Devices and methods for adjusting the insertion depth of a needle for medicament delivery
Inventors
Andino, Rafael Victor • HANCOCK, Shelley Eckert
Assignees
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Publication Number
US-12127975-B2
Publication Date
2024-10-29
Expiration Date
Abstract
An apparatus includes a housing, an adjustment member, and a microneedle. The housing can be coupled to a medicament container, and includes a hub surface that can contact a target surface. The adjustment member is within the housing and separates an inner volume of the housing into a first chamber and a second chamber. The first chamber is fluidically coupled with the medicament container. The adjustment member, which is coupled to the microneedle, can transition between a first configuration and a second configuration. A proximal end portion of the microneedle is fluidically coupled to the first chamber such that a substance can be conveyed from the medicament container through the microneedle. A distal tip of the microneedle extends from the hub surface by a first distance when the adjustment member is in the first configuration, and by a second distance when the adjustment member is in the second configuration.
Core Innovation
The invention relates to an ophthalmic microneedle injector apparatus and associated delivery method for adjusting microneedle insertion depth to target specific ocular regions. A housing defines an inner volume with a hub surface configured to contact a target surface of a target tissue, and an adjustment member transitions between a first configuration and a second configuration, or between first and second positions, to change a distal tip extension distance from the hub surface.
A pressure chamber or first chamber is fluidically coupled to a medicament container so a substance is conveyed through a puncture member via the chamber. The puncture member is coupled to the adjustment member, and a proximal end portion of the puncture member is in fluid communication with the chamber. The distal tip extension is a first distance when the adjustment member is in the first configuration or position and a second, greater distance when the adjustment member is in the second configuration or position.
The delivery behavior is governed by pressure and target-tissue-dependent conditions, including threshold pressure and tissue density or region effects. In the method concept, the distal tip is inserted into a first tissue region with insufficient pressure for medicament flow, and pressure is then increased or maintained so the distal tip moves deeper while medicament flow is permitted only when the tip reaches a second region. The description further frames delivery in terms of pressure overcoming friction and tissue back-pressure, including density-dependent flow behavior linked to the tissue region reached by the distal tip.
Claims Coverage
The partial content includes two independent claims. Across the independent claims, the inventive features center on an adjustment member that transitions between first and second configurations or positions to set puncture-member distal tip extension distance while conveying a substance through a first chamber or a pressure chamber.
First configuration and second configuration for distal tip extension while conveying substance via first chamber
An adjustment member disposed within the inner volume transitions within the inner volume between a first configuration and a second configuration, where a distal tip of a puncture member extending from the hub surface has a first distance when the adjustment member is in the first configuration and a second greater distance when the adjustment member is in the second configuration, while a substance is conveyed from a medicament container through the puncture member via a first chamber.
First distance and second distance from hub surface by first and second positions with pressure chamber delivery
An adjustment member disposed within the inner volume moves relative to the medicament container between a first position and a second position, where a distal tip of a puncture member extends from the hub surface by a first distance when the adjustment member is in the first position and by a second greater distance when the adjustment member is in the second position, while the substance is conveyed from the medicament container through the puncture member via a pressure chamber.
Threshold pressure-driven transition or maintenance with target-tissue density constraint
When the pressure in a chamber exceeds a threshold pressure, the adjustment member transitions from a first to a second configuration, conditioned on the distal tip being within target tissue having density greater than a threshold density and the first-chamber pressure remaining greater than the threshold pressure.
Tissue-region-dependent flow limiting and movement limiting
The apparatus is configured such that moving the adjustment member from a first to a second position extends the puncture-member distal tip and limits substance flow through the puncture member when the distal tip is in a first target-tissue region, but permits substance flow and limits adjustment-member movement when the distal tip is in a second target-tissue region.
Minimum substance viscosity and microneedle gauge constraint
The substance has a viscosity of at least 100 centiPoise, and the puncture member is a microneedle of 30-gauge-or-smaller.
Ophthalmic targeting with specified target surface and regions
The target tissue is an eye, where the target surface is conjunctiva or sclera, the first region is an upper portion of the sclera, and the second region includes at least one of suprachoroidal space, choroid, subretinal space, or retina.
Therapeutic-agent set for medicament container substance
The medicament container holds a substance comprising at least one specified therapeutic agent selected from the listed set of agents.
Actuation force range producing threshold pressure in the chamber
A distal end portion of an actuation rod generates the threshold pressure in a first chamber when the applied force is between about 4 N and about 6 N.
Across the independent claims, the central inventive concept is coupling a distal-tip extension mechanism to chamber-based substance conveyance, with threshold pressure and target-tissue density or region conditions refining device behavior. The partial dependent claims further specify microneedle gauge, substance viscosity, ophthalmic targeting, an enumerated therapeutic-agent set, and an actuation-force range tied to generating threshold pressure.
Stated Advantages
Documented Applications
No documented applications found
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