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: 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 stimulation apparatus for a patient may include an external system configured to transmit transmission signals and an implantable system configured to receive the transmission signals from the external system. The implantable system may include at least one implantable lead, a first implantable device for connecting to the implantable lead during a first time period, and a second implantable device for subsequently connecting to the implantable lead for a second time period.

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.

Abstract: The present disclosure relates generally to methods and apparatus to control delivery of a sealant during an invasive procedure. Disclosed methods and apparatus control movement of a syringe to control injection of sealant stored therein. For example, disclosed methods and apparatus can displace the syringe body relative to the plunger as the syringe is withdrawn from the target site, rather than displacing the plunger relative to the syringe body, to thereby pressurize the sealant or inject the sealant in an amount proportional to a distance the syringe body is withdrawn. This reduces the variability in the amount of sealant delivered along the syringe withdrawal pathway. The disclosed methods and apparatus can increase precision in movement of a syringe, thereby increasing precision in sealant delivery.

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 performing a medical procedure in the intestine of a patient comprises a catheter for insertion into the intestine, a console, and a connector configured to operably attach the catheter to the console. The catheter comprises a shaft including a distal portion, and a functional assembly positioned on the distal portion of the shaft. The functional assembly is configured to receive fluid. The console comprises: a fluid reservoir configured to supply the fluid, a first syringe pump assembly configured to deliver the fluid to the functional assembly, a second syringe pump assembly configured to deliver the fluid to the functional assembly, a fluid heater configured to heat the fluid, and a waste fluid reservoir configured to receive the fluid. The system is configured to treat target tissue of the intestine of the patient. Methods of treating target tissue 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 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 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.