CA1203136A

CA1203136A - Syringe cartridge

Info

Publication number: CA1203136A
Application number: CA000440785A
Authority: CA
Inventors: Ray Urbaniak
Original assignee: American Hospital Supply Corp
Current assignee: American Hospital Supply Corp
Priority date: 1982-11-22
Filing date: 1983-11-09
Publication date: 1986-04-15
Also published as: GB2149668B; GB8416011D0; WO1984002079A1; DE3390336T1; EP0126139A4; EP0126139A1; GB2149668A; US4673396A; US4465472A

Abstract

Abstract of the Disclosure Disclosed is a method for filling a cartridge which can be subsequently capped and closed. This is done by filling to a discrete level and then applying a closure.
A displacement dome is provided at the lower portion of the syringe cartridge closure to first displace a predetermined amount of air or gas and then to displace a minor amount of fluid upon closure to seal the cartridge, and insure zero head space. The entirety of the process of filling is done in a vented environment, and the closure applied at ambient.
The invention also provides an apparatus which includes a syringe cartridge having its open lower portion closed by a plunger piston. The upper portion is closed by a syringe cartridge closure having a leur tip cap. Means are optionally provided interiorly of the tip cap to retain a hollow needle, which is held in position by a leur tip, the latter being vented and provided with a seal for the needle.
The piston plunger at the lower portion of the cartridge can be advanced, desirably by a second plunger, to empty the contents. Upon resealing, the leur tip cap is applied over the leur tip after a bead is formed on the tip. The tip cap then penetrates the leur tip, or optionally the interior of the hollow needle thus completely reclosing the cartridge and sealing the same for storage until intended for further use.

Description

~03~36 1 Field of Invention The Present invention is directed to a s~ringe cartridge, and method for filling and dispensing from the same, which provides for controlled or zero head clearance with the contents, thereby isolating the cont~nts from ambient air.

Summary of the Prior Art Measurement of human blood gases is a well known medical test and is routinely performed with specialized blood gas instruments. These instruments must be frequently tested for accuracy and calibration to insure that reliable measurements are being made. Recently the advantages of using gas-equilibrated, buffered, stabilized human blood cell suspensions as quality control specimens to be run in conjunction with patient specimens have been described. See for example United States patent 4,126,575 to Louderback. However, such blood gas control material requires special handling, including incubation and agitation prior to use, and avoidance of contact with air.
An attempt was made by Intensive Technology, Inc.
of 25 Bay State Road, Boston, Massachusetts, in a product called "Respatrol" to minimize the above problems by sealing the blood gas control with a gel. However, the integrity of the seals as well as opening and resealing of the ampules was less than satisfactory.

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'1 ~L2V3~36 1 It thus becomes highly desirable, in view of the prior art and the problems, to provide for zero head space in a cartridge, and continuing zero head space during the dispensing of the contents of the cartridge, particularly where whole blood or other ingredients are involved that must be sealed from ambient air. It further becomes highly desirable to accomplish such a packaging with resealable and reclosure features which constantly inhibit the ingress of air into the container.
Furthermore it is desirable to be able to dispense the entire contents without contamination by air after repeated usage and resealing.
Summary of the Invention The present invention is directed to a method for filing a cartridge which can be subsequently capped and closed. This is done by filling to a discrete level and then applying a closure. The closure bottom displaces a predetermined amount of air or gas and a sniall amount of product from the interior of the cartridge. The entirety of the process of filling is done in a vented environment, and the clGsure applied at ambient. The invention also provides an apparatus which includes a syringe cartridge having its open lower portion closed by a plunger piston.
The upper portion is closed by a syringe cartridge closure having a leur tip cap. !leans are optionally provided interiorly of the tip cap to retain a hollow needle, X

~2~3~3~i 1 which ls held in position by a leur tip, the latter being vented and provided with a seal for the needle.
A displacement dome is provided at the lower portion of the syringe cartridge closure to displace a minor amount of fluid upon closure to seal the cartridge, and insure zero head space. The piston plunger at the lower portion of the cartridge can be advanced, desirably by a second plunger, to empty the contents. IJpon resealing, the leur tip cap is applied over the leur tip after a bead is formed on the tip. The tip cap then penetrates the leur tip, or optionally the interior of the hollow needle thus completely reclosing the cartridge and sealing the same for storage until intended for further use.
In view of the foregoing it is a principal object of the present invention to provide a syringe cartridge with zero head space in the interior to eliminate ambient air. A related advantagè stems from the use of the subject product with a whole blood control so that equilibration is not required.
Still another object of the present invention is to provide a syringe cartridge which permits continued re-use without contaminating the remaining contents.
Still another object of the present invention is to provide for a needle interiorly o:E the leur tip which is partially driven through the plastic membrane of the closure, to thus avoid plugging the needle due to coring of the needle opening.

