US 3074541 A
Description (OCR text may contain errors)
Z. M. ROEHR MEDICINAL VIAL AND NEEDLE ASSEMBLY Filed Oct. 13, 1959 IIIIIIlIIIAZI/I a I Q 1 a 0 5 n n I M a Jan. 22, 1963 VIIIYIIIIIIJ Inventor zbislaw M-Roebr 15 wM,I.z-\A .Mu 8. NW
fl-l'kornefi United States Patent 33974541 MEEEEQENAL Vi'AL AND NEEDLE ASdEP/EBLY Zbisiaw M. Roehr, Be Land, Fla, assi nor, by mesne assignments, to Brunswick Corporation, a corporation of Delaware iiiied Get. 13, 1%59, Ser. N 846,115 6 Claims. (61. 266-43} The present invention relates generally to a vial-hypodeimic needle assembly, and more particularly to an improved disposable medicinal vial-hypodermic needle assembly and container therefor which maintains the sterility and prolongs the usefulness of the said assembly.
Various pre-assemblcd forms of a medicinal vial containing a medi ament and a hypodermic needle have been devised for use by the medical and dental professions. Generally, the medicinal vial comprises a length of glass tubing which is sealably closed by a pierceable stopper at one end and by a moveable plunger disposed in the other end. Generally, the medicinal vial is maintained with the pierceable stopper end thereof spaced from the hypodermic needle but is readily moveable into piercing engagement with the said needle.
In a medicinal vial-hypodermic needle assembly of the foregoing type, it is difiicult to maintmn the operating parts thereof in a sterile condition during packaging and prolonged storage periods. Another problem frequently encountered in the packaging and distribution of a vialneedle assembly is to prevent the hypodermic needle piercing the closure stopper of the vial prematurely before the assembly is operatively mounted in a hypodermic syringe, while at the same time enabling the vial to be easily moved into piercing engagement with the hypodermic needle immediately prior to administration of the medicament. It is also important in a medicinal-vial needle assembly of the foregoing type to provide the assembly with means permitting aspiration after the needle has been inserted into the patient and before injection of the medicament.
Accordingly, it is an object of the present invention to provide an improved disposable medicinal vial-hypodermic needle assembly which can be maintained in a sterile condition for prolonged periods of storage, and which meet the requirements of the medical and dental professions.
It is still another object of the present invention to provide an improved medicinal vial-hypodermic needle assembly which is less expensive and more convenient for use in a hypodermic syringe than the previously devised assemblies.
it is a further object of the present invention to provide an economical and convenient medicinal vial-needle container assembly in which the hypodermic needle thereof can be more dependably maintained out of piercing engagement with the closure stopper of the medicinal vial during storage and handling.
Other objects of the present invention will be apparent to those skilled in the art, from the following detailed description and accompanying drawing, wherein:
FIGURE 1 is a longitudinal vertical sectional view of the medicinal vial-hypodermic needle container assembly of the present invention;
FIG. 2 is an elevational view along the line 22 of FIGURE 1;
FIG. 3 is a longitudinal vertical sectional view of a modified form of medicinal via1-hypoderrnic needle container assembly;
FIG. 4 is a longitudinal vertical sectional view, partially in side elevation, of a medicinal vial-hypodermic needle hub assembly of the present invention;
FIG. 5 is an enlarged fragmentary horizontal, vertical ectional view of the hypodermic needle hub shown in FIG. 4; and
?atenteri Jan. 22, 1953 FIG. 6 is a horizontal, vertical sectional view of the medicinal vial-hypodermic needle assembly of the present invention operatively mounted in a hypodermic syringe.
With reference to the accompanying drawing, the improved medicinal vial-hypodermic needle assembly 1 of the present invention comprises a hypodermic needle unit 19 supporting in one end thereof a medicinal vial structure 11, which together form a unitary assembly adapted to be removably supported in a supporting container 12.
The hypodermic needle unit 10 comprises a vial sup porting hypodernuc needle hub member 20 having a stepped, generally cylindrical main body section 21, with preferably a stepped axial passage extending therethrough which is adapted to fixedly receive therein a double-ended hypodermic needle 23. The needle 23 has a small diameter cylindrical collar or flanged ring section 24 swedged, or otherwise fixedly secured to the needle intermediate the ends thereof to provide an injection or flesh-piercing cannula 25 at one end and a closure piercing cannula 26 at the other end. The ring section 24 is frictionally held in the axial passage of the hub body section 21 so that the needle 23 does not move axially or rotatably with respect to the body section 21. Extending forwardly from the mm'n body section 21 is an axially extending post section 27 which is adapted to removably support thereon a cannula sheath 29 having, in the preferred form, a flanged end 3% for engagement with a container wall. The hub body section 21 is also provided on the outer surface thereof with thread engageable means which is adapted to retain the hub member 29 in threadable engagement with a hypodermic syringe.
