CN1004925B - Integral plastic container with needle cavity block-proof leakage-free penetrating part - Google Patents

Abstract

A container used for sterile instruments, the part penetrated by the syringe needle can prevent the needle cavity from being blocked, avoid leakage, and form a whole with the container. It uses a double-domed structure to allow the needle to penetrate without clogging the needle cavity and to provide a seal between the container and the needle. Advantages are also provided for ensuring a tight seal when larger plastic needles are used.

Description

Integrated plastic container with needle cavity anti-blocking and leakage-free penetration part

The invention relates to a molded plastic container with a penetration part of a needle cavity anti-blocking block without leakage, in particular to a container, wherein the penetration part and the container are of an integral structure.

In the treatment of patients in hospitals or treatment units, the transfer of medication between a container and a supply line, or between containers, is often accomplished with injection needles and syringes, or transfer needles, or needles mounted at the ends of solution transfer devices.

When liquids or solutions are withdrawn from or poured into containers using needles and syringes, or using transfer needles, typical containers in use today have a rubber stopper with a thinned or membrane-like portion over which the metal needle is inserted. The membrane serves to provide an insertion point for the needle to penetrate and also to create a seal around the needle so that the heel of the needle does not cut the rubber into a small piece or cut a block when the needle pierces the membrane portion of the rubber stopper. The softness and elastomeric nature of the rubber makes such penetration possible.

The above-mentioned cut-out portion or block of rubber, known as a needle lumen block, is stuck in the needle lumen, which creates the possibility of introducing this "particulate" into the patient's blood vessel and may interfere with the transfer of the solution and should be prevented.

When transferring the solution from the container to a supply tube using a transfer device, a large-bore plastic needle is typically used, in a manner similar to the use of the metal needles described above. In this case, needle lumen blocking should also be avoided. However, when the needle body penetrates the stopper, it is difficult to form a seal around it, since it is known that the holes formed by large-bore plastic needles tend to be irregular in shape.

Containers for use in the current application are constructed of glass or rigid plastic with rubber stoppers thereon, or a flexible bag with tubular fitment portions assembled or attached thereto for placement or support of a membranous body for penetration by a metal or plastic needle.

Such containers for use in fluid applications are constructed from separate components that must be combined or assembled. Since the contents of the bottles are generally sterile, sterility must be maintained during bottling. Obviously, the cost of manufacturing or processing such a system to provide a sterile medication to a hospital or hospital bed environment with a combination of components is quite expensive.

Due to recent developments in plastic container manufacturing technology, it is possible to make containers in one process, inject sterile, non-heat generating solutions, and then seal in a sterile state. However, while machines have been available to accomplish such a manufacturing process, heretofore, it has not been possible to create a container configuration that prevents needle lumen blocking when penetrated with an injection needle and forms a seal around the needle body when the needle is inserted into the container.

Methods and apparatus for molding and sealing plastic containers are described in U.S. patent nos. 3,851,029 and 4,172,534. It can be seen from the latter patent that this patent does also solve the problem of the penetration point of the needle, but this construction is expensive and does not make full use of the moulding techniques that are now available.

In accordance with the principles of the present invention, a blow molded container is provided that is sealed with an integrally formed pin point after pouring the solution. The contact pin point can prevent blocking and leakage when the needle is used for puncture.

It has been found that the above-described effect of the rubber stopper film portion can be mimicked by an integrally formed portion. In place of the closure, a double dome is formed on the container in a location generally adjacent to where the closure of a conventional container is located.

The double arch has a main arch extending radially outwardly of the neck of the container. A small dome, also called the secondary dome, is located on the upper surface of the primary dome, eccentrically to the primary dome. The seam line of the mould should deviate from the centre of the main arch on the top of the main arch to avoid interfering with the form of the secondary arch.

The plastic of the primary arch is of sufficient thickness to maintain its shape and the secondary arch is pierced during insertion of the pin without deformation of the primary arch. The secondary dome has a thickness slightly less than the primary dome and varies with the method of manufacture, location, size and depth.

In a preferred embodiment of the present invention, a blow molded plastic container is provided having a body and a neck portion in communication with the body and extending from a solid body. And a hollow dome having a diameter greater than the neck. The dome is located at the other end of the neck, is completely closed, is generally circular, is concentric with the neck, and has a regular arcuate outer surface. The outer surface has a secondary dome thereon having a smaller diameter than the primary dome and being offset from the center line of the primary dome in a direction away from the molding seam line of the primary dome.

