Abstract: Tissue adjustment implants useful for adjusting a position of tissue in a patient are described. In an embodiment, a tissue adjustment implant includes a main body having a series of outwardly-extending projections. The tissue adjustment implants can be used in a variety of treatments, such as in the treatment of Obstructive Sleep Apnea and snoring.

Abstract: A steerable catheter having a hub with a control feature includes a semi-rigid catheter with the hub attached at the proximal end. The distal end of the catheter includes a distal tip and a flexible portion adjacent the distal tip. The catheter includes a working channel, and further includes a channel through which a tension member or wire extends to the distal tip. Tension in the wire causes the distal tip to deflect and be steered. The hub includes a fixed member attached to the catheter, an inner member that moves axially relative to the fixed member, and an outer member that rotates relative to the inner member and the fixed member. Rotation of the outer member results in translation of the inner member, which is attached to the tension member and provides for controlled steering of the distal tip.

Abstract: Medical devices useful in interventional procedures performed under magnetic resonance imaging (MRI) are described herein. A medical device comprises a body member and a marker formed of work-hardened stainless steel attached to the body member. The stainless steel of the marker has an ultimate tensile strength of between about 100 KSI and about 225 KSI. The marker can be attached to the body member in a manner that contributes work to the stainless steel or in a manner that does not contribute work to the stainless steel. Methods of making medical devices, medical imaging methods, and methods of performing interventional medical treatment are also described herein.

Abstract: An example catheter has an elongate member defining an elongate member proximal end, an elongate member distal end, an outer surface, and a main body, the outer surface defining a side opening at a position between the elongate member proximal end and the elongate member distal end, the main body defining a first lumen and a second lumen, the second lumen extending from the elongate member proximal end to the side opening; a balloon disposed on the elongate member between the side opening and the elongate member distal end; and an engagement member disposed in the second lumen, the engagement member defining an engagement member proximal end and an engagement member distal end, the engagement member proximal end extending axially beyond the elongate member proximal end, the engagement member distal end having an engagement portion and extending radially beyond the side opening in a first direction.

Abstract: The present embodiments provide a medical device for implantation in a patient comprising a stent and a valve. The stent comprises a proximal region comprising a cylindrical shape having a first outer diameter in an expanded state, and a distal region comprising a cylindrical shape having a second outer diameter in the expanded state. The second outer diameter is greater than the first outer diameter. A proximal region of the valve is at least partially positioned within the proximal region of the stent, and the distal region of the valve is at least partially positioned within one of tapered and distal regions of the stent. When implanted, the proximal region of the stent and the proximal region of the valve are aligned with a native valve, and the distal region of the valve is distally spaced-apart from the native valve.

Abstract: The disclosure relates to medical devices and methods of assembling medical devices, such as MRI-compatible interventional wireguides. An example of a wireguide includes a series of individual segments, a plurality of connectors, and a plurality of spacers. Each segment in the series of individual segments has a first end and a second end. Each connector of the plurality of connectors joins adjacent segments in the series of individual segments to one another such that a first end of a first segment and a second end of a second segment in the series of individual segments are attached to a connector of the plurality of connectors. A spacer of the plurality of spacers is disposed between each pair of adjacent segments in the series of individual segments. Each of the segments in the series of individual segments is electrically insulated from an adjacent segment in the series of individual segments.

Abstract: The present embodiments provide strain relief members for a medical device delivery system, methods of use thereof, and methods of manufacturing. In one embodiment a strain relief member may include a support having a first end with a first outer diameter, a second end having a second outer diameter, an inner surface facing a support lumen that extends axially through the support along a longitudinal axis, and an outer surface opposite to the inner surface. An embodiment may also include an overlay coupled to a portion of the outer surface of the support, where the overlay comprises a first material and the support comprises a second material, and the first material is more flexible than the second material. A liner may be disposed in a portion of the support lumen and a first connector disposed over a portion of the support.

Abstract: Valve devices, methods of making valve devices, and methods of treating various venous-related conditions, disorders and/or diseases are described. In one embodiment, a valve device includes an expandable support frame and a bioprosthetic valve attached to the support frame. The bioprosthetic valve comprises a leaflet and a contiguous wall portion harvested from a multi-leaflet xenogeneic valve. The contiguous wall portion includes the attachment region where the leaflets attaches to the vessel wall and, in some embodiments, includes the natural margins of attachment between the leaflet and vessel wall.

Abstract: Medical devices for repairing defects in tissue, such as perforations in the tympanic membrane of an animal, methods of manufacturing medical devices, methods of implanting a medical device in a defect in a tissue; and methods of repairing a defect in a tissue are described. In one form, a medical device includes an overlay member having multiple arms and defining an overlay member passageway, an underlay member having multiple flaps and defining an underlay member passageway, and a securement member extending through the overlay member passageway and the underlay member passageway. In methods, the multiple flaps of the underlay member can be sequentially advanced into a defect in a tissue, such as a perforation in a tympanic membrane of an animal.

Abstract: Various aspects of the present disclosure provide compositions including a water-insoluble therapeutic agent and a gallate-containing compound. Other aspects provide methods of using such compositions.

Abstract: The present embodiments provide systems and methods suitable for delivering a therapeutic agent to a target site. A container holds the therapeutic agent and a pressure source has pressurized fluid in selective fluid communication with at least a portion of the container. A catheter, in fluid communication with the container, has a lumen sized for delivery of the therapeutic agent to a target site. In one embodiment, a diameter of particles of the therapeutic agent is in a range of between about 1 micron to about 925 microns, a mass of the particles of the therapeutic agent is in a range of between about 0.0001 mg to about 0.5 mg, a ratio of an inner diameter of the catheter to the diameter of particles is at least 4:1, and a regulated pressure of the pressurized fluid is between about 0.01 psi to about 100 psi.

