Abstract: An implant, insertion tool, combinations, and associated methods, that involve placement of a self-fixating tip at tissue of the pelvic region, wherein an insertion tool includes one or more of an aperture for engaging a guide and an extension guard, the method optionally allowing for initial placement of a self-fixating tip at tissue of the pelvic region and adjustment of the location of the self-fixating tip. A threading guide is provided to assist in threading the guide through the aperture. An anchor also provided to with a retaining member to retain the anchor in tissue.

Abstract: A vascular filter device (1) has a support frame (2) and filter elements (4). The filter elements (4) extend from the support frame towards filter element ends forming an on-axis apex (5) at which they are interconnected by a holder (6). The filter elements (4) are biased such that if unconnected the filter element ends are located between the support frame and said central axis when the vascular filter device is unconstrained. The filter element unconnected positions are provided by the filter element shapes and the angles at which they extend from the support frame, and in one example this is achieved by laser cutting tubing and heat setting the material.

Abstract: The present invention provides devices for removing an embolus or thrombus. The device includes an elongate member configured for insertion into the vasculature, an expandable member that extends from the distal end of the elongate member, and a flow restrictor associated with a proximal portion of the expandable member. The expandable member is configured to transition from a compacted state to an expanded state, in which the expandable portion engages with the embolus. The flow restrictor is configured to restrict blood flow and generate a low pressure zone at a location in the vasculature that is distal to the flow restrictor.

Abstract: A tubular tissue graft device is provided comprising a tubular tissue and a restrictive fiber matrix of a bioerodible polymer about a circumference of the tubular tissue. The matrix may be electrospun onto the tubular tissue. In one embodiment, the tubular tissue is from a vein, such as a saphenous vein, useful as an arterial graft, for example and without limitation, in a coronary artery bypass procedure. Also provided is method of preparing a tubular graft comprising depositing a fiber matrix of a bioerodible polymer about a perimeter of a tubular tissue to produce a tubular tissue graft device. A cardiac bypass method comprising bypassing a coronary artery with a tubular tissue graft device comprising a vein and a restrictive fiber matrix of a bioerodible polymer about a circumference of the vein also is provided.

Abstract: A prosthesis comprising a tissue expander and one or more samples of graft material, wherein the tissue expander is attached to the one or more samples of graft material in a manner that allows the tissue expander and the one or more samples of graft material to be implanted in a patient as a unitary prosthesis; and wherein tissue expander is attached to the one or more samples of graft material in a manner that will allow the tissue expander and the graft material to separate after a period of time following implantation to allow removal of the tissue expander from an implant sites while leaving the graft material within the implant site, the prosthesis comprises a tissue expander having molded grooves, slots, channels, or other shallow cavity spaces on a surface, and wherein the graft material is within the grooves, slots, channels, or other shallow cavity spaces, securing the graft material to the tissue expander.

Abstract: An implantable soft tissue prosthesis device comprising a silicone elastomer-shell filled with silicone gel or liquid, which among the layers that constitute its shell includes a barrier layer formed of a low permeability silicone, which impedes the bleeding or diffusion of the silicone gel from the inside of the implant to its surroundings through the shell. This barrier layer is given a coloration different to the other layers of the shell, making it visible in the finished product. The coloration of the barrier layer gives the fabricator of the implant as well as to medical personnel, the possibility to identify the presence of the barrier layer and its homogeneity, improving the safety of the device.

Abstract: The present invention pertains to accommodating intraocular lens (AIOL) assemblies including a haptics system for self-anchoring implantation in a human eye's annular ciliary sulcus for retaining an AIOL at a desired position along the human eye's visual axis, and an accommodation measurement implant (AMI) for determining accommodation and accommodation forces in an experimental set-up including an animal's eye.

Abstract: A novel single occluder mechanical heart valve (1, 45) that exhibits reduced closing cavitation and potential blood-damaging hemolysis by utilizing guiderails (14, 54) to create a continuously shifting pivot axis to control hydraulic forces so as to minimize tangential velocity of the occluder (3, 53) at the instant of final closing. These forces are also used to effect a quick initial closing movement from the full open position. In the same way, other guiderails (12, 16, 52, 56) are employed to provide a quick opening response while guiding the occluder (3, 53) to its full open position where to two fairly equal flow channels are created.

