US2460641A - Blood collecting apparatus - Google Patents

Blood collecting apparatus Download PDF

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US2460641A
US2460641A US61078045A US2460641A US 2460641 A US2460641 A US 2460641A US 61078045 A US61078045 A US 61078045A US 2460641 A US2460641 A US 2460641A
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tube
end
diaphragm
needle
plug
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Joseph J Kleiner
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Joseph J Kleiner
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150351Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150473Double-ended needles, e.g. used with pre-evacuated sampling tubes
    • A61B5/150496Details of construction of hub, i.e. element used to attach the double-ended needle to a piercing device or sampling device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150732Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154Devices using pre-evacuated means

Description

Feb. i949.

J. J. KLEINER BLOOD COLLECTING APPARATUS Filed Aug. 14, 1945 ATTORNEY Patented Feb. 1,1949

UNITEDQSTATES PATENT OFF {CIE}` Y, 2,460,641 I A Y i BLOOD CQLLEC'EING APPARATUS Joseph Kleiner,.Woodmere, N. Y. 'Application August 14, 1945, Serial No. 610,780

Y 1 SThis'invention relates to structurally and, functionally improved apparatus and more particularly to. apparatus for facilitating drawing or c01- Iecting blood from veins. Y

'It is an object of the inventiony to furnish such an apparatus which Will include yrelatively iew partsycapable'of ready and.-.economical manufacture; such parts being capable of being readily used to achieve the desiredresults. v

A furtherobject is that of furnishing an assembly of -this nature in which,. under proper use, the cannula-or needle'may after each-operation be in effect automatically cleaned. Accordingly, it Will'be ready for substantially immediatev reuse should av second or repeated'operation be desired. VAnadditional Objectis that of' teaching a technique or method. of procedure. calculated to eilicently withdrawlblood Withiminimum discomfort andV pain to the patient andalso minimum effort on the part ofthe physician or otherattendant.

Another object of thelinvention 'is to provide 5 claims. (cl. 12s-214) for use inhlood collection a receptacle-therefor y Acomprisiugan evacuated `tubular vessel having Vready for substantially` instantaneous use when it is desired to employthe same. Moreover, the sealor plug provided. to achieve this result will be of such naturer that it maybe readily associated With the vessel,fbe employed as partl of the assembly under @blood collecting operations, will thereafter eiectivelyreseal the vvessel and may thereupon be readily removedby the technician et seq. Furthermore, this invention contemplates a holder which willA efficiently cooperate with the aforementioned. vessel aswell as the tissue-piercing cannula or needle. With these and, other objects in mind, reference is had to Athe :attached sheet of drawings illus- Atrating practicalembodiments ofthe invention and in which: Y n

Fig. 1 is a vertical section, partially fragmentary, of apparatus embodyingl the invention and showingran initial stepirrz an operating: technique; Fig. 2` is a similar section. of a-fragment of the apparatus showing a second step'in vsuch technique; f f

' Fig. 3 is a sectioni similar to Fig.. V.Zand showing a-thirdstep; f

Fig. 4 is a view similar to Fig. 1 showing-the in- 7 2 vention applied tol a tube of smaller diameter; Figs. 5 and 6 are views similar'to Figs. 2V and 3 showing the manner in which the apparatus functions even though :the tube of Fig. 4'be, canted relativeto the holder. f

Referringnow to rthe vdrawings and particularly to Figs. 1 to`3,.inclusive, I9, indicates a tubular vessel made ofsoine suitablematerial, preferably` glass. One kend .of the tube mayA be integrally closed atl! whilerthe other end of the tube is closed'by a'plug I2.- This plug I2 is vmade ofruhher of suitablefcomposition kand hasv a pe ripheral flange i4 overlying the end of the tube l0. `The plug i2 is hollowed. out part Way therethrough as'at l5, the hollowed out part terminating at-[the'bottom surface ror Wall of a diaphragm It. 'The head part H o the plug extends acon-y siderahledistance beyond the end Vof Vessel HJ and hasa Vcentral depression, or dimple, therein, the bottom Yof `vvhich'terminates at the topf surface of diaphragm i6. This. diaphragm is ofa suitable thickness (axially 0f the plug) as to -be readily pierced by a cannula. The Vbottom edge-0f the plug isbevelled as at i8. l

