Abstract: A wire construct is ferromagnetic and/or biocompatible, while also having a size and geometry appropriate for use as an electrode for insertion into an in vivo implant site. In ferromagnetic embodiments, the wire is magnetically insertable via an electromagnetic driver, which uses high-speed magnetic acceleration to drive the wire material into a neural or other implant site. A helical thread may be formed on the external surface of the wire to facilitate rotational fine positioning after initial implantation. The wire may be formed as a monolithic structure with a magnetic metal alloyed with an inert and biocompatible metal, or may be a bimetallic structure in which a magnetic outer shell has an inert and biocompatible inner core. The wire is sized to allow transmission of electrical signals either to or from the implant site while avoiding immune response, thereby ensuring a long service life.

Abstract: Medical devices and methods are disclosed. An example method for accessing a body lumen may include providing a catheter system. The catheter system may include a catheter shaft having a lumen defined therein and an outer wall surface having a channel formed therein. A first guidewire may be disposed in the channel and a second guidewire may be disposed in the lumen. The method may also include advancing the catheter system through a body lumen to a location where the body lumen splits into a first section and a second section, advancing the first guidewire into the first section, and advancing the second guidewire into the second section, and advancing the catheter shaft along the second guidewire and into the second section. Advancing the catheter shaft along the second guidewire and into the second section may remove at least a portion of the first guidewire from the channel.

Abstract: A medical balloon for a balloon catheter is described. The balloon has at least a first layer made from a first material and a second layer made from a second material, said first and second layers being in overlying relationship with one another and being integral with one another; wherein the first layer has a softening or melting temperature which is higher than a softening or melting temperature of the second layer. A method of forming the medical balloon is also described, including locating a raw tubing in a mold; preheating and inflating the raw tubing so as to cause it to stretch; heating the raw tubing to soften or melt the second layer; setting the inflated raw tubing to form the medical balloon; and cooling the set balloon.

Abstract: Devices and methods for balloon delivery of rapamycin and other hydrophobic compounds to the wall of blood vessels. Balloon catheters, such as those used for balloon angioplasty, are modified with the addition of a reservoir of dry micelles, disposed at a suitable location within the balloon or catheter. The reservoir may be installed within the angioplasty balloon, within a lumen in communication with the angioplasty balloon, either as a loose or packed powder or as a film coating. The micelle preparation is reconstituted and the micelles are mobilized when the aqueous solution used to inflate the balloons is injected into the catheter. The micelles are infused into tissue surrounding the balloon when pressurized fluid within the balloon leaks through the wall of the balloon.

Abstract: A drainage catheter system includes an elongate tube with proximal and distal ends and a filament extending the tube that is adjustable to create a closed loop at the distal end of the tube when the filament is retracted relative to the tube. The filament is coupled to the tube such that the filament and tube are prevented from being separated in the event that the tube and filament are cut at the proximal end at the conclusion of a drainage procedure. The filament can be attached to the tube near the distal end. The filament can be attached to the tube along its length. The catheter system can also include a retraction mechanism having a first fixed position and second fixed position, where the second fixed position retracts the filament proximally relative to the first fixed position by actuating a plunger.

Abstract: A delivery system for delivering an implant to a first space within a body of a patient including an elongate delivery member having a proximal portion, a distal portion, a lumen and a receiving area, the receiving area dimensioned for receipt of the implant. A deforming member is movable with respect to the delivery member from a first position to a second position to apply a force to the implant to deform the implant positioned in the receiving area of the delivery member.

Abstract: Methods for treating hydrocephalus using a shunt, the shunt having one or more CSF intake openings in a distal portion, a valve disposed in a proximal portion of the shunt, and a lumen extending between the one or more CSF intake openings and the valve, the method comprises deploying the shunt in a body of a patient so that the distal portion of the shunt is at least partially disposed within a CP angle cistern, a body of the shunt is at least partially disposed within an IPS of the patient, and the proximal portion of the shunt is at least partially disposed within or proximate to a JV of the patient, wherein, after deployment of the shunt, CSF flows from the CP angle cistern to the JV via the shunt lumen at a flow rate in a range of 5 ml per hour to 15 ml per hour.

