Granted Patent B2

US 12,408,917 · App. 16/916,754 · Granted Sep 9, 2025

Inventor: Alex Khairkhahan (Palo Alto, CA)

Assignee: EVALVE, INC.

A61B17/10A61B17/1285A61B17/320016A61B17/3205A61B18/1492A61B2017/00243A61B2017/00358A61B2017/00783A61B2017/00876A61B17/083A61B2017/22035A61B2017/32006A61B2018/00369A61B2018/00601A61B2018/1407A61B2018/144A61F2/246A61F2/2466

Abstract

Claims (30)

1. A system for excising an implanted clip approximating opposed valve leaflets in a heart valve, said system comprising:

a capture catheter configured to be introduced into a heart chamber adjacent to the valve leaflets on one side of the clip;

a transfer catheter configured to be introduced into the heart chamber adjacent to the valve leaflets on another side of the clip; and

a cutting member configured to be deployed from the transfer catheter to the capture catheter to place the cutting member against tissue of at least one of the valve leaflets to excise the clip, wherein the cutting member comprises a cutting zone formed of an uninsulated conductive member bounded by a first radiopaque marker and a second radiopaque marker.

2. A system as in claim 1 , wherein at least one of the capture catheter and the transfer catheter has a steerable distal tip.

3. A system as in claim 1 , wherein each of the capture catheter and the transfer catheter has a steerable distal tip.

4. A system as in claim 1 , wherein the capture catheter has a magnetic distal tip.

5. A system as in claim 4 , wherein the cutting member is carried by the transfer catheter and has a magnetic element exposed at a distal end of the transfer catheter so that manipulation of the transfer catheter positions within the heart chamber allows the capture catheter to capture the cutting member.

6. A system as in claim 4 , wherein the magnetic distal tip has one of a sphere shape, a bullet shape, or a disc-like shape.

7. A system as in claim 1 , further comprising a clip removal catheter having a distal end configured to engage and capture the clip.

8. A system as in claim 1 , wherein the cutting member comprises a radiofrequency electrode for energized cutting of valve tissue.

9. A system as in claim 1 , wherein the cutting member comprises a mechanically abrasive or sharpened edge for mechanically cutting valve tissue.

10. A system as in claim 1 , further comprising a delivery sheath configured to introduce the capture catheter and the transfer catheter to the heart chamber.

11. A system as in claim 1 , wherein a delivery sheath has a lumen sized to simultaneously accommodate both the capture catheter and the transfer catheter.

12. A system as in claim 1 , wherein a delivery sheath comprises a transseptal sheath.

13. A system as in claim 1 , wherein a delivery sheath comprises a transapical sheath.

14. A system for excising an implanted clip approximating opposed valve leaflets in a heart valve, said system comprising:

a capture catheter configured to be introduced into a heart chamber adjacent to the valve leaflets on one side of the clip, the capture catheter comprising a magnetic tip;

a transfer catheter configured to be introduced into the heart chamber adjacent to the valve leaflets on another side of the clip; and

a cutting member configured to be deployed from the transfer catheter to the capture catheter to place the cutting member against tissue of at least one of the valve leaflets to excise the clip, the cutting member comprising a magnetic element exposed at a distal end of the transfer catheter during delivery so that manipulation of the transfer catheter positions the magnetic element within the heart chamber and allows magnetic attraction of the magnetic tip and the magnetic element so the capture catheter contacts a portion of the cutting member, wherein the cutting member comprises a cutting zone formed of uninsulated conductive member and bounded by a first radiopaque marker and a second radiopaque marker.

15. A system as in claim 14 , further comprising a transseptal sheath configured to receive the capture catheter and the transfer catheter.

16. A system as in claim 15 , wherein the cutting zone includes a radiofrequency electrode, an abrasive region, or a sharpened edge for cutting valve tissue.

17. A system as in claim 16 , further comprising a guidewire with a shapeable tip, the capture catheter being configured to be advanced along the guidewire to the heart chamber.

18. A system as in claim 17 , further comprising a clip removal catheter configured to be introduced into a heart chamber adjacent to the valve leaflets.

19. A system as in claim 18 , further comprising a clip capture element configured to be selectively delivered through a lumen of the clip removal catheter to capture the clip.

20. A system for excising an implanted clip approximating opposed valve leaflets in a heart valve, said system comprising:

a capture catheter configured to be introduced into a heart chamber adjacent to the valve leaflets on one side of the clip;

a transfer catheter configured to be introduced into the heart chamber adjacent to the valve leaflets on another side of the clip; and

a cutting member configured to be deployed from the transfer catheter to the capture catheter to place the cutting member against tissue of at least one of the valve leaflets to excise the clip, wherein the cutting member comprising at least one selected from a group of a sharpened member, an abrasive member, and an RF electrode member, wherein the cutting member comprises an elongate cutting zone formed of an uninsulated conductive member proximate a distal end of the cutting member, the cutting zone bounded by a first radiopaque marker and a second radiopaque marker.

21. A system as in claim 20 , wherein the cutting zone is located near a middle portion of the cutting member.

Assignments (2)

Continuity (4)

References Cited (400)