Abstract: A replacement heart valve, including a securing device and a non-return valve, the securing device including a resiliently deformable material adapted to adopt collapsed and non-collapsed configurations, the resiliently deformable material having a memory such that it returns to the non-collapsed configuration when not held under tension, whereby the valve is adapted to be secured within the valve annulus. Also featured is a method for replacing a heart valve and a kit, which use this replacement heart valve.

Abstract: A delivery system and method for delivering a prosthetic heart valve to the aortic valve. The system includes a delivery catheter having a steering mechanism thereon for delivering a balloon-expandable prosthetic heart valve to the aortic valve through an introducer passing into the left ventricle through its apex. The introducer may have a more floppy distal section than a proximal section to reduce trauma to the heart wall while preserving good operating field stability. The delivery catheter includes a deflecting segment just proximal to a distal balloon to facilitate positioning of the prosthetic heart valve in the proper orientation. A trigger in a catheter handle may be coupled to a deflection wire that actuates the deflecting segment, while a slider in the handle controls retraction of a valve pusher. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

Abstract: Bioactive implant for myocardial regeneration and ventricular chamber support including an elastomeric microporous membrane. The elastomeric microporous membrane being at least one non-degradable polymer and at least one partially degradable polymer. The non-degradable polymer is selected from polyethylacrylate and polyethylacrylate copolymerized with a hydroxyethylacrylate comonomer. The partially degradable polymer is selected from caprolactone 2-(methacryloyloxy)ethyl ester and caprolactone 2-(methacryloyloxy)ethyl ester copolymerized with ethylacrylate. The elastomeric microporous membrane further includes a nanofiber hydrogel, and cells. The bioactive implant, having one or two helical loops, contributes to the restauration of the heart conical shape.

Abstract: The present invention relates to multiphasic, three-dimensionally printed, tissue repair devices or scaffolds useful for promoting bone growth and treating bone fracture, defect or deficiency, methods for making the same and methods for promoting bone growth and treating bone fracture, defect or deficiency using the same. The scaffold has a porous bone ingrowth area containing interconnected struts surrounded by a microporous shell. At the ends of the scaffold, the shell may be extended as a guide flange to stabilize the scaffold between ends of bone. The center of the scaffold may be empty and may serve as a potential marrow space. The porous ingrowth structure may be infiltrated with a soluble filler or carrier, such as, for example calcium sulfate which may be infiltrated with one or more of an antibiotic, a growth factor, a differentiation factors, a cytokine, a drug, or a combination of these agents.

Abstract: The present invention relates to improvements in chemical vapor infiltration processes and devices for depositing a biocompatible material onto a porous substrate to form an orthopedic implant. The substrate may be formed of reticulated vitreous foam and coated with tantalum, niobium, tungsten, or other biocompatible materials.

Abstract: Systems and methods for performing orthopedic surgical procedures to treat a patient are presented herein. The orthopedic anchoring system may include an implant assembly and a delivery tool to perform the orthopedic surgical procedure. The implant assembly may include an implant outer layer, an implant body situated within the implant outer layer, and a fastener attached to a locking element of the implant body. The delivery tool may include a targeting arm, a fastener guide removably attached at a first end of the targeting arm and an implant guide removably attached to a second end of the targeting arm. The delivery tool may maintain a fixed spatial relationship between a longitudinal axis of the fastener and a longitudinal axis of the implant outer layer and implant body. The orthopedic anchoring system may be used to perform orthopedic surgical procedures related to joint reinforcement or immobilization.

Abstract: The invention concerns a method for manufacturing a template (6), whereby a digital or physical model of the shape of at least a part of the jaw (1) is generated. A desired shape for the jaw bone (2) for positioning a bone superstructure (25) is compared to said model and a bone part (5) of the jaw bone (2) is identified, which bone part (5) is to be removed in order to approach said desired shape. A guide surface (8) is provided on the template (6) to guide a milling element (10) in order to remove the identified bone part (5). The invention also concerns a bone superstructure (25).