Abstract: The present invention provides a tissue expander (10) comprising a self-inflating core (12) having a non-inflated state and an inflated state and a coating (14) surrounding said core (12), wherein said core (12) comprises two or more segments (16) of dried compacted material of height H joined to each other by conformable linking portions (18) of height h where H is greater than h. the conformable linking portions (18) allow for the expander (10) to be conformed to a desired profile either before or after insertion under the skin of a patient.

Abstract: The present invention provides a tissue expander (10) comprising a self-inflating core (12 or 2e) having a non-inflated state and an inflated state and a coating (14) surrounding said core (12 or 12e), in which said core (12 or 12e) comprises a compacted self-inflating material and said coating comprises a fluid impermeable material having a plurality of apertures therethrough for allowing the passage of fluid to the core (12 or 12e) and in which the coating (14) is separable or separated from the core (12 or 12e) such as to allow the coating to provide a support function during use. The invention also provides a method of manufacturing the product.

Abstract: Methods and devices to affect types, proportion, quantity, distribution, or proliferation of microorganisms within a female reproductive system.

Abstract: An applicator assembly includes at least one ampoule formed of a frangible material and containing liquid to be applied, a body having a proximal end, a distal end, and an interior portion defining a chamber adapted to receive the at least one ampoule, an application member attached to the distal end of the body, an actuator projecting from the body operable to fracture the at least one ampoule, a trench formed in a surface of the body, and a vent disposed through a surface of the trench.

Abstract: An implantable portal includes a septum that has embedded therein a plurality of formations that together form an indicia adapted to identify at least one characteristic of the portal. The formations are configured from impressions formed on different layers of the septum spatially separated along the vertical axis of the septum. The impressions are filled with a radiopaque material. The superposed formations do not overlap when viewed from atop the septum. When viewed under radiographic imaging from the top of the septum, a 3-D identification indicia is presented to the viewer. The 3-D indicia may be used as a 3-D marker to focus the location of the septum where a needle to access the fluid reservoir of the portal may be inserted.

Abstract: A multi-use intravenous infusion assembly is presented which includes a septum actuator having various features to prevent over-insertion of the septum actuator through a slit in a blood control septum. By preventing over-insertion of the septum actuator, the slit of the septum is able to repeatedly self-close following removal of an external Luer device. Thus, the intravenous infusion assembly may be used repeatedly without exposing a clinician to blood and other infusion fluids.

Abstract: Needle free valve device (1) for controlling the flow of fluid in a pathway, the device (1) being operable in a closed and in an open configuration and comprising a first component (3), a second component (9),a locking means configured to selectively engage the first component (3) with the second component (9) in the open configuration when the first component (3) is displaced in an opening direction (23) along a valve axis toward the second component (9) or in the closed configuration when the first component (3) is displaced against the opening direction (23) away from the second component (9), and a sealing component (15) having a resilient portion (19), the resilient portion (19) comprising at least one slit (26) and engaging the second component (9) to provide a seal in the closed configuration, wherein the resilient portion (19) is adapted to move, buckle or flex to enable fluid flow through the at least one slit (26) upon application of a mechanical force of the second component (9) on the resilient po

Abstract: Needlefree valve device (1) for controlling the flow of fluid in a pathway, the device (1) being operable in a closed and in an open configuration and comprising a first component (3), a second component (9), a locking means configured to selectively engage the first component (3) with the second component (9) in the open configuration when the first component (3) is displaced in an opening direction (23) along a valve axis toward the second component (9) or in the closed configuration when the first component (3) is displaced against the opening direction (23) away from the second component (9), and a sealing component (15) having a first resilient portion (19) and a second resilient portion (16), the first resilient portion (19) comprising at least one slit (26) and contacting the first component (9) to provide a seal in the closed configuration, wherein the first resilient portion (19) is adapted to move, buckle or flex to enable fluid flow through the at least one slit (26) upon application of a mechanica

Abstract: The present disclosure illustrates a silicone concentric electrode and applies to electrical stimulation. The electrode includes at least a silicone electrode sheet and two wires. The silicone electrode sheet has a non-conductive rubber that separates the positive electrode and the negative electrode, and the negative electrode and the positive electrode will be connected to each wire respectively.

Abstract: An implantable lead may include an insulating substrate and a first asymmetric electrode formed on the insulating substrate. The first asymmetric electrode may have external perimeter edges defining a boundary between an exposed portion of the first electrode and the insulating substrate, wherein the external perimeter edges of the first electrode have asymmetric edge lengths.

