US2727516A - Medical sampling devices and specimen containers - Google Patents

Description

Dec. 20, 1955 LOCKHART 2,727,516

MEDICAL SAMPLING DEVICES AND SPECIMEN CONTAINERS Filed March 19, 1955 INVENTOR fl es/74414 Z. [acme Afr *fln ATTORNEYS 2,727,516 Patented Dec. 20, 1955 MEDICAL SAMPLING DEVICES AND SPECIMEN CONTAINERS Marshall L. Lockhart, Rutherford, N. J., assignor to The Compule Corporation, Rutherford, N. J., a corporation of New Jersey Application March 19, 1953, Serial No. 343,415 14 Claims. (Cl. 128-276) The present invention relates to body fluids sampling devices and specimen containers useful to the medical profession, which may be employed to advantage with cannulas and hypodermic syringe needles for withdrawing blood samples and are useful thereafter in processing the same. More particularly, it relates to improvements of the devices of this type which are illustrated in my copending patent applications Serial Nos. 309,421 and 336,467, respectively filed September 13, 1952, and February 12, 1953.

A general object of the present invention is to provide such suction devices and parts thereof which are of simple construction readily producible on an economical basis, and are easily assembled and efiiciently employable; and that feature elastic, collapsible tubular containers or tubes of unique construction which may be provided with novel means readily to receive and temporarily to anchor thereto in an unusually secure manner hub structure of a Luer-lok or similar type of cannula or hollow needle, which assures secure handling, and which may be securely attached to a patients clothing.

A more specific object of the present invention is to provide in such suction devices collapsible tubes readily formed or molded from elastic plastic material, preferably light-transmitting, so as to permit ready filling with blood or other body fluids by pinching and folding the side walls thereof and releasing, with one end of such tubular structure closed by head means having a duct element or hollow neck adapted readily to be telescopically received in a needle hub socket and anchoring means distortably to engage hub flange elements for secure temporary anchorage of the needle, the pinching and folding operations being dictated by certain tube structure in a manner to enhance the anchorage.

Another object of the invention is toprovide such collapsible tubes with grip-assuring means effectively to minimize or eliminate any tendency of the device to spring free and escape during the pinching, folding and/ or release thereof.

A further object of the invention is to provide such collapsible tubes of a construction wherein may be readily formed with the molding of needle-anchoring lugs or projections pierced ears for garments and/or identifying tags.

A still further object of the present invention is to 7 provide uniquely simple structural embodiments of such elastic plastic collapsible tubes which are readily and economically constructed on a commercial scaleand which permit eificient use, as will be more fully apparent from the following descriptions of the embodiments illustrated by way of example in the accompanying drawings.

Other objects of the invention will in part be obvious and will in part appear hereinafter.

The invention accordingly comprises the features of construction, combination of elementts and arrangement of parts, which will be exemplified in the constructions pin attachment to patients operation and functioning thereof,

i, the side walls section 11, prior to closure at illustrated in Figs. 1 to 6 hereinafter set forth, and the scope of the invention will be indicated in the claims.

For a fuller understanding of the nature and objects of the invention, reference should be had to the following detailed description taken in connection with the accompanying drawing, in which:

Fi g. 1 is an exploded perspective view of an embodiment of the elastic collapsible tube of the present invenof the tube container;

Fig. 2 is a perspective view of the assembly resulting from manipulative mounting of the needle on the tube container of Fig. 10, and illustrating insertion of the piercing end of the needle subcutaneously to a vein after volume-reducing manual collapse of the tube and suctioncreating release thereof to draw a sample of blood into the tube;

Fig. 3 is a side elevational view, with parts broken away and in section, of the device illustrated in Fig. 2, after the elastic collapsible tube container thereof has been partially released to draw blood thereinto by suction;

Fig. 4 is an enlarged detailed axial section of the head end portion of the collapsible tube and mounted needle hub illustrated in Fig. 3;

Fig. 5 is aside elevtaional view, with parts broken away, of the structure shown in Fig. 3, illustrating the final step of release of the elastic collapsible tube container to complete the suction loading thereof with a blood sample;

