Abstract: Improvements in plaque removal have been achieved by the applicants' modifications to the Rustogi modification of the Modified Navy Plaque Index. The modification comprise of dividing a tooth into nine separate regions, visual examination each region for plaque; and scoring each region to obtain a plaque index number.

Abstract: Disclosed is an oral care device, comprising: an elongate strip having a major surface; and first and second tabs respectively extending from first and second portions of the major surface. Each of the first and second tabs is movable relative to the strip between a storage position and an operative position. The strip holds an oral care agent at the major surface of the strip. Also disclosed is a stack of the oral care devices located in an airtight package.

Abstract: A hysteropexy apparatus includes a hysteropexy mesh and a package containing the hysteropexy mesh. The hysteropexy mesh includes an anterior vaginal portion that is substantially rectangular in shape, a right broad ligament portion that is substantially L-shaped, a left broad ligament portion that is substantially L-shaped, a sacral portion that is substantially rectangular in shape, and a posterior vaginal portion that is substantially rectangular in shape. The anterior vaginal portion is folded on a longitudinal midline. The sacral portion is folded onto the posterior vaginal portion.

Abstract: Various embodiments of an implant system for treating fecal incontinence are provided. The devices and systems can include a mesh or like device that can include a variable porosity to control the degree of expansion of the anal canal. The mesh can be constructed at least in part of patterned strut members allowing for various geometric configurations, with varying load and tension properties for the designated portions of the device according to the needs for a particular patient application.

Abstract: A system and method of treating vaginal prolapse and incontinence comprises a kit. The kit includes a mesh graft configured for attachment to the anterior and posterior vaginal walls to thereby treat the vaginal prolapse. A graft delivery device is also provided for introducing and placing the mesh graft to a location deep within the peritoneal cavity and for attaching the graft thereto. A leg assembly is provided and coupled to an end of the mesh graft and cooperates with the graft delivery device to anchor and affix the mesh graft to the desired anatomical structures. The method according to the present invention contemplates a laparoscopic graft placement utilizing the components of the kit.

Abstract: Methods, systems, and compositions for treatment are provided. The methods can be used to stretch and completely or nearly completely wrap a composition around an implant or tissue expander. The systems can be used to protect an implant or tissue expander by completely or nearly completely wrapping a composition around the implant or tissue expander. The compositions can be used to completely or nearly completely wrap around an implant or tissue expander to provide support and protection to the implant or tissue expander.

Abstract: The present invention relates to medical prostheses and methods of manufacturing those devices. In particular, the prostheses are temporarily stiffened meshes with particular coatings to provide initial stiffness and thereby permit easier surgical handling for treatment or reconstruction of soft tissue defects. Preferred embodiments include surgical meshes coated with one or more biodegradable polymers that can act as a stiffening agent by coating the filaments or fibers of the mesh to temporarily immobilize the contact points of those filaments or fibers and/or by increasing the stiffness of the mesh by at least 1.1 times its original stiffness. The devices of the invention can also provide relief from various post-operative complications associated with their implantation, insertion or surgical use.

Abstract: A filter assembly and methods of using the filter assembly are disclosed. The filter assembly includes a proximal portion including support members and a distal portion including a mesh. The filter assembly may also include additional portions including additional meshes or support members. The proximal portion of the filter has a first major diameter, and the distal portion of the filter has a second major diameter. In a first unconstrained state, the second major diameter of the filter is less than the first major diameter of the filter. According to certain aspects of the disclosure, the filter assembly further includes a filter wire and a tubular member that may be attached to a proximal or distal end of the filter.

Abstract: A double-structured tissue implant (DSTI) and a method for preparation and use thereof for implantation into tissue defects. The double-structured tissue implant for differentiation, growth and transformation of cells, stem cells, mesenchymal stem cells and bone marrow stem cells. DSTI comprising a primary scaffold and a secondary scaffold consisting of a soluble collagen solution in combination with a non-ionic surfactant generated and positioned within the primary scaffold.

Abstract: Macroporous 3-D tissue engineering scaffold comprising elastomeric cross-linked polymer units and interconnected macropores containing living cells are produced by step of: in a mixture of the cells and elastomeric polymer units comprising activatable crosslinking groups, activating the crosslinking groups to form the scaffold.

