Abstract: An expandable introducer sheath provided with a steering mechanism is disclosed. The introducer sheath is configured for providing a prosthesis delivery system percutaneous access to a patient's vasculature. The introducer sheath includes a sheath component defining a central lumen and having a longitudinally-extending, radially-expandable portion. The sheath component also includes a steering wire slidably disposed within a wall thereof that longitudinally extends along the radially-expandable portion. When the steering wire is in a slackened configuration, the steering wire permits a width of the radially-expandable portion to increase. When the steering wire is in a taut configuration, the steering wire permits a distal portion of the sheath component to be manipulated or bent in order to align a distal port of the introducer sheath, for instance, with an ostium of a branch vessel.

Abstract: A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and an elongated shaft extending from and movable relative to the handle portion. The shaft includes a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic heart valve in a radially compressed state. The handle portion includes a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly. The gear assembly engages the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion.

Abstract: The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation enhancement element for implantation across the valve; a system including the coaptation enhancement element and anchors for implantation; a system including the coaptation enhancement element, catheter and driver; and a method for transcatheter implantation of a coaptation element across a heart valve.

Abstract: Devices, systems, and methods for treating a heart of a patient may make use of structures which limit a size of a chamber of the heart, such as by deploying one or more tensile member to bring a wall of the heart and a septum of the heart into contact. A plurality of tension members may help exclude scar tissue and provide a more effective remaining ventricle chamber. The implant may be deployed during beating of the heart, often in a minimally invasive or less-invasive manner. Trauma to the tissues of the heart may be inhibited by selectively approximating tissues while a pressure within the heart is temporarily reduced. Three-dimensional implant locating devices and systems facilitate beneficial heart chamber volumetric shape remodeling.

Abstract: Patient-adapted articular repair systems, including implants, instruments, and surgical plans, and methods of making and using such systems, are disclosed herein. In particular, various embodiments include methods of selecting and/or designing patient-adapted surgical repair systems using parameterized models and/or multibody simulations.

Abstract: A reconfigurable orthopedic implant trial comprising: (a) a first orthopedic component; (b) a second orthopedic component that includes a second sensor on a second articulating surface thereof, the second orthopedic component configured to removably mount to the first orthopedic component; (c) a third orthopedic component that includes a third sensor on a third articulating surface thereof, the third orthopedic component configured to removably mount to the first orthopedic component, where the second sensor and the third sensor are configured to generate kinematic data.

Abstract: A stemless humeral anchor (10) includes a first end (12) configured to be embedded in a proximal portion of a humerus and a second end (14); a mating portion (16) for an articular component; a transversely extending collar (20); and a rotation control feature (22, 22A) for resisting rotation when the stemless humeral anchor is implanted. A void filling protrusion (24) can extend circumferentially from rotation control feature and can include a porous shell (26), in which a void filling component (28) can be disposed. The rotation control feature can comprise arms. One or more arms (22A) can have a larger radial extent than the others (22). A prosthesis assembly includes a base member (104) that has a helical structure (224) and one or more pathways (300). The pathway is accessible from a proximal end and is directed distally through the helical structure. The pathway is located inward of an outer periphery of the helical structure.

Abstract: A shoulder prosthesis includes a humeral portion and a scapular portion, each having an osseointegrable component and an articular component. The osseointegrable component in the humeral portion includes a humeral body produced as a semicircular asymmetrical cage having a proximal circular ring base facing the scapular portion and an eccentric distal cylindrical base in opposite position, which are connected by arms having one or more holes for favoring the growth of bone tissue and facilitating anchorage to the bone, the proximal circular ring base being configured to be interchangeably coupled with the articular component for an anatomical prosthesis or a concave insert for a reverse prosthesis. The osseointegrable component in the scapular portion includes a glenoid base-plate of asymmetric form for coupling to an articular component, such as a concave glenoid insert, for an anatomical prosthesis or a glenosphere for a reverse prosthesis.

