Abstract: Apparatus, systems, and methods for endoscopic dissection of blood vessels and control over cavity pressure within an endoscopic procedure are described herein. Apparatus, systems, and methods for harvesting of blood vessels are also described herein.

Abstract: An arterial anchor device and a venous anchor device operably coupled by graft material to form an anastomotic convector is provided. The arterial anchor device comprises a generally tubular main body including a distal end and a proximal end, the distal end defining a plurality of flanges integrally formed with the tubular main body and being movable from a first loaded position to a second expanded position. The venous anchor device includes a tubular main body having a metal frame structure and including a distal end and a proximal end, the distal end including a plurality of barbs thereon wherein said distal end has an outer diameter greater than the proximal end. The arterial anchor device and venous devices are fluidly connected by a graft to form an anastomotic connector.

Abstract: A device includes a first end portion, a second end portion, an intermediate portion between the first end portion and the second end portion, and a graft material coupled to at least the intermediate portion. The first end portion has a first end diameter. The second end portion has a second end diameter larger than the first end diameter. The intermediate portion tapers between the first end portion and the second end portion. A method of diverting fluid flow from a first passage to a second passage comprising deploying the device in a third passage between the first passage and the second passage, expanding the first end portion against sidewalls of the first passage, and expanding the second end portion against sidewalls of the second passage.

Abstract: An example implant delivery system is disclosed. The example implant delivery system includes a delivery shaft including a proximal portion, a distal portion and a lumen extending therebetween. The delivery system also includes a frame detachably coupled to the distal portion of the delivery shaft and a tack member coupled to the frame.

Abstract: A system for fixating soft-tissue is described herein. The system includes a soft-tissue fixation device comprising a cable-retention feature. Additionally, the system includes a cable coupleable to the cable-retention feature of the soft-tissue fixation device. The cable is configured to be tensioned to a measurable and adjustable tension.

Abstract: Graft materials and devices for surgical breast procedures may include a sheet of biocompatible material and a plurality of fenestrations distributed across a portion of the sheet of biocompatible material. The sheet of biocompatible material can have a first axis and a second axis coincident with the sheet of biocompatible material. The sheet of biocompatible material can also have a first edge that intersects the second axis and a second edge that intersects the second axis. The first axis can be orthogonal to the second axis. The plurality of fenestrations can be distributed across a portion of the sheet of biocompatible material closer to the first edge than the second edge. Other apparatuses and methods are disclosed.

Abstract: Methods of manufacturing a corneal implant that include creating an implant body that has a meniscus shape, a diameter of approximately 2.5 mm or less, and an index of refraction of 1.376. The implant body can further have a central thickness and an outer edge thickness.

Abstract: An implantation device includes an elongated tube having a first end portion, an opposing second end portion, and a third tapered portion connecting the first and second end portions. The first end portion includes a first opening and an angled tip. The second end portion includes a second opening, and the second end portion is wider than the first end portion. The implantation device also includes a rod inserted through the first opening and extending out of and away from the first end portion. The rod includes a tapered and rounded end. The second end portion is configured to receive a scleral prosthesis into the second opening and to release the scleral prosthesis from the second opening.

Abstract: Accommodating intraocular lenses containing a flowable media and their methods of accommodation.

Abstract: An intraocular lens (IOL) has a clear optic and a curvature changing mechanism in at least a portion the clear optic. The intraocular lens (IOL) can have anterior and posterior portions spaced apart by a cavity, and an actuator for urging change in curvature in at least one of the portions, with energy provided by an energy harvesting mechanism incorporated into haptics of the IOL.

Abstract: Systems and methods for medical interventional procedures, including approaches to valve implantation. In one aspect, the methods and systems involve a modular approach to mitral valve therapy.

Abstract: The present invention is directed to prostheses including a support structure having a proximal end and a distal end, and a motion limiting member attached to the distal end of the support structure, wherein the motion limiting member is configured to restrict radial expansion of the distal end of the support structure. Methods for delivering the prosthesis are also provided.

