Abstract: A ligament assembly (2) comprising a resilient element (20) connected to a bone anchor (4) and a ligament (18), the resilient element (20) acting m a cantilever and resisting toads transmitted between the bone anchor (4) and the ligament (18) by virtue of the resistance to bending of the resilient element. The ligament (18) may comprise an artificial ligament (18) which is adapted to replace a human or animal ligament. The resilient element (20) may comprise a spiral spring and may act as a biasing element/shock absorber operatively coupled to the artificial ligament (18) to control the effective stiffness of the artificial ligament (18). Consequently, the resilient element (20) enables an effective stiffness of the artificial ligament (18) to be achieved that more closely approximates the stiffness of a natural ligament.

Abstract: A tendon overlay device includes an arcuate main body having an outer surface and an inner surface, each of the outer surface and the inner surface extending between a first terminal edge of the main body and a second terminal edge of the main body; a first plurality of teeth disposed along the first terminal edge of the main body; and a second plurality of teeth disposed along the second terminal edge of the main body. Each tooth within the first plurality of teeth projects downward away from the first terminal edge of the main body and is biased inward toward the second plurality of teeth. Each tooth within the second plurality of teeth projects downward away from the second terminal edge of the main body and is biased inward toward the first plurality of teeth. The inner surface of the main body excludes spikes and serrations that can penetrate into an outer surface of a tendon on which the inner surface of the main body is disposable.

Abstract: The present invention relates to a support device for breast prosthesis based on an acellular matrix material of a biological tissue. The support device for breast prosthesis is formed by tailoring a membranaceous material into a petal-shaped planar biological matrix blank and by connecting adjacent edges thereof. The support device can match with the breast prosthesis; and provide a support, fixation and coverage for the breast prosthesis in various surgical operations such as mammoplasty and breast orthopedics, to avoid the ptosis and translocation of the breast prosthesis, thereby achieving desirable effects of plastic surgery. Once being implanted, the matrix material of a biological tissue can be integrated into the surrounding breast tissue of the subject, and thus transformed into new tissues in human body without the retention of foreign bodies. The present invention further relates to a method for manufacturing a support device, and a membranaceous biological matrix material.

Abstract: A tapered sleeve is provided that includes a lubricating coating on an inner surface. An implant (e.g., a pre-filled silicon breast implant) is introduced into a large end of the sleeve and extruded into a surgical pocket of minimal access incision size through a small-sized end of the apparatus.

Abstract: A plate haptic for an accommodating intraocular lens. The plate haptic has a haptic body that is substantially rigid in a longitudinal direction and substantially flexible in a transverse direction. A chassis is integral to the haptic body. The chassis causes the haptic body to be substantially more rigid in a longitudinal direction than in a transverse direction.

Abstract: The invention provides an intra ocular lens assembly comprising an intra ocular lens structure (IOL) for placement in the capsular bag and securing the IOL in an opening in an anterior part of a capsular bag, with an anterior capsular bag flap surrounding said opening, and a secondary intraocular lens (S-IOL) comprising fixing parts for attaching said S-IOL to said IOL.

Abstract: Systems and methods for docking a heart valve prosthesis. A system includes a helical anchor (30) formed as multiple coils (32) adapted to support a heart valve prosthesis (10) with coil portions (32) positioned above and below the heart valve annulus (12). A seal (50) is coupled with the helical anchor (30) and includes portions extending between adjacent coils (32) for preventing blood leakage through the helical anchor (30) and past the heart valve prosthesis (10). An expansible helical anchor (30) is formed as multiple coils (32) adapted to support a heart valve prosthesis (10). At least one of the coils (32) is normally being at a first diameter, and is expandable to a second, larger diameter upon application of radial outward force from within the helical anchor (30).

Abstract: A method of making a tissue valve. The method includes the step of attaching a valve assembly comprised of at least one leaflet to an interior surface of a stent configure to fit within at least one blood vessel. The method also includes the step of lyophilizing the valve assembly.

Abstract: The invention is directed to methods for preparing artificial heart valves by preconditioning a matrix seeded with endothelial cells and smooth muscle cells differentiated from isolated progenitor cells. These cell seeded matrices are exposed to fluid conditions that mimic blood flow through the heart to produce tissue engineered heart valves that are analogous to native heart valves.

