Abstract: Apparatus and methods for nipple and breast formation are described where devices precondition or expand a target nipple tissue to reduce the pressure exerted by the skin on an eventual implant. Generally, the apparatus comprises a mold having a contact surface which is curved in conformance with a breast upon which the mold is positionable, the contact surface having an adhesive for securement upon the breast, and the mold defining a cavity along the contact surface which conforms to a size of a nipple to be formed upon the breast and where the cavity further comprises the adhesive for securement to the nipple. A breast enlargement device comprises a cup larger than the target breast and further defines an inner surface which adheres to the breast when contacted.

Abstract: Described herein are devices for placement in surgically created soft tissue spaces, potential spaces, or cavities. The implantable devices generally include a bioabsorbable body having an open framework that facilitates attachment of tissue thereto in a manner that helps avoid post-surgical deformities. Methods for using the implantable devices in oncoplastic surgery are further described.

Abstract: An intraocular lens including a flexible optic and at least one rigid plate haptic connected to the optic. The at least one rigid plate haptic can include a rigid structure. The at least one rigid plate haptic can be resistant to bending from pressure exerted on a distal end of the at least one haptic by contraction of the ciliary muscle. The intraocular lens can be a non-accommodating IOL having a longitudinal length that is fixed and configured to resist deformation by the action of the ciliary muscle. Various embodiments also include accommodating intraocular lenses.

Abstract: This invention discloses methods and apparatus for providing an ophthalmic lens with a stacked integrated component device for function. In some embodiments, the stacked integrated component device may contain an energy source capable of powering an electrical component incorporated into the lens.

Abstract: Medical devices, systems, methods, and kits for the medialization of a vocal cord are described. An embodiment of a medical device comprises a proximal portion, a distal portion, and an elongate body extending from the proximal portion to the distal portion. The elongate body defines a thread extending from the proximal portion and the distal portion.

Abstract: The invention relates to an implantable valve prosthesis, optionally comprising a support structure and at least one valve leaflet. The valve prosthesis comprises a material structure of unidirectional reinforcing elements of drawn ultra high molecular weight polyolefin, extending in at least two directions, wherein the modulus of elasticity of the polyolefin reinforcing elements is at least 60 GPa. The invention furthermore relates to a method for manufacturing such an implantable valve. The valve is easily manufactured and has an improved durability.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts. A plurality of commissure features is disposed on the stent and coupled to selected ones of the struts, each commissure feature including a body having a proximal end and a distal end, and at least one eyelet in the body. The heart valve further includes a collapsible and expandable valve assembly including a plurality of leaflets. At least one leaflet is connected to the at least one eyelet and to at least one of the selected ones of the struts via a suture pattern.

Abstract: A prosthetic heart valve includes an annular frame that is adapted for (1) delivery into a patient's native heart valve annulus in a circumferentially collapsed condition, and (2) circumferential re-expansion when in the annulus, the frame, in an expanded condition. The frame having a longitudinal axis, an inflow end and an outflow end, a first portion of the frame adjacent the inflow end inclining radially outwardly in a direction toward the inflow end, and a second portion of the frame between the first portion and the outflow end bulging radially outwardly, the second portion of the frame being positioned between a first axial distance from the inflow end and a second axial distance from the inflow end. The frame also includes a plurality of commissure members. The heart valve further includes a flexible leaflet structure disposed in the frame.

Abstract: An assembly and methods for providing a contoured biological tissue are described. The assembly comprises a first plate and a second plate. The first plate is configured to receive a biological tissue. The second plate is configured to apply a compressive force on the biological tissue that is disposed on the first plate. One or both of the first and second plates comprise a defined shape and a contoured area within the defined shape. The contoured area comprises at least first and second elevations and a continuous transition between the first and second transitions. One or more energy sources is associated with one or both of the first and second plates. The one or more energy sources delivers energy while the second plate applies the compressive force on the biological tissue disposed on the first plate.

Abstract: Valve retainers and delivery systems with valve retainers are disclosed. In certain embodiments, a portion of the valve retainer can rotate about a central axis of the delivery system relative to a different portion of the valve retainer. In certain embodiments, a first portion of the valve retainer can include a plurality of first orientation markings. In certain embodiments, a second portion of the valve retainer can include a second orientation marking, which can be aligned with a first orientation marking on the first portion of the valve retainer.

