Ocular injector and methods for accessing suprachoroidal space of the eye
Inventors
Yamamoto, Ronald • Conston, Stanley R. • Sierra, David
Assignees
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Abstract
An ocular medical injector is provided for drug delivery. A method includes inserting a puncture member of the medical injector into the eye until the puncture member reaches the SCS. The puncture member defines a lumen therethrough. With the puncture member disposed within the SCS, a flexible cannula is advanced distally through the lumen of the puncture member, beyond the distal end portion of the puncture member and along the SCS towards a posterior region of the eye. The flexible cannula has an atraumatic distal tip and defines a lumen therethrough. With the distal tip of the flexible cannula disposed within the SCS beyond a distal end portion of the puncture member, a therapeutic substance is administered to the SCS.
Core Innovation
The described invention provides a method for ocular drug-delivery by accessing a suprachoroidal space (SCS) and delivering a drug formulation advanced posteriorly within the SCS. The method inserts a distal end portion of a puncture member of a medical injector into a pars plana region of an eye until the puncture member reaches the SCS, and with the distal end portion disposed within the SCS, advances a flexible cannula distally through a lumen of the puncture member such that the flexible cannula exits the lumen along the longitudinal axis and extends beyond the distal end portion along the SCS toward a posterior region of the eye.
In this approach, the advancing flexible cannula expands the SCS and administers the drug formulation to the expanded SCS so that the drug formulation is advanced posteriorly in the SCS. The cannula has an atraumatic distal tip, and during the advancing the SCS can be illuminated via the flexible cannula to verify disposal of the flexible cannula in the SCS. A lubricious coating is included to aid advancement.
The disclosed method characterizes optional structural and functional features that support delivery in the SCS while reducing harm. The puncture member defines a lumen entirely along a longitudinal axis, and the puncture member can be a needle having a gauge in a range of about 20 to about 25. The flexible cannula can provide an inward distending action to the choroid upon contacting the choroid, which prevents trauma to the choroid.
Claims Coverage
The partial content includes three independent method claims. Each independent claim is directed to the same core SCS access and posterior delivery workflow, with verification/illumination and drug or drug-formulation specificity present across the independent claims.
Pars plana puncture to SCS and distal cannula advancement to expand SCS
Inserting a distal end portion of a puncture member of a medical injector into a pars plana region of an eye until the distal end portion reaches a suprachoroidal space (SCS), the puncture member defining a lumen therethrough and entirely along a longitudinal axis of the puncture member, and with the distal end portion disposed within the SCS, advancing a flexible cannula distally through the lumen such that the flexible cannula exits the lumen along the longitudinal axis and beyond the distal end portion along the SCS towards a posterior region of the eye, thereby expanding the SCS, the cannula having an atraumatic distal tip.
Administering drug formulation advanced posteriorly in expanded SCS
Administering a drug formulation to the expanded SCS such that the drug formulation is advanced posteriorly in the SCS.
Illuminating SCS via flexible cannula to verify cannula disposal
During the advancing, illuminating the SCS via the flexible cannula to verify disposal of the flexible cannula in the SCS.
Across the independent claims, the inventive coverage centers on inserting a puncture member into the pars plana to reach the SCS, advancing an atraumatic distal-tip flexible cannula through the puncture-member lumen so it exits along the longitudinal axis and expands the SCS toward the posterior region, and administering a drug formulation or therapeutic substance such that it is advanced posteriorly in the expanded SCS; one independent claim further requires illuminating the SCS via the flexible cannula during advancement to verify disposal in the SCS.
Stated Advantages
Prevents trauma to the choroid via an inward distending action when contacting the choroid.
Provides an atraumatic distal tip.
Enables verification of flexible cannula disposal in the SCS by illuminating the SCS via the flexible cannula.
Documented Applications
Ocular drug-delivery into or within a suprachoroidal space (SCS) for administering a therapeutic substance or drug formulation advanced posteriorly in the SCS.
Delivery of therapeutic substances including anti-VEGF, steroid, non-steroidal anti-inflammatory, neuroprotectant, and antibiotic.
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