Abstract: The present invention is a method and an apparatus for packaging lyophilized implants and other medical devices. In accordance with the invention, a lyophilized implant may be packaged for delivery to the surgical site in a sealed, flexible/expandable, sterile inner pouch. The inner pouch may be further packaged within an outer, sterile package. The inner pouch contains a resealable port through which rehydration liquid may be introduced into the inner pouch without opening the inner pouch. The inner pouch may be made of a flexible, substantially non-stretchable material so that the pouch can expand only to a predetermined maximum size to accept a predetermined volume of rehydration liquid . After rehydration, any excess rehydration liquid within the pouch may be removed via the same port. Next, the pouch is opened via a second opening to expose the implant for removal from the package.

Abstract: To provide a medical tool that dramatically simplifies operations and has a small number of parts. For this purpose, the medical tool includes: an outer tube; a core that is inserted into the outer tube so as to be movable forward and backward; a medical tool main body that is attached to the core; and a containing member that is attached to the fore end of the outer tube, and is configured such that when by moving the outer tube forward relatively to the core, the containing member is made to approach the medical tool main body released out of the containing member, the containing member makes driving force for operating the medical tool main body act on the medical tool main body.

Abstract: Implant devices for filtering blood flowing through the ostium of an atrial appendage have component structures one or more of which are expandable. Devices with component structures in their unexpanded state have a compact size suitable for intra-cutaneous delivery to an atrial appendage situs. The expandable component structures are expanded in situ to deploy the devices. A device may have sufficiently short axial length so that most or almost all of the device length may fit within the ostium region.

Abstract: Systems and methods for preparing a ligament graft for a ligament reconstruction procedure are provided. In general, the described techniques utilize a graft preparation system having a holder and a delivery suture assembly removably coupled thereto. The delivery suture assembly can include a spine coupled with an anchor suture configured to form a self-tightening knot used to position the assembly around a graft and a plurality of suture windings configured to be affixed to the graft when the assembly is deployed. The assembly is delivered to the graft using the holder and the sutures can be affixed to the graft without penetrating therethrough. The spine helps to evenly distribute the load among the windings compressing the graft which are thus are capable of withstanding increased loads. Thus, an improved, simplified, and time- and labor-saving approach to preparing ligament grafts is provided.

Abstract: Anterior cruciate ligament reconstruction methods and devices are designed to achieve an anatomically accurate double bundle anterior cruciate ligament reconstruction by using a single femoral and tibial tunnel. The method and devices reconstruct the two bundles of the anterior cruciate ligament in a single femoral and tibial tunnel using a bone-patellar tendon-bone graft. The methods and devices enable an accurate anatomical reconstruction of the anteromedial and posterolateral bundles by creating a single femoral and tibial tunnel as opposed to creating two tunnels in the tibia and femur.

Abstract: An optimized breast implant injector includes a hollow tube body and a plunger. The hollow tube body has a short tube reducer at one end and a circular disk at the other end. The plunger includes a push block, a driving device, and two fixed covers. The outer surface of the push block appears to be a circular arc shape. The driving device includes a rotating part, and a driving gear, a driven gear and a rack that mesh together. A user uses the rotating part to easily start the driving gear, the driven gear, and the rack, in order to let the rack drive the push block to move the breast implant in the hollow tube body. Through operating a short tube reducer of the hollow tube body and the push block, the breast implant can be pushed through from the short tube reducer easily.

Abstract: An intraocular lens (IOL) for implantation within a capsular bag of a patient's eye comprises an optical structure and a haptic structure. The optical structure comprises a planar member, a plano convex member, and a fluid optical element defined between the planar member and the plano convex member. The fluid optical element has an optical power. The haptic structure couples the planar member and the plano convex member together at a peripheral portion of the optical structure. The haptic structure comprises a fluid reservoir in fluid communication with the fluid optical element and a peripheral structure for interfacing to the lens capsule. Shape changes of the lens capsule cause one or more of volume or shape changes to the fluid optical element in correspondence to deformations in the planar member to modify the optical power of the fluid optical element.