Referring still toV Fig. 1the apparatus villustrated therein comprises, in addition to the evacuated' tube iii, a holder 20 made of any'desired material, preferably'some transparent synthetic vplastic material. The holder 2li is of generally cylindrical shape having one end substantially closed as at 2li, the end 2i being provided With a central aperture 22. The wall of aperture 22 diverges outwardly to receive, with a friction-fit, a fitting 25 lwhich has a tapered surface for such purpose, andrwhich has a knurled ange; facilitating manipulation thereof. The litting ,25' has' a Acannula 26, 26'; passing' therethrough in vsuch. fashion that one end-2l thereof extends forwardly of the fitting While the other end 26 thereof extends rearwardly thereof a considerable distance iinto'the holder 20. Each end of the cannulais tapered or sharpened, so that Athe outer" end can be inserted into a. veinwhile For best results the plug I2 shouldrbe made' of sufficiently large diameter that forceV is required to insert the plug into any tube of diameter falling within the manufacturing tolerances for a specified size. Also, the diaphragm i5 should ibe so located that when the plug is in place in a tube, the diaphragm formsV part of a solid wall of plug material extending across the mouth of the tube with the Ymajor part of the diaphragm Within the confines of the tube.v

Under these conditions the Wall (including the diaphragm) is placed under cross-axial compression which acts to increase the axial thickness of the diaphragm to a small extent'. In any event as shown it will be apparent, the thickness ofthe diaphragm I6 is such that the inner point of. the needle may be completely imbedded and sealed therein in such manner that in eiect a stopper for the needle bore is provided by this diaphragm portion. Due to this thickness and cross-axial compression of the diaphragm, a can nula, which has pierced the diaphragm, may be withdrawn with a resultant instantaneous sealing of the hole through the diaphragm, preventing the loss of vacuum in the vessel.V .The lines 28 on vessel 20 are preferably spaced aparta distance slightly'less than the thickness of the diaphragm I6 when under compression. It should also be noted, that while a major part of. the diaphragm is within the confines of the tube, the upper end ofthe diaphragm extends into the head portion of the closure above the tube giving added stiffness thereto and vresisting radial collapsing ofthe head portion and thereby niinif 1 mizing the danger of the closure being forced int-o the tube either by atmospheric pressure or by force exerted against the closure when the cannula is inserted into the diaphragm. In this same connection it should be noted that the central depression or dimple in the head portion I1 of the closure tapers in an inward direction so that the wall of the head portion 'becomes progressively thicker as it approaches the diaphragm. This not only serves to'guide the cannula into contact with the diaphragm or piercing Wall'l but also gives greater rigidity or stiffness to the lower end of the head portion and helps to resist collapsing'thereof.

As afore brought out, the stopper is under compression when in position within theV mouth of the tube or equivalent vessel. As illustrated, the side edges of the head part Il extend substantially parallel to the axes of the tube and stopper. Therefore, it is apparent that priorto the application of the stopper to the vessel,'these side edges extend in directions such that Va flaring -or tapered structure is` present. In other words, the stopper is preferably initially manufactured so that the side edges of its head are not parallel to its axis. It is only after the stopper has been compressed incident to being disposed .in themouth of the vessel thatthese edges assume the condition shown in the drawings. The evacuation of each vessel ii can. be Ghlred out by forcing the plug l2 into the end of a vessel, piercing the diaphragm Hi with a hollow needle, and withdrawing the air from the vessel through the needle with suitable pumping equipment. The material of the plug is of such nature and the plug is so constructed, as before explained, that When the needle used in the evacuationris'withdrawn from the plug, the plug has a self-sealingaction to'prevent the failure of the vacuumestablished in the vessel. Vessels in accordance with the construction of the member I 0 can be evacuated at a suitable factory and supplied to the medical profession in that condition.

