Abstract: A torque-limiting device may include a shaft extending axially through upper and lower shanks, a spring, and a nut to an end opening of a handle. The upper and lower shanks may be under a force from the spring and further configured to selectively engage within a predetermined torque limit and disengage at above the predetermined torque limit. Accordingly, the shaft may receive torque up to the predetermined limit as provided by a user operating a handle of the torque-limiting device. The torque-limiting device may be disposable, reusable, economical, and have high torque capabilities. The shaft may be of a plastic material and include a lumen extending there through, and through which a variety of devices and materials may be delivered to a workpiece.

Abstract: Articulation devices, such as comprising pull rings, are provided having improved or increased visibility under conventional visualization techniques, such as fluoroscopy. Such improved visibility is achieved by the presence of at least one insert comprised of a material that is more visible or detectable under imaging techniques than the pull ring. The at least one insert is positionable within a cut-out in the articulation device and fixed into place by a suitable method such as adhesive, soldering, swaging, welding, laser welding, etc. The insert resides within the dimensions of the walls of the pull ring so as to not increase the outer diameter or decrease the inner diameter of the pull ring. This maintains the profile of the overall articulation device.

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: A catheter assembly includes a catheter, a catheter hub fixed to the proximal end of the catheter, a needle positioned inside the catheter, a gripping member connected to a proximal portion of the inner needle, a catheter operating member connected to the catheter hub and movable in the longitudinal direction relative to the inner needle, a guide wire slidably positioned in the inner needle and possessing a length longer than both the inner needle and the catheter, and a wire operating member connected to the guide wire so that movement of the wire operating member results in movement of the guide wire. The catheter operating member is configured to press a portion of the catheter between the proximal end of the catheter and the distal end of the catheter when the user presses on the catheter operating member while puncturing a living body with the needlepoint.

Abstract: The disclosed guidewire includes a wire main body possessing an elongated shape and a cylindrical body possessing a cylindrical shape. The distal portion of the wire main body is positioned in the cylindrical body. The guidewire has an inner coil disposed between the wire main body and the cylindrical body. The inner coil includes a wire rod wound in a spiral shape along the outer circumferential portion of the wire main body. There is an interval between the wire rods adjacent to each other in a longitudinal direction of the wire main body that is adjustable. The guidewire also has an operation member that changes the interval between the wire rods of the inner coil.

Abstract: A guide wire including a core shaft, a coil body that covers an outer periphery of the core shaft, and a distal end joint that joins the core shaft and the coil body, The distal end joint includes tin-zinc based solder. The guide wire has secured joining strength between the core shaft and the coil body no matter the material used for the core shaft and the coil body, and especially when the core shaft and/or the coil body are formed of tungsten.

Abstract: Systems and methods and devices are provided for arresting or reversing the effects of myocardial remodeling and degeneration after cardiac injury, without the potential drawbacks associated with previously existing systems and methods, by at least partially occluding flow through the superior vena cava over multiple cardiac cycles, and more preferably, by adjusting the interval or degree of occlusion responsive to a sensed level of patient activity. In some embodiments, a controller is provided that actuates a drive mechanism responsive to a sensed level of patient activity to provide at least partial occlusion of the patient's superior vena cava, while a data transfer circuit of the controller provides bi-directional transfer of physiologic data to the patient's smartphone or tablet to permit display and review of such data.

Abstract: A supportive balloon catheter which may be used to assist a wire guide in advancing across a lesion which partially or totally occludes an intraluminal passage. The supportive balloon catheter is advanced over the wire guide, close to the location of the lesion. The supportive balloon catheter is then inflated, securing the position of the wire guide in the intraluminal passage. A braid on the catheter may provide additional structural support. The secured catheter restricts the movement of the wire guide advancing across the lesion, preventing kinking or deflection off the surface of the lesion. Once the wire guide has advanced across the lesion, the supportive balloon catheter or a different angioplasty may be used to clear the lesion from the intraluminal passage.

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

Abstract: A system and method for delivering a bathing liquid via a nostril of a face-down user maintains the liquid in prolonged and predictable contact with the nasal and sinus mucosa. A head orientation unit attaches to the head and includes an angle monitoring unit to provide an indication of the angular orientation of the head as it turns to optimize delivery of the liquid to target head structures. A liquid supply delivers the liquid through the user's nostrils to the selected head structures as a function of the angular orientation indication and at a pressure and flow rate that maintains a constant volume of liquid in the nasal and sinus cavities. Indicia on the angle monitoring unit permit the user to orient his/her head to predetermined angular positions.