X

3~L36 1 Yet another object of the present invention is to m;nim; ze the force required to drive the needle by providing seal ribs interiorly of the leur tip, and yet retain the sealing function required to inhibit leakage around the needle.
A further object of the invention is to provide a syringe cartridge which is adaptable to utilization directly as a syringe by applying a hypodermic needle on the leur tip.
Still another important object of the present invention is to provide a method of packaging the contents into a syringe cartridge which is simple and efficient, and inhibits contamination of the contents from ambient air.
Another objective is to prepare a syringe cartridge and method for using the same which can be used with a wide variety of chemicàls and reagents where controlled or zero head space is required to maintain the stability and activity of the contents.
Rrief ~escription of the Drawings Further objects and advantages of the present invention will become apparent as the following description of an illustrative embodiment and method proceeds, taken in conjunction with the accompanying drawings, in which:

)3~36 1 FIG. 1 is a front elevation of an illustrative syringe cartridge showing its principal elemen-ts as the product is sold to a typical user;
E~IG 2 is a front elevation in essentially the same scale as FIG. 1 showing the cartridge in its initial position prior to filling;
FIG. 3 shows the cartridge with its filling station as the same is being filled;
FIG. 4 discloses the filled cartridge after being filled in accordance with FIG. 3 and having the closure applied, FIG. 5 discloses the next sequence in which the needle is inserted into the leur tip;
FIG. 6 is a further sequential view in which the leur tip cap is applied to the cartridge;
FIG. 7 shows the first st~p in preparing the cartridge for usage by inserting preferably a second shaft piston and plunger, and the same is now ready for shipment to the customer;
FIG. 8 shows the second step in which the leur tip cap is depressed, and the needle penetrates a diaphragm providing open communication with the contents of the cartridge;
FIG. 9 is the next sequential view of the user showing the leur tip cap being removed, and pressure applied to the plunger piston and plunger shaft to dispense the contents of the cartridge;

X

~L24~3~3~

1 ~ FIG. 10 shows a further sequential view in which the leur tip cap is placed in position on the needle and the leur tip, thus sealing the same for storage and re-use;
FIG. 11 shows the condition of the cartridge and contents after the syringe or cartridge is virtually depleted of its contents, and the upper piston can no longer function;
FIG. 12 is a front elevation of the syringe cartridge;
FIG. 13 is a transverse sectional view of the plunger piston;
FIG~ 14 is a front elevation partially in section of the plunger shaft;
FIG. 15 is a transverse sectional view of the syringe cartridge closure;
FIG. 16 is a top view of the syringe cartridge closure showing the closure ribse~.ployed for machine torquing;
FIG. 17 is a front elevation of the syringe cartridge closure showing the knurled rim ribs for finger tightening;
FIG. 18 is a front elevation of the needle in enlarged scale and showing its principal components;
FIG. 19 is a transverse sectional view in enlarged scale of the leur tip cap; and FIG. 20 is a bottom vlew of the leur tip cap showing the vent channels and the leur tip grip.

