Patent Description:
For automated assembly purposes, individual drug container pistons are often positioned in array form, i.e. rows and columns. As discussed herein, a piston array may include any number of pistons and is not limited to a particular matrix configuration. Preferably, the arrangement of a piston array is maintained during automated assembly by positioning individual drug container pistons in a piston nest.

A piston nest is typically a substantially planar tray that includes a plurality of individual nesting units. Each nesting unit is configured to receive a drug container piston. Exemplary piston nests are described in <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

During automated assembly of drug containers (e.g. syringes), a piston nest assembly, which includes the piston nest and a plurality pistons arranged in individual nesting units of the piston nest, is positioned above a similarly oriented tray with pre-filled drug container barrels. As assembly of the drug containers progresses, each piston from the piston nest is pressed into and aligned with an underlying drug container barrel, using automated means. Automated means may include, but is not limited to, mechanical pins and/or cams used to push each drug container piston out of a piston nest and into the underlying drug container barrel.

To assure that all assembled parts of the drug container are suitable for use, it is important to properly package the piston nest assembly, and orient individual pistons within the nesting unit for sterilization, as well as various stoppering and filling methods. When piston nest assemblies are properly packaged, various contaminants are prevented from negatively impacting sterilization, integrity and/or usability as a part of a primary container.

Current methods of packaging piston nest assemblies, however, do not include use of a cover or other structure that would protect and/or orient individual pistons for sterilization, stoppering, and filling of the drug container. Accordingly, there is a need for covers for drug container piston arrays and piston nests, as well as packages for cover and piston nest assemblies.

The invention is defined in claims <NUM> and <NUM>. Advantageous embodiments are subject of the dependent claims.

In one preferred embodiment, a cover for a drug container piston array includes a plurality of cover sections configured for positioning over the drug container piston array. Each cover section includes a cover section body, having an open base end and a closed capped end, and a plurality of base sections positioned between the plurality of cover sections and coupled to each base end. Disposed within the cover section body are radially positioned locators placed in substantially equidistant intervals on inner surfaces of the cover section body.

Packages for a cover and piston nest assembly may include either embodiment of the cover and a piston nest disposed within a container.

The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements shown. In the drawings:.

Reference will now be made in detail to the present embodiments of the invention illustrated in the accompanying drawings. Wherever possible, the same or like reference numbers will be used throughout the drawings to refer to the same or like features. It should be noted that the drawings are in simplified form and are not drawn to a precise scale. In reference to the disclosure herein, for purposes of convenience and clarity only, directional terms such as top, bottom, above, below, distal, and transverse, are used with respect to the accompanying drawings. Such directional terms used in conjunction with the following description of the drawings should not be construed to limit the scope of the invention in any manner not explicitly set forth herein. Unless specifically set forth herein, the terms "a", "an" and "the" are not limited to one element but instead should be read as meaning "at least one". The terminology includes the words noted above, derivatives thereof and words of similar import.

Turning in detail to the drawings, <FIG> show various configurations of covers and embodiments of piston nest assemblies and packages for covers and piston nest assemblies. <FIG> show a piston nest <NUM>, a drug container piston array <NUM>, and a cover <NUM>, according to a first configuration, disposed within a container <NUM>. Together these elements form a package <NUM> for a cover <NUM> and a piston nest assembly <NUM>.

The container <NUM> is preferably manufactured from one or more materials, which are suitable for sterilization and protection of a cover and a piston nest assembly <NUM> (<FIG> and <FIG>), particularly from contamination that could render a plurality of pistons <NUM> contained in the assembly unsuitable for subsequent use/assembly with a drug container. The container <NUM> may be any known container, which is suitable for housing sterilized pistons. Container types include STERIBAGS® sterile containers and other pre-sterilized containers known to those skilled in the art. <FIG> and <FIG> show the cover <NUM> and the piston nest assembly <NUM> of <FIG>, while <FIG> and <FIG> show the cover <NUM> and the piston nest assembly <NUM> of <FIG>.

Generally, a piston nest <NUM>, as shown particularly in <FIG> and <FIG>, includes a plurality of spaced apart single nesting units <NUM>, interconnected by a nest web <NUM>. In a preferred configuration, the piston nest <NUM> can include one hundred spaced apart single nesting units <NUM>. The piston nest <NUM>, however, can be configured to include more or less than one hundred nesting units <NUM>. The piston nest <NUM> can also include a piston <NUM> (<FIG>) configured within each of the plurality of spaced apart single nesting units <NUM>.

