Ophthalmic Delivery Device And Ophthalmic Active Agent Containing Compositions
AssigneeOxular Limited
InventorsRobert Steven Bley, Stanley R. Conston, Tien T. Nguyen, Ronald Yamamoto, Brad Michael Howarth, Adam Jonathan Frederick Stops, Ricky Barnett
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Abstract
The present invention provides a delivery device for administration of active agent (12) containing compositions into the suprachoroidal space or supraciliary space. The invention provides methods of treatment of an ocular disease or condition accordingly. The invention also provides active agent containing compositions for delivery into the suprachoroidal space or supraciliary space.
Claims75
A delivery device comprising
- an elongated body with a needle with a lumen at a distal end;
- a reservoir for an active agent containing composition to be delivered through the needle;
- a plunger with a force element configured to provide a delivery force to said active agent containing composition prior to or simultaneous with contact of the distal end of the device to a tissue surface;
- and
- a distal element attached to the distal end of the device thereby sealing the needle lumen from delivery of said active agent containing composition under the delivery force;
- wherein:
- the distal element comprises a tissue interface and a distal seal, 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;
- the penetrated distal element becomes slidable on the needle to allow advancement of the needle into tissue;
- and
- the penetrated distal seal opens a path for flow or delivery of said active agent containing composition from the distal end of the needle.
A delivery device comprising
- an elongated body with a needle with a lumen at a distal end;
- a first reservoir for a volume of gas to be delivered through the needle;
- a second reservoir for an active agent containing composition to be delivered through the needle;
- a gas flow path from the first reservoir to the needle lumen;
- a first plunger with a force element configured to provide a delivery force to said gas prior to or simultaneous with contact of the distal end of the device to a tissue surface;
- a second plunger or push rod configured to provide a delivery force from said force element to said active agent containing composition;
- and
- a distal element attached to the distal end of the device thereby sealing the needle lumen from delivery of the gas under the delivery force;
- wherein:
- the distal element comprises a tissue interface and a distal seal, 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;
- the penetrated distal element becomes slidable on the needle to allow advancement of the needle into tissue;
- the penetrated distal seal opens a path for flow or delivery of the gas from the first reservoir through the gas flow path to the distal end of the needle;
- and
- the active agent containing composition from the second reservoir is delivered through the needle lumen by the plunger or push rod and force element after all or a portion of the volume of gas has been delivered.
The device of any preceding claim wherein the needle comprises a curved distal tip to direct the material for administration at an angle from the long axis of the needle.
The device of any preceding claim wherein the needle comprises an inner deflecting element in the lumen of the needle at the needle bevel to direct the material for administration at an angle from the long axis of the needle.
The device of any preceding claim wherein the needle comprises a deflecting element in the lumen of the needle at the needle bevel to fragment the material for administration prior to delivery of the material for administration from the needle distal tip.
The device of any preceding claim additionally comprising a second force element between the body of the device and the distal element configured to provide a forward directed force on the distal element during penetration of the distal seal by the distal tip of the needle.
The device of any preceding claim further comprising an active agent containing composition wherein the active agent containing composition is a solid or semisolid.
The delivery device of any preceding claim wherein the reservoir is within the lumen of the needle.
The delivery device of any preceding claim wherein the reservoir is within both the lumen of the needle and an extension of the needle into the body of the device.
The device of any preceding claim additionally comprising a collapsible element between the body of the device and the distal element configured to prevent distal movement of the distal element due to the delivery force.
The device of any preceding claim additionally comprising a collapsible element between the body of the device and the distal element configured to provide a forward directed force on the distal element during penetration of the distal seal by the distal tip of the needle.
The device of any preceding claim wherein the tissue interface and distal seal are mounted on a tubular distal housing.
The delivery device of any preceding claim wherein the first and/or second force element is a spring.
The delivery device of any preceding claim wherein the first and/or second force element is a pressurized gas.
The delivery device of any preceding claim wherein insertion of the active agent containing composition into the device activates the force element to apply the delivery force to the active agent containing composition.
The delivery device of any preceding claim wherein the delivery force is activated by a mechanism to compress the first and/or second force element from the exterior of the device.
The delivery device of any preceding claim wherein the first and/or second force element is constrained prior to use and the delivery force is activated by mechanically releasing the constrained force element.
The delivery device of any preceding claim for administration of an active agent containing composition to the suprachoroidal space or supraciliary space with an effective full needle length of 1 to 4 mm.
The delivery device of any preceding claim for administration of an active agent containing composition to the vitreous cavity with an effective full needle length of 10 to 15 mm.
The delivery device of any preceding claim for administration of an active agent containing composition to the subconjunctival space with an effective full needle length of 0.35 to 2 mm.
An active agent containing composition for delivery to the suprachoroidal space or supraciliary space comprising a semisolid material for administration into the suprachoroidal space or supraciliary space,
- wherein the semisolid material comprises an active agent;
- the semisolid material flows under delivery pressure;
- the semisolid material remains localized at the site of administration during and immediately after administration;
- and the semisolid material undergoes dissolution after administration to migrate in the suprachoroidal space.
The composition of 66 wherein the active agent crystals or particles additionally comprise a barrier coating.
Dependencies are inferred from the claim text.