WO1983002559A1

WO1983002559A1 - Safety valve for preventing air embolism or hemorrhage

Info

Publication number: WO1983002559A1
Application number: PCT/US1982/000137
Authority: WO
Inventors: Medical Corporation Whitman; Marvin Gordon; Joseph Lichtenstein
Original assignee: Whitman Med Corp
Priority date: 1982-01-28
Filing date: 1982-01-28
Publication date: 1983-08-04
Also published as: AU8207982A; EP0099360A1

Abstract

A safety valve (10) for catheterization procedures is characterized by a piston (20) having an internal flow path, a portion of the piston (20) being surrounded by an elastomeric member (25) which surrounds a portion of the piston (20) and biases it to a closed position. The elastomeric member (25) also severely restricts fluid flow around the piston (20) to eliminate any flow path other than the internal piston (20) flow path.

Description

SAFETY VALVE FOR PREVENTING AIR EMBOLISM OR HEMORRHAGE

TECHNICAL FIELD

The present invention relates to a valving app¬ aratus and method employed in a catheter arrangement to prevent entry of air into a patient's circulatory sys¬ tem and to prevent uncontrolled hemorrhaging.

BACKGROUND OF THE INVENTION

During various medical catheterization procedures, such as cardiac catheterization, centrl venous cat et- erization for parenteral nutrition, arterial catheter¬ ization, etc., there is a severe dange of a fatal air embolism and/or uncontrolled hemorrhaging. Such serious consequences can occur duing the process of catheter insertion when the syringe is removed in order to thread the catheter, or during tubing changes, or if the intravenous tubing becomes inadvertently detached from the intravenous catheter, or after the catheter has been withdrawn and before the tract seals.

Attempts to prevent inadvertent separation of the tubing have including taping the components together or physically forcing them into one another; however, these attempts have not solved the problem and, in fact, some¬ times result in air leaks by fracturing the hubs. In addition, certain safety valve arrangements have been attempted, such as those described in U.S. Patents Nos.

SUBSTITUTE SHEET 2,693,801 (Foreman); 3,105,511 (Murphy); 3,399,677 (Gould, et al.); and 3,570,484 (Steer, et al.). In each of these devices the mechanism which actuates valve closure to provide the safety feature is disposed in the flow path of the administered fluid. Any tendency of the fluid to agglomerate on the mechanism comprises the safety feature. Moreover, such valves as disclosed In the aforementioned references, tend to be suffici¬ ently complex and expensive as to render them less than ideal for disposability after use in a single procedure, lack of disposability, on the other hand, requires that the valve be cleaned and resterilized before each use. Further, it Is questionable as to whether or not the valves in the aforementioned patents are sufficiently fast-operating to preclude a sudden explosive burst of air from entering the patient's vascular system during the valve closure interval.

SUMMARY OF THE INVENTION

It is a primary object of the present invention to provide a safety valve which is readily inserted in a central venous catheterization line (such as would be used for parenteral nutrition) and which precludes oc¬ currence of an air embolism while the valve is closing as well as after the valve is closed. It is a further object of the present Invention to provide such a safety valve for use in any vascular injection arrange¬ ment and which prevents air embolism and/or hemorrhage. It is another object of the present invention to pro¬ vide a valve of the type described which is inexpensive and simple to manufacture, yet reliable in operation.

SUBSTITUTE SHEET

OM In accordance with the present invention, the bias force for effecting closure in a safety valve is provided by an elastomeric material which also serves the function of diffusing or blocking sudden fluid flow through the valve chamber around the normal valving mechanism. The valve includes a piston arranged to reciprocate 'longitudinally in the valve chamber while opposite ends of the piston- project into inlet and out¬ let openings of the chamber. A flange, in the form of a flat disc, surrounds the piston and extends radially therefrom in the chamber. The elastomeric material likewise surrounds the piston and fills the valve cham¬ ber on one side on the flange, the material being arranged to bias the piston -toward the inlet end of the chamber. The piston is hollow and has an open inlet end, a closed outlet end, and outlet slots defined through the cylindrical wall of the piston proximate the outlet end. When biased fully toward the inlet end, the piston is disposed such that the outlet slots are blocked with respect to the valve outlet. In use, a male adaptor of a catheter tube is forced into the valve inlet end where it is held by frictional engagement. In this position, the tube adaptor is inserted into the open end of the piston and pushes the piston toward the outlet end of the valve chamber against the opposing force of the elastomeric material which is thereby com¬ pressed. This pushes the piston outlet slots to a pos¬ ition wherein they are no longer blocked and permits fluid to pass through the valve from the catheter tube via the piston interior. Should the adaptor become dislodged from its friction fit, the resilience of the elastomeric material acts on the flange to force the piston back toward the inlet end of the chamber into a position wherein the outlet slots are blocked. Import- antly, the elastomeric material is a of a type which

SUBSTITUTE SHEET blocks or severely restricts flow of fluids there¬ through so that sudden air flow into the patient's vascular system by air trapped in the chamber around the outside of the piston is prevented.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be better understood by referring to the accompanying drawings, wherein:

Figure 1 is a plan view in section of a prefer¬ red embodiment of the present invention illustrating the valve in a closed position; and

Figure 2 Is a view similar to that of Figure 1, but illustrating the valve in an open position.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring more specifically to the drawings, the valve 10 of the present invention includes an inlet section 11 and an outlet section 12 separated by a valve chamber 13. Inlet section 11 includes a generally conical portion 14 which tapers or narrows towards valve chamber 13. Conical portion 14 terminates in an annular wall 15 which defines an inlet opening to valve chamber 13- An 0-ring Iβ or the like is disposed in a suitably provided annular notch in wall 15- Inlet section 11 Is arranged to receive and frictionally en¬ gage a male adaptor ^"30 of a catheter tube in a tight fit engagement.

