Abstract: A detection apparatus enables detection of a substance that may be present on the surface based on measurement of a stream probe signal correlating a substance at least partially obstructing the passage of fluid through a stream probe includes a distal optical gum detector transmission portion and a distal optical gum detector reception portion in a position to transmit and to receive, respectively, an optical signal controlled by a controller, enables the controller to determine if an open port of a distal tip of the stream probe is in contact with a substance at least partially obstructing the passage of fluid through the open port and not in contact with the gums of a subject or of a user of the detection apparatus to override false positive signals.

Abstract: The present invention provides a semi-crystalline polymer for a coating on an implantable device for controlling release of drug and methods of making and using the same.

Abstract: An artificial urinary sphincter (AUS) system includes a cuff, a pump, and a single tube that provides the system with an inflatable storage compartment. The single tube is connected between the cuff and the pump and includes a first lumen communicating between the cuff and the pump and a separate second lumen communicating between the cuff and the pump. The cuff is inflatable with a cuff volume of liquid that is sized to selectively close the urethra for treatment of urinary incontinence. The pump is operable to move the cuff volume of liquid out of the cuff to provide the cuff with a deflated state that allows the urethra to open and pass urine. The second lumen has a storage compartment sized to retain the cuff volume of liquid.

Abstract: In an embodiment, the invention discloses a medical device configured to be delivered and placed within a patient's body. The medical device includes an implant and a cover member. The implant is configured to be disposed within the patient's body. The implant includes a support member, a first arm member and a second arm member, an elongated first sleeve, and an elongated second sleeve. The support member includes a crescent shaped opening.

Abstract: A device for performing surgery on a patient includes: a mesh patch comprising a top surface and a bottom surface; and a removable cover positioned adjacent to and in facing engagement with the bottom surface of the mesh patch. The bottom surface has a plurality of hooks positioned thereon. The cover is removed from the mesh patch as the mesh patch is positioned at a surgical site such that the hooks on the bottom of the mesh patch grip surrounding tissue of a patient and secure the mesh patch to surrounding tissue of the surgical site. A method for performing a surgery using such a device is also provided.

Abstract: A catheter assembly comprises a catheter having a distal end and a longitudinal axis, a stent disposed about the distal end of the catheter, and a stent protector. The stent protector has a stent covering portion disposed about the stent and a catheter engagement portion that removably engages the stent protector to the catheter assembly. The stent covering portion is disposed about the stent without substantially engaging the stent.

Abstract: A spinal implant device has a synthetic or metallic or a combination thereof of these materials in an implant body structure and stem cells in a coating, or a sheet, wrap or a membrane wrap applied to surfaces on the implant body structure or alternatively filled with a plug of stem cell laden material. The implant body structure preferably has an aperture or channel. The spinal implant device may include anchoring holes to secure the device to the spinal skeletal structure with fasteners or alternatively can simply be held in place by and between adjacent vertebrae.

Abstract: A medical implant apparatus includes or uses an energy transmission device for wireless transmission of energy of a first form from outside a patient's body. An implanted medical device is operable in response to energy of a second form different than the energy of the first form. An implanted energy transforming device transforms energy of the first form wirelessly transmitted by the energy transmission device into energy of the second form for use in the control and operation of the medical device.

Abstract: A tapered implantable device includes an ePTFE tubular member having a tapered length portion. The tapered length portion provides rapid recovery properties. The tapered length portion can feature a microstructure that includes a multiplicity of bent fibrils.

Abstract: There is provided a method for controlling a flow of fluid and/or other bodily matter in a lumen formed by a tissue wall of a patient's organ. The method comprises gently constricting (i.e., without substantially hampering the blood circulation in the tissue wall) at least one portion of the tissue wall to influence the flow in the lumen, and stimulating the constricted wall portion to cause contraction of the wall portion to further influence the flow in the lumen. The method can be used for restricting or stopping the flow in the lumen, or for actively moving the fluid in the lumen, with a low risk of injuring the organ. Such an organ may be the esophagus, stomach, intestines, urine bladder, urethra, ureter, renal pelvis, aorta, corpus cavernosum, exit veins of erectile tissue, uterine tube, vas deferens or bile duct, or a blood vessel.