Abstract: In one example, an implantable lead includes a substrate and an electrically conductive material disposed on the substrate to form a flexible circuit. The flexible circuit includes a proximal end adapted to electrically connect to an implantable processor, a distal portion adapted to stimulate a cochlear nerve, and a lead body extending from the proximal end to the distal portion, the lead body having a longitudinal axis and comprising a plurality of electrical traces adapted to carry electrical signals from the proximal end to the distal portion. A flag extension is formed in the substrate and extends laterally outward from the lead body longitudinal axis. A method for forming a cochlear lead with a flag extension is also provided.

Abstract: A temperature sensor is included within a lead in proximity to distal electrodes. The temperature sensor measures temperature change at the electrode to tissue interface. Actions can be taken when the temperature exceeds a threshold due to heating from current induced by radio frequency energy from an MRI scan. The actions may include sending a signal via telemetry from the implanted device to an external device to produce an alarm to alert an MRI technician or to instruct the MRI scanner to alter the MRI scan. The actions may include activating a switch in the conduction path of an implanted lead to block some of the RF energy and/or to activate a shunt in the conduction path to divert some of the RF energy. The temperature sensor may be of various forms and may be mounted in various locations within the lead.

Abstract: A medical lead is provided for use in a pulse stimulation system of the type which includes a pulse generator for producing electrical stimulation therapy. The lead comprises an elongate insulating body and at least one electrical conductor within the insulating body. The conductor has a proximal end configured to he electrically coupled to the pulse generator and has a DC resistance in the range of 375-2000 ohms. At least one distal electrode is coupled to the conductor.

Abstract: There is provided a device for neural stimulation of a patient's cochlea, comprising means for providing an input audio signal; a sound processor for generating, from the input audio signal, a neural stimulation signal for neural stimulation of the ipsilateral ear according to the hearing loss of the ipsilateral ear and a bone conduction stimulation signal for vibrational stimulation of the contralateral ear according to the hearing loss of the contralateral ear; an implantable cochlear implant stimulation arrangement comprising a plurality of stimulation channels for stimulating the cochlea of the ipsilateral ear according to the neural stimulation signal; and a bone conduction vibrator for stimulating the contralateral ear according to the bone conduction stimulation.

Abstract: A system for frequency matching a cochlear implant during fitting includes a tissue stimulation device configured to generate a tonal stimulus to mask efferent nerve fibers in a subject, one or more response measurement contacts configured to measure CAP signals during and outside of a refractory period, a frequency matching module in communication with the response measurement contacts and configured to receive the CAP signals during and outside of the refractory period to determine a stimulation location on the cochlear implant based on a comparison of the received CAP signals both during and outside of the refractory period, and a parameter adjusting module in communication with the frequency matching module and configured to interface with the cochlear implant and to adjust its processing parameters based on the stimulation location. Methods for frequency matching a cochlear implant during fitting are also disclosed.

Abstract: A cochlear implant is disclosed in an embodiment. The implant includes a signal level detector configured to determine a total signal level of an incoming acoustic signal and a processing unit configured to determine, in accordance with the determined total signal level, an intermediate knee point for each of a plurality of frequency bands. The implant includes a bandpass filters configured to generate a plurality of band limited audio signals in dependence upon the incoming acoustic signal, each band limited acoustic signal representing an associated audio frequency range relating to at least one electrode of a plurality of an implanted electrode array of the cochlear implant. The implant includes a pulse controller configured to deliver electrical stimulation signals to the plurality of electrodes of the implanted electrode array based on the generated signals and the determined intermediate knee point corresponding to the frequency range.

Abstract: Operational modes or settings of a totally implantable cochlear implant can be adjusted or changed based on movement of an external element. Sensors in the totally implantable cochlear implant detect one of several positions of the external element as that element is moved near the implant. Depending on the position detected, one of a plurality of operational modes or settings can be selected.

Abstract: Methods, systems, and devices for processing an auditory signal to generate auditory prosthesis electrode stimuli in response to an incoming acoustic signal are disclosed. An example method includes dividing the incoming acoustic signal into one or more frequency envelopes. The example method also includes determining which auditory prosthesis electrodes to stimulate. The example method additionally includes determining a temporal reference point to which auditory prosthesis electrode stimuli are referenced. The example method further includes determining a delay for each of the auditory prosthesis electrode stimuli from the temporal reference point. The example method yet further includes determining amplitudes of the auditory prosthesis electrode stimuli. The example method also includes determining a wait period length before each successive temporal reference point.