Abstract: A modular reverse shoulder prosthesis according to embodiments of the present invention includes a stem having a proximal taper and a primary stem axis, the proximal taper extending from the stem about a metaphyseal axis, the metaphyseal axis at an angle with respect to the primary stem axis, a metaphysis having a proximal end, a distal end, a first aperture in the distal end configured to be placed over the proximal taper, and a second aperture in the proximal end having an insert axis that is eccentrically offset from the metaphyseal axis, the metaphysis configured for attachment to the stem at any rotational position of the metaphysis about the metaphyseal axis, and a reverse insert, the reverse insert having a proximal end and a distal end, wherein the proximal end comprises a concave cup formed about a cup axis and configured to receive a glenosphere, and wherein the distal end comprises a locking protrusion, wherein the locking protrusion has an outer surface with a cross-sectional shape that is rotatio

Abstract: A synthetic material can comprise a plurality of rigid components. Each rigid component can be spaced from each adjacent rigid component to define respective interstices between each rigid component and each adjacent rigid component. A flexible material can be disposed within each respective interstice and can extend between and connect to adjacent rigid components.

Abstract: A spinal implant configured for positioning within a space between adjacent vertebral bodies includes an upper end plate including an outer surface extending between first and second end surfaces and opposed side surfaces. The outer surface includes a first convex profile extending between the first and second end surfaces and a second convex profile extending between the opposed side surfaces. The first convex profile and the second convex profile have different curvatures. The spinal implant further includes a lower end plate and a core disposed between the upper and lower end plates and coupled thereto. A method of assembling a spinal implant and a method of performing spinal surgery are also disclosed.

Abstract: A prosthetic intervertebral disc is formed of first and second end plates sized and shaped to fit within an intervertebral space and to be implanted from the back of the patient, thereby decreasing the invasiveness of the procedure. The posterior approach provides for a smaller posterior surgical incision and avoids important blood vessels located anterior to the spine particularly for lumbar disc replacements. The first and second plates are each formed of first, second and third parts are arranged in a first configuration in which the parts are axially aligned to form a low profile device appropriate for insertion through the small opening available in the TLIF or PLIF approaches described above. The three parts of both of the plates rotate and translate with respect to one another in situ to a second configuration or a deployed configuration in which the parts are axially unaligned with each other to provide a maximum coverage of the vertebral end plates for a minimum of insertion profile.

Abstract: The present invention provides expandable devices and insertion tools for deploying the expandable devices. The expandable devices are capable of increasing in height and width when expanded from a closed configuration to an open configuration to occupy a larger volume and to present a larger surface area. The expandable devices are lockable and are capable of rigidly occupying a space after expansion. In some embodiments, the expandable devices are useful as interbody devices for spinal fusions.

Abstract: Embodiments of bony region interbody systems, apparatus, and methods are described generally herein including a spinal interbody for insertion between vertebra, the interbody formed of metals or alloys while providing high radiographic visibility. Other embodiments may be described and claimed.

Abstract: An implant extractor that includes an elongated body having a proximal end for attachment to an extraction device, a first arm extending from the elongated body, and a second arm pivotably connected to the first arm. The second arm includes a moment arm for generating a torque about a distal end of the second arm. The implant extractor further includes a force applicator operatively connected to the first arm and the moment arm to apply a force to one or more of the first and second arms.

Abstract: A method of performing arthroplasty of an anatomical joint for receipt of an implant is disclosed. The method includes developing a preoperative plan, designing a patient specific guide based on the preoperative plan, obtaining the patient specific guide, placing the patient specific guide relative to the identified bone, fixing a pair of pins into the bone to establish an Alpha plane and executing the preoperative plan while referencing the Alpha plane. A desired amount of remaining first bone is determined based on a condition of the anatomical joint and a desired orientation of the implant. The patient specific guide includes a pair of bores defined therein and located in positions to accept a complementary pair of pins. The bores are arranged at locations on the patient specific guide to orient the respective pins in a direction optimized for surgeon access to the first bone and to establish the Alpha plane.

