Abstract: Disclosed herein are patient-specific craniofacial implants structured for filling bone voids in the cranium as well as for simultaneously providing soft tissue reconstruction and/or augmentation for improved aesthetic symmetry and appearance. Pterional voids or defects generally result from a chromic skull deformity along with a compromised temporalis muscle or soft tissue distortion from previous surgery. When muscle atrophy occurs in the pterion, temporal hollowing generally results where there would be soft tissue but for the atrophy. The patient-specific temporal implants herein are configured to have an augmented region adjacent the temporal region of the cranium in order to account for and correct any such temporal hollowing.

Abstract: A temporo-mandibular joint prosthesis comprising: a first part for attaching to a temporal bone; a second part for attaching to a mandible bone; and a mechanism linking the first part and the second part. The mechanism defines a range of motion of the first part relative to the second part for when the first and second parts are attached to a temporal bone and a mandible bone, respectively. The mechanism includes a rotary joint providing a rotational range of motion of the first part relative to the second part; and a first slider joint providing a first translational range of motion of the first part relative to the second part.

Abstract: A scaffold is provided which facilitates integration of both bone and cartilage at an osteochondral lesion, thereby acting as a tissue engineered interface or tissue engineered junction between the two different tissues. The method and systems for engineering this interface may be acellular or may be loaded with cells prior to use.

Abstract: Systems and methods for planning surgical procedures involving custom medical implants that can involve the selection, design and/or creation of custom medical implants and/or the selection, modification, and/or design of custom surgical procedures related to those implants. Certain embodiments allow implants to be selected, designed, created, or otherwise customized and then placed in patients using non-standard surgical techniques. The invention provides greater flexibility in implant use by allowing a surgeon to revise, create, or otherwise select surgical techniques for custom implants and, ultimately, provide better treatment in a greater variety of medical circumstances. Certain embodiments of the invention involve computer assisted surgery to provide for implant-related surgery involving non-standard surgical steps and/or implants.

Abstract: Implants for the fusion or fixation of two bone segments are described. For example, the implants can be used for the fusion or fixation of the sacroiliac joint. The implants can have a matrix structure, have a rectilinear cross-sectional area, and have a curvature.

Abstract: Implants for the fusion or fixation of two bone segments are described. For example, the implants can be used for the fusion or fixation of the sacroiliac joint. The implants can include fenestrations, have a rectilinear overall cross-sectional area, and have a curvature. Some implants can also be used to rescue failed implants.

Abstract: A spinal implant is provided. The spinal implant comprises a body configured for implantation between two adjacent vertebrae, and comprises a retaining member movable between a first position where the retaining member is in an unexpanded configuration and a second position where the retaining member is in an expanded configuration. The retaining member comprises a tissue contacting surface configured to engage a lamina of at least one of the adjacent vertebrae.

Abstract: A spinal implant comprises an implant body extending between an anterior surface and a posterior surface and includes a first vertebral engaging surface and a second vertebral engaging surface. The implant body includes an inner surface that defines at least one cavity that is oriented to implant a fastener oblique relative to a lateral axis of a subject body and adjacent an intervertebral space of the subject body. At least one indicia is disposed with the implant body to facilitate orientation of the implant body with the subject body. Systems and methods are disclosed.

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 spinal fusion device that is expandable. The device features a top and bottom surface for engaging adjacent vertebrae, a hollow center for stacking of bone or bone growth material, and a slidable mechanism with grooves for expanding or unexpanding the device.

Abstract: The present invention provides an intervertebral implant for implantation in a treated area of an intervertebral space between vertebral bodies of a spine. The implant includes a spacer portion having an inferior and superior surface, wherein the inferior and superior surfaces each have a contact area capable of engaging with anatomy in the treated area, and the inferior and superior surfaces define a through-hole extending through the spacer body. The present invention further provides holes extending from a side portion to the inferior and superior surfaces of the spacer portion and a plate portion rigidly coupled to the spacer portion, wherein the plate portion contains holes for receiving screws. A fastener back out prevention mechanism adapted on the plate to prevent the back out of the fasteners from the holes and to secure the spacer to the plate of the intervertebral implant.

Abstract: A distractible intervertebral implant configured to be inserted in an insertion direction into an intervertebral space that is defined between a first vertebral body and a second vertebral body is disclosed. The implant may include a first body and a second body. The first body may define an outer surface that is configured to engage the first vertebral body, and an opposing inner surface that defines a rail. The second body may define an outer surface that is configured to engage the second vertebral body, and an inner surface that defines a recess configured to receive the rail of the first body. The second body moves in a vertical direction toward the second vertebral body as the second body is slid over the first body and the rail is received in the recess.