Abstract: A system and method for collecting operation data associated with a medical apparatus including an internal device implanted in a subject and an external device that is magnetically-coupled to and drives the internal device. The medical apparatus may be monitored to obtain raw data associated with the operation of the medical apparatus and one or more calculations may be performed on the raw data, wherein the raw data and/or calculated values may be associated with voiding frequency and voiding volume of the subject. A report may be generated from the raw data and/or calculated values. In addition, one or more signals may be sent to the external device and/or a docking station, or communicated by other means, to indicate to the subject that the operation of the medical apparatus should be altered.

Abstract: A woven prosthesis, such as a woven vascular graft, woven from warp and weft yarns. Velour warp yarns forming the prosthesis are selectively incorporated into a base layer of the prosthesis so as to provide a bulbous section without compromising the porosity of the prosthesis.

Abstract: The disclosure of the present application provides devices, systems, and methods for replacing damaged or compromised blood vessels and engineering luminal grafts for various medical applications. Such devices are capable of providing viable, small-diameter grafts for use in anastomotic procedures and comprise a tubular construct consisting largely of elastin and some collagen fibers and having at least one diameter of less than or equal to about 5 mm. In one exemplary embodiment, the graft comprises at least one layer of pulmonary ligament tissue and/or pulmonary visceral pleura. Systems and methods for the manufacture of the graft are also provided, which include the use of at least one layer of tissue, a mandrel and a closure mechanism.

Abstract: In accordance with certain embodiments of the present disclosure, a process of forming a prosthetic device is provided. The process includes forming a dispersion of polymeric nanofibers, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs. A tubular frame is positioned over a tubular polymeric structure. Nanofibers from the dispersion are electrospun onto the tubular frame to form a prosthetic device. The prosthetic device is heated.

Abstract: A breast prosthesis, including an elastomeric shell including an elastomeric shell including a front exterior surfaces including a first portion having a first surface texture, and a second portion having a second surface texture different than the first surface texture, and a back exterior surface having a third surface texture, and a front transition area that transitions between the first portion and the second portion of the front exterior surface.

Abstract: A movable ocular prosthetic apparatus and related systems and methods for moving an ocular prosthetic include a support member. An ocular prosthetic is mounted to the support member, wherein the ocular prosthetic is movable about the at least two axes of rotation. A control system controls a movement of the ocular prosthetic based on a sensed movement of a pupil of an eyeball of a human being.

Abstract: A tissue holding assembly for endothelial implantation comprising an open frame having legs for engaging a stem, such that said frame is insertable between a stroma and a Descemet's membrane, said frame being coated with a biological adhesive for adhering to a perimeter of a section of the Descemet's membrane to adhere the section of the Descemet's membrane to the frame for surgical separation of said section by cutting therearound, wherein said frame further comprises a heating element around its inner perimeter.

Abstract: The present inserter, system and method suitable for inserting the IOL may include a lumen having an outer wall and an inner wall, the inner wall including at least one hollowed portion; a plunger for advancing along the lumen, the plunger having a plunger shaft extending into the open proximal end and terminating at a distal plunger end; a reservoir within the lumen between the distal plunger end and the distal insertion tip, the reservoir having an opening that is misaligned with the at least one hollowed portion prior to advancing of the plunger, and that is aligned with the at least one hollowed portion during advancing of the plunger; and a viscous fluid within the lumen, wherein the viscous fluid flows along a bypass formed of the at least one hollowed portion and the opening and into said reservoir, thereby decreasing an inserting displacement force effected at the distal insertion tip from a plunger displacement force applied to said plunger.

Abstract: Methods of implanting corneal inlays, such as small diameter corneal inlays. The inlays may be adapted to change the corneal surface curvature to provide central near vision and peripheral distance vision.

Abstract: In various embodiments, high-viscosity fluids are utilized to fill implantable reservoirs while filling accuracy is improved via elimination of dead space and/or utilization of pushing fluids to urge the high-viscosity fluid into the implantable reservoir.

