Abstract: A hybrid medical device that can aid in reconstructive or augmentative surgery of the breast is disclosed. The device can utilize a suitable biological collagen tissue matrix combined with a synthetic material, for example, that can impart a high initial strength to the repair site while permitting proper healing and revitalization of the implanted device.

Abstract: Blood filter devices and methods of use.

Abstract: Bio-selective textured surfaces are described which mediate foreign body response, bacterial adhesion, and tissue adhesion on devices implanted in a mammalian body. Hierarchical levels of texture, some capable of establishing a Wenzel state others a Cassie state, are employed to interface with living structures, either to promote or discourage a particular biological response/interaction. Since a gaseous state is traditionally required to establish a Cassie or Wenzel state, and gases do not remain long in living tissue, described are tissue/device interactions analogous to the above states with the component normally represented by a gas replaced by a bodily constituent, wherein separation of tissue constituents develops and a desired interaction state evolves.

Abstract: A stent according to the present invention includes: a stent main body that has a plurality of holes formed in the surface thereof and a circumferential part of which the inside is hollow; and a cover that covers one side of the outer circumferential surface of the stent main body, in which the stent main body has an exterior path that provides a channel through which the body fluid secreted from a diverging duct can flow along the longitudinal direction of the stent main body to the outside of the cover.

Abstract: The new variable power accommodative intraocular lens is comprised by a central body or optical zone that has at least four refracting interfaces that separate different materials. These are connected by means of a substrate that holds them in an equatorial manner, and which includes the bases of the fasteners of the lens embedded in its core. The lens changes its power in response to variations in the equatorial diameter of the materials that comprise the optical zone. Thanks to its design, the lens can achieve variations in the optical powers greater than one diopter per micrometer of equatorial compression. This is achieved through the real change of the curvature radii of the refracting interfaces that comprise the optical zone, as well as the central thicknesses along the length of the optical axis of the different materials that limit said refracting interfaces.

Abstract: An intra-annular mounting frame for an aortic valve having native aortic cusps is provided which includes a frame body with native leaflet reorienting curvatures and interconnecting points; the curvatures shaped to be received inside the valve below the native aortic cusps and to reorient the native aortic cusps within the aortic valve, where each of the curvatures extends concavely upward from a reference latitudinal plane tangential to each curvature's base.

Abstract: A cardiovascular prosthetic valve, the valve comprising an inflatable cuff comprising at least one inflatable channel that forms, at least in part, an inflatable structure, and a valve coupled to the inflatable cuff, the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction, the valve comprising a plurality of tissue supports that extend generally in the axial direction and that are flexible and/or movable throughout a range in a radial direction.

Abstract: Embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support member is positioned to at least partially surround the native leaflets of a valve. A locking member is used to couple both ends of the support member, forming a support band. An expandable prosthetic heart valve is delivered into the native heart valve and expanded while the expandable prosthetic valve is at least partially within the support band, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support band and the expanded prosthetic heart valve.

Abstract: A lubricated tubular graft is implanted in the inferior vena cava and the superior vena cava in order to control the inflow of blood to the right atrium. A bifurcated leg with a non-collapsing stent extends across the tricuspid valve. A bioprosthetic valve is positioned proximal of the stent in the bifurcated leg in order to regulate flow through the tricuspid valve and to eliminate tricuspid regurgitation.

Abstract: A valved conduit including a bioprosthetic valve, such as a heart valve, and a tubular conduit sealed with a bioresorbable material. The bioprosthetic heart valve includes prosthetic tissue that has been treated such that the tissue may be stored dry for extended periods without degradation of functionality of the valve. The bioprosthetic heart valve may have separate bovine pericardial leaflets or a whole porcine valve. The sealed conduit includes a tubular matrix impregnated with a bioresorbable medium such as gelatin or collagen. The valved conduit is stored dry in packaging in which a desiccant pouch is supplied having a capacity for absorbing moisture within the packaging limited to avoid drying the bioprosthetic tissue out beyond a point where its ability to function in the bioprosthetic heart valve is compromised. The heart valve may be sewn within the sealed conduit or coupled thereto with a snap-fit connection.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent extending between a proximal end and a distal end. The stent includes an annulus section adjacent the proximal end and having a first diameter, a plurality of first struts forming cells, and a plurality of second struts connected to the annulus section and forming a plurality of deflecting cells expandable to define a second diameter larger than the first diameter. A valve assembly is disposed within the stent and a cuff is coupled to the stent and covers the plurality of deflecting cells.

Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: A prosthetic heart valve configured to replace a native heart valve and for post-implant expansion and having a valve-type indicator thereon visible from outside the body post-implant. The indicator communicates information about the valve, such as the size or orifice diameter of the valve, and/or that the valve has the capacity for post-implant expansion. The indicator can be an alphanumeric symbol or other symbol or combination of symbols that represent information about the characteristics of the valve such as the valve size. The capacity for post-implant expansion facilitates a valve-in-valve procedure, where the valve-type indicator conveys information to the surgeon about whether the implanted valve is suitable for the procedure and informs the choice of the secondary valve.

Abstract: A delivery device (10) for an implantable medical device includes an inner shaft (26) extending in a longitudinal direction and defining a compartment (23) adapted to receive the medical device in an assembled condition, an outer shaft (22) surrounding a longitudinal portion of the inner shaft, and a distal sheath (24) operatively attached to the outer shaft (22). The distal sheath (24) is slidable between a first position enclosing the compartment (23) and a second position exposing the compartment (23) for deployment of the medical device. A sleeve 30 surrounds at least a longitudinal portion of the outer shaft (22) and provides a substantially blood tight bearing surface that facilitates sliding movement of the delivery device (10) in an introducer (2).

Abstract: Disclosed is a medical system for short time replacement and repair of a native valve, which comprises an artificial valve (502); and a device for collecting and arranging chordae and/or leaflets to hold and/or stabilize the artificial valve in a desired position, the device comprising: a unit for grasping a plurality of chordae and/or leaflets. The system and/or device allows for fast and easy replacement of a native valve, fast and easy positioning of a temporary artificial valve, and more time for medical personnel to make decisions, prepare and/or perform surgery/medical intervention.

Abstract: A system for treating mitral valve regurgitation includes a tensioning device having a plurality of helical anchors and a tensioning filament. One embodiment of the invention includes a method for attaching a tensioning device to the annulus of a mitral valve in a trans-leaflet configuration, and applying a tension force to the tension filament in order to exert force vectors on the annulus, thereby reshaping the mitral valve annulus so that the coaption of the anterior and posterior leaflets of the mitral is improved during ventricular contraction.

Abstract: Annuloplasty device for implantation adjacent an annulus of a tricuspid valve, the annulus comprising anterior, posterior and septal aspects adjacent anterior, posterior and septal leaflets, respectively, of the tricuspid valve, the device comprising: a ring body comprising: an anterior portion, a posterior portion and a septal portion shaped to conform to, and for implantation adjacent, the anterior, posterior and septal aspects of the annulus, respectively; and first and second end portions that are more flexible than a remainder of the ring body to provide a gradual transition from the remainder of the ring body to tissue of the tricuspid valve annulus; wherein the ring body is curvilinear, with substantially no flat portions, and forming a shape. Related devices, kits and sizer devices.

Abstract: Improved methods and apparatuses for heart valve repair in a beating heart of a patient utilize an exchangeable heart valve repair system. Heart valve repair system can include a port adapted to be seated in the heart wall and a catheter slidable within the port. The catheter can be selectively locked relative to the port for insertion into the heart and unlocked once the port is seated to allow the catheter to move distally towards target tissue. System elements can be selectively removed from and replaced within port to deploy repair devices while port maintains a seal while elements are and are not inserted.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a surgical delivery instrument, a valve repair device, and a paddle control mechanism. The surgical delivery instrument has at least one lumen. The valve repair device is configured to be delivered through the lumen of the surgical delivery instrument and to attach to a native valve of a patient. The valve repair device includes a first paddle, a second paddle, and a pair of gripping members. The first and second paddles are movable between an open position and a closed position. The paddles and the gripping members are configured to attach to the native valve of the patient. The paddle control mechanism is configured to move the first and second paddles independently of each other.

Abstract: A system for implanting a prosthetic device with an opening into a bone includes a plug that is removably received within the opening of the prosthetic device. The system also includes a bone removal tool that advances into the bone from outside the bone and that removes a portion of the bone while advancing into the bone to reveal the plug. The bone removal tool includes a plug engaging portion that engages with the plug. The bone removal tool at least partially removes the plug from the opening of the prosthetic device while engaged with the plug. Moreover, the system includes an alignment system that detects whether the bone removal tool and the plug are substantially axially aligned.

