Abstract: A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

Abstract: Apparatus for repairing a heart valve and methods for implanting anchors and repairing a heart valve are provided. The apparatus comprises a body, a member attached to the body at a first end and having a plurality of positioning cords spaced laterally across the member and extending away from a second end of the member opposed to the first end, a tube suspended from the plurality of positioning cords, and an adjustment cord extending through the tube. The method comprises implanting at least one annular anchor in a mitral annulus of the heart valve, implanting a papillary anchor through each papillary muscle of the heart, delivering and positioning an apparatus for repairing a heart valve inside the heart valve using the at least one annular anchor and the papillary anchors, and adjusting the apparatus to adjust the extent of atrial displacement of the heart's mitral leaflets during ventricular contraction.

Abstract: An adjustable midurethral sling is provided. The adjustable midurethral sling includes a midurethral sling, a frame, an adjustment suture, a housing, two end parts, tunnel opening hooks, outlets, and tunnel opening hook insertion holes. The adjustable midurethral sling is used in a surgical treatment of an involuntary leakage, wherein the involuntary leakage is defined as a urinary incontinence in cases of an abdominal pressure increase as a result of coughing, sneezing etc.

Abstract: An implantable prosthetic valve has an upper frame section and a lower frame section. The upper frame section has a plurality of struts and a first leaflet receiving surface at a lower portion of the upper frame section. The lower frame section has a second leaflet receiving surface at an upper portion of the lower frame section. An edge of a flexible leaflet is disposed between the first and second leaflet receiving surfaces to attach the leaflet to the upper and lower frame sections.

Abstract: The invention relates to a method for anesthetizing a patient's lips prior to a cosmetic procedure, such as lip augmentation or enhancement.

Abstract: An injection system can have a Syringe Dose and Position Apparatus (SDPA) mounted to a syringe. The SDPA can have one or more circuit boards. The SDPA can include one or more sensors for determining information about an injection procedure, such as the dose measurement, injection location, and the like. The SDPA can also include a power management board, which can be a separate board than a board mounted with the sensors. The syringe can also include a light source in the needle. Light emitted from the light source can be detected by light detectors inside a training apparatus configured to receive the injection. The syringe can have a power source for powering the sensors and the light source. The SDPA and the power source can be mounted to the syringe flange.

Abstract: A prosthetic valve for implantation in a stenosed aortic valve. The prosthetic valve includes a metallic frame formed with intersecting bars having diameters in the range of 0.1 to 0.6 mm. The frame is radially collapsible for advancement into a native aortic valve using a catheterization technique. The frame is radially expandable for embedding the frame within the native aortic valve. The frame has sufficient radial strength to resist the recoil forces of the native aortic valve after implantation. The prosthetic valve includes a collapsible valvular structure made with pericardium. The prosthetic valve also includes an internal cover which forms a substantially impermeable tubular sleeve. The internal cover preferably extends between a lower extremity of the frame and the valvular structure. The internal cover is preferably sutured to the valvular structure. The valvular structure and internal cover are sutured to the bars of the frame.

Abstract: A prosthesis replaces all or a portion of a natural facet joint on a vertebral body. The prosthesis has a prosthesis body accommodating fixation to the vertebral body at or near a pedicle and without support by a lamina. The prosthesis body has a fastening element installed within the vertebral body at or near a pedicle. The prosthesis further has an artificial facet joint structure carried by the prosthesis body at a location spaced from the fastening element. The artificial facet joint structure is adapted and configured to replace all or a portion of a natural facet joint.

Abstract: An expandable implant for treating bone preferably in a minimally invasive manner includes a preferably cylindrical core element extending along a longitudinal axis and preferably a plurality of nestable, expandable sleeves extending along a longitudinal axis for placement radially about the core element. The plurality of nestable sleeves are sequentially insertable over the core element in such a manner that a first nestable sleeve is inserted over the core element and each subsequently inserted nestable sleeve is received between the core element and the previously inserted nestable sleeve such that the insertion of each additional sleeve causes each previously inserted sleeve to outwardly expand.

