Abstract: Apparatus and methods are described herein for various embodiments of a prosthetic heart valve, delivery apparatus and delivery methods for delivering a prosthetic heart valve to a heart of a patient via a transapical or transvascular delivery approach. In some embodiments, a prosthetic heart valve includes an outer frame coupled to an inner frame and the outer frame is movable between a first configuration relative to the inner frame and a second inverted configuration relative to the inner frame. The valve can be delivered to a heart using an apparatus that includes a delivery sheath that defines a lumen that can receive the prosthetic heart valve therein when the outer frame is in the inverted configuration. Actuation wires are releasably coupled to the outer frame and can be used to help revert the outer frame after the valve is deployed outside of the delivery sheath and within the heart.

Abstract: A holding device for a suture ring is provided. The holding device may include a retainer in which a suture ring can be releasably fixed, in particular clamped, and a handle which is connected to the retainer and which has an actuating mechanism for fixing and/or releasing a connection between the retainer and the suture ring. By means of the holding device, a suture ring can be fixed in the retainer such that a tubular part and/or object can be pushed into the suture ring without exerting forces on the tissue to which the suture ring is connected.

Abstract: A needle assembly for a liquid applicator comprises housing with longitudinal channel. The channel comprises upper and lower open ends. A needle bundle is movably mounted in the channel, which comprises needle shaft and needles attached thereto. A biasing member is configured and mounted for (i) biasing the needle bundle longitudinally towards a retracted position and (ii) biasing the needles laterally towards a needle-guiding side wall of the housing adjacent the lower open end. The biasing member is configured and mounted to form a fluid seal between the lower and upper open ends. The biasing member comprises an elastic tubular section with opposite sides. The first side has a first rectified length. The second side has a second rectified length longer than the first rectified length so that the second side is less tensioned than the first side to bias the needles towards the needle-guiding side wall.

Abstract: A medical probe includes a shaft, an expandable membrane and a probe maneuvering assembly (PMA). The shaft is configured for insertion into a cavity of an organ of a patient. The PMA is located inside the expandable membrane and includes a first elastic element, which is fitted along a longitudinal axis of the PMA and is configured to expand the membrane by shortening the PMA, and to collapse the membrane by elongating the PMA. The PMA further includes a second elastic element, which surrounds at least a portion of the first elastic element and is configured to deflect the membrane relative to the longitudinal axis.

Abstract: A method of performing an endoscopic submucosal resection includes using two magnet-attached hemostatic clips that are selectively coupled to one another via their respective magnets.

Abstract: A method for replacing a first sheath, whose distal end is positioned inside a vessel and whose proximal end is positioned outside the skin of a patient, with a second sheath may involve inserting a dilator over a guidewire and into the first sheath until a distal end of the dilator and a distal end of the guidewire are positioned inside the vessel. The dilator may be hubless or include a removable hub. The method may further involve removing the first sheath, thereby leaving only the dilator and the guidewire in place. After removing the first sheath, a second sheath may be passed over the dilator and the guidewire until the distal end of the second sheath is positioned inside the vessel. The method may further involve removing the dilator and the guidewire, leaving only the second sheath in place.

Abstract: Devices and methods can be used to treat long gap esophageal atresia, while obviating much of the delay and complexities associated with current procedures. The devices and methods involve actively stretching the esophagus portions with traction to promote growth of the esophagus portions. Moreover, the devices and methods provided allow for a compression anastomosis to occur between the esophageal ends. This eliminates the need for a second operation to suture the esophageal ends together.

Abstract: The present invention provides devices and methods for removal clots and other obstructive tissue and materials from humans located inside or outside of the patient's endovascular system using aspiration alone, and in combination with rotational maceration and aspiration.

Abstract: Embodiments of a leaflet clip device and method of reducing regurgitation through a native heart valve are disclosed. A leaflet clip device can include an elongated clipping member having a first end portion and a second end portion and a tensioning mechanism coupled to the clipping member. The leaflet clip device can further include one or more tensioning members disposed within a lumen of the clipping member, wherein the one or more tensioning members are operatively connected to the tensioning mechanism to transform the clipping member from a delivery configuration to an implantation configuration.

Abstract: A system and method of variable velocity control of a surgical instrument in a computer-assisted medical device includes a surgical instrument having an end effector located at a distal end of the instrument, an actuator, and one or more drive mechanisms for coupling force or torque from the actuator to the end effector. To perform an operation with the instrument, the computer-assisted medical device is configured to set a velocity set point of the actuator to an initial velocity and monitor force or torque applied by the actuator. When the applied force or torque is above a first force or torque limit it is determined whether a continue condition for the operation is satisfied. When the continue condition is satisfied the operation is paused and when the continue condition is not satisfied it is determined whether forced firing of the actuator should take place.

Abstract: A dilation instrument includes a body, a dilation catheter, a guide member, and a force sensor. The dilation catheter has an expandable dilator. The guide member extends distally from the body and is configured to guide movement of the expandable dilator. The force sensor is operatively connected to the guide member and is configured to sense a force imparted against the guide member for monitoring engagement with an anatomy of a patient.

