Epicardial Ablation Instrument Port with Anatomical Epicardial Structures and Real-Time Lesion Image Processor

Abstract

A method for controlling an epicardial ablation procedure includes: (a) inserting an instrument port having an ablation tool, an optical camera, and an optical light emitter into an epicardial space proximal to a target area; (b) providing optical light to the epicardial space via the optical light emitter to illuminate the target area; (c) acquiring a first image of the target area using the optical camera; (d) steering a tip of the ablation tool toward the target area; (e) applying ablation energy to the target area using the ablation tool to form a lesion in or on the target area; (f) acquiring a second image of the target area using the optical camera; and (g) processing at least one of the first and second images with an image processor to determine characteristics of the lesion.

Description

[Technical field]

[0001] STATEMENT REGARDING FEDERALLY FUNDED RESEARCH This invention was made with Government support under Grant Number R41HL147694 awarded by the National Heart, Lung and Blood Institute of the National Institutes of Health. The United States Government has certain rights in this invention.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 936,736, entitled "Instrument Port for Epicardial Ablation," filed November 18, 2019, and U.S. Provisional Patent Application No. 63 / 076,075, entitled "Instrument Port for Epicardial Ablation with Unidirectional Offset Balloon," filed September 9, 2020, which are incorporated herein by reference.

[0003] This application relates generally to medical devices for treating cardiac disorders such as ventricular tachycardia. [Background technology]

[0004] Endocardial and / or epicardial ablation is currently used to treat ventricular tachycardia, a life-threatening heart rhythm disorder. To perform endocardial ablation, a physician inserts an ablation catheter into the patient's heart through a vein or artery and cauterizes the area of ​​the heart that is causing the arrhythmia. In contrast, epicardial ablation is performed from outside the heart.

[0005] During epicardial ablation procedures, physicians can visualize the ablation catheter and cardiac tissue using fluoroscopy and 3D electroanatomical voltage mapping. However, these visualization methods have limitations. For example, it can be difficult or impossible to identify coronary vessels, scar tissue, fat pads, and phrenic nerves using these visualization methods, which can lead to undesirable complications.

[0006] In addition, as illustrated in FIG. 1, existing ablation catheters are inserted tangentially through the pericardium to lie against the surface of the heart. In this orientation, the ablation catheter 100 releases energy into the cardiac tissue 110 causing lesions 130 in the cardiac tissue 110 and the pericardium 120. Cauterizing the pericardium 120 is undesirable because it may damage the phrenic nerve 140 located on the outer surface of the pericardium. In addition, this orientation provides the physician with little control over the force applied by the ablation catheter 100, which may lead to unstable cardiac tissue contact.

[0007] It would be desirable to overcome these and / or other deficiencies in the art. Summary of the Invention

[0008] The exemplary embodiments described herein have innovative features, none of which is essential or solely responsible for their desirable attributes. The following description and drawings detail certain exemplary implementations of the present disclosure, illustrating some exemplary ways in which various principles of the present disclosure may be implemented. However, the illustrative examples are not exhaustive of the many possible embodiments of the present disclosure. Without limiting the scope of the claims, some of the advantageous features are summarized here. Other objects, advantages, and novel features of the present disclosure are set forth in the following detailed description of the present disclosure, which is intended to illustrate, but not limit, the present invention, and which is taken in conjunction with the drawings.

[0009] An aspect of the invention is a direct to instrument port comprising: an elongate shaft having a proximal end and a distal end and extending along a shaft axis, the elongate shaft having a fluid port defined on an outer surface at the distal end of the elongate shaft; a bendable shaft having a proximal end attached to the distal end of the elongate shaft along the shaft axis, the bendable shaft being configured to bend only within a pivot plane defined by the shaft axis and a pivot axis perpendicular to the shaft axis; and a steerable tip attached to the distal end of the bendable shaft, the steerable tip including an imaging system including a camera disposed at the distal end of the steerable tip and a light emitter disposed at the distal end of the steerable tip. the instrument port also includes an offset balloon attached to an outer surface of the elongate shaft, the offset balloon having an interior volume in fluid communication with the fluid port, the offset balloon having an inflated state and a deflated state; a handle attached to a proximal end of the elongate shaft, the handle including a lever in mechanical communication with the bendable shaft to adjust a customizable angle of the steerable tip, the customizable angle being measured between the shaft axis and the tip axis; a fluid tube disposed on the elongate shaft, the fluid tube fluidly coupled to the fluid port; a working tube disposed on the elongate shaft, the working tube forming a working channel; and an ablation catheter disposed in the working channel, the ablation catheter configured to form a lesion at the surgical site; and a microprocessor-based controller in electrical communication with the imaging system, the controller configured to: acquire image data of the surgical site from the camera; automatically detect a lesion formed at the surgical site in real time; and automatically stop the ablation catheter if the lesion has a predetermined characteristic.

[0010] In one or more embodiments, the predetermined characteristic includes a predetermined size. In one or more embodiments, the predetermined characteristic includes a predetermined color. In one or more embodiments, the customizable angle is in the range of 0° to 90°, and when the bendable shaft is in an unbent state, the bendable shaft extends along a shaft axis and the customizable angle is 0°.

[0011] In one or more embodiments, the offset balloon has an inflated state and a deflated state, and in the inflated state, the offset balloon has a height measured relative to a normal direction perpendicular to the shaft axis that is greater than a bend distance measured from the distal end of the steerable tip to the outer surface of the distal end of the elongate shaft when the customizable angle is 90°. In one or more embodiments, in the inflated state, the offset balloon is radially asymmetrically inflated. In one or more embodiments, a first portion of the wall has a relatively thinner wall thickness compared to a second portion of the wall that has a relatively thicker wall thickness compared to the first portion of the wall, the first portion of the wall being on a first side of the elongate shaft.

[0012] In one or more embodiments, an inner diameter of the working channel is larger than an outer diameter of the ablation catheter, and the fluid channel is defined between the inner diameter of the working channel and the outer diameter of the ablation catheter. In one or more embodiments, the fluid channel is fluidly coupled to a flush liquid source and / or to a vacuum source. In one or more embodiments, the ablation catheter comprises an RF ablation catheter.

[0013] In one or more embodiments, the working tube comprises a flexible cylinder. In one or more embodiments, the flexible cylinder comprises a wire-reinforced liner. In one or more embodiments, the wire-reinforced liner comprises a tube body comprising fluorinated ethylene propylene and a helical wire. In one or more embodiments, the inner surface of the flexible cylinder comprises only the tube body to form a smooth surface for receiving a medical instrument. In one or more embodiments, the shaft comprises a metal tube having an inner surface and an outer surface, and a pattern of slits is defined in the shaft to increase shaft flexibility.

[0014] In one or more embodiments, the metal tube comprises stainless steel. In one or more embodiments, the groove is laser cut. In one or more embodiments, the pattern comprises an interrupted spiral. In one or more embodiments, the pattern comprises a plurality of fins extending circumferentially on first and second sides of the metal tube, the fin on the first side and the fin on the second side being separated by first and second gaps, the first and second gaps extending along a plane defined by a shaft axis and an axis orthogonal to the shaft axis.

[0015] Another aspect of the invention is directed to a method for controlling an epicardial ablation procedure, the method including inserting an instrument port having an ablation tool, an optical camera, and an optical light emitter into an epicardial space proximal to a target area, providing optical light via the optical light emitter to the epicardial space to illuminate the target area, acquiring a first image of the target area using the optical camera, steering a tip of the ablation tool toward the target area, applying ablation energy to the target area using the ablation tool to form a lesion in or on the target area, acquiring a second image of the target area using the optical camera, and processing at least one of the first and second images with an image processor to determine characteristics of the lesion.

[0016] In one or more embodiments, the method further includes, after the step of acquiring the second image, acquiring a third image of the target region and determining a characteristic of the lesion using at least two of the first, second, and third images. In one or more embodiments, the characteristic includes a size of the lesion. In one or more embodiments, the characteristic includes a growth rate of the lesion. In one or more embodiments, the method further includes controlling application of ablation to the target region based on determining that a desired outcome has been achieved at the lesion.

[0017] In one or more embodiments, the characteristics of the lesion are determined in real time. In one or more embodiments, the method further includes processing at least one of the first and second images with an image processor to automatically detect anatomical features of the target area.

[0018] Another aspect of the invention is directed to an instrument port comprising: an elongate shaft having a proximal end and a distal end and extending along a shaft axis, the elongate shaft having a fluid port defined in an outer surface at the distal end of the elongate shaft; a steerable tip attached to the distal end of the shaft; an offset balloon attached to the outer surface of the elongate shaft, the offset balloon having an interior 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 is asymmetrically inflated radially relative to the shaft axis; and a working tube disposed on the elongate shaft, the working tube forming a working channel for receiving a medical instrument.

[0019] In one or more embodiments, the instrument port further comprises a fluid tube disposed on the elongate shaft, the fluid tube being fluidly coupled to the fluid port, In one or more embodiments, a proximal side of the offset balloon is attached to an outer surface of the elongate shaft proximal to the fluid port and a distal side of the offset balloon is attached to an outer surface of the elongate shaft distal to the fluid port.

[0020] In one or more embodiments, the offset balloon is formed from a wall having a variable wall thickness. In one or more embodiments, a first portion of the wall has a relatively thin wall thickness compared to a second portion of the wall having a relatively thicker wall thickness compared to the first portion of the wall, and the first portion of the wall is on a first side of the elongate shaft such that in an inflated state, the offset balloon is radially asymmetrically inflated. In one or more embodiments, the proximal and distal sides of the offset balloon are attached to the outer surface by tie-downs, bonds, and / or heat seals.

[0021] In one or more embodiments, the offset balloon is attached to the outer surface only on a first side of the elongate shaft, and an offset balloon opening of the offset balloon is fluidly coupled to the fluid port. In one or more embodiments, the offset balloon is disposed between the balloon restraining tube section and the outer surface on a second side of the elongate shaft, and the balloon restraining tube section restricts the inflation volume of the offset balloon to only the first side of the elongate shaft when the offset balloon is in an inflated state. In one or more embodiments, the balloon restraining tube section comprises a horizontal cylindrical segment. In one or more embodiments, the offset balloon expands radially asymmetrically relative to an expansion plane, and the shaft axis lies within the expansion plane.

[0022] In one or more embodiments, the offset balloon has a partially inflated state in which the partially inflated volume of the offset balloon is in a range of about 10% to about 90% of the fully inflated volume of the offset balloon, and when the offset balloon is in the inflated state, the offset balloon has a fully inflated volume.

