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

Abstract

A method for controlling an epicardial ablation procedure comprises (a) inserting an instrument port comprising an ablation tool, an optical camera and an optical light emitter into an epicardial cavity adjacent to a target area; (b) providing optical light into the epicardial cavity through the optical light emitter to illuminate the target area; (c) obtaining a first image of the target area using the optical camera; (d) steering the distal end 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) obtaining a second image of the target area using the optical camera; and (g) processing at least one of the first image and the second image in an image processor to determine characteristics of the lesion.

Description

[0001] Statement Regarding Federally Funded Research

[0002] This invention was made with government support under Grant No. R41HL147694 awarded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. The government has certain rights in this invention.

[0003] CROSS-REFERENCE TO RELATED APPLICATIONS

[0004] This application claims priority to U.S. Provisional Patent Application No. 62 / 936,736, filed on November 18, 2019, and entitled “Instrument Port for Epicardial Ablation,” and U.S. Provisional Patent Application No. 63 / 076,075, filed on September 9, 2020, and entitled “Instrument Port for Epicardial Ablation with Unidirectional Offset Balloon,” the contents of which are incorporated herein by reference. Technical Field

[0005] The present application relates generally to medical devices for treating cardiac conditions such as ventricular tachycardia. Background Art

[0006] Ventricular tachycardia, a life-threatening heart rhythm disorder, is currently treated using endocardial ablation and / or epicardial ablation. To perform endocardial ablation, a physician inserts an ablation catheter into the patient's heart through a vein or artery to ablate the area of ​​the heart that is causing the arrhythmia. In contrast, epicardial ablation is performed from the outside of the heart.

[0007] During epicardial ablation procedures, physicians can use fluoroscopy and 3D electroanatomical voltage mapping to visualize the ablation catheter and cardiac tissue. However, these visualization methods have limitations. For example, it is difficult or impossible to identify coronary vessels, scar tissue, fat pads, and phrenic nerves using these visualization methods, which can lead to undesirable complications.

[0008] In addition, if Figure 1As shown, an existing ablation catheter is inserted tangentially through the pericardium so that the ablation catheter lies flat against the surface of the heart. In this orientation, the ablation catheter 100 emits energy into the heart tissue 110 to create a lesion 130 in the heart tissue 110 and the pericardium 120. Ablation of 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 result in unstable heart tissue contact.

[0009] It would be desirable to overcome these and / or other deficiencies in the art. Summary of the invention

[0010] The exemplary embodiments described herein have innovative features, wherein no single feature is indispensable or solely responsible for its required attributes. The following description and accompanying drawings set forth in detail certain illustrative implementations of the present disclosure, which indicate several exemplary ways in which the different 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 protection of the claims, some advantageous features will now be summarized. Other objects, advantages, and novel features of the present disclosure will be set forth in the following detailed description of the present disclosure when considered in conjunction with the accompanying drawings, which are intended to illustrate, but not to limit, the present invention.

[0011] Aspects of the present invention relate to an instrument port comprising: an elongated shaft having a proximal end and a distal end and extending along an axis of the shaft, the elongated shaft having a fluid port defined in an outer surface at the distal end of the elongated shaft; a bendable shaft having a proximal end, the proximal end of the bendable shaft being attached to the distal end of the elongated shaft along the axis of the shaft, the bendable shaft being configured to bend only within a pivot plane defined by the axis of the shaft and a pivot axis orthogonal to the axis of the shaft; a steerable tip attached to the distal end of the bendable shaft, the steerable tip comprising an imaging system comprising: 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 a bias balloon attached to the outer surface of the slender shaft, the bias balloon having an internal volume connected to the fluid of the fluid port, the bias balloon having an expanded state and a contracted state; a handle attached to the proximal end of the slender shaft, the handle including a rod mechanically connected to the flexible shaft to adjust a customizable angle of the steerable end, the customizable angle measured between the axis of the shaft and the axis of the end; a fluid tube disposed in the slender shaft, the fluid of the fluid tube being coupled to the fluid port; a working tube disposed in the slender shaft, the working tube forming a working channel; an ablation catheter disposed in the working channel, the ablation catheter being configured to form a lesion at a surgical site; and a microprocessor-based controller electrically connected to the imaging system, the controller being 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 when the lesion has predetermined characteristics.

[0012] In one or more embodiments, the predetermined feature comprises a predetermined size. In one or more embodiments, the predetermined characteristic comprises 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 the axis of the shaft, and the customizable angle is 0°.

[0013] In one or more embodiments, the biasing balloon has an expanded state and a contracted state, and in the expanded state, the biasing balloon has a height measured relative to a vertical axis orthogonal to the axis of the shaft that is greater than a bend distance measured from the distal end of the steerable tip to an outer surface on the distal end of the elongated shaft when the customizable angle is 90°. In one or more embodiments, in the expanded state, the biasing balloon expands radially asymmetrically. 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, the second portion of the wall has a relatively thick wall thickness compared to the first portion of the wall, and the first portion of the wall is on a first side of the elongated shaft.

[0014] In one or more embodiments, the inner diameter of the working channel is greater than the 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 fluidically coupled to an irrigation fluid source and / or a vacuum source. In one or more embodiments, the ablation catheter comprises an RF ablation catheter.

[0015] 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 and a spiral cable, the tube body comprising fluorinated ethylene propylene. In one or more embodiments, the inner surface of the flexible cylinder comprises only the tube body to form a smooth surface for receiving the medical device. 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 the flexibility of the shaft.

[0016] 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 spiral. In one or more embodiments, the pattern comprises a plurality of fins extending circumferentially on a first side and a second side of the metal tube, the fins on the first side and the fins on the second side being separated by a first gap and a second gap, the first gap and the second gap extending along a plane defined by an axis of the shaft and an axis orthogonal to the axis of the shaft.

[0017] Another aspect of the present invention relates to a method for controlling an epicardial ablation procedure, the method comprising: inserting an instrument port comprising an ablation tool, an optical camera, and an optical light emitter into an epicardial cavity adjacent to a target area; providing optical light into the epicardial cavity through the optical light emitter to illuminate the target area; obtaining a first image of the target area using the optical camera; turning the distal end 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; obtaining a second image of the target area using the optical camera; and processing at least one of the first image and the second image in an image processor to determine characteristics of the lesion.

[0018] In one or more embodiments, the method further includes obtaining a third image of the target area after the step of obtaining the second image, and using at least two of the first image, the second image, and the third image to determine a characteristic of the lesion. In one or more embodiments, the characteristic includes the size of the lesion. In one or more embodiments, the characteristic includes the growth rate of the lesion. In one or more embodiments, the method further includes controlling the application of ablation to the target area based on determining the desired result that has been achieved in the lesion.

[0019] In one or more embodiments, the characteristics of the lesion are determined in real time.In one or more embodiments, the method further comprises processing at least one of the first image and the second image in an image processor to automatically detect anatomical features in the target area.

[0020] Another aspect of the present invention relates to an instrument port, which includes: a slender shaft having a proximal end and a distal end and extending along the axis of the shaft, the slender shaft having a fluid port, the fluid port being defined in the outer surface at the distal end of the slender shaft; a steerable end attached to the distal end of the shaft; a bias balloon attached to the outer surface of the slender shaft, the bias balloon having an internal volume connected to the fluid of the fluid port, the bias balloon having an expanded state and a contracted state, wherein in the expanded state, the bias balloon expands radially asymmetrically relative to the axis of the shaft; and a working tube disposed in the slender shaft, the working tube forming a working channel to receive a medical device.

[0021] In one or more embodiments, the instrument port further comprises a fluid tube disposed in the elongated shaft, the fluid tube being fluidly coupled to the fluid port. In one or more embodiments, a proximal side of the biasing balloon is attached to an outer surface of the elongated shaft on a proximal side of the fluid port, and a distal side of the biasing balloon is attached to an outer surface of the elongated shaft on a distal side of the fluid port.

[0022] In one or more embodiments, the biasing balloon is formed of 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, the second portion of the wall has a relatively thick wall thickness compared to the first portion of the wall, and the first portion of the wall is on a first side of the elongated shaft, whereby in an expanded state, the biasing balloon expands radially asymmetrically. In one or more embodiments, the proximal and distal sides of the biasing balloon are attached to the outer surface by tie-downs, bonding, and / or heat sealing.

[0023] In one or more embodiments, the biasing balloon is attached to the outer surface only on a first side of the elongated shaft, and a biasing balloon hole in the biasing balloon is fluidly coupled to the fluid port. In one or more embodiments, the biasing balloon is disposed between a balloon restraining tube segment and the outer surface on a second side of the elongated shaft, and when the biasing balloon is in the expanded state, the balloon restraining tube segment constrains the expanded volume of the biasing balloon to only on the first side of the elongated shaft. In one or more embodiments, the balloon restraining tube segment includes a horizontal cylindrical section. In one or more embodiments, the biasing balloon expands radially asymmetrically relative to an expansion plane, and the axis of the shaft is located in the expansion plane.

[0024] In one or more embodiments, the bias airbag has a partially expanded state, wherein the partially expanded volume of the bias airbag is in the range of about 10% to about 90% of the fully expanded volume of the bias airbag, and when the bias airbag is in the expanded state, the bias airbag has a fully expanded volume.

[0025] Another aspect of the present invention relates to an instrument port, which includes: a slender shaft having a proximal end and a distal end and extending along the axis of the shaft, the slender shaft having a fluid port, the fluid port being defined in the outer surface at the distal end of the slender shaft; a bendable shaft attached to the distal end of the slender shaft; a steerable end attached to the distal end of the shaft, the steerable end extending along the axis of the end; a bias balloon attached to the outer surface of the slender shaft, the bias balloon having an internal volume fluidically connected to the fluid port, the bias balloon having an expanded state and a contracted state, wherein in the expanded state, the bias balloon expands only on a first side of the slender shaft; a fluid tube disposed in the slender shaft, the fluid tube being fluidically coupled to the fluid port; and a working tube disposed in the slender shaft, the working tube forming a working channel to receive a medical device.

