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Publication Number
US-12390249-B2
Publication Date
2025-08-19
Expiration Date
Abstract
An access sheath and method of assembling the access sheath. The access sheath includes a hub, a cartridge carried by the hub, the cartridge having a first valve, a second valve spaced from the first valve along a central axis, and a spacer disposed between the first valve and the second valve, wherein the first valve and the second valve each have at least two slits that extend along, and twist about, the central axis, and a shaft assembly having a shaft hub and a shaft that extends from the shaft hub in the distal direction. The access sheath provides a liquid-tight seal when receiving the introducer and other devices to prevent leakage and blood loss and to decrease device insertion forces.
Core Innovation
The disclosed invention relates to an access sheath configured to be disposed along a guidewire into a puncture of a vessel. The access sheath includes a hub and a cartridge carried by the hub, with the cartridge containing a first valve and a second valve spaced along a central axis, and a spacer extending inwardly from an internal surface of the cartridge between the first valve and the second valve. The cartridge body is open at longitudinal ends to receive the first valve distal to the spacer and the second valve proximal to the spacer.
Each of the first valve and the second valve includes a valve body having at least two slits that intersect and twist about the central axis, with the slits of the first valve and the slits of the second valve oriented in substantially the same direction diametrically across a portion of the respective valve body. The valves also include at least one set of tabs on a distal surface, configured to couple the first valve to a shaft hub and the second valve to the hub. Valve seating interfaces are described between the shaft hub distal surface and the cartridge body and/or spacer cartridge interface to create fluid-tight seals.
The invention further provides a vascular closure system configured to seal a puncture in a vessel, where the access sheath is inserted into the vessel and includes a hub, a cartridge, and an access channel extending from the hub to a distal end along the central axis. A deployment assembly is insertable into the access channel and into engagement with the first valve and the second valve such that the first valve and the second valve stretch around the deployment assembly. The described hemostasis valve slit geometry and coupled tab/groove relationships are intended to reduce leakage while maintaining a fluid-tight seal during device introduction/exchange.
Claims Coverage
The document provides three independent claims and a separate independent method claim. The claims center on a cartridge carried by a hub that holds a first valve and a second valve separated by a spacer along a central axis, with intersecting slits that twist or spiral about the central axis and distal tabs for coupling to a shaft hub and/or hub.
Access sheath with cartridge-carried first and second twisted-slit valves separated by a spacer
An access sheath includes a hub and a cartridge carried by the hub with a first valve and a second valve spaced along a central axis, and a cartridge body defining a spacer between the first valve and the second valve; each valve body has first and second slits that intersect and twist about the central axis, with the first slits and second slits oriented in substantially the same direction diametrically across respective valve bodies; the cartridge is open at longitudinal ends so the first valve is inserted distal to the spacer and the second valve is inserted proximal to the spacer; and the first and second valves include at least one set of tabs on a distal surface configured to couple the first valve to the shaft hub and the second valve to the hub.
Access sheath with distally extending tabs coupled to a shaft hub
An access sheath comprises a hub and a cartridge carried by the hub having a first valve with a distal surface and at least one tab extending distally from the distal surface, and a second valve with a distal surface; a spacer extending inwardly from an internal surface of the cartridge is positioned between the first valve and the second valve so the first and second valves are spaced apart along a central axis; each of the first and second valves has a valve body and at least two slits extending partially across the respective valve and twisting about the central axis such that the slits of the first and second valves are oriented in substantially the same directions diametrically across a portion of the respective valve body; the cartridge is open at longitudinal ends so the first valve is inserted distal to the spacer and the second valve is inserted proximal to the spacer; and a shaft assembly has a shaft hub coupled to the hub and the at least one tab of the first valve, and a shaft extending distally.
Vascular closure system with deployment assembly stretching first and second valves
A vascular closure system includes an access sheath configured to be inserted into a vessel, with a hub and a cartridge carried by the hub containing a first valve and a second valve spaced along a central axis and a spacer extending from an internal surface between the first valve and the second valve, where each valve has at least two slits that extend partially across the valve and spiral about the central axis such that the slits of the first and second valves are oriented in substantially the same directions diametrically across a portion of the respective valve; each valve further includes a proximal surface and a distal surface with one or more distally extending tabs on the distal surface; the cartridge is open at longitudinal ends so the first valve is inserted into a longitudinal end distal to the spacer and the second valve is inserted into a longitudinal end proximal to the spacer; a shaft assembly having a shaft hub coupled to the hub with a shaft extending distally to define the distal end of the access sheath; an access channel extending from the proximal end at the hub to the distal end along the central axis; and a deployment assembly configured to seal the puncture and insertable into the access channel and into engagement with the first valve and the second valve such that the first valve and the second valve stretch around the deployment assembly.
Method of forming an access sheath by inserting valves into an open cartridge and coupling hub-to-hub
A method provides a first valve and a shaft assembly with a shaft hub and an elongated shaft extending distally; the shaft hub is coupled to a cartridge with a tool, where the cartridge body defines an internal surface and a spacer extending inwardly from the internal surface and is open at longitudinal ends so the first valve is inserted into a first longitudinal end distal to the spacer; a second valve is placed in the cartridge by inserting into a second longitudinal end proximal to and adjacent the spacer such that the second valve is spaced apart from and aligned with the first valve along a central axis and the spacer is disposed between the first valve and the second valve; the first and second valves each have a valve body with a first slit and a second slit that intersect and twist about the central axis with the first slits oriented in substantially the same direction diametrically across respective valve bodies and the second slits oriented in substantially the same direction diametrically across respective valve bodies, and the first and second valves include at least one set of tabs on a distal surface configured to couple the first valve to the shaft hub and the second valve to a hub; and inserting an assembly of the cartridge and the shaft hub to form an access sheath.
Across the independent claims, the core claim coverage centers on a cartridge carried by a hub that holds a first valve and a second valve separated by a spacer along a central axis, where each valve body includes intersecting slits that twist or spiral about the central axis and are oriented in substantially the same diametric directions across corresponding valves. The valves include distal tabs for coupling to a shaft hub and/or hub, and the cartridge is open at longitudinal ends to receive the valves distal and proximal relative to the spacer. In the vascular closure system claim, the deployment assembly engages and stretches both valves around the deployment assembly as part of sealing a puncture in a vessel.
Stated Advantages
Fluid-tight seal while reducing leakage.
Reduced leakage and reduced insertion force.
The system can address larger bore punctures, including femoral artery punctures.
Documented Applications
Use in a vascular closure system to seal a puncture in a vessel by inserting a deployment assembly through an access channel and engaging first and second valves that stretch around the deployment assembly.
Device introduction/exchange along a guidewire into a puncture of a vessel using the access sheath.
Addressing larger bore punctures, including femoral artery punctures, using the described access sheath and system configuration.
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