System with instrument port for epicardial ablation

Inventors

Marchand, Thomas • O'Keefe, Jonathan B.

Assignees

Sage Product Development Inc • Circa Scientific Inc

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Publication Number

US-12279809-B2

Patent

Publication Date

2025-04-22

Expiration Date


Abstract

An instrument port includes an elongated shaft, a bendable shaft, a steerable tip, an offset balloon, and a handle. The bendable shaft has a proximal end attached to the distal end of the elongated shaft along a shaft axis, the bendable shaft configured to bend only within a pivot plane that is defined by the shaft axis and a pivot axis that is orthogonal to the shaft axis. The steerable tip is attached to a distal end of the bendable shaft and includes a camera and a light emitter. The offset balloon is attached to the external surface of the elongated shaft and has an internal volume in fluid communication with a fluid port in the elongated shaft. The handle includes at least one lever in mechanical communication with the bendable shaft to adjust a customizable angle of the steerable tip measured between the shaft axis and the tip axis.

Core Innovation

The invention relates to an instrument port system for epicardial ablation, including an elongated shaft extending along a shaft axis and having a fluid port defined on an external surface at the distal end. The elongated shaft includes a metal tube with a pattern of slits to increase flexibility, and it further includes a fluid tube fluidly coupled to the fluid port and a working tube forming a working channel sized to receive a medical instrument including an RF ablation catheter. The working channel internal diameter is greater than the external diameter of the RF ablation catheter, and a fluid channel is defined between the working channel and the RF ablation catheter.

The instrument port includes a bendable shaft configured to bend only within a pivot plane defined by the shaft axis and a pivot axis orthogonal to the shaft axis, where the bendable shaft bends without affecting any of the position, shape, orientation, or behavior of the elongated shaft. A steerable tip is attached to a distal end of the bendable shaft and includes a camera and a light emitter disposed at the distal end of the steerable tip. An offset balloon is disposed offset proximally to the steerable tip along the shaft axis and is attached to the external surface of the distal end of the elongated shaft, with an internal volume in fluid communication with the fluid port.

The offset balloon has an inflated state and a deflated state, and the bending of the bendable shaft is independent of the inflated state and the deflated state of the offset balloon. A balloon restriction tube is attached to the elongated shaft and positioned over a portion of the offset balloon, such that the balloon restriction tube restricts inflation of the portion of the offset balloon, and in at least one configuration the balloon restriction tube is a horizontal cylindrical segment. A handle attached to the proximal end of the elongated shaft includes at least one lever mechanically communicating with the bendable shaft to adjust a customizable angle of the steerable tip between the shaft axis and a tip axis.

The instrument port system further includes a fluid channel that is fluidly coupled to a flush liquid source and to a vacuum source, supporting an ablation catheter environment within the working channel. In addition, a microprocessor controller is used to acquire camera images and perform real-time lesion detection and anatomical feature detection based on size, color, and optical properties, including coronary vessels, fat pads, phrenic nerve, and scar tissue. The controller automatically stops ablation when predetermined lesion characteristics are met.

Claims Coverage

The provided material includes one independent claim (clm-00001). The independent claim includes three core inventive blocks: (1) an instrument port architecture combining elongated shaft flexibility with a bendable shaft constrained to a pivot plane, (2) a steerable tip with camera and light emitter integrated with an offset balloon whose inflated state is decoupled from bend behavior, and (3) integration of working/flush/vacuum channels sized for an RF ablation catheter, together with mechanical angle adjustment via a lever-driven handle.

Pivot-plane bendable shaft with decoupled elongated shaft behavior

A bendable shaft configured to bend only within a pivot plane defined by the shaft axis and a pivot axis orthogonal to the shaft axis, where the bendable shaft bends without affecting any of the position, shape, orientation, or behavior of the elongated shaft.

Steerable tip with distal camera and light emitter

A steerable tip attached to a distal end of the bendable shaft, including a camera disposed at a distal end of the steerable tip and a light emitter disposed at the distal end of the steerable tip.

Offset balloon fluidly connected to a distal fluid port with bending independent of inflation state

An offset balloon offset proximally to the steerable tip along the shaft axis and attached to the external surface of the distal end of the elongated shaft, having an internal volume in fluid communication with the fluid port, with an inflated state and a deflated state, wherein the bending of the bendable shaft is independent of the inflated state and the deflated state of the offset balloon.

Balloon restriction tube restricting inflation of a portion of the offset balloon

A balloon restriction tube attached to the elongated shaft and positioned over a portion of the offset balloon, such that the balloon restriction tube restricts inflation of the portion of the offset balloon, wherein the balloon restriction tube is a horizontal cylindrical segment.

Lever-driven handle adjusting customizable steerable-tip angle

A handle attached to the proximal end of the elongated shaft, including at least one lever mechanically communicating with the bendable shaft to adjust a customizable angle of the steerable tip measured between the shaft axis and a tip axis.

Working channel and fluid channel for RF ablation catheter with flush and vacuum coupling

A working tube disposed in the elongated shaft forming a working channel to receive a medical instrument, including an RF ablation catheter having an internal diameter of the working channel greater than an external diameter of the RF ablation catheter, a fluid channel defined between the internal diameter of the working channel and the external diameter of the RF ablation catheter, and wherein the fluid channel is fluidly coupled to a flush liquid source and to a vacuum source.

The independent claim integrates a pivot-plane-constrained bendable shaft, a steerable tip with camera and light emitter, and an offset balloon whose inflated/deflated state does not control bending behavior, while simultaneously providing a working channel and a flush/vacuum fluid channel configured around an RF ablation catheter, with steerable-tip angle adjusted by a lever-driven handle.

Stated Advantages

automatically stops ablation when predetermined lesion characteristics are met

supports real-time lesion detection and anatomical feature detection using camera images

provides bending within a defined pivot plane while maintaining independent/decoupled bending behavior relative to the elongated shaft

Documented Applications

Epicardial ablation, including RF ablation, with visualization and real-time detection during an ablation procedure

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