Abstract: Nanofiber-based biomaterials containing fibroin for wound repair and tissue replacement and, more particularly, heart valve replacement.

Abstract: Disclosed herein are valves, such as an aortic valve replacement can be delivered via a transcatheter approach can be deployed by a single operator through a lower profile (e.g., 8-12 French, or even less) delivery system. Lower profile delivery systems can advantageously potentially expedite procedures and reduce complications, as they tend to be easier to navigate through the vascular anatomy. In some embodiments, the valve system can be deployed in a multiple stage approach as two separate components, rather than a single unified component; first a stent, followed by a discrete structure such as a valve support that includes the valve leaflets. The components can be positioned separately during delivery at different locations in and over the catheter. The stent can include a pair of rows of hooks directed in directions opposite to one another.

Abstract: A system for replacing a heart valve of a patient. The system includes a delivery device and a prosthetic heart valve. The system is configured to be transitionable between a loaded state, a partially deployed state and a deployed state. In the loaded state, the prosthetic heart valve engages a coupling structure and is compressively retained within a primary capsule, which constrains the prosthetic heart valve in a compressed arrangement. In the partially deployed state, the prosthetic heart valve engages the coupling structure and is compressively retained within a secondary capsule, which constrains the prosthetic heart valve to a partially deployed arrangement. The partially deployed arrangement is less compressed than the compressed arrangement and less expanded than a deployed arrangement. In the deployed state, the primary and secondary capsules are retracted from over the prosthetic heart valve, which expands to the deployed arrangement and is released from the coupling structure.

Abstract: An inflatable structure for use in biological lumens and methods of making and using the same are disclosed. The structure can have an inflatable balloon formed into a plurality of cells encircled by a shell. A strap can extend between the cells. The shell can have proximal and distal tapered necks, longitudinally-oriented flutes, and apertures at the proximal and distal ends of the shell. The shell can include a reinforcement having tapered sections over the necks and strips extending between the tapered sections. A semi-compliant or compliant balloon can be placed around the outside of the inflatable structure.

Abstract: A heart valve delivery apparatus includes a valve carrying member. A prosthetic valve is crimped onto the valve carrying member at a location that is distal or proximal to the balloon member, thereby providing a smaller profile delivery apparatus.

Abstract: A catheter (14), advanced toward an anatomical site, has a proximal end and a steerable distal end. An anchor (32, 2332) is advanced through the catheter. An anchor driver (36) drives the anchor out of the catheter's distal end (104), anchoring the anchor at the site. A first constraining member (1602, 1652) engages tissue, and inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver's distal end, on a first axis between the anchor driver's distal end and a site at which the first constraining member engages the tissue. A second constraining member (26) inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver's distal end, on a second axis. Other embodiments are also described.

Abstract: Catheter devices provide for rolling movement between the inner and outer catheter tubes with a roller assembly in a radial gap between the inner and outer catheter tubes. Devices of the invention are particularly useful in minimally invasive implantations, such as the implantation of a vascular implant. A particular application is interventional catheter-assisted aortic valve implantation.

Abstract: Systems, devices, and methods for locating a geometric plane within a patient's vasculature, for example, an entry plane to a valve, are disclosed. In one example, a medical device can include a body member and an expandable element. The body member can extend along a longitudinal axis of the medical device and at least partially define a lumen. The body member can include at least one opening disposed in fluid communication with the lumen. The expandable element can include at least two radiographic markers and can be movable between at least a first configuration and a second configuration. The at least two radiographic markers can be disposed within the lumen when the expandable element is in the first configuration. The at least two radiographic members can be disposed outside of the lumen and can be radially offset from the longitudinal axis when the expandable element is in the second configuration.

Abstract: A prosthetic heart valve may include a stent having an inflow end, an outflow end, a collapsed condition, and an expanded condition. The prosthetic valve may also include a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets. The prosthetic valve and/or stent may include features to anchor the prosthetic valve to a native valve annulus and to seal the prosthetic valve with respect to the native valve annulus, such as planar and/or nonplanar annular sealing members coupled to ends of the stent. The stent may include one or more circumferential rows of anchor members or hooks extending radially outwardly from the stent. These hooks may be configured to extend in a particular direction when the stent is in the collapsed condition to facilitate resheathing of the stent if, upon deployment, a user determines the prosthetic heart valve is not positioned optimally.

