Abstract: Various embodiments of the present disclosure encompass an endoluminal therapy system employing an endoluminal therapy device (21) and an endoluminal therapy monitoring controller (10). In support an endoluminal procedure, the endoluminal therapy device (21) is controlled to treat a site to be treated within a lumen. The controller (10) is operated to synchronize an activated dwell timing of the endoluminal therapy device (21) within the lumen to a tracked positioning of the endoluminal therapy device (21) contiguous with the site to be treated within the lumen. The controller (10) is further operated to monitor the site to be treated within the lumen induced by the endoluminal therapy device (21) during the synchronization by the controller (10) of the activated dwell timing of the endoluminal therapy device (21) within the lumen to the tracked positioning of the endoluminal therapy device (21) contiguous with the site to be treated within the lumen.

Abstract: Cryogenic methods, systems, and devices cryogenic system for alleviating lower back pain in a patient. The cryogenic device includes a handpiece having a size and shape suitable for supporting in a hand of an operator and a needle probe coupled to a distal portion of the handpiece. The needle probe includes a probe body, at least one needle coupled the probe body, and a silica supply tube extending within the needle lumen. The system includes an introducer configured to receive and position the at least one needle proximate to a location of a target tissue associated with lower back pain, wherein the cryogenic device is configured to provide a desired ice ball shape that remains on a distal portion of the introducer after the at least one needle is removed therefrom. The system further includes a needle guard configured to house the needle probe.

Abstract: A device for providing mammalian pelvic cavitary contrast therapy is presented. The system may comprise a human interface device, fluid tubing, a pump, and a reservoir. The system may be operable to apply any combination of heat or cold thermal energy transfer. The system may be operable to impart a desired therapy temperature to the human interface device and to expand a membrane containing a therapy fluid. The expanded membrane may conform to the contours of a therapy site. Operation of the human interface device may be controlled using a remote-control device. The therapy recipient is able to control the temperature of the fluid circulating through the membrane and is able to control the pressure of the fluid within the membrane.

Abstract: In one aspect, the present invention provides a method of cooling to produce selective disruption of visceral fat tissue in a non-infant human subject comprising infusing a cooled fluid into the abdominal or peritoneal cavity, or into other parts of the body containing visceral fat, to cool the proximal tissue sufficiently to selectively disrupt lipid-rich cells therein, for example, to promote subsequent damage and absorption of lipid-rich cells by the body without producing unwanted effects in non-lipid-rich cells; e.g., without injury to internal organ tissues that could otherwise produce life-threating risks. The cooled fluid can be infused using a catheter arrangement. The cooled fluid can be retained within the abdominal category for a particular duration, and then drained using the catheter arrangement. In certain embodiments, the cooled fluid can be simultaneously introduced into the abdominal cavity and drained therefrom.

Abstract: A monitor device for connecting to a sensor patch of an ostomy appliance includes a housing, electronic circuitry, a first interface for collecting sensor data from the sensor patch, and a tail portion having a proximal end and a distal end. The tail portion has an electrode extending from the proximal end of the tail portion to a first coupling element on the distal end. The monitor device is adapted to couple mechanically and electrically to the sensor patch of the ostomy appliance for relaying signals from the sensor patch to the monitor device.

Abstract: The present disclosure relates to a system for temperature management for patients in stationary and mobile ECLS and/or ECMO therapy, with a disposable and a fluid circuit, wherein the disposable comprises a reservoir or bag provided with at least one supply line and a drain line, further comprising a pumping unit element as part of the disposable, by means of which liquid in the reservoir or bag can be pumped through the fluid circuit, wherein in the mounted state of the system all fluid-guiding parts of the system are completely encapsulated and separated from intracorporeal and extracorporeal blood circuit of the patient undergoing the ECLS and/or ECMO therapy.

Abstract: An injectate delivery device for expanding tissue is provided. The injectate delivery device comprises: at least one fluid delivery tube comprising a proximal end, a distal end and a lumen therebetween; at least one fluid delivery element in fluid communication with the at least one fluid delivery tube lumen; a radially expanding element comprising the at least one fluid delivery element; a supply of vacuum constructed and arranged to cause tissue to tend toward the at least one fluid delivery element; and at least one control constructed and arranged to perform a function. The at least one control can be constructed and arranged to expand the radially expandable element and activate the supply of vacuum. Systems and method of injectate delivery are also provided.