Fig. 6 is a side elevational view of the collapsible tube container of the Figs. 1 and 2 device after a fluid sample has been drawn thereinto and it has been capped and tagged for identification; and

Fig. 7 is an axial section, with parts broken away, of the head end of a modified form of the elastic collapsible tube container of the present inventio Referring to the drawings, in which like numerals identify similar parts throughout, it will be seen that embodiments of the present invention are as body fluids sampling devices and specimen containers in the taking of such samples, such as samples of blood, and/or processing thereof including centrifuging. Accordingly, an embodiment of the present invention, as incl., may take the form of a flexible, elastic collapsible tube or tubular container 10, preferably formed of light-transmitting material to permit one readily to see into the chamber thereof, such as a polyethylene composition. The elastic plastic collapsible tube 10 of the present invention preferably is molded from substantially transparent polythene. The elastic plastic collapsible tube 10 preferably is provided with a substantially cylindrical, flexible, elastic side wall section 11, closed at one end by headmeans 12, preferably molded integral therewith, and at the other end 13 by pinching of and sealing the opposite sides together to form a closed collapsible tube type of container structure having an internal chamber 14.

Since head means 12 is preferably molded integral with the opposite end 13 the tubular container is in the form of a deep cup. The molding thereof produces a pair of diametricallyopposed, longitudinally-extending, internal, stiffening seam beads 15, 15 which are utilized in the incorporation of an :advantageous feature of the collapsible tube of the present invention, as will be explained later.

In the molding of the elastic plastic collapsible tube 10, a medial zone or circumferentially-extending band 16 thereof preferablyis provided with a substantially smooth external surface so as to facilitate visual identification thereon of volume markings formed in the molding, such as the 5 cc. panel 17 and associated circumferential rib line 18, and the l cc. panel 19 and its associated circumferential rib line 20. With the collapsible tube 10 inverted with its head means 12 extending downwardly, fluid drawn into the tube by suction will be of a quantity of about ccs. when the surface thereof is substantially aligned with the volume line 18, and about ccs. when the surface thereof is substantially aligned with the volume line 20.

In accordance with another feature of the present invention, external surfaces of the tube side walls 11 are provided with means to enhance or assure secure manual grip. Molded plastic composition, particularly elastic plastic, of the type preferred for construction of the present tubes, frequently has a slippery surface that may be rendered more slippery if the tube or hands are damp; and collapse of the elastic plastic tubes of the present invention and release thereof to create suction requires considerable manipulation of their side walls. At least the external surfaces of end zones 21 and 22 of the side walls 11 are suitably roughened or provided with grip-enhancing means or projections, preferably in the form of a plurality of circumferentially-extending, axially-spaced, external ribs 23-23, as is best seen from Figs. 3 and 4; although, if desired, substantially the entire external side wall surfaces may be provided therewith.

As indicated in Fig. 4, the head means or portion 12 of the elastic plastic collapsible tube 10 comprises a transversely-extending head wall 24 having a hollow, coaxiallyextending tubular neck 25 molded integral therewith, and provided with a passage or bore 26 in communication with the chamber 14. In the form of the invention illustrated in Figs. 1 to' 6 incl., the elastic plastic collapsible tube 10 is preferably provided with means for anchoring to the head end 12 a Luer-lok hypodermic needle 27. As is well known, such a needle unit 27 comprises a hollow cannula or needle 28 having a sharp piercing end 29 for subcutaneous insertion and coaxially mounted upon a socketed metal hub 30. As is best seen in Fig. 4, the hub 30 is provided with an axially-extending socket 31 adapted telescopically to receive the collapsible tube neck 25 for communicating the needle bore with the container chamber 14. Adjacent the mouth of the socket 31, hub 30 is preferably provided with a circumambient flange 32 having arcs or portions thereof omitted or removed substantially at quarter points so that the base end of the hub is substantially rectangular in shape, as shown in Fig. 1, and to provide two pairs of diametrically-opposed engaging projections or wings 3333.