Abstract: An apparatus and method for treating sleep apnea and/or snoring is provided. The apparatus includes an appliance sized and structured to be placed in the pharyngeal region of a human or animal and being effective in treating sleep apnea and/or snoring, for example in maintaining openness of an oropharyngeal region of a human or animal during natural sleep, advantageously while not interfering with normal functioning of the epiglottis. Preferably, the appliance is non-circumferential in form and includes rounded, spaced apart end portions.

Abstract: A prosthesis replaces all or a portion of a natural facet joint on a vertebral body. The prosthesis has a prosthesis body accommodating fixation to the vertebral body at or near a pedicle and without support by a lamina. The prosthesis body has a fastening element installed within the vertebral body at or near a pedicle. The prosthesis further has an artificial facet joint structure carried by the prosthesis body at a location spaced from the fastening element. The artificial facet joint structure is adapted and configured to replace all or a portion of a natural facet joint.

Abstract: A medical device for placement in a body of a mammal is provided. The medical device comprises (1) a polymeric matrix forming the device and defining a lumen through the device, the matrix comprising polymer macromolecules and defining spaces between the polymer macromolecules; (2) a drug contained within at least some of the spaces of the matrix; and (3) a material contained within at least some of the spaces of the matrix to affect diffusion of the drug out of the polymeric matrix when the medical device is placed in the body of the mammal.

Abstract: A femoral prosthesis. The femoral prosthesis includes an implant body having a proximal end and a distal end and a shoulder at the proximal end, the shoulder being structured and dimensioned for a tight press fit into the neck of a femur. The implant body includes a trunk at the distal end, the trunk having a wedge formed by a tapered portion extending in the direction of the distal end of the implant body. The implant body also includes a medial column extending from the shoulder toward the distal end and a lateral column extending from the shoulder toward the distal end. The wedge, the medial column, and the lateral column to provide multi-planar stability for the implant body and surface area for fixation of the implant body.

Abstract: A femoral prosthesis. The femoral prosthesis includes an implant body having a proximal end and a distal end and a shoulder at the proximal end, the shoulder being structured and dimensioned for a tight press fit into the neck of a femur. The implant body includes a trunk at the distal end, the trunk having a wedge formed by a tapered portion extending in the direction of the distal end of the implant body. The implant body also includes a medial column extending from the shoulder toward the distal end and a lateral column extending from the shoulder toward the distal end. The wedge, the medial column, and the lateral column to provide multi-planar stability for the implant body and surface area for fixation of the implant body.

Abstract: A medical device, for example a stent, has a surface which in use contacts body tissue, wherein said surface has on it a biocompatible coating layer comprising a polymer having covalently bound allyl-terminated pendent groups, said pendent groups comprising a moiety selected from -0-CH2—CH?CH2—S—CH2—CH?CH2—S(=0)-CH2—CH?CH2—Se—CH2—CH?CH2 and —Se (=0 J-CH2—CH?CH2. This surface has good biocompatibility and can bind strongly to a metallic surface. The polymer may be made from an electropolymerisable monomer, e.g. a pyrrole.

Abstract: Presented herein are methods, systems, and computer-readable medium for presenting imaging data related to an anatomical site. These include obtaining a first set of imaging data related to the anatomical site and tracking units at the anatomical site and, thereafter, optionally, obtaining a second set of imaging data related to the anatomical site. A deformed version of the first set of imaging data is then determined based on the relative arrangements of one or more of the tracking units at the time when the first set of imaging data is obtained and when the second set of imaging data is obtained. Then the relative emplacements of the second set of imaging data set and of the deformed version of the first set of imaging data set are determined and used, along with the second set of imaging data set and the deformed version of the first set of imaging data, as a basis for displaying image guidance data.