Abstract: A method and apparatus for manipulating a temperature set-point of a human or homeothermic-animal for increasing or decreasing the body temperature above or below the prevailing body temperature for therapeutic purposes. The method includes the steps of warming or cooling sphenoid sinuses externally resulting in manipulation of the temperature of the pituitary gland which in turn results in manipulation of the body-temperature set-point and the body temperature manipulates accordingly to the new temperature set-point. A heat exchange medium can be used to warm or cool sphenoid sinuses and thus the pituitary gland. The heat exchange fluid can be liquid, or gas maintained at a predetermined temperature. Alternatively, a temperature-controlled probe can be used that upon contact with the sphenoid sinuses provides for the heat exchange.

Abstract: Systems and techniques are disclosed to adjust programming of an implantable electrical neurostimulation device for treating chronic pain of a human subject, through the use of a dynamic model adapted to identify pain treatment parameters for a human patient and determine a best device operational program to implement the pain treatment parameters to address the chronic pain condition. In an example, the system to adjust programming of the neurostimulation device performs operations that: obtain data related to a state of pain of the human subject; identify pain treatment parameters using a dynamic model adapted to evaluate the pain treatment parameters in the human subject over a time period, based on the data related to the state of pain; and select a neurostimulation program for the neurostimulation device, corresponding to at least a portion of the identified pain treatment parameters.

Abstract: Some embodiments relate to a method of reducing excess mucosa production and/or secretion in the respiratory tract, comprising: introducing into a respiratory tract lumen a device configured for damaging nerve tissue or blocking neural conduction in the surroundings of said lumen, the device comprising a plurality of energy emitters; positioning the energy emitters of the device inside the lumen at a distance from walls of the lumen; and activating the energy emitters to emit energy suitable to damage the nerve tissue enough to suppress parasympathetic nerve activity which causes excess mucosa production and/or secretion.

Abstract: Reinforced esophageal heat transfer devices are disclosed. An example reinforced esophageal heat transfer device includes a distal end configured for nasopharyngeal or oropharyngeal insertion into an esophagus of a subject, a proximal end including an inlet port and an outlet port, a heat transfer region between the distal end and the proximal end, one or more lumens configured for providing a fluid path for flow of a heat transfer medium to and from the heat transfer region, and one or more reinforcing elements configured for reinforcing the one or more lumens to enable the heat transfer medium to flow through the fluid path via negative pressure.

Abstract: A portable system for cold therapy with optional compression therapy is disclosed, including a cooling mechanism, a reservoir, and a control assembly. The cooling mechanism includes a compressor, a condenser, a fan, and a heat exchanger. The compressor has an air inlet connected to the heat exchanger through a first tube. The heat exchanger is connected to the condenser through a second tube. The condenser is connected to an air outlet of the compressor through a third tube. The first tube and the second tube are connected by fluid, and the second tube and the third tube are connected by fluid. The fan has a working surface facing the condenser. The liquid in the reservoir flows into the heat exchanger for cooling and then flows into the body wrap, and the liquid in the body wrap can flow into the heat exchanger or flow back into the reservoir.

Abstract: This present disclosure provides devices, systems, and methods relating to the modulation of tissue temperature. In particular, the present disclosure provides devices, systems, and methods for rapidly cooling or heating tissue in a subject as a therapeutic and/or prophylactic means for treating tissue that has been injured or damaged.

Abstract: This document describes methods and materials for the treatment of pathological conditions, including arrhythmias and trauma, using temperature modulation via implantable devices. For example, this document relates to methods and devices for treating atrial and/or ventricular fibrillation by cooling the epicardium.

Abstract: A portable system for cold therapy with optional heat and compression therapy is disclosed, including a cooling mechanism, a reservoir, and a control assembly. The cooling mechanism includes a compressor, a condenser, a fan, and a heat exchanger. The compressor has an air inlet connected to the heat exchanger through a first tube. The heat exchanger is connected to the condenser through a second tube. The condenser is connected to an air outlet of the compressor through a third tube. The first tube and the second tube are connected by fluid, and the second tube and the third tube are connected by fluid. The fan has a working surface facing the condenser. The liquid in the reservoir flows into the heat exchanger and then flows into the first body wrap, and then can flow into the heat exchanger or flow back into the reservoir.