Abstract: Provided is a spacer device for assisting a surgeon during knee surgery on a patient, the spacer device having a housing, a support portion and an electronic force sensor. The housing includes a lateral member having an outer surface and an inner surface and a pair of side members that comprise respective, internal, opposed side walls. The support portion includes a first end portion disposed between the side walls of the housing and including a first pair of lateral projections and a second end portion. The support portion is further adapted for axial slidable movement relative to the housing so as to define a first space and a second space between a first pair of lateral projections and respective side members for receiving one or more spacer elements therein. A surgical system including the spacer device as well as methods of using same are also provided.

Abstract: A prosthetic device has a movable body and foot member with an end effector for contacting an external surface. A base body is coupled to a first joint of the foot member. A compliant linking member is disposed between a second joint of the foot member and a first joint of the moveable body. The compliant linking member can be a spring or flexible beam. A passive linking member is coupled between a third joint of the foot member and a third joint of the moveable body. An actuator is disposed between the base body and the second joint of the movable body. The actuator can be a motor with an extension member. The compliant linking member extends during roll-over phase. The actuator acts to assist with the extension of the compliant linking member during roll-over phase to aid with push-off phase in the gait cycle.

Abstract: The present invention relates to an intraluminal vessel prosthesis system for implantation in the region of the aortic arch of a patient, comprising a hollow cylindrical main vessel prosthesis, wherein the hollow cylindrical main vessel prosthesis is configured and dimensioned for implantation in the region of the artic arch and the descending aorta (Aorta descendens) of the patient and wherein the main vessel prosthesis, at least over part of the length L2 of the anchoring vessel prosthesis, and wherein the diameter D2 of the anchoring vessel prosthesis is at least 45% smaller than the diameter D1 of the main vessel prosthesis and wherein the length L2 of the anchoring vessel prosthesis is shorter than the length L2 of the main vessel prosthesis.

Abstract: An illustrative stent may comprise an elongated tubular member having a longitudinal axis, the elongated tubular member comprising at least one knitted filament forming a plurality of twisted knit stitches with intermediate rung portions extending circumferentially between radially adjacent twisted knit stitches. Each twisted knit stitch may be interconnected with a longitudinally adjacent twisted knit stitch forming a series of linked stitches. The elongated tubular member may be configured to move between a collapsed configuration and an expanded configuration, wherein in the collapsed configuration the series of linked stitches form longitudinal columns and in the expanded configuration the series of linked stitches extend helically around the elongated tubular member.

Abstract: This disclosure concerns medical devices, such as catheters and implantable devices, having radially adjustable features. More particularly, the catheters and implantable devices can radially expand and contract to perform various functions within the body. Expansion and contraction can be performed by a radially adjustable structure mounted on the medical device. For example, a medical device can include an body configured for in vivo introduction, a strip attached to the body and rolled into a ring such that layers of the strip radially overlap each other, and at least one motor actuatable by electrical energy to move the radially overlapping layers of the strip relative to one another and change a diameter of the ring and the body.

Abstract: Delivery system embodiments for treatment of a vascular defect of a patient's vasculature that may include an endoluminal prosthesis loaded on a delivery catheter. In some cases, an inflatable balloon used to facilitate deployment of the endoluminal prosthesis may be disposed within an inner lumen of a tubular graft portion of the endoluminal prosthesis.

Abstract: Methods, apparatuses and systems are described for delivering a stent through an access hole of a body lumen and covering up the access hole after deploying the stent. Stents are described that include a stent body defining a body lumen contact surface area and a deployable member configured to deploy from the stent body and increase the body lumen contact surface area of the stent. Deployable members that hinge, unroll, extend, expand, and coaxially translate with respect to the stent body are described. A system for delivering a stent into a body lumen are described that may include a coverage member configured to at least partially cover the hole in the wall of the stent upon withdrawing a tubular member through the hole in the wall of the stent. Coverage members may include a self-sealing membrane, a flap valve, or a hinged valve.