Abstract: Modular IOL systems including a base and a lens, wherein the lens includes fixed and actuatable tabs for connection to the base. The modular IOL allows for the lens to be adjusted or exchanged while leaving the base in place, either intra-operatively or post-operatively. Drug delivery capabilities and/or sensing capabilities may be incorporated into the base. Injector devices may be used to facilitate placement of the base and the lens sequentially or simultaneously into the eye.

Abstract: Embodiments of the invention relate to an intraocular lens system having a plurality of haptics for use with an optic. In general, the haptics are adapted to move independently in response to forces associated with a ciliary muscle and/or zonules of an eye when implanted. The optic may be releasably secured to the system using, for example, a plurality of optic securing arms. Alternatively, the optic may be fused to the haptics, which may project radially outward from the optic. A restraining arm may be included to limit movement of the haptics during accommodation and/or disaccommodation. Clamping members may be included for securing the system to a capsular bag of the eye. Methods of implanting the intraocular lens system into the eye are also described.

Abstract: Fluid-filled accommodating intraocular lenses include components enabling the lens to effectively respond to the eye's natural accommodation process, thereby allowing the patient to visualize over a range of focal distances with minimal complications. Internal components may include, for example, a rigid member that alters optical power of the lens and/or a spanning member extending across the lens that affects the response to accommodative action and/or to filling, or overfilling, of the lens with an optical fluid. Various combinations of internal and external components may be implanted in distinct successive steps or during separate operations to minimize complications and incision size.

Abstract: A tonic ophthalmic lens is described in which refractivity of the lens differs between a first direction on a plane perpendicular to an optical axis of the lens and a second direction which differs from the first direction on the plane. In addition, refractivity difference which is the difference between the refractivity in the first direction and the refractivity in the second direction varies depending on a position of the lens in a radial direction.

Abstract: In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion, wherein the prosthetic device is movable between a compressed configuration, in which the spacer body portion is radially compressed and is axially spaced relative to the anchor portion, and an expanded configuration, in which the spacer body portion expands radially outwardly relative to the compressed configuration and overlaps at least a portion of the anchor portion.

Abstract: Apparatus and methods are provided for use with a mitral valve of a heart of a subject. The apparatus includes a P1-anchor, a P2-anchor, and a P3-anchor, that are anchored to tissue in a vicinity of, respectively, P1, P2 and P3 segments of a posterior leaflet of the mitral valve, a tether being fixedly coupled to the P2-anchor, and slidably coupled to the P1 and P3 anchors. A cardiac-site anchor anchors the tether to an anchoring location that is at a cardiac site that is anterior and inferior to the posterior leaflet. Other embodiments are also described.

Abstract: The present invention relates to a stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient. Specifically, the present invention relates to an expandable stent for an endoprosthesis used in the treatment of a narrowing of a cardiac valve and/or a cardiac valve insufficiency. So as to ensure that no longitudinal displacement of a valvular prosthesis fastened to a stent will occur relative the stent in the implanted state of the stent, even given the peristaltic motion of the heart, the stent according to the invention comprises at least one fastening portion via which the valvular prosthesis is connectable to the stent. The stent further comprises positioning arches and retaining arches, whereby at least one positioning arch is connected to at least one retaining arch.

Abstract: Systems and methods for medical interventional procedures, including approaches to valve implant. In one aspect, the methods and systems involve a modular approach to treatment.

Abstract: This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Abstract: The present invention provides engineered valves, tubular structures, and sheets comprising oriented polymeric fibers, e.g., nanofibers, methods of fabricating such structures, and methods of use of such structures as, for example, patches, grafts and valves, e.g., cardiac valves.

Abstract: An anchoring device (1) designed for anchoring a prosthetic heart valve inside a heart, includes an extraventricular part (2) designed to be positioned inside an atrium or an artery and a ventricular part (3) designed to be positioned inside a ventricle, wherein the ventricular part includes a double wall composed of an outer wall (4) and an inner wall (5) spaced apart at the level where the prosthetic heart valve is intended to be inserted, and wherein the anchoring device further includes a predefined V-shaped groove (8) formed between the extraventricular part (2) and the ventricular part (3). The present invention also relates to an anchoring system (11) for anchoring a prosthetic heart valve inside a heart, including the anchoring device (1), a prosthetic heart valve support (12) and a prosthetic heart valve (13) connected to the prosthetic heart valve support (12).

