Abstract: Some embodiments of an electrical stimulation system employ wireless electrode assemblies to provide pacing therapy, defibrillation therapy, or other stimulation therapy. In certain embodiments, the wireless electrode assemblies may include a guide wire channel so that each electrode assembly can be advanced over a guide wire instrument through the endocardium. For example, a distal tip portion of a guide wire instrument can penetrate through the endocardium and into the myocardial wall of a heart chamber, and the electrode assembly may then be advanced over the guide wire and into the heart chamber wall. In such circumstances, the guide wire instrument (and other portions of the delivery system) can be retracted from the heart chamber wall, thereby leaving the electrode assembly embedded in the heart tissue.

Abstract: A medical device including a shaft having an elongated inner member and an elongated tubular reinforcing member disposed over at least a portion of the inner member. In some embodiments, at least a portion of the outer surface of the inner member is spaced from the inner surface of the reinforcing member, defining a space substantially free of any other structures of the device. In some embodiments, the shaft can include a tip structure disposed on a distal portion of the inner member. In some such embodiments, the reinforcing member has a distal end, and the tip structure is disposed on the distal portion of the inner member adjacent the distal end of the reinforcing member. Additionally, in some embodiments, the reinforcing member can include a plurality of apertures defined therein, for example, to enhance the flexibility or other such characteristics of all or portions of the reinforcing member.

Abstract: A method for generating a composite image using an intravascular imaging device includes receiving reflected echo signals from at least one transducer along a first of a plurality of radial scan lines. The received echo signals are passed through a plurality of signal processing channels to form a plurality of filtered signals. The filtered signals include a high-resolution tissue structure signal and at least one first pre-blood-flow-mask signal. High-resolution tissue structure signals are processed to form a high-resolution tissue structural image. First pre-blood-flow-mask signals are cross-correlated with second pre-blood-flow-mask signals from an adjacent radial scan line to form blood-flow-mask signals. Blood-flow-mask signals are processed to form a blood-flow mask.

Abstract: Dilation catheters including a mechanism used in, for example, removing gas or air from the catheters are disclosed. A dilation catheter may include an elongated tubular member having a distal end and a proximal end, a proximal handle proximate the proximal end of the tubular member, and an inflatable balloon proximate the distal end of the tubular member with inflatable balloon being in fluid communication with a fluid port to supply inflation liquid to the inflatable balloon. The inflatable balloon may include an opening for permitting gas to exit the inflatable balloon. In the proximate location of the opening, an expandable material or a barrier material that permits gas to exit through the opening, while retaining inflation liquid in the inflatable balloon.

Abstract: Embodiments of the present disclosure include methods and systems for a catheter assembly including a catheter shaft, a balloon positioned on the catheter shaft, where the balloon has a first balloon waist, a first lead extending longitudinally through the catheter shaft, and a first sealing member adjacent the first balloon waist and coupled to the first lead, where the first lead can provide electrical current to reversibly transition the first sealing member from a nonactivated state to an activated state in response to a temperature change in the first sealing member, and where at least a portion of the balloon rotates relative the catheter shaft in the nonactivated state and the first sealing member engages the first balloon waist to form a fluid tight seal and to prevent rotation of the balloon relative the catheter shaft in the activated state.

Abstract: A method for forming a valve-like mechanism in a body of a mammal having an esophagus extending through a lower esophageal sphincter to a stomach and formed by a wall having a muscle layer and a mucosal layer. The method comprises the step of forming at least one implant in the muscle layer of the wall in the vicinity of the lower esophageal sphincter. The at least one implant inhibits opening of esophagus at the lower esophageal sphincter and causes the mucosal layer to appose in the vicinity of the implants.

Abstract: A balloon catheter may comprise a primary inflation balloon and a secondary inflation balloon located to one side of the primary inflation balloon. The secondary balloon comprises a first portion and a second portion, the first portion located closer to the primary balloon. The second portion has a greater size than the first portion, and a portion of the second portion extends outwardly beyond the first portion and overhangs the first portion. In some embodiments, a cross-sectional shape of the secondary balloon in an inflated state comprises a mushroom shape.

Abstract: An emboli filtration apparatus is provided including a guide wire having a filter element captured thereon, so that the guide wire is free to rotate and translate while the filter element remains stationary. The apparatus allows for movement and rotation of the guide wire as devices are advanced over it to treat occlusive disease, substantially without dislodging the filter element. In a preferred embodiment, the guide wire includes a proximal stop configured to reposition the filter element during a medical procedure without having to remove or insert additional interventional devices.

Abstract: Medical devices including a substrate that are expandable from a compressed state to an expanded state; a coating on the substrate, the coating having a drug agent incorporated therein; and a sheath over the coating. The sheath is expandable from a compressed state to an expanded state and has at least one perforation therein. The medical devices are configured such that when the substrate is in a compressed state, the sheath is also in a compressed state and the perforation is substantially closed. When the substrate is in an expanded state, the sheath is also in an expanded state and the perforation is substantially open. The invention also includes a method of using the medical devices for the controlled, localized delivery of a drug agent to a target location within a mammalian body.

