NZ198131A - Fluid specimen collector - Google Patents

Description

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S 9 Reg^.) Fee: £55.00 J-LW ZEALAND Priority C." : ;s,; Complete Cp^cii'icati.?/! f iLd: ih-Z.M C!ass: .. )fO5).|3?) • »•*•••»« v' Publication Date: P. }. J?.®/...

P.O. Journal, No: ... ggfe 198131 o Insert nunber of Provisional Spccification(s) (if anv) and d.itp(s) of filing; otbemise leave blank.

Insert Title of Invention.

Insert full name, full street address and nationality of (each) applicant. c PATENTS ACT 195 3 Number: Date: COMPLETE SPECIFICATION DIAGNOSTIC SPECIMEN COLLECTOR j|/WE TRANS-MED CORPORATION, a corporation organized in accordance with the laws of the State of California and doing business at, and having a business address of 1621 Collingwood Drive, San Diego, California 92109, U.S.A. hereby declare the invention for which I/we pray that a patent may be granted to me/us and the method by which it is to be performed, to be particularly described in and by the following statemeirfe-:- The following page is numbered la Indicate if following page is numbered '1(a)' 1.5.80 iff Field of the Invention 198131 The present invention is in the field of medical diagnostic devices, and more particularly, in that portion of this field in which fluid specimens are collected for subsequent analysis in a laboratory.

: OO t o ■>-. j Z r)uu P- V9" o 04 & Background of the Invention and Prior Art The taking of fluid specimens for laboratory analysis is an important diagnostic tool in the treatment of medical diseases and ailments. It is clearly evident that specimens should be as free as possible from any possible secondary contamination, be it from the area from which the specimen is taken or the ambient conditions external to the subject but through which the specimen collecting device must be moved. Conventionally, fluid specimens are withdrawn from a subject by syringe, having generally a hypodermic needle attached thereto for penetration of the subject. Often there is a need to introduce the collected specimen to a specimen maintenance agent, reagent, or culture media to induce specimen growth, specimen identification, or sustain the collected specimen's values constant and viable for subsequent laboratory procedures. It is not generally desired to introduce the specimen agent, reagent, or culture media, nor a specimen to which any of these media have been applied to a patient, the matter of toxicity being the question. Specimens may be body liquids such as blood or urine, or other tissue fluids, or may be anaerobic specimens collected from varipus organs within the body, or may consist of water or other non-body fluids.

In some institutions, the practice has been to place a cork or stopper over the end of the needle after - ia - 198131 it is withdrawn from the subject in order to seal and protect the collected specimen, and then the syringe is carried to the laboratory. In other situations, the syringe collected specimen is injected through a rubber stopper into an otherwise sealed vial or tube. These vials and tubes often containing a specimen agent are then sent to the laboratory.

Sometimes, a specimen is ejected from the syringe into a tube containing specimen maintenance media which tube is then closed and taken to the laboratory, sealing and maintenance of the specimen being of primary importance in preserving the viability of the specimen and its quantitative values.

In attempts to increase the viability of the specimen and further minimize secondary contamination, there has been developed a vacuum operated system for taking liquid samples. The system comprises a bottle often containing a specimen maintenance or culture medium which is evacuated and then sealed with a rubber diaphragm to maintain the negative pressure within the container.

To use such a device, use is made of a special hypodermic needle which may be considered as double ended. One of the needles is inserted into the subject and the other end of the needle is then inserted through the rubber diaphragm. The negative pressure in the container automatically draws fluid into the container. The draw is sudden and uncontrollable, and has been known to cause veins to collapse. Also, the vacuum within the container may be less than necessary to withdraw the desired amount of fluid. Because the interior volume of such containers : " 1 ■ *T-~— ■■>■•-»--■ 198131 cannot be variably controlled, such containers are made available in many capacity sizes such as 5, 7, 10, 15, and 20 cc capacities, resulting in the need to stock many sizes of the containers to meet varying requirements.