Abstract: Apparatus is provided for use at a native valve of a heart of a subject. The apparatus includes a delivery tube, transluminally advanceable to the heart; and a prosthetic valve support, configured to support a prosthetic valve at the native valve, and comprising an upstream support portion. The upstream support portion has a working configuration in which it is generally annular and has (1) a tissue-contacting side configured to be placed against an atrial surface of the native valve, and (2) an opposing side, and defines an opening therebetween. The upstream support portion also has a delivery configuration in which the upstream support portion is rolled up to define a channel, and is disposed within the delivery tube. The upstream support portion is configured to be transitioned from the delivery configuration to the working configuration by being exposed from the delivery tube, and unrolled.

Abstract: Packaging for prosthetic heart valves including an assembly for securely retaining a heart valve within a jar and facilitating retrieval therefrom. The assembly includes a packaging sleeve that fits closely within the jar and has a clip structure for securing a valve holder. Contrary to previous designs, in one embodiment the valve holder is directed downward into the jar, and the valve is retained with an inflow end upward. The valve may have flexible leaflets, and a leaflet parting member on the end of the shaft extends through the leaflets and couples with the valve holder. The assembly of the packaging sleeve, valve, and holder can then be removed from the jar and a valve delivery tube connected with the holder, or to the leaflet parting member. The packaging sleeve may be bifurcated into two halves connected at a living hinge to facilitate removal from around the valve/holder subassembly.

Abstract: A method for single-stage cranioplasty reconstruction includes prefabricating a clear craniofacial implant, creating a cranial, craniofacial, and/or facial defect, positioning the clear craniofacial implant over the cranial, craniofacial, and/or facial defect, tracing cut lines on the clear craniofacial implant as it lies over the cranial, craniofacial, and/or facial defect, cutting the prefabricated clear custom craniofacial implant along the hand-marked lines for optimal fit of the clear implant within the cranial, craniofacial, and/or facial defect, and attaching the final clear craniofacial implant to the cranial, craniofacial, and/or facial defect with standard fixation methods of today.

Abstract: According to one example, a posterior-stabilized femoral prosthesis for a knee arthroplasty. The femoral prosthesis can include medial and lateral condyles, a femoral cam and a recess. The medial and lateral condyles can be shaped to articulate with a tibial articular surface of a tibial bearing component through a range of motion, in which full extension corresponds to zero degrees flexion of a knee joint and positive flexion corresponds to greater than zero degrees flexion of the knee joint. In a sagittal plane, the medial and lateral condyles can define medial and lateral multi-radius curves, respectively. The medial multi-radius curve can have a single common radius swept through a first angular extent to define a single arc length that extends from between substantially ?20 degrees flexion to substantially 90 degrees flexion, inclusive.

Abstract: A two-part joint replacement device for replacing damaged soft joint tissue, such as a meniscus or cartilage tissue. In one form, the device may include a free floating soft joint tissue replacement component comprising a first tissue-interface surface shaped to engage a first anatomical (bone and/or cartilage) structure of a joint having damaged soft tissue. The device may also include a free floating rigid base component comprising a second tissue-interface surface shaped to engage a second anatomical (bone and/or cartilage) structure of the joint. The free floating soft joint tissue replacement component may be shaped to slidably interface with the rigid base component. In another form, the free floating soft joint tissue replacement component and the rigid base component are fixed together.

Abstract: According to one example, a tibial replacement assembly for a knee arthroplasty can be configured to couple to a resected proximal surface of a tibia of a human knee. The tibial replacement assembly can include a tibial tray and a first spike. The tibial tray can include a proximal surface and a distal surface opposing the proximal surface. The distal surface can be configured to be disposed on a resected proximal surface of a tibia. The first spike can be removably secured to the tibial tray and can extend generally distally away from the distal surface. The first spike can be configured to extend beneath the resected proximal surface of the tibia.

