EP0044850A4

EP0044850A4 - Plastic container with non-coring penetrable wall portion.

Info

Publication number: EP0044850A4
Application number: EP19810900369
Authority: EP
Inventors: David Bellamy; David A Winchell
Original assignee: Baxter Travenol Laboratories Inc
Current assignee: Baxter International Inc
Priority date: 1980-02-08
Filing date: 1980-12-18
Publication date: 1983-07-04
Also published as: ES256000U; IL61888A; EP0044850A1; WO1981002286A1; AU6773181A; NO813363L; DK433881A; JPS57500050A; IL61888A0; ES256000Y

Abstract

Plastic blow-molded container (20) having at least one and preferably a plurality of penetrable wall portions (22) or sites which are sufficiently thin to permit piercing by a needle (41), spike or the like without coring or fragmenting, and also having a thicker recessed wall portion (32) adjacent to each penetrable wall portion. Each penetrable wall portion (22) is formed during the blow-molding process by expanding the plastic parison (24) over a projection (28) in the mold cavity (26) and into an adjacent recess (30) in the cavity (26). The thin penetrable portion (22) of the container (20) is formed within the mold recess (30) and the thicker recessed portion (32) of the container (20) is formed by the mold projection (28). With a plurality of penetrable sites (22), liquid may be withdrawn or added through a needle (41) or spike inserted through one site, while displacement air is vented through a needle or the like inserted through another site. The sites (22) may be spaced sufficiently close together to permit sterilization, for example by swabbing, in one motion.

Description

PLASTIC CONTAINER WITH NON- CORING PENETRABLE WALL PORTION

BACKGROUND OF THE INVENTION

The present invention generally relates to plastic con¬ tainers. More particularly, it relates to plastic containers in which the contents are withdrawn or added by puncturing the wall of the container with a needle-like member. _ It is often desirable and convenient to package liquids in sealed plastic containers for later dispensing through a needle or needle-like member, such as a spike, which is inserted through the wall of a container. For example, in the medical field, a variety of liquid medicaments and other fluids, such as sterile water and saline solution, are often packaged in small glass or plastic "unit-dose" vials which hold a small quantity of the fluid, usually the amount nor¬ mally required for a single patient dose. The contents of the vial are withdrawn into a syringe, the needle of which is inserted through a penetrable portion of the container or through an open end of the container, typically provided by removing a break-off closure. Vials with break-off closures often require additional manufacturing steps or operations which tend to slow the production process, as well as extra quality control procedures.

On the other hand, vials with penetrable portions also have drawbacks. Glass vials, for example, are relatively expensive and require careful handling to prevent breakage and quality control procedures to detect minute cracks or glass particles in the fluid. Although plastic vials do not suffer from these shortcomings, both plastic and glass vials with penetrable portions have a potential for "coring" when the needle is inserted into the container. Coring generally is a cutting of the rubber or plastic during in- sertion of the needle, resulting in particles of plastic becoming lodged in the needle lumen or falling into the vial.

Before a needle can be inserted through a container wall, the surface of the container must also be sterilized, usually with a cotton swab wet with a sterilizing agent. In one previous plastic unit-dose container, a target are for puncture was delineated by a raised rib on the contai However, this resulted in shallow collection or pooling o sterilizing agent at the puncture site, with the potentia for rendering the contents of the vial unusable when the wall is punctured by a needle.

Accordingly, as set forth in the appended claims, it is a general object of the present invention to provide a improved plastic container or vial with a penetrable wall portion which does not suffer from the drawbacks discusse above.

It is a more particular object of the prevent inventi to provide a plastic container with a penetrable wall por tion which is not subject to coring upon penetration by a needle-like member and may be sterilized without retainin or pooling sterilizing agent.

It is another object of the prevent invention to pro vide a container with a plurality of penetrable wall porti to permit withdrawal of fluid from one penetrable portion while displacement air is admitted through another.

These and other objects of the prevent invention are set forth in the following detailed description of the pre ferred embodiment of the prevent invention as shown in the attached drawings, of which: Figure 1 is a perspective view of a plastic vial havi a pair of penetrable wall portions embodying the present invention.

