US 3110309 A
Abstract available in
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Description (OCR text may contain errors)
Nov. 12, 1963 J. L. HIGGINS PLASTIC CARTRIDGE NEEDLE ASSEMBLY 2 Sheets-Sheet 1 Filed Aug. 15, 1960 nventor John. L. l't' 5g, l) Jim, jH-lzarneg u w n. .n 4 4 o e w w w 7 o Nov. 12, 1963 .1.L.H1GGxNs PLASTIC CARTRIDGE NEEDLE ASSEMBLY 2 Sheets-Sheet 2 Filed Aug. l5, 1960 s.. w m .mf m .mmow f n I../ LwiNa l m w mi. O 9 z l 1n .o JL.
United States Patent O 3,11%,39 PLASHC CARTPJDGE NEEDLE ASSEMBLY lohn L. Higgins, Daytona Beach, Fia., assigner, by mesne assignments, te Brunswick Corporation, a corporation of Delaware Filed Aug. l5, 1956, Ser. No, 49,584 4 Claims. (Cl. EZB-4N) The present invention relates generally to a disposable medicinal cartridge structure and assembly adapted for insertion into a hypodermic cartridge syringe or for use directly as a hypodermic syringe for injecting a medicament. More particularly, the present invention relates to an improved disposable plastic cartridge and plastic cartridge-needle assembly for use in a hypodermic cartridge syringe.
Therapeutic doses of medicaments are frequently packaged in disposable sterile cartridges or disposable cartridge-ieedle assemblies which are adapted to be inserted in a hypodermic cartridge syringe or used directly for administration of a medicament. Various cartridge syringe units hae been devised to accommodate a disposable cartridge or cartridge-needle assembly and the particular form of cartridge syringe is of no importance to the present invention which is concerned primarily with the disposable cartridge and cartridge-needle assembly.
The present invention is particularly concerned with a novel plastic cartridge and plastic cartridge-needle assembly of the foregoing type which is adapted for insertion in an axial opening of a reusable Tu-bex type dental syringe or the like, and wherein the cartridge containing an injectable medicament is maintained in spaced relation to a diaphragm piercing cannula. Preferably the plastic cartridge is slidably held in a sleeve section which also flxedly supports a hypodermic needle so that the needle can be readily brought into communication with the interior of the cartridge by having one end of the hypodermic needle pierce the diaphragm section of the cartridge when the cartridge is moved longitudinally inwardly within the sleeve section.
ln the medicament-containing cartridges and cartridgeneedle assemblies of the instant type which have a reciprocable piston member slidably :mounted in one end thereof. the cartridges have heretofore been fabricated by providing a tubular section of rigid material, such as glass, which is open at both ends with the reciprocable piston member sealably mounted therein and a penetrable closure or diaphragm stopper sealably disposed in the opposite end thereof. The diaphragm stopper which is mounted fixedly in the lower opening of the cylindrical section is usually for-med of rubber or similar penetrable and resilient material which can be readily pierced by a bi/,eodermic needle cannula and which forms a sealing engagement about said hypcderrnic needle cannula to prevent lealtage of the medicament. Since the diaphragm stopper has heretofore been preformed of relatively expensive rubber or the like resilient material and requires individually mounting in the end of the cartridge, the cost of the cartridge is substantially increased and in some instances is a significant part of the total cost of the cartridge. It is thus evident that there would be several economic advantages if a cartridge unit could be molded entirely of a synthetic plastic material and thereby avoid the step of xedly mounting a rubber diaphragm stopper in one end of a tubular section. Nevertheless, there has heretofore been no successful all plastic cartridge devised which has an integral plastic diaphragm sea-lably closing one end thereof.
