DEVICES AND METHODS FOR DELIVERING AN ENDOCARDIAL DEVICE

• US 20110087066A1
• Filed: 09/29/2010
• Published: 04/14/2011
• Est. Priority Date: 08/09/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cardiokinetix Incorporated
• Inventors: Khairkhahan, Alexander, Nikolic, Serjan D., Boutillette, Michael P., Alexander, Miles D., Kermode, James R.
• Granted Patent: US 9,078,660 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12081 detachable by inflation
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 5/007 for contrast media

Abstract

Described herein are systems for partitioning a ventricle of a heart. The systems may include a partitioning device or implant, and an applicator for inserting, repositioning and/or removing the partitioning device. The implant may support the ventricle wall and may reduce the volume of the ventricle. In particular, described herein are systems for delivering and deploying a partitioning device into a ventricle. The delivery system may include a catheter having a distal coupling element for coupling to a partitioning device in a collapsed configuration; the catheter may also have an expansion member for applying force to the partitioning device to fully expand it into a deployed configuration and to secure or seal it against the ventricle wall.

Claims

1. A delivery system for delivering a ventricular partitioning device into a patient'"'"'s ventricle and deploying the partitioning device to reduce the effective volume of the ventricle by expanding the partitioning device from a collapsed delivery configuration into an expanded deployed configuration, the system comprising:

an elongate guide catheter having a proximal end and a distal end;

an expansion member near the distal end of the guide catheter and configured to expand a plurality of struts of the partitioning device by applying pressure to the collapsed partitioning device to open the partitioning device and secure it in the ventricle; and

a coupling element distal to the expansion member and configured to deployably secure to a hub of the partitioning device to retain the expansion member at least partially surrounded by the collapsed partitioning device prior to deployment.

2. The system of claim 1 further comprising an expansion control for expanding the expansion member to apply pressure and expand the ventricular partitioning device.

3. The system of claim 2, wherein the expansion control comprises an inflation lumen connected to the expansion member.

4. The system of claim 2, wherein the expansion control comprises a pullwire for pulling on the expansion member to expand it.

5. The system of claim 2, wherein the expansion control comprises a button, knob, slider, or dial on the proximal end of the elongate guide catheter for controlling expansion of the expansion member.

6. The system of claim 1 further comprising a deployment control for releasing the coupling element from the hub of the ventricular partitioning device.

7. The system of claim 6, wherein the deployment control comprises a torque shaft connected to the coupling element for unscrewing the coupling element from the ventricular partitioning device.

8. The system of claim 6, wherein the deployment control comprises a pullwire connected to the coupling element for pulling a hitch pin to release the ventricular partitioning device.

9. The system of claim 1 further comprising a ventricular partitioning device wherein the ventricular partitioning device comprises an umbrella-like structure having a plurality of struts joined at a central hub.

10. The system of claim 1, wherein the expansion member is a hydraulic expansion member comprising a plurality of openings for releasing pressurized fluid to apply pressure to expand the ventricular partitioning device.

11. The system of claim 1, wherein the expansion member is an inflatable balloon.

12. The system of claim 1, wherein the expansion member is a mechanical expander comprising a plurality of struts joined at their proximal and distal ends and configured to expand outwards when the proximal and distal ends are brought closer together.

13. The system of claim 1, wherein the coupling element comprises a helical screw.

14. The system of claim 1, wherein the coupling element comprises a hitch pin.

15. The system of claim 1, wherein the guide catheter further comprises a proximal handle having a one-handed activation release.

16. The system of claim 1 further comprising a steering mechanism that bends the distal end region of the guide catheter.

17. A delivery system for delivering a ventricular partitioning device into a patient'"'"'s ventricle and deploying the partitioning device to reduce the effective volume of the ventricle by expanding the partitioning device from a collapsed delivery configuration into an expanded deployed configuration, the system comprising:

an elongate guide catheter having a proximal end and a distal end;

an expansion member near the distal end of the guide catheter and configured to expand the partitioning device by applying pressure to open the collapsed partitioning device and secure it in the ventricle;

a coupling element distal to the expansion member and configured to deployably secure to a hub of the partitioning device to retain the expansion member at least partially surrounded by the collapsed partitioning device prior to deployment;

an expansion control at the proximal end of the elongate guide catheter for expanding the expansion member to apply pressure and expand the partitioning device; and

a deployment control for releasing the partitioning device from the guide catheter by separating the coupling element from the hub of the partitioning device.

18. The system of claim 17, wherein the expansion control comprises an inflation lumen connected to the expansion member.

19. The system of claim 17, wherein the expansion control comprises a pullwire for pulling on the expansion member to expand it.

20. The system of claim 17, wherein the expansion control comprises a button, knob, slider, or dial on the proximal end of the elongate guide catheter for controlling expansion of the expansion member.

21. The system of claim 17, wherein the deployment control comprises a torque shaft connected to the coupling element for unscrewing the coupling element from the ventricular partitioning device.

22. The system of claim 17, wherein the deployment control comprises a pullwire connected to the coupling element for pulling a hitch pin to release the ventricular partitioning device.

23. The system of claim 17 further comprising a ventricular partitioning device wherein eh ventricular partitioning device comprises an umbrella-like structure having a plurality of struts joined at a central hub.

24. The system of claim 17, wherein expansion member is a hydraulic expansion member comprising a plurality of openings for releasing pressurized fluid to apply pressure to expand the ventricular partitioning device.

25. The system of claim 17, wherein the expansion member is an inflatable balloon.

26. The system of claim 17, wherein the expansion member is a mechanical expander comprising a plurality of struts joined at their proximal and distal ends and configured to expand outwards when the proximal and distal ends are brought closer together.

