Abstract: A gel cap is loaded on a folded flange of a voice prosthesis which is loaded on an end portion of an inserter, wherein a tip of the end portion is pressed against a valve flap of the voice prosthesis. The voice prosthesis includes a strap that is stretched for engagement with an attachment portion on the inserter. The voice prosthesis, gel cap, and inserter are inserted into the tracheoesophageal puncture. The patient then swallows fluids to cause the gel cap to dissolve to allow the esophageal flange to deploy, whereby upon deployment of the esophageal flange, the tip of the end portion of the inserter presses the valve flap open, allowing the inserter to move axially relative to the voice prosthesis until a stop collar of the inserter engages the voice prosthesis providing external visual confirmation to the user that the gel cap has dissolved and the esophageal flange has deployed.

Abstract: A stent constructed from at least two individual monolithic stent units is provided. The stent includes at least two individual stent units. Each individual stent unit has, as a monolithic structure, a first strut, a second strut, and a third strut. A first apex adjoins the first and second struts, and a second apex adjoining the second and third struts, where the second apex is disposed in a direction generally opposite the first apex. The monolithic stent unit includes an attachment mechanism at the end of at least the first strut. The first strut of each monolithic stent unit is joined at an attachment point to the third strut of an adjacent monolithic stent unit. The attachment mechanism is bent to form an angle relative to the attachment point. A method of manufacturing the same stent also is provided.

Abstract: Materials and methods for repairing or replacing an intervertebral disc or disc nucleus using natural biological tissue. The tissue may be used alone without an additional core material, or it may be used to encapsulate an elastomeric or hydrogel core. When used alone the tissue may be rolled, folded, braided, or layered to provide a solid plug of natural biological material. When used to encapsulate an elastomeric or hydrogel core the tissue acts as a constraining jacket to support the core. The natural tissue implants may further include a drawstring to assist in folding the implant when the device is implanted in an intervertebral disc space. Multiple units of the natural tissue implants may be used together.

Abstract: A venous valve apparatus, system and method for valve replacement. The valve includes a valve frame, a valve leaflet joined to the valve frame, and a support frame. The valve leaflet includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid. The support frame meets the valve frame on an axis, where the valve frame and the support frame extend from the axis in an opposing direction. The system further includes a catheter, where the valve can be reversibly joined to the catheter at a location between a proximal end and a distal end of the catheter. The system can be used to deploy the valve from the catheter at a predetermined location.

Abstract: A prosthetic valve assembly for implantation within a native aortic valve using a catheterization technique. The prosthetic valve assembly includes a collapsible and expandable metallic frame. The frame is constructed to resist the recoil forces of the native aortic valve. The frame may be formed with a concave profile. A valvular structure made with pericardial tissue is sewn to the frame for permitting blood flow in one direction. An internal cover is provided along an internal surface of the frame and provides a sleeve which prevents blood from passing through gaps in the frame.

Abstract: A valve prosthesis which is especially useful in the case of aortic stenosis and capable of resisting the powerful recoil force and to stand the forceful balloon inflation performed to deploy the valve and to embed it in the stenotic aortic annulus, comprises a collapsible valvular structure and an expandable frame on which said valvular structure is mounted. The valvular structure is composed of physiologically compatible valvular tissue that is sufficiently supple and resistant to allow the valvular structure to be deformed from a closed state to an opened state. The valvular tissue forms a continuous surface. The valve prosthesis can be delivered percutaneously, surgically, or endoscopically.

Abstract: A stent for use in a bifurcated body lumen having a main branch and a side branch. The stent comprises a radially expandable generally tubular stent body having proximal and distal opposing ends with a body wall having a surface extending therebetween. The surface has a geometrical configuration defining a first pattern, and the first pattern has first pattern struts and connectors arranged in a predetermined configuration. The stent also comprises a branch portion comprised of a second pattern, wherein the branch portion is outwardly expandable from the stent body.

Abstract: A system of reconstruction for a spinal joint allows adjacent vertebrae to move relative to each other in a generally pivotal manner and in a limited sliding manner in either or both of the anterior-posterior direction and the medial-lateral direction. The system includes base components and a middle component. The base components are for attachment to adjacent vertebrae and support a pivoting cooperative engagement of a concave or cup-shaped component with a convex or dome-shaped component.

Abstract: Instrumentation for implanting an artificial intervertebral disc includes static trials and a dynamic trial for determining the appropriate size of disc to be implanted, static trial holders for manipulating the static trials, inserter/impactors for inserting and removing the static trials and for inserting the artificial intervertebral discs, repositioners/extractors for repositioning and extracting the static trials or the artificial intervertebral discs, and a leveler for setting the proper position of the artificial intervertebral disc. Methods for using the same are also disclosed. Features for artificial intervertebral discs and intervertebral spacer devices useful for manipulation by the instrumentation are also disclosed.

Abstract: Instrumentation for implanting an artificial intervertebral disc includes a dynamic trial for distracting an intervertebral space and/or determining the appropriate size of disc to be implanted, which dynamic trial includes a shaft, at least two distal extensions coupled to the shaft, a bifurcated trial having a first trial half of the bifurcated trial coupled to a first of the extensions and having a second trial half of the bifurcated trial coupled to a second of the extensions, and a pin located between the extensions, wherein movement of the pin in a distal direction increases a separation between the extensions, and wherein varying the separation between the extensions varies a separation between the trial halves.

