# US 11,109,838 B2 · System and catheter for image guidance and methods thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,109,838 B2 - Document ID: US11109838B2 - Status: Granted - Kind: B2 - Application number: 15/705,321 - Filed: 2017-09-15 - Published: 2018-01-04 - Granted: 2021-09-07 - Earliest claimed: 2008-12-08 - Assignees: ACIST Medical Systems, Inc. - Applicants: ACIST Medical Systems, Inc. - Inventors: Thomas C. Moore; Kendall R. Waters; Stephanie J. Buech; Robert Zelenka - Web page: https://patentgrep.com/patent/US11109838B2 ## CPC - A61B 8/445: {Details of catheter construction} - A61B 1/00082: {Balloons} - A61B 1/233: for the nose, i.e. nasoscopes {, e.g. testing of patency of Eustachian tubes} - A61B 1/2733: {Oesophagoscopes} - A61B 1/3137: {for examination of the interior of blood vessels} - A61B 8/0841: {for locating instruments} - A61B 8/0883: {for diagnosis of the heart} - A61B 8/12: in body cavities or body tracts, e.g. by using catheters - A61B 8/4461: {Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe} - A61B 8/4466: {involving deflection of the probe} - A61B 8/4494: {characterised by the arrangement of the transducer elements} - A61B 8/5223: {for extracting a diagnostic or physiological parameter from medical diagnostic data (for algorithms to analyse biomedical images G06T7/0012)} - A61B 8/5253: {combining overlapping images, e.g. spatial compounding} - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61B 34/25: {User interfaces for surgical systems} - A61B 90/37: {Surgical systems with images on a monitor during operation} - G16H 50/30: for calculating health indices; for individual health risk assessment - A61B 1/018: for receiving instruments - A61B 2017/00243: {cardiac} - A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)} - A61B 2017/00991: {Telescopic means} - A61B 2018/00577: {Ablation} - A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes} - A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter} - A61B 2090/3784: {both receiver and transmitter being in the instrument or receiver being also transmitter} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract A catheter-based imaging system comprises a catheter having a telescoping proximal end, a distal end having a distal sheath and a distal lumen, a working lumen, and an ultrasonic imaging core. The ultrasonic imaging core is arranged for rotation and linear translation. The system further includes a patient interface module including a catheter interface, a rotational motion control system that imparts controlled rotation to the ultrasonic imaging core, a linear translation control system that imparts controlled linear translation to the ultrasonic imaging core, and an ultrasonic energy generator and receiver coupled to the ultrasonic imaging core. The system further comprises an image generator coupled to the ultrasonic energy receiver that generates an image. ## Claims ### Claim 1 An apparatus for ablation lesion monitoring and assessment at an ablation site in a tissue of a patient, the apparatus comprising: a catheter having an imaging core that is configured to acquire baseline image data at the ablation site prior to ablating and post-ablation image data at the ablation site after ablating, wherein the imaging core is adapted to image a left atrial wall and pulmonary veins of the patient from an esophagus of the patient during a procedure; an imaging engine having a display and a processing unit, the imaging engine configured to: compensate the baseline image data and post-ablation image data for motion of the patient relative to the imaging core, co-register the compensated baseline image data and the compensated post-ablation image data to produce co-registered baseline and post-ablation image data, segment the co-registered baseline and post-ablation image data of the left atrial wall of the patient from surrounding tissue to produce segmented baseline and post-ablation image data corresponding to the left atrial wall, calculate one or more ultrasound tissue classifiers of the segmented baseline and post-ablation image data, wherein the one or more calculated ultrasound tissue classifiers correlate to collagen content at the left atrial wall, identify a susceptible substrate based on the collagen content at the left atrial wall being greater than normal left atrial wall tissue, provide an indication on the display based on the identified susceptible substrate, and map one or more ablative lesions responsive to the one or more calculated ultrasound tissue classifiers. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein the one or more calculated ultrasound tissue classifiers are based on a time-domain analysis or a frequency-domain analysis of the segmented image data. ### Claim 3 (depends on 1) The apparatus of claim 1, wherein the one or more calculated ultrasound tissue classifiers comprise at least one of integrated backscatter, slope of attenuation, and speed of sound. ### Claim 4 (depends on 1) The apparatus of claim 1, further comprising a temperature monitor that monitors luminal esophageal temperature responsive to the one or more calculated ultrasound tissue classifiers. ### Claim 5 (depends on 1) The apparatus of claim 1, wherein the apparatus is configured as a transesophageal echocardiographic system adapted to guide cardiac interventions. ### Claim 6 (depends on 1) The apparatus of claim 1, wherein the indication provided on the display is selected from the group consisting of: a location indication of a potential adverse event based on the one or more calculated ultrasound tissue classifiers and a location indication of necrosed tissue based on the one or more calculated ultrasound tissue classifiers. ### Claim 7 (depends on 6) The apparatus of claim 6, wherein the location indication of the potential adverse event includes a location