Abstract: A method for fixating a dysfunctional sacroiliac joint for SI joint fusion including implanting a joint implant at the sacroiliac joint. The joint implant may include a body extending a length between a proximal end and a distal end, an exterior surface, an interior surface opposite the exterior surface and defining an internal volume therein, a wall thickness extending between the exterior surface and the interior surface, a proximal opening extending into the internal volume, and a first plurality of voids along the length and extending through the wall thickness from the exterior surface to the interior surface. The first plurality of voids may be arranged along the length in a repeating pattern of a group of voids, wherein each void of the first plurality of voids is generally polygonal in shape.

Abstract: An orthopedic implant comprising: (a) a distal femoral component comprising a first condyle bearing surface having a first profile comprising at least three consecutive arcs of curvature; and (b) a proximal tibial component comprising a first condyle bearing surface having a second profile comprising at least three parallel arcs of curvature.

Abstract: A method and apparatus for replacing damaged meniscal tissue includes a meniscus implant including a porous body having a plurality of interconnected open micro-pores and one or more open cavities for receiving meniscal tissue. The interconnected micro-pores are arranged to allow fluid to flow into the porous body and are in fluid communication with the one or more open cavities.

Abstract: A modular patella trial system and method is provided. A modular patella trial includes an articular element and at least one sizing element. The articular element has a length, a width, and a thickness. The articular element has a posterior and anterior surfaces separated by their thickness. The anterior surface has protrusions extending outwardly. Any of the sizing elements have a length, width, and thickness. Any such sizing elements have posterior and anterior surfaces separated by their thickness. At least one aperture extends through the posterior and anterior surfaces of the sizing elements. Such apertures are capable of receiving a corresponding protrusion of the articular element. The modular patella trial has a thickness substantially equal to the total of the thicknesses of the articular element and the sizing elements used in conjunction with the articular element.

Abstract: A method and implant to treat anterior cruciate ligament (ACL) injuries are disclosed. The method involves advancing the insertion of the patellar ligament to the proximal tibia. The implant includes a spacer (30) which is inserted between the patellar ligament and the tibia and fixed to the tibia. The spacer decreases the angle between the patellar ligament and the tibia plateau and consequently modifies the internal joint force, restoring stability to the joint even if the ACL is ruptured. The method and implants are applicable to both human and canine patients.

Abstract: A bearing for a total or partial joint replacement prosthesis: the bearing having a body and a reinforcing element which strengthens the bearing and which forms an attachment member, and/or the bearing being formed at least partially from polymeric or composite material the bearing comprising a lower modulus portion and a higher modulus portion, one portion of the bearing being at least partially encased by the other portion of the bearing. Also provided is a method for of forming the bearing, and a total or partial joint replacement prosthesis comprising the hearing.

Abstract: A cemented tibial prosthesis having a bone-contacting surface with a porous outer rim. With the bone-contacting surface seated against a resected proximal tibia, bone cement or another suitable adhesive will travel into the pores of the porous outer rim to enhance the connection between the tibial prosthesis and the tibia.

Abstract: Methods for altering the natural history of degenerative disc disease and osteoarthritis of the spine are proposed. The methods focus on the prevention, or delayed onset or progression of, subchondral defects such as bone marrow edema or bone marrow lesion, and subchondral treatment to prevent the progression of osteoarthritis or degenerative disc disease in the spine and thereby treat pain.

Abstract: A placeholder for vertebrae or vertebral discs includes a tubular body, which along its jacket surface has a plurality of breakthroughs or openings for over-growth with adjacent tissue. The placeholder includes at least a second tubular body provided with a plurality of breakthroughs and openings at least partially inside the first tubular body. The first and second tubular bodies can have different cross-sectional shapes, can be are arranged inside one another by press fit or force fit or can be connected to each other via connecting pins and arranged side by side to one another in the first body.

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 has a bore therein from a proximal end to a distal end thereof to accept the interbody device in an unrelaxed shape. The distal end is shaped for insertion into an intervertebral space. The insertion rod may be positioned within the bore of the insertion guide whereby the interbody device is positioned within the intervertebral space by advancing the insertion rod into the insertion guide.

Abstract: A vertebral insert may include a first linkage, a second linkage, and a third linkage. The first, second, and third linkages may at least partially defining a cavity. The insert may be movable between a collapsed configuration and an expanded configuration, and the movement of the first and second linkages with respect to one another may be configured to reciprocally move the insert between the collapsed and expanded configurations.

Abstract: Disclosed is an expandable interbody fusion implant that is configured to have an initial configuration having a first footprint width suitable for being inserted into an intervertebral space and an expanded configuration having a second footprint width that is greater than the first footprint width. The implant may include a first body member and a second body member that is pivotally coupled to the first body member. The implant may be expanded using an inflatable balloon. The implant may be expanded bilaterally such that both body members rotate relative to the other or the implant may be expanded unilaterally such that one of the body members rotates relative to the other.