Abstract: A heart valve assembly has a leaflet support structure and a leaflet assembly. The leaflet support structure has a wire frame that supports the leaflet assembly. The leaflet assembly has first and second separate leaflets, each of which is comprised of a skirt section and a sinus leaflet section. Each skirt section has a flange portion and a body portion that has a smaller diameter than the flange portion, with the body portion having opposing side edges, and a curved opening defined by a first stitching edge at about the central portion of the body portion. Each sinus leaflet section has an outflow edge, and a curved second stitching edge, with the sinus leaflet section stitched to the skirt section along the first and second stitching edges. The opposing side edges of the body portion of the first leaflet are stitched to the corresponding side edges of the body portion of the second leaflet.

Abstract: Heart valve implants and methods utilizing those valves designed to reduce or eliminate the regurgitant jet associated with an incompetent atrioventricular valve. The heart valve implants, which are deployed via a transcatheter venous approach, comprise a collapsible framework connected to an anchored guide shaft, a valve portion and an apron which permits ingrowth of native heart tissue into the apron.

Abstract: The present disclosure relates to valve replacement devices that are foldable for catheter-based deployment to the site of implantation, as well as systems for the delivery of valve prostheses, including prostheses having the special characteristics of the disclosed valve replacement devices. The devices include highly effective adhering mechanisms for secure and enduring precision implantation. The adhering mechanisms may employ a unique sealing mechanism that includes a cuff that expands slowly whereby the device is not secured in place until the completion of the implantation procedure. The implanted device, optionally together with the cuff, prevents perivalvular leaks and incorporate an appropriate leaflet system for reliable functioning in situ.

Abstract: A prosthetic heart valve includes an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts, the inflow end having an inflow edge, a plurality of leaflets disposed inside the supporting structure and operative to allow flow in an antegrade direction from the inflow end to the outflow end but to substantially block flow in a retrograde direction from the outflow end to the inflow end, a first material disposed on a luminal surface of the supporting structure adjacent the inflow end, and a second material disposed on an abluminal surface of the supporting structure adjacent the inflow end, the first material and the second material being secured to selected struts of the supporting structure, and separately secured to each other adjacent the inflow edge.

Abstract: A prosthetic valve assembly includes an annular frame having an inner radial surface, an outer radial surface, and defining an inner lumen. The prosthetic valve assembly further includes a leaflet assembly including at least one leaflet having an inner radial surface and an outer radial surface. The at least one leaflet is disposed at least partially within the inner lumen of the annular frame. The prosthetic valve assembly includes a crimping accessory device having a handle and at least one shielding member removably disposed between the outer radial surface of the at least one leaflet and the inner radial surface of the annular frame. The at least one shielding member is configured to reduce physical contact between the at least one leaflet and the inner radial surface of the annular frame.

Abstract: An improved holder and storage system for a tissue-type prosthetic mitral heart valve that constricts the commissure posts of the valve and prevents suture looping. A rod axially movable relative to the holder tensions lengths of attachment sutures that extend between the commissure post tips to create a tent and flex the tips inward, thus helping to prevent looping of any of an array of pre-implanted sutures around the leading tips during delivery of the valve. The holder has a safety mechanism that prevents valve delivery before the rod is deployed. One embodiment automatically deploys the rod upon opening a storage jar. One embodiment permits a delivery handle to directly deploy the rod, while another uses a separate worm screw and coupling. A holder clip that attaches to a packaging sleeve may be formed of flexible members meshed together from which the heart valve and holder are easily pulled free to eliminate a step of decoupling the clip from the sleeve.

Abstract: Degradation rate is suppressed to be low by suppressing the occurrence of structural defects. Provided is an implant manufacturing method including a molding step of molding a molded item by treating a raw-material piece constituted of a biodegradable metal material with plastic processing and a grain-size adjusting step of increasing metal grain size by applying a heat treatment to the molded item molded in the molding step.

