Abstract: A system for soothing an agitated patient, including a motor, a linkage operationally connected to the motor, an armature operationally connected to the linkage, and a lifelike hand connected to the armature. Energization of the motor enables the lifelike hand to move in a generally circular, rubbing motion.

Abstract: A Foley catheter kit includes a surface defining a single layer tray with at least two compartments at least partially separated by a barrier. A first syringe is disposed in a first compartment, while a Foley catheter, coupled to coiled tubing and a fluid drain bag, is disposed within a second compartment. The first compartment defines a lubricating jelly application chamber to lubricate at least a portion of the Foley catheter when the portion is passed from the second compartment to the first compartment. Printed instructions for using the single layer tray can be molded into the single layer tray.

Abstract: A compact packaged intermittent urinary catheter having a longitudinally elongated intermittent urinary catheter retained within a longitudinally compacted elastic package. A method of using the catheter wherein at least a portion of the package is used as a drainage tube for the catheter. A package for an intermittent urinary catheter including a longitudinally compacted elastic package having a longitudinally extending receiving chamber containing a lubricating medium. The package having two longitudinal ends that may be removed to open the package and enable conversion of the package from a compacted state to an extended state. A method of using the package as a clean handling sleeve through which an intermittent urinary catheter may be passed to coat it with a lubricating medium.

Abstract: Medical instruments such as catheter systems and endoscopic systems that exhibit reduced backlash during their operation are disclosed. The reduction of backlash avoids the use of protrusions or fins that can significantly obstruct fluid flow through working channels of the instruments. According to one embodiment, a medical instrument comprises a first member having an inside surface defining a first lumen and a second member extending in the first lumen and having an outside surface cooperating with the inner surface of the first member to define an intermediate longitudinal passage therebetween. One of the inside surface of the first member and the outside surface of the second member is permanently formed to have a sinuous shape defining predisposed locations for contacting the other one of the inner surface of the first member and the outer surface of the second member to reduce backlash during relative longitudinal movement.

Abstract: A urinary catheter and a method of its manufacture are disclosed. The urinary catheter comprises a tubular shaft extending between an insertion end and a discharge end, the tubular shaft being formed of at least two materials having different properties. The materials are arranged substantially separated from each other in distinct zones, wherein at least one of the width and thickness of said zones varies over the length of the tubular shaft, to form two or more uniform sections of the tubular shaft having various relative amounts of said materials, and wherein at least one transition between two such uniform sections is formed by at least one transition section providing a gradual transition between the uniform sections. The catheter can e.g. be produced by intermittent extrusion.

Abstract: An apparatus includes a first catheter defining a first longitudinal axis and a first lumen. A first actuator can be coupled to the first catheter and configured to rotate about the first longitudinal axis to deflect a distal end of the first catheter relative to the first longitudinal axis. A second catheter can define a second longitudinal axis and a second lumen. At least a portion of the second catheter can be configured to slide within the first lumen. A magnetic member can be coupled to a distal end of the second catheter. The magnetic member can define a third lumen. The third lumen can be in fluid communication with the second lumen. A second actuator can be coupled to the second catheter and configured to move linearly along the second longitudinal axis so as to vary a spacing between the magnetic member and the first catheter.

Abstract: The present disclosure provides an access system having a maneuverable catheter assembly configured for providing access to and navigating a desired vessel for subsequent treatment thereof. The access system includes an adjustable delivery handle assembly and an access catheter subassembly having a maneuverable access catheter configured to be delivered to desired site (e.g., within duodenum) to assist in treatment of a condition (e.g., drainage of a bile ducts via Endoscopic Ultrasound Guided Biliary Drainage (EUS-BD) techniques). The access catheter includes at least a distal section having an adjustable portion along a length thereof configured to transition to a pre-defined arcuate shape to provide directional control over the distal end of the catheter as it is navigated through a vessel (e.g., bile duct). The handle assembly includes additional elements configured to allow a clinician to maneuver and manipulate the distal end of the access catheter.

