GB1590516A

GB1590516A - Article having a fracturable seal

Info

Publication number: GB1590516A
Application number: GB9914/78A
Authority: GB
Original assignee: Baxter Travenol Laboratories Inc
Current assignee: Baxter International Inc
Priority date: 1977-03-14
Filing date: 1978-03-13
Publication date: 1981-06-03
Also published as: MX146319A; IL54167A; SE433340B; FR2383845B1; LU79215A1; IE780509L; IT7821101A0; ES467864A1; JPS53113688A; ATA169478A; ES252108U; NL7802685A; JPS613691B2; PT67769A; CH627703A5; IT1093214B; BR7801483A; IE46673B1; ES252108Y; AU3381478A

Abstract

The container closure connects a first plastic part (21) to a second plastic part (12) which has a substantially flat surface. The first plastic part has an outer wall which runs substantially perpendicular to the flat surface and whose one end produces a connection to the second plastic part at the flat surface thereof. This connection is formed by a thin, frangible section (24). Formed in the second plastic part (12) on the outside of the connection and adjacent thereto is a depression (23) whose inner wall is formed by the thin, frangible section (24). <IMAGE>

Description

(54) ARTICLE HAVING A FRACTURABLE SEAL (71) We, BAXTER TRAVENOL LABORA TORIES INC., a Corporation organised and existing under the laws of the State of Delaware, United States of America, of One Baxter Parkway, Deerfield, Illinois 60015, United States of America, do hereby declare the invention, for which we pray that a patent may be granted to us and the method by which it is to be performed, to be particularly described in and by the following state ment:- This invention relates to an article having a fracturable seal between a first plastics part such as a closure member, and a second plastics part having a planar surface, such as a planar surface surrounding an opening in the neck of a container. The invention is also concerned with a method of producing such a seal.

Sterile pharmaceutical solutions, such as 5 percent-dextrose, normal saline and the like, are supplied to hospitals for infusion into a patient's veins from a container hanging above the patient. The sterile liquid flows by gravity through a tubular administration set connected at one end to the container and at an opposite end to a venous needle in the patient.

Such containers are frequently formed of thermoplastic material, and will include a neck portion having one or more ports or openings extending through the neck portion.

Such ports may be commonly hermetically sealed to provide sterile sealed contents in the container.

It is desirable that the port be in a sterile environment. Difficulty is experienced with thermoplastic closures bonded directly to the bottle neck in that excessive force is required to fracture or remove the closure. Frangible thermoplastic closures are known wherein a frangible section is provided around its base defined by a series of slots or cuts in the closure; such closure does not maintain the sterile environment within the closure. An example of this type of closure is shown in United States Patent No. 3,904,060. Thermoplastic closures are also known which are bonded entirely around their base to provide a hermetic seal; a frangible section may be provided adjacent the seal. The frangible sections commonly require flexural shear force to fracture and the required force frequently is too great for many applications.

An example of a closure requiring a separate threaded screw-jack ring to attain flexural shear force to fracture the frangible section is shown in United States Patent No. 3,923,182.

The present invention provides an article including a hollow first plastics part having an aperture defined by an edge which is joined to a generally planar surface of a second plastics part to seal the opening, the joint including a thin frangible section around the aperture between the two parts, the second part having a depression in its generally planar surface, the depression being adjacent to and surrounding the thin frangible section so that the latter defines an extension of a wall of the depression, which wall is generally perpendicular to said planar surface.

The invention also provides a method of forming a fracturable seal between first and second plastics parts, of the type wherein the first part is hollow and has an aperture defined by an edge which is joined to a generally planar surface of the second part, said method comprising the steps of assembling the first part on the second part with said edge seated on the planar surface thereof; heating a sealing die above the melting point of the plastics material of said parts; bringing said sealing die towards said planar surface and in heat exchange relationship with the first part; and pressing said sealing die into said planar surface to form a depression in the planar surface with a thin frangible section fused to and joining said-parts, the depression being adjacent to and surrounding the thin frangible section so that the latter defines an extension of a wall of the depression, which wall is generally perpendicular to said planar surface.

