Abstract: Among other things, there are disclosed embodiments of belts or bands that can be used in treatments for tricuspid valve regurgitation. In some embodiments, such belts may be heat-set in a particular configuration to effectively decrease tricuspid annulus when deployed around the atrioventricular groove. Embodiments include one or more tensioning sutures for applying cinching or tightening to belts when deployed, and structure for effectively distributing force during such tightening. Embodiments of tensioning members, protective members, and devices and methods for open-surgical placement (e.g. around a heart for annuloplasty) are also disclosed.

Abstract: Intravascular devices and systems useful for blocking the opening of an aneurysm or a vessel branch are disclosed. In some aspects, the disclosure provides arrangements that align a covering material of a stent graft with an opening in the vessel wall before, during, and/or after expansion of the stent graft within the vasculature of a patient. In some instances, systems and devices include a sheath with a side aperture arranged to align a portion of the sheath and/or a portion of a stent graft contained within the sheath with the mouth of an aneurysm. Similarly, the present disclosure also provides embodiments in which the stent graft comprises an aligning member arranged to align the stent graft and/or a sheath with the mouth of an aneurysm. Other embodiments are disclosed.

Abstract: Among other things, there are disclosed embodiments of devices used for minimally-invasive treatments, such as treatment of mitral valves. In a system for placing an annuloplasty belt around the heart, embodiments for tensioning a suture associated with the belt are provided, as are embodiments of a suture lock for holding the suture with the applied tension. A delivery device that permits placement and tensioning of such a belt and activation of the suture lock in one procedure is also disclosed. Methods for making and using these features are also disclosed.

Abstract: A filling and sealing system is provided for efficiently filling a series of individual vials with therapeutic liquids. In particular embodiments, the system includes a filling zone or station, a sealing zone or station, an unloading zone or station, and electronic controls.

Abstract: There are disclosed embodiments of devices and methods for imaging the inside of a body part, particularly a blood vessel. In particular embodiments, a catheter has a tip chamber, within which is an ultrasound transducer mounted on a pivot mechanism, a motor for turning the transducer, and an implement for pivoting the transducer. Examples of such an implement are a linear motor, a shaft or filament, and the pivot mechanism may be biased to return to a base position when the implement is not pivoting the transducer. In other embodiments, a mirror reflecting ultrasound signals from the transducer may be rotated and/or pivoted, using similar mechanisms.

Abstract: Devices and methods for obtaining a real-time, three-dimensional image of a body part, particularly a blood vessel. A catheter has a chamber in its tip. The chamber contains an ultrasound transducer and reflector which generally face each other and rotate about a common axis. The transducer element on the transducer and the reflective face on the reflector are both tilted off-axis. The difference in angular velocity generally creates a phase shift between the transducer and the reflective face. The phase shift allows the transducer and the reflective face to actively scan a three-dimensional volume that is generally bounded interiorly by a hyperboloid and exteriorly by the effective range of the ultrasound beam. The transducer and reflector may rotate at constant speeds or nonconstant speeds as well in the same direction or in opposite directions.

Abstract: There are shown and described embodiments of a closure device for closing holes in tissue, for example in the right atrial appendage. The closure device in particular embodiments includes first and second mesh closure members and a tether or stem connecting them. Embodiments of a delivery device for the closure device are also described.

Abstract: Among other things, there is disclosed structure and methods for registering images obtained through internal (e.g. intravascular) ultrasound devices. Embodiments of a device with a rotating ultrasound beam is provided, with a wall of the device being anisotropic in ultrasound passage. As examples, a cable opaque to ultrasound is attached along the wall of the device, so that the ultrasound beam at the location of the cable is blocked, reflected or scattered. As another example, a thin film of metallic material is placed on or in the wall to allow a portion of the beam to be blocked or attenuated. The imaging system recognizes the changes to the signals made by the anisotropic wall, and registers successive images according to those changes.

Abstract: There are disclosed embodiments of devices and methods for imaging the inside of a body part, particularly a blood vessel. In particular embodiments, a catheter has a tip chamber, within which is an ultrasound transducer mounted on a pivot mechanism, a motor for turning the transducer, and an implement for pivoting the transducer. Examples of such an implement are a linear motor, a shaft or filament, and the pivot mechanism may be biased to return to a base position when the implement is not pivoting the transducer. In other embodiments, a mirror reflecting ultrasound signals from the transducer may be rotated and/or pivoted, using similar mechanisms.

