# US 12,213,817 B2 · Systems and methods for radiographic monitoring of shunts > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,213,817 B2 - Document ID: US12213817B2 - Status: Granted - Kind: B2 - Application number: 17/919,491 - Filed: 2021-04-23 - Published: 2024-01-04 - Granted: 2025-02-04 - Earliest claimed: 2020-04-23 - Assignees: Shifamed Holdings, LLC - Applicants: Shifamed Holdings, LLC - Inventors: Scott Robertson; Brian Fahey; Miles Alexander; Peter Andriola; William Jason Fox; Anthony Pantages - Web page: https://patentgrep.com/patent/US12213817B2 ## CPC - A61B 6/12: Arrangements for detecting or locating foreign bodies - A61B 6/022: {Stereoscopic imaging} - A61B 6/503: {for diagnosis of the heart} - A61B 6/5217: {extracting a diagnostic or physiological parameter from medical diagnostic data} - A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)} - A61B 17/11: for performing anastomosis; Buttons for anastomosis - A61B 17/12036: {partial occlusion} - A61B 5/7292: {Prospective gating, i.e. predicting the occurrence of a physiological event for use as a synchronisation signal} - A61B 6/5264: {due to motion} - A61B 2017/00022: {Sensing or detecting at the treatment site} - A61B 2017/00243: {cardiac} - A61B 2017/00398: {using powered actuators, e.g. stepper motors, solenoids} - A61B 2017/00411: {actuated by application of energy from an energy source outside the body} - A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects} - A61B 2017/00597: {Implements comprising a membrane} - A61B 2017/00606: {Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening} - A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections} - A61B 2090/3966: {Radiopaque markers visible in an X-ray image} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract The present technology relates to interatrial shunting systems and methods. In some embodiments, the present technology includes a method for monitoring a shunting element implanted in a patient and having a lumen fluidly coupling cavities of the patient's heart. The method can comprise obtaining first and second radiographic images of at least two radiopaque elements associated with the lumen of the shunting element. A spatial relationship between the radiopaque elements varies according to a size of the lumen. The first radiographic image can be taken from a first viewing angle and the second radiographic image can be taken from a second viewing angle generally orthonormal to the first viewing angle. The method also includes determining the size of the lumen based, at least in part. on locations of the radiopaque elements in the first and second radiographic images. ## Claims ### Claim 1 A method for monitoring a shunting element implanted in a patient and having a lumen fluidly coupling a first body region of the patient and a second body region of the patient, wherein the lumen of the shunting element is selectively adjustable to control fluid flow therethrough, the method comprising: receiving a first radiographic image of at least two radiopaque elements associated with the lumen, wherein a spatial relationship between the at least two radiopaque elements varies according to a size of the lumen, and wherein the first radiographic image is taken from a first viewing angle; receiving a second radiographic image of the at least two radiopaque elements, wherein the second radiographic image is taken from a second viewing angle different than the first viewing angle; and determining the size of the lumen based, at least in part, on locations of the at least two radiopaque elements in the first and second radiographic images. ### Claim 2 (depends on 1) The method of claim 1 wherein the second viewing angle is orthogonal to the first viewing angle. ### Claim 3 (depends on 1) The method of claim 1 wherein the second viewing angle is orthonormal to the first viewing angle. ### Claim 4 (depends on 1) The method of claim 1 wherein the at least two radiopaque elements are positioned at or near a perimeter of the lumen. ### Claim 5 (depends on 4) The method of claim 4 wherein the at least two radiopaque elements include a first radiopaque element and a second radiopaque element positioned at diametrically opposite locations at or near the perimeter of the lumen. ### Claim 6 (depends on 1) The method of claim 1 wherein the shunting element includes a structure at least partially surrounding the lumen, wherein the structure comprises one or more of a frame, a stent, a membrane, a ring, or a band, and wherein the structure includes the at least two radiopaque elements. ### Claim 7 (depends on 1) The method of claim 1 wherein the at least two radiopaque elements comprise bands, markers, discs, rivets, fasteners, or beads. ### Claim 8 (depends on 1) The method of claim 1 wherein the at least two radiopaque elements each have a