Abstract: Apparatus and methods to treat skin defects include a pump with reservoirs for a pressurization gas and a fluid. Upon activation, the pump generates a gas introduced into the gas reservoir, a movable wall of which displaces a movable wall of a fluid source, thus dispensing the fluid into the dressing to spread throughout irrespective of orientation of the dressing, maintaining a transport fluid (e.g. carrier) in the dressing and in contact with a skin defect being treated. The dressing may have a distribution network, and multiple members, dispensing the fluid into the dressing and in contact with a skin defect being treated.

Abstract: Embodiments for superficial tissue compliance modulation and negative pressure wound therapy for stabilization of a chronic percutaneous implant are disclosed. An external cap is coupled to a compliance gradient of progressively decreasing stiffness. Together the external cap and compliance gradient act as a stress shield that allows forces that would otherwise act on the skin at the skin-implant interface to be dissipated over a larger area. In addition, negative pressure and fluids may be applied through negative pressure and fluid adapters, respectively, to the skin-implant interface, the status of which may be further monitored through the use of one or more sensors.

Abstract: A disposable connector suitable for engagement on a substitution port of a hemofiltration machine includes a main body defining a duct, and a pliable element that engages an end of the main body. The pliable element includes a membrane occluding the duct and performing a valve function, and a seal portion radially expanding outward of the duct.

Abstract: A coupling device for a tubular arrangement for medical use including a first connector part and a second connector part and, an engagement/disengagement member for at least assisting in engaging and disengaging the engagement between said connector parts, wherein the first connector part includes at least two female connecting portions arranged in a first connector surface and a guiding edge protruding from the first connector surface arranged around the at least two female connecting portions and the second connector part includes at least two male connecting portions arranged in a second connector surface, and wherein at least one of the first connector part and the second connector part includes a locking element arranged to rotatably engage with the engagement/disengagement member.

Abstract: A cap for medical fluid lines and the like includes a hollow body within which a male or female connector accessible at one end of the body is coaxially housed. The connector is configured to inviolably obstruct the passage through the body. A unidirectional coupling locks in rotation the connector with respect to the body in the direction corresponding to the screwing of the connector, and a complementary connector, and to enable free rotation of the connector in the opposite direction. The connector can be possibly locked in rotation with respect to the body in the unscrewing direction, only following a positive command.

Abstract: According to a preferred embodiment of the present invention there is provided a stopcock including a housing element defining at least first, second and third ports, a handle element which is selectably positionable relative to the housing element, at least one fluid passageway communicating between at least two of the at least first, second and third ports, the at least one fluid passageway being selectably defined by at least one of the housing element and the handle element, the at least one fluid passageway being configured for enabling flushing an internal volume of at least one of the first, second and third ports by a fluid flow which does not flow entirely through the port whose internal volume is being flushed.

Abstract: Described herein are injection devices capable of automatically injecting substances into the soft tissue of a patient. The devices can inject low to high viscosity materials at predetermined, user selected injection rates, allowing the operator more control than a traditional syringe. The devices can allow mixing of more than one substance and/or reconstitution of a solid substance for injection. The injection devices described herein can allow the operator to easily inject one or more low to high viscosity liquid or gel soft-tissue augmentation fillers, one or more drugs, one or more other biocompatible materials, or combinations thereof.

Abstract: Transcutaneous electrical nerve stimulation devices and magnetic stimulation devices are disclosed, along with methods of treating medical disorders using energy that is delivered noninvasively by such devices. The disorders comprise migraine and other primary headaches such as cluster headaches, including nasal or paranasal sinus symptoms that resemble an immune-mediated response (“sinus” headaches). The devices and methods may also be used to treat rhinitis, sinusitis, or rhinosinusitis, irrespective of whether those disorders are co-morbid with a headache. They may also be used to treat other disorders that may be co-morbid with migraine or cluster headaches, such as anxiety disorders. In preferred embodiments of the disclosed methods, one or both of the patient's vagus nerves are stimulated non-invasively. In other embodiments, parts of the sympathetic nervous system and/or the adrenal glands are stimulated.

Abstract: A medical therapy arrangement, for applying electrical stimulation to a subject, includes a garment having electrodes at an inner surface. A control unit controls each electrode to work as one or more of anode, cathode or disconnected state, per a predetermined therapy stimulation program. Furthermore, the arrangement includes: at least one connection unit having a predetermined number of connection elements respectively electrically connected to the electrodes via separate connection lines being flexible and elastic and integrated into the garment; at least one connection board having a predetermined number of connection pads electrically connected to the control unit.