Abstract: A delivery device for a collapsible heart valve includes an operating handle and a catheter assembly. The operating handle includes a frame defining a movement space therein, a carriage assembly moveable in a longitudinal direction within the movement space, and a coupler having locked and unlocked conditions, the coupler being operatively connected to the carriage assembly for movement therewith. The catheter assembly includes a shaft around which a valve-receiving compartment is defined, the shaft being operatively connected to one of the frame or the carriage assembly, and a distal sheath operatively connected to the carriage assembly for movement therewith between a closed condition adapted to maintain the valve in the compartment and an open condition adapted to fully deploy the valve.

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: Excessive dilation of the annulus of a mitral valve may lead to regurgitation of blood during ventricular contraction. This regurgitation may lead to a reduction in cardiac output. Disclosed are systems and methods relating to an implant configured for reshaping a mitral valve. The implant comprises a plurality of struts with anchors for tissue engagement. The implant is compressible to a first, reduced diameter for transluminal navigation and delivery to the left atrium of a heart. The implant may then expand to a second, enlarged diameter to embed its anchors to the tissue surrounding and/or including the mitral valve. The implant may then contract to a third, intermediate diameter, pulling the tissue radially inwardly, thereby reducing the mitral valve and lessening any of the associated symptoms including mitral regurgitation.

Abstract: An orthopaedic hip prosthesis system is disclosed. The orthopaedic hip prosthesis system comprises a femoral head component configured to articulate with a natural or prosthetic acetabulum of a patient, the femoral head component having a tapered bore formed therein, a femoral stem component having a tapered trunnion configured to be received in the tapered bore of the femoral head component, and a shell positioned over the tapered trunnion of the femoral stem component. The shell includes a frame extending over the tapered trunnion, and a protective coating applied to the frame and the tapered trunnion. A method of performing an orthopaedic surgery is also disclosed.

Abstract: The invention provides an implantable medical device for treatment of a proximal humerus fracture, comprising a base element to be anchored in the medullar cavity of the humeral shaft, a support element to be fixed with respect to the base element, wherein the support element is configured to support one or more bone fragments, wherein the medical device comprises positioning members configured to position the support element with respect to the base element in a range of rotational positions and axial positions, and wherein the medical device comprises a fixation device to fixate the support element, within the range of rotational positions and axial positions, in a desired rotational and axial position with respect to the base element. In an embodiment, the medical device is a non-occluding medical device, wherein after implantation the medullar cavity is not occluded by the medical device due to the open and non canal filling structure of the device preserving blood flow to the reattached bone fragments.

Abstract: In an orthopaedic knee joint prosthesis, an intercondylar fossa of a femoral component cooperates with a spine formed in a tibial component to reproduce the screw home mechanism of a natural knee. When the femoral component and tibial component are positioned to correspond with slight flexion of the knee, the components are mutually rotationally locked against internal or external rotation. At higher degrees of flexion, such as greater than about 10-20 degrees of flexion, internal/external rotation of the tibia is permitted. The tibia is in an externally rotated position when locked, thereby reproducing the screw home mechanism and providing high stability.

Abstract: A partial reverse shoulder prosthesis includes a humeral stem and a variable angle tray including a plate including a through hole including at least two cutouts oriented horizontally across from one another, and a repositionable variable angle stem occupying at least a portion of an internal cavity defined by the through hole and including a first washer including threads at least partially defining a first opening, a post at least partially occupying the internal cavity, and a pin insertable into the first opening and having a threaded head sized to engage the threads of at least one of the first washer and the post; wherein the wall of the internal cavity is sized to retain the first washer and at least a portion of the post.

Abstract: Improved bone plate systems are described herein. In some instances, a bone plate system can include a base plate, at least one retainer plate, and at least one spacer. The at least one retainer plate is configured to reside on the base plate in a free floating manner and can receive at least one fastener to secure the retainer plate to the at least one spacer, thereby providing a plate system that attaches to a spacer. In other instances, a bone plate system can include a base plate having one or more push plates that can engage at least one spacer.

