Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: A system for implanting a heart valve includes a radially self-expandable tubular body having an inflow end and an outflow end and a preformed groove disposed at an outer surface of the tubular body between the inflow end and the outflow end. The preformed groove extends at least partially around the tubular body, and has a circumferential opening facing radially outward of the tubular body. A valve is disposed within and attached to the tubular body, and a trapping member is configured to be moved into the preformed groove and form at least a partial loop around the preformed groove. An insertion member is configured to push the trapping member into the preformed groove. Additionally, a coupling member can provide a releasable attachment between the trapping member and the insertion member.

Abstract: A system for implanting a heart valve that includes a radially self-expandable tubular body having an inflow end and a preformed groove disposed at an outer surface of the tubular body between the inflow end and the outflow end, wherein the preformed groove extends at least partially around the tubular body and having a circumferential opening facing radially outward of the tubular body. A valve may be disposed within and attached to the tubular body. Additionally, a trapping member may be configured to form at least a partial loop encircling the preformed groove so as to trap portions of native valve leaflets and/or chords in the preformed groove, the trapping member including one or more barbs.

Abstract: A system for implanting a heart valve includes a radially self-expandable tubular body having an inflow end and an outflow end, a decorrelation portion, and a preformed groove disposed at an outer surface of the tubular body between the decorrelation portion and the outflow end. The preformed groove extends at least partially around the tubular body, and has a circumferential opening facing radially outward of the tubular body. A valve is disposed within and attached to the tubular body. The decorrelation portion is configured to dissociate axial and radial movements between the inflow end of the tubular body and the outflow end of the tubular body.

Abstract: A system for implanting a heart valve includes a radially self-expandable tubular body having an inflow end and an outflow end and a projection extending from a side surface of the tubular body toward the inflow end. The system further includes a valve disposed within and attached to the tubular body, and may include fabric that forms a pouch between the tubular body and the projection.

Abstract: Procedures may be performed on the heart after the installation of a mitral valve fixation device. In order to prepare the heart for such procedures, the fixation device may be removed or disabled in minimally invasive ways (e.g., through an endovascular procedure), without requiring open access to the heart. The fixation device may be partitioned so that one portion may remain attached to each leaflet of the mitral valve. In another example, the leaflets may be cut along the edges of the distal element(s) of the fixation device, so as to cut the fixation device from the leaflet(s). Systems and devices for performing such procedures endovascularly are disclosed. Fixation devices with improved access to a release harness are also disclosed.

Abstract: Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band. The band is positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets, to inhibit prolapse into the left atrium. At least one marginal chordae is severed, to permit leaflet closure against the band.

Abstract: A vascular device for treating vein valve insufficiency including an elongated member, a first retention portion movable from a first elongated insertion position to an expanded position and a second retention portion movable from a first elongated insertion position to an expanded position. An intermediate looped portion is positioned between the first portion and the second portion. The valve is supported by the intermediate looped portion and is movable between an open position to allow blood flow therethrough and a closed position to inhibit blood flow therethrough. The intermediate looped portion is adjustable to loops of different diameters dependent on an inner diameter of the vessel wall.

Abstract: The embodiments provide provides devices, instruments, and associated methods for treating joint pain. A joint is evaluated using magnetic resonance imaging to detect any defects in the subchondral bone. For example, using T2-weighted MRI images, bone marrow lesions or edemas can be identified, and using T1-weighted MRI images, associated regions of sclerotic bone adjacent to the bone marrow lesion can be identified. The treatment method may involve introducing a bone void filler material at the site to address the bone marrow lesion or edema, and/or drilling and inserting an implant to address the sclerotic bone, bone marrow lesion or edema, and insufficiency or stress fractures. An access path is mapped to a location in the subchondral region where the insufficiency fracture resides. The access path attempts to preserve an articular surface of the joint. A reinforcing member that stabilizes the insufficiency fracture is then implanted via the access path.