[0026] In one or more embodiments, the instrument port further includes a handle attached to the proximal end of the elongated shaft, the handle including a handle fluid port, the handle fluid port fluidically coupled to the fluid tube to introduce or receive fluid. In one or more embodiments, the distal end of the fluid tube is capped to define a closed fluid path between the fluid port and the fluid port. In one or more embodiments, the fluid tube includes a fluid tube hole, and the fluid tube is attached to the inner surface at the distal end of the elongated shaft to fluidically couple the fluid tube hole to the fluid port.

[0027] In one or more embodiments, the proximal side of the biasing balloon is attached to the outer surface of the elongated shaft on the proximal side of the fluid port, and the distal side of the biasing balloon is attached to the outer surface of the elongated shaft on the distal side of the fluid port. In one or more embodiments, the biasing balloon is formed by 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, the second portion of the wall has a relatively thick wall thickness compared to the first portion of the wall, and the first portion of the wall is on a first side of the elongated shaft, whereby the biasing balloon expands radially asymmetrically relative to the axis of the shaft in an expanded state.

[0028] In one or more embodiments, the proximal and distal sides of the biasing balloon are attached to the outer surface by tie-downs, bonding, and / or heat sealing. In one or more embodiments, the proximal and distal sides of the biasing balloon are attached to the outer surface on the first side of the elongated shaft, and the biasing balloon hole in the biasing balloon is fluidly coupled to the fluid port.

[0029] In one or more embodiments, the biasing balloon is disposed between the balloon restraining tube section and the outer surface on the second side of the elongated shaft, and when the biasing balloon is in an expanded state, the balloon restraining tube section constrains the expanded volume of the biasing balloon to only on the first side of the elongated shaft. In one or more embodiments, the balloon restraining tube section includes a horizontal cylindrical section. In one or more embodiments, the biasing balloon expands radially asymmetrically relative to an expansion plane, and the axis of the shaft is located in the expansion plane.

[0030] In one or more embodiments, the biasing airbag has a partially expanded state, wherein the partially expanded volume of the biasing airbag is in the range of about 10% to about 90% of the fully expanded volume of the biasing airbag, and when the biasing airbag is in the expanded state, the biasing airbag has a fully expanded volume.

[0031] Yet another aspect of the present invention relates to an instrument port, which includes: an elongated shaft having a proximal end and a distal end and extending along the axis of the shaft, the elongated shaft having a fluid port defined in an outer surface at the distal end of the elongated shaft; a bendable shaft attached to the distal end of the elongated shaft; a steerable tip attached to the distal end of the shaft and extending along the axis of the tip; a bias balloon attached to the outer surface of the elongated shaft, the bias balloon having an internal volume fluidically connected to the fluid port, the bias balloon having an expanded state and a contracted state; a fluid tube disposed in the elongated shaft, the fluid tube being fluidically coupled to the fluid port; and a working tube disposed in the elongated shaft, the working tube forming a working channel to receive a medical device.

[0032] In one or more embodiments, the instrument port further includes a handle attached to the proximal end of the elongated shaft, the handle including a handle fluid port, the handle fluid port fluidically coupled to the fluid tube to introduce or receive fluid. In one or more embodiments, the distal end of the fluid tube is capped to define a closed fluid path between the fluid port and the fluid port. In one or more embodiments, the fluid tube includes a fluid tube hole, and the fluid tube is attached to the inner surface at the distal end of the elongated shaft to fluidically couple the fluid tube hole to the fluid port.

[0033] In one or more embodiments, the proximal side of the biasing balloon is attached to the outer surface of the elongated shaft on the proximal side of the fluid port, and the distal side of the biasing balloon is attached to the outer surface of the elongated shaft on the distal side of the fluid port. In one or more embodiments, in the expanded state, the biasing balloon expands radially symmetrically with respect to the axis of the shaft.

[0034] In one or more embodiments, the bias airbag has a partially expanded state, wherein the partially expanded volume of the bias airbag is in the range of about 10% to about 90% of the fully expanded volume of the bias airbag, and when the bias airbag is in the expanded state, the bias airbag has a fully expanded volume.

[0035] Another aspect of the present invention relates to an instrument port, which includes: a slender shaft having a proximal end and a distal end and extending along the axis of the shaft; a flexible shaft attached to the distal end of the slender shaft, the flexible shaft being configured to bend only within a pivot plane defined by the axis of the shaft and a pivot axis orthogonal to the axis of the shaft; a steerable tip attached to the distal end of the shaft, the steerable tip extending along the axis of the tip; a handle attached to the proximal end of the slender shaft, the handle including a rod mechanically connected to the flexible shaft to adjust a customizable angle of the steerable tip, the customizable angle being measured between the axis of the shaft and the axis of the tip; and a working tube disposed in the slender shaft and the flexible shaft, the working tube forming a working channel to receive a medical device.

[0036] In one or more embodiments, in an unbent state: the flexible shaft extends along the axis of the shaft, and the flexible shaft comprises: a plurality of mechanical rings concentrically arranged along the axis of the shaft, the plurality of mechanical rings comprising adjacent mechanical ring pairs, and each adjacent mechanical ring pair is mechanically coupled by a pair of mechanical coupling devices, wherein a corresponding third axis passes through each pair of mechanical coupling devices, and the corresponding third axis is orthogonal to the shaft and the pivot axis. In one or more embodiments, the pair of mechanical coupling devices mechanically constrains the bending direction of the flexible shaft to the pivot plane.

[0037] In one or more embodiments, the rod is mechanically coupled to a cable extending to the distal end of the flexible shaft, the cable being attached to an inner surface of the flexible shaft through which the pivot axis passes. In one or more embodiments, the rod is mechanically coupled to a wire rope extending to the distal end of the flexible shaft, the wire rope comprising the cable.

[0038] In one or more embodiments, the rod is mechanically coupled to a shaft disposed in the handle. In one or more embodiments, the cable is attached to the shaft, and pulling the rod causes the shaft to rotate to pull the cable toward the proximal end of the elongated shaft, thereby causing the flexible shaft to bend in a first direction.

[0039] In one or more embodiments, the handle includes a mechanical lock that applies a force against the rotating shaft to set the customizable angle of the flexible shaft.

[0040] 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 axis of the shaft, and the customizable angle is 0°. In one or more embodiments, the instrument port further comprises a biasing balloon attached to the distal end of the elongated shaft.

[0041] In one or more embodiments, the elongated shaft is flexible, the elongated shaft has a flexed state and an unflexed state, and in the unflexed state, the elongated shaft extends along the axis of the shaft. In one or more embodiments, the elongated shaft remains in the unflexed state when the customizable angle is adjusted. In one or more embodiments, the elongated shaft remains in the flexed state when the customizable angle is adjusted, and the elongated shaft has the same flexed position while adjusting the customizable angle.

[0042] Another aspect of the present invention relates to an instrument port, the instrument port comprising: an elongated shaft having a proximal end and a distal end and extending along an axis of the shaft; a flexible shaft attached to the distal end of the elongated shaft, the flexible shaft being configured to bend only within a pivot plane defined by the axis of the shaft and a pivot axis orthogonal to the axis of the shaft; a steerable tip attached to the distal end of the shaft, the steerable tip extending along the axis of the tip; a handle attached to the proximal end of the elongated shaft, the handle comprising: a first rod mechanically coupled to a first A cable, the first cable having an end attached to a first side of the flexible shaft, the first rod being configured to pull the first cable to deflect the flexible shaft in a first direction within the pivot plane; and a second rod being mechanically coupled to the second cable, the second cable having an end attached to a second side of the flexible shaft, the second rod being configured to pull the second cable to deflect the flexible shaft in a second direction opposite to the first direction, the second direction being within the pivot plane; and a working tube disposed in the elongated shaft and the flexible shaft, the working tube forming a working channel to receive a medical device.

[0043] In one or more embodiments, in an unbent state: the flexible shaft extends along the axis of the shaft, and the flexible shaft comprises: a plurality of mechanical rings concentrically arranged along the axis of the shaft, the plurality of mechanical rings comprising adjacent mechanical ring pairs, and each adjacent mechanical ring pair is mechanically coupled by a pair of mechanical coupling devices, wherein a corresponding third axis passes through each pair of mechanical coupling devices, and the corresponding third axis is orthogonal to the shaft and the pivot axis. In one or more embodiments, the pair of mechanical coupling devices mechanically constrains the bending direction of the flexible shaft to the pivot plane.

[0044] In one or more embodiments, the first side and the second side of the flexible shaft include an inner surface disposed at the distal end of the flexible shaft, and the pivot axis passes through the inner surfaces of the first side and the second side. In one or more embodiments, the first rod and the second rod are mechanically coupled to the first wire rope and the second wire rope, respectively, and the first wire rope and the second wire rope include a first cable and a second cable, respectively.

[0045] In one or more embodiments, the first and second rods are mechanically coupled to a shaft disposed in the handle. In one or more embodiments, the first and second cables are attached to the shaft, and the shaft is configured to rotate in a first direction when the first rod is pulled to pull the end of the first cable toward the proximal end of the elongated shaft, thereby causing the flexible shaft to bend in the first direction, and the shaft is configured to rotate in a second direction when the second rod is pulled to pull the end of the second cable toward the proximal end of the elongated shaft, thereby causing the flexible shaft to bend in the second direction. In one or more embodiments, the shaft is configured to release a first force on the first cable when the shaft is rotated in the second direction, and the shaft is configured to release a second force on the second cable when the shaft is rotated in the first direction.