[0023] Another aspect of the invention is directed to an instrument port comprising: an elongate shaft having a proximal end and a distal end and extending along a shaft axis, the elongate shaft having a fluid port defined on an outer surface at the distal end of the elongate shaft; a bendable shaft attached to the distal end of the elongate shaft; a steerable tip attached to the distal end of the shaft, the steerable tip extending along a tip axis; an offset balloon attached to the outer surface of the elongate shaft, the offset balloon having an interior volume in fluid communication with the fluid port, the offset balloon having an inflated state and a deflated state, in the inflated state the offset balloon is inflated only on a first side of the elongate shaft; a fluid tube disposed on the elongate shaft, the fluid tube fluidly coupled to the fluid port; and a working tube disposed on the elongate shaft, the working tube forming a working channel for receiving a medical instrument.

[0024] In one or more embodiments, the instrument port further comprises a handle attached to the proximal end of the elongate shaft, the handle including a handle fluid port fluidly coupled to a fluid tube for introducing or receiving fluid. In one or more embodiments, the distal end of the fluid tube is capped to define a closed fluid pathway between the fluid tube and the fluid port. In one or more embodiments, the fluid tube includes a fluid tube opening, the fluid tube attached to an inner surface at the distal end of the elongate shaft fluidly coupling the fluid tube opening and the fluid port.

[0025] In one or more embodiments, a proximal side of the offset balloon is attached to the outer surface of the elongate shaft proximal to the fluid port and a distal side of the offset balloon is attached to the outer surface of the elongate shaft distal to the fluid port. In one or more embodiments, the offset balloon is formed from a wall having a variable wall thickness. In one or more embodiments, a first portion of the wall has a relatively thinner wall thickness compared to a second portion of the wall having a relatively thicker wall thickness compared to the first portion of the wall, and the first portion of the wall is on a first side of the elongate shaft such that the offset balloon is radially asymmetrically inflated relative to the shaft axis in an inflated state.

[0026] In one or more embodiments, the proximal and distal sides of the offset balloon are attached to the outer surface by tie-downs, bonds, and / or heat seals. In one or more embodiments, the proximal and distal sides of the offset balloon are attached to the outer surface on a first side of the elongate shaft, and the offset balloon opening of the offset balloon is fluidly coupled to the fluid port.

[0027] In one or more embodiments, the offset balloon is disposed on the second side of the elongate shaft between the balloon restraining tube section and the outer surface, and the balloon restraining tube section restricts the inflation volume of the offset balloon to only the first side of the elongate shaft when the offset balloon is in an inflated state. In one or more embodiments, the balloon restraining tube section comprises a horizontal cylindrical segment. In one or more embodiments, the offset balloon expands radially asymmetrically relative to an expansion plane, and the shaft axis lies within the expansion plane.

[0028] In one or more embodiments, the offset balloon has a partially inflated state in which the partially inflated volume of the offset balloon is in a range of about 10% to about 90% of the fully inflated volume of the offset balloon, and when the offset balloon is in the inflated state, the offset balloon has a fully inflated volume.

[0029] Yet another aspect of the invention is directed to an instrument port comprising: an elongate shaft having a proximal end and a distal end and extending along a shaft axis, the elongate shaft having a fluid port defined on an outer surface at the distal end of the elongate shaft; a bendable shaft attached to the distal end of the elongate shaft; a steerable tip attached to the distal end of the shaft, the steerable tip extending along a tip axis; an offset balloon attached to the outer surface of the elongate shaft, the offset balloon having an interior volume in fluid communication with the fluid port, the offset balloon having an inflated state and a deflated state; a fluid tube disposed on the elongate shaft, the fluid tube fluidly coupled to the fluid port; and a working tube disposed on the elongate shaft, the working tube forming a working channel for receiving a medical instrument.

[0030] In one or more embodiments, the instrument port further comprises a handle attached to the proximal end of the elongate shaft, the handle including a handle fluid port fluidly coupled to a fluid tube for introducing or receiving fluid. In one or more embodiments, the distal end of the fluid tube is capped to define a closed fluid pathway between the fluid tube and the fluid port. In one or more embodiments, the fluid tube includes a fluid tube opening, the fluid tube attached to an inner surface at the distal end of the elongate shaft fluidly coupling the fluid tube opening and the fluid port.

[0031] In one or more embodiments, the proximal side of the offset balloon is attached to the outer surface of the elongate shaft proximal to the fluid port and the distal side of the offset balloon is attached to the outer surface of the elongate shaft distal to the fluid port, In one or more embodiments, in an inflated state, the offset balloon is radially symmetrically inflated relative to the shaft axis.

[0032] In one or more embodiments, the offset balloon has a partially inflated state in which the partially inflated volume of the offset balloon is in a range of about 10% to about 90% of the fully inflated volume of the offset balloon, and when the offset balloon is in the inflated state, the offset balloon has a fully inflated volume.

[0033] Another aspect of the invention is directed to an instrument port comprising: an elongate shaft having a proximal end and a distal end and extending along a shaft axis; a flexible shaft attached to the distal end of the elongate shaft, the flexible shaft configured to bend only in a pivot plane defined by the shaft axis and a pivot axis perpendicular to the shaft axis; a steerable tip attached to the distal end of the shaft, the steerable tip extending along a tip axis; a handle attached to the proximal end of the elongate shaft, the handle including a lever in mechanical communication with the flexible shaft to adjust a customizable angle of the steerable tip, the customizable angle being measured between the shaft axis and the tip axis; and a working tube disposed on the elongate shaft and the flexible shaft, the working tube forming a working channel for receiving a medical instrument.

[0034] In one or more embodiments, in an unbent state, the flexible shaft extends along a shaft axis, the flexible shaft including a plurality of mechanical rings arranged concentrically along the shaft axis, the plurality of mechanical rings including adjacent mechanical ring pairs, each adjacent mechanical ring pair mechanically coupled by a pair of mechanical links, a respective third axis passing through each pair of mechanical links, each respective third axis being orthogonal to the shaft axis and the pivot axis. In one or more embodiments, the pairs of mechanical links mechanically constrain the bending direction of the flexible shaft relative to the pivot plane.

[0035] In one or more embodiments, the lever is mechanically coupled to a wire that extends to a distal end of the flexible shaft, the wire being attached to an inner surface of the flexible shaft, the pivot axis passing through the inner surface. In one or more embodiments, the lever is mechanically coupled to a wire rope that extends to a distal end of the flexible shaft, the wire rope comprising a wire.

[0036] In one or more embodiments, the lever is mechanically coupled to a spindle disposed on the handle. In one or more embodiments, the wire is attached to a main shaft, and pulling the lever rotates the main shaft and pulls the wire toward the proximal end of the elongate shaft, thereby bending the flexible shaft in a first direction. In one or more embodiments, the handle includes a mechanical lock that applies a force against the main shaft to set a customizable angle of the flexible shaft.

[0037] In one or more embodiments, the customizable angle is in the range of 0° to 90°, and when the flexible shaft is in an unbent state, the flexible shaft extends along the shaft axis and the customizable angle is 0°. In one or more embodiments, the instrument port further comprises an offset balloon attached to a distal end of the elongate shaft.

[0038] In one or more embodiments, the elongate shaft is flexible and has a bent state and an unbent state, in which the elongate shaft extends along the shaft axis. In one or more embodiments, when the customizable angle is adjusted, the elongate shaft remains in the unbent state. In one or more embodiments, when the customizable angle is adjusted, the elongate shaft remains in the bent state, and the elongate shaft has the same bent position while the customizable angle is adjusted.

[0039] Another aspect of the invention is a surgical instrument comprising an elongate shaft having a proximal end and a distal end and extending along a shaft axis; a flexible shaft attached to the distal end of the elongate shaft, the flexible shaft configured to bend only in a pivot plane defined by the shaft axis and a pivot axis perpendicular to the shaft axis; a steerable tip attached to the distal end of the shaft, the steerable tip extending along a tip axis; and a handle attached to the proximal end of the elongate shaft, the handle comprising a first lever mechanically coupled to a first wire having an end attached to a first side of the flexible shaft, the first lever being configured to bend the first lever. The bar is directed to an instrument port comprising a handle including a first lever configured to pull a first wire to deflect the flexible shaft in a first direction in the pivot plane, and a second lever mechanically coupled to a second wire having an end attached to a second side of the flexible shaft, the second lever configured to pull the second wire to deflect the flexible shaft in a second direction opposite the first direction, the second direction being in the pivot plane, and a working tube disposed on the elongate shaft and the flexible shaft, the working tube forming a working channel for receiving a medical instrument.

[0040] In one or more embodiments, in an unbent state, the flexible shaft extends along a shaft axis, the flexible shaft including a plurality of mechanical rings arranged concentrically along the shaft axis, the plurality of mechanical rings including adjacent mechanical ring pairs, each adjacent mechanical ring pair mechanically coupled by a pair of mechanical links, a respective third axis passing through each pair of mechanical links, each respective third axis being orthogonal to the shaft axis and the pivot axis. In one or more embodiments, the pairs of mechanical links mechanically constrain the bending direction of the flexible shaft relative to the pivot plane.

[0041] In one or more embodiments, the first and second sides of the flexible shaft include inner surfaces disposed at a distal end of the flexible shaft, and the pivot axis passes through the inner surfaces of the first and second sides. In one or more embodiments, the first and second levers are mechanically coupled to first and second wire ropes, respectively, the first and second wire ropes comprising first and second wires, respectively.

[0042] In one or more embodiments, the first and second levers are mechanically coupled to a spindle disposed on the handle. In one or more embodiments, the first and second wires are attached to the spindle, the spindle configured to rotate in a first direction when the first lever is pulled to pull an end of the first wire toward the proximal end of the elongate shaft, thereby bending the flexible shaft in a first direction, and the spindle configured to rotate in a second direction when the second lever is pulled to pull an end of the second wire toward the proximal end of the elongate shaft, thereby bending the flexible shaft in a second direction. In one or more embodiments, the spindle is configured to release a first force on the first wire when the spindle is rotated in a second direction, and the spindle is configured to release a second force on the second wire when the spindle is rotated in the first direction.

[0043] In one or more embodiments, the handle includes a mechanical lock that applies a force against the primary axis to set a customizable angle of the flexible shaft. In one or more embodiments, the customizable angle is in the range of -90° to 90°, and when the flexible shaft is in an unbent state, the flexible shaft extends along the shaft axis and the customizable angle is 0°. In one or more embodiments, the customizable angle is adjustable while the bent position and bent orientation of the elongate shaft are maintained.

