Abstract: A method and apparatus for a suture less injectable retinal detachment sponge and method for placing the sponge in a pocket beneath the surface of the sclera is the subject of the present invention. An exterior accessible pocket can be created in the sclera by making an incision in the outer surface. The incision can be made utilizing a crescent blade. The apparatus used to perform the procedure for insertion of the sponge in the pocket utilizes an injector having a cylinder and plunger combination. The cylinder can have a sponge removably contained therein and a plunger for injecting the sponge out of the cylinder portion of the injector to the desired location within the pocket.

Abstract: The invention concerns a device for ocular application of an active principle (1) comprising a main electrode (2) including an insulating layer, an adhesive layer designed to bind the insulating layer to a conductive layer, characterized in that the main electrode comprises a zone (21, 22) designed to be urged into contact with an eyelid.

Abstract: A method of delivering safe, suitable, and repeatable dosages to a subject for topical, oral, nasal, or pulmonary use and a device for droplet ejection includes a fluid delivery system capable of delivering a defined volume of the fluid in the form of droplets having properties that afford adequate and repeatable high percentage deposition upon application. The method and device include a housing, a reservoir disposed within the housing for receiving a volume of fluid, an ejector mechanism configured to eject a stream of droplets having an average ejected droplet diameter greater than 15 microns, the stream of droplets having low entrained airflow such that the stream of droplets deposit on the eye of the subject during use.

Abstract: Lacrimal implants for treating diseases or disorders are disclosed. More particularly, lacrimal implants, methods of making such implants, and methods of treating ocular, respiration, inner ear or other diseases or disorders using such implants are disclosed.

Abstract: The present invention includes methods and devices for delivering an active agent into the eye of a subject. One such device may include an anode assembly having an anode housing and an anode configured to electrically couple to a power source, the anode assembly being configured to contact and remain against a surface of the eye. The device may also include a cathode assembly having a cathode housing and a cathode configured to electrically couple to the power source, the cathode assembly being configured to contact and remain against the surface of the eye. Additionally, the device may include at least one active agent reservoir functionally associated with at least one of the anode assembly and the cathode assembly.

Abstract: The present invention relates to the use of a fully human antigen binding fragment of an antibody for the manufacture of a medicament for the treatment or diagnosis of an ocular disease upon topical administration. The invention further relates to a pharmaceutical composition comprising a fully human binding fragment of an antibody for ocular topical administration for treatment or diagnosis of an ocular disease. In particular, the antibody neutralizes HSV1 and HSV2.

Abstract: Intraocular devices having a drug delivery construct attached thereto, and methods for using the devices for intraocular drug delivery and the treatment and/or prevention of conditions.

Abstract: Devices and methods are provided for selectively delivering a drug by laser activation. The device includes structural elements forming a hermetic, enclosed reservoir, and at least one drug unit contained in the enclosed reservoir. The at least one drug unit includes a drug. The device is able to absorb laser irradiation effective to open the enclosed reservoir to permit release of the drug. The method includes implanting a drug delivery device into a tissue site of a patient, and irradiating at least a portion of the drug delivery device to breach the enclosed reservoir to permit the drug to be released in tissues at the tissue site.

Abstract: A viscoelastic medium is useful for the manufacture of a medicament, such as a medical device, for treatment of increased intraocular pressure in the eye of a human or animal. The medicament is administerable into at least one sclerally penetrating fistula of the eye such that the fistula is filled with the medicament. The medium is also useful in a method of treating increased intraocular pressure in the eye of a human or an animal in need thereof, comprising the step of injecting the viscoelastic medium into at least one sclerally penetrating fistula in the eye such that the fistula is filled with the medium.

Abstract: Systems and methods for fluid control during aspiration. In an embodiment, an aspiration system includes an aspiration line having distal and proximal ends and an aspiration port defined in the distal end; a fluid transport device operatively coupled to the proximal end of the aspiration line; and a flow restrictor operatively coupled to the aspiration line in between the fluid transport device and the aspiration port. To measure occlusion within the line, first and second pressure sensors are utilized, the first sensor being operatively coupled to the aspiration line between the port and the restrictor and the second sensor being operatively coupled to the aspiration line between the restrictor and the fluid transport device. The pressure differential between the two sensors can provide an indication of the onset, presence, and/or elimination of an occlusion.

