Patent Description:
A syringe nest is typically a substantially planar tray which sits in a syringe tub and has a plurality of individual nesting units, typically referred to as chimneys, each capable of receiving a syringe, to contain, transport and fill syringes in various manufacturing processes. The syringe nest is typically used in automation processes for the assembly of, for example, pre-filled syringes. The chimneys of a syringe nest have a defined center to center distance that must remain accurate, in order to ensure that the nest is compatible with existing manufacturing, packaging, and filling equipment. The quantity sizes of syringe nests have been increasing in recent years, with <NUM> chimneys/nest potentially becoming the new standard.

This has caused the syringe chimneys to be formed significantly closer together, particularly for nests requiring larger chimney diameters due to integrated safety systems. As the standard circular chimneys get closer together, moldability of such nests may become impossible and/or injection mold geometry may become thinner and less robust. In turn, manufacturing cycle time is increased and the mold life is reduced. Document <CIT> for example discloses a known syringe nest.

Accordingly, there is a need for a syringe nest with chimneys that meet the standard requisite center to center distance, but which can be optimized for injection molding.

In accordance with one embodiment, the present invention relates to a syringe nest having a hexagonal structure that enables more robust mold geometry, but which also preserves manufacturer-specified center to center distance of nest chimneys and syringes, such that the nest is acceptable for use in existing automation and filling equipment. In another embodiment, the present invention also relates to a syringe nest which reduces or eliminates the troublesome and unpredictable warping condition that syringe nests may exhibit post sterilization procedures (e.g., by gamma irradiation, ethylene oxide, autoclaving, etc.).

Briefly stated, in one embodiment, the present invention relates to a syringe nest according to annexed independent claim <NUM>. Other advantageous features are defined in the annexed dependent claims.

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 and instrumentalities shown. In the drawings:.

Reference will now be made in detail to the present embodiments of the invention illustrated in the accompanying drawings. It should be noted that the drawings are in simplified form and are not drawn to precise scale. Certain terminology is used in the following description for convenience only and is not limiting. The words "right," "left," "top," "bottom" and "lower" designate directions in the drawings to which reference is made. The words "first," "second," "third" and "fourth" designate an order of operations in the drawings to which reference is made, but do not limit these steps to the exact order described. The words "inwardly" and "outwardly" refer to directions toward and away from, respectively, the geometric center of the device and designated parts thereof. 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.

Referring to the drawings in detail, wherein like numerals and characters indicate like elements throughout, there are shown in <FIG>, presently preferred embodiments of syringe nests in accordance with the present invention. With reference initially to <FIG>, the syringe nest, generally designated <NUM>, includes a plurality of single nesting units, referred to herein as chimneys, <NUM>. The nest <NUM> can include a syringe <NUM> (e.g., see <FIG>) received within each of the plurality of chimneys <NUM>.

The nest <NUM> is generally configured as a planar tray. While the present embodiment is configured with the nest <NUM> configured as a planar square tray, the nest <NUM> can alternatively be configured into any planar fashion suitable for its intended use, such as a planar circular, rectangular, oval, or octagonal shaped tray.

Referring to <FIG>, the nest includes a base <NUM> having a first surface 16a and an opposing second surface 16b. Each chimney <NUM> includes a generally hollow body <NUM> that extends distally from the first surface 16a of the base <NUM>. The hollow body <NUM> includes a first open end 14a distal from the base <NUM> and a second open end 14b proximate the base <NUM>. The hollow body <NUM> also includes a generally smooth interior wall surface <NUM> and an exterior wall surface <NUM>.

Referring to <FIG> and <FIG>, in a first embodiment, each of the chimneys <NUM> preferably has a hexagonal shape or geometry. Thus, each chimney <NUM> has six sidewalls <NUM> and six connecting lines (also known as vertices or corners) <NUM>. The hexagonal chimneys <NUM> are aligned symmetrically in a point to point, vertex to vertex, or corner to corner orientation. That is, the chimneys <NUM> are interconnected in such a manner that each line/vertex/corner <NUM> of one chimney <NUM> also forms the line/vertex/corner <NUM> of another chimney <NUM>. Each chimney <NUM> thus shares at least one line/vertex/corner <NUM> with at least one other chimney <NUM>. More preferably, except for the perimeter chimneys <NUM>, every line/vertex/corner <NUM> of each chimney <NUM> is common to that of another chimney <NUM>. Thus, each chimney <NUM> shares a common line/vertex/corner <NUM> with two or more other chimneys <NUM>.