[0044] Another aspect of the invention is directed to an instrument port comprising: an elongate shaft having a proximal end and a distal end and extending along a shaft axis, the elongate shaft having a fluid port defined on an outer surface at the distal end of the elongate shaft; a bendable shaft having a proximal end attached to the distal end of the elongate shaft along the shaft axis, the bendable shaft configured to bend only in a pivot plane defined by the shaft axis and a pivot axis perpendicular to the shaft axis; and a steerable tip attached to the distal end of the bendable shaft, the steerable tip including a camera disposed at the distal end of the steerable tip and a light emitter disposed at the distal end of the steerable tip. The instrument port further comprises an offset balloon attached to an outer surface of the elongate shaft, the offset balloon having an interior volume in fluid communication with the fluid port, the offset balloon having an inflated state and a deflated state; a handle attached to a proximal end of the elongate shaft, the handle including at least one lever in mechanical communication with the bendable shaft to adjust a customizable angle of the steerable tip, the customizable angle being measured between the shaft axis and the tip axis; a fluid tube disposed on the elongate shaft, the fluid tube fluidly coupled to the fluid port; and a working tube disposed on the elongate shaft, the working tube forming a working channel for receiving a medical instrument.

[0045] In one or more embodiments, the customizable angle is in the range of -90° 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°. In one or more embodiments, the offset balloon has an inflated state and a deflated state, and in the inflated state, the offset balloon has a height measured relative to a vertical axis perpendicular to the shaft axis that is greater than a bend distance measured from the distal end of the steerable tip to the outer surface of the distal end of the elongate shaft when the customizable angle is 90°. In one or more embodiments, in the inflated state, the offset balloon is radially asymmetrically inflated. In one or more embodiments, a first portion of the wall has a relatively thin wall thickness compared to a second portion of the wall having a relatively thicker wall thickness compared to the first portion of the wall, the first portion of the wall being on a first side of the elongate shaft.

[0046] In one or more embodiments, the instrument port further comprises an RF ablation catheter, wherein an inner diameter of the working channel is larger than an outer diameter of the RF ablation catheter and a fluid channel defined between the inner diameters of the working channels is larger than an outer diameter of the RF ablation catheter, In one or more embodiments, the fluid channel is fluidly coupled to a flush liquid source and / or to a vacuum source.

[0047] In one or more embodiments, the working tube comprises a flexible cylinder. In one or more embodiments, the flexible cylinder comprises a wire-reinforced liner. In one or more embodiments, the wire-reinforced liner comprises a tube body comprising fluorinated ethylene propylene and a helical wire. In one or more embodiments, the inner surface of the flexible cylinder comprises only the tube body to form a smooth surface for receiving a medical instrument.

[0048] In one or more embodiments, the elongate shaft comprises a metal tube, and a pattern of slits is defined in the shaft to increase shaft flexibility. In one or more embodiments, the metal tube comprises stainless steel. In one or more embodiments, the grooves are laser cut. In one or more embodiments, the pattern comprises an interrupted helix. In one or more embodiments, the pattern comprises a plurality of fins extending circumferentially on first and second sides of the metal tube, the fins on the first side and the fins on the second side being separated by first and second gaps, the first and second gaps extending along a plane defined by the shaft axis and an axis perpendicular to the shaft axis.

[0049] In one or more embodiments, the offset balloon has a partially inflated state in which the partially inflated volume of the offset balloon is in a range of about 10% to about 90% of the fully inflated volume of the offset balloon, and when the offset balloon is in a fully inflated state, the offset balloon has a fully inflated volume. [Brief description of the drawings]

[0050] For a more complete understanding of the nature and advantages of the present concepts, reference is made to the detailed description of the preferred embodiment and the accompanying drawings.

[0051] [Figure 1] FIG. 1 is a block diagram of a medical procedure using an ablation catheter according to the prior art. [Diagram 2] FIG. 1 illustrates a perspective view of an instrument port, according to one embodiment. [Diagram 3] FIG. 13 is a perspective view of a distal portion of an instrument port, according to one embodiment. [Figure 4] FIG. 13 is a perspective view of a distal portion of the instrument port when the offset balloon is radially asymmetrically inflated, according to one embodiment. [Diagram 5] FIG. 13 is a cross-sectional view of a distal portion of an instrument port when the offset balloon is radially asymmetrically inflated, according to one embodiment. [Figure 6]FIG. 13 is a cross-sectional view of a distal portion of an instrument port when the offset balloon is radially asymmetrically inflated, according to an alternative embodiment. [Figure 7] 1 illustrates a side view of an instrument port when an offset balloon is radially asymmetrically inflated during a medical procedure, according to one embodiment. [Figure 8] 1 illustrates a side view of an instrument port when the offset balloon is radially asymmetrically inflated and the bendable shaft is in a bent state during a medical procedure, according to one embodiment. [Figure 9] FIG. 13 is a cross-sectional view of a distal portion of an instrument port when the offset balloon is radially asymmetrically inflated, according to another embodiment. [Figure 10] FIG. 13 is a perspective view of a distal portion of the instrument port when the offset balloon is radially symmetrically inflated, according to one embodiment. [Figure 11] 1 illustrates a side view of an instrument port when an offset balloon is radially symmetrically inflated during a medical procedure, according to one embodiment. [Figure 12] FIG. 13 is a perspective view of a distal portion of an instrument port without an offset balloon to illustrate an embodiment of a bendable shaft in an unbent state. [Figure 13] FIG. 13 is a perspective view of a distal portion of an instrument port with an offset balloon to illustrate an embodiment of a bendable shaft in a bent state. [Figure 14] FIG. 2 is a perspective view of a bendable shaft and steerable tip in an unbent state according to one embodiment. [Figure 15] FIG. 2 is a perspective view of a wire tension adjuster according to one embodiment. [Figure 16] FIG. 13 is a perspective view of a distal portion of an instrument port, according to one embodiment. [Figure 17] FIG. 2 is an isolated perspective view of a working tube according to one embodiment. [Figure 18] FIG. 2 illustrates an isolated perspective view of an elongate shaft according to one embodiment. [Figure 19]FIG. 13 is an isolated perspective view of an elongate shaft according to another embodiment. [Figure 20] FIG. 2 is a cross-sectional view of a long shaft. [Figure 21] FIG. 1 illustrates a top view of an instrument port system, according to one embodiment. [Figure 22] FIG. 13 is a perspective view of a proximal portion of a handle of an instrument port, according to one embodiment. [Diagram 23] FIG. 2 is a cross-sectional view of the proximal portion of the handle. [Figure 24] FIG. 13 is a top view of a portion of the handle with the housing removed. [Diagram 25] FIG. 25 is an isolated perspective view of the tip steering device illustrated in FIG. 24. [Figure 26] 13 is a cross-sectional view of a portion of the handle to further illustrate the mechanical lock. [Figure 27] FIG. 2 is a block diagram of subsystems that may be included in the controller. [Figure 28A] Illustrated is a lesion having a first size and / or first optical attributes at a first time. [Figure 28B] Illustrated is a lesion having a second size and / or second optical attributes at a second time. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0052] The instrument port includes a handle, an elongated shaft, a bendable shaft, and a steerable tip. One or more levers on the handle can be used to controllably bend the bendable shaft in one plane. The proximal end of the bendable shaft is mechanically coupled to the elongated shaft, and the distal end of the bendable shaft is mechanically coupled to the steerable tip. When the bendable shaft is in an unbent state, the bendable shaft extends along a shaft axis along which the elongated shaft extends. When the bendable shaft is in a bent state, the bendable shaft bends or flexes relative to the shaft axis to direct the steerable tip to a customizable angle or orientation relative to the shaft axis. The bendable shaft can bend without affecting the position, shape, orientation, and / or behavior of the elongated shaft. For example, the elongated shaft can remain in a bent state while the bendable shaft 220 transitions from an unbent state to a bent state. Alternatively, the elongated shaft can remain in a non-bent state while the bendable shaft 220 transitions from an unbent state to a bent state.

[0053] The customizable angle can improve the viewing of an anatomical region during a medical procedure using an imaging system disposed on the steerable tip. Additionally, the customizable angle can set an advantageous angle at which a medical instrument, such as an ablation catheter, exits the steerable tip.

[0054] The offset balloon is attached to the distal end of the elongate shaft. The offset balloon can be transitioned from a deflated state to an inflated state during a medical procedure. In the inflated state, the offset balloon can be disposed against an anatomical feature (e.g., cardiac tissue) to provide a space between the elongate shaft and the anatomical feature. This space can be used to transition the bendable shaft from an unbent state to a bent state. The offset balloon can be inflated symmetrically or asymmetrically. Additionally, the offset balloon can be partially inflated to, for example, customize the space between the elongate shaft and the anatomical feature.

[0055] The working channel extends from the proximal end to the distal end of the working channel through the instrument port. The working channel can be configured to have an inner radius larger than the outer radius of the medical instrument to form a flush / vacuum channel between the working channel and the medical instrument. The flush / vacuum channel can be fluidly coupled to a flushing liquid and / or vacuum source and can be used to flush the outer surface of the medical instrument prior to a medical procedure, clean the face of the device to provide a clear image through a camera, flush the surgical site during a medical procedure, and / or apply a vacuum as needed to remove liquids and / or bodily fluids such as blood.

[0056] The instrument port can have various features, which are described in the accompanying figures, and which can be combined and / or eliminated in various embodiments.

[0057] 2 is a perspective view of an instrument port 20 according to one embodiment. The instrument port 20 includes a handle 200, an elongate shaft 210, a bendable shaft 220, and a steerable tip 230. The handle 200 is at a proximal end 202 of the instrument port 20. The steerable tip 230 is at a distal end 204 of the instrument port 20.

[0058] The bendable shaft 220 can bend depending on the position of one or more levers 240 on the handle 200. The bendable shaft 220 can be configured to bend only in one plane (e.g., up and down) and not in an orthogonal plane (e.g., left and right). The position and / or orientation of the steerable tip 230 can be controlled by actuating the levers 240 on the handle 200, which can bend the bendable shaft 220 to set a customizable angle of the steerable tip 230 relative to the elongate shaft 210. In some embodiments, the bendable shaft 220 is optional. The bendable shaft 220 can bend without affecting the position, shape, orientation, and / or behavior of the elongate shaft 210.

