# US 10,307,147 B2 · System for improving cardiac function by sealing a partitioning membrane within a ventricle

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- Number: US 10,307,147 B2
- Document ID: US10307147B2
- Status: Granted
- Kind: B2
- Application number: 15/452,435
- Filed: 2017-03-07
- Published: 2017-06-22
- Granted: 2019-06-04
- Earliest claimed: 1999-08-09
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Alexander Khairkhahan; Serjan D. Nikolic; Hugh R. Sharkey
- Web page: https://patentgrep.com/patent/US10307147B2

## CPC

- 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)}
- 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)}
- A61B 17/12122: {within the heart (for closing a cardiac septal defect A61B17/0057)}
- A61B 17/12172: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)}
- A61B 17/12195: {comprising a curable material}
- A61F 2/2487: {Devices within the heart chamber, e.g. splints}
- A61B 17/1214: {Coils or wires}
- A61B 2017/00243: {cardiac}
- A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)}
- A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects}
- A61B 2017/00579: {Barbed implements}
- A61B 2017/00592: {Elastic or resilient implements}
- A61B 2017/00597: {Implements comprising a membrane}
- A61B 2017/00601: {Implements entirely comprised between the two sides of the opening}
- A61B 2017/00615: {Implements with an occluder on one side of the opening and holding means therefor on the other}
- A61B 2017/00632: {Occluding a cavity, i.e. closing a blind opening}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/0649: {Coils or spirals}
- A61B 2017/12095: {Threaded connection}
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 2)

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

### Claim 4 (depends on 2)

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

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 6)

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.

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 8)

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.

### Claim 10 (depends on 1)

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

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 1)

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

### Claim 13 (depends on 1)

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

### Claim 14 (depends on 13)

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.

### Claim 15 (depends on 1)

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.

### Claim 16 (depends on 1)

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.

### Claim 17 (depends on 1)

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

### Claim 18 (depends on 1)

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.

### Claim 19 (depends on 18)

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.

### Claim 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.

### Claim 21 (depends on 20)

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.