Abstract: A void filling prosthesis, which includes first and second ends that define a length therebetween and outer and inner surfaces that define a sidewall therebetween. The sidewall is at least partially curved about an axis that extends along the length of the prosthesis. The prosthesis also includes a fixation prominence extending from the outer surface. The fixation prominence includes a first aperture extending in a direction toward the sidewall and a second aperture extending in a direction transverse to the sidewall.

Abstract: A prosthesis according to the present disclosure includes a shell. A liner is disposed within the shell, and a femoral head may be disposed within the liner. A locking mechanism may assist in securing the liner within the shell. The locking mechanism may be removed when the shell, liner, and femoral head are implanted. The shell extends beyond a hemisphere of the shell, and the liner extends beyond a hemisphere of the liner.

Abstract: In one embodiment, the instant invention is a method that includes at least providing a prosthesis that includes at least an implant capable of deformation under pressure; inserting the implant in a void space in a joint; inflating the implant by adding a first amount of a filler to the implant, where the first amount of the filler is X; articulating the joint; relating a second amount of the filler from the implant through a pressure regulating valve based on a predetermined pressure in the implant, where the second amount of the filler released from the implant is Y; and sealing the implant, where X is greater than Y.

Abstract: A spinal implant that allows for fluid injection of material is disclosed. The implant includes a fitting with a passage and holes that are in fluid communication with the passage. The holes extend through upper and lower surfaces and/or into a central cavity of the implant. The implant allows for material to be introduced into the implant after initial implantation thereof. Methods of implanting the implant are also disclosed.

Abstract: Methods and devices are provided for improving the stability, flexibility, and/or proper anatomical motion of a spinal column and more particularly, spinal implant devices are provided for use between adjacent vertebral bones. Intervertebral disc spacer devices may comprise two joined surfaces formed of compressible materials. The surfaces may be convex or any variety of shapes. Certain embodiments of intervertebral disc spacer devices include apertures through which nutrients may pass. Additionally, certain embodiments include a partial enclosure or open region between the two surfaces so as to provide an environment conducive to regrowth or stimulation of natural intervertebral disc material. In certain embodiments, the two surfaces may be attached by one or more springs. Alternatively, intervertebral disc spacer embodiments may be comprised of a coiled wire. Methods of introducing intervertebral disc spacer devices into patients are also provided.

Abstract: An expandable implant for engagement between vertebrae includes an inner member, an outer member, and a gear member positioned coaxial with respect to each other such that the inner and outer members are moveable relative to each other along an axis. The inner member includes a longitudinal groove configured to engage a pin extending through the outer member such that the pin prevents the inner member from translating completely through the outer member and aids in alignment and limits rotation of the second endplate. Portions of the implant may be provided with a series of markings such that when the markings are aligned, the implant is aligned in a specific configuration and for a specific implantation approach.

Abstract: A spinal implant including porous and solid portions is disclosed. The implant includes porous portions on upper and lower surfaces and in an interior thereof. Methods of manufacturing and implanting such implants are also disclosed.

Abstract: Systems for interbody fusion of adjacent bone portions may include an expanding implant and related instruments. An expanding implant may be formed as a linkage which is movable between a compact configuration and an expanded configuration. A shaft of the implant may increase and decrease in length to move between the compact and expanded configurations, and an implant width perpendicular to the length may be increased in the expanded configuration. The implant width may increase more in a first direction than a second direction opposite the first direction. An inserter instrument may releasably grasp the spacer and transform the implant between the compact and expanded configurations.

Abstract: A spinal fusion system method and apparatus can include: providing segments including a first segment and a second segment; and coupling the first segment to the second segment with a flexible member, the flexible member configured to have a deformable state based upon a temperature of the flexible member being below a transition temperature range or based upon a stress being applied to the flexible member, and the flexible member configured to enter a shape-set state from the deformable state based on the temperature of the flexible member rising above the transition temperature range, or based upon the stress being removed from the flexible member and the temperature of the flexible member being above the transition temperature range.

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

Abstract: A modular implant for performing an intervertebral fusion on adjacent vertebral bodies in a patient including a first spacer portion, a second spacer and a container having a first end and a second end, the first end of the container constructed to operably engage a first spacer and the second end of the container constructed to operably engage the second spacer.