[0059] FIG. 3 is a perspective view of a distal portion 300 of the instrument port 20, according to one embodiment. In addition to the bendable shaft 220 and the steerable tip 230, the distal portion 300 also includes an offset balloon 310, which in FIG. 3 is in a deflated state. The offset balloon is located at the distal end or portion 215 of the elongate shaft 210. During a medical procedure, the offset balloon 310 can be inflated to create a space between an anatomical feature and the instrument port 20. For example, the space created by the inflated offset balloon 310 can be used to bend the bendable shaft 220 to create a customizable angle of the steerable tip 230 during a medical procedure to customize the angle at which a medical instrument (e.g., an ablation catheter such as the ablation catheter 100) passes through the working channel 320 at the distal end 204 of the instrument port 20. When the inflated offset balloon 310 is disposed against an anatomical feature, the offset balloon 310 can provide stability to the instrument port 20 during a medical procedure.

[0060] The offset balloon 310 may be inflated with a fluid (e.g., gas and / or liquid). In one example, the offset balloon 310 is inflated with air. In another embodiment, the offset balloon 310 is inflated with saline or semi-saline. The liquid may include a contrast agent that may be used to view the offset balloon 310 during a medical procedure, such as in medical imaging (e.g., ultrasound, MRI, or another medical imaging technique). The interior volume of the offset balloon 310 is fluidly coupled to a fluid port 340 defined at or near the distal end 215 of the elongate shaft. The fluid port 340 may be used to introduce and remove fluid to / from the offset balloon 310 to inflate and deflate the offset balloon 310, respectively.

[0061] In the inflated state, the offset balloon 310 can be configured to be radially symmetric or asymmetric about a shaft axis 330 that passes through the centers of the elongate shaft 210, the bendable shaft 220, and the steerable tip 230 when the bendable shaft 220 is in an unbent state (e.g., as illustrated in FIGS. 1-3). The shaft axis 330 can be an axis of symmetry for the elongate shaft 210, the bendable shaft 220, and the steerable tip 230 when the bendable shaft 220 is in an unbent state.

[0062] The offset balloon 310 is attached to the distal end 215 of the elongate shaft 210 to create a fluid tight seal around the fluid port 340. The proximal and distal ends 312, 314 of the offset balloon 310 are attached proximally and distally, respectively, of the fluid port 340 using tie-downs 350, FIG. 3. In another embodiment, the offset balloon 310 can be attached by bonding the end 312 of the offset balloon 310 to the elongate shaft 210, for example, using an adhesive. In another embodiment, the offset balloon 310 can be attached by heat sealing the wall of the offset balloon 310 to the elongate shaft 210. These and / or other attachment means can be used in other embodiments.

[0063] A sleeve 250 is disposed over at least the bendable shaft 220 and the steerable tip 230. The sleeve 250 can provide a smooth surface for insertion into a patient during a medical procedure to reduce the possibility of tissue damage. The sleeve 250 can be flexible and conformable to the bendable shaft 220 and the steerable tip 230 as their relative orientations and / or angles are adjusted during a medical procedure. The sleeve 250 can include and / or consist of a polyolefin, a fluoropolymer, a polyether block amide (e.g., PEBAX® available from Arkema), and / or another material.

[0064] 4 is a perspective view of the distal portion 300 of the instrument port 20 with the offset balloon 310 asymmetrically inflated in the radial direction, according to one embodiment. In this embodiment, the offset balloon 310 is more inflated on the first side 332 of the shaft axis 330 than on the second side 334 of the shaft axis 330. In one embodiment, the offset balloon 310 can have a variable wall thickness. In another embodiment, a portion of a semi-rigid tube can be disposed on the second side 334 of the shaft axis 330 such that the offset balloon 310 is inflated on the first side 332 of the shaft axis 330 and not inflated on the second side 334 of the shaft axis.

[0065] In some embodiments, the offset balloon 310 can be partially inflated. For example, the offset balloon 310 can have a partially inflated volume that is a percentage of a fully inflated volume. In certain examples, the offset balloon 310 can have a partially inflated state in which the partially inflated volume of the offset balloon 310 is in a range of about 10% to about 90% of the fully inflated volume, including about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, and about 80%, or any percentage or percentages between any two of the aforementioned percentages. When the offset balloon 310 is in an inflated state (e.g., a fully inflated state), the offset balloon 310 has a fully inflated volume.

[0066] 5 is a cross-sectional view of the distal portion 300 of the instrument port 20 when the offset balloon 310 is radially asymmetrically inflated, according to one embodiment. The cross-sectional view is taken through plane 5-5 of FIG. 4. This embodiment illustrates that the offset balloon 310 is formed from a wall 500 having a variable cross-sectional thickness. The wall 500 on the first side 332 of the shaft shaft 330 has a thinner cross-sectional thickness compared to the cross-sectional thickness of the wall 500 on the second side 334 of the shaft shaft 330. Similarly, the wall 500 on the second side 334 of the shaft shaft 330 has a thicker cross-sectional thickness compared to the cross-sectional thickness of the wall 500 on the first side 332 of the shaft shaft 330. Because the relatively thicker cross-sectional thickness of the wall 500 on the second side 334 of the shaft shaft 330 requires more force to expand and the relatively thinner cross-sectional thickness of the wall 500 on the first side 332 of the shaft shaft 330 requires less force to expand, the offset balloon 310 will expand more on the first side 332 of the shaft shaft 330 than on the second side 332 of the shaft shaft 330. For example, when the offset balloon 310 is inflated, about 60% to about 90% of the inflated volume of the offset balloon 310 may be on the first side 332 of the shaft shaft 330, while only about 10% to about 40% of the inflated volume of the offset balloon 310 may be on the second side 332 of the shaft shaft 330.

[0067] The variable cross-sectional thickness of the wall 500 can also be measured relative to an expansion plane 510. The expansion plane 510 passes through the middle of the elongate shaft 210, the bendable shaft 220, and the steerable tip 230 along the shaft axis 330 when the bendable shaft 220 is in an unbent state. Thus, the shaft axis 330 lies within the expansion plane 510. In one embodiment, the expansion plane 510 can be described or defined by the shaft axis 330 extending along the length of the instrument port 20 and a width axis 360 (FIG. 4) extending along the width of the instrument port. The width axis 360 is orthogonal to the shaft axis 330. Below 512 (e.g., on a first side) of the expansion plane 510, the offset balloon wall 500 has a thinner cross-sectional thickness compared to the cross-sectional thickness of the wall 500 above 514 (e.g., on a second side) of the expansion plane 510. Similarly, above 514 (e.g., on the second side) of the expansion plane 510, the offset balloon wall 500 has a thicker cross-sectional thickness compared to the cross-sectional thickness of the wall 500 below 512 (e.g., on the first side) of the expansion plane 510. When the offset balloon 310 is inflated, about 60% to about 90% of the expansion volume of the offset balloon 310 may be below 512 (e.g., on the first side) of the expansion plane 510, while only about 10% to about 40% of the expansion volume of the offset balloon 310 may be above 514 (e.g., on the second side) of the expansion plane 510.

[0068] 6 is a cross-sectional view of the distal portion 300 of the instrument port 20 when the offset balloon 310 is radially asymmetrically inflated, according to an alternative embodiment. The cross-section is taken through a line through the plane 5-5 of FIG. 4. In this embodiment, the wall 500 of the offset balloon 310 has a uniform cross-sectional thickness. A portion of a balloon restraining tube 610 (e.g., a tube cut along its length, such as a horizontal cylindrical segment) is attached to the elongate shaft 210 over or on a portion of the offset balloon 310. The balloon restraining tube 610 is rigid and constrains or limits the expansion of the offset balloon 310, such that the offset balloon 310 only inflates where the balloon restraining tube 610 is not located. A balloon restraining tube 610 can be disposed over or on the offset balloon 310 above 514 (e.g., on a second side) of the expansion plane 510 such that the offset balloon 310 is only inflated below 512 (e.g., on a first side) of the expansion plane 510. The balloon restraining tube 610 can include plastic, metal, and / or another material. The offset balloon 310 is inflated more on the first side 332 of the shaft axis 330 than on the second side 334 of the shaft axis 330.

[0069] 7 illustrates a side view of the instrument port 20 when the offset balloon 310 is radially asymmetrically inflated during a medical procedure, according to one embodiment. Inflating the offset balloon 310 increases the distance between the thermal tissue 110 and the instrument port 20 (e.g., the elongate shaft 210, the bendable shaft 220, and the steerable tip 230). One technical advantage is that as the offset balloon 310 is inflated, the distance between the thermal tissue 110 and the instrument port 20 increases, providing the space needed to bend the bendable shaft 220 toward the cardiac tissue 110 to customize the position and angle of the steerable tip 230 relative to the elongate shaft 210, for example, as illustrated in FIG. For example, the offset balloon 310 can have a radius or height 810 that is equal to or greater than a bend distance 820 between the distal end 204 of the steerable tip 230 and the outer surface 812 of the distal end of the elongate shaft 210 when the bendable shaft 220 is in a bent state (e.g., when the customized angle between the steerable tip 230 and the elongate shaft 210 is 90°). The radius / height 810 and bend distance 820 can be measured relative to a vertical axis 830 that is orthogonal to the shaft axis 330. This provides sufficient space between the bendable tip 220 to bend and adjust the customizable position and angle of the steerable tip 210.

[0070] The customizable position and angle of the steerable tip 230 can facilitate improved imaging of the cardiac tissue 110 using the imaging system 800 located at the distal end 234 of the steerable tip 230. Additionally, the customizable position and angle of the steerable tip 230 can enable an ablation catheter inserted through the instrument port 20 to create deeper lesions in the cardiac tissue 110 (e.g., as compared to the catheter 100) while protecting the phrenic nerve 140 from any damage. Furthermore, the offset balloon 310 can provide more precise and / or stable contact between the distal end 234 of the steerable tip 230 and the cardiac tissue 110, which can enable the contact force required to perform ablation with an ablation catheter inserted through the instrument port 20. The ablation catheter can operate using any ablation technique, including radio frequency (RF), cryoablation, needle ablation, laser ablation, and / or electroporation.