of at least one of microbubble formation, overheating of an esophageal wall of the patient, or thrombus formation. ### Claim 8 (depends on 1) The apparatus of claim 1, wherein the imaging core comprises at least one transducer array having a plurality of transducer elements. ### Claim 9 (depends on 8) The apparatus of claim 8, wherein the imaging core is configured to acquire baseline and post-ablation image data of volumes of interest in the tissue of the patient from a first direction using a first transducer element and a second different direction using a second transducer element. ### Claim 10 An apparatus for ablation lesion monitoring and assessment at an ablation site in a tissue of a patient, the apparatus comprising: a catheter having an imaging core that is configured to acquire baseline image data at the ablation site prior to ablating and post-ablation image data at the ablation site after ablating, wherein the imaging core is configured to acquire baseline and post-ablation image data of volumes of interest in the tissue of the patient from a first direction using a first transducer element and a second different direction using a second transducer element; an imaging engine having a display and a processing unit, the imaging engine configured to: compensate the baseline image data and post-ablation image data for motion of the patient relative to the imaging core, co-register the compensated baseline image data and the compensated post-ablation image data to produce co-registered baseline and post-ablation image data, segment the co-registered baseline and post-ablation image data of a left atrial wall of the patient from surrounding tissue to produce segmented baseline and post-ablation image data corresponding to the left atrial wall, calculate one or more ultrasound tissue classifiers of the segmented baseline and post-ablation image data, wherein the one or more calculated ultrasound tissue classifiers correlate to collagen content at the left atrial wall, identify a susceptible substrate based on the collagen content at the left atrial wall being greater than normal left atrial wall tissue, provide an indication on the display based on the identified susceptible substrate, and map one or more ablative lesions responsive to the one or more calculated ultrasound tissue classifiers. ### Claim 11 (depends on 10) The apparatus of claim 10, wherein the imaging engine is configured to combine baseline and post-ablation image data acquired from the first and second different directions into a single spatial compound image. ### Claim 12 (depends on 10) The apparatus of claim 10, wherein the imaging core is adapted to image the left atrial wall and pulmonary veins of the patient from an esophagus of the patient during a procedure. ### Claim 13 A method of ablation lesion monitoring and assessment at an ablation site in a tissue of a patient, the method comprising the steps of: providing a catheter-based imaging system including: a catheter having an imaging core that is arranged for linear translation and rotation, wherein the imaging core is adapted to image a left atrial wall and pulmonary veins of the patient from an esophagus of the patient during a procedure, and an imaging engine having a processing unit and a display; acquiring baseline image data at the ablation site with the imaging core prior to ablating; acquiring post-ablation image data at the ablation site after ablating; compensating the baseline image data and post-ablation image data for motion of the patient relative to the imaging core; co-registering the baseline image data and the post-ablation image data to produce co-registered baseline and post-ablation image data; segmenting the co-registered baseline and post-ablation image data of the left atrial wall of the patient from surrounding tissue to produce segmented baseline and post-ablation image data corresponding to the left atrial wall; calculating one or more ultrasound tissue classifiers of the segmented baseline and post-ablation image data, wherein the one or more calculated ultrasound tissue classifiers correlate to collagen content at the left atrial wall; identify a susceptible substrate based on the collagen content at the left atrial wall being greater than normal left atrial wall tissue; mapping one or more ablative lesions responsive to the one or more calculated ultrasound tissue classifiers; and providing an indication on the display based on the identified susceptible substrate. ### Claim 14 (depends on 13) The method of claim 13, wherein calculating the one or more ultrasound tissue classifiers is based on a time-domain analysis or a frequency-domain analysis of the segmented image data. ### Claim 15 (depends on 13) The method of claim 13, wherein the calculated one or more ultrasound tissue classifiers include at least one of integrated backscatter, slope of attenuation, and speed of sound. ### Claim 16 (depends on 13) The method of claim 13, wherein the imaging core is configured to acquire baseline and post-ablation image data of volumes of interest in the tissue of the patient from a first direction using a first transducer element and a second different direction using a second transducer element. ### Claim 17 (depends on 13) The method of claim 13, wherein providing the indication on the display is selected from the group consisting of: indicating a location of a potential adverse event based on the one or more calculated ultrasound tissue classifiers and indicating a location of necrosed tissue based on the one or more calculated ultrasound tissue classifiers. ### Claim 18 (depends on 17) The method of claim 17, wherein indicating the location of the potential adverse event includes indicating a location of at least one of microbubble formation, overheating of an esophageal wall of the patient, or thrombus formation.