Abstract: Methods, apparatuses and systems are described for stent delivery and positioning to cover an access site. The method may include delivering the stent through an access site in a wall of the body lumen. In some cases, the method may include repositioning the stent within the body lumen to at least partially cover the access site with the stent. The stent may be repositioned within the body lumen by retracting the stent towards the access site such that a proximal portion of the stent at least partially covers the access site. The stent may then expand within the body lumen. In some cases, the stent may expand within the body lumen by releasing a primary constrainment member from the stent by pulling the primary constrainment member in a proximal direction away from the stent.

Abstract: Methods, apparatuses and systems are described for stent delivery and positioning to cover an access site. A stent delivery system may include a tubular member configured to advance through an access site and a primary constrainment member configured to releasably couple the stent to the tubular member. The stent delivery system may further include a secondary constrainment member at least partially disposed around the primary constrainment member, the stent, and the tubular member. In some cases, the tubular member and the primary constrainment member may be configured to reposition the stent within the body lumen after removal of the secondary constrainment member such that at least a portion of the stent covers the access site after withdrawal of the tubular member, the primary constrainment member, and the secondary constrainment member from the body lumen through the access site.

Abstract: Methods, apparatuses and systems are described for expandable stent delivery apparatus to cover an access site. The method may include delivering the stent through an access site and deploying a distal portion of the stent from within an outer sheath. In some cases, the method may further include pushing a proximal portion of the stent from the outer sheath such that upon fully exiting the outer sheath, the proximal portion extends proximally to at least partially cover the access site with the stent. The system for delivering the stent into the body lumen may include a stent, a stent delivery apparatus, and an outer sheath. The system may further include an internal pusher configured to push a proximal portion of the stent from the outer sheath and axially compress the stent such that upon fully exiting the outer sheath, the proximal portion extends proximally to cover the access site.

Abstract: Methods, apparatuses and systems are described for expandable stent delivery apparatus to cover an access site. The method may include delivering a stent delivery system through an access site, where the stent delivery system comprises a positioning member with a first portion that is rotatable with respect to a second portion, and where the stent is releasably coupled with the first portion of the positioning member. In some cases, the method may further include withdrawing an outer constrainment member from the stent to deploy a proximal portion of the stent within the body lumen and rotating the proximal portion of the stent away from the access site by withdrawing the positioning member proximally and back through the access site. The method may further include covering the access site with the proximal portion of the stent upon fully deploying the proximal portion from the outer constrainment member.

Abstract: Stent delivery systems including a deployment sheath for the stent, and an anti-catch member positionable adjacent to a proximal end of the deployment sheath and designed to allow the proximal end of the deployment sheath to be passed through the stent without catching on the stent.

Abstract: A personalized prosthesis for implantation at a treatment site of a patient includes a self-expanding mesh and/or membrane having collapsed and expanded configurations. The collapsed configuration is adapted to be delivered to the treatment site, and the expanded configuration is oversized relative to the treatment site and configured to engage the personalized prosthesis with the treatment site. The self-expanding mesh is configured to reduce in one or more dimensions in response to being constrained in the one or more dimensions, such that the mesh in the expanded configuration self-adjusts to the treatment site without buckling of the mesh. The self-expanding mesh or membrane forms a central lumen configured to allow blood or other body fluids to flow therethrough. Methods of manufacturing and delivery of the personalized prosthesis are also disclosed.

