethysmogram (PPG), and phonocardiogram (PCG) waveforms, and collectively processes these to determine the vital signs and hemodynamic parameters. The sensor that measures PPG waveforms also includes a heating element to increase perfusion of tissue on the chest.

Abstract: A catheter apparatus can include a first magnet coupled to a catheter and a second magnet configured to couple to a patient's skin. When the catheter and the first magnet are positioned within a patient's body, the second magnet can exert a magnetic force on the first magnet that stabilizes the catheter relative to the second magnet. The second magnet can be directly attached to the patient's skin or secondary devices such as straps can be used to place the second magnet in a fixed position relative to the patient's body. In some implementations, a plurality of magnets can facilitate holding the catheter in a substantially fixed position within the patient.

Abstract: Bio-selective textured surfaces are described which mediate foreign body response, bacterial adhesion, and tissue adhesion on devices implanted in a mammalian body. Hierarchical levels of texture, some capable of establishing a Wenzel state others a Cassie state, are employed to interface with living structures, either to promote or discourage a particular biological response/interaction. Since a gaseous state is traditionally required to establish a Cassie or Wenzel state, and gases do not remain long in living tissue, described are tissue/device interactions analogous to the above states with the component normally represented by a gas replaced by a bodily constituent, wherein separation of tissue constituents develops and a desired interaction state evolves.

Abstract: Provided is a piezoelectric substrate, containing an elongate piezoelectric body that is helically wound, in which the piezoelectric body includes an optically active polypeptide, a length direction of the piezoelectric body and a main orientation direction of the optically active polypeptide included in the piezoelectric body are substantially parallel to each other, and the piezoelectric body has a degree of orientation F of from 0.50 to less than 1.00, as determined from X-ray diffraction measurement by the following Formula (a): Degree of orientation F=(180°??)/180°??(a) in Formula (a), ? represents a half width (°) of a peak derived from orientation.

Abstract: This disclosure relates to an implantable probe for electrical stimulation of an organ and/or for detection of electrical potentials on this organ. The probe comprises a distal end able to come into contact with the tissues of the organ, this end comprising an insulating substrate, and at least one conductive interface carried by the substrate. The probe further comprises a probe body having at least one bonding conductor connected to a respective conductive interface. The conductive interface comprises at least one deformable conductive wire, at least partially exposed, with a woven, embroidered, braided or knitted configuration for anchoring the deformable wire to the substrate.

Abstract: A biosensor includes an array of metal nanorods formed on a substrate. An electropolymerized conductor is formed over tops of a portion of the nanorods to form a reservoir between the electropolymerized conductor and the substrate. The electropolymerized conductor includes pores that open and close responsively to electrical signals applied to the nanorods. A dispensing material is loaded in the reservoir to be dispersed in accordance with open pores.

Abstract: Medical devices allow for the complete removal of a portion of an implantable component that contains a magnet. Such structure allows a recipient to undergo MRI procedures without interference from the implanted magnet. The magnet can also be contained within a larger, non-magnetic chassis that acts as an enlarged lever arm having a greater torque resistance against the generated magnetic forces.

Abstract: A burr hole plug includes a base having a flange configured to rest on the skull of a patient and a sidewall configured to extend into a burr hole. The burr hole plug also includes a flexible cover configured to be disposed entirely over, and coupled to, the base. The flexible cover includes a skirt to fit around an outer perimeter of the base and a rim that fits inside the sidewall of the base. Between the skirt and the rim is an inset region having a shape corresponding to a shape of the flange of the base. Alternatively or additionally, the burr hole plug may include two lead retention members, each of the lead retention members including a lead engagement surface to engage and hold a lead; and a locking member for locking the two lead retention members in the base.

Abstract: The present disclosure relates to a bioelectric hydrogel. In one embodiment, a hydrogel comprises a hydrophilic polymer base and one or more biocompatible electrodes configured to generate at least one of a low level electric field (LLEF) or low level electric current (LLEC). The hydrogel is configured to provide a three-dimensional energy source within the hydrogel or to devises proximate to the hydrogel.

