Abstract: An apparatus includes an intraocular pseudophakic contact lens having an optical lens and haptics extending radially from the optical lens. The haptics are configured to be inserted under an anterior leaflet of a capsular wall in an eye in order to capture and confine the haptics under the anterior leaflet and secure the intraocular pseudophakic contact lens against an artificial intraocular lens in the eye. Anterior surfaces of the haptics are configured to contact an inner capsular wall surface at the anterior leaflet. Posterior surfaces of the haptics include ridges configured to capture at least one edge of the artificial intraocular lens in order to secure the intraocular pseudophakic contact lens to the artificial intraocular lens.

Abstract: A posterior chamber phakic intraocular lens comprising a central optical part, a peripheral haptic part comprising a plurality of support elements arranged to lie on a ciliary zonule of an eye, and at least one flexible haptic comprising a reticulated distal region arranged to lay into a ciliary sulcus of the eye.

Abstract: There is provided an intraocular lens including an optic portion having a circular shape from one side thereof and including a first pattern which includes a ridge and a groove, and a plurality of haptic portions extending from an outer circumferential edge of the optic portion and each including a second pattern which includes a ridge and a groove, in which at least one of the ridges included in the first pattern and the second pattern and at least one of the grooves included in the first pattern and the second pattern includes a section in which a width is formed differently.

Abstract: The present disclosure concerns a curvature-changing, accommodative intraocular lens (IOL) for implantation in the capsular bag of a patient's eye. The IOL includes a fluid optic body having a cavity for containing an optical fluid, the cavity at least partially defined by a sidewall extending around the cavity and defining a diameter of the cavity and a deformable optical membrane intersecting the sidewall around a circumference of the sidewall and spanning the diameter of the cavity. The IOL further includes a second optic body spaced a distance apart from the fluid optic body and a plurality of struts extending from the sidewall and coupling the fluid optic body to the second optic body. The struts are configured such that axial compression of the capsular bag causes the struts to deform the sidewall in a manner that increases the diameter of the cavity, modifying a curvature of the deformable optical membrane.

Abstract: To solve the problem of making available a speech valve for persons who have undergone a laryngectomy or tracheotomy, which speech valve in particular has a long useful life, a speech valve is proposed having a housing with a proximal opening and at least one filter at least partially received in the housing, and with a piston-like valve element, wherein the filter at least partially surrounds the valve element, wherein the valve element is movable on a valve seat, arranged on the proximal opening, in order to produce a closure position and can be returned with a spring action to an open position of the speech valve, and wherein the valve element has a lower end which faces towards the proximal opening and which is assigned to the valve seat in the open position and, with the valve seat, forms a gap through which an air stream can be guided.

Abstract: Bioprosthetic heart valves and methods for fabricating bioprosthetic heart valves are provided. Biological tissue is attached to biocompatible material. The biocompatible material is folded to form a tubular structure with the attached biological tissue located on the inner surface of the tubular structure, the biological tissue forming leaflets of the heart valve. A stent is secured around the outer surface of the tubular structure. A region of the biocompatible material is cut. The biocompatible material is folded at the cut region away from the tissue and around the downstream edge of the stent and is secured to the stent's outer surface. The biocompatible material is folded at the upstream end of the tubular structure around the upstream edge of the stent and attached to the stent's outer surface so that the stent's inner and outer surfaces are covered with no more than a single layer of the biocompatible material.

Abstract: Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a mechanically coupled leaflet. The described leaflet frames have projections that are configured to couple with a leaflet attachment region of a leaflet. Some embodiments include a leaflet retention feature that engages the leaflet frame projections and operates to secure the leaflet to the leaflet frame. Methods of making and using such prosthetic valve devices are also described.

Abstract: A catheter is transluminally advanced to a heart of a subject. Via the catheter, a prosthetic valve is advanced to the native valve. The prosthetic valve includes an upstream skirt, and a downstream skirt that has a first portion and a second portion. The first portion defines a lumen therethrough. The second portion circumscribes the first portion, and defines a plurality of anchoring arms that are coupled to the second portion. A plurality of prosthetic leaflets, within the lumen, are attached to the first portion. The upstream skirt is expanded in the atrium, and the anchoring arms are expanded in the ventricle, the anchoring arms extending radially outward and toward the upstream skirt. Subsequently, native valve tissue is squeezed between the upstream skirt and the anchoring arms by causing the anchoring arms to move with respect to the prosthetic leaflets, and toward the upstream skirt.