Abstract: Acetabular prosthesis comprising an acetabular cup, defining a coupling cavity, and an insert, able to be inserted inside the coupling cavity. The acetabular cup and the insert have a common coupling axis and comprise respective clamping means for their reciprocal clamping in an assembled condition.

Abstract: Prosthetic hip stems for use in prosthetic hip joints and, in particular, provides prosthetic hip stems that are designed to achieve more optimized outcomes with certain types of patient anatomy, such as the anatomy of female patients and/or patients having osteoporosis. Each hip stem in a family or set of hip stems has diaphyseal width, metaphyseal width, offset, and head height dimensions. In a set of hip stems of increasing nominal size, the diaphyseal width dimension increases substantially non-proportionally to the corresponding increase of the metaphyseal width, offset, and head height dimensions, thereby providing a family or set of hip stems that is particularly adapted for patients having osteoporosis, in which the cortical bone of the diaphysis of the femur becomes thinner with progression of the osteoporosis.

Abstract: A femoral knee replacement prosthesis is disclosed including a femoral component, a tibial bearing component, and a tibial platform component. The femoral component includes an anterior condyle with a proximal lateral aspect adjacent a proximal medial aspect and separated by a patella groove, a distal lateral aspect adjacent a distal condyle medial aspect, and a lateral posterior condyle parallel with a medial posterior condyle. The distal condyle lateral and medial aspects are inferior the proximal lateral and medial aspects and the lateral and medial posterior condyles extend posteriorly from the distal condyle lateral and medial aspects. The tibial bearing component includes a proximal side for mating with the femoral component and a distal side. The tibial platform component includes a proximal side with an opening for receiving the tibial bearing component and a distal side including a post adapted to be fixed in a tibia.

Abstract: A femoral augment, or set of augments, for use with a knee joint prosthesis, where the femoral augment includes a main body portion, an aperture formed within the main body portion and extending in a generally distal/proximal direction, and a pair of legs extending outwardly from said main body portion in a generally posterior direction. In the preferred embodiment, the aperture is configured to receive a stem extension implant, and to allow it to pass through. Additionally, the legs of the femoral augment are preferably configured to be seated proximal of a proximal side of a pair of condylar portions of a femoral component of a knee joint prosthesis. The present invention is intended for situations in which the distal portion of the femur is defective, and it provides a method and devices that allow for preservation of healthy peripheral bone, while still providing the necessary augmentation to the distal portion of the femur.

Abstract: A system for implanting an interbody device between adjacent vertebrae comprises an interbody device having a plurality of lobes extending outwardly from a longitudinal rib, and having a relaxed shape approximating the shape of the disc being replaced. An insertion guide is provided having a bore therein from a proximal end to a distal end thereof to accept said interbody device in an unrelaxed shape, wherein said distal end is shaped for insertion into an intervertebral space. The insertion rod may be positioned within said bore of said insertion guide whereby said interbody device is positioned within said intervertebral space by advancing said insertion rod into said insertion guide.

Abstract: An expandable intervertebral implant (10) includes superior (20) and inferior (30) bone contacting members and at least one vertical wire netting (50) interconnecting the superior and inferior bone contacting members. The superior and inferior bone contacting members include at least two bone contacting components interconnected via one or more lateral wire nettings such that the implant is vertically and laterally expandable in situ from a first insertion configuration to a second expanded configuration. The vertical and lateral wire netting are preferably constructed of a plurality of individual link members. The present invention also preferably relates to an associated method of manufacturing the intervertebral implant such that the intervertebral implant can be manufactured as an integral component or part.

Abstract: Structural allograft fusion devices containing a single integral piece of cortical bone in combination with one or more pieces of cancellous bone, wherein the cortical and cancellous pieces are pinned together.

Abstract: An expandable bone device that includes a plurality of linking elements pivotally connected to one another about a hinge, wherein each of the linking elements has upper and lower support plates. An expansion mechanism is operatively connected to the linking elements and can move the upper support plate closer or further with respect to the lower support plate.