Abstract: A method of treating a hip joint of a human patient by providing at least one hip joint surface comprising the steps of: cutting the skin of the human patient, dissecting an area of the pelvic bone on the opposite side from the acetabulum, creating a hole in the dissected area from the opposite side from the acetabulum, the hole passing through the pelvic bone and into the hip joint of the human patient, and providing at least one hip joint surface to the hip joint from the opposite side from the acetabulum, through the hole in the pelvic bone of the human patient.

Abstract: Systems, devices, and methods are provided for orthopedic implants, The implants may include a base member, such as an acetabular shell or an augment, that is configured to couple with an augment, flange cup, mounting member, or any other suitable orthopedic attachment. An implant may include abuse member that has at least two projections with a gap between the projections. The gap between the projections allows the implant to be implanted around another implanted component, such as around a bone screw of an acetabular shell. The implant may include a fixation element, such as a screw or a cement trough, on one or more projections to couple the implant to an implanted acetabular shell. The implant may also include timing marks to facilitate alignment with corresponding marks on another implanted component.

Abstract: The disclosure includes methods and systems for making orthopedic connections where there is unique adjustability to the connection. Illustratively, one embodiment provides a connecting assembly for connecting a plurality of orthopedic components. Such connecting assemblies can include a first orthopedic component that provides a female bore. Additionally the assembly can include a second orthopedic component that can be or include a male-type connecting member that is positionable in the bore of the first orthopedic component. In one preferred form, the male-type connecting member will be a quasi-spherical member. The quasi-spherical member can include a textured outer surface, e.g., for contacting one or more walls or surfaces in the bore in a fashion that removeably locks or helps to removeably lock or fix the quasi-spherical member in the bore.

Abstract: The present disclosure describes a glenoid implant including a body and a fixation member. The body has an articular surface and a scapula-engaging surface opposite from the articular surface. At least a portion of the scapula-engaging surface is configured to mirror and conform to a surface of a scapula of a specific patient based on a three-dimensional (3D) model of the scapula. The fixation member extends from the scapula-engaging surface for fixing the glenoid implant to the scapula.

Abstract: An intervertebral implant is a porous structure formed of a plurality of metal balls, and the intervertebral implant includes a bone support area and a bone growth area. The bone support area and the bone growth area each have a plurality of connecting holes, and a porosity of the bone support area is smaller than that of the bone growth area.

Abstract: Method and apparatus are disclosed for distracting tissue and particularly spinal tissue. The device and method may include insertion of at least one elongated member and an augmenting member to form a structure between the tissues to be distraction, such that a dimensional aspect of the structure is augmented upon movement of the augmenting structure.

Abstract: A device to space vertebral members with first and second members that may have at least one ramped section. The first and second members may be positioned in a vertically overlapping arrangement with interior sides of the members facing together. The device may be positionable between a first orientation with the ramped section of the first member positioned away from the ramped section of the second member, and a second orientation with the ramped section of the first member positioned against the ramped section of the second member. The device may include a greater height measured between the exterior sides in the second orientation than in the first orientation.

Abstract: The invention relates to a referencing apparatus for application onto a patient at least partially covered by surgical drapes. The referencing apparatus includes a plurality of locking elements shaped for engagement with the surgical drapes. The surgical drapes are disposed intermediate the plurality of locking elements and a respective plurality of predefined anatomical sites on the patient. The engagement causes a docking system disposed on the referencing apparatus to assume a reference orientation relative to the plurality of predefined anatomical sites.

Abstract: The present invention involves systems and related methods for performing surgical procedures and assessments, including the use of neurophysiology-based monitoring to: (a) determine nerve proximity and nerve direction to surgical instruments employed in accessing a surgical target site; (b) assess the pathology (health or status) of a nerve or nerve root before, during, or after a surgical procedure; and/or (c) assess pedicle integrity before, during or after pedicle screw placement, all in an automated, easy to use, and easy to interpret fashion so as to provide a surgeon-driven system.

Abstract: The invention relates to a method for controlling an orthopaedic joint device of a lower extremity. The joint device has an upper part (2) and a lower part (3) mounted in a hinged manner on the latter. Arranged between the upper part (2) and the lower part (3) is an energy converter (5) by which, during walking, kinetic energy from the relative movement between the lower part (3) and the upper part (2) is converted or stored and supplied again to the joint in order to support the relative movement, wherein kinetic energy within one movement cycle is converted and/or stored and, within the same movement cycle, is supplied again as kinetic energy to the joint device (1) in a controlled manner and staggered in time.