The piston nest <NUM> is generally configured as a planar tray with the single nesting units <NUM> connected in a planar fashion by the nest web <NUM>. While the piston nest <NUM> is shown configured as a planar rectangular tray, the piston nest <NUM> can alternatively be configured into any planar fashion suitable for its intended use. For example, the outer perimeter <NUM> of the piston nest <NUM> may be configured as a square, a circle, an oval, an octagon, or various other shapes.

The piston nest <NUM> is preferably formed from one or more rigid materials such as rigid or semi-rigid polymeric materials, including, but not limited to, polyethylene, polycarbonate, polypropylene and/or composite combinations of materials. The chosen materials of construction preferably maintain the integrity of the pistons as well as not deform to a point of affecting machinability. Polypropylene, however, is preferred as the material for piston nests <NUM> because materials such as polypropylene are able to withstand autoclaving processes better than piston nests formed from other polymeric materials. Alternatively, as radiation is another preferred method of sterilization, a material which is stable following exposure to standard radiation sterilization processes (e.g., gamma radiation), such as gamma stable polypropylene, is preferred. Other suitable materials will be apparent to those skilled in the art.

As shown particularly in <FIG>, a single nesting unit <NUM> includes a generally hollow cylindrical body <NUM>, also known as a chimney, which extends distally from (below) the web <NUM>, to form an open lower end <NUM>. The nesting unit <NUM> may also include one or more retention members <NUM>, which are used to retain individual pistons <NUM> within cylindrical bodies <NUM> of the piston nest <NUM>. In the current embodiment, the retention members <NUM> comprise diametrical protrusions that inwardly extend toward a central axis β of the cylindrical body <NUM> such that an individual piston <NUM> is retained within the cylindrical body <NUM> with a generally vertical orientation (parallel to the axis β). Further details on exemplary piston nest configurations are shown and described in <CIT>. As such, the piston nest configuration shown and described herein should not be construed as limiting.

The purpose of the cover configurations and assembly and package embodiments, shown and described herein, is to protect interior portions of the pistons <NUM> and/or the hollow cylindrical bodies <NUM> of the piston nest <NUM> from a variety of potential contaminants. Such contaminants are of the type that would otherwise infiltrate the interior portions of the pistons <NUM> and the hollow cylindrical body <NUM>. Contaminants may come from a variety of sources, including, but not limited to packaging materials and air particles.

The cover configurations shown and described herein are also used to provide at least some additional structural support to the piston nest <NUM>. Preferably, each cover configuration provides at least some additional structural support that would assist in alleviating warping of piston nests <NUM> that is known to occur over time. Cover configurations may also be such that movement of the cylindrical bodies/chimneys <NUM> of the piston nest <NUM> is restricted. As such, the covers may have an interference fit with the piston nest <NUM> or pistons <NUM> included in a piston array.

<FIG> is a partially exploded perspective view of the cover <NUM> and the piston nest assembly <NUM>, shown in <FIG>. More particularly in <FIG>, a first configuration of a cover <NUM> for the piston nest <NUM> is shown. The cover <NUM> is particularly suited for positioning over (but on the bottom of) the open lower ends <NUM> of the piston nest <NUM>, as particularly shown in <FIG>.

Referring to <FIG>, <FIG>, <FIG>, the cover <NUM> includes a plurality of cover sections <NUM> configured for positioning over a drug container piston array <NUM>, preferably with the piston array <NUM> contained within a piston nest <NUM>. <FIG> shows the cover <NUM> in alignment with the piston nest <NUM> and pistons <NUM> contained within respective nesting units <NUM> of the piston nest <NUM>. Each individual cover section <NUM> includes an elongated cover body <NUM>, having an open base or upper end <NUM>, as particularly shown in <FIG>, <FIG>, and <FIG>, and a closed capped end bottom <NUM>, as particularly shown in <FIG>. Chamfers <NUM> (<FIG>), 43a (inner chamfer, <FIG>), 43b (outer chamfer, <FIG>), may optionally be included around the base end <NUM> and/or the capped end <NUM> (interior portion <NUM>, shown in <FIG>). Chamfers <NUM>, 43a, 43b are included around the base end <NUM> and/or the capped end <NUM> to facilitate insertion of the piston nest <NUM> into the cover <NUM>. A wall <NUM> (<FIG>) extends between the base end <NUM> and the capped end <NUM> such that the elongated cover body <NUM> is formed, as shown particularly in <FIG>.

