Pill with needle delivery system having outwardly expanding mechanical actuation
Inventors
Bennett, Eric • Kam, Kimberly • Sheridan, Martin • Karicherla, Annapurna • MacPhail, Kassidy
Assignees
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Publication Number
US-12465737-B2
Publication Date
2025-11-11
Expiration Date
Abstract
A device can include a capsule containing an array of microneedles and a mechanical actuator. The device can be in an ingestible form for delivery to a duodenum or other target location within a subject and can release the mechanical actuator from constraint by the capsule in response to stimuli or conditions in or en route to the duodenum or other target location. The mechanical actuator upon release from constraint by the capsule can expand outwardly (e.g., responsive to a bias provided by a flexibly resilient material of the mechanical actuator) in a direction away from a central longitudinal axis of the mechanical actuator and drive the array of microneedles into penetrating engagement with a lining of the duodenum or other target location. The penetrating engagement can facilitate delivery of a biotherapeutic agent or other payload via the microneedles.
Core Innovation
The patent describes an ingestible pill or capsule system that includes a capsule with an inner surface defining an interior volume and an outer surface, and a carrier sized to fit within the interior volume and bearing an array of microneedles. A mechanical actuator moves the carrier outwardly to cause the microneedles to engage tissue, with deployment triggered when the mechanical actuator moves from a collapsed state toward an expanded state. The actuator is constrained by the capsule in the collapsed state and expands outward after release from capsule constraint in or near the duodenum, so the microneedles are driven into the gastrointestinal lining for payload delivery.
The core actuator concept uses a foldable biasing member having a foldable portion comprising a flexibly resilient material, with the flexibility permitting first and second ends to be foldable toward one another for movement from an expanded state toward a collapsed state in which the mechanical actuator fits within the capsule interior volume. The flexibly resilient material has resiliency that biases the first and second ends apart from one another, so moving from collapsed state toward expanded state moves the carrier outwardly when the mechanical actuator overcomes or escapes capsule constraint. A holder is hingedly attached to the first end via a hinge distinct from the foldable portion, and the holder pivots relative to the biasing member to provide a support surface supporting the carrier bearing the microneedles.
The disclosure further addresses lumen blockage and shearing by using central through-passages and substantially normal microneedle deployment, and it describes multiple mechanical actuator embodiments for outward expansion away from a central longitudinal axis. It includes several actuator architectures, including flexibly resilient outwardly expanding stent-like tubes, hinged lateral columns, unwinding or overlapping coils, curved arms, double-hinged arms, and foldable biasing members with hinge-mounted holders. Optional biodegradable materials and microneedle geometries are discussed to mitigate a “bed-of-nails effect,” and the background describes using hinge-stopping limits and spacing constraints for microneedle tips via channels or linkages.
Claims Coverage
The partial content includes two independent claims with inventive features centered on a capsule-constrained, foldable, flexibly resilient biasing member that expands from a collapsed state to deploy an array of microneedles via a hinge-pivotable holder. Across both independent claims, the core inventive structure is the same: foldable resilient biasing member, hinge-distinct holder with a support surface, and outward carrier movement from collapsed to expanded states for microneedle engagement.
Capsule-constrained microneedle carrier deployment with outward mechanical actuator
A system including a capsule with an inner surface defining an interior volume and an outer surface, a carrier sized to fit within the interior volume and bearing an array of microneedles, and a mechanical actuator operable for moving the carrier outwardly to cause the microneedles to engage tissue.
Foldable flexibly resilient biasing member drives expanded state
The mechanical actuator includes a foldable biasing member having a foldable portion comprising a flexibly resilient material that permits first and second ends to be foldable toward one another for movement from an expanded state toward a collapsed state in which the mechanical actuator fits within the capsule interior volume, and that biases the first and second ends apart for movement from the collapsed state toward the expanded state to move the carrier outwardly upon overcoming or escaping constraint provided by the capsule.
Hinge-distinct holder pivots to support carrier
A holder hingedly attached with the first end of the biasing member by a hinge distinct from the foldable portion such that the holder is pivotable about the hinge relative to the first end of the biasing member, the holder comprising a support surface for supporting the carrier bearing the array of microneedles.
Mechanical actuator for microneedle delivery expands from collapsed state to expanded state
A mechanical actuator configured for microneedle delivery including a foldable biasing member with a flexibly resilient material having resiliency that biases first and second ends apart, and that permits movement from an expanded state toward a collapsed state in which the mechanical actuator fits within a volume sized to fit within a capsule, thereby enabling movement from the collapsed state toward the expanded state.
Pivotable holder support surface for deployment of microneedles
A holder hingedly attached with the first end of the biasing member by a hinge distinct from the foldable portion such that the holder is pivotable about the hinge relative to the first end of the biasing member, where the holder comprises a support surface configured for supporting a carrier bearing an array of microneedles and for supporting the carrier for outward movement for deployment of the microneedles in response to movement from the collapsed state toward the expanded state.
The independent claims focus on a capsule-constrained deployment mechanism where a foldable, flexibly resilient biasing member moves from a collapsed state to an expanded state to move a carrier outward. A hinge-distinct, pivotable holder provides the support surface for the microneedle array and transfers the expansion motion into microneedle engagement with tissue or microneedle deployment.
Stated Advantages
Reduce lumen blockage.
Reduce shearing.
Provide central through-passages and substantially normal microneedle deployment.
Mitigate a “bed-of-nails effect”.
Documented Applications
Microneedle delivery in or near the duodenum for engaging gastrointestinal lining and payload delivery.
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