Patent Description:
Secondary packaging refers to components intended to protect a product and its primary packaging. Secondary packaging has two central functions. First, secondary packaging plays a vital role in the marketing strategy surrounding the product. Second, secondary packaging groups several products together for ease of handling, transport, and storage. This means that secondary packaging must be able to contain relatively large volumes of primary packaged products, transport the product safely to its retail or consumer destination, and keep the primary packaging in its original condition during storage. Secondary packaging should protect not only the product but also the primary packaging, which often is the packaging most visible to the consumer in retail displays. The most common examples of secondary packaging include cardboard boxes and cardboard/plastic crates.

Hemodialysis dialyzers contain a filtration membrane, such as a hollow-fiber membrane, enclosed in a housing that typically has an elongated shape. Some hemodialysis dialyzers, such as Bellco Phylther hemodialysis dialyzers, have an inlet and an outlet at the opposite ends of the dialyzer, and a pair of Hansen connectors positioned in a direction perpendicular to the elongated housing. The housing and Hansen connectors of a hemodialysis dialyzer are sensitive to vibration and crashing during transportation and storage. Loss of dialyzers due to damages during shipment results in an extra expense to the business.

There is, therefore, a need for a container and a method for packaging hemolysis dialyzers, which will provide a stable secondary packaging configuration to protect a hemodialysis dialyzer's integrity during transportation and storage.

<CIT> describes display containers having a plurality of tiers, each tier having a base tray, at least one spine, and two or more cross supports.

<CIT> describes a packing box including lattice members which are arranged in a stacked state into stages, and a stage-partition plate which is arranged between the lattice members.

<CIT> describes a shipping container comprising an outer container of corrugated paper board and an internal structure for dividing the space within the container into separate compartments.

<CIT> describes a secondary packaging container for a plurality of hemodialysis dialyzers. The container comprises a plurality of tray bodies having supporting parts for supporting the dialyzers, the tray bodies being stacked horizontally within a box.

<CIT> describes a blister package for sterile packaging of a medical filter module.

The present invention addresses this need, by providing a secondary packaging container having a plurality of hemodialysis dialyzers packaged therein, as defined in claim <NUM>. The invention further provides a method as defined in claim <NUM> of packaging hollow-fiber hemodialysis dialyzers to form a secondary packaging container according to the first aspect of the invention. Preferred features of the invention are defined in the dependent claims.

The secondary packaging container of the invention comprises a packaging division capable of housing a plurality of hemodialysis dialyzers in a horizontal way to prevent the collision among the dialyzer pieces. The packaging division allows hemodialysis dialyzers to be efficiently assembled and resistant to harsh transportation conditions. The packaging division comprises a plurality of housing cavities, each containing a dialyzer. The housing cavities are formed by a first separator set and a second separator set, each with a plurality of separators arranged in parallel. The first separator set is vertically arranged against the second separator set to form the housing cavities.

The secondary packaging container includes a box and one or more the above-mentioned packaging divisions which are placed horizontally in the box. The box has one or more side walls and a bottom surface, with the bottom surface connected to an edge of the side wall. The box can be in a configuration of cube, cuboid, cone, cylinder, sphere, or polygonal prism. Each packaging division may be separated from another by an insert. The housing cavities of the packaging division may have a substantially uniformed size which is configured to accommodate the dialyzer.

The box of the secondary packaging container may further comprise a substantially C-flute rippled cardboard layer. Each of the separators of the packaging division may comprise a substantially B-flute rippled cardboard layer. The insert may comprise a substantially M-flute rippled cardboard layer.

The secondary packaging container of the invention may be constructed from a kit which may include a packaging division mentioned above and one or more dialyzers. The secondary packaging product may be made up from one or more kits in which each dialyzer may be a standard-length dialyzer, a short-length dialyzer, or an extended-length (XL) dialyzer. The dialyzers may be placed in the housing cavities respectively, with a Hansen connector of each of the dialyzers orientated upward above the horizontal plane of the packaging division. The Hansen connector of each of the dialyzers may be orientated upward and at a predetermined angle (e.g., <NUM>-<NUM>°, <NUM>-<NUM>°, <NUM>-<NUM>°, about <NUM>°) to a vertical axis.

In a second aspect, the present invention provides a method of packaging hollow-fiber hemodialysis dialyzers as defined in claim <NUM>. Each of the dialyzers can be positioned in the housing cavity of the packaging division with a Hansen connector of each of the dialyzers orientated upward and at a predetermined angle to a vertical axis.