Abstract: Some embodiments described herein include a heart valve replacement system that may be delivered to the targeted heart valve site via a delivery catheter. In some embodiments, the heart valve replacement system can assemble a valve device after the valve device is delivered to the heart. In some embodiments, heart valve replacement system includes two anterior flaps that are separate but overlap each other.

Abstract: Embodiments hereof relate to centering devices for use with a valve delivery system and methods of delivering a valve prosthesis within a vasculature. A valve centering catheter is configured for use with a valve delivery system. The valve centering catheter includes a circumferential centering device at a distal portion thereof, and the circumferential centering device defines a central opening there-through when in an expanded configuration. The circumferential centering device is annular or has a C-shaped cross-section. The valve delivery system is tracked through the vasculature until the valve prosthesis is positioned through the central opening of the expanded circumferential centering device. The valve centering catheter may alternatively include a longitudinal centering device which acts as a marker for depth control during delivery of a valve delivery system, which may include an integral circumferential centering device.

Abstract: An intravascular device delivery system includes an elongated member with a distal end cap and a delivery disc that are longitudinally movable using a disc handle. A main body of the disc handle is configured to move the distal end cap and a movable body of the disc handle is configured to move the delivery disc. The movable body is movable relative to the main body, and the main body and movable body are movable together.

Abstract: An assembly for collapsing a prosthetic heart valve includes a compression member having a plurality of arms pivotable between a first orientation in which side edges of adjacent arms are spaced apart from one another and a second orientation in which the adjacent arms contact one another. A translating member is movable along the arms to pivot the arms from the first orientation to the second orientation to collapse the prosthetic heart valve. A separation tool includes ribs defining channels sized to receive the struts of a stent of a prosthetic heart valve to keep the struts separated from one another as the prosthetic heart valve is collapsed.

Abstract: The invention relates to delivery system for deployment of a prosthetic valve, having a hypotube sheathed guidewire assembly having an outer sheath and an inner guidewire shaft that pushes against a guidewire collar on a tension arm of a compressed transcatheter valve to deliver the valve and position the valve to the RVOT or other location in the body.

Abstract: An assembly for replacing a native heart valve can have a prosthetic heart valve with an annular metal frame made from shape-memory material and a valve member disposed in an interior of the metal frame. The assembly can have a delivery apparatus with a handle, a shaft with a proximal end portion and a distal end portion. The proximal end portion can be coupled to the handle and the distal end portion can be releasably coupled to the prosthetic heart valve. The delivery apparatus can also have a delivery sheath and a hydraulic power source operatively connected to the delivery sheath. The prosthetic heart valve can be positioned within the delivery sheath in a radially compressed state. The hydraulic power source can be configured to move the delivery sheath longitudinally relative to the valve to allow the valve to self-expand from the radially compressed state to a radially expanded state.

Abstract: A tissue shaping device adapted to be disposed in a vessel near a patient's heart to reshape the patient's heart. The device comprises a first anchor and a second anchor adapted to be deployed by a catheter to engage a vessel wall while the first anchor is adapted to resist the compression of a first part of the first anchor and resist the expansion of a second part of the first anchor in response to a compressive force on the first part.

Abstract: Methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. A delivery device for staged deployment of an implantable device to a target area. The delivery device includes a deployment handle and one or more lock lines extending from the deployment handle through the catheter to the implantable device, the one or more lock lines being configured to engage with the implantable device to allow locking of the implantable device.