Abstract: Improved devices, systems, and methods facilitate the placement, orientation, seating and/or securement of customized, patient-specific, patient-adapted and/or patient engineered prosthetic joint components during a joint replacement procedure. Specifically, a tool has an impacting face, the impacting face including a first surface portion shaped to negatively-match at least a portion of a surface of a first implant component. Additionally, the surface of the first implant component is shaped based, at least in part, on patient-specific information associated with the joint.

Abstract: An orthopedic impacting tool including a motor, an energy storage chamber, a striker, and an anvil. The motor stores energy in the energy storage chamber and then releases it, causing the striker to apply a controlled force on an adapter to create a precise impact for use in a surgical setting. The tool may further comprise a combination anvil and adapter. Alternatively, the tool may comprise a gas spring assembly system for generating an impact force. The tool further allows forward or backward impacting for expanding the size or volume of the opening or for facilitating removal of a broach, implant, or other surgical implement from the opening. An energy adjustment control of the tool allows a surgeon to increase or decrease the impact energy. A light source and hand grips improve ease of operation of the tool.

Abstract: Devices and methods for removing a spinal disc are provided herein. Discectomy instruments are disclosed that can remove a spinal disc in a single-pass, i.e., without repeatedly inserting and removing the instrument from a patient. In an exemplary embodiment, the discectomy instrument includes a distal housing, at least one cutting blade, and a handle. When the distal housing is positioned adjacent to a spinal disc, a handle can be actuated to advance the cutting blade along a substantially arc-shaped path through the disc. In certain aspects, the path of the blade can correspond to the anatomy of the disc and to the approach used to access the spine. A second cutting blade can be advanced through the disc and can intersect with the arc-shaped path, forming a complete cut. The cut disc can be received in the distal housing and removed from the patient.

Abstract: The disclosure describes a direct skeletal attachment (DSA) device including a micro-miniature chainmail skin-to-DSA interface. The interface comprises various porous architectures for skin ingrowth and integration as barriers against pathogens. Failure of skin-to-DSA interfaces can occur due to mismatches in mechanical compliance between pliable skin and more rigid DSA interfaces. To address this problem, in embodiments disclosed herein is an interface having a gradient in mechanical compliance or link mobility, ranging from fully flexible, to less compliant, to rigid where it attaches to the main DSA body.

Abstract: A prosthetic system includes a prosthetic foot with a foot member defining a first end portion, a second end portion, and an intermediate portion defining a curvature and extending between the first and second end portions. A pump mechanism is coupled to the foot member. The pump mechanism includes a housing defining a cavity, and a membrane situated in the cavity. The pump mechanism is movable between an original configuration and an expanded configuration. A movable member includes a first portion coupled to the membrane and a second portion arranged to slidably engage the foot member. Relative movement between the first and second end portions moves the first portion of the movable member relative to the housing and slides the second portion along a length of the foot member to shift the pump mechanism between the original and expanded configurations.

Abstract: A determination system includes a mastoid electrode that is located on a left mastoid of a user when an intention of the user to move a portion on a right side of a body of the user is detected and that is located on a right mastoid of the user when an intention of the user to move a portion on a left side of the body of the user is detected; an ear hole electrode that is located in an ear hole of the user; an electroencephalogram signal measurer that obtains a voltage between the mastoid electrode and the ear hole electrode; and a determiner that determines whether or not a change in the voltage includes the intention to move the portion on the right side of the body or the intention to move the portion on the left side of the body.

Abstract: A stent with varying porosity is described. The stent can be comprised of multiple stents attached together. A braided stent may have selected regions of increased thickness. The stent may be comprised of wires that are welded together at their ends in order to minimize vessel trauma. The stent may comprise a helically wound radiopaque wire wound through the stent.

Abstract: A biodegradable, bioabsorbable medical device with a coating for capturing progenitor endothelial cells in vivo and delivering a therapeutic agent at the site of implantation. The coating on the medical device is provided with a biabsorbable polymer composition such as a bioabsorbable polymer, copolymer, or terpolymer, and a copolymer or terpolymer additive for controlling the rate of delivery of the therapeutic agent.

