US 3162195 A
Description (OCR text may contain errors)
Dec. 22, 1964 P. DICK 3,162,195
VACUATED BODY FLUID COLLECTION VIAL 4 Filed Jan. 2. 1962 Fl G 2 INVENTDC|).K
PETER United States Patent Ofitice 3,162,195 Patented Dec. 22., 1964 3,162,195 VACUATED BODY FLUID COLLECTION VHAL Peter Dick, 225 W. 232nd St., Bronx, N.Y. Filed Jan. 2, 1962, Ser. No. 164,227 3 Claims. (Cl. 128-276) This invention relates to a new and useful device for the withdrawal of body fluids from human beings or other animals. The invention more particularly relates to a new device by means of which blood may be withdrawn into an evacuated container through a hollow needle and a unique valve mechanism.
For analytical purposes, blood must frequently be withdrawn from the vein of a patient, into a suitable container, which is subsequently submitted to an analytical laboratory. Various devices have been used for this purpose, from a simple hypodermic needle, or syringe, to evacuated containers using a double ended needle. In the latter type of device, one end of the needle was inserted into the vein of the patient, while the other end was forced through a rubber plug afiixed into an evacuated container. The puncturing of the rubber plug while the needle was inserted in the arm of the patient was awkward and inconvenient, while the piercing of a rubber plug by a hollow needle sometimes resulted in the coring of the needle. Furthermore, no means was provided to start and stop the flow of the blood after the penetration of the needle into the evacuated container, thus making reinsertion of the needle into a different site impractical. Attempts to introduce a standard valve into the evacuated container resulted in a complex, expensive assembly, whose numerous parts made it difiicult to maintain the vacuum essential for protracted shelf life of the unit.
The principal object of this invention is to provide the medical operator with one integral, preassembled, disposable, sterile, evacuated unit, equipped with a simple efficient valve, ready for immediate use, without further preparation. Another object of this invention is to provide the medical operator with a means of stopping and starting the flow of blood, at will, without losing the vacuum in the system.
A further object of this invention is to provide the medi cal analyst with a sealed unit whose seal may be easily removed by the operator, but which will not come off accidentally after restoppering.
Other objects of the invention will become apparent from the following description of one practical embodiment thereof, when taken in conjunction with the drawings which accompany, and form a part of, this specification.
In the drawing:
FIGURE 1 is a side elevation of the collection unit embodying the principles of the present invention.
FIGURE 2 is a top plan view of the collection vial.
FIGURE 3 is a vertical section through the needle, with the details of the actuator, the seal, and valve mechanism, shown on an enlarged scale and taken on the line 33 of FIGURE 1.
In general, the invention comprises a container, previously evacuated and sealed with a prepunctured rubber stopper, containing a hollow needle. The extreme outer end of the needle is sealed by a solid rubber plug, which is integral to a rubber sheath which covers the entire length of the needle and could be used to protect the sterility of the needle. The inner end of the needle projects into the evacuated container and is hermetically sealed. Adjacent to the inner end of the needle, and sealed within the prepunctured rubber stopper is a perforation in the needle, which acts as a valve.
Referring to the drawing in detail, a vial is shown as a glass tube 3 with a flat bottom, and a recessed lip at the top. Tube 3 is shown inserted into a transparent actuator 1, which is shown flanged at the bottom 4, to provide a finger grip for the operator. The top end of tube 3 is provided with a sleeve type rubber plug or closure 11 which, as shown, overlaps the tube and forms an external seal. Plug 11 is prepunctured with a centrally located hole, of a diameter which is smaller than that of the needle, and is prelubricated with any suitable lubricant to permit easy movement of the needle within the plug.
Needle 13 is closed at the lower end 14, and has a lateral perforation at 12 adjacent end 14. The needle is preassembled in such a way that the sealed end 14 projects into the tube 3, but the perforation 12 remains within the plug, thus forming the primary valve seal. The upper end of the needle 6 is sealed into the upper portion of the sheath 2 which has a solid rubber tip 5 integral with the sheath. This forms the secondary seal.
The needle is affixed to an anchor 8- in any suitable manner, such as for example with an epoxy cement, or by means of a force fit. The shoulder 7 of anchor 8 acts as a third seal, and also protects the sterility of the needle. Anchor 8 is undercut at 15 to receive actuator 1, if anchor 8 is not molded as an integral part of the actuator.
When it is desired to use the unit, sheath 2 is removed by pulling up at 5. The needle will be sterile since it has been protected up to that point by the hermetic seal at 7 and at 6.
The needle is then inserted into the vein of the patient in a conventional manner, while the operator grasps the unit by the actuator 1. The operator may then ascertain whether the vein has been properly entered by gently squeezing the tube 3 against the actuator flange 4, in a manner used to operate a hypodermic syringe.