Abstract: Prosthetic replacement for a posterior element of a vertebra comprising portions that replace the natural lamina and the four natural facets. The prosthetic replacement may also include portions that replace one or more of the natural spinous process and the two natural transverse processes. If desired, the prosthesis replacement may also replace the natural pedicles. A method for replacing a posterior element of a vertebra is also provided.

Abstract: An expandable tube having a substantially semicircular unexpanded shape is inserted into the disc space after the disc material has been removed therefrom. A plurality of expandable lockable rings are passed over this tube in their unexpanded states and positioned along the anterior edge of the endplates. The tube is then expanded, thereby forcing the rings to expand. The rings hold their final expanded configuration via a one-way locking mechanism. Once sufficient distraction is achieved and the rings locked, the tube is collapsed and removed, thereby leaving the expanded, locked rings behind to support the disc space.

Abstract: A protective cover prevents undesired leakage of materials out of a spinal implant. In one embodiment, the implant is a lateral interbody fusion implant that accommodates biologically active material to promote bone ingrowth. The protective cover prevents unintended migration of the biologically active material out of the implant and into surrounding tissue.

Abstract: Thermal memory springs may form arches, or have coils or spring arms and truss arms that expand from a relaxed state when the thermal memory springs warm to a temperature that is about the body temperature of a human being. The thermal memory springs may be used to expand interbody implants from a compact state into an expanded state once the implant has been inserted into the desired location within the body and the thermal memory springs that form a part of the implant warms to body temperature. Ends of the expanded thermal memory spring may contact a bone surface, thereby being an anti-expulsion edge.

Abstract: The present invention provides an intervertebral implant for implantation in a treated area of an intervertebral space between vertebral bodies of a spine. The implant includes a spacer portion having an inferior and superior surface, wherein the inferior and superior surfaces each have a contact area capable of engaging with anatomy in the treated area, and the inferior and superior surfaces define a through-hole extending through the spacer body. The present invention further provides screw holes extending from a side portion to the inferior and superior surfaces of the spacer portion and a plate portion coupled to the spacer portion through a coupling means, wherein the plate portion contains screws holes for receiving screws. A screw back out prevention mechanism adapted on the plate portion and prevents the back out of screws from the screw holes.

Abstract: An expandable interbody fusion device configured for placement into the intradiscal space between vertebral bodies in a lumbar spine from a lateral approach. The device is expanded by the insertion of a plurality of wafers into the device in situ. The length of the device is configured to extend on the vertebral body endplate from pedicle to pedicle and to reside interiorly of the ring apophysis with at least a portion of the device resting on the area of increased bone density at the posterior portion of the endplate between the pedicles.

Abstract: Various surgical devices and methods for facilitating distraction of adjacent vertebrae and/or insertion of an intervertebral implant material therebetween are disclosed. The devices include an elongated barrel having a cannula. A distal end of the barrel is configured to engage the adjacent vertebrae. Slots may be formed on at least a portion of the barrel such that at least the distal end of the barrel may be expanded to distract vertebrae. In one embodiment, an inner member is reciprocally positioned within the barrel. The inner member includes features that engage one or more surfaces of the barrel to expand the distal end of the barrel as the inner member moves with respect to the barrel. In some embodiments, cams are used to expand the distal end of the barrel.

Abstract: A spinal fusion surgery instrument for implanting and an intervertebral cage thereof are provided. The spinal fusion surgery instrument includes a body, a gripper subassembly, a first control subassembly, and a second control subassembly. The first control subassembly is provided to generate a displacement between a first connecting member and a second connecting member of the gripper subassembly to change the angle of gripper of the intervertebral cage. The second control subassembly is provided to enable a first gripper member and a second gripper member of the gripper subassembly separating smoothly from the dowel pins of the intervertebral cage. By means of the operation model, the spinal fusion surgery instrument may be controlled easily, and the orientation of the intervertebral cage may be promoted in the process of the surgery.

