System for improving cardiac function by sealing a partitioning membrane within a ventricle

• US 10,307,253 B2
• Filed: 02/21/2013
• Issued: 06/04/2019
• Est. Priority Date: 08/09/1999
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Khairkhahan, Alexander, Nikolic, Serjan D., Sharkey, Hugh R.
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US13/773,235
• Publication Number:
  US 20130165735A1
• Time in Patent Office: 2,294 Days
• Field of Search: 600 16, 600 37, 600375, 604508, 606200, 606213, 606232, 623 2367, 623 316, 623 111
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

Partitioning devices that may be secured and sealed within a heart chamber for separating a patient'"'"'s heart chamber into a productive portion and a non-productive portion are described herein. The partitioning devices described herein may include a reinforced membrane with outwardly biased members. The reinforced membrane may have a central hub with a distally extending support stem with a plurality of feet which extend radially from a centerline axis and preferably have ends that are aligned in a common plane. These devices may be secured within the heart chamber by sealing them to the wall of the heart chamber, for example, by inflating an inflatable element on the periphery of the device. The non-productive portion may be filled with a material, including occlusive materials. Sealing and/or filling the non-productive portion formed by the devices described herein may help prevent leakage from the non-productive region.

Claims

1. A device for partitioning a ventricle of a patient'"'"'s heart into a productive portion and a non-productive portion, the device comprising:

a membrane and a membrane support frame, the membrane and the membrane support frame sized to span the patient'"'"'s ventricle, wherein the membrane and the membrane support frame are configured to have a collapsed configuration and an expanded configuration, wherein the membrane and membrane support frame are concave to form a trumpet-shaped surface in the expanded configuration;

at least one securing element on a peripheral portion of the membrane or membrane support frame configured to secure the membrane to a wall of the ventricle; and

a container secured to the device and positioned between the membrane support frame and the non-productive portion of the subject'"'"'s ventricle when the device is deployed in the subject'"'"'s ventricle.

2. The device of claim 1, wherein the container is secured to the membrane.

3. The device of claim 1, wherein the container extends from a peripheral portion of the membrane.

4. The device of claim 1, wherein the container is configured to substantially conform to the ventricular wall.

5. The device of claim 1, wherein the container is configured as a bag.

6. The device of claim 1, wherein the container is expandable.

7. The device of claim 1, wherein the container is made of a flexible material.

8. The device of claim 1, wherein the container is configured to be filled with a fluid.

9. The device of claim 1, wherein the container is configured to be filled with one or more coils.

10. The device of claim 1, further comprising a valve providing access into the container.

11. The device of claim 10, wherein the valve is a one-way valve configured to allow the container to passively fill with blood from the ventricle.

12. The device of claim 1, further comprising a central hub.

13. The device of claim 1, further comprising a stem.

14. The device of claim 13, wherein the stem is positioned within the container.

15. The device of claim 1, further comprising:

a central hub, the membrane support frame extending from a first side of the central hub; and

a foot extending form a second side of the central hub.

16. The device of claim 15, wherein the foot is entirely encompassed by the container.

17. The device of claim 1, wherein the membrane support frame is resilient.