Abstract: A valve leaflet resection device includes a catheter (110), an electrode assembly (140) slidably disposed within the catheter and deployable from the catheter and configured to remove a portion of a leaflet of a heart valve, a leaflet retainer (130) slidably disposed within the catheter and deployable from the catheter, the leaflet retainer configured to grasp a leaflet of a heart valve, and a capture basket (120) configured to capture a resected portion of the leaflet of the heart valve upon retraction of the leaflet retainer.

Abstract: A medical device for forming tissue punctures includes an elongate shaft with a distal region and an electrode structure secured to the distal region. The electrode structure contains one or more electrode pairs with first and second electrode segments extending radially from a center point. An electrical conductor extends through the shaft and couples to the electrode structure. The device includes an insulative layer over portions of the electrode structure, with electrode pairs extending above the insulative layer surface to form cutting edges. The electrode structure creates three-dimensional cut patterns generating tissue flaps that fold away from the puncture. The cutting edges may be arranged in various configurations, including spiral patterns, bisecting patterns through the center point, or multiple edges that do not intersect the center point. The device forms cuts sized to accommodate catheter insertion through the resulting puncture.

Abstract: A system for lacerating a tissue includes a catheter including one or more lacerators, where the one or more lacerators are configured to lacerate the tissue at a first exposure window and a second exposure window. The system also includes one or more aligners, where the one or more aligners are deployable and configured to, when deployed, promote contact between the one or more lacerators and the tissue at the first exposure window and/or the second exposure window.

Abstract: A medical device includes an elongate shaft with an inflatable balloon at its distal region. The balloon has an outer surface and can switch between deflated and inflated configurations. An electrocautery electrode is located on the balloon's outer surface. A shield member extends along the valve leaflet opposite to the balloon, such that the leaflet sits between them. The shield member can conform to the deflated balloon and extend laterally when inflated. It protects surrounding anatomy and prevents electrical contact with previously implanted heart valve frameworks. The device includes alignment features to help position the balloon both translationally and rotationally relative to the valve leaflet. The shield member can be made of polymeric or metallic materials and can extend into adjacent valve cusps. This medical device is designed for safely and precisely lacerating valve leaflets while protecting surrounding tissues.

Abstract: A medical device for positioning a cutting device relative to a heart valve leaflet includes an elongate shaft extending from a proximal region to a distal region and configured to accept a cutting device therethrough. A stabilization loop extends from the distal region of the shaft, featuring first and second loop sides that terminate in respective ends. The device includes a control knob slidably mounted on the elongate shaft and coupled to the stabilization loop. The control knob is configured to translate along the shaft to move the stabilization loop and can be rotated to selectively lengthen one of the first or second loop sides, thereby moving the distal region relative to the heart valve. This selective lengthening capability enables precise positioning of the device relative to the valve leaflet during cardiac procedures such as valve leaflet laceration.

Abstract: A system for lacerating heart valve leaflets includes a coronary guidewire and a laceration device including an ablative cutting element. A system may include a first guidewire for insertion into a left ventricle and a guide catheter configured to translate along the first guidewire. The guide catheter may include a steering element configured to direct the coronary guidewire toward the coronary artery. The laceration device cooperates with the coronary guidewire to align the ablative cutting element with a nadir of a heart valve leaflet. A method of lacerating heart valve leaflets includes advancing the coronary guidewire into a coronary artery, translating the laceration device along the coronary guidewire to a position adjacent a heart valve leaflet, positioning the ablative cutting element in contact with a nadir of the heart valve leaflet, and lacerating the heart valve leaflet from the nadir to a free edge of the heart valve leaflet.

Abstract: A system for cutting at least one valve leaflet of a heart valve having multiple valve leaflets includes an elongate shaft, an expandable balloon coupled to the elongate shaft, an expandable framework disposed radially outward of the expandable balloon, and at least one electrode disposed on the expandable framework. The expandable balloon is configured to shift between a deflated configuration and an inflated configuration, and the expandable framework is configured to shift between a collapsed configuration and an expanded configuration. When the expandable framework is in the expanded configuration, the at least one electrode is configured to cut the at least one valve leaflet.

Abstract: A device for radially compressing a stent includes a housing and a first iris positioned adjacent the housing. The first iris includes a circumferential ring, a plurality of arms extending radially inward from the ring, and a lever extending radially outward from the ring. The first iris includes an open position recess, a closed position recess, and a guide recess formed in the ring. The device may include a second iris positioned adjacent the housing, and a spacer plate disposed between the first and second irises. The spacer plate includes first and second locking elements disposed radially inward of the outer circumference of the spacer plate. The first locking element engages with the first iris to selectively lock in open and closed positions. The second locking element engages with the second iris to selectively lock in open and closed positions. The first and second locking elements are circumferentially spaced apart.

Abstract: A medical device may be used for lacerating valve leaflets and includes an elongate shaft extending proximally from a distal region, an expandable element that is secured within the distal region and is movable between a collapsed configuration and an expanded configuration, and a conductive member including an electrocautery electrode portion extending over the expandable element. The electrocautery electrode portion has a first length when the expandable element is in the collapsed configuration and a second length greater than the first length when the expandable element is in its expanded configuration. The conductive member is adapted to return the electrocautery electrode portion to the first length when the expandable element returns to the collapsed configuration.