Abstract: Various features are described that are adapted to improve performance of interference-relief type delivery systems. A delivery system provided herein comprises an implant comprising a socket at a proximal end of the implant; an elongate sleeve having (i) a proximal section, (ii) a distal section slidably disposed within the socket, and (iii) a window between the proximal section and the distal section, the window extending through a wall of the sleeve; and a core member having a proximal portion slidably received within the proximal section of the sleeve and a distal portion extending through the window to a space outside the sleeve and within the socket. The distal portion of the core member provides an interference fit with the distal section of the sleeve within the socket until the core member is withdrawn.

Abstract: The imperfect hemodymamics and non-endothelialized surface of the BT shunt and RV-PA conduit can be improved by utilizing a shape that has more uniform flow and lower shear stress. Accordingly, the shunt will have an acute takeoff angle with a fluted inlet portion that eliminates fluid separation and maintains the shear stress within or near the physiologic range. The distal aspect of the shunt may be fluted in one or both directions along the pulmonary artery to improve the flow transition and reduce the shear forces on the posterior wall the pulmonary artery. An autologous umbilical vein may be used as the shunt with fluted proximal and distal portions with an autologous endothelialized surface to minimize platelet deposition and thrombus formation. The umbilical vein shunt may have an external support for diameter constraint and maintaining the hemodynamically optimized fluted design.

Abstract: A recyclable and adjustable interventional stent for intravascular constriction. The stent main body is divided into three parts and shaped like a waist drum with expansion parts (1, 4) being arranged on the upper and lower parts of the stent main body respectively for supporting and positioning. A variable aperture part (2) is arranged in the middle of the stent main body. The upper expansion part (1) is or is not provided with a coating; the middle variable aperture part (2) and the upper half part of the lower expansion part (4) are covered with a pericardium (3) subjected to anti-calcification treatment; and a metal wire ring (5) is passed through the lowermost edge of the stent. A compound conveying guide pipe is composed of an outer sheath (6) and a core (7). The core (7) is a hollow pipe and a wire hanging groove is arranged on the outer side wall of the tip of the pipe to hang the metal wire ring (5) of the lowermost edge of the stent.

Abstract: A suture anchor device and method for attaching soft tissue to bone includes an anchor body and a suture locking wedge movably disposed within the anchor body. The suture locking wedge includes lateral portions which engage slots or windows in the anchor body. Tension applied to one limb of a suture causes the suture locking wedge to translate and rotate to a position which compresses the suture, thereby locking the suture in the anchor.

Abstract: An injection port assembly for a tissue expander and/or mammary prosthesis comprising a composite silicone matrix having embedded fiber layers. The composite matrix materials may cover or extend from the outside perimeter of the injection port assembly and provide self sealing polymeric materials if punctured by a needle. The tissue expander and injection port assemblies and structures may be formed of MR scannable materials. The injection port structures may have palpation lumps for locating the injection port structure subsequent implantation. The injection port structure may be remotely located from the tissue expander and connected thereto via tubing.

Abstract: The present invention relates to a method of altering the refractive properties of the eye, the method including forming a pocket in a cornea of an eye of a patient so as to gain access to tissue bounding the pocket; after the pocket in the cornea has been formed, applying a photosensitizer inside the pocket so that the photosensitizer permeates at least a portion of the tissue bounding the pocket, the photosensitizer facilitating cross-linking of the tissue bounding the pocket; inserting a lens implant into the pocket so as to change the refractive properties of the eye; and irradiating the cornea so as to activate cross-linkers in the portion of the tissue bounding the pocket and thereby stiffen the cornea and prevent corneal ectasia of the cornea.

Abstract: An accommodating intraocular lens (AIOL) for implantation in a human eye includes a housing including an anterior member with a leading surface, a posterior member with a trailing surface, a leading shape memory optical element adjacent the anterior member and resiliently elastically deformable between a non-compressed shape in a non-compressed state of the AIOL and a compressed shape in a compressed state of the AIOL, and a trailing shape memory optical element adjacent the posterior member and elastically deformable between a non-compressed shape in the AIOL's non-compressed state and a compressed shape in the AIOL's compressed state for selectively bulging into the leading shape memory optical element on application of a compression force the said longitudinal axis against the trailing surface from a posterior direction for modifying the shape of the leading shape memory optical element with respect to its non-compressed shape in the AIOL's the non-compressed state.

