US 2689564 A
Abstract available in
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Description (OCR text may contain errors)
Sept. 21, 1954 J. ADAMS ET AL I 2,689,564
BLOOD DONOR ASSEMBLY Filed Nov. 29, 1951 3 Sheets-Sheet 1 l M l m 5 53 51 if 5 25 INVENTORS Jilin a. fldam 3y Jase 411.1 17(1)! ,Duu W M HTTOR/VEYS p 1954 J. Q. ADAMS ETAL BLOOD DONOR ASSEMBLY 3 Sheets-Sheet 2 Filed Nov. 29, 1951 r III/III/IIIIIIIII 44 INVENTORS d. fl(ldfft6 Sept. 21, 1954 J- Q. ADAMS ET AL 2,689,564
BLOOD DONOR ASSEMBLY Filed Nov. 29, 1951 3 Sheets-Sheet 3 /,/"'4'\ 7 WW 7 V BY Jbscya 11mm Patented Sept. 21, 1954 BLOOD DON OR AS SEMBLY "John Q. Adams, Rutherford, N. J and Joseph J. Kleiner, Woodmere, N. Y., assignors to 'Becton Dickinson and Company, Rutherford, N. -J., a "corporationwof New Jersey Application November-29, 1951, Serial No."258,942
2 Claims. -1
This invention relates to 'a structurally and functionally improved assembly used in connection with blood donation and transfer; the present assembly being also capable of use with liquids other than blood and certain of the elements thereof being useful apart from'the assembly. The presentapplication is "a continuation in part of our earlier application for patent filed in the United States Patent Ofiice on May 15, 1951, and identified under Serial No. 226,462.
It is an object of the invention to furnish apparatus of this nature-and in which a sterile assembly will be instantly-available for use. After such use (which may involve eitherasingle operation or a series of steps) the apparatus may conveniently be discarded if it is impracticable .or undesirable to clean and sterilize the parts of the same for reuse.
An additional object is that of providing a cannula or needle as part of the assembly; this unit being capable of a ready manipulation although it may at alltimes, when not in use, be maintained. in a housed or protected condition.
Still another object is that of designing an assembly which may "be readily and economically manufactured; the several components of the assembly being capable of ready connection to each other to furnish aunitary apparatus which maybe employed with facility.
With these and other objects in mind, reference is had to the attached sheets of drawings illustrating practical embodiments of .the invention and in which:
Fig. l is a sectional side view-of the upper end of a sealed container and showing the penetrating cannula moved to apoint adjacent to same;
Fig. 2 illustrates the cannula prior to its seal penetration Fig. 3 shows the cannula extending through the seal;
Fig, 4 illustrates the manipulationof the cannula assembly after its removal .fromthe seal;
Fig. 5 is a sectional side view of an alternative structure and illustrating a venaneedleassociated therewith;
6 is a perspective view of the entire .assembly but showing .an alternative .form of hub design as well as a manipulating plate;
Fig. 7 is a fragmentary perspective view showing the manipulating plate detached .from the cannula hub;
Fig. 8 is a sectional "side view of a puncture needle assembly;
"Fig. 9 shows a holder preferably used'with this assembly;
Fig. 10 is a sideview of the holder with the assembly mounted thereon and in process of application to 'a receptacle;
Fig. 11 is a fragmentary view ofthe receptacle and needle assembly with the blood in courseof transfer to the receptacle;
Fig. 12 shows :in section one form of tube mounting;
Fig. 13 is a transverse sectional view taken along-lines IS-I13 of Fig. 12; and
Fig. 14 illustrates another form of mounting.
Considering the seal-puncturing needle, the numeral It) indicates a cannula providedat its outer end -with'a penetrating :point. The opposite end-of the needle furnishes a hub structure conveniently embracing a 'flange :portion l1 and a gripping portion, which, asin 'F'igswl to 4, may be in the for'mloi a truncated cone 2 having its outer face formed with -a series of grooves t3. The fiange ll is separated "from the'conicaliportion I2 by a neck 14 integral with both of these parts. The *entire hub assembly is, of course, secured in any desirable and acceptable manner against movement with respect to the cannula iii. The latter projects beyond the rear of the hub assembly. As shown in Fig. .5 and subsequent views, the truncated cone formation may be superseded by a hub structure 12' of generally cylindrical configuration.
