MEDICAL TEST DEVICE PACKAGE, PACKAGING SYSTEM AND METHOD OF PACKAGING A MEDICAL TEST DEVICE

BACKGROUND AND TECHNICAL FIELD

The present disclosure relates to a method and system for packaging test strips, in particular lateral flow device strips for medical test devices.

Lateral flow tests or lateral flow devices are used in medical diagnostic applications, such as for detecting the presence of one or more target antigens or antibodies, including, for example, pregnancy testing, COVID tests, flu and respiratory viruses, as well as enzyme-linked immunosorbent assays. Traditional systems and methods for packaging for lateral flow device strips include injection molding cassettes, inserting the strips into the cassettes, and thereafter sealing the strips in the cassettes. However traditional injection molded cassettes is time-consuming and further creates a lot of plastic waste.

SUMMARY

A method of packaging lateral flow test strips, said method comprising providing an elongated first web, wherein the elongated first web comprises thermo-formable material, thermoforming a plurality of recesses in the elongated first web, wherein the recesses are at spaced intervals along the elongated first web, providing a supply of lateral flow test strips, providing an elongated second web, retaining lateral flow test strips within the recesses of the elongated first web by attaching the second web to the first web, and cutting the attached together first web and second web to separate the thus retained lateral flow test strips into packages.

In particular embodiments, the thermoforming a plurality of recesses in the first web comprises forming receptacles for receiving the lateral flow test strips, with the method including placing lateral flow test strips in the recesses of the elongated first web prior to said retaining lateral flow test strips within the recesses of the elongated first web.

The elongated second web may also comprise a thermo-formable material, with the method including thermoforming features in the second web at spaced intervals along the elongated second web wherein the features comprise thermoformed features, and positioning at least a portion of the second web at the first web such that thermoformed features of the second web are disposed at recesses of the first web. The thermoformed features may include recesses and/or windows or apertures.

Further aspects of the method may include cutting sections of the second web prior to positioning at least a portion of the second web at the first web, where each section of the second web comprises a plurality of thermoformed features for engagement with a plurality of recesses. In the case of thermoformed features comprising recesses, the retaining lateral flow test strips within the recesses may include securing the second web to the first web with recesses of the second web disposed at recesses of the first web.

The method may also include feeding the elongated first web in a feed direction and placing the lateral flow test strips in the recesses of the elongated first web while the elongated first web is fed in the feed direction. For example, the elongated first web may be wound on a reel with the method comprising unwinding the reel while feeding the elongated first web in the feed direction. The step of thermoforming the plurality of recesses in the elongated first web may occur prior to winding the elongated first web on the reel.

In a further configuration, the method may comprise placing lateral flow test strips on the elongated second web at spaced intervals and placing the first web on the second web with recesses of the first web disposed about the lateral flow test strips on the second web.

In any of the embodiments the elongated first web and/or elongated second web may each include lateral edges, with the method further comprises forming a plurality of apertures adjacent at least one edge of the first web and/or the second web, where the apertures may be used for feeding the first web and/or second web.

The thus individually packaged lateral flow test strips comprise lateral flow test cassettes.

An alternative method of packaging test strips includes providing a supply of a pre-formed thermo-formable web formed from a planar thermo-formable web with a plurality of thermoformed recesses formed therein and connected by the thermo-formable web, and which are spaced at along the longitudinal axis of the pre-formed thermo-formable web and are sized for receiving strips of lateral flow tape therein. The method further includes feeding the pre-formed thermo-formable web in a feed direction and providing a supply of strips of lateral flow tape, which are then placed in the thermoformed recesses of the pre-formed thermo-formable web while the pre-formed thermo-formable web is fed in the feed direction. Once placed in the recesses, the strips are then sealed in the recesses.

In one aspect, the method further includes providing a reel, and feeding the pre-formed thermo-formable web with the reel in the feed direction.

In another aspect, the method further includes providing a thermoforming apparatus and a reel having a supply of a planar thermo-formable web, wherein the feeding the pre-formed thermo-formable web includes feeding the planar thermo-formable web with the reel into the thermoforming apparatus to form the recesses to form the supply of pre-formed thermo-formable web, and feeding the pre-formed thermo-formable web from the thermoforming apparatus in the feed direction.

In any of the above, the method further includes providing a supply of a backing web, and feeding the backing web over the strips after the strips are placed in the recesses, and the sealing includes sealing the backing web with the pre-formed thermo-formable web to thereby seal the strips in the recesses.

In a further aspect, providing a supply of backing web comprises providing a planar web with an adhesive layer, and the sealing includes sealing the strips in the recesses of the pre-formed thermo-formable web with the adhesive layer.