Hexagonal chimneys <NUM> arranged in the line to line orientation naturally also form contiguous walls <NUM> that are advantageous for injection molding. Circular chimneys, as shown in the prior art nest of <FIG>, would not allow for contiguous walls to be made without creating geometry that is disadvantageous to injection molding, namely a thin walled tool geometry. The geometry of the nest <NUM> according to the first preferred embodiment allows for maintaining a predetermined center to center distance D (e.g., as required by manufacturers), that is a predetermined distance D between a center C of one chimney <NUM> and a center C of an adjacent chimney <NUM>, without excessive sidewall <NUM> thickness.

The line to line arrangement of the hexagonal chimneys <NUM> naturally creates voids <NUM>, and more particularly triangular-shaped voids <NUM>, between chimneys <NUM>. It will be understood by those skilled in the art that the voids <NUM> may have any shape based on the shape of the chimneys <NUM>. In one aspect, in order to further enhance moldability and reduce manufacturing cycle time, an intermediate wall <NUM> is provided between the first and second open ends 30a, 30b of each of the triangular voids <NUM> (best seen in <FIG>). The intermediately wall <NUM> preferably has a shape that conforms with the geometric shape of the void <NUM> (e.g., a triangular shaped intermediate wall <NUM>). The intermediate wall <NUM> is horizontally-oriented (i.e., perpendicular to the direction in which the body <NUM> of each chimney <NUM> extends). Such walls <NUM> allow for more shallow injection molding draws and increase mold robustness.

In an example not being part of the invention, the plurality of hexagonal chimneys <NUM> are arranged in a honeycomb pattern, in order to maintain the predetermined center to center distance D of the chimneys <NUM>, and more particularly the predetermined center to center distance D between the syringes to be placed within each chimney <NUM> (<FIG>). That is, the chimneys <NUM> are interconnected in such a manner that at least one sidewall <NUM>, and preferably each sidewall <NUM>, of one chimney <NUM> also forms a sidewall <NUM> of another chimney <NUM> (i.e., contiguous walls), such that no triangular or other voids are formed between adjacent chimneys <NUM>. Each chimney <NUM> thus shares at least one sidewall <NUM> with at least one other chimney <NUM>. More preferably, with the exception of the outer peripheral chimneys <NUM>, every sidewall <NUM> of each chimney <NUM> is common to that of another chimney <NUM>. Thus, each chimney <NUM> shares a common sidewall <NUM> with a plurality of other chimneys <NUM>.

Conventionally, utilizing solely a honeycomb structure based on the desired center to center chimney distance would require excessive wall thickness to form a platform on which flanges of the syringes may rest, which would be disadvantageous for injection molding. The second preferred embodiment of the present invention avoids such excess wall thickness. In particular, each of the hexagonal chimneys <NUM> has a relatively large diameter that enables maintaining the predetermined center to center distance D, but also does not have an excessive sidewall <NUM> thickness. Accordingly, the diameter DC of each chimney <NUM> is generally larger than the diameter of the flange of the syringe <NUM>. As such, the syringe flange cannot rest on the chimney sidewalls <NUM>.

In the embodiments and examples shown in <FIG>, the entirety of the body <NUM> of each chimney <NUM> is positioned on one side of the planar base <NUM>, namely on the first surface 16a of the base <NUM>. In another embodiment, as shown in <FIG>, a first portion of the body <NUM> extends distally from the first surface 16a of the base <NUM> and a second portion of the body <NUM> extends proximally from the second surface 16b of the base <NUM>. In other words, the base <NUM> is positioned at an intermediate point between the first open end 14a and the second open end 14b of each hollow body <NUM>. Preferably, the base <NUM> is positioned at a geometric center point between the first and second ends 14a, 14b, but it will be understood that the base <NUM> may be located at any position between the two ends 14a, 14b.

As such, the base <NUM> essentially serves as a peripheral flange that extends in a midline plane of the plurality of chimneys <NUM>, and which provides strength and stiffness to the nest <NUM> to reduce warping effects which occur during molding (e.g., by facilitating consistent cooling), post molding (e.g., by facilitating more uniform shrinkage), and sterilization (e.g., by providing a robust geometry that is more resistant to sterilization temperatures). The peripheral flange <NUM> also further enhances moldability and reduces injection molding cycle time, allowing for more shallow draws and increased mold robustness.