Abstract: A heart valve prosthesis has an annular body (2) and with several flap elements (4) which are movably connected to the annular body (2) via joints (10). The joints (10) engage on the flap elements (4) at their ventricular surface (18).

Abstract: Apparatus and associated methods useful in Implantable Penile Prosthesis, including an expandable polymeric sleeve that may be positioned over an inner inflatable body to limit a maximum expansion of the inner body.

Abstract: An artificial hip joint includes a stem having a neck portion which has a truncated conical outer circumferential surface decreased in diameter toward a tip thereof; a head provided with a concavity in which the neck portion is inserted, an inner surface of the concavity including a truncated conical inner circumferential surface decreased in diameter toward an insertion direction of inserting the neck portion; and a sleeve inserted between the outer circumferential surface of the neck portion and the inner circumferential surface of the head. The sleeve has an inner circumferential portion which makes contact with the outer circumferential surface of the neck portion, and an outer circumferential portion which makes contact with the inner circumferential surface of the head, a starting end of the outer circumferential portion being located at a position retracting from an opening portion of the concavity in the insertion direction.

Abstract: A glenoid implant is provided and may include a body and a fixation member. The body may include an articular surface and a scapula-engaging surface opposite from the articular surface. The fixation member may extend from the scapula-engaging surface for fixing the glenoid implant to a scapula. The fixation member may include an annular fin having a peripheral surface that defines at least one dimple.

Abstract: An apparatus can include a base plate. A glenosphere can be configured to be mountable to the base plate. The glenosphere can be adapted to operate with a complementary humeral component. The base plate can include a removable taper member on a side of the base plate facing the glenosphere. The taper member can be configured to mount the glenosphere to the base plate.

Abstract: An expandable intervertebral cage device includes a first base plate and a second base plate, a proximal block with internal threading that mechanically couples the first base plate and the second base plate, and a distal block comprising an internal passage. The device has exactly two arm assemblies, one on each side. Each arm assembly includes a first arm mechanically coupled to the first base plate and the distal block, and a second arm is mechanically coupled to the second base plate and the distal block. A screw is arranged partially within the internal threading of the proximal block and passes through the internal passage of the distal block, such that rotation of the screw relative to the proximal block causes a change in distance between the proximal block and the distal block, and a corresponding change in the spacing and lordosis of the device.

Abstract: A spinal implant. The spinal implant includes a spacer having an upper surface for contacting a superior vertebral body, a lower surface for contacting an inferior vertebral body, a first insertion end portion, and a second end portion opposite the first insertion end portion; a fixation frame coupled to the second end portion of the spacer and including a bridge portion oriented substantially coplanar with the spacer and at least one arm extending from the bridge portion; and at least one fixation element having a first insertion end for penetrating the superior or inferior vertebral bodies and a second end coupled to the at least one arm of the fixation frame.

Abstract: Improved methods and apparatuses for vertebral body distraction and fusion in accordance with various embodiments of the present invention employ flexure members. Flexure members connect a plurality of structural members to end plates on one end and blocks on another end. Upon insertion into the disc space, a drive screw or similar mechanism can be actuated to drive expansion blocks closer together, which causes flexure members to deflect, resulting in expansion of the structural members and distraction of the end plates. The distracted device can then remain in the body and be used for vertebral body fusion.

Abstract: An inserter can be used to implant a distractible intervertebral body fusion device into a disc space and expand the device. The inserter includes a shaft frame and a drive shaft assembly for expanding the device and a support shaft assembly for stabilizing the device extending distally from the shaft frame. A drive housing can be operably connected to the shaft frame and extend outwardly from shaft frame distal of a proximal end of the shaft frame. Drive housing can have an internal passage that provides access into the shaft frame to a proximal end of the drive shaft assembly. An actuation tool can be disposed with the drive housing with a distal end extending through the access into the shaft frame to interface with the proximal end of the drive shaft assembly such that activation of the actuation tool rotates the drive shaft assembly to expand the device.

Abstract: An intervertebral spacer for therapeutic treatment of a patient includes a link sized and dimensioned to fit within an intervertebral space in the patient, and is configured to maintain a separation of two adjacent vertebrae for a period of time. A rigid guiding object, which may be a tool or a successive link, is insertable into the patient, to guide the link into the patient using an MIS approach. A pivot is connected within the links configured to limit a relative range of angular orientation between the link and the guiding tool.

