# US 2019/0167241 A1 · Apparatus and methods for accessing and closing multiple penetrations on a blood vessel

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- Number: US 2019/0167241 A1
- Document ID: US20190167241A1
- Status: Published application
- Kind: A1
- Application number: 16/002,996
- Filed: 2018-06-07
- Published: 2019-06-06
- Earliest claimed: 2017-12-01
- Assignees: Cardiva Medical, Inc.
- Applicants: Cardiva Medical, Inc.
- Inventors: Zia Yassinzadeh; John L. Russell; Justin L. Ballotta
- Web page: https://patentgrep.com/patent/US20190167241A1

## 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 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00592: {Elastic or resilient implements}
- A61B 2017/0061: {Implements located only on one side of the opening}
- A61B 2017/00623: {Introducing or retrieving devices therefor}
- A61B 2017/00637: {for sealing trocar wounds through abdominal wall}
- A61B 2017/0065: {the implement being an adhesive}
- A61B 2017/00672: {Locating means therefor, e.g. bleed back lumen}
- A61B 2017/00676: {promotion of self-sealing of the puncture}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61B 2090/378: {using ultrasound}
- A61B 2090/3925: {ultrasonic}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Multiple vascular wall penetrations are formed and sealed in a single blood vessel, typically a vein, for performing cardiac and other catheter-based procedures. Access sheaths are placed in two or more tissue tracts each having a vascular wall penetration at a distal end and into a lumen of the blood vessel. A catheter is advanced though each of the access sheaths to perform a therapeutic or diagnostic procedure. A vascular closure device is introduced through each access sheath, typically sequentially, and an occlusion element at a distal end of the device is deployed against an inner wall of the blood vessel in a manner so that the adjacent access sheath does not interfere or overlap with the deployed occlusion element. The vascular penetration at the distal end in that tissue tract may then be sealed prior to using another vascular closure device to seal a caudally adjacent vascular wall penetration.

## Claims

### Claim 1

A method for forming and sealing a plurality of access penetrations in a blood vessel, said method comprising:
forming two or more tissue tracts each having a vascular wall penetration at a distal end thereof, including at least a cephalad-most and a caudal-most tissue tract;
placing an access sheath through each tissue tract and vascular wall penetration and into a lumen of the blood vessel;
advancing a therapeutic or diagnostic catheter though each of the access sheaths and performing a therapeutic or diagnostic procedure therewith;
providing a plurality of -vascular closure devices, each device including a shaft and an occlusion element at a distal end of the shaft;
introducing one shaft of each device through each tissue tract to position the occlusion element of the device in the lumen of the blood vessel;
deploying the occlusion element against an inner wall of the blood vessel, wherein an adjacent access sheath does not overlap with the deployed occlusion element; and
sealing the vascular wall penetrations.

### Claim 2 (depends on 1)

A method as in claim 1, wherein the two or more tissue tracts are formed along parallel paths from a skin surface to the blood vessel.

### Claim 3 (depends on 2)

A method as in claim 2, wherein the parallel paths have a minimum spacing along a cephalad-caudal axis equal to the sum of (1) one-half of a deployed length or diameter of the occlusion element and (2) one-half a diameter of the access sheath.

### Claim 4 (depends on 2)

A method of claim 2, wherein the parallel paths are spaced apart along the cephalad-caudal axis by at least a full length or a full diameter of the occlusion element.

### Claim 5 (depends on 2)

A method as in claim 2, wherein the parallel paths are axially spaced apart by a distance in the range from 0.5 cm to 1 cm.

### Claim 6 (depends on 2)

A method as in claim 2, wherein the blood vessel is a femoral vein and parallel paths are deployed at an acute angle relative to an upstream segment of the femoral vein.

### Claim 7 (depends on 6)

A method as in claim 6, wherein the acute angle is in the range from 30° to 60°.

### Claim 8 (depends on 2)

A method as in claim 2, wherein the blood vessel is a femoral artery and parallel paths are deployed at an acute angle relative to a downstream segment of the femoral artery.

### Claim 9 (depends on 8)

A method as in claim 8, wherein the acute angle is in the range from 30° to 60°.

### Claim 10 (depends on 1)

A method as in claim 1, wherein the vascular wall penetration in the cephalad-most tissue tract is sealed and the vascular closure device withdrawn prior to introducing the shaft of a second vascular closure device into a second caudally adjacent access sheath.

### Claim 11 (depends on 10)

A method as in claim 10, wherein the vascular wall penetration in the second caudally adjacent tissue tract is sealed and the second vascular closure device withdrawn prior to introducing the shaft of a third vascular closure device into a third access sheath caudally adjacent to the second access sheath.

### Claim 12 (depends on 11)

A method as in claim 11, wherein the vascular wall penetration in the third caudally adjacent tissue tract is sealed and the vascular closure device withdrawn prior to introducing the shaft of a fourth vascular closure device into a fourth caudally adjacent access sheath.

### Claim 13 (depends on 10)

A method as in any one of claim 10, wherein the access sheath is partially withdrawn before the insertion of the vascular closure device to prevent the occlusion element from interfering with the distal ends of the indwelling sheath(s).

### Claim 14 (depends on 13)

A method as in claim 13, wherein sealing comprises releasing a hemostatic plug from the shaft of the vascular closure device over the vascular wall penetration at the distal end of the tissue tract.

### Claim 15 (depends on 14)

A method as in claim 14, wherein the cephalad-most vascular closure device is fluoroscopically or ultrasonically imaged prior to releasing a hemostatic plug and removal such that there no access sheaths interfering with imaging of the vascular closure device.

### Claim 16 (depends on 15)

A method as in claim 15, wherein withdrawal of a cephalad-positioned access sheath and vascular closure device exposes a caudally adjacent access sheath and vascular closure device for fluoroscopic imaging.

### Claim 17 (depends on 1)

A method as in claim 1, wherein all vascular closure devices are placed with their occlusion elements deployed and all access sheaths are removed prior to sealing each vascular wall penetration.

### Claim 18 (depends on 17)

A method as in claim 17 wherein vascular closure devices are configured to be imaged after removal of the access sheaths.

### Claim 19 (depends on 1)

A method as in claim 1, wherein the therapeutic or diagnostic procedure comprises a cardiac procedure.

### Claim 20 (depends on 1)

A method as in claim 1, wherein the shaft of each device is introduced through the access sheath in each tissue tract.

### Claim 21 (depends on 1)

A method as in claim 1, further comprising:
collapsing the occlusion elements on each device; and
withdrawing the shaft and collapsed occlusion element of each device from the tissue tract.