US 3734080 A
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United States Patent [191 Petterson et a1.
 BLOOD COLLECTING SHUT-OFF VALVE  Inventors: Dewitt R. Petterson; John S. Assenza, both of Basking Ridge; Henry A. W. Kipp, Somerville, all of NJ.
 Assignee: Johnson & Johnson, New Brunswick,N.J.
 Filed: Oct. 16, 1970  Appl. No.: 81,352
Related US. Application Data  Continuation-impart of Ser. No. 832,567, June 12,
[ 1 May 22,1973
2,836,180 5/1958 Strauss, Jr. ..128/2l5 FOREIGN PATENTS OR APPLICATIONS 1,239,808 5/1967 Germany ..l28/DIG. 5
Primary Examiner-Kyle L. Howell Attorney-James R. Hulen and Robert L. Minier [5 7 ABSTRACT A blood collecting shut-off valve adapted to be placed over that portion of a double-ended blood collecting needle used for puncturing a vacuum container for blood collection. The shut-off valve comprises a flexible tubular needle sheath unattached to the needle hub, having a closed pierceable end adjacent to the needle point and needle contacting means on the inner surface of the sheath adjacent to the point of the needle and pressing against the needle cannula to serve as a seal against the passage of blood toward the open end of the sheath and to maintain the sheath 0n the needle surface. The sheath is composed of a material having the ability to distort under compression when the pierceable end of the sheath and the stopper of the vacuum container are pierced by the point of the needle and the needle cannula enters the vacuum container, with the sheath returning to its original position covering and sealing off the needle point after removal of the vacuum container from the needle.
14 Claims, 15 Drawing Figures PATENTEWYZZIQB I 3,734,080
SHEET 2 UF 2 f illfill lllllllllfl i 1i "IIIIIJ'iEQiIIIIIIIIII OH/VIS. 5 -24 BY firmer/f mp ATTORNEY BLOOD COLLECTINGSHUT-OFF VALVE This is a continuation-in-part of application Ser. No. 832,567, filed June 12, 1969, now abandoned.
The present invention relates to blood collecting units involving a hollow needle with piercing points at both ends, one point being employed to pierce and penetrate through a stopper in a vacuum container and the other being employed to penetrate a blood vessel. More specifically, this invention pertains to a structur ally and functionally improved shutoff valve serving as a sealed cover for the stopper-piercing needle before penetration of the needle through the stopper and after removal of the needle from the stopper.
BACKGROUND OF THE INVENTION With the advent of sophisticated blood analyzing equipment, the practice of taking multiple blood samples from a single patient has substantially increased. This is preferably accomplished by utilizing a single venipuncture and sequentially drawing the samples through a double ended cannula into a plurality of rubber stoppered vacuum containers.
The basic device traditionally used to collect single or multiple blood samples is described and illustrated in US. Pat. No. 2,460,641. This device comprises a double ended needle having a hub intermediate its ends which is secured through a threaded aperture to one end of a cylindrical plastic holder. In the use of the device, one needle point is placed into the vein of a patient and a rubber stoppered vacuum container is passed through the holder and into engagement with the other end of the needle. As the needle punctures the rubber stopper, blood is drawn from the vein into the container. It will be obvious that, in order to take additional samples, it is necessary to use additional containers and, thus, it is necessary to remove the needle from the first container. It is, therefore, desirable to alleviate any problems associated with the use of multiple vacuum containers and to provide a suitable means for preventing the undesirable loss of blood during multiple sampling.
Many prior devices have been designed to prevent the flow of blood or other fluids from the end of a needle when the needle was not actually being used for its intended purpose.
One such device is shown in US. Pat. No. 2,847,995 wherein a needle sheath is provided with an open end which is stretched over the needle hub to provide a secure leak-proof attachment.
U.S. Pat. No. 3,469,5 72 illustrates another attempt to pi'ovide a shut-off valve in the form of a rubber sheath which is in intimate contact with the entire needle shank and axially compressible to uncover an opening in the side of the needle adjacent the pointed end thereof.
SUMMARY OF THE INVENTION The present invention provides a shut-off valve for a needle in the form of a flexible tubular compressible sheath having a closed pierceable end adjacent to the needle point and an open end adjacent to the needle hub. The inner surface of the sheath is provided with needle contacting means which is adapted to make continuous circumferential contact with the needle shank adjacent the pointed end thereof. The entire inner surface of the sheath, except for the needle contacting means, is spaced from the needle surface and, in some embodiments of the invention, the open end of the sheath is flared outwardly to present an enlarged passageway for facilitating the assembly of the sheath and needle.