Abstract: A method for repairing or modifying an area of a patient's anatomy that comprises directing at least a portion of a scanning beam assembly to an area of a patient's anatomy, applying a radiation-responsive agent to portion of the anatomy, and exposing the radiation-responsive agent to radiation directed onto the agent by the reflector to cause the agent to therapeutically interact with the site. The scanning beam assembly including a radiation source capable of emitting radiation, a reflector that receives the radiation from the radiation source to direct the radiation onto the anatomy, wherein the reflector oscillates in at least two directions to create a scan of the anatomy, a detector to detect radiation returned from the anatomy, and a controller to convert the detected radiation into a displayable anatomy image.

Abstract: Devices for assessing the size, shape, and topography of vessel lumens and hollow portions of organs are described. The devices are particularly adapted for determining the size, shape, topography, and compliance of the native heart valves to facilitate the later implantation of a prosthetic heart valve. The devices are typically catheter-based having an assessment mechanism fixed to a distal end of the catheter. The assessment mechanism generally includes an expandable member, such as a balloon. The assessment mechanism may also include an imaging member, a physical assessment member, an electronic mapping construction, an alignment mechanism, a valvuloplasty balloon, or any combination thereof.

Abstract: An apparatus and methods for treating sleep apnea and/or snoring are provided. The apparatus includes an appliance sized and structured to be placed in the pharyngeal region of a human or animal. The appliance, when so placed is effective in treating sleep apnea and/or snoring, for example in maintaining openness of an oropharyngeal region of a human or animal during natural sleep. Preferably, the appliance is non-circumferential in form and includes rounded, spaced apart end portions.

Abstract: The present invention provides methods and devices for treating the annulus of an intervertebral disc. The methods and devices can employ an expandable treatment device which is deployed at least partially in the subannular space. Fixation devices and methods are also disclosed, which help to secure the treatment device in place.

Abstract: The present invention provides methods and devices for treating the annulus of an intervertebral disc. The methods and devices employ a fixation device delivery tool having a curved body portion. Fixation devices and methods are also disclosed for placement in intervertebral disc tissue.

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 minimally invasive spinal disc defect repair method is disclosed. The method relates to insertion of disc defect repair materials that are substantially two-dimensionally shaped and which allow for insertion and preferably self retention within the disc defect with plugging of the annulus fibrosis.

Abstract: The present invention provides methods and devices for treating the annulus of an intervertebral disc. The methods and devices can employ an expandable treatment device which is deployed at least partially in the subannular space. Fixation devices and methods are also disclosed, which help to secure the treatment device in place.

Abstract: A stent, or device for repair and reconstruction of the spinal disc wall, or annulus fibrosus, after surgical incision or pathologic rupture, which is inserted through an aperture into the subannular space. The stent has radial extensions which are caused or allowed to expand into an expanded configuration to bridge the aperture. The stent thereby occludes the defective region from the inside of the vertebral disc and prevents the migration of nucleus pulposus therethrough, while also providing a scaffold for tissue growth.

Abstract: A stent, or device for repair and reconstruction of the spinal disc wall, or annulus fibrosus, after surgical incision or pathologic rupture, which is inserted through an aperture into the subannular space. The stent has radial extensions which are caused or allowed to expand into an expanded configuration to bridge the aperture. The stent thereby occludes the defective region from the inside of the vertebral disc and prevents the migration of nucleus pulposus therethrough, while also providing a scaffold for tissue growth.

Abstract: A method of determining the size and/or placement of a prosthetic disc in a disc space between adjacent endplates of two vertebrae in a selected spinal area, comprising: using a computer to identify the disc space parameters of height, width, depth and lordosis between the adjacent vertebral endplates; using a computer to create an artificial volume corresponding to an actual prosthetic disc that can be positioned in the disc space in accordance with a manufacturer's size and lordosis specifications for prosthesis; using a computer to determine the center of the disc space and the center of rotation of the prosthetic disc volume; using a computer to position the prosthetic disc volume in the disc space such that the center of rotation of the prosthetic disc volume is positioned posterior to the center of the disc space; and using a computer to determine the prosthetic disc volume that fits within the disc space in accordance with a surgeon's or manufacturer's specification for prosthesis.

