Abstract: A medical appliance for the treatment of one or more sleep disorders such as obstructive sleep apnea in a patient, the appliance comprising: a biasing member for inserting behind and exerting a force upon the patient's soft palate or tongue, wherein the biasing member is inserted in a reduced or minimized form and then expanded or firms once in place to exert the force. The appliance may be nasally inserted or be placed through the mouth. In a particular configuration, both the soft palate and tongue are biased to prevent obstruction of the flow of air in the nasopharyngeal airway.

Abstract: Systems, devices, compositions, and methods for treating diabetes are provided, including co-administering insulin and glucagon to a patient. Data collected from studies conducted to observe co-administration of insulin and glucagon to a patient are also provided. Optimal ratios of insulin and glucagon administration, as well as target doses for each, are also provided.

Abstract: A system for treating a patient comprises a stimulator for stimulating brain tissue, a controller for setting stimulation parameters and a diagnostic tool for measuring patient parameters and producing diagnostic data. The stimulation parameters comprise test stimulation parameters and treatment stimulation parameters. The stimulator delivers test stimulation energy to the brain tissue based on at least one test stimulation parameter and delivers treatment stimulation energy to the brain tissue based on at least one treatment stimulation parameter. One or more treatment stimulator parameters are determined based on the diagnostic data produced by the diagnostic tool The system is constructed and arranged to treat a neurological disease or a neurological disorder. Methods of treating a neurological disease or neurological disorder are also provided.

Abstract: A system for editing an arrangement comprising information regarding the relationship between two or more source data files comprises a processing unit, a first library comprising one or more source data files, and a user interface. The user interface comprises a display and a user input. The processing unit provides a graphical user interface on the display. The processing unit is configured such that a user can modify an initial arrangement of source data files via the graphical user interface to produce a modified arrangement of source data files.

Abstract: Systems, devices and methods treat target tissue to provide a therapeutic benefit to the patient. A tissue treatment device comprises a tissue treatment element constructed and arranged to treat target tissue, such as duodenal mucosa and/or submucosal tissue. Patients treated can safely eliminate or reduce their daily insulin intake.

Abstract: An ablation system comprises: an ablation catheter and a console. The ablation catheter comprises: a shaft including a proximal end, a distal portion and a distal end; an ablation element configured to deliver energy to tissue; and a force maintenance assembly comprising a force maintenance element and configured to control and/or assess contact force between the ablation element and cardiac tissue. The console is configured to operably attach to the ablation catheter and comprises: an energy delivery assembly configured to provide energy to the ablation element. Methods of ablating tissue are also provided.

Abstract: Provided is a flex-PCB catheter device that is configured to be inserted into a body lumen. The flex-PCB catheter comprises an elongate shaft, an expandable assembly, a flexible printed circuit board (flex-PCB) substrate, a plurality of electronic components and a plurality of communication paths. The elongate shaft comprises a proximal end and a distal end. The expandable assembly is configured to transition from a radially compact state to a radially expanded state. The plurality of electronic elements are coupled to the flex-PCB substrate and are configured to receive and/or transmit an electric signal. The plurality of communication paths are positioned on and/or within the flex-PCB substrate. The communication paths selectively couple the plurality of electronic elements to a plurality of electrical contacts configured to electrically connect to an electronic module configured to process the electrical signal. The flex-PCB substrate can have multiple layers, including one or more metallic layers.

Abstract: A device for ablating target tissue of a patient with electrical energy is provided. An elongate shaft includes a proximal portion and a distal portion, and a radially expandable element is attached to the distal portion. An ablation element for delivering electrical energy to target tissue is mounted to the radially expandable element. The device can be constructed and arranged to ablate the duodenal mucosa of a patient while avoiding damage to the duodenal adventitial tissue. Systems and methods of treating target tissue are also provided.

Abstract: An imaging system for use in a patient is provided. The system includes an imaging probe, a rotation assembly, and a retraction assembly. The imaging probe collects image data from a patient site and includes an elongate shaft with a proximal end and a distal portion, with a lumen extending therebetween. A rotatable optical core is positioned within the elongate shaft lumen and an optical assembly is positioned in the elongate shaft distal portion. The optical assembly directs light to tissue at the patient site and collects reflected light from the tissue. The rotation assembly connects to the imaging probe and rotates the optical assembly. The retraction assembly connects to the imaging probe and retracts the optical assembly and the elongate shaft in unison.

Abstract: Provided herein are imaging systems for a patient comprising an imaging probe and an imaging assembly. The imaging probe comprises: an elongate shaft comprising a proximal end, a distal portion, and a lumen extending between the proximal end and the distal portion; a rotatable optical core comprising a proximal end and a distal end, wherein at least a portion of the rotatable optical core is positioned within the lumen of the elongate shaft; and an optical assembly positioned proximate the distal end of the rotatable optical core, the optical assembly configured to direct light to tissue to be imaged and collect reflected light from the tissue to be imaged. The imaging assembly is constructed and arranged to optically couple to the imaging probe. The imaging assembly is configured to emit light into the imaging probe and receive the reflected light collected by the optical assembly.