Abstract: Eye diseases such as glaucoma can be treated using a composition containing cross-linked hyaluronic acid or a cross-linked salt of hyaluronic acid such as sodium hyalurate. The composition can be a monophasic gel. The composition can include a cross-linking agent such as 1,4-butanediol diglycidylether. The composition can contains about 2.25% (w/w) of the salt of hyaluronic acid. The composition can have a cross-linking rate of about 0.5 to 50%.

Abstract: Methods and systems are disclosed for creating an aqueous flow pathway in the trabecular meshwork, juxtacanalicular trabecular meshwork and Schlemm's canal of an eye for reducing elevated intraocular pressure. Some embodiments described apparatus and methods useful in photoablation of tissues. In some embodiments, a photoablation apparatus is used to perforate a tissue, forming an aperture into a space behind the tissue. Gases formed during a photoablation process can be used to pressurize the space behind the tissue to enhance patency of the space. In some embodiments the tissue is the trabecular meshwork of the eye and a wall of Schlemm's canal, and the space behind the tissue is a portion of the lumen of Schlemm's canal. In some embodiments, the method is useful in the treatment of glaucoma by improving outflow from the anterior chamber of the eye into Schlemm's canal, reducing intraocular pressure.

Abstract: The invention is generally directed to systems and methods for fluid control, and more particularly to systems and methods for power and flow rate control for aspiration. In accordance with one embodiment, an aspiration system includes an aspiration line having distal and proximal ends and an aspiration port defined in the distal end; a fluid transport device operatively coupled to the proximal end of the aspiration line; and a flow restrictor operatively coupled to the aspiration line in between the fluid transport device and the aspiration port. To measure occlusion within the line, first and second pressure sensors are utilized, the first sensor being operatively coupled to the aspiration line between the port and the restrictor and the second sensor being operatively coupled to the aspiration line between the restrictor and the fluid transport device. The pressure differential between the two sensors can provide an indication of the onset, presence, and/or elimination of an occlusion.

Abstract: The present invention provides devices, systems, and methods for delivery of an active agent into the eye of a subject. In one aspect, for example, an ocular active agent delivery device (10) can include an active agent reservoir (14) disposed in an annular housing (12), the annular housing (12) being configured to fit inside of a lens capsule and at least partially encircling a line of sight of an intraocular lens within the lens capsule. The device (10) can further include a semipermeable membrane (16) operatively coupled to the active agent reservoir (14), where the semipermeable membrane (16) is configured to allow diffusion of an active agent from the active agent reservoir (14). Additionally, a valve (18) can be operatively coupled to the active agent reservoir (14), where the valve (18) is configured to allow filling of the active agent reservoir (14) with an active agent.

Abstract: The present disclosure relates to methods for visualizing the opening of a drug reservoir of an implantable medical device. In particular, the present disclosure provides methods for observing the release or exposure of contents from a drug reservoir of a medical device placed within the vitreous of an eye of a subject. The methods include implanting a drug delivery device within an anatomy of a subject. The drug device includes a plurality of reservoirs, each loaded with a therapeutic agent and a marker. Furthermore, the drug delivery device comprises a plurality of barrier layers for separating the contents of one of the plurality of reservoirs from the anatomy. The method further includes irradiating at least one of the plurality of barrier layers such that at least one of the plurality of reservoirs is breached, thereby triggering release of the therapeutic agent and the marker from the device.

Abstract: An agent delivery apparatus for administering a pharmacological agent formulation to a sub-mucosal compartment of a body organ, comprising injector means having an internal formulation chamber that is adapted to receive and contain the pharmacological agent formulation therein and an elongated agent delivery member having a first end that is in communication with the internal formulation chamber and a second ejection end, the injector means including force generating means that is adapted to generate sufficient force to expel the pharmacological agent formulation from the injector means and into and through the agent delivery member, and out of the ejection end of the elongated agent delivery member. In one embodiment of the invention, the delivery member comprises a needleless delivery member.

