Apparatus and methods for accessing and closing multiple penetrations on a blood vessel
Inventors
Yassinzadeh, Zia • Russell, John L. • Ballotta, Justin L.
Assignees
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Publication Number
US-11723640-B2
Publication Date
2023-08-15
Expiration Date
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 relates to a method for forming and closing a plurality of penetrations in a blood vessel by creating separate tissue tracts from a skin surface to a lumen. A first tissue tract defines a cephalad penetration positioned closer to a head of a patient than a caudal penetration defined by a second tissue tract, and respective first and second sheaths are placed through the first and second tissue tracts into the blood vessel lumen.
The method includes performing a diagnostic or an interventional procedure through the first sheath and the second sheath. A distal region of a first vascular closure device is positioned through the cephalad penetration into the blood vessel lumen, with a requirement that the second sheath does not mask imaging of the distal region of the first vascular closure device, and the cephalad penetration is then closed with the first vascular closure device positioned through the cephalad penetration into the blood vessel lumen.
After closing the cephalad penetration, the method positions a distal region of a second closure device through the caudal penetration into the lumen and closes the caudal penetration with the second closure device. The imaging is described as including fluoroscopic or ultrasonic imaging to verify device positioning and closure.
Claims Coverage
The document includes one independent method claim and multiple dependent claims. The core coverage is directed to forming cephalad and caudal tissue tracts, using dual sheaths for a diagnostic or interventional procedure, and closing each penetration with a corresponding vascular closure device while maintaining imaging visibility of the distal region of a first closure device.
Cephalad and caudal tissue tract penetrations
A method comprising forming a first tissue tract from a skin surface to a lumen of a blood vessel, the first tissue tract defining a cephalad penetration; and forming a second tissue tract from the skin surface to the lumen, the second tissue tract defining a caudal penetration, wherein the cephalad penetration is positioned closer to a head of a patient than is the caudal penetration.
Dual sheath placement with non-masking imaging
Placing a first sheath through the first tissue tract into the lumen; placing a second sheath through the second tissue tract into the lumen; performing a diagnostic or an interventional procedure through the first sheath and the second sheath; positioning a distal region of a first vascular closure device through the cephalad penetration into the blood vessel lumen, wherein the second sheath does not mask imaging of the distal region of the first vascular closure device; and closing the cephalad penetration with the first vascular closure device positioned through the cephalad penetration into the blood vessel lumen.
Sequential closure of first and second penetrations
Positioning a distal region of a second closure device through the caudal penetration into the lumen of the blood vessel; and closing the caudal penetration with the second closure device positioned through the caudal penetration into the lumen of the blood vessel.
Overall claim coverage focuses on forming cephalad and caudal tissue tracts, using dual sheaths such that the second sheath does not mask imaging of the distal region of the first closure device, and closing each penetration with its corresponding closure device in sequence.
Stated Advantages
Allows imaging of the distal region of a first vascular closure device without being masked by a second sheath.
Documented Applications
Performing a diagnostic or an interventional procedure through the first sheath and the second sheath prior to closing the penetrations.
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