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-10531868-B2
Publication Date
2020-01-14
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 disclosed invention provides a method for forming and sealing a plurality of access penetrations in a blood vessel using two or more tissue tracts from a skin surface to access vascular wall penetrations. The method includes at least a cephalad tissue tract and a cephalad access penetration and a caudal tissue tract and a caudal access penetration positioned at different locations along the blood vessel.
Access sheaths are placed through the cephalad and caudal tissue tracts into the lumen of the blood vessel, with a distal portion of the cephalad access sheath lying between a distal portion of the caudal access sheath and the skin surface. The method further provides a cephalad vascular closure device and a caudal vascular closure device, each having a shaft and an occlusion element at a distal end of the shaft. A diagnostic or an interventional procedure is performed while the sheaths and devices are in use.
The method introduces and deploys the cephalad vascular closure device by positioning and deploying the cephalad occlusion element in the lumen while imaging the blood vessel lumen. The caudal access sheath is arranged so that it does not overlap with or mask imaging of the cephalad occlusion element as the cephalad occlusion element is being deployed. After sealing the cephalad access vascular wall penetration, the method introduces and deploys the caudal vascular closure device to deploy the caudal occlusion element against the inner wall of the blood vessel and seals the caudal access penetration.
Claims Coverage
The independent claim covers a sequential, imaging-aware deployment of two vascular closure devices for two access penetrations made via a cephalad and a caudal tissue tract. Dependent claims refine the method by adding additional tract(s), specifying sealing mechanisms, narrowing imaging modalities, and constraining geometry such as minimum spacing and deployment angles.
Two distinct tissue tracts with cephalad and caudal access penetrations
forming two or more tissue tracts from a skin surface to the access having a vascular wall penetration in a wall of the blood vessel at a distal end of the tissue tract, including at least (1) a cephalad tissue tract and a cephalad access penetration and (2) a caudal tissue tract and a caudal access penetration, wherein the cephalad tissue tract and access penetration are positioned on the blood vessel at a location closer to a head of the patient than the caudal tissue tract and access penetration
Cephalad and caudal access sheaths into the vessel lumen
placing a cephalad access sheath through the cephalad tissue tract and access vascular wall penetration and into a lumen of the blood vessel; placing a caudal access sheath through the caudal tissue tract and access penetration and into the lumen of the blood vessel, wherein a distal portion of the cephalad access sheath lies between a distal portion of the caudal access sheath and the skin surface
Sequential deployment of cephalad closure while imaging without masking
introducing the shaft of the cephalad vascular closure device through the cephalad access sheath to position a cephalad occlusion element of the cephalad vascular closure device in the lumen of the blood vessel above the distal portion of the caudal access sheath; deploying the cephalad occlusion element against an inner wall of the blood vessel, wherein the caudal access sheath does not overlap with or lie over and mask imaging of the cephalad occlusion element as said cephalad occlusion element is being deployed; imaging the blood vessel lumen; sealing the cephalad access vascular wall penetration
Sequential deployment of caudal closure and sealing
introducing the shaft of the caudal vascular closure device through the caudal access sheath to position a caudal occlusion element in the lumen of the blood vessel; deploying the caudal occlusion element against the inner wall of the blood vessel; and sealing the caudal access penetration
Overall, the claim coverage centers on a method that forms and seals multiple access penetrations using two independently deployed closure devices, with the caudal access sheath positioned to avoid overlap and masking of imaging during deployment of the cephalad occlusion element, followed by sealing of both the cephalad and caudal access penetrations.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Performing a diagnostic or an interventional procedure during the method.
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