Abstract: The invention is generally directed to systems and methods for fluid control, and more particularly to systems and methods for power and flow rate control for aspiration. In accordance with one embodiment, an aspiration system includes an aspiration line having distal and proximal ends and an aspiration port defined in the distal end; a fluid transport device operatively coupled to the proximal end of the aspiration line; and a flow restrictor operatively coupled to the aspiration line in between the fluid transport device and the aspiration port. To measure occlusion within the line, first and second pressure sensors are utilized, the first sensor being operatively coupled to the aspiration line between the port and the restrictor and the second sensor being operatively coupled to the aspiration line between the restrictor and the fluid transport device. The pressure differential between the two sensors can provide an indication of the onset, presence, and/or elimination of an occlusion.

Abstract: Methods and devices are provided for targeted administration of a drug to a patient's eye. In one embodiment, the method includes inserting a hollow microneedle into the sclera of the eye at an insertion site and infusing a fluid drug formulation through the inserted microneedle and into the suprachoroidal space of the eye, wherein the infused fluid drug formulation flows within the suprachoroidal space away from the insertion site during the infusion. The fluid drug formulation may flow circumferentially toward the retinochoroidal tissue, macula, and optic nerve in the posterior segment of the eye.

Abstract: The present invention includes methods and devices for delivering an active agent into the eye of a subject. One such device may include an anode assembly having an anode housing and an anode configured to electrically couple to a power source, the anode assembly being configured to contact and remain against a surface of the eye. The device may also include a cathode assembly having a cathode housing and a cathode configured to electrically couple to the power source, the cathode assembly being configured to contact and remain against the surface of the eye. Additionally, the device may include at least one active agent reservoir functionally associated with at least one of the anode assembly and the cathode assembly.

Abstract: A delivery device that allows for the sustained release of an agent, particularly useful for the sustained release of a therapeutic agent to limited access regions, such as the posterior chamber of the eye and inner ear. The delivery device is minimally invasive, refillable and may be easily fixed to the treatment area. The delivery device includes a hollow body with an inlet port at its proximal end for insertion of the agent, a reservoir for holding the agent and a delivery mechanism for the sustained delivery of the agent from the reservoir to the patient.

Abstract: The present invention relates to a device and methods for culturing stem cells, and in particular, for culturing ocular stem cells and the use of stem cells cultured using the devices and methods of the invention for the treatment of diseases.

Abstract: An agent delivery apparatus for administering a pharmacological agent formulation to a sub-mucosal compartment of a body organ, comprising injector means having an internal formulation chamber that is adapted to receive and contain the pharmacological agent formulation therein and an elongated agent delivery member having a first end that is in communication with the internal formulation chamber and a delivery nozzle end, the injector means including force generating means that is adapted to generate sufficient force to expel the pharmacological agent formulation from the injector means and into and through the agent delivery member, and out of the delivery nozzle end of the elongated agent delivery member with a delivery pressure in the range of approximately 50-1000 psi.

Abstract: Implantable drug delivery devices, and kits and methods incorporating them are described. The devices may, for example, be configured for implantation into an ocular region of a subject. The drug delivery devices may comprise multiple, selectively-triggerable drug reservoirs for administration of sequential or concomitant drug regimens. Some variations of devices may comprise one or more reservoirs that may be triggered by an optical stimulus, e.g., light having a wavelength within a certain wavelength range. The devices, methods, and kits may be useful in the treatment chronic ocular conditions, such as age-related macular degeneration.

Abstract: The present invention includes methods and devices for non-invasively delivering an active agent to the eye of a subject. In one aspect, for example, a device for delivering an active agent to an eye of a subject may include an ocular lens-shaped housing configured to contact a surface of the eye, and a reservoir coupled to the housing and configured to deliver an active agent to the eye, wherein the reservoir is located entirely within a 180 degree section of the housing. In another aspect, the reservoir is located entirely within a 150 degree section of the housing.

