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-10722396-B2
Publication Date
2020-07-28
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 relates to an apparatus and kit for conveying axitinib through a puncture member into an eye. The apparatus includes a medicament container, a housing configured to receive the medicament container, and a hub defining a passageway through which the puncture member is disposed. 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, and a distal end surface of the hub is configured to contact a target surface of the eye when axitinib is conveyed through the puncture member.
The apparatus further includes an actuation rod at least partially disposed within the medicament container. The medicament container, the actuation rod, and the puncture member are collectively configured so that a portion of the actuation rod moves within the medicament container in response to a force on the actuation rod when a distal end portion of the puncture member is disposed within a suprachoroidal space of the eye. 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 the sclera of the eye, where the force has a magnitude less than a threshold value.
In one embodiment, the invention is provided as a kit including a vial containing axitinib and a medical injector. The medical injector includes a housing coupled to a medicament container, a hub defining a passageway for the puncture member, and a distal end surface portion of the hub having a hemispherical shape or a convex shape with a sealing portion configured to define a substantially fluid-tight seal with a target surface of an eye. In this kit configuration, axitinib conveyed through the puncture member is provided with a substantially fluid-tight seal at the target surface, while the actuation rod movement is allowed when the puncture member is in the suprachoroidal space and is limited when the puncture member is in sclera under a force below a threshold value.
Claims Coverage
The independent claims identified are clm-00001, clm-00012, and clm-00022. Across these independent claims, the coverage centers on three inventive aspects: axitinib delivery via a hub-fixed puncture member into a target eye surface, force-responsive limitation of actuation rod movement when the puncture member is in sclera below a threshold, and hub distal end surface sealing/contact features defining a substantially fluid-tight seal with a target eye surface.
Axitinib-conveying ocular apparatus with hub fixedly coupled puncture member
A medicament container including axitinib, a housing configured to receive a portion of the medicament container, 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, wherein a distal end surface of the hub is configured to contact a target surface of the eye when the axitinib is conveyed through the puncture member.
Force-limited actuation rod movement based on suprachoroidal space versus sclera
An actuation rod at least partially disposed within the medicament container, configured so that a portion of the actuation rod moves within the medicament container in response to a 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 is limited when the distal end portion of the puncture member is disposed within a portion of the sclera of the eye, the force having a magnitude less than a threshold value.
Kit with vial axitinib and medical injector with hub sealing portion
A kit including a vial containing axitinib and a medical injector with a housing, a medicament container configured to receive axitinib from the vial, a hub coupled to the medicament container and defining a passageway through which a puncture member is disposed fixedly coupled to the hub, a distal end surface portion of the hub having a hemispherical shape or a convex shape and a sealing portion configured to define a substantially fluid-tight seal with a target surface of an eye when the axitinib is conveyed through the puncture member.
Across clm-00001, clm-00012, and clm-00022, the claims cover axitinib delivery through a hub-fixed puncture member with hub distal end surface contact, including sealing portion and specified hub surface shape, together with force-responsive actuation rod movement that is permitted in a suprachoroidal space and limited in a sclera portion when the force magnitude is less than a threshold value.
Stated Advantages
Provides a substantially fluid-tight seal with a target surface of an eye when axitinib is conveyed through the puncture member.
Limits movement of the actuation rod when the distal end portion of the puncture member is disposed within a portion of the sclera under a force magnitude less than a threshold value.
Documented Applications
Not explicitly described in patent.
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