Abstract: An expandable implant for engagement between vertebrae includes an inner member, an outer member, and a gear member positioned coaxial with respect to each other such that the inner and outer members are moveable relative to each other along an axis. The inner member includes a longitudinal groove configured to engage a pin extending through the outer member such that the pin prevents the inner member from translating completely through the outer member and aids in alignment and limits rotation of the second endplate. Portions of the implant may be provided with a series of markings such that when the markings are aligned, the implant is aligned in a specific configuration and for a specific implantation approach.

Abstract: Disclosed is an assembly and method for implant installation between adjacent vertebral bodies of a patient. The implant has a support body and a rotatable insert therein and the support body is curved for installation between adjacent vertebral bodies transforaminally. An installation instrument is also disclosed for removable attachment to implant and engagement with the rotatable insert to selectively permit rotation between the insert and the support body. The installation instrument extends along a longitudinal tool axis and when the installation instrument is in a first position the insert is rotationally fixed with respect to the support body and when the installation instrument is in a second position the support body may rotate with respect to the insert.

Abstract: The embodiments of the present disclosure relate to a spinal implant assembly having features to prevent or minimize fixation elements, such as screws, from being dislodged, or from backing out over time and with use. The spinal implant assembly may comprise an implantable body having first apertures for receiving fixation elements. A plate configured to nest against the posterior portion of the implantable body and comprising one or more second apertures can be provided. These second apertures permit access to the head portions of the fixation elements. One or more locking elements are then passed through the second apertures and engage the head portions of the fixation elements. In addition, the plate may comprise an adjustable arm to allow the plate to be used with implantable bodies of different size.

Abstract: An intervertebral implant frame that is configured to engage a spacer can include a pair of arms that extend longitudinally from a support member such that the arms engage the spacer. The spacer can be made from bone graft, and include a first spacer body made of cortical bone, and a second spacer body made of cancellous bone.

Abstract: A total artificial expansile disc and a method for posterior insertion between a pair of vertebral endplates are disclosed. The total artificial expansile disc includes at least one pair of substantially parallel plates that move apart along a first axis, in order to occupy a space defined by the vertebral endplates. In another embodiment, each of substantially parallel plates includes a first plate and a second sliding plate. An expansion device or tool is used to move the substantially parallel pair of plates apart along the first axis. A core is disposed between the pair of plates, and the core permits the vertebral endplates to move relative to one another. A ball limiter or ball extender prevents the core from being extruded from between the substantially parallel plates.

Abstract: A method for inserting an intervertebral disc prosthesis into a space between two vertebrae involves inserting the prosthesis partway into the space under constraint to prevent endplates of the prosthesis from articulating, releasing the prosthesis from constraint, and inserting the unconstrained prosthesis farther into the space. In some embodiments, the method involves grasping the prosthesis with a grasping device to insert the prosthesis partway under constraint, loosing the grasping device to release the prosthesis from constraint, and pushing the prosthesis farther into the disc space using the grasping device and/or one or more separate pusher devices. A system includes a grasping device, at least one separate pushing device, and optionally a vertebral spreading device and/or a vertebral midline indicator device.

Abstract: A prosthetic ankle and foot combination has an ankle joint mechanism constructed to allow damped rotational movement of a foot component relative to a shin component. The mechanism provides a continuous hydraulically damped range of ankle motion during walking with dynamically variable damping resistances, and with independent variation of damping resistances in the plantar-flexion and dorsi-flexion directions. An electronic control system coupled to the ankle joint mechanism includes at least one sensor for generating signals indicative of a kinetic or kinematic parameter of locomotion, the mechanism and the control system being arranged such that the damping resistances effective over the range of motion of the ankle are adapted automatically in response to such signals. Single and dual piston hydraulic damping arrangements are disclosed, including arrangements allowing independent heel-height adjustment.

Abstract: An ankle brace for a prosthetic device includes a prosthetic foot and a lower leg piece. The ankle brace may bridge a gap between the prosthetic foot and the lower leg piece. The ankle brace may include a main member which is made of a flexible material and includes a cavity for accommodating the prosthetic device. At least one reinforcement element may be arranged on the main member which may increase the inherent stability of the ankle brace.