The invention provides a secondary packaging container and a method for packaging hollow-fiber hemodialysis dialyzers, as defined in the accompanying claims. The secondary packaging container includes a box and one or more packaging divisions which are placed horizontally in the box. The box has one or more side walls and a bottom surface, with the bottom surface connected to an edge of the side wall. The packaging division comprises a plurality of housing cavities, each capable of receiving a dialyzer. The housing cavities are formed by a first separator set and a second separator set, each with a plurality of separators arranged in parallel. The first separator set is vertically arranged against the second separator set to form the housing cavities.

The following definitions are provided to facilitate an understanding of the present invention:
The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

The term "(s)" following a noun contemplates the singular or plural form, or both.

As used herein, the term "comprising" includes, but is not limited to, whatever follows the word "comprising. " Thus, use of the term indicates that the listed elements are required or mandatory but that other elements are optional and may or may not be present.

As used herein, "have", "having", "include", "including", "comprise", "comprising" or the like are used in their open ended sense, and generally mean "including, but not limited to.

As used herein, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

As disclosed herein, a number of ranges of values are provided. It is understood that each intervening value, to the tenth of the unit of the lower limit, unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither, or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range.

The term "about" generally refers to plus or minus <NUM>-<NUM>% of the indicated number. For example, "about <NUM>" may indicate a range of <NUM> to <NUM>, and "about <NUM>" may mean from <NUM>-<NUM>. Other meanings of "about" may be apparent from the context, such as rounding off, so, for example "about <NUM>" may also mean from <NUM> to <NUM>.

As used herein, "box" refers to a three-dimensional structure that can be used to hold or transport a plurality of articles. The box may have one or more side walls and a bottom surface, with the bottom surface connected to an edge of the side wall. The horizontal cross sectional shape of the box body may include, without limitation, circular, elliptical, square, rectangular, and polygonal.

"Horizontal" and grammatical equivalents as used herein generally refer to a position or a direction substantially parallel to the plane of the horizon and at right angles to the vertical.

The phrase "horizontal plane" as used herein refers to a surface substantially parallel to the horizon. For example, the horizontal plane of a packaging division is defined by the bottom edges of the separators in the horizontally-positioned packaging division.

As used herein, "separator" refers to a planar object for maintaining an article out of direct contact with one another. Two sets of vertically arranged separators constitute the packaging division to form a plurality of housing cavities for holding hemodialysis dialyzers.

As used herein, "division" refers to a three-dimensional object comprising a plurality of housing cavities capable of receiving dialyzers. The division may comprise one or more separator sets configured to form housing cavities. The separator sets may be arranged vertically against each other. Each separator set may comprise one or more separators.

The term "insert" as used herein refers to a planar object for separating the adjacent packaging divisions to minimize the direct contact between the packaging divisions. An insert may have substantially the same shape and dimensions as the packaging division, and may additionally include two mutually opposed folded-up handles configured to fit the two sides of the packaging division.

As used herein, "dialysis" is a type of filtration, or a process of selective diffusion through a membrane. Dialysis removes solutes of a specific range of molecular weights via diffusion through a membrane from a fluid to be dialyzed into a dialysate. During dialysis, a fluid to be dialyzed is passed over a filter membrane, while dialysate is passed over the other side of that membrane. Dissolved solutes are transported across the filter membrane by diffusion between the fluids. The dialysate is used to remove solutes from the fluid to be dialyzed. The dialysate can also provide enrichment to the other fluid.

As used herein, the term "dialyzer" refers to a cartridge or container with two flow paths separated by semi-permeable membranes. One flow path is for blood and one flow path is for dialysate. The membranes can be in the form of hollow fibers, flat sheets, or spiral wound or other conventional forms known to those of skill in the art. Membranes can be selected from the following materials of polysulfone, polyethersulfone, poly (methyl methacrylate), modified cellulose, or other materials known to those skilled in the art.

As used herein, "hemodialysis" is a technique where blood and a "cleansing fluid" called dialysate are exposed to each other separated by a semi-permeable membrane. Solutes within the permeability range of the membrane pass while diffusing along existing concentration gradients. Water and solutes are also transferred by convection across a pressure gradient that may exist across the dialysis membrane. The dialysate employed during hemodialysis has soluble ions such as sodium, calcium and potassium ions and is not pure water. The sieving properties of the membrane exclude certain solutes above a certain threshold from crossing the membrane. One common sieving property is "albumin sieving. " In most situations it is not desirable to remove albumin during renal replacement therapy, as lower blood serum albumin is associated with increased mortality rates.