Abstract: A stented prosthetic heart valve including a stent assembly, a leaflet assembly, and mounting members. The stent assembly includes a stent post frame, a stent post frame covering, and a base frame. The stent post frame includes a continuous rail forming a closed-curved shape defining a longitudinal axis, and a plurality of circumferentially-spaced posts projecting from cusp segments in a direction of the longitudinal axis. The cloth covering encompasses the rail. The base frame supports the cusp segments. The valve leaflet assembly is attached to the stent assembly, and includes a leaflet clamped between one of the cusp segments and the base frame. The mounting members each directly pass through the stent post frame cloth covering, the first leaflet and the base frame. The rail can have a constant cross-sectional shape with a major axis dimension that is greater than a minor axis dimension.

Abstract: A heart valve includes a valve body made of a flexible material such as pericardium. The valve body is made of two layers of material, an outer layer, and an inner layer that defines a plurality of leaflets. The leaflets of the inner layer are attached to the outer layer. In some embodiments the valve body is made by cutting a single piece of flat source tissue, folding the cut tissue and forming it into a tubular pattern having the inner and outer layers. The multi-layer valve body can be mounted on a stent for delivery within a patient's heart.

Abstract: A method for delivering a heart valve prosthesis to a native valve annulus comprises expanding an expandable frame at the native valve annulus and positioning a replacement heart valve within the expandable frame. The expandable frame preferably includes a first anchoring portion that is positioned on a first side of the native valve annulus and a second anchoring portion that is positioned on a second side of the native valve annulus. The first anchoring portion engages tissue on the first side of the native valve annulus and the second anchoring portion engages tissue on the second side of the native valve annulus for securing the expandable frame to the native valve annulus. The replacement heart valve comprises a plurality of leaflets for replacing the function of the native valve.

Abstract: A delivery system for delivering a collapsible prosthetic heart valve includes a valve support structure for supporting a collapsible prosthetic heart valve, and a distal sheath movable in a longitudinal direction relative to the valve support structure between a first position in which the distal sheath is adapted to surround a collapsible prosthetic heart valve supported on the valve support structure, and a second position in which the distal sheath is adapted to expose the collapsible prosthetic heart valve for deployment. The distal sheath is at least partially formed of an inner polymer layer, an outer polymer layer, and a tubular supporting member sandwiched between the inner polymer layer and the outer polymer layer.

Abstract: Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves via a trans-apical approach to accessing the heart. A guiding sheath may be introduced into a ventricle of the heart through an access site at an apex of the heart. A distal end of the guiding sheath can be positioned retrograde through the target valve. An annuloplasty ring arranged in a compressed delivery geometry is advanced through the guiding sheath and into a distal portion of the guiding sheath positioned within the atrium of the heart. The distal end of the guiding sheath is retracted, thereby exposing the annuloplasty ring. The annuloplasty ring may be expanded from the delivery geometry to an operable geometry. Anchors on the annuloplasty ring may be deployed to press into and engage tissue of the annulus of the target valve.

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

Abstract: A device is described for crossing the atrial septum to properly size a valve annulus for treatment or replacement, having a catheter with an expandable braided tubular structure attached at its distal end. The proximal and distal end regions of the braided tube have an open structure to allow blood flow to pass freely through the gaps or spaces between the braided fibers. The lumen within the tube includes a temporary, artificial valve that acts similar to a native valve, allowing blood to flow in one direction and preventing blood flow in the opposite direction.

Abstract: Embodiments disclosed herein are directed to implants having a modifiable structural connectivity. A modifiable implant includes a body and a release member associated including a reactive composite material associated therewith. The structural connectivity of the implant can be modified upon activation of the release member, such as for removal of the implant. Systems and methods of using the same are disclosed.

Abstract: Particulate alloplastic bone replacement material and methods comprise a multitude of particles, whereby the particles comprise a core and at least six pins extending from the core, whereby the pins each comprise at least one connecting element, and whereby the pins are deformable elastically such that, upon multiple particles being pressed together, the connecting elements of different particles interlock with and/or snap into each other and the particles that are interlocked with and/or snapped into each other form an open-pored body of particles that are interlocked with and/or snapped into each other.