Abstract: A method of manufacturing a stent delivery system and a stent delivery system that can reduce an insertion resistance of an outer tube relative to an inner wall surface of another medical appliance, such as a catheter. The method includes: deforming, by disposing an insertion member in a lumen of the inner-side tube, opposing two locations of the inner-side tube; disposing the respective operation wires in the pair on outer peripheral sides of the opposing two locations of the inner-side tube; disposing the outer-side tube at an outer peripheral side of the inner-side tube so as to surround the inner-side tube and the pair of the operation wires; and disposing, in a state where an insertion member is disposed in the lumen of the inner-side tube, a retaining member that retains a cross-sectional shape of the inner-side tube in a space formed between the inner-side tube and the outer-side tube.

Abstract: A soft brace to prevent injury to one or more target joints or body segments is disclosed. The soft brace includes one or more tensile elements configured to limit motion of one or more target joints based on placement of the one or more tensile elements relative to the one or more target joints such that the placement and tension of each of the one or more tensile elements provides resistance against motion of the one or more target joints; one or more soft tissue anchors positioned on a body around the one or more target joints, the one or more anchors being configured to anchor one or more of the one or more tensile elements to the body to provide force distribution relative to the one or more target joints; and wherein at least one of the one or more tensile elements is routed in parallel with the approximate center of rotation of at least one of the one or more target joints.

Abstract: This orthosis manufacturing system is designed to manufacture an orthosis to be fitted on a human body and provided with: an orthosis modeling data generation unit (2) for generating orthosis modeling data (D4) for the orthosis on the basis of three-dimensional data (D1) of the human body generated by measuring the shape of a portion of the human body to which the orthosis is to be fitted, a model shape data (D2) for the orthosis, and manufacture history data (D3) relating to other orthoses manufactured in the past; and an orthosis formation unit (3) for three-dimensionally forming the orthosis on the basis of the modeling data (D4).

Abstract: A nasal splint and methods for using such splints are provided. The nasal splint may include an elongate generally planar member comprising first and second ends, and a first outer surface and an opposite second outer surface; a tubular airway extending along the first outer surface at least partially between the first and second ends, thereby defining a lumen having an opening adjacent the first end; and a structure on one of the elongate member and tubular airway adjacent the first end supporting a feature that is spaced apart from the first outer surface and configured to support a suture across the opening when the suture is directed through the elongate member adjacent the first end and the feature.

Abstract: A drainable ostomy appliance including: first and second walls connected to each other at or near their peripheries, the first wall having a stoma-receiving opening; a collecting cavity defined between the first and second walls; a connection member connected to the first wall for attaching the appliance to a user or for attaching the appliance to a flange for attaching the appliance to a user; an outlet which extends away from the stoma-receiving opening, the outlet having an opening for waste and the outlet being formed from at least one wall which terminates at a wall edge; and a stiffening member which is connected to the wall forming the outlet, the stiffening member being positioned such that it overlaps the edge of said wall effectively extending the length of the outlet.

Abstract: A drainable ostomy appliance includes first and second walls connected to each other at or near their peripheries. The first wall has a stoma-receiving opening, and a collecting cavity is defined between the first and second walls. A connection member is connected to the first wall for attaching the appliance to a user or for attaching the appliance to a flange for attaching the appliance to a user. An outlet extends away front the stoma-receiving opening and terminates at an opening. A stiffening member is positioned at or near the opening which extends across the outlet. The stiffening member has first and second sides which extend across the outlet, with the first side being closer to the stoma receiving opening than the second side. A thickness of the stiffening member increases as it extends from the first side to the second side.

Abstract: An improved gauntlet wet cell battery provides a plurality of elongated hollow spines filled with active material in a cathode array. Bottom ends of the cathode array are closed with an electrically conductive bottom end cap that electrically and mechanically interconnects the free ends of each spine so as to close and substantially rigidly locate the free ends of said spines with respect to one another. In this manner, electrical continuity between the spines is maintained even if one of the spines fractures, cracks, or otherwise becomes mechanically disassociated from an upper portion of the same spine.