Positioned between each individual cover section <NUM> and coupled to each base end <NUM> is a plurality of base sections <NUM>, as shown particularly in <FIG> and <FIG>. The base sections <NUM> are used to interconnect the cover sections <NUM>. Upon formation of the cover <NUM>, the cover sections <NUM> may be positioned to be laterally offset with respect to one another or configured in substantially aligned rows and columns, which are not offset with respect to one another. Cover section positioning, however, is preferably such that the cover <NUM> can be positioned over the open lower ends <NUM> of the cylindrical bodies <NUM> of various piston nest arrangements.

<FIG> and <FIG>, respectively show interior portions of the plurality of cover sections <NUM>. Included within each cover section <NUM> is a plurality of locators <NUM>, which are used to position and at least partially orient the cylindrical bodies <NUM> of the piston nest <NUM>. Preferably, the locators <NUM> are positioned within each cover section <NUM> such that the orientation of the cylindrical bodies <NUM> is centered with respect to a central axis B. The locators <NUM> are preferably integrally incorporated into each cover section <NUM> and manufactured from materials that are the same as the cover <NUM>. Preferably, the configuration of the locators <NUM> is such that each locator frictionally fits against and engages each cylindrical body <NUM> of each piston nest <NUM>.

In the present cover configuration, three locators <NUM> are radially positioned on interior faces <NUM>, <NUM> of the cover section body <NUM>, as shown in <FIG>. The locators <NUM> function to orient and locate the cylindrical bodies <NUM> of the piston nest <NUM>. Preferably, each respective locator <NUM> is disposed on an inner edge <NUM> and positioned between the distal end of the wall <NUM> and the capped end <NUM> of the cylindrical body <NUM>. The plurality of locators <NUM> are also radially positioned at substantially equidistant intervals around the inner diameter of the cover section body <NUM>. <FIG> shows individual piston locators <NUM> positioned at an angle α, with respect to one another, which is approximately <NUM>° (degrees). Fewer or more locators <NUM> may be positioned within the cover section body <NUM>, depending upon various factors, including the piston diameters. Preferably, the outer shape or perimeter of the cover <NUM>, however, is complementary in shape and size to the outer shape or perimeter of a piston nest <NUM>.

<FIG> is a bottom perspective view of the cover <NUM>, which includes a plurality of cover reinforcements <NUM> positioned between cover sections. Individual cover reinforcements <NUM> are preferably integral with individual cover sections <NUM> such that the cover <NUM> provides structural support of the piston nest <NUM> after insertion into the cover <NUM>. Preferably, outer surfaces of the inner cover section bodies 44a have at least five cover reinforcements <NUM> positioned radially in substantially equidistant intervals around the outer diameter of each inner cover section body 44a. Outer surfaces of outer cover section bodies 44b have cover sections that inwardly extend toward the center of the cover <NUM> and at least one cover reinforcement <NUM> positioned on a side of the cover section body <NUM>. The overall configuration of the cover <NUM> from a bottom perspective due to the positioning of the cover section bodies <NUM> and the cover reinforcements <NUM> results in a honeycomb-like configuration, as shown particularly in <FIG>.

To facilitate the passage of sterilizing agents and/or process agents (e.g. steam from an autoclave) through the cover <NUM> and the piston nest <NUM>, base sections <NUM> may include apertures <NUM>, as shown in <FIG>, <FIG>, and <FIG>. Although shown with a circular shape, the aperture shape should not be limiting. As used herein, the term "aperture" should be broadly construed as any opening positioned in base sections <NUM>, which is suitable for the passage of sterilizing agents and/or process agents. As such, the aperture <NUM> may have a slot, square, oval, or other polygonal shape.

The cover <NUM> may be attached to the piston nest assembly <NUM> with either an interference fit or a clearance fit, however a slight clearance fit is preferred. With an interference fit, the interior face <NUM> of the wall <NUM> of the cover <NUM> abuts against exterior surfaces of the cylindrical bodies <NUM> of the piston nest <NUM>. The piston nest assembly <NUM> may alternatively be inserted into the cover <NUM> to have a clearance fit such that there is generally a small space between the interior face <NUM> of the wall <NUM> of the cover <NUM> and the exterior surfaces of the cylindrical bodies <NUM> of the piston nest <NUM>. However, with either an interference fit or a clearance fit, the open lower end <NUM> of the cylindrical body <NUM> preferably rests against the locators <NUM> and the interior face <NUM> of the cover <NUM>.