Abstract: Devices and methods are provided for the treatment of pathological conditions including arrhythmias and trauma using temperature modulation via implantable or worn devices. For example, in one example embodiment this document relates to devices and methods for treating atrial or ventricular fibrillation by cooling the epicardium. The devices and methods can also be used to treat other disorders by applying heating and/or cooling to a patient in a number of different manners.

Abstract: An apparatus includes a shaft, a balloon, a tip member, and a heating feature. The tip member is distal to the balloon and has a larger outer diameter than the shaft. The heating feature is operable to ablate tissue of the Eustachian tube contacting the balloon in the expanded state. The heating feature may include an illuminating element and a photosensitive coating on the balloon. Alternatively, the heating feature may include a thermal heating element that heats the balloon inflation fluid and thereby heats the wall of the balloon. Another apparatus includes a shaft, a tip member, and an electrode assembly. The electrode assembly includes a plurality of electrodes positioned along the shaft near the distal end, proximal to the tip member. The electrodes are spaced apart from each other along a longitudinal axis and are operable to apply RF energy to tissue to thereby ablate the tissue.

Abstract: Devices, systems, and methods for therapeutically treating tissue. The devices and methods are suitable for minimally invasive surgery or open surgical procedures. More particularly, methods and devices described herein permit treating large areas of tissue with a therapeutic device. In some variations, the method and devices allow for large area treatment without having to reposition the device. The methods and devices described herein discuss the treatment of cardiac tissue for purposes of illustration.

Abstract: A temperature management system is configured to control a temperature of a patient's body using a heat exchange device. The temperature management system is configured to deliver temperature management treatment or therapy to a patient. A user interface of the system is configured to display operational data and patient data on the user interface in a configuration that allows a user to determine or review one or more periods of the performed temperature management treatment.

Abstract: A method for treating vascular diseases is provided. The method includes fabricating a sterile ice slurry including water and ice particles, cooling the sterile ice slurry to a predetermined temperature, and injecting the sterile ice slurry into a desired tissue region. The desired tissue region includes perivascular adipose tissue.

Abstract: Ultrasound transducer element arrays using acoustic ensonification drive patterns via a patient interface for sonosensitizer activation in sonodynamic therapy. Incoherent acoustic field generation varying phase, frequencies, and/or amplitude via controlled delivery of low intensity planar acoustic waves. Method includes generating a first and a second signal to generate respective acoustic ensonification drive patterns with phase, frequency, and amplitude and generating at least one relative phase, frequency or amplitude difference to generate a third incoherent acoustic ensonification pattern to activate a sonosensitizer. Calibration and complementary therapy procedures to improve cell susceptibility of cells to sonodynamic therapy are disclosed.

Abstract: Devices that are implantable within a patient's body, and more specifically, to implantable joints (e.g. hip joint, knee joint, shoulder joint, etc.) having a heating system. For example, a device implantable within a patient's body may include a first member configured to be coupled to a first bone and a second member configured to be coupled to a second bone, the first and second members being operatively coupled to form a moveable joint. A heating system may be configured to controllably heat at least a portion of the at least one of the first and second members. The heating system may include a controller operable to cause a heating element to apply heat based on one or more external conditions (e.g. temperature, humidity, etc.).

Abstract: Dialysis systems and methods for operating dialysis machines (e.g., peritoneal dialysis machines) for conducting dialysis treatments are disclosed. The dialysis system may include a dialysis machine for transferring dialysate to a patient from a dialysate source. The dialysate may flow from the dialysate source through a cartridge or cassette (e.g., a disposable cartridge or cassette) positionable within the dialysis machine. The cassette includes a fluid flow channel. The dialysis machine includes a heating chamber for in-line heating of the dialysate in the fluid flow channel. The fluid flow channel is arranged and configured to provide turbulent flow of the dialysate through the fluid flow channel to provide increased heat transfer from the heating chamber to the dialysate.