Abstract: A method of inserting an intervertebral disc implant into a disc space includes accessing a spinal segment having a first vertebral body, a second vertebral body and a disc space between the first and second vertebral bodies. The method includes securing a first pin to the first vertebral body and a second pin to the second vertebral body, using the first and second pins for distracting the disc space, and providing an inserter holding the intervertebral disc implant. The method also desirably includes engaging the inserter with the first and second pins, and advancing the inserter toward the disc space for inserting the intervertebral disc implant into the disc space, whereby the first and second pins align and guide the inserter toward the disc space.

Abstract: A spinal implant comprises an implant body extending between an anterior surface and a posterior surface, and including a first vertebral engaging surface and a second vertebral engaging surface. The implant body includes an inner surface that defines at least a first cavity and a second cavity. The cavities are oriented to implant fasteners in alignment with an oblique surgical pathway relative to a bilateral axis of a subject body and adjacent an anterior portion of an intervertebral space of the subject body. Systems and methods are disclosed.

Abstract: A trial medical instrument for aligning an acetabular component, comprising: a first portion configured to fit within a patient's acetabulum; and a second portion extending from the first portion; wherein the second portion extends from the first portion in a direction that mimics a shape formed by a femoral implant component coupled with an acetabular implant component when a femur to which the femoral implant component is coupled is in a position relative to an acetabulum to which the acetabular implant component is coupled that is near an extent of a typical range of motion of the femur. As used herein, the phrase “extent of a typical range of motion” describes typical angular displacements of a femur as usually limited by patient anatomy.

Abstract: Multiple, small, staple-like supports are inserted through a small tube into the disc space then rotated into position on the edge of the vertebral bodies. The tooth-like geometry of the proximal and distal faces of these staples mates with the outer edge of the vertebral body, extending past the front of the endplate anteriorly. The staples have teeth that dig into the endplate on the inside of the rim as well.

Abstract: Prosthetic feet that provide for variable and adjustable stiffness are provided. A foot element can include a tongue portion defined or formed by a slot in the foot element that at least partially separates the tongue portion from a remainder of the foot element. The tongue portion can be operably connected to the remainder of the foot member to increase the stiffness of the foot member or operably disconnected from the remainder of the foot member to increase the flexibility of the foot member. The prosthetic foot further includes a mechanism for adjusting whether the tongue portion is operably connected or disconnected from the remainder of the foot member. The mechanism can be selectively actuated to adjust the stiffness of the foot element in dorsiflexion and/or plantarflexion and/or to adjust the degree to which the tongue portion is allowed to flex relative to the remainder of the foot member.

Abstract: A prosthesis includes a socket for receiving a residual limb, the socket having a socket wall defining a limb-receiving surface; a heat pipe including a working fluid and a wicking structure, the heat pipe having a socket section and a heat sink section, the heat pipe extending along its length through the socket wall proximate to or exposed at the limb-receiving surface, wherein the working fluid has a boiling point of from about 0° C. to 90° C. such that the working fluid is adapted to evaporate to form vapor under the influence of the heat of a residual limb in the socket thus drawing heat from and cooling the residual limb. A heat sink section of the heat pipe passes through the heat sink, the heat sink reducing the temperature of the working fluid.

Abstract: Described are various embodiments of an improved endoprosthesis that includes a generally tubular graft, a plurality of independent stent hoops connected to the graft and at least one suture. The at least one suture connects one apex of one stent hoop to two apices of another stent hoop to reduce a predetermined distance between distinct stent hoops so that in a released configuration in a body vessel, the stent-graft is curved away from the longitudinal axis to conform to the body vessel and reduce formation of a gap between one end of the stent-graft with an inner surface of the body vessel.

Abstract: A polymer scaffold is crimped to a balloon while the polymer material is in a thermodynamically unstable state, or a transient state including crimping shortly after a tube or scaffold processing step that imparts memory to the material, or shortly after rejuvenation of the scaffold.

Abstract: A process for making a product including an expandable member is provided. The process can include braiding a plurality of wires to form a tubular structure that is capable of being manipulated such that a region of the tubular structure changes in diameter from a first dimension to a second dimension different from the first dimension. The process can also include initially heat-treating the tubular structure while the region is in the first dimension, changing the diameter of the tubular structure such that the region achieves the second dimension, and subsequently heat-treating the tubular structure while the region is in the second dimension.

