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Publication Number
US-11439378-B2
Publication Date
2022-09-13
Expiration Date
Abstract
A method for closing a puncture in tissue that includes advancing a guide member into proximity with the tissue, the guide member having a needle guide, positioning a distal end of the guide member with the needle guide toward the tissue to present an opening of the needle guide toward the tissue the needle guide cooperating with a suture securing device that is slidably coupled to the guide member and a suture attached to the suture securing device, deploying the suture securing device, the suture securing device comprising a body with an anchor point for the suture and features that allow the suture securing device to pierce the tissue and resist retraction through the tissue, and establishing tension in the suture to move the suture securing device toward another suture securing device to thereby close the puncture in the tissue.
Core Innovation
The invention relates to systems and methods for closing a puncture in tissue, including a guide member having a needle guide and a suture securing device cooperatively coupled to the guide member for sliding deployment. The needle guide presents an opening toward the tissue while the distal end of the guide member maintains a position proximal to an anterior side of the tissue. During deployment, tissue-piercing and retraction-resistant features of the suture securing device move distally beyond and radially outward from the distal end of the guide member, and then pass through the tissue on opposing sides of the puncture.
The methods establish tension in a suture attached to the suture securing device to move the suture securing device toward another suture securing device, thereby closing the puncture in the tissue. In related embodiments, a guide member positions a distal end proximal to an anterior side of a vessel wall, and a needle guide cooperates with an anchor having an anchor point for the suture and features configured to pierce tissue and resist retraction. Detachable needles of the anchor engage the needle guide, move distally beyond and radially outward through the tissue on opposing sides, and are released by withdrawing the needle guide while moving the anchor toward a longitudinal axis of the guide member to close the puncture.
Further embodiments deploy a plurality of anchors through a vessel wall, with piercing and retraction-resistant features moved first distally beyond and radially outward from the distal end of the guide member and then through the vessel wall on opposing sides of the puncture. A constricting member is advanced distally along a length of the suture to constrict the suture and move the plurality of anchors toward the longitudinal axis of the guide member to close the puncture. The disclosures also describe optional components and structural variations, including an optional plug positioned against a vessel wall, and structural configurations such as tapered bodies and low-profile-to-expanded configurations with cutouts/projections and tissue-engaging elements, including embodiments having a tapered outer sheath tip and angle adjustment members to vary a deployment angle.
Claims Coverage
The document contains three independent claims that share the core inventive concept of positioning a guide member and deploying tissue-piercing, retraction-resistant features distally beyond and radially outward from the distal end, then using a suture tension or constriction step to draw securing elements toward a longitudinal axis to close a puncture. Across the independent claims, the inventive features focus on guide/needle-guide positioning, outward deployment through opposing sides of the puncture, and closure by suture tension or constriction, with distinctions around a suture securing device, an anchor with detachable needles, or a plurality of anchors with a constricting member.
Needle guide positioning relative to puncture and anterior side
Advancing a guide member into proximity with the tissue, the guide member having a needle guide, and positioning a distal end of the guide member with the needle guide toward the tissue to present an opening of the needle guide toward the tissue while maintaining a position proximal to an anterior side of the tissue.
Suture securing device deployment with anti-retraction piercing beyond and radially outward
Deploying the suture securing device in a distal direction, wherein the suture securing device comprises a body with an anchor point for the suture and features that allow the suture securing device to pierce the tissue and resist retraction through the tissue, and during deployment the piercing and resist-retraction features are moved distally beyond and radially outward from the distal end of the guide member and then through the tissue on opposing sides of the puncture.
Suture tension to move securing device(s) toward closure
Establishing tension in the suture to move the suture securing device toward another suture securing device to thereby close the puncture in the tissue.
Anchor with detachable needles for piercing and resist retraction through opposing sides
Positioning a distal end of a needle guide toward the tissue, deploying an anchor in a distal direction, the anchor comprising a body with an anchor point for a suture and detachable needles configured to selectively engage the needle guide, allowing the anchor to pierce the tissue and resist retraction through the tissue, wherein during deployment the detachable needles are moved distally beyond and radially outward from the distal end of the guide member and then through the tissue on opposing sides of the puncture.
Needle guide withdrawal to release detachable needles and anchor movement toward longitudinal axis
Withdrawing the needle guide in a proximal direction to release the detachable needles from the needle guide, and moving the anchor toward a longitudinal axis of the guide member to close the puncture in the tissue.
Plurality of anchors deployment through vessel wall on opposing sides
Advancing a distal end of a guide member in a distal direction to position openings near the distal end into proximity with a puncture in tissue while maintaining a position proximal to an anterior side of the tissue, deploying a plurality of anchors, each anchor comprising a body with an anchor point for a suture and features that allow the anchors to pierce the tissue and resist retraction through the tissue, wherein during deployment the piercing and resist-reist-retraction features are first moved distally beyond and radially outward from the distal end of the guide member and then through the vessel wall on opposing sides of the puncture.
Constricting member advancing along suture to constrict and move anchors to close
Advancing a constricting member in a distal direction along a length of the suture to constrict the suture and move the plurality of anchors toward the longitudinal axis of the guide member to close the puncture in the tissue.
Across the independent claims, puncture closure is achieved by positioning a guide member or needle guide relative to the puncture and deploying tissue-piercing, retraction-resistant securing structures outward and distally so they pass through opposing sides, including through a vessel wall in the plurality-anchor embodiment. Closure is then obtained by establishing tension in the suture to move securing elements together, or by advancing a constricting member along the suture to constrict the suture and draw the anchors toward a longitudinal axis.
Stated Advantages
Documented Applications
No documented applications found
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