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.il./; :
i ~2~3~3 1 De~cription oE tlle Preferred EmbodimentS

2 The subject syril~e .c~rtridge is shown in FIG. 1,

3 where it will be seen that it has an elongated cartridge

4 body 11, and filled with contents 12. ~ plunger piston 14 seals off the lower portion of the cartridge 11, and a 6 syringe cartridge closure 15 is provided at the top. The 7 syringe cartridge closure 15 has a leur tip cap assembly 16 a which completes the closure. Con~eniently shown is a typical 9 wrap around label 18.
Turning to FI~. 2, it wlll be seen that the first 11 step in assembling -the syringe cartridge 10 is to provlde a 12 cartridge 11, p~eferably a sterilized glass tubular member, 13 witl the plunger piston 1~ in place. To be notecl lS the 14 upper portion of the cartridge 11 is providecl with a t~read finish 19, terminating in an open filling end.
16 The next step illustrated in ~IG. 3 is to fill the 17 cartridge 11 with contents 12 in a drawbac]c system. This is 18 accomplished essentially by providin~ a filler head assembly 19 25 having a support bar or filler bar 26,~and a cartridge cover 28 supported by a spring loade~ suspellsion 29 from tlle 21 filler support bar 26. A contents tube 30 is provided to 22 penetrate through the cartridge cover 28 and dispense 23 conten-ts 12 into the cartridge 1~. At the same time, a vent 24 tube 31 is employed to permit the ambient atmosphere and excess product inside the cartridge 11 to be dispelled as 26 the contents 12 are inserted. Pragmatically 27 as well as theoreiically, a precis0 contrdlled I.~li i: . .
~z03i3~

l fill level 32 is calculate(l so that when the syringe cartridge 2 closure 15 is applied, there w.ill ~e an essent.ially-total 3 head space displacement, and the inter.ior portion of the 4 cartridge 11 will b~ solely occupied by its contents 12.
As shown in FIG`. 4, when the closure 15 is applied 6 to the threaded finish 19 of the cartridge 11, there is an 7 observable leur tip 34, at the hottom of which .is a diaphragm 8 36, ~rom whicll extends the dome of ~he content displacement 9 portion of the closure 15. The leur tip 34 also defines a leur tip needle bore 39 in its lnterior portion. The threaded 11 fillish 19 of thç bottle along with the interior threads oE
12 the closure 15 form a contents displacelnent trap, which will 13 become apparent as the closure 15 is subsequently describe~
14 in greater detail along with drawings of more specific details. In closing the contellts displacement trap 35 a 16 small amount oE the con-tents lZ will spill over hut be 17 trapped at the threaded joints between the closure 15 and ~8 the threaded fi~ish 19 of the upper portion of the cartridge.
19 As shown in FIG. 6, a hollow needle 40 is subse-quently inserted into the lellr t.ip needle bore 39. The 21 needle 40, as shown in.speci~ic detail Oll F`IG. 18, shows t2le 22 termination at one end with a bevel 41 defining a point 42.
23 The shank 44 oE the needle contai~s a bore 45 which terminates 24 at the dispensing end 46 of the needle 40. The opposite end of the bore 45 terminates at the bevel face 41 where the 26 point 42 is defined. As will be shown, the leur tip dispens~

/

ll/~iU,~ ~
~203~3,6 1 ing end ~8 -i~ substalltially flusll wi~h the needle dispensing 2 end 46 when the unit is act-ivated. FIG. 7 shows the insertion 3 of the shaft piston 61 secured to -the plunger shaft 60. The 4 point 42 penetrates the diaphragm 36 (as shown in FIG. 8) but the bevel 41 only partially penetrates the diaphragm 3 6 to reduce any tendency for coring which would plug the 7 needle 40.
8 Referring now to FIG. 9, after the needle 40 has 9 been pressed into the contents and the tip 42 has penetrated the diaphragm 36 and is in contact with the contents 12 of 11 the cartridge 11, the leur tip cap 50 is removed. Pressure 12 is applied to the plunger 14, and the product then injected 13 in accordance wi-th the particular control coupler required.
14 Alternatively the product can be lispensed into an intermediate container to be later drawn into the aspirating instrument.
16 Upon conclusion of the dispensing, a small head of contents 17 12 is formed at the top oE the needle dispensing end 46 18 flush with the dispensing end 48 of the leur tip. Thereafter, 19 as shown in FIG. 10, the technician replaces th~ leur tip cap and the syringe cartridge 10 is ready or storage until 21 it is to be reused again. Finally, as shown in FIG. 11, the 22 plunger piston 14 ultimately reaches a point in the neck of 23 the cartridge 11 where no more ~ntents can be dispelled, 24 and the syringe cartridge and its contents are ready for disposal.