Optionally, when providing the planar web, the planar web may have a release strip over the adhesive layer, which is them removed before feeding the backing web over the strips placed in the recesses.

In yet another aspect, providing a supply of pre-formed thermo-formable web includes providing a first pre-formed thermo-formable web, and the providing a supply of backing web comprises providing a supply of a second pre-formed thermo-formable web with a plurality of thermoformed recesses formed therein and connected by the second pre-formed thermo-formable web. The thermoformed recesses in the second pre-formed thermo-formable web are spaced at a second spacing along the longitudinal axis of the second pre-formed thermo-formable web, with the second spacing being equal to the first spacing.

According to yet another aspect, the method may include providing structures on the pre-formed thermo-formable web and/or the backing web to assist in aligning the strips and the recesses.

According to yet further aspects, the method may further include cutting between each strip after being sealed in a respective recess to form individually packages strips.

Additionally, the individual packaged strips may be enclosed in foil.

In yet another aspect, the method may further include providing a supply of treated web for forming the strips of lateral flow tape and cutting the treated web into the strips of lateral flow tape.

According to yet another form, a test strip packaging system includes a supply of a pre-formed thermo-formable web formed from a planar thermo-formable web, with a longitudinal axis and a plurality of thermoformed recesses formed therein, and which connected by said thermo-formable web. The thermoformed recesses are spaced at a first spacing along the longitudinal axis of the planar thermo-formable web and are sized for receiving strips of lateral flow tape therein. The system also includes a feed apparatus that feeds the thermo-formable web in a feed direction and a supply of strips of lateral flow tape, with a pick and place apparatus to pick and place strips from the supply of strips in the thermoformed recesses of the thermo-formable web while the thermo-formable web is fed in the feed direction. The system also includes a seal apparatus to seal the strips in the recesses.

In one aspect, the test strip packaging system includes a reel to feed the supply of pre-formed thermo-formable web.

In another aspect, the test strip packaging system includes a thermoforming apparatus and a reel having a supply of a planar thermo-formable web, with the reel feeding the planar thermo-formable web into the thermoforming apparatus to form the recesses to thereby form the supply of pre-formed thermo-formable web.

In yet another aspect, the test strip packaging system further includes a supply of a backing web and a feed apparatus to feed the backing web over the strips after the strips are placed in the recesses. The seal apparatus then seals the backing web with the pre-formed thermo-formable web to thereby seal the strips in the recesses.

In still a further aspect, the backing web comprises a planar web with an adhesive layer, with the adhesive layer sealing the strips in the recesses of the pre-formed thermo-formable web. Optionally, the backing web further includes a release strip over the adhesive layer, with the test strip packaging system further including an apparatus to remove the release strip.

According to yet other aspects, the pre-formed thermo-formable web comprises a first pre-formed thermo-formable web, and the backing web comprises a second pre-formed thermo-formable web with a plurality of thermoformed recesses formed therein and which are connected by the second pre-formed thermo-formable web. The thermoformed recesses in the second pre-formed thermo-formable web are spaced at a second spacing along the longitudinal axis of the second pre-formed thermo-formable web, with the second spacing is equal to the first spacing.

In yet other aspects, the test strip packaging system further includes a cutting apparatus to cut between each strip after being sealed in a respective recess to form individually packages strips. Optionally, the system may also include an apparatus to enclose the individual packaged strip in foil.

According to yet another aspect, in any the above, the test strip packing system may further include a supply of treated web for forming the strips of lateral flow tape and a cutting apparatus to cut the treated web into the strips of lateral flow tape.

According to yet another embodiment, a method of packaging test strips includes providing a supply of a backing web, which has a longitudinal axis, feeding the backing web in a feed direction, providing a supply of strips of lateral flow tape, and placing strips from the supply of strips on the backing web at a first spacing along the longitudinal axis while the backing web is fed in the feed direction. The method further includes providing a supply of a pre-formed thermo-formable web, with a plurality of thermoformed recesses formed therein and which are connected by the thermo-formable web. The thermoformed recesses are spaced at a second spacing along the longitudinal axis of the pre-formed thermo-formable web and are sized for receiving strips of lateral flow tape therein, with the second spacing is equal to the first spacing. The pre-formed thermo-formable web is fed onto the backing web after the strips are placed on the backing web and then sealed therein.