Rubber plug 11 on tube 3 is compressed and moves up on the lower end of the needle until lateral perforation 12 is no longer sealed inside the plug, but is exposed to vacuum in the tube 3. If proper entry into the vein has been achieved, the blood being under higher pressure than the pressure in the tube (which may be held to less than one pound absolute) will commence to flow into tube 3. Absence of a proper flow is indicative of an improper entry intov the vein. The operator may then maintain the integrity of the vacuum by merely releasing the pressure on the tube. The resiliency of plug 11, plus the tapered lower end of the anchor at 16, act as an automatic spring and retract the lateral perforation 12 into plug 11 thus sealing oif the vacuum from the outside environment The needle may then be retracted and reinserted at another site, or in the other arm of the patient, without any danger of losing the vacuum.
Should it be necessary to draw blood from the patient into more than one tube, the full tube may be removed from the actuator, and another empty tube inserted. This may be accomplished while the actuator and needle are not removed.
The entire device, including the valve mechanism consists of only 5 components, each simple, inexpensive and easy to fabricate. The device is adapted to have but a single use, and is therefore disposable. Use of a plastic material, such as polypropylene, will make it possible to sterilize the entire package by steam under pressure, which is the most eflicient type of sterilization procedure used in the laboratory. At the same time, molding actuator 1 an anchor 8 out of polypropylene, in one piece, will permit 21 very cheap manufacture of the package.
It will be readily apparent that the collection vial will be simpler, more convenient and more economical to use, with a valved actuator containing the sterile needle in place and ready to use when purchased. The sheath will form a complete seal against leakage, and will also maintain the sterility of the needle prior to use.
The new structure will simplify assembly, materially reduce the costs of component parts, and significantly reduce the overall costs of the unit, without sacrificing any of the advantages of a valved disposable unit. While in the "above one practical embodiment of the invention has been disclosed, it will be understood that the details of structure described and shown are'rnerely for the purpose of illustration, and the invention maytake other formsfwithin the scope of the appended claims;
What is claimed is: j l. A device for collection of body fluidsrcomprisinga 4 i I a in said closure and sealed thereby, an actuator slidably mounted on the outer surface of 'said' container, and having an endiadjac ent said closure, said end having an opening for passage of said needle therethrough, means anchoring said needle in said opening of said actuator, and means coupled to said last-mentioned means compressing gsaid closure in response to movement of said actuator to container having its interior under'reduced pressure and t having oneendopen, a resilient plug sealablyjseatedwithin said open end of said container and extending beyond) the outer edge ofsaid end, said plug having'an axialiopeib ing therethrough, a tubular needle having an axial bore 7 with one end closed and slidably mounted within said plug opening in airtight relation, said needle having between its ends a transverse opening communicating with said bore and disposed within said plug, said plug sealing said opening, whereby said plug and said needle form anairtight seal with said container, a cylindrical sleeve partially surrounding said container and'having one end partially closed, said partially closed end abutting said plug, and
'having an opening therethrough coaxial to said plug open ing, said needle extending throughtsaid sleeve end opene ing and projecting outwardly, and-means anchoringsaid needle to said sleeve end, said sleeve being movablewith respect to said container, said anchoring means ,com-t pressing said plug in response to a closing force applied to said sleeve and said container and projecting said transverse opening of said needle into the interior of said container and in communication withtsaid reduced pressure therein, said plug returning to its original position in response to release of said closing force andurging said sleeve end outwardly for returning said transverse opening of saidneedle into sealed relation with said plug.
2. A device for collection of bodyfiuids comprising a said closure, and simultaneously urging said needle furtherinto said evacuated portion of said container so that container having one end open and adapted to withstand evacuation, a resilient closure sealably seated withinsaid openend of said container, said closure having an axial opening therethrough, a tubular needle having an axial bore slidably mounted within said opening of said closure and formingan airtight seal-therewith, said needle having one end closed and having between its ends a transverse opening communicating with said bore and disposed withfposition within said closure;
ward saidclosure, said needle being s'lidablymoved in said closure opening in response to said movement of said actuator toward said closure, so that said transverse fopening is projected into the interior of said container, the
'resiliency of said closure exerting a displacement force onrsaid actuator forzurging said-actuator away from said closure and return said transverselopening into sealed 3. A disposable throw-away device f or'collection of body fluids comprising a containerhavingone end open vand adapted to withstand evacuation, a resilient closure sealably seated within said open end of said container, said closure having a longitudinal uniform cylindrical opening therethrough,-'saidcontainer beingevacuated, a tubular-needle having an axial bore slidably mounted within said opening of said closure and forming an airtight seal therewith, said needle having one end closed and having between its ends a transverse opening communicating with said bore and disposed within said "closure and sealed thereby, s'aidneedle transverse opening being sealed directly by the'wallxof saidclosure opening, said closed'end'of said needle projecting beyond said closure and into said container, and means compressing said transverse opening therein communicates with the f interior of said container.
ReferencesCited in the-file ofthis patent H V UNITED STATES PATENTS 2,460,641
Germany Aug. 25, 1931