Abstract: A balloon catheter capable of delivering torque and pushing through obstructions includes a relatively weak balloon segment of a catheter and rotatable asymmetric tip. A reinforcement sleeve increases column strength and torque transmission to push the balloon and rotate the tip to facilitate passage through said obstructions. The tip is preferably asymmetric around its axis, usually being beveled, and the reinforcement slide includes a slide lock mechanism which increases shaft flexibility after balloon deployment.

Abstract: A method for planning an infusion into hepatic tissue into a patient includes: obtaining anatomical and/or physiological patient data of the patient's liver or a region of the liver; determining at least one patient parameter from the patient data; planning the infusion using the anatomical patient data, physiological patient data, and/or at least one patient parameter, wherein planning includes determining how an administered substance is distributed in the tissue and/or how the administered substance influences physiological properties of the tissue; and determining a distribution and/or effectiveness of a therapeutic agent administered with the substance or after the substance.

Abstract: The present invention provides a microneedle patch which can solve the problem that microneedle production is difficult and requires high accuracy, the problem that time and mental burdens on a health professional and a patient are large, and the problem caused by compounding a plurality of drugs. The microneedle patch comprises a large number of drug-carrying microprojections 4 erected on one support sheet, each microprojection 4 having a drug layer 5 soluble in vivo at its top part and having an intermediate layer 6 under the drug layer 5, the intermediate layer 6 containing a polymeric substance for adhesion of the drug layer 5 to the support sheet, the drug layer 5 at the top part of the microprojection 4 containing a single drug, the microprojections 4 holding difference types of drugs being arranged together on the support sheet 2.

Abstract: According to some embodiments herein, systems for delivering therapeutic agents and/or methods of using such systems are provided. The systems can be configured to administer solution comprising therapeutic agent to a subject, and can further comprise an ultrasound applicator for applying ultrasound energy to the subject.

Abstract: This invention provides methods and systems uniquely capable of enhancing medicant delivery and/or effectiveness through the use of energy to predictably disrupt membranes and mechanically and thermally modulate cells and tissues. In exemplary embodiments, the methods and systems disclosed herein are capable of modulating multiple layers of tissue. In an exemplary embodiment, the energy is acoustic energy (e.g., ultrasound). In other exemplary embodiments, the energy is photon based energy (e.g., IPL, LED, laser, white light, etc.), or other energy forms, such radio frequency electric currents, or various combinations of acoustic energy, electromagnetic energy and other energy forms or energy absorbers such as cooling. Medicants can be first introduced to the region of interest by diffusion, circulation, and/or injection. An exemplary system for enhancing medicant delivery and/or effectiveness comprises a control system, a probe, and a display or indicator system.

Abstract: The present invention is a hemostatic plug for use with Extracorporeal Membrane Oxygenation (ECMO) cannulas that allow quick access to the blood vessel as well as maintaining a sterile environment to resume ECMO, if needed. It is designed to be a universal fit for use with adult ECMO circuits. The plug consists of a hemostatic membrane, a collection chamber and a cap. The membrane is designed to allow catheter delivery of up to a 19 French diameter through the ECMO cannula. The collection chamber allows the distribution of blood pressure over a broader surface, which allows additional hemostasis in addition to the membranes. The plug is then further reinforced with a cap that provides additional hemostasis, but when removed, allows hemostatic access into the blood vessel via the ECMO cannula.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

Abstract: A connector includes a housing defining a male connector insertion section into which a male connector is inserted from the outside and an elastic valve body having a slit and blocking the male connector insertion section. The elastic valve body includes a top face having the slit and a bottom face located opposite to the top face. The housing includes a holding section having contact with the top face and the bottom face of the elastic valve body to hold the elastic valve body. The holding section surrounds the slit when the valve body is viewed from the top face. The diameter of a bottom face side holding section having contact with the bottom face is smaller than the diameter of a top face side holding section having contact with the top face.

Abstract: An assembly for mounting medical connector caps includes a carrier formed from a sheet of material and having an array of holes. The assembly also includes a plurality of medical connector caps. Each cap is inserted into one of the holes of the array. The assembly also includes a plurality of sealing tabs. The tabs may be retained on the carrier by friction fit into the holes of the carrier. The carrier may also include a mounting hole to hang on a pole of an IV line.

Abstract: A closure device for a fluid system for medical purposes is disclosed. The closure device includes a support housing, which has at least one opening to a fluid reservoir or a fluid line, and also with a connection piece, which includes a Luer connecting portion for connecting to a syringe or some other Luer connection part, and with an elastically deformable closure membrane, which closes a fluid passage of the connection piece and opens it when the syringe or other Luer connection part is connected. A nonreturn valve is configured for opening both in the direction of the connection piece and in the direction of the opening to the fluid reservoir or to the fluid line is arranged in the support housing at a distance from the closure membrane in the direction of the fluid. The closure device has applications in several areas, including in infusion systems for medical purposes.