Abstract: Systems and methods for medializing a paralyzed vocal cord are disclosed. In some embodiments, an apparatus includes a lateral portion, a medial portion, and a strut coupled to the lateral and the medial portions. Either the medial portion or the lateral portion can be adjustable in two dimensions which are not parallel to the length of the strut, which can also be adjustable. In some embodiments, the medial portion and/or the lateral portion can each comprise two adjustable arms and a base member which has a curvilinear configuration.

Abstract: A prosthetic heart valve includes a prosthetic valve annulus and at least one prosthetic valve leaflet member including at least one coaptation surface configured for cooperating with at least one corresponding coaptation surface of the prosthetic heart valve. At least one valve leaflet member is displaceable by blood flow between a closed position and an open position to produce, correspondingly, a contact and a separation of cooperating coaptation surfaces. In the open position the separation of the cooperating coaptation surfaces enables the blood flow through the orifice in a first direction, and in the closed position the contact of the cooperating coaptation surfaces prevents the blood flow through the orifice in a second direction, opposite to the first direction.

Abstract: Catheter apparatuses and methods are provided for repairing heart valves, particularly mitral valves. The method includes providing a catheter having an elongate, flexible body, with a proximal end and a distal end. The distal end can be transluminally advanced from the left atrium through the mitral valve and along the left ventricular outflow tract into the ascending aorta. A valve repair device is deployed to permanently connect leaflets at a mid-section of a mitral valve while permitting medial and lateral portions of the natural leaflets to open and close. The valve repair device detachably connects the distal and proximal ends of the catheter.

Abstract: An adjustable implantable annuloplasty apparatus suited for post-implantation adjustments according to changing needs of the patient. The apparatus comprises a ring shaped main body, and a designated adjustment section extending from the main body. The main body and designated adjustment section of a deployed apparatus are fully contained within a 5 cm diameter. Optionally, the apparatus is mechanically adjusted in a minimally invasive procedure, for example by engaging the designated adjustment section using a balloon catheter. Optionally, the apparatus is adjusted at least one month post implantation.

Abstract: A prosthetic heart valve includes a self-expanding wire frame body, a valve disposed in the body, a leaflet clip coupled to the body, and a control element operably coupled to the leaflet clip. The body has a proximal end and a distal end. The leaflet clip is configured to be transitioned between a first configuration in which the prosthetic valve can be inserted into a heart, and a second configuration in which the leaflet clip is disposed to capture a native valve leaflet between the leaflet clip and the wire frame body when the body is disposed in a native annulus of an atrioventricular valve of a heart. The control element extends from the leaflet clip through a ventricle of the heart and out a wall of the ventricle to allow a user to transition the leaflet clip from its first configuration to its second configuration.

Abstract: An anchor deployment tool is provided that includes a flexible tube, which defines an anchor storage area in which tissue anchors are stored before deployment, and a distal anchor manipulation area that has a length of at least 3 cm. The tool also includes a rotating deployment element, which is positioned within the flexible tube, and is configured to, while the distal anchor manipulation area is disposed within a lumen defined by a wall of a sleeve, (i) directly engage the anchors in the anchor storage area a single one at a time, (ii) advance each of the anchors, while thus directly engaged, in a distal direction into the anchor manipulation area, and (iii) anchor the sleeve to tissue of a subject by deploying each of the tissue anchors through a distal end of the flexible tube, through the wall of the sleeve, and into the tissue.

Abstract: A resorbable bone graft scaffold material, including a plurality of overlapping and interlocking fibers defining a scaffold structure, plurality of pores distributed throughout the scaffold, and a plurality of glass microspheres distributed throughout the pores. The fibers are characterized by fiber diameters ranging from about 5 nanometers to about 100 micrometers, and the fibers are a bioactive, resorbable material. The fibers generally contribute about 20 to about 40 weight percent of the scaffold material, with the microspheres contributing the balance.

Abstract: Osteochondral graft composition comprising a cartilage component and a bone component, and further comprising one or more perforations in the bone component and/or the cartilage component, are provided. Methods of manufacturing and using osteochondral graft compositions comprising one or more perforations in the bone component and/or the cartilage component are also provided.