Thev preferred technique employed in collect- -ingblood with Vapparatus such as hereinbefore holder, causing the diaphragm to be penetrated by the cannula 26. This movement is continued until the top 'of the plug has attained a posi,- tion'relative to the neXt guide line v28 similar i to that relative Ato the rstguide line first noted.

Since the guide lines are spacedv aparta distance less than the thickness of the diaphragm, the operator is then assured that the cannula has almost completely pierced the diaphragm, and that only a small additional movement of the tube will accomplish that result. Cannula 2,6? is then introduced into a Vein or tissue, and when so positioned to the satisfaction of the operator, the tube is moved to complete the piercing yof the diaphragm (Fig. 3) whereupon the vacuum in thetube becomes effective to cause blood to flow into the tube by suction, As soon as the ,desired amount of blood is in the container, cannula 26 is withdrawn from the veinror tissue Vand any residual vacuum effectively drains the cannula passage of blood. Should vein entry be unsuccessful (as indicated by failure of blood fiow following complete diaphragm piercing) and further exploration prove futile, the tube should be withdrawn from the holder'before the cannula is withdrawn from .the tissue. Since the dia phragm is self-sealing the vacuum is retained and the preferred technique can berepeated with the same tube.

It will be seenfrom the drawings that the head part i'ijof the plug has a diameter closely approximating that of the tube lil. Accordingly, both the plug and theY tubecooperate in guiding thetube in the holder so that proper piercing of the diaphragm will result. The fit fof the plug in the holder is a loose sliding t for this purpose.

The sameholder can be used with'tubes of smaller diameter as illustrated in Figs. 3 to 5, inclusive. In these figures the holder is the same as previously described while tube l I0 has a' considerably smallerv diameter than tube IB. Plug l l2 has a wide flange 'H4 caused by reducing 'thediameter of that part of the plug fitting in thetube. This vplug H2 has a head part/Ill corresponding in all details vto head i'i with a central depression or dimple terminating atthe top'of diaphragm H6. The hollowed" out part H5, however, has a greater diameter than part l5 as shown. 'i Y The same technique is employed with this'type `lend of its' 5 off-tube as Apreviously describe'dgthe-successive steps being illustrated in the three figures. V The headpart lil yuf the fplug'l'serves to guide the tube into proper` relative' -positionsfbetween can nula y'26- and diaphragm I l'without appreciable assistance "from tube' H0; Since thisztube .is of smaller diameterthan tuberl, some canting of the tube 'in' the `holder is almost inevitable.' This` canting, however, is'notobjecti'onable sincej the hallowed Vout/part H hasa large enough diamet'r to preventtheen'df of-fcannula from being embedded in-V the plug wall as. is 'clear from' Figs. 4"-and`5. i f 1T Evacuatedr vessels ofthe type describedirhereinbefore possess [advantages overA vessels kutilizedl for similar purposes'fas heretofore known` to thefartl VesselsV made in accordance withthis `ini'rention vcan vbe Y` produced in quantityaand of uniform quality more inexpensively than'previousv types of devices and have the-advantage that ausermay have all incidental equipment at hand'lforrepeated re-use. Thus, no parts-'are -discardedafter a single use as hasbeen vthe common'pra'ctice. These vessels in additionto being evacuated, lmay also have the usual coagulation preventing material therewithin, suchias potassium oxalate', sodium fluoride, desiccated lox-'bileand thelik'e a's'iscustomary in this art. Moreover, if theneedle-islwithdrawn from the iveinfbut left-lnl communication withthe interior Aof 'the vessel without lthelatteri vbeing completely lled, it isV apparent that any bloodV or other liquid remaining in the bore oi"` the :cannulal will be evacuated therefrom." Therefore', this bore cleared'and vthe needle 'lisimmediately availableV fora;successiveoperation.