Abstract: Systems, methods and devices for providing stabilization between first and second vertebrae are provided. More particularly, in one form a system includes an implant configured to be positioned in a disc space between the first and second vertebrae and a freestanding plate for engagement with extradiscal surfaces of the first and second vertebrae. The system also includes an insertion instrument with an engaging portion configured to releasably engage with the implant and the plate such that the implant and plate can be positioned together relative to the first and second vertebrae. In one aspect, an angular orientation of the implant relative to the plate is adjustable when the implant and the plate are engaged by the instrument. In this or another aspect, the implant and plate are held in a contiguous relationship when engaged by the instrument. However, different forms and applications are also envisioned.

Abstract: An orthopedic tool for loosening the connection between orthopedic components. In one embodiment, the orthopedic tool includes a housing and a wedge. The housing has a head, an upper portion, a lower portion, and an opening between the upper and lower portions. The wedge is positioned at least partially between the upper portion and the lower portion of the housing and is actuatable to move toward the head of the housing. When at least a portion of the head of the housing is placed in mating engagement with the junction between two assembled orthopedic components, advancement of the wedge towards the head results in separation of the upper portion and lower portion of the housing. Thus, as the wedge is advanced toward the head, the upper and lower portions of the housing are separated, which results in corresponding separation of the assembled orthopedic components.

Abstract: A modular femoral hip implant trialing system. The system generally includes a proximal body, a fastener, and a fastener retention member. The proximal body includes a proximal bore, a tapered distal bore, and a passageway connecting the proximal bore to the distal bore. The proximal bore, the distal bore, and the passageway are aligned along a first axis. The fastener includes a head in the proximal bore and a stem in the distal bore, the fastener is aligned along the first axis. The fastener retention member is positioned in the proximal bore and is operable to retain at least a portion of the fastener within the proximal bore.

Abstract: Disclosed is a modular trial system to select a neck length. The system may be in a hexagonal or click embodiments. A neck member may having at least a locating step with a locating step face. A head member may have at least a first groove and a second groove in an internal bore. The head member may be rotated relative to the neck member to select various trial lengths of the neck.

Abstract: A prosthetic device comprising an upper member, and a lower member having a conical terminating section, the conical terminating section fitting into a conical void defined in the upper member. A prosthetic device kit, comprising an upper member and a number of lower members each having a conical terminating section in which the conical terminating sections of each lower member fit into a conical void defined in the upper member.

Abstract: A device for connecting a pump, having a through-hold provided in a prosthesis shaft, wherein the device comprises at least one channel having a first outlet for connecting to the through-hole in the prosthesis shaft and a second outlet which can be connected to the pump and at least one valve, wherein the valve can be switched to a first mode and to a second mode, and the valve is a one-way valve in the first mode and a two-way valve in the second mode.

Abstract: A prosthetic device includes a first place including a first end portion arranged for attachment to a foot member of a prosthetic foot. A second end portion is arranged to extend freely over at least a portion of the top surface of the foot member. A second plate includes a first end extending over a heel member of the prosthetic foot and a second end extending over and attached to the second end portion of the first plate. The second end portion of the first plate situated between the foot member and the second plate. A pump mechanism includes a housing secured to the second plate and a membrane operatively connected to the first place and the housing. The pump mechanism defines a fluid chamber between a bottom surface of the housing and a top surface of the membrane.

Abstract: An artificial blood vessel that can be transplanted to blood vessels with a small diameter, can be adjusted to an arbitrary size of a diameter, improves in invasiveness when a graft is taken, and overcomes the problem on the provision of a graft is provided. An artificial blood vessel prepared from a decellularized tubular structure, which is prepared by processing a decellularized, sheet-like blood vessel (decellularized blood vessel sheet) into a roll structure, and a tissue adhesive, wherein a portion which is contacted with blood that flows within the artificial blood vessel consists of the tissue of the tunica intima lined with the tissue of the tunica media whereas a portion of the sheet that overlaps when the sheet is processed into a roll structure (overlap width) consists of the tissue of the tunica media and wherein a tissue adhesive is applied to the overlap width.

Abstract: The drug eluting folded stent and a stent delivery system, which includes a stent having a plurality of struts interconnected to form a tubular body. At least one of the struts includes a U-shaped strut having in cross-section a first leg, a second leg, and a closed end connecting the first leg and the second leg, wherein the first leg, the second leg, and the closed end define a recess having a drug release opening opposite the closed end; and a drug coating disposed on the first leg, the second leg, and the closed end within the recess. The drug release opening is sized to release a drug from the drug coating at a predetermined drug elution rate.