Abstract: Steady flow hydrodynamic performance testing is performed on a valved prosthesis mounted in a test conduit. The system is configured with prescribed test condition inputs into control software. Upon test initiation, a steady flow pump is activated and automatically adjusts its flow based on the software logic to meet the prescribed first test condition. During forward flow pressure drop testing, the flow pump is automatically adjusted to achieve and hold a particular flow rate. During back flow leakage testing, the steady flow pump is automatically adjusted to achieve and hold a particular differential pressure across the test prosthesis while a flow rate of the leakage flow is measured. After a first test condition has been achieved, the system control software then automatically adjusts the pump flow rate to meet a second test condition. This process then continues until all conditions set by software inputs are evaluated.

Abstract: Devices and methods for providing localized pressure to a region of a patient's heart to improve heart functioning, including: (a) a jacket made of a flexible biocompatible material, the jacket having an open top end that is received around the heart and a bottom portion that is received around the apex of the heart; and (b) at least one inflatable bladder disposed on an interior surface of the jacket, the inflatable bladder having an inelastic outer surface positioned adjacent to the jacket and an elastic inner surface such that inflation of the bladder causes the bladder to deform substantially inwardly to exert localized pressure against a region of the heart.

Abstract: A scaffold is provided which facilitates integration of both bone and cartilage at an osteochondral lesion, thereby acting as a tissue engineered interface or tissue engineered junction between the two different tissues. The method and systems for engineering this interface may be acellular or may be loaded with cells prior to use.

Abstract: A coated powder composite may include a core particle of Ca or an alloy thereof, or of Mg or an alloy thereof. One or more coating layers may be disposed about the core particle, cladding the core particle. The coated powder composite may be biodegradable.

Abstract: A femoral hip joint spacer. The spacer has a prosthesis body with a ball head, a neck, a stem and an anchoring sleeve which encloses the stem on a proximal side of the stem with a circumferential fastening area, irrigation liquid inlet and outlet openings in the body surface, at least one irrigation liquid discharge opening on a distal side of the stem and at least one irrigation liquid intake opening on the ball head or on the neck. The discharge opening is connected in a liquid-permeable manner to the inlet opening but not to the outlet opening and the intake opening is connected inside the prosthesis body in a liquid-permeable manner to the outlet opening but not to the inlet opening. A cavity open on two sides is formed inside the anchoring sleeve and connects a proximal side to a distal side of the sleeve in a liquid-permeable manner.

Abstract: A radial head assembly is provided that includes a stem, a collar, a locking ring, and an articular member. The stem has a convex articular head on one end thereof. The locking ring has a ring wall, which has a ring opening. The ring wall has an angular outer surface and a slot configured to permit the ring wall to radially expand. The angular outer surface engages an angular portion of an interior surface of the collar. The articular member and the locking ring define an articular space within the collar. The articular space is configured to receive the convex articular head.

Abstract: Disclosed is an expandable interbody device that includes a support structure having a top side and a bottom side, a top plate positioned on the top side of the support structure, a bottom plate positioned on the bottom side of the support structure, a gear rotatably connected to the support structure, wherein the gear is rotatable relative to the support structure, a first rack that is operationally coupled to the top plate, wherein the first rack is operationally connected to the gear such that rotating the gear in an opening direction moves the top plate away from the support structure by moving the first rack relative to the gear, and a second rack that is operationally coupled to the bottom plate, wherein the second rack is operationally connected to the gear such that rotating the gear in an opening direction moves the bottom plate away from the support structure by moving the second rack relative to the gear.

Abstract: Embodiments herein are generally directed to spinal implants, systems, apparatuses, and components thereof that can be used in spinal fusion and/or stabilization procedures, as well as methods of installation. The spinal implants may include an intervertebral spacer and a plate member.

Abstract: Intervertebral spacer implants with dynamic load spreading features responsive to external loads and having attachment mechanisms. The dynamic load spreading features having a native state and a loaded state, which complements vertebral end plate geometry and disperses load to the epiphyseal rim.

Abstract: Systems and methods for placement of both the prosthetic acetabular cup and the prosthetic femoral head which takes account of the patient's particular anatomy, with inter-operative testing of the patient's body to find an optimum positioning (angles) for the components. The system allows a procedure with less pre-operative and inter-operative imaging, providing for reduced radiation exposure for doctors and patients.

