Apparatus, systems and methods for transvascular access to the brain
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Publication Number
US-11497552-B2
Publication Date
2022-11-15
Expiration Date
Abstract
The present disclosure discusses a devices, systems and methods for transvascular, transvenous and/or transdural access, to the brain parenchyma, subarachnoid or subdural spaces. In some embodiments, the disclosed systems and methods may be used for local drug delivery, tissue biopsy, nanofluidic or microelectronic device/component delivery/insertion/implantation, in situ imaging, ablation of abnormal brain tissue and the like. Embodiments of the present disclosure include an access catheter system for extravascular procedures in the brain having an elongate, flexible tubular body, with at least one lumen extending axially there through between a proximal end, and a distal end. The access catheter system may include a side exit port and a distal end port. Further, the access catheter system may include a selective deflector positioned within the lumen configured to deflect a procedure catheter and permit a guide catheter.
Core Innovation
The disclosed invention provides transvascular access to an extravascular site by positioning an access catheter with a side exit port adjacent to a target site of a vessel. A selective deflector in the access catheter deflects a procedure catheter out through the side exit port while permitting a guide to advance distally beyond the deflector and out of a distal end of the access catheter.
At the target site, a second device is advanced through a vein wall to create a venous puncture site. A wire is advanced through the second device at the venous puncture site to deploy a second procedure catheter with advanced functionality, and the second device is removed after deployment.
The access catheter is then repositioned such that supporting expandable structural elements overlay the venous puncture site. The access catheter provides post-procedural hemostasis by inflating a balloon so that it contacts the venous puncture site and tamponades the venous puncture site to produce hemostasis.
If balloon tamponade is insufficient, the method evaluates whether hemostasis has been achieved and deploys an implantable biosynthetic, bioabsorbable hemostatic material from the side exit port responsive to lack of adequate balloon tamponade hemostasis, including Poly(L) polymer and Dextran-Sucrose-Sodium Citrate polymer.
Claims Coverage
The document contains one independent method claim describing transvascular access using an access catheter with a side exit port and selective deflector, followed by deployment of devices and hemostasis. Dependent claims add conditional hemostasis evaluation and specify an implantable biosynthetic, bioabsorbable hemostatic material, including Poly(L) polymer and Dextran-Sucrose-Sodium Citrate polymer.
Side exit port access with selective deflector passage
Advancing an access catheter over a guide to position a side exit port adjacent to a target site of a vessel; retracting the guide; advancing a procedure catheter through the access catheter and to the target site via the side exit port such that a selective deflector deflects the procedure catheter out through the side exit port while permitting the guide to advance distally beyond the deflector and out of a distal end of the access catheter; deploying the procedure catheter through the side exit port.
Venous puncture site creation and advanced functionality catheter deployment
Advancing a second device through a vein wall at the target site to create a venous puncture site; advancing a wire through the second device at the venous puncture site to deploy a second procedure catheter with advanced functionality; removing the second device.
Expandable structural elements with balloon tamponade hemostasis
Deploying supporting expandable structural elements of the access catheter; repositioning the access catheter such that at least a balloon overlays the venous puncture site; inflating the balloon so that it contacts the venous puncture site and thereby tamponading the venous puncture site to produce hemostasis.
Responsive implantable biosynthetic bioabsorbable hemostatic material
Evaluating whether hemostasis has been achieved after balloon tamponade by deflating the balloon of the access catheter; if not achieved, deploying an implantable biosynthetic, bioabsorbable hemostatic material from the side exit port responsive to lack of balloon tamponade hemostasis.
Poly(L) polymer and Dextran-sucrose-sodium citrate polymer hemostatic material
Deploying a biosynthetic, bioabsorbable hemostatic material comprising at least one of Poly(L) polymer and Dextran-Sucrose-Sodium Citrate polymer.
The core coverage centers on side-exit transvascular access using a selective deflector to route a procedure catheter out the side exit port, creation of a venous puncture site for deploying a second procedure catheter with advanced functionality, and stabilization plus post-procedural hemostasis using expandable structural elements and a balloon. Dependent claims further cover conditional deployment of an implantable biosynthetic, bioabsorbable hemostatic material from the side exit port when balloon tamponade is insufficient.
Stated Advantages
Provides transvascular access to an extravascular site using a side exit port and a selective deflector while allowing a guide to advance distally beyond the deflector.
Enables creation of a venous puncture site and deployment of a second procedure catheter with advanced functionality.
Produces hemostasis by tamponading the venous puncture site with an inflating balloon of the access catheter.
Supports additional hemostasis by deploying an implantable biosynthetic, bioabsorbable hemostatic material from the side exit port when balloon tamponade does not achieve adequate hemostasis.
Documented Applications
Transvascular access to intracranial extravascular targets including brain parenchyma, subdural space, and subarachnoid space.
Tissue biopsy, in situ imaging, ablation, delivery/implantation of electrode arrays/electrocorticography, local drug delivery, and wireless deep brain stimulation.
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