Introducer sheath systems and methods
Introducer sheath systems including a pressure regulator operably coupled to a hemostatic valve, wherein the pressure regulator includes a chamber filled with a gas that is fluidly isolated from the hemostatic valve. The introducer sheath systems may include a tubular sheath, a hub assembly, and a dilator disposed therein connected to a proximal end of the sheath; the hub assembly including a housing and a hemostatic valve disposed therein; a pressure regulator connected to the hub and in fluid communication with the hemostatic valve; and a sealed chamber defined by the pressure regulator, the chamber having an interior, wherein the interior of the chamber is filled with a gas that is fluidly isolated from the hemostatic valve.
1 . An introducer sheath system, comprising:
a tubular sheath;
a hub assembly connected to a proximal end of the tubular sheath;
a dilator extending through the hub assembly and the tubular sheath;
the hub assembly including a housing and a hemostatic valve disposed therein;
the hemostatic valve comprising a non-collapsible valve body and a collapsible member, wherein the collapsible member closes when a space between the collapsible member and the valve body is pressurized;
a pressure regulator connected to the hub assembly and in fluid communication with the space between the collapsible member and valve body; and
a sealed chamber defined by the pressure regulator, the sealed chamber having an interior, wherein the interior of the sealed chamber includes a fixed volume and is fluidly isolated from the space between the collapsible member and the valve body.
2 . The introducer sheath system as in claim 1 , wherein the sealed chamber comprises a closed-cell foam.
3 . The introducer sheath system as in claim 1 , wherein the collapsible member is secured to valve body by an O-ring disposed in a notch of the valve body.
4 . The introducer sheath system as in claim 1 , wherein the sealed chamber comprises a chamber housing.
5 . The introducer sheath system as in claim 1 , wherein the space between the collapsible member and the valve body is filled with a liquid.
6 . The introducer sheath system as in claim 5 , wherein the sealed chamber is filled with a gas.
7 . The introducer sheath system as in claim 6 , wherein the collapsible member comprises a sleeve.
8 . The introducer sheath system as in claim 7 , wherein the collapsible member comprises ePTFE.
9 . The introducer sheath system as in claim 7 , wherein the collapsible member comprises densified ePTFE.
10 . The introducer sheath system as in claim 7 , wherein the collapsible member comprises a laminate of FEP over ePTFE.
11 . The introducer sheath system as in claim 7 , wherein the collapsible member is inverted and wrapped around ends of the valve body.
12 . The introducer sheath system as in claim 1 , wherein the pressure regulator mitigates a valve pressure increase as a function of a device size at a rate less than 0.70 PSI/F.
13 . The introducer sheath system as in claim 1 , wherein the pressure regulator mitigates a valve pressure increase as a function of a device size at a rate less than 0.50 PSI/F.
14 . The introducer sheath system as in claim 1 , wherein the pressure regulator mitigates a valve pressure increase as a function of a device size at a rate less than 0.35 PSI/F.
15 . An introducer sheath system, comprising:
a tubular sheath;
a hub assembly connected to a proximal end of the tubular sheath, the hub assembly including a primary port and a secondary port;
a dilator extending through the primary port, the hub assembly and the tubular sheath;
the hub assembly including a housing and a hemostatic valve disposed therein;
the hemostatic valve comprising a valve body and a collapsible member, wherein the collapsible member closes when a space between the collapsible member and the valve body is pressurized, and wherein the collapsible member is secured to the valve body by an O-ring disposed in a notch of the valve body;
a pressure regulator connected to the hub assembly and in fluid communication with the space between the collapsible member and the valve body; and
a sealed chamber defined by the pressure regulator, the sealed chamber having an interior, wherein the interior of the sealed chamber includes a fixed volume and is fluidly isolated from the space between the collapsible member and the valve body.
16 . The introducer sheath system as in claim 15 , wherein the housing of the hub assembly defines a bubble capture chamber with a vertical apex, and wherein a flush line is connected to the bubble capture chamber at the vertical apex to vent air bubbles from the bubble capture chamber.
17 . The introducer sheath system as in claim 16 , wherein the housing defining the bubble capture chamber is transparent to facilitate viewing bubbles in the bubble capture chamber.
18 . The introducer sheath system as in claim 15 , further comprising a brake connected to the housing of the hub assembly, wherein the brake is configured to engage a device inserted into at least one of the primary port and the secondary port.
19 . The introducer sheath system as in claim 15 , wherein the hub assembly includes a connector associated with one of the primary port or secondary port, wherein the connector is configured for connection to ECMO tubing for receiving oxygenated blood flow.
20 . An introducer sheath, comprising:
a tubular sheath;
a hub assembly connected to a proximal end of the tubular sheath;
the hub assembly including a housing and a hemostatic valve disposed therein;
a brake connected to the housing of the hub assembly, wherein the brake includes a first configuration and a second configuration;
a pressure regulator connected to the hub assembly and in fluid communication with the hemostatic valve, wherein the pressure regulator is positioned coaxially with the hemostatic valve; and
a sealed chamber defined by the pressure regulator, the sealed chamber having an interior, wherein the interior of the sealed chamber includes a fixed volume and is filled with a gas that is fluidly isolated from the hemostatic valve.