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Publication Number

US-12310566-B2

Patent

Publication Date

2025-05-27

Expiration Date


Abstract

A device and system for allowing real-time viewing of a procedure beyond a distal end of an endoscope. An exemplary device includes a sheath that has at least two lumens and a handle. The handle includes a connector that connects to a proximal end of an endoscope, a shaft portion that rotatably connects to a proximal end of the connector and a manifold that is slidably received by the shaft portion. The manifold connects to the sheath and allows for insertion of a radial ultrasound probe and a medical tool into the sheath. A stopping device in the manifold avoids accidental needle deployment.

Core Innovation

A device includes a sheath comprising at least two lumens and an actuator comprising a needle handle shaft including a distal end couplable to a proximal end of a needle and a proximal end configured to connect to an aspirating source, where the needle handle shaft includes an annular groove adjacent the distal end. A handle includes a connector configured to connect to an endoscope and a shaft portion rotatably connected to a proximal end of the connector. A manifold is slidably received by the shaft portion and includes a distal end configured to connect to the sheath, with the distal end lumens having longitudinal axes that align with respective sheath lumens.

The manifold further includes a first proximal port having a longitudinal axis configured to match the longitudinal axis of one distal-end lumen and configured to receive a radial ultrasound probe. The manifold also includes a second proximal port configured to receive the needle, where the second proximal port has a longitudinal axis at an angular relationship to the longitudinal axis of a second distal-end lumen and allows the needle to pass to that second lumen. This provides aligned radial ultrasound probe placement together with an angularly oriented needle passage through the multi-lumen sheath and manifold.

The device and system further include a lock mechanism or locking device that arrests distal motion of the needle below a predefined threshold value or predefined force threshold value and releases or permits distal motion of the needle upon application of a longitudinal force or force above the threshold. The locking device includes an actuator arm and a button to disengage the lock mechanism, and the actuator arm is configured to engage the annular groove to arrest distal motion. In additional disclosed configurations, a distal exit ramp is provided on the sheath to allow needle deflection, and mechanical anti-buckling structures and keyed or clocked orientation features are used to align the needle relative to the ramp and to maintain directional targeting.

Claims Coverage

The provided portion includes two independent claims. Across these claims, the inventive features focus on an endoscope-connected handle-manifold arrangement that aligns a radial ultrasound probe lumen with one sheath lumen and angles a needle passage relative to another sheath lumen, and a needle actuator lock mechanism that arrests distal needle motion below a predefined force threshold and permits motion above the threshold.

Manifold aligning radial ultrasound probe and angular needle passage

A manifold configured to be slidably received by a handle shaft portion, the manifold comprising a distal end configured to connect to a sheath, where each lumen of the distal end has a longitudinal axis that aligns with a respective one of the at least two lumens of the connected sheath; a first proximal port having a longitudinal axis configured to match the longitudinal axis of one of the at least two lumens and configured to receive a radial ultrasound probe; and a second proximal port having a longitudinal axis at an angular relationship to the longitudinal axis of a second one of the at least two lumens and configured to allow the needle to pass to the second one of the at least two lumens.

Force-threshold locking of needle distal motion using annular groove

A lock mechanism or locking device configured to arrest distal motion of the needle below a predefined threshold value or below a predefined force threshold value and release the needle handle shaft or continue distal motion upon application of a longitudinal force or a force above the predefined threshold value, the lock mechanism including an actuator arm and a button to disengage the lock mechanism, the actuator arm configured to engage the annular groove adjacent the distal end of the needle handle shaft to arrest distal motion.

Overall, the claim coverage centers on a sheath-and-manifold geometry that aligns a radial ultrasound probe port with one sheath lumen while directing an angularly oriented needle port through another lumen, combined with an annular-groove-driven locking device that arrests distal needle motion until a predefined force threshold is exceeded.

Stated Advantages

Provides aligned receiving of a radial ultrasound probe and an angularly oriented needle passage through the multi-lumen sheath and manifold.

Arrests distal motion of the needle below a predefined threshold value/force threshold and permits continued motion upon application of force above the predefined threshold.

Documented Applications

Real-time endoscope-based peripheral lung procedures using a radial ultrasound probe and a needle for sampling or drug delivery in a multi-lumen endoscope-based sampling system [application described in provided summary context].

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