Title:

Radially compressed self-sealing septum

United States Patent Application 20030201239

Kind Code:

A1

Abstract:

A septum used for sealing an opening formed in a neck of a container, the septum includes a top septum member that fits over the outside of the opening in the container and a bottom radial septum member structurally connected below the top septum to seal inside the neck of the container.

Inventors:

Hudak, Philip J. (Thousand Oaks, CA, US)
Kiliszewski, Lawrence C. (Valencia, CA, US)

Application Number:

10/131905

Publication Date:

10/30/2003

Filing Date:

04/25/2002

Export Citation:

Click for automatic bibliography generation

Assignee:

MEDTRONIC MINIMED, INC.

Primary Class:

215/247

Other Classes:

215/355

International Classes:

A61J1/00; A61J1/14; B65D39/00; B65D51/00; (IPC1-7): B65D39/00

View Patent Images:

Download PDF 20030201239

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Primary Examiner:

NGO, LIEN M

Attorney, Agent or Firm:

MEDTRONIC MINIMED, INC. (Northridge, CA, US)

Claims:

What is claimed is:

1. A septum used for sealing an opening formed in a neck of a container, the septum comprising: a top septum member that fits over the outside of the container forming an opening; and a bottom radial septum member structurally connected below the top septum to seal inside the neck of the container.

2. The septum of claim 1, wherein the bottom radial septum member has an upper portion and a lower portion, and wherein the upper portion of the bottom radial septum member is structurally connected to the top septum.

3. The septum of claim 2, wherein the bottom radial septum member has a radial middle section, and wherein the radial middle section has a diameter greater than the upper and lower portion of the bottom radial septum member to create compression against the interior of the container.

4. The septum of claim 2, wherein the lower portion of the bottom radial septum member has a concave spherical geometry, and wherein the concave spherical geometry of the bottom radial septum member lower portion prevents the septum from bowing out when in a compressed state.

5. The septum of claim 1, wherein the septum is composed of a self-sealing septum material.

Description:

FIELD OF THE INVENTION

[0001] This invention relates generally to septums for containers and, in particular embodiments, to a septum for a vial that utilizes a radially compressed self-sealing septum.

BACKGROUND OF THE INVENTION

[0002] Pharmaceutical vials are used to hold liquid medications such as insulin for later administration to a patient. Traditionally, these vials include a lid, having a layer of septum to seal in the contents of the vial. Medication is generally extracted from the vial by piercing the septum with a sharp point such as a hypodermic needle.

[0003] Typically, the septum is fixed onto an open end of the vial and is secured by a fitted metal collar that covers the septum. The fitted metal collar is crimped to conform to the open end of the vial and to secure the septum in place. A portion of the collar includes an opening to expose the septum beneath and to allow access for a needle to pierce the septum as described above. The septum layer is generally intended to be resealing to prevent the contents of the vial to leak out after the needle is withdrawn. However, in many instances leakage from the pierced septum layer does occur after the removal of the needle. Furthermore, gaps caused by the piercing of the septum may contribute to contaminants entering into the vial.

SUMMARY OF THE DISCLOSURE

[0004] It is an object of an embodiment of the present invention to provide a radially compressed self-sealing septum, which obviates for practical purposes, the above mentioned limitations.

[0005] According to an embodiment of the invention, a septum used for sealing an opening formed in a neck of a container includes a top septum member that fits over the outside of the opening in the container, and a bottom radial septum member structurally connected below the top septum member to seal inside the neck of the container. The bottom radial septum member has an upper portion, a lower portion, and a radial middle section. Preferably, the radial middle section has a diameter greater than the upper and lower portion of the bottom radial septum member to create compression against the interior of the container.

[0006] In a further embodiment of the present invention, the lower portion of the bottom radial septum member has a concave spherical geometry. It is the concave spherical geometry of the lower portion of the bottom radial septum member that prevents the septum from bowing out when in a compressed state. Furthermore, the septum is composed of a self-sealing septum material.

[0007] In an alternative embodiment of the present invention, a closure may be used for sealing an opening in a container. The closure includes a neck of a container, a radially compressed self-sealing septum which seals the neck of the container, a collar fitted over the septum and neck of the container to secure the septum in place.