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

Abstract: The disclosure is directed to programming implantable stimulators to deliver stimulation energy via one or more implantable leads having complex electrode array geometries. The disclosure also contemplates guided programming to select electrode combinations and parameter values to support efficacy. The techniques may be applied to a programming interface associated with a clinician programmer, a patient programmer, or both. A user interface permits a user to view electrodes from different perspectives relative to the lead. For example, the user interface provides a side view of a lead and a cross-sectional view of the lead. The user interface may include an axial control medium to select and/or view electrodes at different axial positions along the length of a lead, and a rotational control medium to select and/or view electrodes at different angular positions around a circumference of the lead.

Abstract: The present disclosure provides a closed-loop system for real-time control of epidural and/or subdural electrical stimulation comprising electrodes for applying to a subject neuromodulation with adjustable stimulation parameters, the electrodes being operatively connected with a real-time monitoring component comprising sensors continuously acquiring feedback signals from said subject, said signals being neural signals and/or signals providing features of motion of said subject, said system being operatively connected with a signal processing device receiving said feedback signals and operating real-time automatic control algorithms, said signal processing device being operatively connected with the electrodes said and providing the electrodes with new stimulation parameters, with minimum delay. The system of the disclosure improves consistency of walking in a subject with a neuromotor impairment.

Abstract: In some examples, a system includes an implantable medical device configured for implantation in a chamber of the heart, an extension attached to the implantable medical device, the extension comprising a housing comprising at least one electrode, the housing defining a hole, and a tether comprising a first tether portion and a second tether portion and configured to be threaded through the hole. When the tether is threaded through the hole, the first tether portion and the second tether portion are on opposite sides of the hole. The tether may be used to implant the extension in a different chamber of the heart of the patient than the implantable medical device.

Abstract: A fixation tool for applying torque to a terminal pin of an active fixation medical electrical lead includes a first handle, a second handle, an elastic member, a first jaw, a second jaw, and an insert. The insert is disposed at an end of the tool slot proximal to the elastic member. The insert includes an insert slot configured to align with the tool slot. The fixation tool is configured such that pressing the first handle and the second handle toward each other causes a movement of the first jaw and the second jaw relative to each other to change a width of the insert slot. The first jaw and the second jaw are comprised of a first material. The insert is comprised of a second material. The first material is harder than the second material.

Abstract: Systems and methods for epicardial pacing are provided. For example, this document provides epicardial pacing using a percutaneously delivered bifurcated pacing lead that has multiple electrodes that are directionally insulated to prevent extracardiac stimulation, including prevention of phrenic stimulation. In addition, the devices, systems, and methods provided can be used for ablation, defibrillation, and/or defibrillation in combination with pacing.

Abstract: A shield layer is added to an existing lead or lead extension by applying the shield layer to the lead body between the proximal contact and distal electrode of the lead body. The shield layer may be covered with an outer insulative layer. An inner insulative layer may be applied over the lead body prior to adding the shield layer and the outer insulative layer. The shield layer may have a terminator applied to the end of the shield layer to prevent migration of the shield layer through the outer insulative layer. The shield layer may be of various forms including a tubular braided wire structure or a tubular foil. The tubular braided wire structure may be applied to the lead body by utilizing the lead body as a mandrel within a braiding machine.

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

Abstract: Overvoltage protection circuitry configured to protect internal integrated circuits within an implantable device in the presence of a high voltage event such as defibrillation or electrocautery. The circuitry allows for an internal node to rise above the voltage level of the high voltage event to insure that an overvoltage protection element is triggered, even if the voltage level of the high voltage event is below the voltage trigger level of the overvoltage protection element.

Abstract: A device for transcutaneous electrical stimulation is provided. The device comprises circuitry configured to generate transcutaneous stimulation signals. The device also comprises a first signal output component for electrically connecting to a first electrode connector to deliver generated transcutaneous stimulation signals. The first signal output component comprises a first four-pole electrical connector part. The device further comprises a second signal output component for electrically connecting to a second electrode connector to deliver generated transcutaneous stimulation signals. The second signal output component comprises a second four-pole electrical connector part. The device further comprises a controller to selectively control output of the stimulation signals to selected pairs of poles across the first and second four-pole electrical connector parts.

Abstract: An electrode connector assembly for the use in transcutaneous electrical stimulation includes a flexible web extending in a plane and first, second, third and fourth electrode connectors carried by the web and spaced from each other about the web in the plane. The electrode connector assembly further includes an electrical connector and first, second, third and fourth conductors electrically coupling the respective first, second, third and fourth electrode connectors to the electrical connector.

Abstract: A self-contained “battery-free” iontophoresis apparatus and method are provided.