Abstract: A lead wire assembly apparatus for an implantable medical device (IMD), the apparatus including a lead having first and second ends and a plurality of separate conductive segments serially located therebetween; a cover defining at least one cavity situated about ends of adjacent conductive segments; and a fluid located in the at least one cavity and coupling the adjacent conductive segments to each other. The fluid electrically couples adjacent conductive segments to pass driving signals of the implantable medical device. The fluid may further attenuate induced signals generated by radiofrequency (RF) signals of a magnetic resonance (MR) system.

Abstract: A medical implant, such as an implantable component (22) of a tissue-stimulating prosthesis. One example of such a prosthesis being a cochlear implant. The component (22) is adapted to be implanted at or adjacent a tissue surface within the recipient, such as a bone surface. The component (22) has a housing and at least one flange (42) extending outwardly therefrom. The flange (42) can be secured to the tissue surface via a tissue fixation device, such as a bone screw (43).

Abstract: The present disclosure provides systems and methods for reducing RF heating in implantable leads. An implantable lead includes a first electrode, and a coupling component spaced from the first electrode, wherein the first electrode and the coupling component form a capacitor, wherein the first electrode and the coupling component are electrically isolated from one another at therapy frequencies, and wherein the first electrode and the coupling component are electrically coupled to one another at magnetic resonance imaging (MRI) frequencies.

Abstract: A neuromodulation system includes modulation output circuitry and control circuitry. The modulation output circuitry may be configured to deliver therapeutic electrical energy including therapeutic sub-threshold electrical energy and therapeutic a super-threshold electrical energy. The sub-threshold electrical energy is below a patient-perception threshold and the super-threshold electrical energy is above the patient-perception threshold. The patient-perception threshold is a boundary below which a patient does not sense delivery of the electrical energy and above which the patient does sense delivery of the electrical energy. The control circuitry is configured to control the modulation output circuitry to deliver the therapeutic electrical energy using alternating cycles of the sub-threshold electrical energy below the patient-perception threshold and the super-threshold electrical energy above the patient-perception-threshold.

Abstract: A kit or arrangement for securing a burr hole plug that includes a guide base having an upper flange, a lower flange, and a connecting member coupling the upper flange to the lower flange, each of the upper flange and the lower flange defining one or more guide holes, wherein the one or more guide holes of the upper flange are aligned with the one or more guide holes of the lower flange; a drill shank including a cutting element and a main shaft that are configured to pass through any one of the one or more guide holes in the upper flange; and one or more guide collets including a collet shaft and a fastener tube extending from the collet shaft to receive a fastener, where the collet shaft and fastener tube are configured for insertion into any one of the guide holes in the upper flange.

Abstract: Disclosed are micro-wire stimulators that magnetically stimulate nearby cells and/or their processes (e.g., nerve fiber, axons, dendrites, etc.). The micro-wire includes one or more bends. The micro-wire stimulator can facilitate the creation of stronger field gradients in one direction with much smaller gradients in orthogonal directions, allowing for selective targeting, or avoiding, of specific cell types within a targeted region. The bent micro-wire stimulator may be implanted into the cortex of the brain to selectively stimulate nearby neural cells having a particular orientation relative to the stimulator. A tip portion of the micro-wire may be rounded, or it may have corners forming other suitable geometric shapes.

Abstract: An implantable medical therapy delivery device includes a non-conductive filament extending along a length of an outer surface of an insulative body of the device, wherein the filament includes a plurality of fixation projections and is secured to the outer surface of the insulative body such that the projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface. The filament may be wound about the length with an open pitch. In some cases, the insulative body includes an open-work member forming at least a portion of the outer surface thereof, and the filament may be interlaced with the open-work member. In these cases, the filament may be bioabsorbable, for example, to provide only acute fixation via the projections thereof, while the open-work member provides a structure for tissue ingrowth and, thus, more permanent or chronic fixation.

