Valves and valve actuation – With correlated flow path – Valve operated by joining flow path sections
Utility Patent
1996-12-30
2001-01-02
Lee, Kevin (Department: 3753)
Valves and valve actuation
With correlated flow path
Valve operated by joining flow path sections
C251S149100, C604S249000, C604S256000
Utility Patent
active
06168137
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to flow control and, more particularly, to swabbable check valves for the needless control of injected fluids.
A valve is a device that regulates flow. A check valve permits flow in one direction only. Where fluids need to be introduced into the body, it is common practice to do so through a check valve connected to a catheter, which is a slender hollow tube inserted into a body passage or cavity for passing fluids.
For example, medication can be injected into a check valve connected to a catheter. In prior practice, medication from the syringe has been introduced using a needle, but this can be undesirable, since in modern medical practice, needle sticks are to be avoided. A number of attempts have been made to achieve the introduction of medication without the need for using syringes with needles.
Illustrative examples of attempted needless control of injected fluids are disclosed in Newgard et al., U.S. Pat. No. 5,064,416; Sivert, U.S. Pat. No. 4,915,687; Jackson, U.S. Pat. No. 4,429,856; Kilmarx, U.S. Pat. No. 3,352,531 and Faust et al. U.S. Pat. No. 5,116,021. All of these illustrative arrangements have the objection that pathogens can enter their inlets without being easily sterilized. While attempts have been made to maintain sterility by capping the inlets, the requirement of caps presents additional complexity and expense. In addition, caps can become dislodged during storage and handling, rending the devices unusable or requiring special sterilization procedures.
Newgard '416 is typical in having a long inlet passage before there is access to a moveable member which is pierceable and controls flow by the extent to which a valving member can be dilated. Sivert, Johnson, Kilmarx and Faust are similarly objectionable.
Still another consideration is desire to operate flow control devices with low “cracking” pressures, i.e. the pressure at which a control member moves away from its seat. For such devices, it is desirable to use relatively thin diaphragms. Unfortunately, thin diaphragms pose problems of stability. The diaphragm may move slightly away from its central position and become lodged against a side wall, causing a problem of leakage.
The catheters used with check valves are of various types. One type includes a tubular member for the introduction of fluids into a blood channel which may be venous or arterial. Another type is a double-walled flexible tube which terminates at its outer end in two separate branches. One branch continues as an outer tube and terminates at its inner end in a inflatable portion. The other branch continues as an inner tube with a through passage that extends to the inflatable portion of the outer tube. There are various other types of catheters as well.
With all types of catheters, it is desirable to be able to control the through flow of fluid using a suitable valve, which can be used in non-catheter applications as well.
Accordingly, it is an object of the invention to provide a miniature check valve which can be used without needles and is swabbable by being easily wiped with disinfectant across its inlet to eliminate contamination and pathogens. A related object is to allow the check valve to be readily usable with devices, such as catheters, to control fluid flow while restricting operation by a patient or unauthorized personnel.
A further object of the invention is to provide a simple and expendable check valve, which can be mass produced, readily assembled and provide ease of operation.
SUMMARY OF THE INVENTION
In accomplishing the foregoing and related objects a miniature check valve is provided by a tubular housing having centered at its inlet bore a solid-ended and non-moveable probe surrounded by an annular sealing member so that both the probe and the sealing member can be cleansed by swabbing, i.e., wiping, the inlet end before the annular sealing member is depressed by, for example, the blunt end of a syringe in order to engage an internal passageway of the probe and permit passage of fluid from the syringe through the valve.
The sealing member abuts an inwardly facing shoulder or valve seat, and is held in its closed position by, for example, a spring, which can be elastomeric, until the sealing member is disengaged from the valve seat by an external member, such as the hollow blunt end of a syringe containing fluid that is to be injected through the valve, for example, into a catheter.
In accordance with a broad aspect of the invention, the housing has an input and output; a probe within the housing extends from the output to beyond the input; the probe has a passageway thereinto connected to the output; and a depressible member seals the input, surrounding the probe and being depressible therealong to expose the passageway.
Because of the extension of the probe beyond the input swabbing of the probe is permitted before the depression of the sealing member.
The input has an entrance and the sealing means can be substantially flush with the entrance. Where the entrance has a prescribed level, the sealing member can terminate at the prescribed level, or below it.
The probe is configured to facilitate contact with an external member, such as a Luer fitting for depressing the sealing member. The probe can terminate in a rounded end beyond the input or in a flattened end.
The sealing member seals to the housing and to the probe, and the sealing to probe can be at a plurality of positions therealong. The sealing member can include provision for applying spring force thereto.
In a method of the invention the steps include: sealing an input by a depressible member surrounding a probe extending beyond the input; and depressing the member to uncover, in the probe, a passageway connected to an output. As a result, the depression of the member permits flow from the input to the output.
The member is depressible from a position substantially flush with the entrance to the input. Where the entrance has a prescribed level, the member is depressible from the prescribed level, or from below the prescribed level.
The method further includes the step of contacting the probe by an outside member, such as a Luer termination, for depressing the sealing member. The step of contacting the probe takes place at a rounded end beyond the input, or astride a flattened end beyond the input.
The sealing to the probe can be at a plurality of different locations therealong, spring force can be applied to the sealing member.
In a method of manufacturing a swabbable check valve the steps include: (a) providing a housing having an input and containing a probe within the housing extending from a output to beyond the input; (b) proving, into the probe, a passageway that is connected to the output; and (c) sealing the input by a member surrounding the probe and depressible therealong to expose the passageway. The extension of the probe beyond the input permits the swabbing thereof before the depression of the sealing member.
A miniature check valve in accordance with the invention includes a tubular housing having an outlet and an inlet at a level surrounded by an exterior surface; a bore extending from the exterior surface into the housing; a stationary probe centered at the inlet at the level of the exterior surface, with the probe having an internal channel extending to the outlet, and a passageway at a position where there is communication outwardly from the interior channel; and there is an annular member between the probe and the interior of the housing for sealing the inlet, with the annular member being depressible to the position of the passageway in the stationary probe. Because of the location of the probe and the annular member relative to the inlet easy swabbing across the inlet and exterior surface is facilitated. Swabbing is further facilitated where the annular member is flush with the inlet.
The apparatus of the invention encompasses means having an exterior surface at a level containing an inlet; means centered in the inlet at the level of the exterior surface and having a passageway fo
Kersey G.
Lee Kevin
LandOfFree
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