Abstract: A drainable ostomy appliance including: first and second walls connected to each other at or near their peripheries, the first wall having a stoma-receiving opening; a collecting cavity defined between the first and second walls; a connection member connected to the first wall for attaching the appliance to a user or for attaching the appliance to a flange for attaching the appliance to a user; an outlet which extends away from the stoma-receiving opening, the outlet terminating at an opening; and a first stiffening member positioned immediately adjacent the opening on a wall of the outlet facing the user, in use, the first stiffening member extending across the outlet; and a second stiffening member positioned next to the first stiffening member, further away from the outlet than the first stiffening member and on the same wall as the first stiffening member, the second stiffening member also extending across the outlet.

Abstract: A flexible menstrual cup includes a cup including an internal space having an opening, an outer side wall, and an inner side wall; and a stem. The opening is provided with an overflow stopping convex ring. A top surface of the overflow stopping convex ring is a bevel face. An inner side wall is provided with a plurality of vertical grooves.

Abstract: Methods and systems herein relate to receiving dentition data of a patient; processing the dentition data in a server to determine a vertical displacement and a forward mandibular position to enable the patient to breathe during sleep by opening the airway of the patient; and forming a homogeneous dental appliance via direct manufacture using the processed dentition data, the vertical displacement and the forward mandibular position, the dental appliance including a lower dental tray and an upper dental tray, the lower dental tray inclusive of a pair of vertical displacement bite pads with the vertical displacement and a first pair of button protrusions, the upper dental tray inclusive of a second pair of button protrusions, the first pair of button protrusions and the second pair of button protrusions providing the forward mandibular position when two elastic bands are attached to connect the upper dental tray and the lower dental tray.

Abstract: Disclosed herein are splints for a mandibular advancement device, each splint comprising one or more guided fins, wherein each guided fin is located at a distance D from back of the splint; a back post; at least one threaded rod connecting the back post to the guided fin, wherein the distance between the guided fin and the back post is changed when the threaded rod is turned either clockwise or counterclockwise; and a guiding mechanism.

Abstract: An intrauterine device includes a central support member, first and second internal flexures and first and second external flexures. The first and second internal flexures each include a first section having a first stiffness, a second section having a second stiffness, and third section having a third stiffness, wherein the second stiffness is more flexible than the first and third stiffness and wherein the first section of each internal flexure is coupled to the central support member. The first and second external flexures are coupled to the central support member and coupled to the third sections of the first and second internal flexures, the first and second external flexures in combination with the first and second internal flexures being configured to extend from a collapsed position parallel to the central support member to a deployed position flexing away from the central support member.

Abstract: A system and method are provided, the system including a monitoring device to monitor sensory data of a patient and to provide a sensory data response thereto, and a control unit configurable to cool or warm circulated fluid through at least one contact pad for thermal exchange with the patient. The monitoring device can be configured to monitor a 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. A processor can be provided to process the monitoring signal and provide an output employable by medical personnel. The processor can be programmed to control automatically a temperature of the circulated fluid to cool or warm the patient in different treatment phases in accordance with a predetermined protocol, and process the sensory data signal to provide an output signal indicative of a sensory measurement.

Abstract: Disclosed is a frostbite prevention pad for a cryolipolysis procedure, which is used for a cryolipolysis procedure using a cryolipolysis device. The frostbite prevention pad includes: a base member made of a fiber material; one or more waterproof members made of a resin material and placed to overlap the base member; and one or more sewn parts formed by sewing the base member and the waterproof member to couple the base member and the waterproof member in a state in which the base member and the waterproof member overlap each other.

