A cutting system for use prior to valve replacement that includes a cutting assembly and a sheath. The cutting assembly includes an expansion member that is movable between a stowed position and an expanded position, and at least a first cutting member associated with the expansion member. The first cutting member is configured to incise a first leaflet. The sheath defines a lumen therethrough and the cutting assembly is movable within the lumen.

A device for introduction into a body vessel includes a shaft (105), a balloon (115) positioned at the distal end of the shaft (105), and at least one longitudinal scoring wire (135) to score a vascular lesion attached to the distal end of the shaft (105), disposed over the balloon (115). The shaft (105) includes a support (119), such as a wire or tube having one or more spirally cut portions (119A, 119B), which improves pushability and trackability, thereby allowing for use with an external guidewire in a “short rapid exchange” (SRX) format. The balloon (115) expands when fluid is delivered to the balloon (115) through the inflation lumen. This expansion pushes the scoring wire and guidewire against the vascular lesion.

A catheter (10) for introduction into a body vessel includes a shaft, a balloon (12) positioned at the distal end of the shaft, and at least one scoring wire (30) to score a vascular lesion. A distal end portion of the scoring wire is detachably connected to the catheter, such as by way of magnetic coupling (30a), thereby allowing for selective use of the catheter in a scoring or non-scoring configuration. The balloon expands when fluid is delivered to the balloon through an inflation lumen. This expansion pushes the scoring wire against the vascular lesion.

An exoskeleton device is capable of being positioned over an expandable instrument, such as a balloon catheter. The exoskeleton device may include an expandable section that receives an expander of the expandable instrument. Expansion of the expander may cause the expandable section of the exoskeleton device to expand and force the expandable section of the exoskeleton device against a surface to be treated. The expandable section may be capable of scoring the surface against which it is forced.

The invention provides a device for generating shock waves. The device may comprise an elongated tube and a conductive sheath circumferentially mounted around the elongated tube. The device may further comprise first and second insulated wires extending along the outer surface of the elongated tube. A portion of the first insulated wire is removed to form a first inner electrode, which is adjacent to a first side edge of the conductive sheath. A portion of the second insulated wire is removed to form a second inner electrode, which is adjacent to a second side edge of the conductive sheath. Responsive to a high voltage being applied across the first inner electrode and the second inner electrode, a first shock wave is created across the first side edge and the first inner electrode, and a second shock wave is created across the second side edge and the second inner electrode.

An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including proximal and distal ends, a lumen extending there between, and a balloon on the distal end. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The valve may be biased to be closed, e.g., by a spring element disposed within the balloon. Optionally, the apparatus also includes an actuator for expanding a helical member within the balloon interior, e.g., either before or after expanding the balloon, such that the helical member and balloon may adopt an expanded helical shape for removing material within a body lumen.

Devices and methods for treating a target site in a body lumen are provided. A medical device includes a stent-like structure including a plurality of scoring and non-scoring filaments interwoven with one another. Generally, the stent-like structure will have more non-scoring filaments than scoring filaments to provide greater structural support and to focus the scoring forces on only a few select areas. The stent-like structure is expanded within the target site to score the target site and to provide temporary structural support while the target site is infused with a therapeutic agent. Such therapeutic agent infusion occurs with the use of a drug eluting or drug coated balloon disposed within the stent-like structure or by occluding the target site and introducing a drug into the occluded target site to sit for a period of time.

Some embodiments provide a soft tissue device, such as a transverse carpal ligament cutting device having one or more balloons that are deflated when the device is in an inactive position and are inflated when the device is in an active position. Other embodiments provide a soft tissue cutting method, such as a method of cutting a transverse carpal ligament that uses a soft tissue cutting device.

A device for dividing a fibrous structure comprising a catheter; an expandable member positioned near a distal end of the catheter and in fluid communication with a lumen of the catheter; and a cutting element situated on an outer surface of the expandable member. A method for dividing a fibrous structure comprising positioning, proximate the fibrous structure, an expandable member having a cutting element situated thereon; expanding the expandable member outwards to tension the fibrous structure across the cutting element; and activating the cutting element to weaken or cut the fibrous structure. A method for treating carpal tunnel syndrome comprising inserting a needle into the carpal tunnel; directing a guidewire to a position proximate the transverse carpal ligament; advancing, along the guidewire, a device having an expandable member and a cutting element; positioning the cutting element; tensioning the ligament across the cutting element; and weakening or cutting the ligament.

A gastrectomy device includes an elongated member and a tube. The elongated member has a proximal end and a distal end and defines a longitudinal side window disposed adjacent the distal end. The elongated member defines a first longitudinal channel, a second longitudinal channel, and a plurality of side apertures. The first longitudinal channel is in communication with the longitudinal side window and the plurality of side apertures is in communication with the second longitudinal channel. The tube extends through the first longitudinal channel. An array of lights is associated with the tube to provide illumination. The tube is movable through the elongated member between a first state, in which the tube is disposed within the first longitudinal channel of the elongated member, and a second state, in which a portion of the tube extends through the longitudinal side window of the elongated member.