Abstract: The present invention relates to a handle assembly (100) for an implant delivery device for folding or unfolding at least one medical implant by means of at least one tension thread, wherein the handle assembly (100) comprises a drum (14) for winding the tension thread thereon by rotating the drum (14); a knob (9) to be rotated by a user of the handle assembly (100) in order to fold or unfold the medical implant by tightening or winding the tension thread or by releasing or unwinding the tension thread, the knob (9) being arranged or interconnected with the drum (14) such that the drum (14) may be rotated when the knob (9) is rotated; and a brake frame assembly (25) comprising at least one brake element and at least one spring (256, 257) arranged to act on the brake element such that the brake elements contact one surface of the rear knob (9).

Abstract: A stent delivery system is provided that includes a self-expanding stent with a longitudinal length and a plurality of individual suture loops spaced along the longitudinal length of the stent, wherein the stent is compressed by the plurality of individual suture loops. The stent delivery system also includes a longitudinal pull member that secures the plurality of individual suture loops about the stent, wherein the plurality of individual suture loops are configured to separate from about the stent when the longitudinal pull wire is removed.

Abstract: A device for electrical stimulation of muscles involved in the physiological gait of a human includes an element for electrical muscle stimulation. A sensor detects information relevant to the muscle stimulation. The sensor includes a gyroscope constructed to detect information including an angular speed ? and a swing direction in an extension direction and flexion direction of an anatomical lower leg of the human. An evaluation unit, including a microprocessor, evaluates the information detected by the gyroscope, determines a defined switching time for the muscle stimulation on the basis of the angular speed o.) and the swing direction, and transmits the determined switching time to a control and regulation unit that triggers muscle stimulation by the element in response to receipt of the determined switching time.

Abstract: A lumbar support structure comprises: a lumbar pad; two circling knee devices, disposed at two sides of the lumbar pad, each possessing a first strip member and a second strip member; two knee pads, movably female-connected with the first strip members, each possessing a penetrating portion with a through channel, the first strip member and the knee pad fabricating a knee-binding structure; two adjustment buckles, each disposed between the first strip member and the second strip member, a front end of the adjustment buckle being fastened with the first strip member, the second strip member penetrating through the adjustment buckle and elongating toward the lumbar pad in order to form an embracing portion, wherein the embracing portion elongates toward the lumbar pad in order to form a movable adjustment band.

Abstract: A sacroiliac belt with a non-elastic inner belt to wrap around the user's hips and an elastic outer belt to wrap from the back to opposite sides of the inner belt. Non-cinchable hook and loop fastener construction is used to secure the inner and outer belts in position. The inner belt includes an inside elastomeric foam layer with open-cell frictional gripping surface, a non-elastic outside layer of loop material, and a hook tab for engaging the loop material to close the belt. The inner belt may be established with a non-elastic composite foam-fabric structure comprising a bi-laminate of the foam and elastic fabric, and a strip of loop material secured lengthwise onto the fabric side of the bi-laminate. The outer belt includes an elastic strip and hook tabs for connecting to the strip of loop material. The non-elastic composite foam-fabric may be used in other orthopedic braces and supports.

Abstract: A cervical collar for ensuring an open airway comprises an occipital portion, right and left mandible engaging sections extending from the occipital portion, and right and left sternum engaging portions extending from the occipital portion. Each of the mandible engaging sections comprises an adjustable airway opening member for assuring opening of the airway. In one embodiment, each of the mandible engaging sections comprises a baseplate, and a carrier for the airway opening member which is controllably displaceable along a groove formed in the baseplate. A strap is attachable to an anterior portion of each baseplate, so that right and left straps are simultaneously tensionable and fastenable together on the chin of a subject to ensure symmetric stabilization. The anterior triangle of the neck is unobstructed following fastening together of the straps and of the sternum engaging portions, to facilitate monitoring of various throat related clinical conditions following a traumatic event.