Extending from the main hub body section 21, in an axial direction oppositely from the injection cannula 25', is a sleeve section 36 symmetrically disposed about the closure piercing cannula 26 and adapted to supportably retain therein the medicinal vial 11. The sleeve section 36 has a diameter slightly smaller than the outer diameter of the vial 11 but has sufficient inherent flexibility to yieldably and slidably hold therein the vial 11. Adjacent the inner end of the sleeve section 36 and spaced axially from the transverse end Wall 37 of the hub body section 21, are a plurality of radially inwardly extending resilient projections 38, which define a vial abutting and retaining ring means. The sleeve section 36 with its inwardly extending projections 38 is preferably formed of a resilient, yieldable plastic material, such as plasticized polyvinyl chloride or polyethylene. The sleeve 35 preferably extends substantially beyond the end of the closure piercing stopper 26 to enclose a substantial portion of the said vial 11, thereby providin" a bacterial seal therebetween to maintain the sterility of the closure piercing cannula 26 and associated parts.
The medicinal vial 11 which is supported in the sleeve section 36 of the hub member 26 consists in general (FIG. 6) of a cylindrical member 44}, such as a section of glass tubing, preferably having a restricted end section. The cylindrical member 40 has the end opposite the restricted section 41 closed by a sealing plunger 42 reciprocably mounted therein. The cylindrical member 40 is sealed at the forwardly end by means of a pierceable closure assembly which comprises a stopper 44 composed of a resilient elastomeric material, such as rubber, having a diameter sufficient to engage the periphery of the reduced diameter end section 41 and a retaining metal cap member 45 which has the lateral wall thereof crimped around the end section 41 and compresses the stopper against the end section 41 to form a sealing engagement therewith and leaving a reduced diameter transverse ring section 46 spaced axially from the end of the cap 45. The cap member 45 is preferably provided with an axial opening 46 through which the closure piercing cannula 26 3 passes when the vial 1 1 is moved into operative engagement therewith.
"The medicinal vial 11 is normally held within the sleeve 7 section 36 with the closure assembly 43 maintained spaced longitudinally from the closure piercing cannula 2.6. The latter spaced relationship is effected by so arranging and proportioning the sleeve 36 and the projections 38 that the vial 11 when inserted into the sleeve section 36 with the cap member 45 on the forwardly end; thereof. will abut the oroiections 38 before the cap member 45 contacts the end of the closure piercing cannula 26 and will be restrained against further axial movement until a substantially greater axial force is applied thereto. While the vial 11 and needle unit 10 are normally frictionally held in the foregoing spaced assembled position, it is preferred-to provide locking means for positively maintaining vial 11 and needle uni-t 10 int-he latter spaced assembledposition so that there is no likelihood of the vial beingseparatedfrom the sleeve section 36'. Thus, a. short length of pressure-sensitive tape 56 is preferablyplaced along the entire length of the line defining the juncture between the outer end of sleeve 36 and the lateral surface of vial 11. An end tab 51 is provided to facilitate removal of the tape 50. The tape 50, in addition to. preventing relative movement between the vial 11- and the sleeve 36, also positively prevents bacterial contamination entering the, sleeve 36.