[0071] 7 and 8 also illustrate that the bendable shaft 220 can bend without affecting the position, shape, orientation, and / or behavior of the elongate shaft 210. For example, FIGS. 7 and 8 illustrate that the elongate shaft 210 can maintain the position of the elongate shaft 210 along the shaft axis 330 as the bendable shaft 220 bends. In addition, the shaft axis 330 maintains the same relative position and angle (e.g., the shaft axis 330 does not move) as the bendable shaft 220 bends. Thus, the shaft axis 330 can remain stationary while the bendable shaft 220 transitions from an unbent state to a bent state. Alternatively, the elongate shaft 210 can be kept in a bent state and in the same bent position, bent configuration, and / or bent orientation while the bendable shaft 220 transitions from an unbent state to a bent state. Thus, the bendable shaft 220 can bend and a customizable angle can be adjusted or set independently of the elongate shaft 210.

[0072] 9 is a cross-sectional view of the distal portion 300 of the instrument port 20 when the offset balloon 310 is radially asymmetrically inflated according to another alternative embodiment. The cross-section is taken through plane 5-5 of FIG. 4. In this embodiment, the offset balloon 310 is attached only below 512 (e.g., on a first side) of the expansion plane 510. Because the offset balloon 310 is not attached above 514 (e.g., on a second side) of the expansion plane 510, the balloon 310 inflates only below 512 of the expansion plane 510. The offset balloon 310 inflates only on the first side 332 of the shaft axis 330 and not on the second side 334 of the shaft axis 330. A side view of this alternative embodiment would look the same as that illustrated in FIG. 8.

[0073] FIG. 10 is a perspective view of the distal portion 300 of the instrument port 20 when the offset balloon 310 is radially symmetrically inflated, according to one embodiment. In this embodiment, the offset balloon 310 is equally (or substantially equally) inflated on the first and second sides 332, 334 of the shaft axis 330. FIG. 11 illustrates a side view of the instrument port 20 when the offset balloon 310 is radially symmetrically inflated during a medical procedure, according to one embodiment. A radially symmetric balloon provides the same or substantially the same technical advantages as a radially asymmetric balloon. However, the advantage over a radially asymmetric balloon is that a larger balloon can be used without compromising cardiac hemodynamics, compared to a radially symmetric balloon. For example, in FIG. 11, the upper portion 1110 of the radially symmetric balloon 310 is disposed against the pericardium 120, which can generate a force or pressure against the cardiac tissue 110. This force or pressure is undesirable as it can affect the blood flow of the heart.

[0074] As discussed above, the offset balloon 310 can be partially inflated. For example, the offset balloon 310 can have a partially inflated volume that is a percentage of a fully inflated volume. In certain examples, the offset balloon 310 can have a partially inflated state in which the partially inflated volume of the offset balloon 310 is in the range of about 10% to about 90% of the fully inflated volume, including about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, and about 80%, or any percentage or percentages between any two of the aforementioned percentages. When the offset balloon 310 is in an inflated state (e.g., a fully inflated state), the offset balloon 310 has a fully inflated volume.

[0075] FIG. 12 is a perspective view of the distal portion 300 of the instrument port 20 without the offset balloon 310 to illustrate one embodiment of the bendable shaft 220 in an unbent state. The bendable shaft 220 includes a plurality of mechanical rings 1200 arranged concentrically along the shaft axis 330. The mechanical rings 1200 may include articulation links. Each adjacent pair 1210 of the mechanical rings 1200 is mechanically coupled by a pair of mechanical links 1220. A respective third axis 1230 passes through each pair of the mechanical links 1220. The third axis 1230 may be the same as or parallel to the width axis 360. The mechanical links 1220 provide a structure that limits the flexibility of the bendable shaft 220 within a rigid plane 1240 defined by the shaft axis 330 and the third axis 1230. The rigid plane 1240 may be the same as the expansion plane 510.

[0076] The mechanical rings 1200 are spaced along the shaft axis 330 to provide flexibility or bending upwards or downwards about a pivot axis 1250 that is orthogonal to the shaft axis 330 and a third axis 1330. The pivot axis 1250 and the shaft axis 330 define a pivot plane 1260 about which the bendable shaft 220 can bend upwards or downwards. The rigid plane 1240 and the pivot plane 1260 are orthogonal to one another.

[0077] The mechanical ring 1200 and the mechanical link 1220 can be formed of a metal (e.g., stainless steel or titanium) or a plastic (e.g., polyamide, polyetherimide, and / or another plastic). In one embodiment, the proximal end of the bendable shaft 220 is welded to the distal end of the elongate shaft 210. Additionally, the distal end of the bendable shaft 220 can be coupled to the proximal end of the steerable tip 230.

[0078] 13 is a perspective view of the distal portion 300 of the instrument port 20 with an offset balloon 310 to illustrate one embodiment of the bendable shaft 220 in a bent state. In the bent state, the mechanical rings 1200 are spaced further apart on the side of the bendable shaft 220 away from the direction of the bend, and the mechanical rings 1200 are spaced closer together on the side of the bendable shaft 220 toward the direction of the bend. The bendable shaft 220 can be adjusted in the bendable state to form a customizable angle 1300 of the steerable tip 230 relative to the elongate shaft 210. The customizable angle 1300 can be measured between the shaft axis 330 and a tip axis 1310 that extends through the working channel 320 of the steerable tip 230. In the unbent state, the tip axis 1310 and the shaft axis 330 are collinear.

[0079] 12 and 13 also illustrate that the bendable shaft 220 can bend without affecting the position, shape, orientation, and / or behavior of the elongate shaft 210. For example, the elongate shaft 210 maintains its position along the shaft axis 330 as the bendable shaft 220 bends. In addition, the shaft axis 330 maintains the same relative position and angle (e.g., the shaft axis 330 does not move) as the bendable shaft 220 bends. Thus, the shaft axis 330 can remain stationary while the bendable shaft 220 transitions from an unbent state to a bent state. Alternatively, the elongate shaft 210 can be held in a bent state while the bendable shaft 220 transitions from an unbent state to a bent state.

[0080] Also, note that the elongate shaft 210 is flexible in some embodiments (as described herein, for example, in FIGS. 18 and 19). In an unbent state, the elongate shaft 210 extends along the shaft axis 330. In a bent state, some or all of the elongate shaft 210 does not extend along the shaft axis 330. For example, the elongate shaft 210 can be bent or curved to a bent state such as to be positioned around an anatomical feature (e.g., the heart). In either case (bent or unbent state), the bendable shaft 220 can remain stationary (e.g., in the same bent or unbent configuration, bent or unbent position, bent or unbent state, bent or unbent orientation, etc.) while the bendable shaft 220 transitions from an unbent state to a bent state. Thus, the bendable shaft 220 can bend and a customizable angle can be adjusted or set independently of the elongate shaft 210.

[0081] 14 is a perspective view of the bendable shaft 220 and steerable tip 230 in an unbent state, according to one embodiment. In this view, the mechanical ring 1200 and mechanical link 1220 are partially transparent to illustrate the first and second wires 1401, 1402 of the bendable shaft 220. A first end 1411 of the first wire 1401 is attached to a first side 1421 (e.g., an inner surface) of the distal end of the bendable shaft 220. A second end 1412 of the second wire 1402 is attached to a second side 1422 (e.g., an inner surface) of the distal end of the bendable shaft 220. The first and second ends 1411, 1412 may be crimped and / or welded to the distal end of the bendable shaft 220. In an unbent state, the first and second ends 1411 , 1412 are attached to opposite sides 1421 , 1422 of the bendable shaft 220 along the pivot axis 1250 .

[0082] The first and second wires 1401, 1402 extend to the handle 200 where they can be pulled (e.g., by one or more levers) to bend the bendable shaft 220 in a corresponding direction within the expansion plane 1260. For example, the first wire 1401 can be pulled to bend the bendable shaft 220 upward (e.g., in a first direction corresponding to the first side 1421). Similarly, the second wire 1402 can be pulled to bend the bendable shaft 220 downward (e.g., in a second direction corresponding to the second side 1422). Each wire 1401, 1402 can pass through one or more guide sleeves 1430. In one embodiment, the first and second wires 1401, 1402 can comprise first and second wire ropes.

[0083] Each wire 1401, 1402 can optionally pass through and / or be attached to a densely wound coil 1440 that is part of a wire tension adjuster 1500, as illustrated in FIG. 15. The distal end 1442 of the densely wound coil 1440 is fixedly attached (e.g., welded) to a mechanical ring 1200 (e.g., the mechanical ring 1200 toward the proximal end 202 of the instrument port 20). The wire tension adjuster 1500 includes a densely wound coil 1440 and a tension adjuster 1510. The tension adjuster 1510 is attached to the adjuster plate 2440 (FIG. 24) of the handle 200. The tension adjuster 1510 includes a counterbore 1520 that includes internal threads that engage external threads on the densely wound coil. The tension adjuster 1510 can be rotated in a first direction to increase the tension in the wire 1402 and in a second direction to decrease the tension in the wire 1402. Although the wire tension adjuster 1500 is illustrated with respect to the wire 1402, the same wire tension adjuster 1500 can be used with the wire 1401.

[0084] 16 is a perspective view of the distal portion 300 of the instrument port 20, according to one embodiment. In this view, the steerable tip 230 is partially transparent and the bendable shaft 220 has been removed to illustrate an imaging system 1600 disposed at the distal end 204 of the instrument port 20 (and at the distal end of the distal tip 230). The imaging system 1600 includes first and second light emitters 1610 disposed about a camera 1620. Each light emitter 1610 may include a fiber optic cable or a bundle of fiber optic cables. The optical fiber is optically coupled to a light (e.g., an LED light, an incandescent light, a laser, or another light) at a proximal end of the optical fiber and transmits light through the optical fiber, which is output at the distal end 204 of the instrument port 20. In an alternative embodiment, the light emitter 1610 may include one or more lights (e.g., LEDs) disposed at the steerable tip 230 and outputting light at the distal end 204 of the instrument port 20. Additional or fewer light emitters 1610 may be included in other embodiments.

[0085] The camera 1620 includes a light sensor that is sensitive to one or more frequencies of light emitted from the light emitter 1610. The camera 1620 is electrically coupled to a cable 1630 that extends to the proximal end 202 of the instrument port 20, where the cable 1630 can be connected to a controller. The controller can include a light for the light emitter 1610. The light emitted by the light emitter 1610 can be modified by the controller by changing the intensity of the light using analog controls on the controller or digital controls in the display software, as well as by changing the emission spectrum by well-known means such as polarization and / or bandpass filtering. The camera 1620 can be used to acquire still or moving (e.g., video) image data of the area in front of (e.g., distal to) the distal end 204 of the instrument port 20. For example, the camera 1620 can be used to acquire still or moving image data of the cardiac tissue 110, the pericardium 120, and the lesion 130 as it forms. These images can be used to train advanced image feature detection algorithms, such as machine learning techniques. In some embodiments, the image data can be used to automatically detect characteristics (e.g., size, color, etc.) of the lesion 130 to automatically stop ablation when the lesion 130 has a predetermined characteristic (e.g., size, color, etc.). The camera 1620 can acquire 2D or 3D image data (e.g., 3D image data can include stereo still images and / or stereo video images). The imaging system 1600 can be the same as or different from the imaging system 800.