Abstract: A glenosphere includes a body and a flange. The body includes a first body surface and a spherical second body surface, and includes an engagement feature to engage with an attachment structure attachable to a bone. The flange extends radially outward from the body and includes a first flange surface contiguous with a first body surface and a second flange surface contiguous with the second body surface. The flange has a flange length extending from a first end and a second end such that an angle defined by a first line from a center of the body to the first end and a second line from the center of the body to the second end is less than 180 degrees.

Abstract: Devices and systems can be used to treating spinal conditions. For example, this document describes artificial facet joint systems that can be implanted to treat spinal conditions while facilitating normal stability and motions of the spine. Such systems and methods can be used to treat spinal conditions such as, but not limited to, spondylosis, vertebral fractures, and the like.

Abstract: Instrumentation for implanting a cervical disc replacement device includes cervical disc replacement trials for determining the appropriate size of replacement device to be implanted, an insertion plate for maintaining the elements of the replacement device in fixed relation to one another for simultaneous manipulation, an insertion handle for attachment to the insertion plate for manipulation of the elements, an insertion pusher for releasing the insertion handle from the insertion plate, a drill guide that cooperates with the insertion plate to guide the drilling of tap holes for bone screws to be placed through bone screw holes in the flanges of the replacement device, clips that are applied to the flanges after placement of the bone screws to resist screw backout, and a clip applicator for applying the clips to the flanges.

Abstract: A system for implanting an inter-body device between adjacent vertebrae comprises an inter-body device having a plurality of cans secured to a flexible bridge and having a relief portion therebetween. An inserter tube and complementary bullnoses are advantageously secured to the vertebrae by an extension arm for securing the assembly precisely in place. A plurality of articulating trial implants are provided to test fit a disc space for the proper sized inter-body device.

Abstract: The present invention provides an expandable fusion device capable of being installed inside an intervertebral disc space to maintain normal disc spacing and restore spinal stability, thereby facilitating an intervertebral fusion. In one embodiment, the fusion device includes body, a first endplate, and a second endplate, a middle ramp piece, a stem, and two ramp pins. The middle ramped piece is operable to move to generate lordotic expansion of the first and second endplates followed by parallel expansion. The fusion device is operable to be deployed down an endoscopic tube.

Abstract: Disclosed herein is a spinal implant with a solid frame and a porous inner layer. The implant may have a cavity defined by the porous inner layer. The solid frame may have one or more ribs extending from a medial wall to a lateral wall. The thickness of the porous layer may vary relative the thickness of the solid frame at various locations. An inserter to place a spinal implant and a method to perform same are also disclosed.

Abstract: A method of inserting an intervertebral disc implant into a disc space includes accessing a spinal segment having a first vertebral body, a second vertebral body and a disc space between the first and second vertebral bodies. The method includes securing a first pin to the first vertebral body and a second pin to the second vertebral body, using the first and second pins for distracting the disc space, and providing an inserter holding the intervertebral disc implant. The method also desirably includes engaging the inserter with the first and second pins, and advancing the inserter toward the disc space for inserting the intervertebral disc implant into the disc space, whereby the first and second pins align and guide the inserter toward the disc space.

Abstract: The present invention relates to a method for manufacturing a bone graft material using 3D printing of a DLP system. The method includes (1) dispersing a powder material including calcium phosphate-based ceramics in a solvent; (2) recovering the calcium phosphate-based ceramics by removing the solvent from a solution in which the calcium phosphate-based ceramic material is dispersed in Step 1; (3) producing a photocurable resin composition by adding a binder resin including a crosslinking agent and a photoinitiator to the calcium phosphate-based ceramics obtained in Step 2; (4) performing 3D rapid prototyping on a bone graft material molded body from the composition for a bone graft material produced in Step 3 by 3D printing of a DLP system; and (5) debinding and sintering organic materials remaining in the bone graft material molded body subjected to prototyping in Step 4.