Abstract: A pull wire attachment system for a minimally invasive medical instrument comprises an anchoring element fixedly attached to the medical instrument. The anchoring element has a first outer diameter. The system also includes a pull wire assembly comprising an elongate pull wire having a proximal end and a distal end and a securing element coupled to the distal end of the pull wire. The securing element includes a second outer diameter sized smaller than the first outer diameter of the anchoring element. The securing element is coupled to the anchoring element to prevent proximal translation of the distal end of the pull wire along a longitudinal axis of the medical instrument past the anchoring element.

Abstract: Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors.

Abstract: An access device places a medical article within a body space of a patient. The device has a needle that includes an elongated body and a needle hub. The device further includes a dilator disposed on and slideable along the elongated body of the needle and a medical article. The medical article is disposed on and slideable along the dilator. A track extends in a proximal direction from the dilator. The needle hub slides along at least a portion of the track between a first position and a second position. The device further includes a locking mechanism operably disposed between the track and the needle hub so as to inhibit further axial movement of the needle in the proximal direction when the needle hub is in the second position.

Abstract: An introducer sheath is disclosed, which includes a tube body that is percutaneously inserted into a body lumen; and a hub that is connected to a proximal portion of the tube body. The tube body contains a polyvinylidene fluoride resin, a ratio of a thickness to an inner diameter of the tube body is 1/16 or lower, and a ration of a kink radius to an outer diameter of the tube body is 9.5 or lower.

Abstract: An introducer sheath (10) comprises a tubular body (11) with a distal portion (12) and a proximal portion (13), the proximal portion (13) being configured to be inserted into the patient's body. Introducer sheath can be separated along its length in a longitudinal direction. The introducer sheath (10) further comprises at least a first handle (15) which is pivotable about a fulcrum (21). The first handle (15) has a first end portion (151) and a free second end portion (152) so as to form a lever, such that pivoting the handle (15) about the fulcrum (21) causes a contacting portion (23) of the handle to act on a respective counter portion (24) that is operatively connected to the distal portion (12) of the tubular body (11). This creates a breaking force that causes the distal portion (12) of the tubular body (11) to break.

Abstract: One aspect of the invention provides a balloon catheter having a distal tip that does not extend distally beyond the distal end of the catheter balloon when the catheter balloon is inflated. In one embodiment, the distal end of the catheter balloon has a substantially flat profile when inflated. Other aspects of the invention provide methods of manufacturing and of using the balloon catheter. In one embodiment, the balloon catheter is used in the treatment of kidney stones.

Abstract: A setting adjustment tool for a magnetically adjustable device implanted in a patient includes a circumference. A plurality of magnetic coils can be circumferentially distributed on a circumference of the tool. One of the magnetic coils can be movable along the circumference between a plurality of predetermined positions associated with the selectable performance settings. The magnetic coils may also be capable of attracting or repulsing the at least one magnet of the rotor of the implanted device in a radial direction by at least a predetermined angle within a plane of rotation of an at least one magnet of the rotor thereby inducing a rotating moment into the rotor.

Abstract: Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.

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

Abstract: Implementations of a delivery device and method are disclosed. One implementation is a delivery device comprising a flow chamber with an inlet port for receiving a fluid flow in the flow chamber, and an outlet port for exiting a material from the flow chamber. The flow chamber may include a formation portion in which a suspension of the material is formed, and a collection portion that directs the suspension toward and/or into the outlet port. An amount of the material may collect in the collection portion adjacent the outlet port. The device may further comprise an insertion port for permitting insertion of the material in the flow chamber, and/or a pusher operable to move the amount of material through the outlet port. Related devices and methods also are disclosed.

Abstract: A system and method for providing oxygen saturated water or other oxygen saturated solution to a wound or body part is provided wherein the system includes a vessel containing a relatively stable aqueous solution having a dissolved oxygen content of at least 18 mg/L.

Abstract: A dermal device for skincare therapy is provided including: a fluid circuit including a fluid pump and a reservoir; and a dermal interface configured to contact a user's skin, the dermal interface including at least one electrode and part of the fluid circuit having at least one perforation, wherein the electrode(s) is configured to deliver an energy pulse to the contacted skin, wherein the reservoir is configured to hold at least one topical, wherein the fluid pump is configured to pump the least one topical through the fluid circuit and extrude the topical through the dermal interface.