Abstract: Suturing rings and methods of use thereof facilitating initial implantation of new and replacement of dysfunctional tissue or mechanical heart valve mechanisms supported by the suturing ring are disclosed. The suturing ring annulus is adjustable to receive and engage the valve frame of the heart valve mechanism within the annulus. An interlocking mechanism applies restraint to fix the adjusted suturing ring annulus engaged against the valve frame to support the heart valve mechanism during chronic implantation. Sutures affixing the suturing ring to the valvar rim can be routed and entrapped between the suturing ring annulus and the valve frame when the suturing ring is restraint is applied. The restraint is released to replace a dysfunctional heart valve mechanism and reapplied when a new heart valve mechanism is fitted into the annulus.

Abstract: Minimally invasive techniques utilized in bypass grafting are disclosed. For instance, a method of implanting an end portion of a graft in the body of a patient during a bypass grafting procedure includes the steps of (i) advancing a medical instrument within a circulatory system of said body, (ii) guiding a distal end of said medical instrument out of said circulatory system through an opening defined in said circulatory system after said medical instrument advancing step, (iii) advancing said end portion of said graft within said medical instrument after said guiding step, and (iv) securing said end portion of said graft to a blood vessel of said circulatory system after said end portion advancing step.

Abstract: A prosthesis replaces all or a portion of a natural facet joint on a vertebral body. The prosthesis has a prosthesis body that accommodates fixation to the vertebral body at or near a pedicle and without support by a lamina. The prosthesis also has an artificial facet joint structure carried by the prosthesis body. The artificial facet joint structure is adapted and configured to replace all or a portion of a natural facet joint.

Abstract: A method of implanting a resilient self-molding annuloplasty ring including stretching it to an expanded diameter and attaching it to a heart valve annulus, then permitting the ring to contract to reduce the diameter of the annulus. The ring may be positioned on an insertion device that maintains the ring in its expanded diameter while attaching to the annulus. The resilient self molding annuloplasty ring which may be enlarged prior to implantation to facilitate implantation within a dilated or otherwise incompetent valve annulus having sufficient contractive force to render a valve competent. The self molding annuloplasty ring of the invention may further comprise integral attachment devices to aid in the implantation process.

Abstract: A spinal disc annulus repair stent for repair and reconstruction of the spinal disc wall (annulus) after surgical invasion or pathologic rupture, which may incorporate suture closure or other means of stent insertion and fixation, designed to reduce the failure rate of conventional surgical procedures on the spinal discs. In an illustrative embodiment, the design of the spinal disc annulus stent advantageously allows ingrowth of normal cells of healing in an enhanced fashion strengthening the normal reparative process.

Abstract: A catheter system has a balloon angioplasty device disposed about a common lumen near its distal end. The balloon catheter is pre-fitted with a stent which is deployed when the balloon is inflated. The common lumen is in communication with multiple lumens within a proximal region of the catheter body to allow for positioning of the catheter over a movable guide wire and convenient delivery of imaging or interventional devices to a desired region of a body passageway being treated. The procedure for stent deployment optionally includes steps of imaging a lumen by ultrasound before and after stent deployment to identify the site at which a stent is needed, to confirm that the stent is being and has been deployed at a longitudinal position which does not overlap a branched segment of the body passageway, and to ensure that the stent has been radially opened to an optimum diameter.

Abstract: A surgical method of repair and reconstruction of the spinal disc wall (annulus) after surgical invasion or pathologic rupture, incorporating suture closure, or stent insertion and fixation, designed to reduce the failure rate of conventional surgical procedures on the spinal discs. The design of the spinal disc annulus stent allows ingrowth of normal cells of healing in an enhanced fashion strengthening the normal reparative process.

Abstract: A method of securing soft tissue to a prosthesis that has a retaining member secured thereto is disclosed. The method includes looping a first end portion of a first band around the retaining member such that both the first end portion of the first band and a second end portion of the first band extend outwardly from the retaining member. The method further includes looping a first end portion of a second band around the retaining member such that both the first end portion of the second band and a second end portion of the second band extend outwardly from the retaining member. Moreover, the method includes securing the soft tissue to (i) the first end portion and the second end portion of the first band, and (ii) the first end portion and the second end portion of the second band.