Abstract: A spine implant for a TLIF surgical procedure is configured to be guided into place during implantation in conjunction with a complementary insertion instrument. The cage of the implant is constrained to a limited range of rotation about a pivoting post carried by the cage. The insertion instrument is configured to hold the post while controllably rotating the cage relative to the post in order to angularly position the implant during implantation. Range of rotational motion is controlled by the configuration of an opening in and end of the cage and a groove in the pivot post. A retaining pin of the implant extends from the cage into the groove of the post to rotationally connect the cage to the post.

Abstract: Surgical tools which are used to separate from one another a femoral cup and an acetabular ball in an implanted hip replacement prosthesis. At its distal end, elements of the surgical tool engage the femoral cup and the acetabular cup. When proximal handles of the tool are squeezed toward one another, the engagement elements move away from one another. Thus, a surgeon is able to separate the femoral cup and the acetabular ball from one another without pulling the acetabular cup away from the acetabulum or the femoral cup and/or femoral implant away from the femur, thereby accomplishing the separation without disrupting any bone ingrowth.

Abstract: A method for making a mould of an amputation stump, in which the amputation stump is inserted into a liner of a moulding aid, the liner having a longitudinal direction and a circumference, and the liner having an expansion coupling such that when the liner is extended in the longitudinal direction, this necessarily results in a reduction of the circumference.

Abstract: An improvement to a prosthetic device which provides a spring member between first and second structural members that are rotatably connected to one another, the spring member providing predictable resistance as it is compressed by the rotation of the first and second structural members with respect to each other. The known resistance of the spring is used as an input to a model controlling a motor control circuit to provide counter-torque as rotational torque is applied to compress the spring.

Abstract: The Prosthetic Vacuum Pump is a manually-operated device, that is affixed to or integral with a prosthetic socket. The manual operation allows a wearer to increase the vacuum in the socket cavity if there is any noticeable decrease at any time. The Prosthetic Vacuum Pump includes a removable pump mechanism that allows a user to customize the level of vacuum drawn by the Prosthetic Vacuum Pump. The intake valve of the Prosthetic Vacuum Pump is in direct connection with the cavity of a prosthetic socket. By eliminating vacuum lines, the vacuum pump creates an immediate vacuum in the cavity. The result is an immediate suspension when the prosthetic limb is put on without the need to walk or wait for the battery to draw a sufficient vacuum. The compact construction and optional depress-lock is easily hidden beneath clothing.

Abstract: Systems and methods for the manufacture of an hourglass shaped stent-graft assembly comprising an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilatation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium.

Abstract: Some embodiments relate in part to endovascular prostheses and methods of deploying same. Embodiments may be directed more specifically to stent grafts and methods of making and deploying same within the body of a patient. Stent embodiments may include tapered struts for an even distribution of strain. Stent embodiments may also include portions which are enlarged in a circumferential direction which may be configured to stabilize the stent in a constrained state.

Abstract: A catheter delivery device for a self-expanding stent is described. The delivery device includes a distal catheter component and a distal sheath that releases the stent by moving proximally relative to the distal catheter component and the stent. A proximal catheter shaft including a tube and a pull wire within a lumen of the tube may be provided, the pull wire being attached to the distal sheath such that pulling the pull wire proximally relative to the tube pulls the distal sheath proximally to release the stent progressively. A casing tube may be provided to surround the catheter shaft, the casing tube having a distal end that receives telescopically a proximal end of the distal sheath.

Abstract: A knee brace with an articulation assembly connectable with a first cuff movable with respect to the articulation assembly about a first location defining a first pivot axis between the first cuff and articulation assembly, and movable about a second location defining a first rotation axis between the first cuff and articulation assembly. The knee brace may have a second cuff connectable with the articulation assembly and movable with respect to the articulation assembly about a third location defining a second pivot axis between the second cuff and articulation assembly. The second cuff is movable about a fourth location defining a second rotation axis between the second cuff and articulation assembly. The first pivot axis and first rotation axis may intersect each other or be offset from intersecting each other, the second pivot axis and second rotation axis may intersect each other or be offset from intersecting.