Many of these types of containers are sold in a non-sterile state, and thus the institutions utilizing them must subject them to sterilization or run the risk of contaminated cultures. It has been noted that in many instances the autoclaving for sterilization reduces the • amount of negative pressure within the container, and such containers do not provide the means to expel the fluid within them. 4 In the recent developments in the field of collecting devices, is a syringe type device which is shown in US Patent 4,04 3,33 6. This patent is a hollow body member with a plunger therein. The so-called closed end of the end portion of the body member has a circular disk adhesively secured near the closed end, but providing space for another disk between the secured disk and the interior surface of the closed end. The second disk contains a nipple which extends outwardly through a slot in the closed end. Both disks have an orifice in each, and each movement of the disk with the nipple in the slot and the closed end of the syringe brings the two orifices into communication or out of communication. This device may contain an exterior protrusion on the side of the body-member into which may be placed some form of medium for automatic and instant application to the specimen as it is being collected. vV §: Summary of the Present Invention 198131 The present invention is an elongated hollow body open at one end and closed at the opposite end with an orifice in the closed end. A plunger with sealing means on one end is slidably inserted into the body to variate the interior volume while maintaining a sealing of the interior of the body. Movable closure means are exteriorly mounted on the closed end of said body. The closure has an outwardly extending fitting, with an orifice therethrough, adapted to receive compatible fittings or medical collection devices such as needles or multiple specimen collecting devices or adaptors used on diagnostic equipment. The closure means can be moved from a position in which both the orifices are in communication so that a specimen can be drawn into the body and the closure means orifice, then moved out of communication so that the orifice in the closed end of } the body is sealed. An o-ring seal for the orifice in 1 the closed end is positioned around the orifice in an i annular groove formed in the closed end of the body. I i The invention a-lco—inoludoe an agont for contacting the collected specimen which is placec^-dfn the V closure member and brought into communication with the specimen that has been collected whteii the closure means j has been moved to place the^fetfo orifices out of communication i and bring the agent ijrZo communication with the orifice in the closed en^&f the body after the device is removed ; from Uj^specimen source. This precludes any possibility gr Gpooimon with an agent being injected—into a patient:. / / Thoro alGO—ic includod.a novol plungor having / / a.ipyvotal1 vortical member on tho ctom of—fcho plungor whicb. / 198131 ongagae the opon and of a body mcimbor of any—fcype oyyiage aftar a specimen has boon drawn into fcho body mombois The wall sections of the body member and the closure means can be of specially selected materials in a thickness to provide maximum protection from any possible oxygen gas permeation while the device is exposed to ambient conditions. 198181 The embodiments of the device of the present invention provide: Devices of practical design and structure for the reasonable cost manufacture and assembly required of a disposable syringe.

Syringes with a sealing means useful not only in collecting fluid specimens but also useful as pre-filled devices for dispensing fluids of medical or non-medical nature.

Syringes having self-contained specimen agents for application to the specimen.

Syringes having self-contained specimen agents and providing protection to the patient or specimen source from cross-contamination with the self-contained specimen agent by preventing mixing of the specimen and the specimen agent until the syringe has been removed from communication with the specimen source.

A syringe having self-contained specimen agents and a plunger with graduated protective check-stops to minimize chances of patient or specimen source being reinjected with fluid that has already come in contact with the specimen agents. This novel plunger also provides volume indices. 198131 Syringes having connector fittings compatible with what are commonly called "luer" fittings but not necessarily limited to such. It will be recognized that such a fitting could be used directly as the dispensing nozzle without additional nozzle means.

.. Qe " n o ) O \ ^ V h— ui i O ol */] jf Brief Description of the Drawings The present invention is shown by way of illustration in the following drawing figures in which FIG. 1 is an exploded perspective view of one 5 embodiment of the present invention.

FIG. 2 is a partial cross-sectional view in elevation of the embodiment shown in FIG. 1 showing a specimen being collected.

FIG. 3 is an elevation view along the 10 section plane 3-3 in FIG. 2.

FIG. 4 is a cross-sectional view along section plane 4-4 in FIG. 2.

