Access sheath with valve assembly

An access sheath configured to be disposed along a guidewire into a puncture of a vessel, the access sheath comprising:

• a hub having a proximal end and a distal end spaced from the proximal end;
• a cartridge carried by the hub, the cartridge including:
• a first valve that includes a distal surface and at least one tab extending distally from the distal surface,
• a second valve that includes a distal surface, and
• a cartridge body defining an internal surface and defining a spacer extending inwardly from the internal surface, the spacer positioned between the first valve and the second vale so that the first valve and the second valve are spaced apart with respect to each other along a central axis,
• wherein;
• each of the first valve and the second valve has a valve body and at least two slits that extend partially across the respective valve and twist about the central axis as they extend through the valve body such that the at least two slits of the first valve and the at least two slits of the second valve are oriented in substantially the same directions diametrically across a portion of the respective valve body, and
• the cartridge body is open at longitudinal ends so that the first valve is inserted into a first longitudinal end of the cartridge body distal to the spacer, and the second valve is inserted into a second longitudinal end of the cartridge body proximal to the spacer;
• and
• a shaft assembly having a shaft hub coupled to the hub and the at least one tab of the first valve, and a shaft that extends from the shaft hub in a distal direction.

A vascular closure system configured to seal a puncture in a vessel, the vascular closure system comprising:

• an access sheath configured to be inserted into the vessel, the access sheath having a proximal end and a distal end spaced from the proximal end along a central axis, the access sheath further including
• a hub;
• a cartridge carried by the hub, the cartridge having a first valve, a second valve spaced from the first valve along the central axis, and
• a spacer defined by and extending from an internal surface of the cartridge between the first valve and the second valve,
• wherein:
• the first valve and the second valve each having at least two slits that extend partially across the first valve and the second valve, respectively, and spiral about the central axis such that the at least two slits of the first valve and the at least two slits of the second valve are oriented in substantially the same directions diametrically across a portion of the respective valve,
• the first valve and the second valve each further comprises a proximal surface and a distal surface, the respective distal surfaces each including one or more distally extending tabs, and
• the cartridge is open at longitudinal ends so that the first valve is inserted into a first longitudinal end of the cartridge distal to the spacer, and the second valve is inserted into a second longitudinal end of the cartridge proximal to the spacer;
• a shaft assembly having a shaft hub coupled to the hub, and a shaft that extends from the shaft hub in a distal direction to define the distal end of the access sheath;
• and
• an access channel that extends from the proximal end at the hub to the distal end along the central axis;
• and
• a deployment assembly having a sealing element configured to seal the puncture in the vessel, wherein the 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.

A method, comprising:

• providing a first valve and a shaft assembly having a shaft hub and an elongated shaft that extends from the shaft hub in a distal direction;
• coupling the shaft hub to a cartridge with a tool, the cartridge including:
• a cartridge body defining an internal surface and defining a spacer extending inwardly from the internal surface, the cartridge body is open at longitudinal ends so that the first valve is inserted into a first longitudinal end of the cartridge body distal to the spacer:
• placing a second valve in the cartridge by inserting into a second longitudinal end of the cartridge body 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, wherein:
• the first valve includes a valve body having a first slit and a second slit that intersect each other and twist about the central axis,
• the second valve includes a valve body having a first slit and a second slit that intersect each other and twist about the central axis,
• the first slit of the valve body of the first valve and the first slit of the valve body of the second valve are oriented in substantially the same direction diametrically across the respective valve body;
• the second slit of the valve body of the first valve and the second slit of the valve body of the second valve are oriented in substantially the same direction diametrically across the respective valve body, and
• the first valve and the second valve include at least one set of tabs disposed on a distal surface of each valve body and 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 the hub to a hub to form an access sheath.