Abstract: A pelvis correction equipment includes: a pelvis belt for tightening for fastening a lower abdomen of a body, the pelvis belt being used for correcting opening of or strain on a joint portion between a sacral bone and an iliac bone which form a pelvis; a pressing position mark indicated on a surface of the pelvis belt for indicating a plurality of pressing correction portions; and a pressing correction equipment configured to be operated in such a manner that the pressing correction equipment presses the plurality of pressing correction portions along the pressing position mark of the pelvis belt mounted on the lower abdomen by fastening by way of the pelvis belt.

Abstract: An orthopedic walking boot includes a housing configured to encompass at least a user's foot, a mechanically adjustable ramp insert including a ramp surface and disposed in the housing, and an adjusting mechanism configured to adjust an elevation angle of the ramp surface. The mechanically adjustable ramp insert includes a base, a threaded shaft secured to the adjusting mechanism at a first end and configured to rotate with the adjusting mechanism, a first slider nut including internal threads, a bracket in physical contact with the ramp surface, a first support coupled to the first slider nut at a first end and to the bracket at a second end, and a second support coupled to the base at a first end and to the bracket at a second end.

Abstract: A calf brace for the treatment of MTSS (shin splints) and other conditions of the lower leg, including the foot, includes a strap arrangement that is used to locate pressure nodes that target specific areas of a wearer's calf muscle to facilitate release of the calf muscle. In one embodiment, the straps are anchored to a sleeve that can be pulled onto the wearer's calf muscle over the foot. Targeted zones may include the point on the calf where the soleus muscle attaches to the posterior head of the fibula, the point where the soleus muscle attaches to the middle third of the tibia; and the back of the calf at approximately the junction of the Achilles tendon and the triceps surae muscle. A compressive rod may also be aligned with approximately the distal one third of the medial border of the tibia where periosteal elevation and inflammation is thought to occur.

Abstract: A shoulder support system includes an arm support configured for supporting an arm of a user; a convertible shoulder strap convertible between a loop configuration positionable around a shoulder of the user or as straight strap positionable to overlie the shoulder of the user; a front strap connectable between the convertible shoulder strap and a front of the arm support; and a rear strap connectable between the convertible shoulder strap and a rear of the arm support. The shoulder support may also include an abduction pad. In which case the arm support includes an elongate flexible extension affixed to the arm support and extendable outward from the arm support and positionable to be folded about the abduction pad.

Abstract: An ostomy appliance comprising an adhesive wafer (2) for attachment to a skin surface of a user. The adhesive wafer includes a backing layer (13), an adhesive layer (12), and at least one release liner (17). The release liner comprises an enclosure (9) capable of containing a liquid or a wipe (14). The enclosure (9) can be filled with liquid before removal from the wafer, thereby providing a temperature impact on the adhesive. The wipe (14) can be impregnated with an activating agent for providing an activation of the adhesive prior to use.

Abstract: An adaptable ostomy base plate having a substantially convex shape for initial engagement with a peristomal skin surface and can be inverted to a substantially concave shape to fittingly engage to a topography of the peristomal skin surface for permanent engagement thereto. The base plate comprises a reinforcement ring arranged on a distal surface of the top film and the inner section of the base plate, being inside the reinforcement ring is provided with undulations defined by a series of concentric ridges and valleys, said series progresses outwardly from the stoma-receiving through-going hole towards the reinforcement ring and at least partly under the reinforcement ring.

Abstract: An appliance and methods are described that include embodiments of a mandibular advancement or positioning device which can use elastic bands to pull the jaw forward. The appliance has an upper plastic tray conforming to the patient's upper teeth and including a set of retention hooks coupled to the upper plastic tray via being encased in plastic, one on the right and one on the left anterior buccal portion of an upper plastic base. The appliance also has a lower plastic tray conforming to the patient's lower teeth and has a set of bite pads integrated with a second set of plastic retention hooks encased in plastic extending outwardly from the teeth. The appliance includes the upper and lower plastic trays and specially formed elastic bands of a plurality of lengths and strengths replaceably attached to the retention hooks on both sides of the trays to pull the mandible forward for treatment.

