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

• US 10,307,147 B2
• Filed: 03/07/2017
• 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): Tanner, Jocelin C
• Application Number:
  US15/452,435
• Publication Number:
  US 20170172742A1
• Time in Patent Office: 819 Days
• 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 for prostheses A61F2210/0014
• 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
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas

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 membrane with a plurality of inflatable elements. The membrane may include a valve disposed in a central region of the membrane with a plurality of inflation channels extending radially from the valve. These devices may be secured within the heart chamber by sealing them to the wall of the heart chamber, for example, by inflating the plurality of inflatable elements 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 ventricular partitioning device comprising:

a membrane disposed around a center region;

a valve positioned in the center region; and

an inflation channel radially extending from the valve to a peripheral region of the membrane, wherein the inflation channel is in fluid communication with the valve,

wherein the valve is configured to control passage of a fluid into the inflation channel,

wherein the membrane is outwardly expandable when the fluid passes into the inflation channel, and

wherein the device further comprises an inflatable element positioned on or in the peripheral region of the membrane, wherein the inflatable element is in fluid communication with the inflation channel and the valve.

2. The ventricular partitioning device of claim 1, wherein the membrane comprises two layers.

3. The ventricular partitioning device of claim 2, wherein the inflatable element is defined by a cavity between the two layers forming the membrane.

4. The ventricular partitioning device of claim 2, wherein the inflation channel is formed by an unsealed channel between the two layers forming the membrane.

5. The ventricular partitioning device of claim 1, wherein the membrane comprises ePTFE.

6. The ventricular partitioning device of claim 1, wherein the inflation channel comprises a plurality of inflation channels.

7. The ventricular partitioning device of claim 6, wherein one or a subset of the plurality of inflation channels are configured to inflate when fluid passes through the valve.

8. The ventricular partitioning device of claim 1, wherein the inflatable element comprises a plurality of inflatable elements.

9. The ventricular partitioning device of claim 8, wherein one or a subset of the plurality of inflatable elements are configured to inflate when fluid passes through the valve.

10. The ventricular partitioning device of claim 1, wherein the ventricle partitioning device circumferentially expands when fluid passes into the inflatable element.

11. The ventricular partitioning device of claim 1, wherein the partitioning device radially expands when fluid passes into the inflation channel.

12. The ventricular partitioning device of claim 1, wherein the fluid comprises a gas or liquid.

13. The ventricular partitioning device of claim 1, further comprising a plurality of struts coupled to the membrane.

14. The ventricular partitioning device of claim 13, wherein each of the plurality of struts comprises an anchor configured to secure to a wall of the ventricle.

15. The ventricular partitioning device of claim 1, wherein the valve is connectable to an applicator, and wherein the applicator is configured to provide fluid to the valve.

16. The ventricular partitioning device of claim 1, wherein the inflatable element conforms to a surface of a wall of a ventricle when inflated within the ventricle.

17. The ventricular partitioning device of claim 1, wherein the partitioning device is non-circular when expanded in a ventricle.

18. A device as claimed in claim 1, wherein the inflatable element is located just proximal to a peripheral edge of the device, so that a portion of the membrane extends distally past the inflatable element.

19. A device as claimed in claim 18, wherein the portion of the membrane that extends distally past the inflatable element is loose and is adapted to help seal the device to a wall of the ventricle.

20. A ventricular partitioning device comprising:

a membrane disposed around a center region;

a valve disposed in a portion of the ventricular partitioning device; and

an inflation channel radially extending from the valve to a peripheral region of the membrane, wherein the inflation channel is in fluid communication with the valve, wherein the valve is configured to control passage of a fluid into the inflation channel, wherein the membrane is outwardly expandable when the fluid passes into the inflation channel; and

wherein the membrane comprises two layers.

21. A device as claimed in claim 20, wherein the device further comprises an inflatable element positioned on or in the peripheral region of the membrane, wherein the inflatable element is in fluid communication with the inflation channel and the valve.