# US 2014/0194918 A1 · Rapid exchange temporary blood flow cessation device for large bore closure

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- Number: US 2014/0194918 A1
- Document ID: US20140194918A1
- Status: Published application
- Kind: A1
- Application number: 13/787,204
- Filed: 2013-03-06
- Published: 2014-07-10
- Earliest claimed: 2013-01-04
- Assignees: St. Jude Medical Puerto Rico LLC
- Applicants: St. Jude Medical Puerto Rico LLC
- Inventors: Zachary J. Tegels
- Web page: https://patentgrep.com/patent/US20140194918A1

## CPC

- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- 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 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61B 17/1204: {temporary occlusion}
- A61B 17/12109: {in a blood vessel}
- A61B 17/12136: {Balloons}
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61B 2017/00663: {the implement being a suture}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/0472: {Multiple-needled, e.g. double-needled, instruments}
- A61M 2025/0183: {Rapid exchange or monorail catheters}
- A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A blood flow cessation device includes a catheter, an expandable member, and a rapid exchange port. The catheter includes a distal end portion and a proximal end portion. The expandable member is positioned at the distal end portion and is selectively expandable to stop blood flow through a vessel. The rapid exchange port is formed in the catheter at a location proximal of the expandable member. The rapid exchange port is configured receive a guidewire that passes through the distal end portion of the catheter to be positioned within the vessel.

## Claims

### Claim 1

A blood flow cessation device, comprising:
a catheter having a distal end portion and a proximal end portion;
an expandable member positioned at the distal end portion and being selectively expandable to stop blood flow through a vessel;
a rapid exchange port formed in the catheter at a location proximal of the expandable member, the rapid exchange port being configured to receive a guidewire that passes through the distal end portion of the catheter to be positioned within the vessel.

### Claim 2 (depends on 1)

The blood flow cessation device of claim 1, further comprising a guidewire lumen extending from the rapid exchange port distally through the distal end portion of the catheter.

### Claim 3 (depends on 1)

The blood flow cessation device of claim 1, wherein the expandable member comprises an inflatable balloon, and the catheter includes an inflation lumen that extends from the proximal end portion to the expandable member.

### Claim 4 (depends on 3)

The blood flow cessation device of claim 3, further comprising a valve positioned at the proximal end portion and operable to control flow of inflation fluid relative to the inflation lumen.

### Claim 5 (depends on 4)

The blood flow cessation device of claim 4, wherein the valve comprises one of a duckbill valve and a Tuohy Borst valve.

### Claim 6 (depends on 1)

The blood flow cessation device of claim 1, wherein the expandable member comprises a shape memory material.

### Claim 7 (depends on 6)

The blood flow cessation device of claim 6, wherein the expandable member comprises a Nitinol mesh positioned in an elastic membrane.

### Claim 8 (depends on 1)

The blood flow cessation device of claim 1, further comprising a manifold positioned at the proximal end portion, the manifold being sized to pass through an introducer sheath.

### Claim 9 (depends on 1)

The blood flow cessation device of claim 1, wherein the rapid exchange port is formed in a sidewall of the catheter.

### Claim 10

A blood flow cessation system, comprising:
a blood flow cessation device comprising:
a catheter having a distal end portion and a proximal end portion;
an expandable member positioned at the distal end portion;
a rapid exchange port formed in the catheter at a location proximal of the expandable member and distal of the proximal end portion;
a treatment device;
a guidewire extending through the rapid exchange port and through the distal end portion;
wherein the blood flow cessation device is configured to advance along the guidewire through a vessel puncture and into a vessel where the expandable member is expandable to limit blood flow in the vessel, and the treatment device is configured to advance along the guidewire to the vessel puncture.

### Claim 11 (depends on 10)

The blood flow cessation system of claim 10, further comprising an insertion sheath positionable in the vessel puncture, the blood flow cessation device being insertable through the insertion sheath into the vessel.

### Claim 12 (depends on 11)

The blood flow cessation system of claim 11, wherein the insertion sheath is configured to be withdrawn over the blood flow cessation device prior to advancing the treatment device over the guidewire through the vessel puncture.

### Claim 13 (depends on 10)

The blood flow cessation system of claim 10, wherein the treatment device comprises a large bore closure device.

### Claim 14 (depends on 10)

The blood flow cessation system of claim 10, wherein the expandable member comprises an inflatable balloon and the catheter includes an inflation lumen coupled in flow communication with the inflatable balloon.

### Claim 15 (depends on 10)

The blood flow cessation system of claim 10, wherein the catheter further comprises a guidewire lumen extending from the rapid exchange port through the distal end portion of the catheter.

### Claim 16

A method of treating a vessel having a vessel puncture, the method comprising:
providing a blood flow cessation device, a guidewire, and a treatment device, the blood flow cessation device comprising a catheter having distal and proximal end portions, an expandable member, and a rapid exchange port positioned proximal of the expandable member and distal of the proximal end portion;
advancing the guidewire through the vessel puncture and into the vessel;
advancing the blood flow cessation device along the guidewire and into the vessel with the guidewire extending through the rapid exchange port;
operating the expandable member to limit blood flow through the vessel;
advancing the treatment device along the guidewire through the vessel puncture;
treating the vessel with the treatment device.

### Claim 17 (depends on 16)

The method of claim 16, further comprising providing an insertion sheath, and inserting the insertion sheath through the vessel puncture, the guidewire extending through the insertion sheath.

### Claim 18 (depends on 17)

The method of claim 17, wherein advancing the blood flow cessation device includes advancing the blood flow cessation device through the insertion sheath.

### Claim 19 (depends on 18)

The method of claim 18, further comprising withdrawing the insertion sheath proximally along the blood flow cessation device prior to advancing the treatment device along the guidewire.

### Claim 20 (depends on 16)

The method of claim 16, wherein operating the expandable member includes delivering a volume of inflation fluid through the catheter to expand the expandable member.

### Claim 21 (depends on 16)

The method of claim 16, wherein treating the vessel includes at least partially closing the vessel puncture.
