Devices and methods for delivering an endocardial device

• US 10,064,696 B2
• Filed: 04/19/2016
• Issued: 09/04/2018
• Est. Priority Date: 08/09/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Boutillette, Michael P., Kermode, James R., Alexander, Miles D., Khairkhahan, Alexander, Nikolic, Serjan D.
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US15/133,080
• Publication Number:
  US 20160302924A1
• Time in Patent Office: 868 Days
• 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 2017/00526 Methods of manufacturing
• 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 2017/12095 Threaded connection
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: B29C 43/18 incorporating preformed parts or layers, e.g. compression moulding around inserts or for coating articles B29C43/206 takes precedence
• CPC Class Codes: B29C 65/18 using heated tools
• CPC Class Codes: B29C 66/1122 Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/532 Joining single elements to the wall of tubular articles, hollow articles or bars
• CPC Class Codes: B29C 66/53261 Enclosing tubular articles between substantially flat elements
• CPC Class Codes: B29C 66/545 one hollow-preform being placed inside the other
• CPC Class Codes: B29C 66/636 using a support which remains in the joined object
• CPC Class Codes: B29C 66/71 characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/712 the composition of one of the parts to be joined being different from the composition of the other part
• CPC Class Codes: B29C 66/727 : being porous, e.g. foam
• CPC Class Codes: B29C 66/729 : Textile or other fibrous material made from plastics
• CPC Class Codes: B29C 66/81429 : comprising a single tooth
• CPC Class Codes: B29C 66/81431 : comprising a single cavity, e.g. a groove
• CPC Class Codes: B29C 66/8322 : Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29C 70/74 : Moulding material on a relatively small portion of the preformed part, e.g. outsert moulding B29C70/845 takes precedence
• CPC Class Codes: B29K 2023/06 : PE, i.e. polyethylene
• CPC Class Codes: B29K 2023/065 : HDPE, i.e. high density polyethylene
• CPC Class Codes: B29K 2027/18 : PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29L 2031/753 : Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008

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 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.