In yet another embodiment, a test strip packaging system includes a supply of a backing web, a first feed apparatus to feed the backing web in a feed direction, a supply of strips of lateral flow tape, a pick and place apparatus to pick and place strips from the supply of strips on the backing web at a first spacing along the longitudinal axis of the backing web while the backing web is fed in the feed direction. The test strip packaging system further includes a supply of a pre-formed thermo-formable web, with a plurality of thermoformed recesses formed therein and which are connected by the thermo-formable web. The thermoformed recesses are spaced at a second spacing along the longitudinal axis of the pre-formed thermo-formable web and are sized for receiving strips of lateral flow tape therein, with the second spacing is equal to the first spacing. The test strip packaging system further includes a second feed apparatus to feed the pre-formed thermo-formable web onto the backing web after the strips are placed on the backing web and a seal apparatus to seal the strips between the backing web and the pre-formed thermo-formable web in the recesses.

Accordingly the method and system described herein provide an improved method of packaging medical test devices using a process that increases and produces less waste, such as by the production of thermoformed lateral flow test cassettes or cartridges.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic drawing of a test strip packaging system;

FIG. 2 is an exploded perspective view of a plurality of test strip packages joined and formed together from a thermo-formable web;

FIG. 3 is a schematic drawing of another embodiment of a test strip packaging system

FIG. 4 is an exploded perspective view of another embodiment of a plurality of test strip packages formed by the test strip packaging system;

FIG. 5 is a schematic drawing of yet another embodiment of a test strip packaging system;

FIG. 6A is a perspective view of a third embodiment of a test strip packaging system;

FIG. 6B is an enlarged perspective view of a section of the test strip packaging system of FIG. 6A;

FIG. 7 is a close-up perspective view of a pick and place apparatus of the strip packaging system of FIGS. 6A and 6B;

FIG. 8 is an enlarged perspective view of a section of an embodiment of a portion of a thermoformed lateral flow test cassette;

FIG. 9 is a plain view of the section of FIG. 8;

FIG. 10 is a cross-sectional view taken along line X-X of FIG. 9;

FIG. 11 is a cross-sectional view taken along line XI-X I FIG. 9;

FIG. 12 is an enlarged perspective view of a section of an embodiment of a portion of a thermoformed lateral flow test cassette for mating with the section of FIG. 8;

FIG. 13 is a plan view of the of the section of FIG. 12;

FIG. 14 is a cross-sectional view taken along line XIV-XIV of FIG. 12; and

FIG. 15 is a cross-sectional view taken along line XV-XV of FIG. 12.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1, the numeral 10 generally designates a packaging system for packaging a medical test device, such as a lateral flow element, including a lateral flow strip. As will be more fully described below, packaging system 10 packages the medical test devices using a thermoformed web that is fed into a steady packaging process stream that enables a high-speed packaging production. The thermoformed web may be pre-formed with recesses or formed with recesses during the packaging process stream, which recesses form at least part of the packaging or “cartridges” for the medical test devices. As will be described below, the recesses to receive the medical test devices can be provided in both top and bottom sides of the packaging, or just one side. Further, during at least the forming and filling portion of this process, the cartridges are connected together and conveyed together to provide a continuous or steady stream of cartridges, which speeds up the process and, further, reduces waste. Once the cartridges are formed with the medical test devices contained therein, they are then separated into individual cartridges or packages that can then be post processed, such as using conventional subsequent packaging that improves shelf life of the medical test device, also as more fully described below.

Referring again to FIG. 1, packaging system 10 includes a supply 12 of a thermo-formable web 14, which is used to form one side of the packaging for the medical test device, a supply 16 of a backing web 18, which together with the thermo-formable web 14 are used to enclose the medical test device. Packaging system 10 further includes a medical test device placement apparatus 20 for placing medical test devices 22 (FIG. 2) on the thermo-formable web 14, and a sealing apparatus 24 that seals the thermo-formable web and the backing web together in a steady process stream, as will be more fully described below. As discussed below, packaging system 10 includes a thermoforming apparatus 26 to create features in the thermo-formable web 14, such as cavities or recesses.

In the illustrated embodiment, supply 12 includes a reel 12a, such as a motorized reel, of the thermo-formable web 14 that is wound on the reel (like a tape) while the thermo-formable web is still in its planar thermo-formable web form (with opposed planar top and bottom surfaces with no recesses formed therein). When unwound, the reel 12a then feeds the thermo-formable web 14 to thermoforming apparatus 26, such as a thermoforming press that applies heat and may additionally provide pressure, to form cavities or recesses 28 (FIG. 2) in the thermo-formable web 14. A suitable thermoforming apparatus may be designed for the particular desired lateral flow cartridge, such as from a thermoforming apparatus of a tape and reel assembly. A suitable thermo-formable web 14 may be formed from a variety of thermoplastics, Acrylonitrile butadiene styrene (ABS), High Impact Polystyrene (HIPS), Polyvinyl chloride (PVC), and Polyethylene terephthalate (PET), including biodegradable plastics. Optionally, web 14 may be formed from a non-plastic material suitable for thermoforming, such as Sulapac, which is a sustainable plastic alternative, including Sulapac based materials such as polystyrene (PS), polypropylene (PP), and polylactic acid (PLA). Further, a suitable thickness for web 14 may have a thickness in a range of about ¼ mm or ⅛ mm or less, though a thicker web may be used.