In accordance with one feature of the present invention, as embodied in the structure of Figs. 1 to 6 incl., the head end 12 of the collapsible tube 10 is provided with means for anchoring such a needle unit 27, preferably in the form of substantially longitudinally-extending, laterally-spaced, integral projections or lugs 34, 34 in the form of thickened arcuate portions of said head end, and having opposed faces 35, 35 arranged in laterally-spaced relation on opposite sides of the base of the neck 25. Being of elastic material, the faces 35, 35 of the anchoring projections or lugs 34, 34 will permit projections or wings of harder material, such as metal, to dig therein for temporary anchorage. Accordingly, the tips of a diametrically-opposed pair of metallic wings or projections 33, 33 on the needle hub 30 are spaced apart a distance appreciably greater than the lateral spacing of the opposed faces 35, 35 of the anchoring lugs 34, 34 while the external diameter of the needle hub 30 preferably is somewhat less than the spacing between those lug faces. As a result, an operator may readily mount the needle unit 27 upon the head end 12 of collapsible tube 10 by telescoping the socketed hub 30 over the tube neck 25 with the shaped flange 32 orientedrelative to the space between the opposed'pair of anchoring lugs 34, 34, as illustrated in Fig. 1, to be receptive therein. Then, the operator rotates the needle hub 30 on the collapsible tube neck 25 approximately through an angle of about forty-five degrees in either direction so as to turn a pair of opposed, engaging, needle hub projections 33, 33 into the faces 35, 35 of the anchoring lugs, as illustrated in Figs. 2 and 4. The elasticity of the anchoring lugs 34, 34 permits the engaging projections or hub wings 33, 33 to dig into the lug faces 35, 35 and the elastic material thereof to flow around those hub wings, as illustrated in Fig. 4, securely to anchor the needle hub 30 to the collapsible tube container 10.

It has been found that when a needle unit 27 of that type is so mounted on such a collapsible tube 10, if the opposite tube side walls are pinched toward each other, particularly in the vicinity of the head end 12, in a plane substantially parallel to the planes of the lug faces 35, 35, the resultant attendant spreading of the diametricallyopposed, longitudinal folds in the tube side walls at the locality of pinch and accompanying convergence of the intermediate side wall portions will cause the opposed faces 35, 35 of the anchoring lugs 34, 34 to be levered outwardly to relative oblique diverging positions. This may be enhanced if diametrically-opposed portions of the tube side walls are stiffened, such as by internal ribs or beads 15, 15, when they are arranged in a plane substantially parallel to the opposed lug faces 35, 35. Thus, when pinch is applied to opposite side walls of the tube 10, in the vicinity of the mid-portions of the bases of the anchoring lugs 34, 34, they will be levered outwardly so that the opposed anchoring faces 35, 35 thereof will diverge and spread. This spreading action decreases the effectiveness of the clamping action of the anchoring lugs 34, 34 relative to the needle hub wings 33, 33. As a result, the effectiveness of the secure anchorage of the needle unit 27 to the collapsible tube 10 may be reduced sufficiently to permit the needle hub to be disengaged from the tube head 12 when the operator, after taking a blood sample, attempts to withdraw the needle 28 from a patients flesh with pull upon the collapsible tube 10. It is desirable that any psychological effect, which may result from the needle remaining in a patients flesh when he had expected its withdrawal with pull away of the tube, is to be avoided.