The medicinalvial-needle 11 'otthe, present invention is adapted to being removably; supported by a container structure 12, preferably.made.from a relatively yieldable plastic material such as polyethylene, so as to avoid having any axial pressure applied to the vial 11 forcing the vial into closure piercing engagementwith the cannula 26 and causing the cannula 26 to enter the interior of vial 11. Thus, in the 'form shown in FIGURE 1 of the drawing, there is provided a cylindrical container body section 60 having suificient strength to protect the 'vial 11 against being crushed, and provided with an end wall 61 having an a'x'ial passage extending thereth-rough. The opposite end-of the body section 60 has an unrestricted opening which permits the vial-needle assembly 1. being inserted therein. The inner diameter of the container body section 60 is substantially the same as-the external diameter of the sleevesection 36, whereby the sleeve 36 is. frictionally and resiliently heldv inthe body section-60 when the assembly 1 is inserted therein. The axial passage in the end wall 61 is'so proportioned that it permits insertion therein of the cannula sheath 29 until the cannula sheath 29' projects substantially beyond theend wall 61 and so that the flanged end 30 of the sheath 29 is frictionally engaged by the end wall 61 and is securely held within the'axial passage. A- closure cap 65 is mounted'over the open end of the body sect-ion 61 into abutment with a peripheral flange 66, thus completing the container structure. The cap 65 and flange 66 are so proportioned and disposed that the cap does not forcethe vial 11 into piercing engagement with the cannula 26 which would effect entry thereof into the interior of the vial 11. When the vial-needle assembly 1 is thus, positioned in the container body section 60 with the sheath 29 frictionally engaged by the endwall 61 and the sleeve 36 frictionally engaged -by the'inner wall surface of the container body section 60, the vial-needle assembly 1 is disposed entirely within the body section 60 and securely held within the body section 69, thereby providing a safe and efiective protective container for the said assembly. 1 when the end cap section 65'is fitted over the open end of the body section 60.
"ln'the modified form of the container assembly shown in FIG; 3 of'the drawing, the medicinal vial-hypodermic needle assembly comprises a vial 11 slidably mounted in the sleeve36 of the needle hub body section 21 which'is provided'with a slightly modified sheath member 70 removably mounted in: the: end oftheneedle hub; body section 21. The sheath 70 is provided with an end flanged section 71 and an enlarged transverse section 72 spaced axially a short distance outwardly from the end flanged section 71. The sheath section 70 of the said vial-needle assembly is adapted to be inserted into the cap member 73 until the flanged section 71 frictionally engages the. inner surface of the transverse end Wall 74 of the cap meme. ber 73. When so disposed, the sheath 71 is restrained against axial inwardly movement relative to the said cap member 73 by the enlarged section 72 frictionally engag ing the outer surface of the end wall 74. The vial-needle assembly is thus restrained against being accidentally separated from the cap member 73, or being moved in= wardly toward the left by accidental contactbeing made with the sheath 70. The vial-needle assembly is then inserted into position within the container body section 76 by mounting the cap member 73 on the end of the container body section 76..
Whenthe medicinal vial-needle assembly '1 is to be used, theassembly is removed from the supporting con: tainer structure described herein withoutremoving the protective sheath from the hubsection'. The vial-needle assembly is then mounted in, a standard Tubex type syringe80, as shown in FIG. 6, wherein the vial-needle.
assembly is inserted into the tubular barrel section 81 of the syringe which is-provided with the usual longitudinal lateralopenings while the pivotally mountedhead section. 83 is movedto one side. The vial-needle as: sembly 1 is. threadably engaged with the internally threaded section at the lower end of the syringe barrel 81 by rotatingthe vial-needle assembly until the thread engageable means 35 of the hubbody section 21 operatively engage the threaded section 85. The. plunger rod 84 mounted in the head section 33 and having a thumb-rest-piece sfi at the outer end/thereof is then op= eratively. engaged at its inner end with the plunger 42 of the vial 11. The plunger 42 is preferably provided with threadable means for engagement with the piston rod 8r4 to permit inwardly and outwardly movement of the plunger 4-2, whereby aspiration can be performed after the injection cannula 25isinserted' into the patient and before injection of the medicament. Before'aspiration or rnsertion of the said cannula 25 into the patient, the vial 11 1s fully seated by moving the vial forwardlyv in the sleeve 36 until the closure piercing cannula 26 pierces the stopper 44 to efiect communication with theinterior of the vial 11 and the end of the closure assembly abuts theend wall 37, whereuponthe vial '11 is locked in the sleeve 36. The locking action between the vial 11 and the sleeve 36 1s effected when the vial 11 is fully seated in the sleeve 36 by means of the projections-38 resiliently engaging the reduced diameter section 46 of the vial 11. The pro ections 38 thus restrain the axial movement of the vial 11 when the piston rod'84 and plunger 42 are moved outwardly during aspiration. I
The improved medicinal vial-hypodermic needle-assembly of the present invention is preferably supplied by the pharmaceutical manufacturer in the forms shown in'FIGS. Land 3. If preferred, however, the assembly canbe shipped in the form shown in FIG. 4. It should be understood that the pharmaceutical manufacturer will, under normal conditions, obtain the hypodermic needle hub member 20 of the present invention separately from the medicinal vial 11 which must be filled with the desired medicament by the pharmaceutical manufacturer and thereafter assembled, as described herein, with the hub section and the supporting container.