In an example not being part of the invention, as shown in <FIG>, the nest <NUM> further includes a plurality of reinforcing members or stiffening members <NUM>. Preferably, a plurality of stiffening members <NUM> are provided on the first surface 16a and on the second surface 16b of the base <NUM>. More preferably, the stiffening member <NUM> are provided on the perimeter of the first and second surfaces 16a, 16b of the base <NUM> surrounding the plurality of chimneys <NUM>. In one embodiment, the stiffening members <NUM> are elongated stiffening ribs <NUM>, each of which has a first end 42a proximate a chimney <NUM> and an opposing second end 42b proximate an edge of the base <NUM>. Preferably, each stiffening rib <NUM> extends at an angle from the peripheral edge of the base <NUM> toward the chimneys <NUM> to provide stiffness and strength to the base <NUM>.

In one embodiment, an arcuate shaped edge ridge <NUM> also extends generally perpendicularly from the planar base <NUM> and defines an edge hole <NUM> (see, e.g., <FIG> and <FIG>). In another embodiment, portions of the planar base <NUM> are merely recessed or indented to form the edge holes <NUM> (see, e. One or more edge holes <NUM> are preferably included in the base <NUM> such that a user is able to insert a finger or tool through the edge holes <NUM> for ease of gripping. The edge rib <NUM> (if present) provides stiffness and strength for the base <NUM> proximate the edge holes <NUM>. The edge holes <NUM> and edge rib <NUM> are not limited to inclusion in the edge of the base <NUM> and may be instead positioned at nearly any location on the base <NUM>.

In one embodiment, to prevent the syringe from falling through the chimney <NUM>, while also keeping each syringe <NUM> centered within a respective chimney <NUM> (i.e., a concentric arrangement) and preventing excessive movement of the syringe <NUM> within the chimney <NUM>, at least one chimney <NUM>, and more preferably a plurality of the chimneys <NUM>, each includes at least one retention member <NUM>, and more preferably a plurality of retention members <NUM> (see <FIG> and <FIG>). Each retention member <NUM> is preferably a radially inwardly extending member. For example, each retention member <NUM> may be configured as a longitudinally extending rib formed on the interior wall surface <NUM> of each chimney <NUM>. The retention members <NUM> may alternatively be configured as an annular rib, a flange, a flange-like rib, bumps, walls, shelves, pegs or the like extending from one or more of the internal surface <NUM> of the hexagonal chimney <NUM> sidewalls <NUM> proximate the first distal end 14a.

In an example not being part of the invention, as shown in <FIG>, each retention member <NUM> is in the form of a longitudinally extending rib that extends from the first distal end 14a of each chimney <NUM> toward the second proximal end 14b. Each rib <NUM> thus has a first end 32a proximate the first distal end 14a of each chimney <NUM> and a second end 32b proximate the second proximal end 14b of each chimney <NUM>. As such, in use, the syringe <NUM> flange rests on the exposed surface (i.e., the first end 32a) of the one or more retention members <NUM> above the plane of the first distal end 14a of each chimney <NUM>, as shown in <FIG>. Preferably, each rib <NUM> extends along an entire height or length of each chimney <NUM> (i.e., from the first distal end 14a to the second proximal end 14b), but it will be understood that each rib <NUM> need not extend all the way to the second proximal end 14b. In an example not being part of the invention, as shown in <FIG>, one or more ribs <NUM>, and more preferably each rib <NUM>, may be chamfered (preferably at the first end 32a), to assist in centering the syringe <NUM> within a respective chimney <NUM> and keeping the syringe <NUM> flange contained therein. Such a configuration may also prevent catching a safety system (not shown) on the chamfered ribs <NUM> during insertion of a syringe <NUM> into a chimney <NUM>.

In an example not being part of the invention, as shown in <FIG>, each retention member <NUM> is in the form of a longitudinally extending rib that does not extend to the first distal end 14a of each chimney <NUM> (i.e., the open top of the chimney <NUM>). That is, each rib <NUM> extends from the second proximal end 14b toward the first distal end 14a, but terminates before reaching the first distal end 14a. The first end 32a of the rib <NUM> is thus below the plane of the first distal end 14a. As such, in use, the syringe <NUM> flange rests on the exposed surface (i.e., the first end 32a) of the one or more retention members <NUM> below the plane of the first distal end 14a of each chimney <NUM>.