FIG. 5 is a partial cross-sectional view in elevation of the embodiment shown in FIG. 2 after 15 the specimen has been collected.

FIG. 6 is an end view in elevation of the embodiment shown in FIG. 5.

FIG. 7 is an elevation view in cross-section of a modification of a portion of the embodiment shown 20 in FIG. 2 in the specimen collecting position.

FIG. 8 is an elevation view of the left end of the embodiment shown in FIG. 7.

FIG. 9 is a partial elevation view in cross-section of an additional embodiment of the invention 25 disclosed in FIG. 2.

FIG. 10 is an elevation view in partial £.] section of another embodiment of the invention as shown in DB. 2. 198181 FIG. 11 is an exploded perspective view of another embodiment of the invention as seen in FIG. 2.

I n A98131 FIG. 12 is an elevation view in partial section of the embodiment in FIG. 10 when the invention is in the specimen collecting position.

FIG. 13 is a right end view in elevation of the embodiment seen in FIG. 11.

FIG. 14 is an elevation view in partial section of the embodiment shown in FIG. 12 after the specimen has been collected.

FIG. 15 is an elevation view of the right end of the embodiment in FIG. 14.

FIG. 16 is a further embodiment of the invention as can be seen in FIGS. 11-15.

FIG. 17 is an elevation view of the embodiment shown in FIG. 12 in the specimen collecting position.

FIG. 18 is an elevation view of the embodiment seen in FIG. 17 after the specimen has been collected.

FIGS. 19-21 are elevation views in partial cross-section showing variations in the sealing means between the cap and closure body of the embodiment of the invention seen in FIGS. 11-18.

FIG. 22 is a perspective view of a novel plunger for use with the present invention.

FIG. 23 is an elevation view in partial cross-section showing the invention of FIG. 22 employed in the embodiment seen in FIGS. 2-9.

FIG. 24 is an exploded perspective view of e end portion of an additional embodiment of the rnvention.

FIG. 25 is an elevation view of the right end of the embodiment shown in FIG. 24 in an assembled position. 198131 FIGS. 26-27 are exploded perspective and end views of another embodiment.

FIGS. 28-30 are exploded perspective and sectional views of a further embodiment.

Figure 31 is a sectional view of another embodiment of the cap which may be employed with the present invention.

Figure 32 is an end view in elevation of the cap employed in the present invention as shown in Figures 11-18.

Figure 33 is a partial cross-section of another embodiment of the present invention.

Figure 34 is a partial cross-section of another embodiment of the invention as shown in Figure 33.

Figure 35 is a partial cross-section of another embodiment of the present invention.

Figure 36 is yet another embodiment of the present invention.

Figure 37 is a further embodiment of the present invention.

I ... *1 198131 Detailed Description of the Inventic Referring now to Figure 1, the invention is seen to comprise a generally well-known type of syringe having a hollow cylidrical body 11 open at one end to receive a plunger 24 and having a substantially closed end 12 opposite the open end. The closed end 12 has an orifice 13 around which there is an annular recess 14 to receive an 0-ring 15. Adjacent the closed end 12 is an annular recess 16 which receives an internal inwardly extending bead 17 in a cap 18. It will be apparent that other concepts of movably retaining the closure on the closed end such as threads, bayonet mount and the like may be employed. The cap 18 has an open end to be fitted over the body 11. The cap also has a closed end 19 from which there extends a cannula receiving member 20 having an orifice 21 therethrough. The cannula receiving member 20, hereinafter referred to as a nipple, is of a configuration which will receive a cannula of the conventional type and also will receive adaptors, known in the medical art, which will permit the use of a single venal puncture by cannula and the successive application of the syringes of the present invention for the purposes of taking a plurality of samples. These adaptors are normally configured with means therein to permit closure thereof after a sample has been taken so as to prevent exodus of any body fluid due to the pressure of the fluid within the human body. Fitted into hollow body member 11 is a plunger 24 of the type which is well known in the medical arts. Generally, it is configured with a plunger tip having a concial end surface 25 although the end surface may be 198131 flat 26 as shown in Figure 10. The plunger tip is positioned on one end of a stem shown to consist of a pair of longitudinal members 27 and 28 arranged at right angles to each other along the axis of the plunger and along which are a plurality of circular disks 29. The plunger stem terminates in a thumb ring (not shown) or finger plate 30 opposite the plunger tip. In addition to the end surface 25 or 26, the plunger tip includes at least one annular ring 31 generally of a resilient material, which provides a sealing relationship with the interior wall of the hollow body member 11 to insure that the movement of the plunger 24 would not result in any fluid medium escaping by the plunger These annular rings may be considered seals.

