Abstract: Lung conditions are diagnosed and optionally treated using a functional assessment catheter or a functional lung assessment and treatment catheter. A flow restrictive component is initially placed in a bronchus or lung passageway upstream from a diseased lung region. The isolated lung region is then functionally assessed through the catheter, while the flow restrictive component remains in place. If the patient is a good candidate for treatment by occlusive or restrictive treatment techniques, the flow resistive component may be left in place. If the patient is not suitable for such treatment, the flow resistive component may be removed.

Abstract: A delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two flat wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two flat wires are slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the at least two flat wires from the first and second frames releases at least the first frame from the delivery system.

Abstract: A deployment control apparatus to control deployment of an array at an end of a catheter includes a pair of walls, a slider assembly, and a deployment shaft. The walls project from a first surface of the interior of a handle. The slider assembly includes a rigid body, an elastomeric element, a tab, and a knob. The elastomeric element is connected to the rigid body and at least partially disposed between the walls to frictionally engage with a surface of each wall. The knob is connected to the rigid body and is configured to maintain the elastomeric element between the walls. The deployment shaft connects the rigid body to the array, wherein a force applied to the knob sufficient to overcome the frictional engagement between the elastomeric element and the surface of each wall causes movement of the slider assembly and the deployment shaft to control deployment of the array.

Abstract: Disclosed herein are proximally-flaring stents and balloon catheter systems and methods for using the same to restore patency to a side branch and its ostium at a vessel bifurcation, where the side branch can only be approached from the direction of the main artery. The system and methods include a proximally-flaring stent (10) and one or more balloon catheters (250, 400) with inflatable balloons that are able to push a flanged proximal portion (40) of the proximally-flaring stent entirely against the artery walls of the main artery of the side branch so that blood flow is not occluded.

Abstract: An implantable leadless pacing device may comprise a power source and circuitry operatively coupled to the power source. The circuitry configured to pace a patient's heart and/or sense electrical activity of the patient's heart. A housing may at least partially enclose the circuitry. The pacing device may further include a first electrode secured relative to the housing and a fixation mechanism secured relative to the housing. The fixation mechanism may comprise a plurality of tines configured to move between an elongated delivery configuration and a curved deployed configuration. Each tine of the plurality of tines may include a radiopaque material.

Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium, and apparatus for delivery the device, are provided. The delivery apparatus may include one or more latching legs, a release ring, a pull chord, and a catheter wherein the latching legs are configured to engage the device for delivery. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

Abstract: A delivery catheter and a method for deploying a cardiovascular prosthetic implant using a minimally invasive procedure are disclosed. The delivery catheter comprises an elongate, flexible catheter body having a proximal end and a distal end, wherein the distal end has an outer diameter of 18 French or less, a cardiovascular prosthetic implant at the distal end of the catheter body, wherein the cardiovascular prosthetic implant comprises an inflatable cuff and a tissue valve coupled to the inflatable cuff, and at least one link between the catheter body and the cardiovascular prosthetic implant.

Abstract: A controlled expansion stent graft delivery system has an adjustment configuration in which a retractable sheath is at a retracted position out of contact with a stent graft, but expansion of the stent graft is controlled by a control tether, which has a middle segment wrapped around a fabric tube of the stent graft. The stent graft changes diameter responsive to a tension level in the control tether. At least one of an orientation and a position of the stent graft may be adjusted during controlled expansion via the control tether.

Abstract: Devices, methods, and systems are provided for sealing a lung region. The target lung compartment is accessed and isolated via an isolation catheter. Fluid is delivered into the target lung compartment such that the target compartment is pressurized and the fluid flows through the collateral flow channel. A sealing agent is injected into the isolated lung compartment such that the agent is carried by the fluid to the collateral flow channel, thereby sealing the collateral flow channel. Variables of air flow may be measured or analyzed prior to injection of the sealing agent, or the sealing agent may be introduced into the region after a suitable time has elapsed.

Abstract: A device for delivering and deploying a radially expandable prosthesis is disclosed and comprises a proximal prosthesis release mechanism having a first resistance and a distal prosthesis release mechanism having a second resistance. The device further comprises an actuation mechanism for actuating the distal and proximal release mechanisms in a single coordinated movement and a biasing compensator for regulating the relationship between the first resistance and the second resistance. Additional aspects of the invention include devices and methods for delivering and deploying a radially expandable prosthesis.