Abstract: The present invention provides improved devices for removing energy and fluid from body fluid containing spaces and surfaces of a mammal, the devices including isolated air and water delivery systems configured to simultaneously deliver streams of dry air and liquid water to the nostrils of a patient, without allowing the streams to come into contact with one-another until it enters the patient's nostrils.

Abstract: The present disclosure relates to ejector mechanisms and devices for generating a directed stream of droplets, as well as improved methods for delivering an ejected stream of droplets to a target. The device and methods may be useful for the delivery of fluid for ophthalmic, topical, oral, nasal, or pulmonary use, more particularly, for use in the delivery of ophthalmic fluid to the eye. Certain aspects of the disclosure relate to devices and methods for the delivery of a therapeutically effective low dosage volume medicament composition to a target, e.g., by controlling charge, droplet size and/or droplet deposit parameters of the medicament composition.

Abstract: Described are implantable devices having expandable reservoirs for the sustained release of therapeutic agents. The device is configured to be at least partially implanted in an eye and includes a retention structure and a penetrable element coupled to and extending within at least a portion of the retention structure. A porous drug release mechanism is positioned in fluid communication with an outlet of the device; and a reservoir having a volume configured to contain one or more therapeutic agents is in fluid communication with the outlet through the porous drug release mechanism. The device is at least partially inserted along an axis of insertion. The reservoir enlarges from an insertion configuration having a first three-dimensional shape to an expanded configuration having a second three-dimensional shape, the second three-dimensional shape being eccentrically positioned relative to the axis of insertion.

Abstract: An eye drop guide includes a frame including at least one eye-covering member, and a plurality of apertures arranged in columns, each column having multiple apertures, the apertures in each column being vertically offset from apertures in adjacent columns.

Abstract: A method is provided for treating a gland or duct of a patient. In a particular embodiment, an obstruction in a gland or duct and the orifice thereof can be alleviated; in another, a substance can be injected thereinto; in yet another, the gland can be aspirated. The method includes the step of inserting an elongated probe into a gland or duct via an orifice thereinto. In some embodiments the probe can have a longitudinal lumen therethrough, with at least one distal hole through the probe wall in fluid communication with the lumen. The lumen can be used in concert with a source of suction for removing debris from the gland or duct, and/or with a source of a fluid and pumping means, for injecting a substance into the gland or duct.

Abstract: A phacoemulsification cutting tip, including a rigid tubular portion and a flexible and expandable tip portion located distal to the rigid tubular portion. The flexible and expandable tip portion presents an axial length and an unexpanded radius and is formed such that the axial length shortens while the unexpanded radius increases when differential pressure due to an occlusion of an opening of the flexible tip portion exists.

Abstract: In some embodiments, an illuminated microsurgical instrument system includes a microsurgical instrument having a distally projecting tubular member arranged to perform a medical procedure. The tubular member has a distal tip and an outer surface, the outer surface having a flat surface formed therein. The instrument includes a sheath member surrounding a portion of the tubular member and extending toward the distal tip of the tubular member and an optical fiber extending along a length of the flat surface between the tubular member and the sheath member. The instrument may include an opening such as a slot in the distal end of the sheath member to direct exiting air away from the tip of the optical fiber. The instrument may further include a slack chamber, collar structure, and fiber guard member to support and guide the optical fiber to the distal tip.

Abstract: Intraocular pressure in an eye is reduced by delivering a high resolution optical coherence tomography (OCT) beam and a high resolution laser beam through the cornea, and the anterior chamber into the irido-corneal angle along an angled beam path. The OCT beam provides OCT imaging for surgery planning and monitoring, while the laser beam is configured to modify tissue or affect ocular fluid by photo-disruptive interaction. In one implementation, a volume of ocular tissue within an outflow pathway in the irido-corneal angle is modified to create a channel opening in one or more layers of the trabecular meshwork. In another implementation, a volume of fluid in the Schlemm's canal is affected by the laser to bring about a pneumatic expansion of the canal. In either implementation, resistance to aqueous flow through the eye is reduced.