For the transfer of liquid by puncturing the container with the injection needle, the tip of the needle is pressed against the secondary dome. When the needle pierces the secondary dome, a dimple is first formed in the top wall of the secondary dome.

The dimple is formed on the surface of the auxiliary vault, so that the needle cavity can be prevented from being blocked, and for a small-aperture steel needle, the tight contact between the plastic material and the needle body can be ensured, so that the needle can be correctly sealed when being inserted in the container.

For plastic needles, the diameter of the inner surface of the neck is calibrated to match the diameter of a large plastic needle, so that the seal is maintained as long as the outer surface of the plastic needle is in contact with the inner surface of the neck.

Thus, the construction described above can accommodate both metal needles and plastic needles, preventing the needle cavity from blocking during the infusion of liquid with the needle in both cases, while ensuring a correct seal.

It is therefore a primary object of the present invention to provide a molded, sealed container having an integrally formed needle cavity blocking prevention and leak free portion.

Other objects and advantages of the present invention will become apparent from the following description of other desirable embodiments of the present invention.

Fig. 1 is a perspective view of a container embodying principles of the present invention.

Fig. 2 is a side view, partially in section, of the upper portion of the dome.

Fig. 3 is a top view of the dome of fig. 2.

Fig. 4 to 7 show the patterns of the steel needle puncture auxiliary dome.

Fig. 8 is a view of a plastic needle inserted into the container of fig. 1.

As shown in FIG. 1, the container 10 has a hollow body 12 which may have any convenient cross-section, such as square, rectangular or circular, a neck 14 having a regular circular inner diameter over a substantial portion of its length, and a symmetrical major dome 16 of larger cross-section.

The container 10 is molded from any commercially available suitable plastic material, the plastic characteristics of which are described below, using blow molding. A mold seam line 18 is provided, as is known in the art, depending on the equipment used to manufacture the container.

Referring more particularly to fig. 2 and 3, the integral anti-block leak-free puncture site, which forms a major aspect of the present invention, includes a main dome 16 having a generally circular outer edge 22 and an upper outer surface (or shell) 24. The outer surface is generally convex outwardly with a regular curved surface and has a uniform thickness. Shoulder 25 provides additional support to dome 16.

A secondary dome 26 is formed on the outer surface 24 and is offset from the centerline of the neck 14, has a diameter substantially less than the dome 16, and is reduced in thickness. It can be seen that the seam line 18 has a curved arc that diverges the secondary dome 26 toward the other side of the centerline so that the seam line does not pass through the centerline and does not interfere with or affect the shape and thickness of the secondary dome. The height of the primary dome 16 in the vertical line should be at least the same as the height of the secondary dome 26 in the vertical line, and preferably be relatively high, so that the secondary dome 26 is not damaged by the mechanical trimming of the excess material on the seam 18.

The plastic material comprising the container 10 is suitably rigid to maintain its shape in normal use and movement, but should also have a suitable yield and flexibility, as will be appreciated from the state of the art, to enable it to function in the manner described below.

As shown in fig. 4-7, a hollow steel needle 28 with a sharp tip 32 and an opening or lumen 34 is piercing the secondary dome 26. It will be appreciated that needle 28 may extend from a syringe (not shown) or may simply be a needle transfer device to which liquid in container 10 is transferred or vice versa from the device to container 10.

As shown in FIG. 4, tip 32 is positioned at the center of secondary dome 26 in a direction that is about the centerline of neck 14 and is slightly inclined by about 20 degrees. When pushing the needle 28 downwardly, a dimple 36 is first formed in the dome wall 26, and then the needle 28 penetrates the top wall. The dimple can be formed prior to penetration because dome 26 has a desired shape and reduced thickness compared to main dome 16. Dimple is necessary because the open edge 38 of the dome 26 can be pushed away from the needle cavity 34 so that no blocking occurs and the open edge of the downwardly curved plastic wall abuts the outer surface of the needle 28 as the needle 28 is pushed into the body 12, thereby providing a seal against contaminants entering the container 10.

It is tolerable for the outer surface 24 of the main dome 16 to bend slightly downwardly, but the thickness of the dome 16, and particularly the side wall 22, should be sufficient to prevent the side wall from collapsing. Which is described herein as an accidental deformation of the dome 16, should be prevented. The outward bulge of the outer wall 24 is an important feature that allows for slight deformation, while helping to prevent collapse, or accidental deformation, of the dome 16, with the shoulder 25 facilitating this effect.