Abstract: An elongate inserter has a distal end releasably connected to an expandable device for expanding body tissue and a proximal end including a trigger actuator. The expandable device comprises a superior endplate and an inferior endplate that are movable in an expansion direction relative to each other between opposing tissue surfaces of a body. The inserter includes a lifting platform comprising ramp surfaces that upon operation of the trigger actuator cooperatively engage complementary surfaces of expansion structure within the device to cause the superior and inferior endplates to move relatively away from each other. A driver is supported by the inserter for pushing an insert between the superior and inferior endplates after expansion of the device.

Abstract: A dexterous robotic apparatus includes an asymmetrical hand mechanism including only two finger components: a first independent finger and a second independent finger, and a respective first finger motor and a respective second finger motor disposed in the hand mechanism, wherein the hand mechanism is characterized by only two continuous degrees of freedom.

Abstract: A medical device that is formed of a backbone portion and a plurality of ribs. The ends of one or more of the ribs are not connected together when the medical device is in the expanded position.

Abstract: The present patent application relates to a method of applying a radiopaque marker to a tubular stent. A radiopaque marker for a tubular stent is constructed of a radiopaque material and configured with a roof portion and a pair of wall portions extending approximately perpendicular to the roof portion. The radiopaque marker is applied to a tubular stent by a method including the steps of forming the tubular stent with a pair of openings through a wall of the tubular stent; inserting the wall portions of the radiopaque marker into the openings in the wall of the tubular stent; and heat treating the tubular stent to retain the wall portions of the radiopaque marker within the openings in the wall of the tubular stent. The heat treating step also embeds the roof portion of the radiopaque marker onto the wall of the tubular stent. The method of the invention is particularly adapted for applying a radiopaque marker to a bioresorbable polymeric vascular stent.

Abstract: A biodegradable device capable of producing a high radial force is described. Such a force will be created in devices made of relatively inelastic materials that are to be deployed to the vasculature or a body cavity in a patient. As the halves of the devices move together subject to a longitudinal force, at the point where they are in contact and unable to move closer together in the longitudinal direction, a radial force is created. The devices may have a tension element that assists in bringing the device halves together and which may partially and optionally remain within the body of the device.

Abstract: A fully absorbable intraluminal device, comprising a magnesium alloy structure having a polymer surface coating, the magnesium alloy structure being substantially free of rare earth metals; and an expandable polymeric mesh sleeve at least partially bondable to the polymer surface coating to form a mechanical coupling with the magnesium alloy structure.

Abstract: The invention relates to medicine, in particular, to vascular and endovascular surgery. The objective of the invention is to provide accurate positioning of a coated stent in the carotid artery. The device is made in the form of a frame with an interior coating, the frame being made in the form of two rings interconnected by rods. A stopper limiting the introduction of the frame is fixed at one of the rings. The frame and the rings can have different shapes.

Abstract: A system for implanting a prosthesis includes a control lumen and a nose cone affixed at a distal end of the control lumen. At least one supporting wire is affixed at one end, is substantially parallel to a major axis of the control lumen and is free at an opposite end, wherein the free end of at least one of the supporting wires is arcuate.

Abstract: A sealable vascular endograft system for placement in a vascular defect includes a delivery catheter shaped to be disposed within a blood vessel. The delivery catheter includes an implant delivery catheter sheath defining an implant delivery catheter lumen and an endovascular implant removably disposed within the implant delivery catheter lumen in a compressed or folded state for delivery thereof to the vascular defect. The endovascular implant includes a tubular implant body and a sealable circumferential collar including a variable sealing device and a control lead traversing from the variable sealing device to a user and controlling variability of the variable sealing device by the user. The sealing device and the control lead cooperate to reversibly expand and contract the sealable circumferential collar to circumferentially adjust during deployment thereof to achieve a repositionable fluid-tight seal between the sealable circumferential collar and the internal walls proximal to the vascular defect.

