Abstract: A vascular occlusion treatment system includes an ultrasound imaging system having an imaging control circuit communicatively coupled to an ultrasound imaging probe and to a display screen, and an ultrasonic vibration system having an ultrasonic generator operatively coupled to a medical ultrasonic object, such as an ultrasonic catheter. The ultrasonic catheter has a corewire with a distal tip. The ultrasonic generator has a generator control circuit that alternatingly switches between an ultrasonic work frequency and a tracking frequency. The generator control circuit sends a notification to the imaging control circuit when the generator control circuit has switched from the ultrasonic work frequency to the tracking frequency. The imaging control circuit responds by initiating a search in an ultrasound imaging space to locate the distal tip that is vibrating at the tracking frequency, and indicating a location of the distal tip in the ultrasound image displayed on the display screen.

Abstract: Provided herein are dual-lumen catheters, systems, and methods thereof. In some embodiments, for example, a catheter assembly configured for modifying intravascular lesions is provided including a core wire, a dual-lumen extrusion including the core wire, and a manifold disposed around a portion of the dual-lumen extrusion. The core wire includes a proximal end configured to vibrationally couple to an ultrasound transducer. The dual-lumen extrusion includes a first lumen and a second lumen. The core wire is disposed within the first lumen, and the second lumen is configured to accommodate a guidewire. The manifold is disposed around at least a skived proximal-end portion of the dual-lumen extrusion, wherein the skived portion includes the second lumen without the first lumen. In some embodiments, the catheter assembly further includes the ultrasound transducer. In some embodiments, a system console includes the ultrasound transducer.

Abstract: Methods for preparing a drug-loaded microbead compositions and embolization compositions include loading a therapeutic agent into a water-swellable polymer material to form microbeads, then removing water from the microbeads. The drug-loaded microbead compositions include microbeads of a water-swellable polymer material and a complex of a carrier and a therapeutic agent chemically bonded to the carrier. The complex is embedded in the polymer material. The therapeutic agent is not chemically bonded to the water-swellable polymer material. The drug-loaded microbead composition has a water content of less than 1% by weight, based on the total weight of the drug-loaded microbead composition. The drug-loaded microbead composition may be rehydrated to form an embolization composition for use in in embolization therapy.

Abstract: An endovascular apparatus includes a first cannula, a second cannula, and an operator handle. The first cannula has a proximal end, a distal end, and a first lumen. The second cannula is slidably coupled to the first cannula. The second cannula has a proximal end portion, a distal end portion, and a second lumen. The distal end portion is extendable in a distal direction beyond the distal end of the first cannula. The operator handle is operably coupled to the second cannula. The operator handle may be configured to articulate the distal end portion of the second cannula relative to the first cannula. The second cannula may include an articulation joint. Optionally, the operator handle may be configured to extend, retract, and rotate the second cannula relative to the first cannula. Also, optionally, the endovascular apparatus may include a magnetic coupler.

Abstract: Provided herein in some embodiments is an apparatus including a composite balloon with a tubular fiber layer and a polymeric balloon layer over the fiber layer. Also provided herein in some embodiments is a method including inserting a collapsed fiber tube into an expanded polymeric balloon, expanding the collapsed fiber tube to provide an expanded fiber tube, and securing an outer surface of the expanded fiber tube to an inner surface of the expanded polymeric balloon. The method can further include inserting a distal portion of an elongate catheter body through a center of the composite balloon and securing the composite balloon to the distal portion. Thereby, the method can include forming the catheter body with the composite balloon configured to apply a pressure to surrounding walls of an anatomical vessel in an inflated state of the composite balloon to modify one or more intravascular lesions in the anatomical vessel.

Abstract: A surgical instrument and its method of use are disclosed. In one embodiment, the surgical instrument may include a handle and an elongated shaft assembly extending distally from the handle. The elongated shaft assembly may include an articulable portion with an articulation direction. The elongated shaft assembly may also include a tubular member with a flexible portion with a preferential bending direction and a direction of bending resistance. The tubular member may permit articulation of the elongated shaft assembly when the preferential bending direction is aligned with the articulation direction.