Abstract: A medical device for implantation in a hip joint of a patient is provided. The medical device is adapted to be fixated to the pelvic bone of the patient. The medical device comprises an inner and an outer surface, a contacting portion of the inner surface is spherical and adapted to face the center of the hip joint when said medical device is implanted, and said medical device is adapted to receive a caput femur or a prosthetic caput femur having a spherical portion. The medical device comprises at least one extending portion adapted to clasp the caput femur, or prosthetic caput femur, for restraining said caput femur, or prosthetic caput femur in said medical device. The medical device is adapted to release the caput femur or prosthetic caput femur from the medical device when a predetermined strain is placed on the medical device.

Abstract: Tibial prosthesis having one or more fins for use in a total or unicompartmental knee athroplasty procedure are disclosed. The one or more fins can be adapted to fix a tibial prosthesis to the tibia and can engage with corresponding channels formed in the resected tibia. Additionally, intercondylar components and methods for use in a total or unicompartmental knee athroplasty procedure are disclosed. The intercondylar component can be integral with or attached to a baseplate configured for attachment to a partially resected proximal surface of the tibia that retains at least a portion of the intercondylar eminence and the anterior cruciate ligament (ACL) and/or the posterior cruciate ligament (PCL). Inner surfaces of the intercondylar component can be configured to engage with at least a portion of the intercondylar eminence remaining with the partially resected tibia. In an example, the intercondylar component or the one or more fins can be formed of a porous material, such as to facilitate bone growth.

Abstract: A humeral prosthesis includes a first body having a first body articulating surface defining a generally circular outer periphery, and a first centerline axis. The first body having a support surface opposite to the first body articulating surface, the first body is hollow and configured to receive a head of the humerus, and a stem extending away from the support surface, the stem defining a second centerline axis which is coincident with the first centerline axis. The prosthesis further includes a second body in the form of a flange which extends laterally from a portion of the circular outer periphery, the first body articulating surface and a surface of the second body defining a boundary portion between them which is generally smooth and continuous, wherein the second body is located superiorly and the surface of the second body which bounds the first body articulating surface is a second articulating surface.

Abstract: A prosthesis to replace a portion of the anatomy, such as the humerus, can include a first shell. A second prosthesis can be positioned relative to the shell to provide the bearing surface to articulate with a glenoid prosthesis or glenoid. The second prosthesis can include a connection portion to engage a connection portion in the shell.

Abstract: A prosthetic ankle comprising a talar component and a tibial component. At least a portion of top surf ace of the talar component has a convex curvature, relative to a location above the top surface, in the anterior to posterior direction as viewed in a sagittal plane cross-section, a concave curvature relative to a location above the top surf ace, in the medial to lateral direction, and an average radius of curvature of at least a major portion of the medial side of the top surface of the talar component is larger than an average radius of curvature of at least a major portion of the lateral side of the top surface of the talar component as viewed in sagittal plane cross-sections on the lateral and medial sides. A bearing component for location between the tibial and talar component is also described.

Abstract: A spinal implant comprises an implant body extending between an anterior surface and a posterior surface. The implant body includes a first vertebral engaging surface and a second vertebral engaging surface. The implant body includes an outer surface that defines an oblique surface. A wall is connectable with the implant body and translatable relative to the oblique surface. Systems and methods are disclosed.

Abstract: An apparatus for disrupting tissue in the intervertebral disc space that includes a barrier member having a first configuration for insertion into the disc space and a second configuration when deployed within the disc space. The second configuration of the barrier member is adapted to at least partially define a perimeter of a working region within the disc space. The apparatus also includes a tissue disruption tool configured for insertion into the working region.

Abstract: Intervertebral arthrodesis for insertion in an intervertebral space separating opposite faces of two adjacent vertebrae has a ring shaped intervertebral cage having a bar that extends perpendicular to the axis of the spine. The bar has a height less than the rest of the cage. A surface of the cage contacting the vertebrae has an undulating shape for limiting sliding of the cage in a plane parallel to the vertebrae faces.

Abstract: A tibial component placement guide for use in a knee arthroplasty procedure involving a knee joint comprising a tibia, a patella, and a femur, the guide comprising an overlay configured to be overlaid a resected tibia, the overlay including at least one of an indicia and an opening indicative of at least one of an orientation and a position of at least one of a first axis of the femur, a second axis of the femur, and a first axis of the patella.