In one embodiment, the closure material is made of the same type of material as the neck of the container so that compatibility difficulties to not arise. The closure is nonreusable; once the closure is removed, it cannot be reapplied to the container. Moreover, the closure is inexpensive.

Additionally, the closure can be used on multiple port containers; one moulded closure may be bonded to yield multiple closed chambers which cover different ports.

The closure may also be advantageously placed over a port tube projecting from the neck of the container. The closure surrounds but is spaced from the port tube, so that sufficient clearance exists when bending the closure sideways to rupture the frangible section without the port tube interfering with the closure. The closure is also adapted for closing or covering the opening in the neck of a container.

The closure may also be placed over a cannula or spike to protect it from contamination. Thus in one embodiment of the invention, the container is a hypodermic syringe with the closure being used to cover the needle.

A more detailed explanation of preferred embodiments of the invention is provided in the following description and is illustrated in the accompanying drawings, wherein: Figure 1 is a fragmentary perspective view of a container having a protective closure incorporating the present invention; Figure 2 is an elevational cross-sectional view of the container of Figure 1; Figure 3 is an enlarged fragmentary view of the frangible sealed section of the closure and container prior to rupture; Figure 4 is an enlarged fragmentary view of the frangible sealed section of Figure 3 after rupture and drawn to a larger scale; Figure 5 fragmentarily illustrates an asassembly step in the manufacture and assembly of the container of Figure 1; Figure 6 is a fragmentary perspective view of a container closure having multiple ports and protective closures according to the present invention; Figure 7 is a top plan view of the Figure 6 container closure, prior to heat sealing; Figure 8 is a cross-sectional elevation thereof, taken along the plane of the line 8-8 of Figure 7; Figure 9 is a top plan view of the Figure 6 container closure, subsequent to heat sealing; Figure 10 is an enlarged, fragmentary, cross-sectional elevation thereof, taken along the plane of the line 10-10 of Figure 9; and Figure 11 is a fragmentary cross-sectional elevation of a protective closure used on a hypodermic syringe.

Referring now to the embodiment of Figures 1 through 5, there is fragmentarily illustrated a thermoplastic container having a body 11 and an integral neck portion 12. As used herein the term neck portion 12 includes the generally vertically oriented neck of the container and any generally horizontally oriented platform or base extending from the neck or depending from the neck. The neck portion 12 is formed integrally with body 11 of the container in a conventional manner. In the illustrative embodiment, a port 15, here illustrated as a port tube formed integrally with and projecting from the neck portion 12, is provided. The port tube 15 is hermetically sealed as by a threaded closure cap 16.

A thermoplastic protective closure or protector 20 covers cap 16 to provide a hermetically sealed sterile environment. The closure 20 is generally cup-shaped having a closure cap or body portion 21 and originally has an integral thin radially outwardly extending base or flange 22 (Figure 5). in a preferred embodiment, a chamber 26 is defined between the flange 22 and body portion 21. The flange 22 is removed from the body portion during heat sealing and is formed into an annular bead 19 as a result of downward heat and pressure. The downward heat and pressure also forms a depression 23 (Figure 3) around the top surface of neck 12.

A frangible web or section 24 is thus formed normal to the top surface of neck 12 with frangible section 24 forming an extrusion of the vertical side wall of depression 23, the chamfer 26 being located adjacent frangible section 24.

Advantageously the frangible section 24 will rupture under tensile load to provide a horizontal break as shown in Figure 4. The tensile strength of one suitable polyolefin, e.g., polypropylene, is in the range of 4300 and 5500 psi (about 302 to 386 kg./cm.2), compared with its flexural yield strength of 6000 to 8000 psi (about 421 to 562 kg./cm.2). The seal will therefore rupture under less load than prior commercial seals to make removal of the closure easier. Therefore, although the closure may be used with a screw jack, it does not require a screw jack to fracture the frangible section. Additionally, the illustrated horizontal break of the frangible section minimizes the undesirable sticking of a portion of the section, because of the relatively clean and simple rupture of the frangible section as compared with frangible sections requiring a rupture by shear force. The closure is sealed completely around the port with no vent or opening, so that sterilty is thus secure.