[0046] In one or more embodiments, the handle includes a mechanical lock that applies a force against the shaft to set the 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 axis of the shaft and the customizable angle is 0°. In one or more embodiments, the customizable angle is adjustable while the flexed position and flexed orientation of the elongated shaft are maintained.

[0047] Another aspect of the present invention relates to an instrument port, which includes: a slender shaft having a proximal end and a distal end and extending along the axis of the shaft, the slender shaft having a fluid port, the fluid port being defined in an outer surface at the distal end of the slender shaft; a bendable shaft having a proximal end attached to the distal end of the slender shaft along the axis of the shaft, the bendable shaft being configured to bend only within a pivot plane defined by the axis of the shaft and a pivot axis orthogonal to the axis of the shaft; 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 includes a biasing balloon attached to the outer surface of the slender shaft, the biasing balloon having an internal volume connected to the fluid port fluid, the biasing balloon having an expanded state and a contracted state; a handle attached to the proximal end of the slender shaft, the handle including at least one rod mechanically connected to the bendable shaft to adjust a customizable angle of the steerable end, the customizable angle measured between the axis of the shaft and the axis of the end; a fluid tube disposed in the slender shaft, the fluid tube being fluidically coupled to the fluid port; and a working tube disposed in the slender shaft, the working tube forming a working channel to receive a medical device.

[0048] 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 axis of the shaft, and the customizable angle is 0°. In one or more embodiments, the bias balloon has an expanded state and a contracted state, and in the expanded state, the bias balloon has a height measured relative to a vertical axis orthogonal to the axis of the shaft, which is greater than the bending distance measured from the distal end of the steerable tip to the outer surface on the distal end of the slender shaft when the customizable angle is 90°. In one or more embodiments, in the expanded state, the bias balloon expands radially asymmetrically. In one or more embodiments, the first portion of the wall has a relatively thin wall thickness compared to the second portion of the wall, the second portion of the wall has a relatively thick wall thickness compared to the first portion of the wall, and the first portion of the wall is on the first side of the slender shaft.

[0049] In one or more embodiments, the instrument port further comprises an RF ablation catheter, wherein: the inner diameter of the working channel is greater than the outer diameter of the RF ablation catheter, and the fluid channel is defined between the inner diameter of the working channel and the outer diameter of the RF ablation catheter. In one or more embodiments, the fluid channel is fluidically coupled to an irrigation fluid source and / or a vacuum source.

[0050] In one or more embodiments, the working tube comprises a flexible cylinder. In one or more embodiments, the flexible cylinder comprises a wire reinforcement liner. In one or more embodiments, the wire reinforcement liner comprises a tube body and a spiral cable, the tube body comprising fluorinated ethylene propylene. In one or more embodiments, the inner surface of the flexible cylinder comprises only the tube body to form a smooth surface to receive a medical device.

[0051] In one or more embodiments, the elongated shaft comprises a metal tube, and a pattern of slits is defined in the shaft to increase the flexibility of the shaft. 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 spiral. In one or more embodiments, the pattern comprises a plurality of fins extending circumferentially on a first side and a second side of the metal tube, and the fins on the first side and the fins on the second side are separated by a first gap and a second gap, and the first gap and the second gap extend along a plane defined by an axis of the shaft and an axis orthogonal to the axis of the shaft.

[0052] In one or more embodiments, the bias airbag has a partially expanded state, wherein the partially expanded volume of the bias airbag is in the range of about 10% to about 90% of the fully expanded volume of the bias airbag, and when the bias airbag is in the fully expanded state, the bias airbag has a fully expanded volume. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] For a fuller understanding of the nature and advantages of the present concepts, reference is made to the detailed description of the preferred embodiments and to the accompanying drawings.

[0054] Figure 1 is a block diagram of a medical procedure using an ablation catheter according to the prior art.

[0055] Figure 2 is a perspective view of an instrument port according to an embodiment

[0056] Figure 3 is a perspective view of a distal portion of an instrument port according to an embodiment.

[0057] Figure 4 is a perspective view of a distal portion of an instrument port when a biasing balloon is radially asymmetrically expanded according to an embodiment.

[0058] Figure 5 is a cross-sectional view of a distal portion of an instrument port when a biasing balloon is radially asymmetrically expanded according to an embodiment.

[0059] Figure 6 is a cross-sectional view of a distal portion of an instrument port when a biasing balloon is radially asymmetrically expanded according to an alternative embodiment.

[0060] Figure 7 A side view of an instrument port is shown when a biasing balloon is radially asymmetrically expanded during a medical procedure, according to an embodiment.

[0061] Figure 8 A side view of the instrument port is shown when the biasing balloon is radially asymmetrically expanded and the bendable shaft is in a bent state during a medical procedure according to an embodiment.

[0062] Fig. 9 is a cross-sectional view of a distal portion of an instrument port when a biasing balloon is radially asymmetrically expanded according to another embodiment.

[0063] Fig.10 is a perspective view of a distal portion of an instrument port when a biasing balloon is radially symmetrically inflated according to an embodiment.

[0064] Fig.11 A side view of an instrument port is shown when a biasing balloon is radially symmetrically expanded during a medical procedure, according to an embodiment.

[0065] Fig.12 is a perspective view of a distal portion of an instrument port without a biasing balloon to illustrate an embodiment of a bendable shaft in an unbent state.

[0066] Fig.13is a perspective view of a distal portion of an instrument port with a biasing balloon to illustrate an embodiment of a bendable shaft in a bent state.

[0067] Fig.14 is a perspective view of a bendable shaft and a steerable tip in an unbend state according to an embodiment.

[0068] Fig.15 is a perspective view of a cable tension adjuster according to an embodiment.

[0069] Fig.16 is a perspective view of a distal portion of an instrument port according to an embodiment.

[0070] Fig.17 is an isolated perspective view of a working tube according to an embodiment.

[0071] Fig.18 is an isolated perspective view of an elongated shaft according to an embodiment.

[0072] Fig.19 is an isolated perspective view of an elongated shaft according to another embodiment.

[0073] Fig. 20 is a cross-sectional view of an elongated shaft.

[0074] Fig.21 is a top view of an instrument port system according to an embodiment.

[0075] Fig. 22 is a perspective view of a proximal portion of a handle of an instrument port according to an embodiment.

[0076] Fig.23 is a cross-sectional view of the proximal portion of the handle.

[0077] Fig.24 is a top view of a portion of the handle with the housing removed.

[0078] Fig.25 yes Fig.24 An isolated perspective view of the end steering device shown in FIG.

[0079] Fig.26 is a cross-sectional view of a portion of the handle to further illustrate the mechanical lock.

[0080] Fig. 27 is a block diagram of subsystems that may be included in a controller.

[0081] Fig.28A A lesion is shown having a first size and / or a first optical property at a first time.

[0082] Fig.28B The lesion is shown having a second size and / or second optical properties at a second time. DETAILED DESCRIPTION

[0083] An instrument port includes a handle, an elongated shaft, a bendable shaft, and a steerable end. The bendable shaft can be controllably bent in a plane using one or more rods on the handle. 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 end. When the bendable shaft is in an unbent state, the bendable shaft extends along the axis of the shaft along which the elongated shaft extends. When the bendable shaft is in a bent state, the bendable shaft bends or flexes relative to the axis of the shaft to guide the steerable end to a customizable angle or orientation relative to the axis of the shaft. The bendable shaft can be bent without affecting the position, shape, orientation, and / or behavior of the elongated shaft. For example, when the bendable shaft 220 is converted from an unbent state to a bent state, the elongated shaft can remain in a flexed state. Alternatively, when the bendable shaft 220 is converted from an unbent state to a bent state, the elongated shaft can remain in an unbent state.

[0084] The customizable angle can improve the view of the anatomical region during a medical procedure using an imaging system disposed on the steerable tip. In addition, the customizable angle can set the angle at which a medical device such as an ablation catheter exits the steerable tip, which is advantageous.

[0085] A biasing balloon is attached to the distal end of the elongated shaft. The biasing balloon can be converted from a contracted state to an expanded state during a medical procedure. In the expanded state, the biasing balloon can be placed against an anatomical feature (e.g., cardiac tissue) to provide a space between the elongated shaft and the anatomical feature. The space can be used to convert the bendable shaft from an unbent state to a bent state. The biasing balloon can be expanded symmetrically or asymmetrically. In addition, the biasing balloon can be partially expanded, for example to customize the space between the elongated shaft and the anatomical feature.

[0086] The working channel extends through the instrument port from the proximal end of the instrument port to the distal end of the instrument port. The working channel can be configured to have an inner radius greater than an outer radius of the medical device to form an irrigation / vacuum channel between the medical device and the working channel. The irrigation / vacuum channel can be fluidly coupled to an irrigation liquid and / or vacuum source, which can be used to rinse the outer surface of the medical device before the medical procedure, clean the face of the device during the medical procedure to provide a clear image through the camera, irrigate the surgical site, and / or apply a vacuum to remove liquids and / or body fluids, such as blood, as needed.

[0087] The instrument port can have various features as described in the figures. These features can be combined and / or removed in various embodiments.

[0088] Figure 22 is a perspective view of an instrument port 20 according to an embodiment. The instrument port 20 includes a handle 200, an elongated shaft 210, a bendable shaft 220, and a steerable tip 230. The handle 200 is on the proximal end 202 of the instrument port 20. The steerable tip 230 is on the distal end 204 of the instrument port 20.

