Systems and methods for ocular drug delivery
Inventors
Andino, Rafael Victor • GODFREY, Thomas Edward • HANCOCK, Shelley Eckert • Patel, Samirkumar • MAHN, Keleigh Jo • YOO, Jesse • ZARNITSYN, Vladimir
Assignees
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Publication Number
US-11596545-B2
Publication Date
2023-03-07
Expiration Date
Abstract
Devices, methods, and kits for ocular drug delivery are described herein. An apparatus can include a housing, an energy storage member, a barrel, and a hub. The housing contains the energy storage member. A proximal end portion of the barrel is coupled to a distal end portion of the housing. The barrel is configured to contain medicament and includes at least a portion of a piston and an elastomeric member. The piston is configured to move the elastomeric member within the barrel in response to a force produced by the energy storage member. The hub is coupled to a distal end portion of the barrel. An inner surface of the hub defines a nozzle through which the medicament flows when the elastomeric member moves within the barrel. The nozzle and the energy storage member are collectively configured to produce a fluid jet to access a target location within an eye.
Core Innovation
The disclosure relates to ocular drug-delivery systems and methods. It provides apparatus for delivering a medicament having an ionic charge into an eye, including a housing with a distal end portion configured to contact a surface of an eye, a reservoir configured to contain the medicament, and walls with a charge opposite a charge of the medicament so the reservoir is configured to hold the medicament. The apparatus further includes a puncture member fluidically coupled to the reservoir and configured to be inserted into and deliver the medicament to a target region within the eye.
An electrode is operably coupled to the medicament disposed within the reservoir and is configured to produce a charge sufficient to convey the medicament from the reservoir to a distal end of the puncture member within the target region within the eye. A controller is configured to send a signal to the electrode to adjust the charge such that the medicament is conveyed from the reservoir. A sensor is configured to detect at least one of the charge of the electrode, a level of the medicament within the reservoir, or an indication of delivery depth of the medicament.
In various configurations, the invention conveys medicament to a distal end at a delivery depth within a predetermined range in the eye, where the delivery depth is dependent on an intensity of the charge. The predetermined range can include suprachoroidal space or subretinal space, and the apparatus can further include a membrane covering an opening and having an ionic charge that limits medicament passage when the ionic charge of the membrane is similar to the ionic charge of the medicament, and permits passage when the ionic charge of the membrane is different from the ionic charge of the medicament, with the electrode configured to produce the ionic charge of the membrane.
Claims Coverage
The document provides multiple independent apparatus claims, directed to ionic-charge medicament delivery in an eye using an electrode-controlled charge, with sensor-based monitoring and delivery depth control. The inventive features recur across the independent claims, including a charged reservoir, a puncture member delivering to a target region, electrode charge adjustment to convey medicament, sensor detection, and delivery-depth limitation with an optional ionic-charge membrane gating opening passage.
Ionic-charge reservoir and electrode-controlled conveying to a target region
A housing having a distal end portion configured to contact a surface of an eye, the housing defining a reservoir configured to contain a medicament having an ionic charge, the reservoir having walls with a charge opposite a charge of the medicament such that the reservoir is configured to hold the medicament in the reservoir; a puncture member fluidically coupled to the reservoir and configured to be inserted into and deliver the medicament to a target region within the eye; an electrode operably coupled to the medicament disposed within the reservoir, the electrode configured to produce a charge sufficient to convey the medicament from the reservoir to a distal end of the puncture member within the target region within the eye; and a controller configured to send a signal to the electrode to adjust the charge such that the medicament is conveyed from the reservoir.
Sensor detection of charge, reservoir level, or delivery depth
A sensor configured to detect at least one of the charge of the electrode, a level of the medicament within the reservoir, or an indication of delivery depth of the medicament.
Delivery depth within a predetermined range dependent on charge intensity
An electrode configured to produce a charge sufficient to convey the medicament from the reservoir to a distal end of the puncture member at a delivery depth within a predetermined range in the eye, the delivery depth dependent on an intensity of the charge; and a controller configured to adjust the charge to convey the medicament to the medicament delivery depth within the predetermined range.
Ionic-charge membrane covering an opening to limit or permit passage
A membrane covering the opening and having an ionic charge such that when the ionic charge of the membrane is similar to the ionic charge of the medicament, the membrane limits the medicament from passing therethrough, and when the ionic charge of the membrane is different from the ionic charge of the medicament, the medicament can pass therethrough, the electrode configured to produce the ionic charge of the membrane.
Target region and delivery depth range including suprachoroidal space or subretinal space
The predetermined range in the eye includes the suprachoroidal space of the eye, and/or the predetermined range in the eye includes the subretinal space of the eye.
Across the independent claims, the core coverage centers on ionic-charge-based ocular delivery: a reservoir that holds an ionic-charge medicament via oppositely charged reservoir walls; an electrode whose charge is adjusted by a controller to convey the medicament through a puncture member to a target region; delivery depth constrained to a predetermined range dependent on charge intensity; monitoring via a sensor; and, in further configurations, a membrane over a channel opening whose ionic-charge similarity or difference limits or permits passage under electrode control.
Stated Advantages
Enables formation of a delivery pathway to posterior ocular targets, including suprachoroidal and/or subretinal spaces.
Provides controlled delivery using a fluid jet generated by an expelling mechanism via a hub nozzle.
Allows adjustable penetration and/or medicament delivery depth using sensing and feedback such as sensors and/or loss of resistance.
Supports multiple alternate pathway formation and delivery approaches, including energy-beam, rigid-member leave-behind, iontophoretic, and membrane-based delivery.
Supports energy-assisted activation and targeted release of medicament carriers.
Documented Applications
Therapeutic uses of suprachoroidal-space delivery for VEGF antagonists and other drugs, including rapamycin (sirolimus) and extensive anti-inflammatory, anti-angiogenic, fibrosis, and ocular disease indications.
Ocular disease targets explicitly mentioned include CNV/subfoveal choroidal neovascularization (subfoveal wet AMD), diabetic macular edema/diabetic retinopathy, ocular inflammation, fibrosis/myelofibrosis, ocular hypertension, cancer, and leukemias.
Delivery of ocular medicaments to posterior ocular targets including suprachoroidal space and subretinal space.
Ocular gene-based therapy using DNA/RNA/oligonucleotides.
Delivery of rapamycin (Sirolimus) for ocular applications.
Delivery of VEGF inhibitors/antagonists for ocular applications.
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