Since it is necessary to have the wall section of the cartridge of the instant type formed of relatively rigid material and have the walls thereof sufficiently thick to Patented Nov. l2, i963 lCe be form-retaining so that the piston mounted on one end thereof could be readily reciprocable therein, a diaphragmend wall integrally formed with the lateral walls of the cartridge and having appreciable thickness is found to be difficult to penetrate 'by a diaphragm-piercing cannula, particularly if the diaphragm is formed with the saine Wall thickness as that of the cartridge.V And, when the integrally formed cartridge diaphragm is made sufficiently thin to permit ready penetration by a diaphragm piercing cannula there is a definite tendency for the medicament to leak from the cartridge during administration thereof. Thus, it has been observed that when the reciprocable piston member is moved forwardly to discharge the medicament through the needle cannula communicating with the interior of the plastic cartridge, considerable force is exerted on the inner surface of the diaphragm and the diaphragm frequently ruptures with small slits radiating outwardly from the cannula, thereby increasing the amount of leakage which occurs around the cannula.
lt is therefore an object of the present inventionto provide a more economical medicinal-containing cartridge-support assembly having means for preventing lealtage of a medicament from a medicinal-containing cartridge during administration thereof While held in said support.
lt is a further object of the present invention to provide an im roved plastic medicnial-containing cartridgesupport assembly which reduces leakage of a medicament through the diaphragm portion thereof which is penetrated by a diaphragm piercing cannula held in said support.
A still further object of the present invention is to provide an inexpensive plastic cartridge-support assembly having means for forming a scalable engagement with a cylindrical supporting section in which it is slidably mounted.
lt is still another object of the presen-t invention to provide in a plastic cartridge-support assembly a novel fluid sealing engagement .between said plastic cartridge and said support to prevent the loss of medicament.
Another object of the present invention is to provide a medicinal plastic cartridge-support assembly of the instant type which can safely emp-loy a hard plastic material for molding the pentrable diaphragm portion of the cartridge regardless of any splintering thereof during penetration by a needle cannula.
Gther objects of the present invention will be apparent to those skilled in the art from the fol-lowing detailed description and claims to follow when read in conjunction with the accompanying drawing wherein: V
FIG. l is a vertical sectional View of a medicinal cartridge-needle assembly of the present invention with the cartridge `disposed rin spaced relation to the needle thereof and having protective means sealably enclosing the ends thereof.
FIG. 2 is a vertical sectional View partially in side elevation showing the cartridge-needle assembly of FIG. l operatively mounted in a hypodermic cartridge syringe;
FlG. 3 is a vertical sectional view of a modified .for-m of medicinal-containing cartridge-needle assembly;
ElG. 4 is a vertical sectional view of a still funther modified form of a meidicinal-contahiing cartridge-needle assembly of the present invent-ion; arid FIG. 5 is a side elevational view partially in vertical section of a medicinal cont ining cartridge of the present invention.
kIn rFlGS. 1 and 2 of the accompanying drawing is shown a preferred embodiment of the presentinvention wherein a novel medicinal containing cartridge lil is reciprocably disposed Within a sleeve or cartridge hypodermic needle retaining member `ll which coacts With the cartridge lll in a unique manner to provide a unitary scalable structure adapted to be removably mounted in a hypodermic cartridge syringe dBi?. The medicinal cartridge lil is comprised of an elongated body section having a generally cylindrical plastic wall with an unrestricted opening 16 at one end and a transversely extending end wall 17 integrally formed gwith the lateral wall l5 to sealably close the other end. The transverse end wall section 17 contains a plastic diaphragm portion` 18 integrally formed therein and preferably thinner than the lateral wall of the cartridge so that a diaphragm piercing cannula can readily penetrate therethrough. rthe lateral walls .15 adjacent the end wall 7 is preferably provided with a frustoconical or tapered section 19 which is adapted to form a sealing engagement with the needle retaining sleeve member ll. The frustoconical section l19 preferably begins at the periphery of the diaphragm .1S and extends axially a short distance forming -a small angle with the longitudinal axis of the cartridge it?. The end of the fnustoconical section 1,9 ywhich is spaced axially and radially upwardly from the end wall 13 term-inates in an annular recess 26' which forms an annular connecting portion having -a reduced wall thickness between the frustoconical section 19 and the cylindrical wall section 15 which imparts a degree of flexibility to the Wall section. The annular recess 2d coacts with a complementary ring section d4 formed on the inner surface of the sleeve 11 to form a locking engagement therebetween.