Abstract: The present disclosure refers to systems for electrical neurostimulation of a spinal cord of a subject in need of nervous system function support. In one example, a system comprises a signal processing device configured to receive signals from the subject and operate signal-processing algorithms to elaborate stimulation parameter settings; one or more multi-electrode arrays suitable to cover a portion of the spinal cord of the subject; and an Implantable Pulse Generator (IPG) configured to receive the stimulation parameter settings from the signal processing device and simultaneously deliver independent current or voltage pulses to the one or more multiple electrode arrays, wherein the independent current or voltage pulses provide multipolar spatiotemporal stimulation of spinal circuits and/or dorsal roots. Such system advantageously enables effective control of nervous system functions in the subject by stimulating the spinal cord, such as the dorsal roots of the spinal cord, with spatiotemporal selectivity.

Abstract: An electrostimulation device comprises a hand-held electrostimulation generator receiving an input music signal and providing at an output a nerve electrostimulation signal modulated by the music signal, an electronic signal conduit having conductive leads conductively connected to the output of the electrostimulation generator, and an electrode coupler comprising an earbud.

Abstract: Apparatus for transcutaneous electrical nerve stimulation in a user, the apparatus comprising: a housing; stimulation means for electrically stimulating at least one nerve; an electrode releasably mounted to the housing and connectable to the stimulation means for electrical stimulation of the at least one nerve; monitoring means for monitoring the user's body orientation and movement; analysis means for analyzing said orientation and movement; and control means for controlling the output of the stimulation means in response to said analysis of said orientation and movement.

Abstract: A method of treating heart failure in a patient is disclosed that includes implanting a stimulation device into the identified patient to electrically stimulate the spinal cord, and activating the device to deliver electrical stimulation to the spinal cord.

Abstract: The present disclosure provides a medical stimulation system that includes a plurality of implantable channels each operable to obtain a voltage signal from a designated area of a body tissue. The medical stimulation system includes an impedance measurement device. The impedance measurement device includes a plurality of attenuators each coupled to a respective one of the channels. The attenuators are each operable to attenuate an amplitude of the voltage signal received from its respectively-coupled channel. The impedance measurement device includes a multiplexing component that receives the amplitude-attenuated voltage signals from each of the attenuators. The multiplexing component selectively outputs two of the amplitude-attenuated voltage signals. The impedance measurement device includes a differential amplifier that receives the two amplitude-attenuated voltage signals outputted from the multiplexing component as a differential input signal.

Abstract: System and methods are provided for determining a stimulation threshold for closed loop spinal cord stimulation (SCS). The system and methods provide a lead coupled to an implantable pulse generator (IPG). The system and methods deliver SCS pulses from the IPG to the lead electrodes in accordance with an SCS therapy, and determine an evoked compound action potential (ECAP) amplitude based on an ECAP waveform resulting from the SCS therapy. The system and methods increase the SCS therapy by increasing at least one of an amplitude, a duration, and number of the SCS pulses associated with the SCS therapy. The system and methods also include iteratively repeat the delivering, determining and increasing operations until the ECAP amplitude exhibits a downward trend divergence. The system and methods define a stimulation threshold based on the ECAP amplitude at the trend divergence.

Abstract: Systems and methods for detecting intrathecal penetration are disclosed. A method in accordance with one embodiment includes detecting a value corresponding to an impedance of an electrical circuit that in turn includes an electrical contact located within the patient, and patient tissue adjacent to the electrical contact. The method further includes comparing the detected value to a predetermined criterion, and, if the detected value meets the predetermined criterion, identifying penetration of the patient's dura based at least in part on the detected value.

Abstract: Devices and methods described herein may, among other uses, favorably cause the activation and/or deactivation of vascular baroreceptors in order to achieve a desired impact on a physiological condition, such as baroreflex-regulated conditions, hypertension, hypotension, nervous system disorders, metabolic disorders, cardiovascular disease, heart failure, cardiac arrhythmia, renal disease, respiratory disease, diabetes, and insulin resistance. The devices and methods may be used in concert with each other and/or other treatments, medications, interventions, or behavioral regimens. They may also be used in concert with devices and methods that perform or assist with assessing or measuring a mammal's blood pressure assessing, measuring, or predicting the impact of the described methods and devices on the patient's condition (including blood pressure), and/or protecting the surrounding anatomy from adverse effects.

Abstract: A method for controlling a position of a patient's tongue includes attaching at least one electrode to the patient's Hypoglossal nerve and applying an electric signal through the electrode to at least one targeted motor efferent located within the Hypoglossal nerve to stimulate at least one muscle of the tongue. Methods may also include the use of more than one contact to target more than one motor efferent and stimulating more than one muscle. The stimulation load to maintain the position of the tongue may be shared by each muscle. The position of the patient's tongue may be controlled in order to prevent obstructive sleep apnea.