Abstract: Described herein is an implantable access port device with a catheter compartment which permits lengthening or shortening the catheter in response to changes in tension of the distal catheter. Implantable access port devices are used extensively in the medical field to facilitate the performance of recurrent therapeutic tasks such as repeated drug delivery, drainage, blood sampling, transfusions, or total parental nutrition. In current access port systems, the catheter is rigidly attached to the access port via a connection ring. As such, the system does not provide any flexibility or ability for catheter length adjustments, which can lead to long-term complications such as dislodgement of catheters, migration of catheters, port separation with extravasation, suture disruption, and mechanical failure of the access port system. These catheter-related complications carry serious risks for the patients.

Abstract: A disposable set of components for an organ perfusion system comprising a fluid supply duct for supplying fluid to the organ, a fluid removal duct for removing fluid from the organ, and a surrogate organ removably connected between the fluid supply duct and the fluid removal duct so as to form a fluid circuit, so that fluid can be circulated in the circuit in preparation for connection of the organ.

Abstract: A method of monitoring neural activity responsive to a stimulus in a brain, the method comprising: applying the stimulus to one or more of at least one electrode implanted in a target neural structure of the brain; detecting a resonant response from the target neural structure evoked by the stimulus at one or more of the at least one electrode in or near the target neural structure of the brain; and determining one or more waveform characteristics of the detected resonant response.

Abstract: A system including a controller to determine an in-body time of a medical device in a patient during a medical procedure. The controller to: receive signals from at least one temperature sensor; detect insertion of the medical device into the patient by one or more of determining the temperature of the medical device and determining the change of temperature of the medical device with respect to time; increment an in-body time counter to measure the in-body time of the medical device after detecting insertion of the medical device into the patient; detect that the medical device has been removed from the patient by determining that the change of temperature of the medical device with respect to time is negative; and stop incrementing the in-body time counter in response to detecting that the medical device has been removed.

Abstract: Closed loop heat exchange catheters having bi-directional flow heat exchange regions and their methods of manufacture and use. The heat exchange region may be formed of expandable or non-expandable tubular conduit(s) that are configured in a series of loops or coiled configuration defining a supply flow path and a return flow path through which heat exchange medium is circulated. The individual loops of convolutions of the coiled configuration may be the same or different size. In some embodiments, the tubular conduit(s) may be passed through generally transverse bore holes formed in a catheter shaft so that the loops or convolutions of protrude from the catheter shaft.

Abstract: An epicardial device, system, and method for stabilizing the left atrial appendage during a left atrial appendage ligation/occlusion procedure. A cryoadhesion device including a stabilization element is positioned within the pericardial space proximate the left atrial appendage through subxiphoid access. Once the stabilization element is in contact with the left atrial appendage, the stabilization element is cooled to a temperature that is sufficient to cryoadhere the stabilization element to the left atrial appendage. In this way, the cryoadhesion device stabilizes the left atrial appendage in order to perform left atrial appendage ligation/occlusion with a secondary medical device.

Abstract: In one example in accordance with the present disclosure a method is described. According to the method, an emitter of a transcranial electromagnetic treatment (TEMT) system is positioned at a location relative to a head of a patient such that the emitter emits an electromagnetic frequency signal toward the head of the patient. The emitter is activated to apply TEMT to the patient to treat amyloid oligomers. In some examples, the TEMT has a frequency between 1 MHz and 430 THz.

Abstract: A method and apparatus for creating lesions in a tissue comprising a puncturing member and a probe. The puncturing member comprises a body with a proximal portion comprising a hub, a distal portion comprising a conductive tip, and a lumen extending between the proximal and distal portion. The probe comprises a handle at the proximal end and a probe body, wherein the probe body is dimensioned to extend through the lumen of the puncturing member, and wherein the probe body comprises at least one displacement portion that is biased to contact the inner wall of the puncturing member when the probe is inserted into the puncturing member, whereby when the probe body contacts the inner wall, energy is delivered from the probe to the conductive tip of the puncturing member.