Abstract: The present invention provides for microneedle arrays and related systems and methods. Particularly, microneedle arrays that are configured to deliver active agents, including nucleic acids and vaccines, are provided. Additional related methods of vaccinating and minimizing the amount of vaccine necessary for effective inoculation are also provided.

Abstract: An applicator and method for applying a microneedle device to a skin surface. The applicator can include a first portion comprising a microneedle array, and a second portion coupled to the first portion via a connector. The connector can be configured to yield or fracture by changing from a first state in which the connector is intact to a second state in which the connector is yielded or fractured when a threshold application force is applied to at least one of the first portion and the second portion in a direction substantially perpendicular with respect to the first portion. The method can include pressing the applicator in a direction substantially perpendicular to the first portion to press the microneedle array into the skin surface until the threshold application force is met or exceeded and the connector is changed to its second state.

Abstract: Various embodiments of a device, a kit and method for delivering a drug depot are disclosed. The device comprises a housing including a lower body, an upper body, a ring member; and a drug cartridge. The lower body defines a lower body channel. The upper body defines an upper body channel. The drug cartridge defines a depot channel. The ring member is disposed extending upward from an annular step surface of the lower body toward a housing upper end. The ring member includes indicia indicating a characteristic of one or more drug depots in the drug cartridge. A plunger has a push rod for expelling the drug depot through the cannula to a site in the patient. A kit comprises the above components. A method includes assembling the components including selecting a ring member having indicia corresponding to one or more drug depots in the drug cartridge.

Abstract: A fluid pathway connection includes a piercing member, a connection hub, and a sliding pierceable seal, wherein the sliding pierceable seal is configured to move from a first position, where the piercing member is initially retained within a sterile cavity between the connection hub and the sliding pierceable seal, to a second position, where the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. The fluid pathway connection may further be configured to move to a third position where one or more interconnects and/or one or more corresponding contacts are permitted to transmit a signal to the user. Such fluid pathway connections may be integrated into a drug container having a barrel and a plunger seal. A drug delivery pump includes such integrated fluid pathway connections and drug containers.

Abstract: A connection device includes a connection body which has a hose adapter and a connector piece for releasably fastening a further fluid conduit component or fluid storage component. The connection body is coaxially surrounded by a securing sleeve. The securing sleeve is axially securable on the connection body in two securing positions that are axially mutually spaced apart relative to a central longitudinal axis of the connection body. Rotatability of the securing sleeve is possible in a first securing position, and jamming of the securing sleeve on a hose portion that is plug-fitted onto the hose adapter is possible in a second securing position.

Abstract: Tumors in portions of a subject's body that have a longitudinal axis (e.g., the torso, head, and arm) can be treated with TTFields by affixing first and second sets of electrodes at respective positions that are longitudinally prior to and subsequent to a target region. An AC voltage with a frequency of 100-500 kHz is applied between these sets of electrodes. This imposes an AC electric field with field lines that run through the target region longitudinally. The field strength is at least 1 V/cm in at least a portion of the target region. In some embodiments, this approach is combined with the application of AC electric fields through the target region in a lateral direction (e.g., front to back and/or side to side) in order to apply AC electric fields with different orientations to the target region.

Abstract: A neuromuscular stimulation device is described having a plastic casing housing a printed circuit board bearing control electronics, with the casing including an external integral flexible portion which is capable of being flexed into the interior of the casing so as to cause an electrically insulative substrate on which is carried an electrically conductive pathway to be pushed into contact with the PCB in order to complete an electrical circuit. Such a switch is relatively inexpensive to produce, as it has few moving parts, can be formed in a usual manufacturing process, and is robust.

Abstract: The present disclosure relates to methods, devices and systems used for the treatment of medical disorders via stimulation of the superficial elements of the trigeminal nerve. More specifically, cutaneous methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infraorbital, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, infraorbital, nasal and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein.