Abstract: In various embodiments, implants including reservoirs, such as intraocular lenses, feature flexible membranes and valves integrated therewith, the valves having apertures that are normally closed.

Abstract: An ophthalmic device is provided for a patient that has a basic prescription for distant vision, the ophthalmic device including a primary optic and a supplemental optic. The primary optic is configured for placement in the eye and has a base optical power configured to substantially provide the basic prescription. The supplemental optic has an optical power that is less than the optical power of the primary optic and is configured to provide, in combination with the primary optic, a combined optical power that provides the basic prescription of the patient. In addition, at least one surface of the primary optic is configured to deform in response to an ocular force so as to modify the combined optical power by at least 1 Diopter. The ophthalmic device may further include a movement assembly operably coupled to the primary optic that is structured to cooperate with the eye to effect accommodating deformation of the primary optic in response to an ocular force produced by the eye.

Abstract: Described are devices and methods for medically sealing a perivalvular leak associated with implanted valves. For example, a bioresorbable tissue infiltratable sheet is provided for insertion through a perivalvular leak. A filament extending through the sheet is also provided which when pulled causes the sheet to gather around the filament on either side of the perivalvular leak. The gathered position of the sheet may be secured by a series of stops and/or use of a capping member.

Abstract: A prosthetic heart valve includes a base and a plurality of polymeric leaflets. Each leaflet has a root portion coupled to the base, and each leaflet has an edge portion substantially opposite the root portion and movable relative to the root portion to coapt with a respective edge portion of at least one of the other leaflets of the plurality of leaflets. Each leaflet includes) at least two polymers along at least one portion of the leaflet, and each leaflet has a composition gradient of each of the at least two polymers along at least one portion of the leaflet.

Abstract: A method of preparing a tissue swatch comprising one or more desired thicknesses for use in the manufacture of a bioprosthetic device, said method comprising sectioning a sheet of frozen tissue to produce a tissue swatch of said one or more desired thicknesses.

Abstract: The present disclosure provides aortic valve prosthetic devices that are constructed in a non-axisymmetric shape, or are expandable to a non-axisymmetric shape for improved results in the repair of defective aortic valves. The devices can be surgically implanted, or they can be implanted percutaneously through an insertion catheter. The expandable devices can be self-expanding or expanded by an inflatable balloon to a non-axisymmetric cross-section geometry.

Abstract: A stentless support structure capable of being at least partly assembled in situ. The support structure comprises a braided tube that is very flexible and, when elongated, becomes very long and very small in diameter, thereby being capable of placement within a small diameter catheter. The support structure is preferably constructed of one or more thin strands of a super-elastic or shape memory material such as Nitinol. When released from the catheter, the support structure folds itself into a longitudinally compact configuration. The support structure thus gains significant strength as the number of folds increase. This radial strength obviates the need for a support stent. The support structure may include attachment points for a prosthetic valve.

Abstract: Apparatus, systems, and methods are provided for percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves. An annuloplasty ring includes an outer tube, an inner body member, and an anchor deployment system. The outer tube includes a plurality of windows and has an axis along its length. The internal body member includes a plurality of anchors formed perpendicular to the axis. The anchor deployment system selectively rotates the internal body member with respect to the axis of the outer tube. The rotation deploys the plurality of anchors through the plurality of windows.

Abstract: Biocompatible mesh materials are employed to make implants for repairing or replacing a bone or for soft tissue repair. The mesh materials can be comprised of bioabsorbable materials, non-bioabsorbable materials or bioabsorbable and non-bioabsorbable materials. Pharmaceutical actives, bone growth enhancers and the like can be combined with the implants.

Abstract: Apparatus is provided for placement at an anatomical site, including an orthopedic implant, which has front and rear ends, a top and bottom, right and left sides, and a central part connecting the sides. A distance between the top and the bottom is (a) greater at a first location at one of the sides than at a second location opposite the first location at the other side, and (b) greater at a third location at the front end than at a fourth location opposite the third location at the rear end. At least a portion of the implant is a porous matrix, which is shaped to define pores that extend through the porous matrix in at least each of: (a) a front-to-rear direction, (b) a left-to-right direction, and (c) a top-to-bottom direction.