27. The system of claim 17, wherein the coupling element comprises a helical screw.

28. The system of claim 17, wherein the coupling element comprises a hitch pin.

29. The system of claim 17, wherein the guide catheter further comprises a proximal handle having a one-handed activation release.

30. The system of claim 17 further comprising a steering mechanism that bends the distal end region of the guide catheter.

31. A delivery system for delivering an umbrella-shaped ventricular partitioning device into a patient'"'"'s ventricle and mechanically deploying the partitioning device to reduce the effective volume of the ventricle by expanding the partitioning device from a collapsed configuration into an expanded configuration, the system comprising:

an elongate guide catheter having a proximal end and a distal end;

a mechanical expander near the distal end of the guide catheter having a plurality of arms configured to extend outwards when operated to apply pressure to the partitioning device to open the partitioning device; and

a coupling element distal to the expansion member and configured to deployably secure to a central hub of the partitioning device and to retain the expansion member at least partially surrounded by the collapsed partitioning device prior to deployment.

32. A delivery system for delivering an umbrella-shaped ventricular partitioning device into a patient'"'"'s ventricle and deploying the partitioning device to reduce the effective volume of the ventricle by expanding the partitioning device from a collapsed configuration into an expanded configuration, the system comprising:

an elongate guide catheter having a proximal end and a distal end;

a mechanical expander near the distal end of the guide catheter comprising a plurality of arms joined at their proximal and distal ends and configured to expand outwards when the proximal and distal ends are brought closer together, the mechanical expander configured to apply pressure the partitioning device to open the partitioning device and secure it in the ventricle; and

a coupling element distal to the expansion member and configured to deployably secure to a hub of the partitioning device and to retain the expansion member at least partially surrounded by the collapsed partitioning device prior to deployment.

33. A delivery system for delivering an umbrella-shaped ventricular partitioning device into a patient'"'"'s ventricle and deploying the partitioning device to reduce the effective volume of the ventricle by expanding the partitioning device from a collapsed configuration into an expanded configuration, the system comprising:

an elongate guide catheter having a proximal end and a distal end;

an inflatable expander near the distal end of the guide catheter configured to extend outwards when inflated to apply pressure to open the partitioning device and to secure the partitioning device in the ventricle;

a distal nose spacer distal to the inflatable expander on the guide catheter and configured to space the inflatable expander proximally from a central hub region of the partitioning device;

a taper region between the distal nose spacer and the inflatable expander; and

a coupling element distal to the expansion member and configured to deployably secure to the central hub of the partitioning device and to retain the expansion member at least partially surrounded by the partitioning device prior to deployment.

34. A delivery system for delivering an umbrella-shaped ventricular partitioning device into a patient'"'"'s ventricle and mechanically deploying the partitioning device to reduce the effective volume of the ventricle by expanding the partitioning device from a collapsed configuration into an expanded configuration, the system comprising:

an elongate guide catheter having a proximal end and a distal end;

a pressure expander near the distal end of the guide catheter comprising a plurality of openings from a fluid source line extending along the length of the elongate catheter, the plurality of openings positioned near the distal end region of the elongate guide catheter and configured to release fluid and apply pressure to the proximal end region of the partitioning device to expand the partitioning device; and

a coupling element distal to the expansion member and configured to deployably secure to a central hub of the partitioning device and to retain the expansion member at least partially surrounded by the partitioning device prior to deployment.

35. A system for reducing the effective volume of the ventricle by securing a ventricular partitioning device within the ventricle, the system comprising:

an umbrella-shaped ventricular partitioning device having a central hub, a plurality of struts, and a membrane, wherein the partitioning device has a collapsed delivery configuration and an expanded deployed configuration; and

a delivery system comprising;

an elongate guide catheter having a proximal end and a distal end;

a mechanical expander near the distal end of the guide catheter comprising a plurality of arms joined configured to extend outwards to expand the ventricular partitioning device by applying pressure against the struts to open the ventricular partitioning device;

a expansion pullwire coupled to the mechanical expander; and

a coupling element distal to the expansion member and configured to deployably secure to the central hub of the partitioning device and to retain the expansion member at least partially surrounded by the collapsed partitioning device prior to deployment.

37. The method of claim 35 further comprising securing the periphery of the partitioning device to the ventricle wall.

38. The method of claim 35, further comprising sealing the periphery of the partitioning device to the ventricle wall.

39. The method of claim 35, further comprising percutaneously guiding the partitioning device on the end of the guide catheter into the ventricle.

40. The method of claim 35, further comprising advancing the partitioning device into the ventricle through an inner lumen of a delivery catheter.

41. The method of claim 35, wherein the step of expanding the expansion member comprises expanding an inflatable expansion member near the distal end of the guide catheter.

42. The method of claim 35, wherein the step of expanding the expansion member comprises expanding a plurality of arms joined at their proximal and distal ends by expand bringing the proximal and distal ends closer together.

43. The method of claim 35, wherein the step of expanding the expansion member comprises expelling fluid from a plurality of openings positioned near the distal end region of the guide catheter to apply pressure to the proximal end region of the partitioning device to expand the partitioning device.

44. The method of claim 35, wherein the step of releasing comprises rotating a torque shaft rotates to withdraw a helical coil screw from a hub of the partitioning device.

36. A method of reducing ventricular volume to treat heart disease, the method comprising:

positioning an umbrella-shaped, expandable partitioning device having a reinforced membrane in a contracted configuration near the apex of a patients'"'"' ventricle using an elongate guide catheter to which the partitioning device is releasably coupled;

expanding an expansion member near the distal end of the guide catheter to apply pressure to the proximal end region of the contracted partitioning device to expand the partitioning device; and

releasing a coupling element distal to the expansion member on the guide catheter to deploy the partitioning device.