Th apparatus hereinwdescribed' possesses;v a further advantage"thaty anl operator can draw any desired amount 'of blood from avein into ra vessel I0 and when-r l the desired amount has been drawntherein,l stop'tlfieedrawing operation by merely Withdrawingthevessel from a position in which the diaphlgmof Ythe, plug is penetrated Aby the needle. IUpon such withdrawal of the needle "the diaphragm is limmediately resealed maintaining a partial. vacuum Within `the vessel so that othermaterialcan be' added to the blood v"in 'the vessel .by merely introducing the saline through-a needle or cannularom a suitable supply' in Y. the -same .mannen Consequently suitable materials often' added to blood ,can'be 'supplied to that quantity originally drawn 'finto thev'essel.

-Since the'head partei each 'a lug extends a considerable distance beyondrthe tube,-such headv part is subject to thumb pressureor other manipulation for readily withdrawing the plugA from the tube. This may ordinarily be effected with the vacuum condition exhausted, by simply bringing pressure to bear in an inward and upward direction on the head portion il or I Il of the Stoppers.

The operating technique herein set forth is preferred over other techniques for the reason that in practicing the same the interior of the holder remains clean and free of blood which would dri-p thereinto from the needle bore upon piercing a vein, if the inner end of the needle -were not imbedded in the plug diaphragm. Thus the holder can be used repeatedly without requiring washing or sterilization since av sterile needle can be attached thereto for each collection. However, lany technique may be employed at the will of the user of equipment of the type herein disclosed.

As will be understood, the graduations orindicatng marksZS couldbe of anydesired nurn-Y ber vor else eliminated entirely. Inthe latter connection, it shouldr be appreciated that while these marks are most helpful inthe use 'of the apparatus, they need `not be present where :a skilled technician is employing the same.v In other-words, an operator utilizing theapparatus for theA first few times will vordinarilyzbe guided by a mark or marks of this nature. A. Aiter, however, he once acquires the ,feel of the 'riparte incooperationwith. each other, vit'will not 4be necessary for him Vto visually check inv order to determine thaty suiiicient projection has occurred to a. Seal the inner end'of the needle and b. To cause Vthat inner end to extend in com- K munication with the interi-or of the vessel'. Rather, he willdepend upon'his sense of touch to determine. this.

As willalso be understood after the lled'or partially filled tube has been removedufrom, `connection with'the patient, any desired' number of drops of blood may be dispensed therefrom without unsealing it. 'This will be especially use'- ful where it is desired to `achieve red and' white cell counts, lblood smears, haematology, etc.` AThe procedure under these circumstances, will either beto maintain the vessel or tube in association with the holder or else to reconnect them' solth'at the inner end of the needle extends throughth diaphragm. @Thereupon the Yoperator rby, simply vpressing against the'closed end of the tube,- will cause' the stopper toengage against the endwall loi thehold'er; Successive pressureimpulses will cause aflexing tothe diaphragm. This will result in suicient'pressurev being built4 up Within the `tube to dispense a drop of blood through' the needleunder'each pressure impulse. j

'.Thus, among others, the' -several objects of the invention as specifically afore noted, are achieved. It is vobvious that numerous changes in structure as. wellas certaindepartures inthe'elstepsof the l claims technigqu'e might .be adopted without departing invention as defined .by the from the `spiritof the What is claimed is:

1, In an assembly for drawing blood, inconibination a vcup-shapedholder Yhaving an aper- 'turedlbasa a double ended hollow bored needle,

havingr its ends pointed, extending through said aperture and. y'supported against movement with respect to said ibase, said needle having its inner end extending into .a .plane shortfof that finto whichr the edges of the sidewalls of the vcup project, an evacuated tube having aleri'gth greater than the depth of said cup, a stopper including an enlarged head and a plug portion, the plug portion being disposed under compression within said tube, the head thereof bearing against the edge of the latter, the thickness of the effective seal provided by Vsaid stopper being less than the effective height of the inner needle" stopper head is at a point adjacent the cup-V base, and means short of such point for indieating when the tube has been introduced into said cup Vto a position at which the inner'needle end is completely embedded within and has its bore closed by, the seal aorded by'said stopper. n 2. An assembly for drawing blood and which assembly includes a cup-shaped holder, a mounting associated with a double ended hollow needle to be supported by said holder with the outer end lof the needle extending beyond and the inner end of the needle extending within the holder,

an evacuated stoppered tube to be guided by the sidewalls of said holderA so that its stopper is brought to bear against and be penetrated by that end of the needle which is within said holder, said holder havng a diameter in excess of the diameter of any tube and stopper to be'received therein, the holder end Wall constituting a stop to be engaged by and to limit the inw-ard movement of the tube into said cup, said wall being Vprovided with an aperture of less size than the needle mounting, for the passage of the inner needle end therethrough and said Wall providing mounting meanswadjacent said aperture to cooperate with and retain the needle-mounting against movement with respect thereto and with the inner needle end extending within said cupshaped body for a fixed and pre-determined distance.