The closure 20 may be sufficiently long so that when manually pushed sideways, a sufficient mechanical advantage or leverage is provided so that the frangible section will rupture. It has been found that a length at least as great as the diameter of the body portion 21 is satisfactory. Moreover, the diameter of the closure 20 should be sufficiently greater than the diameter of the port tube so that the port tube will not interfere with or support the closure when the body portion thereof is bent sideways.

A preferred method of assembling the closure 20 with the container is illustrated in Figure 5. As therein illustrated, the closure 20 is assembled over the port or opening with the flange 22 resting on the planar top surface of the neck portion 12. A heat and pressure sealing die 28 is heated above the melting temperature of the plastics materials. The chamfer 26 will aid in centering the sealing die 28.

The sealing die 28 melts the closure flange 22 and continued downward pressure forms the depression 23 and also forms the thin frangible section 24 in the side wall of the depression 23 in the area of the internal diameter of the sealing die. The downward heat and pressure also forms the flange material into an annular bead 19.

Suitable thermoplastic materials include various polyolefins, for example, polyethylene, polypropylene and copolymers of these.

The heating die 28 may be heated in the range of 1 F. to 100 F. (about 0 5 to 55 C.) above the melting point of the plastics, preferably about 50"F. (about 27"C.).

In a particular embodiment, a depression 0 020 inch (about 5cam.) deep (dimension a, Figure 3) was formed and a thin, vertical frangible section 24 normal to the planar surface of the neck portion 0005 inch (about 013 cm.) wide remained. It is preferred that the depression be at least 0.005 inch (about 0-13 cm.) deep. The frangible section 24 will fracture horizontally in a generally horizontal plane due to tension stress when the closure is removed.

There is illustrated in Figures 6--10 an embodiment of a container having a neck portion 30 bondable to the container and provided with multiple ports. As illustrated, the neck portion 30 is formed of molded thermoplastic material and has a first port tube 33 projecting above the neck portion 30.

A resilient, pierceable seal 32 is pressure fitted on port tube 33, over a frangible disc-shaped seal 331, to form an injection site. A second port tube 31 is formed with the neck portion 30 and includes a frangible disc-shaped seal.

A protective closure 34 covers both port tubes 31 and 33. The protective closure includes a projecting first closure cap portion 35 extending over the port tube 31 and a projecting second closure cap portion 36 covering the port 33. As shown in Figures 78, closure 34 orginally includes a flange portion 38 extending radially outwardly from and interconnecting closure cap portions 35 and 36.

As with the Figures 1-5 embodiment, the closure 34 is assembled over port tubes 31 and 33 with the flange portion 38 resting on the planar top surface 40 of the neck portion 30.

A heat and pressure sealing die is heated above the melting temperature of the plastics materials. The sealing die melts the flange portion 38 and continued downward pressure forms a depression 42 completely surrounding cap portions 35 and 36 and forces the flange portion material to be completely displaced and resultingly deposited as an annular bead 44, which annular bead is substantially the outline of the sealing die. As a result of this sealing action, a frangible section 46 is formed normal to the planar surface 40 with the frangible section forming a vertical side wall of depression 42. Frangible section 46 will rupture under tensile load to provide a horizontal break in the same manner that frangible section 24 of the Figures 1-5 embodiment ruptures.

Each of the protective closure cap portions 35, 36 have a length to diameter ratio which provides good leverage at the surface 40 to provide sufficient mechanical advantage permitting manual rupture at surface 40. A length at least as great as the diameter of the closure cap portions 35, 36 has been found to work satisfactorily.