[0008] Other features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, various features of embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] A detailed description of embodiments of the invention will be made with reference to the accompanying drawings, wherein like numerals designate corresponding parts in the several figures.

[0010] FIG. 1 is an enlarged cross-sectional side view of the septum and vial, in accordance with an embodiment of the present invention;

[0011] FIG. 2 is an enlarged cross-sectional side view of the septum and vial in accordance with the embodiment shown in FIG. 1;

[0012] FIG. 3 is an enlarged cross-sectional view of the septum in accordance with the embodiment shown in FIG. 1;

[0013] FIG. 4 is an enlarged perspective bottom view of the septum in accordance with the embodiment shown in FIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] As shown in the drawings for purposes of illustration, the invention is embodied in a radially compressed self-sealing septum. In preferred embodiments of the present invention, a septum having a top septum member structurally connected to a bottom radial septum member, and is used to seal a vial, or the like, to contain fluids, such as medications, drugs, vitamins, vaccines, peptides or the like. Preferred embodiments of the vial are made out of glass. However, alternative embodiments of the vial may be formed from plastic, metal, ceramic, composite, laminates, or the like.

[0015] Preferred embodiments of the present invention include a top septum member structurally connected above a bottom radial septum member. The bottom radial septum member is inserted into a vial, or the like, to seal the contents within. The bottom radial septum member includes a radial middle portion of a large diameter which becomes compressed when inserted within the vial, or the like, having a smaller diameter. This compression creates a self-sealing effect on the entire bottom radial septum, specifically allowing a puncture from a hypodermic needle, or the like, to self-seal.

[0016] FIGS. 1 and 2 illustrate a radially self-sealing septum 10 and container 12 in accordance with a first embodiment of the present invention. The radially self-sealing septum 10 includes a top septum member 14, and a bottom radial septum member 16.

[0017] In preferred embodiments, the top septum member 14 serves as a closure first for the opening in the container (for example, a vial). The top septum member 14 is generally external to the container and is composed of an elastomer type material such as but not limited to rubber, or the like, that is capable of being pierced by a sharp object such as a hypodermic needle, or the like, and has the ability to self-seal when in a compressed state. In alternative embodiments, it may be necessary for the top septum member 14 to be composed of a different material or a combination of materials such as silicone, bromobutyl, natural synthetic isoprene, nitrile, ethylene propylene diene monomers, or the like, to prevent a damaging interaction between the septum material and the fluids within the container.

[0018] In preferred embodiments, the bottom radial septum member 16 is structurally connected below the top septum member 14. An upper portion 18 of the bottom radial septum member is attached to the top septum member 14, where a lower portion 20 of the bottom radial septum member 16 is unattached and is within the container when the septum 10 is in use. The bottom radial septum member 16 includes a radial middle section 22 having a diameter larger than the top 18 and lower portion 20 of the bottom radial septum member 16, but similar to the top septum 14. In alternative embodiments, the diameter of the radial middle section 22 may vary depending on the type of container used, and may exceed the diameter of the top septum. However, the diameter of the radial middle section 22 will exceed the diameter between the interior walls 24 of the container. The large diameter of the radial middle section 22 of the bottom radial septum member 16 extends outwardly and becomes compressed by the interior walls 24 of the container when the bottom radial septum member 16 is inserted into the container. Consequently, the compression causes the bottom radial septum member 16 to self-seal when a hypodermic needle, or the like, is withdrawn.

[0019] FIGS. 3 and 4 illustrate the self-sealing septum 10 in accordance with an embodiment of the present invention that utilizes the septum shown in FIGS. 1 and 2. In preferred embodiments, the self-sealing septum 10 includes a bottom radial septum member 16 having a lower portion 20 with a concave spherical geometry. The lower portion 20 of the bottom radial septum member 16 is spherically indented to prevent the bottom radial septum member 16 from bowing out when it is in a compressed state, therefore maintaining its ability to self-seal. In alternative embodiments, the lower portion 20 of the bottom radial septum member 16 may differ in its geometry to adapt to varying degrees of compression.

[0020] While the description above refers to particular embodiments of the present invention, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention.

[0021] The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, rather than the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

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