The term "standard-length dialyzer" as used herein refers to hemodialysis dialyzers having dimensions of about <NUM>-<NUM> (length) and about <NUM>-<NUM> (diameter), including, without limitation, Bellco Phylther HF13UP, HF15UP and HF17UP hollow-fiber dialyzers. The dimensions of the Bellco standard-length dialyzers are shown in <FIG>.

The term "short-length dialyzer" as used herein refers to hemodialysis dialyzers having dimensions of about <NUM>-<NUM> (length) and about <NUM>-<NUM> (diameter), including, without limitation, Bellco dialyzers HFT03, HFT05, DIDECO DHF02, DHF06, BLS <NUM>, BLS <NUM>, AQUAMAX HF <NUM>, INFOMED DF <NUM> hollow-fiber dialyzers. The dimensions of the Bellco short-length dialyzers are shown in <FIG>.

The term "XL-length dialyzer" as used herein refers to hemodialysis dialyzers having dimensions of about <NUM>-<NUM> (length) and about <NUM>-<NUM> (diameter), including, without limitation, Bellco Phylther HF20UP and HF22UP hollow-fiber dialyzers. The dimensions of the Bellco XL-length dialyzers are shown in <FIG>.

<FIG> illustrates a perspective view showing one embodiment of the invention. Another embodiment of the secondary packaging is integrated by the components shown in <FIG>, which includes a box <NUM> with the desired dimensions, one or more packaging divisions <NUM>, one or more inserts <NUM> to separate a packaging division from adjacent ones, a plurality of dialyzers <NUM>, an instruction manual <NUM>, and a box label <NUM> attached to the outside of the box.

The container and method for secondary packaging may package different types of dialyzers. The dialyzer may be a hollow-fiber hemodialysis dialyzer. The container and method for secondary packaging may package dialyzers of various sizes. Depending on the number of dialyzers per packaging division and the number of packaging divisions per container, the secondary packaging container is capable of receiving dialyzers with various combinations of length and diameter to match the dimensions of the packaging division and the container. In one embodiment, the dialyzer is a standard-length hollow-fiber hemodialysis dialyzer, including, without limitation, Bellco Phylther HF13UP, HF15UP and HF17UP. In one embodiment, the dialyzer is a short-length hollow-fiber hemodialysis dialyzer, including, without limitation, Bellcodialyzers HFT03, HFT05, DIDECO DHF02, DHF06, BLS <NUM>, BLS <NUM>, AQUAMAX HF <NUM>, INFOMED DF <NUM>. In one embodiment, the dialyzer is a XL-length hollow-fiber hemodialysis dialyzer, including, without limitation, Bellco Phylther HF20UP and HF22UP.

The secondary packaging container of the invention can provide the same external box used for the different types of dialyzers, including the standard-length, short-length, or XL-length hollow-fiber hemodialysis dialyzers. The box may have one or more side walls and a bottom surface, with the bottom surface connected to an edge of the side wall. The horizontal cross sectional shape of the box body includes, without limitation, circular, elliptical, square, rectangular, and polygonal. In one embodiment, the box with a rectangular horizontal cross sectional shape measures about <NUM> long, about <NUM> wide and about <NUM> high, as shown in <FIG>.

In one embodiment, the packaging division <NUM> for housing the hollow-fiber hemodialysis dialyzers may comprise two separator sets. Each separator set may contain a plurality of separators arranged in parallel. The first separator set <NUM> can be arranged vertically against the second separator set <NUM> to form a plurality of housing cavities <NUM> with a substantially uniformed size configured to accommodate dialyzers. The separated housing cavities reduce the contacts between the dialyzer pieces, and therefore reduce damages of dialyzers and primary packaging during transportation and storage. <FIG> illustrates the configurations of the separator sets for accommodating the different types of dialyzers, including the standard-length, short-length, and XL-length hollow-fiber hemodialysis dialyzers. In one embodiment, the packaging division for housing the standard-length hollow-fiber hemodialysis dialyzers includes a first separator set having two separators and a second separator set having seven separators, arranged vertically to hold up to seven standard-length dialyzers per packaging division. In another embodiment, the packaging division for housing the short-length hollow-fiber hemodialysis dialyzers includes a first separator set having three separators and a second separator set having seven separators, arranged vertically to hold up to fourteen short-length dialyzers per packaging division. In yet another embodiment, the packaging division for housing the XL-length hollow-fiber hemodialysis dialyzers includes a first separator set having two separators and a second separator set having six separators, arranged vertically to hold up to six short-length dialyzers per packaging division. Regardless of the different configurations of the packaging divisions for the standard-length, short-length, and XL-length dialyzers, the overall dimensions of the packaging divisions are substantially identical.

