Flush-valve assembly for blood pressure measurement catheter

• US 4,934,375 A
• Filed: 08/07/1989
• Issued: 06/19/1990
• Est. Priority Date: 03/04/1988
• Status: Expired due to Term

• Current Assignee: Becton Dickinson Critical Care Systems Pte Ltd. (Becton, Dickinson & Co)
• Original Assignee: Spectramed, Inc.
• Inventors: Savage, Douglas R., Warren, Maurice A., Cole, James E.
• Primary Examiner(s): Sykes, Angela D.
• Application Number:
  US07/394,253
• Time in Patent Office: 316 Days
• Field of Search: 128/672-675, 128/748, 604/30, 604/32-34, 604/246-249, 604/236-238, 604/256, 251/61.1, 251/331-334, 251/335.1-335.3, 251/117-118, 251/309, 251/209, 137/238, 137/510
• US Class Current: 600/486
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61M 39/225 Flush valves, i.e. bypass valves for flushing line

Abstract

A resilient valve core, biased against its seat in a molded body, controls large flow volumes for flushing. A small resilient tube embedded in the core bypasses the valve to provide smaller flow volumes for IV-fluid drip. For flushing, the core is deformed, rather than bodily moved, relative to the body. A fluid-flow channel is recessed along one side of the valve cavity, and the valve seat forms a short barrier across this channel. The core is a T-shaped unitary member; the center of the "upper" surface of the T crossbar is biased against the seat, and the extrema of the crossbar are hermetically sealed against the valve body, while the stem of the T extends outward from the body. A user squeezes a cowling mounted outside the body to start and control flushing. The cowling itself deforms to pull the stem of the T outward, deforming the T and separating the middle of its crossbar portion from the valve seat. A user can elect to grasp and pull the stem directly. Parts of the upper side of the extrema of the T crossbar are relieved, forming a smooth fluid-flow transition with the inlet and outlet. These paths, the relieved parts of the crossbar, and the cavity interior are all smooth, gently tapering and well fitted, forming nearly an in-line flush path to minimize gas-bubble trapping.

Claims

1. A flush valve for a blood-pressure monitoring system, comprising:

a formed substantially rigid body;

fluid inlet and outlet paths defined in the body;

a valve-core cavity defined in the body, said cavity having an interior and a floor;

a valve seat defined at the floor of the cavity;

a valve core of a resilient material disposed in the cavity and biased against the valve seat to cooperate with the valve seat in substantially preventing flush-rate fluid flow between the inlet and outlet paths;

drip-rate fluid-flow means comprising a small-diameter lumen passing through said valve core of resilient material bypassing the valve seat to communicate between the inlet and outlet paths to permit drip-rate fluid flow between the inlet and outlet paths; and

operable flush-control means for deforming the resilient valve core to overcome the bias and separate part of the core from the seat, to permit flush-rate fluid flow between the inlet and outlet paths.

2. The valve of claim 1, for use with such a blood-pressure monitoring system that monitors pressure in fluid at one side of the valve core, primarily during a quiescent condition when the flush-control means are not operated to permit flush-rate fluid flow;

and wherein;

the drip-rate fluid flow and flush-rate fluid flow are mutually substantially parallel;

the surface area through which fluid at said one side of the valve core is adapted to be coupled to the resilient material of the valve core is small;

in such quiescent condition when the flush-control means are not operated to permit flush-rate fluid flow, the resilient valve core is biased against the seat by the resiliency of the core itself, in a positive engaging action that is transverse to the drip-rate and flush-rate fluid flows, with the valve-core material in compression;

said biasing in a positive engaging action transverse to the fluid flows, with the valve-core material in compression, reduces the effective resilience of the valve core during such quiescent condition;

whereby the smallness of the fluid coupled surface area minimizes the mechanical oscillatory coupling of the resilient material to fluid;

whereby the smallness of the fluid coupled surface area and the reduced effective resilience during such quiescent condition, together minimize the compliance of the monitoring system as a resonant system and thereby raise the frequency of mechanical oscillation of the monitoring system during such quiescent condition substantially outside the range of frequencies of interest in such blood-pressure monitoring; and

whereby adverse resonant effects on accurate operation of such blood-pressure monitoring system are made substantially insignificant.

3. The valve of claim 2, wherein:

the surface area through which fluid at said one side of the valve core is adapted to be coupled to the resilient material of the valve core is less than fifteen square millimeters.

4. The valve of claim 2, wherein:

the surface area through which fluid at said one side of the valve core is adapted to be coupled to the resilient material of the valve core is a resilient surface of the core itself that is adapted to be exposed to the fluid.

5. The valve of claim 2, wherein:

the compression of the valve core produces compliance in the monitoring system on the order of 0.08 cubic millimeters per hundred millimeters of mercury;

the elasticity of the valve core when uncompressed is on the order of 7×

10¹⁰ dynes/cm² ;

the effective elasticity of the valve core when in compression during said quiescent condition is on the order of 14×

10⁶ dynes/cm² ; and

resonant frequencies of the monitoring system are raised to thirty hertz and higher.