Abstract: A delivery device for deploying an expandable prosthesis and method of use thereof are described. The delivery device includes an outer sheath that is capable of retracting in a proximal direction and resheathing over the prosthesis in a distal direction. The device includes a drive pulley that can engage gears to retract or resheath the outer catheter in relation to the prosthesis. In some embodiments, the delivery device may include a reinforced outer sheath disposed over an inner elongate member, the reinforced outer sheath comprising a proximal section reinforced with a braid, a distal section reinforced with a coil and an overlapping section extending between the proximal section and the distal section. Additionally or alternatively, the delivery device may include a stabilizing element for releasably holding the stent to the inner catheter.

Abstract: A catheter device having a shaft that extends from a proximal end to a distal end to carry on its distal end a self-expanding implant for intraluminal advance on a guidewire and delivery of the implant to an implant site by proximal withdrawal of a sheath that lies radially outside the implant in the catheter, the catheter including a first shaft element to pull the sheath proximally and a second shaft element to push the implant distally to prevent the implant moving proximally with the sheath when the sheath is pulled proximally, wherein the second shaft element carries a stopper for abutting the implant, the stopper including proximal and distal portions having different radiopacities.

Abstract: A system for mechanically deploying intraluminal implants is disclosed. The system is used with an implant that is delivered and/or deployed via a pull wire and includes a handle having a funnel and receiving channel for receiving the pull wire, a slider having a thumb grip and a wedge, and a shuttle having a grabber for grasping the pull wire. The thumb grip is pulled proximally to retract the wedge to cause the grabber to grasp the wire and retract the shuttle but not the wire. An extension spring linked between the slider and the shuttle abruptly pulls the shuttle to retract the pull wire after the slider is fully retracted.

Abstract: A method for performing a gastrectomy (stomach reduction surgery).

Abstract: Described herein is a device, comprising a base and a positioning member, for preventing or reducing the severity of external hemorrhoids in a patient during childbirth. The base has a first longitudinal axis and a surface extending from a first side of the base in a first direction corresponding to a height of the surface, which has a second longitudinal axis with a constant angular orientation relative to the first longitudinal axis, is of a size greater than the anal orifice, is anatomically configured to contact only the perianal region and to not substantially enter the anal canal or substantially interfere with the birthing canal. The positioning member extends from a second side of the base in a second direction away from the first side, and includes a substantially rigid structure configured for gripping by a user to position and hold the device against the anal orifice.

Abstract: A hand-and-wrist brace that includes a body having first and second support members, both having inner and outer surfaces, the first support member having a first position along a wrist support path where the left and right ends are uncoupled and a second position along the wrist support path where the left and right ends are coupled to substantially encapsulate a user's wrist, and the second support member having a proximal end, a distal end, extending outwardly from and coupled to an upper end of the first support member, having a first position along a secondary support path with distal end uncoupled to the first support member, and having a second position along the secondary support path with the distal end being removably-couplable to a plurality of locations on the outer surfaces of both the first support member and the second support member.

Abstract: An orthopedic knee brace includes an upper medial upright; a lower medial upright; an upper lateral upright; a lower lateral upright; a medial hinge connected rotatably to the upper and lower medial uprights; a lateral hinge connected rotatably to the upper and lower lateral uprights; and wherein one of the medial and lateral hinges is configured such that its respective uprights rotate from a flexion to an extended relative positioning while striking a radially-decreasing arc, while the other of the medial and lateral hinges is configured such that its respective uprights rotate from a flexion to an extended relative positioning while striking a radially-increasing arc.

Abstract: An easily-accessible, self-adjustable orthopedic clavicle brace and method of use for preventing and treating damage to the clavicle. The brace supports the shoulder region of a user's body during the healing or mending of an injured, dislocated, fractured or broken clavicle. The device uses a simple coupling means located towards the front of the user to allow for easy accessibility by the user for self-application, self-adjustment, and self-removal of the brace without having to rely on assistance by a second party.