Abstract: The present invention relates to an intervertebral disc prosthesis comprising at least three pieces including an upper plate (1), a lower plate (2), and a movable core (3) at least in relation to a plate, wherein it also comprises two anatomic adaptation elements (11, 22) of which each has, on one hand, a surface (110, 220) in contact with a surface of a vertebra and, on the other hand, a surface (111) of which at least a part has a surface in contact with at least a part of the plate (1 or 2) opposite to which the anatomic adaptation element (11 or 22) is mounted, the anatomic adaptation elements (11, 22) being fixed onto the plates (1, 2) via fixation means (113, 223).

Abstract: Anchoring devices, anchoring systems for intervertebral implants, intervertebral implants, and instruments and methods for implanting implants are disclosed. In preferred configurations, these various objects share the feature of comprising or cooperating with an anchoring device having a body comprising at least one curved plate elongated along a longitudinal axis, designed to be inserted through a passage crossing at least a part of implant, in order to penetrate into at least one vertebral endplate and attach implant onto this vertebral endplate by means of at least one stop retaining the implant, characterized in that the body comprises at least one longitudinal rib on at least a part of at least one of its faces, said rib being designed to cooperate with a groove made in passage of implant. In some preferred configurations, anchoring device comprises withdrawal stops or latches, and/or means for withdrawing the anchor from an inserted position.

Abstract: Spinal disk including a shell, first endplate, second endplate and core. The shell includes sidewalls, back wall, front wall, top wall, and bottom wall defining a compartment. The first endplate includes a first base, first top and first attachment. The first base is retained in the compartment. The first top is disposed about a first opening in the top wall to form a top contact surface. The first attachment extends from the first top portion. The second endplate includes a second base, second top and second attachment. The second base is retained in the compartment. The second top is disposed about a second opening in the bottom wall to form a bottom contact surface. The second attachment extends from the second top portion. The core includes a material injectable into a constrained space in the compartment between the first base and the second base.

Abstract: The invention relates to an implant for the transforaminal intracorporeal fusion of lumbar vertebral column segments. At least some sections of the surface areas that are in direct contact with the spinal column are provided with an anti-dislocation mechanism (1) while an attachment part (4) for a positioning instrument (10) is provided in or on the implant and holes (6) or hollow spaces are disposed in the implant for filling purposes. According to one embodiment of the invention, the attachment part is configured as a revolute joint. In a further embodiment, the implant member has the shape of a sickle, the curvature of which is oriented ventrally and the interior of which is oriented dorsally. The attachment part is located at one end of the sickle while the opposite end of the sickle has a beak-type, tapering shape (5). At least one filling hole is provided between the sickle walls.

Abstract: Various surgical devices and methods are disclosed herein. Also disclosed is multi-component prosthesis, which can be used as an ankle prosthesis. One of the disclosed surgical alignment systems includes a guide arm, a ratchet arm frame configured to be coupled slidably to the guide arm, a ratchet arm configured to be coupled to the ratchet arm frame, and a sagittal sizing guide body configured to be coupled to the ratchet arm. The sagittal sizing guide body includes a first radiopaque object disposed at a first position and a second radiopaque object disposed at a second position that is spaced apart from the first position.

Abstract: Various embodiments of the present invention provide a distal femoral trial that allows a surgeon to cut the central box geometry of a distal femur using an implant-shaped trial. The trial includes a cutting guide that is removable from the trial and adjustable with respect to the trial. The guide is intended to control the depth and direction of the cutting instruments used to prepare the femur for a posterior stabilized implant.