Abstract: A jointed mechanical device is provided. The device includes at least one element having a fixed end and a deflectable end. The device also includes at least one actuating structure having a first end coupled to at least the deflectable end of the element, where the actuating structure includes at least one elastic element in series with at least one non-elastic element. The device further includes at least one force actuator configured to apply an actuator force to a second end of the actuating structure. Additionally, the device includes a control system for adjusting an operation of the force actuator based at least one actuation input, an amount of the actuator force, and an amount of displacement generated by the force actuator.

Abstract: A transdermal intraosseous device for coupling a bone stump to an external prosthetic device includes a bone fixator, an external connector and a plurality of modular interface components. The bone fixator includes a proximal portion configured for anchoring into the bone stump of the patient and a distal portion including a base collar configured for subcutaneous implantation. The external connector has a distal portion for coupling to the external prosthetic device and a proximal portion for coupling to the distal portion of the bone fixator. Each interface component can be removably coupled to the base collar and has different size and shape to provide a surgeon-selected transition between the prosthetic device and the patient's skin.

Abstract: Methods for forming an expandable tubular body having a plurality of braided filaments including a first filament including platinum or platinum alloy and a second filament including cobalt-chromium alloy. The methods include applying a first phosphorylcholine material directly on the platinum or platinum alloy of the first filament and applying a silane material on the second filament followed by a second phosphorylcholine material on the silane material on the second filament. The first and second phosphorylcholine materials each define a thickness of less than 100 nanometers.

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 dilation 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. The encapsulated stents may also be used to treat pulmonary hypertension.

Abstract: A tack device for holding plaque against blood vessel walls in treating atherosclerotic occlusive disease can be formed as a thin, annular band of durable, flexible material. The tack device may also have a plurality of barbs or anchoring points on its outer annular periphery. The annular band can have a length in the axial direction of the blood vessel walls that is about equal to or less than its diameter as installed in the blood vessel. A preferred method is to perform angioplasty with a drug eluting balloon as a first step, and if there is any dissection to the blood vessel caused by the balloon angioplasty, one or more tack devices may be installed to tack down the dissected area of the blood vessel surface.

Abstract: A coated coronary stent, comprising a stainless steel sent framework coated with a primer layer of Parylene C, and a rapamycin-polymer coating having substantially uniform thickness disposed on the stent framework, wherein the rapamycin-polymer coating comprises polybutyl methacrylate (PBMA), polyethylene-co-vinyl acetate (PEVA) and rapamycin, wherein substantially all of the rapamycin in the coating is in amorphous form and substantially uniformly dispersed within the rapamycin-polymer coating.

Abstract: The invention relates to medical devices and methods of using them. The devices are prostheses which can be percutaneously deliverable with (or on) an endovascular catheter or via other surgical or other techniques and then expanded. The prostheses are configured to have a lattice resistant to dilation and creep, which is defined by a plurality of openings. The prosthesis may also optionally have a stent disposed proximal to the lattice. In exemplary embodiments, the fluoropolymer is expanded polytetrafluoroethylene. The composite materials exhibit high elongation while substantially retaining the strength properties of the fluoropolymer membrane. In at least one embodiment, the lattice is made of a composite material that includes a least one fluoropolymer membrane including serpentine fibrils and an elastomer. A lattice including a generally tubular member formed of a composite material including a least one fluoropolymer membrane containing serpentine fibrils and an elastomer is also provided.

Abstract: Devices that can be delivered into a vascular system to divert flow are disclose herein. According to some embodiments, devices are provided for treating aneurysms by diverting flow. An expandable device can comprise, for example, first a plurality of strut regions and a plurality of bridge regions. Each of the bridge regions may connect a first strut of a first strut region to a second strut of a second strut region. The first strut region may comprise a first plurality of apices defining a first circumferential plane, and the second strut region may comprise a second plurality of apices defining a second circumferential plane. A first curved segment of the bridge may extend across the first circumferential plane towards the first strut region, and a second curved segment of the bridge may extend across the second circumferential plane towards the second strut region.