Abstract: A cooling device and method inhibit the infectious growth of pathogens in a body cavity, primarily to cure VulvoVaginal Candidiasis (VVC) and Bacterial Vaginosis (BV) in the vagina, and to reduce biofilms. The device has a shell having an internal chamber containing a freezable or cooling filler that reduces the body cavity temperature. The device may be comprised of an optional coating compound (agent) covering at least a portion of an outer surface of the shell and an optional stainless steel sleeve that covers the shell or optional stainless steel particles that are impregnated into the shell material to enhance both thermal conductance and cooling efficacy. Pathogenic biofilms dissolve and bacteria colony counts decrease at lowered temperatures in body cavities, and infectious, temperature sensitive organisms (fungi, yeast, bacteria, viruses, parasites, and protozoans) become dormant, change morphology, or cease growing under the same lowered body cavity temperatures.

Abstract: A device for exchanging heat with a subject having skin is provided. The device includes a heat exchanging member having a heat transfer surface configured to form a heat conducting interface with the subject's skin. The device further includes a substantially flexible sensing device disposed in the interface between the heat exchanging member and the subject's skin. The sensing device is configured to measure a parameter of the interface without substantially impeding heat transfer between the heat exchanging member and the subject's skin.

Abstract: A method of treating a subject in need thereof, is carried out by (a) administering said subject a therapeutic intervention (e.g., an active agent) in a treatment effective amount; and concurrently (b) administering said subject caloric vestibular stimulation in a treatment effective amount, said caloric vestibular stimulation administered so as to enhance the efficacy of said active agent. In some embodiments, the caloric vestibular stimulation is administered as an actively controlled time varying waveform.

Abstract: Embodiments include methods and systems for treating back pain associated with a nerve. A needle of a cryogenic system may be inserted beneath a skin surface. The needle may include an electrically conducting structure at least partially surrounded by an electrical insulator for conducting electrical energy. The needle may include an outer lumen and an inner lumen extending distally within the outer lumen, the inner lumen include a distal opening open to the outer lumen. The needle may be positioned at a desired location in proximity to the nerve, and a cooling therapy including cooling cycles and thawing periods may be performed to cool tissue at the desired location. The cooling therapy may sufficiently reduce the back pain.

Abstract: The present disclosure relates to relates to systems and methods for on-demand delivery of a therapeutic agent from an eye mounted device. Particularly, aspects of the present invention are directed to a method of delivering a therapeutic agent, the method including receiving, at a controller of a therapeutic agent release and delivery device, a first command signal for delivery of a therapeutic agent based on a dosing time window. Upon receipt of the first command signal, the controller determines whether one or more compliance conditions are satisfied. When the one or more conditions are satisfied, the controller initiate a release and delivery protocol that commands a signal generator to generate and send a second command signal causing a capacitor or one or more circuits to deliver an actuation signal causing one or more therapeutic agent delivery mechanisms to open and release the therapeutic agent from one or more reservoirs.

Abstract: The present disclosure relates to devices and systems for targeted and controlled delivery of a therapeutic agent to a treatment site of an eye. Particularly, aspects are directed to a therapeutic agent delivery device that includes a polymeric substrate having a release region, a delivery region, and a receiving region; one or more reservoirs formed within the release region; a therapeutic agent disposed within the one or more reservoirs; an active, passive, or combination thereof controlled release mechanism for release of the therapeutic agent from the one or more reservoirs into the delivery region; and a circuit formed on the polymeric substrate, the circuit having a current source, a first iontophoresis electrode located within the delivery region for transport of the therapeutic agent from the delivery region into a target tissue via electromigration, and a second iontophoresis electrode located within the receiving region for maintaining electroneutrality within the tissue.

Abstract: The invention provides a syringe for use in an ophthalmic injection. The syringe comprises a body, a stopper and a plunger. The body comprises an outlet at an outlet end and the stopper is arranged within the body such that a front surface of the stopper and the body define a variable volume chamber from which a fluid can be expelled though the outlet. The plunger comprises a plunger contact surface at a first end and a rod extends between the plunger contact surface and a rear portion. The plunger contact surface is arranged to contact the stopper but not couple thereto, such that the plunger can be used to force the stopper towards the outlet end of the body, reducing the volume of the variable volume chamber, but not to move the stopper away from the outlet end.