Devices and methods for delivering an endocardial device

Patent metadata

Field	Value
Publication number	US-10064696-B2
Application number	US-201615133080-A
Country	US
Kind code	B2
Filing date	Apr 19, 2016
Priority date	Aug 9, 2000
Publication date	Sep 4, 2018
Grant date	Sep 4, 2018

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.

First claim

What is claimed is:

1. A method of reducing ventricular volume to treat heart disease, the method comprising:
positioning an umbrella-shaped; expandable partitioning device having a reinforced membrane on a rib structure in a contracted configuration near an apex of a patient's ventricle using an elongate delivery catheter to which the partitioning device is releasably coupled;
expanding the partitioning device by expanding an expansion member comprising an expandable structure of the delivery catheter proximal to a distal end of the delivery catheter to apply pressure to a proximal end region of the contracted partitioning device; and
releasing a coupling element distal to the expansion member on the delivery catheter to deploy the partitioning device.

2. The method of claim 1 further comprising securing a periphery of the partitioning device to a wall of the ventricle.

3. The method of claim 1 further comprising sealing a periphery of the partitioning device to a wall of the ventricle.

4. The method of claim 1 further comprising percutaneously guiding the partitioning device on the distal end of the delivery catheter into the patient's ventricle.

5. The method of claim 1 further comprising advancing the partitioning device into the patient's ventricle through an inner lumen of a guide catheter.

6. The method of claim 1 , wherein expanding the partitioning device by expanding the expansion member further comprises expanding an inflatable expansion member near the distal end of the delivery catheter.

7. The method of claim 1 , wherein expanding the partitioning device by expanding the expansion member comprises expanding a plurality of discrete arms of the delivery catheter, joined at their proximal and distal ends, by bringing the proximal and distal ends closer together.

8. The method of claim 1 , wherein releasing a coupling element comprises rotating a torque shaft to withdraw a helical coil screw from a hub of the partitioning device.

9. The method of claim 1 further comprising pulling pull wire to expand the expansion member.

10. The method of claim 1 further comprising rotating a torque shaft of the delivery catheter to release the coupling element from the partitioning device.

11. The method of claim 1 , wherein the expandable structure of the delivery catheter is self-expanding and comprises a shape memory material.

12. 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 patient's ventricle using an elongate delivery catheter to which the partitioning device is releasably coupled;
expanding a mechanical expander comprising an expandable structure of the delivery catheter proximal to a distal end of the delivery catheter to apply pressure to a proximal end region of the contracted partitioning device to expand the partitioning device; and
releasing a coupling element distal to the mechanical expander on the delivery catheter to deploy the partitioning device.

13. The method of claim 12 , wherein the mechanical expander comprises a plurality of discrete arms.

14. The method of claim 12 further comprising securing the partitioning device against a wall of the ventricle to create a seal.

15. The method of claim 12 further comprising percutaneously guiding the partitioning device on the distal end of the delivery catheter into the ventricle.

16. The method of claim 12 further comprising advancing the partitioning device into the ventricle through an inner lumen of a guide catheter.

17. The method of claim 12 , wherein releasing a coupling element comprises rotating a torque shaft to withdraw a helical coil screw from a hub of the partitioning device.

18. The method of claim 12 further comprising pulling a pull wire to expand the mechanical expander.

19. The method of claim 12 further comprising rotating a torque shaft of the delivery catheter to release the coupling element from the partitioning device.

20. The method of claim 12 , wherein the mechanical expander is self-expanding.

21. A method of reducing ventricular volume to treat heart disease, the method comprising:
percutaneously guiding an expandable partitioning device having a membrane on a frame and a contracted configuration on an end of an elongate delivery catheter to which the partitioning device is releasably coupled, into a patient's ventricle through an inner lumen of a guide catheter;
positioning the expandable partitioning device in the contracted configuration near an apex of the patient's ventricle;
expanding the partitioning device by expanding an expansion member comprising an expandable structure of the delivery catheter proximal to a distal end of the delivery catheter, to apply outward pressure to the contracted partitioning device to expand the partitioning device;
securing and sealing a periphery of the partitioning device to a wall of the ventricle;
releasing a coupling element distal to the expansion member on the delivery catheter to deploy the partitioning device; and
after the step of expanding the partitioning device by expanding an expansion member, collapsing the expansion member and withdrawing the delivery catheter from the patient's ventricle;
wherein the step of expanding the partitioning device by expanding an expansion member comprises expanding a structure of the delivery catheter comprising a plurality of discrete arms joined at their proximal and distal ends, by bringing the proximal and distal ends closer together.

Assignees

• Edwards Lifesciences Corp

Inventors

• Boutillette Michael P
• Kermode James R
• Alexander Miles D
• Khairkhahan Alexander
• Nikolic Serjan D

Classifications

• A61B2017/00526

  Methods of manufacturing · CPC title

• B29C66/71

  characterised by the composition of the plastics material of the parts to be joined (welding bar compositions B29C65/125) · CPC title

• B29C66/729

  Textile or other fibrous material made from plastics · CPC title

• B29C66/532

  Joining single elements to the wall of tubular articles, hollow articles or bars · CPC title

• A61B17/12172

  having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526) · CPC title