[0089] The bendable shaft 220 can be bent according to the position of one or more rods 240 on the handle 200. The bendable shaft 220 can be configured to bend only in one plane (e.g., upward or downward) and not in an orthogonal plane (e.g., from one side to the other). The position and / or orientation of the steerable end 230 can be controlled by actuating the rod 240 on the handle 200, which can set a customizable angle of the steerable end 230 relative to the elongated shaft 210 by bending the bendable shaft 220. In some embodiments, the bendable shaft 220 is optional. The bendable shaft 220 can be bent without affecting the position, shape, orientation and / or behavior of the elongated shaft 210.

[0090] Figure 3 FIG. 2 is a perspective view of a distal portion 300 of an instrument port 20 according to an embodiment. In addition to the bendable shaft 220 and the steerable tip 230, the distal portion 300 also includes a Figure 3 20. The bias balloon 310 is located at the distal end or distal portion 215 of the elongated shaft 210. During a medical procedure, the bias balloon 310 can be inflated to create a space between an anatomical feature and the instrument port 20. The space created by the bias balloon 310 in the inflated state can be used to bend the bendable shaft 220 to create a customizable angle of the steerable tip 230 during a medical procedure, for example to customize the angle of the working channel 320 at the distal end 204 of the instrument port 20 through which a medical device (e.g., an ablation catheter such as the ablation catheter 100) is passed. When the inflated bias balloon 310 is placed against the anatomical feature, the bias balloon 310 can provide stability to the instrument port 20 during the medical procedure.

[0091] The bias balloon 310 can be inflated with a fluid (e.g., a gas and / or a liquid). In one example, the bias balloon 310 is inflated with air. In another embodiment, the bias balloon 310 is inflated with saline or semi-saline. The liquid may include a contrast agent that can be used to visualize the bias balloon 310 during a medical procedure, such as with medical imaging (e.g., ultrasound, MRI, or another medical imaging technique). The internal volume of the bias balloon 310 is fluidly coupled to a fluid port 340 defined at or near the distal end 215 of the elongated shaft. The fluid port 340 can be used to introduce fluid to the bias balloon 310 to inflate the bias balloon 310 and remove fluid from the bias balloon 310 to deflate the bias balloon 310, respectively.

[0092] In the expanded state, the biasing balloon 310 can be configured to be radially symmetrical or asymmetrical relative to the shaft axis 330, and when the flexible shaft 220 is in an unflexed state (e.g., Figures 1 to 3 ), the shaft axis 330 passes through the centers of the elongated shaft 210, the bendable shaft 220, and the steerable tip 230. The shaft axis 330 may be an axis of symmetry for the elongated shaft 210, the bendable shaft 220, and the steerable tip 230 when the bendable shaft 220 is in an unbent state.

[0093] A biasing balloon 310 is attached to the distal end 215 of the elongated shaft 210 to create a fluid tight seal around the fluid port 340. Figure 3 The tether 350 in the embodiment of the present invention attaches the proximal end 312 and the distal end 314 of the biasing balloon 310 at the corresponding proximal and distal sides of the fluid port 340. In another embodiment, the biasing balloon 310 can be attached by bonding the end 312 of the biasing balloon 310 to the elongated shaft 210, for example, using an adhesive. In another embodiment, the biasing balloon 310 can be attached by heat sealing the wall of the biasing balloon 310 to the elongated shaft 210. In other embodiments, these and / or other attachment methods can be used.

[0094] The cannula 250 is disposed at least on the bendable shaft 220 and the steerable tip 230. The cannula 250 can provide a smooth surface for insertion into a patient during a medical procedure to reduce the possibility of tissue damage. The cannula 250 can be flexible to conform to the bendable shaft 220 and the steerable tip 230 as their relative orientation and / or angle are adjusted during a medical procedure. The cannula 250 can include and / or can be made of a polyolefin, a fluoropolymer, a polyether block amide (e.g., a polyamide available from Arkema). ), and / or other materials.

[0095] Figure 4 3 is a perspective view of the distal portion 300 of the instrument port 20 when the biasing balloon 310 is radially asymmetrically expanded according to an embodiment. In such an embodiment, the biasing balloon 310 expands more on a first side 332 of the shaft axis 330 than on a second side 334 of the shaft axis 330. In an embodiment, the biasing balloon 310 can have a variable wall thickness. In another embodiment, a portion of a semi-rigid tube, which can be the biasing balloon 310, can be disposed on the second side 334 of the shaft axis 330 such that the biasing balloon 310 expands on the first side 332 of the shaft axis 330 and does not expand on the second side 334 of the shaft axis.

[0096] In some embodiments, the biasing balloon 310 can be partially inflated. For example, the biasing balloon 310 can have a partially inflated volume that is a percentage of the fully inflated volume. In a specific example, the biasing balloon 310 can have a partially inflated state, wherein the partially inflated volume of the biasing 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 a percentage between any two of the foregoing percentages. When the biasing balloon 310 is in an inflated state (e.g., a fully inflated state), the biasing balloon 310 has a fully inflated volume.

[0097] Figure 5 is a cross-sectional view of the distal portion 300 of the instrument port 20 when the biasing balloon 310 is radially asymmetrically expanded according to an embodiment. The cross-sectional view is through Figure 4 5. This embodiment shows that the biasing bladder 310 is formed by a wall 500 having a variable cross-sectional thickness. The wall 500 on the first side 332 of the shaft axis 330 has a thinner cross-sectional thickness than the cross-sectional thickness of the wall 500 on the second side 334 of the shaft axis 330. Similarly, the wall 500 on the second side 334 of the shaft axis 330 has a thicker cross-sectional thickness than the cross-sectional thickness of the wall 500 on the first side 332 of the shaft axis 330. Since the relatively thick cross-sectional thickness of the wall 500 on the second side 334 of the shaft axis 330 requires a larger force to expand, and the relatively thin cross-sectional thickness of the wall 500 on the first side 332 of the shaft axis 330 requires a smaller force to expand, the biasing bladder 310 expands more on the first side 332 of the shaft axis 330 than on the second side 332 of the shaft axis 330. For example, when the biasing bladder 310 is expanded, approximately 60% to approximately 90% of the expanded volume of the biasing bladder 310 may be on the first side 332 of the shaft axis 330, while only approximately 10% to approximately 40% of the expanded volume of the biasing bladder 310 may be on the second side 332 of the shaft axis 330.

[0098] The variable cross-sectional thickness of the wall 500 can also be measured relative to the expansion plane 510. When the bendable shaft 220 is in an unbent state, the expansion plane 510 passes through the middle of the elongated shaft 210, the bendable shaft 220, and the steerable tip 230 along the shaft axis 330. Thus, the shaft axis 330 is located in the expansion plane 510. In an embodiment, the shaft axis 330 extending along the length of the instrument port 20 and the width axis 360 extending along the width of the instrument port ( Figure 4) describes or defines the expansion plane 510. The width axis 360 is orthogonal to the shaft axis 330. The offset bladder wall 500 below 512 of the expansion plane 510 (e.g., on the first side thereof) has a thinner cross-sectional thickness than the cross-sectional thickness of the wall 500 above 514 of the expansion plane 510 (e.g., on the second side thereof). Likewise, the offset bladder wall 500 above 514 of the expansion plane 510 (e.g., on the second side thereof) has a thicker cross-sectional thickness than the cross-sectional thickness of the wall 500 below 512 of the expansion plane 510 (e.g., on the first side thereof). When the biasing airbag 310 is inflated, approximately 60% to approximately 90% of the expanded volume of the biasing airbag 310 may be below 512 of the expansion plane 510 (e.g., on a first side thereof), while only approximately 10% to approximately 40% of the expanded volume of the biasing airbag 310 may be above 514 of the expansion plane 510 (e.g., on a second side thereof).

[0099] Figure 6 is a cross-sectional view of the distal portion 300 of the instrument port 20 when the biasing balloon 310 is radially asymmetrically expanded according to an alternative embodiment. The cross section is through Figure 4 5-5 in FIG. 5 . In such an embodiment, the wall 500 of the biasing balloon 310 has a uniform cross-sectional thickness. A portion of the balloon restraining tube 610 (e.g., a tube cut along its length, such as a tube cut along a horizontal cylindrical section) is attached to the elongated shaft 210 above or on a portion of the biasing balloon 310. The balloon restraining tube 610 is rigid and limits or constrains the expansion of the biasing balloon 310, such that the biasing balloon 310 only expands where the balloon restraining tube 610 is not positioned. The balloon restraining tube 610 can be disposed above or on the biasing balloon 310 above 514 of the expansion plane 510 (e.g., on a second side thereof), such that the biasing balloon 310 only expands below 514 of the expansion plane 510 (e.g., on a first side thereof). The balloon restraining tube 610 can include plastic, metal, and / or other materials. The biasing bladder 310 expands more on a first side 332 of the shaft axis 330 than on a second side 334 of the shaft axis 330 .

[0100] Figure 7 A side view of the instrument port 20 is shown when the biasing balloon 310 is radially asymmetrically inflated during a medical procedure according to an embodiment. Inflating the biasing balloon 310 increases the distance between the thermal tissue 110 and the instrument port 20 (e.g., the elongated shaft 210, the bendable shaft 220, and the steerable tip 230). One technical advantage is that when the biasing balloon 310 is inflated, the increased distance between the thermal tissue 110 and the instrument port 20 provides the necessary space to bend the bendable shaft 220 toward the cardiac tissue 110, such as Figure 8As shown, the steerable tip 230 can be steered to customize the position and angle of the steerable tip 230 relative to the elongated shaft 210. For example, when the bendable shaft 220 is in a bent state (e.g., when the customized angle between the steerable tip 230 and the elongated shaft 210 is 90°), the biasing balloon 310 can have a radius or height 810 that is greater than or equal to a bending distance 820 between the distal end 204 of the steerable tip 230 and the outer surface 812 of the distal end of the elongated shaft 210. The radius / height 810 and the bending distance 820 can be measured relative to a vertical axis 830 that is orthogonal to the axis 330 of the shaft. This provides sufficient room for the bendable tip 220 to bend to adjust the customizable position and angle of the steerable tip 210.