1 0 / ~
~LZ~:)3136 1 In greater de-tail, it will be seen in FIG. 12, 2 that the syringe cartridge ll h.as a thread finish 1~ at one 3 end "~hich is the filling end 20. The opposite plunger end 4 21 is left open and receives the plunger 14.
In FIG. 13 the plunger piston 14 is shown having a 6 dome 62. Interiorly a pis-ton shaft lock colar 64 is provided 7 to receive the piston shaft which will be described later.
8 Exteriorly, a pair of seal rinc3s.65 are shown which engage 9 the interior wall of the cartridge 11. Optionally -the dome 62 may be provided with ribs 66 which can serve to strengtllen, 11 as well a. s~parate the plunger p.iston 14 fron~ the second 12 piston.
13 TurniJIg now to FIG. 1~1, the ba~ic structure of the 14 plunger shaft 60 is shown, and more specifically the connector lS head 68 which couples Wit]l the lock colar 64 of the plunger 16 piston 14. The body 69 separa-tes the connector head 68 from 17 the thumb plate 70, which is used l~y the technician to 18 activate the displacement oE the contents 12 Erom the 19 cartridge 11.
The syringe cartridge closure 1~ is shown in 21 detail in FIG. 15. There it will be seen tllat the upper 22 portion of tlle leur tip 34 termillates in a dispensing end 23 48. The leur tip 34 has an interior leur tip bore 39. The 24 dome for product displacement 38 is shown at the bottom of the leur tip 34, and centrally it will be seen that a 26 diaphragm 36 is provided for penetration by a needle 40.

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~ 3~3~ 1 l The contents displacement t.rap 35 is defined by the interior 2 threads 72 of the skirt 71 ~hi.ch terminate in a seal at the 3 interior of the upper portion of the s}.irt 71.
4 As shown in FIG. 16, closure ribs 76 are provided above the seal portion 75 for machine torquing of the closure 6 15 onto the cartridge 11. As shown in FIG. 17, the closure 7 15 has knurled skirt ribs 78 to assist in hand tightening.
8 Fin~lly! thc leur tip cap 50 is shown in FIG.S. 19 9 and 20. Turning specifically to FIG. 19, it will be seen ~ that the leur tip cap 50 has a hody portion 51, terminating ll in a tnumb plate 52. In the interior portion of the body 51 12 means are provided to define vent channels 5~, separatin~
13 leur tip grips 56. A needle seal 55 is fo~med beneath the 14 central portion of the thumb plate 52, and proportionecl to fit into the dispensing end 46 of the needle upon reclosure.
16 Another view of the vent channéls end 54 and leur tip grip 17 56 appear in FIG. 20.
18 The Method l9 The method of fillinc3, is primarily illustrated in FIG. 3. This presupposes, ho~ever, that a cart:ridge 11 has 21 been provided with a plun(3er piston 14. As noted, the 22 contents 12 are filled until ~ discrete level 32 has been 23 reached, <~t a predetermined volu~e for displacement hy the 24 closure. The closure is then applied in such fashion that a "
small portion of the contents will flow into a trap so that 26 when this position oE the contents dry .it will not be seen ~Z~3136 ' 1, I
1 about the closure. The whole procedure is accomplished in 2 such a fashion that zero head s~ace remains between the 3 contents 12 and the lower portion of -the closure 15. The 4 method for usage contemplates a leur tip cap which can be pressed downwardly and insert a dispensing needle through a 6 ~ diaphragm in the closure, and can be reseale'd by replacing the leur tip cap.
8 While the embodiment described is directed to a g blood gas control medium, where other reagents are used which are not reactive to certain inert gases, æero head 11 space is not essential. Then a small amount of gas, such as 12 nitrogen, can b~ applied aEter filling. Then the closed 13 cartridge does not require zero head space. A 0~-5~ head 1~ space is then Eilled witll an inert gas.
Although par-ticular embodiments of'the inv~ntion 16 have been shown and described in full here, there is no 17 intention to thereby limit the invention to the details of 18 such embodiments. On the contrary, the intention is to 19 cover all modifications, altern'a-tives, emhodiments, usages and equivalents of the subjèct invention as fall within the 21 spirit and scope of the spec`ification and the appended 22 claims.