Referring to FIG. 2, recesses 28 are formed in thermo-formable web 14 at uniformly spaced intervals or spacings along longitudinal axis 14a of thermo-formable web 14 in the packaging process stream or feed direction (arrow A in FIG. 1) as the thermo-formable web 14 is fed through thermoforming apparatus 26. As best seen in FIG. 2, recesses 28 are sized to receive medical test devices 22 therein. After the recesses 28 are formed in the thermo-formable web 14, the thermo-formable web 14 is then conveyed in the packaging process stream direction A to a strip placement location where the medical test devices 22 are then placed on the thermo-formable web 14 in the recesses 28. After the medical test devices are placed in the recesses, the devices are then enclosed by backing web 18, which is placed and then sealed over medical test devices 22.

As described in more detail with reference to FIGS. 3 and 4, backing web 18 may also comprise a thermo-formable web that is thermoformed with recesses. However, in the illustrated embodiment of FIGS. 1 and 2, backing web 18 comprises a planar backing web with planar surfaces on both post sides of the web without any recesses. For example, backing web 18 may be formed from a non-plastic material, such as Sulapac as noted above, or any paper based product, which can reduce the amount of plastic used in the packaging process.

Optionally, backing web 18 may include an adhesive layer on some or all of the side facing web 14 so that when in contact the adhesive joins the two webs together and then is sealed by the sealing apparatus 24, which may then simply apply pressure in lieu of heat—though heat could also be added by the sealing apparatus. In addition, backing web 18 may have a release strip over the adhesive layer, which is then removed by a release liner removal apparatus (described in reference to FIG. 5), before feeding the backing web 18 over the strips 22a placed in the recesses 28.

Referring to FIG. 1, backing web 18 is fed into the process stream after the medical test devices are placed in the respective recesses 28 of thermo-formable web 14. As noted above, medical test devices 22 may comprise lateral flow elements, such as lateral flow strips 22a. The lateral flow strips 22a may be formed in the packaging process stream, such as described in reference to FIG. 5, or may be pre-formed and then placed in the recesses. Once formed as lateral flow strips, the lateral flow strips are placed into the respective recesses 28 on thermo-formable web 14 by a placement apparatus 20, such as a pick and place apparatus commercially available from Kinematic Automation, as the thermo-formable web moves in the feed direction of the packaging process stream.

As best understood from FIG. 2, after the lateral flow strips 22a are placed in the recesses 28 of thermo-formable web 14, backing web 18 is fed onto the thermo-formable web 14 and thereafter sealed with thermo-formable web 14 by sealing apparatus 24. Similar to thermo-formable web 14, backing web 18 may be supplied by and wound around a reel 16a, such as a motorized reel, that feeds the backing web into the packaging process stream. The sealing apparatus 24 may include a variety of types of sealing apparatus, including a laminator that heat seals the longitudinal edges and the transverse portions (the portions between the recesses) of the two webs together as the web is passed through the sealing apparatus. A suitable sealing apparatus may comprise a conventional sealing apparatus, such as thermal sealing apparatus, an ultrasonic welding apparatus, a laser welding apparatus, an induction sealing apparatus, or, as noted, may be sealed using pressure sensitive pressure adhesive, which then is subject to applied pressure.

After the two webs are sealed together, the individual packages may then be separated by a cutting apparatus 30. A suitable cutting apparatus is commercially available cutting apparatus, such as a rotary slitting apparatus, guillotine shearing apparatus, a laser cutting apparatus, or a die cutting apparatus, such a rule die apparatus or a punch-and-die apparatus. As shown in FIG. 2, the thus formed packages comprise lateral test flow cassettes or cartridges 47 that are initially connected together in an elongated strip or band as formed from and/or on the thermo-formable web 14 until the cartridges 47 are separated by the cutting apparatus 30. It should be appreciated that the cartridges 47 may be individually separated or a number of cartridges 47 may remain connected together but be separated from the thermo-formable web 14.

The individual packages or cassettes or cartridges 47 are then deposited on a take-away conveyor 32, such as a motorized belt conveyor, which optionally transports the individual packages to bins for further handling.