spherical, cylindrical, or circular shape. ### Claim 9 (depends on 1) The method of claim 1 wherein: the first and second radiographic images each include image data of at least one calibration element having a spherical, cylindrical, or circular shape; and the method further comprises determining a scaling factor for the first and second radiographic images based at least in part on the image data of the at least one calibration element. ### Claim 10 (depends on 9) The method of claim 9 wherein the at least one calibration element is carried by the shunting element. ### Claim 11 (depends on 9) The method of claim 9 wherein the at least one calibration element is external to the patient's body. ### Claim 12 (depends on 1) The method of claim 1 wherein the first viewing angle is an anterior-posterior viewing angle and the second viewing angle is a lateral viewing angle. ### Claim 13 (depends on 1) The method of claim 1 wherein the first and second radiographic images are gated based on one or more of a respiratory cycle or a cardiac cycle of the patient. ### Claim 14 (depends on 1) The method of claim 1 wherein determining the size of the lumen comprises: determining two-dimensional measurements of the at least two radiopaque elements in each of the first and second radiographic images; and calculating a three-dimensional distance between the at least two radiopaque elements based on the two-dimensional measurements. ### Claim 15 (depends on 1) The method of claim 1, further comprising adjusting the lumen of the shunting element before, during, and/or after obtaining the first and second radiographic images. ### Claim 16 (depends on 1) The method of claim 1 wherein the first body region includes a first cavity of a heart of the patient and the second body region includes a second cavity of the heart of the patient, and wherein the first and second cavities of the heart of the patient include: (a) a left atrium and a right atrium, (b) a left ventricle and a right ventricle, or (c) a coronary sinus and the left ventricle. ### Claim 17 A system for monitoring a shunting element implanted in a patient and having a lumen fluidly coupling a first body region of the patient and a second body region of the patient, the system comprising: a processor; and a memory storing instructions that, when executed by the processor, cause the system to perform operations comprising: receiving first radiographic image data of at least two radiopaque elements associated with the lumen, wherein a spatial relationship between the at least two radiopaque elements varies according to a size of the lumen, wherein the lumen of the shunting element is selectively adjustable to control fluid flow therethrough, and wherein the first radiographic image data is taken from a first viewing angle; receiving second radiographic image data of the at least two radiopaque elements, wherein the second radiographic image data is taken from a second viewing angle different than the first viewing angle; and determining the size of the lumen based, at least in part, on locations of the at least two radiopaque elements in the first and second radiographic image data. ### Claim 18 (depends on 17) The system of claim 17 wherein the second viewing angle is orthogonal to the first viewing angle. ### Claim 19 (depends on 17) The system of claim 17 wherein the second viewing angle is orthonormal to the first viewing angle. ### Claim 20 A non-transitory computer-readable medium storing instructions that, when executed by a processor of a system for monitoring a shunting element implanted in a patient and having a lumen fluidly coupling a first body region of the patient and a second body region of the patient, cause the system to perform operations comprising: receiving first radiographic image data of at least two radiopaque elements associated with the lumen, wherein a spatial relationship between the at least two radiopaque elements varies according to a size of the lumen, wherein the lumen of the shunting element is selectively adjustable to control fluid flow therethrough, and wherein the first radiographic image data is taken from a first viewing angle; receiving second radiographic image data of the at least two radiopaque elements, wherein the second radiographic image data is taken from a second viewing angle different than the first viewing angle; and determining the size of the lumen based, at least in part, on locations of the at least two radiopaque elements in the first and second radiographic image data. ### Claim 21 (depends on 20) The non-transitory computer-readable medium of claim 20 wherein the second viewing angle is orthogonal to the first viewing angle. ### Claim 22 (depends on 20) The non-transitory computer-readable medium of claim 20 wherein the second viewing angle is orthonormal to the first viewing angle.