Claims

THE EMBODIMENTS OF AN INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A syringe comprising, in combination, - a cylindrical cartridge having two open ends, - movable plunger means for closing one end of the cartridge, - a first closure means for the other end of the cartridge for displacement of product within the cartridge to achieve predetermined head space therein, - and a second closure means removably secured to said first closure means, - said second closure means having reseal means interacting with said first closure means to reseal with predetermined head space by displacing a portion of product in the first closure means.

2. In the syringe of claim 1, - tubular means interior of a central bore in an extension of said first closure means proportioned to penetrate a diaphragm in said first closure means and conduct product from said cartridge for dispensing.

3. In the syringe of claim 2, - said second closure means having product displacement means for displacing product from said tubular means to reclose said first closure means with zero head space

4. In the syringe of claim 3, - said tubular means having a dispensing end and pointed end.

5. In the syringe of claim 1, - said second closure means having a vented portion to permit air to escape when reclosing.

6. A syringe cartridge comprising, in combination, - a cartridge of elongate cylindrical configuration having two open ends, - a plunger piston sealing the lower open end of said cartridge, - a syringe cartridge closure secured to the upper open end of the cartridge, - a leur tip having a dispensing end extending from said closure, - a leur tip cap proportioned to reclosably cover the dispensing end of the leur tip, - a leur tip bore centrally and longitudinally of the leur tip, - a diaphragm at the lower portion of said leur tip bore and closing the same to contents of the cartridge, - an inverted dome at the lower portion of the closure defining a predetermined head space relationship between the closure, cartridge, and contents, - the leur tip cap being proportioned for positioning over the leur tip.

7. In the cartridge of claim 6 above, - a hollow needle interior of the leur tip proportioned to penetrate the diaphragm upon depressing the leur tip cap.

8. In the syringe cartridge of claim 6 above, - said syringe cartridge closure having a contents displacement trap defined by its interior upper threaded portion, and the mating engagement with a threaded finish on the cartridge.

9. In the syringe cartridge of claim 6 above, - said leur tip cap having a vent means, whereby ambient air can be vented upon reclosing the leur tip cap.

10. In the syringe cartridge of claim 8 above, - said leur tip cap having a vent means, whereby ambient air can be vented upon reclosing the leur tip cap.

11. In the syringe cartridge of claim 7 above, - said leur tip cap having an interior needle seal proportioned to engage the upper end of the needle to assist in puncturing the diaphragm; and subsequently to assist in sealing the upper end of the needle.

12. In the syringe cartridge of claim 6 above, - a plunger shaft for engaging the plunger piston and forceably ejecting the contents of the cartridge through the hollow bore in the needle.

13. In the syringe cartridge of claim 6 above, - a second shaft piston proportioned for mating engagement with the plunger piston, and - a shaft for engaging the shaft piston for forceably ejecting the contents of the cartridge through the hollow bore in the needle.

14. In the syringe cartridge of claim 7 above, - a plurality of needle seal rings interior of said leur tip needle bore, whereby the needle is supported for orientation upon penetration, and sealed from leakage of the contents.

15. A method for filling the contents of a syringe cartridge having predetermined head space between the contents and a plunger piston at one end of the cartridge and closure at its other end comprising the steps of, - positioning the cartridge in a vertical orientation, - closing off the open upper portion of the cartridge, - inserting contents into the cartridge while constantly venting the cartridge to permit normal escape of the air replaced by the contents, - terminating the fill at a level beneath the top of the cartridge of an air volume to be displaced upon closing the cartridge, - closing the cartridge with a syringe cartridge closure having a displacement dome and contents displacement trap, - and predetermining the fill so that a portion of the contents will pass outside of the cartridge and into the contents displacement trap of the cartridge and the reclosure means of the syringe closure top.

16. In the method of claim 15, the additional step of, - opening the cartridge by depressing a pointed hollow needle held in a leur tip on the closure.

17. In the method of claim 16, the additional steps of, - reclosing the closure at its leur tip by first expressing a bead of contents on the end of the leur tip, - and then applying a reclosure member to partially penetrate the leur tip.

18. In the method of claim 16, - predetermining the fill to permit a gas control to be applied atop the contents which remains in the cartridge after sealing.