Abstract: Needleless connectors are described. An example needleless connector includes a housing and a compressible valve. The housing may define an internal cavity and may include a body section having a first port and one or more internal contact tabs and a base section having a valve mount and a second port. The compressible valve may be disposed within at least a portion of the internal cavity and be movably retained within the housing. The compressible valve may include a flange portion for securing the compressible valve within the housing. A central longitudinal axis of the housing may be defined by a coaxial arrangement of the first and second port. The one or more internal contact tabs may be arranged to contact an outer side surface of the flange portion such that a radial force substantially orthogonal to the central longitudinal axis is provided for securement.

Abstract: A flexible patch is provided that is capable of emitting light in the UV, visible, and/or infrared electromagnetic spectrums. The patch contains a feedback process and system using one or more sensors and a controller on the patch to (1) accelerate the wound healing process by providing adaptable, controlled light exposure and electrical stimulation, (2) monitor the healing process for signs of infection (3) eliminate bacterial infections by sanitizing the infected site and (4) relaying the information wirelessly to a central location for storage and interpretation by a physician as well as by providing the ability to receive feedback and operating instructions from the physician from a remote location.

Abstract: Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. Specifically, the tissue separating device includes a handle, an elongate sheath and a circular cutting blade that may extend from the distal end of the sheath upon actuating the handle. The elongate sheath, particularly its distal end, includes a non-uniform wall thickness having one or more thicker portions in the outer sheath, particularly the outer cam member, and/or one or more thicker portions in an inner member disposed radially inward of the blade.

Abstract: A vestibular stimulation array is disclosed having one or more separate electrode arrays each operatively adapted for implantation in a semicircular canal of the vestibular system, wherein each separate electrode array is dimensioned and constructed so that so that residual vestibular function is preserved. In particular, the electrode arrays are dimensioned such that the membranous labyrinth is not substantially compressed. Furthermore, the electrode array has a stop portion to limit insertion of the electrode array into the semi-circular canal and is stiff enough to avoid damage to the anatomical structures.

Abstract: Embodiments presented herein are generally directed to a stimulating assembly of a cochlear implant that includes a perimodiolar flexure. The perimodiolar flexure is formed in a basal section of the stimulating assembly and has elastic properties and a shape so as to, after insertion into the cochlea, position the stimulating contacts disposed in the basal section of the stimulating assembly adjacent to a modiolar wall of the cochlea.

Abstract: Leads having directional electrodes thereon. Also provided are leads having directional electrodes as well as retention ledges to secure the electrodes to the leads. Also provided are leads with directional electrodes where all the electrodes have the same surface area. Methods of manufacturing leads and methods of treating conditions and selectively stimulating regions of the nervous system are also provided.

Abstract: A paddle lead assembly for providing electrical stimulation of patient tissue includes a paddle body having a longitudinal axis and a lateral axis transverse to the longitudinal axis. The paddle body includes a plurality of electrodes disposed into at least four columns extending parallel with the longitudinal axis. The at least four columns include two lateral columns and at least two medial columns disposed therebetween. The electrodes of the at least two medial columns are arranged into rows aligned along the transverse axis. The electrodes of the two lateral columns are each longitudinally offset from the rows of electrodes of the at least two medial columns. An array of terminals are disposed on each of at least one lead body coupled to the paddle body. A plurality of conductive wires couple each of the electrodes to at least one terminal of the terminal arrays.

Abstract: Delivery tools of interventional medical systems facilitate deployment of relatively compact implantable medical devices that include extensions, for example, cardiac pacing devices that include an extension for atrial sensing, wherein an entirety of the device is contained within the delivery tool while a distal-most portion of the tool is navigated to a target implant site. Once at the implant site, a device fixation member may be exposed out from a distal opening of the tool, for initial deployment, while the extension remains contained within the delivery tool. The tool includes a grasping mechanism, operable, within and without a lumen of the tool, to alternately grip and release the device extension, for example, to position a distal end of the extension after the tool has been withdrawn from over an entirety of the initially deployed device.

Abstract: Disclosed herein are devices and methods for shielding certain medical conductors, such as neurotherapy leads from MRI energy. Preferred embodiments comprise a heat sink; a first antenna coil extending from the heat sink and wound around the longitudinal axis of the therapeutic conductor in a first longitudinal direction; and a second antenna coil extending from the heat sink and wound around the longitudinal axis of the therapeutic conductor in a second longitudinal direction.