[0101] 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. In addition, the customizable position and angle of the steerable tip 230 can allow an ablation catheter inserted through the instrument port 20 to create a deeper lesion in the cardiac tissue 110 (e.g., compared to the catheter 100) while protecting the phrenic nerve 140 from any damage. In addition, the biasing balloon 310 can provide more precise and / or more stable contact between the distal end 234 of the steerable tip 230 and the cardiac tissue 110, which can allow the contact force required to perform ablation using the ablation catheter inserted through the instrument port 20. The ablation catheter can be operated using any ablation technique including radio frequency (RF), cryoablation, needle ablation, laser ablation, and / or electroporation.

[0102] Figure 7 and Figure 8 It is also shown that the bendable shaft 220 can be bent without affecting the position, shape, orientation and / or behavior of the elongated shaft 210. For example, Figure 7 and Figure 8 It is shown that when the bendable shaft 220 is bent, the elongated shaft 210 can maintain its position along the axis 330. In addition, when the bendable shaft 220 is bent, the axis 330 of the shaft maintains the same relative position and angle (e.g., the axis 330 of the shaft does not move). Therefore, when the bendable shaft 220 is converted from the unbent state to the bent state, the axis 330 of the shaft can remain stationary. Alternatively, when the bendable shaft 220 is converted from the unbent state to the bent state, the elongated shaft 210 can remain in the flexed state and the same flexed position, flexed configuration and / or flexed orientation. Therefore, the bendable shaft 220 can be bent and the customizable angle can be adjusted or set independently of the elongated shaft 210.

[0103] Fig. 9 is a cross-sectional view of the distal portion 300 of the instrument port 20 when the biasing balloon 310 is radially asymmetrically expanded according to another alternative embodiment. The cross section is through Figure 4 5-5 in FIG. 5. In this embodiment, the biasing balloon 310 is attached only below 512 of the expansion plane 510 (e.g., on a first side thereof). Since the biasing balloon 310 is not attached above 514 of the expansion plane 510 (e.g., on a second side), the balloon 310 is inflated only below 512 of the expansion plane 510. The biasing balloon 310 is inflated 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 appear similar to FIG. Figure 8 Same as shown.

[0104] Fig.10 is a perspective view of the distal portion 300 of the instrument port 20 when the biasing balloon 310 is radially symmetrically expanded according to an embodiment. In such an embodiment, the biasing balloon 310 expands equally (or substantially equally) on the first side 332 and the second side 334 of the shaft axis 330. Fig.11 310 is inflated radially symmetrically during a medical procedure. Radially symmetrical balloons provide the same or substantially the same technical advantages as radially asymmetric balloons. However, an advantage of radially asymmetric balloons over radially symmetrical balloons is that larger balloons can be used without compromising the heart's hemodynamics. For example, in Fig.11 In the embodiment of the present invention, the upper portion 1110 of the radially symmetrical balloon 310 is disposed against the pericardium 120, which may generate a force or pressure on the heart tissue 110. Such a force or pressure is undesirable because it may affect blood flow in the heart.

[0105] As discussed above, the biasing airbag 310 can be partially inflated. For example, the biasing airbag 310 can have a partially inflated volume that is a percentage of the fully inflated volume. In a specific example, the biasing airbag 310 can have a partially inflated state, wherein the partially inflated volume of the biasing airbag 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 foregoing percentages. When the biasing airbag 310 is in an inflated state (e.g., a fully inflated state), the biasing airbag 310 has a fully inflated volume.

[0106] Fig.123 is a perspective view of the distal portion 300 of the instrument port 20 without the biasing balloon 310 to illustrate an embodiment of the bendable shaft 220 in an unbent state. The bendable shaft 220 includes a plurality of mechanical rings 1200 concentrically arranged along the axis 330 of the shaft. The mechanical rings 1200 may include an articulated coupling. Each adjacent pair 1210 of the mechanical rings 1200 is mechanically coupled by a pair of mechanical couplings 1220. A corresponding third axis 1230 passes through each pair of mechanical couplings 1220. The third axis 1230 may be the same as or parallel to the width axis 360. The mechanical couplings 1220 provide a structure that constrains the flexibility of the bendable shaft 220 within a stiffness plane 1240 defined by the axis 330 of the shaft and the third axis 1230. The stiffness plane 1240 may be the same as the expansion plane 510.

[0107] The mechanical ring 1200 is spaced apart along the axis 330 to provide upward or downward flexibility or bendability relative to a pivot axis 1250 that is orthogonal to the axis 330 and the third axis 1330. The pivot axis 1250 and the shaft axis 330 define a pivot plane 1260 in which the bendable shaft 220 can bend upward or downward. The stiffness plane 1240 and the pivot plane 1260 are orthogonal to each other.

[0108] The mechanical ring 1200 and the mechanical coupling device 1220 can be formed of metal (e.g., stainless steel or titanium) or plastic (e.g., polyamide, polyetherimide and / or other plastics). In an embodiment, the proximal end of the bendable shaft 220 is welded to the distal end of the elongated shaft 210. In addition, the distal end of the bendable shaft 220 can be coupled to the proximal end of the steerable tip 230.

[0109] Fig.13 3 is a perspective view of a distal portion 300 of an instrument port 20 with a biasing balloon 310 to illustrate an embodiment of a bendable shaft 220 in a bent state. In the bent state, the mechanical rings 1200 are spaced farther apart on a side of the bendable shaft 220 away from the bending direction, and the mechanical rings 1200 are spaced closer together on a side of the bendable shaft 220 toward the bending direction. 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 elongated shaft 210. The customizable angle 1300 can be measured between the shaft axis 330 and the tip axis 1310 of the working channel 320 extending through the steerable tip 230. In the unbent state, the tip axis 1310 and the shaft axis 330 are collinear.

[0110] Fig.12 and Fig.13It is also shown that the bendable shaft 220 can be bent without affecting the position, shape, orientation and / or behavior of the elongated shaft 210. For example, when the bendable shaft 220 is bent, the elongated shaft 210 maintains its position along the axis 330 of the shaft. In addition, when the bendable shaft 220 is bent, the axis 330 of the shaft maintains the same relative position and angle (e.g., the axis 330 of the shaft does not move). Therefore, when the bendable shaft 220 is converted from an unbent state to a bent state, the axis 330 of the shaft can remain stationary. Alternatively, when the bendable shaft 220 is converted from an unbent state to a bent state, the elongated shaft 210 can remain in a flexed state.

[0111] It should also be noted that in some embodiments, the elongated shaft 210 is flexible (e.g., as in Fig.18 and Fig.19 ). In the unflexed state, the elongated shaft 210 extends along the axis 330 of the shaft. In the flexed state, some or all of the elongated shaft 210 does not extend along the axis 330 of the shaft. For example, the elongated shaft 210 can be bent or flexed in the flexed state to, for example, position around an anatomical feature (e.g., a heart). In either case (flexed or unflexed state), the flexible shaft 220 can remain stationary (e.g., in the same flexed or unflexed configuration, flexed or unflexed position, flexed or unflexed state, flexed or unflexed orientation, etc.) when the flexible shaft 220 transitions from the unflexed state to the flexed state. Therefore, the flexible shaft 220 can be bent and the customizable angle can be adjusted or set independently of the elongated shaft 210.

[0112] Fig.14 1 is a perspective view of the bendable shaft 220 and the steerable tip 230 in an unbend state according to an embodiment. In this view, the mechanical ring 1200 and the mechanical coupling device 1220 are partially transparent to show the first cable 1401 and the second cable 1402 in the bendable shaft 220. The first end 1411 of the first cable 1401 is attached to a first side 1421 (e.g., at an inner surface) of the distal end of the bendable shaft 220. The second end 1412 of the second cable 1402 is attached to a second side 1422 (e.g., at an inner surface) of the distal end of the bendable shaft 220. The first end 1411 and the second end 1412 can be crimped and / or welded to the distal end of the bendable shaft 220. In the unbend state, the first end 1411 and the second end 1412 are attached to opposite sides 1421, 1422 of the bendable shaft 220 along the pivot axis 1250.

[0113] The first cable 1401 and the second cable 1402 extend to the handle 200, where they can be pulled (e.g., by one or more rods) to bend the bendable shaft 220 in corresponding directions within the expansion plane 1260. For example, the first cable 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 cable 1402 can be pulled to bend the bendable shaft 220 downward (e.g., in a second direction corresponding to the second side 1422). Each of the cables 1401, 1402 can pass through one or more guide sleeves 1430. In an embodiment, the first cable 1401 and the second cable 1402 can include a first steel cable and a second steel cable.

[0114] Each of the cables 1401, 1402 may optionally be threaded through and / or attached to a tightly wound coil 1440, which may be a Fig.15 14. A portion of a cable tension adjuster 1500 is shown. The distal end 1442 of the tightly wound coil 1440 is fixedly attached (e.g., welded) to the mechanical ring 1200 (e.g., the mechanical ring 1200 toward the proximal end 202 of the instrument port 20). The cable tension adjuster 1500 includes the tightly wound coil 1440 and the tension adjuster 1510. The tension adjuster 1510 is attached to the adjuster plate 2440 ( Fig.24 ). The tension adjuster 1510 includes a counterbore 1520 including internal threads that engage external threads on the tightly wound coil. The tension adjuster 1510 can be rotated in a first direction to increase the tension on the cable 1402, and rotated in a second direction to decrease the tension on the cable 1402. Although the cable tension adjuster 1500 is shown with respect to the cable 1402, the same cable tension adjuster 1500 can be used with the cable 1401.