Abstract: A catheter for delivery of intraluminal and expandable devices. The catheter is provided with a flexible curved tip distal to the device loaded onto the catheter for delivery to a desired site within a body conduit. The curved distal tip causes the catheter to rotate to a preferred rotational orientation, which may be desirable for any device having asymmetric features, particularly when used in tortuous body conduits.

Abstract: A delivery device according to principles described herein includes a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft at least partially extending over the inner core and the outer sheath. A timing belt having a plurality of belt teeth on a surface of the timing belt is coupled to an outer sheath over a medical device or stent on the inner core such that movement of the timing belt link causes movement of the outer sheath from its position over the medical device or stent. The delivery device is actuated by rotation of a thumbwheel a thumbwheel coupled to a barrel having a plurality of teeth such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath.

Abstract: Transcatheter heart valve delivery systems having a tip assembly configured to close the hole or perforation made in a patient's septal wall after transseptal delivery of a stented prosthetic heart valve to a defective heart valve (e.g., a mitral valve). The delivery device is configured to permit in vivo release of the tip assembly immediately after deployment of the stented prosthetic heart valve to implant the tip assembly into the septal wall proximate the hole through which the stented prosthetic heart valve is delivered. Methods of treating the defective heart valve, including closing the hole made during transseptal delivery of the stented prosthetic heart valve with the tip assembly of the delivery device are also disclosed.

Abstract: A system and method for restoring (e.g., replacing) a defective heart valve of a patient. A delivery system is manipulated to percutaneously deliver and implant a stented prosthetic heart valve to a native heart valve. A post-dilatation balloon is percutaneously delivered to the implantation site, and a compliant segment thereof is arranged within a region of the implanted prosthesis. The balloon is inflated such that the compliant segment expands and contacts the prosthesis, expanding a remodeling region of the prosthesis to a remodeled state. With these and related techniques, remodeling of an implanted, stented prosthetic heart valve to better match the native valve shape is possible, providing many benefits such as reducing the risk of paravalvular leaks.

Abstract: A catheter having a distal balloon and a deformable guidewire shaft of the catheter. The deformable guidewire shaft is adjacent to and external to the balloon. Inflation of the balloon bends the deformable guidewire shaft in order to orient or deflect a distal tip of the deformable guidewire shaft in a desired direction to guide and direct a guidewire extending through the deformable guidewire shaft towards a specific endovascular region. For example, it may be desired to orient the distal tip of the guidewire shaft towards a target vessel of a bifurcation or the balloon catheter may be used to bypass a Chronic Total Occlusion (CTO).

Abstract: An implant delivery system has one or more interlock assemblies which connect the implant delivery catheter to the implant, an improved inner tubular member and an outer tubular member. The interlock assemblies, improved inner tubular member and outer tubular member cooperate to place the implant in tension during deployment, thereby reducing implant deployment force.

Abstract: A crimping tool is provided, where the tool comprises a mandrel (1) having a first portion (3) with a first outer diameter, and a second portion (5) with a second outer diameter which is greater than the first outer diameter. A chamfered abutment face (7) is provided between the first and second portions (3,5). At least one first collar (9) is mountable on the first portion (3) of the mandrel (5) and has a chamfered first end (11) which in use abuts the abutment face (7). At least one second collar (13) is mountable on the second portion (5) of the mandrel (1) and has a chamfered second end (15) which in use abuts the first end (11) of the first collar (9). A method of using the tool to form one or more crimps in a piece of fabric is also disclosed.

Abstract: One aspect of the invention provides a three-dimensional scaffold including at least one layer of highly-aligned fibers. The at least one layer of highly-aligned fibers is curved in a direction substantially perpendicular to a general direction of the fibers. Another aspect of the invention provides a method for fabricating a three-dimensional scaffold. The method includes: electro spinning a plurality of fibers to produce at least one layer of highly-aligned fibers and forming the at least one layer of highly-aligned fibers into a three-dimensional scaffold without disturbing the alignment of the highly-aligned polymer fibers. A further aspect of the invention provides methods for using a three-dimensional scaffold to treat nerve or spinal cord injury.

Abstract: Example stent grafts and methods for placement thereof are provided. An example stent graft may include (a) a main body stent graft defining a lumen that has a first end and a second end, (b) a diaphragm coupled to the main body stent graft, where the diaphragm defines at least three openings and (c) at least three stent graft extensions each defining a lumen, where a first end of each of the three stent graft extensions is coupled to one of the three openings.