Abstract: A drug administration device which applies a voltage between electrodes so as to percutaneously administer a drug measures a current value between the electrodes at predetermined time intervals, calculates an administration rate of the drug, based on the measured current value, and causes a display to display the calculated administration rate.

Abstract: Methods for a new, drug-free therapy for treating solid skin tumors through the application of nanosecond pulsed electric fields (“nsPEFs”) are provided. In one embodiment of the invention, the cells are melanoma cells, and the applied nsPEFs penetrate into the interior of tumor cells and cause tumor cell nuclei to rapidly shrink and tumor blood flow to stop. This new technique provides a highly localized targeting of tumor cells with only minor effects on overlying skin.

Abstract: Systems and methods are described for monitoring, treating, and preventing a repetitive stress injury, arthritis or other medical condition. A system embodiment includes, but is not limited to, a deformable substrate configured to interface with a skin surface; a sensor assembly coupled to the deformable substrate, the sensor assembly including a motion sensor and a physiological sensor, the sensor assembly configured to generate one or more sense signals based on detection of a movement of a body portion by the motion sensor and a physiological parameter of the body portion by the physiological sensor; a processor operably coupled to the sensor assembly and configured to receive the one or more sense signals; and an effector operably coupled to the processor and configured to affect the body portion responsive to control by the processor.

Abstract: The present invention relates to a cochlear implant apparatus, and more particularly, to a cochlear implant apparatus capable of controlling the sensitivity or selectivity of sound through actuators. In accordance with an exemplary embodiment of the present invention, a cochlear implant apparatus for active feedback control which is inserted into the human body and configured to detect a sound in each frequency band includes a sensor unit configured to detect vibration according to a sound and generate an electrical signal corresponding to a magnitude of the vibration and actuators disposed in the sensor unit and each configured to react to the electrical signal and to control sensitivity according to the magnitude of the sound or the selectivity of a sound detected in each frequency band.

Abstract: A system includes means for providing an input audio signal; a sound processor for generating an electric stimulation signal from the input audio signal; and a cochlear implant electrode arrangement comprising a plurality of stimulation channels for stimulating the cochlea according to the electric stimulation signal.

Abstract: Presented herein are trans-modiolar stimulation techniques in which stimulation current is sourced (delivered) by at least one intra-cochlear stimulating contact and is sunk at a group of other intra-cochlear stimulating contacts. The group of other infra-cochlear stimulating contacts is positioned (located) across a section of the recipient's modiolus from the intra-cochlear stimulating contact that sources the stimulation. As such, stimulation current generally passes through the modiolus to stimulate spiral ganglion cells and evoke a hearing percept.

Abstract: An implantable pulse generator (IPG) that generates spinal cord stimulation signals for a human body has a programmable signal generator that can generate the signals based on stored signal parameters without any intervention from a processor that controls the overall operation of the IPG. While the signal generator is generating the signals the processor can be in a standby mode to substantially save battery power.

Abstract: An implantable pulse generator (IPG) that generates spinal cord stimulation signals for a human body has a programmable signal generator that can generate the signals based on stored signal parameters without any intervention from a processor that controls the overall operation of the IPG. While the signal generator is generating the signals the processor can be in a standby mode to substantially save battery power.

Abstract: A system for decreasing the blood flow of a targeted organ in case of bleeding or a medical requirement includes an integrated electrostimulator and a subsystem.

Abstract: Systems and methods for modulating a physiological process are provided to enable precise delivery of signals to a predetermined treatment site. The systems may comprise an implantable device and an electrical lead body. The electrical lead body may comprise a plurality of transducer contacts in close proximity to an end of the electrical lead body, and a control unit positioned within the lead body in close proximity to the plurality of transducer contacts.

Abstract: An implantable pulse generator (IPG) that generates spinal cord stimulation signals for a human body includes a timing generator and high frequency generator. The timing generator generates timing signals that represent stimulation signals for multiple channels. The high frequency generator determines whether to modulate the timing signals and modulates them at a burst frequency according to stored burst parameters if the decision is yes. As such, the IPG provides the ability to generate both the low frequency and high frequency stimulation signals in different channels according to user programming.

Abstract: An implantable pulse generator (IPG) that generates spinal cord stimulation signals for a human body includes a timing generator and high frequency generator. The timing generator generates timing signals that represent stimulation signals for multiple channels. The high frequency generator determines whether to modulate the timing signals and modulates them at a burst frequency according to stored burst parameters if the decision is yes. The high frequency generator can also independently control the pulse frequency of each channel according to the stored parameters. As such, the IPG provides the ability to generate both the low frequency and high frequency stimulation signals at different frequencies in different channels according to user programming in order to provide maximum flexibility in treatment.