The cartridge-needle retaining member 11 has a generally stepped cylindrical body section 21 with a generally cylindrical hub engaging section 22 provided with a stepped cylindnical axial passage 23 extending therethrough and which is adapted to xedly receive therein the :hub 24 of the double-ended hypodermic needle 25. The hub 24 has a collar or flanged ring section 26 iixedly secured to the cannula 27 of the Ehypodermic needle 2S intermediate the ends thereof to provide an administration cannula portion 28 extending in one axial direction and a shorter diaphragm piercing portion 29 extending axially in the opposite direction. The ring section 26 is frictionally held in the axial passage 23 to iixedly retain the needle therein.
Extending forwardly from the body section l21 is an axial post section 39 which is adapted to removably support thereon a cannula sheath 31 which sealably encloses the cannula portion 27S. The body section 21 is also provided on the outer surface with syringe engaging means 315, such as a threaded section, which is adapted to retain the body section 2l in threadable engagement `with the lower end of the cartridge syringe ll.
The body section 21 has an integrally formed elongated sleeve section 4t? with a generally cylindrical inner Wall section 41 extending axially beyond and symmetrically disposed about the said diaphragm piercing cannula portion 29. The cylinder wall section 41 has an unrestricted opening 42 at one end thereof with an inner diameter sufiicient to slidably receivetherein the cartridge lll. The sleeve section is adapted to slidablyV retain therein by frictional engagement the medicinal cartridge 'titl in spaced relation tothe end of the diaphragm piercing cannula portion 29 until'such time as it is desired to administer the medicament.
In order to prevent leakage of medicament from the cartridge aro-und the cannula portion 29 after the plastic diaphragm 118 is pierced, means are provided in the lateral wall section of the sleeve section 4Q for radially compressing the end of the cartridge unit surrounding the diaphragm '18 and simultaneously forming a sealing engagement between the lateral wall sections of the sleeve section y4t) and the cartridge l@ adjacent the plastic diaphragm portion 1.8. jIn the preferred form illustrated in FIGS. 1 and 2 of the drawing, the portion of the inner wall section 41 of the sleeve section 4l) adjacent the closed end wall 45 which has the cannula portion Z9 extending axially therethrough is provided with an inner lateral surface dehning a frustoconical section 46. The frustoconical section 45 has substantially the same longitudinal length as the corresponding section i9 of the cartridge 16 but has the inner lateral wall surfaces thereof spaced slightly less than the corresponding lateral Wall surfaces of sectioni9. Thus, the closed end of the cartridge V19 including the diaphragm 18 thereof is compressed radially inwardly and simultaneously a fluid sealing engagement is formed between the lateral wall section of the cartridge lll and the sleeve section 4d adjacent the end of the cannula portion 29 when the cartridge 1li is fully seatedin the sleeve section lill. The cartridge lll is preferably held in sealing engagement with the sleeve section lll by the interengagement of projection and recess means on the sleeve section il and cartridge lil, respectively, as illustrated in FIG. 2 of the drawing.
lt will be evident that the frustoconical section 46 efectively exerts a radially inwardly compression force on the diaphragm 18 of the cartridge lll and thereby forming a fluid-tight sealing engagement about the cannula portion 29, because the inwardly tapered form of the lower end of the cartridge dll tends to transmit any inwardly directed force thereon to the diaphragm-end -wall section. Also, with the frustoconical section 19 being connected to the cylindrical wall section lil' by means of an annular recess yZtl having a reduced wall thickness, the radially inwardly compression of the diaphragm section 13 by the frustoconical section 19 is greatly facilitated.
Klt will also be evident that the'uid sea-ling engagement between the two frustoconica-l sections 19 and 46 of the cartridge lil and the sleeve section 4), respectively, provides an improved means for substantially preventing any loss of medicament from the intenior of the plastic cartridge lll, even in the absence of a fluid-tight seal being formed between the diaphragm 'l and the cannula portion 29. Thus, by providing the cartridge 1li with a tapered outer lateral surface adjacent the inner end thereof Iwhich forms a fluid-tight sealing engagement with the similarly tapered inner lateral Wall surface of a needlesupporting sleeve member, such as sleeve section 4d or a suitable formed barrel of a cartridge syringe, any medicament which may leak from the cartridge .10 around a cannula extending therethrough or through a rupture in the diaphragm section during administration will be sealably retained between the transverse end Wall 117 of the cartridge 10 and the closed end wall 45 of the sleeve 4l). Since only a very small volume of medicament can collect between the wall surfaces 17 and 4S, the tapered sealing engagement between the cartridge 19 and sleeve lil prevents leakage of any significant amount of the medicament from the cartridge dil.V Thus, with the improved sealing -stnucture of the present invention, loss of medicament from the all-plastic cartridge is reduced to a minimum, thereby making it economically feasible for the iirst time to use an all plastic cartridge for storing and dispensing a medicament.