Abstract: This disclosure relates to a stent for use in vascular interventions, the stent comprising a first portion for placing in a first lumen and a second portion for placing in a region of a branch point at which the first lumen branches off a second lumen, the second portion comprising one or more rings linked by second links to the first portion and, if the second portion comprises two or more rings, together. The first and second portions are configured to be different to facilitate controlled longitudinal deformation of the second portion.

Abstract: An apparatus and method for a micro-patterned thin film Nitinol (TFN) that is used as a cover for an expandable stent structure, and has elongation/expansion properties that are configured to match the elongation/expansion properties of the expandable stent structure is presented.

Abstract: A stent delivery device is provided that includes an inner member defining a distal tip and a stent holding region, and an outer tubular member slidingly disposed over the inner member and configured to engage the distal tip. Seal members may be disposed on one or more of an outer surface of the inner member, the distal tip, and the outer tubular member. The seal members define a liquid-tight sealed chamber surrounding the stent holding region.

Abstract: A crimper device can facilitate sheathing of a stent frame for vascular delivery. The device can include first and second components that rotate relative to each other to drive radial movement of one or more compression members of the device. The one or more compression members can direct and balance a compressive force within an aperture of the device. In use, the stent frame can be positioned within the aperture and be compacted by actuation of the compression members.

Abstract: The present disclosure describes implantable medical devices comprising covers, such as a balloon cover. Such devices can comprise a first layer of a porous polymeric material, such as ePTFE, surrounded by layers of a porous polymeric material having an imbibed elastomer, such as polyurethane. The cover can be used to assist in deployment of an expandable implant, such as a stent-graft, within the body of the patient.

Abstract: A delivery system for delivering a prosthesis includes a sheath, a slide shaft having a threaded outer surface, and a handle. The handle includes an internal spring assembly for selectively engaging and disengaging the handle with the threaded outer surface of the slide shaft. The internal spring assembly includes at least one spring arm, a head coupled to the spring arm and having a circumferentially rounded threaded inner surface, and a ring slidably disposed over the spring arm. When the ring is in a first longitudinal position, the threaded inner surface of the head is spaced apart from the threaded outer surface of the slide shaft. When the ring is in a second longitudinal position, the threaded inner surface of the head is threadedly engaged with the threaded outer surface of the slide shaft. The handle may include a resilient cover to provide the internal spring assembly with a biased or nominal operational position.

Abstract: Provided is a method and device for walking assistance that may estimate a state vector of a foot of a user and a variance matrix corresponding to the state vector, adjust a probability of a contact sensor based on at least one estimate included in the estimated state vector in response to receiving a contact signal from the contact sensor, calculate a combination rate between a measurement value of an acceleration sensor and the estimated state vector based on a measurement error matrix including the adjusted probability, update the estimated state vector and the estimated variance matrix based on the calculated combination rate, determine whether the foot lands on the ground based on the updated state vector and the updated variance matrix, and change an operation mode of a walking assistance device based on a result of the determination.

Abstract: Some aspects of the present disclosure describe an orthopedic brace for a portion of a user's upper extremity distal to the elbow. The orthopedic brace includes a body configured to surround said portion of the user's upper extremity. The body includes a first region configured to stabilize said portion of the user's upper extremity. The orthopedic brace includes a second region coupled to the first region. The second region has sufficient elasticity to enable the body to adjust circumferentially to fit said portion of the user's upper extremity.

Abstract: An orthotic device is disclosed. The orthotic device may be adapted to be inserted into a shoe to enable the foot to replicate normal motion so that the user regains substantially normal operation of the foot. The orthotic device may have a frame system formed of a lightweight supportive material and configured to extend along at least the bottom of the user's foot, and an electronically actuated muscle operatively connected to the frame system for expanding and contracting at predetermined levels to adjust the inclination of the user's foot and mimic movement of the foot, when functioning normally. The orthotic device may also have a controller operatively connected to the muscle for transmitting signals corresponding to the predetermined levels to the muscle, and a sensor controlled by the user for actuating the muscle.