Figure 2 is an enlarged perspective view of the pene¬ trable wall portions of the vial of Figure 1. Figure 3 is top plan view of one of the penetrable wa portions of the vial of Figure 1.

Figure 4 is a sectional view taken along line 4-4 of Figure 3.

Figure 5 is a vertical sectional view of molding ap- paratus embodying the present invention and employed in making the vial of Figure 1.

Figure 6 is an enlarged sectional view, partially removed, of the portion of the mold apparatus of Figure 5 which forms the penetrable wall portion of the vial of Figure 1.

Figure 7 is a plan view of the interior end of a mold insert member employed in molding the penetrable wall por¬ tion of the vial of Figure 1.

Figure 8 is a vertical sectional view of mold apparatus illustrating the first step of making the vial in Figure 1. Figure 9 is a vertical sectional view of mold apparatus employed in a further step of making the vial shown in Figure 1.

Figure 10 is an enlarged sectional view illustrating the molding of the penetrable wall portion of the vial of Figure 1 in accordance with the present invention. Figure 11 illustrates the step of sealing and releas¬ ing the vial of Figure 1 from the mold apparatus.

The present invention, as depicted in the attached draw¬ ings for the purpose of illustration and not limitation, is generally embodied in a plastic vial 20 which has at least one penetrable wall portion 22, through which a needle or the like may be inserted to withdraw or add-to the contents there¬ of. Referring briefly to Figures 8-10, the plastic vial 20 is of the type molded by expanding a heated plastic parison 24 against the interior surface of a mold cavity 26, some- times referred to as blow molding. In accordance with the present invention, the penetrable wall portion 22 is molded sufficiently thin to prevent coring by expanding the plastic parison 24 over an inwardly extending projection or step 28 in the mold cavity and into an adjacent recessed area 30. It is understood that the projection 28, somewhat like a dam, restricts the flow of plastic into the adjacent recessed area 30 as seen, e.g., in Figure 10. Accordingly, the vial 20 which results from this molding process has a very thin up¬ standing penetrable wall portion 22, which is formed within the mold cavity recess 30, adjacent to a thicker indented wall portion 32, which is formed around the mold projection or step 28. As shown in Figures 1 and 2, the vial 20 may include at least a pair of preferably adjacent penetrable wall portions 22, one, for example, whi:h is punctured to admit displacement air as fluid is withdrawn into a syring inserted through the other. The adjacent positioning of t 5 penetrable wall portions permits sterilization of both in one swabbing motion, while the flat surface of the penetra portion prevents pooling or collecting of the sterilizing

• -: agent.

Turning now to a more detailed description of the

10 preferred embodiment of the present invention as illustrat in the attached drawings, the vial 20 is depicted as a uni dose container, which holds a small quantity of medical li quid, typically the amount needed for a single dosage for a human patient. The vial 20 is of one-piece, integral

15 plastic construction, preferably made of polyolefin materi such as polyethylene or polypropylene. It has a bottom wall 34-, a generally cylindrical upright side wall 36, and an upwardly inclined shoulder 38 which terminates in an ex tending neck portion 40. The end of the neck 40 is flatte

20 by a heat seal to keep the contents of the vial in a steri condition. To permit contraction or expansion of the vial 20 upon removal or addition of liquid, the sidewall 36 has a collapsible, accordian-shaped portion generally at 42. In addition, the collapsible sidewall permits manual de-

25 pression of the bottom of the container to force contents from the vial more quickly if emptied through the neck 40.

Most often, the contents of the container will be wit drawn by inserting the needle 41 of a syringe through one the penetrable wall portions 22, which are also commonly

30 called injection sites (Figure 4) . It should be recognize however, that these sites may be used for adding as well as withdrawing fluid from the vial. For example other flu may be added if admixture of the contents of the vial is needed. Upon the addition of fluid, the accordian section

35 42 permits expansion of the container.

