Abstract: A tether-securing device is provided that includes a tubular element, which is shaped so as define a lateral wall that surrounds a lumen. The lateral wall is shaped so as to define a one-way locking opening. The tether-securing device further includes at least one tether, which (a) has at least a first tether end portion, and (b) passes through the lumen and the one-way locking opening. The tether-securing device additionally includes first and second tissue anchors. The first tissue anchor is connected to the first tether end portion. The one-way locking opening is configured to (a) allow sliding of the at least one tether in a first direction through the one-way locking opening, and (b) inhibit sliding of the at least one tether in a second direction opposite the first direction. Other embodiments are also described.

Abstract: According to one representative embodiment, a method of treating aortic insufficiency comprises delivering a support structure to a position around the leaflets of a native heart valve. The support structure comprises an annular body defining an interior and at least one projection extending radially inwardly from the annular body. An expandable prosthetic heart valve can be advanced into the native heart valve and into the interior of the annular body. The prosthetic heart valve can be expanded into contact with the leaflets of the native valve, thereby causing the leaflets of the native valve to be frictionally secured between an inner surface of the annular body and an outer surface of the prosthetic heart valve and causing the at least one projection and a portion of one of the leaflets contacted by the at least one projection to extend into an opening of the frame of the prosthetic valve.

Abstract: A balloon catheter is provided that may be used to dilate hardened regions of a stenosis. The balloon catheter is provided with one or more dilation elements that extend along a surface of a balloon. Each dilation element is connected to an outer surface of the balloon by a connector. The connector is sufficiently sized and designed to undergo stress-induced plastic deformation incurred during blow molding so that a significant portion of each of the dilation elements does not become absorbed into the wall of the final blow molded balloon, thereby maintaining the structural integrity of each of the dilation elements.

Abstract: A retrieval device includes an elongate element having a collapsible retriever at its distal end, wherein the collapsible retriever can be axially delivered over or through an introducer to the site of an object to be retrieved, e.g., a failed endoluminal device. When the retrieval device reaches the failed endoluminal device, the endoluminal device and the retrieval device are withdrawn together through the introducer. The introducer is configured to force the retrieval device down over the endoluminal device reducing the French size of the spent endoluminal device upon extraction. The collapsible retriever can be configured to side-mount a delivery element, or it can be integrated into a delivery system.

Abstract: A method and device for reducing the damaging effects of a blast or concussive event includes applying pressure to at least one jugular vein to reduce the egress of blood from the cranial cavity during the incidence of the concussive event. Reducing blood out flow from the cranial cavity increases intracranial pressure of the cerebrospinal fluid to reduce the risk of traumatic brain injury and injuries to the spinal column. Reducing blood out flow further increases the intracranial pressure, and thereby increases the pressure of the cochlear fluid, the vitreous humor and the cerebrospinal fluid to thereby reduce the risk of injury to the inner ear, internal structure of the eye and of the spinal column. In addition, increasing intracranial pressure reduces the likelihood of brain injury and any associated loss of olfactory function.

Abstract: A device is described which has an instrument portion secured to a sleeve/cuff portion, where the sleeve/cuff portion is configured to receive a portion of user's finger therein and to radially compress onto the user's finger to hold the instrument portion thereon. The present invention is particularly well suited for use in minimally invasive surgical procedures. The present invention also teaches a method of forming a knot in suture material as well as other techniques for treating patients.

Abstract: The invention relates to a balloon catheter comprising a catheter tube, an inflatable balloon, the ends of which are attached to the catheter tube, and a stent attached around the balloon. The stent extends at least partly along the length of the balloon. In an uninflated state, at least the outside surface of the balloon not covered by the stent is provided with a relief structure which is substantially disappeared in an inflated state of the balloon. The invention also relates to a method for manufacturing such a balloon catheter.

Abstract: The invention relates to an instrument for stimulating or irritating and/or abrasively treating and/or polishing a membrane or surface or inner surface in the human or animal eye, comprising a handle (1), which comprises an actuating element (2), and a probe (3), which adjoins the handle (1) and which is open at the free distal end, for introducing into the eye. The invention is characterized in that the probe (3) comprises a loop (4) in the interior, and the loop can be at least slightly pushed out of the probe (3) and pushed or pulled back into the probe (3) by means of the actuating element (2).

Abstract: An introducer sheath includes an inner liner having a passageway extending longitudinally therethrough, a coil positioned over the inner liner, and an outer jacket positioned over the liner and the coil. The outer jacket is bonded to the inner liner between the coil turns. The coil turns have a cross-section comprising opposing end portions, and a center portion disposed between the opposing end portions. The center portion has a thickness not exceeding about one-third of a thickness of the end portions for reducing a bending modulus of the coil, and the end portions have a generally curved outer surface. At least a distal end portion of the outer jacket has a durometer between about 70 and 90 on the Shore D scale.

Abstract: A stent delivery system includes a wire collection device which is constructed with a thumbwheel coupled to a collection spindle that is rotatable to collect a retraction wire about the collection spindle. A proximal end of an outer stent-constraining sheath is coupled to the collection spindle by the retraction wire and a distal end of the outer sheath retractably surrounds a distally-disposed self-expanding stent. The wire collection device includes a first set of gears at a higher gear ratio and a second set of gears at a lower gear ratio. Stent deployment speed may be controlled or varied by switching or alternating between engaging the first of gears and the second set of gears, thereby accommodating changing resistance as the outer sheath is retracted and releases binding force of the stent.