Abstract: Providing stimulation signals for an implanted auditory prosthesis including receiving first and second sound signals at first and second sound input devices, each of the first and second signals having a signal-to-noise ratio; determining a signal parameter related to said signal-to-noise ratio of each of the first and second signals; selecting one of the first and second signals which has the greater signal-to-noise ratio; and generating stimulation signals for the implanted auditory prosthesis based on said selected sound signal.

Abstract: An exemplary system includes an electro-acoustic stimulation (“EAS”) device, a cochlear implant, an electrode lead comprising a plurality of basal electrodes configured to be disposed within a basal region of a cochlea of a patient and a plurality of apical electrodes configured to be disposed within an apical region of the cochlea; and a loudspeaker communicatively coupled to the EAS device. The EAS device is configured to operate in an EAS mode by 1) disabling the apical electrodes for standard electrical stimulation, 2) detecting, while the apical electrodes are disabled for standard electrical stimulation, audio content presented to the patient and included in an acoustic stimulation frequency range, 3) directing the loudspeaker to apply acoustic stimulation representative of the audio content included in the acoustic stimulation frequency range to the patient, and 4) periodically directing the cochlear implant to apply conditioning stimulation by way of the disabled apical electrodes.

Abstract: Aspects of the invention include system and method for transmitting neural data extracted from an electrical signal of a non-human mammal to a human. The system includes an electrode implantable into the animal auditory nerve, brainstem, or midbrain of the non-human mammal, configured to record the electrical signal of the non-human mammal, the electrical signal being in the form of sequences of pulses or pulse trains encoding frequency information of the non-human mammal, a processing device electrically coupled with the electrode, configured to process the electrical signal and convert the processed electrical signal into a digital signal, a transmitting device electrically coupled with the processing device, configured to transmit the digital signal, and a receiving device electrically coupled with the transmitting device, configured to receive the transmitted digital signal, convert the received digital signal into a sensory output perceptible to the human, and apply the sensory output to the human.

Abstract: This disclosure concerns a method for enhancing vision for a vision impaired user comprises. A processor, such as a controller of a retinal prosthesis, determines based on input image data a shape associated with an object represented by the input image data. The processor then determines for each of multiple areas of the input image data a coverage value that indicates to what extent the shape covers that area of the input image. Each of the multiple areas is associated with one of multiple imaging elements of the retinal prosthesis. The processor then determines an output value for each of the multiple imaging elements of the retinal pros thesis, such that when the output values are applied to the imaging elements to create a visual stimulus, a contrast is perceivable between a first element and a second element based on their respective coverage values.

Abstract: A visual prosthesis in the form of a retinal implant, which is distinguished by the least possible space requirement inside the eye, is achieved by a visual prosthesis having an intraocular implant and an extraocular implant, which supplies the intraocular implant with energy and controls it. Virtually all the electronic components, which do not necessarily need to be accommodated with the intraocular implant inside the eye, can be arranged outside the eyeball, for example on the sclera. In this way, the space requirement of the stimulation system inside the eye is reduced and the operative intervention for implanting the stimulation system inside the eye is kept as small as possible. A bidirectional inductive interface between an extracorporeal part of the visual prosthesis and an intracorporeal part, including the intraocular and extraocular implants, via which a current supply and bidirectional data transmission can be carried out is provided.

Abstract: A method for titrating a stimulation parameter for one or more electrode contacts in a system for stimulating a hypoglossal nerve of a patient includes activating one of the one or more electrode contacts to stimulate the hypoglossal nerve of the patient, obtaining a first and/or second physiological measurement from the patient, comparing the first and/or second physiological measurement to a first and/or second predetermined target value, adjusting a stimulation parameter for the one of the one or more electrode contacts if the first and/or second physiological measurement differs from the first and/or second predetermined target value.