Abstract: Embodiments disclosed herein are directed to implants having a modifiable structural connectivity between one or more members thereof. In an embodiment, a modifiable implant includes a first member coupled to a second member by a reactive composite material having a release mechanism therein. A structural connectivity of the implant can be modified upon activation of the release mechanism. Systems and methods of using the same are disclosed.

Abstract: Planar alloplastic bone replacement material and methods comprise at least one plate for augmentation of bone defects, whereby the bone replacement material consists of a biocompatible plastic material, a biocompatible metal and/or a biocompatible metal alloy, whereby the at least one plate comprises a planar structure and comprises a plurality of pins extending outwards from the planar structure of the at least one plate, whereby the pins each comprise at least one connecting element, whereby the pins are deformable elastically and are arranged sufficiently close to each other such that pressing the surfaces of multiple plates onto each other causes the connecting elements of different plates to interlock with and/or snap into each other and the mutually interlocked and/or snapped-in plates form an open-pored body of mutually interlocked and/or snapped-in plates.

Abstract: An orthopedic device for implanting between adjacent vertebrae comprising: an arcuate balloon and a hardenable material within said balloon. In some embodiments, the balloon has a footprint that substantially corresponds to a perimeter of a vertebral endplate. An inflatable device is inserted through a cannula into an intervertebral space and oriented so that, upon expansion, a natural angle between vertebrae will be at least partially restored. At least one component selected from the group consisting of a load-bearing component and an osteobiologic component is directed into the inflatable device through a fluid communication means.

Abstract: Embodiments herein are generally directed to expandable spinal implants, systems, apparatuses, and components thereof that can be used in spinal fusion and/or stabilization procedures, as well as methods of installation. The expandable spinal implants may be configured for lateral insertion.

Abstract: Lumbar and cervical interbody or intervertebral devices for implantation between adjacent vertebrae of a spine and/or within intermediary canals of long bones are characterized by a body defining a superior end and an inferior end whose surfaces have serrations or teeth thereon forming anti-backout structures that allow implantation of the body but inhibit removal or backing out therefrom. The one-way structures may extend from the anterior end to the posterior end. The one-way structures may take different shapes but are always configured to allow insertion of the interbody device in an anterior-first manner while preventing and/or inhibiting the interbody device from backing out posteriorly. The various interbody devices may be further characterized by a body defining a cavity that is in communication with the superior and inferior ends of the body and at least one lateral side thereof via openings in the body.

Abstract: A spinal implant comprises an implant body including a first vertebral engaging surface and a second vertebral engaging surface. The vertebral engaging surfaces define a profile. The implant body further including an ipsilateral surface and a contralateral surface. A wall is disposed with the contralateral surface and is movable between a first orientation such that the wall is aligned with the profile and a second orientation such that the wall projects from the profile. Systems and methods are disclosed.

Abstract: A unitary intervertebral device, having no moving components is provided for non-fusion articulation applications. The interbody articulating device allows for limited flexion and rotation between adjacent vertebrae, helping to preserve or restore near-normal motion between adjacent vertebrae. Rotational motion is achieved through one or more protrusions incorporated into the spinal interbody device. In one articulating form, a first protrusion extends perpendicularly from the superior aspect of the disc-shaped interbody device to form a spike or rotational protrusion, while a second protrusion extends axially from the inferior aspect of the interbody device to form a second spike or rotational protrusion. Protrusions preferably extend perpendicular from the apex of both the first and second arcuate articulating surfaces.

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: An intervertebral device comprises a plurality of struts that are rotatably associated with each adjacent strut to form a modifiable inner volume V for bone graft containment.

Abstract: An orthopedic device for implanting between adjacent vertebrae comprising: an arcuate balloon and a hardenable material within said balloon. In some embodiments, the balloon has a footprint that substantially corresponds to a perimeter of a vertebral endplate. An inflatable device is inserted through a cannula into an intervertebral space and oriented so that, upon expansion, a natural angle between vertebrae will be at least partially restored. At least one component selected from the group consisting of a load-bearing component and an osteobiologic component is directed into the inflatable device through a fluid communication means.