Ocular injector and methods for accessing suprachoroidal space of the eye

Inventors

Yamamoto, RonaldConston, Stanley R.Sierra, David

Assignees

Clearside Biomedical Inc

Interested in licensing this patent?

MTEC can help explore whether this patent might be available for licensing for your application.

Publication Number

US-11944703-B2

Patent

Publication Date

2024-04-02

Expiration Date


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 suprachoroidal space (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

A method advances a distal end portion of a puncture member of a medical injector through a sclera of an eye until the distal end portion reaches a suprachoroidal space (SCS). The puncture member defines a lumen having a longitudinal axis, and an atraumatic flexible cannula is moved so its distal end exits the lumen along the longitudinal axis and beyond the distal end portion along the SCS, thereby expanding the SCS.

After expanding the SCS, the method administers a drug formulation or a therapeutic substance to the expanded SCS. The therapeutic substance and/or the drug formulation is advanced posteriorly in the SCS, and the flexible cannula is movably disposed in the puncture-member lumen and includes an atraumatic distal tip.

The disclosure further includes guiding placement using a sensor and illuminating the SCS via a flexible cannula to verify that the flexible cannula has been disposed in the SCS. Additional refinements include a lubricious coating on the flexible cannula, an inwardly distending action of the flexible cannula upon contacting the choroid to prevent trauma to the choroid, and in-line alignment of distal and proximal end portions of the puncture member.

Claims Coverage

The independent claims are clm-00001, clm-00010, and clm-00016. Across the independent claims, the inventive features focus on advancing a puncture member to the SCS, advancing an atraumatic flexible cannula beyond the puncture member to expand the SCS, and administering a therapeutic substance or drug formulation so it advances posteriorly in the SCS.

Puncture-member advancement to SCS and lumen with longitudinal axis

Advancing a distal end portion of a puncture member of a medical injector through a sclera of an eye until the distal end portion reaches a suprachoroidal space (SCS), the puncture member defining a lumen having a longitudinal axis.

Atraumatic flexible cannula exits lumen beyond puncture member to expand SCS

Moving a flexible cannula distally relative to the puncture member such that an atraumatic distal end of the flexible cannula exits the lumen along the longitudinal axis and beyond the distal end portion along the SCS, thereby expanding the SCS.

Administering drug formulation to expanded SCS

Administering a drug formulation to the expanded SCS.

Therapeutic substance advanced posteriorly in expanded SCS

Administering the therapeutic substance to the expanded SCS such that the therapeutic substance is advanced posteriorly in the SCS.

Drug formulation advanced posteriorly in expanded SCS

Administering the drug formulation to the expanded SCS such that the drug formulation is advanced posteriorly in the SCS.

Across clm-00001, clm-00010, and clm-00016, the claim coverage centers on reaching the SCS with a puncture member, expanding the SCS by advancing an atraumatic flexible cannula beyond the puncture member lumen, and delivering a drug formulation or therapeutic substance to achieve posterior advancement in the SCS. Dependent refinements further cover illumination verification, sensor-guided placement, lubricious coating, structural alignment, and inward distending interaction with the choroid to prevent trauma.

Stated Advantages

Prevent trauma to a choroid, via an inward distending action when the flexible cannula contacts the choroid.

Documented Applications

Administering a therapeutic substance or drug formulation to an eye by delivering it to an expanded suprachoroidal space (SCS) such that the substance or formulation is advanced posteriorly in the SCS.

JOIN OUR MAILING LIST

Stay Connected with MTEC

Keep up with active and upcoming solicitations, MTEC news and other valuable information.