Abstract: The present invention provides a drug composition comprising particles comprising a biodegradable or bioerodable polymer and a drug, a soluble, biodegradable or bioerodible excipient, a bulking agent and a reconstitution aid. The invention also provides a pharmaceutical formulation and a unit dosage form of the pharmaceutical formulation. The invention provides methods of treatment of a disease or condition accordingly. The invention also provides a drug composition for use in a cannulation device.

Abstract: The present invention provides a drug composition comprising particles comprising a biodegradable or bioerodable polymer and a drug, a soluble, biodegradable or bioerodible excipient, a bulking agent and a reconstitution aid. The invention also provides a pharmaceutical formulation and a unit dosage form of the pharmaceutical formulation. The invention provides methods of treatment of a disease or condition accordingly. The invention also provides a drug composition for use in a cannulation device.

Abstract: The present invention provides a composition for treatment of ophthalmic disease comprising a solid or semi-solid containing drug shaped as an elongated body for injection or delivery into tissue spaces of the eye. The composition may comprise a plurality of drug-containing particles and at least one excipient to form the drug particles into a flexible solid or a semisolid. The excipient comprises a substance that undergoes dissolution in the physiological conditions of the tissue space after injection to allow the microspheres to disperse and migrate in the tissue space. Formulations for the drug containing compositions, methods of fabrication and methods of use are also disclosed.

Abstract: A device for controlled delivery of an injection material to tissue spaces of an eye that are not normally open, such as the subconjunctival space, the suprachoroidal space and the subretinal space. The device comprises an elongated body with a hollow cannula at the distal end, a slidable plunger at the proximal end, and a reservoir for the material to be injected residing between the cannula and the plunger. The plunger is mechanically coupled to a source of force such as a spring or pressurized gas reservoir such that an injection force is applied to the injection material within the device prior to delivery of the injection material into an eye. A valve that is normally closed to prevent flow of the injection material during application of the injection force is placed in the flow path between the cannula and reservoir. Due to the injection force placed on the injection material, actuation of the valve allows controlled flow from the reservoir through the cannula and into the tissue space.

Abstract: Injection device comprising an elongated body (1) with a hollow needle (8) at a distal end; a reservoir for an injection material to be delivered through the needle; a plunger (3) with a first force element (5) configured to provide an injection force to said injection material, and a distal element (10) attached to the distal end of the device thereby sealing a needle lumen, wherein the distal element comprises a tissue interface and a distal seal (11), and wherein the distal seal is penetrable by a distal tip of the needle by the application of pressure on a tissue surface with the distal end of the device, wherein the penetrated distal element becomes slidable on the needle to allow advancement of the needle into tissue, wherein the penetrated distal seal opens a path for flow or delivery of the injection material from the distal end of the needle.

Abstract: The present invention provides a drug composition comprising particles comprising a biodegradable or bioerodable polymer and a drug, a soluble, biodegradable or bioerodible excipient, a bulking agent and a reconstitution aid. The invention also provides a pharmaceutical formulation and a unit dosage form of the pharmaceutical formulation. The invention provides methods of treatment of a disease or condition accordingly. The invention also provides a drug composition for use in a cannulation device.

Abstract: The present invention provides a cannulation device for administering an active agent containing composition into the eye. The invention provides methods of treatment of an ocular disease or condition accordingly. The invention also provides a method for injection of a material accordingly.

Abstract: A device for controlled delivery of an injection material to tissue spaces of an eye that are not normally open, such as the subconjunctival space, the suprachoroidal space and the subretinal space. The device comprises an elongated body with a hollow cannula at the distal end, a slidable plunger at the proximal end, and a reservoir for the material to be injected residing between the cannula and the plunger. The plunger is mechanically coupled to a source of force such as a spring or pressurized gas reservoir such that an injection force is applied to the injection material within the device prior to delivery of the injection material into an eye. A valve that is normally closed to prevent flow of the injection material during application of the injection force is placed in the flow path between the cannula and reservoir. Due to the injection force placed on the injection material, actuation of the valve allows controlled flow from the reservoir through the cannula and into the tissue space.

Abstract: The present invention provides a composition for treatment of ophthalmic disease comprising a solid or semi-solid containing drug shaped as an elongated body for injection or delivery into tissue spaces of the eye. The composition may comprise a plurality of drug-containing particles and at least one excipient to form the drug particles into a flexible solid or a semisolid. The excipient comprises a substance that undergoes dissolution in the physiological conditions of the tissue space after injection to allow the microspheres to disperse and migrate in the tissue space. Formulations for the drug containing compositions, methods of fabrication and methods of use are also disclosed.