The needle contacting means is preferably in the form of an inwardly projecting ring or plurality of rings which contact the needle surface and provide a seal between the closed end of the sheath and the rings so that blood will not be free to flow exteriorly of the sheath through the space between the needle surface and the inner surface of the sheath. The rings are also effective to slidably retain the sheath on the needle surface.
It will be apparent from the foregoing that the present invention provides a unique shut-off valve for a multiple blood collecting device, which valve is slidably positioned on the needle and, yet, not attached or secured at the open end of the needle sheath. The invention also provides a novel sealing arrangement which prevents the accidental spilling of blood. In addition, the enlarged internal diameter of the sheath facilitates the assembly of the device and renders the sheath more compressible when axial force is applied thereto.
Other objects of the invention will be apparent from the following description and claims taken together with the drawings wherein:
FIG. 1 is a plan view of a capped and sealed container for a sterile double pointed hollow needle with a hub secured intermediate of the needle points and the sterile shut-off valve of this invention sheathing the needle point adapted for penetration of a vacuum container stopper;
FIG. 2 is a plan view of the container of FIG. I with the cap removed;
FIG. 3 is a perspective view showing the positioning of the needle and shut-off valve for assembly with a holder which serves as a guide for a vacuum container;
FIG. 4 is a perspective view showing the completed assembly of the needle and shut-off valve with the holder;
FIG. 5 is a perspective view showing the assembled vacuum container-piercing needle, shut-off valve and a portion of the holder with the needle container re moved to expose the other needle point adapted for penetration into a blood vessel. A portion of a vacuum container with the stopper positioned to show its relation to the holder is also shown;
FIG. 6 is a sectional view of the needle, valve and holder assembly together with a vacuum container in position in the holder prior to penetration by the needle and with the other end of the needle positioned in a blood vessel;
FIG. 7 is an enlarged sectional view of portions of the needle, holder and vacuum container showing the compression and distortion of the shut-off valve when the vacuum container is penetrated by the needle within the holder;
FIG. is a sectional view of portions of the needle and holder assembly showing the shut-off valve returned as a result of its resiliency to cover the needle point, and the telltale drop of blood that forms at the site of the resealed puncture in the closed end of the shut-off valve;
FIG. 9 is a perspective view of the shut-off valve showing the telltale drop of blood;
FIG. 10 is a sectional view of a preferred embodiment of the shut-off valve of this invention showing the ring projections that hold the valve in slidable position on the needle cannula and serve as a seal to prevent spilling of blood from the needle;
FIGS. 11, 12 and 13 are sectional views of further embodiments of the shut-off valve of this invention;
FIG. 14 is a perspective view of one embodiment of the shut-off valve of this invention showing the end construction of the valve; and
FIG. 15 is a perspective view of another embodiment of the shut-off valve of this invention showing the end construction of the valve.
Referring to FIGS. 1-15 of the drawings, there is shown a blood collection needle shut-off valve 1 according to a preferred embodiment of the invention which comprises a cylindrical hollow member 2 of flexible, resilient material having a closed flat end 3 and an open end 4. Within the bore on the inner surface of the flexible hollow member 2, raised sealing ring projections 5 (see FIG. are provided adjacent to the area which covers the needle point 6. The raised sealing ring projections S are in slideable contact with the exterior surface 7 of the needle 8 and form a series of seals preventing the passage of blood from the closed end portion 9 of the flexible hollow member 2. The flexible hollow member 2 is of a length sufficient to enclose needle 8 from point 6 to the hub 10 which is secured to needle 8, but there is no attachment of the flexible hollow member 2 to needle hub 10.
Shut-off valve 1 of this invention may be employed with various types of needle-hub combinations, including a threaded hub 10, a friction fitted hub (not shown) and needles secured within the base of a holder 11 (not shown), although this latter arrangement is somewhat cumbersome for positioning and removing the shut-off valve.
Conventional holders and vacuum containers, such as those described in the above-cited US. Pat. No. 2,460,641, may be employed, a preferred embodiment being a clear plastic holder 11 (see FIG. 3) with a threaded aperture 12 in the base 13 thereof, and a vacuum container 14 (see FIG. 6) consisting of a glass vial or tube 15 and a pierceable, self-sealing stopper 16. A blood preservative, or other liquid or solid laboratory reagents, such as anticoagulants or heparin, some of which may be useful for subsequent analytical tests, may be present in the container before vacuum is provided by introducing the loosely stoppered flask into a chamber for evacuation, then releasing the chamber vacuum causing the flasks vacuum to draw the stopper into closed position.