[0115] Fig.16is a perspective view of the distal portion 300 of the instrument port 20 according to an embodiment. In this view, the steerable tip 230 is partially transparent and the bendable shaft 220 is removed to show the imaging system 1600 disposed at the distal end 204 of the instrument port 20 (and the distal end of the distal tip 230). The imaging system 1600 includes a first light emitter and a second light emitter 1610 disposed around a camera 1620. Each light emitter 1610 may include a fiber optic cable or a bundle of fiber optic cables. The optical fibers are optically coupled to a light source (e.g., an LED light, an incandescent light, a laser, or other light source) at their proximal ends and transmit light through the optical fibers, which is output at the distal end 204 of the instrument port 20. In alternative embodiments, the light emitter 1610 may include one or more light sources (e.g., LEDs) disposed in the steerable tip 230 to output light at the distal end 204 of the instrument port 20. In other embodiments, additional or fewer light emitters 1610 may be included.

[0116] 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 source 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, and by changing the emission spectrum by well-known methods 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 the distal end 204 of the instrument port 20 (e.g., distal end). For example, the camera 1620 can be used to acquire still or moving image data of the heart tissue 110, the pericardium 120, and the lesion 130 as it is formed. These images can be used to train advanced image feature detection algorithms such as in 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 predetermined characteristics (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.

[0117] The working tube 1640 is disposed in at least the proximal portion 1650 of the bendable shaft 220 and the steerable tip 230. The working tube 1640 and the tip channel 1660 defined in the distal portion 1670 of the steerable tip 230 form the working channel 320. The working tube 1640 can extend to the proximal end 202 of the handle 200 and / or the instrument port 20. The working tube 1640 can also extend to the distal portion 1670 of the steerable tip 230 to replace part or all of the tip channel 1660.

[0118] Fig.17 1 is an isolated perspective view of a working tube 1640 according to an embodiment. The working tube 1640 includes a helical or spiral-shaped wire 1700 that structurally flexibly supports a working tube body 1710. The working tube body 1710 may include a polyether block amide (e.g., ) and / or another material having an ethylene propylene (FEP) liner and / or a polytetrafluoroethylene (PTFE) liner. The FEP and / or PTFE can provide a relatively smooth surface through which to insert a medical device (e.g., an ablation catheter such as ablation catheter 100). In a relaxed state, the working tube 1640 extends along and / or parallel to the axis 330 of the shaft. The working tube 1640 can flex and / or bend relative to one or more axes orthogonal to the axis 330 of the shaft, such as axis 1720 (e.g., parallel to the height of the working tube 1640) and / or axis 1730 (e.g., parallel to the width of the working tube 1640).

[0119] Fig.18 2 is a perspective view of an elongated shaft 210 according to an embodiment. The elongated shaft 210 includes an elongated tube 1800 extending along and / or parallel to the axis 330 of the shaft in a relaxed state. The elongated tube 1800 may be formed of a metal (e.g., stainless steel, titanium, and / or other metals), a plastic, and / or other materials. A plurality of slits or holes 1810 are defined in the flexible tube 1800 to create flexibility in the elongated tube 1800. The slits 1810 may be formed by machining, laser etching, or other techniques. The slits 1810 may be configured to provide flexibility (e.g., passive flexibility) relative to a first plane 1820, which is defined by the axis 330 of the shaft and a width axis 1830 orthogonal to the axis 330 of the shaft. The width or diameter of the elongated tube 1800 may be measured relative to the width axis 1830. The slit 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 that is orthogonal to the shaft axis 330 and the width axis 1830. The height or diameter of the elongated tube 1800 can be measured relative to the height axis 1850. In an unflexed state (e.g., Fig.18 As shown), the elongated tube 1800 extends along the axis 330 of the shaft.

[0120] The gaps 1810 form a pattern that can provide flexibility within the planes 1820, 1840, such as an intermittent spiral pattern. Fig.19 As shown, the slits 1810 are arranged as a plurality of fins extending circumferentially on the first side 1802 and the second side 1804 of the elongated tube 1800. The gap 1900 is provided on the third side 1806 of the elongated tube 1800, the third side 1806 being located between the slits 1810 on the first side 1802 and the slits 1810 on the second side 1804 of the elongated tube 1800. The second gap 1900 is provided on the fourth side 1808 of the elongated tube 1800, the fourth side 1808 being located 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 on the third side 1806 and the fourth side 1808 are aligned with respect to the width axis 1830. The gap 1900 corresponds to an area of ​​the solid elongated tube 1800 (e.g., not including the slit 1810) that is less flexible (e.g., more rigid) than the area of ​​the elongated tube 1800 that includes the slit 1810. Thus, Fig.19 The elongated tube 1800 in FIG. 1 is flexible relative to the plane 1840 , but is not flexible relative to the plane 1820 .

[0121] Fig. 20 is through Figure 320-20 in order to illustrate the relative arrangement of certain components described herein. The cross-sectional view shows an exemplary arrangement of the first cable 1401 and the second cable 402, the optional tightly wound coil 1440, the fluid tube 2000, the working tube 1640, the first fiber optic cable 2011 and the second fiber optic cable 2012, and the imaging cable 2020. The fluid tube 2000 is fluidly coupled to the fluid port 340 to provide fluid to the biasing balloon 310 and / or receive fluid from the biasing balloon 310. In an example, the fluid tube 2000 includes an orifice disposed against the fluid port 340, and the distal end of the fluid tube 2000 is capped or sealed to force fluid to flow into the fluid port 340 to the biasing balloon 310 or out of the fluid port 340 from the biasing balloon 310 (e.g., to define a closed fluid path between the fluid port 340 and the biasing balloon 310). The first fiber optic cable 2011 and the second fiber optic cable 2012 are electrically coupled to the first light emitter 1610 and the second light emitter 1610. In an embodiment, the first light emitter and the second light emitter 1610 include the first fiber optic cable 2011 and the second fiber optic cable 2012. The imaging cable 2020 is electrically coupled to the camera 1620 to send image data from the camera 1620 to an external controller (or other device), to send commands from the external controller to the camera 1620 (e.g., to adjust the focus of the camera), and / or to provide power to the camera 1620. In alternative embodiments, the camera 1620 may be battery powered and / or may communicate wirelessly with an external controller (or other device).

[0122] An optional medical device 2030 (e.g., an ablation catheter, such as ablation catheter 100) is inserted into the working channel 320 within the working tube 1640. The working tube 1640 is configured to have a radius 2040 (e.g., a working tube radius) that is greater than a radius 2050 (e.g., a medical device radius) 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 (e.g., with a liquid such as saline or semi-saline) the outer surface 2034 of the medical device 2030 and / or a surgical site during and / or prior to a medical procedure. In an additional or alternative embodiment, 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 a surgical site to, for example, remove debris and / or liquid (e.g., saline or semi-saline, blood, etc.) therefrom.

[0123] Fig.212 is a top view of an instrument port system 2100 according to an embodiment. The instrument port system 2100 includes an instrument port 210, a fluid source 2110, a microprocessor-based controller 2120, and a vacuum / liquid irrigation source 2130. In this figure, the elongated shaft 210 of the instrument port 20 is disconnected to fit the instrument port 20 into the page. The handle 200 includes a first rod 2101 and a second rod 2102 that are mechanically coupled to the first cable 1401 and the second cable 1402, respectively. The first rod 2101 is pressed toward the proximal end 202 of the instrument port 20 to generate tension in the first cable 1401 to bend the bendable shaft 220 in a first direction. Pressing the first rod 2101 toward the proximal end 202 of the instrument port 20 can also release the tension in the second cable 1402. The second rod 2102 is pressed toward the proximal end 202 of the instrument port 20 to generate tension in the second cable 1402 to bend the bendable shaft 220 in the second direction. Pressuring the second rod 2102 toward the proximal end 202 of the instrument port 20 can also release the tension in the first cable 1401. The first rod 2101 and the second rod 2102 can be the same as the rod 240. The mechanical lock 2105 can lock the relative position of the first rod 2101 and the second rod 2102, which can fix the tension on the corresponding cables 1401, 1402, thereby locking the orientation (e.g., angle 1300) of the bendable shaft 220 and the steerable tip 210. Fig.21 In the embodiment of the present invention, the mechanical lock 2105 is positioned in a locked state (eg, toward the distal end 204). The mechanical lock 2105 can also be moved toward the proximal end 202 to switch to an unlocked state.

[0124] The handle fluid port 2140 is formed in the handle 200 (e.g., at the proximal end of the handle 200). The handle fluid port 2140 is fluidly coupled to the fluid source 2110 and the fluid tube 2000, which is fluidly coupled to the fluid port 340 and the biasing balloon 310. The fluid source 2110 can releasably store a predetermined volume of liquid or gas for expanding the biasing balloon 310. The fluid source 2110 can include a syringe, a canister, or other device that can releasably store a fluid. The fluid source 2110 can also receive a predetermined volume of liquid or gas from the biasing balloon 310 to deflate the biasing balloon 310.

[0125] An optical system port 2150 is also formed in the handle 200 (e.g., at the proximal end of the handle 200). One or more cables can be inserted through the optical system port 2150 and 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 may include a light source (e.g., an LED, a laser, etc.) optically coupled to the fiber optic cables 2011, 2012. The controller 2120 may 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 it and receive image data from it. The controller 2120 may optionally be in electronic communication with a computer display 2170, which can display images corresponding to the image data acquired by the imaging system 1600.

[0126] In some embodiments, the controller 2120 is configured to improve and / or analyze the image data acquired by the imaging system 1600. In addition to the images themselves, additional useful information may be recorded, such as the time each still or moving image was acquired. 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 moving image sequence, the controller 2120 may aggregate portions of still or moving images to enhance certain features, apply smoothing, sharpening, edge detection, etc., to still or moving images, and / or decompose the images into multiple colors or wavelengths optimized for feature detection.