Abstract: A coronary predilatation and stent deployment catheter assembly includes a sheathless unitary catheter body having a proximal end and a distal end. A predilatation balloon is located at the distal end of the body. A stent inflation balloon is located along the body proximally of the predilatation balloon and an expandable stent is disposed over the stent inflation balloon. A predilatation balloon inflation connection is located proximally of the stent inflation balloon and in fluid communication with the predilatation balloon and a stent balloon inflation connection is located proximally of the stent inflation balloon and in fluid communication with the stent inflation balloon. A method of operating the catheter assembly is also disclosed.

Abstract: A delivery device for a collapsible prosthetic heart valve includes an operating handle and a catheter assembly. The operating handle may include a housing defining a movement space therein, a carriage assembly moveable in a longitudinal direction within the movement space, a deployment actuator coupled to the housing and rotatable relative to the housing, and a coupling assembly rotationally fixed to the deployment actuator. The catheter assembly may include a first shaft around which a compartment is defined and a distal sheath operatively connected to the carriage assembly. Movement of the carriage assembly in the longitudinal direction in the movement space may move the distal sheath between the closed condition and the open condition. The coupling assembly may have an engaged position in which rotation of the deployment actuator moves the carriage assembly, and a disengaged position in which rotation of the deployment actuator does not move the carriage assembly.

Abstract: A delivery system for a stent-graft is disclosed having a tip capture device and a tip release handle mechanism configured to actuate the tip capture device. The tip release handle mechanism includes a rotatable grip component and a tip release actuation component. The grip component may be rotatable in a first direction to transition a proximal stent of the stent-graft from the delivery state to a partially deployed state and rotatable in an opposite, second direction to transition the proximal stent from the partially deployed state to a fully deployed state. The grip component is operably coupled to the tip release actuation component. The delivery system further includes a shaft component operably coupled to the tip release actuation component and the tip capture device.

Abstract: Apparatuses for manipulating a collapsible medical device include a sheath, a first shaft including a first grasping member and a second grasping member. The second grasping member is separated from the first grasping member by a distance. The collapsible medical device may be manipulated by actuating the first grasping member and the second grasping member and by increasing the distance between the first grasping member and the second grasping member. Methods of using the apparatuses are provided.

Abstract: A transorally implanted intragastric balloon or treating obesity and for weight control including a variable size balloon with one or interconnected regions acting to exert a pressure on the stomach, to provide a stomach volume occupying effect, and/or to anchor the balloon within the stomach.

Abstract: Devices and methods for forming and securing tissue folds and elongated invaginations in stomach tissue are used as a treatment for obesity. In a first embodiment, a plurality of tissue folds is formed in the fundus region of the stomach. In methods for surgically altering stomach tissue to change gastric emptying, plications are formed in the stomach to speed up or slow down gastric emptying, depending on the number and locations of plications used.

Abstract: Described herein is a system for inducing weight loss in a patient, which comprises an extragastric space occupier positionable in contact with an exterior surface of a stomach wall to form an inward protrusion of wall into the stomach, and a retention device positionable in contact with the wall to retain the inward protrusion and to thereby capture the extragastric space occupier within the protrusion.

Abstract: A frame configured of a plurality of links pivotally connected to one another is flexibly bent, and pins that connect the plurality of links that constitute the frame are inserted into and slide in a curve-shaped slot and a slot in a vertical direction so that, even though the frame is bent, the entire length of the frame is increased and ends of the frame can be moved along a straight line that is horizontal with respect to the ground.

Abstract: A high torque active mechanism for an orthotic and/or prosthetic joint using a primary brake which can be provide by magnetorheological (MR) rotational damper incorporating and an additional friction brake mechanism driven by the braking force generated by the MR damper. This combination of MR damper and friction brake mechanism allows an increase in torque density while keeping the same level of motion control offered by the MR damper alone. The increased torque density achieved by this high torque active mechanism allows to minimize the size of the actuating system, i.e. its diameter and/or breath, while maximizing its braking torque capability. In this regard, the friction brake mechanism is advantageously positioned around the MR damper, such that the dimension of the package is minimized.

Abstract: A knee brace including a pair of longitudinal supports, a plurality of primary straps, and a plurality of secondary straps overlaying the primary straps. The plurality of primary straps each include an inner layer and an outer layer. Optionally, the primary strap may be used as a musculoskeletal support.

