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Publication Number
US-9108034-B2
Publication Date
2015-08-18
Expiration Date
Abstract
An intravascular valve assembly having a valve case and a flexible pressure-actuated flow control valve. The valve case includes attached proximal and distal case portions that present respective spaced apart fluid ports and a fluid passageway extending between the ports. The flexible pressure-actuated flow control valve is disposed within the fluid passageway and includes a slitted central valve wall. The proximal case portion includes an axially-extending boss that projects distally, with a portion of a distal end of the boss contacting the flow control valve. The valve permits fluid flowing in a distal direction to pass through the slit. Fluid flowing in a proximal direction, however, causes the valve to compresses against the boss and the slit to close, thus restricting fluid flow in a proximal direction.
Core Innovation
The invention relates to an intravascular check valve assembly configured to control fluid flow through the assembly in opposite distal and proximal directions. The valve assembly includes a valve case having attached proximal and distal case portions with spaced apart fluid ports and a fluid passageway extending between the ports. A flexible pressure-actuated flow control valve is disposed along the fluid passageway to control fluid flow therethrough.
The flexible pressure-actuated flow control valve includes a valve wall having a slit at a distal end of the wall, and the valve wall presents distal-facing and proximal-facing surfaces. The proximal case portion includes an axially-extending boss that distally projects from the proximal case and presents an exterior surface, a proximal end, and a distal end. At least a portion of the exterior surface of the boss is complementally shaped to at least a portion of the proximal-facing surface of the valve wall to prevent mechanical inversion of the valve and a corresponding fluid flow through the fluid passageway in a proximal direction.
The boss includes a radial edge at the proximal end of the boss and at least one generally axially directed channel positioned axially through the boss and fluidly connecting the fluid port of the proximal case to the proximal-facing surface of the valve wall. The valve wall flexes to open the slit in response to fluid flowing in a distal direction through the at least one channel, and the valve wall compresses against the boss and closes the slit in response to fluid flowing in a proximal direction, thereby preventing fluid flow through the valve assembly in the proximal direction.
Claims Coverage
The independent claim covers an intravascular check valve assembly with a flexible pressure-actuated slitted valve wall and an axially extending boss having axially directed channels to achieve distal-opening and proximal-closing while preventing mechanical inversion. Dependent claims further refine the mechanical inversion prevention and geometric and channel constraints of the boss and channel arrangement.
Flexible pressure-actuated slitted valve wall with distal slit and bidirectional operation
A flexible pressure-actuated flow control valve disposed along the fluid passageway to control fluid flow therethrough, the valve including a valve wall having a slit at a distal end of the wall, the valve wall presenting distal-facing and proximal-facing surfaces, the valve wall flexing to open the slit in response to fluid flowing in a distal direction, and the valve wall compressing against the boss and closing the slit in response to fluid flowing in a proximal direction, thereby preventing fluid flow through the valve assembly in the proximal direction.
Complementally shaped axially-extending boss to prevent mechanical inversion and proximal flow
An axially-extending boss that distally projects from the proximal case, the axially-extending boss having an exterior surface, a proximal end, and a distal end, wherein at least a portion of the exterior surface of the boss is complementally shaped to at least a portion of the proximal-facing surface of the valve wall to prevent mechanical inversion of the valve and a corresponding fluid flow through the fluid passageway in a proximal direction.
Axially directed channel through boss fluidly connecting proximal port to valve wall
The axially-extending boss including a radial edge at the proximal end of the boss and at least one generally axially directed channel positioned axially through the boss and fluidly connecting the fluid port of the proximal case to the proximal-facing surface of the valve wall, wherein the at least one channel includes a proximal opening in the proximal end of the boss and a distal opening in the distal end of the boss, and the proximal opening is a non-nominal distance from the radial edge of the boss.
Boss distal end direct contact configuration to prevent proximal-direction opening
A further embodiment wherein the proximal case portion of the valve case includes an axially-extending boss, and a distal-most portion of the boss directly contacts the proximal-facing surface of the valve wall to prevent mechanical inversion of the valve and a corresponding fluid flow through the fluid passageway in a proximal direction.
Boss distal end spacing configuration to prevent valve flexing in proximal direction
A further embodiment wherein a distal-most portion of the distal end of the boss is spaced away from the proximal-facing surface of the valve wall by at least a nominal distance to prevent the valve from flexing open in the proximal direction.
Three equally spaced axially directed channels in boss
A further embodiment wherein the axially-extending boss has at least one channel implemented as three equally spaced channels within the boss interior.
Hemispherical boss shape
A further embodiment wherein the axially-extending boss is generally hemispherical in shape.
Channel longitudinal axis orientation parallel to check valve assembly axis
A further embodiment wherein the longitudinal axis of the at least one channel of the axially-extending boss is generally parallel to the longitudinal axis of the check valve assembly.
Overall, the independent claim defines distal-direction opening and proximal-direction closing of a flexible pressure-actuated valve using a slit valve wall and an axially-extending boss with axially directed channels, while the complemental boss-to-valve-wall geometry prevents mechanical inversion and corresponding proximal flow. The dependent claims narrow the mechanical inversion prevention by specifying direct contact versus spacing and further constrain boss shape and channel geometry and orientation.
Stated Advantages
Prevents fluid flow through the valve assembly in the proximal direction.
Prevents a mechanical inversion of the valve and a corresponding fluid flow through the fluid passageway in a proximal direction.
Enables opening of the slit in response to distal-direction fluid flow.
Enables closing of the slit by compressing against the boss in response to proximal-direction fluid flow.
Documented Applications
Intravascular infusion check valve assemblies for IV catheters, configured as an inline check valve system, a Y-site check valve system, and a manifold check valve system with downstream fluid mixing while restricting upstream reflux, including connector types using luer lock fitting and slip luer fitting.
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