Abstract: A system and method for sharing and absorbing energy between body parts. In one particular aspect, the system is an unlinked structure which facilitates absorbing energy between members forming a joint such as between articulating bones.

Abstract: A method of repairing and/or stabilizing a joint by administering mesenchymal stem cells to the joint. Such a method provides for the regeneration of cartilaginous tissue in the joint, including meniscal tissue.

Abstract: A biocompatible prosthetic device comprising a thin low friction spacer for location to overlie a bone member in an interpositional location between opposed bone joint articular surfaces. The prosthesis is preferably a thin spacer with at least one low friction surface, the spacer being adapted for location about a bone member in an interpositional location between opposed bone joint articular surfaces preferably about a margin of articular cartilage of a bone member's condyle, preferably without any modification of the articular surface of the condyle. One preferred use of a prosthesis is in a human temporomandibular joint as a thin cap-like member fitted closely over the mandibular condyle to be disposed intermediate of the mandibular condyle and the mandibular fossa of the temporomandibular joint.

Abstract: Systems, devices, and methods are described for providing orthopedic augments having recessed pockets that receive a fixation material. The orthopedic augments include an outer surface that interfaces with a patient's tissue or bone, and an inner surface that interfaces with an implant, the inner surface comprising a recessed pocket configured to receive a fixation material, a rim around at least a portion of the recessed pocket, and a port in the rim, wherein the recessed pocket extends along the inner surface in at least a direction laterally from the port.

Abstract: The modular stem component may include a shaft portion, a head, and a sleeve. The shaft portion is configured for receipt within the intramedullary canal of a bone and the head is configured to receive another component of a modular prosthetic system, such as a femoral neck, thereon. In one exemplary embodiment, the head extends radially around at least a portion of the stem and includes a rib defining a flange extending therefrom. The sleeve, which is formed as an independent part of the modular stem component and is made at least partially of a highly porous biomaterial, includes opposing ends and has a bore extending therethrough. The bore is configured to facilitate sliding receipt of the sleeve on the head.

Abstract: A fixed-bearing prosthesis includes a femoral component having a medial condyle surface and a lateral condyle surface. The knee prosthesis also includes a bearing having a medial bearing surface configured to articulate with the medial condyle surface of the femoral component, and a lateral bearing surface configured to articulate with the lateral condyle surface of the femoral component. A tibial tray is secured to the bearing. The tibial tray has a platform with an elongated stem extending downwardly from a lower surface thereof. A posterior buttress extends along a posterior section of the perimeter of the tray's platform, and an anterior buttress extends along an anterior section of the perimeter of the tray's platform. Differently-sized tibial trays are interchangeable with differently-sized bearings.

Abstract: An implant set having modularity with conformity for total knee replacement. The set having a femoral metal component, Tibial Component (4) with locked tibial Insert (2) therein and Patella to provide the exact conformity of combination of femoral component (1) and tibial component (4). The improvement involves such way that each of the Femoral component (1) to tibial insert (2) pair, there will be at least three sizes of tibial components (4) available, namely, a minus size tibial component (4), a standard tibial component (4), and a plus size tibial component (4); the dimensions of the locking mechanism will be same on all the three sizes, i.e. on minus size, standard size, and plus size.

Abstract: Knee prosthesis includes a femoral component adapted to fit on a distal end of the femur and a tibial insert component. The femoral component includes a measured anterior/posterior dimension defined by the posterior condyle surface and the interior surface of the anterior flange and a distal peg provided on a distal bone facing surface of each of the lateral and medial condylar structures, wherein the distal pegs are positioned at a midpoint of the measured anterior/posterior dimension. The implant system provides two distinct sizing segments and the tibial insert has a medial tibial aspect ratio of 0.74 and a lateral tibial aspect ratio of 0.65 to 0.68 for all sizes.

Abstract: Arthroplasty components include an articular surface and a bone-facing surface. The bone-facing surface includes a concave arrangement of planar surfaces which converge as they approach a middle portion of the articular surface. Instruments and implantation methods are also disclosed.

Abstract: Arthroplasty components include an articular surface and a bone-facing surface. The bone-facing surface bears at least one anchoring element adapted for an oblique implantation trajectory. The anchoring element includes a reinforcement plate, a dowel, and surface features. Each surface feature resists forces acting along a different direction.