Figure 11 a closure cap 50 is shown covering the needle 52 of a hypodermic syringe 54. The body 56 of syringe 54 includes a neck portion 58 on which closure cap 50 is seated, having a frangible section 60, formed in the same manner as the frangible section 24 of the Figures 1-5 embodiment is formed.

Advantageously the protective closures may be applied on single port or multiple port containers and are sealed completely around each port, with no vent or opening, thus securing the sterility of the port. The mechanical advantage provides sufficient leverage so that the closure can conveniently be removed by pushing sideways to rupture the frangible section. On a multiple port protector, each of the protective closures may be removed without disturbing the other.

The closure may be applied to all types of containers, including bottles, syringes, bags, etc.

WHAT WE CLAIM IS: 1. An article including a hollow first plastics part having an aperture defined by an edge which is joined to a generally planar surface of a second plastics part to seal the aperture, the joint including a thin frangible section around the aperture between the two parts, the second part having a depression in its generally planar surface, the depression being adjacent to and surrounding the thin frangible section so that the latter defines an extension of a wall of the depression, which wall is generally perpendicular to said planar surface.

2. An article according to claim 1, wherein said second part is a container having a neck portion provided with an opening, said generally planar surface being on said

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Claims

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with or support the closure when the body portion thereof is bent sideways.

A preferred method of assembling the closure 20 with the container is illustrated in Figure 5. As therein illustrated, the closure 20 is assembled over the port or opening with the flange 22 resting on the planar top surface of the neck portion 12. A heat and pressure sealing die 28 is heated above the melting temperature of the plastics materials. The chamfer 26 will aid in centering the sealing die 28.

The sealing die 28 melts the closure flange 22 and continued downward pressure forms the depression 23 and also forms the thin frangible section 24 in the side wall of the depression 23 in the area of the internal diameter of the sealing die. The downward heat and pressure also forms the flange material into an annular bead 19.

Suitable thermoplastic materials include various polyolefins, for example, polyethylene, polypropylene and copolymers of these.

The heating die 28 may be heated in the range of 1 F. to 100 F. (about 0 5 to 55 C.) above the melting point of the plastics, preferably about 50"F. (about 27"C.).

In a particular embodiment, a depression 0 020 inch (about 5cam.) deep (dimension a, Figure 3) was formed and a thin, vertical frangible section 24 normal to the planar surface of the neck portion 0005 inch (about

013 cm.) wide remained. It is preferred that the depression be at least 0.005 inch (about 0-13 cm.) deep. The frangible section 24 will fracture horizontally in a generally horizontal plane due to tension stress when the closure is removed.

There is illustrated in Figures 6--10 an embodiment of a container having a neck portion 30 bondable to the container and provided with multiple ports. As illustrated, the neck portion 30 is formed of molded thermoplastic material and has a first port tube 33 projecting above the neck portion 30.

A resilient, pierceable seal 32 is pressure fitted on port tube 33, over a frangible disc-shaped seal 331, to form an injection site. A second port tube 31 is formed with the neck portion 30 and includes a frangible disc-shaped seal.

A protective closure 34 covers both port tubes 31 and 33. The protective closure includes a projecting first closure cap portion 35 extending over the port tube 31 and a projecting second closure cap portion 36 covering the port 33. As shown in Figures 78, closure 34 orginally includes a flange portion 38 extending radially outwardly from and interconnecting closure cap portions 35 and 36.

As with the Figures 1-5 embodiment, the closure 34 is assembled over port tubes 31 and 33 with the flange portion 38 resting on the planar top surface 40 of the neck portion 30.

A heat and pressure sealing die is heated above the melting temperature of the plastics materials. The sealing die melts the flange portion 38 and continued downward pressure forms a depression 42 completely surrounding cap portions 35 and 36 and forces the flange portion material to be completely displaced and resultingly deposited as an annular bead 44, which annular bead is substantially the outline of the sealing die. As a result of this sealing action, a frangible section 46 is formed normal to the planar surface 40 with the frangible section forming a vertical side wall of depression 42. Frangible section 46 will rupture under tensile load to provide a horizontal break in the same manner that frangible section 24 of the Figures 1-5 embodiment ruptures.