Referring now to Figure 2, there is a showing of one embodiment of the invention extracting a specimen. The plunger 24 has been partially withdrawn within the hollow body member 11 to collect the fluid specimen 33 which has come from a specimen source 34 via a conventional type cannula 35. In this figure it will be noted that the 0-ring 15 forms a seal with the inner surface 36 of the cap 18, thus insuring that the fluid specimen enters only the interior of the hollow body member 11.

The cross-sectional view of Figure 4 of the plunger 24 principally illustrates that the right angle position of the members 27 and 28 not only provides resistance to vertical and lateral flexing of the plunger, but the outer surfaces of these members also serve to provide bearing or guide surfaces for the plunger so that it is not displaced from its central axis sufficiently to destroy the vacuum created by the inner sealing members 3 198131 Referring now to Figure 5, it will be seen that the cap 18 has been rotated through a given number of degrees in accordance with the length of the slot 22 in cap 18 as controlled by the stop member 23 on the outer surface of hollow body member 11 (see FIG. 11). This means for orienting the cap relation to the hollow member is configured so that the slot 22 permits movement of the cap 18 from the specimen collecting position shown in Figure 2 to the position shown in Figure 4 by a clockwise rotation of the body member 11 with respect to cap 18 when cap 18 is held. By such rotation, the portion of the inner surface 36 of cap 18 which does not contain the orifice 21 is placed over the passageway 13 in hollow body member 11, thus sealing it effectively. Other external and/or internal means may be substituted to indicate the orientation of the cap relation to the hollow member.

Figure 7 shows substantially the embodiment seen in Figure 2 with the exception that in the inner surface of closed end 12 of the hollow body member 11 there is a recess 37, shown in Figure 7 to be circular, but which may have a rectilinear form into which is placed a substance 38 which is considered generally as an agept which reacts with the specimen being collected to maintain it or react with the fluid to develop a culture of the specimen or to react with the specimen to identify various substances in the specimen. The agent may be in the form of a liquid, solid, or a semi-solid such as a firm gel and can be of a composition well known in the art.

In Figure 9 there is seen a modification of the embodiment of the invention shown in Figure 7 in that the agent 39 has been formed as a layer on the interior surface of the end wall 12 of the hollow body member.

TV- 19313! Referring now to Figure 10, there is seen another variation of the embodiment of the invention shown in Figure 7 in that the interior wall of the closed end 12 of the hollow body member 11 now has a flat surface and the passageway 13 now extends through an inwardly extending tubular member 40 to form an annular recess in which the agent 41 is placed. In this embodiment, it will be noted that the end surface 26 of the plunger 24 has a flat surface which matches the interior surface of the closed end 12..

Referring now to Figure 11, there will be seen an embodiment of the invention which is shown in Figure 1, with the exception of the presence of a plunger 24 which could be substantially the same as that shown in Figure 1.

In this instance, the hollow body member 11 has the closed end 12 but differs from the embodiment shown in Figure 1 in that in place of the annular recess 14 in Figure 1 there is shown an orifice protrusion 4 2 which provides an orifice 43 of a substantially larger diameter than orifice 13 as seen in Figure 1, and the purpose of which will be subsequently explained. In lieu of the 0-ring 15 shown in Figure 1 there is now provided a sealing disk 44 having an aperture 4 5 which is in engagement with the outer surface of the annular protrusion 4 2 to prevent rotation of the disk when the cap is rotated. The cap 4 6 in Figure 10 has substantially the same overall configuration as the cap 18 in Figure 1 with a nipple 20 and an orifice 21 therethrough.