Abstract: Tumors in portions of a subject's body that have a longitudinal axis (e.g., the torso, head, and arm) can be treated with TTFields by affixing first and second sets of electrodes at respective positions that are longitudinally prior to and subsequent to a target region. An AC voltage with a frequency of 100-500 kHz is applied between these sets of electrodes. This imposes an AC electric field with field lines that run through the target region longitudinally. The field strength is at least 1 V/cm in at least a portion of the target region. In some embodiments, this approach is combined with the application of AC electric fields through the target region in a lateral direction (e.g., front to back and/or side to side) in order to apply AC electric fields with different orientations to the target region.

Abstract: This disclosure relates to an in vivo treatment of a skin lesion of a mammal comprising application of electrical energy to the skin lesion in a form of electrical pulses. At least one electrical pulse is applied. The pulse duration may be at least 0.01 nanoseconds at the full-width-at-half-maximum. This treatment may at least prevent growth of the lesion.

Abstract: An electrode fixing sleeve for fixing an electrode lead to biological tissue, the electrode fixing sleeve including a distal sleeve section and a proximal sleeve section, at least one distal electrode guiding region on the distal sleeve section and at least one proximal electrode guiding region on the proximal sleeve section, the distal electrode guiding region and proximal electrode guiding region having a common longitudinal axis. The distal and proximal sleeve sections are adjustable relative to one another along the common longitudinal axis. The electrode fixing sleeve additionally includes at least one electrode fixing element at least parts of which have elastic properties, the electrode fixing element being mounted on both the distal and proximal sleeve sections, and being designed so that at least parts of it move along the common longitudinal axis if a tensile force acts on the electrode fixing element along the common longitudinal axis.

Abstract: A method produces a device adapted to be implanted into the human body for purposes such as neural stimulation, sensing or the like. The method includes: providing a stretchable layer or membrane of an insulating material; forming on the layer or membrane at least one stretchable conductive path; depositing at least one small bolus of a soft and conductive paste or material onto pre-defined areas or portions of the at least one conductive path, and inserting a first end portion of a conductive element 71 into the at least one bolus of soft conductive paste or material. A second end portion of the conductive element opposite to the first end portion is not inserted into the at least one bolus.

Abstract: An implantable leadless cardiac pacing device and associated retrieval features. The implantable device includes a docking member extending from the proximal end of the housing of the implantable device including a covering surrounding at least a portion of the docking member configured to facilitate retrieval of the implantable leadless cardiac pacing device.

Abstract: A Wearable Cardiac Defibrillator (WCD) system is configured to be worn by a patient who carries a mobile communication device. The mobile communication device has a user interface that is configured to enable the patient to enter wireless inputs. The WCD system includes a communication module that is configured to establish a local comlink with the mobile communication device. The WCD system also includes a tethered action unit that has a user interface configured to enable the patient to enter action inputs. The WCD system can perform some of its functions in response to the action inputs or to the wireless inputs. Since the wireless inputs can be provided from the mobile communication device instead of the action unit, the patient is less likely to attract attention when entering them, and thus exhibit better compliance.

Abstract: Embodiments of the invention provide methods for the transdermal delivery of therapeutic agents for the treatment of addictive cravings e.g., nicotine compounds for the treatment of nicotine cravings from tobacco use. An embodiment of a method for such delivery comprises positioning at least one electrode assembly in electrical communication with a patient's skin. The assembly includes a solution comprising a therapeutic agent which passively diffuses into the skin. A dose of agent is delivered from the assembly into the skin during a first period using a first current having a characteristic e.g., polarity and magnitude, to repel the agent out of the assembly. During a second period, a second current having a characteristic to attract the agent is used to retain the agent in the assembly such that delivery of agent into skin is minimized. A dose of agent may be delivered on demand by an input from the patient.

Abstract: A handling and control system for expandable electrodes of a handpiece is provided that includes a plurality of flexible electrodes made of elastic cables carried by a support assembly with needle-shaped front portions that protrude from the support assembly and move in a three-dimensional space under the push of actuators.

