Medical device for removing an implanted object using laser cut hypotubes

Inventors

Grace, Kenneth P.LEE, Weston H.KAGARISE, Brian E.Carver, Robert L.

Assignees

Spectranetics LLC

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Publication Number

US-12303165-B2

Patent

Publication Date

2025-05-20

Expiration Date


Abstract

Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. A surgical device includes a handle, an elongate inner sheath and a circular cutting blade that extends from the distal end of the sheath upon actuating the handle. The circular cutting blade is configured to engage the tissue surrounding an implanted lead and cut such tissue in a coring fashion as the surgical device translates along the length of the lead, thereby allowing the lead to enter the device's elongate shaft. The surgical device has a barrel cam cylinder in the handle assembly that imparts rotation of the blade. The inner sheath and outer sheath are constructed of laser-cut hypotubes, thereby allowing the surgical device, particularly the sheath assembly, to have a smaller profile for navigating smaller sized vasculature.

Core Innovation

The invention is a device for removing an implanted object from a body vessel using a sheath assembly and a handle assembly. The sheath assembly includes an outer sheath assembly with an outer hypotube and an inner sheath assembly with an inner hypotube positioned at least partially within the outer hypotube, and the inner sheath includes a tip coupled to a distal portion of the inner sheath. The proximal end of the inner sheath is coupled to the actuator so that the tip translates longitudinally and rotates with the actuator.

The handle assembly includes a trigger and an actuator in which movement of the trigger causes the actuator to rotate about a longitudinal axis. The trigger comprises a trigger pin that is received by a slot of the actuator, and the slot is configured to cause the actuator to rotate in a first direction for movement of the trigger pin for a first distance range along the longitudinal axis and to rotate in a second direction, opposite the first direction, for movement of the trigger pin for a second distance range along the longitudinal axis.

The sheath assembly further includes at least one of the outer sheath or the inner sheath comprising a plurality of cuts and a plurality of non-cut portions in at least one of the outer hypotube or the inner hypotube. The disclosed mechanical-path and guide relationships coordinate trigger pin movement with actuator rotation, while the sheath cuts and non-cut portions define the cutting structure on the hypotubes for an implant-removal slicing/coring action.

Claims Coverage

The independent claim covers an implanted-object removal device with a two-sheath hypotube assembly and a handle assembly in which trigger movement rotates an actuator so the distal tip both translates longitudinally and rotates. The claim also requires a trigger-pin/actuator-slot arrangement that reverses rotational direction for different trigger-pin distance ranges, and requires cuts and non-cut portions in at least one hypotube of the sheath assembly.

Trigger-pin actuator with reversible rotation direction

The trigger comprises a trigger pin, and the actuator comprises a slot configured to receive the trigger pin and cause the actuator to rotate in a first direction for movement of the trigger pin for a first distance range along the longitudinal axis and cause the actuator to rotate in a second direction, opposite the first direction, for movement of the trigger pin for a second distance range along the longitudinal axis.

Longitudinal translation and rotation-coupled tip

Movement of the trigger causes the actuator to rotate about a longitudinal axis, wherein a proximal end of the inner sheath is coupled to the actuator such that the movement of the trigger causes the tip to translate longitudinally and rotate with the actuator.

Inner and outer hypotube sheath assembly with distal tip

A sheath assembly comprising an outer sheath assembly and an inner sheath assembly, wherein the outer sheath comprises an outer hypotube, and the inner sheath comprises an inner hypotube positioned at least partially within the outer hypotube, wherein the inner sheath comprises a tip coupled to a distal portion of the inner sheath.

Cuts and non-cut portions on at least one hypotube

At least one of the outer sheath or the inner sheath comprises a plurality of cuts and a plurality of non-cut portions in at least one of the outer hypotube or the inner hypotube, respectively.

Overall, the claim set centers on a hypotube-based sheath assembly with an inner tip coupled to a trigger-driven actuator that reversibly rotates and drives longitudinal tip translation, combined with hypotube sections that include plurality-of-cuts and plurality-of-non-cut portions.

Stated Advantages

Reduce kinking risk.

Documented Applications

Device for removing an implanted object from a body vessel.

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