Abstract: Implantable medical devices and method for making and using implantable medical devices are disclosed. An example implantable medical device may include a tubular body having a plurality of openings formed therein. A filter layer may be disposed along an outer surface of the tubular body. The filter layer may include a shape memory material. The filter layer may be capable of allowing fluids to pass therethrough and may be resistant to tissue ingrowth.

Abstract: Methods are disclosed including thermally processing a scaffold to increase the radial strength of the scaffold when the scaffold is deployed from a crimped state to a deployed state such as a nominal deployment diameter. The thermal processing may further maintain or increase the expansion capability of the scaffold when expanded beyond the nominal diameter.

Abstract: An apparatus for loading material into a stent strut can comprise a chamber capable of maintaining an internal pressure below pressure external to the chamber. The chamber carries within it the stent and the material to be loaded into a lumen within the stent strut. Pressure within the chamber is decreased. The decreased pressure can draw the material into lumen. The decreased pressure can draw air out of the lumen so that, after a subsequent increase in pressure in the chamber, the material is drawn into the lumen.

Abstract: The present application concerns embodiments of methods, systems, and apparatus for treating aortic insufficiency. Disclosed methods, systems and apparatus can also be used to treat aortic root dilation. Certain embodiments include a percutaneous or minimally invasively implantable prosthetic device, such as a stented graft, that is configured to be implanted in the sinus of Valsalva (the aortic sinuses) and anchored within one or both of the coronary arteries. An expandable prosthetic heart valve can then be implanted in the previously implanted prosthetic device. In patients suffering from root dilation, another percutaneous or minimally invasively implantable graft can be implanted within the ascending aorta.

Abstract: Delivery systems for a polymeric tubular implant, kits that include such delivery systems, and methods of treating patients by implanting tubular implants using the delivery systems. The delivery systems include an inner shaft, an expandable member slidably disposed about the inner shaft and configured to receive the tubular implant, and a tubular outer shaft disposed about the inner shaft.

Abstract: A gastric balloon includes a scaffold structure, one or more internal inflatable compartments within the scaffold structure, and one or more inflatable bladders formed over the space-filling compartment. The gastric balloon may be deployed transesophageally using a gastroscope and is inflated in situ, preferably using a combination of liquid and gas inflation media.

Abstract: A prosthesis that when implanted in the gastrointestinal tract does not impede the normal function of the pyloric sphincter. In some instances, the prosthesis is implanted as part of, or after, a sleeve gastrectomy procedure. The prosthesis includes a stent with an outer surface and a polymeric cover fully covering the outer surface of the stent. The stent includes a proximal stent flange; a proximal stent segment extending distally from the proximal stent flange; and an enlarged stent segment extending distally from the proximal stent segment.

Abstract: The invention relates to an instrument (10) intended to be used to modify the volume of the stomach of a patient. The invention is characterized in that the instrument comprises: a body (12) having a distal end (12a); a clamping device (16) comprising first (18) and second (20) arms pivotably mounted at the distal end (12a) of the body (12) while pivoting relative to each other, each of the first and second arms (18, 20) comprising a plurality of guides for passage of a suture needle; an opening device (30) for moving the first and second arms (18, 20) apart from each other by having them pivot relative to each other, said opening device comprising a spring member (32) connecting the first and second arms (18, 20) and tending to keep them apart from each other; and a closing device (40) for bringing the first and second arms (18, 20) together by having them pivot relative to each other.

Abstract: A finger orthosis for moving a joint of a finger is provided. The finger orthosis includes a first cuff configured to couple to a first finger portion, a second cuff configured to couple to a second finger portion, and an actuator member coupled to said first and second cuffs, said actuator member configured to provide relative rotation between said first and second cuffs when a force is applied to said actuator member.

Abstract: An extra-light orthosis includes a woven elastic fabric sleeve, shaped to exert compression forces on a member on either side of and on a joint, and a plate fixed onto an inner face of the sleeve to come into direct contact with the skin on the joint, the plate including an elastic fabric layer onto which a layer of polymer gel is adhered, an annular part shaped to surround the top of a joint protruding area, and a tab extending from an outer edge of the annular part, in an axial direction of the sleeve, the plate adhering to the skin such that, under the effect of the compression forces exerted by the sleeve, when the sleeve is longitudinally stretched, the plate remains stretched and applies tensile forces locally to the skin parallel to the surface of the skin, toward the center of the annular part and of the joint.

Abstract: A dynamic orthotic support (1) for the management of plantar fasciitis has a sock (3) with a sole portion (7) formed from a resilient material. The sole portion is shaped such that, when worn, lines of tension are initiated in the sole portion that act to urge a wearer's foot into a closed position. At least one resilient reinforcement panel (15, 17, 19, 21) may be attached to the sole portion.