Abstract: A flexible sheet for neurostimulation is described having a flexible non-conductive substrate matrix in which electrodes are embedded along a lower surface. Electrically conductive wires extend from the electrodes through the flexible substrate to another exterior surface of the substrate. Methods of making the flexible sheet and making a device using the flexible sheet are also disclosed.

Abstract: A device for electrically stimulating one or more anatomical target sites in a patient and for use in the treatment of a plurality of biological conditions of the patient. The device has a pulse generator providing electrical stimulation to the anatomical target sites; a power source for powering the pulse generator; stimulator electrodes connected to the pulse generator for stimulating the anatomical target sites; one or more optional sensing electrodes for monitoring physiological parameters with reference to the anatomical target sites; and a microprocessor programmed to vary a plurality of therapy protocol parameters governing the electrical stimulation to thereby modify operational life parameters of the power source.

Abstract: A device is provided for the stimulation of neurons that includes a non-invasive stimulation unit to generate stimuli in multiple stimulation channels, where the stimulation unit stimulates a neuron population in the brain and/or spinal cord of a patient in different locations for each of the stimulation channels. Moreover, the device includes a control unit that controls the stimulation unit to generate repetitive bursts in each of the stimulation channels, where each of the bursts includes multiple stimuli and is designed so that they do not reset the phase of the neuronal activity of the respective stimulated neurons.

Abstract: A bilateral hearing implant system has a left side and a right side. There is an interaural time delay (ITD) processing module on each side that adjusts ITD characteristics of the stimulation signals based on defined groups of stimulation channels that include: i. an apical channel group on each side corresponding to a lowest range of audio frequencies up to a common apical channel group upper frequency limit, wherein a common number of one or more stimulation channels is assigned to each apical channel group, and wherein corresponding apical channel group stimulation channels on each side have matching bands of audio frequencies, and ii. one or more basal channel groups on each side corresponding to higher range audio frequencies above the apical channel group upper frequency limit.

Abstract: An implantable processor arrangement is described for an active implantable medical device (AIMD) system implanted under the skin of a patient. An implantable communications coil arrangement is configured for transdermal transfer of an implant communications signal. An implantable processor is coupled to and controls the implantable communications coil arrangement so as to operate in two different communications modes. In a normal operation mode, the processor configures the communications coil arrangement for peridermal communication with an external communications coil placed on the skin of the patient immediately over the implantable communications coil arrangement using load modulation of the communications coil arrangement, wherein the implantable communications coil has a resonance frequency matching the transmission frequency.

Abstract: An implantable neurostimulator-implemented method for managing tachyarrhythmias through vagus nerve stimulation is provided. An implantable neurostimulator, including a pulse generator, is configured to deliver electrical therapeutic stimulation in a manner that results in creation and propagation (in both afferent and efferent directions) of action potentials within neuronal fibers of a patient's cervical vagus nerve. Operating modes of the pulse generator are stored. A maintenance dose of the electrical therapeutic stimulation is delivered to the vagus nerve via the pulse generator to restore cardiac autonomic balance through continuously-cycling, intermittent and periodic electrical pulses. A restorative dose of the electrical therapeutic stimulation is delivered to prevent initiation of or disrupt tachyarrhythmia through periodic electrical pulses delivered at higher intensity than the maintenance dose.

Abstract: A system for use with a neurostimulator coupled to one or more electrodes implanted adjacent neural tissue of a patient. The system comprises a user input device configured for allowing a user to select different nerve fiber diameters and to select a set of stimulation parameters. The system further comprises processing circuitry configured estimating regions of activation within the neural tissue of the patient based on the selected nerve fiber diameters and the selected stimulation parameter set. The system further comprises a display device configured for displaying the estimated regions of tissue activation. The user input device may further be configured for allowing the user to select different tissue regions of therapy, in which case, the display device may display the different tissue region on a human body map, and different indicia associating the displayed tissue regions for therapy to displayed estimated regions of tissue activation.