The blood collection unit thus described is designed for the taking of multiple blood samples from a given patient, during which undertaking the outer end 6 of needle 8 is maintained in the blood vessel 17 (see FIG. 6). Consecutive vacuum containers 15 are placed in the holder and pressed into engagement with the needle point. This engagement first involves penetration of the closed flat end 3 of flexible hollow member 2 by the needle point 6, then a piercing of the stopper 16 and finally penetration of the hollow needle point 6 into the interior 18 of the vacuum container 14, whereupon blood from the blood vessel 17 is drawn into the vacuum container 14 through the double ended needle 8 from the punctured blood vessel 17. At this stage shutoff valve 1 is compressed in distorted fashion as shown at 19 in FIG. 7. Upon removal of vacuum container 14 from needle 8, shut-off valve 1 returns to the initial position as in FIG. 8 where it again covers the needle point 6. A telltale drop 20 of blood appears at the site 21 of the resealed needle puncture. The drop 20 appears after the first vacuum container 14 is withdrawn from the holder and appears again after each successive vacuum container is thus withdrawn. The drop 20 of blood serves to indicate that an entry into a blood vessel was effected. If no drop appears and the vacuum container 34 remains empty of blood, the venipuncture has not been successful. If the drop 20 of blood appears and the vacuum container 14 remains empty of blood, the indication is that the vacuum in the vacuum container 14 has failed and the container 14 should be discarded and replaced by another one. Although it is less likely to occur, the absence of the telltale drop 20 and the absence of blood in the vacuum container may be due both to an unsuccessful venipuncture and a loss of vacuum in the vacuum container.
Shut-off valve 1 has been found to function satisfactorily for six or more blood samples employing as many vacuum containers. After the last sample has been taken, shut-off valve 1 may be removed from the needle 8 by applying the needle container 22 with the cap 23 removed as a wrench to the end 6 of needle 8 protruding from holder 11 and turning hub 10 counterclockwise to disengage the hub threads 24 and thereafter separating the needle 8 from the holder. Shut-off valve 1 is then manually removed, needle 8 is reinserted in the holder, and hub 10 is screwed into holder 11. The residue of blood in the hollow needle 8 may then be employed for slide tests and may be ejected on to the slide by blowing into the open end 25 of the holder 11 and allowing the drop of blood so ejected to spill on to a slide.
There are other occasions on which the use of the shut-off valve 1 is not desired. In these situations, the valve 1 may be readily slipped off of needle 8 when the cap 23 is removed from the needle container 22, or if needle 8 and shut-off valve 1 are already in place in the holder 11, a tweezer or other suitable instrument may be employed to remove the shut-off valve. During the training of young technicians, it may be desirable to have them experience the problems of obtaining a suitable venipuncture. Or a seasoned technician may have an extraordinarily difficult time in effecting a proper venipuncture. In such instances it is most helpful to be able to remove the shut-off valve readily.
The preferred embodiment of the shut-off valve of this invention is shown in FIG. 10 and is the valve dis cussed hereinabove. Other embodiments are shown in FIGS. 11-13. The valve 26 of FIG. 11 is similar to the preferred embodiment but has a rounded closed end. The same is true of the embodiment 27 of FIG. 12 which has, in addition, a flared or tapered end 28 which abuts the hub 10 but is not connected thereto. The three ring projections 29, as shown, present a narrow ridge of contacts with the needle surface 7, in contrast to the rounded surfaces employed in the embodiments of FIGS. 10 and 11. The embodiment 30 of FIG. 13 involves a constricted internal diameter wherein the constriction 31 is adjacent to the needle point 6 and the tapered internal diameter is increased as shown at 32 as the open end 33 of the valve is approached. Embodiments 27 and 30 may have a flat closed end (not shown) as in the case of the embodiment of FIG. 10. In the shut-off valve of this invention there is no seal between the open end 4 of the shut-off valve and base 34 (see FIG. 2) of hub 10. This applies to all embodiments of the shut-off valve of this invention.
In the preferred embodiment shown in FIG. 10, a series of two sealing rings are shown. A single sealing ring may be employed instead, or the number can be increased. It is not desirable to employ too many sealing rings since that would impair the compression and particularly the return function of the shut-off valve.
The material used for the shut-off valve may be natural rubber, or rubber compositions, or rubber-like synthetic elastomers that possess the compression and rebound of rubber when in the form and shape of the shut-off valve described herein. The closed end of the shut-off valve of this invention may be coated with a liquid silicone such as Dow-Corning 360 Medical Fluid to prevent adhesion of the closed end 3 of valve 1 to the stopper 16 of the vacuum container 14. In place of, or in addition to, the use of a silicone or other lubricant on the exterior of the closed flat end 3, the end may also be provided with raised projections (see FIGS. 14 and 15) to further prevent adhesion of the valve 1 to the vacuum container stopper 16 by minimizing the contact area available for adhesion. In the FIG. 14 embodiment, the projection is illustrated as a raised rib 40 which extends diametrically across the end 3 of valve 1. Four spaced buttons 41 are utilized on the end 3 of valve 1 in the FIG. 15 embodiment to prevent adhesion between the valve and stopper 16. Both of the foregoing embodiments have been successfully tested with the valve of the subject invention.