Abstract: Medical devices, and in particular implantable structures, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the formation of blood clots. Also, the devices may be modified to promote endothelialization.

Abstract: A method of implanting a heart valve prosthesis is disclosed. A valve is mounted within a support apparatus that is deformable between an expanded and a reduced cross-sectional condition. The prosthesis can be implanted into a patient's heart, such as during a direct vision procedure through a generally tubular implantation apparatus that maintains the prosthesis in its reduced cross-sectional condition until discharged from the tubular apparatus at a desired implantation site.

Abstract: Knee prostheses are provided. In some embodiments, the knee prostheses include a body formed of a resilient polyurethane having contact surface area that changes during use according to physical loading factors. In some embodiments, the knee prostheses include a femoral component configured for secure engagement with a lower portion of a femur without penetrating the femur and a tibial component configured for secure engagement with an upper portion of a tibia without penetrating the tibia. In that regard, the tibial component is also configured for moving engagement with the femoral component in some instances.

Abstract: An intervertebral spacer device having a pair of opposing plates for seating against opposing vertebral bone surfaces, separated by at least one spring mechanism. The preferred spring mechanism is at least one belleville washer having radially spaced concentric grooves. In a preferred embodiment there is a single such belleville washer which is modified to mount onto a ball-shaped head. The lower plate of this embodiment includes a post extending upwardly from the inner surface of the plate, the post including a ball-shaped head. The modified belleville washer can be rotatably mounted to the head such that the wider portion of the washer seats against the upper plate.

Abstract: Bioresorbable inflatable devices and tunnel incision tool and methods for treating and enlarging a tissue or an organ or a tube or a vessel or a cavity. The device is composed of a hollow expanding pouch made of a resorbable material that can be attached to a filling element. The pouch can be filled with a biocompatible materials, one or more times in few days interval, after the insertion of the device. While filling the pouch every few days the tissue expands and the filling material if it is bioactive start to function. The tunnel incision tool composed of a little blade that emerges from the surface of the tool in order to make shallow incisions in the surrounding tissue therefore enabling easy expansion of the tissue.

Abstract: An implantable, varied-diameter graft is seamlessly flat-woven to provide a seamless, varied-diameter graft. The graft includes a flat-woven tubular portion having opposed first and second tubular ends with a contiguous bulbous woven section therebetween. The bulbous woven section has opposed first and second open ends with the first bulbous end being contiguous with the first tubular end. The second bulbous end is contiguous with the second tubular end. The first tubular end has a first number of warp yarns interlaced with a plurality of fill yarns in a woven pattern to define a first flat-woven tubular diameter. The second end has a second number of warp yarns interlaced with a plurality of fill yarns in a woven pattern to define a second flat-woven tubular diameter. The bulbous section has a third number of warp yarns interlaced with a plurality of fill yarns in a woven pattern to define a third flat-woven tubular diameter.

Abstract: Orthopaedic implants, orthopaedic implant sets, and/or methods for making the same. Aspects and embodiments of the present invention may include orthopaedic implants having an elongated insertion region including proximal, distal, and transition portions, wherein at least portions of at least one face each of the proximal and transition portions are defined by spaced apart constant radii of curvature. The same or other aspects and embodiments may include sets of orthopaedic implants in which proximal portions of the implants grow at different rates than distal portions of the implants. The same or other aspects and embodiments may include methods for making implants and/or sets of implants by studying the geometries of differently sized bony anatomies.

Abstract: An intervertebral spacer device having a pair of opposing plates for seating against opposing vertebral bone surfaces, separated by at least one spring mechanism. The preferred spring mechanism is at least one spirally slotted belleville washer having radially spaced concentric grooves. In a preferred embodiment there is a single such belleville washer which is modified to mount onto a ball-shaped head. The lower plate of this embodiment includes a post extending upwardly from the inner surface of the plate, the post including a ball-shaped head. The modified belleville washer can be rotatably mounted to the head such that the wider portion of the washer seats against the upper plate.

Abstract: An improved total disc replacement system and related methods, wherein a pair of anchor plates, each adapted to engage a vertebral body, and a translating internal member are provided. The translating internal member boasts the ability to move or translate between the anchor plates without compromising the conformity of the interface between the translating internal member and the anchor plates. In a significant aspect, the anchor plates may be locked in place relative to one another after implantation to effect fusion between the vertebral bodies.

Abstract: A modular keel or stem for use as a tibial implant has a central stem portion including a tongue-like coupling portion for insertion into a grooved portion in a bone contacting portion of a tibial baseplate. The modular keel or stem may also include a pair of anti-rotation fins or ribs which extend medially and posteriorly on the medial side and laterally and posteriorly on the lateral side. Proximal portions of the ribs or fins may engage receptacles in the bone contacting of the tibial baseplate. A locking element is provided for engaging the keel or stem coupling portion and the baseplate after the coupling portion of the keel is inserted into the groove to prevent the disassembly the keel from the baseplate. In one embodiment, the baseplate is capable of being inserted in a direction offset from the anterior-posterior direction, such as a medial-lateral direction, after the keel has been implanted. A polymeric bearing insert is provided for placement onto the baseplate in a standard manner.