Abstract: A delivery/deployment system for delivering an implantable device within an implantable device housing and for deploying the implantable device from the implantable device housing. A stylet may be used to longitudinally advance or retract the implantable device with respect to the implantable device housing, such as to extend and deploy the implantable device from the implantable device housing. The delivery/deployment system has an implantable-device-extension-limiter arrangement configured to limit the distance which the implantable device may be extended from the implantable device housing. The delivery/deployment system optionally also has an implantable-device-rotation-limiter arrangement configured to limit rotation of the implantable device with respect to the implantable device housing.

Abstract: The present disclosure relates generally to the field of medical devices for delivering artificial chordae tendineae in a patient. A system for adjusting tension in an artificial chordae tendineae includes an artificial chordae tendineae coupleable between a clip and an anchor. The clip is engageable with a leaflet of a heart valve while the anchor is engageable with a papillary muscle or heart wall. The anchor includes a body portion, and a locking portion coupleable with the artificial chordae tendineae and configured to allow movement of the artificial chordae tendineae in a first direction while preventing movement of the artificial chordae tendineae in a second direction opposite the first direction. An actuator is coupled to the locking portion for selectively releasing the locking portion to enable selective movement of the artificial chordae tendineae in the second direction.

Abstract: The present disclosure relates generally to the field of medical devices for delivering artificial chordae tendineae in a patient. A system for adjusting tension in an artificial chordae tendineae includes an artificial chordae tendineae coupleable between a clip and an anchor. The clip is engageable with a leaflet of a heart valve while the anchor is engageable with a papillary muscle or heart wall. The anchor includes a body portion, and a locking portion coupleable with the artificial chordae tendineae and configured to allow movement of the artificial chordae tendineae in a first direction while preventing movement of the artificial chordae tendineae in a second direction opposite the first direction. An actuator is coupled to the locking portion for selectively releasing the locking portion to enable selective movement of the artificial chordae tendineae in the second direction.

Abstract: The present disclosure relates generally to the field of medical devices for clamping a leaflet of a heart valve. In particular, the present disclosure relates to medical devices, systems, and methods for delivering artificial chordae tendineae in a patient. In an embodiment, a system may include a clamp having a plurality of arms at a first end. The plurality of arms may have a closed configuration in which the arms are oriented toward each other, and an open configuration in which the arms are oriented away from each other. A spring portion may be coupled to the plurality of arms at a second end that is configured to bias the arms to the closed configuration. The arms of the clamp may be configured to fixedly engage with a leaflet of the heart valve. The second end of the clamp may be configured to couple to an artificial chordae tendineae.

Abstract: Implantable devices formed of materials which are not readily imageable, and which may shift from a delivery configuration to a deployment configuration upon deployment, are delivered and deployed with a deployment/delivery device having sensors generating a signal indicating contact of the delivery/deployment device with tissue to guarantee purchase of the implantable device with tissue upon deployment. The implantable device may be a tissue anchor with talons which shift from a delivery configuration to a deployed configuration. The sensors may be positioned along a distal end of the delivery/deployment device to indicate purchase of the device with tissue, to ensure purchase of the talons with tissue upon deployment. The sensors may include at least three sensors, which may be spaced apart from one another, to indicate full contact of the distal end of the delivery/deployment device with tissue. The sensors may optionally be aligned with the talons.

Abstract: An introducer assembly is adapted for deploying a medical device. The introducer assembly includes an introducer body that is adapted to accommodate a volume of blood therein. An antechamber is coupled with the introducer body. A first hemostasis valve is disposed proximal of the antechamber and fluidly couples the introducer body with the antechamber. A second hemostasis valve is disposed distal of the antechamber and is adapted to allow the medical device to pass therethrough.

Abstract: Implantable devices formed of materials which are not readily imageable are delivered and deployed with a deployment/delivery device having one or more sensors generating a signal indicating a condition of the implantable device relative to the deployment site. For instance, the signal indicates at least one or more of the following: purchase of the implantable device with tissue, level of purchase of the implantable device with tissue, the position of the implantable device relative to the deployment site, seating of tissue with respect to the implantable device, extent of contact of the implantable device with tissue, or further information about the implantable device and/or the delivery/deployment device. As such, the implantable device need not be imaged to determine the relationship of the implantable device relative to the deployment site.

Abstract: The present disclosure relates generally to the field of medical devices for clamping a leaflet of a heart valve. In particular, the present disclosure relates to medical devices, systems, and methods for delivering artificial chordae tendineae in a patient. In an embodiment, a system may include a clamp having a plurality of arms at a first end. The plurality of arms may have a closed configuration in which the arms are oriented toward each other, and an open configuration in which the arms are oriented away from each other. A spring portion may be coupled to the plurality of arms at a second end that is configured to bias the arms to the closed configuration. The arms of the clamp may be configured to fixedly engage with a leaflet of the heart valve. The second end of the clamp may be configured to couple to an artificial chordae tendineae.

Abstract: A clip and a clip deployment and delivery system. The clip may be engaged with a clip spreader such that simple relative movement, such as sliding movement, between the clip and clip spreader causes the clip and clip spreader to disengage from each other. A clip spreader actuator may be coupled to one arm of the clip spreader, extend distally around a distal end of the clip spreader, proximally along the other clip spreader arm, and to a proximal end at which the actuator may be controlled to open or close the clip spreader. The clips may be leaflet clips having teeth on one arm thereof and bumps on another arm thereof. The arms of the leaflet clip may be biased into a closed configuration by a flex zone which has an expanded portion extending laterally away from only one of the clip arms.