Each of the protective closure cap portions 35, 36 have a length to diameter ratio which provides good leverage at the surface 40 to provide sufficient mechanical advantage permitting manual rupture at surface 40. A length at least as great as the diameter of the closure cap portions 35, 36 has been found to work satisfactorily.

Figure 11 a closure cap 50 is shown covering the needle 52 of a hypodermic syringe 54. The body 56 of syringe 54 includes a neck portion 58 on which closure cap 50 is seated, having a frangible section 60, formed in the same manner as the frangible section 24 of the Figures 1-5 embodiment is formed.

Advantageously the protective closures may be applied on single port or multiple port containers and are sealed completely around each port, with no vent or opening, thus securing the sterility of the port. The mechanical advantage provides sufficient leverage so that the closure can conveniently be removed by pushing sideways to rupture the frangible section. On a multiple port protector, each of the protective closures may be removed without disturbing the other.

The closure may be applied to all types of containers, including bottles, syringes, bags, etc.

WHAT WE CLAIM IS: 1. An article including a hollow first plastics part having an aperture defined by an edge which is joined to a generally planar surface of a second plastics part to seal the aperture, the joint including a thin frangible section around the aperture between the two parts, the second part having a depression in its generally planar surface, the depression being adjacent to and surrounding the thin frangible section so that the latter defines an extension of a wall of the depression, which wall is generally perpendicular to said planar surface.
2. An article according to claim 1, wherein said second part is a container having a neck portion provided with an opening, said generally planar surface being on said

neck portion and lying in a plane transverse to the opening, said first part being a cupshaped protective closure covering the opening in the neck portion.
3. An article according to claim 2, wherein the outer peripheral surface of the closure forms an extension of said wall of the depression and said outer peripheral surface is provided with a chamfer spaced axially from said frangible section.
4. An article according to claim 2 or 3, wherein said closure member has a length to diameter ratio providing sufficient mechanical advantage leverage to rupture the frangible section when the closure member is pushed sideways by hand.
5. An article according to claim 4, wherein the length of said closure is at least equal to the diameter thereof.
6. An article according to claim 4 or 5, wherein the container opening is provided with a port tube projecting from the container neck portion, the closure is spaced from said tube whereby said protective closure may be pushed sideways to rupture the frangible section without interference from the tube.
7. An article according to any one of claims 2 to 6, wherein the opening is defined by at least two ports.
8. A method of forming a fracturable seal between first and second plastics parts, of the type wherein the first part is hollow and has an aperture defined by an edge which is joined to a generally planar surface of the second part, said method comprising the steps of assembling the first part on the second part with said edge seating on the planar surface thereof; heating a sealing die above the melting point of the plastics material of said parts; bringing said sealing die towards said planar surface and in heat exchange relationship with the first part; and pressing said sealing die into said planar surface to form a depression in the planar surface with a thin frangible section fused to and joining said pants, the depression being adjacent to and surrounding the thin frangible section so that the latter defines an extension of a wall of the depression, which wall is generally perpendicular to said planar surface.
9. A method according to claim 8, wherein said sealing die is heated in the range of 1"F. to 100 F. above the melting point of said plastics material.
10. A method according to claim 8 or 9, wherein said first part includes a chamfer and said method includes the step of centering said sealing die on said chamfer.
11. A method according to claim 8, 9 or 10, wherein said planar surface is depressed at least 005 inch from its original height by the sealing action of the die.
12. A method according to any one of claims 8 to 11, in which a horizontal annular flange is provided on the first part and extends into the path of the die.
13. A method accordingto any one of claims 8 to 12, wherein the first part is a cupshaped closure member and the second part includes in said planar surface which is closed by the closure.
14. A sealed container substantially as herein described with reference to the embodiment of Figures 1 to 4, the embodiment of Figures 6, 7 and 8, the embodiment of Figures 9 and 10, or the embodiment of Figure 11.