The foregoing needle-cartridge assembly is preferably supplied as a complete sterile package, as shown in FIG. l; by providing the needle-retaining member 11 with a protective sheath memberk 3l which is removably mounted on the lower end thereof to sealably enclose the axially extending administration or flesh piercing portion of the needle and a cap member el? mounted on the upper end of the member 11. in the form illustrated in FlGS. l and 2, the open end of the sheath member 31 frictionally engages the cylindrical post Sil at the end of the member 11 Vto form a bacterial seal therewith. VThe open upper Y end of the retaining member 1l and the projecting end of the cartridge 10 are enclosed by the cap member 69,
which forms a facterial seal with the end ofthe sleeve member 11. In its preferred form the closure cap mernber 69 is provided with an interior end section 61 at the open end thereof which has a diameter such that the end section forms a tight frictional sealing engagement with the outer surface of thesleeve 11. A shoulder section 64 'is also preferably formed on the inner surface of the cap 6d spaced from the open end which engages the transverse end wall 65 of the sleeve so that the closed end wall 66 oi the cap 6@ is spaced rom the end of the cartridge 1%, thereby preventing accidentally forcing the cartridge lil into engagement with the diaphragm piercing cannula 29.
in the modifiedl form of the present invention shown in FIG. 3 of the rawing, the plastic medicinal cartridge lil has a generally cylindrical lateral wall section 7l with an unrestricted opening '72 at one end and a transversely extending end Wall '73 integrally formed with the lateral wall section 71 which has a plastic diaphragm section '74 integrally formed therewith. The wall section 7l adjacent the end wall 73 and for a short distance axially thereof is in the form of a reduced diameter cylindrical section 7 The cartridge-needle retaining member has a generally stepped cylindrical body section Si similar in form to that of the embodiment shown in FlGS. l and 2. The body section Si holds securely therein a double-ended needle 9i? with an elongated administration or flesh pierc- 'mg portion 9i extending axially outwardly and a shorter diaphragm piercing portion 92 extending axially inwardly. A sleeve section 32 extends axially in the same direction as the diaphragm piercing portion 92 of the needle @il and performs the same functions as the sleeve 4l? of FGS. l and 2. However, the sleeve section S2 differs structurally rom sleeve by having the inner surface adjacent the closed end thereof in the form of a cylindrical section 85 having a diameter slightly less than the exterior diameter of the cylindrical section 75' of the cartridge 7i). T he cylindrical section S5, in addition to compressing the diaphragm section 74, forms a sealing engagement with the lateral Wall surface or" the cartridge 7l) adjacent the diaphragm 7d when the later is pierced by the needle 9i?. The cylindrical section S5 also provides a shoulder stop portion S5 at the end thereof spaced from the closed end oi the sleeve 32 which engages the end of the cartridge 7l? and prevents the diaphragm 74- accidentally being moved into contact with the diaphragm piercing portion 52 of the needle 9%.
As in the form shown in FEC-S. l and 2, the body section and the sleeve section S2 are provided with a protective sealing closure cap 95 and a detachable needle sheath 9d, respectively, to form a complete sterile package.
in the further modilied form of the invention shown in 4, substantially the same medicinal cartridge and sleeve structures of FlGS. l and 2 are used except the needle ismolded integrally with sleeve. in the latter modiilcation, however, the sheath ld@ v hich protectively encloses the administration cannula 15d has the open end thereof detachably mounted in bacterial sealing engagement with the generally cylindrical unthreaded lateral surface lili? of the body section lili. The longitudinally spaced closed end lilQ; of the sheath lb@ is provided with an axial recess 1&3 which is threaded for engagement with a correspondingly threaded post lZil atiixed in the piston head lZl reciprocably and sealably mounted in the end of the medicinal cartridge 125. lt will be apparent that in the latter embodiment, the sheath ltlt can, if necessary, be used as the piston rod for moving the head lil axially within the cartridge 225.