Abstract: An implantable pulse generator (IPG) that generates spinal cord stimulation signals for a human body includes an electrode driver for each electrode, which adjusts the amplitude of the timing signals and output an output current corresponding to the adjusted signals for transmission to the associated electrode so as to enable independent amplitude control of the stimulation signals for each stimulation pattern channel.

Abstract: Delivery tools of interventional medical systems facilitate deployment of relatively compact implantable medical devices that include sensing extensions, for example, right ventricular cardiac pacing devices that include a sensing extension for atrial sensing. An entirety of such a device is contained within a delivery tool while a distal-most portion of the tool is navigated to a target implant site; the tool is configured to expose, out from a distal opening thereof, a distal portion of the device for initial deployment, after which sensing, via a sense electrode of the aforementioned sensing extension of the device, can be evaluated without withdrawing the tool from over the remainder of the device that includes the sensing extension.

Abstract: The control module of a first pacemaker included in an implantable medical device system including the first pacemaker and a second pacemaker is configured to set a pacing escape interval in response to a far field pacing pulse sensed by the first pacemaker. The far field pacing pulse is a pacing pulse delivered by the second pacemaker. The pacing escape interval is allowed to continue without restarting the in response to a far field intrinsic event sensed by the first pacemaker during the pacing escape interval. The first pacemaker delivers a cardiac pacing pulse to the heart upon expiration of the pacing escape interval.

Abstract: A medical device system including at least a first implantable medical device and a second implantable medical device is configured to establish by a control module of the first implantable medical device whether the second implantable medical device is present in a patient and self-configure an operating mode of the control module in response to establishing that the second implantable medical device is present.

Abstract: Aspects herein include an implantable medical device, such as an implantable cardiac rhythm management device. The implantable medical device can include a housing, control circuitry disposed within the housing, and telemetry circuitry in electrical communication with the control circuitry. The control circuitry can be configured to execute a post-procedural system check procedure after the expiration of a preselected first time period. The first time period can be greater than or equal to 0.5 hours and less than or equal to 48 hours. In various aspects, the post-procedural system check procedure can include measuring diagnostic properties for one or more electrodes of an electrical stimulation lead attached to the implantable medical device. The first time period can begin to elapse after detection of a triggering event or a command by a system operator.

Abstract: The invention relates to an implantable energy source comprising at least one energy storage sub-system (171) constructed in the form of a stack of thin layers (175) on a substrate (176), characterised in that said energy storage sub-system has a plurality of through-openings (174) for allowing the development and the passage of blood vessels. Preferably, the energy source thereof has a thickness of less than, or equal to, 1 mm, over at least 80% of its surface.

Abstract: Some implementations provide a method of treating chronic pain or inflammation with neural modulation, the method including: placing a surgical instrument to reach into a torso section of a patient's body, the patient suffering from chronic pain or inflammation in a primary area in the torso section; placing a wireless device into an opening on the surgical instrument, the wireless device suitable to fit into the opening and configured to receive electromagnetic energy non-inductively from a source located outside the patient's body; through the opening on the surgical instrument, positioning the wireless electrode lead adjacent to or near excitable tissue in the primary area in the torso section of the patient; and causing electrical pulses to be delivered to one or more electrodes on the wireless device such that neural modulation is applied to the excitable tissue in the primary area in the torso section.

Abstract: Devices, systems, and methods are disclosed for relaying information from a cardiac pacemaker to an external device. Logic on the pacemaker modulates a heartbeat clock of the pacemaker to encode information onto a blood pressure sequence by adding or subtracting a small subinterval to or from a pulse repetition interval of the pacemaker. A muscle stimulator beats the heart according to the modulated sequence. A monitoring device external to the body monitors the blood pressure to retrieve the encoded information, or message. The encoded information is then decoded to determine the information in the message. This information may concern the pacemaker as well as other devices within the body that communicate with the pacemaker such as blood monitors, etc. Since the message is conveyed via simple modulation of the heart beat intervals, no separate transmitter is required in the pacemaker which would otherwise increase cost and decrease battery life.

Abstract: A defibrillator and method that uses ECG signals from limb lead electrodes for display and monitoring, even when a separate set of therapy pads are present at the patient. The limb lead ECG signal is used for display and to determine whether electrotherapy is necessary. The determination is a prerequisite to arming and delivery of the electrotherapy.

Abstract: A method, system and device to detect and use clean ECG segments, which do not need filtering to remove artifact or CPR-induced noise, is described to provide a reliability score for the decision made by shock advisory algorithms. The method can be implemented in a system and/or device that is provided with a display for indicating to a user the relative quality of the determination of an electrotherapy analysis circuit.