Abstract: Injection device comprising an elongated body (1) with a hollow needle (8) at a distal end; a reservoir for an injection material to be delivered through the needle; a plunger (3) with a first force element (5) configured to provide an injection force to said injection material, and a distal element (10) attached to the distal end of the device thereby sealing a needle lumen, wherein the distal element comprises a tissue interface and a distal seal (11), and wherein the distal seal is penetrable by a distal tip of the needle by the application of pressure on a tissue surface with the distal end of the device, wherein the penetrated distal element becomes slidable on the needle to allow advancement of the needle into tissue, wherein the penetrated distal seal opens a path for flow or delivery of the injection material from the distal end of the needle.

Abstract: An ophthalmic microsurgical system is described for treatment of eye diseases, such as glaucoma, using minimally invasive surgical techniques. The microsurgical system includes a thin walled outer sheath microcannula 1 slidably disposed about an inner member 4, which extends slightly beyond the distal end of the microcannula 1. The inner member 4 may be straight or curved and may optionally include a surgical instrument and/or a sensor or signaling beacon. The microsurgical system is used in a surgical procedure for opening Schlemm's Canal to provide drainage of aqueous fluid in order to relieve excess intraocular pressure that results from glaucoma and other diseases of the eye.

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 a novel apparatus for the treatment of ocular disease, particularly glaucoma. The apparatus consists of a locating device to locate Schlemm's Canal within the anterior portion of the eye and a surgical tool to access the canal for treatment. The apparatus allows for guided, minimally invasive surgical access to Schlemm's Canal to enable surgical procedures to be performed on the canal and trabecular meshwork to reduce intraocular pressure. The apparatus may also deliver devices or substances to Schlemm's Canal in the treatment of glaucoma.

Abstract: A device is provided to enable placing an implant within the full circumference of Schlemm's canal of an eye. The device comprises a flexible elongated solid element with a proximal end and a distal tip that transmits light such as one or more strands of a fiber optic. The device is characterized by selected mechanical characteristics to allow advancement within Schlemm's canal. The fiber optic element transmits light from a proximal connector to the distal tip to provide a lighted tip that may be viewed transclerally when the device is advanced along Schlemm's canal.

Abstract: An implant is placed within Schlemm's canal of the eye and provides tension to the trabecular meshwork. The tension is continuous and increases the aqueous outflow without the necessity of administering cholinergic drugs to treat glaucoma.

Abstract: A method is provided for increasing the outflow of fluid through Schlemm's canal that is useful for treatment of glaucoma. The implant is placed in Schlemm's canal by use of a flexible delivery instrument attached to the implant. The instrument and implant are positioned within the canal, the implant is released and the distal and proximal ends of the implant are connected to apply sufficient axial tensioning force on the inner wall of the canal to increase fluid permeability. In another embodiment a delivery instrument attached to the implant is positioned in the canal securing one of the distal or proximal ends of the implant within the canal. The implant provides sufficient axial tensioning force on the inner wall of the canal to increase fluid permeability of the inner wall of the canal. The other of the distal or proximal ends may be secured to maintain the tensioning force on the inner wall of the canal.

Abstract: The present invention provides implantable devices and associated methods for interconnecting human vessels in a side-to-side or an end-to-side arrangement rapidly, safely and in a minimally invasive manner. The devices comprise a vessel connector and a intravascular support mechanism for establishing fluid communication between two vessels. Certain embodiments further include a sealing member for further sealing the openings in the vessels created for inserting the subject devices.

Abstract: A porous three-dimensional tissue repair matrix is provided which is biodegradable. The matrix is preferably formed from mineralized collagen where the mineral comprises particulate calcium phosphate immobilized in the matrix.

Abstract: The invention provides minimally invasive microsurgical tools and methods to form an aqueous humor shunt or bypass for the treatment of glaucoma. The invention enables surgical creation of a tissue tract (7) within the tissues of the eye to directly connect a source of aqueous humor such as the anterior chamber (1), to an ocular vein (4). The tissue tract (7) from the vein (4) may be connected to any source of aqueous humor, including the anterior chamber (1) ), an aqueous collector channel, Schlemm's canal (2), or a drainage bleb. Since the aqueous humor passes directly into the venous system, the normal drainage process for aqueous humor is restored. Furthermore, the invention discloses devices and materials that can be implanted in the tissue tract to maintain the tissue space and fluid flow.

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.