In accordance with one feature of the present invention characterizing the structure of Figs. 1 to 6 incl., the anchoring lugs 34, 34 are oriented relative to the tube side wall structure in such manner as to cause such collapse pinching of the tube to tend to lever the anchoring lugs 34, 34 convergingly inward, rather than divergingly outward, so as to strengthen rather than weaken the anchorage of the needle unit thereto. This is accomplished by molding the anchoring lugs 34, 34 on the tube head 21 in such positions as to arrange the lug faces 35, 35 in planes substantially normal to the plane of the seam beads 15, 15. It is natural for an operator to collapse the side walls of the tube 10 by pinching in localities which at least visually appear to be and actually are more flexible. This, of course, is in localities intermediate the beads 15, 15. As will be best noted from Figs. 3 and 4, the pinching in such localities tends to spread or flare the beads 15, 15 and to pull inwardly and/ or bend the weaker or more flexible portions of the head wall 24 in the space between the lugs 34, 34. As a result, the anchoring lugs 34, 34 are levered convergingly inward rather than divergingly outward, so that their opposed engaging faces 35, 35 approach rather than recede from each other. Consequently, the anchoring lugs 34, 34 become more securely engaged about the needle hub wings 33, 33 instead of gripping them less securely. As a result, the structure of the collapsible tube 10 of Figs. 1 to 6 incl. makes certain that the operator naturally will so manipulate the tube in the taking of blood samples as to assure that, after a desired quantity of the blood has been sucked into the tube, pull upon the latter will remove the needle from the patients flesh. Freeing of the needle from the tube may be facilitated by pinch in the plane of the seam beads 15, 15.

In operation of the embodiment illustrated in Figs. 1 to w i l 6 incl., particularly for the purpose of taking a'sample of a patients blood, the operator will mount needle unit 27 upon the elastic collapsible tube 10 in the manner indicated above and as illustrated in Figs. 1 and 2. The operator then collapses the side walls 11 'of' the tube by pinching toward each other opposed portions thereof which are of relatively high flexibility, i. e., squeezes in localities intervening the seam beads 15, which constitute visual delineating means identifying those intervening portions of higher flexibility, and thus reduces the internal capacity ofthe chamber 14 with expulsion of air through the needle. The operator may further reduce the internal capacity of the tube chamber 14 with further expulsion of air by then folding over the closed end 13 toward the head end 12 so as to lap together the opposite ends of the tube. a patients flesh, such as that illustrated at 36 in Fig. 2, to communicate with a vein, such as that illustrated at 37 in Fig. 2. Thereafter, the operator releases the end 13 of the tube 10 while retaining a firm grip upon the roughened head end portion 21, so that the released end will automatically swing back, due to the elasticity of the tube, to the full line position illustrated in Fig. 2 and finally to the dot-dash position at 38. This action increases the internal capacity of the chamber 14, thereby creating suction to draw a quantity of blood up into the tube, such as is illustrated at 39 in Fig. 3. Finally the tube walls will substantially recover to their full line positions shown in Fig. 1 with opposed portions of the tube walls intervening the seam beads 15, 15 moving outwardly in opposite directions, as indicated by the arrows in Fig. 5.

The operator controls the amount of the fluid sample drawn into the tube chamber 14 by using the volume lines 18 and 20 and information indicia at17 and 19. Of course, he may not with accuracy withdraw the precise quantity of blood desired in the tube in the initial instance while attempting to employ such volume markings. However, with proper instruction, he should learn readily that the surface of the quantity of blood in the tube chamber 14 should be collected to a point somewhat beyond the selected volume marking to accommodate a volume differential inherent in any such distortion of the tube walls in the creating of the needle 28 from the patients flesh, he may reduce the volume of the sample taken to a precise amount as dictated by the selected volume marking by discharging a small amount of the sample through the Withdrawn needle by slight flexing of the tube walls 11.

Thereafter, the operator removes the needle unit 27 from the tube 10 by again rotating the needle hub 30 through approximately forty-five degrees, so as to free the hub Wings 33, 33 from engagement with the anchoring lugs 34, 34, and withdrawing the needle hub from off of the tube neck 25. The operator then closes the loaded tube 10 by mounting any suitable capv structure on the neck 25, such as that illustrated at 40 in Fig. 6 which constitutes the subject matter of my above identified patent application Serial No. 336,467. The loaded and closed tube is then ready for processing in accordance with established procedure, such as by centrifuging discussed in that copending application.