Abstract: A system may include a processor configured to automatically obtain magnetic resonance imaging compatibility information relating to compatibility of an active implantable medical device implantable in a patient with an MRI modality from at least two information sources. The processor may also be configured to automatically determine compatibility of the active implantable medical device with the magnetic resonance imaging modality based on the magnetic resonance imaging compatibility information.

Abstract: An implantable medical device includes an enclosure having a sidewall and a welded seam in the sidewall, the seam extends along a perimeter of the enclosure. A thermoform is located adjacent a surface of the enclosure and is secured in place within the enclosure. A metalized surface is located adjacent an interior surface of the enclosure sidewall and is secured in place by the thermoform. The metalized surface extends along a perimeter of the enclosure and is configured to obstruct laser energy during a weld seam process. The metalized surface may be provided as a separate backup band component or may be integrated in a perimeter sidewall of the thermoform.

Abstract: An electrical stimulation system provides stimulation therapy to a patient. The system includes a neurostimulation lead that contacts patient tissue and couples with an implantable stimulation device, such as an implantable pulse generator, that receives stimulation parameters for providing stimulation therapy to a patient. The implantable stimulation device includes a header with a plurality of connector assemblies that receive an end of the neurostimulation lead, and a case containing a charging coil and a telemetry coil coupled to programming circuitry on a printed circuit board, which is in turn coupled to the connector assemblies via a feedthrough assembly. The telemetry coil receives data from an external programmer and transmits the data to the programming circuitry, which in turn uses the data to communicate to the connector assemblies and the neurostimulation lead to provide stimulation therapy to a patient.

Abstract: A wearable, multiphasic cardioverter defibrillator system and method are provided.

Abstract: The present disclosure relates, according to some embodiments, to an electromagnetic resonance-based disease treatment system that comprises a processing unit configured to generate a resonant frequency signal and a radiating antenna configured to radiate an electromagnetic field based on the resonant frequency signal. The resonant frequency signal may carry at least one frequency at which reference materials related to a disease condition resonate. An antenna configuration may be used to determine one or more resonant frequencies of the reference materials. A subject having or at risk of having the disease condition may be exposed to the electromagnetic field in order to treat the disease condition.

Abstract: A system for treating neurological conditions by low-frequency time varying electrical stimulation includes an electrical device for applying such low-frequency energy, in a range below approximately 10 Hz, to the patient's brain tissue. An implantable embodiment applies direct electrical stimulation to electrodes implanted in or on the patient's brain, while a non-invasive embodiment causes a magnetic field to induce electrical currents in the patient's brain.

Abstract: Systems and methods of the present disclosure are directed to systems and methods for treating cognitive dysfunction in a subject in need thereof. The system can include eyeglasses, a photodiode positioned to detect ambient light, light sources, and an input device. The system can include a neural stimulation system that retrieves a profile and selects a light pattern having a fixed parameter and a variable parameter. The neural stimulation system can set a value of the variable parameter of the light pattern, construct an output signal, and then provide the output signal to the light sources to direct light towards the fovea.

Abstract: A space for conducting photodynamic therapy (PDT) for treatment of skin diseases, especially for treatment of superficial skin tumors such as actinic keratoses, basal cell carcinomas, and initial carcinomas, wherein an active ingredient is applied to a skin area to be treated in order to form porphyrins and irradiation with light is conducted to form singlet oxygen based on the porphyrins in order to destroy diseased skin cells, wherein the space has side walls, a ceiling, and a floor, as well as at least two lighting fixtures, which are separated from one another by at least 50 cm and illuminate at least a subregion of the space, wherein there is an illuminance of at least 8,000 lux at every point in the subregion and the subregion has horizontal dimensions of at least 1 m2 and a vertical height of at least 40 cm. This invention also relates to a luminous ceiling system and method for conducting PDT.

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

Abstract: The invention relates to a method for identifying the location at least one treatment channel from a group of a plurality of treatment channels as wells as a system for effecting radiation treatment on a pre-selected anatomical portion of an animal body. According to the invention the identifying method being characterized by the steps of A selecting at least one of said plurality of treatment channels; B reconstructing the actual location of said selected treatment channel relative to said animal body; and C comparing said reconstructed location said pre-planned plurality of locations. Furthermore the system according to the invention is characterized in that identifying means are present for identifying the location of at least one treatment channel from said group of said plurality of inserted treatment channels and comparing said identified location with one or more of said pre-planned locations present in said treatment plan.