Abstract: Devices, systems, and methods controllably cool blood vessels and other body lumens. The blood vessel will often be treated for atherosclerotic or other diseases by inflating a balloon so as to engage the surrounding luminal wall. Controlled cooling of the balloon effected by a change in phase of a cryogenic fluid within the balloon typically a change from a liquid phase to a gas phase can be provided with a controlled, gradual inflation of the balloon. A single control system can be used for any of a variety of alternative selectable balloon catheters having significantly differing cooling fluid flow characteristics.

Abstract: Methods, apparatus, and systems for occluding a left atrial appendage are provided. One embodiment includes an elongate body having a tissue apposition member extendably positioned within a lumen of the elongate body to appose tissue of the LAA. An energy emitting device coupled to the elongate body can be used for emitting high intensity focused ultrasound to the tissues to fuse the tissues.

Abstract: A method of coating an implantable medical device may include providing an implantable medical device, applying a polymer base to the medical device, and directing a first solution including therapeutic agent and solvent through the nozzle onto a target zone of the polymer base coating to penetrate the polymer base coating. The solution may be directed at the target zone until a predetermined concentration of the therapeutic agent can be integrated within the polymer base coating.

Abstract: A method for positioning a guide element in a patient and a kit for use in the method. In one embodiment, the method involves transorally inserting an endoscope into a patient's stomach. An incision site is externally indicated by transilluminating the stomach and abdominal walls of the patient from within the stomach. Next, a scalpel incision is made at the indicated incision site, and an access needle is inserted into the incision, the proximal end of the access needle remaining external to the patient and the distal end of the access needle extending into the patient's stomach. The stylet of the access needle is then removed from the patient while keeping the cannula in place. Next, the distal end of a grasping tool is inserted through the cannula and into the patient's stomach. The looped leading end of a pullwire is then inserted through the endoscope and into the stomach. The tool is then manipulated until a distal hook on the tool catches the looped leading end.

Abstract: An imaging transducer assembly is combined with a sensor of a medical positioning system, forming a transducer/sensor assembly. In one embodiment, the sensor includes a coil proximally coupled with the imaging transducer. A cable having first and second wires are proximally coupled to the coil. A non-conductive potting layer is wrapped around the coil. Traces are formed in the non-conductive potting layer that are used to electrically couple the imaging transducer with the first and second wires of the cable.

Abstract: Systems and methods are described for displaying classifier output and confidence measure in an image. The confidence measure advantageously provides additional information to the user indicating the accuracy of the classification result. Based on the classification accuracy, the user may accept or reject the classification result. In an exemplary embodiment, the classifier output is displayed on the image by color coding regions in the image based on their classifications. The confidence measure is displayed by adjusting the transparencies of the color coded regions according to their confidence measures. In one embodiment, only the classifications having confidence measures above a threshold are displayed. In other embodiments, the classifier output and confidence measure may be displayed separately, contour lines may be drawn through image regions having similar confidence measures, and the confidence measure may be displayed for a region under a pointer that the user can move within the image.

Abstract: Embolization, as well as related particles, compositions and methods, are disclosed.

Abstract: A method and apparatus for reducing the longitudinal aspect of the catheter to stent force having at least one grip member for use with a stent delivery system. The grip engages a stent in the unexpanded state prior to delivery of the stent. The stent may be deployed by retracting a stent retaining sheath. The grip has a body region having an outer diameter, a first end and a second end. The outer diameter of the first end is greater than the outer diameter of the second end. The grip is at least partially constructed from a polymeric material.

Abstract: The invention, in various embodiments, provides systems, devices, and methods for treating urinary incontinence.

Abstract: The systems and methods described herein provide for fast and accurate image segmentation through the application of a multi-stage classifier to an image data set. An image processing system is provided having a processor configured to apply a multi-stage classifier to the image data set to identify a distinctive region. The multi-stage classifier can include two or more component classifiers. The first component classifier can have a sensitivity level configured to identify one or more target regions in the image data set and the second component classifier can have a specificity level configured to confirm the presence of the distinctive region in any identified target regions. Also provided is a classification array having multiple multi-stage classifiers for identification and confirmation of more than one distinctive region or for the application of different classification configurations to the image data set to identify a specific distinctive region.

Abstract: Systems and methods for imaging a body cavity and for guiding a treatment element within a body cavity are provided. A system may include an imaging subsystem having an imaging device and an image processor that gather image data for the body cavity. A mapping subsystem may be provided, including a mapping device and a map processor, to identify target sites within the body cavity, and provide location data for the sites. The system may also include a location processor coupled to a location element on a treatment device to track the location of the location element. The location of a treatment element is determined by reference to the location element. A treatment subsystem including a treatment device having a treatment element and a treatment delivery source may also be provided. A registration subsystem receives and registers data from the other subsystems, and displays the data.