Apparatus and methods for ocular injection
Inventors
Andino, Rafael Victor • ZARNITSYN, Vladimir • YOO, Jesse • Brooks, Christopher John • Kahute, Trent John • Arsenault, Justin William • Trettin, David Jackson • Bauer, Andrew Kent • Lewis, Stephanie Elaine
Assignees
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Publication Number
US-12201558-B2
Publication Date
2025-01-21
Expiration Date
Abstract
An apparatus includes a housing coupled to a medicament container, which is coupled to a needle. An injection assembly is disposed within the housing and includes an energy storage member and an actuation rod. A distal end portion of the actuation rod is disposed within the medicament container. The energy storage member can produce a force on a proximal end portion of the actuation rod sufficient to move the distal end portion of the actuation rod within the medicament container. This can convey at least a portion of a substance from the medicament container via the needle when a distal tip of the needle is disposed within a first region of a target location. The force is insufficient to move the distal end portion of the actuation rod within the medicament container when the distal tip of the needle is disposed within a second region of the target location.
Core Innovation
The invention provides an apparatus and related kit for conveying an adeno-associated virus (AAV) through a puncture member into an eye while coordinating hub contact and actuation-rod movement. A hub defines a passageway through which the puncture member is disposed, and the hub is fixedly coupled to the puncture member such that the hub moves with the puncture member when the puncture member is moved relative to an eye. The distal end surface of the hub is configured to contact a target surface of the eye when the AAV is conveyed through the puncture member.
A manually-applied actuation rod is disposed within a medicament container and cooperates with the puncture member such that rod movement is enabled when a distal end portion of the puncture member is disposed within a suprachoroidal space of the eye. The apparatus is configured so that movement of a distal end portion of the actuation rod within the medicament container is limited when the distal end portion of the puncture member is disposed within a portion of a sclera of the eye, where the force has a magnitude less than a threshold value.
At least a portion of the distal end surface of the hub has a convex shape, and in related embodiments the distal end surface is hemispherical and includes a sealing portion configured to define a substantially fluid-tight seal with a target surface of an eye during conveyance through the puncture member. The hub is configured to contact the target surface when the AAV is conveyed through the puncture member.
Claims Coverage
The identified independent claims center on an ocular AAV injector apparatus and a kit. The claims recite a hub fixedly coupled to a puncture member with hub contact or sealing at a target ocular surface, and an actuation rod whose movement is permitted when the puncture member distal end is in a suprachoroidal space and limited when it is in a sclera portion under a force magnitude less than a threshold value.
AAV conveying apparatus with hub-fixed puncture coupling and suprachoroidal actuation enabling
An apparatus including an AAV medicament container, a housing, and a hub fixedly coupled to a puncture member such that the hub moves with the puncture member when the puncture member is moved relative to an eye, where the hub defines a passageway and a distal end surface of the hub contacts a target surface when the AAV is conveyed through the puncture member.
Actuation rod movement limited by sclera disposition under a force threshold
An actuation rod disposed within the medicament container such that a portion of the actuation rod moves within the medicament container in response to a manually-applied force on the actuation rod when a distal end portion of the puncture member is disposed within a suprachoroidal space of the eye, and movement of a distal end portion of the actuation rod within the medicament container is limited when the distal end portion of the puncture member is disposed within a portion of a sclera of the eye, the force having a magnitude less than a threshold value.
Kit with AAV vial and sealed hub distal end for substantially fluid-tight seal
A kit comprising a vial containing an AAV and a medical injector having a housing coupled to a medicament container, a hub defining a passageway through which a puncture member is disposed and fixedly coupled to the hub, where at least a portion of a distal end surface of the hub has a hemispherical shape and includes a sealing portion configured to define a substantially fluid-tight seal with a target surface of an eye when the AAV is conveyed through the puncture member, and an actuation rod that cooperates with suprachoroidal-space disposition versus sclera disposition with movement limited under a force magnitude less than a threshold value.
Convex distal end hub configured to contact target surface during AAV conveyance
An apparatus including a medicament container containing an AAV and a hub defining a passageway through which a puncture member is disposed, where the hub is fixedly coupled to the puncture member such that the hub moves with the puncture member, and at least a portion of a distal end surface of the hub having a convex shape is configured to contact a target surface of the eye when the AAV is conveyed through the puncture member, with an actuation rod that moves with manual force when the puncture member distal end is disposed within a suprachoroidal space and is limited when the puncture member distal end is disposed within a portion of a sclera under a force magnitude less than a threshold value.
Across the independent claims, the coverage centers on an injector apparatus and a kit that convey an AAV through a hub-defined passageway and puncture member while using a mechanically-actuated rod whose movement is permitted when the puncture member distal end is disposed within a suprachoroidal space and is limited when disposed within a sclera portion under a force magnitude less than a threshold value, together with hub distal-end geometry and sealing/contact features for interaction with the target surface.
Stated Advantages
Improved sealing via a sealing portion configured to define a substantially fluid-tight seal with a target surface when the AAV is conveyed through the puncture member.
Documented Applications
Delivery/injection of an AAV medicament into an eye by conveying the AAV through a puncture member and hub into a suprachoroidal space, with hub contact on a target surface and actuation-rod movement controlled based on whether the puncture member distal end is in the suprachoroidal space or within a portion of the sclera.
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