That end of the cannula which extends forwardly of the'hub assembly is enclosed in a sheath or-cap l 5'for1ned of rubber orany other proper material. The length of the cap should be in excess of the enclosed needle'porticn. The outer end of the cap is sealed as at 16. Its opposite end is mounted againstdeta'chment from the hub assembly by conveniently extending over the flange H into the groove provided by the reduced neck portion I l. The rear end of the cannula is ensleeved by the end of a tube IT. The latter is preferably a vinyl plastic tubing and has a normal bore diameter substantially identical with the bore of needle 10. The end edge of the "tubing may abut the outer end of the gripping portion.
Now considering the intravenous needle shown in Fig. 5, it will be noted that the body of the same is indicated at Hi. This needle is provided with the usual pointed outer end portion. At a point suitably spaced from this end it is en circled by a hub assembly. The latter preferably includes a flange i9 and an enlarged rear portion '20 provided with a groove it. The flange l9 and rear portion are connected by an integral reduced neck "portion 22. The end of tubing ll opposite to that mounting needle I is connected to the portion of cannula I8 which projects rearwardly of its hub assembly. The bore of cannula It is preferably the same diameter as the bore of cannula It]. Therefore, in effect a continuous uninterrupted passage of constant diameter will extend from the pointed end of one needle through to the pointed end of the second needle.
Needle i8 is preferably protected by being enclosed in a sheath or cap 23. The latter may be formed of any suitable material such as vinyl tubing. Its length is such that it conveniently extends substantially beyond the pointed end of needle i8 when its opposite end extends into the reduced neck portion 22 and encloses flange E9. The outer end of the sheath 23 may be obstructed by a plug 24 conveniently of cotton and saturated with alcohol if desired.
As is well understood by physicians and other skilled personnel, it is customary to extend one needle of a set into the vein of the donor. The opposite needle of that set is caused to penetrate a seal for a container, the interior of which is conveniently evacuated. Such a container has been shown in Figs. 1 and 6 and indicated by the reference numeral 25 which may mount a protecting cap (not shown). It is provided with a neck portion conveniently furnished with an outer thread 26. The mouth or bore of this neck is sealed by a stopper embracing a body 27 and a head 28. This stopper may be formed of rubber or other proper materials but in any event should embody resiliency. It is provided in its upper and lower faces with aligned recesses 29 and 33 as well as 3! and 32. The bases of these recesses are separated by partitions or diaphragm portions 33 which are relatively thin and disposed in a zone such that they will lie below the pouring lip of receptacle 25 when the stopper is in fully seated position. So seated, that stopper will be under radial compression. Therefore, any perforations of minor size through the diaphragm portions will substantially seal upon withdrawal of the needle which has perforated them.
As heretofore described in connection with Fig. the hub shown in the lower portion of that figure is associated with the intravenous needle. A similar hub may be associated with the stopper-perforating needle 40 as shown in Figs. 6 and 7. Thus, in these figures the numeral 34 indicates a hub portion formed with a roove 35 and I a reduced part 36 over which the inner end of the sheath or cap 31 is ensleeved. A plate 38 formed with a notch 39 may be provided as part of the assembly. This notch has extending into it detent fingers d2, the ends of which are curved inwardly and rearwardly and are separated a distance less than the diameter of the base of groove 35. Accordingly, the hub of the needle 40 may have its groove aligned with these fingers and be pressed rearwardly. It will cam against the fingers and due to the resiliency incorporated in the latter they will be spread apart to a point at which the maximum diameter of the hub groove has passed beyond their most closely separated faces. So positioned, the hub of the needle will be retained in association with the plate and the latter will serve as a manipulating portion to permit the operator to force the needle to penetrate the stopper or to withdraw that needle from such stop er.
In this manner no diificulty will be experienced in furnishing a gripping portion permitting of the ready manipulation of this needle. As is obvious the plate may readily be detached from the needle hub whenever desired. Also as shown in these views the hub of the intravenous needle 45 may, if desired, be plain or knurled. The hub will provide a manipulatin part for that needle. The two needles are connected by tubing H as heretofore described in connection with Fig. 5.