In another embodiment, as shown in <FIG>, each retention member <NUM> is in the form of an annular shelf or shoulder extending inwardly from the interior surface <NUM> of the chimney <NUM> body <NUM> proximate the first distal end 14a. More particularly, the shelf <NUM> is formed below the plane of the first distal end 14a, such that, in use, the syringe <NUM> flange rests on the exposed surface of the shelf <NUM> below the plane of the first distal end 14a of each chimney <NUM>. The shelf <NUM> may extend around only a portion of the interior periphery of the body <NUM>, but preferably extends around the entire interior periphery thereof.

In another variation, as shown in <FIG>, cut-outs, ramps, or a cam geometry is implemented at the first distal end 14a (i.e., the top) of each chimney <NUM>. The first open end 14a of each chimney <NUM> includes at least one cam 36a and at least one associated recess 36b, such that a syringe flange 34a contacts and travels over the at least one cam 36a and subsequently comes to rest in the at least one associated recess 36b. More particularly, at the first distal end 14a, a first plurality of the sidewalls <NUM> is provided as a rounded cam 36a, while a second plurality of the sidewalls <NUM> is provided with a cut-out 36b. Such a geometry allows a syringe flange 34a to initially contact and pass or travel over the cams 36a and then rest on the cut-outs 36b, such that the syringe flange 34a falls or cams into a centered position within a respective chimney <NUM> via gravity, mechanical assist (e.g., vibration), tilting, or any other similar movement, as shown in the progression depicted in <FIG>.

Two additional variations of cam geometries are shown in <FIG> and <FIG>, respectively. The cams <NUM>, <NUM> of the variation of <FIG> and 23A-23E function in a manner similar to the cams 36a of <FIG>. In the variation of <FIG> and <FIG>, the cams <NUM>, <NUM> are still formed at the first distal end 14a of each chimney <NUM>, but are formed within the interior of the hexagonal chimney walls <NUM>. This is beneficial because the overall geometry of the chimney <NUM> is more compact and will not interfere with a Tyvek seal, filling, etc..

In the cam geometry of <FIG>, first and second opposing and symmetrical pyramidal-shaped cams <NUM> are provided on the interior surface <NUM> of each chimney <NUM> at the first distal end 14a thereof. In use, when the syringe flange 34a is dropped into the chimney <NUM>, it naturally drops into a flange-shaped recess <NUM> created by the cams <NUM>, thus facilitating orientation of the syringes <NUM> to the requisite center-to-center distance D. Similar to the embodiment of <FIG>, the syringe flange 34a falls or cams into the centered position within a respective chimney <NUM> via gravity, mechanical assist (e.g., vibration), tilting, or any other movement that facilitates dropping of the flange 34a into the recess <NUM>. The symmetrical cam design enables the possibility for the syringe <NUM> to balance across the top and/or edges of the opposing cams <NUM>.

In the cam geometry of <FIG>, first and second asymmetric cams <NUM> are provided. The cams <NUM> are in the form of opposing inclined surfaces, upon which the syringe flange 34a may slide and/or rotate to travel down into a recess <NUM>. Similar to the embodiment of <FIG>, , the syringe flange 34a falls or cams into the centered position within a respective chimney <NUM> via gravity, mechanical assist (e.g., vibration), tilting, or any other movement that facilitates dropping of the flange 34a into the recess <NUM>.

The asymmetrical cam design makes a more effective use of gravity, as the syringe flange 34a will always fall on an incline (i.e., the inclined cams <NUM>) or into the recess <NUM>. The asymmetrical cam design also includes a vertical drop <NUM> into the flange recess <NUM> that is below the bottom cam <NUM>. The vertical drop <NUM> will prevent the syringe <NUM> from rotating back up the cams <NUM> (e.g., during transportation, filling, etc.) and moving out of tolerance of the necessary center-to-center distance D. It will be understood that such a vertical drop may also be included in the symmetrical cam design of <FIG>.

In another embodiment, as shown in <FIG>, the present invention is directed to a syringe <NUM>' having a flange 34a' of a shape and size that conforms with the shape of the chimney <NUM>. That is, the flange 34a' has a generally hexagonal geometry or shape. Preferably, the interior periphery of the body <NUM> of the chimney <NUM> at its first end 14a is sized and contoured such that the syringe flange 34a' is pressure fit within the chimney <NUM>, as shown in <FIG>. However, it will be understood that the chimney <NUM> may include one or more snap beads, ledges, bumps, ribs and the like to facilitate centering and capturing of the syringe flange 34a' within the chimney <NUM>.