Abstract: A treatment method and medical device are disclosed for cutting a substance inside a body lumen. The medical device for cutting substances inside a body lumen, the medical device including a rotatable tubular drive shaft; a treatment member connected to a distal side of the drive shaft; an elongated tube extending through the drive shaft; and a bearing member connecting a distal side of the treatment member and the elongated tube.

Abstract: An implant delivery device (100) includes a casing (110); and inner and outer tube driving members (150, 160), an inner tube (120), an intermediate tube (130), an outer tube (140) and an air-evacuation locking assembly (170), each at least partially accommodated in the casing (110). The three tubes are sequentially nested in one another, and first, second and third spaces are formed between neighbouring tubes. The inner tube driving member (150) has a proximal end that is sealingly fixed to a proximal end of the inner tube (120), and the outer tube driving member (160) is sealingly fixed to a proximal end of the outer tube (140). The intermediate tube (130) has a proximal end that is sealingly fixed to the inner tube driving member (150), and the intermediate tube extends through and is sealingly connected to the outer tube driving member (160). The air-evacuation locking assembly (170) is detachably coupled to the inner tube driving member (150).

Abstract: A tissue resecting instrument includes an end effector assembly having a proximal hub housing, a retainer cap extending proximally therefrom, an elongated outer shaft extending distally from the proximal hub housing, an inner cutting shaft rotatably disposed within the elongated outer shaft, and an inner core drive assembly that includes a proximal driver and a distal driver. The distal driver is coupled to the inner cutting shaft such that rotation of the distal driver rotates the inner cutting shaft relative to the elongated outer shaft. The proximal driver is slidable relative to the distal drive between a more-proximal position wherein the proximal driver is engaged with the retainer cap to rotationally fix the proximal driver, thereby rotationally locking the inner cutting shaft, and a more-distal position wherein the proximal driver is disengaged from the retainer cap permitting rotation thereof thereby permitting rotation of the inner cutting shaft.

Abstract: Delivery devices for delivering a stented prosthesis to a target site are disclosed. Certain disclosed delivery devices include a handle assembly including an actuator, a shaft assembly interconnected to the handle assembly, and are configured to releasably retain the stented prosthesis to the delivery device with at least one elongate tension member. The delivery devices further include a torque shaft that is configured to apply and adjust the amount of tension in the each tension member. For example, the torque shaft can be configured to wind and unwind each elongate tension member around the torque shaft to correspondingly compress and expand the stented prosthesis. The torque shaft can be controlled with an actuator provided in the handle assembly, for example. In some embodiments, the actuator is further configured to axially move the torque shaft.

Abstract: A surgical instrument has at least one tool unit including at least one first tool element, at least one second tool element, and at least one coupling element that is connected to the second tool element, the at least one coupling element and the second tool element being supported in such a way that they are together displaceable relative to the first tool element along at least one displacement axis, and has an actuation, which includes at least one actuation element that is coupled with the coupling element in at least one first position of the coupling element relative to the second tool element, wherein for the purpose of releasing the actuation element, the coupling element is transferred from the first position into at least one second position relative to the second tool element.

Abstract: A reposable surgical clip applier (10) is provided and includes a handle assembly (100), an endoscopic assembly (200) selectively connectable to a housing of the handle assembly (100), and a clip cartridge assembly (300) selectively loadable in and connectable to the endoscopic assembly (200).

Abstract: One aspect of the invention provides a vaginal stent system including: an inflatable vaginal stent and a removable handle. The inflatable vaginal stent include includes: an elastomeric exterior wall and a first fitting located at a base of the inflatable vaginal stent. The removable handle is adapted and configured for insertion, inflation, and removal of the inflatable vaginal stent from a subject's vagina. The removable handle includes a second fitting complementary to the first fitting and adapted and configure to form substantially fluid tight coupling when the handle is coupled to the inflatable vaginal stent. Another aspect of the invention provides a method of fabricating a customized vaginal stent or dilator. The method includes: generating a 3D model of a vaginal stent or dilator; and controlling a 3D printer to fabricate a vaginal stent or dilator according to the 3D model.

Abstract: Various embodiments of a frame for attaching an adjunct to an end effector of a surgical device are provided. In one embodiment, the end effector can include upper and lower jaws, and the frame can include features for releasably engaging one or the jaws. The frame can also include retaining features for coupling an adjunct to a tissue-facing surface of the frame, thereby releasably coupling the adjunct material to the jaw of the end effector. In some implementations, the frame can include a plurality of retaining features that are configured to engage the adjunct material to create a tension in the adjunct material, which can further assist with securing the frame to the jaw. In other embodiments, a removable applicator member is provided for retaining at least one adjunct material and for aligning and coupling the adjunct material to a frame.

Abstract: A vascular flow diverter includes a tubular mesh framework which includes a mesh cover and an opening. The tubular mesh framework is collapsible and configured to expand from a collapsed shape to a tubular shape when the vascular flow diverter is deployed. The mesh cover conforms to the shape of the tubular mesh, is surrounded by the tubular mesh framework, and is less porous than the tubular mesh framework. The opening is located within the mesh cover. A delivery wire passes through the opening in order to guide the flow diverter into place over an aneurysm.