Abstract: A clamp assembly for a prosthetic limb includes a plug and a clamp. The plug includes a base and a rounded head defined by a cylindrical wall projecting from the base. The clamp includes a hollow head portion defining a plug bore configured to receive the rounded head of the plug, the head portion comprising a plurality of holes extending through the head portion, each hole configured to receive one of a screw or a bolt for engagement with the rounded head of the plug to fix the plug relative to the head portion. The clamp also includes a clamping portion connected to the hollow head portion and defining a tube bore configured to receive a tube of a prosthetic limb.

Abstract: A prosthetic joint system for users comprising a housing having an interior cavity, a center axis in said interior cavity, and an attachment means for fixedly connecting said housing to said user; an inner cylinder disposed in said housing interior cavity wherein said inner cylinder rotates around said center axis of said housing; an appendage attached to said inner cylinder; a sensor system attached to said appendage; and a dampening system, having a power source, in communication with said sensor system, said inner cylinder, and said housing for controlling dampening of the rotation of said inner cylinder around said center axis of said housing.

Abstract: A system for powering a prosthetic arm is disclosed. The system includes at least one internal battery located in the prosthetic arm, at least one external battery connected to the prosthetic arm, and a master controller configured to connect either the at least one internal battery or the at least one external battery to a power bus to power the prosthetic arm.

Abstract: The invention relates to a connection device for connecting an implant system anchored in bone with an external prosthesis component, such as a limb prosthesis, prosthetic knee elbow or finger. The connection device includes a main housing, a first attachment portion arranged for attachment to the implant system and a second attachment portion arranged for attachment to the prosthesis component. It further includes a safety mechanism to protect the implant system from high mechanical forces, including rotational forces and or bending forces. According to one aspect of the invention the safety mechanism includes a rotational force release mechanism. This includes a first component including a ring unit having an inner surface with at least one depression and a second component includes at least one plunge unit urged into contact with said the depression by said spring means.

Abstract: An adjustable prosthetic socket includes proximal and distal ends and an axis extending between the proximal and distal ends. A distal base is adapted to support a distal portion of a residual limb and is located at the distal end of the socket. At least one strut extends upwardly from the distal base toward the proximal end. The at least one strut defines at least part of a circumference of the socket about the axis. At least one support member is located at or near the proximal end of the socket and extends from the at least one strut. The at least one support member is arranged to distribute pressure from the at least one strut over a portion of the residual limb. A tensioning system is operatively connected to the at least one strut and arranged to selectively adjust the circumference of the socket.

Abstract: An extravascular anastomosis device for facilitating side-to-side arteriovenous fistula creation and maintenance of patency thereof is presented. The device comprises two device halves each containing an anastomosis window which is in fluid connection with an interior space of the device. Further, the device comprises a pair of vessel capture spaces in which portions of the vessels to be joined are captured. The invention also has an embodiment wherein a method of joining a vein and an artery in order to create a fistula is presented.

Abstract: The present patent application relates to a method of crimping a tubular stent having a stent lumen onto an inflatable balloon of a stent delivery catheter.

Abstract: Indwelling body lumen expanders which allow for the maintenance and patency of a body lumen, such as the prostatic urethra to relieve urethral obstruction, are described. Because the one or more expanders are configured to be relatively larger in diameter than the diameter of the body lumen, the expanders may become invaginated into the lumen wall thus enabling the prostheses to avoid fluid exposure which in turn prevent the prostheses from becoming encrusted or calcified.

Abstract: A stent formed by slitting a tube to create a matrix of struts, the slitted tube being radially expandable to a stenting disposition in which the struts exhibit a zig-zag pattern in successive loops around the circumference of the stent, the zig-zag pattern exhibiting a cusp between any two adjacent struts, with selected tied cusps of any one loop being connected by a bridge to a facing cusp of the adjacent loop and with intervening free cusps, characterized by lengthwise staggering of circumferentially adjacent said slits within said loops, wherein any two struts that are contiguous with a said tied cusp are of different lengths and any strut that extends from one free cusp to another free cusp has the same length as any other such strut such that, in the said stenting disposition, the free cusps of adjacent loops are circumferentially displaced from each other.