It will be understood that the parts of this assembly are manufactured in accordance with acceptable procedures. They are cleaned, sterilized and assembled. So assembled an apparatus is furnished in which all essential parts are adequately protected against contamination. In packaging, if a surplus or an inadequate amount of air is present then in effect a breather provision is afforded by the tube 23 through the plug 24. At any time the physician or other tech nician desires to employ the apparatus it will be instantly available for use. All that will be necessary is for the user to remove the assembly from its package and if a receptacle such as 25 is to be employed, to remove the cap or other covering (not shown) which maintains the sterility of the upper surface of stopper 2'5. Beyond this the procedure will be as follows:
The site of the vena puncture is selected and the surface is sterilized in accordance with ac ceptable technique. If employed, the sheath 23 is stripped from the needle l E or ii and that needle is inserted into the vein. Due to the normal pressure of blood in the vein and the compressibility of air the blood will flow through the bore of cannula i8 and into tube E, a distance of around 4" to 5". Because of the translucent nature of tube ll this will be readily apparent to the user. No clamp will be necessary to prevent the blood from flowing into the tube ii to a greater length or height because air may not escape from needle is and sheath i5. Of course if a sheath or its equivalent is not employed, then any suitable clamping structure or provision may be resorted to when it is desired to prevent a flow of liquid through the assembly. Due to the relatively small bore sizes involved, the assembly will function as a metering structure to prevent too rapid a discharge of blood from the vein of a donor. Therefore, no valving mechanism will have to be associated with the needles or tube.
With the removal of the covering from the neck of receptacle 25 the sterile face of stopper head 28 is exposed. If desired, that face may be further sterilized. In any event if the assembly embraces the parts as in Figs. 1 to 4 and with cap or sheath l5 in position on the needle as shown in Fig. 1, the point of that needle is brought to a posltion overlying diaphragm 33 at the base of recess 29. Cap l5 will not enter that recess. Rather, it will tend to fold or extend angularly with respect to the axis of needle id as shown in Fig. 2. Therefore, continued pressure upon the hub of the puncturing needle will force the point of that needle to penetrate the sheath l5 and to thereupon penetrate diaphragm 33. Under these circumstances the cap will in effect be collapsed as shown in Fig. 3. Duringthis projection of the parts it is apparent that if a conical hub portion [2 is provided, the operators fingers will easily grip the same and be able to force the parts to the desired positions. So shifted they will remain in those positions because the resiliency of the sheath [5 under which it seeks to reestablish its initial position, will be far less than the resistance to movement which occurs due to the frictional contact between the outer face of cannula lil and A the surfaces of the diaphragm 3%. Hub portions l2 or IE (Fig. 5) will also serve as manipulating acsaecu parts etc permit :of ithewithdrawal of the :needle from the position k'ShOWIl ill]. Fig. :3 to that illustratedinrEig-A. .In thellatter figurepitwVillbe observedthatithefingers of Ithe operator may grip the end :of :the :cap ror "sheath and .stretch the same. Under ztheseacircumstances, thepoint of the :needle will withdraw from the perforation in thecap and :be completely :houserl rand ;substan-- tially sealed within the latter. Where alplate tilt is employed, it 'may :readily be coupled with a needle such :las 40 :to permit pf :manipulation of the latter.
.As will-be understood-whenthegpointof :needle .I 6 penetrated cap tithe bore of the cannula exposed to atmospheric pressure. Therefore, under thepressurerwithimthe-vein,=the blood was free to rise or-flow within-tube .1 l from-needle it towards needle :l-fl. Immediately after "puncturing the cap -.or-.sheath the point of needle iii penetrated diaphragm .31 atithebase of recess 25. Therefore, before blood discharged from needle t0 the endlof that .needle was .in communication Withthe interior oftheivesselit as shown in Fig. 3. The body of that vessel being under vacuum, .the flow .ofblood would, if anything, ac celerate through .the tube I 'l. The parts are left in these positions.until a-desired. amount .of blood has been taken. When .this has occurred either bygrasping themeedle. hulror usingla plate such as 38, needle It or All is withdrawn from association with the stopper or other seal. Diaphragm portion 33 being under radialcompression it follows that the perforationinthe latter'will be selfsealing. When cap 15 .hasbeen manipulated as in Fig. 4,-needle .tllis enclosed in the cap. Ifdesired, a seriesof tubes or otherreceptacles may now be employed for the purposeof taking terminal blood samples. These are conveniently closed by stoppers similar to thataforedescribed. It will .be understoodthat if anysubstantial delay is encountered in taking these samples the enclosing ofneedle N! by the cap will preventcoagulation or leakage.
