Diagnostic Specimen Collector

The present invention is in the field of medical diagnostic devices, and more particularly, in that portion of this field in which field specimens are collected for subsequent analysis in a laboratory.

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 Conventionally, fluid specimens are withdrawn from a subject by syringe, having generally a hypodermic needle attached thereto for penetration of the subject.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 various 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In some institutions, the practice has been to place a cork or stopper over the end of the needle after it is withdrawn from the subject in order to seal and protect the collected specimen, and then the syringe is carried to the laboratory.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 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.

In the recent developments in the field of collecting devices, is a syringe type device which is shown in U.S. Pat. No. 4,043,336. 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. The design of this device does not provide for the separation of the self-contained specimen agent from the fluid in the chamber of the syringe.

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 one-piece 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. Sealing means for the orifice in the closed end are positioned around the orifice between the closed end of the body and the closure means to create a friction-free space between the closed end and the inner surface of the closure.

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.

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 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.

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 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 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 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 of the invention shown in FIG. 2 in the specimen collecting position.

FIG. 8 is an elevation view of the invention shown in FIG. 2 after the specimen has been collected.

Referring now to FIG. 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 O-ring 15. Adjacent the closed end 12 is an annular recess 16 which receives an internal inwardly extending bead 17 in a one-piece 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 a skirt extension which forms an open end to be fitted over the closed end portion of the body 11 and to rotate thereabout. The cap also has a closed end 19 from which there extends outwardly 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 flat. 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 FIG. 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 O-ring 15 seated in recess 16 has a portion extending outwardly from the closed end surface 12 into contact with the inner surface 36 of closed end 19 of cap 18, the extension thus preventing contact between closed end 12 and this inner surface. This extending protion of O-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. Study of FIGS. 2 and 5 discloses that the extending portion of O-ring 15 in contact with inner surface 36 functions as a sealed bearing surface about which cap 18 rotates.

The cross-sectional view of FIG. 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 31.

Referring now to FIG. 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 (FIGS. 7 and 8). 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 FIG. 2 to the position shown in FIG. 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 relative to the hollow member.