Abstract: An orthopedic device includes a patient-specific acetabular guide that can be used for preparing an acetabulum of a patient to receive an acetabular implant. The acetabular guide has a body with an outer three-dimensional surface configured to match an acetabulum of a specific patient's hip joint designed from data of the patient's hip joint. The acetabular guide can further include a peripheral annular rim.

Abstract: A prosthetic breast form and a method of making thereof provides for a flexible stretchable substantially round or crescent-shaped pillow-like soft pouch adapted to be filled with a desired quantity of granular material to simulate shape and volume of a natural human breast. The pouch has an opening formed in a seam and a pair of closure members is fitted inside the opening. When the closure members are closed they form a visual continuation of the seam of the pouch. The method provides for the user to fill the pouch with the desired quantity of the filler material suitable for a particular lingerie item or garment. In the preferred embodiment, the granular filler comprises waterproof non-spherical beads.

Abstract: An articulated mechanism system includes a plurality of fingers (articulated mechanisms) arranged in parallel, each of which has a mounting member, a first digital part rotatably connected to the mounting member by a first connecting part, a second digital part rotatably connected to the first digital part by a second connecting part, and a first driving part rotatably connected to the second digital part by a fourth connecting part and connected to a third connecting part. By extruding the third connecting part toward the fourth connecting part, the first digital part and the second digital part are integrally rotated about the first connecting part, or the second digital part is rotated about the second connecting part when the rotation of the first digital part is blocked. The third connecting parts are driven by a single driving mechanism for the same distance and in the same direction at a time.

Abstract: Various features for improving the performance of prosthetic sport feet are provided. Prosthetic sport feet according to the present disclosure can be designed to improve performance in board sport activities, for example, surfing, windsurfing, kitesurfing, wakeboarding, skateboarding, snowboarding, skiing, and the like. A prosthetic board sports foot can have a wide profile and large area for contacting the board or ground to improve stability. The board sports foot can include a traction sole to reduce slippage on the board. The board sports foot can also include an attachment member for attaching the foot to a user's residual limb or another prosthetic component. The attachment member can include a tendon designed to allow for flexibility over an initial short range of movement. The tendon can be interchangeable, and tendons having various stiffnesses can be provided.

Abstract: A prosthetic device includes an inner socket assembly including an upper interface member having a generally cylindrical outer periphery, the outer periphery defining a diameter and a length, the diameter being substantially greater than the length, and an outer socket assembly including a lower interface member having a recess correspondingly-shaped to the outer periphery of the upper interface member. At least a portion of the upper interface member is received within the recess of the lower interface member to secure the inner socket assembly to the outer socket assembly.

Abstract: The present invention relates to a stent, comprising: a plurality of radially-expandable rings arranged along a longitudinal axis, wherein each radially-expandable ring may comprise a plurality of bar arms and a plurality of crowns, and adjacent crowns are connected by the bar arms therebetween; and a plurality of connectors between the radially-expandable rings for connecting such radially-expandable rings; wherein a cross-sectional shape of the bar arms, the crowns or the connectors may comprise helical structures, specific cross-sectional shapes, or a combination thereof. New stent manufacturing techniques, such as the 3D additive printing, could be used for making these proposed stents feasible.

Abstract: According to one aspect of the present disclosure, a method and technique for manufacturing a stent are disclosed. The stent is a non-metallic stent having a furled small-diameter state and an expanded large-diameter state where the stent, in the furled small-diameter state, includes a plurality of central lobes arranged at spaced-apart intervals and extending longitudinally defining a stent axis, the plurality of central lobes defining a cylindrical plane of the stent. The stent also includes at least one peripheral lobe formed on at least one of the plurality of central lobes, the peripheral lobe oriented along the cylindrical plane.

Abstract: An implantable prosthesis can comprise a strut having a lumen, radiopaque particles within the lumen, and a polymer binder. The polymer binder retains the radiopaque particles within the lumen. The strut may have side holes through which a therapeutic agent may pass and through which the radiopaque particles are incapable of passing. The polymer binder may be absent or optional. The radiopaque particles can have sizes that prevent them from escaping out of the lumen through the side holes. The radiopaque particles placed within the lumen can improve visualization of the prosthesis during an implantation procedure.