Initaking terminal'bloodsamples -it.is, of course, not necessary to enclose needle in within the cap or sheath in the manner shown in Fig. 4 if van undesirable time interval does not elapse. However, .in addition to protecting that needle from contamination the cap wi1las :afore brought out-prevent continuing discharge of blood from the veinwhen such cap encloses the needle. .Upon theconclusionofthe operationneedle ill is withdrawn from the final stopper or seal. .Thereupon needle t8 is'withdrawnfrom the vein. [is will be appreciated by employing tubing Il of the characterdescribed "hemolysis is prevented. This will be because in efiect a single continuous passage free from constriction and enlargements is provided from "the outer end .of one needle through to the outer 'end of the second needle. Therefore, the blood in flowing through this passage will not be buffeted and subjected to accelerated as well as retarded "flows with .consequent detriment to the blood discharged .into receptacle or other "receptacles. The purpose of recesses 3 I -32 andany other recesses through the stopper 2 8 will be apparent .in that one or more vents, tubeconnections or other expedients may thus be provided and by means of which the contents of the receptacle :may be caused to flow as desired. As will finally be understood, the tubing connecting the two .needles :is preferablyformed of that type-of plastic which'when stretcheditends to return to its normalposition. Therefore, .a tight seal is provided between the needles and athe tubing. Additionally, the bores of all three .are substantially constant throughout the entireassembly. The shrinking of the tube into contact with the rear needle surfaces .be seen that the stopper-penetrating needle or cannula All may be enclosed ina sheath of protective material "4|. This sheath or cap is conveniently provided by a suitable plastic which will have resiliency such that its open end constricts around andfrictionally engages those portions of the "cannula assemblywhich are adjacent the hub. The latter asaforedescribed is formed with a groove which :in these views have been indicated by the reference numeral 42. As previously taught, the rear end .portion 43 of the cannula is connected bya tube 44 with the vena needle.
A needle manipulating holder and clamp has been shown in Figs. 9 .and '10. This isconveniently formed of :metal and includes a base plate 45 formed with a notch "46. In common with the notchstructure heretofore described in connection with :Figs. 6 and 7, arms preferably extend into this recess .at'a point such that the grooved portion of the needle may beinserted into the notch and removed therefrom. When in sertedlthe needle 'willibe retained as a unit with plate 45 .and against any probability of accidental detachment. Extending upwardly from this plate is a portion *617 formed with a slit d8. The outer end of the latter has its edges diverging and separated :a distance such that tube it may readily be accommodated therein. When this tube is moved downwardly into the slit it is pinched or constricted to a point where no how of fluid may occur through it. Due to the retricted series of bores which provide the conduit for the flow :of blood that fiow will be metered so that 'there Will'bEiIlO danger or discomfort on the part of the donor. The straight edge portions of the slit "it will assure that there will be no tendency of the tube "to accidentally ride out of the slit. .A-s shown the plate adjacent the slit may "be reduced. aslindica'ted at '48. This reductiondn thickness "will assure that the edge portions defining the slit :aresufiiciently narrow so that while a proper clamping action may occur between them and "the surface of the tube, too great -.a frictional contact between these parts will not occur. Thestopper-penetrating needle together with the holder ha e been shown with the sheath reinovediin Fig. '10. Also, in that View tube 13 3 has been shown in a position Within the slot where it is properly constricted.
In using an assemblyof this nature needle iii has the grooved portion 32 of its 'hub inserted into notch A portionor" tubing l-6i adjacent this cannula would then be disposed within the slit and wedged by the edges of the latter so as to prevent any flow of fluid through tube s i.
. Thereupon,:-if cap 41 is used it may be removed and plate did is grasped between the thumbs index lingers of 'both hands. By'exerting'asteady straight pressure down on the selected site of stopper 49 "the latter will be penetrated by the needle. The receptacle fiil which is sealed by this stopper .:may, in common with the receptacle contain any desirable material such as acid citrate dextrose. This will act as a preservative, anticoagulant and feeding agent for the blood. The receptacle 50 is now inverted as indicated in Fig. 11 and properly supported. When the vein has been punctured by the needle connected to the opposite end of tube 44, that tube '44 is removed from clamping engagement with the slit or slot 48. Plate 45 may now be detached from the needle. Under these circumstances blood will flow to the receptacle. Such flow will be accelerated incident to the vacuum existing within that receptacle. However, as indicated in Fig. 11, the blood will merely bubble to the surface of the body of liquid 5| within the same and will not spurt into contact with the receptacle surfaces, upon which it would tend to coagulate. A lack of spurting will be because, with a metered flow and substantial constant bore existing from the vena needle through to and including the stopper-penetrating needle, there will be no tendency for the latter to act as a nozzle and for surges to occur within the tube assembly.
After the desired, quantity of blood has been withdrawn tube 44 is again disposed in clamping relation with the edges of slit 48. Holder plate 45 has its notch arranged in line with groove 42 and by lateral movement the needle is coupled with that holder. By placing the index finger of each hand under the opposite ends of the plate a gentle steady pull may be exerted to withdraw the needle from the stopper. The latter as afore brought out is preferably self-sealing. The holder may remain on the needle until terminal bloods are taken. After this operation has been completed the intravenous needle is withdrawn. The holder is removed from the needle 48 and the latter together with its connected tube and vena needle are discarded.
