IP Library › Granted Patent US 12,213,817
Granted Patent B2
US 12,213,817 · App. 17/919,491 · Granted Feb 4, 2025

Systems and methods for radiographic monitoring of shunts

Inventors: Scott Robertson (Portland, OR); Brian Fahey (Menlo Park, CA); Miles Alexander (Fremont, CA); Peter Andriola (Castro Valley, CA); William Jason Fox (San Mateo, CA); Anthony Pantages (San Jose, CA)
Assignee: Shifamed Holdings, LLC
A61B6/12A61B6/503A61B6/5217A61B6/5264
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Quick Facts
Patent No.
US 12,213,817
App. No.
17/919,491
Granted
Feb 4, 2025
Kind
B2
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 (37)

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.

2. The method of claim 1 wherein the second viewing angle is orthogonal to the first viewing angle.

3. The method of claim 1 wherein the second viewing angle is orthonormal to the first viewing angle.

4. The method of claim 1 wherein the at least two radiopaque elements are positioned at or near a perimeter of the lumen.

5. 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.

6. 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.

7. The method of claim 1 wherein the at least two radiopaque elements comprise bands, markers, discs, rivets, fasteners, or beads.

8. The method of claim 1 wherein the at least two radiopaque elements each have a spherical, cylindrical, or circular shape.

9. 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.

10. The method of claim 9 wherein the at least one calibration element is carried by the shunting element.

11. The method of claim 9 wherein the at least one calibration element is external to the patient's body.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

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.

18. The system of claim 17 wherein the second viewing angle is orthogonal to the first viewing angle.

19. The system of claim 17 wherein the second viewing angle is orthonormal to the first viewing angle.

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.

21. The non-transitory computer-readable medium of claim 20 wherein the second viewing angle is orthogonal to the first viewing angle.

22. The non-transitory computer-readable medium of claim 20 wherein the second viewing angle is orthonormal to the first viewing angle.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 9, 2023
From: ROBERTSON, SCOTT; FAHEY, BRIAN; ALEXANDER, MILES; ANDRIOLA, PETER; FOX, WILLIAM JASON; PANTAGES, ANTHONY
To: SHIFAMED HOLDINGS, LLC
Reel/Frame 065163/0394 →
Continuity (2)
Provisional Application 63014318 · Apr 23, 2020
Related Publication 20240000404A1 · Jan 4, 2024
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