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: 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: A spacer member is provided that is configured to be implanted adjacent an anatomical structure. The spacer member defines a curved bore, a first opening in a side wall of the spacer member and a second opening in one of a top wall and a bottom wall of the spacer member. Each of the first opening and the second opening are in fluid communication with the curved bore. A flexible anchoring member is configured to be inserted through the side opening and through the curved bore of the spacer member such that a distal end portion of the flexible anchoring member extends out of the second opening at an angle relative to the one of the top wall and the bottom wall of the spacer member.

Abstract: A nucleus implant includes a core (10) arranged inside a nucleus pulposus space (Es) obtained after nucleotomy of the intervertebral disk (Di) and at least one extension (11) penetrating inside at least one channel (Co) formed in the vertebral body of the corresponding vertebra (Va, Vb) to strengthen and ensure a connection between the nucleus implant (1) and the bone body of the vertebra (Va) and/or (Vb) through the diffusion or migration of the viscoelastic material making up the nucleus implant in the cancellous bone of the vertebra.

Abstract: An implant configured to completely replace degenerated or damaged nucleus pulposus in an intervertebral disc. The implant comprises a silicone elastomer shell that is implanted into a void within the annulus fibrosus created by at least partial removal of the nucleus pulposus therefrom. A colloidal suspension of platinum cured silicone-based polymer and carbon nanotubes is injected into the elastomer shell. The colloidal suspension is irradiated with electromagnetic radiation, particularly infrared or near infrared light, to the point that it hardens. The hardened implant becomes a mechanical replacement for the original nucleus pulposus in the intervertebral disc.

Abstract: The present disclosure generally relates to an intervertebral disc prosthesis for partially or totally replacing an organic intervertebral disc. The disc prosthesis includes an interbody device, a face plate and a pair of locking mechanisms for achieving dual fixation in the cephalad and caudal direction. Methods according to the present disclosure achieve such dual fixation in a single fixation step.

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: 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: An artificial disc is provided which more closely matches the movement of the natural spine. The artificial disc uses one or more projections and corresponding recesses to provide a sliding articulation. The artificial joint is inherently stable in that compressive forces placed on the disc such as the weight placed upon the joint or the tension of surrounding tissues urges the joint towards a neutral position and not farther away from a neutral position.

Abstract: Disclosed are surgical implants for providing therapy to a treatment site, tool sets and methods for percutaneously accessing and deploying the implants within the spines. The treatment site may be a vertebral body, disc, and/or motion segments in the lumbar and sacral regions of the spine.

Abstract: A system for implanting an inter-body device between adjacent vertebrae comprises an inter-body device having a plurality of cans secured to a flexible bridge and having a relief portion therebetween. An inserter tube and complementary bullnoses are advantageously secured to the vertebrae by an extension arm for securing the assembly precisely in place. A plurality of articulating trial implants are provided to test fit a disc space for the proper sized inter-body device.

Abstract: A selectively expanding spine cage has a minimized cross section in its unexpanded state that is smaller than the diameter of the neuroforamen through which it passes in the distracted spine. The cage conformably engages between the endplates of the adjacent vertebrae to effectively distract the anterior disc space, stabilize the motion segments and eliminate pathologic spine motion. Expanding selectively (anteriorly, along the vertical axis of the spine) rather than uniformly, the cage height increases and holds the vertebrae with fixation forces greater than adjacent bone and soft tissue failure forces in natural lordosis. Stability is thus achieved immediately, enabling patient function by eliminating painful motion. The cage shape intends to rest proximate to the anterior column cortices securing the desired spread and fixation, allowing for bone graft in, around, and through the implant for arthrodesis whereas for arthroplasty it fixes to endpoints but cushions the spine naturally.

Abstract: A bi-directional fixating transvertebral (BDFT) screw/cage apparatus includes an intervertebral cage having a plurality of internal angled screw guides and screw members and a screw locking mechanism. The screw locking mechanism has leaf springs mechanically interacting with ratcheted screw heads of the screws and allowing the ratchet teeth of the screw heads to rotate only in a penetrating direction and preventing rotation of the screw head in an opposite direction. The intervertebral cage is adapted for posterior lumbar intervertebral placement, anterior lumbar intervertebral placement, anterio-lateral thoracic intervertebral placement, or anterior cervical intervertebral placement.