Actively bendable sheath for delivering medical instrument therethrough and method thereof

Inventors

Wei, XiboLiu, Geping

Assignees

Otu Medical Inc

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Publication Number

US-11344188-B1

Patent

Publication Date

2022-05-31

Expiration Date


Abstract

An actively bendable sheath such as ureteral access sheath (UAS) and a method for delivering a medical instrument (e.g. a ureteroscope) therethrough are disclosed. The sheath's tubular wall includes a deflectable or bendable segment at or adjacent to the distal sheath end. Two pull/control wires are slidably disposed within two separate dedicated channels/lumens and attached to points distally beyond the deflectable segment. The bendable segment may be passively bended by force from a bending medical instrument within it or by the force of a surgeon pulling one of the two pull/control wires.

Core Innovation

The invention relates to an actively bendable sheath used for delivering an endoscope or an ureteroscope that is not part of the sheath. The sheath includes a proximal sheath end, a distal sheath end, and an intermediate sheath region between them, and defines only one sheath lumen through a tubular wall extending from the proximal sheath end to the distal sheath end for the endoscope or the ureteroscope to pass through.

The tubular wall includes a deflectable or bendable segment at or adjacent to the distal sheath end. Bending is controlled by only two pull wires, including a first pull wire and a second pull wire, each slidably disposed within a respective pull wire channel/lumen that is connected to, and extended along, the tubular wall of the sheath, with distal ends affixed to corresponding attachment points located distally beyond at least a portion of the deflectable segment.

The distal sheath end includes a soft and bendable portion as the deflectable or bendable segment, and the soft and bendable portion has more than 2 holds of size 1–1.2 mm for kidney stones to flow through. The actively bendable sheath itself does not include an imaging device, a CMOS camera, a surgical tool, or an illuminating device as functional components of an endoscope and related scopes or instruments.

Claims Coverage

The document includes one independent claim covering an actively bendable medical access sheath delivery system, with dependent claims refining the tubular wall, the pull-wire control mechanism, the distal soft portion, and the absence of integrated functional components. The inventive coverage centers on five inventive features.

Actively bendable sheath with single lumen and distal deflectable segment

An actively bendable sheath used for delivering an endoscope or an ureteroscope that is not part of the sheath, comprising a proximal sheath end, a distal sheath end, and an intermediate sheath region disposed between them, with only one sheath lumen defined by a tubular wall extending from the proximal sheath end to the distal sheath end and configured for the endoscope or the ureteroscope to pass through it, the tubular wall comprising a deflectable or bendable segment at or adjacent to the distal sheath end.

Two pull wires with attachment points beyond the deflectable segment

Only two pull wires including a first pull wire slidably disposed within a first pull wire channel/lumen connected to, and extended along, the tubular wall, with a distal end affixed to a first attachment point in the first pull wire channel, and a second pull wire slidably disposed within a second pull wire channel/lumen connected to, and extended along, the tubular wall, with a distal end affixed to a second attachment point in the second pull wire channel; wherein the first attachment point and the second attachment point are located distally beyond at least a portion of the deflectable segment.

Pull-wire channels protruded at the deflectable segment but buried proximally

The first pull wire channel and the second pull wire channel are located onto and therefore protruded out from the internal surface of the tubular wall of said deflectable or bendable segment, but they are located within and therefore buried into a tubular wall proximally to said deflectable or bendable segment.

Distal soft and bendable portion with holds for kidney stones

The distal sheath end includes a soft and bendable portion as said deflectable or bendable segment, wherein said soft and bendable portion has more than 2 holds of size 1–1.2 mm for kidney stones to flow through.

Sheath without integrated imaging or illumination functional components

The actively bendable sheath itself does not include an imaging device, a CMOS camera, a surgical tool, or an illuminating device as functional components of an endoscope, a hysteroscope, a sigmoidoscope, a bronchoscope, a trocar, a guidewire, and an interventional catheter.

Across the independent claim and its dependents, the main inventive coverage centers on an actively bendable, single-lumen sheath with a distal deflectable or bendable segment controlled by exactly two pull wires whose attachment points are located beyond the deflectable segment, with specific channel placement relative to the deflectable segment, a distal soft segment including holds sized for kidney-stone flow, and an explicit lack of integrated imaging or illumination functional components.

Stated Advantages

Endoscope-guided deflection without fluoroscopy.

Auto memory/auto-lock of deflection angle.

Minimal lumen reduction.

Transparent distal tip.

Routine deflection up to about 120 degrees.

Dual-durometer flexibility to reach renal calyces.

Documented Applications

Delivering an endoscope or an ureteroscope using an actively bendable sheath.

Ureteral/renal access for kidney stone flow through a soft and bendable distal portion with holds.

Bending/deflecting the sheath to reach renal calyces.

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