Apparatus and methods for accessing and closing multiple penetrations on a blood vessel

Inventors

Yassinzadeh, Zia • Russell, John L. • Ballotta, Justin L.

Assignees

Cardiva Medical Inc

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.

Core Innovation

The invention provides a method for forming and closing a plurality of penetrations in a blood vessel by using cephalad and caudal tissue tracts that both extend from a skin surface to a lumen of a blood vessel. A cephalad tissue tract defines a cephalad penetration positioned closer to a head of a patient than a caudal penetration, and a caudal tissue tract defines the caudal penetration.

Corresponding cephalad and caudal sheaths are placed through the respective tissue tracts into the lumen to enable diagnostic or interventional procedures with catheters placed through both sheaths. After the procedure, the catheters are removed and closure devices are positioned through the penetrations to close each penetration.

The method coordinates placement of a distal region of a cephalad closure device through the cephalad penetration such that the caudal sheath does not mask imaging of the distal region of the cephalad closure device, and then closes the cephalad penetration with the cephalad closure device positioned through the cephalad sheath. The method further positions a distal region of a caudal closure device through the caudal penetration into the lumen and closes the caudal penetration with the caudal closure device positioned through the caudal sheath.

Related aspects position a distal end of a cephalad closure device through a cephalad penetration to deploy an occlusion element, and then position a distal end of a caudal closure device through a caudal penetration to close both penetrations. Imaging compatibility and sequential positioning of cephalad and caudal closure components are integrated so that the adjacent sheath does not interfere with visualization.

Claims Coverage

The provided independent claims cover forming and closing two penetrations in a blood vessel using cephalad and caudal tissue tracts and sheaths, and then deploying respective closure devices with attention to device sequencing and imaging compatibility. Across the independent claims, the inventive coverage is organized around cephalad/caudal tracts, simultaneous procedure access via respective sheaths, sequential closure using distal closure regions/end positioning, and occlusion element placement relative to the other sheath and penetration to avoid masking and enable closure of both penetrations.

Across the independent claim coverage, the invention is directed to closing multiple blood vessel penetrations using cephalad and caudal tissue tracts and sheaths, coordinating diagnostic or interventional access through both sheaths, and then deploying respective cephalad and caudal closure devices in a sequence and spatial relationship that addresses imaging masking and occlusion element positioning relative to the other sheath while closing both penetrations.

Stated Advantages

Documented Applications