The relative orientation of the XL-length dialyzers in the packaging division may differ from those of the standard-length and short-length dialyzers, as shown in <FIG>. The XL-length dialyzers are aligned with the longer length of the packaging division, whereas the standard and short-length dialyzers are aligned with the shorter length of the packaging division. This does not change the direction which the packaging divisions are fitted in relative to the box. The advantage is that the boxes can be used for shipping both short-length and long length dialyzers by altering the direction they are laid in the box. This also makes it possible to ship the dialyzers of different sizes in the same box, by placing the longer dialyzers on one level, and the shorter dialyzers on another level in the proper orientation. In one embodiment, the secondary packaging container comprises three packaging divisions, with one packaging division having a plurality of standard-length dialyzers, one packaging divisions having a plurality of short-length dialyzers, and the third packaging divisions having a plurality of XL-length dialyzers. In one embodiment, the secondary packaging container comprises a packaging division having a plurality of standard-length dialyzers and a second packaging division having a plurality of short-length dialyzers. In one embodiment, the secondary packaging container comprises a packaging division having a plurality of standard-length dialyzers and a second packaging division having a plurality of XL-length dialyzers. In another embodiment, the secondary packaging container comprises a packaging division having a plurality of short-length dialyzers and a second packaging division having a plurality of XL-length dialyzers.

<FIG> depicts a packaging division capable of receiving a plurality of dialyzers. The packaging division may comprise a first separator set <NUM> and a second separator set <NUM>, each with a plurality of separators arranged in parallel. The first separator set is vertically arranged against the second separator set to form a plurality of housing cavities <NUM>. The housing cavities are capable of receiving a plurality of dialyzers which are positioned in the housing cavity of the packaging division.

<FIG> shows a kit which may include a packaging division and one or more dialyzers placed in one or more of the housing cavities of the packaging division respectively. A secondary packaging product may comprises one or more kits. <FIG> also illustrates top views of the packaging divisions <NUM> in some embodiments housing the standard-length, short-length, and XL-length dialyzers <NUM>, respectively. <FIG> illustrates side views of the packaging divisions in some embodiments housing the standard-length, short-length, and XL-length dialyzers, respectively. The dialyzers are arranged side-by-side with the Hansen connectors facing upward above the horizontal plane of the packaging division and at a predetermined angle θ to the vertical axis <NUM>. The predetermined angle may be any angle smaller than <NUM> degrees (e.g., <NUM>-<NUM>°, <NUM>-<NUM>°, <NUM>-<NUM>°, about <NUM>°). In some embodiments, the predetermined angle is about <NUM> degrees. The main reason of this rotation of the dialyzers is to protect the Hansen connectors and reduce potential damages to the primary packaging.

When packaging one or more packaging divisions, an insert may separate the packaging divisions, as shown in <FIG>. The insert may have substantially the same size as that of the packaging division. In one embodiment, the insert may have two mutually opposed folded-up handles configured to fit the two sides of the packaging division. When three packaging divisions are packaged, two inserts may be used, with one placed between the first and the second packaging divisions and the other placed between the second and the third divisions.

The box, the packaging division, and the insert may be made of the same or different materials and may contain one or more materials. The box may be manufactured from a material capable of providing adequate strength for shipping and storing the dialyzers. The box may be made of cardboard, recycled paper products, a composite material, or other conventional materials. Likewise, the packaging division and the insert may also be made of cardboard, recycled paper products, a composite material, or other conventional materials. In some embodiments, the box, the packaging division, and the insert may be made of one of corrugated cardboard materials, including, without limitation, a C Flute rippled cardboard (Flute thickness of about <NUM>), a B Flute rippled cardboard (Flute thickness of about <NUM>), and a M Flute rippled cardboard (Flute thickness of about <NUM>), shown in <FIG>. In one embodiment, the box comprises one or more substantially C-flute rippled cardboard layer. In one embodiment, each of the separators of the packaging division comprises one or more substantially B-flute rippled cardboard layer. In another embodiment, the insert comprises one or more substantially M-flute rippled cardboard layers.