Abstract: A securement device configured to secure an external portion of a medical device to the skin surface of a patient after an internal portion of the device has been placed in the patient is disclosed. The securement device includes a retainer that is employed to securely retain the external portion of the medical device in place. The retainer is attached to a base, such as an adhesive pad that adhesively attaches to the skin surface. In one embodiment, therefore, a retainer comprises a body defining a channel configured to receive therein a portion of the medical device, and at least one foot extending from the body that is configured to stabilize the retainer with respect to a skin surface. The retainer body further includes a nose that is configured to deflect a portion of the external portion of the medical device toward the skin insertion site.

Abstract: A method for performing an endovascular procedure using ultrasonic energy includes providing a first sheath having a proximal end portion and a distal end portion, and having a first window in the distal end portion; positioning a wave guide in the first sheath for delivering the ultrasonic energy through the first window for performing the endovascular procedure; and selectively covering the first window with a cover.

Abstract: An access port including a housing, a first septum, a second septum, and a radiographic indicator. The first septum and the second septum can respectively cover a first reservoir and a second reservoir of the access port. The first septum can include a first sub-pattern of protrusions and the second septum can include a second sub-pattern of protrusions. The radiographic indicator can include a first portion including information pertaining to the first sub-pattern, and a second portion including information pertaining to the second sub-pattern.

Abstract: A repair prosthetic for repairing a hernia is disclosed. In some embodiments, the repair prosthetic includes a patch body, a frame that assists in spreading the patch body from a reduced configuration to an expanded configuration, and a plurality of tethers attached to the patch body at locations between the frame and a periphery of the patch body. In various embodiments, the tethers can be tensioned to mitigate curling or creasing in the patch body to flatten the patch to facilitate attachment to tissue.

Abstract: A method for using an endoluminal device to modify an intravascular lesion includes providing an ultrasound-producing mechanism that converts an electric current into vibrational energy at an ultrasonic frequency; providing a sheath including a sheath lumen, wherein the sheath is configured to retract from a first, fully extended position of the sheath and extend from a second, fully retracted position of the sheath; providing a core wire disposed within the sheath lumen of the sheath, the core wire being coupled to the ultrasound-producing mechanism via a sonic connector, the core wire being excited by the vibrational energy at the ultrasonic frequency when the ultrasound-producing mechanism is activated; and retracting the sheath relative to the core wire to expose a working length of a distal portion of the core wire for ultrasound-based modification of one or more intravascular lesions.

Abstract: A catheter securement device holds a medical article such as a catheter in position upon the body of a patient and at least inhibits longitudinal movement of the medical article. The securement device includes a retainer and a clamp. The retainer and clamp can include interengaging structure that can include a ratchet mechanism that allows a single securement system to be used with medical articles that have different longitudinal lengths as well as medical articles that have distally located contact surfaces.

Abstract: An access port for subcutaneous implantation is typically connected to a catheter, a distal portion of which is disposed within a vein or other vessel of the patient. The access port described herein is configured with enhanced fluid handling features to improve fluid flow therethrough while reducing the likelihood of clotting or occlusions in the attached catheter, thus improving system patency. The access port includes a body defining a reservoir, a needle-penetrable septum covering the top opening of the reservoir, a stem including a lumen in fluid communication with the reservoir, and a volume control device positioned in the reservoir. The volume control device includes a floor designed to move from a first position below the side opening to a second position adjacent the bottom surface, and a spring element positioned between the floor and the bottom surface, the spring element biasing the floor in the first position.