In accordance with one aspect of the present inventio coring or fragmentation of plastic in the penetrable wall_

Cl portion 22 when punctured by a needle-like member, such as a needle or spike, is prevented by molding the vial 20 so that the penetrable wall portion 22 is very thin, pre¬ ferably less than about 0.01 inches thick, as compared to 5 the thickness of other portions of the vial which may be between about 0.02 and 0.03 inches. Referring particularly to Figures 2-4, the penetrable wall portion 22 is generally circular in shape and is located at the flat end of a gen-

^:- erally truncated conical projection, generally at 44, which 0 extends upwardly from the shoulder 36 of the vial 20. As noted earlier, the penetrable wall portion 22 is molded by expanding a plastic parison 24 over a projection or step 28 in the mold cavity 26 and into an adjacent recess 30. The projecting step 28 forms the recessed portion 32 in the 5 vial 20, which of course corresponds in shape to the pro¬ jecting step. As best seen in Figure 4, the recessed wall portion 32 of the vial 20 is generally cross-sectionally v- shaped, with the sidewall of the truncated projection 44 extending down into and forming one side of the recess. 0 Referring to Figures 2 and 3 for clarity, it may be seen that the recess 32 circumscribes the truncated conical pro¬ jection 44 for about 180° on the lower side of the shoulder 38.

As noted earlier, the vial 20 preferably has two pene- 5 trable portions or injection sites 22. This provides an extra site which may be punctured or into which a needle- only may be inserted to allow displacement air to enter the vial as fluid is withdrawn through the other site. This permits virtually all the fluid in the vial to be easily 30 withdrawn into a syringe, without excessive suction force which may tend to extract air bubbles from the fluid or cause collapse of the vial wall.

Also, the injection sites 22 are typically "prepped" before insertion of a needle by swabbing the surface with

35 sterilizing agent. The close adjacent positioning of the two sites permit both to be prepped in one swabbing motion, and the flat surface of the site does not collect or pool the sterilizing agent.

The injection sites 22 themselves are not necessarily large. For example, in the illustrated embodiment, for a vial with a diameter of almost one inch, the injection sit 5 preferably have a diameter of about 0.09 inches and are sp about 25 apart on the shoulder of the vial.

Turning now to Figures 5-7, the vial 20 is molded wit the mold cavity 26, which has a shape of the desired vial : .lan thus similarly includes a bottom wall surface 46, side

10 wall surface 48 and shoulder surface 50. However, it shou be noted that a vial or container need not have this parti lar shape to incorporate a penetrable wall portion in ac¬ cordance with the present invention. The illustrated mold cavity 26 is generally formed of two mold halves, 26(a) an

15 26 (b) , each of which define one half of the body of the vi and are joined at the parting line 52 and topped by a neck ring 54 which defines the shoulder 50.

For ease of machining and assembly, the conical reces 30 and projecting step 28 in the mold cavity 26 which, re-

20 spectively, form the penetrable wall portion 22 and recess wall portion 32 of the vial, are defined on the inside sur of a cylindrical insert 56 received within a drilled openi in the neck ring 54. The recess 30 is generally centrally located at the end of the insert and preferably of truncat

25 conical shape, corresponding to the shape of the truncated conical projection 44 of the vial 20 formed therewithin, a having a draft angle for easy removal of the vial from the mold. Of course, other shapes, e.g., spherical or inverte dish shaped, could also be used without departing from the

30 present invention. As best seen in Figures 5, 6 and 10, o half of the inside surface 58 of the insert is flush with inside surface of the neck ring, but the other half, on the lower side of the shoulder, extends into the mold cavi to form the projecting step 28 of the cavity surface. In

35 a vial with an injection site of about 0.09 inches in diam as described above, the step 28 extends about 0.05 inches past the inside surface of the neck ring. Referring to Figures 6 and 7 together, it may be seen that the portion of the insert 56 which forms the step 28 is generally arcuate in that it extends for 180° around the truncated conical recess 30, and also has a tapered cross-sectional 5 shape with one side 60 of the tapered portion also being a wall of the conical recess and the other side 62 facing generally ^'downwardly into the mold cavity. Although the preferred shape of the projecting step 28 has been described ,

■ .: as with the conical recess 30, the projecting step may be of 0 various shapes or sizes and still function in accordance with the present invention to provide a vial with a non- corning penetrable wall portion. It may be seen in Figure 5 that the insert 56 is mounted in the neck ring 54 diagonally opposite the lower left corner of the cavity 26. With the 5 finished vial also having this relationship, there is plenty of room to insert a needle into the penetrable wall portion without undue risk of also penetrating a side or bottom wall of the vial. Although only one insert 56 is shown in Figures 5 and 6 for simplicity, to form a pair of penetrable wall 0 portions as shown in Figure 1, would of course require two spaced apart inserts as described above or an equivalent construction.

