Medical Implant Delivery And Deployment Tool

• US 20060173524A1
• Filed: 02/02/2006
• Published: 08/03/2006
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Valencia, Hans, Haug, Ulrich R., Brandt, Brian, Salahieh, Amr, Saul, Tom, Morejohn, Dwight
• Granted Patent: US 7,824,443 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/9517 handle assemblies therefor

Abstract

An apparatus for endovascularly replacing a patient'"'"'s heart valve. In some embodiments, the apparatus includes a replacement heart valve implant comprising a valve and an expandable anchor; and a deployment tool adapted to endovascularly deliver the replacement heart valve implant to an implant site within the patient, the deployment tool comprising an actuator adapted to exert an axially directed force on the anchor. The invention also provides a method for endovascularly replacing a heart valve of a patient. In some embodiments, the method includes the steps of endovascularly delivering a replacement heart valve implant having a valve and an anchor to an implant site within the patient; and applying an axially directed force from an actuator outside of the patient to the anchor. In invention also provides deployment tools for performing the method.

Claims

1. An apparatus for endovascularly replacing a patient'"'"'s heart valve, the apparatus comprising:

a replacement heart valve implant comprising a valve and an expandable anchor; and

a deployment tool adapted to endovascularly deliver the replacement heart valve implant to an implant site within the patient, the deployment tool comprising an actuator adapted to exert an axially directed force on the anchor.

2. The apparatus of claim 1 wherein the deployment tool is adapted to provide a force of 5 to 35 pounds from the actuator to the anchor.

3. The apparatus of claim 1 wherein the implant further comprises a lock, the deployment tool being adapted to lock the implant in an expanded configuration.

4. The apparatus of claim 3 wherein the deployment tool is further adapted to unlock the implant.

5. The apparatus of claim 1 wherein the deployment tool is adapted to provide a mechanical advantage of at least 2:

1 from the actuator to the anchor.

6. The apparatus of claim 5 wherein the mechanical advantage is variable over a movement range of the actuator.

7. The apparatus of claim 1 wherein the actuator comprises an anchor actuator, the deployment tool further comprising a sheath and a sheath actuator adapted to move the sheath with respect to the anchor.

8. The apparatus of claim 1 wherein the actuator comprises an anchor actuator, the deployment tool further comprising an unlocking actuator adapted to unlock the anchor from a locked configuration.

9. The apparatus of claim 1 wherein the actuator comprises an anchor actuator, the deployment tool further comprising a valve actuator adapted to move the valve with respect to the anchor.

10. The apparatus of claim 1 wherein the actuator comprises an anchor actuator, the deployment tool further comprises a nosecone and a nosecone actuator adapted to move the nosecone with respect to the anchor.

11. The apparatus of claim 1 wherein the deployment tool further comprises an anchor actuation element operably connecting the actuator with the anchor, the actuator and anchor actuation element being adapted to provide movement of a distal end of the anchor actuation element at a variable speed as the actuator moves at a constant speed.

12. The apparatus of claim 1 wherein the deployment tool further comprises a feedback mechanism providing information indicating a deployment state of the implant.

13. The apparatus of claim 1 wherein the deployment tool further comprises a plurality of actuators each adapted to perform a different deployment operation.

14. The apparatus of claim 13 wherein the deployment tool further comprises an actuator interlock adapted to prevent operation of one of the actuators before operation of another of the actuators.

15. The apparatus of claim 13 wherein the actuators are arranged on the deployment tool in a preferred order of operation.

16. The apparatus of claim 15 wherein the actuator comprises an anchor actuator, the deployment tool further comprising a sheath, a sheath actuator adapted to move the sheath with respect to the anchor, an implant attachment element adapted to attach the implant to the deployment tool, and a release actuator adapted to detach the attachment element from the implant;

the anchor actuator being disposed between the sheath actuator and the release actuator on the deployment tool.

17. The apparatus of claim 1 wherein the deployment tool further comprises a plurality of actuation elements, the actuator being adapted to operate the plurality of actuation elements.

18. The apparatus of claim 17 wherein the actuator is further adapted to operate the actuation elements sequentially.

19. The apparatus of claim 1 wherein the actuator comprises a power source.

20. The apparatus of claim 1 wherein the deployment tool further comprises a clutching mechanism adapted to limit a force transmitted from an actuator to an implant.

21. A method for endovascularly replacing a heart valve of a patient, the method comprising:

endovascularly delivering a replacement heart valve implant comprising a valve and an anchor to an implant site within the patient; and

applying an axially directed force from an actuator outside of the patient to the anchor.

22. The method of claim 21 further comprising using an actuator to move a sheath with respect to the anchor.

23. The method of claim 21 further comprising using an actuator to release the anchor from the deployment tool.

24. The method of claim 21 further comprising using an actuator to lock the anchor in an expanded configuration.

25. The method of claim 21 further comprising using an actuator to unlock the anchor from a locked configuration.

26. The method of claim 21 further comprising using an actuator to move the replacement valve with respect to the anchor.

27. The method of claim 21 further comprising applying an outward pressure from expansion of the anchor to the implant site of at least about 7 psi.

28. The method of claim 21 whereon the actuator provides a mechanical advantage of at least about 2:

1.

29. The method of claim 21 wherein the actuator provides a mechanical advantage that varies over an actuator movement range.

30. The method of claim 21 wherein an anchor actuation element operably connects the actuator with the anchor, the applying step comprising moving a distal end of the anchor actuation element at a variable speed as the actuator moves at a constant speed.

31. The method of claim 21 further comprising providing information about completion of actuation through a feedback mechanism.

32. The method of claim 21 wherein the applying step comprises applying the expansion force with a first actuation element, the method further comprising performing a second replacement valve deployment operation using a second actuation element.

33. The method of claim 32 wherein the actuator interfaces with the first and second actuation elements.

34. The method of claim 32 further comprising the step of operating an actuator interlock before operating the second actuation element.

35. The method of claim 32 wherein the actuator is a first actuator, the performing step comprising performing the second replacement valve deployment operation with a second actuator.

36. The method of claim 35 further comprising performing a third replacement valve deployment operation with a third actuator, wherein the actuators are arranged in an operation order, the method further comprising the step of operating the actuators in the operation order.