When the medicinal cartridge-needle assembly or" FIGS. l and 2 is used, the closure cap member 65B is removed the cartridge lll is fully seated in the sleeve section dit by applying axial pressure on the end of the cartridge ld.
is conveniently done by placing the end of the cartridge l@ which projects from the end ofthe sleeve section [lil against a dat surface While holding the assembly with the body section between the fingers of one hand and applying axial pressure. As the axial pressure is increased, the cartridge li) is moved into engagement with the diaphragm piercing cannula portion 2@ and the diaphragm i3 is pierced. TWhen the cartridge itil is fully seated, as
evidenced by the outer end of the cartridge being flush with the outer end of the sleeve, the diaphragm i8 of the cartridge l@ is compressed radially inwardly by the tapered lateral walls of the sleeve section to prevent leakage of iluid around the cannula. Simultaneously, as sealing engagement is formed between the lateral walls of the cartridge l@ and the sleeve 4@ at points adjacent the diaphragm in to retain in a confined area at the lower end of the assembly any medicament or blood which leaks from the cartridge lll during administration or aspiration. rl`he cartridge i@ is maintained in sealing engagement with the sleeve section fi-li by the interengagement of complementary locking means formed on the cartridge and sheath, respectively, or, in the absence of locking ring 44, the cartridge l@ can be held in the barrel and sleeve 4:0 by means of the syringe structure.
The cartridge needle assembly having the parts thereof disposed in the relative positions shown in FIG. 2 of the drawing is then inserted into the open end of a standard cartridge-type syringe E39, such as a Tubex dental syringe as shown in FlG. 2, without removing the protective sheath 3ft which encloses administration needle. The cartridge-needle assembly is then securely mounted within the barrel i of the syringe, as by threadably engaging the threaded means 3S with a short threaded section formed in the lower end of the syringe body. The plunger rod 132 of the syringe is then operatively connected with the plunger 3.3 mounted in the end of the cartridge l@ to permit reciprocably moving the plunger.
VJhile it is preferred to mount the plastic cartridge Il@ in the needle-retaining sleeve section 1l, it is Within the road scope of the present invention to mount the cartridge directly in the barrel of the cartridge syringe with the pivotal upper end assembly of the syringe adapted toV hold the cartridge Within the barrel or by providing conventional threadable means for holding the cartridge therein.
The modified forms of the invention shown in FiGS. 3 and 4 of the drawing can also be operated in substanti lly the same manner as described in connection with the embodiment shown in FIGS. 1 and 2.
ln the modified form of the invention shown in PEG. 4, the cartridge-needle assembly can also be operated without inserting in a cartridge-type syringe. When used clirectly, the cartridge 12S is moved into piercing engagement with the cannula lill in the same manner as described in connection with FiGS. l and 2. Thereafter, the sheath is removed from the lower end of the body section i-"SS :and the threaded recess 193 is brought into threaded engagement with the post lid of the piston head Ml. The sheath thus serves as the piston rod to administer the medicament Within the cartridge or for drawing rluid into the cartridge.
T he medicinal cartridge including the diaphragm portion of the present invention is preferably made of unplasticized polypropylene, since polypropylene is inert to most medicines and has a very low moisture transmission rate, while at the same time being relatively light in weight. Gther plastic materials having similar chemical and physical properties can be used, such as polyethylene and nylon plastics. ri'he sheath, cap and the cartridge sleeve needle-reta ing member do not necessarily have to possess the same low moisture vapor ltransmission properties nor the chemically inert properties of the medicinal-containing cartridge. Thus, the latter parts of the assembly can be made from polypropylene, polyethylene, nylon, polyvinyl chloride, and the like plastic materials.