Abstract: A suspension liner is provided for use as an interface between a residual limb and a prosthetic socket. The liner has an elongate, generally conical liner body formed from at least one material segment that is at least radially elastically extensible from a relaxed non-extended condition and including proximal and distal end areas, and a seal component connected to the liner body and having an exterior surface defining at least one exterior seal protruding from the exterior surface and extending radially outwardly from the seal component relative to a longitudinal axis of the liner body. The at least one interior seal is located along an interior surface of the seal component and defines at least one blade extending obliquely toward the liner body. A portion of the seal component carrying the interior seal extends freely and is movable relative to the liner body.

Abstract: Bioactive-coated medical devices are provided, including coated vascular stents. The medical device coating can include a coating layer posited over at least a portion of the medical device surface, and can include a butyl methacrylate polymer or an ethylene-vinyl acetate copolymer in combination with a bioactive material that can function as both an immunosuppressive agent and an antiproliferative agent. Optionally, multilayer coatings can further include an adhesion promoting layer comprising parylene positioned between the coating layer and the medical device surface, a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer, or both. The coating layer preferably comprises between about 0.5 and 2.0 ?g/mm2 of the bioactive material on the outer surface of the medical device. The bioactive material can be absorbed into the coating layer, which can have a thickness of between about 0.5 ?m to about 5 ?m.

Abstract: The invention provides an improved stent design for repairing vasculature, the stent having rings including struts defining first peaks and second peaks, selected second peaks of adjacent rings being connected by links. The stent design incorporates non-linear links with undulating portions extending generally perpendicular to or circumferentially with respect to a longitudinal axis of the stent and adjacent first peaks with different longitudinal lengths such that stent flexibility is increased without sacrificing stent compression for delivery.

Abstract: Provided is a stent pusher assembly (100) for positioning a ureteral stent (50), the stent pusher assembly having an inner (102) and outer stent pusher (104). The stent pusher assembly positions the ureteral stent in a patient's kidney and bladder without a bladder fixing portion (52) of the stent entering a ureteral passage-way, thereby minimizing irritation to the patient.

Abstract: Provided herein are balloon systems and related methods for the treatment of obesity. The system includes a trans-abdominal gastric cannula and size-varying balloons that, with the assistance of the cannula(s) and anchors, are specially positioned and anchored to the gastric wall. The size-varying balloon may have an annulus that in combination with reliable and precise balloon positioning, minimizes the risk of gastric obstruction during use. A malabsorption sleeve may be positioned in the small intestine to further restrict caloric intake through the small intestine. The specially-configured gastric cannula provides a platform for accessing the gastric environment that facilitates precise handling, manipulation, and placement of balloons, including an annular-shaped balloon, in the gastric environment, including by balloon anchors connecting the balloon wall to the lumen-facing stomach wall.

Abstract: Transoral implantable devices includes an inflatable body made of a material that permits it to be compressed into a substantially linear transoral delivery configuration and that when implanted in the stomach is adapted to reduce obesity or weight by stimulating the stomach walls of the patient. The body has a plurality of popout features on its surface that reside generally flush with the inflatable body in relaxed, refracted states, and which respond to an increase in pressure within the inflatable body by projecting outward from the body in a stressed, deployed state. The popout features may convert between their retracted and deployed states by movement of rolling diaphragms formed in the inflatable body.

Abstract: This invention relates to an expanded device and its uses in human medical care, which include, inter alia, appetite suppression in a subject in need thereof and kits comprising thereof.

Abstract: A releasably-securable gastric band having a tail end and a head end for receiving the tail end is disclosed. The gastric band also includes a releasable locking structure means that releasably secures the head and tail ends together. The tail end may include a tooth and the head end may include a notch for engaging the tooth. Upon insertion of the tail end into the head end, the tooth mates with the notch and releasably locks the tail end in the head end. The releasably-securable gastric band includes a release tab. When force is applied to the release tab in a direction perpendicular to a central axis of the gastric band, the tooth is disengaged from the notch to allow the gastric band to be released.