The wall thickness of the flexible hollow member 2 is preferably 0.040 inch. A preferred range of wall thickness of 0.030 to 0.050 may be employed. An overall range of 0020-0070 may be employed, depending upon the various factors involved. This thickness is a factor in providing a satisfactory return or spring-back of the flexible hollow member. Other factors involved, and which influence each other as well as influencing the wall thickness, are the composition of the rubber or elastomer, the hardness of the rubber or elastomer, the presence or absence of a lubricant on needle 8 or on or within the rubber or elastomer composition, the presence or, absence of ring projections and the interference fit of ring projections 5 or constriction 31 with respect to needle 8. A relatively soft, spongy rubber may render possible a thicker wall. A harder rubber may require a thinner wall. The objective is to provide a balance of these factors that will insure a return or rebound of the shut-off valve 1 to the initial position (as in FIG. 8) where it again covers and seals off needle point 6. Gum rubber or a rubber composition containing a wax have been found satisfactory. It is important that the interference fit between sealing ring projections 5 or construction 31 be established to insure a fluid seal and to maintain shut-off valve 1 on needle 8 but permit the self-return of shut-off valve 1 to its initial position on needle 8. The needles 8 are preferably wiped with a liquid silicone solution on a cotton mass. This serves to provide lubrication and facilitates the return or spring-back of the shut-off valve as shown in FIG. 8.
In addition to serving as a shut-off valve on the vacuum container piercing needle of a multiple sample blood collecting unit as described and illustrated herein, the novel shut-off valve of this invention may be employed on other needles in the same manner as described and illustrated herein. For example, shut-off valve 1 may be placed on a hypodermic needle attached to a syringe used for the intravenous or intramuscular administration (not shown) to the same pa tient of consecutive or repeated doses of medication from a simple syringe, for example in anesthesia or cardiac stimulation. In between such closes, the shut-off valve springs back and seals off the needle until the next dose is administered. Other uses for the shut-off valve of this invention will become apparent to those skilled in this art.
Having now described the invention in specific detail and exemplified the manner in which it may be carried into practice; it will be readily apparent to those skilled in the art that innumerable variations, applications, modifications and extensions of the basic principles involved may be made without departing from its spirit or scope.
What is claimed is:
l. A blood collecting shut-off valve unit, comprising: a hollow needle with piercing points at both ends and a hub intermediate said ends for attaching said unit to a holder; and an elastomeric tubular sheath extending over one of said needle ends from said piercing point to the base of said hub, said sheath having a closed pierceable end adjacent the piercing point on said one end and an open end adjacent said hub, the inner surface of said sheath having means contacting the exterior surface of said needle adjacent the piercing point on said one end to provide slidable contact between said needle surface and said sheath and to provide a fluid seal for the space between the closed end of said sheath and said needle contacting means, said inner surface being entirely spaced from said needle surface and said sheath being entirely unsecured to said needle and said hub except for said needle contacting means.
2. The valve of claim 1 wherein. said needle contacting means comprises at least one continuous needle contacting member.
3. The valve of claim 2 wherein said needle contacting member is an inwardly projecting ring.
4. The valve of claim 3 wherein said ring is formed integral with said inner surface at a right angle to the longitudinal axis of said sheath.
5. The valve of claim 4 wherein said needle contacting means comprises a plurality of spaced circumferential rings.
6. The valve of claim 1 wherein said closed end is substantially flat.
7. The valve of claim 6 wherein means are provided to reduce the adhesion between the external surface of said flat closed end and a sheath compressing member.
8. The valve of claim 7 wherein said adhesion reducing means is at least one raised projection integral with said flat closed end.
9. The valve of claim 8 wherein said projection is a raised rib extending diametrically across said end.
10. The valve of claim 8 wherein said projection is a plurality of spaced buttons.
11. The blood collecting unit of claim 1, wherein said needle contacting means is a continuous circumferential constriction of said inner surface and the remainder i of said inner surface tapers outwardly from said constriction to said open end of said sheath.
12. The blood collecting unit of claim 11, wherein the closed end of said sheath is substantially flat and at least one raised projection isformed on said flat end.
said projection is a plurality of spaced buttons.