Abstract: A pre-curved catheter tube of a catheter assembly or other elongate medical device and methods for forming such a device using a heating procedure is disclosed. Pre-curving of the catheter tube is desirable to impart to the catheter assembly a desired positional configuration when the catheter assembly is inserted into a patient. The heating procedure may include heat sterilization procedures commonly used to sterilize medical devices prior to use. One method for curving a catheter tube of a catheter assembly includes constraining the catheter tube into a curved configuration using the tube constraint, heating the catheter tube in the curved configuration for a predetermined time at a predetermined temperature, and releasing the catheter tube from the tube constraint after the heating is complete.

Abstract: A surgical fastener is provided for various surgical fastening applications, including attaching an implantable prosthesis, such as a soft tissue repair fabric, to tissue and/or muscle. The surgical fastener may include a coil body and a separate head that is attached to the coil body. The head may include an internal thread that is threadably attached to the coil body. The head may also be further secured to the coil body with a compression fit therebetween. A locking feature may prevent back-out of the coil body from the head. The surgical fastener may be assembled by threading the coil body through the head.

Abstract: A deployment device for positioning a soft tissue repair prosthesis includes a self-expanding support body releasably attachable to the prosthesis. The support body may be removably insertable into a pocket of the prosthesis. A handle coupled to the support body facilitates positioning the patch and/or removal of the support body from the pocket. The support body may substantially occupy the pocket in an expanded configuration. The handle may be arranged to direct a pulling force to the outer peripheral edge of the support body and/or cause a portion thereof to be pulled downward and below the body during withdrawal of the deployment device from the prosthesis. The support body may include support segments pivotally coupled together and foldable to collapse the support body for insertion into and removal from the pocket. One or more resilient support members may be provided for collapsing and expanding the support body and the prosthesis.

Abstract: An embolic filter is disclosed and can include a head. A plurality of bent legs can extend from the head. Each bent leg can be configured to engage an inner wall of a vein and prevent the embolic filter from migrating in a cranial direction. A plurality of straight legs can also extend from the head. Each straight leg can be configured to prevent the embolic filter from migrating in a caudal direction.

Abstract: An implantable prosthesis for mending anatomical defects, including a groin hernia. The prosthesis includes a prosthetic repair patch that may be implanted in different tissue planes to mend a defect. The patch may include a medial portion configured to be positioned in a first tissue plane and a lateral portion configured to be positioned in a second tissue plane offset from the first tissue plane. The patch may include a transition region configured to extend through tissue and/or muscle, such as fascia, separating the tissue planes and transition the patch from one tissue plane to the other tissue plane. The transition region may be configured to inhibit buckling and/or bunching of the patch when implanted through the fascia. The lateral portion of the patch may have a level of stiffness that facilitates implantation of the patch in different tissue planes while inhibiting patient sensation to the implanted patch.

Abstract: An implantable prosthesis for mending anatomical defects, including a groin hernia. The prosthesis includes a prosthetic repair patch that may be implanted in different tissue planes to mend a defect. The patch may include a medial portion configured to be positioned in a first tissue plane and a lateral portion configured to be positioned in a second tissue plane offset from the first tissue plane. The patch may include a transition region configured to extend through tissue and/or muscle, such as fascia, separating the tissue planes and transition the patch from one tissue plane to the other tissue plane. The transition region may be configured to inhibit buckling and/or bunching of the patch when implanted through the fascia. The lateral portion of the patch may have a level of stiffness that facilitates implantation of the patch in different tissue planes while inhibiting patient sensation to the implanted patch.

Abstract: Urinary catheter-insertion kits can include a working tray, a storage tray, a urinary catheter, and a drainage system including drainage tubing and a drainage receptacle. The working tray can be configured to nest with the storage tray by suspending the working tray from the storage tray. At least the working tray includes a number of preformed sections configured to hold a number of components of the urinary catheter-insertion kit. At least one section of the preformed sections of the working tray includes a catheter section configured to hold the urinary catheter. The storage tray can be configured to hold the drainage system. Methods of urinary catheterization include use of the urinary catheter-insertion kits.