System and method for visual confirmation of pulmonary vein isolation during abalation procedures

• US 10,154,888 B2
• Filed: 12/01/2015
• Issued: 12/18/2018
• Est. Priority Date: 12/03/2014
• Status: Active Grant

• Current Assignee: Cardiofocus Incorporated
• Original Assignee: Cardiofocus Incorporated
• Inventors: Sagon, Stephen, Melsky, Gerald
• Primary Examiner(s): LUAN, SCOTT
• Application Number:
  US14/956,052
• Publication Number:
  US 20160157954A1
• Time in Patent Office: 1,113 Days
• CPC Class Codes: A61B 1/00009 of image signals during a use of endoscope
• CPC Class Codes: A61B 1/042 characterised by a proximal camera, e.g. a CCD camera
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/2272 with reflective or refractive surfaces for deflecting the beam A61B2018/2261, A61B2018/2266 take precedence
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation

Abstract

The present disclosure relates to ablation instruments and methods of use thereof, in particular to ablation catheters and methods for providing visual confirmation of pulmonary isolation during an ablation procedure and preferably, in real-time.

Claims

1. A tissue ablation system configured to provide visual confirmation of pulmonary vein isolation during an ablation procedure in which a lesion formed by directed energy emission at a treatment site of a patient, the tissue ablation system comprising:

a tissue ablation instrument includes an inflatable balloon for contacting tissue and for use at the treatment site and having a movable directed energy emitter configured to emit a variable amount of directed energy for ablating tissue and forming the lesion at the treatment site;

an imaging device that is configured to obtain at least one of live video and still images of the treatment site; and

a computer having a processor, database and a display and a plurality of modules executing in the processor so as to configure the computer to perform operations, the plurality of modules including an analysis module configured to analyze a visual change in a distal pool of blood within the pulmonary vein at the treatment site and based on the analysis to determine whether a degree of electrical isolation of the pulmonary vein as a result of formation of the lesion therearound during the ablation procedure meets a threshold value;

wherein the analysis module is configured to perform analysis of the live video and still images from the imaging device and perform a comparison between a baseline image of the distal pool of blood prior to initiating the ablation procedure and one or more subsequent images of the distal pool of blood as the ablation procedure is being performed or has been completed, wherein the analysis module calculates a degree of completion of the lesion by analyzing a level of perturbation of the distal blood pool within the pulmonary vein including analysis of a presence or absence of visible fluid characteristics that are indicative of blood motion and are observed in the one or more subsequent images of the distal blood pool at an interface between the distal blood pool and the tissue.

2. The system of claim 1, wherein the imaging device comprises an endoscope to permit real-time observation of the treatment site including the distal pool of blood.

3. The system of claim 1, wherein the imaging device includes a CCD camera.

4. The system of claim 1, wherein the tissue ablation instrument is sized and configured to provide access to an ostium of the pulmonary vein.

5. The system of claim 4, wherein the lesion is formed on the ostium surrounding the pulmonary vein.

6. The system of claim 1, wherein the level of perturbation is at a maximum value in the baseline image and the level of perturbation in the subsequent image is less than the maximum value.

7. The system of claim 6, wherein electrical isolation of the pulmonary vein is represented by an at least substantial reduction of the level of perturbation of the distal blood pool.

8. The system of claim 1, wherein electrical isolation of the pulmonary vein is represented by a reduction of the level of perturbation of the distal blood pool and completion of the ablation procedure occurs when the level of perturbation falls below a threshold value.

9. The system of claim 1, wherein the level of perturbation of the distal blood pool is calculated by analyzing each image for physical characteristics of the distal blood pool that are indicative of perturbation.

10. The system of claim 1, further including a split-screen module for simultaneously displaying the live video image and the baseline image.

11. The system of claim 1, wherein the processor is configured to provide a signal to a user of the tissue ablation instrument indicating completion of the electrical isolation of the pulmonary vein a result of formation of the lesion which is effective to block the conduction of electrical signals at the pulmonary vein.

12. A method for confirming electrical isolation of a pulmonary vein during an ablation procedure in which a lesion is formed by directed energy emission at a treatment site of a patient, the method comprising:

analyzing a visual change in a distal pool of blood within the pulmonary vein at the treatment site;

wherein the step of analyzing the visual change in the distal pool of blood comprises the step of comparing;

     1) a target optimal image of the distal pool of blood that results after performing the ablation procedure and

     2) an image taken in real-time of the distal pool of blood as the ablation procedure is being performed, wherein the step of analyzing comprises the step analyzing a degree of perturbation of the distal pool of blood by overlying the image taken in real time with the target optimal image to highlight any areas of perturbation in the real time image.

13. The method of claim 12, wherein any perturbations visible in the real time image are highlighted in a different color than the target optimal image for assessing the degree of perturbation in the real-time image of the distal pool of blood.

14. A tissue ablation system configured to provide visual confirmation of pulmonary vein isolation during an ablation procedure in which a lesion formed by directed energy emission at a treatment site of a patient, the tissue ablation system comprising:

a tissue ablation instrument includes an inflatable balloon for contacting tissue and for use at the treatment site and having a movable directed energy emitter configured to emit a variable amount of directed energy for ablating tissue and forming the lesion at the treatment site;

an imaging device that is configured to obtain at least one of live video and still images of the treatment site; and

a computer having a processor, database and a display and a plurality of modules executing in the processor so as to configure the computer to perform operations, the plurality of modules including an analysis module configured to analyze a visual change in a distal pool of blood within the pulmonary vein at the treatment site and based on the analysis to determine whether a degree of electrical isolation of the pulmonary vein as a result of formation of the lesion therearound during the ablation procedure meets a threshold value;

wherein the step of determining whether a degree of electrical isolation of the pulmonary vein as a result of formation of the lesion therearound during the ablation procedure meets the threshold value comprises the steps of;

detecting significant change in a movement of a distal blood pool border comprises measuring the excursion of the border of the blood pool and involves the following steps;

(a) provide a signal gated to either a high voltage recurring component of the ECG or at the point of photographic evidence of the maximum excursion of the blood pool border throughout the cardiac cycle;

(b) measure the length of two or more orthogonal diagonals at the time of activation gated to either of these signals;

(c) compute a first maximum, minimum, and average length measurement;

(d) measure the length of two or more orthogonal diagonals at a recurring isoelectric ECG phase in between gated activation or at the point of photographic evidence of the minimum excursion of the blood pool border throughout the cardiac cycle;

(e) compute a second maximum, minimum and average length measurement;

(f) calculate a difference between the first and second measurements;

(g) program an indicator representing an achievement of a predetermined percentage reduction in the excursion of the border of the blood pool measurements or at a point potentially referencing a representative point at which electrical activity has been shown to have been eliminated.