Abstract: A surgical method of repair and reconstruction of the spinal disc wall (annulus) after surgical invasion or pathologic rupture, incorporating suture closure, or stent insertion and fixation, designed to reduce the failure rate of conventional surgical procedures on the spinal discs. The design of the spinal disc annulus stent allows ingrowth of normal cells of healing in an enhanced fashion strengthening the normal reparative process.

Abstract: A surgical method of repair and reconstruction of the spinal disc wall (annulus) after surgical invasion or pathologic rupture, incorporating suture closure, or stent insertion and fixation, designed to reduce the failure rate of conventional surgical procedures on the spinal discs. The design of the spinal disc annulus stent allows ingrowth of normal cells of healing in an enhanced fashion strengthening the normal reparative process.

Abstract: Biocompatible, implantable material comprising flexible, elongate tape and a plurality of elongate elements, each elongate element being aligned along and independently translatable in the longitudinal direction of the tape; implants manufactured from this material, for the partial or total replacement or reinforcement of connective tissue such as ligament, cartilage, bone, meniscus tendon, skin.

Abstract: An implant for treating insufficiency of a heart valve, in particular of the mitral valve, has an elongate body which can be converted from a first, substantially elongated and substantially flexible state to a second state with a reduced bending radius. The implant also has a flexible tensioning element extending along the body for the purpose of converting the body from the first state to the second state. The body is made up of a plurality of elements which are arranged in series to form a chain and which, in the first state, are movable relative to one another. In the second state of the body, the tensioning element tensions the elements with respect to one another so as form an arc, said elements being substantially immovable relative to one another in the second state and forming, on an internal radius face of the arc, a substantially continuous planar support surface.

Abstract: A method for controlling the circumference of internal anatomic passages corrects physiologic dysfunctions resulting from a structural orifice or lumen which is either too large or too small. Implants are disclosed which employ various means for adjusting and maintaining the size of an orifice to which they are attached. Systems permit the implants to be implanted using minimally invasive procedures and permit final adjustments to the circumference of the implants after the resumption of normal flow of anatomic fluids in situ. Methods are disclosed for using the implants to treat heart valve abnormalities, gastroesophageal abnormalities, anal incontinence, and the like.

Abstract: Endoluminally delivered tissue patches and related systems and methods for delivering the tissue patches for treating lesions of the alimentary tract are disclosed. A tissue patch includes a tissue implant imbedded in a substrate to form a first layer and a second layer of substrate on a top surface and a bottom surface of the tissue implant. A predetermined thickness of the first layer is different from a predetermined thickness of the second layer. A tissue patch may include a tissue implant imbedded in a substrate formed of a plurality of sections capable of being folded into a contracted state for endoluminal delivery to the lesion. A system for delivering a tissue implant includes a catheter having an expandable member at a distal end portion, a carrier placed around the expandable member, and the carrier configured to expand from a contracted state to an expanded state and to receive the tissue implant.

Abstract: A spinal implant insertion instrument for intervertebral implant surgery formed from a hollow first element of various external diameters, including a channel to accommodate and incorporate a vertebral pedicle, and a second element joined by a hinge to the first element, allowing reduction of the external diameter of the leading edge of the spinal implant insertion element sufficient to allow the passage of the spinal implant insertion instrument into the intervertebral disc space in a safe fashion, as the first maneuver, to be followed by activation of the second element upon the first, restoring the internal diameter of the spinal implant insertion instrument to a sufficient radius to allow successive passage of cutting, reaming, tapping instruments, and subsequent implantation of a spinal interbody implant device.