Others may practice the invention in any of the numer ous ways which are suggested to one skilled in the art, by this disclosure, and all such practice of invention are considered to be a part hereof which fall within the scope of the appended claims.
1. A disposable medicinalvial and needle assembly for insertion as a unit in a cartridge-type hypodermic syringe comprising, a hypodermic needle hub section provided with an axial passage extending therethrough, a doubleended hypodermic needle fixedly mounted in said axial passage with an injection cannula extending therefrom in one direction and a closure piercing cannula extending in the opposite direction, a protective sheath removably connected with the said hub section enclosing the said injection cannula, said hub section having thereon means for being detachably secured to a cartridge-type hypodermic syringe, a sleeve section formed integrally with said hub section and extending axially from the hub section, said sleeve section being disposed symmetrically about said closure piercing cannula and projecting axially substantially beyond the end of said piercing cannula, said sleeve section adapted to yieldably engage a substantial area of the lateral surface of a medicinal vial disposed in said sleeve section to provide a bacterial seal therebetween a medicinal vial slidably disposed in said sleeve section and normally spaced from said piercing cannula but moveable axially into piercing engagement with said cannula, and said assembly adapted to be fixedly mounted as a unit within a barrel of said cartridge-type hypodermic syringe.
2. A medicinal vial and needle assembly as in claim 1, wherein the said sleeve section resiliently engages the lateral surface of the said vial along the entire circumference thereof and extends in resilient sliding engagement therewith axially about half the length of said vial, thereby forming a bacteria impervious barrier to maintain the sterility of said closure piercing cannula.
3. A medicinal vial and needle container assembly, comprising a hypodermic needle hub section provided with a hypodermic needle mounted axially therein, said needle having one end forming an injection cannula and the other end forming a closure piercing cannula, a sleeve section formed integrally with said hub section and extending axially from the said hub section disposed symmetrically about the said piercing cannula and adapted to receive therein a medicinal vial, a medicinal vial mounted in said sleeve section and adapted to be operatively connected with the said hypodermic needle, a protective sheath member removably connected with the said hub section enclosing said injection cannula, a container adapted to removably support therein the said vial and needle assembly and frictionally engage the said sleeve section with the medicinal vial supported therein without contacting said medicinal vial, said container being provided with an axial passage in one end wall thereof which frictionally and sealably engages the said sheath adjacent the hub section with which the said sheath is associated, whereby the said needle and hub assembly is removably and sealably supported within the said container body.
4. A medicinal vial and needle container assembly as in claim 3, wherein the said container is comprised of a closure cap member and a main body section adapted to frictionally engage the said sleeve section with a transverse end wall at one end thereof provided with said axial passage for sealably receiving therein said sheath, and a closure cap member removably and sealably mounted on the opposite end of said main body section.
5. A medicinal vial and needle container assembly as in claim 3, wherein the said container is comprised of a closure cap member and a main body section adapted to frictionally engage said sleeve section, said closure cap member removably mounted on the other end of the said body section, and said ClOSlll'B cap member having one end thereof provided with said axial passage for sealably receiving therein said sheath.
6. A disposable hypodermic needle assembly for insertion as a unit in a barrel of a cartridge-type hypodermic syringe and adapted to slidably retain therein a medicinal vial comprising, a hypodermic needle hub having an axial passage extending therethrough, a double-ended hypodermic needle fixedly mounted in said axial passage with an injection cannula extending in one direction and a closure piercing cannula extending in the opposite direction, a protective sheath removably connected with the said hub enclosing said injection cannula, said hub having thereon means for being detachably secured to a cartridgetype hypodermic syringe, a sleeve section formed integrally with said hub section and extending axially from the hub disposed symmetrically about said closure piercing cannula and projecting axially substantially beyond the end of said piercing cannula, and said sleeve section being resilient and adapted to slidably and sealably retain therein a medicinal vial to form an integral unit which is adapted to be detachably mounted as a unit in said barrel of said cartridge-type hypodermic syringe.
References Cited in the file of this patent UNITED STATES PATENTS 2,728,341 Roehr Dec. 27, 1955 2,828,743 Ashkenaz et a1. Apr. 1, 1958 2,842,126 Brown July 8, 1958 FOREIGN PATENTS 720,652 Great Britain Dec. 22, 1954 818,956 France June 28, 1937