Outlet section 12 includes an annular wall 17 which defines the outlet opening from chamber 13. An

SUBSTITUTE SHEET

OM O-ring or the like is disposed within a suitably pro¬ vided annular notch in wall 17- The portion of outlet section 12 downstream of wall 17 tapers in a generally conical manner to a diameter suitable for connection to a catheter tube by means of Luer lock 19 or the like.

Valve chamber 13 is generally cylindrical in the illustrated embodiment, but this configuration is by no means a limiting factor of the invention. The chamber inlet opening, defined by wall 15, and the chamber out- let opening, defined by wall 17, are generally aligned and sized to permit a piston 20 to slide longitudinally therethrough. Piston 20 has an open inlet end 21 and a closed outlet end 22. A plurality of outlet slots 23 are defined through the piston wall proximate outlet end 22 so as to define a flow path from open Inlet end 21 through the piston interior, and out through slots 23. The outer periphery of piston 20 is sized to provide a pressure seal contact with each of O-ring l^β, 18 while permitting- the piston to freely slide within those 0-rings. A disc-like flange 24, preferably formed integrally with the piston, surrounds the piston and extends radially therefrom in the valve chamber 13• Disc 24 is larger than either the inlet opening 15 or outlet opening 17 of the valve chamber and thereby retains the piston in the chamber.

The region of valve chamber 13 between disc 24 and outlet opening 17 is filled with an elastomeric material 25 which surrounds piston 24. Material 25, in the embodiment shown, Ls generally doughnut-shaped so as to entirely fill the valve chamber portion below flange 24. Of course, if chamber 13 is not cylindrical, the shape of material 25 should be changed accordingly. Material 25 is sufficiently resilient to exert suffici¬ ent force on flange 24 to bias the piston and flange

SUBSTITUTE SHEET OM toward chamber inlet 15 to the position illustrated in Fig. 1. This is defined as the closed position of the valve. It Is noted that, in this position, the flange 24 abuts the Inlet end of the valve chamber 13 while inlet end 21 of the piston 20 projects through inlet opening 15 into region 14. Theoutlet end 22 is disposed such that outlet slots 23 are blocked from communica¬ tion with outlet- section 12 by outlet wall 17 and O-ring 18. Material 25 must be able to perform this biasing function while serving to block, or at least severely restrict, the flow of liquids and gases through the chamber, even in the closed position of the valve (Fig. 1) wherein the material is expanded. Elastomeric materials of this nature are quite well known, examples of such comprising cellular or non-cellular material or synthetic rubbers or plastics, such as highly dense or closed cellular polyurethane, styrene butadenes, iso- prenes, and the like.

In use, as Illustrated in Figure 2, the adaptor 30 of a catheter tubing is inserted into inlet section

11 until firmly wedged or friction engaged in conical portion 14. In this position the tip of the adaptor is inserted into inlet opening 21 of piston 20 and forces the piston into chamber 13 against the biasing action of resilient material 25. Specifically, flange

24 compresses material 25 as it is urged into chamber

13 by the frictionally engaged adaptor 30. In this position, outlet slots 23 extend beyond chamber outlet

17 and into valve outlet section 12 so that fluid being administered can flow from adaptor 30 through piston 20 and out through outlet section 12 to the attached catheter tube. This is the open position of the valve.

If the adaptor should become dislodged, either acciden¬ tally or intentionally during a tubing change, the adaptor 30 will no longer push the piston against the

SUBSTITUTE SHEET ^JSl OMPI bias force of material 25. This material therefore returns the piston to the closed position of Figure 1 wherein outlet slots 23 are blocked from communication with outlet section 12 of the valve. It should be noted that in any valve position, material 25 precludes the existence of a flow path between chamber inlet 15 and chamber outlet 17 around the outside of the piston. That Is, material 25, being closed cell or very dense open cell material, blocks or severely restricts fluid flow through the chamber position it fills. Thus, if the adaptor 30 Is dislodged, an initial inrush of air through the main valve flow path (i.e. through piston 20) is precluded while the valve is closing because of the supply fluid remaining therein immediately after the adaptor 30 is ^"removed. In addition, the resilient material precludes air trapped in the valve from flowing around the piston to the out- • let section. Thus, the valve positively precludes air embolism. Likewise, the valve precludes uncontrolled hemorrhaging by virtue of the same main valve path safety closure and the blockage or restriction provided by material 25- Thus, not only is the valve useful for central venous catheterization to provide parenteral nutrition, but it is also useful as a diagnostic gate to permit multiple blood withdrawals from an artery or vein without fear of uncontrolled hemorrhaging.