Abstract: Methods and apparatuses for manipulating the temperature of a surface are provided. Devices of the present disclosure may include a thermal adjustment apparatus, such as a controller in electrical communication with one or more thermoelectric materials, placed adjacent to the surface of skin. The device may generate a series of thermal pulses at the surface, for providing an enhanced thermal sensation for a user. The thermal pulses may be characterized by temperature reversibility, where each pulse includes an initial temperature adjustment, followed by a return temperature adjustment, over a short period of time (e.g., less than 120 seconds). The average rate of temperature change upon initiation and upon return may be between about 0.1° C./sec and about 10.0° C./sec. In some cases, the average rate of the initial temperature adjustment is greater in magnitude than the average rate of the return temperature adjustment.

Abstract: A sensor device includes a housing defining a cavity, an inlet to receive fluid pumped from an instrument device, an outlet to return the fluid to a fluid reservoir, and a fluid channel defined inside the cavity between the inlet and the outlet. A heat pump is mounted inside the cavity, and has a side surface thermally coupled to the fluid channel and an opposite side surface thermally coupled to a plate. The heat pump is configured to induce a temperature change. A sensor unit is aligned with an aperture in the plate and includes an optical component and a thermal component. The optical component configured to measure a vascular endothelial response from the induced temperature change.

Abstract: Disclosed are methods of using planar acoustic waves for providing non-invasive sonodynamic therapy. The method includes acoustically coupling an array of flat piezoelectric transducers to a patient. A controller is configured to generate an electrical drive signal at a frequency selected from a range of frequencies, modulate the drive signal, and drive the transducer with the modulated drive signal at the frequency to produce a modulated planar acoustic wave to produce an average acoustic intensity sufficient to activate a sonosensitizer in a treatment region without damaging healthy cells in the treatment region.

Abstract: An apparatus for cooling tissue or a fluid for an elongate medical device comprising an elongate shaft extending along a longitudinal axis and comprising a shaft proximal end and a shaft distal end; a support structure located at the shaft distal end, where the support structure is expandable from a contracted state to an expanded state, and a plurality of thermoelectric elements, wherein the thermoelectric elements are located on the support structure. A medical device comprising a first catheter end shape, a second catheter end shape located distally with respect to the first catheter end shape, a support structure that extends between the first and the second catheter end shape, and a plurality of thermoelectric elements. A system for cooling a tissue or a fluid for an elongate medical device, comprising a plurality of thermoelectric elements, a thermocouple, an electronic control unit (ECU).

Abstract: A method is presented for predicting heat stroke of a subject. The method includes an earbud covered with a waterproof moisture permeable membrane allowing for moisture penetration, the earbud including an infrared (IR) temperature sensor for measuring core body temperature of the subject, wherein the IR temperature sensor is covered with a waterproof IR transmittable film to inhibit water drops from contacting a detector of the IR temperature sensor, a first humidity sensor positioned within a sweat flow path within the earbud, a second humidity sensor positioned outside the earbud, and a sodium ion (Na+) concentration sensor for measuring hydration levels of the subject.

Abstract: Disclosed herein are devices and methods for removing tissue. In one aspect, a device for removing tissue includes a hollow elongate member having an outer wall and a lumen, a selectively deployable tissue-cutting element extending from the hollow elongate member, and an actuation member extending through the lumen and coupled to the hollow elongate member at a location that is distal to the tissue-cutting element. Movement of the actuation member can cause the tissue-cutting element to move from the insertion configuration where the tissue-cutting element is not deployed to a tissue-cutting configuration where the tissue-cutting element is deployed such that it is radially extended relative to the insertion configuration.

Abstract: Relatively non-invasive devices and methods for heating or cooling a patient's body are disclosed. Devices and methods for treating ischemic conditions by inducing therapeutic hypothermia are disclosed. Devices and methods for inducing therapeutic hypothermia through esophageal cooling are disclosed. Devices and methods for operative temperature management are disclosed.

Abstract: A teether is provided for infant use. The teether comprises an exterior portion and a mouthpiece wherein the mouthpiece includes a substantially U-shaped biting section comprising first and second arms extending from a central portion. At least part of said central portion is resiliently collapsible upon application of pressure thereto during use of the teether by an infant.

Abstract: Systems and methods for delivering a drug or other therapy over an extended period of time (e.g., several hours, days, weeks, months, years, and so forth) are disclosed herein, as are systems and methods for monitoring various parameters associated with the treatment of a patient. Systems and methods are also disclosed herein that generally involve CED devices with various features for reducing or preventing backflow.