Abstract: The invention relates to a device of ocular iontophoresis for delivering active substances, comprising a reservoir having an outer wall and a hollow body at least partly delimited by the outer wall, wherein the hollow body is capable of receiving an electrical conductive medium and active substances contained in the medium and has an outlet defining a surface, so-called “application surface”, intended to received a determine part of an eyeball surface, the application surface being at least partly limited by an outer line concave towards the optical axis of the eyeball, wherein the outer wall extends from the outer line with a global outwardly with respect to the said optical axis.

Abstract: A contact lens product, a method and system for forming the contact lens product, and a method of using the contact lens product. The contact lens product includes a soft disposable contact lens loaded with a drug and the carriers which carry the drug. The lens has a mechanical and optical structure formed by the core polymer included within the lens. The contact lens product is configured to have the drug released from its carrier continuously into an eye of a mammal while the contact lens product is adhered to the eye of the mammal during a continuous period of time, the drug being configured to treat or prevent at least one adverse condition of the eye of the mammal during the continuous period of time. The mammal may be a human being or a veterinary animal.

Abstract: A subconjunctival injection apparatus for administering a pharmacological agent formulation to a subconjunctival compartment of an eye, the apparatus including a jet injector having force generating means that is adapted to generate sufficient force to expel the pharmacological agent formulation from the jet injector and through the conjunctiva. In one embodiment of the invention, the jet injector comprises a needleless jet injector. In one embodiment, the needleless jet injector provides a delivery pressure in the range of approximately 100-1000 psi.

Abstract: Described and illustrated are various insertion instruments, cap, plug, method and kit. In one aspect, a cap for a punctal insertion instrument is shown and described. In a further aspect, a punctum plug insertion system that includes the instrument and the cap is provided. In yet a further aspect, a method of releasing a punctum plug from a plug holder is provided. Additionally, a kit that contains the plug insertion instrument, cap, plugs, and instructions for use is provided.

Abstract: The invention provides surgical devices that provide access to the sub-retinal space using delicate traction to hold the sensory retina to create and maintain a patent sub-retinal space of sufficient size to introduce and perform treatments on the eye. Such treatments may include the introduction of illumination or imaging agents or tools, surgical tools, the infusion of pharmaceutical or biological agents, and the placement of grafts, transplants or implants and the closure of the site through the delivery of a sealant.

Abstract: The invention relates to method of preparing a viscoelastic therapeutic liquid comprising a viscoelastic agent and a homogenously distributed therapeutically active agent, wherein the therapeutically active agent is distributed throughout the viscoelastic compound when the viscoelastic compound is in dry form. In one embodiment of the invention, the viscoelastic compound in dry form is mixed with an aqueous solution of the therapeutically active agent. The invention further relates to utilities of homogenous viscoelastic compositions in therapeutic applications including ophthalmic surgery.

Abstract: Shunt devices and a method for continuously decompressing elevated intraocular pressure in eyes affected by glaucoma by diverting excess aqueous humor from the anterior chamber of the eye into Schlemm's canal where post-operative patency can be maintained with an indwelling shunt device which surgically connects the canal with the anterior chamber. The shunt devices provide uni- or bi-directional flow of aqueous humor into Schlemm's canal.

Abstract: A method for suspending colorant in a subconjunctival space of a human eye, including steps of accessing the subconjunctival space, injecting colorant into the subconjunctival space, suspending colorant in the subconjunctival space, spreading the colorant into a desired pattern, and closing access to the subconjunctival space. The system avoids tattooing, implanting, and corneal modification. Permanent results may be obtained. Colorants may be suspensions or stains.

Abstract: A novel system for coloring the sclera of a human eye, including steps of accessing the conjunctiva, drying a portion of the conjunctiva, applying one or more colorants to the dried portion of the conjunctiva, drying the colorant, and closing access to the conjunctiva. The system avoids tattooing, implanting, and corneal modification. Permanent results may be obtained. Colorants may be coverings or stains.