It will be noted that body member 11 has an annular bead 47 adjacent end 12 which is received in an annular recess 4 8 on the interior of cap 46. The interior surface of end wall 49 of closure 46 contains a recess 50 198131 to retain an agent 37 which may generally be in tablet or pellet but could be a gel or paste. The agent will normally begin to dissolve and blend into the collected specimen. The thickness of the tablet or pellet may require a depth of recess which would not provide adequate wall thickness. In such cases, the outer surface of cap 4 6 may be extended as shown in phantom at 51- It will be seen in Figure 12 that the agent is sealed from the specimen until such time as the cap 46 is rotated in a manner as previously described so that the agent 37 is now placed over the orifice 43, and as seen in Figure 14, it can then come in contact with the specimen 33 which has been collected within the device.

The embodiment of the invention as shown in Figures 11-15 indicates the presence of a recess and extension 51 to accommodate an agent in the cap 46. In Figure 16, it will be seen that the cap 4 6 now has two recesses with extensions 52 and 53, each of which could contain a different agent. It will be apparent to those of skill in the art that a third, and possibly a fourth, recess could be formed on the cap for receipt of a third or fourth agent. In this particular modification of the embodiment seen in Figures 11-15, it is evident that appropriate indices would be placed on the cap 4 6 and the hollow body member 11 so that each agent could in turn, or as desired, be placed in contact with the collected specimen.

Figures 17 and 18 show the positive indication of the positioning of the cap from an open position to a closed position by means of the slot 22 formed therein which is in contact with the stop member 23.

Referring now to Figure 19, there will be seen a modification of the means to seal the orifice 4 3 and the cap in that in place of the sealing disk 44, in Figures 11-14 or the O-ring 15 in Figures 1-10 there is an annular groove 54 formed in the end 12 of the hollow body member 11 which has a surface 55 which makes contact with the interior surface of the cap 46. Thus, the agent is sealed from the specimen at the time of withdrawal of the specimen into the body member and as would be apparent, • the orifice 21 in the nipple 20 would be equally closed off when the cap 4 6 has been rotated about the hollow body member.

Figure 20 is yet another modification of the means for sealing the orifice 4 3 from the agent in that an annular bead 56 is formed integrally on the inner surface of cap 4 6 around orifice 43 and, similarly, an annular bead 57 is formed around the recess 50 in cap 4 6 to protect the agent 37 Figure 21 is a modification of the sealing embodiment shown in Figure 20 in that an annular recess 58 is formed around the orifice 21 and nipple 20 and an O-ring 59 is inserted therein. Similarly, an additional annular recess 60 is formed in the interior surface of the cap 4 6 and encompassing the recess 49 for the agent 37, and an O-ring 61 is inserted in this recess. This particular embodiment might be considered most suitable for uses in which the agent 37 was in a more fluid state or had a need to be maintained in a sealed state.

Figures 22 and 23 show a novel plunger which selectively may be incorporated with the hollow body chamber of the various embodiments of the present invention, or which may be used with other hollow body members unrelated to the 198131 present invention. A novel plunger 62 resembles to a great extend the plunger 24 shown in Figure 1 in that it has a plunger tip having a tapered inner face 63 which contacts the matching tapered interior of a body chamber just as surface 25 in Figure 1. It is provided with at least one annular resilient bead 54 providing sealing with an inner wall of a body chamber. It is also provided at the end opposite the tapered surface 63 with a gripping disk 30.

