IP Library › Granted Patent US 12685584

Granted Patent B2

US 12685584 · App. 16/951,903 · Granted Jul 21, 2026

Instrument port for epicardial ablation with anatomical epicardial structures and real-time lesion image processor

Inventors: Thomas Marchand (Boston, MA); Jonathan B. O'Keefe (North Attleboro, MA)

Assignee: Circa Scientific, Inc.

A61B18/1492 A61B1/000094 A61B1/00082 A61B1/0011 A61B1/00128 A61B1/00148 A61B1/0052 A61B1/0056 A61B1/015 A61B1/018 A61B1/0676 A61L29/02 A61M25/0043 A61M25/005 A61M25/0054 A61M25/0136 A61M25/0147 A61M25/1002 A61B1/05 A61B1/0646 A61B1/0661 A61B2018/0022 A61B2018/00363 A61B2018/00577 A61B2018/00696 A61B2018/00982 A61B2218/002 A61B2218/007 A61M25/0013

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Quick Facts

Patent No.: US 12685584
App. No.: 16/951,903
Granted: Jul 21, 2026
Kind: B2

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Abstract

A method for controlling an epicardial ablation procedure comprises (a) inserting an instrument port comprising an ablation tool, an optical camera and an optical light emitter into an epicardial cavity proximal to a target region; (b) providing optical light into said epicardial cavity through said optical light emitter to illuminate said target region; (c) obtaining a first image of said target region using said optical camera; (d) steering a tip of said ablation tool towards said target region; (e) applying an ablation energy to said target region using the ablation tool so as to form a lesion in or on said target region; (f) obtaining a second image of said target region using said optical camera; and (g) processing at least one of said first and second images in an image processor so as to determine a characteristic of said lesion.

Claims (68)

1 . An instrument port comprising:

an elongated shaft having proximal and distal ends and extending along a shaft axis, the elongated shaft having a fluid port defined in an external surface at the distal end of the elongated shaft;

a bendable shaft having a proximal end attached to the distal end of the elongated shaft along the 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 bendable shaft further comprising a plurality of mechanical rings disposed along the shaft axis, each of the plurality of mechanical rings coupled to another of the mechanical rings by a pair of mechanical links, wherein each of the pair of mechanical links comprise a first mechanical link having an interior surface dynamically coupled to an exterior surface of a second mechanical link;

a steerable tip attached to a distal end of the bendable shaft, the steerable tip including an imaging system that includes:

a camera disposed at a distal end of the steerable tip; and

a light emitter disposed at the distal end of the steerable tip;

an offset balloon attached to the external surface of the elongated shaft, the offset balloon having an internal volume in fluid communication with the fluid port, the offset balloon having an inflated state and a deflated state, wherein in the inflated state the offset balloon creates space between the elongated shaft and an anatomical feature to permit the bendable shaft to bend within the pivot plane, and wherein the mechanical links mechanically restrict a bending direction of the bendable shaft to the pivot plane;

a handle attached to the proximal end of the elongated shaft, the handle including a spindle in mechanical communication with the bendable shaft to adjust a customizable angle of the steerable tip, the customizable angle measured between the shaft axis and the tip axis;

a mechanical lock having a locked state and an unlocked state, wherein the customizable angle of the steerable tip is locked while the mechanical lock is in the locked state, the mechanical lock comprising:

a shaft comprising a locking shaft axis extending through the spindle and threads configured to couple to a flared shaft brake, the flared shaft brake configured to engage the spindle while in the locked state and to disengage the spindle while in the unlocked state;

a locking housing comprising a locking channel slidably coupled to the shaft, the locking channel comprising:

a locked side; and

an unlocked side;

wherein the locking channel transitions between the locked state and the unlocked state by sliding linearly in a direction perpendicular to the locking shaft axis,

wherein the mechanical lock is in the locked state when the shaft slides to the locked side, and

wherein the mechanical lock is in the unlocked state when the shaft slides to the unlocked side;

a fluid tube disposed in the elongated shaft, the fluid tube fluidly coupled to the fluid port;