<FIG> show an exemplary embodiment of a cover <NUM> and a piston nest assembly <NUM>, which does not belong to the invention. <FIG> shows a package <NUM> that includes the same piston nest <NUM>, drug container piston array <NUM>, and container <NUM>, shown in <FIG>. The cover <NUM>, however, has a different configuration such that rows or columns of a piston array or cylindrical bodies of a piston nest are positioned in a plurality of transversely elongated cover sections <NUM>. <FIG> is a partially exploded view of the cover and piston nest assembly <NUM>, shown in <FIG>.

The cover <NUM> includes a plurality of transversely elongated cover sections <NUM> configured for positioning over rows or columns a drug container piston array <NUM>, preferably with the piston array contained within a piston nest <NUM>. <FIG> shows the cover <NUM> in alignment with the piston nest <NUM> and pistons <NUM> contained within respective nesting units <NUM> of the piston nest. Each respective cover section <NUM> includes an open base or upper end <NUM> and a closed capped or lower end <NUM>. Chamfers <NUM>, <NUM> may also be optionally included around the outer perimeter of the base end <NUM> and/or the inner edge <NUM> of the capped end <NUM>. Chamfers located on the inner edge <NUM> may also serve to facilitate distribution of sterilizing and processing agents along the cover sections.

A wall <NUM> extends between the base end <NUM> and the capped end <NUM> such that a cover section body <NUM> is formed, as shown particularly in <FIG> and <FIG>. Upon formation of the cover <NUM>, cover sections <NUM> may be positioned to be laterally offset with respect to one another or in configured in rows, which are substantially aligned (i.e. not laterally offset).

Positioned between each cover section <NUM> and coupled to each base end <NUM> to extend around the cover is an interconnecting cover web <NUM>. The interconnecting cover web <NUM> preferably has an outer perimeter <NUM> that is similar to that of the piston nest <NUM>, as shown in <FIG>.

<FIG> and <FIG>, respectively show interior portions of the plurality of cover sections <NUM>. Included within the interior of each cover section <NUM> is a plurality of locators <NUM>, which are used to position and at least partially orient rows and/or columns of a piston array or a piston nest <NUM>. In this configuration, the locators <NUM> are positioned at intervals along sidewalls <NUM>, <NUM>, <NUM>, <NUM> and the bottom wall <NUM> of the cover section body <NUM>.

<FIG> shows a total of <NUM> locators <NUM> - one locator positioned on sidewalls <NUM>, <NUM> and eight locators positioned on sidewalls <NUM>, <NUM>. The numbers of locators positioned within the cover section body <NUM>, however, should not be construed as limiting. Fewer or more locators <NUM> may be positioned within the cover section body, depending, in part, on the total number of pistons <NUM> and/or cylindrical bodies <NUM> of the piston nest <NUM>.

<FIG> is a bottom perspective view of the cover <NUM>, and particularly shows a plurality of cover reinforcements <NUM> positioned between cover sections <NUM>. Individual cover reinforcements <NUM> are preferably integral with individual cover sections <NUM> such that the cover <NUM> provides structural support of rows and/or columns of the piston nest <NUM> after insertion into the cover <NUM>. Here, the cover reinforcements <NUM> are coupled to outer surfaces of the cover section bodies <NUM> and positioned at intervals transversely along the length of each cover section. The cover also include lateral cover reinforcements <NUM> coupled to end walls <NUM> and disposed between the outermost ends <NUM> of cover sections <NUM> (i.e. those closest to the outer perimeter <NUM>).

Claim 1:
A cover (<NUM>) for a drug container piston array (<NUM>) or piston nest (<NUM>) including a plurality of spaced apart nesting units (<NUM>) interconnected by a nest web (<NUM>), and extending distally therefrom, each nesting unit (<NUM>) for retaining a piston (<NUM>) therein, the cover (<NUM>) comprising:
a plurality of cover sections (<NUM>) configured for positioning over the drug container piston array (<NUM>), each cover section (<NUM>) comprising an elongated cover section body (<NUM>), having an open base end (<NUM>), a closed capped end (<NUM>), a wall (<NUM>) extending between the base end (<NUM>) and the capped end (<NUM>) and a plurality of piston locators (<NUM>); and a plurality of base sections (<NUM>) positioned between the plurality of cover sections (<NUM>) and coupled to each base end (<NUM>),
characterized in that
the plurality of piston locators (<NUM>) are positioned in radial intervals along an interior face (<NUM>) of the wall (<NUM>) of each elongated cover body (<NUM>), each piston locator (<NUM>) being configured and positioned to engage and orient the nesting units (<NUM>) of the piston nest (<NUM>) within corresponding elongated cover bodies (<NUM>).