Abstract: There are shown and described embodiments of a closure device for closing holes in tissue, for example in the right atrial appendage. The closure device in particular embodiments includes first and second mesh closure members and a tether or stem connecting them. Embodiments of a delivery device for the closure device are also described.

Abstract: Described in one aspect is a multi-pressure monitoring system for cell or other therapy includes a first catheter having a first lumen for accepting a treatment device, a second lumen for inflating a balloon, a pressure sensor for monitoring fluid pressure within the first lumen, and a flow restrictor such as a hemostasis valve for limiting the exchange of fluids into and out of the first lumen while treatment devices are present or exchanged in the first lumen. Also disclosed is a method of using the first catheter with a first pressure monitor coupled to the first pressure sensor along with a second catheter attached to a second pressure sensor coupled to a second pressure monitor. The second catheter is positioned within the first lumen of the first catheter during treatment operations and the first and second pressure monitors are used to verify proper pressures throughout the procedure.

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: Described are guidewires having at least one echolucent segment, and associated apparatuses and methods. The guidewires can be combined with devices equipped with intravascular ultrasound probes and used to effectively image regions during procedures underway in the vascular environment. The echolucent segment can have one or more echogenic markers to enable detection of the segment and/or relative movement of the segment using intravascular ultrasound.

Abstract: Described are methods and systems and system components useful for percutaneously delivering or retrieving vascular implant devices, such as filters, utilizing intravenous ultrasound (IVUS) imaging alone or in combination with external (e.g. transabdominal) ultrasound or other imaging technology. Implants deliverable by such systems, such as vena cava or other vascular filters, can have two or more echogenic markers spaced at such a distance that they are separately discernible by IVUS and/or external ultrasound imaging.

Abstract: Among other things, there are shown embodiments of locking mechanisms for holding sutures in tension. Such devices may be used with implants that use or require sutures, and are easily locked remotely. In particular embodiments, a lock includes a housing member, a pin member at least partially within the housing member, and a spring biasing the pin member into the housing member. The pin member includes a gripping portion, and has a retracted condition and a locked condition. When retracted, a suture can move through the housing member and around the gripping portion of the pin member. When locked, the gripping portion of the pin member engages the suture and presses it against the interior of the housing member.

Abstract: Among other things, there is disclosed structure and methods for maintaining access to a location in the body while reducing or eliminating the potential for pulling an access device (e.g. a catheter) back through an opening. An introducer sheath includes a distal indented portion and a balloon, so that once placed in a desired location through tissue, the balloon can be inflated to anchor the sheath against retraction. In particular embodiments, structure and methods for accessing the pericardial cavity via the right atrial appendage are shown.

Abstract: Systems and methods for treating a blood clot positioned within a blood vessel are disclosed. In one embodiment, a balloon member is positioned on a distal end region of a catheter and an ultrasound emitting element is positioned within the balloon member and arranged for actively emitting ultrasound. In some exemplary embodiments, the disclosure provides a multi-wall balloon member and a multi-lumen catheter with at least one and/or all cavities of the balloon member arranged for heat transfer with the ultrasound emitting element. The disclosure also provides catheter arrangements with an ultrasound emitting element arranged to heat tissue adjacent to the balloon member. Additionally, in some embodiments, at least one and/or all walls of the balloon member have apertures arranged to release a therapeutic agent such as a thrombolytic drug.

Abstract: Methods and apparatus are provided for treating tissue with apparatus that includes an priming portion for initiating a healing response in the tissue to be treated, and which delivers a bioactive agent during or after preparing tissue adjacent the apparatus, as by generating or aiding a healing, regeneration or repair response in the tissue. The priming portion may comprise an abrasive surface, fluid ejection ports, and/or stimulation by electrical, thermal, or light energy.

Abstract: Disclosed are embodiments of devices and methods for imaging the inside of a body part, such as a blood vessel. In particular embodiments, a catheter has a chamber within which is a transducer. A wire guide channel extends throughout the length of the catheter. The transducer is rotatable around the wire guide channel.

Abstract: A system for monitoring the flow of blood within an endoluminal passage is provided comprising a medical device and a sensor. The medical device is implantable within the endoluminal passage and includes a shaft and an expandable segment coupled to the shaft. The expandable segment is movable between a first state and a second state. Movement of the expandable segment is responsive to a change in the fluid pressure external to the expandable segment. The sensor is positioned on the medical device and is adapted to collect information associated with the state of the expandable segment.