Abstract: A system for treatment target tissue comprises an ablation device and an energy delivery unit. The ablation device comprises an elongate tube with an expandable treatment element. The system delivers a thermal dose of energy to treat the target tissue. Methods of treating target tissue are also provided.

Abstract: Systems, devices and methods for performing medical procedures in the intestine of a patient are provided. A medical device for performing a treatment and/or a diagnostic procedure can include an elongate shaft assembly comprising at least a shaft assembly first section comprising a distal section of the shaft assembly, and a shaft assembly second section proximal to the first section, and a functional assembly positioned on the shaft assembly first section. Additional sections of the shaft assembly can be included, and each section can comprise a different construction, such as to achieve a different stiffness as described herein. Variable stiffness along the length of the shaft assembly can be provided to aid in translation of the device through the patient's GI tract (e.g. through the stomach and into the small intestine), as described herein.

Abstract: Provided are systems for performing a medical procedure in the intestine of a patient. The system comprises an elongate device and a console. The elongate device comprises a proximal portion, a middle portion, and a distal portion. The elongate device further comprises a functional assembly positioned on the distal portion, the functional assembly being configured to treat and/or diagnose target tissue. The console comprises a human interface device and a controller. The console is configured to robotically manipulate one or more portions of the elongate device, and/or the functional assembly.

Abstract: Provided herein are systems for providing therapy to the heart of a patient. The systems include an implantable device for implantation proximate the heart of the patient. The implantable device includes: an anchoring element for maintaining the position of the implantable device after implantation in the patient, at least one sensing electrode for sensing the electrical activity of the heart, at least three pacing electrodes for delivering electrical energy to the tissue of the heart, and a controller including an algorithm for determining when the patient requires therapy. The systems further include an external device having a transceiver for transmitting energy to the implantable device.

Abstract: Systems and methods for treating a cognitive disease or disorder are provided. A treatment method comprises: selecting a target volume of brain tissue to be stimulated; identifying at least one avoidance volume of brain tissue; selecting a first stimulation lead comprising at least one stimulation element; identifying at least one proposed trajectory for placement of the first stimulation lead based on the target volume and the at least one avoidance volume; placing the first stimulation lead along a placement trajectory selected from the at least one proposed trajectory; attaching the first stimulation lead to a stimulator; and stimulating the target volume with the first stimulation lead at least one stimulation element to treat at least one of a cognitive disease or a cognitive disorder. Systems include a stimulator with one or more stimulation leads and an image analyzer for identifying a proposed trajectory for placing the stimulation leads.

Abstract: A method of forming an oral device to measure biological variables includes providing a mold configured to impart a contour of an oral retainer sized to extend about a plurality of teeth. The method includes removing the first layer of the retainer from the mold. The method includes attaching at least one sensor to the retainer, the sensor having a profile and defining a boundary edge. The method includes trimming to form a lip of the first layer of material extending beyond the boundary edge of the at least one sensor component. The method includes attaching the first layer of the retainer and at least one sensor component to the mold, forming a second layer of the retainer with the mold, wherein the first layer of retainer retains the mold contour, and wherein the at least one sensor component is disposed between the first and second layer.

Abstract: A system for performing a medical procedure on mucosal tissue in an intestine of a patient is provided. The system including a catheter a catheter for insertion into the intestine, and a console. The catheter comprises: a shaft including a distal portion, and a functional assembly on the distal portion of the shaft. The functional assembly is configured to receive fluid. The console comprises: at least one pumping assembly configured to deliver the fluid to the functional assembly; and a connector configured to operably attach the catheter to the console. The functional assembly is configured to treat target tissue of the intestine of the patient. Methods of treating intestinal mucosal tissue are also described.

Abstract: A system for creating an output comprises a processing unit, a user input module operably connected to the processing unit, and a display operably connected to the processing unit. The processing unit provides on the display: a grid image comprising multiple cells, each cell representing a duration of time; and a selection area comprising multiple select icons, each select icon representing a source data file. The processing unit is configured such that a user can create a grid layout representing the correlation between individual selected source data files and one, two, or more of the multiple cells. The processing unit produces the output based on the correlation.

Abstract: A system comprises a catheter configured for delivery to a body cavity defined by surrounding tissue; a plurality of ultrasound transducers coupled to a distal end of the catheter; and an electronics module configured to selectively turn on/off each ultrasound transducer according to a predetermined activation sequence and to process signals received from each ultrasound transducer to produce at least a 2D display of the surrounding tissue. A user can selectively calculate and display various aspects of cardiac activity. The user can display Dipole Density (DDM), Charge Density (CDM), or Voltage (V-V). The shape and location of the chamber (surface), and the potentials recorded at electrodes can be displayed. The system can also change back and forth between the different display modes, and with post processing tools, can change how various types of information is displayed. Methods are also provided.

Abstract: Systems, devices, and methods for treating a nerve injury in a patient are provided. The system includes an extracellular matrix, a neutralizing element, and a reconstituting element. The extracellular matrix is configured to promote and/or sustain the growth of tissue and/or associated tissue properties proximate the nerve injury.