Abstract: A surgical cast venting material comprises a waterproof, flexible substrate made of a plastics material and having first and second sides. The first side has a plurality of shallow, concave recesses distributed over the substrate and spaced-apart from one another while the second side has a plurality of protrusions distributed across the substrate. The substrate is perforated with a plurality of small holes distributed across its length and width. Also, a surgical cast venting device is disclosed for venting a bent region of a patient's limb. It has a flexible, central portion that can cover a major part of the bent region of the limb including opposite side surfaces and a front or rear surface. The device also has flexible connecting straps extending from two corners of the central portion.

Abstract: A heel float therapeutic footwear for people that spend a large amount of time in bed. The heel float therapeutic footwear includes a lower leg support portion, a foot support portion, and a wing support structure. The foot support portion extends from the lower leg support portion and includes a foot support platform. The wing support structure is permanently attached to the foot support platform. The wing support structure is adjustably fastenable to a side of the lower leg support portion to adjustably support a position and an angle of the foot support platform with respect to the lower leg support portion. A method of making a heel float therapeutic footwear is also disclosed.

Abstract: A dilation apparatus comprises an elongate member and a dilation assembly that is slidable along the elongate member. The dilation assembly comprises a platform and an inflatable dilator. The platform and the elongate member cooperate to absorb inflation forces from the dilator directed toward the longitudinal axis of the elongate member, such that the dilation forces are exerted against tissue asymmetrically relative to the longitudinal axis of the elongate member. The dilation apparatus may be used to dilate the ethmoid infundibulum in a human patient. Various devices may be used to maintain the dilated state of an ethmoid infundibulum, including a wedge, a mesh, and a tether. An illuminator may be configured to reach around an uncinate process, retract the uncinate process, and then illuminate the ethmoid infundibulum to provide improved visualization of the ethmoid infundibulum.

Abstract: An apparatus for assisting in copulation and preventing discomfort due to testicular retraction or displacement (e.g., retractile testicle) during copulation and other activities is disclosed. The apparatus substantially encompasses, circumferentially, the upper portion of the shaft of a penis without constricting the urethra area at the base of the shaft of the penis. The apparatus further conforms to the torso behind the scrotal sack (i.e., between scrotum and torso) to prevent undesired movement of testicles into the abdomen area. The apparatus has a substantial U-shape, the legs curving inwardly toward respective anchoring nodes. Anchoring nodes may be included at the end of each leg of the apparatus to assist in minimizing movement of the apparatus while in use. The apparatus may rigid or may be slightly flexible and, when in use as a copulation aid, provides pressure to restrict outflow of blood from corpora cavernosa thus assisting to maintain erection.

Abstract: A percutaneous ostomy implant for implantation into the abdominal wall of a patient is provided, which includes a connecting member for mounting an external detachable device thereto; a first tubular ingrowth member depending from the connecting member; and a second tubular ingrowth member depending from the connecting member and being radially outwardly spaced from the first tubular ingrowth member. The first tubular ingrowth member is configured and dimensioned to receive a bowel segment within it to allow the stoma and serosal tissue of that bowel segment to infiltrate the first tubular ingrowth member. The second tubular member is configured and dimensioned to abut dermal tissue to allow the dermal tissue to infiltrate the second tubular ingrowth member, thereby securing and sealing the ostomy implant to the dermis.

Abstract: A nasal cannula includes a cannula body having a passageway extending therethrough from a first end to a second end and an airflow restrictor coupled to the cannula body and positioned to selectively restrict air flow through the passageway during exhalation. A flow regulator is settable to a plurality of airflow positions and cooperates with the airflow restrictor to regulate the air flow during exhalation such that the air flow during exhalation is variable in response to the airflow position of the flow regulator. In one embodiment, an airflow restrictor is deformable from an at-rest configuration to an inhalation configuration during inhalation, and exerts a substantially constant backpressure during exhalation for a predetermined range of expiration flow rate. Methods of use are also provided.

Abstract: A method and apparatus for diagnosing sleep apnea and for comfortably fitting an oral device to treat the condition. The patient is screened to reduce snoring using a device which changes the airway, and then using an airway dilation simulator having sequentially sized elements to determine the mandibular position maximizing the upper airway dimension. An oral device is then fabricated to retain the maximum position during sleep.