It is desirable practice physically to associate a sample with the patient for ready identification. Thus, in accord ance with one embodiment of the present invention and as illustrated in Figs. 1 to 6 incl., apertured cars 41, 41 preferably are provided on the elastic collapsible tube 10. Such cars 41, 41 are preferably molded integral with the anchoring lugs 34, 34; and in the preferred form constitute substantially axially-extending fins substantially aligned with the seam beads 15, 15, whereby they may serve to stiffen the lugs and aid in the levering action of the latter. In such positions, the apertured ears 41, 41 form strengthening or stiffening fins for the anchoring lugs 34, 34 in the plane of the seam beads, 15, 15, so as to enhance the levering action previously described. One

He then thrusts the needle tip 29 into suction. Then, upon removal of the of the apertured ears 41 may be employed for reception of a safety pin to attach the container to a patients garment, and, as illustrated in Fig. 6, the other apertured ear may be employed for connecting thereto an identifying tag to facilitate identification of the contained sample and also,

if desired, the patient.

As illustrated in Fig. 7, the elastic plastic collapsible tube of the present invention may be provided in a form in which the needle anchoring lugs 34, 34 are omitted. Such a simplified form of tube is particularly usefulin connection with the taking of samples of body fluids where the needle is not or need not be employed as an adjunct to the taking of the sample. However, needles having socketed hubs, such as of the Luer-lok type, may be mounted upon the neck 25 of the elastic plastic collapsible tube 100 of the Fig. 7 embodiment with reliance upon frictional grip between the external surface of the tube neck 25 and the internal surface of the needle hub socket 31. Such frictional engagement may be considerable, particularly since the tube neck 25 preferably is molded integral with the body of the tube and thus from elastic material, preferably polythene. As a consequence, when the tube neck 25 is jammed with considerable force into a needle hub socket which, due to relative dimensions, causes appreciable contraction of the tube neck, a secure frictional grip is attained. Preferably, the elastic plastic collapsible tube of the Fig. 7 embodiment is provided with the other features of the embodiment of Figs. 1 to 6 incl. and, more particularly, the grip-enhancing means such as the ribs 2323.

it will thus be seen that the objects set forth above, among those made apparent from'the preceding description, are efi'iciently attained and, since certain changes may be made in the above construction and different embodiments of the invention could be made without departing from the scope thereof, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.

Having described my invention, what I claim as new and desire to secure by Letters Patent is:

l. A medical sampling and specimen container com prising, in combination; an elongated, elastic plastic, collapsible tube closed at one end and having another head end extending transversely of and integral with the side Walls of said tube to define an internal liquid chamber, the side Walls of said tube being provided with longitudinally-extending, diametrically-opposed, stiffening seam beads, extending to the vicinity of said head end; an integral hollow neck coaxially extending from said head end with its bore in communication with said chamber; and a pair of external, longitudinally-extending, laterallyspaced, needle-anchoring projections on said head end disposed on opposite sides of the base of said neck at points in the vicinity of said beads, whereby pinching together opposite portions of the tube side walls intermediate said beads levers said needle-anchoring projections inwardly toward each other in converging relation.

2. A medical sampling and specimen container comprising, in combination; an elongated, elastic plastic, collapsible tube closed at one end and having another head end extending transversely of and integral with the side walls of said tube to define an internal liquid chamber; an integral hollow neck coaxially extending from said head end with its bore in communication with said chamber; visual delineating means identifying opposed relatively highly flexible portions of said side walls in the vicinity of said head end to be pinched toward each other for chamber-capacity reduction; and a pair of external, longitudinally-extending, laterally-spaced, needle-anchoring projections on said head end disposed on opposite sides of the base of said neck at points intermediate said defined opposed portions whereby pinching together the latter levers said needle-anchoring projections inwardly toward each other in converging relation.

3. A medical sampling and specimen container comprising, in combination; an elongated, elastic plastic, collapsible and foldable tube having a transverse head; a hollow neck extending coaxially from said head; visual delineating means identifying opposed relatively highly flexible side wall portions of said tube in the vicinity of said head to be pinched toward each other for chambercapacity reduction; and a pair of longitudinally-extending, laterally-spaced, needle-anchoring projections fixed to said head and disposed on opposite sides of said neck at points intermediate said opposed defined side wall portions.