Abstract: A method for controlling a powered device to augment a joint function of a human during a gait cycle using a powered actuator that supplies an augmentation torque, an impedance, or both to a joint is disclosed. In some embodiments, the method modulates the augmentation torque, the impedance, and a joint equilibrium according to a phase of the gait cycle to provide at least a biomimetic response. Accordingly, the actuator is capable of normalizing or augmenting human biomechanical function, responsive to a wearer's activity, regardless of speed and terrain.

Abstract: An orthotic medical device, including a proximal receiving element receiving part of an upper area of a human limb and a distal receiving element receiving part of a lower area of the human limb. The distal receiving element, with part of the lower limb area are pivotally movable with respect to the proximal receiving element. A foot supporting arrangement is adapted to receive at least a portion of a foot of the human limb, A first ankle joint, is fixedly attached to the foot supporting arrangement and to the distal receiving element on a first, and a second ankle joint arrangement is disposed on a second side and includes a rigid elongated element slidably disposed within a channel in the distal region of the distal receiving element, and an ankle joint fixedly attached to the foot supporting arrangement and to a distal end of the rigid elongated element.

Abstract: A system, comprising a support adapted to be worn on a head and support a light source to administer an effective amount of light to a nose of the head sufficient to treat a nasal disorder.

Abstract: A medical apparatus for supporting the shoulder complex and humerus in a neutral position includes an upper body garment and a forearm sleeve adjustably fastened to the garment in an anterior and transverse orientation. The patient inserts her arm in the sleeve and fastens an elbow strap around the elbow to secure the forearm in a horizontal anterior position near waistline. The sleeve is adjustable in position to place the humerus inline with the spinal column, thereby preventing adduction and internal rotation of the glenohumeral joint. A weight distribution strap further elevates the sleeve and forearm. The strap is secured in a superior anterior region of the shoulder and spaced from the neck thereby preventing injury to the internal anatomies in the neck region. Optionally, thermal therapy to the shoulder is supported by a removable thermal therapy pouch.

Abstract: In an embodiment, a surgical implant includes a body extending from a distal end to a proximal end, the body having a first section proximal to the distal end and a second section between the first section and the proximal end, a needle attachment member located at the distal end of the body, the needle attachment member configured to attach to a needle for insertion of the surgical implant into a patient's tissue, a plurality of first barbs located on the first section of the body, the first barbs pointed towards the proximal end of the body, and a plurality of second barbs located on the second section of the body, the second barbs pointed towards the distal end of the body, wherein the second barbs are configured to be folded inwardly for insertion of the surgical implant into the patient's tissue by the needle.

Abstract: The present disclosure relates to a fluency aid comprising: a first microphone; a second microphone; and an altered auditory feedback, AAF, generator operable to receive a first input signal derived from sound detected by the first microphone and to generate a feedback signal for providing altered auditory feedback to a user of the fluency aid; wherein the fluency aid is configured such that a second input signal derived from sound detected by the second microphone bypasses the AAF generator.

Abstract: A treatment pad for applying heat, cooling or an antiseptic fluid to a subject's body surface incorporates a heat transfer member or a wound treatment member that is adapted to be held in place by application of a vacuum pressure. The heat transfer member may comprise an electrical resistance wire arranged in a serpentine pattern within a housing or, alternatively, may comprise interconnected heat transmissive tubing through which either a heated or a cooled fluid may be made to pass. Alternatively, the pad may contain a gel that can be cooled in a refrigerator or heated in a microwave oven and held in place on the subject's body by application of a vacuum to the assembly. The wound treatment member may comprise a gaseous antiseptic delivery pad held in place on the patient's body by use of a vacuum.