In the several forms of apparatus as illustrated it is preferred that the internal diameter of tube H or 44 be on the order of .05". By employing a tube having this bore size with needles of customary gauge, very satisfactory results are achieved. In the average case and employing a receiving receptacle of accepted capacity, the bleeding time runs between four and a half and seven minutes. A separate metering structure is unnecessary in that the bore sufiiciently controls the flow in a manner entirely satisfactory.
To prevent an accidental detachment of tubing I! from the rear of the needle, a sleeve 50-as in Fig. 5may be provided of plastic or other suitable material. 'This sleeve has a bore incorporating a diameter such that it may freely receive the tubing in its initial state. However, where that tubing is expanded over the rear of the needle i it will be intimately engaged by the sleeve bore. This will prevent any relative and accidental movements between that needle and the tube portion mounted thereby. If, instead of threading the sleeve on the tube it is desired to mount the former by lateral movement, it may be slotted as at in Fig. 5, the width of this slot being less than the exterior diameter of the tube. Thus, the sleeve may be moved laterally so that the tubing passes similarly to the structure at 50, it may be shifted axially to the position shown. In both instances the sleevein addition to constricting the tubing around the rear portion of the cannu1awill provide a guard preventing the fingers of the operator from axially compressing the tubing to enlarge its bore diameter. Accordingly, the danger of accidental detachment of the needle from the tube is reduced.
Alternative structures in this connection are shown in Figs. 12, 13 and 14. In the first two views a needle has been shown at 52 which is provided with a hub 53 having a rearwardly tapered surface 54 and an extended portion 55 beyond the same. The tube I1 is mounted upon this portion and a split sleeve 56 is applied to the parts in the manner described in connection with sleeve 5|. The sleeve 56, having bevelled entrance portions 51, will wedgingly engage tapered surface 54 and thus be firmly mounted to act as a guard.
As in Fig. 14, the needle 58 may be provided with a hub 59 beyond which a threaded portion 60 is disposed. In that instance the. sleeve 6! has its opposite end provided with corresponding threads. Therefor, this sleeve may also be fixedly mounted by the needle assembly. These sleeves may be formed of metal or other suitable material. As shown, they may be slotted. If desired they might incorporate dimensions such that their bores engage part of the exterior surface of the tubing ensleeved over the rear cannula end. Thus, in addition to functioning as guards, they would serve to further restrain movement of the mounted tube portion with respect to the needle.
Thus, among others, the several objects of the invention as aforenoted are achieved. Obviously numerous changes in construction and rearrangement of the parts might be resorted to Without departing from the spirit of the invention as defined by the claims.
1. In an assembly of the character described a needle mounting and manipulating plate, said plate being formed with a needle-receiving notch and resilient detent arms extending from said plate into said notch and separated a distance such that they cooperate with the hub portion of a needle disposable in said slot.
2. In an assembly of the character described a plate to be secured to a needle, an upwardly prcjecting extension forming a part of said plate, said extension being formed with a slit defined by spaced side edges to receive between them and constrict a tube connected to a needle and the thickness of said plate adjacent such edges being reduced.
References Cited in the file of this patent UNITED STATES PATENTS Number Name Date 231,072 McKay Aug. 10, 1880 766,203 Walsh Aug. 2, 1904 1,050,042 Sellar Jan. 7, 1913 1,522,198 Marcy Jan. 6, 1925 1,961,490 Hein June 5, 1934 1,975,360 I-Iarrison 1 Oct. 2, 1934 2,121,123 Erikson et al June 21, 1938 2,222,371 Nesset Nov. 19, 1940 2,256,657 Swabacker Sept. 23, 1941 2,271,288 Cuff Jan. 27, 1942 2,362,537 Butler Nov. 14, 1944 2,366,424 Perry Jan. 2, 1945 2,367,806 Shaw Jan. 23, 1945 2,410,546 McCabe Nov. 5, 1946 2,442,983 Nesset June 8, 1948 2,452,644 Fields Nov. 2, 1948 2,461,558 Meagher Feb. 15, 1949 2,517,490 I-Ivam Aug. 1, 1958 FOREIGN PATENTS Number Country Date 567,078 France Nov. 30, 1923 452,825 Great Britain Aug. 31, 1936 573,611 Great Britain Nov. 28, 1945 587,280 Great Britain Apr. 21, 1947