Abstract: Provided is footwear whereby it is possible to desirably carry out correction and stretching of a transverse arch of a foot. A transverse arch pressure part which protrudes such that a cross-section in the width direction is an arc shape is formed between portions in a foot contact surface of an article of footwear directly below the ball of the large toe and the ball of the little toe , and a pair of runners which do not support the ball of the large toe or the ball of the little toe are formed in the foot contact surface directly below the ball of the large toe and the ball of the little toe.

Abstract: The present disclosure provides a custom or pre-fabricated ankle support brace providing tri-planar control of the ankle foot structure and allows for free plantar dorsi flexion. The ankle support brace comprises a stirrup-shaped brace body composed of reinforcement strips and a closure mechanism.

Abstract: An ankle-foot orthosis for a lower leg, ankle, and foot of a patient, the ankle-foot orthosis including: a foot plate; a calf-cuff member; and a strut member extending between the foot plate and the calf-cuff member, the strut member coupling to a posterior side of the foot plate and the calf-cuff member, the strut member being formed from layers of carbon fiber and at least one layer of a thermoplastic material.

Abstract: A compression foot garment is integrally knit of a body yarn, and adapted for wear on a foot of a user. The foot garment incorporates first and second high compression zones, and a compression release zone between the high compression zones. The first high compression zone is adapted for applying substantially circumferential compression to the foot below the plantar fascia between the calcaneus and metatarso-phalangeal joints and generally around the midfoot. The second high compression zone is adapted for applying substantially circumferential compression to the foot above the calcaneus and generally around an ankle of the user. The first and second high compression zones may comprise elastic yarns integrated with the body yarn. The compression release zone is adapted for applying reduced compression to the foot in an area between the first and second high compression zones.

Abstract: An adjustable lordosis orthopedic insert and method of adjusting the lordosis orthopedic insert for an anatomy of a patient has a first support member configured to support a lordosis of a user's spine and a second adjustable member permanently connected to the first support member. The second adjustable member also has a relatively movable other end with a plurality of lordotic position settings to match corresponding first support member lordotic attachment positions to enable the first support member to conform to a desired setting angle. Fasteners extend through the first support member and the second adjustable member to permanently fix one of the plurality of lordotic position settings to configure the first support member at the desired lordosis setting angle. When appropriately adjusted to a setting angle, the lordosis orthopedic insert can be mounted within the flexible padded covering member for fixation to an appropriate back.

Abstract: A spinal brace having a waist or abdominal portion, a dorsal lumbar insert, shoulder straps, and one or more cable tensioning systems that enables a user to tighten the waist or abdominal portion while at the same time tightening the shoulder straps to encourage extension.

Abstract: A wrist-hand-finger orthosis (100, 200) comprises a splint (110, 210) comprising a supporting splint section (120, 220) extending over the MCP joints and at least a greater portion of the fingers. The supporting splint section (120, 220) has a dorsal main surface (126, 226) adapted to face the palmar side of the hand. A wrist and forearm splint section (130, 230) is connected to or integral with the supporting splint section (120, 220). Inflatable bladders (140, 240; 150, 250) are arranged on the dorsal main surface (126, 226) at a MCP portion (122, 22) and a phalanx portion (124, 224) of the supporting splint section (120, 220) to be aligned with the MCP joints of the hand and the phalanges of fingers, respectively. The orthosis (100, 200) is particularly useful for human subjects having suffered from neurological diseases or cerebrovascular accident (CVA).

Abstract: A belt, a band affixed to the front of the belt, and a strap affixed to the side or rear of the belt comprises an arm sling for an infant. The belt wraps around the infant's abdomen and fastens together with a fastening element, such as a hook-and-loop fastener. The infant's arm is inserted into the band in front of the infant. The strap that is attached to the side or rear of the belt then wraps across the upper arm in a loop, and fastens to the belt in front to immobilize the arm against the infant's body.

Abstract: Disclosed is a nasal modulator that reduces or eliminates snoring. The disclosed nasal modulator is placed in the nasal passages and modulates air in an approximate frequency range of snoring. This modulation of inhaled air disrupts the vibration of respiratory structures by being out of phase with the normal resonance of these structures. The resonant air pressure wave is also out of phase with the inhaled modulated air. This cancellation of pressure waves and vibration of structures inhibits the loud auditory result associated with snoring.