Abstract: A medical device for cutting valve leaflets includes an elongate shaft that extends proximally from a deflectable distal region, where the deflectable distal region includes a distal end and the deflectable distal region includes a biased configuration. A piercing is electrode disposed relative to the distal end and is adapted to pierce through a valve leaflet. A lacerating electrode is spaced from the piercing electrode and is adapted to lacerate the valve leaflet subsequent to the piercing electrode piercing the valve leaflet. The piercing electrode and the lacerating electrode are independently energized.

Abstract: A medical device for lacerating valve leaflets includes an elongate shaft extending proximally from a distal region and an expandable element rotatably secured to the distal region, the expandable element is movable between a collapsed configuration and an expanded configuration. An electrocautery electrode is supported by the expandable element, the electrocautery electrode is urged in an outward direction when the expandable element is in the expanded configuration.

Abstract: A medical device that is adapted for excising a valve leaflet portion of a valve leaflet from a heart valve includes an elongate shaft including a distal region and an inflatable balloon that is secured to the distal region and that is adapted to extend through the heart valve. The inflatable balloon has an outer surface and includes a deflated configuration and an inflated configuration. An electrocautery electrode is disposed relative to the inflatable balloon such that the electrocautery electrode is positioned to excise the valve leaflet portion when RF energy is applied to the electrocautery electrode and the inflatable balloon is in the inflated configuration. In some cases, the heart valve includes an artificial heart valve. In some cases, the valve leaflet includes an artificial valve leaflet.

Abstract: A device for radially compressing a stent includes a housing and a first iris including a first circumferential ring and a first plurality of arms extending inward from the ring, each arm defining a first outer hinge point and a first inner hinge point. Rotation of the ring in a first direction is configured to shift the inner hinge point from a first side to a second side of a first radius extending through a central longitudinal axis of the iris and the first outer hinge point. A radially outward force exerted against the arms biases the ring in a first direction in a first configuration and in a second direction in a second configuration. A method of loading a stent includes inserting a stent into the iris, and rotating the ring to shift the arms from the first to the second configuration.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an elongate shaft having a proximal end region and a distal end region. A first lumen may be defined in the shaft. A second lumen may be defined in the shaft. The distal end region may include a common lumen region in fluid communication with the first lumen and the second lumen. A deflectable member may be disposed within the shaft. The deflectable member may be designed to shift between a first configuration where the deflectable member directs a first medical device disposed within the common lumen region into the first lumen and a second configuration where the deflectable member allows a second medical device to move between the common lumen region and the second lumen.

Abstract: Improvements to devices, systems, and methods for delivering and/or deploying an implantable medical device are described. An implantable medical device may include an annuloplasty ring for implantation on a valve of a patient. Systems and methods may be configured to present graphical user interfaces with device images to implement efficient and accurate implantation of the implantable medical device. The device images may be based on sensor information obtained via sensors associated with the implantable medical device, such as a camera device, a diagnostic imaging device, position sensors, and/or the like. In other aspects, systems and methods may determine optimized configurations for the implantable medical device based on device characteristics including, without limitation, a shape formed by components of the implantable medical device and/or component coordinate information.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an elongate shaft having a proximal end region and a distal end region. A first lumen may be defined in the shaft. A second lumen may be defined in the shaft. The distal end region may include a common lumen region in fluid communication with the first lumen and the second lumen. A deflectable member may be disposed within the shaft. The deflectable member may be designed to shift between a first configuration where the deflectable member directs a first medical device disposed within the common lumen region into the first lumen and a second configuration where the deflectable member allows a second medical device to move between the common lumen region and the second lumen.

Abstract: An implantable device delivered and deployed with a visualization and/or imaging system. An imaging element is positioned on a distal end of a flexible elongate member of the visualization/imaging system. The distal end with the imaging element is positioned adjacent the implant and/or the implant site, and moved relative to the longitudinal axis of the flexible elongate member to adjust the viewing field of the imaging device.

Abstract: Devices, systems, and methods for delivering various implantable devices, such as heart valve implants, with the use of a steerable imaging element are described. An imaging element is positioned adjacent the implantable device and implant site, a relationship between the implantable device and the implant site is visualized and/or imaged, and the implantable device is anchored and/or adjusted with reference to the visualization and/or imaging thereof.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an elongate shaft having a proximal end region and a distal end region. A first lumen may be defined in the shaft. A second lumen may be defined in the shaft. The distal end region may include a common lumen region in fluid communication with the first lumen and the second lumen. A deflectable member may be disposed within the shaft. The deflectable member may be designed to shift between a first configuration where the deflectable member directs a first medical device disposed within the common lumen region into the first lumen and a second configuration where the deflectable member allows a second medical device to move between the common lumen region and the second lumen.

Abstract: In one embodiment, an implant includes a body member, a first arm member and a second arm member. The body member is formed of a first material and has a first side portion and a second side portion. The body member has a first stiffness and includes multiple apertures through the body member. The first arm member is formed of a second material and is coupled to and extends from the body member. The second arm member is formed of the second material and is coupled to and extends from the body member. The first arm member and the second arm member have a second stiffness, the second stiffness being more than the first stiffness.