Positive-flow valve

Details Positive-flow valve Positive-flow valve

1999-10-04

2002-08-06

Casler, Brian L. (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S256000, C604S246000, C251S149300, C251S149700, C251S004000

Reexamination Certificate

active

06428520

ABSTRACT:

FIELD OF THE INVENTION
This invention relates generally to a medical valve, and in particular to a positive flow valve which, when connected between a medical implement and a catheter to facilitate fluid flow therethrough, induces a positive flow of fluid through a tip of the catheter from the valve upon disconnection of the medical implement, thereby eliminating the problem of blood-clogging or clotting in the catheter.
BACKGROUND OF THE INVENTION
The manipulation of fluids for parenteral administration in hospitals and medical settings routinely involves the use of connectors and valves for facilitating the movement of fluids between two points. Fluid connectors and valves typically employ needles or luers to pierce a septum or seal covering sterile tubing or to pierce a septum or seal of a medicament container of fluid. Fluid then passes from the container or fluid-filled tubing into a syringe or second set of tubing. Since the ready passage of fluids through the connectors and valves is often critical to patient survival, it is imperative that the connectors and valves function reliably and repeatedly. Connectors and valves that malfunction during use may be life-threatening.
Many connectors or valves, especially those employing several mechanical components, have a relatively high volume of fluid space within them. There is potential for the creation of a “dead space” (i.e. an increase in the fluid containment area which will cause fluid within the patient to be drawn therein) in the fluid space during removal or disconnection of the tubing or other medical implements such as conduits, syringes, IV sets (both peripheral and central lines), piggyback lines, and similar components which can be used in connection with a medical valve. Withdrawal of the medical implement creates a suction force which draws fluid back toward the valve in a phenomenon known as “backflash.” This is particularly troublesome in the case where the valve is connected through a catheter to a patient. A suction force is generated by the withdrawal of the medical implement which draws blood from the patient into the catheter. This blood clot and clog the catheter near its tip, rendering it inoperable, and may even result in a clot of blood in the patient, which may prove fatal. Attempts to avoid backflash by coating the inner surface of the catheter near its tip in order to prevent blood from sticking to the interior surfaces of the catheter and clogging it have not been successful.
The risk of blood clogging of the catheter is significantly heightened where the inner diameter of the catheter is small (e.g., 27 gauge). These small catheters have the advantage, however, that they reduce the trauma and discomfort caused by insertion into a patient. Because these catheters have a very small passage therethrough, even a small suction force may draw sufficient amount of fluid back through a catheter toward the valve to introduce blood into the catheter tip, which blood may clog the catheter's passage. This back flow is hereinafter referred to as a negative flow.
FIG. 1
shows an example of a catheter
50
having a small portion near the tip
52
that is inserted into the patient, and a valve
54
connected between one end of the catheter and a medical implement
56
. The problem associated with the creation of “dead space” or a drawing of fluid from the catheter towards the valve is illustrated by this Figure. As illustrated therein, when the tip or nose of the medical implement
56
is withdrawn from the valve
54
, the space previously occupied by the implement
56
becomes “dead space.” This newly created space has a lower pressure than the fluid within the valve, catheter and patient, such that fluid is drawn into that space, and thus travels from the patient in the direction of the dead space. To avoid blood from being drawn into the catheter, a zero flow or a positive flow, defined as flow or fluid displacement directed from the valve through the catheter tip to the patient, must be effected at the time the medical implement is withdrawn. For a sufficient margin of safety, a positive flow toward the patient is desirable.
To avoid negative flow or backflash, healthcare workers presently practice the method of disconnecting the valve and simultaneously transferring fluid through the catheter by manipulating the medical implement to induce positive flow. This method is clumsy and difficult, and may result in an inaccurate transfer of medicament.
One way to induce a positive flow in the catheter is illustrated in
FIGS. 2
a
and
2
b.
Here, the proximal end of a valve
180
is enclosed with a stylet or displacer
182
upon withdrawal of the medical implement (not shown). An elongated portion
184
of the stylet
182
takes up at least a portion of the fluid space, thereby reducing the volume of the fluid space, and may eliminate the dead space therein. The elongated portion
184
, however, must be sufficiently long to displace more fluid than that volume of fluid which may be drawn from the catheter towards the valve by the withdrawal of the implement, and hence may be difficult to construct for proper performance. The use of the stylet
182
further requires an additional step that may be overlooked by the nurse and the stylet
182
may be misplaced or lost. In addition, this specific type of valve
180
has many significant drawbacks, among them the fact that it does not have a seal with a swabbable surface that can be swabbed after each use for sterility.
SUMMARY OF THE INVENTION
In accordance with the present invention there is provided a positive flow valve which is advantageously utilized between a catheter and another medical implement, and with which the flow of a fluid between the implement and catheter (and a patient within which the catheter is employed). The valve of this invention has several features, no single one of which is solely responsible for its desirable attributes.
In general, the positive flow valve of the present invention has the attributes of safety, positive flow for eliminating dead space, reliable and repeatable performance, simplicity of manufacture and use, a seal for use in establishing fluid flow which need not be pierced with a sharp spike or cannula, suitability of high pressure applications, and employment of a valve that is swabbable after use to provide sterility and has a fluid-tight seal at high pressure.
The present invention is a swabbable, needle-less, positive flow valve that has a fluid space which automatically expands upon insertion of a medical implement and contracts upon withdrawal of the medical implement. When the valve is connected to a catheter, it induces a positive flow from the valve to the catheter tip upon disconnection of the medical implement to avoid the potential problems of blood-clogging. After use, the valve is swabbed in the conventional manner with a suitable substance to maintain sterility. The design of the valve avoids accidental needle or spike sticks. The valve is particularly suited for applications with a catheter where it is desirable to avoid backflash, but may be used for other applications as well.
Preferably, the valve includes a housing having a first end adapted for receiving one end of medical implement, and having a second end in communication with a catheter. The valve includes means for establishing a fluid flow path through the housing and between the medical implement and the catheter, and which is also useful in occluding the flow path through the housing and thereby preventing fluid flow between the medical implement and catheter.
Preferably, this means comprises a seal movably positioned within the housing. The seal has a passage therethrough which defines, in at least one area, a fluid containment area. The seal has a first end adapted for engagement by the medical implement. In a first position, the passage through the seal is closed at its first end, and in a second position, when the medical implement is utilized to press the seal distally within the housing of the valve, the passage through the valve

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