Abstract: A medical device includes an elongate member configured to be at least partially disposed within a body of a patient. The elongate member has an outer surface. The outer surface of the elongate member has a first ridge and a second ridge.

Abstract: Implant tools and techniques for implantation of a medical lead, catheter or other implantable component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An example implant tool for implanting a medical lead includes a rod and a sheath configured to be placed on the rod. The rod includes a handle, a shaft having a proximal end adjacent to the handle and a distal end, and an attachment feature toward the distal end of the shaft, the attachment feature configured to couple to the medical lead. The sheath is configured to be placed in multiple positions along the rod including a first position in which the sheath does not interact with the attachment feature and second position in which the sheath does interact with the attachment feature.

Abstract: To reduce the stress of a patient as much as possible during a percutaneous spine surgery for inserting an interbody cage between two vertebrae, between which the intervertebral disk was damaged and was therefore removed, a guide sleeve is provided for the spine surgery, which is characterized by a non-cylindrical jacket. A kit is further provided for spine surgery with at least one guide sleeve of the above-mentioned type and a dilator, having an outer contour that is adapted to the contour of the lumen of the guide sleeve. A kit for spine surgery is further provided including a guide sleeve and an interbody cage, which is to be inserted through this guide sleeve. The lumen of the guide sleeve is adapted to a maximum cross-sectional contour of the interbody cage.

Abstract: Medical devices and methods for using medical devices are disclosed. An example medical device may include a tubular member having a lumen defined therein and a proximal end. A shaft may extend through the lumen. The shaft may have a distal end and a proximal end. An end effector may be attached to the distal end of the shaft. A handle may be coupled to the proximal end of the tubular member. The handle may include a base, a first hub member attached to the base, a second hub member coupled to the first hub member, and a cap attached to the second hub member.

Abstract: Tactile sensing devices, systems, and methods to image a target tissue location are disclosed. When force is applied to the tactile sensing device, voltage data is detected and visualized on a screen, indicating the target tissue location.

Abstract: In some embodiments, a method includes releasably attaching an image capture assembly to a distal portion of a TEE device. Next, the TEE device coupled to the image capture assembly is inserted into an oral cavity of the patient. With the image capture assembly releasably attached to the distal portion of the TEE device, image data of an esophagus of the patient captured by the image capture assembly is displayed. While viewing the display of image data, the TEE device coupled to the image capture assembly can be moved within the esophagus. With both the TEE device and the image capture assembly disposed within the esophagus, the image capture assembly is detached from the TEE device. With the image capture assembly detached from the TEE device, and with the TEE device disposed at least in part within the esophagus, the image capture assembly is removed from the patient.

Abstract: Implanting an intraocular shunt into an eye can involve creating an opening in the cornea and positioning a shunt in the anterior chamber of the eye such that the shunt terminates between layers of Tenon's capsule, thereby facilitating fluid flow out of the anterior chamber into a space between the layers of Tenon's capsule.

Abstract: A transluminal delivery system and a method of assembling. The system includes a cylindrical, inner-catheter component and a retractable sheath surrounding the component and defining a space between the component and the sheath to receive a self-expanding luminal prosthesis between the component and the sheath. The inner-catheter component may include at least one sleeve having fibers, at least one connected sleeve portion connected to the inner catheter, and at least one unconnected sleeve portion slidably engaging the inner catheter such that when the sheath retracts, the unconnected portion expands and sleeve fibers engage the prosthesis's luminal surface, wherein the engagement opposes proximal stent movement.

Abstract: A delivery and release device for stent-graft includes a guiding head and a central tube connected thereto, an outer tube sleeving on the outside of the central tube, a positioning tube sheathed between the central tube and the outer tube, a front fixator, a back fixator and a positioner successively sheathed between the positioning tube and the outer tube. The stent-graft is placed between the back fixator and the positioner. A metal bar is connected to the guiding head along its axial direction with a ring suture being connected to the front fixator. The ring suture sleeves onto the metal bar after passing through the stent-graft. During the release process, the metal bar moves forward in the axial direction to detach from the ring suture, thereby the stent-graft is released.

Abstract: Polymeric stents having fracture toughness and resistance to recoil after deployment are disclosed along with methods of manufacturing such stents. Improvements to mechanical characteristics and other improvements may be achieved by having polymer chains within individual stent struts oriented in a direction that is closer to or in line with the axis of the individual stent struts. The struts are connected to each other by hinge elements that are configured to bend during crimping and deployment of the stent. Ring struts form ring structures. A ring structure can have an overall curvilinear length from about 12 mm to about 15 mm.