[0086] The working tube 1640 is disposed on the bendable shaft 220 and at least a proximal portion 1650 of the steerable tip 230. The working tube 1640 and a tip channel 1660 defined in a distal portion 1670 of the steerable tip 230 form the working channel 320. The working tube 1640 can extend to the handle 200 and / or the proximal end 202 of the instrument port 20. The working tube 1640 can also extend to the distal portion 1670 of the steerable tip 230 to replace some or all of the tip channel 1660.

[0087] FIG. 17 is an isolated perspective view of working tube 1640, according to one embodiment. Working tube 1640 includes a helical or spiral wire 1700 that flexibly structurally supports working tube body 1710. Working tube body 1710 can include another material with a polyether block amide (e.g., PEBAX®) and / or an ethylene propylene (FEP) liner and / or a polytetrafluoroethylene (PTFE) liner. FEP and / or PTFE can provide a relatively smooth surface for threading a medical device (e.g., an ablation catheter such as ablation catheter 100). In a relaxed state, working tube 1640 extends along and / or parallel to shaft axis 330. Working tube 1640 can bend and / or flex about one or more axes perpendicular to shaft axis 330, such as axis 1720 (e.g., parallel to the height of working tube 1640) and / or 1730 (e.g., parallel to the width of working tube 1640).

[0088] 18 is an isolated perspective view of the elongate shaft 210, according to one embodiment. The elongate shaft 210 comprises an elongate tube 1800 that extends along and / or parallel to the shaft axis 330 in a relaxed state. The elongate tube 1800 can be formed of a metal (e.g., stainless steel, titanium, and / or another metal), a plastic, and / or another material. A plurality of slits or openings 1810 are defined in the flexible tube 1800 to cause flexibility in the elongate tube 1800. The slits 1810 can be formed by machining, laser etching, or another technique. The slits 1810 can be configured to provide flexibility (e.g., passive flexibility) relative to a first plane 1820 defined by the shaft axis 330 and a width axis 1830 perpendicular to the shaft axis 330. The width or diameter of the elongate tube 1800 can be measured relative to the width axis 1830. The slits 1810 can also provide flexibility (e.g., passive flexibility) relative to a second plane 1840 defined by the shaft axis 330 and a height axis 1850 perpendicular to the shaft axis 330 and the width axis 1830. The height or diameter of the elongate tube 1800 can be measured relative to the height axis 1850. In an unflexed state (as illustrated in FIG. 18 ), the elongate tube 1800 extends along the shaft axis 330.

[0089] The slits 1810 form a pattern, such as an interrupted spiral pattern, that can provide flexibility in the planes 1820, 1840. In another embodiment, the slits 1810 are arranged as a plurality of fins extending circumferentially on the first and second sides 1802, 1804 of the elongated tube 1800, as illustrated in FIG. 19. A gap 1900 is disposed on a third side 1806 of the elongated tube 1800 between the slits 1810 on the first side 1802 and the slits 1810 on the second side 1804 of the elongated tube 1800. A second gap 1900 is disposed on a fourth side 1808 of the elongated tube 1800 between the slits 1810 on the first side 1802 and the slits 1810 on the second side 1804 of the elongated tube 1800. The gaps 1900 in the third and fourth sides 1806, 1808 are aligned with the width axis 1830. The gaps 1900 correspond to regions of the elongated tube 1800 that are solid (e.g., do not include slits 1810) that are less flexible (e.g., stiffer) compared to regions of the elongated tube 1800 that include slits 1810. Thus, the elongated tube 1800 in FIG. 19 is flexible with respect to the plane 1840, but not with respect to the plane 1820.

[0090] FIG. 20 is a cross-sectional view of the elongate shaft 210 through line 20-20 in FIG. 3 to illustrate the relative arrangement of certain components described herein. The cross-sectional view illustrates an example arrangement of the first and second wires 1401, 1402, the optional densely wound coil 1440, the fluid tube 2000, the working tube 1640, the first and second fiber optic cables 2011, 2012, and the imaging cable 2020. The fluid tube 2000 is fluidly coupled to the fluid port 340 to provide and / or receive fluid to / from the offset balloon 310. In one example, the fluid tube 2000 includes a hole disposed abutting the fluid port 340, and a distal end of the fluid tube 2000 is capped or sealed (e.g., to define a closed fluid path therebetween) to force fluid flow into or from the fluid port 340 to / from the offset balloon 310. The first and second fiber optic cables 2011, 2012 are electrically coupled to the first and second light emitters 1610. In one embodiment, the first and second light emitters 1610 comprise first and second fiber optic cables 2011, 2012. The imaging cable 2020 is electrically coupled to the camera 1620 for transmitting image data from the camera 1620 to an external controller (or other device), for transmitting commands from the external controller to the camera 1620 (e.g., to adjust the focus of the camera), and / or for providing power to the camera 1620. In an alternative embodiment, the camera 1620 can be battery powered and / or can communicate wirelessly with the external controller (or other device).

[0091] An optional medical device 2030 (e.g., an ablation catheter such as ablation catheter 100) is inserted into a working channel 320 inside a working tube 1640. The working tube 1640 is configured to have a radius 2040 (e.g., working tube radius) that is greater than a radius 2050 of the medical device 2030. A fluid channel 2060 is formed between an outer surface 2034 of the medical device 2030 and an inner surface 1642 of the working tube 1640. The fluid channel 2060 can be used to flush the outer surface 2034 of the medical device 2030 and / or the surgical site (e.g., with a liquid such as saline or semi-saline) during and / or prior to a medical procedure. Additionally or alternatively, the fluid channel 2060 can be fluidly coupled to a vacuum source to apply a vacuum to the outer surface 2034 of the medical device 2030 and / or the surgical site to remove debris and / or liquid (e.g., saline or semi-saline, blood, etc.) therefrom, etc.

[0092] 21 is a top view of an instrument port system 2100, according to one embodiment. The instrument port system 2100 includes an instrument port 20, a fluid source 2110, a microprocessor-based controller 2120, and a vacuum / liquid flush source 2130. The elongate shaft 210 of the instrument port 20 is broken away in this view to fit the instrument port 20 in the page. The handle 200 includes first and second levers 2101, 2102 that are mechanically coupled to first and second wires 1401, 1402, respectively. Pressing the first lever 2101 toward the proximal end 202 of the instrument port 20 creates tension in the first wire 1401, causing the bendable shaft 220 to bend in a first direction. Pressing the first lever 2101 toward the proximal end 202 of the instrument port 20 can also release tension in the second wire 1402. Pressing the second lever 2102 towards the proximal end 202 of the instrument port 20 creates tension in the second wire 1402, causing the bendable shaft 220 to bend in a second direction. Pressing the second lever 2102 towards the proximal end 202 of the instrument port 20 can also release tension in the first wire 1401. The first and second levers 2101, 2102 can be the same as the lever 240. The mechanical lock 2105 can lock the relative positions of the first and second levers 2101, 2102, which can adjust the tension in the respective wires 1401, 1402, thereby locking the orientation (e.g., angle 1300) of the bendable shaft 220 and steerable tip 210. The mechanical lock 2105 is positioned in a locked state (e.g., towards the distal end 204) in FIG. 21 . The mechanical lock 2105 may also be moved towards the proximal end 202 to transition to an unlocked state.

[0093] A handle fluid port 2140 is formed in the handle 200 (e.g., at a proximal end of the handle 200). The handle fluid port 2140 is fluidly coupled to a fluid source 2110 and to a fluid tube 2000, which is fluidly coupled to the fluid port 340 and to the offset balloon 310. The fluid source 2110 can releasably hold a volume of liquid or gas for inflating the offset balloon 310. The fluid source 2110 can comprise a syringe, tank, or other device capable of releasably holding a fluid. The fluid source 2110 can also receive a volume of liquid or gas from the offset balloon 310 to deflate the offset balloon 310.

[0094] An optical system port 2150 is also formed in the handle 200 (e.g., at a proximal end of the handle 200). One or more cables can be inserted through the optical system port 2150, which can extend to the imaging system 1600. For example, the fiber optic cables 2011, 2012 and / or the imaging cable 2020 can be inserted through the optical system port 2150. The proximal ends of the cables can be optically and / or electrically coupled to the controller 2120. The controller 2120 can include lights (e.g., LEDs, lasers, etc.) optically coupled to the fiber optic cables 2011, 2012. The controller 2120 can also include a power source for the camera 1620 and / or a microprocessor-based computer in signal communication with the camera 1620 to send commands to the camera 1620 and receive image data from the camera 1620. The controller 2120 can optionally be in electronic communication with a computer display 2170 capable of displaying images corresponding to image data acquired by the imaging system 1600 .

[0095] In some embodiments, the controller 2120 is configured to improve and / or analyze image data acquired by the imaging system 1600. In addition to the image itself, additional useful information may be recorded, such as the acquisition time of each still or video image. As an example of image data improvement, the controller 2120 may apply one or more well-known image analysis algorithms to filter noise and / or reduce glare from each still or video image series, aggregate sections of still or video images to enhance certain features, apply kernels such as smoothing, sharpening, edge detection, etc. to the still or video images, and / or decompose the images into various colors or wavelengths optimized for feature detection.

[0096] The controller 2120 can be configured to automatically (e.g., in real-time) detect certain anatomical features that may be relevant to the planned medical procedure. An optimal combination of illumination from the light emitter, acquisition using the camera, and / or processing in the controller 2120 can be selected to enhance detection of the relevant features. In an epicardial ablation procedure, the controller 2120 can be configured to automatically (e.g., in real-time) detect the cardiac tissue 110, the pericardium 120, the coronary arteries, the fat pads, and / or the phrenic nerve 140. The controller 2120 can automatically detect the anatomical features using artificial intelligence, image recognition, machine learning inference, and / or other methods. Where corresponding, such detected features can be digitally identified on the display system as superimposed on still or moving images captured from the camera or acquired in real time. Additionally or alternatively, the controller 2120 can be configured to automatically detect and / or track lesions created by any ablation technique (e.g., RF, cryoablation, needle ablation, laser ablation, and / or electroporation) in real time during epicardial ablation. In one embodiment, the controller 2120 can be configured to automatically detect the size, color, and / or other characteristics or attributes of the lesion 130 in real time during epicardial ablation. The controller 2120 can be configured to be in electrical communication with the medical device 2030 (e.g., the ablation catheter) and to stop the epicardial ablation in real time when the lesion 130 reaches a predetermined size, color, and / or characteristics or attributes, such as by using artificial intelligence, image recognition, and / or other methods.