It is noted that the valve as described, has no obstructions in the- main valve path which would collect residual blood clotting or block intravenous fluid. The size of disc-like flange 24 should be as large as possible to provide as large a possible surface over which the bias force of material 25 can act. In addition, flange 24 should be as thin as possible with¬ out sacrificing rigidity, so that the mass of the piston

SUBSTITUTE SHEET and flange Is minimized whereby the speed of valve response is maximized. Of course, the limitation of flange size is the contour of chamber 13; that is, the edges of flange 24 should not contact the chamber wall because the resulting drag would slow valve response.

O-rlngs lβ, 18 may be dispensed with If the material used for piston 20 and walls 15, 17, and the sizes of the piston and these walls are selected to provide the necessary fluid sealing while permitting sufficient- freedom for the piston to slide in these walls. In this regard, Teflon may be a suitable mat¬ erial for walls 15 and 17-

The instant invention is not to be limited to the exact details of constructions shown and described, for obvious modifications can be made a person skilled in the art,

SUBSTITUTE SHEET

Claims

I CLAIM :

1. An improvement in safety valves of the type used in catheterization procedures wherein a valve chamber includes a piston which is reciprocable between two positions in said chamber by means of a resilient bias member which urges the piston to a first of said two positions in which the valve is closed and by means of a connection to a fluid conduit which urges said pis¬ ton to a second of said two positions wherein said valve is open, said improvement comprising: an internal flow path in said piston in¬ cluding means responsive to said piston being in said second position for freely conducting flow- through said piston; means for blocking flow through said internal flow path when said piston is in said first position; and wherein said bias member comprises elastomeric flow restrictive means surrounding a portion of said piston in said chamber for at least severely restricting flow through said chamber^" around said pis¬ ton.

2, The valve according to Claim 1, wherein said elastomeric flow restrictive means is made of rubber.

3. The valve according to Claim 1, wherein said elastomeric flow restrictive means is made of highly dense plastic material.

SUBSTITUTE SHEET

4. The valve according to Claims 1, 2 or 3, wherein said connection to a fluid conduit comprises a generally conical receiving section for frictionally engaging an end of a catheter tube.

5. A safety valve for use In administering fluid into and withdrawing fluid from a patient, said valve comprising: a valve chamber having first and second openings; a valve member positioned in said chamber, said valve member having first and second ends projec¬ ting through and slidable within said first and second openings, respectively, said valve member having an inlet opening at said first end, an outlet opening proximate said second end and an internal flow path between said inlet and outlet openings; retainer means projecting transversely from said valve member in said chamber for preventing removal of said valve member from said first and second open¬ ings while defining first and second extreme positions of said valve member in said chamber, said retainer means defining a sub-chamber in said valve chamber which sub-chamber is disposed between said retainer means and said second opening and changes in volume as the valve member slides; closure means for preventing fluid flow through said outlet opening when said valve member is in said first position and permitting such flow when said valve member is In said second position; bias means disposed in said valve chamber for biasing said valve member to said first position, said bias means comprising a resilient elastomeric member

SUBSTITUTE SHEET located between said retainer means and said second opening and comprised of a material which is at least severely restrictive to flow therethrough when in a. relaxed state; and a valve inlet section Including means for engaging a flow tube with the flow tube in communication with said inlet opening while forcing said valve mem¬ ber to said second position.

6. The valve according to Claim 5, wherein said chamber is substantially cylindrical, wherein said valve member is a generally cylindrical piston, wherein said retainer means is an annular disc surrounding and projecting radially from said piston, and wherein said resilient member is a generally doughnut-shaped member.

7. The valve according to Claim 6, wherein said resilient member is made of rubber.

8. The valve according to Claim β, wherein said valve member Is made of plastic.

9. A safety valve for use in catheterization procedures comprising: a valve chamber having first and second ^"openings; a movable member disposed in said chamber; means for constraining said movable member to move between first and second positions in said cham¬ ber; a flow passage defined internally of said movable member and having inlet and egress openings;

SUBSTITUTE SHEET

OMPI means for constraining said Inlet opening into permanent flow communication with said first cham¬ ber opening for all positions of said movable member; means responsive to insertion of a fluid conduit into said first chamber opening for forcing said movable member to said second position; means for blocking flow through said egress opening in said position of said movable member; means for conducting flow from said egress opening out through said second chamber in said second position of said movable member; and bias means for continously moving said mov¬ able member toward said first position, said bias means comprising an elastomeric member made of material which is at least severely restrictive to flow therethrough, said elastomeric member being disposed in said chamber to surround said movable member.

10. The safety valve according to Claim 9, wherein said bias means further comprises a flange pro¬ jecting from said movable member to sub-divide said chamber into first and second compartments which vary in volume with positional changes of the movable member in the chamber, said first compartment communicating directly with said second chamber opening, and wherein said elastomeric member entirely fills the volume of said second compartment surrounding said movable member.

SUBSTITUTE SHEET