6. The flush valve of claim 2, wherein said small-diameter lumen is oriented substantially perpendicular to the direction of said bias between said valve core and said valve seat, and communicating between the inlet and outlet paths and bypassing the valve seat.

7. The flush valve of claim 2, wherein:

said small diameter lumen comprises;

a small-diameter tube disposed within and through the valve core and oriented substantially perpendicular to the direction of said bias between said valve core and said valve seat, and communicating between the inlet and outlet paths and bypassing the valve seat;

the tube has an end that protrudes out from the valve core into the inlet path;

thereby minimizing occlusion of the tube by particles funneled into the tube along the inlet path and valve core; and

the tube is sufficiently resilient to deform away from the valve seat with the valve core, when the operable means are operated to permit flush-rate fluid flow;

but is sufficiently rigid in comparison with the valve-core material to remain open when the valve-core material is in compression.

8. The flush valve of claim 7, wherein:

the tube has an internal diameter on the order of one-twentieth millimeter; and

the drip-rate fluid flow is on the order of three cubic centimeters per hour.

9. The flush valve of claim 7, wherein:

the tube has an internal diameter on the order of one-tenth millimeter; and

the drip-rate fluid flow is on the order of thirty cubic centimeters per hour.

10. The flush valve of claim 1, wherein:

said small diameter lumen comprises a small-diameter resilient tube disposed within and through the valve core and oriented substantially perpendicular to the direction of said bias between said valve core and said valve seat, and communicating between the inlet and outlet paths and bypassing the valve seat; and

the resilient tube has an end that protrudes out from the valve core into the inlet path;

thereby minimizing occlusion of the tube by debris funneled into the tube along the inlet path and valve core.

11. The flush valve of claim 10, wherein:

the tube has an internal diameter on the order of one-twentieth millimeter; and

the drip-rate fluid flow is on the order of three cubic centimeters per hour.

12. The flush valve of claim 10, wherein:

the tube has an internal diameter on the order of one-tenth millimeter or less; and

the drip-rate fluid flow is on the order of thirty cubic centimeters per hour.

13. The flush valve of claim 1, further comprising:

at least one fluid flow channel formed as a distinct recess in and along a surface of the cavity and communicating with the fluid inlet or outlet path; and

wherein the valve seat is disposed to block the channel;

wherein the valve core in cooperating with the valve seat substantially prevents flush-rate fluid flow between the inlet and outlet paths along the channel; and

wherein the operable flush-control means permit flush-rate fluid flow between the inlet and outlet paths along the channel.

14. The flush valve of claim 1, wherein:

the core comprises a generally T-shaped resilient member;

said T-shaped resilient member comprising a staff and a cross bar forming said T-shape, said cross bar having an upper surface and two extrema,

the upper surface of the crossbar of the T shape of the resilient member is biased against the seat by the resilience of the member;

the extrema of the crossbar of the T shape of the resilient member are hermetically sealed against the body;

the staff of the T shape of the resilient member extends outward from the body; and

the operable flush-control means operate by pulling outward on the staff of the T shape of the resilient member to deform the resilient member and separate the crossbar of the T shape from the seat.

15. The flush valve of claim 14, wherein:

the T-shaped resilient member is a unitary formed member.

16. The flush valve of claim 15, wherein:

the small diameter lumen comprises a small-diameter resilient tube disposed within and through the T-shaped resilient member, communicating between the inlet and outlet paths and bypassing the valve seat.

17. The flush valve of claim 16, wherein:

the T-shaped resilient member is molded around the small-diameter resilient tube.

18. The flush valve of claim 14, wherein:

portions of the upper surface of the extrema of the crossbar of the T shape of the resilient member that are aligned with the inlet and outlet paths respectively are relieved to cooperate with the interior of the valve-core cavity to form a smooth fluid-flow transition with the inlet and outlet paths.

19. The flush valve of claim 18, wherein:

the inlet and outlet paths, the relieved portions of the crossbar of the resilient member, and the interior of the valve-core cavity are all defined by smooth, gently tapering, well-fitted surfaces forming a substantially in-line flush path, substantially without crevices or eddy points that might trap gas bubbles and prevent their being flushed out of the valve.

20. The flush valve of claim 1, wherein the operable flush-control means comprise:

a generally extensile member secured to or integral with a back side of the valve core, and extending therefrom outward from the body; and

manually manipulable means disposed substantially outside the body for drawing the extensile member outward with respect to the body to deform the core and effect flushing.

21. The flush valve of claim 20, wherein:

the manually manipulable means comprises a resilient cowling that is secured to exterior sides of the body, and that engages the extensile member outside the body, and that is adapted to be manually squeezed between two fingers to force the extensile member outward from the body, to deform the core and effect flushing;

whereby the manually manipulable means resists inadvertent actuation by pressure applied at only one side of the valve.

22. The flush valve of claim 20, wherein:

the extensile member is also directly accessible outside the body to be manually directly grasped and pulled outward to deform the core and effect flushing;

whereby a user of the valve can select between manipulating said manually manipulable means and direct grasping and pulling of the extensile member, to effect flushing.

23. The flush valve of claim 1, further comprising:

an electromechanical pressure transducer mounted in the body and exposed to fluid pressure within the outlet path, for generating electrical signals used in measurement of such blood pressure adapted to be transmitted through fluid in the valve; and

electrical connections from the transducer for connection to electronic apparatus for utilization of the signals and determination of such blood pressure.

24. The flush valve of claim 1, further comprising:

an electromechanical pressure transducer mounted in the body and exposed to fluid pressure within the outlet path, for generating electrical signals used in measurement of such blood pressure adapted to be transmitted through fluid in the valve; and

electrical connections from the transducer for connection to electronic apparatus for utilization of the signals and determination of such blood pressure;

said electronic apparatus being operated to monitor blood pressure primarily during a quiescent condition when the flush-control means are not operated to permit flush-rate fluid flow;

wherein the drip-rate fluid flow and flush-rate fluid flow are mutually substantially parallel;

wherein the resilient surface of the valve core that is exposed to fluid is much smaller than the rigid surface of the body that is exposed to fluid;

wherein in such quiescent condition when the flush-control means are not operated to permit flush-rate fluid flow, the resilient valve core is biased against the seat by the resiliency of the core itself, in a positive engaging action that is transverse to the drip-rate and flush-rate fluid flows, with the valve-core material in compression;

wherein said biasing in a positive engaging action transverse to the fluid flows, with the valve-core material in compression, reduces the effective resilience of the valve core during such quiescent condition;

whereby adverse resonant effects on accurate operation of such blood-pressure monitoring system are made substantially insignificant.

25. The flush valve of claim 1, wherein:

the operable means are manually operable.

26. A flush valve for a blood-pressure monitoring system, comprising:

a formed substantially rigid body;

fluid inlet and outlet paths defined in the body;

a valve-core cavity defined in the body and having an interior;

at least one fluid flow channel defined along one side of the cavity and communicating with the fluid inlet or outlet path;

a valve seat defined at the same side of the cavity and disposed to block the channel;

a valve core of a resilient material disposed in the cavity and biased against the valve seat to cooperate with the valve seat in substantially preventing flush-rate fluid flow between the inlet and outlet paths along the channel, and wherein;

the core comprises a generally T-shaped resilient member, said T-shaped resilient member comprising a staff and a cross bar forming said T-shape, said cross bar having an upper surface and two extrema;

the upper surface of the crossbar of the T shape of the resilient member is biased against the seat by the resilience of the member,

the extrema of the crossbar of the T shape of the resilient member are hermetically sealed against the body,

the staff of the T shape of the resilient member extends outward from the body;

a small-diameter resilient tube disposed within and through the valve core and bypassing the valve seat to communicate between the inlet and outlet paths; and

manually manipulable means disposed substantially outside the body for drawing the staff of the T shape of the resilient member outward with respect to the body to deform the resilient valve core overcoming the bias and separate the core from the seat, to effect flush-rate fluid flow along the channel between the inlet and outlet paths; and

wherein portions of the extrema of the crossbar of the T shape of the resilient member that are aligned with the inlet and outlet paths respectively are relieved to cooperate with the channel to form a smooth fluid-flow transition with the inlet and outlet paths; and

wherein the inlet and outlet paths, the relieved portions of the crossbar of the resilient member, and the interior of the valve-core cavity are all defined by smooth, gently tapering, well-fitted surfaces forming a substantially in-line flush path, substantially without crevices or eddy points that might trap gas bubbles.

27. The flush valve of claim 26, wherein:

the T-shaped resilient member is a unitary formed member.

28. The flush valve of claim 26, wherein:

the manually manipulable means comprises a resilient cowling that is secured to exterior sides of the body, and that engages the staff of the T shape of the resilient member outside the body, and that is adapted to be manually squeezed between two fingers to force the staff outward from the body, to deform the core and effect flushing;

whereby the manually manipulable means resists inadvertent actuation by pressure applied at only one side of the valve.

29. The flush valve of claim 28, wherein:

the staff of the T is also directly accessible outside the body to be manually directly grasped and pulled outward to deform the core and effect flushing;

whereby, to effect flushing, a user of the valve can select between (1) manipulating the manually manipulable means and (2) direct grasping and pulling of the staff of the T.

30. The flush valve of claim 26, further comprising:

an electromechanical pressure transducer mounted in the body and exposed to fluid pressure within the outlet path, for generating electrical signals used in measurement of such blood pressure adapted to be transmitted through fluid in the valve; and

electrical connections from the transducer for connection to electronic apparatus for utilization of the signals and determination of such blood pressure.