# US 10,499,892 B2 · Temporary occlusion balloon devices and methods for preventing blood flow through a vascular perforation

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- Number: US 10,499,892 B2
- Document ID: US10499892B2
- Status: Granted
- Kind: B2
- Application number: 15/071,533
- Filed: 2016-03-16
- Published: 2017-02-16
- Granted: 2019-12-10
- Earliest claimed: 2015-08-11
- Assignees: The Spectranetics Corporation
- Applicants: The Spectranetics Corporation
- Inventors: Ryan Michael Sotak; Grant Foy; Phil Aranas; Jay Harper
- Web page: https://patentgrep.com/patent/US10499892B2

## 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 17/00491: {Surgical glue applicators}
- A61B 17/12109: {in a blood vessel}
- A61B 17/1204: {temporary occlusion}
- A61B 17/12136: {Balloons}
- A61B 2017/00292: {mounted on or guided by flexible, e.g. catheter-like, means}
- A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)}
- A61B 2017/00597: {Implements comprising a membrane}
- A61B 2017/00623: {Introducing or retrieving devices therefor}
- A61B 2017/0065: {the implement being an adhesive}
- A61B 2017/00659: {located only on one side of the opening}
- A61B 2017/00676: {promotion of self-sealing of the puncture}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61M 2025/1079: {having radio-opaque markers in the region of the balloon}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A device for occluding a perforation in a blood vessel includes a catheter shaft that has a first lumen and a second lumen. The first lumen is adapted to receive at least one of a guidewire and an implanted cardiac lead, and the second lumen is adapted to receive an inflation fluid. The device further includes an inflatable balloon that is carried by the catheter shaft. The inflatable balloon is adapted to receive the inflation fluid from the second lumen. The inflatable balloon has a working length of about 65 mm to about 80 mm and an inflated diameter of about 20 mm to about 25 mm.

## Claims

### Claim 1

A device for occluding a perforation in a superior vena cava, the device comprising:
a catheter shaft having a first lumen and a second lumen, the first lumen being adapted to receive at least one of a guidewire and an implanted cardiac lead, and the second lumen being adapted to receive an inflation fluid, wherein the second lumen includes a cross-sectional area at a location along a length of the catheter shaft between 0.65 mm2 and 1.90 mm2; and
an inflatable balloon carried by the catheter shaft and adapted to receive the inflation fluid from the second lumen, the inflatable balloon having a working length of about 65 mm to about 80 mm, and the inflatable balloon having an inflated diameter of about 20 mm to about 25 mm.

### Claim 2 (depends on 1)

The device according to claim 1, wherein the inflatable balloon comprises polyurethane.

### Claim 3 (depends on 1)

The device according to claim 1, wherein the inflatable balloon comprises a proximal tapered portion, a distal tapered portion, and a working portion disposed between the proximal tapered portion and the distal tapered portion, the working portion having the inflated diameter of about 20 mm to about 25 mm.

### Claim 4 (depends on 1)

The device according to claim 1, wherein the first lumen and the second lumen are non-concentrically disposed within the catheter shaft.

### Claim 5 (depends on 4)

The device according to claim 4, wherein the cross-sectional area of the second lumen includes a crescent shape.

### Claim 6 (depends on 5)

The device according to claim 5, wherein the cross-sectional area of the second lumen is about 1 mm2.

### Claim 7 (depends on 5)

The device according to claim 5, wherein the crescent shape provides the cross-sectional area with a crescent-like cross-sectional shape, and wherein the crescent-like cross-sectional shape has a radius of about between 0.50 mm to 1.50 mm.

### Claim 8 (depends on 7)

The device according to claim 7, wherein the radius of the crescent-like cross-sectional shape is about 1 mm.

### Claim 9 (depends on 1)

The device according to claim 1, further comprising at least two radiopaque markers, wherein a first radiopaque marker is carried by the catheter shaft and a second radiopaque marker is carried by the catheter shaft.

### Claim 10 (depends on 9)

The device according to claim 9, wherein the at least radiopaque markers further comprise a third radiopaque marker.

### Claim 11 (depends on 10)

The device according to claim 10, wherein the inflatable balloon comprises a proximal portion, a distal portion, and an intermediate portion disposed between the proximal and distal portions, wherein the first, second, and third radiopaque markers are carried within the inflatable balloon, and wherein the first radiopaque marker is axially aligned with the proximal portion, the second radiopaque marker is axially aligned with the intermediate portion, and the third radiopaque marker is axially aligned with the distal portion.

### Claim 12 (depends on 1)

The device according to claim 1, further comprising an occlusion patch detachably carried by the inflatable balloon, the occlusion patch being deployable from the inflatable balloon to occlude the perforation.

### Claim 13 (depends on 12)

The device according to claim 12, wherein the occlusion patch includes at least one adhesive adapted to maintain a position of the occlusion patch within the superior vena cava.

### Claim 14 (depends on 13)

The device according to claim 13, wherein the at least one adhesive is adapted to be activated by application of at least one of heat, pH, and light.

### Claim 15 (depends on 12)

The device according to claim 12, wherein the occlusion patch includes a scaffold structure adapted to facilitate tissue growth therein.

### Claim 16 (depends on 12)

The device according to claim 12, wherein the occlusion patch includes stem cells to facilitate bioabsorption of the occlusion patch.

### Claim 17 (depends on 12)

The device according to claim 12, wherein the occlusion patch includes at least one hormonal agent adapted to promote wound healing.