The actual molding of the preferred vial 20 is illustrated in Figure 8-11. Figure 8 depicts the formation of the plas- 5 tic parison 24 about a fill tube 64, through which the con¬ tents of the vial are injected. The fill tube 64 is first positioned within the cavity of a mold 66 mounted within mold framework 68. The mold cavity defines a narrow space around the fill tube, into which molten plastic is injected 0 via bottom sprue 70 in the cavity. Flow of molten plastic into the parison mold cavity is regulated by a control pin 72 which is axially movable to open or block flow through the sprue 70.

After the plastic parison 24 has been injection molded 5 around the fill tube 64 , the fill tube and parison are re¬ moved from the mold 66 and inserted into the mold cavity 26 which has the selected shape of the vial 20. The fill tube and parison are positioned in the cavity with only a rela¬ tively small distance between the bottom of the parison 24 and the bottom surface 46 of the cavity. The parison 24 is then expanded, as shown in Figure 9, to conform to the 5 inside surface of the mold cavity by pressurized injection of the actual contents of the vial through valve 74 in the lower end of the fill tube. Although not intending to rel upon a single theory for the success of the present inven- :.:tibn, it is presently understood and believed that the par 0 expands initially to conform to the lower surface of the cavity and thence upwardly along the sidewalls and shoulde of the mold cavity. As the plastic moves upwardly along the sidewalls, the inwardly protruding, wedge-shaped step 28 acts as a plastic dam, restricting or blocking the flow 5 of plastic material into the truncated conical recess 30. Thus, as seen in Figure 10, the portion of the plastic par son spanning the recess thins as it moves into the recess and results in a uniform and very thin penetrable wall por tion 22 across the end of the truncated conical recess. I 0 other words, projection 28 is positioned between the reces 30 and the lower end of the fill tube, with the downwardly facing surface 62 thereof being engaged first by the plast flow to obstruct and restrict the otherwise natural tenden of the molten plastic to flow into the recess 30. 5 After the vial 20 is filled with liquid, the fill tub is removed, a heated pin is inserted into the neck to melt the inside surface, and a pair of sealing jaws 76 compress the end of the neck 40 to form a flattened heat seal which preserves the sterility of the vial contents. The mold ^*0 halves 26(a) and 26(b) then separate to release the finish vial.

In summary, the present invention is directed to a unique plastic container with a very thin non-coring pene¬ trable wall portion that is easy to produce in large quant 5 and at relatively low cost. The pair of penetrable wall portion formed in the illustrated embodiment permit full utilization of the vial contents, are easy to prep and do not pool or collect liquid used to sterilize the surface. Although described in terms of the preferred embodiment, the present invention, as set forth in the following claims, is intended to include those equivalent structures and steps, some of which may be apparent upon initial reading of this specification, and others which may only become apparent after some study.

Claims

WHAT IS CLAIMED IS:

1. In a plastic container having walls defining an interior chamber for containing medical fluids and the lik the improvement comprising, in combination:

5 a penetrable wall portion in one of said container wa for receiving a needle-like member therethrough, said pene trable wall portion being sufficiently thin to prevent cor of plastic when penetrated by the needle-like member, and a recessed wall portion adjacent to said penetrable w 10 portion and inward of said one container wall portion, sai recessed wall portion being thicker than said penetrable wall portion.

2. A plastic container in accordance with claim 1 wh in said penetrable wall portion - is less than 0.01 inches

15 thick.

3. A plastic container in accordance with claim 1 wh in said recessed wall portion is peripherally disposed rel tive to said penetrable wall portion and only partially circumstances said penetrable wall portion.

20 4. A plastic container in accordance with claim 1 wh in said recessed wall portion is positioned between said penetrable wall portion and one end of said container.

5. A plastic container in accordance with claim 3 wh in said penetrable wall portion is generally circular, and

25 said recessed wall portion extends about 180 around said penetrable wall portion.

