IP Library › Granted Patent US 12,201,521
Granted Patent B2
US 12,201,521 · App. 17/655,978 · Granted Jan 21, 2025

Anchor position verification for prosthetic cardiac valve devices

Inventor: Amr Salahieh (Saratoga, CA)
Assignee: Shifamed Holdings, LLC
A61F2/2418A61M5/007A61F2220/0008A61F2250/0098A61M2210/125
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Quick Facts
Patent No.
US 12,201,521
App. No.
17/655,978
Granted
Jan 21, 2025
Kind
B2
Abstract

A device for treating a diseased native valve in a patient is provided, the device including a frame structure and a plurality of leaflets. The device can further include a spiral anchor configured to extend around an outer circumference of the frame structure. The anchor can be configured to deliver a contrast agent into or near a target tissue. Other embodiments and methods of use are also provided.

Claims (28)

1. A prosthesis for treating a diseased native valve, the prosthesis comprising:

a frame structure having a plurality of leaflets therein; and

a spiral anchor configured to extend around an outer perimeter of the frame structure, comprising

a wall defining a lumen that is an exterior wall along an outer perimeter of the spiral anchor (e.g., a monorail), and

at least one port in fluid communication with the lumen,

the lumen and the at least one port shaped and sized to transport and deliver a contrast agent that is detectable by a visualization modality.

2. The prosthesis of claim 1 , wherein the wall defining the lumen is an interior wall within an outer perimeter of the spiral anchor.

3. The prosthesis of claim 2 , wherein the wall defining the lumen is continuous from a proximal end to a distal end of the spiral anchor.

4. The prosthesis of claim 1 , wherein a proximal end of the wall is configured to fluidly couple with a distal end of a contrast agent delivery catheter, during the delivery of the prosthesis.

5. The prosthesis of claim 1 , wherein the at least one port is at a distal tip of the anchor.

6. The prosthesis of claim 1 , wherein the at least one port is proximal to a distal tip of the anchor.

7. The prosthesis of claim 1 , wherein the at least one port is oriented toward a leaflet and/or an annulus of the diseased native valve, when the spiral anchor is near a delivery position with respect to the diseased native valve.

8. The prosthesis of claim 7 , wherein the delivery position is a sub-annular space of the diseased native valve.

9. The prosthesis of claim 1 , wherein the contrast agent comprises barium-sulfate, iodine, or an iodine-based material.

10. A method of delivering a valve prosthesis, comprising:

advancing a distal end of a delivery device to a first side of a native valve;

deploying an anchor from a delivery configuration to a deployed configuration on the first side of the native valve, the anchor comprising at least one port for delivering a contrast agent therefrom;

advancing the anchor in the deployed configuration from the first side of the native valve to a second side of the native valve;

rotating the anchor in the deployed configuration around one or more structures on the second side of the native valve;

delivering the contrast agent through the at least one port into a blood flow path of the heart;

identifying a characteristic of the contrast agent in an image to confirm that the anchor has been rotated around the one or more structures.

11. The method of claim 10 , further comprising releasing the anchor from the distal end of the delivery device.

12. The method of claim 10 , wherein delivering the contrast agent comprises delivering following the step of advancing to the second side of the native valve.

13. The method of claim 12 , wherein confirming that the anchor has been fully rotated comprises confirming that dispersion of the contrast agent is substantially confined to a selected region.

14. The method of claim 11 , wherein the characteristic of the contrast agent comprises an extent of dispersion.

15. The method of claim 14 , wherein the selected region comprises a sub-annular space of the native valve.

16. The method of claim 14 , further comprising repeating at least one of the rotating, delivering, and identifying steps until the extent of dispersion is within the selected region.

17. The method of claim 10 , wherein the image comprises a fluoroscopic image.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 29, 2025
From: SHIFAMED HOLDINGS, LLC
To: TIOGA CARDIOVASCULAR, INC.
Reel/Frame 073425/0381 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 8, 2022
From: SALAHIEH, AMR
To: SHIFAMED HOLDINGS, LLC
Reel/Frame 061695/0547 →
Continuity (2)
Provisional Application 63164514 · Mar 22, 2021
Related Publication 20230044256A1 · Feb 9, 2023
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