[0097] The controller 2120 can include and / or be programmed to include one or more subsystems, controllers, and / or features as illustrated in Figure 27. For example, the controller 2120 can include and / or be programmed to include an illumination subsystem 2701, an acquisition subsystem 2702, a filtering subsystem 2703, an annotation subsystem 2704, a feature detection subsystem 2705, a display subsystem 2706, a storage and retrieval subsystem 2707, a lesion estimator subsystem 2708, a scar tissue tracker subsystem 2709, a fat pad tracker subsystem 2710, a coronary vessel tracker subsystem 2711, an ablation control subsystem 2712, and / or a user interface and control subsystem 2713.

[0098] The controller 2120 can control the lights of the light emitter 1610 using the illumination subsystem 2701, or the controller 2120 can use the illumination subsystem 2701 to generate light (e.g., a light source) that can be transmitted to the light emitter 1610 via an optical fiber. In addition, the controller can control the camera 1620 and receive image data using the image acquisition subsystem 2702. The received image data can be passed through a filtering subsystem 2703, an annotation subsystem 2704, a feature detection subsystem 2705, and a display subsystem 2706. For example, the filtering subsystem 2703 can filter noise and / or reduce glare from the image data. The annotation subsystem 2704 can be used to automatically annotate the image data to indicate any anatomical features that are automatically detected. The annotation subsystem 2704 can also automatically add date, time, patient name or ID, and / or other information to the image data. The annotation subsystem 2704 can also manually add information based on user input from the user interface and control subsystem 2713.

[0099] The feature detection subsystem 2705 can include artificial intelligence, image recognition, machine learning inference, and / or other methods for automatically detecting anatomical features and / or other information (e.g., in real-time). The image data can be automatically annotated to indicate the detected features using the annotation subsystem 2704. The feature detection subsystem 2705 can detect the anatomical features and / or other information based on the size, color, shape, and / or other characteristics of the anatomical features. In some embodiments, the feature detection subsystem 2705 can be programmed with a target area for a medical procedure that can improve the detection speed (thus, the feature detection subsystem 2705 does not attempt to detect anatomical features that are not near a target area for a medical procedure).

[0100] The display subsystem 2706 may be used to generate an image after the received image data has passed through the filtering subsystem 2703, the annotation subsystem 2704, and / or the feature detection subsystem 2705. The storage and retrieval subsystem 2707 may be used to store and / or retrieve the image data, such as storing the image data in and / or retrieving the data from memory accessible to the controller 2120 (e.g., internal and / or external memory, which may include network-accessible memory).

[0101] The lesion estimator subsystem 2708 can estimate or determine one or more characteristics of the lesion 130 during the medical procedure. The characteristics of the lesion can include a size, a color, and / or other characteristics or attributes of the lesion 130. The lesion estimator subsystem 2708 can also be configured to automatically generate a stop signal that causes the ablation catheter to stop epicardial ablation when the lesion 130 reaches a predetermined size, color, and / or characteristic or attributes, such as by using artificial intelligence, image recognition, and / or other methods. For example, the lesion estimator 2708 can determine that the lesion 2830 has a first size and / or first optical attributes at a first time and that the lesion 2830 has a second size and / or second optical attributes at a second time, as illustrated in FIGS. 28A and 28B, respectively. In another embodiment, the lesion estimator 2708 can determine a rate of change of the size, optical attributes, and / or other characteristics, such as a rate of change between a first time and a second time in FIGS. 28A and 28B, respectively.

[0102] The scar tissue tracker subsystem 2709 can localize and / or track (e.g., in real time) existing scar tissue in the myocardium, such as due to a previous myocardial infection. The output of the scar tissue tracker subsystem 2709 can be used by the ablation control subsystem 2712 to automatically control the ablation, such as by adjusting the ablation energy. In addition, the output of the scar tissue tracker subsystem 2709 can be sent to the annotation subsystem 2703 to annotate the detected scar tissue in the displayed image. These annotations are useful for an operator (e.g., a physician) to guide an ablation catheter or other medical instrument to healthy tissue and away from the detected scar tissue. In addition, the operator can use the scar tissue annotations to manually adjust the ablation energy. The scar tissue annotations can include a graphical overlay (e.g., a colored line such as a red line) and / or a transparent colored filter. The scar tissue tracker subsystem 2709 can use artificial intelligence, image recognition, and / or other methods.

[0103] The fat body tracker subsystem 2710 can localize and / or track (e.g., in real time) epicardial fat bodies that may be near the target site. The output of the fat body tracker subsystem 2710 can be used by the ablation control subsystem 2712 to automatically control the ablation, such as by adjusting the ablation energy. For example, fat bodies may be insulators and require additional energy to ablate. In addition, the output of the fat body tracker subsystem 2710 can be sent to the annotation subsystem 2703 to annotate the detected fat bodies in the displayed image. These annotations are useful for an operator (e.g., a physician) to optionally move the ablation catheter or other medical instrument away from the detected fat bodies. In addition, the operator can use the fat body annotations to manually adjust the ablation energy. For example, performing ablation on a fat body generally requires more ablation energy than performing ablation on other tissues. The fat body annotations can also be used to improve ablation efficiency. The fat body annotations can include a graphical overlay (e.g., a colored line such as a red line) and / or a transparent colored filter. The fat body tracker subsystem 2710 can use artificial intelligence, image recognition, and / or other methods. For example, the fat body tracker subsystem 2710 can recognize fat bodies based on color (e.g., yellow) and / or shape.

[0104] The coronary vessel tracker subsystem 2711 can localize and / or track (e.g., in real-time) coronary vessels that may be near a target site. The output of the coronary vessel tracker subsystem 2711 can be used by the ablation control subsystem 2712 to automatically control ablation, such as by automatically stopping ablation close to a coronary vessel. Ablation of a coronary vessel is generally undesirable and may injure a patient and / or cause undesirable complications during a medical procedure. In addition, the output of the coronary vessel tracker subsystem 2711 can be sent to the annotation subsystem 2703 to annotate detected fat bodies in the displayed image. These annotations can be useful for an operator (e.g., a physician) to move an ablation catheter or other medical instrument away from any coronary vessels to avoid cauterizing the coronary vessels. The coronary vessel annotations can include graphical overlays (e.g., colored lines such as red lines) and / or transparent color filters. The coronary vessel tracker subsystem 2711 can use artificial intelligence, image recognition, and / or other methods. For example, the coronary vessel tracker subsystem 2711 may recognize coronary vessels based on color (eg, blue or red) and / or shape.

[0105] The ablation control subsystem 2712 can control the strength, frequency, and / or other settings of the ablation catheter, which may be manually or automatically controlled. The ablation control subsystem 2712 can start and stop ablation in response to control signals. For example, the ablation control subsystem 2712 can start or stop ablation in response to user input via the user interface and control subsystem 2713. Additionally or alternatively, the ablation catheter can include a button that, when pressed, generates a first signal that causes the ablation control subsystem 2712 to start ablation. When the button is released, a second signal can cause the ablation control subsystem 2712 to stop ablation. The ablation control subsystem 2712 can also stop ablation in response to a stop signal sent from the lesion estimator subsystem 2708.

[0106] Returning to FIG. 21, a flushing and / or vacuum port 2160 is formed in an adapter 2180 attached to the proximal end of the handle 200 . Alternatively, a flushing and / or vacuum port 2160 can be formed at the proximal end of the handle 200 (e.g., similar to ports 2140, 2150). The flushing and / or vacuum port 2160 is fluidly coupled to the fluid channel 2060 and to a vacuum / liquid flush source 2130 for applying a vacuum and / or introducing liquid into the fluid channel 2060. The adapter 2180 preferably comprises a Tuohy-Borst adapter which can include a working port 2200 through which a medical device 2030 (e.g., an ablation catheter) can be inserted into the working channel 320, as illustrated in FIG. 22 . If desired, a valve 2210 can be disposed between the flushing and / or vacuum port 2160 and the working port 2200 to direct liquid and / or vacuum into the working channel 320. The valve 2210 can be actuated by rotating the adapter 2180.

[0107] Figure 23 is a cross-sectional view of the proximal portion of the handle 200 through line 23-23 of Figure 22. The cross-section does not include the medical instrument 2030. This view illustrates an example of how the actuation tube 1640, the fluid tube 2000, and the imaging cable 2300 are coupled to the respective ports 2200, 2140, 2150 of the handle 200. The imaging cable 2300 can include fiber optic cables 2011, 2012, and / or the imaging cable 2020.

[0108] 24 is a top view of a portion of the handle 200 with the housing removed to illustrate the structure and operation of the levers 2101, 2102, according to one embodiment. The levers 2101, 2102 are attached to a main shaft 2400 on which the first and second ends 2411, 2412 of the first and second wires 1401, 1402 are attached to form a tip control 2430. In the figure, the first lever 2101 is pushed toward the proximal end 202, which rotates the main shaft 2400 clockwise (e.g., in a first direction) and increases the tension in the first wire 1401 (e.g., by decreasing its effective length). Rotating the main shaft 2400 clockwise also decreases the tension in the second wire 1402 (e.g., by increasing its effective length) and moves the second lever 2102 toward the distal end 204.

[0109] Conversely, pushing the second lever 2102 towards the proximal end 202 rotates the main shaft 2400 counterclockwise (e.g., in a second direction) increasing the tension in the second wire 1402 (e.g., by decreasing its effective length). Rotating the main shaft 2400 counterclockwise also decreases the tension in the first wire 1401 (e.g., by increasing its effective length) and moves the first lever 2101 towards the distal end 204. As can be seen, the first and second levers 2101, 2102 are mechanically coupled via the main shaft 2400 and are out of phase. For example, when the first lever 1401 is pushed in one direction (e.g., toward the distal end 204), the second lever 1402 is pushed in the opposite direction (e.g., toward the proximal end 202), which causes a corresponding increase in tension in the first or second wire 1401, 1402 and a corresponding decrease in tension in the second or first wire 1402, 1401, respectively.