a working tube disposed in the elongated shaft, the working tube forming a working channel;

an ablation catheter disposed in the working channel, the ablation catheter configured to form a lesion at a surgical site; and

a microprocessor-based controller in electrical communication with the imaging system, the microprocessor-based controller configured to:

acquire image data of the surgical site from the camera associated with a plurality of images;

analyze, using an image processor, the image data of the surgical site from the camera by comparing the image data of the plurality of images to a second of the plurality of images;

automatically detect, in real time, the lesion formed at the surgical site; and

automatically stop the ablation catheter when the lesion has a predetermined characteristic;

wherein the predetermined characteristic is derived from the image data of the surgical site.

2 . The instrument port of claim 1 , wherein the micro-processor based controller further comprises a lesion estimator subsystem, wherein the predetermined characteristic comprises a predetermined size and the lesion comprises a first size detected in a first of the plurality of images and a second size detected in a second of the plurality of images, wherein the lesion estimator subsystem is operative to determine a rate of change in lesion size between the first and second sizes.

3 . The instrument port of claim 1 , wherein the predetermined characteristic comprises a predetermined color.

4 . The instrument port of claim 1 , wherein:

the customizable angle is within a range of 0° to 90°, and

when the bendable shaft is in an unbent state:

the bendable shaft extends along the shaft axis, and

the customizable angle is 0°.

5 . The instrument port of claim 1 , wherein in the inflated state, the offset balloon is radially asymmetrically inflated, wherein the offset balloon is inflated more on a first side of the shaft axis than on a second side of the shaft axis.

6 . The instrument port of claim 1 , wherein:

an internal diameter of the working channel is greater than an external diameter of the ablation catheter, and

a fluid channel is defined between the internal diameter of the working channel and the external diameter of the ablation catheter.

7 . The instrument port of claim 6 , wherein the fluid channel is fluidly coupled to a flush liquid source or to a vacuum source.

8 . The instrument port of claim 1 , wherein the ablation catheter comprises an RF ablation catheter.

9 . The instrument port of claim 1 , wherein the working tube comprises a flexible cylinder.

10 . The instrument port of claim 9 , wherein the flexible cylinder comprises a wire-reinforced liner.

11 . The instrument port of claim 10 , wherein the wire-reinforced liner comprises a tube body comprising fluorinated ethylene propylene and a spiral wire, and wherein an internal surface of the flexible cylinder comprises only the tube body to form a smooth surface to receive the medical instrument.

12 . The instrument port of claim 1 , wherein:

the elongated shaft comprises a metal tube having an internal surface and an external surface, and

a pattern of slits is defined in the elongated shaft to increase a shaft flexibility.

13 . The instrument port of claim 12 , wherein the metal tube comprises stainless steel.

14 . The instrument port of claim 12 , wherein the pattern of slits is laser cut.

15 . The instrument port of claim 12 , wherein the pattern of slits comprises an interrupted spiral.

16 . The instrument port of claim 12 , wherein:

the pattern of slits comprises a plurality of fins that extend circumferentially on first and second sides of the metal tube, and

the plurality of fins on the first side and the plurality of fins on the second side are separated by first and second gaps, the first and second gaps extending along a plane defined by the shaft axis and an axis orthogonal to the shaft axis.

17 . The instrument port of claim 1 , wherein the spindle comprises a first lever and a second lever, wherein pressing the first lever toward the proximal end causes the spindle to rotate in a first direction, wherein pressing the second lever toward the proximal end causes the spindle to rotate in a second direction, and wherein rotating the spindle in the first direction or the second direction adjusts the customizable angle.

18 . The instrument port of claim 1 , wherein the locking housing further comprises an external surface traversing a length of the locking channel, wherein the external surface comprises an elevated external surface being higher on the locked side of the locking channel than on the unlocked side of the locking channel relative the locking shaft axis, and wherein sliding the shaft to the locked side causes the elevated external surface to create an upward force on the shaft so that the shaft moves upward to engage the flared shaft brake with the spindle to enter the locked state.

19 . An instrument port comprising: