Abstract: A plurality of individual tools is provided where each tool is uniquely configured to perform a step or a portion of a step in a novel procedure associated with the implantation of a stabilizing device (e.g., an interspinous spacer) for stabilizing at least one spinal motion segment. The tools are usable individually, or more preferably as a tooling system in which the tools are collectively employed to implant an interspinous spacer, generally in a minimally invasive manner. For example, each of the tools is arranged with coordinated markings and/or other features to ensure consistent depths of insertion, proper orientation of the tools with respect to each other or an anatomical feature of the patient, and precise delivery of the spacer to maintain safe positioning throughout the implantation procedure.

Abstract: A cardiac information dynamic display system comprises one or more electrodes and a cardiac information console. The one or more electrodes record sets of electric potential data representing cardiac activity at a plurality of time intervals. The cardiac information console includes a signal processor and a user interface module. The signal processor calculates sets of cardiac activity data at the plurality of time intervals using the recorded sets of electric potential data. The cardiac activity data is associated with surface locations of one or more cardiac chambers. The user interface module displays information related to the cardiac activity data. The information is presented relative to a graphical representation of surfaces of the one or more cardiac chambers.

Abstract: A system for producing a graft device for a patient may comprise: an imaging device configured to produce image data of a tubular conduit; and a processing unit configured to receive the image data from the imaging device. The processing unit may comprise an algorithm configured to process the image data, and produce a construction signal based on the image data. A material delivery device may be configured to receive the construction signal from the processor, and deliver material to produce a 3D covering based on the construction signal. The graft device may comprise the 3D covering positioned about the tubular conduit. Graft devices and methods of producing graft devices may also be 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 treating a patient comprises an elongate shaft, an expandable reservoir and a fluid delivery assembly. The elongate shaft comprises a distal portion and is constructed and arranged to be introduced into a gastrointestinal lumen. The expandable reservoir is positioned on the elongate shaft distal portion and is constructed and arranged to receive a first fixed amount of ablative fluid and to deliver a first thermal dose of energy to a first portion of target tissue. The fluid delivery assembly is in fluid communication with the expandable reservoir and is constructed and arranged to deliver the first fixed amount of ablative fluid to the expandable reservoir. Devices and methods for treating tissue of a patient are also provided.

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: 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: Provided herein are systems, devices, and methods for performing a medical procedure on a patient. The system comprises an ablation catheter comprising a shaft, at least one therapeutic element positioned on the shaft, and one or more tissue-contact sensing components configured to provide a contact signal related to the level of contact between the at least one therapeutic element and tissue. The system further comprises: an energy delivery unit configured to deliver ablative energy to the at least one therapeutic element to create a lesion in target tissue, and to provide an energy delivery data; a force module configured to receive the contact signal and provide contact data; and a processing unit configured to determine an ablation index based on both the energy delivery data and the contact data. The ablation index can represent the status of the lesion being created.

Abstract: A system for treating and/or diagnosing tissue from a tissue surface comprises: a console; an interface assembly; and a mobile device. The mobile device is configured to navigate a tissue surface and can comprise: a first tissue attachment assembly; a second tissue attachment assembly; and at least one articulation assembly. The interface assembly operably connects the console to the mobile device. The console is configured to manipulate the at least one articulation assembly via the interface assembly. The at least one articulation assembly is configured to navigate from a first tissue location to a second tissue location. The mobile device is configured to diagnose and/or treat tissue at the second tissue location. Methods of treating and/or diagnosing tissue are also described.

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: Methods of generating a graphical representation of cardiac information on a display screen are provided. The method comprises: electronically creating or acquiring an anatomical model of the heart including multiple cardiac locations; electronically determining a data set of source information corresponding to cardiac activity at the multiple cardiac locations; electronically rendering the data set of source information in relation to the multiple cardiac locations on the display screen. Systems and devices for providing a graphical representation of cardiac information are also provided.

Abstract: Systems, methods, and software products provide increased trust in authentication of a user to an authentication server when a trusted witness client device witnesses the authentication of the user on the user's root client device. Both the root and the witness client devices cooperate to present the user with an interactive task during the authentications and each client device independently captures movement of the user performing the interactive task, during which, the user is authenticated to the root client device. An increased level of trust in the authentication of the user is achieved by the authentication server when the captured movements match expected movements of the user performing the interactive task and the authentication server has proof that the witness client devices witnessed a successful authentication.

Abstract: A tissue fixation system including a delivery tube and an elongated fastener with a loop at a proximal end and a distal end, A proximal end of an elongated curved needle is attached to the delivery tube. A distal end of the needle is configured to penetrate tissue. The needle includes an open channel sized to receive the elongated fastener with the loop located near the proximal end of the elongated curved needle and the distal end of the elongated fastener located near the distal end of the elongated curved needle. A capture needle is slidably positioned in the delivery tube to slide through the loop in the proximal end of the elongated fastener. The capture needle is configured to grasp the distal end of the elongated fastener and pull the distal end of the elongated fastener through the loop to cinch the elongated fastener.

Abstract: A method for performing a medical procedure in an intestine of a patient is provided. The method comprises providing a system comprising: a catheter for insertion into the intestine, the catheter comprising: an elongate shaft comprising a distal portion; and a functional assembly positioned on the shaft distal portion and comprising at least one treatment element. The catheter is introduced into the patient, and target tissue is treated with the at least one treatment element. The target tissue comprises mucosal tissue of the small intestine, and the medical procedure can be configured to treat polycystic ovarian syndrome (PCOS).

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: Systems, devices, and method for performing a medical procedure on a patient are provided. A system includes a tissue interface device and a console. The tissue interface device is configured to image tissue and/or deliver energy to tissue. The tissue interface device includes a transmission assembly. The console is configured to transmit energy to the tissue interface device.

Abstract: A tubular tissue graft device is provided comprising a tubular member and a restrictive fiber matrix of a bioerodible polymer about a circumference of the tubular tissue. The matrix may be electrospun onto the tubular tissue. In one embodiment, the tubular tissue is from a vein, such as a saphenous vein, useful as an arterial graft, for example and without limitation, in a coronary artery bypass procedure. Also provided is method of preparing a tubular graft comprising depositing a fiber matrix of a bioerodible polymer about a perimeter of a tubular tissue to produce a tubular tissue graft device. A cardiac bypass method comprising bypassing a coronary artery with a tubular tissue graft device comprising a vein and a restrictive fiber matrix of a bioerodible polymer about a circumference of the vein also is provided.

Abstract: Provided herein are methods for providing a therapeutic benefit to a patient. A method of treating a patient with a metabolic disease and/or a pancreatic disease includes: selecting a patient with a metabolic disease and/or a pancreatic disease; selecting one or more pancreatic deposit sites; advancing a depositing device comprising a at least one depositing element to the selected one or more pancreatic deposit sites; and delivering a treatment agent through the at least one depositing element into the selected one or more pancreatic deposit sites. Systems and devices are also described.

Abstract: A system for treating a patient comprises a delivery device and injectate. The delivery device comprises an elongate shaft with a distal portion and at least one delivery element positioned on the elongate shaft distal portion. The delivery device is constructed and arranged to deliver the injectate through the at least one delivery element and into tissue to create a therapeutic restriction in the gastrointestinal tract. Methods of creating a therapeutic restriction are also provided.

Abstract: A tissue fixation system including a delivery tube and an elongated fastener with a loop at a proximal end and a distal end. A proximal end of an elongated curved needle is attached to the delivery tube. A distal end of the needle is configured to penetrate tissue. The needle includes an open channel sized to receive the elongated fastener with the loop located near the proximal end of the elongated curved needle and the distal end of the elongated fastener located near the distal end of the elongated curved needle. A capture needle is slidably positioned in the delivery tube to slide through the loop in the proximal end of the elongated fastener. The capture needle is configured to grasp the distal end of the elongated fastener and pull the distal end of the elongated fastener through the loop to cinch the elongated fastener.