Abstract: One aspect is a housing for an implantable medical device, including first housing portion of metal, an intermediate portion of metal and having first and second sides opposite one another and having integrated features, and a second housing portion of metal. The first housing portion is sealed to the first side of the intermediate portion and the second housing portion is sealed to the second side of the intermediate portion thereby forming an housing internal space within first and second housing portions and containing the intermediate portion and its features, such that the features are hermetically sealed within the housing relative to an external space that is outside the housing.

Abstract: One aspect is a method of fabricating a housing for an implantable medical device, including forming a first housing portion of metal using an additive manufacturing process such that features are integrated into the first portion. A second housing portion of metal is also formed. The first and second housing portions are joining thereby sealing an internal space of the housing within first and second portions and fully containing the features such that they are hermetically sealed relative to an external space outside the housing.

Abstract: User interface for external power source, recharger, for an implantable medical device. At least some of patient controls and display icons of an energy transfer unit are common with at least some of the patient controls and the display icons of a patient control unit. An energy transfer unit is operable by the patient with less than three operative controls to control energy transfer from the external energy transfer unit to the implantable medical device. An external antenna having a primary coil can inductively transfer energy to a secondary coil of the implantable medical device when the external antenna is externally placed in proximity of the secondary coil. An energy transfer unit has an external telemetry coil allowing the energy transfer unit to communicate with the implantable medical device through the internal telemetry coil in order to at least partially control the therapeutic output of the implantable medical device.

Abstract: An implanted stimulator can deliver a patient-detectable electrical stimulation to remind or prompt a patient to interact with an implanted therapeutic device (e.g., neurostimulator) when a prompting event occurs. For example, the apparatuses and methods described herein may be configured to apply a prompting patient-detectable electrical vagus nerve stimulation to remind a patient that it is time to administer a therapeutic dose. When the therapeutic device is operated in an automatic fashion, the apparatus can also deliver a patient-detectable warning stimulation prior to the therapeutic stimulation to let the patient know that a therapeutic stimulation will be delivered soon thereafter.

Abstract: An emergency medical device (20) (e.g., an external defibrillator/monitor) employing an emergency medical subsystem (21) for executing an emergency medical procedure (e.g., a monitoring subsystem (21) and a therapy subsystem (21)), and an emergency medical controller (23) for controlling an activation of the emergency medical subsystem (21). The subsystem (21) includes one or more operational components (22). In operation, the controller (23) conditionally actuates a device readiness indicator (24) (e.g., auditory or visual) indicative of an operational readiness of the operational component(s) (22), and conditionally actuates a failure warning indicator (25) (e.g., auditory or visual) indicative of a pending failure of the operational readiness of the operational component(s) (22).

Abstract: An apparatus and method is provided for a defibrillator that specifies treatment protocols in terms of number of chest compressions instead of time intervals. The defibrillator includes a connection port that is configured to attach with a plurality of electrodes that are capable of delivery of a defibrillation shock and/or sensing one or more physical parameters. An energy storage device capable of storing a charge is attached to the plurality of electrodes. A controller is coupled to the plurality of electrodes and the energy storage device, the controller is configured to provide CPR chest compression instructions in terms of the numbers of CPR chest compressions.

Abstract: A semiconductor device comprises a first chip bonded on a second chip. The first chip comprises a first substrate and first interconnection components formed in first IMD layers. The second chip comprises a second substrate and second interconnection components formed in second IMD layers. The device further comprises a first conductive plug formed within the first substrate and the first IMD layers, wherein the first conductive plug is coupled to a first interconnection component and a second conductive plug formed through the first substrate and the first IMD layers and formed partially through the second IMD layers, wherein the second conductive plug is coupled to a second interconnection component.

Abstract: A defibrillator and method for using a defibrillator which adopts an ECG analysis algorithm that can detect a cardiac arrhythmia in the presence of noise artifact induced by cardio pulmonary resuscitation (CPR) compressions. The apparatus and method offers guidance throughout a cardiac rescue protocol involving both defibrillation shocks and CPR that improves the effectiveness of the rescue, resulting in more CPR “hands-on” time, better treatment of refibrillation, and reduced transition times between CPR and electrotherapy.