Abstract: A leadless pacing device may include a power supply for providing a power supply voltage, a housing having a first end and a second end with a side extending between the first end and the second end, and a set of electrodes supported by the housing and in communication with the power supply. When leadless pacing device is disposed within a coronary sinus of a patient's heart, the housing may facilitate blood flow across the housing. The housing may include fixing members extending radially outward from the side of the housing to engage a wall of the coronary sinus and expand the coronary sinus to allow blood to flow past the housing. In some cases, the housing may have a recess along a length thereof that allows blood to flow past the housing. The recess may include a groove, a flat feature, or other feature.

Abstract: Methods and devices are provided for activating brown adipose tissue (BAT) using electrical energy. In general, the methods and devices can facilitate activation of BAT to increase thermogenesis. The BAT can be activated by applying an electrical signal thereto that can be configured to target sympathetic nerves that can directly innervate the BAT. The electrical signal can be configured to target the sympathetic nerves using fiber diameter selectivity. In other words, the electrical signal can be configured to activate nerve fibers having a first diameter without activating nerve fibers having diameters different than the first diameter. Sympathetic nerves include postganglionic unmyelinated, small diameter fibers, while parasympathetic nerves that can directly innervate BAT include preganglionic myelinated, larger diameter fibers.

Abstract: An insert for receipt within a plate aperture having an inner wall along the plate aperture includes a body and collar. The body has inner and outer surfaces. The inner surface defines an insert aperture having a longitudinal axis. The collar extends from the outer surface in a first radial direction perpendicular to the longitudinal axis and extends along only a portion of the outer surface in a second radial direction transverse to the first radial direction and the longitudinal axis. The collar defines a first radial distance from the longitudinal axis at a first position of the collar and a second radial distance from the longitudinal axis at a second position of the collar that differs from the first radial distance. A fixation system includes the plate and insert which is receivable within the plate aperture such that the collar contacts and is slideable along the inner wall.

Abstract: A connector assembly for connecting external power sources to an implanted medical device enables continual supply of electrical power to the implanted medical device during replacement of an external power source. A connector assembly includes a distal driveline contact assembly, a first driveline contact assembly, and a second driveline contact assembly. The second driveline contact assembly is connectable to the distal driveline contact assembly prior to disconnection of the first driveline contact assembly from the distal driveline contact assembly.

Abstract: An exemplary method treating a chronic low back pain condition in a patient includes 1) generating, by an electroacupuncture device implanted beneath a skin surface of the patient, stimulation sessions at a duty cycle that is less than 0.05, and 2) applying, by the electroacupuncture device in accordance with the duty cycle, the stimulation sessions to a target tissue location within the patient by way of an electrode array located within the patient at an acupoint corresponding to the target tissue location.

Abstract: One aspect relates to a production method for a ring electrode, to a ring electrode, and to an electrode system. One method for the ring electrode includes providing an outer element, including an outer tube, providing a first inner element, including a first inner tube having a first core of a sacrificial material, providing a second inner element, including a second core of a sacrificial material, forming a composite tube by arranging the first inner element and the second inner element inside the outer element, the first inner element and the second inner element being arranged off-center with respect to one another, drawing the composite tube in a longitudinal direction of the composite tube, separating a composite tube disk from the composite tube, removing the sacrificial material of the first core, and removing the sacrificial material of the second core in order to obtain a contacting opening in the ring electrode.

Abstract: A sheet-shaped application member includes: a first region, and a second region extending around the first region, wherein: the first region comprises a first region attachment surface to which a medical device is attachable, and a first region application surface opposite the first region attachment surface and adapted to be applied to a subject, the second region comprises a second region application surface adapted to be applied to the subject, and the first and second application regions are adapted such that, when the application member is applied to the subject, adhesion at the second region application surface is stronger than adhesion at the first region application surface; and an application member tear portion adapted to allow for tearing of a portion within the first region or for tearing the first region from the second region.

Abstract: Devices and systems for obtaining conductance data and methods of manufacturing and using the same. In at least one embodiment of a device of the present disclosure, the device is an elongated body with at least one groove defined therein, the at least one groove configured to receive one or more conductor wires therein. In another embodiment, the device is an elongated core body having a plurality of conductive elements positioned thereon and a coating to result in a device having an overall round-cross section.