Abstract: Thermogelling polymers are described containing poly (n-isopropyl acrylamide). Solutions of this polymer, copolymers or mixtures of the polymer with a second polymer such as poly(ethylene glycol), poly (vinyl pyrrolidone) or poly(vinyl alcohol) are liquids at room temperature and solids at body temperature. Thus, also provided are methods of implanting a hydrogel into a mammal by injecting the solution as a liquid at a temperature below body temperature into a selected site in the mammal at a temperature below body temperature, which then undergoes thermal phase transition to form a solid hydrogel in situ in the body as the implant warms to body temperature. Methods for using these thermal gelling materials in various applications including nucleus pulposus replacement/augmentation, wound care, disk replacement, cartilage replacement, joint replacement, surgical barriers, gastrointestinal devices, cosmetic and reconstructive surgery, and breast enlargement are also provided.

Abstract: A method for inducing the repair of damaged or diseased liver tissue in vivo is provided. The method comprises the step of administering to the patient a graft composition comprising basement membrane tissue of a warm-blooded vertebrate in an amount effective to induce the repair of the liver tissue at the site of administration of the graft composition.

Abstract: The invention relates to a device for intraoperative navigation and placing of a medical implant, in particular, a prosthesis, using a mobile medical imaging device A) a position determination device (15) for the spatial position measurement of the reference elements (1) relative to a spatially-fixed coordinate system (13); B) a mobile medical imaging device (3), comprising a radiation source (10) and a receiver unit (11), C) a computer (6) connected to the position determination device (15) and comprising a screen (7) whereby D) radiation source (10) and receiver unit (11) are connected to an imaging unit (18), which may be displaced about the room in a manner as to be fixed relative to each other and E) a reference element (1) is fixed to each of the imaging device (18), the bones (2) for treatment, and the surgical instrument (14).

Abstract: A method and device to treat cardiovascular vulnerable plaque is provided by heating an implanted structure placed adjacent to a vulnerable plaque tissue to conduct heat into the vulnerable plaque tissue for a period of time. In a preferred embodiment, the implanted structure is a stent-like structure (SLS), and the heating of the implanted structure is a non-invasive inductive heating. The detecting of the vulnerable plaque tissue can be accomplished by techniques, such as Magnetic Resonance Imaging (MRI), infrared spectroscopy, thermography, blood tests, ultrasound, and X-ray, etc.

Abstract: A method for deploying an aortic valve prosthesis includes the steps of: making a first opening leading to the left atrium; passing the valve prosthesis through the opening and into a cardiac chamber of the left side of the heart using a first manipulation instrument; making a second opening in the arterial system and advancing one end of a second manipulation instrument through the arterial opening and into the cardiac chamber; securing the second manipulation instrument to the valve prosthesis; and using the second manipulation instrument to retract at least a portion of the valve prosthesis out of the cardiac chamber.

Abstract: Disclosed is an apparatus for deploying a bronchial isolation device in a bronchial passageway in a lung of a patient. In one embodiment, the apparatus includes an outer shaft having a distal end. A housing is coupled to the distal end of the outer shaft and configured to receive the bronchial device. An inner shaft is slidably disposed within the outer shaft. A handle is adapted to move the outer shaft relative to both the inner shaft and the handle while the inner shaft remains fixed relative to the handle so as to eject the bronchial isolation device from the housing.

Abstract: A device and method for improving flow through a native blood vessel valve, such as the aortic valve, are provided. The present invention allows a miniature valve to be implanted into affected leaflets percutaneously, obviating the need for coronary bypass surgery. The method includes the cutting of small holes, on the order of 4 mm, in the leaflets of a targeted valve, thereby allowing blood to flow through the newly formed holes. The holes are used as attachment sites for the miniature valves of the present invention.

Abstract: This invention is a method for the implantation of a combination of cells or cell-microcarrier aggregates wherein one component comprises a solid implantable construct and a second component comprises an injectable formulation. For example, in one embodiment, the solid implant may be first implanted to fill the majority of the cavity receiving the implant, and then cells or cell-microcarrier aggregates in an injectable format, with or without the addition of gelling materials to promote rapid gelling in situ, may be injected into spaces surrounding the solid implant in order to secure the solid implant in the site and/or to promote rapid adherence and/or integration of the solid implant to surrounding tissues. Also contemplated in this embodiment is that the cellular composition of the injectable component may differ from that of the solid component.