Apparatus and methods for sealing a vascular puncture
Inventors
Uchida, Andy • To, Kevin • Fell, Brandon • Swenson, Peter Alan
Assignees
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Publication Number
US-10314567-B2
Publication Date
2019-06-11
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 The introducer sheath and cartridge are then withdrawn, exposing the sealant within the puncture.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 relates to sealing a puncture extending through tissue to a body lumen, where the puncture has an introducer sheath therein. An apparatus is provided at least partially within the introducer sheath, including an elongate positioning member with proximal and distal ends and a cartridge slidable on the elongate positioning member. The cartridge includes a tubular member with a lumen extending between a proximal end and a distal end having one or more slits, with a sealant disposed within the lumen and an advancer member disposed within the tubular member lumen.
The cartridge also includes a sleeve slidably disposed over the one or more slits in the tubular member distal end. The distal end of the positioning member is advanced through a lumen of the introducer sheath until a positioning element thereon is disposed within the body lumen, and the cartridge is advanced over the positioning member until the sleeve contacts a proximal end of the introducer sheath.
The cartridge is further advanced to a distal position such that the cartridge distal end enters the introducer sheath lumen while the sleeve is stopped by the introducer sheath and slides over the tubular member to expose the tubular member distal end within the introducer sheath lumen. The introducer sheath and tubular member are then retracted at least partially from the puncture relative to the advancer member, thereby exposing the sealant via the one or more slits of the tubular member distal end within the puncture distally beyond the introducer sheath.
The disclosed apparatus and method thereby position sealant for hemostatic sealing through the slitted distal end in a puncture that extends through tissue into a body lumen. The positioning element is expandable to support placement within the body lumen, and retraction exposes sealant beyond the introducer sheath so expansion and hydration can occur for hemostasis.
Claims Coverage
The partial content provides one independent claim directed to a method for sealing a puncture through tissue to a body lumen using a specific introducer-sheath/cartridge arrangement, with four inventive features.
Slitted tubular-member sealant cartridge with sleeve over slits
An apparatus within the introducer sheath includes an elongate positioning member and a cartridge slidable on the elongate positioning member, the cartridge including a tubular member with one or more slits, a sealant disposed within the tubular member lumen, an advancer member within the tubular member lumen, and a sleeve slidably disposed over the one or more slits in the tubular member distal end.
Advancing positioning member to place positioning element in the body lumen
The distal end of the positioning member is advanced through a lumen of the introducer sheath until a positioning element thereon is disposed within the body lumen.
Sleeve exposure sequence driven by introducing cartridge distal end into the introducer sheath lumen
The cartridge is advanced over the positioning member until the sleeve contacts a proximal end of the introducer sheath, and further advanced to a distal position such that the cartridge distal end enters the introducer sheath lumen while the sleeve is stopped by the introducer sheath and slides over the tubular member to expose the tubular member distal end within the introducer sheath lumen.
Retracting introducer sheath and tubular member to expose sealant distally beyond the introducer sheath
The introducer sheath and tubular member are retracted at least partially from the puncture relative to the advancer member, thereby exposing the sealant via the one or more slits of the tubular member distal end within the puncture distally beyond the introducer sheath.
The claim coverage centers on delivering internal sealant within a tubular member having slits while a slidable sleeve is held by the introducer sheath to expose the slitted distal end inside the sheath lumen, and then retracting the introducer sheath and tubular member relative to an internal advancer to expose the sealant beyond the sheath for puncture sealing.
Stated Advantages
Enables hemostatic sealing of a puncture extending through tissue to a body lumen by exposing sealant through one or more slits within the puncture distally beyond the introducer sheath.
Documented Applications
Hemostatic sealing of a vascular puncture extending through tissue to a body lumen using an introducer sheath and a cartridge with a tubular member having slits and internal sealant.
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