It was found that when large diameter plastic infusion needles are applied to the container 10, a choking event would not occur, but that when the dome 16 is pierced, there is no proper seal around the needle body, as it would appear to be due to the irregular holes that the needle pierces. But may be penetrated by such large diameter needles and also because, as described above, the secondary dome 26 has a desired shape and a desired thinned portion.

As can be seen from fig. 5, when a plastic needle 42 is used, the neck 14 forming part of the container 10 has an inner surface 44 which is circular in cross section, has a diameter no greater than the outer diameter of the needle 42, and has a certain measure to match the outer diameter of the plastic needle, and has no seams over a substantial length, and is regularly shaped to ensure a tight seal between the needle 42 and the surface 44. In relatively small capacity bottles, such as 5 ml capacity, where a plastic needle cannot be used, a neck inside diameter of a prescribed size is not required. If the prescribed measure is not used, an unnecessary process can be omitted during the molding process.

The container 10 may thus be used with either a steel needle 28 or a conventional oversized plastic needle 42, except for the special cases described above. In some cases, the container 10 may be used for both transferring liquids and transferring gaseous medications.

Containers made in accordance with the principles of the present invention may be blow molded, filled with a drug or aqueous solution, and then sealed, all in a continuous operation using commercially available machinery. For example, a container having the shape shown in the drawings is molded from "Kanetowax" (Tenite) polysomy (M7853-296E) manufactured by Isoman chemical Co (EASTMAN CHEMICAL Co.) and low density polyethylene (Rexene PE 107) manufactured by El Paso Polyolefins. Both are commercially available. The machine used was a "Bottle Pack" machine available from Sulzbach-Laufen Kocher Plastik, inc. The diameter of the primary dome is 14 mm and the rim height is 1mm, the total height of the dome 16 to the top of the secondary dome 26 excluding the shoulder 25 is 6.5 mm. Dome 26 has a diameter of 5.5 mm and a depth of 1mm. The minor crown wall has a minimum thickness of 0.2 mm to prevent blocking with steel needles and to provide a proper seal, typically in the range of 0.2 to 0.25 mm. The thickness of the main dome 16 is greater than this.

It can thus be seen that the invention provides a container having an integrally formed, non-leakage puncture point for the penetration of steel and plastic needles.

The containers produced according to the principles of the present invention make it possible to produce containers of high quality and reliability at a far lower cost than those currently available and suitable for the purposes described herein.

While only the preferred embodiments of the present invention have been disclosed herein, it will be appreciated that various changes and modifications may be made to the invention without departing from the principles defined in the following claims.

Claims (5)

1. A blow molded sealed container of unitary construction having a puncture site for penetration by a steel or plastic needle, comprising:

a) A body for containing or receiving a liquid,

B) A hollow neck portion extending from said body and communicating with the interior thereof,

Characterized in that it further comprises a hollow, fully closed main dome means formed on the other side of said neck and communicating with the interior thereof, a substantially circular shell of uniform thickness having a generally regular arcuate surface projecting outwardly of a diameter greater than said neck and concentric with the central axis of the neck, the outer surface of said shell having a non-leaking pin portion which is a secondary dome (26) of smaller diameter than said arcuate shell and having a curved surface which is dimpled by the needle prior to penetration and which is pressed against the outside of the needle by the open edge around the hole formed by the needle after penetration to seal the hole against entry of contaminants.

2. A container as claimed in claim 1 wherein the wall of said primary dome means has a thickness sufficient to prevent accidental deformation of said primary dome when said steel or plastic needle is depressed and penetrated in said secondary dome. The wall thickness of the secondary dome is much smaller than the wall thickness of the primary dome assembly to ensure that the steel or plastic needle achieves a non-blocking penetration on the secondary dome and maintains a seal around the outer surface of the steel needle.

3. A container as claimed in claim 2 wherein a moulded seam line passes over said primary dome means, said seam line being curved on the outer surface of said primary dome means to bypass said secondary dome.

4. A container as in claim 3 wherein the centerline of said secondary dome extending into said primary dome means is inclined about 20 degrees from the centerline of said neck portion, the primary dome means being at least as high on a vertical line as the secondary dome.

5. The container of claim 1 wherein said neck has a circular inner bore with a constant diameter that matches the diameter of the plastic needle over a substantial length to prevent leakage.

Images