4. A medical sampling and specimen container comprising, in combination; an elongated, elastic plastic, collapsible and foldable tube having an integral head; a hollow integral neck extending coaxially from said head; visual delineating identifying opposed relatively highly flexible side wall portions of said tube in the vicinity of said head to be pinched toward each other for chambercapacity reduction; and a pair of longitudinally-extending, laterally-spaced, needle-anchoring lugs integral with said head and disposed on opposite sides of said neck at points intermediate said opposed defined side wall portions.

5. A medical sampling and specimen container comprising, in combination; an elongated, elastic plastic, collapsible tube closed at one end and having another head end extending transversely of and integral with the side walls of said tube to define an internal liquid chamber; an integral hollow neck coaxially extending from said head end with its bore in communication with said chamber;'a pair of diametrically-opposed, longitudinally-extending, internal side wall-stiffening seam beads extending to and merged with said head end; and a pair of external, longitudinally-extending, laterally-spaced, needleanchoring lugs integral with said head end and having opposed faces disposed in planes substantially equidistantly spaced on opposite sides of the base of said neck, said lugs being located on said head end at points of mergence of said seam beads with said head end and in positions which dispose said faces in planes substantially normal to the plane of said seam beads, whereby pinching together opposite portions of the tube side walls intermediate said beads levers said opposed lug faces inwardly toward each other in converging relation.

6. The container as defined in claim 5 characterized by said lugs constituting thickened arcuate portions of said head end each substantially medially merged with one of said integral seam beads, the intervening thinner portion of said head end centrally carrying said integral neck and being relatively flexible on diametrically opposite sides Y of said neck base.

7. The container as defined in claim 6 characterized by said lug faces being disposed in substantially parallel planes whereby pinch together of side walls of the tube intermediate said seam beads swing said lug faces convergingly inward toward each other and similar pinch in a normal direction swing said lug faces divergingly outward away from each other.

8. The container as defined in claim 5 characterized by the provision of grip-assuring projections on the external side wall surfaces of said tube at least adjacent its opposite ends.

9. The container as defined in claim 8 characterized by the provision of said projections in the form of longitudinally-spaced, circumferentially-extending ribs.

10. The container as defined in claim 9 characterized by substantial confinement of said ribs to end zones with an intermediate zone carrying volume markings.

11. The container as defined in claim 5 characterized by the provision of each lug with a pierced ear.

12. The container as defined in claim 5 characterized by the provision of each lug with a pierced ear constituting a substantially axially-extending fin in the vicinity of the seam bead which is merged with that lug.

13. The container as defined in claim 6 characterized by a pair of longitudinally-extending fins each integral with the outer end of one of said lugs to stiffen the same and being substantially aligned with the seam bead which is merged with that lug, each of said fins being pierced.

14. A blood sampling container comprising an elongated, elastic plastic, collapsible and foldable tube closed at one end and having an integral transverse head at the other end; an elongated, outwardly-tapered, integral neck coaxially extending from said head communicable with the interior of said tube; a series of circumferentiallyextending, axially-spaced, small raised ribs on the exterior surface of said tube adjacent said head, and a similar series of said ribs adjacent said closed end; a medial zone defined between said two series of ribs and having volume markings therein, the side walls of said tube being provided with .longitudinally-extending, diametrically-opposed, stiffening seam beads, extending to the vicinity of said head; and a pair of external, longitudinally-extending, laterally-spaced, needleanchoring projections integral with said head disposed on opposite sides of the base of said neck at points in the vicinity of said beads, whereby pinching together opposite portions of the tube side walls intermediate said beads levers said needle-anchoring projections inwardly toward each other in converging relation.

References Cited in the file of this patent UNITED STATES PATENTS 972,095 Booth Oct. 4, 1910 1,959,896 Beebe May 22, 1934 2,158,593 Scrimgeour May 16, 1939 2,615,446 Lingenfelter Oct. 28, 1952 2,625,157 Lockhart Jan. 13, 1953

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