Instrument and methods for surgically closing percutaneous punctures
Inventors
Walters, Greg A. • Roubin, Gary • Nispel, Michael Thomas • Dotsey, Michael Austin • Arora, Piyush
Assignees
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Publication Number
US-12521103-B2
Publication Date
2026-01-13
Expiration Date
Abstract
Methods for sealing a percutaneous puncture in a wall of a body passageway are disclosed herein. The methods include inserting a deployment instrument into the puncture via a toggle along the guidewire, and actuating the deployment instrument to move the first component and the second component relative to each other such that the toggle abuts the wall of the artery proximate the puncture to seal the puncture.
Core Innovation
The invention relates to an arterial percutaneous puncture closure system and methods for sealing a puncture in a wall of an artery. One approach includes inserting a guidewire through the puncture and inserting a deployment instrument into the puncture via a toggle along the guidewire. The deployment instrument has a distal end section including a first component and a second component in actuatable relationship, where the toggle is supported by one of the components.
Another approach includes deploying a closure device carried by a deployment instrument along a guidewire through the puncture into the artery, where the closure device includes a toggle, a plug, and a continuous elongate filament. A tensioner assembly applies tension to the filament in a direction away from the toggle, drawing the plug towards the toggle, and the plug includes an aperture configured to receive the guidewire, such that the toggle and the plug are slidable along the guidewire.
The disclosed systems and methods are directed to sealing a percutaneous arterial puncture and include additional mechanical and structural features across embodiments. The description elaborates deployment instrument components such as a toggle, plugs, lock, filament, tamper, radiopaque markers, and deployment tube/release tube arrangements, and variations involving different toggle and plug geometries and multi-plug embodiments.
Claims Coverage
The independent claims cover three related method categories for sealing a percutaneous arterial puncture: (i) a toggle abutment mechanism driven by actuation of a deployment instrument with first and second components, (ii) a tensioner-driven toggle-and-plug engagement mechanism using a continuous elongate filament with increasing tension force, and (iii) an engagement-and-locking mechanism using the filament with subsequent locking and guidewire removal. Across the independent claims, the inventive features focus on guidewire-based deployment, toggle support and actuation, and tension-based drawing and engagement of a plug and toggle on opposite sides of the artery wall.
Actuatable first and second components to abut the artery wall with a toggle
A method of sealing a puncture in a wall of an artery by inserting a guidewire into the puncture, inserting a deployment instrument into the puncture via a toggle along the guidewire, where the deployment instrument has a distal end section including a first component and a second component in actuatable relationship and rigidly supports the toggle, and actuating the deployment instrument to move the first component and the second component relative to each other such that the toggle abuts the wall of the artery proximate the puncture.
Tensioner assembly with continuous elongate filament to draw plug toward toggle for opposite-side engagement
A method of sealing a percutaneous puncture in a wall of an artery by inserting a deployment instrument along a guidewire through the puncture into the artery, positioning a distal end of the deployment instrument such that the toggle is positioned in the artery, and pulling the tensioner assembly away from the puncture while a filament connected to the tensioner assembly applies a mechanically induced tension force that increases with increasing distance to draw the toggle and the seal into engagement with the wall of the artery at opposite sides of the wall, with the plug having an aperture configured to receive the guidewire so the toggle and plug are slidable along the guidewire.
Locking plug and toggle in place along the filament and removing the guidewire
A method of sealing a percutaneous puncture in a wall of an artery by inserting a deployment instrument along a guidewire through the puncture into the artery, positioning a distal end of the deployment instrument such that the toggle is positioned in the artery, and pulling the tensioner assembly away from the puncture while the filament connected to the tensioner assembly applies a mechanically induced tension force that increases with increasing distance to draw the toggle and the seal into engagement with the wall of the artery at opposite sides, locking the plug and the toggle in place along the filament to seal the puncture, and removing the guidewire from the toggle and the artery.
Across the independent claims, the coverage centers on deploying and actuatably moving a deployment instrument with first and second components so a toggle abuts the artery wall proximate the puncture, and on deploying a closure device with a toggle, plug, and continuous elongate filament where increasing tension force draws the toggle and plug into engagement with opposite sides of the artery wall, including locking the plug and toggle in place prior to guidewire removal.
Stated Advantages
Documented Applications
The description states applicability to large-bore access procedures, including balloon aortic valvuloplasty (BAV) and percutaneous aortic valve replacement (PAVR).
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