Abstract: A cutting device is provided that includes an outer tube. The outer tube includes an inner surface defining a passageway. An inner tube is movably disposed in the passageway such that a distal end of the inner tube extends beyond a distal end of the outer tube. The distal end of the inner tube includes a first cutting element. An inner surface of the inner tube defines a lumen. A shaft is slidably disposed in the lumen. The shaft has a distal end including a second cutting element. A deployment mechanism is coupled to a proximal end of the outer tube. The deployment mechanism includes a body, a push button disposed within the body and a collar disposed about the body. The shaft is fixed relative to the collar and the inner tube is fixed relative to the push button. Systems and methods are disclosed.

Abstract: A surgical clip applier is provided and includes a ratchet mechanism having a rack member connected to a drive channel such that axial translation of the drive channel results in axial translation of the rack member, the rack member defining a first set of teeth along a first side thereof and a second set of teeth along a second side thereof. The ratchet mechanism including a first pawl and a second pawl each tiltably supported in the housing and disposed on respective opposed sides of the rack member; and a buckling spring interposed between the first pawl and the second pawl and constrained in a slot formed in the rack member, wherein the buckling spring is dimensioned so as to bow in one of a proximal direction and a distal direction.

Abstract: A paddle lead insertion tool includes an insertion tool body having a delivery end portion, a delivery end portion, and a slider slit; a slider partially disposed within the slider slit; extenders coupled to the slider and extending to the delivery end portion to receive a paddle body between or upon the extenders; and a center push piece coupled to the slider and disposed between the extenders to push against a proximal end of the paddle body. The slider moves between an insertion position and a delivery position. The insertion tool extends the extenders and center push piece when the slider moves from the insertion position to the delivery position to extend a paddle body received by the insertion tool. The insertion tool retracts the extenders without retracting the center push piece when the slider moves from the delivery position towards the insertion position.

Abstract: Disclosed are methods and devices for obtaining patent hemostasis of the radial artery by compressing the uninstrumented ulnar artery to increase radial artery flow. The device comprises a band having an inflatable bladder for applying blunt pressure to the ulnar artery. The method comprises applying a pressure to the homolateral ulnar artery and applying a pressure to the radial artery at the access site to obtain hemostasis at the access site. The method further comprises administering an anticoagulant to a patient at a dose ranging from about 20 units per kg of body weight to about 30 units per kg of body weight.

Abstract: A replacement heart valve and method of treating valve insufficiency includes an expandable frame configured to engage a native valve annulus. A valve body is coupled to the frame. The valve body can include a leaflet portion and possibly a skirt portion. A portion of the frame has a foreshortening portion configured to longitudinally expand when urged to a radially compacted state and longitudinally contract when urged to a radially expanded state. In one embodiment the valve skirt is attached to the frame so that it can adapt to changes in the length of the frame. A delivery device in some embodiments can use one or more coverings, such as sheaths, to controllably release the replacement heart valve at a native heart valve.

Abstract: A suture passing device includes a grasping mechanism and cannula having a sharp edge on a distal end. The grasper mechanism includes a hollow shaft slidably disposed within the cannula, with a first jaw fixedly secured thereto, and a second jaw pivotally coupled thereto, to pivot between a closed position wherein the second jaw engages the first jaw, and an open position. The slidable shaft permits the jaws to occupy a retracted position within the cannula, and an extended position. A plunger is slidably disposed within the hollow shaft, and pivotally coupled to the second jaw. A first handle is secured to the shaft, while a second handle is secured to the plunger, for jaw engagement/disengagement. The device also include means for locking sliding travel of the shaft relative to the cannula, after a full cycle of the slidable travel of the jaws between the extended and retracted positions has occurred.

Abstract: A device may be used for capturing and retrieving vascular debris. The device may include: at least two segments radially expandable from a collapsed state to an expanded state, each of the at least two segments having (a) a waist including a radially largest region of the segment and (b) two longitudinal ends; at least one intermediate portion, each of the at least one intermediate portion including a pivot that connects adjacent segments, each pivot having a diameter less than a diameter of the waist; wherein each of the at least two segments includes at least two struts that extend longitudinally from a proximal end to a distal end of the segment, the at least two struts tapering from the waist radially inward toward a longitudinal axis of the device as the at least two struts approach an adjacent intermediate portion.

Abstract: An instrument for delivering a suture transfascially may include a handle, a shaft extending from the handle, and at least one needle that is moveable to an extended position beyond the end of the shaft. A suture may be delivered transfascially with the instrument. The instrument may include a suture catch associated with each needle for retaining and releasing a suture segment. A shield may be provided to shield the sharp end of each needle when it is moved to the extended position. A method of delivering a transfascial suture may include inserting an instrument into an abdominal cavity and deploying, from within the abdominal cavity, each needle through a soft tissue repair patch and then through at least part of the abdominal wall. A suture or suture segment may be advanced across the fascia with the at least one needle.

Abstract: The present invention relates generally to the field of micro-scale or millimeter scale devices and to the use of multi-layer multi-material electrochemical fabrication methods for producing such devices with particular embodiments relate to shredding devices and more particularly to shredding devices for use in medical applications. In some embodiments, tissue removal devices are used in procedures to removal spinal tissue and in other embodiments, similar devices are used to remove thrombus from blood vessel.

Abstract: An atherectomy device with an exchangeable drive shaft is disclosed, having a drive shaft gear at a distal end of the exchangeable drive shaft for meshing engagement with a prime mover gear on the output shaft of the prime mover. The exchangeable drive shaft is inserted into an opening at the distal end of the handle housing and moved axially in a proximal direction. Surface features on at least the prime mover housing and the engageable drive shaft help to align the drive shaft gear with the prime mover gear for meshing engagement.