[0127] The controller 2120 can be configured to automatically detect (e.g., in real time) certain anatomical features that may be associated with a planned medical procedure. The optimal combination of illumination from a light emitter, acquisition using a camera, and / or processing in the controller 2120 can be selected to enhance detection of relevant features. In an epicardial ablation procedure, the controller 2120 can be configured to automatically detect (e.g., in real time) cardiac tissue 110, pericardium 120, coronary arteries, fat pads, and / or phrenic nerves 140. The controller 2120 can use artificial intelligence, image recognition, machine learning reasoning, and / or other methods to automatically detect anatomical features. When enabled, such detected features can be digitally identified on a display system as superimposed on a still or moving image captured or acquired in real time from a camera. 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 an embodiment, the controller 2120 may be configured to automatically detect the size, color, and / or other features or characteristics of the lesion 130 in real time during epicardial ablation. The controller 2120 may also be in electrical communication with a medical device 2030 (e.g., an ablation catheter) and configured to stop epicardial ablation in real time when the lesion 130 has reached a predetermined size, color, and / or features or characteristics (e.g., by using artificial intelligence, image recognition, and / or other methods).

[0128] The controller 2120 may include and / or may be programmed to include: Fig. 27 For example, the controller 2120 may include and / or may 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.

[0129] The controller 2120 can use the illumination subsystem 2701 to control the light in the light emitter 1610, 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 through an optical fiber. In addition, the controller can use the image acquisition subsystem 2702 to control the camera 1620 and receive image data. The received image data can pass through the filtering subsystem 2703, the annotation subsystem 2704, the feature detection subsystem 2705, and the 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 the 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.

[0130] The feature detection subsystem 2705 may include artificial intelligence, image recognition, machine learning reasoning, and / or other methods for automatically detecting (e.g., in real time) anatomical features and / or other information. The image data may be automatically annotated using the annotation subsystem 2704 to indicate the detected features. The feature detection subsystem 2705 may detect 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 may be programmed with a target area for a medical procedure, which may increase the speed of detection (e.g., so that the feature detection subsystem 2705 does not attempt to detect anatomical features that are not near the target area for the medical procedure).

[0131] 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 image data, such as storing image data in a memory accessible to the controller 2120 (e.g., internal memory and / or external memory that may include network accessible memory) and / or retrieving data from a memory accessible to the controller 2120.

[0132] The lesion estimator subsystem 2708 may estimate or determine one or more characteristics of the lesion 130 during a medical procedure. The characteristics of the lesion may include the size, color, and / or other characteristics or properties of the lesion 130. The lesion evaluator subsystem 2708 may also be configured to automatically generate a stop signal, such as by using artificial intelligence, image recognition, and / or other methods, that causes the ablation catheter to stop epicardial ablation when the lesion 130 has reached a predetermined size, color, and / or characteristics or properties. For example, Fig.28A and Fig.28B As shown, the damage estimator 2708 can determine that the damaged portion 2830 has a first size and / or a first optical property at a first time, and the damaged portion 2830 has a second size and / or a second optical property at a second time. In another embodiment, the damage estimator 2708 can determine the rate of change of the size, optical property, and / or other characteristics, such as at Fig.28A and Fig.28B The rate of change between the first time and the second time in .

[0133] The scar tissue tracker subsystem 2709 can locate and / or track (e.g., in real time) existing scar tissue of 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 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 scar tissue detected in the displayed image. These annotations are useful for an operator (e.g., a physician) to guide an ablation catheter or other medical device 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 filter. The scar tissue tracker subsystem 2709 can use artificial intelligence, image recognition, and / or other methods.

[0134] The fat pad tracker subsystem 2710 can locate and / or track (e.g., in real time) epicardial fat pads that may be near the target site. The ablation control subsystem 2712 can use the output of the fat pad tracker subsystem 2710 to automatically control ablation, such as by adjusting the ablation energy. For example, fat pads are insulators and may require additional energy to ablate. In addition, the output of the fat pad tracker subsystem 2710 can be sent to the annotation subsystem 2703 to annotate the fat pads detected in the displayed image. These annotations are useful for the operator (e.g., a physician) to optionally guide the ablation catheter or other medical device away from the fat pad. In addition, the operator can use the fat pad annotation to manually adjust the ablation energy. For example, performing ablation on a fat pad generally requires more ablation energy than performing ablation on other tissues. Fat pad annotations can also be used to improve ablation efficiency. Fat pad annotations can include graphic overlays (e.g., colored lines such as red lines) and / or transparent filters. The fat pad tracker subsystem 2710 can use artificial intelligence, image recognition, and / or other methods. For example, the fat pad tracker subsystem 2710 may identify a fat pad based on color (eg, yellow) and / or shape.

[0135] The coronary vessel tracker subsystem 2711 can locate and / or track (e.g., in real time) coronary vessels that may be near a target site. The ablation control subsystem 2712 can use the output of the coronary vessel tracker subsystem 2711 to automatically control ablation, such as by automatically stopping ablation near a coronary vessel. During medical procedures, ablation of coronary vessels is generally undesirable and may harm the patient and / or cause undesirable complications. In addition, the output of the coronary vessel tracker subsystem 2711 can be sent to the annotation subsystem 2703 to annotate the fat pads detected in the displayed image. These annotations are useful for an operator (e.g., a physician) to guide an ablation catheter or other medical device away from any coronary vessels to avoid ablating them. The coronary vessel annotations may include a graphic overlay (e.g., a colored line such as a red line) and / or a transparent filter. The coronary vessel tracker subsystem 2711 can use artificial intelligence, image recognition, and / or other methods. For example, the coronary vessel tracker subsystem 2711 can identify coronary vessels based on color (e.g., blue or red) and / or shape.

[0136] The ablation control subsystem 2712 can control the intensity, frequency and / or other settings of the ablation catheter, which can be controlled manually or automatically. The ablation control subsystem 2712 can start and stop ablation in response to a control signal. For example, the ablation control subsystem 2712 can start or stop ablation in response to user input via the user interface and the control subsystem 2713. Additionally or alternatively, the ablation catheter can include a button that generates a first signal when pressed, which 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.

[0137] return Fig.21 , an irrigation and / or vacuum port 2160 is formed in an adapter 2180 attached to the proximal end of the handle 200. Alternatively, the irrigation and / or vacuum port 2160 may be formed in the proximal end of the handle 200 (e.g., similar to ports 2140, 2150). The irrigation and / or vacuum port 2160 is fluidly coupled to the fluid channel 2060 and the vacuum / liquid irrigation source 2130 for applying a vacuum and / or for introducing a liquid into the fluid channel 2060. For example, Fig. 22As shown in , the adapter 2180 preferably comprises a Tuohy-Borst adapter, which may include a working port 2200 through which a medical device 2030 (e.g., an ablation catheter) may be inserted into the working channel 320. A valve 2210 may be provided between the irrigation and / or vacuum port 2160 and the working port 2200 to direct liquid and / or vacuum into the working channel 320 as needed. The valve 2210 may be actuated by rotating the adapter 2180.

[0138] Fig.23 is through Fig. 22 23-23 in the cross-section of the proximal portion of the handle 200. The cross-section does not include the medical device 2030. This figure shows an example of how the working tube 1640, the fluid tube 2000, and the imaging cable 2300 are coupled to the corresponding ports 2200, 2140, 2150 in the handle 200. The imaging cable 2300 may include fiber optic cables 2011, 2012 and / or an imaging cable 2020.

[0139] Fig.24 2 is a top view of a portion of the handle 200 with the housing removed to illustrate the structure and operation of the rods 2101, 2102 according to an embodiment. The rods 2101, 2102 are attached to the shaft 2400, to which the first and second ends 2411, 2412 of the first and second cables 1401, 1402 are attached to form a terminal steering device 2430. In this figure, the first rod 2101 is pressed toward the proximal end 202, which causes the shaft 2400 to rotate clockwise (e.g., in a first direction) to increase the tension on the first cable 1401 (e.g., by reducing its effective length). Rotating the shaft 2400 clockwise also reduces the tension on the second cable 1402 (e.g., by increasing its effective length) and causes the second rod 2102 to move toward the distal end 204.

[0140] Conversely, pressing the second rod 2102 toward the proximal end 202 causes the shaft 2400 to rotate counterclockwise (e.g., in the second direction) to increase the tension on the second cable 1402 (e.g., by reducing its effective length). Rotating the shaft 2400 counterclockwise also reduces the tension on the first cable 1401 (e.g., by increasing its effective length) and causes the first rod 2101 to move toward the distal end 204. As can be seen, the first and second rods 2101, 2102 are mechanically coupled via the shaft 2400 and are out of phase. For example, when the first rod 1401 is pushed in one direction (e.g., toward the distal end 204), the second rod 1402 is pushed in the opposite direction (e.g., toward the proximal end 202), which causes a corresponding increase in tension on the first cable 1401 or the second cable 1402 and a corresponding decrease in tension on the second cable 1402 or the first cable 1401, respectively.

[0141] This figure also shows an adjuster plate 2440 in the handle 200. The adjuster plate 2440 includes a threaded aperture that engages with an external thread on the tension adjuster 1510. The adjuster plate 2440 is attached to and / or fixed in 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 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 the first direction causes the tension of the corresponding cables 1401, 1402 to increase. Conversely, moving the tension adjuster 1510 in the second direction causes the tension of the corresponding cables 1401, 1402 to decrease.