Abstract: A sheath used to protect a medical device has one or more strips formed over a portion thereof. The medical device is a scaffold crimped to a balloon and mounted to a catheter. The sheath is two-piece, including a protecting and constraining sheath part. The strips facilitate removal of the constraining sheath from the scaffold in manner that reduces instances of damage caused by improper removal of the sheath from the medical device.

Abstract: Intragastric volume-occupying devices and methods for treating obesity are provided. The devices, which are inflated by carbon dioxide, include an aluminum or silicon oxide barrier layer providing carbon dioxide retention and an alkylene vinyl alcohol polymer layer providing structural integrity in vivo.

Abstract: According to aspects of the present disclosure, a system may include a loading device including an exterior surface. The system may also include an expandable member mounted on the exterior surface of the loading device. The expandable member may be configured to selectively transition between a collapsed state and an expanded state. The system may also include a covering mounted on the expandable member. The covering may extend around the expandable member and the loading device. The loading device may be configured to position the expandable member and the covering for mounting on an exterior surface of an elongate introduction sheath.

Abstract: The present invention provides an athletic brace which is composed of a flexible sleeve and a rigid framed brace. An elastic tubular shaped fabric sleeve is first placed over the elbow or knee joint and has upper front and lower rear raised lips that are used to prevent the rigid and compact framed brace from slipping downwards during usage. The tight fit of the rigid brace inside the raised lip gaps of the sleeve prevents the framed brace from slipping down from the elbow or knee joint during usage. This brace is designed to also be compact in size to allow for everyday wear in both contact and non-contact sports for both elbow and knee protection.

Abstract: The present invention relates to a new system, method, and device for assisting a user in maintaining proper posture. More specifically, the present invention relates to a new system, method, and device for applying pressure to one or more of a person's posture pressure points when the person has poor posture, for example because the person's body is misaligned.

Abstract: Spinal distraction systems including methods of use.

Abstract: Some embodiments of the present disclosure include a traction device for relieving lower back pain and stiffness and reducing lumbar spine intervertebral disc displacement. The device may include a sliding spine assembly attached to a head rest pad, a torso pad, and a hip pad, an adjustable length vector bar extending outwardly from the spine assembly, wherein the vector bar is rotatably attached to the sliding spine assembly such that the vector bar is configured to move in a plurality of vectors, a cross bar foot brace tube attached to the vector bar; a foot rest positioned on the foot brace tube, a belt positioned proximate to the torso pad, and a strap assembly attached to the foot brace tube or the distal end of the vector bar, the strap assembly configured to attach to the belt and apply traction to a user's back.

Abstract: An integrated thermoformable splint and heater and method for manufacturing same includes a thermoplastic material and an oxygen activated heater operatively associated with the thermoplastic material. The integrated thermoformable splint and heater are sealed within an oxygen impermeable housing. Oxygen is allowed to activate the heater either by removing the assembly from the sealed housing, or, by displacement of a removable seal that will allow oxygen to penetrate a porous region in the housing, and, in turn, come into contact with the heater.

Abstract: A thermoformable medical member and heater and method for manufacturing same. A thermoplastic material is converted from a relatively rigid state to a formable state over a narrow temperature range, and, which reverts back to a clinically rigid state within a relatively short period of time, and, which remains in that state even at elevated ambient temperatures.

Abstract: A patient transfer device is utilized to transport infant patients between locations within a hospital environment. The patient transfer device includes a center, support section and a pair of side sections that can be moved into contact with each other to surround the infant patient. The first and second side sections each include a handle that can be brought into close proximity to each other and can be grasped by a single hand of a clinician. The patient transfer device includes a stiffening device that is positioned within the center section to provide support for the infant patient during transport. A hold down device is included on one or both of the first and second side sections to securely hold tubes and wires connected to the infant patient during transport of the infant patient.