Abstract: A stimulator and a method for the treatment of intractable pain syndromes by electrical stimulation of the spinal cord is disclosed in which implantable electrodes positioned around a targeted area of the spinal cord transmit an interferential current that has a base medium frequency alternating current between 500 Hz-20 KHz. A digital signal processor generates a sine-wave-like waveform from a pulse generator which after further processing is used to generate at least two circuits for use in producing the beat frequency signal. An effective area of stimulation is controlled by the quantity of electrodes, positioning of the electrodes and electrode cross pattern orientation. Amplitude modulation of electrical circuits created at the electrode placements also augments the effective area of stimulation. The stimulator and method reduce accommodation of the body to the electrical stimulation and provide deeper penetration of the resultant signal.

Abstract: Some embodiments provide a method, comprising performing a neural stimulation test routine for stimulating a neural target in a cervical region of a patient, wherein for each of a plurality of head positions, performing the neural stimulation test routine includes testing a plurality of electrode configurations. The method further comprises recording threshold data for each of the tested electrode configurations for the plurality of head positions, and recommending an electrode configuration based on the recorded threshold data.

Abstract: The disclosure relates to a device including a circuit for adjusting the energy of the stimulation pulses, independently controlling the pulse width and the voltage of each stimulation pulse. An iterative search algorithm for determining the optimum energy includes changing both the pulse width and voltage at each new pulse delivered, by setting a high energy value and a low energy value, and delivering a stimulation pulse with the low energy value. A capture test is then carried out. In the presence of a capture, a current iteration is complete and a new iteration is done with the current low energy as a new high energy value. In the absence of capture, the algorithm is terminated with selection of the last energy value that produced the capture as the value of optimum energy.

Abstract: An example includes an apparatus for use within a header of an implantable medical device, the apparatus including a substantially annular spring, sized and shaped to be disposed in the header, the spring defining a loop extending about a central axis, the spring including a plurality of elastically deformable switchback portions that both zigzag and curve transversely about the loop to define a surface that at least partially encompasses the loop.

Abstract: A method and device is described, which provides electrical stimulation to the brain of a person, where the device comprises an external portion and at least one implantable portion. The external portion provides the energy source for stimulation to the implantable portions. The implantable portions provide at least two conductive paths through the skull and use the skull's high impedance to generate a current loop with the focus of stimulation lying in the current path.

Abstract: Devices, systems and methods for transcutaneous charging of implanted medical devices are provided herein. Such devices include a portable charging device and an attachment device for affixing the portable charging device to a skin of the patient in a suitable location and alignment over the implanted medical device to facilitate charging. The attachment device can include a frame having an opening through which the charging device is mounted and one or more tabs extending laterally from the opening, each tab including an adhesive surface and being movable from a first position extending away from a skin of the patient to facilitate positioning of the charging device and a second position extending toward the skin of the patient so as to engage the skin of the patient and affix the charging device to the patient after being properly positioned.

Abstract: A pulse generator that includes a communications module is disclosed herein. The communication module includes a transceiver and an antenna circuit. The antenna circuit includes a first pathway having a capacitor and a second, parallel pathway including a capacitor, and a resistor, and a radiating element arranged in series. The antenna circuit is tuned to have a resonant frequency corresponding to a desired transmission frequency and a bandwidth corresponding to shifts in the resonant frequency arising from the implantation of the antenna circuit in a patient's body.

Abstract: A neurostimulation system having an external or an implantable pulse generator programmed to innervate a specific nerve or group of nerves in a patient through an electrode as a mode of treatment, having a patient remote that wirelessly communicates with the pulse generator to increase stimulation, decrease stimulation, and provide indications to a patient regarding the status of the neurostimulation system. The patient remote can allow for adjustment of stimulation power within a clinically effective range and for turning on and turning off the pulse generator. The patient remote and neurostimulation system can also store a stimulation level when the pulse generator is turned off and automatically restore the pulse generator to the stored stimulation level when the pulse generator is turned on.

Abstract: An external control device, a neurostimulation system, and a method for providing therapy to a patient are provided. A plurality of stimulation parameter sets are defined, electrical stimulation energy is serially conveyed to tissue of the patient in accordance with the plurality of stimulation parameter sets, a historical log file is stored, and the plurality of stimulation parameter sets are logged in the historical log file.