Abstract: A brace structure is placed or is embedded into a shoe and contains a body. The body includes a flexibly protective piece, a shape of which is formed in a U shape so as to correspond to a profile of an ankle. The flexibly protective piece has a support portion defined between two ends thereof so as to support a sole of a foot. The flexibly protective piece also has two lining portions extending upwardly from two ends of the flexibly protective piece so as to cover the ankle. Each lining portion has at least one protecting layer mounted on an inner surface thereof, the flexibly protective piece further has two tabs extending upwardly from two upper ends of the two lining portions, and each tab has at least one fixing portion for corresponding to at least one hole on the shoe.

Abstract: A wearable robotic device for the rehabilitation training of a limb with moisture and pressure management functions. Such wearable robotic device comprises a motor rotation system and a bracing system, wherein the motor rotation system comprises a motor and a motor control system; and the bracing system comprises a framework of structural members that is attachable to and detachable from the limb, one or more textile bracing cushions and one or more fastening belts attached to each of the textile bracing cushions such that the fastening belts and the textile bracing cushions in combination are capable of attaching the wearable robotic device onto the limb.

Abstract: According to an embodiment, a lacing system for opening and closing an article includes a tensioning device having a first mode of operation and a second mode of operation, a first tension member that is coupled with the tensioning device and tensionable thereby, and a second tension member that is coupled with the tensioning device and tensionable thereby. The tensioning device is configured to: effect tensioning of the first tension member to close and tighten the article upon operation of the tensioning device in the first mode of operation and effect tensioning of the second tension member to loosen and open the article upon operation of the tensioning device in the second mode of operation.

Abstract: A cable driven actuator and actuator method involve a movable link that is movable about a path by a cable connected to the link, and a movable support member having a cable routing element. The support member is movable in a manner to change a moment arm of the cable acting on the link to control torque applied to the joint.

Abstract: Orthopedic devices, systems, and methods of using the same are disclosed. In an embodiment, an orthopedic device intended for use with at least one moveable body part of a user may comprise a tubular body forming an interior surface and an exterior surface. The tubular body may include at least one opening and one or more shrinkable materials. The tubular body may be moveable between a first position, wherein the tubular body is configured to at least partially receive and at least partially surround the at least one moveable body part of the user, and a second position, wherein one or more portions of the tubular body are configured to generally conform to and at least partially restrict movement of the at least one moveable body part in one or more directions. The tubular body may be configured to move from the first position to the second position in response to a treatment.

Abstract: The invention relates to a lockable hinge for an orthosis. The lockable hinge comprises a first side bar and a second side bar, a bridging element and a locking mechanism. A first end of the first side bar is fixedly mounted to a first portion of the bridging element, and a first end of the second side bar is rotatably mounted to a second portion of the bridging element. The locking mechanism is supported by the first side bar, and the locking mechanism comprises a locking block being slidable along the longitudinal extension of the first side bar between a locked position and an unlocked position. In the locked position the locking block engages by wedging between the second side bar and the bridging element, whereby the second side bar in the locked position is fixedly aligned with the first side bar.

Abstract: An orthosis including a supporting region that has fastening means for placing the orthosis on a limb, wherein the supporting region has opposing receiving sections, that the orthosis further includes pockets for receiving the receiving sections in the fastening means.

Abstract: A water resistant light compression and/or retention bandage for retaining an orthopaedic splint, padding or medical device against a body part, includes a knitted fabric formed of synthetic yarns having a moisture vapor transmission rate from an inner face of the bandage to an outer face of the bandage of at least 500 g/m2 per 24 hours.

Abstract: A therapeutic device has a body (2) with a shoulder-engaging part (12) and a chest-engaging part (11) and elevated pivot supports (12) extending upwardly from the shoulder-engaging part (12) at locations to be on opposed sides of a patient's head in use. A head support (3) with a chin cradle (35) is pivotally connected by pivot joints (20) to the pivot supports (12). Torsion springs (24) bias the head support (3) upwardly. Sensors wirelessly provide data to a processor such as a smartphone so that the extent of movement of the head support can be monitored.