Lying between the gripping disk 30 and the sealing ring 64 is a horizontal member 6 5 serving the same purpose as surface 28 in Figure 1. Perpendicular to surface 63 is a vertical surface 66 which provides stability in the plunger against flexing. A plurality of disks 29 are provided as bearing surfaces for the plunger during its travel within a hollow body chamber. A semi-circular disk 67 is interposed on member 66 between the two disks 29. A short vertical member 68 is inserted between the sealing ring 64 and the first circular disk 29. Interposed between the two circular disks 29 is a vertically-pivotal member 69 which has a hinging action at its juncture with disk 29 to allow the member 69 to be depressed toward the horizontal member 6 5 for insertion of the plunger into a hollow body chamber. A plurality of notches or stepped surfaces 71 are provided on the outer surface of the member 69. The purpose of the notched surfaces is to provide a means on the plunger whereby after it has been withdrawn, thus drawing a specimen into the chamber/ the notch will engage the outer ring 7 2 of the body chamber 11 and will hold the plunger against being pushed back towards the closed end of the chamber thus expelling the fluid. To permit the plunger to be 198131 pushed(downjinto the hollow chamber, it would be necessary to depress member 69 towards horizontal member 65, thus disengaging the stepped surface 71 from contact with the holding ring 72. The stepped surfaces 71 may also have a length which by calibration would be an indication of a volume of specimen which has been withdrawn into the hollow body chamber.

Figure 24 discloses another embodiment of a closure means for the present invention in which the hollow body member 73 is formed with a closed end surface 74 which has a diametral slot 7 5 formed therein, the bottom surface of the slot 7 5 being undercut as seen at 76 with respect to the outer surface 74. The slot 75 has orifice 77 communicating with the interior of the chamber 73. Surrounding the orifice is an annular recess 78 into which is inserted an O-ring 79. The closure for the outer chamber in this embodiment comprises basically a plate valve 80 having a protruding nipple 81 to receive a cannula or to be connected to an adaptor which permits multiple sample taking. The nipple has an orifice 8 2 which communicates with orifice 77 in chamber 73 when the plate valve 80 is in the open position. The inner surface of plate valve 80 may contain at least one cylindrical recess on its inner surface formed in the inner surface of the plate valve for the receipt of an agent. It will be noted that the longitudinal surfaces 84 of the valve have a bevel so that the bevelled edges 84 mate with the undercuts 76 in the slot 75.

In Figure 25, the embodiment shown in Figure 24 has been assembled with the plate valve 80 inserted into 198131 the slot 7 5, and the nipple 81 in alignment with the orifice 77. The dotted lines show the position of the plate 80 when it has been moved into a closed position after the specimen has been drawn into the chamber 73.

Figure 26 discloses yet another embodiment of a closure means for the present invention in which a hollow body member 90 is formed with a closed end surface 91 which has a peripheral groove 92 formed therein which mates with an annular protrusion (not shown) on the inner surface of wall 9 3 of cap 94. 10 It will be understood that the groove and protrusion may be interchanged. The end surface 91 has an orifice 95 communicating with the interior of the chamber 90. Surrounding the orifice is an annular recess 96 into which is inserted an O-ring 97. The closure for the orifice 95 in this embodiment comprises the 15 cap 94 and a slidable plate valve 98. The cap 94 has a fitting 99 extending outwardly from surface 9 3a to receive compatible specimen taking medical devices. The fitting 99 has an orifice 100 which communicates with orifice 95 by way of orifice 101 in plate valve 98 when the plate valve is in the open position. The inner surface of plate valve 80 may contain at least one cylindrical recess 102 on its inner surface formed in the inner surface of the plate valve for the receipt of an agent. It will be noted that the wall 93 and end 93a of the cap have slots 103 formed at their juncture to receive valve 98. A stop 104 is 25 on one end of valve 98.

In Figure 27, the embodiment shown in Figure 26 has been assembled with the plate valve 98 inserted into slots 103 *"1 with the orifices 100, 101 and 95 in alignment. The dotted lines in this figure show the position of valve 98 when it has been 198131 moved to the position closing off communication between orifice 95 and orifice 100. In the event an agent has been placed in recess 102, the closing off of communication between orifices 95 and 100 positions the recess over orifice 95 for intermingling of the agent and the fluid which has been drawn into body member 90.