[0142] Fig.25 yes Fig.24 24 is a perspective view of the end steering device 2430 shown in FIG. The end steering device 2430 includes rods 2101, 2102, a mechanical lock 2105 and a rotating shaft 2400. The cables 1401, 1402 are arranged in a Fig.25. The mechanical lock 2105 is mechanically coupled to the shaft 2500, which is slidably coupled to the locking channel 2510 in the locking housing 2520. As measured relative to the axis 2530 of the shaft, the outer surface 2525 of the locking housing 2520 on the locking side 2512 of the locking channel 2510 is relatively higher than the outer surface 2525 of the locking housing 2520 on the unlocking side 2514 of the locking channel 2510. The edge 2405 of the shaft 2500 mechanically engages the outer surface 2525 of the locking housing 2420. When the shaft 2500 slides to the locking side 2512 of the locking channel 2510, the raised outer surface 2525 creates an upward force on the shaft 2500 to lock the rotation of the rotating shaft 2400 (e.g., by engaging the flared shaft brake 2540). Fig.25 The center shaft 2400 is partially transparent to further illustrate the end steering device 2430. In other embodiments, the mechanical lock 2105 may include a button, a lever, a dial, or other mechanism.

[0143] Fig.26 is through Fig.25 A cross-sectional view of a portion of the handle 200 taken along line 26-26 in FIG. 200 is provided to further illustrate the mechanical lock 2105. Fig.26 25, the mechanical lock 2105 is in an unlocked state. In the unlocked state, one or more upper edges 2602 of the shaft 2400 are disengaged from one or more inner edges 2604 of the handle 200 to allow the shaft 2400 to rotate freely. In the locked state, the raised outer surface 2525 causes the shaft 2500 to move upward (e.g., away from the shaft 2400 along the axis 2530 of the shaft). The shaft 2500 is mechanically coupled to (e.g., by threads) and / or includes a flared shaft brake 2540, which moves upward and downward with the shaft 2500 (e.g., relative to the axis 2530 of the shaft). When the shaft 2500 and the flared shaft brake 2540 move upward to convert the mechanical lock 2105 to the locked state, the flared shaft brake 2510 mechanically engages the shaft 2500 to push the shaft 2500 upward, which causes the upper edge 2602 of the shaft 2400 to mechanically engage the inner edge 2604 of the handle housing 2610. The mechanical engagement of the upper edge 2602 and the inner edge 2604 increases the friction therebetween to mechanically lock the rotation of the shaft 2400. Locking the rotation of the shaft 2400 sets or locks the tension (or lack of tension) on the cables 1401, 1402 to set or lock the customizable angle 1300 of the bendable shaft 220 relative to the elongated shaft 210 and the steerable end 230.

[0144] The present invention should not be considered to be limited to the specific embodiments described above. After reading this disclosure, various modifications, equivalent processes and multiple structures applicable to the present invention will be clear to those skilled in the art for which the present invention is directed. The embodiments described above can be implemented in a variety of ways. One or more aspects and embodiments related to the execution of a process or method can be performed or controlled by program instructions that can be executed by a device (e.g., a computer, a processor or other device) to execute or control the execution of a process or method.

[0145] In this regard, various inventive concepts may be implemented 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 transient or non-transitory digital storage units, field programmable gate arrays, or other semiconductor devices, circuit configurations, or other tangible computer storage media), which, when executed on one or more computers or other processors, implement one or more of the methods in the various embodiments described above. When implemented in software (e.g., as an application), the software code may be executed on any suitable processor or collection of processors, whether provided in a single computer or distributed among multiple computers.

[0146] Further, it should be understood that the computer may be implemented in any of a variety of forms, such as, by way of non-limiting example, a rack-mounted computer, a desktop computer, a laptop computer, or a tablet computer. In addition, the computer may be embedded in a device not generally regarded as a computer but having suitable processing capabilities, including a personal digital assistant (PDA), a smart phone, or any other suitable portable or fixed electronic device.

[0147] Likewise, the computer may have one or more communication devices that can be used to interconnect the computer to one or more other devices and / or systems, for example, one or more networks in any suitable form including local or wide area networks such as enterprise networks and intelligent networks (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.

[0148] Likewise, a computer may have one or more input devices and / or one or more output devices. These devices may be particularly useful for presenting 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 the output and a speaker or other sound generating device for sound presentation of the output. Examples of input devices that may be used for a user interface include a keyboard and a pointing device such as a mouse, a touch pad, and a digitizing tablet. As another example, a computer may receive input information by voice recognition or in other sound formats.

[0149] One or more non-transitory computer readable media may be transportable so that one or more programs stored thereon may be loaded onto one or more different computers or other processors to implement one or more of the various aspects described above. In some embodiments, the computer readable medium may be a non-transitory medium.

[0150] The terms "program", "application" and "software" herein are used in a general sense to refer to any type of computer code or computer executable instruction set that can be used to program a computer or other processor to implement various aspects as described above. In addition, it should be understood that, according to one aspect, one or more computer programs that perform the methods of the present application when executed do not need to remain on a single computer or processor, but can be distributed in a modular manner among multiple different computers or processors to implement various aspects of the present application.

[0151] Computer executable instructions can be in many forms such as program modules that are executed by one or more computers or other devices. Typically, program modules include routines, programs, objects, components, data structures, etc. that perform specific tasks or implement specific abstract data types. The functionality of program modules can be combined or distributed as needed in various embodiments.

[0152] Likewise, data structures may be stored in computer-readable media in any suitable form. To simplify illustration, data structures may be shown as having fields that are related by location in the data structure. Such relationships may also be achieved by assigning storage in a computer-readable medium with locations that convey the relationships between the fields. However, any suitable mechanism may be used to establish relationships between information in the fields of a data structure, including by using pointers, tags, or other mechanisms that establish relationships between data elements.

[0153] Thus, the present disclosure and claims include new and novel improvements to existing methods and techniques that were previously unknown and not implemented to achieve the useful results described above. Users of the present methods and systems will gain tangible benefits from the functionality now made possible by the specific modifications described herein that cause the effects in the system and its output to its users. It is expected that significantly improved operation can be achieved using the technical components described herein when implementing the claimed invention.

[0154] Likewise, as described, some aspects may be embodied as one or more methods. The actions performed as part of the method may be ordered in any suitable manner. Thus, embodiments may be constructed in which the actions are performed in an order different from the order shown, which may include performing some actions simultaneously, even though shown as continuous actions in the illustrative embodiments.

Claims

1. An instrument port, comprising: an elongated shaft having a proximal end and a distal end and extending along a shaft axis, the elongated shaft having a fluid port defined in an outer surface at the distal end of the elongated shaft; a bendable shaft having a proximal end attached to the distal end of the elongated shaft along the shaft axis, the bendable shaft being configured to bend only within a pivot plane defined by the shaft axis and a pivot axis orthogonal to the shaft axis; a steerable tip attached to the distal end of the bendable shaft, the steerable tip comprising an imaging system comprising: a camera disposed at a distal end of the steerable tip; and a light emitter disposed at the distal end of the steerable tip; a biasing balloon attached to an outer surface of the elongated shaft, the biasing balloon having an interior volume in fluid communication with the fluid port, the biasing balloon having an expanded state and a deflated state; a handle attached to the proximal end of the elongated shaft, the handle including a rod mechanically coupled to the bendable shaft to adjust a customizable angle of the steerable tip, the customizable angle being measured between an axis of the shaft and an axis of the tip; a fluid tube disposed in the elongated shaft, the fluid tube being fluidly coupled to the fluid port; a working tube disposed in the elongated shaft, the working tube forming a working channel; an ablation catheter disposed in the working channel, the ablation catheter being configured to form a lesion at a surgical site; and a microprocessor-based controller electrically connected to the imaging system, the controller being configured to: acquiring image data of the surgical site from the camera, the image data being associated with a plurality of images; Processing image data of a first image among the plurality of images and image data of a second image among the plurality of images using an image processor to automatically detect the lesion formed at the surgical site in real time; and In response to detecting that the lesion has a predetermined characteristic, automatically stopping the ablation catheter, wherein the controller further comprises a damage estimator subsystem, wherein the predetermined characteristic comprises a predetermined size, and the damaged portion comprises a first size detected in a first image of the plurality of images and a second size detected in a second image of the plurality of images, wherein the damage estimator subsystem operates to determine a rate of change of a size of the damaged portion between the first size and the second size.

2. The instrument port of claim 1, wherein: The predetermined characteristic also includes a predetermined color.

3. The instrument port of claim 1, wherein: 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 an axis of the shaft, and The customizable angle is 0°.

4. The instrument port of claim 1, wherein: In the expanded state, the biasing balloon expands radially asymmetrically.

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

6. The instrument port of claim 5, wherein: The fluid channel is fluidly coupled to a source of irrigation fluid 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 cylindrical body.

9. The instrument port of claim 8, wherein: The flexible cylindrical body includes a wire reinforcement lining.

10. The instrument port of claim 9, wherein: The wire-reinforced liner includes a pipe body and a spiral cable, wherein the pipe body includes fluorinated ethylene propylene.

11. The instrument port of claim 10, wherein: The inner surface of the flexible cylinder includes only the tube body to form a smooth surface to receive a medical device.

12. The instrument port of claim 1, wherein: 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 flexibility of the shaft.

13. The instrument port of claim 12, wherein: The metal tube includes stainless steel.

14. The instrument port of claim 12, wherein: The grooves are laser cut.

15. The instrument port of claim 12, wherein: The pattern comprises interrupted spirals.

16. The instrument port of claim 12, wherein: The pattern includes a plurality of fins extending circumferentially on a first side and a second side of the metal tube, The fins on the first side and the fins on the second side are separated by a first gap and a second gap extending along a plane defined by an axis of the shaft and an axis orthogonal to the axis of the shaft.

Images