Apparatus and method for sealing a vascular puncture
Inventors
Joe, Wesley Chung • Avuthu, Sravanthi • GUYER, CURT D. • Repp, Richard • Schnitzer, Martin
Assignees
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Publication Number
US-11737740-B2
Publication Date
2023-08-29
Expiration Date
Abstract
Closure devices for sealing a puncture and methods of sealing a puncture are described herein. A closure device may be used to position a sealant in a puncture. The sealant may be provided in a sheath which is retracted to expose the sealant in the puncture. A support member may be advanced to compress the sealant. The device may have a lock that prevents the support member from advancing prematurely. The lock may be unlocked when the sheath is at least partially retracted. The device may have an actuator that controls movement of the sheath and the support member. The lock may remain in a locked position until the sheath is at least partially retracted.
Core Innovation
The invention relates to a vascular puncture closure device and methods for deploying a sealant to close a puncture by inserting a device into the puncture and using relative axial movement of a sealant sleeve and coordinated pull and push rack mechanisms. The device includes a sealant disposed in a sealant sleeve, a pull rack coupled to a proximal section of the sealant sleeve, and a push rack coupled to a proximal section of a support member disposed in the sealant sleeve proximal to the sealant. A push rack lock provided in a locked position prevents advancement of the push rack until the sealant is sufficiently exposed.
Deployment is controlled by retracting the pull rack and the sealant sleeve to expose at least a portion of the sealant, wherein retracting the pull rack moves the push rack lock to an unlocked position in which the push rack is advanceable. In one disclosed mechanical implementation, the push rack lock includes a push rack engagement portion and is moved to the unlocked position by displacing the engagement portion in a substantially lateral direction until the engagement portion is spaced from the push rack. An arm-based structure can be used, where the push rack engagement portion is at an end of the arm and is laterally displaced by applying an axial force to the arm.
The system further includes a deployment actuator having an unlocked position, a partially actuated position, and a fully actuated position to coordinate staged transitions between locked, partially actuated, and fully actuated states. In the stage-based operation, the method retracts the pull rack and the sealant sleeve to expose the sealant, moves the deployment actuator between states to unlock the push rack, and then advances the push rack and the support member to compress the sealant. Additional disclosed positioning uses an elongate member with an expandable positioning element on a distal portion that is expanded inside a vessel and that contacts a vessel wall to apply tension, thereby moving the deployment actuator from a locked position to an unlocked position before actuation.
Claims Coverage
The partial claims provided include seven independent claims. Across these claims, the coverage centers on coordinated retraction and staged unlocking of a push rack lock to allow advancement of a push rack and compression/deployment of a sealant, including actuator state control and, in additional embodiments, tension-based unlocking via an expandable positioning element.
Sealant in an axially movable sealant sleeve with pull rack and push rack
A device comprising a sealant disposed in a sealant sleeve axially movable relative to the sealant, a pull rack coupled to a proximal section of the sealant sleeve, and a push rack coupled to a proximal section of a support member disposed in the sealant sleeve proximal to the sealant.
Push rack lock preventing advancement until retraction unlocks
A push rack lock provided in a locked position in which advancement of the push rack is prevented, wherein retracting the pull rack and the sealant sleeve to expose at least a portion of the sealant moves the push rack lock to an unlocked position in which the push rack is advanceable.
Push rack unlocking by retracting pull rack followed by compressing sealant
Retracting the pull rack and the sealant sleeve to expose at least a portion of the sealant, advancing the push rack and the support member to compress the sealant.
Arm-based push rack lock with lateral spacing by axial force
A push rack lock comprising an arm and a push rack engagement portion at an end of the arm, the push rack lock having a locked position in which the push rack engagement portion contacts the push rack to prevent distal movement and an unlocked position in which the push rack engagement portion is laterally spaced from the push rack, wherein the push rack lock is moveable from the locked position to the unlocked position upon application of an axial force to the arm.
Locked-by-default deployment actuator moved to unlocked by tension
A deployment actuator having a locked position and an unlocked position, wherein the deployment actuator is provided in the locked position and is moveable to the unlocked position upon application of tension to an elongate member.
Expandable positioning element applies tension to unlock deployment actuator
Expanding an expandable positioning element inside the vessel, withdrawing the device until the expandable positioning element contacts a wall of the vessel, continuing to withdraw to apply tension to the elongate member and moving the deployment actuator to an unlocked position, and actuating the deployment actuator to deploy the sealant.
Push rack lock unlocking by displacing engagement portion in substantially lateral direction
A push rack lock comprising a push rack engagement portion, wherein the push rack lock is provided in a locked position in which advancement of the push rack is prevented, displacing the push rack engagement portion in a substantially lateral direction until the push rack engagement portion is spaced from the push rack, thereby moving the push rack lock to an unlocked position.
Deployment actuator staged unlocked, partially actuated, and fully actuated
A deployment actuator having an unlocked position, a partially actuated position, and a fully actuated position, wherein the method retracts the pull rack and the sealant sleeve to expose the sealant, moves the deployment actuator from the unlocked position to the partially actuated position thereby retracting the pull rack and the sealant sleeve and moving the push rack lock to an unlocked position, and then advances the push rack and the support member to compress the sealant.
Full-stage actuator progression from partially actuated to fully actuated
A deployment actuator having an unlocked position, a partially actuated position, and a fully actuated position, wherein after retracting the pull rack and the sealant sleeve to expose at least a portion of the sealant and moving the push rack lock to an unlocked position, moving the deployment actuator from the partially actuated position to the fully actuated position thereby advancing the push rack and the support member to compress the sealant.
Across the independent claims, the document’s inventive coverage is primarily directed to deploying sealant from a sealant sleeve controlled by pull and push rack members, preventing push rack advancement with a push rack lock until unlocking is triggered by retraction and actuator state transitions, and enabling controlled advancement to compress or deploy the sealant. Several independent claims further specify the unlocking mechanism, including substantially lateral displacement and arm or axial-force actuation, as well as a staged deployment actuator and a tension-based unlocking arrangement using an expandable positioning element.
Stated Advantages
Documented Applications
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