One particular embodiment according to <FIG> comprises a box with a rectangular horizontal cross sectional shape measures about <NUM> inches long, about <NUM> inches wide and about <NUM> high, as shown in <FIG>. The secondary packaging container further comprises a packaging division configured to substantially fit the size of a standard-length dialyzer, a short-length dialyzer, and an XL-length dialyzer. The dialyzers are placed in the housing cavities of the packaging division, such that the Hansen connector of each of the dialyzers is orientated upward above the horizontal plane of the packaging division and at about <NUM> degrees. The box of the secondary packing container further comprises one or more substantially C-flute rippled cardboard layer. The packaging division of the secondary packaging container further comprises one or more substantially B-flute rippled cardboard layer. The insert of the secondary packaging container comprises one or more substantially M-flute rippled cardboard layers. The secondary packaging container further comprises three packaging divisions separated by one or more inserts and a box label attached to the box.

The present invention also provides a method of packaging hollow-fiber hemodialysis dialyzers as defined in claim <NUM>. The method includes placing a plurality of dialyzers in a packaging division and placing horizontally the packaging division in a box. The box has one or more side walls and a bottom surface, with the bottom surface connected to an edge of the side wall. The packaging division comprises a plurality of housing cavities, each capable of receiving a dialyzer. The housing cavities are formed by a first separator set and a second separator set, each with a plurality of separators arranged in parallel. The first separator set is vertically arranged against the second separator set to form the housing cavities. Each of the dialyzers is positioned in the housing cavity of the packaging division with a Hansen connector of each of the dialyzers orientated upward and at a predetermined angle to a vertical axis.

In some embodiments, the method may involve placing a plurality of standard-length, short-length, or XL-length hemodialysis dialyzers in the housing cavities of the packaging division. In some embodiments, the method may involve inserting the dialyzer into the housing cavity of the packaging division and then rotating it to one lateral division, such that the Hansen of each dialyzer is orientated upward and at a predetermined angle. In one embodiment, the method may involve inserting the dialyzer into the housing cavity of the packaging division, such that the Hansen of each of the dialyzers is orientated upward above the horizontal plane of the packaging division. In one particular embodiment, the method may involve inserting the dialyzer into the housing cavity of the packaging division, such that the Hansen of each of the dialyzers is orientated upward and at about <NUM> degrees.

In some embodiments, the method may involve placing one or more packaging divisions, separated by the inserts. When three packaging divisions are placed in the box, two inserts may be used for separating the packaging divisions, with one insert placed between the first and the second packaging divisions and the other insert placed between the second the third packaging divisions.

In some embodiments, the method may further involve placing the dialyzers in the housing cavities of the packaging division, wherein the housing cavities have a substantially uniformed size configured to accommodate the dialyzer.

In some embodiments, the method may involve placing the dialyzers in the box having a substantially C-flute rippled cardboard layer. In some embodiments, the method may involve placing the dialyzers in the housing cavities of the packaging division formed by the separators having a substantially B-flute rippled cardboard layer. In some embodiments, the method may involve placing the dialyzers in the packaging division to form the packaging divisions separated by the insert having a substantially M-flute rippled cardboard layer.

The horizontal cross sectional shape of the box body includes, without limitation, circular, elliptical, square, rectangular, and polygonal. In one embodiment, the box with a rectangular horizontal cross sectional shape measures about <NUM> long, about <NUM> wide and about <NUM> high, as shown in <FIG>.

Claim 1:
A secondary packaging container packaging a plurality of hemodialysis dialyzers (<NUM>), comprising:
a box (<NUM>) having one or more side walls and a bottom surface, wherein the bottom surface is connected to an edge of the side wall; and
one or more packaging divisions (<NUM>), the packaging divisions comprising a plurality of housing cavities (<NUM>), each housing cavity having one dialyzer (<NUM>) received therein in a horizontal way, wherein each packaging division (<NUM>) is placed horizontally in the box (<NUM>),
characterized in that the housing cavities (<NUM>) of each packaging division (<NUM>) are formed by a first separator set (<NUM>) and a second separator set (<NUM>), each of the separator sets having a plurality of separators arranged in parallel, wherein the first separator set (<NUM>) is vertically arranged against the second separator set (<NUM>) to form the housing cavities (<NUM>).