Abstract: Provided is a curable orthopedic splint. The curable orthopedic splint includes: an inner shell contacting a bone fracture site, an outer shell bonded to the inner shell, a curable core accommodated between the inner shell and the outer shell, the curable core being cured to match a shape of the bone fracture site, and a fixing holder contacting a surface of the outer shell to surrounding the curable core and the bone fracture site, the fixing holder having both ends that are detachably bonded to each other or detachably bonded to the surface of the outer shell so as to closely attach and fix the curable core to the bone fracture site.

Abstract: A modular footbed comprised of a forefoot portion, a heel portion, a bridge and arch support can be fashion to place the knee in dynamic alignment with the femoral head of the femur and the ankle. Standing on one leg and repetitively extending and flexing the knee of the supporting leg, one can observe side-to-side deviations of the knee from a natural position. Various components of the modular footbed are incorporated so as to enable the knee to remain aligned throughout its range of motion.

Abstract: A predetermined spatial locale is selectively operationally stimulated through local heating by exposing magnetic particle(s) associated with such local to alternating magnetic field parameters of which are chosen to generate hysteretic losses in magnetic particle(s). When different types of particles are associated with different locales such as different biological cells, different cells can be accessed and stimulated independently from one another. Switching between stimulation of first and second types of cells is carried out by changing parameters of stimulating magnetic field, while optionally maintaining the field strength-frequency product substantially constant. Embodiments facilitate multiplexed release of chemical payloads, triggering changes in electrical polarization, and changing a shape of a unit placed at the chosen locale.

Abstract: An extracorporeal blood cooling or heating circuit includes an intravenous catheter for withdrawing a patients blood coupled to a combined pump/heat exchanger device. One or more sensors are provided upstream and/or downstream of the pump/heat exchanger device for measuring pressure, temperature, fluid flow, blood oxygenation, and other parameters. A controller is operatively coupled to the pump/heat exchanger device and the one or more sensors to control the speed of the pump inside the pump/heat exchanger device and regulate the blood temperature by controlling the operation of the heat exchanger. The combined pump/heat exchanger device includes a housing having at least one inlet and at least one outlet, a pump portion defining a blood circuit inside the housing, and a heat exchanger portion contained within the housing for selectively heating or cooling the blood.

Abstract: A thermotherapeutic pack and a method of manufacturing a thermotherapeutic pack are disclosed. The thermotherapeutic pack comprises a pouch formed from at least one laminate sheet. The at least one laminate sheet includes an outer polyester layer, an intermediate nylon layer and an inner polyethylene layer. The pouch is permanently sealed closed. A thermotherapeutic composition is pre-loaded into the pouch. The thermotherapeutic composition is for providing thermal therapy in the form of hot therapy and cold therapy when the pouch is applied against a body part. The thermotherapeutic pack can have at least one strap and at least one buckle that co-operate with each other to retain the pouch against a body part during thermal therapy.

Abstract: A device for providing thermal treatment to a patient's hand is provided. The device includes a therapy component for applying thermal therapy, compression therapy, or both; a sleeve for receiving the therapy device and sized and shaped to cover the patient's hand; and a hand support for supporting the patient's hand in a relaxed state.

Abstract: Moisture diverters attachable to a region above the eye and below the eyebrow that prevents sweat, liquid, moisture, or the like from entering the eyes of a wearer is described. A moisture diverter may include a substrate having an inner surface facing the wearer and an outer surface facing away from the wearer. The inner surface and upper surfaces include a lower section and an upper section, the lower section of the inner surface having an attachment structure for releasably attaching the diverting apparatus to a wearer in a region above the eye and below the eyebrow of the wearer, the upper section shaped or shapeable to abut or protrude from the eyebrow region of the wearer to divert sweat, liquid, moisture, or the like away from the eye.

Abstract: The present invention relates to a bottle for packaging a liquid to be distributed drop by drop comprising a reservoir the walls of which can be reversibly elastically deformed by letting air into the container, surmounted by a liquid dispensing head comprising a dropper nozzle protruding from the bottle and an anti-bacterial filter membrane, that is partially hydrophilic and partially hydrophobic, interposed across the path of the liquid and the air, at the base of the said nozzle. In the dispensing head, the proposal is to create the nozzle by itself out of a material containing a bactericidal agent that has the effect of preventing any bacterial growth on the surface of the said nozzle on the outside of the antibacterial membrane. A porous core is advantageously positioned inside the duct through which liquid is expelled and air is admitted.