Abstract: System and methods for channeling a path into bone include a trocar having a proximal end, distal end and a central channel disposed along a central axis of the trocar. The trocar includes a distal opening at the distal end of the trocar. The system includes a curved cannula sized to be received in the central channel, the curved cannula comprising a curved distal end configured to be extended outward from the distal opening to generate a curved path extending away from the trocar. The curved cannula has a central passageway having a diameter configured to allow a treatment device to be delivered through the central passageway to a location beyond the curved path.

Abstract: In some examples, the disclosure describes a medical assembly that includes a stent including a primary electrode, where the stent is configured to expand from a collapsed configuration to an expanded configuration, a secondary electrode, and an energy source configured to deliver an electrical signal between the primary electrode and the secondary electrode through a fluid in contact with the primary electrode to cause the fluid to undergo cavitation to generate a pressure pulse wave within the fluid.

Abstract: A use of an umbilical splint for shaping an umbilicus after an abdominal operation is described. The umbilical splint may comprise an insertion portion extending in a longitudinal direction and terminating at an insertion end for insertion into the umbilicus. Furthermore, the insertion portion may comprise a bulbous section near the insertion end. The bulbous section may be operable to apply pressure to a tissue of the umbilicus after the abdominal operation. The insertion portion may have different cross-sectional shapes including circular and oval. Finally, the insertion portion may be configured to engage the umbilicus such that the umbilical splint is retained within the umbilicus.

Abstract: A system and method for applying energy, particularly radiofrequency (RF) electrical energy, to a living body can be used in tissue ablation.

Abstract: The present disclosure provides a device and a method for cooling living tissues for a medical purpose and other purposes. The cooling device comprises: a container configured to accommodate a cooling medium and thermally coupled with the cooling medium by directly contacting the cooling medium; a cooling generator configured to be thermally coupled with the container by a direct contact and thereby to provide cooling energy to the cooling medium; and a heat sink dissipating heat from the cooling generator, the heat sing being configured to be spaced apart from the cooling generator and to be thermally coupled with the cooling generator without a direct contact with the cooling generator.

Abstract: A medical device for tissue ablation may include a catheter shaft, an expandable member disposed on or coupled to the catheter shaft, and a plurality of elongate electrode assemblies each constructed as a flexible circuit. The expandable member may be configured to shift between an unexpanded configuration and an expanded configuration. The plurality of electrode assemblies may be disposed on an outer surface of the expandable member. Each of the plurality of electrode assemblies may include a temperature sensor aligned with two or more electrodes.

Abstract: Systems and methods for ablating tissue in the living body can include a cool electrode.

Abstract: Methods and devices are disclosed herein that generally involve applying thermal therapy to tissue (e.g., localized cooling or heating of tissue), and in particular applying thermal therapy to the spinal canal, tissue disposed within the spinal canal, and/or nerve roots extending from the spinal canal. In some embodiments, tissue can be cooled or heated by implanting a malleable or deformable thermal device in proximity to the targeted tissue. The thermal device can be left in place following surgery to facilitate application of post-surgical thermal therapy. In some embodiments, the thermal device can be removed post-surgery in a minimally- or non-invasive manner. The thermal device can be connectionless or can include penetrable regions, pre-attached tubing, or detachable connectors to facilitate application of cooling or heating means to the device. Methods are disclosed for utilizing thermal devices and for carrying out various treatment regimens that involve cooling or heating tissue using such devices.

Abstract: An in-ear stimulation device for administering caloric stimulation to the ear canal of a subject includes (a) first and second earpieces configured to be insertable into the ear canals of the subject; (b) at least first and second thermoelectric devices thermally coupled to respective ones of the first and second earpieces; (c) a first heat sink thermally coupled to the first thermoelectric device opposite the first earpiece and a second heat sink thermally coupled to the second thermoelectric device opposite the second earpiece; and (d) a controller comprising a waveform generator in communication with the first and second thermoelectric devices, the waveform generator configured to generate a first control signal to control a first caloric output to the first thermoelectric device and a second control signal to control a second caloric output to the second caloric device.

Abstract: Systems and methods for ablating tissue in the living body can include a cool electrode.