_*

6. A plastic container in accordance with claim 1 wh in said container has a generally vertical side wall porti a neck wall portion, and an inclined shoulder wall portion

30 between said side wall portion and said neck portion, sai penetrable wall portion being disposed in said shoulder wa portion. 7. A plastic container in accordance with claim 6 where¬ in said injection site is spaced above said shoulder wall portion.

8. A plastic container in accordance with claim 1 where- 5 in said recessed portion is cross-sectionally v-shaped.

9. A plastic container in accordance with claim 1 com- ^: ' prising a plurality of said penetrable wall portions in said container for receiving a pluiality of needle-like members therethrough to transfer contents through one of said pene- 10 trable portions while displacement air passes through another penetrable portion, said plurality of penetrable wall por¬ tions being sufficiently closely spaced to permit swabbing of said portions with sterilizing agent in generally one motion.

'15 10. A plastic container in accordance with claim 9 where¬ in said container has a pair of said penetrable wall portions.

11. A plastic container in accordance with claim 9 where¬ in said walls define a shoulder on said container, said pene¬ trable wall portions being located in said shoulder.

20 12. A plastic container in accordance with claim 11 wherein said container has a pair of said penetrable portions carried substantially side by side on said shoulder.

13. A plastic container in accordance with claim 9 wherein said container is a unit-dose vial. AMENDED CLAIMS

(received by the International Bureau on 29 May 1981 (29.05.81))

1. In a plastic container having walls defining a interior chamber for containing medical fluids and the the improvement comprising, in combination:

5 a penetrable wall portion in one of said container walls for receiving a needle-like member therethrough, penetrable wall portion being sufficiently thin to prev

^{: •}' coring of plastic when penetrated by the needle-like me ber, and

3_g a recessed wall portion adjacent to said penetrabl wall portion and inward of said one container wall, sai recessed wall portion being thicker than said penetrabl wall portion, wherein said recessed wall portion is positioned

15 between said penetrable wall portion and a bottom wall said container.

2. A plastic container in accordance with claim 1 wherein said penetrable wall portion is less than 0.01 inches thick.

20 3. A plastic container in accordance with claim 1 wherein said recessed wall portion is peripherally dis¬ posed relative to said penetrable wall portion and only partially circumscribes said penetrable wall portion.

4. A plastic container in accordance with claim 3

25 wherein said penetrable wall portion is generally circu and said recessed wall portion extends about 180° aroun said penetrable wall portion.

5. A plastic container in accordance with claim 1 wherein said container has a generally vertical side wa

30 portion, a neck wall portion, and an inclined shoulder wall portion between said side wall portion and said neck portion, said penetrable wall portion being disposed in said shoulder wall portion.

6. A plastic container in accordance with claim 5 wherein said injection site is spaced above said shoulder wall portion.

7. A plastic container in accordance with claim 1 wherein said recessed portion is cross-sectionally v- shaped.

8. A plastic container in accordance with claim 1 comprising a plurality of said penetrable wall portions in said container for receiving a plurality of needle-like members therethrough to transfer contents through one of said penetrable portions while displacement air passes through another penetrable portion, said plurality of penetrable wall portions being sufficiently closely spaced to permit swabbing of said portions with steriliz¬ ing agent in generally one motion.

9. A plastic container in accordance with claim 8 wherein said container has a pair of said penetrable wall portions.

10. A plastic container in accordance with claim 8 wherein said walls define a shoulder on said container, said penetrable wall portions being located in said shoulder.

11. A plastic container in accordance with claim 10 wherein said container has a pair of said penetrable por¬ tions carried substantially side by side on said shoulder. 12. A plastic container in accordance with claim 8 wherein said container is a unit-dose vial .

STATEMENTUNDERARTICLE19

The above-identified changes in the claims were made to overcome indefiniteness. In Claim 1 the word "portion" has been deleted so that "one container wall" has'a proper antecedent basis. Also, the subject matter of Claim 4 has been substantially incorporated into Claim 1, with minor changes. A change has been made in Claim 3 to correct an obviously typographical error. The claims have been renumbered further to the cancellation of Claim 4. Applicant's attorney states that the entire subject matter of these claims is disclosed in the specification of the international application as filed.

OMPI