3. An assembly for drawing blood and which assembly includes a cup-shaped holder, a mounting associated with a double ended hollow needle to be supported by said holder with the outer end of the needle extending beyond and the inner end of the needle extending within the holder, an evacuated stoppered tube to be guided by the sidewalls of said holder so that its stopper is brought to bear against and be penetrated by that -end of the needle which is within said holder, said holder having a diameter in excess of the diameterV of any tube and stopper to be received therein, -the holder end wall constituting `a stop tobe engaged 'by and to limit the inward movementof the tube into said cup, said wall being provided with an aperturel of less size than the needle mounting for the passage of the inner needle end therethrough, said wall providing mounting means adjacent said aperture to cooperate with and retain the needle mounting against movement withre-spect thereto and withrthe inner needle end extending within said cup-shaped body for a fixed and pre-determined distance, said holder` being constructed to permit of the viewing of a tube and stopper disposed therein and indicating means associated with the holder to indicate when the stopper of said tube has advanced towards and is spaced from the inner face of the holder end .wall a distance such that the inner needle end .8 is enveloped and Vsealed by the body of said stopper. Y

4. An evacuated stoppered tube for use as'part of an assembly for drawing blood, said tube comprising a holdow body having a bore and having one end'closed and its opposite end open, a stopper of resilient material for such 4open end, said stopper including an enlarged head and a plug portion, both said head and plug portion being formed with recesses in their end faces, an imperforate self-sealing diaphragm separate ing the base portions of said recesses, the inner face of the diaphragm extending to a point materially within the body of the plug andthe outer diaphragm face extending into the thickness-area of said head, the lower edge ofjthe head lying adjacent the edge of, the open tube end and the plug extending under compression within the tubebore. l

5. An evacuated stoppered tube for use as part of an assembly for drawing blood, said tube comprising a hollow body having a bore land having one end closed and its opposite end open, a stopper of resilient material for'such open end, said stopper including an enlarged head and a plug portion, both said head and plug portion being formed with recesses in their end faces, an. imperforate self-sealing diaphragm separat'- ing the base portions of saidV recesses, the inner Y face of the diaphragm extending to a point materially within the body of the plug and the outer diaphragm face extending into thethickness-area of said head, the lower edge of the head lying adjacent the edge of the open Vtube end, the plug extending under compression within the tube bore and theV degree of compression being such that the diaphragmis thickened in a direction axially of the stopper.

JOSEPH J. KLEINER.

REFERENCES CITED l The following references are of record in the le of this patent: 'Y p Y 4 UNITED STATES PATENTS France f. Dec. 20, 1929

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US9694140B2 (en) 2010-06-23 2017-07-04 Sta-Med, Llc Automatic-locking safety needle covers and methods of use and manufacture
US8162882B2 (en) 2010-06-23 2012-04-24 Sta-Med, Llc Automatic-locking safety needle covers and methods of use and manufacture
US8747355B2 (en) 2010-06-23 2014-06-10 Sta-Med, Llc Automatic-locking safety needle covers and methods of use and manufacture
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US9848810B2 (en) 2011-05-31 2017-12-26 Sta-Med, Llc Blood collection safety devices and methods of use and manufacture
US8663129B2 (en) 2011-05-31 2014-03-04 Sta-Med, Llc Blood collection safety devices and methods of use and manufacture
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WO2015198031A1 (en) * 2014-06-23 2015-12-30 University Hospitals Of North Midlands National Health Service Trust Improvements in and relating to sample collection
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