Abstract: A medical device for cutting a suture during a minimally invasive procedure may include an elongate shaft having a proximal end, a distal end, and a central longitudinal axis, a handle disposed at the proximal end of the elongate shaft, the handle including an actuation mechanism, and a cutting blade disposed proximate the distal end of the elongate shaft. The cutting blade is axially translatable within the elongate shaft in response to operation of the actuation mechanism. The elongate shaft includes a distal port to receive a suture. The elongate shaft includes a transverse slot extending inward from an outer surface of the elongate shaft generally perpendicular to the central longitudinal axis. The elongate shaft includes a suture lumen extending from the distal port axially within the elongate shaft to the transverse slot. The cutting blade intersects the transverse slot adjacent the suture lumen.

Abstract: An implantable medical device includes a first component including a first material, a second component including a second material, and a fiber matrix including a plurality of fibers. The fiber matrix joins the first component to the second component. The fiber matrix includes a first a first portion connected to the first component, and a second portion connected to the second component. The first portion of the fiber matrix is interpenetrated with, and mechanically fixed to, the first material. The first portion of the fiber matrix directly contacts the first material.

Abstract: A tissue anchor and an anchor delivery and deployment system. The tissue anchor is shiftable between a delivery configuration when housed in anchor garage of the anchor delivery and deployment system, and a deployment configuration when deployed outside the anchor garage. The anchor has a plurality of talons which may be formed from a laser cut tube. The talons may taper, such as widthwise.

Abstract: Imaging devices, imaging systems, and methods are presented for determining distances, depths, and sizes of a viewed tissue or object through a visualization device. The device may include an elongated shaft and an imaging component. The imaging component may extend through the elongated shaft. The imaging component may have a lens and may be configured to capture an image of an area exterior of the elongated shaft in a field of view of the lens. A transparent cover may extend over the lens. The transparent cover may be configured to cause one or more identifiers to appear in the image. The imaging device may include or be used with a computing device to analyze image data of captured images.

Abstract: A method for making an insertable or implantable medical device including a lubricous coating on a silicone substrate includes treating the silicone substrate with an atmospheric plasma at about atmospheric pressure, the atmospheric plasma formed from a noble gas; applying a solution directly to the treated silicone substrate, the solution including a thermoplastic polyurethane; and heating the silicone substrate and the applied solution to form the lubricous coating on the silicone substrate.

Abstract: Methods and materials related to ostomy devices, and particularly to valves for use with continent ostomies (e.g., ileostomies) are provided herein.

Abstract: A medical device may include a plurality of links reciprocally movable between a loose configuration having a first rigidity and a compact configuration having a second rigidity greater than the first rigidity, wherein application of a force to a distalmost link of the plurality of links when the plurality of links are in the loose configuration causes the plurality of links to change orientation relative to one another, and application of the force to the distalmost link when the plurality of links are in the compact configuration does not cause the plurality of links to change orientation relative to one another.

Abstract: Devices, systems, and method for adjusting and setting tension of an artificial chordae tendineae. The artificial chordae tendineae is coupleable between a leaflet clip and a tissue anchor. A locking assembly, through which the artificial chordae tendineae extends, is shiftable between a tension-adjusting configuration, in which the artificial chordae tendineae is movable to adjust tension on the leaflet, and a tension-setting or locked configuration, in which the artificial chordae tendineae is inhibited or prevented or locked against moving with respect to the locking assembly to set or fix tension on the leaflet.

Abstract: Tissue puncture devices, and systems and methods for accessing tissue (e.g., cardiovascular tissue) according to the present disclosure may include a tubular sheath extending along a longitudinal axis, the tubular sheath having a proximal end and a distal end, a needle disposed coaxially in the sheath, the needle having a proximal end and a distal end and being movable along the longitudinal axis of sheath, and a needle control mechanism disposed at the proximal end of the needle, the needle control mechanism being configured to lock the distal end of the needle in a first position retracted within the distal end of the sheath, and release the needle to an unlocked second position such that the distal end of the needle is extendable beyond the distal end of the sheath.

Abstract: A medical device may include a plurality of links reciprocally movable between a loose configuration having a first rigidity and a compact configuration having a second rigidity greater than the first rigidity, wherein application of a force to a distalmost link of the plurality of links when the plurality of links are in the loose configuration causes the plurality of links to change orientation relative to one another, and application of the force to the distalmost link when the plurality of links are in the compact configuration does not cause the plurality of links to change orientation relative to one another.

Abstract: Tissue puncture devices, and systems and methods for accessing tissue (e.g., cardiovascular tissue) according to the present disclosure may include a tubular sheath extending along a longitudinal axis, the tubular sheath having a proximal end and a distal end, a needle disposed coaxially in the sheath, the needle having a proximal end and a distal end and being movable along the longitudinal axis of sheath, and a needle control mechanism disposed at the proximal end of the needle, the needle control mechanism being configured to lock the distal end of the needle in a first position retracted within the distal end of the sheath, and release the needle to an unlocked second position such that the distal end of the needle is extendable beyond the distal end of the sheath.