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Publication Number
US-10952894-B2
Publication Date
2021-03-23
Expiration Date
Abstract
The present invention provides devices to access the suprachoroidal space or sub-retinal space in an eye via a minimally invasive transconjunctival approach. The devices may also be used after a partial dissection, for example after dissection of the outer scleral layer of the eye, and using the device within the dissection to access the suprachoroidal space or the sub-retinal space.
Core Innovation
Described is a minimally invasive transconjunctival ocular access device and method for reaching the suprachoroidal space or sub-retinal space of an eye and delivering therapeutic/diagnostic materials. The approach uses an elongated shaft with a sharp or beveled distal tip and a lumen for subsequent advancement of a hollow needle. An access port or tubular sleeve is provided for introducing additional instruments to the target region.
The device includes a movable guarding element that displaces choroid or retina and controls penetration. In embodiments, the guarding element is mechanical, or it is fluidic by conveying a fluidic guard using gas or fluid to apply a forward directed force against the retina while advancing the hollow needle through the pathway into the subretinal space. Sealing elements are used in some embodiments to reduce leakage, and depth stop or flange/stop mechanisms constrain penetration depth.
Examples described include providing a pathway via dissection of a sclera and inserting a distal end of a tubular member into the suprachoroidal space, then advancing a hollow needle distally through a lumen of the tubular member to pierce the choroid and enter the subretinal space. Therapeutic substance is conveyed via the hollow needle into the subretinal space, while the fluidic guard is conveyed to displace retinal tissue away from the tubular member.
Claims Coverage
The independent claims cover a method of administering a therapeutic substance to a subretinal space of an eye via a suprachoroidal space without piercing a retina, using a tubular member and a hollow needle together with conveying a fluidic guard to manage the relationship between the delivery pathway and the retina. Across the independent claims, the core inventive features include creating an external-to-suprachoroidal pathway by scleral dissection, advancing a hollow needle through a tubular lumen to pierce the choroid and reach the subretinal space, conveying a fluidic guard into the subretinal space to provide forward directed force against the retina and optionally displace retinal tissue away from the tubular member, and delivering the therapeutic substance through the hollow needle into the subretinal space.
Creating a pathway from outside the eye to the suprachoroidal space via a dissection of a sclera of the eye
A pathway is created from outside the eye to the suprachoroidal space via a dissection of a sclera of the eye.
Inserting a distal end of a tubular member into the suprachoroidal space via the pathway
A distal end of a tubular member is inserted into the suprachoroidal space via the pathway.
Advancing a hollow needle through a lumen of the tubular member, piercing the choroid, and into the subretinal space
With at least a portion of the tubular member disposed within the suprachoroidal space, a hollow needle is advanced distally through a lumen of the tubular member, piercing the choroid, and into the subretinal space of the eye.
Conveying a fluidic guard to the subretinal space to provide a forward directed force against the retina
With at least a portion of the tubular member in the suprachoroidal space, a fluidic guard is conveyed to the subretinal space to provide a forward directed force against the retina.
Conveying the therapeutic substance into the subretinal space via the hollow needle
With a distal end of the hollow needle disposed within the subretinal space, the therapeutic substance is conveyed, via the hollow needle, into the subretinal space of the eye.
Displacing retinal tissue away from the tubular member using the fluidic guard
The fluidic guard is conveyed to the subretinal space to displace retinal tissue away from the tubular member.
Securing the tubular member to the eye
Further comprising, during or after inserting the tubular member into the suprachoroidal space, securing the tubular member to the eye.
Viewing the fluidic guard located in the subretinal space using an external imaging system
Further comprising viewing the fluidic guard located in the subretinal space using an external imaging system.
Specifying the fluidic guard as a sodium-containing liquid
Further comprising specifying that the fluidic guard is a liquid containing sodium.
Configuring the hollow needle distal end with a non-linear curve tangential to a curve of the eye
Configuring the distal end of the hollow needle with a non-linear curve such that, as the needle is advanced into the subretinal space, the piercing path is tangential to a curve of the eye.
Limiting the non-linear curve between 10 degrees and 60 degrees
Limiting the non-linear curve to between 10 degrees and 60 degrees.
Delivering the therapeutic substance via an opening at the distal end positioned at an angle offset from the hollow needle longitudinal axis
Conveying the therapeutic substance via an opening at the distal end of the hollow needle, with the opening positioned at an angle offset from the hollow needle’s longitudinal axis at the proximal portion.
Across the independent claims, the inventive coverage is directed to administering a therapeutic substance to a subretinal space without piercing the retina by creating an external pathway to the suprachoroidal space via scleral dissection, inserting a tubular member into the suprachoroidal space, advancing a hollow needle through the tubular lumen to pierce the choroid and enter the subretinal space, and conveying a fluidic guard to the subretinal space to provide forward directed force against the retina and optionally displace retinal tissue away from the tubular member, followed by conveying the therapeutic substance through the hollow needle into the subretinal space.
Stated Advantages
Provides a forward directed force against the retina during delivery.
Displaces retinal tissue away from the tubular member in some embodiments.
Allows administration of a therapeutic substance to a subretinal space via a suprachoroidal space without piercing the retina.
Enables minimally invasive ocular access to the suprachoroidal or sub-retinal space.
Documented Applications
Administering therapeutic substance to a subretinal space via a suprachoroidal space without piercing a retina.
Delivering therapeutic/diagnostic materials to the suprachoroidal space or sub-retinal space.
Examples include delivery involving triamcinolone acetonide (Kenalog-40) with sustained drug availability quantified by HPLC over 30 days.
Examples mention therapeutic agents including gene therapy/cell therapy/stem cells as therapeutic substances.
Experimental confirmation of guard deployment and target-space access using OCT imaging and ultrasound.
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