In addition to alignment geometry, it is also beneficial to ensure that a safety system, which has a diameter or width larger than that of the syringe <NUM> barrel, does not get caught on the bottom of the nest <NUM> during removal, a risk which is particularly present in embodiments utilizing a ledge or ribs within the chimneys <NUM>. Accordingly, at least in such embodiments, each chimney <NUM> includes one or more chamfers <NUM> on the interior wall surface <NUM> to prevent catching on the chimney <NUM> during removal, as shown in <FIG>.

13A-13D show various other examples of the chimney <NUM> geometry. In these embodiments, the chimneys <NUM> no longer have a hexagonal geometry, but are still arranged in a honeycomb pattern, so as to provide a surface on which the syringe <NUM> flange may rest, to maintain the predetermined center to center distance D, and to minimize sidewall thickness.

<FIG> shows another example not being part of the invention, in which the hexagonal chimneys <NUM> are arranged in a spaced-apart manner, such that the sidewalls <NUM> are not contiguous and a void or gap <NUM> surrounds each chimney <NUM>. That is, aside from the chimneys <NUM> located on the outer periphery of the nest <NUM>, a uniform gap <NUM> fully surrounds each chimney <NUM>. The uniform gaps <NUM> between each chimney <NUM> result in uniform cooling of the mold. In contrast, the gaps between circular chimneys, as in the prior art nest of <FIG>, would create varying thicknesses that are disadvantageous to mold heating and cooling.

In an example not being part of the invention, shown in <FIG>, the body <NUM> of each chimney <NUM> includes a plurality of longitudinally extending slits <NUM> which separate the body <NUM> into a plurality of spaced apart portions. One or more of the portions of the body <NUM> may be formed as flexing members <NUM> for improved securing and centering of the syringe <NUM> barrel and flange within a respective chimney <NUM>. Centering and securing the syringes <NUM> in the chimneys <NUM> enables consistent filling and minimal movement of the syringes <NUM> during transit and/or shipping. The flexing members <NUM> may have a geometry, such as being angled, tapered or ramped from one end 14a, 14b of the body <NUM> of the chimney <NUM> toward the other end 14a, 14b, so as to allow for easy flexing of the members <NUM> and, in turn, easy insertion and removal of a syringe <NUM>.

It will be understood that the concept of flexing members is not limited to a chimney <NUM> of a hexagonal geometry, but instead may be utilized on a chimney of various geometries, such as, for example, circular, square, triangular, and the like.

In an example not being part of the invention, as shown in <FIG>, a chimney <NUM> may have only one flexing member <NUM> that provides support to a syringe <NUM> to be inserted therein from one direction, thereby intentionally off-centering the syringe <NUM> barrel within the chimney <NUM>. However, to compensate, the chimney <NUM> pattern is similarly offset from center, such that once the syringes <NUM> are fully inserted within the chimneys <NUM>, the syringes <NUM> are centered and aligned within the chimneys <NUM> for the filling position.

Claim 1:
A syringe nest (<NUM>) comprising:
a planar base (<NUM>) comprising a first surface (16a) and an opposing second surface (16b), the planar base (<NUM>) including a plurality of stiffening members (<NUM>) extending from at least one peripheral edge of the planar base (<NUM>) toward the plurality of nesting units (<NUM>); and
a plurality of nesting units (<NUM>) extending from and interconnected by the planar base (<NUM>) and having contiguous walls (<NUM>), a perimeter of the planar base (<NUM>) surrounding the plurality of nesting units (<NUM>), each nesting unit (<NUM>) comprising a hollow hexagonal body (<NUM>) having a first open end (14a) and an opposing second open end (14b),
wherein the first open end (14a) of each body (<NUM>) is distal from the planar base (<NUM>) and the second open end (14b) is proximate the planar base (<NUM>), and
wherein the nesting units (<NUM>) are aligned symmetrically in a vertex to vertex orientation and each nesting unit (<NUM>) has a diameter larger than a diameter of a flange of a syringe (<NUM>) nesting in the respective nesting unit (<NUM>),
characterised in that
the nesting units (<NUM>) are arranged in a spaced apart manner, such that triangular shaped voids (<NUM>) are formed between the nesting units (<NUM>).