Abstract: Irrigation fluid is aspirated from an eye and through an aspiration instrument by operating a vacuum pump, including moving first and second plungers between respective suction strokes and discharge strokes. Vacuum pressure at an input side of the pump is maintained at a desired vacuum pressure setting by controlling speeds and directions of the plungers, and controlling positions of input and output valves communicating with cylinders in which the plungers move. Controlling is based on the pressure setting and measured pressures in the cylinders. Vacuum pressure is maintained while transitioning from the suction stroke of the first plunger to the suction stroke of the second plunger, by synchronizing respective positions of the plungers and the valves, such that initiation of the suction stroke of the second plunger during the transitioning is delayed until a vacuum pressure in the second cylinder is equal to a vacuum pressure in the first cylinder.

Abstract: Method for delivering a stent coupled with a catheter, to a selected position within a lumen of the body of a patient, the method includes the procedures of: selecting a single image of the lumen, among a plurality of images of an image sequence of the lumen, receiving a position input associated with the selected image and respective of the selected position, the position input is defined in a coordinate system respective of a medical positioning system (MPS), detecting the current position of the stent in the coordinate system, according to position data acquired by an MPS sensor attached to the catheter in the vicinity of the stent, superimposing on at least one maneuvering associated image of the lumen, at least one stent representation respective of the current position, and at least one marking representation respective of the position input, according to a real-time organ timing signal of an inspected organ of the body, maneuvering the catheter through the lumen, toward the selected position, according

Abstract: A novel system for an iris of the human eye includes drying the tissue surface, applying colorant to the dried surface, and then drying the applied colorant. The system avoids tattooing, implanting, and corneal modification. Permanent results may be obtained. Colorants may be coatings or stains. Blown gas is controllably infused to maintain a constant pressure in the anterior chamber, and the blown gas is turned on and off by opening a path to the outside of the eye and closing such path, respectively.

Abstract: Methods and systems are provided for delivering drug to the eye. The method and system may include implanting into the eye a device which comprises two or more discrete reservoirs, each reservoir containing a drug; and directing focused light to the implanted device to open a first one of the reservoirs and thereby permit the drug to diffuse from the first reservoir to the patient's eye.

Abstract: The present invention generally relates to methods for deploying intraocular shunts without the use of an optical apparatus that contacts an eye, such as a goniolens. In certain embodiments, methods of the invention involve inserting into an eye a deployment device configured to hold an intraocular shunt, determining that a distal portion of the device is properly positioned within the eye without use of an optical apparatus that contacts the eye, and deploying the shunt from the device.

Abstract: An extraction sleeve assembly for use in extracting a viscous fluid from the posterior segment of an eye during vitreoretinal surgery is disclosed. The extraction sleeve assembly includes a luer lock fitting and a flexible, tubular extraction sleeve. The extraction sleeve assembly facilitates a shorter extraction time for the viscous fluid.

Abstract: Delivery systems and methods for delivering riboflavin (R/F) and UVA irradiation to the sclera are disclosed. The R/F is delivered and then activated with UVA irradiation through the use of LEDs or optical fibers, thereby causing cross-linking of the collagen tissue. Delivery systems include implantable structures which provide surfaces that conform to the sclera. The delivery systems include various types of structures for delivery of R/F onto the sclera surface. Additionally, the delivery systems include UVA sources which provide irradiation of R/F in sclera collagen tissue.

Abstract: Shunt devices and a method for continuously decompressing elevated intraocular pressure in eyes affected by glaucoma by diverting excess aqueous humor from the anterior chamber of the eye into Schlemm's canal where post-operative patency can be maintained with an indwelling shunt device which surgically connects the canal with the anterior chamber. The shunt devices provide uni- or bi-directional flow of aqueous humor into Schlemm's canal.

Abstract: A drug introduction sleeve is disclosed that includes a selectively expandable body portion. The body portion is defined by a first open end and a second open end. A hollow interior is formed within the body portion. The body portion is selectively expandable from a first unexpanded configuration to a second expanded configuration whereby the volume of the hollow interior is increased when the body portion is expanded to the second expanded configuration, sufficient to temporarily retain a drug bolus.

