Abstract: A catheter system and method of dilating first and second anatomies includes a guide catheter extending along a longitudinal axis that has a breakaway distal end portion with a conduit in communication with the lumen. The conduit is configured to guide a dilation catheter at a first predetermined angle relative to the longitudinal axis and a second predetermined angle relative to the longitudinal axis for respectively dilating the first and second anatomies. The breakaway distal end portion includes first and second guide segments at least partially defining the conduit and respectively extending the first and predetermined angles to first and second distal openings. The second guide segment is removably connected to the first guide segment for selectively guiding the dilation catheter along the second predetermined angle when connected and along the first predetermined angle when disconnected.

Abstract: An atherectomy catheter having an inner shaft which rotates a distal rotary tissue borer with a helical cutting surface which enables the catheter to out it and cross a CTO. Additionally, the atherectomy catheter has a distal cutting element rotated by an outer drive shaft configured to cut material from the wall of a vessel at a treatment site as the catheter is pushed distally through the treatment site. The atherectomy catheter includes a collection chamber positioned proximally of the cutting element and rotary tissue borer. The atherectomy catheter may include means to direct material cut from the treatment site into the collection chamber, means to break down larger portions of material that may block or clog the collection chamber and means of transporting the material collected from the treatment site to a proximal opening in the atherectomy catheter.

Abstract: The invention provides medical devices, systems and methods for tissue approximation and repair and in particular to reduce mitral regurgitation by means of improved coaptation. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the cardiovascular system, heart, other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site.

Abstract: A kit including a medical guide template, and a sterilizable receptacle accommodating the guide template, the kit being configured to allow deformation of the template into an operational medical guide.

Abstract: A system for replacing a heart valve of a patient. The system includes a delivery device and a prosthetic heart valve. The system is configured to be transitionable between a loaded state, a partially deployed state and a deployed state. In the loaded state, the prosthetic heart valve engages a coupling structure and is compressively retained within a primary capsule, which constrains the prosthetic heart valve in a compressed arrangement. In the partially deployed state, the prosthetic heart valve engages the coupling structure and is compressively retained within a secondary capsule, which constrains the prosthetic heart valve to a partially deployed arrangement. The partially deployed arrangement is less compressed than the compressed arrangement and less expanded than a deployed arrangement. In the deployed state, the primary and secondary capsules are retracted from over the prosthetic heart valve, which expands to the deployed arrangement and is released from the coupling structure.

Abstract: The present invention provides methods and systems for an eye marker device that includes a handle and an eye marker tip, wherein the eye marker tip includes at least two arms dimensioned for placing at least one mark or indicator on a cornea, sclera or sclera/cornea junction.

Abstract: Devices and implantation methods utilizing subcutaneous placement into a patient are disclosed for the insertion, advancement and positioning of a subcutaneous implantable medical device (SIMD) such as a medical electrical lead. The device for implanting the SIMD is configured having a pre-biased distal curve for creating a pathway to an implant location within a substernal space.

Abstract: A dermatome (10) comprising at least two oscillating blades (20a-d) arranged parallel to each other and configured to simultaneously cut separate skin grafts (2a-d) at different depths from a donor site (1).

Abstract: An apparatus for coupling two elongated tissue portions of a subject, such as two portions of a ruptured tendon, comprising first and second repair elements, each repair element comprising a distal end configured for insertion into the tissue portion, an elongated body configured to extend axially within the tissue portion and to engage the tissue, and a proximal end. In some embodiments, at least one of the first and second repair elements comprises, at the proximal end, an integrally formed connector for coupling the proximal end of the first repair element to a proximal end of the second repair element, to attach between the two tissue portions.

Abstract: A method for improving leaflet prolapse and/or valve regurgitation associated with a heart valve involves delivering a spacer device into a ventricle of a heart using a delivery system comprising a catheter, fixing the spacer device to a wall of the ventricle, expanding the spacer device to reposition a papillary muscle disposed in the ventricle away from the wall, the papillary muscle being connected to a leaflet of an atrioventricular heart valve via chordae tendineae, and releasing the spacer device from the catheter.

Abstract: Systems, devices, and methods for treating a diseased native valve in a patient, the system comprising a compressible and expandable frame structure and an anchor. The anchor comprises a wire having a free end and is configured to be fully advanced from an atrial side of a native valve in a patient into a ventricle of the heart and anchor the frame structure to the native valve when the frame structure is in the expanded configuration adjacent the native valve.

Abstract: A medical device includes a surgical needle attached to an elongated mesh suture. The suture is constructed of macroporous flat wall that facilitates and allows tissue integration into the suture core subsequent to introduction to the body, thereby preventing suture pull-through and improving biocompatibility.