Abstract: An apparatus is disclosed. The apparatus has a patient support cushion and a heating device that is integrated in the patient support cushion. The apparatus also has a temperature sensor that is integrated in the patient support cushion and a patient support cushion controller. The patient support cushion controller controls the heating device that is integrated in the patient support cushion based on an actual temperature value detected by the temperature sensor and a predetermined temperature value. The patient support cushion controller controls heating of the patient support cushion by the heating device based on a closed control loop that includes the heating device that is integrated in the patient support cushion and the temperature sensor that is integrated in the patient support cushion.

Abstract: The invention relates to a three-dimensional nonwoven material which reduces the temperature at specific body parts to a small extent and, as a result, causes a fat-burning action and can therefore reduce fat directly as a result of the removal of energy at said body parts and/or indirectly as a result of specific mechanisms of lipometabolism. In addition, a skin-firming effect can also be caused by the temperature reduction. The invention is characterized in that the body points are defined and the lipolytic, fat-burning and/or skin-firming effect can be reinforced further in the form of the combination of the 3D nonwoven material with lipolytic, fat-burning and/or skin-firming active substances.

Abstract: A kit for cooling the blood in the carotid arteries includes a cervical immobilization collar and a cooling element. The cooling element may include a body-facing panel attached on a body-facing surface to a lining layer, an outward-facing panel, and cooling material disposed between the body-facing panel and the outward facing panel. The cooling material may comprise urea and Carbamakool™ in an amount sufficient to produce a temperature of 20° F. to 35° F. within a minute of activation when measured on the body-facing surface of the body-facing panel.

Abstract: A system for storing and delivering a predetermined amount of fluid includes a syringe including a barrel, a flange disposed at the proximal end of the barrel, and a plunger assembly configured to be received in the lumen of the barrel. The plunger assembly includes a piston and a plunger rod. The plunger rod is removably couplable to the piston at the distal end of the plunger rod and includes a thumb press flange at the proximal end of the plunger rod. The system further includes a stop feature that is removably couplable to the syringe or the plunger assembly. The stop feature is configured to arrest distal advancement of the plunger assembly relative to the syringe when the plunger assembly reaches a predetermined position relative to the syringe. The stop thus ensures that a predetermined amount of fluid remains in the barrel.

Abstract: A surgical system comprises a pressurized irrigation fluid source; an irrigation line fluidly coupled to the pressurized irrigation fluid source; a hand piece fluidly coupled to the irrigation line; an irrigation pressure sensor located at or along the pressurized irrigation fluid source or irrigation line; and a controller for controlling the pressurized irrigation fluid source. The controller controls the pressurized irrigation fluid source based on a reading from the irrigation pressure sensor and an estimated flow value modified by a compensation factor.

Abstract: The present invention relates to a femtosecond laser ophthalmological apparatus and method that creates a flap on the cornea for LASIK refractive surgery or for other applications that require removal of corneal and lens tissue at specific locations, such as in corneal transplants, stromal tunnels, corneal lenticular extraction and cataract surgery. The femtosecond laser is transferred from the main cabinet to a hand piece module via a rotating mirror set module. In the hand piece, the femtosecond laser beam is scanned and guided to the patient's eye. The ablation pattern is based on dividing the area of the ablation area into a matrix grid made up of cells. Predetermined ablation pattern is completed in an individual cell before moving on to the next cell until ablation is complete in the entire matrix grid mapped on the ablation area.

Abstract: The present invention relates to a method of altering the refractive properties of the eye, the method including applying a substance to a cornea of an eye, the substance configured to facilitate cross linking of the cornea, irradiating the cornea so as to activate cross linkers in the cornea, and altering the cornea so as to change the refractive properties of the eye.

Abstract: A method of generating three dimensional shapes for a cornea and lens of an eye, the method including illuminating an eye with multiple sections of light and obtaining multiple sectional images of said eye based on said multiple sections of light. For each one of the obtained multiple sectional images, the following processes are performed: a) automatically identifying arcs, in two-dimensional space, corresponding to anterior and posterior corneal and lens surfaces of the eye by image analysis and curve fitting of the one of the obtained multiple sectional images; and b) determining an intersection of lines ray traced back from the identified arcs in two-dimensional space with a known position of a section of space containing the section of light that generated the one of the obtained multiple sectional images, wherein the determined intersection defines a three-dimensional arc curve.

Abstract: A steerable laser probe may include an actuation structure, a nosecone fixed to the actuation structure by one or more links and one or more link pins, a housing tube having a first housing tube portion with a first stiffness and a second housing tube portion with a second stiffness, and an optic fiber disposed in the housing tube and the actuation structure. A compression of the actuation structure may be configured to gradually curve the housing tube and the optic fiber. A decompression of the actuation structure may be configured to gradually straighten the housing tube and the optic fiber.