Abstract: An athletic brace is provided. The athletic brace has a fabric layer and a gripping layer. The fabric layer includes an inner surface and an outer surface and is shaped to secure to a portion of the user's body so that the inner surface of the fabric layer is facing the skin. The gripping layer is attached to the inner surface, and thereby is in direct contact with the skin. The gripping layer provides additional support to an injured area and promotes blood flow.

Abstract: A knee traction apparatus may include an upper frame provided to be worn on a thigh region and including an upper fraction member disposed in an end of the upper frame, and a lower frame provided to be worn on a lower leg region and including a lower traction member that is disposed in an end of the lower frame and is to rotate in mesh with the upper traction member. The upper traction member and the lower traction member may be in contact with each other in front of a knee joint.

Abstract: A garment and device generally designated as an upper torso compression and support harness with a detachable neck, chin and head covering or scarf. The scarf fabric is of similar construction to common turtle necks, but is connected to the harness via multiple connection methods, including, but not limited to buttons, VELCRO, or sewing attachment. Specifically, the present invention consisting of lightweight compression and elastic fabric bands of a certain width, configured in a comfortable and efficient pattern to enable compression assistance to the participant and a secure attachment point for a scarf of head covering. The present invention also envisions design elements to provide locations to affix team insignias, sponsor marks and logos, and additional means of customization. The harness straps cross the upper torso in an X-shaped pattern with lateral support straps running down the length of the torso.

Abstract: A spring-biased nasal molding device for presurgical molding of cleft lip deformities, the device having a V-shaped spring member joined to a pair of intra-nasal shaping members for insertion in a nostril, and having an extra-nasal shaping member to be positioned external to the nostril connected to each intra-nasal shaping member, wherein the intra-nasal and extra-nasal shaping members are brought together by the spring member to mold the nasal anatomy into the desired shape.

Abstract: A customized disposable surgical coversheet for a perinatal care device comprising a shield that is configured to be placed over a patient's lower thorax to provide a cost effective and efficient method of providing skin to skin contact between the mother and baby during and following cesarean section birth. The coversheet will provide high barrier strength and protection with comfort and softness for use with the perinatal care device.

Abstract: A medical securing unit is configured to secure the position of a patient and/or a medical accessory unit. The medical securing unit has at least one securing belt element and a belt stowing unit.

Abstract: A removable, adjustable intraoral apparatus having an upper plate and a lower plate, which, upon insertion into a user's mouth, cause advancement of the lower jaw relative to the upper jaw. One of either the lower plate or the upper plate can include length-adjustable blocks on the occlusal (biting) side thereof for causing further advancement of the lower jaw. Each length-adjustable block includes an advancement screw which is embedded in and extends from one of a pair of stationary raised block portions, and each of the plates without the embedded advancement screws also has a pair of raised block portions extending therefrom. The pairs of upper and lower blocks include contact surfaces which cooperate with each other to exert opposing forces upon the upper and lower dental arches and cause mandibular advancement. The length-adjustable portions allow for further mandibular advancement.

Abstract: A massage tool includes a main body; and an active member coupled to the main body. The active member includes an active material capable of being heated for transferring heat to the main body so as to activate or reactivate the massage tool. If necessary, more than one active material may be included in the active member. Heat can be transferred from the active material to the main body by way of conduction of the active material or convection of an active vapor released from the active material. The active vapor, for example, can be steam for providing heat and/or vaporized essential oil for aromatic treatment. The active material, for example, can be heated by an external heating source or an internal heating source.

Abstract: Thermal packs adapted for use in a muscle stimulation system, comprising an external housing with a first material therein and at least one phase change element therein.

Abstract: Methods, devices, and systems employ cryolysis of oropharyngeal adipose tissues to selectively remove fat cells from the tissues causing obstructive sleep apnea. In various embodiments, a chilled liquid—e.g., a liquid or air—is applied to the target tissue at a temperature and for a duration sufficient to cause cryolysis.

Abstract: Devices and methods for controlling the operation of endovascular heat exchange devices and/or body surface heat exchange devices such as blankets.

Abstract: Described is an apparatus for intraocular injection comprising a body adapted to accommodate a syringe having a needle, a needle cover adapted to cover the needle, and two or more resilient arms extending distally from the body. The body has a longitudinal axis. The arms are adapted to selectively engage the needle cover.