[0110] This view also illustrates an adjuster plate 2440 of the handle 200. The adjuster plate 2440 includes a threaded hole that engages with the external threads of the tension adjuster 1510. The adjuster plate 2440 is attached and / or fixed to the handle 200. The tension adjuster 1510 can be rotated in a first direction to move toward the proximal end 202 of the instrument port 20 (e.g., toward the main shaft 2400) and rotated in a second direction to move toward the distal end 204 of the instrument port 20. Because the tightly wound coil 1440 is attached to the mechanical ring 1200 and the tension adjuster 1510 (e.g., in the counterbore 1520), moving the tension adjuster 1510 in a first direction increases the tension in the corresponding wire 1401, 1402. Conversely, moving the tension adjuster 1510 in a second direction decreases the tension in the corresponding wire 1401, 1402.

[0111] FIG. 25 is an isolated perspective view of the tip control 2430 illustrated in FIG. The tip control 2430 includes levers 2101, 2102, a mechanical lock 2105, and a shaft 2400. Wires 1401, 1402 are not illustrated in FIG. 25. The mechanical lock 2105 is mechanically coupled to a shaft 2500 that is slidably coupled to a lock channel 2510 of a lock housing 2420. An outer surface 2525 of the lock housing 2520 is relatively higher on a locked side 2512 of the lock channel 2510 than on an unlocked side 2514 of the lock channel 2510, as measured relative to the shaft axis 2530. An edge 2405 of the shaft 2500 mechanically engages the outer surface 2525 of the lock housing 2420. When the shaft 2500 slides into the locked side 2512 of the locking channel 2510, the raised outer surface 2525 creates an upward force on the shaft 2500, locking the rotation of the spindle 2400 (e.g., by engaging the flared shaft brake 2540). The spindle 2400 is partially transparent in FIG. 25 to further illustrate the tip control 2430. In other embodiments, the mechanical lock 2105 can include a push button, lever, dial, or other mechanism.

[0112] FIG. 26 is a cross-sectional view of a portion of the handle 200 through line 26-26 of FIG. 25 to further illustrate the mechanical lock 2105. The mechanical lock 2105 is in an unlocked state in FIG. 26. In the unlocked state, one or more top edges 2602 of the main shaft 2400 are disengaged from one or more inner edges 2604 of the handle 200, allowing the main shaft 2400 to rotate freely. In the locked state, the elevated outer surface 2525 moves the shaft 2500 upward (e.g., away from the main shaft 2400 along the shaft axis 2530). The shaft 2500 is mechanically coupled (e.g., by a thread) to and / or includes a flared shaft brake 2540, which moves up and down with the shaft 2500 (e.g., relative to the shaft axis 2530). When the shaft 2500 and the flare shaft brake 2540 move upwardly, transitioning the mechanical lock 2105 to the locked state, the flare shaft brake 2510 mechanically engages the main shaft 2500, forcing the main shaft 2500 upward, which mechanically engages the top edge 2602 of the main shaft 2400 with the inner edge 2604 of the handle housing 2610. The mechanical engagement of the top edge 2602 and the inner edge 2604 increases the friction between them, mechanically locking the rotation of the main shaft 2400. Locking the rotation of the main shaft 2400 sets or locks the tension (or lack of tension) in the wires 1401, 1402, which sets or locks the bend of the bendable shaft 220 and the customizable angle 1300 of the steerable tip 230 relative to the elongate shaft 210.

[0113] The present invention should not be construed as being limited to the specific embodiments described above. Various modifications, equivalent processes, as well as numerous structures to which the present invention may be applicable will be readily apparent to those of ordinary skill in the art to which the present invention is directed upon review of this disclosure. The above-described embodiments may be implemented in numerous ways. One or more aspects and embodiments involving the execution of a process or method may utilize program instructions executable by a device (e.g., a computer, processor, or other device) to perform the process or method or to control its performance.

[0114] In this regard, the various inventive concepts may be embodied as a non-transitory computer-readable storage medium (or multiple non-transitory computer-readable storage media) encoded with one or more programs (e.g., any suitable type of computer memory, including a transient or non-transitory digital storage unit, a circuit configuration of a field programmable gate array or other semiconductor device, or other tangible computer storage medium) that, when executed on one or more computers or other processors, performs a method that implements one or more of the various embodiments described above. If implemented in software (e.g., as an app), the software code may be executed on any suitable processor or group of processors, whether provided on a single computer or distributed across multiple computers.

[0115] Further, it should be understood that the computer may be embodied in any of a number of forms, such as, by way of non-limiting examples, a rack-mounted computer, a desktop computer, a laptop computer, or a tablet computer. Additionally, the computer may be incorporated into devices not generally considered to be computers, but having suitable processing capabilities, including personal digital assistants (PDAs), smartphones, or any other suitable portable or fixed electronic device.

[0116] The computer may also have one or more communication devices that may be used to interconnect the computer to one or more other devices and / or systems, such as one or more networks of any suitable form, including, for example, an enterprise network, and a local area network or a wide area network, such as an Intelligent Network (IN) or the Internet. Such networks may be based on any suitable technology and may operate according to any suitable protocol, and may include wireless networks or wired networks.

[0117] A computer may also have one or more input devices and / or one or more output devices. These devices may be used, among other things, to present a user interface. Examples of output devices that may be used to provide a user interface include a printer or display screen for visual presentation of output, and a speaker or other sound generating device for audible presentation of output. Examples of input devices that may be used for a user interface include keyboards and pointing devices such as mice, touchpads, and digitizing tablets. As another example, a computer may receive input information via speech recognition or in other audible formats.

[0118] One or more non-transitory computer-readable media may be transportable such that one or more programs stored thereon may be loaded into one or more different computers or other processors to implement a variety of one or more of the aspects described above. In some embodiments, the computer-readable medium may be a non-transitory medium.

[0119] The terms "program," "app," and "software" are used herein in a generic sense to refer to any type of computer code or set of computer-executable instructions that may be used to program a computer or other processor to implement various aspects as described above. Additionally, according to one aspect, it should be understood that one or more computer programs that, when executed, perform the methods of the present application need not reside on a single computer or processor, but may be distributed in a modular manner among several different computers or processors to implement various aspects of the present application.

[0120] Computer-executable instructions may be in many forms, such as program modules, executed by one or more computers or other devices. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. The functionality of the program modules may be combined or distributed as desired in various embodiments.

[0121] Also, data structures may be stored in a computer-readable medium in any suitable form. For ease of illustration, the data structures may be shown as having fields that are related through their locations in the data structure. Such relationships may in turn be achieved by allocating storage for the fields with locations in the computer-readable medium that convey the relationships between the fields. However, any suitable mechanism may be used to establish relationships between information in fields of a data structure, including through the use of pointers, tags, or other mechanisms that establish relationships between data elements.

[0122] Thus, the present disclosure and claims include new and novel improvements over existing methods and techniques not previously known or implemented to achieve the useful results set forth above. Users of the method and system will tangibly benefit from the functionality enabled by the specific modifications described herein that effect the system and its output to its users. Using the technical components recited herein, it is anticipated that significantly improved operation can be achieved in the practice of the claimed invention.

[0123] Also, as described, some aspects may be embodied as one or more methods. The acts performed as part of a method may be ordered in any suitable manner. Thus, although shown as sequential acts in an exemplary embodiment, embodiments may be constructed in which acts are performed in an order different from that illustrated, which may include performing some acts simultaneously.

Claims

1. An instrument port, comprising: an elongate shaft having a proximal end and a distal end and extending along a shaft axis, the elongate shaft having a fluid port defined in an outer surface at the distal end of the elongate shaft; a bendable shaft having a proximal end attached to the distal end of the elongate shaft along a shaft axis, the bendable shaft configured to bend only in a pivot plane defined by the shaft axis and an orthogonal axis perpendicular to the shaft axis; a steerable tip attached to a distal end of the bendable shaft, the steerable tip comprising an imaging system; a camera disposed at a distal end of the steerable tip; a light emitter disposed at the distal end of the steerable tip; an offset balloon attached to the outer surface of the elongate shaft, the offset balloon having an interior volume in fluid communication with the fluid port, the offset balloon having an inflated state and a deflated state, the offset balloon configured to be radially asymmetric with respect to the shaft axis in the inflated state; a handle attached to the proximal end of the elongate shaft, the handle including a lever in mechanical communication with the bendable shaft to adjust a customizable angle of the steerable tip, the steerable tip extending along a tip axis, the customizable angle being measured between the shaft axis and the tip axis; a fluid tube disposed on the elongate shaft, the fluid tube being fluidly coupled to the fluid port; and a working tube disposed on the elongate shaft, the working tube defining a working channel; an ablation catheter disposed in the working channel, the ablation catheter configured to create a lesion at a surgical site; a microprocessor-based controller in electrical communication with the imaging system, the controller comprising: acquiring image data of the surgical site from the camera; automatically detecting the lesion formed at the surgical site in real time; and a controller configured to automatically stop ablation by the ablation catheter if the lesion has a predetermined characteristic.

2. The instrument port of claim 1 , wherein the predetermined characteristic comprises a predetermined size.

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

4. the customizable angle is in the range of 0° to 90°; When the bendable shaft is in an unbent state, the bendable shaft extends along the shaft axis; The instrument port of claim 1 , wherein the customizable angle is 0°.

5. an inner diameter of the working channel that is greater than an outer diameter of the ablation catheter; The instrument port of claim 1 , wherein a fluid channel is defined between the inner diameter of the working channel and the outer diameter of the ablation catheter.

6. The instrument port of claim 5 , wherein the fluid channel is fluidly coupled to a source of flush liquid and / or a source of vacuum.

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

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

9. The instrument port of claim 8 , wherein the flexible cylinder comprises a wire reinforced liner.

10. The instrument port of claim 9, wherein the wire reinforced liner comprises a tubular body comprising fluorinated ethylene propylene and a helical wire.

11. The instrument port of claim 10, wherein an inner surface of the flexible cylinder comprises only the body of the tube to form a smooth surface for receiving a medical instrument.

12. the shaft comprising a metal tube having an inner surface and an outer surface; The instrument port of claim 1 , wherein the shaft has a pattern of slits defined therein for increasing 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 slit pattern is laser cut.

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

16. the pattern includes a plurality of fins extending circumferentially on first and second sides of the metal tube; 13. The instrument port of claim 12, wherein the fin on the first side and the fin 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 perpendicular to the shaft axis.

Images