Abstract: A method for manufacturing a medical device. The method can include forming a medical device from a tube having a first diameter; uniformly expanding the medical device from the first diameter to a second diameter at which the medical device can be left within a body vessel, the medical device being expanded from the first diameter to the second diameter while being continuously positioned on an expander; and heat setting the expanded medical device at the second diameter while the medical device is positioned on the expander.

Abstract: A variable scale medical implant deployment device comprising a variable inner diameter scale sleeve insert is provided. Also described are kits containing the variable scale medical implant deployment device and methods for deploying a medical implant into a body lumen using a variable scale medical implant deployment device.

Abstract: Devices and methods for treating obesity are provided. More particularly, intragastric devices and methods of fabricating, deploying, inflating, monitoring, and retrieving the same are provided.

Abstract: In accordance with one embodiment, an apparatus and method for facilitating weight loss are provided which constitute improvements over prior surgical treatments by providing a proven way to promote desirable weight loss in overweight patients through induced appetite reduction. The invention is comfortable enough to be used everyday without causing undue agitation to the wearer and provides measurable reductions in appetite and increased weight loss.

Abstract: A deflation device including a catheter having a proximal opening at a proximal end and a distal opening at a distal end; and a coring member disposed within the catheter and comprising a handle disposed near the proximal end of the catheter, a cable, and a coring tip disposed near the distal end of the catheter; wherein pressing said distal end of said catheter against said wall of said balloon creates a substantially normalized surface of said balloon relative to a coring tip and wherein the coring tip is a sharpened, hollow cylinder. A method for deflating and removing an implantable, inflatable device comprising: pressing a distal end of a catheter against the wall of an inflated balloon of an implanted device; advancing the coring tip within the catheter beyond the distal end of the catheter and into the balloon, whereby a hole adapted for advancing the catheter is created in the wall of the balloon; and advancing the catheter into the balloon.

Abstract: A versatile orthopedic device is arranged to convert between ligament and osteoarthritis treatment, and to accommodate a variety of leg anatomies. The orthopedic device is preferably configured as a double-upright brace indicating struts, frame component sections and associated hinges preferably intended to be along both medial and lateral sides of a wearer's leg. A strap kit with an unloading strap system may be added to the orthopedic device for conversion into an orthopedic device for osteoarthritis relief.

Abstract: A cervical collar provides height adjustment using a locking member disposed on a height adjustment member extending through a height adjustment aperture. As the locking member is moved between locked and unlocked positions, ridges on a main collar body and on a chin support member may be interlocked or allowed to slide over each other from one desired position to another, thereby providing a height adjustment mechanism for the cervical collar.

Abstract: Provided is an adaptable protective device configured to include a portion of body to protect, including: a main casing impermeable to the passage of fluid, flexible and defining a main volume, the main casing being configured to be placed at least partially around the portion of body to protect so that the portion of body to protect is outside the main volume, the main casing defining an inner surface substantially in contact with the portion of body to protect and an outer surface not in contact with the portion of body to protect, an inner casing placed inside the main casing, permeable to the passage of fluid and flexible; and including a plurality of filler particles, a first valve, configured to form or interrupt a connection for fluid passage between the main volume and the external environment, a closure casing impermeable to the passage of fluid, flexible and including sealing means configured to create a fluid seal between the closure casing and the portion of body to protect thereby forming a close

Abstract: A thermoformable laminate for use in making orthopedic splints is composed of a sheet of thermoformable splinting material having opposite sides and a covering layer applied to at least one of those sides as padding for more comfortable application and wear on a patient's limb. The covering layer may be applied to the thermoformable sheet by a fiber flocking process and is chosen to allow heating of the thermoformable sheet to a deformable state by means such as hot air blowers or immersion in hot water. The laminate may be cut with scissors or the like and formed to custom shapes resulting in ready-to-apply orthopedic splints after attachment of splint retaining straps.