Abstract: A brace for immobilising a traumatized or operated shoulder including: at least one cushion configured to at least partly adhere to the body of a user having a traumatized or operated shoulder to be immobilised; at least one arm support sling extends from the cushion and with it delimits a compartment for housing a forearm of the user corresponding to the traumatized or operated shoulder; at least one abdominal band configured to envelope and/or surround at least one abdominal and lumbar area of the user; at least one support harness engaged to the cushion to support the cushion at a predetermined position and level. The support harness includes at least one rest portion configured to engage at least one shoulder of the user to support the cushion and the arm support sling. The support harness is configured to engage, resting thereon, the user's traumatized or operated shoulder.

Abstract: A system for managing and controlling bodily fluids such as urine and menstrual flow includes a garment with a latex envelope, for receiving the fluids from the male or female genitalia, and a system for disinfecting the male or female genitalia within the envelope.

Abstract: A sperm collecting apparatus that has a generally cylindrical housing and an inner sleeve disposed inside the housing and made from a gel-like material. The housing defines an interior chamber and has a proximal opening at a proximal end of the housing. The inner sleeve defines an internal insertion channel that is sized for closely receiving a human penis and has an insertion opening at the proximal opening of the housing, The length of the housing is adjustable in length. The housing includes a proximal end configured for telescopic engagement with a housing distal end so that the housing proximal and distal ends can be moved longitudinally with respect to each other to adjust the length of the housing. The housing distal portion includes two opposing side portions configured so they can be removably assembled together.

Abstract: Systems, methods, devices, and apparatus for positioning a patient's mandible in response to sleep apnea status are provided herein. In one aspect, a system for monitoring and treating sleep apnea in a patient comprises one or more sensors configured to monitor the patient for symptoms associated with sleep apnea; an intraoral appliance worn by the patient, one or more processors, and memory comprising instructions executable by the one or more processors to cause the one or more processors to: receive a set of sensor data from the one or more sensors, detect, using a machine learning algorithm, onset of a sleep apnea event based on the set of sensor data, and transmit a control signal to the intraoral appliance to cause the intraoral appliance to displace a lower jaw of the patient from a first position to a second position in order to treat the sleep apnea event.

Abstract: Improved systems, methods, and devices for treating sleep apnea are provided herein. In one aspect, an intraoral appliance for treating sleep apnea in a patient comprises an appliance shell comprising a plurality of cavities shaped to receive teeth of a jaw of the patient. The appliance shell can comprise an advancement structure arranged to interact with an opposing jaw of the patient so as to displace the lower jaw anteriorly relative to the upper jaw. The plurality of cavities can comprise cavity geometries shaped to reduce repositioning of one or more received teeth elicited by displacement of the lower jaw anteriorly relative to the upper jaw.

Abstract: The present invention discloses a negative-pressure oral apparatus capable of relieving discomfort of soft tissues in the oral cavity and improving fixation of the oral apparatus to prevent the oral apparatus from falling off due to mouth opening. The oral apparatus is compact and elastic so that it fits various shapes and sizes of the oral cavity and is easy to be put on and taken off to provide convenience and safety to the user. In another embodiment, a method for maintaining a negative oral pressure and collecting liquid by coupling the oral apparatus to a liquid collecting apparatus capable of effectively providing the oral cavity with a negative pressure to expel liquid in the oral apparatus and deliver the liquid to an absorbing element in the liquid collecting apparatus so as to prevent liquid leakage or contamination.

Abstract: In a stimulus method, a stimulus applying apparatus is attached to an area selected from a group of specific parts of a body surface by an acupuncture needle(s) or heating etc. thereby releasing the stress, and a stress-free medical treatment method based on the stimulus method.

Abstract: In a stimulus method, a stimulus applying apparatus is attached to an area selected from a group of specific parts of a body surface by an acupuncture needle(s) or heating etc. thereby releasing the stress, and a stress-free medical treatment method based on the stimulus method.

Abstract: A body cooling tool that can be used to cool any portion of a body and can be easily used at any time is provided. A body warming tool that can realize a high heat retaining property is provided. A body cooling tool has a cooling member being a narrow long shape and having a water-absorbent material 11; and an elastic member 20 provided at an end portion of the cooling member 10. When the body cooling tool is wound around the predetermined portion of the body, the cooling member 10 is pressed against the predetermined portion of the body by elastic force of the elastic member 20, and the density of the water-absorbent material is increased so that cooling efficiency is enhanced.