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 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 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, 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: 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: 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: 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: 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: 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 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 at least one of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH).

Abstract: A device for expanding tissue comprises at least one fluid delivery tube and at least one fluid delivery element in fluid communication with the at least one fluid delivery tube. The at least one fluid delivery tube comprises a proximal end, a distal end, and a lumen therebetween. The device is constructed and arranged to perform a near full circumferential expansion of luminal wall tissue. Systems and methods are also provided, including a system for expanding tissue layers and treating tissue proximate to the expanded tissue layers.

Abstract: Methods, systems and devices for treating a patient include performing a first treatment to treat a first portion of tissue and performing a second treatment to treat a second portion of tissue. The second portion of tissue is treated at least twenty-four hours after the first portion of tissue is treated. In particular embodiments, the first portion of tissue includes duodenal tissue, and the second portion of tissue includes duodenal or other gastrointestinal tissue.

Abstract: An injectate delivery device for expanding tissue is provided. The injectate delivery device comprises: at least one fluid delivery tube comprising a proximal end, a distal end and a lumen therebetween; at least one fluid delivery element in fluid communication with the at least one fluid delivery tube lumen; a radially expanding element comprising the at least one fluid delivery element; a supply of vacuum constructed and arranged to cause tissue to tend toward the at least one fluid delivery element; and at least one control constructed and arranged to perform a function. The at least one control can be constructed and arranged to expand the radially expandable element and activate the supply of vacuum. Systems and method of injectate delivery are also provided.

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: Provided herein are systems for treating a patient, the systems comprising: a treatment device for treating a minimum amount of mucosal tissue of the patient's small intestine. The system is configured to treat a medical condition of the patient. Methods of treating a patient are also provided.

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: 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: Methods, systems and devices for treating a patient include providing a tissue treatment element constructed and arranged to deliver energy to tissue and treating tissue of the gastrointestinal tract by causing the tissue treatment element to deliver energy to an energy delivery zone. Treatment results in a reduction in the luminal surface area of at least a portion of the gastrointestinal tract. In particular embodiments, the methods, systems and devices are used to treat diabetes.

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: Methods, systems and devices for treating a patient include performing a first treatment to treat a first portion of tissue and performing a second treatment to treat a second portion of tissue. The second portion of tissue is treated at least twenty-four hours after the first portion of tissue is treated. In particular embodiments, the first portion of tissue includes duodenal tissue, and the second portion of tissue includes duodenal or other gastrointestinal tissue.