Catheter assemblies and methods for stabilizing a catheter assembly within a subintimal space
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10143824-B2
Publication Date
2018-12-04
Expiration Date
Abstract
Catheter assemblies include a stabilization mechanism disposed at a distal end of the catheter assembly for stabilizing the catheter assembly within a subintimal space. The stabilization mechanism includes a self-expanding support structure that is slidably positionable within an inflatable balloon. The catheter assemblies include an outer shaft which has the balloon at a distal end thereof and an inner shaft which has the support structure mounted on a distal end thereof. The inner shaft is slidably disposed within a lumen of the outer shaft and has a first configuration in which the support structure is held in a compressed state within the outer shaft and a second configuration in which the support structure is permitted to return to an expanded state within the inflatable balloon. In the expanded state, the stabilization mechanism has a flattened laterally-extending profile.
Core Innovation
The document describes catheter assemblies and a method of stabilizing a catheter assembly within a subintimal space by tracking a distal end of the catheter assembly to a treatment site within the subintimal space. A self-expanding support structure is held in a compressed state during tracking, and the distal portion is positioned using that tracked configuration within the subintimal space.
The self-expanding support structure is positioned within an inflatable balloon of the catheter assembly so that the support structure returns to an expanded state within the balloon. Inflating the balloon around the support structure causes the support structure to constrain balloon expansion so that the balloon has a flattened laterally-extending profile, including a flattened non-circular cross-section.
The document further describes that the self-expanding support structure can include first and second wings that bow outward in opposite directions when expanded in the balloon, and deployment/alignment can be carried out using longitudinal translation and/or relative rotation and/or window-aligned deployment mechanisms for positioning within the balloon. The disclosed use includes subintimal reentry for chronic total occlusion (CTO) recanalization, including deployment prior to/around a puncturing needle and optional creation of a subintimal conduit for guidewire and stent placement, while the balloon remains inflated around the expanded support structure.
Claims Coverage
The independent claim covers a method of stabilizing a catheter assembly within a subintimal space using a self-expanding support structure held compressed during tracking, positioned within an inflatable balloon for constrained expansion that yields a flattened laterally-extending balloon profile. No additional independent claims are provided in the supplied claim list; dependent claim features refine alignment and an optional subintimal conduit step.
Compressed-state tracking within a subintimal space
Tracking a distal end of the catheter assembly to a treatment site within the subintimal space with a self-expanding support structure held in a compressed state therein.
Balloon-constrained deployment to an expanded state
Positioning the self-expanding support structure within an inflatable balloon of the catheter assembly to permit the support structure to return to an expanded state within the balloon.
Inflating balloon to yield a flattened laterally-extending profile
Inflating the balloon around the support structure, wherein the support structure constrains expansion of the balloon such that the balloon has a flattened laterally-extending profile.
Wings that bow outward in opposite directions
The self-expanding support structure has first and second wings that bow outward in opposite directions when expanded in the balloon, with the wings kept compressed inside the outer tubular component proximal to the balloon during tracking.
Longitudinal alignment by relative sliding
Placing the self-expanding support structure inside an inflatable balloon includes longitudinally aligning it inside the balloon by relative sliding movement between inner and outer tubular components.
Circumferential alignment by relative rotation
Circumferentially aligning a self-expanding support structure inside an inflatable balloon by rotating an inner tubular component relative to an outer tubular component.
Creating a subintimal conduit with balloon inflated
Creating a subintimal conduit using a catheter assembly that routes from a proximal true lumen to a distal true lumen through the subintimal space while the balloon stays inflated around an expanded support structure.
Overall, the claim set (as provided) centers on stabilizing a distal catheter portion in a subintimal space using a self-expanding support structure that is tracked while compressed, deployed inside an inflatable balloon to produce an expanded, balloon-constraining configuration, and optionally used while creating a subintimal conduit, with dependent features addressing wing behavior and longitudinal/circumferential alignment.
Stated Advantages
Improves anchoring and reduces tissue damage.
Documented Applications
Subintimal reentry for chronic total occlusion (CTO) recanalization, including deployment prior to/around a puncturing needle and optional creation of a subintimal conduit for guidewire and stent placement.
Interested in licensing this patent?