Figures 28-30 disclose a different means for closing the aperture 95 in body 90 of the device shown in Figures 26-27, the concept of functioning of the closure device being substantially identical. In Figure 28, the body member 90 has secured to the end wall 91 a cap 105 fitted over the orifice 95 in wall 91. The orifice 95, as seen in Figure 29, is surrounded by an annular recess 96 into which is inserted O-ring 97. The cap as seen in Fig. 29, is attached to body 90 by means of an annular ring 106 on the inner surface of the cap 105 which snaps into a recess 10 7 adjacent the end wall 91 of body 90. Extending outwardly from the cap 105 is a cylindrical sleeve 108 having therein an aperture 109 which is coaxial at all times with the aperture 95 in body member 90. The sleeve 108 has a fitting 110 extending outwardly and coaxially to receive compatible specimen taking medical devices. The cylindrical sleeve 108 contains a transverse aperture 111 into which there is rotatably inserted a cylindrical plug 112 having an aperture 113 which is in coaxial relationship with apertures 95 and 109. The plug 112 contains at least one recess 114 to receive an agent.

Other embodiments for closing the aperture 95 in body 90, such as a pivotal outwardly extending fitting, may be employed within the scope of the invention as set forth in the following claims. 1OQ'71 i , C i J . oo cr> <s> —30 Referring now to Figure 31, the cap 120 differs from caps previously disclosed in this invention in that the cap has a removable nipple 122 which is inserted into a sleeve 121 formed on the forward and the outward face of cap 120. The nipple is of a truncated, conical configuration in its outer portion and has an inner portion 124 of reduced diameter which fits into the opening 125 in the sleeve 121. A cap such as this might find application in industrial use wherein the contents of the body might tend to solidify upon exposure to air, as in the case of some of the exotic adhesives. With this removable nipple 122, the contents could be continually dispensed merely by replacing the nipple. It is also considered of a possible use to provide a flexible tube 126 which can be inserted into the opening in the nipple.

In Figure 32, there is shown a slight modification of the cap previously disclosed in Figures 13 and 15 in that there is a single repository 12 9 for insertion of an agent as described with reference to Figure 11-18. The repository 129 is directly opposed to the nipple 128 as seen in Figures 13 and 15. With the offset of repository 129 as shown in Figure 32, the cap can be rotated from the position shown in Figure 32 with the nipple at the twelve o'clock position to a position where the repository 129 is at the twelve o'clock position and then the cap may be again rotated either clockwise or counterclockwise to a position indicated as 130 which would be at the twelve o'clock position. Such a cap would provide for positioning the repository 129 over the orifice in the corresponding body to allow- the agent to enter into contact with the contents of the body and then by rotating o 198131 the cap until the position 130 was at the twelve o'clock position, the device would remain sealed with the agent in active contact with the contents of the body.

Figure 33 illustrates an embodiment of the present invention wherein filtering means are provided within the cap. As seen in the Figure, the body of the device 131 has a cap 132 which may be considered as a two-part cap. The base portion of the cap 133 has a recess in its outer surface which may be filled with a filtering material or as illustrated in the drawing, a filter screen 136 may be placed there. The outer portion of the cap 134 would then be secured to the base portion 133 and the nipple 135 being present to receive the lower fitting from the hypodermic needle.

Figure 34 has a modification of the filtering concept shown in Figure 3 3 in that the filtering material 139 is placed in the recess 138 in the forward face 137 of the body member.

Figure 35 illustrates an embodiment of the present invention wherein the previously described plungers 24 are not inserted within the body of the device. As seen in this figure, the body of the device 140 has a cylindrical wall 141 of a thin, flexible material terminating in a base portion 142 of more rigid characteristics. In Figure 35, the end portion 142 has been pushed into the interior of the body 140 by folding the thin walls 141 back over themselves to create what is referred to in the art as a "rolling seal". The end portion 14 3 of the body of the device is a thickened wall to provide the necessary bearing surface for the cap 145. The cap has the previously-identified sealing means 146 MSI 31 surrounding the orifice in that end of the body cap was also provided with the nipple 147 to receive the lure.

