Apparatus and methods for sealing a vascular puncture
Inventors
Uchida, Andy • To, Kevin • Fell, Brandon • Swenson, Peter Alan
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11534150-B2
Publication Date
2022-12-27
Expiration Date
Abstract
An apparatus for sealing a puncture through tissue having an introducer sheath therein includes an elongate positioning member including a housing on a proximal end and an expandable member on a distal end, and a cartridge advanceable along the positioning member from a proximal position to a distal position. The cartridge includes a tubular member including a sealant and an advancer member disposed within lumen of the tubular member. A sleeve is slidably disposed over the tubular member distal end such that, when the tubular member is advanced over the positioning member, the tubular member distal end enters the introducer sheath while the sleeve is stopped and slides over the tubular member to expose the tubular member distal end within the introducer sheath. The introducer sheath and cartridge are then withdrawn, exposing the sealant within the puncture.
Core Innovation
The invention provides a system for sealing a puncture using an introducer sheath, a positioning member with an expandable positioning element, and a cartridge that is advanceable along the positioning member. The introducer sheath includes an introducer sheath hub, a distal end sized for insertion through a puncture, and an introducer sheath lumen. The positioning member includes a housing on the proximal end and an expandable positioning element on the distal end for positioning and anchoring a seal site within the vessel.
The cartridge advances from a proximal position adjacent the housing to a distal position, and includes a tubular member with a lumen, a cartridge hub, sealant disposed within the tubular member lumen adjacent the tubular member distal end, and an advancer member disposed within the tubular member lumen. The advancer member exposes the sealant distally from the tubular member lumen when the tubular member is retracted proximally relative to the advancer member, thereby exposing sealant at the puncture site.
To control entry and exposure, a sleeve slidably disposed over the tubular member distal end abuts the introducer sheath hub so that, when the tubular member is advanced to the distal position, the tubular member distal end enters the introducer sheath lumen through the introducer sheath hub while the sleeve is stopped by the introducer sheath hub and slides to expose the tubular member distal end within the introducer sheath lumen. The cartridge hub further includes a pocket that receives a detent positioned on the positioning member to limit distal movement of the cartridge relative to the positioning member after the cartridge is advanced to the distal position.
Claims Coverage
The document includes three independent claims that cover a puncture-sealing system and an apparatus for puncture sealing, each sharing a common inventive architecture with introducer sheath, positioning member with expandable positioning element, and an advanced/withdrawn cartridge that exposes sealant using controlled sleeve and limited cartridge travel features. Across the independent claims, five main inventive features recur: the expandable positioning member, the cartridge advanceable along the positioning member with sealant adjacent the tubular distal end, the sleeve-and-introducer-hub controlled exposure during advancement, the advancer member exposing sealant during retraction, and the detent-and-pocket mechanism limiting distal movement after the cartridge reaches the distal position.
Expandable positioning member for puncture site positioning
A positioning member including a proximal end and a distal end, a housing on the proximal end, and an expandable positioning element on the distal end.
Cartridge advanceable along positioning member with sealant adjacent tubular distal end
A cartridge advanceable along the positioning member from a proximal position adjacent the housing to a distal position, the cartridge comprising a tubular member comprising a proximal end, a distal end sized for insertion into the introducer sheath lumen, and a tubular member lumen extending between the tubular member proximal and distal ends; a cartridge hub provided on the proximal end of the tubular member; a sealant disposed within the tubular member lumen adjacent the tubular member distal end.
Sleeve and introducer sheath hub controlled exposure of tubular distal end
A sleeve slidably disposed over the tubular member distal end, at least a portion of the sleeve sized to abut the introducer sheath hub such that, when the tubular member is advanced from the proximal position to the distal position, the tubular member distal end enters the introducer sheath lumen through the introducer sheath hub while the sleeve is stopped by the introducer sheath hub and slides over the tubular member to expose the tubular member distal end within the introducer sheath lumen.
Advancer member exposing sealant by proximal retraction of tubular member
An advancer member disposed within the tubular member lumen for exposing the sealant distally from the tubular member lumen when the tubular member is retracted proximally relative to the advancer member.
Detent and pocket limiting distal movement after distal advancement
A cartridge hub further comprises a pocket positioned therein and wherein a detent is positioned on the positioning member, the detent configured to be received within the pocket when the cartridge is advanced to the distal position, wherein the detent and the pocket limit distal movement of the cartridge relative to the positioning member after the cartridge is advanced to the distal position.
Collectively, the independent claims cover puncture sealing using a cartridge that advances to position sealant and sleeves that coordinate with the introducer sheath hub to control exposure, followed by proximal retraction relative to an advancer member to expose the sealant. Movement is constrained by a detent received in a pocket on the cartridge hub to limit distal movement after the distal position is reached, while an expandable positioning element on the positioning member provides the basis for positioning and anchoring the seal site.
Stated Advantages
Improved positioning of the seal site using a positioning member with an expandable distal element.
Reduced exposure of collagen, as contrasted with prior plug/collagen approaches.
Hemostasis without external prolonged pressure, as contrasted with prior approaches.
Documented Applications
Sealing a puncture using an introducer sheath, a positioning member with an expandable positioning element, and a cartridge that advances to deploy sealant and exposes the sealant at the puncture site.
Interested in licensing this patent?