Abstract: An orthopedic attachment system includes a first bone anchor, a second bone anchor, and a flexible connector. The flexible connector is connected between the first bone anchor and the second bone anchor. The flexible connector includes a sliding loop, a tensioning end and a fixed end. The sliding loop is connected to a sling loop bone anchor, and the fixed end is connected to the fixed end bone anchor. The tensioning end is slidably connected and lockable to the fixed end. A flexible connector, a method for attaching a flexible connector between at least two bone anchors in a patient's body, and a method of making a flexible connector are also disclosed.

Abstract: The present invention provides devices and methods for percutaneously retrieving an embolized or malpositioned heart valve or foreign bodies from a patient's body. Several of these devices may include a catheter system with expandable and retractable baskets attached to a catheter and guidewire system. The guidewire may be inserted through the lumen of the embolized or malpositioned heart valve, capturing the valve in the baskets, and deploying a mechanism to crush the valve within the baskets. Then the crushed baskets and valve may be retrieved either from the body or to a safer location such as but not limited to the descending aorta. This system is advantageous because it does not require open surgery to retrieve the valve or embolized material.

Abstract: A cardiac valve cutter of the present disclosure has a flexible housing with a central lumen for receiving a guide wire. A high-speed cutting blade is disposed within the housing near an edge of the housing. A trough cut into a side of the housing exposes a portion of the cutting blade so that the cutting blade can cut valve tissue. Two pusher wires are disposed on an opposite side of the housing from the cutting blade. Troughs cut into the side of the housing form openings from which the pusher wires can extend. The pusher wires are staggered with respect to one another in the longitudinal direction. When the pusher wires are advanced, they extend outwardly from the troughs and can be used to stabilize the cutter at the cardiac valve and push the cutting blade against the valve on the opposite side.

Abstract: In one embodiment, a multi-layer suture fastener that includes a generally disc-shaped body defining a plurality of axially spaced-apart layers. Each layer can include an inner axial surface and an outer axial surface. A suture opening can extend from the inner axial surface to the outer axial surface of each layer. The suture openings can have an open configuration and a closed configuration. One or more lines of suture can be passed through the suture openings when in the open configuration. The suture openings can be placed in the closed configuration. In the closed configuration, the one or more lines of suture can be restricted by radial surfaces of the suture opening from sliding through the suture openings in at least one longitudinal direction of the one or more lines of suture.

Abstract: In some embodiments, an apparatus includes a handle, an actuator, a pusher device, and a puncture member. A distal anchor is disposed at a distal end portion of an artificial chorda, or suture, and is in a delivery configuration. The artificial chorda, or suture, is coupled to the actuator and extends through a lumen of the puncture member. The actuator can be actuated to move the puncture member distally a preset distance, and to move the pusher device distally such that at least a portion of the distal anchor is moved distal to the distal end of the puncture member and the distal anchor is moved from its delivery configuration to a deployed configuration.

Abstract: Mechanical thrombectomy apparatuses (devices, systems, etc.) and methods for positioning them within a vessel and using them to remove a thrombus, e.g., clot, from within a vessel. In particular, described herein are methods of advancing an inverting tractor thrombectomy apparatus having a tractor comprising a flexible tube of material that inverts over itself as it rolls over a distal end opening of an elongate inversion support by extending the tractor region and/or a puller coupled to the tractor distally beyond the end of the catheter. Also described herein are power-driven mechanical thrombectomy apparatuses.

Abstract: Methods and apparatuses are disclosed for the diagnosis and removal of the devitalized and/or dead cell material formed in the lid margin to attempt to restore a normal lid margin. In this manner, the devitalized and/or dead cell material are removed or the amount present is reduced or no longer present to prevent, reduce, or affect the transport of lipid secreted by the meibomian glands to the tear film to reduce evaporative dry eye and improve dry eye conditions in patients. The diagnosis and removal of devitalized and/or dead cell material may be performed at desired intervals. Patients that suffer from conditions that block meibomian gland orifices, partial, infrequent, or inhibited blinking resulting in reduced lipid secretions from meibomian glands, and/or blockages in meibomian gland channels reducing secretion of lipids through the meibomian gland orifices may require more frequent diagnosis and treatment to remove devitalized and/or dead cell material.

Abstract: A self-articulating joint is disclosed for a minimally invasive surgical apparatus. The self-articulating joint has a first elbow component pivotably coupled to a second elbow component, wherein the first and second elbow components are biased to form a non-linear angle relative to each other. The self-articulating joint also has an elbow latch configured to releasably hold the first and second elbow components at a substantially fixed non-linear operating angle.