Abstract: The present invention provides devices and methods for attachment of an endolumenal gastrointestinal device, such as an artificial stoma device, a gastrointestinal bypass sleeve or other therapeutic or diagnostic device, within a patient's digestive tract. In one application of the invention, an endolumenal bypass sleeve is removably attached in the vicinity of the gastroesophageal junction to treat obesity and/or its comorbidities, such as diabetes. The bypass sleeve may be at least partially deployed by eversion.

Abstract: A method for treating a patient includes creating at least one incision to gain access to an peritoneal cavity, performing a gastric volume reduction procedure and introducing a device to prevent gastric contents from interacting with at least a portion of the duodenum.

Abstract: A delivery catheter having one or more securement devices can be used to control deployment of an implant from the delivery catheter. The securement device can be outwardly biased to automatically release the implant, or the securement device can be user actuated. The securement device allows the implant to be recaptured and repositioned during deployment if desired. The delivery catheter can be telescoping which allows the length and diameter of the implant to be controlled during deployment. A pullback system can be used to control deployment of the implant from the delivery catheter.

Abstract: Embodiments include systems, methods and devices for the percutaneous delivery of therapeutic agents to tendons, ligaments and muscle. Certain embodiments include a device comprising a needle-catheter based delivery system with adjustable characteristics to allow a clinician to control the angle and depth of needle and/or catheter deployment to a desired location. System embodiments may include a controller unit where a clinician can adjust the axial position depth and location of needles and/or catheters.

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.

Abstract: The present invention relates to apparatus for methods for endovascularly replacing a patient's heart valve. The apparatus includes an expandable anchor with leaflet engagement elements on the proximal end of the anchor and a replacement valve. The leaflet engagement elements can be used to prevent distal migration and insure proper positioning of the apparatus.

Abstract: A catheter that comprises a sheath that is connected at opposing ends to concentric tubes that move relative to each other in a manner that alternatively covers and exposes a medical device loaded onto the catheter. A portion of the sheath is arranged so as to invert upon itself so that axial movement of one tube relative to the other simultaneously moves the inversion point over or away from the device, alternatively covering or exposing the device.

Abstract: Inflation systems and methods for inflating a balloon member are provided. The inflation system includes an inflation tool. The inflation tool includes a first component having a first arm where the first arm extends longitudinally along an axis of movement of the first component. The first arm includes a first and a second positioning member, the first positioning member is longitudinally spaced apart from the second positioning member. The first component is adapted to advance distally for inflation of the balloon member. Each positioning member corresponds to an inflation increment for the balloon member.

Abstract: A low profile stepped delivery system for retracting trigger wires from a prosthesis to release the prosthesis from a delivery device. A rod is disposed within an axial bore of a handle. The rod has a first longitudinal surface and a second longitudinal surface. A first engagement mechanism is disposed on the first longitudinal surface and a second engagement mechanism disposed on the second longitudinal surface. A wire coiling assembly is disposed at an end of the of the handle and comprises a first rotary gear that is adapted to be rotated by the first engagement mechanism, a second rotary gear that is adapted to be rotated by the second engagement mechanism, a first wire spool that is coupled to a rotation of the first rotary gear, and a second wire spool that is coupled to the rotation of second rotary gear. The first wire spool is configured to secure a first trigger wire and the second wire spool is configured to secure a second trigger wire.

Abstract: A catheter devices/systems and methods therefrom are described herein for treating acute kidney injury, especially the contrast-induced acute kidney injury wherein the devices prevent the contrast dyes from entering into kidney and/or facilitate blood flow of kidney by said catheter system.

Abstract: The present invention relates to a deployment handle for a prosthesis delivery device and to a delivery device including such a handle. The handle assembly facilitates the controlled release of a prosthesis from the delivery device, while ensuring that various deployment steps are performed in a particular sequential order. The handle assembly comprises a main handle and a second handle which is rotatably and/or longitudinally moveable relative to the main handle. The second handle has an initial position on the main handle such that it prevents access to, and premature manipulation of, a proximal stent release mechanism, until the stent graft has been at least partially unsheathed.

Abstract: A prosthetic valve assembly includes an annular frame having an inner radial surface, an outer radial surface, and defining an inner lumen. The prosthetic valve assembly further includes a leaflet assembly including at least one leaflet having an inner radial surface and an outer radial surface. The at least one leaflet is disposed at least partially within the inner lumen of the annular frame. The prosthetic valve assembly includes a crimping accessory device having a handle and at least one shielding member removably disposed between the outer radial surface of the at least one leaflet and the inner radial surface of the annular frame. The at least one shielding member is configured to reduce physical contact between the at least one leaflet and the inner radial surface of the annular frame.

