Systems and methods for improved delivery of expandable catheter assemblies into body lumens

Inventors

WAHR, Dennis • Wales, Larry • Mertens, Steven P.

Assignees

Nuvaira Inc

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Publication Number

US-11771492-B2

Patent

Publication Date

2023-10-03

Expiration Date


Abstract

A pulmonary treatment catheter and handle system including a catheter assembly with insertion tube coupled to a handle assembly. The system is further removably coupleable to a delivery device, such as a flexible bronchoscope or endoscope, having a port for coupling the handle assembly thereto, and a working channel in communication with the port for delivering the catheter assembly through the delivery device and into a body lumen. Optionally, a port channel of the port can be collinear with the working channel of the delivery device. The catheter assembly, handle assembly, and delivery device cooperate together to facilitate delivery and positioning of a catheter electrode in a treatment site, such as an airway, conduit, or vessel for treatment of the tissue, while minimizing damage to portions of the catheter assembly, the delivery device, or both.

Core Innovation

The invention is a pulmonary targeted lung denervation catheter-and-handle system for loading an expandable ablation electrode assembly through a bronchoscope/endoscope. It provides a catheter assembly that includes an elongate shaft with a positioning handle assembly and an ablation assembly configured to be positioned within an airway to deliver energy to target tissue. The ablation assembly includes an expandable member movable between a retracted configuration and an expanded configuration and an energy emitter coupled to the expandable member for positioning proximate the target tissue when expanded.

A substantially smooth insertion tube is slidably positioned over the elongate shaft and is configured and dimensioned to move between a first position and a second position. In the first position, the ablation assembly in the retracted configuration is compacted within the insertion tube. In the second position, the ablation assembly extends outside of the insertion tube and the insertion tube is nested entirely within the handle assembly, while a controller delivers energy from an energy source to the energy emitter.

The loading interface is defined by coupling the insertion tube with an insertion port of a delivery device that communicates with a working channel. The document emphasizes minimizing drag/resistance and minimizing damage by using collinear or pivotable alignment of the delivery-device port and the working channel, including collinear port/channel and working-channel alignment. Optional insertion-tube geometries include constant or tapered diameters and a flared leading end, and the working channel includes linear and non-linear portions to define an insertion extent relationship while the insertion tube is fixed to the insertion port.

Claims Coverage

The document provides coverage for an airway ablation system and a corresponding method. Across the independent claims, the key inventive features are the expandable ablation assembly with energy emitter, the substantially smooth insertion tube that compacts and nests within the handle assembly, and delivery through a delivery device working channel while the insertion tube remains fixed to the insertion port.

Expandable ablation assembly with energy emitter positioned in airway

An ablation assembly coupled to the distal end of the elongate shaft, configured to be positioned within the airway to deliver energy to target tissue, including an expandable member movable between a retracted configuration and an expanded configuration and an energy emitter coupled to the expandable member, wherein the energy emitter is configured to be positioned proximate the target tissue when the expandable member is in the expanded position.

Positioning handle assembly and elongate shaft architecture

A positioning handle assembly coupled to the proximal end of the elongate shaft, with the elongate shaft having a proximal end and a distal end, wherein an ablation assembly is coupled to the distal end of the elongate shaft and a controller is configured to deliver energy from an energy source to the energy emitter.

Substantially smooth insertion tube that compacts and nests in handle

An insertion tube having a substantially smooth outer surface slidably positioned over the elongate shaft, configured and dimensioned to move between a first position in which the ablation assembly, in the retracted configuration, is compacted within the insertion tube and a second position in which the ablation assembly extends outside of the insertion tube and the insertion tube is nested entirely within the handle assembly.

Method sliding insertion tube over retracted ablation assembly

Sliding the insertion tube over the ablation assembly when the expandable member is in the retracted configuration and coupling the insertion tube with the ablation assembly therein to an insertion port of a delivery device.

Moving ablation assembly and elongate shaft through working channel while insertion tube fixed

Moving the ablation assembly and elongate shaft through a working channel of the delivery device while the insertion tube is fixed to the insertion port, wherein the insertion tube is entirely nested within the handle assembly.

Overall claim coverage centers on an airway ablation catheter system where an expandable member with an energy emitter is handled in a retracted configuration by a substantially smooth insertion tube that compacts and then nests entirely within a handle assembly, and where the ablation assembly and shaft are advanced through a delivery-device working channel while the insertion tube remains fixed to the insertion port and remains nested in the handle assembly.

Stated Advantages

Reducing drag/resistance during delivery through the bronchoscope/endoscope and delivery device interface.

Minimizing damage by using collinear or pivotable port/working-channel alignment.

Documented Applications

Pulmonary targeted lung denervation using a catheter-and-handle system for loading an expandable ablation electrode assembly through a bronchoscope/endoscope into an airway of a patient.

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