it will now be apparent to those skilled in the art that the material from which the diaphragm portion of the cartridge of the present invention can be made is not limited to a soft, rubber-like material and, in fact, is preferably made or" a hard plastic material, such as unplasticized polypropylene. The use of such a material, however, is made possible only because the occurrence of splintering or radial fracturing of the diaphragm 7 during penetration thereof by a hypodermic needle cannula does not result in leakage of medicament from the cartridge. Any leakage of medicament which does occur through the diaphragm is sealably confined between the diaphragm end wall of the cartridge and the transverse end wall of the support member by the scalable engagement formed between the contiguous lateral surfaces ofV the cartridge and support member.
lt will also be evident to those skilled in the artt that making the diaphragm portion of a hard plastic material also makes it possible to use any type or needle point to penetrate the cartridge diaphragm, even a needle which has no point, such as a'single ended needle. llt is entirely unnecessary for the needle to cut through the diaphragm and thereby form a small plastic core or slug which iloats loosely within the cartridge and tends to block the needle or cause serious injury if injected into the patient. With the present cartridge, it is possible and preferred to simply push a hole through the plastic diaphragm without cutting and completely severing a portion of the diaphragm.
It will be further understood by those skilled in the art that the plastic medicinal cartridge of the present invention which has a reciprocable piston sealably closing one end with the other end being closed by an integral plastic diaphragm section can, if desired, also be used in a cartridge syringe other than the Tuben syringe shown in FG. 2 of the drawing, with or Without the supporting sleeve member.
it will be apparent to those skilled in the art that many changes and modifications may be made in the specic embodiments disclosed herein without departing from the present invention. The specic description is not intended to limit the scope of the invention, which is dened by the appended claims.
l claim: Y
1. A. cartridge-needle assembly which comprises in combination: a plastic cartridge adapted to retain a iluid therein formed of a substantially hard plastic material which has low vapor transmission properties and which in sections readily pierceable by a hypodermic needle is inherently lacking in ability to form a permanent sealing engagement with a hypodermic needle cannula, said cartridge having a cylindrical lateral Wall section with a piston means slidably mounted therein and having one end of said cylindrical lateral wall section sealably closed by a readily pierceable plastic diaphragm end Wall section integral with contiguous portions of said cylindrical lateral wall section and being formed of said substantially hard plastic material, and a cartridge-needle support member having a cylindrical sleeve section in which said cartridge is supported with one end of said sleeve section open to receive said cartridge and the other end closed by a sleeve end wall adapted to support a ciaphragm piercing needle cannula with one end of said cannula extendable axially witnin said sleeve section, and said sleeve section having formed at the end thereolC adjacer said sleeve end wall a reduced diameter section providing :a sleeve lateral wall section engageable with said cylindrical 'lateral wall section adjacent said one end to form a luid sealing engagement between said lateral wall sections of said cartridge and said sleeve section for retaining within said sleeve section liuid leaking from said diaphragm section when said cartridge and cannula are disposed in diaphragm piercing seating engagement within said sleeve section.
2. A cartridge-needle assembly as in claim l, wherein said cylindrical lateral wall section adjacent said one end of said cartridge and said reduced diameter section of said sleeve section each have inwardly tapering lateral walls providing frustroconical sections which form said fluid sealing engagement. Y
3. A cartridge-needle assembly as in claim l, wherein said cylindrical lateral Wall section adjacent said one end of said cartridge and said reduced diameter section of said sleeve section each have cylindrical lateral Walls providing cylindrical sections which form said fluid sealing engagement.
4. A cartridge-needle assembly as in claim l, wherein said plastic cartridge is formed of `a plastic material selected from the group consisting of substantially unplasticized polypropylene, polyethylene and nylon.
References Cited in the file of this patent UNITED STATES PATENTS 978,488 Roesch Dec. 13, 191() 1,779,634 Smith July 15, 1930 2,688,965 Huber Sept. 14, 1954 2,720,880 Whitaker et al. Oct. 18, 1955 2,828,743 Ashlcenaz Apr. 1, 1958 2,859,750 Stroop Nov. 11, 1958 2,884,123 Dann et al. Apr. 28, 1959 2,922,4l9 Bednarz lan. 26, 1960 2,986,141 Hart May 30, 1961 FGREIGN PATENTS 202,100 Australia June 6, 1956 l,l03,541 France Oct. 22, 1956 (Addition to No. 66,437)