Abstract: An implantable leadless cardiac pacing device and associated delivery and retrieval devices. The implantable device includes a docking member extending from the proximal end of the housing of the implantable device configured to engage with the delivery and/or retrieval device to facilitate delivery and/or retrieval of the implantable leadless cardiac pacing device.

Abstract: Stent delivery systems and associated methods for delivering stents are disclosed herein. In several embodiments, a handle assembly for delivering a stent from a tubular enclosure can include a first lead screw having a first lead thread of a first pitch and first handedness, a second lead screw having a second lead thread of a second pitch and second handedness different from the first handedness, and a housing defining threads of the first and second pitches. The first lead screw can be in mechanical communication with the tubular enclosure, and the second lead screw can be in mechanical communication with the stent. Upon rotation of a portion of the housing, the housing threads can engage the lead screws so as to induce simultaneous translations of the lead screws in opposite directions. The simultaneous translations are configured to deploy the stent from the tubular enclosure.

Abstract: A handle for an implant deployment device converts rotational movement into longitudinal movement in order to provide controlled release of one or more trigger wires. The handle also allows the trigger wire to be withdrawn into the device so that it does not need to be separately removed. A preferred handle includes a rotatable portion (120) and a slideable portion (122). Releasable locks (88, 188) ensure that the handle is used to carry out implant deployment steps in a specific order.

Abstract: An apparatus includes a positioning system and a patient reference sensor (PRS). The positioning system acquires a plurality of raw PRS readings over time, which can indicate the position and orientation of the PRS. A filter is configured to process the raw PRS readings and output filtered PRS readings. The filter outputs filtered PRS readings as a baseline value while the raw PRS readings stay within a predetermined range and output filtered PRS readings as unchanged raw PRS readings when the raw PRS readings reach or vary outside of the predetermined range. A motion compensation function generated based on at least the filtered PRS readings can be used to correct a subject position and orientation (P&O) to compensate for the motion of the moving region of interest over time.

Abstract: Delivery systems for liquid embolics and methods of using them are disclosed. The devices generally include a catheter and one or more retention elements to limit migration of the liquid embolic to non-target sites.

Abstract: An apparatus, system and methods that comprise adding a removable or detachable carrier containing a camera and illumination to a TEE probe, thereby allowing the user to view the placement of the probe and minimize or reduce the risk of esophageal and pharyngeal complications during the positioning of the TEE probe into the patient's esophagus. The reduction or minimization of complications occurs by allowing the cardiologist direct visualization of pharyngeal and esophageal structures during intubation. This device and procedure eliminate any “blind procedure”, whereby direct visualization of the pharyngeal structures and esophagus present a possible solution to these mechanical complications. Once the TEE probe has been properly positioned in the esophagus, the carrier is removed from the esophagus. The removable or detachable camera of the present disclosure can be used in other industries.

Abstract: Stent-valves (e.g., single-stent-valves and double-stent-valves), associated methods and systems for their delivery via minimally-invasive surgery, and guide-wire compatible closure devices for sealing access orifices are provided.

Abstract: An implant assembly for introducing and positioning implants within patients may comprise an implant device, an implant, and a sheath. The implant device may include a head, an upper beam, a lower beam, and an implant positioning component. The implant may be disposed between the upper beam and the lower beam and may include a first face engaged with the upper beam and a second face engaged with the lower beam. Additionally, the implant may be at least partially disposed around the implant positioning component. The sheath may be disposed around the implant positioning device and the implant.

Abstract: A prosthesis delivery device includes an inner cannula, a positioner disposed coaxially over a first portion of the inner cannula, a concentric cannula disposed coaxially over a second portion of the inner cannula, and a tip assembly disposed over a third portion of the inner cannula. A distal end of the concentric cannula is attached to a proximal end of the positioner. The tip assembly comprises a distal tip segment and a proximal tip segment, with the distal tip segment attached to a proximal end of the concentric cannula and the proximal tip segment attached to a proximal end of the inner cannula. A prosthesis is carried on the concentric cannula and a sheath is mounted coaxially over the prosthesis. The sheath comprises a split defining a proximal sheath segment and a distal sheath segment. A proximal end of the proximal sheath segment is attached to the proximal tip segment.