Abstract: A therapeutic agent delivery device that is particularly suitable for delivery of a therapeutic agent to limited access regions, such as the posterior chamber of the eye and inner ear. Preferred devices of the invention are minimally invasive, refillable and may be easily fixed to the treatment area. Preferred delivery devices of the invention also include those that comprise a non-linear shaped body member housing one or more substances and a delivery mechanism for the sustained delivery of the one or more substances from the non-linear shaped body member to the patient.

Abstract: The invention relates to a device of ocular iontophoresis for delivering active substances, comprising a reservoir having an outer wall and a hollow body at least partly delimited by the outer wall, wherein the hollow body is capable of receiving an electrical conductive medium and active substances contained in the medium and has an outlet defining a surface, so-called “application surface”, intended to receive a determine part of an eyeball surface, the application surface being at least partly limited by an outer line concave towards the optical axis of the eyeball, wherein the outer wall extends from the outer line with a global outwardly with respect to the said optical axis.

Abstract: Systems and methods for treating ocular disorders are disclosed. One system has an implant and a delivery device. The implant has inlet and outlet portions, a lumen extending therebetween and communicating with inlet and outlet ports. The implant is sized so that in use aqueous humor flows from an anterior chamber of an eye through the implant and into a uveal scleral outflow path of the eye. The delivery device is configured to advance the implant from within the anterior chamber, with the outlet portion leading the inlet portion, to a location where the outlet and inlet ports respectively communicate with the uveal scleral outflow path and the anterior chamber. One method involves advancing an implant from within the anterior chamber, and draining fluid from therein such that fluid flows into an implant inlet port and out through an implant outlet port and into the uveal scleral outflow path.

Abstract: Devices and approaches for activating cross-linking within at least one eye component of an eye to stabilize and strengthen corneal tissue or other tissues of the eye. Cross-linking is activated within the at least one eye component by conveying a cross-linking agent to regions of the at least one eye component and then activating the cross-linking agent by delivering an initiating element to the at least one eye component. Approaches disclosed herein allow for precisely controlling the three dimensional region of strengthened tissue by conveying the cross-linking agent to regions of the at least one eye component. Approaches allow for conveying the cross-linking agent to a depth below the corneal surface such that cross-linking is activated below the corneal surface.

Abstract: The present invention provides devices, systems, and methods for delivery of an active agent into the eye of a subject. In one aspect, for example, an ocular active agent delivery device (10) can include an active agent reservoir (14) disposed in an annular housing (12), the annular housing (12) being configured to fit inside of a lens capsule and at least partially encircling a line of sight of an intraocular lens within the lens capsule. The device (10) can further include a semipermeable membrane (16) operatively coupled to the active agent reservoir (14), where the semipermeable membrane (16) is configured to allow diffusion of an active agent from the active agent reservoir (14). Additionally, a valve (18) can be operatively coupled to the active agent reservoir (14), where the valve (18) is configured to allow filling of the active agent reservoir (14) with an active agent.

Abstract: A subconjunctival injection apparatus for administering a pharmacological agent formulation to a subconjunctival compartment of an eye, the apparatus including a jet injector having force generating means that is adapted to generate sufficient force to expel the pharmacological agent formulation from the jet injector and through the conjunctiva. In one embodiment of the invention, the jet injector comprises a needleless jet injector. In one embodiment, the needleless jet injector provides a delivery pressure in the range of approximately 100-1000 psi.

Abstract: A flow regulating implant is provided with one or more grooves for allowing fluid flow. One or more grooves may have a constant or varying cross-section along its length. One or more grooves may have in it biodegradable material, absorbable material, and/or threads or sutures. A resilient band or coating may be placed around the implant or one or more grooves, to act as a pressure regulator. The implant may have a side projection, such as a side pin, for engaging tissue. The implant may comprise two or more parts that are held at a distance from each other to allow fluid flow between the parts.

Abstract: The invention relates to sustained release implants and to methods for treating eyes, particularly the eyes of mammals having eye disorders or diseases. By using the implants and methods described herein, the delivery of the one or more bioactive agents can be localized at a desired treatment site, particularly the choroid and the retina.