Figure 36 discloses a modification of Figure 35 in that the body 148 of the device has a flexible wall which is joined together at one end in a pinched sealing relationship. The contents are dispensed from the cap 151 by squeezing the walls 149 in a manner similar to discharge of adhesives from conventional adhesive tubes having a • screw top or similar capping means. The cap 151 has the conventional sealing means 152 around the orifice in the body and a dispensing element 15 3. It will be noted that the end of the body 148 opposite the pinched end has a thickened wall similar to that shown in Figure 35.

Figure 37 is another embodiment employing a "squeeze bottle" concept for a body. In this embodiment, the bottle member 154 has a cylindrical wall and bottom of generally uniform thickness, but of a flexible nature so that the bottle may be compressed much as in the case of the familiar containers for items such as mustard and ketchup. The cap 156 is generally conventional with respect to the other embodiments shown in this invention and the device has the previously-disclosed sealing means 157. A dispensing element 158 is disposed on the outer surface of the cap 156.

The embodiments in Figures 31, 35, 36, and 37 appear to be very useful for industrial or other applications such as the dispensing of condiments, adhesives, lubricants, and the like.

It also should be understood that the nipple fitting provided on the caps disclosed in the present invention 198131 which are intended to receive the lure of hypodermic needles may also be formed with the needle integrally molded in the nipple, thus eliminating the need for separate needles.

The foregoing is a description of various embodiments of the present invention which are given here by way of examples only. The invention is not to be taken as limited to any one of the specific embodiments as described, but comprehends all such variations of the described embodiments as come within the scope of the following claims.

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Claims (7)

WHAT WE CLAIM IS:

1. A diagnostic specimen collector comprising: an elongated hollow body open at one end and closeci at its 5 opposite end ana having a single orifice in the closed end; a plunger having sealing means on an end portion thereof which is slidably inserted into, ana in sealing relationship with, the said body to vary the interior volume of the said body; O 10 a closure for the said orifice consisting of a one-piece cap having an end wall with a skirt extension exteriorly mounted to encompass the closed end of the said body concentrically and rotatably thereabout, a nipple shaped to receive compatible fittings of specimen taking medical devices 15 extending outwardly ot the cap from the end wall ot the cap, and an orifice in the closure passing axially through the nipple anc the end wall of the cap, the closure being rotatable trow a first position in which the orifices are not in communication with each other and the orifice in the closed eno 20 of the said body is in a sealed condition to a second position in which both orifices are in sealed communication for passage ot a specimen upon movement of the plunger and back to the first position after passage of such specimen; . . ana an O-ring seal for the orifice in the closed end of the 25 saia body, the O-ring being positionea concentrically relative -25- A 198131. to such orifice in an annular groove formed in an outer surface of the closed end of the said body, a portion of the O-ring extending above such surface to create a friction-free space between such surface and an inner surface of the end wall of the cap except for a moving area of sealing contact between the said portion of the O-ring and the inner surface of the end wall of the cap, the said portion of the O-ring providing a bearing surface for rotation of the closure relative to the closed end of the said body.

2. The collector according to claim 1 wherein a filter is disposed in the path of specimen passing into the said body through the orifices.

3. The collector according to claim 2 wnerein a filter is disposed in the orifice in the closed end -sf the said body.

4. The collector according to claim 3 wherein the filter is disposed in a widened portion of such orifice which opens onto the outer surface of the end wall of the said body.

5. The collector according to any preceding claim wherein the closure is engaged with the said body by a co-operating annular recess and bead arranged on an outer surface of an end portion of the said body adjacent to the closed end thereof and on an i « - 198131 ' inner surface of the skirt respectively.

6. A diagnostic specimen collector according to claim 1, substantially as herein described with reference to Figures 1 to 6 of the accompanying drawings.

7. A diagnostic specimen collector according to claim 1, substantially as herein described with reference to Figure 34 of the accompanying drawings. Patent Attorneys for the Applicant(s).