Abstract: Systems, methods, and devices for treating cancer can produce field potentials of between 20 mV and 70 mV. In some cases, systems, methods, and devices provided herein can include a plurality of particles. The particles can include at least a first material and at least a second material, which can have electrode potentials configured to form a galvanic couple in the location of cancerous tissue to form a field potential adapted to preferentially target cancerous tissue over healthy tissue.

Abstract: The invention relates to a system for electrical and/or magnetic neuronal stimulation, comprising a signal generator for generating a stimulation signal, in particular an alternating-current stimulation signal, an applicator for applying the stimulation signal, in particular in an area on or directly around the optic nerve, a lead for deriving a measurement signal, in particular an EEG signal, a biomarker calculation unit for calculating a biomarker based on the measurement signal, and an optimization unit, in particular for performing a stochastic optimization process, for optimizing the value of the biomarker by varying the stimulation signal.

Abstract: The present disclosure provides compositions and methods for controlling pain. The present disclosure provides methods for identifying agents that control pain.

Abstract: A device for activating light-induced rupture of endocytic vesicles in target cells of a patient so as to effect delivery of an administered antigen to cytosol in the target cells, is described. The device is adapted to be worn by a patient over a region of skin where an antigen and a photosensitising agent are to be administered. The device comprises a rear surface that is rounded or otherwise configured to be worn against the patient's skin. It has a retaining part for retaining the device in place over the region of the patient's skin during an activation cycle. A light source is arranged to illuminate the patient's skin from the rear of the device. A control system is configured to vary the output of the light source with respect to time in accordance with a pre-configured output sequence.

Abstract: This invention provides methods for treating wounds using localized electromagnetic radiation directed at excitable tissues, including affected tissues, nerves, muscles, and blood vessels. By controlling the wavelength, the wavelength bandwidth, pulse duration, intensity, pulse frequency, and/or variations of those characteristics over time, and by selecting sites of exposure to electromagnetic radiation, improvements in the function of the different tissues and organs can be provided. Responses can be monitored by using visible and nonvisible characteristics of wounds. Changes in wound characteristics can become more visible under RGB and blue light wavelengths.

Abstract: A method of image guided radiation treatment (IGRT) is described. The method may include receiving a pre-acquired image data set of the body part acquired in a reference frame generally independent of a reference frame of an IGRT apparatus, processing a first population of x-ray cone beam projection images to compute therefrom a first tomosynthesis image volume; and operating a radiation treatment head of the IGRT apparatus to deliver treatment radiation to the body part based at least in part on a comparison between the first tomosynthesis image volume a pre-acquired image data set of the body part.

Abstract: A spot scanning (SS) ion therapy system configured for dynamic trimming of an ion particle pencil beam to reduce the amount of the radiation dosage outside of a target boundary.

Abstract: The invention relates to a HDR brachytherapy system comprising an ultrasound sensor for being arranged at the location of a brachytherapy catheter (12), wherein the ultrasound sensor is adapted to generate an ultrasound signal based on ultrasound radiation, which has been sent by an ultrasound imaging device preferentially comprising a TRUS probe (40) and which has been received by the ultrasound sensor. The position of the ultrasound sensor is determined based on the generated ultrasound signal, and based on this position of the ultrasound sensor the pose and shape of the brachytherapy catheter and/or the position of a HDR radiation source are determined. This allows for a very accurate determination of the pose and shape of the brachytherapy catheter and/or of the position of the HDR radiation source, which in turn can lead to an improved HDR brachytherapy.

Abstract: A radiation targeting system is provided. The system can include an introducer and an implant. The implant can be disposed within a cannula of the introducer and the implant can include a wire stem and multiple different wire branches each extending outwardly from a proximal portion of the wire stem. A radiation source can then be used to target the implant so that radiation therapy can be delivered to a patient. Optionally, a loader and a trocar can be included with the system.

Abstract: The invention comprises a system for patient specific control of charged particles in a charged particle beam path using one or more trays inserted into the charged particle beam path, such as at the exit port of a gantry nozzle in close proximity to a tumor of a patient. Each tray holds an insert, such as a patient specific insert for controlling the energy, focus depth, and/or shape of the charged particle beam. Examples of inserts include a range shifter, a compensator, an aperture, a ridge filter, and a blank. Trays in a tray assembly are optionally retracted into an output nozzle of a charged particle cancer treatment system. Optionally and preferably, each tray communicates a held and positioned insert to a main controller of the charged particle cancer therapy system.