Abstract: An arm restraint system is provided for restraining movement of an arm of a patient's body lying over a top surface of a table. The system includes a rigid support frame located at a lateral edge of said table and a padded restraint configured to at least partially receive the arm of said patient. The padded restraint is securely fixed to the rigid support frame, via a repositionable fastener, to inhibit movement of the patient's arm relative to the rigid support frame and thereby maintain the arm at a position laterally adjacent to the patient's body without the arm being restrained by tucking.

Abstract: A non-invasive system for inducing penile blood vessel and erectile tissue volume changes, comprising a cylindrical socket, having interior walls and an open end with a circumferential sealing element, and a control unit connected to pressure pumps are provided, wherein a compartment defined by the sealing element and the interior walls is in a state of positive pressure, or in a state of sub-atmospheric pressure. Pressure reservoirs, connectable to the compartment and to the pressure pumps, and mechanical switching elements connected to the pressure reservoirs are provided. Measuring elements are also provided, wherein the control unit is capable of receiving a signal from the measuring elements and determining a time, rate and shape of measured pulse-waves, and wherein the control unit is gated by the measuring element to control the switching elements to switch connectivity of the compartment to the reservoir and alternately switch the compartment between states.

Abstract: Disclosed is an anchoring element for engagement with a base plate for a collecting bag for human body wastes. Also disclosed is a kit for securing collecting bags for human body wastes to skin, comprising an anchoring element and an adhesive base plate and optionally a collecting bag for the human body wastes.

Abstract: An ostomy appliance includes a first adhesive having a first surface and a second surface opposing the first surface. The first surface is provided to contact a partly electrically conductive object. The appliance also includes a first layer situated on the second surface of the first adhesive, and a first electrode situated on the first layer and electrically isolated from the first adhesive.

Abstract: A device is embodied and broadly described herein which provides the user with a breathable comfortable device for urinary incontinence and leakage. The first preferred embodiment of the invention includes a generally collapsible cylindrically-shaped body having an open end and a closed end made of a flexible and breathable netting material that can expand and contract with the natural expanding and contracting of the penis. A sheet is attached to the inside of the closed end, having a layer of moisture absorbent material, a layer of waterproof material to prevent leakage onto the users clothing, and being attached to the inside of the closed end of the body by an adhesive. An additional embodiment of the invention includes sheet having a non-permanent adhesive material bonding the sheet to the body, allowing the user to remove the sheet from the netting and replace it with a new sheet.

Abstract: A human female contraceptive device and a method for placing a human female contraceptive device are disclosed. The contraceptive device includes a lumen surface-conforming occlusive agent that is shaped to occlude a fallopian tube of a human female and a skeleton affixed to the occlusive agent. The skeleton further includes a cavity-conforming material that is shaped to fit at a junction of a uterus and the fallopian tube of the human female; and anchors affixable onto the skeleton and into the myometrium of the uterus of the human female. The method include the steps of fitting an occlusive agent sized to occlude at least a portion of the channel of a fallopian tube of the human female and placing a skeleton at a junction of a uterus and the fallopian tube of the human female as an anchor for the collusive agent.

Abstract: Devices and methods for warming or cooling blood flowing through the vasculature of a human or animal subject so as to alter or control the temperature of all or part of the subject's body. Heat exchangers are positioned within the subject's vasculature and heated or cooled heat exchange fluid is circulated through the heat exchanger. For certain therapeutic applications, the heat exchanger and associated elements of the system have sufficient power to lower the subject's body temperature by at least 3 degrees C. in less than 30 minutes.

Abstract: An ophthalmic surgical device in accordance with various embodiments of the present disclosure comprises an elongate element and a filament. The device may further comprise one or more of a shaft, an actuator, an actuator handle, a shaft handle, a vent, and a filament stop. The device may be used to mechanically push objects, as in retinal detachment repair, gasp objects, as in the removal of a dislocated intraocular lens or an intraocular foreign body, aspirate fluid, and cut materials, such as intraocular fragments.