Devices and methods for delivering an endocardial device

• US 9,078,660 B2
• Filed: 09/29/2010
• Issued: 07/14/2015
• Est. Priority Date: 08/09/2000
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cardiokinetix Incorporated
• Inventors: Boutillette, Michael P., Kermode, James R., Alexander, Miles D., Khairkhahan, Alexander, Nikolic, Serjan D.
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US12/893,832
• Publication Number:
  US 20110087066A1
• Time in Patent Office: 1,749 Days
• Field of Search: 623/2.17, 623 316- 32, 600/16, 600/37
• US Class Current: 1/1
• 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 for prostheses A61F2210/0014
• 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

Systems for partitioning a ventricle of a heart 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. The delivery system for delivering and deploying a partitioning device into a ventricle 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 delivery catheter having a proximal end and a distal end;

an expansion member near the distal end of the delivery catheter and configured to expand a plurality of struts extending from a central hub located at a distal end 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 configured to removably secure to the 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 delivery 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 delivery 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 delivery catheter.

17. The system of claim 1, wherein the coupling element is distal to the expansion member.

18. The system of claim 17, wherein the coupling element is entirely distal to the expansion member.

19. 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 delivery catheter having a proximal end and a distal end;

an expansion member near the distal end of the delivery 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 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, the hub located on a distal end of the partitioning device;

an expansion control at the proximal end of the elongate delivery 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 delivery catheter by separating the coupling element from the hub of the partitioning device.

20. The system of claim 19, wherein the expansion control comprises an inflation lumen connected to the expansion member.

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

22. The system of claim 19, wherein the expansion control comprises a button, knob, slider, or dial on the proximal end of the elongate delivery catheter for controlling expansion of the expansion member.

23. The system of claim 19, wherein the deployment control comprises a torque shaft connected to the coupling element for unscrewing the coupling element from the ventricular partitioning device.

24. The system of claim 19, wherein the deployment control comprises a pullwire connected to the coupling element for pulling a hitch pin to release the ventricular partitioning device.

25. The system of claim 19 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.

26. The system of claim 19, 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.

27. The system of claim 19, wherein the expansion member is an inflatable balloon.

28. The system of claim 19, 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.

29. The system of claim 19, wherein the coupling element comprises a helical screw.

30. The system of claim 19, wherein the coupling element comprises a hitch pin.

31. The system of claim 19, wherein the delivery catheter further comprises a proximal handle having a one-handed activation release.

32. The system of claim 19 further comprising a steering mechanism that bends the distal end region of the delivery catheter.

33. 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 delivery catheter having a proximal end and a distal end;

a mechanical expander near the distal end of the delivery catheter having a plurality of discrete 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 removably 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.

34. 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 delivery catheter having a proximal end and a distal end;

a mechanical expander near the distal end of the delivery catheter comprising a plurality of discrete 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 removably 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.

35. 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 delivery catheter having a proximal end and a distal end;

an inflatable expander near the distal end of the delivery catheter configured to extend outwards when inflated to apply pressure to open the partitioning device and to secure the partitioning device in the ventricle, wherein the inflatable expander has a proximal end that is distal the proximal end of the partitioning device in the collapsed delivery configuration; and

a coupling element configured to removably secure to a central hub of the partitioning device and to retain the inflatable expander at least partially surrounded by the partitioning device prior to deployment, the central hub located on a distal end of the partitioning device.

36. The system of claim 35, further comprising:

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

37. The system of claim 36, further comprising a taper region between the distal nose spacer and the inflatable expander.

38. 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 delivery catheter having a proximal end and a distal end;

a pressure expander near the distal end of the delivery 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 of the elongate delivery catheter and configured to release fluid that directly contacts and applies 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 removably 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.