Abstract: A device for use with a uterine tamponade balloon catheter apparatus, such as the Bakri postpartum hemorrhage balloon, is disclosed. The device comprises a stylet comprising a hub at its proximal end and an atraumatic tip at its distal end. The device is configured to be removably coupled to the tamponade balloon catheter apparatus to aid in the insertion and positioning of the tamponade balloon catheter within the uterine cavity, allowing the balloon to function as intended for the control and management of postpartum hemorrhage and uterine bleeding. The tamponade balloon catheter includes an echogenic element to aid in visualization by ultrasound during insertion and use. Methods of use of the device are also disclosed.

Abstract: A tubular graft for use in a stent graft. The tubular graft may include a first woven layer that forms a first side of the tubular graft, where the first woven layer has a set of first warp ends. A second woven layer may forma a second side of the tubular graft, where the second woven layer has a set of second warp ends, and where the second warp ends are distinct from the first warp ends. A woven pocket flap may extend from the first woven layer, where a pocket opening is defined between the woven pocket flap and the first woven layer, and where the woven pocket flap includes at least one common weft yarn with the first woven layer.

Abstract: Storage devices, loading devices, delivery systems, kits, and associated methods for implantable medical devices are described. An example embodiment of a storage device includes a storage member, a first cap, and a second cap. The storage member has a first end, a second end, and a main body that defines a first opening, a second opening, a passageway, a separating wall, and a plurality of holes. The passageway has a first portion and a second portion. The first portion extends from the first end of the storage member to the separating wall and the second portion extends from the second end of the storage member to the separating wall. Each hole of the plurality of holes extends through the separating wall and provides access between the first portion and the second portion. Each of the first and second caps is releasably attached to the storage member.

Abstract: A stent graft having an internal bidirectional branch formed from a tubular segment of graft material. The internal bidirectional branch extends within the lumen of the stent graft and proximally and distally from a lateral opening in the sidewall of the stent graft. The tubular segment from which the stent graft is made is partitioned into first and second sections along a length of the tubular segment to form the internal bidirectional branch. The lateral opening has a length and a width that may be greater than the diameter of the internal bidirectional branch and may be in the shape of a quadrilateral. The internal bidirectional branch and the stent graft are formed from a single piece of graft material.

Abstract: A multipurpose handle incorporated into a medical device delivery system. The multipurpose handle includes an elongate handle body, an actuation button, and a locking member. The elongate handle body has a proximal end extending to a distal end, which defines a longitudinal axis. The elongate body further includes a cutout that creates a movement space therein in which the actuation button is disposed and is connected to a medical device. The actuation button is movable within the cutout along the longitudinal axis and rotatable within the cutout. The locking member is connected to the elongate handle body and movable between a locked position and unlocked position. The locking member may be in contact with the actuation button and be configured to restrict the movement of the actuation button along the longitudinal axis when in the locked position.

Abstract: An endovascular system is disclosed. The system includes deployment device and a stent-graft assembly. The stent-graft assembly includes an elongate vessel wall engaging graft portion and a proximal-end self-expanding stent comprising a plurality of terminal portions. The deployment device includes an elongate guide wire catheter adapted to be deployed over a guide wire; a tip at a proximal end of the guide wire catheter. The tip has a proximal nose and a distal receiving zone. The distal receiving zone comprises a plurality of circumferentially spaced apart elongate recesses, each recess receiving at least one of the terminal portions. A trigger wire arrangement retaining the at least one terminal portions within each corresponding recess of the receiving zone is also provided. Retention of the terminal portions within the recess of the receiving zone constrains against relative twisting between the stent-graft assembly and the tip.

Abstract: Described are drainage catheter hub devices which seal the hub from leakage when connected to a catheter. The catheter hub includes a hub body having an aperture with a sealing element mounted therein and a fluid passageway that communicates with the aperture. The fluid passageway and sealing element are configured to receive a tension member. A lever arm attached to the hub body is operable to secure the position of the tension member in the sealing element in a locked position or allow movement of the tension member through the sealing element in an unlocked position. The lever arm is configured to engage and compress the sealing element to block fluid flow through the sealing element and the aperture when the lever arm is in any position. The hub body may include a centering tab to align the tension member along a longitudinal axis of the hub body.

Abstract: Systems and methods of adjusting the diameter of an endoluminal prosthesis that allows for controlled radial deployment of the endoluminal prosthesis and the ability to revise the positioning of the endoluminal prosthesis after unsheathing. The endoluminal prosthesis includes a stent graft having a tubular graft wall, a stent, a main strand, a proximal strand, and a distal strand.

Abstract: A handle assembly for a prosthesis delivery device is disclosed. The handle assembly comprises a stationary main handle having a proximal end and a distal end and an outer surface extending therebetween. A first helical groove is formed in at least a portion of the outer surface of the main handle and a first trigger wire actuation mechanism disposed about the main handle and rotatably moveable relative to the main handle. A first trigger wire is operatively connected to the first trigger wire actuation mechanism, the first trigger wire having a prosthesis capture condition and a prosthesis release condition. Movement of the first trigger wire actuation mechanism causes movement of the first trigger wire thereby moving the first trigger wire from the prosthesis capture condition to the prosthesis release condition. Additional trigger wire actuation mechanisms operatively connected to one or more additional trigger wires may also be disposed about the main handle.