Abstract: A stent includes a tubular support structure extending from a distal end to a proximal end, the tubular support structure including an inner surface and an outer surface. A retractable anchor system is disposed relative to the tubular support structure and includes a frame member and a plurality of retractable anchors secured to the frame member. The plurality of retractable anchors are biased to a deployed configuration in which the plurality of retractable anchors extend radially outward from the outer surface of the tubular support structure but are radially inwardly compressible into a delivery configuration.

Abstract: An endoprosthesis may include an expandable tubular framework expandable from a compressed state to an expanded state and include a plurality of strut rows, wherein adjacent strut rows define interstices spacing the adjacent strut rows apart, and a plurality of connectors extending across the interstices and interconnecting adjacent strut rows, at least some of the plurality of connectors defining a flexible hinge portion. The lengths of the interstices between adjacent strut rows may vary along the length of the expandable tubular framework. The plurality of connectors extend radially outward beyond an outer diameter of the plurality of strut rows in the expanded state. The plurality of connectors are configured to engage a wall of a body lumen in the expanded state to inhibit migration of the endoprosthesis subsequent implanting the endoprosthesis in the body lumen.

Abstract: The present invention relates to an endoluminal device for implantation in a body lumen, such as a pancreatic duct. The device is provided with a distal end region having greater flexibility than that of a medial region of the device.

Abstract: A stent delivery assembly and methods of use are provided. The assembly can comprise a catheter, a cover member, a core member, a stent, and a stent retention mechanism. The stent can extend within the cover member lumen and have a section extending at least partially between an inner layer of the cover member and the core member. The stent retention mechanism can be coupled to the core member and comprise an outer surface that is configured to exert a radially outward force against the stent for axially restraining the stent relative to the core member when the stent is in contact with the inner layer of the cover member.

Abstract: Methods for delivering and deploying an endovascular graft to the common and internal iliac arteries are described. A system including a pre-loaded delivery device with a releasably attached extension cannula and an extension sheath for use with such methods is also described.

Abstract: A gastrointestinal implant device (2800) comprises a planar proximal element (220) configured to reside in a stomach to resist distal migration, a distal element (222) configured to reside in an intestine to resist proximal migration and one or more tethers (224) coupling the planar proximal element to the distal element.

Abstract: An access port comprising a port body and a catheter, the port body defining a cavity into which a fluid can be delivered or extracted through one side of the port body, the catheter being in communication with the cavity and being disposed on an opposed side of the port body, thus protecting the catheter from needle stick damage. An access port comprising a port body and a catheter, the port body defining a cavity into which a fluid can be delivered or extracted from through one side of the port body, the port body being configured to extend partly through a hole in the body of a patient in which the access port is implanted and thus plug the said hole. The port body comprising integral means for anchoring the port body to the body of the patient. Also is provided a method for anchoring the access port to the hole and extracting the access port from the hole as well as the applicator, extractor and delivery sheath for anchoring and extracting the access port.

Abstract: A foot support for a prosthetic boot has a shape-holding layer and cushion layers on opposite sides of the shape-holding layer. Covers made of nylon and vinyl laminates surround the layers. The vinyl laminates are fused by welding edges of the cover around the foot support. The edge welding surrounds the foot support. An inner parallel welding holds a valve and forms an inflation passage. The inner welding continues around concave curved edges of the shape-holding and cushion layers and terminates where it rejoins the outer welding, forming an inflatable tarsal and metatarsal supporting chamber. A small hard pump has two ends to either increase or reduce pressure in the supporting chamber.

Abstract: An ostomy pouch replacement device is provided to allow ostomates with a surgically created stoma to collect, contain and dispose of bodily fluids during frequent hygienic maintenance. The device is customizable to each ostomate's unique stoma diameter and provides a disposable waste receptacle designed to have a hollow absorbent section and a solid absorbent section for sanitary, discreet and odorless disposal of both urine and excrement. The device preferably consists of a disposable waste receptacle that may be positioned over the stoma and further includes an absorbent inner material for capturing any waste that may be discharged, a push cap for pressing the absorbent material to the stoma, a cap or plug for sealing the device after use, and a collar stand for pressing an adhesive wafer to the skin and for holding the assembled device in an upright position.

Abstract: An ostomy closure is disclosed for sealing an ostomy pouch after use and removal from an ostomy mounting plate. The ostomy closure may comprise a flexible storage bag having a bag base and a bag opening and define a bag chamber. The bag base may couple to an exterior surface of the ostomy pouch. The bag opening may retract over the ostomy pouch and define a bag pouch enclosure for encapsulating the ostomy pouch within the bag chamber to prevent leakage of contents within the ostomy pouch from and through flexible storage bag upon being securely sealed at an opened end.