Abstract: An external nasal dilator comprises resilient and engagement elements. The engagement element functions primarily to affix, adhere, or otherwise engage the dilator to the skin surface of the nose. The resilient element comprises one part that provides out-of-plane resiliency, or spring biasing forces, and another part that provides in-plane elasticity, or stretching or tensioning forces. The dilator includes horizontal regions adapted to engage outer wall tissues of first and second nasal passages of a nose. When in use the dilator stabilizes or expands nasal outer wall tissues and prevents the outer wall tissues from drawing inward during breathing.

Abstract: A lockout valve assembly of an implantable penile prosthetic includes a body and a lockout valve. The body is attachable between a reservoir and a pump of the implantable penile prosthetic. The lockout valve includes a core rotatably disposed inside the body, an inflation channel formed through a portion of the core, a deflation pathway separate from the inflation channel and formed through a diameter of the core, and a one-way check valve disposed in the deflation pathway of the core.

Abstract: One embodiment of the mini condom (1) having a substantially tubular unitary mini body (10) a nipple reservoir at the closed end (12), a ring(s) (2) and (3) at the opening of the condom, an adhesive ring (4), which has adhesive material on the inner circumference of the condom's wall above the ring at the opening, and an additional ring (13) above ring (3). Other embodiments are described as shown.

Abstract: A portable heat exchanging apparatus for regulating body temperature. At least one coil of thermally conductive tubing is formed to define a plurality of consecutive, concentric windings. A connection tubing connects the at least one coil to an external fluid supply. In some embodiments, a protective covering tightly encloses the at least one coil, providing a smooth surface for user comfort, easy sanitization, and reusability.

Abstract: A transparent portable warming device to insure normothermia during medical transport, particularly for transporting pediatric patients and infants is disclosed. The warming device includes a one or more layers of a thin, flexible, transparent material. A heating element includes a parallel circuit of resistive wires controlled by a battery-powered power controller. The controller maintains the temperature of the blanket at a predetermined temperature level for periods of time suitable for transporting patients. In one embodiment, the resistive wires are nichrome, and the flexible material comprises polyvinylchloride. The system can be powered by a lightweight twelve volt battery.

Abstract: A system and method are provided that employ a monitoring device to monitor at least one patient physiological response to a change in temperature of the patient (e.g. pursuant to induced hypothermia therapy), wherein a monitoring signal is provided by the monitoring device. In turn, an output (e.g. a visual and/or auditory output) may be provided to a user indicative of at least one measure of patient response to the change in temperature. Alternatively or additionally, a processor may be provided to process the monitoring signal and provide an output employable by medical personnel to control a patient shivering response to the patient temperature change. Such information may comprise information regarding one or more anti-shivering medicament(s), e.g. corresponding dosage and/or frequency information for use by medical personnel in the administration of the anti-shivering medicament.

Abstract: A cryotherapy device includes a flexible strip (1) having a receiving compartment (4) and a fixing section (5), and an insert having at least one chamber filled with a cooling fluid for maintaining a decrease in temperature and shaped in such a way as to be housed and held in the receiving compartment (4). The insert is a flexible silicone pouch filled with a thermal material gel able to maintain thermal cooling. The receiving compartment (4) is arranged on a first end of the fixing section (5) of the flexible strip (1). The flexible strip (1) is a self-adhesive strip having a length (L) longer than 1.0 m, which has self-attaching means for allowing the first surface of the strip to attach and adhere to the second surface of the strip.

Abstract: The present application discloses a transfer device for warming an infant patient during movement of the patient. The transfer device comprises a center section positionable beneath the patient, and the center section comprises a warming device. The transfer device also comprises a first side section connected to the center section and including a first handle and a second side section connected to the center section and including a second handle. The first and the second side sections are movable toward each other such that the first and second handles are located proximate to each other and the first and second side sections surround the patient.

Abstract: A surgical imaging system can include at least one light source, configured to generate a light beam; a beam guidance system, configured to guide the light beam from the light source; a beam scanner, configured to receive the light from the beam guidance system, and to generate a scanned light beam; a beam coupler, configured to redirect the scanned light beam; and a wide field of view (WFOV) lens, configured to guide the redirected scanned light beam into a target region of a procedure eye; wherein the beam coupler is movably positioned relative to the procedure eye such that the beam coupler is selectively movable to change at least one of an incidence angle of the redirected scanned light beam into the procedure eye and the target region of the procedure eye.