Delivery devices for therapeutic substances

Inventors

MAHER, MATTHEW GARDNERGUERRERO PALACIO, ANGEL LEONARDOMarchand, Philippe

Assignees

BlueRock Therapeutics LP

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Publication Number

US-12296154-B2

Patent

Publication Date

2025-05-13

Expiration Date


Abstract

In some embodiments, a delivery device includes a device actuator and a cannula portion through which a therapeutic substance is ejected. The cannula portion includes an outer shaft, a needle that is configured to move through the outer shaft, and a plunger that is configured to move through the needle, forming a positive displacement arrangement.

Core Innovation

The invention relates to a cell/particle delivery system in which a needle moves in a retraction direction while a plunger moves through a needle lumen in a deployment direction opposite the retraction direction to eject a therapeutic substance from a delivery end of the needle. The positive displacement arrangement coordinates simultaneous needle retraction and plunger deployment so that ejection occurs as the needle retracts.

A key aspect is managing fluid communication and air handling using an air vent with controlled vent open/closed behavior tied to plunger position and loading versus ejection. In addition, a priming/flushing function includes an outer shaft/valve/port arrangement and a subsequent draining step by exposing the space between the outer shaft and the needle to atmospheric pressure to mitigate suction during withdrawal.

The delivery motion is implemented using a device actuator and a translation-screw mechanism with oppositely oriented threaded passages to drive needle retraction and plunger deployment with controlled relative travel/distance ratios. An optional planetary gear system and an indicator mechanism with indicia, including a Geneva gear system, are described for mechanical indication of dosage/ready state, and the system is described in a stereotactic-frame compatible context with tracking/display concepts.

Claims Coverage

The independent claims cover coordinated needle retraction and plunger deployment for ejecting a substance, actuator-driven motion using a threaded translation mechanism, and target-site delivery by retracting a needle while delivering into a volume of space occupied by the needle. Across the independent claims, the main inventive features are the simultaneous opposite-direction motion relationship, actuator rotation driving needle/plunger translation, and target-site retraction-delivery sequencing.

Simultaneous retraction and deployment in opposite directions with positive displacement ejection

Moving a needle in a retraction direction, the needle having a needle lumen; and moving a plunger through the needle lumen in a deployment direction simultaneously with movement of the needle in the retraction direction to eject the substance from a delivery end of the needle, wherein the retraction direction is opposite the deployment direction.

Actuator rotation causing opposite-direction needle retraction and plunger deployment

Rotating a device actuator of the delivery device, whereby rotation of the device actuator causes a needle to move in a retraction direction and causes a plunger to move through a lumen in the needle in a deployment direction opposite the retraction direction to eject the substance out of the delivery device.

Target-site delivery by retracting the needle from a volume of space while delivering with plunger movement

Moving a needle of a delivery device to a target site and occupying a volume of space at the target site with the needle; actuating a device actuator causing the needle to retract from the volume of space and a plunger to move through a needle lumen of the needle toward the volume of space; and delivering the substance into the volume of space as the needle retracts from the volume of space.

Overall, the claim set defines delivering a substance by coordinating needle retraction with plunger movement in an opposite deployment direction, including actuator rotation that drives this motion through the needle lumen, and delivering into a target-site volume as the needle retracts.

Stated Advantages

Reduces backflow.

Reduces cell settling.

Reduces shear damage from fast ejection.

Reduces waste from back-loading.

Mitigates suction effect during withdrawal by draining toward atmospheric pressure.

Provides dose assurance via an indicator with indicia for a delivered dosage/ready state.

Documented Applications

Delivery of a therapeutic substance comprising cells/particles to a target site using a stereotactic-frame compatible context including tracking/display concepts.

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