Abstract: The ICD/VAD defibrillator electromagnet is used with patients who possess either an ICD or a VAD. The electromagnet has a slim, low-profile design and an adhesive pad that allows for proper positioning to patient's chest, a decrease risk for pressure related wounds, and also permits the positioning of the patient in any of multiple planes while in surgery/X-ray without worry about displacement or shifting of the electromagnet. The electromagnet provides protection and safety for patients undergoing surgery involving electrocaurtery as well as, helping patients in X-ray/CT/MRI procedures that produce high magnetic fields that interfere with ICD/VAD proper function.

Abstract: A radio frequency annular phased array hyperthermia system providing a relatively small heated focal zone in a relatively large tissue mass includes a plurality of radio frequency energy applicators in at least one ring adapted to surround the relatively large tissue mass. A bolus having a dielectric constant is positioned between the energy applicators and the tissue mass. The energy applicators operate at a frequency high enough to create the relatively small heated focal zone. The spacing between adjacent applicators in the at least one ring is less than a critical distance and spacing between adjacent rings when the at least one ring is a plurality of side by side rings is less than a critical distance with such critical distances being interdependent on the frequency of the energy radiated, the dielectric constant of the bolus, the size of the bolus, and the size of the relatively large tissue mass.

Abstract: Systems that integrate Transcranial Stimulation Biofeedback (TSB) Detector functions and Transcranial Magnetic Stimulation (TMS) functions, as well as methods of manufacturing such systems and methods of performing TSB detection and TMS using such systems, are provided. A system can include a hardware component and a software component in operable communication with the hardware component. The hardware component can include or be in operable communication with a TMS machine, and the software component can be configured to receive waveforms from the TSB Detector hardware.

Abstract: A device and method are provided for treatment of peripheral nerve pain using a tMS stimulator for directing a low frequency, focused magnetic flux to a treatment area. A control module in wired and powered communication with the tMS stimulator, and a portable electronic device in wireless communication with the control module receive, generate and transmit feedback and control settings relating to a treatment parameters. The tMS stimulator may be configured in different sizes and shapes to provide varying pulse and magnetic field strengths. Guidance tools and measurement sensors may be provided to aid in positioning and directing the magnetic flux.

Abstract: Stimulation of target cells using light, e.g., in vivo, is implemented using a variety of methods and devices. In one such device, target cells are stimulated using an implantable device. The device includes a light source for producing light from electrical power. An optical transmission element is made from a material that is substantially transparent to the light from the light light source. This transmission element substantially encases the light source at a proximal end. The transmission element delivers light from the light source to a distal end. The shape and size of the transmission element facilitates implanting of the element within a patient. A fixation portion physically couples to the optical transmission element and secures the device to the patient. A heat dissipation portion removes heat from the near optical transmission element and the light source and dissipates the removed heat through the fixation portion.

Abstract: Deep Tissue Low Intensity Laser Therapy or Treatment (DT-LILT) as described here is a novel methodology through which selective destruction of nociceptive (pain) nerves can be brought upon by a medical laser delivery system using the phenomenon of absorption and cell resonance. Using this method nerve cells that transmit pain can be selectively destroyed leaving the surrounding tissues intact as no heat is generated. The delivery system incorporates a fine needle through which a 703 nm (range 690 to 710) pulsed wave low intensity laser is delivered deep into the body, directly to the area of pain causing selective destruction of pain nerves. Laser devices based on this methodology should be used only by the physician or equivalent professional community since diagnosing and defining the area of pain is critical to providing successful pain relief.

Abstract: Medical devices with a light source and antimicrobial solution include a solution retainer adapted to retain an antimicrobial solution against a user; a fiber optic cable; a light termination on the fiber optic cable that provides light from the fiber optic cable to the antimicrobial solution in the solution retainer; and a light source that provides a light of a predetermined wavelength to the fiber optic cable. Medical device includes a container, a bowl, a full body suit, garments for body parts, a helmet, and a catheter.

Abstract: A device having medical and veterinary applications of light to antimicrobial and antineoplastic chemicals includes a solution retainer adapted to retain a therapeutic solution against a user, the therapeutic solution including an antimicrobial chemical, an antineoplastic chemical, or both; a fiber optic cable; a light termination on the fiber optic cable that provides light from the fiber optic cable to the therapeutic solution in the solution retainer; and a light source that provides a light of a predetermined wavelength to the fiber optic cable; wherein the light provides a synergistic effect in the therapeutic solution that inhibits microbial or neoplastic growth.