Devices and methods for delivering an endocardial device

• US 9,332,993 B2
• Filed: 03/14/2013
• Issued: 05/10/2016
• Est. Priority Date: 08/05/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cardiokinetix Incorporated
• Inventors: Kermode, James R., Alexander, Miles D., Davila, Matthew T.
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US13/828,184
• Publication Number:
  US 20130274595A1
• Time in Patent Office: 1,153 Days
• US Class Current: 1/1
• 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

Described herein are devices, systems and methods for delivering an endocardial device. The systems for delivering the device transvascularly may generally include an elongate guide catheter having a proximal end and a distal end; a conical dilator at the distal end of the elongate guide catheter, the conical dilator being removable to enable delivery of the ventricular portioning device; a delivery catheter having a proximal and distal end; an expansion member near the distal end of the delivery catheter and configured to expand a plurality of struts of the partitioning device; and a coupling element configured to deployably secure to a hub of the partitioning device. The systems for delivering the device transapically may generally include an elongate access sheath; an elongate delivery catheter; an expansion member; and a coupling element proximal to the expansion member and configured to deployably secure to a hub of the partitioning device.

Claims

1. A delivery system for transvascular delivery of 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;

a conical dilator at the distal end of the elongate guide catheter, the conical dilator being removable to enable delivery of the ventricular partitioning device;

a delivery catheter having a proximal and distal end, wherein the delivery catheter is configured for loading into the guide catheter, and after removal of the conical dilator, to deliver the ventricular partitioning device through the delivery catheter;

an expansion member near the distal end of the delivery 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 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 delivery system of claim 1 further comprising the ventricular partitioning device wherein the ventricular partitioning device comprises an umbrella-like structure, wherein the plurality of struts are joined at the hub.

3. The delivery system of claim 2, where the partitioning device has a central axis of symmetry.

4. The delivery system of claim 2, where the partitioning device has an asymmetric configuration around the hub.

5. The delivery system of claim 2, wherein the hub is coupled to the coupling element such that the hub is distal to the plurality of struts.

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

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

8. The delivery system of claim 1, wherein the guide catheter further comprises a steering mechanism that bends a distal end region of the guide catheter to steer the guide catheter into the patient'"'"'s ventricle.

9. The delivery system of claim 1, further comprising at least one radio-opaque marker.

10. The delivery system of claim 1, further comprising a guidewire lumen in at least one of the guide catheter or delivery catheter, wherein the guidewire lumen is configured for receiving a guidewire therethrough.

11. The delivery system claim 10, wherein the guidewire lumen is continuous through the length of the delivery system.

12. The delivery system of claim 10, wherein the guidewire lumen is configured as a rapid-exchange feature.

13. The delivery system of claim 10, further comprising the guidewire, wherein the guidewire is configured to be threaded through at least a portion of the delivery system to position the delivery system in the patient'"'"'s ventricle.

14. The delivery system of claim 13, wherein the guidewire comprises a distal tip with an anchoring mechanism for anchoring to a cardiac wall.

15. The delivery system of claim 1, wherein the delivery catheter comprises a steering mechanism to steer the delivery catheter into the patient'"'"'s ventricle.