In addition, packaging system 10 may also include a conveying surface 34 for collecting scrap that is generated during the packaging process, which may then be collected on a take-up reel for later processing, including for use in forming thermo-formable web 14. For example, the scrap material may be wound up on a reel to be discarded or chopped up and then conveyed via a waste conveyor, for example, to a waste receptacle.

System 10 may also include suitable rollers R for redirecting the webs 14, 18 and conveying surface 34 to accommodate various arrangements of reels 12a, 16a, and 36. Rollers R may be passive rollers or powered motor, depending on the desired control, such as speed of the packaging process stream.

Referring to FIGS. 3-4, in an alternate embodiment, similar to packaging system 10, packaging system 110 includes a supply 112 of a thermo-formable web 114, a supply 116 of a backing web 118, a medical test device placement apparatus 120 for placing medical test devices 122 (FIG. 4) on the thermo-formable web 114, and a sealing apparatus 124 that seals the thermo-formable web 114 and the backing web 118 together in a steady process stream.

In the illustrated embodiment, similar to the first embodiment, supply 112 also includes a reel 112a, such as a motorized reel, of the thermo-formable web 114 that is wound on the reel (while the thermo-formable web is still in its planar web form, with opposed planar top and bottom surfaces with no recesses formed therein). When unwound, the reel 112a then feeds the thermo-formable web 114 to a thermoforming apparatus 126a, such as a thermoforming press, to form recesses 128a in the thermo-formable web 114. For a suitable thermoforming apparatus and a suitable web reference is made to the first embodiment.

Referring to FIG. 4, similar to recesses 28, recesses 128a are formed in thermo-formable web 114 at uniformly spaced intervals or spacings along longitudinal axis 114a of thermo-formable web 114 in the packaging process stream or feed direction as the thermo-formable web 114 is feed through thermoforming apparatus 126a. As best seen in FIG. 4, recesses 128a are sized to at least partially receive medical test devices 122 therein. After the recesses 128a are formed in the thermo-formable web 114, the thermo-formable web 114 is then conveyed in the packaging process stream direction A to a strip placement location where the medical test devices 122 are then placed on the thermo-formable web 114 in the recesses 128a, similar to the previous embodiment. After the medical test devices 122 are placed in the recesses, the devices are then enclosed by backing web 118, described below.

As noted above, backing web 118 may also comprise a thermo-formable web that is thermoformed with recesses 128b which together with recesses 128a enclose the medical test devices 122 there between. Similar to thermo-formable web 114, backing web 118 is fed into the process stream after the medical test devices 122 are placed in the respective recesses 128a of thermo-formable web 114. Similar to devices 22, devices 122 may also comprise lateral flow elements, such as lateral flow strips 122a. The lateral flow strips 122a may also be formed in the packaging process stream, such as described in reference to FIG. 5.

After the lateral flow strips 122a are placed in the recesses 128a of thermo-formable web 114, backing web 118 is fed onto the thermo-formable web 114 and thereafter sealed with thermo-formable web 114 by sealing apparatus 124. Similar to thermo-formable web 114, backing web 118 may be supplied by and wound around a reel 116a, such as motorized reel, that feeds the backing web 118 into a second thermoforming apparatus 126b, which then forms recesses 128b in backing web 118, prior to placement over trips 122a. After backing web 118 is placed over strips 122a, the longitudinal edges and lateral portions of webs 114 and 118 are then sealed together by a sealing apparatus 124, such as described above.

After the two webs are sealed together, the individual packages may then be separated by a cutting apparatus 130. The individual packages are then deposited on a conveyor 132, such a motorized belt conveyor, which optionally transports the individual packages to bins, for example, for further handling. For discussion of a suitable cutting apparatus reference is made to the above embodiment.

As understood from FIG. 4, the mating together of the two thermo-formable webs 114, 118 with recesses 128a, 128b forms cartridges or cassettes 147, where in the illustrated embodiment of FIG. 4 each cassette 147 includes a cassette portion 147a formed from a section of the lower thermo-formable web 114 having a recess 128a and a cassette portion 147b formed from a section of the upper thermo-formable web 118 having a recess 128b. As also shown in FIG. 4, during the thermoforming process in the lower thermo-formable web 114, features 129a are formed adjacent or at recesses 128a, and likewise during the thermoforming process in the upper thermo-formable web 118, features 129b are formed adjacent or at recesses 128b. Features 129a, 129b may be projections and receptacles, or the like, and may be used for aligning and/or mating the cassette portions 147a, 147b together. Alternative and/or additional features may be provided for aligning and/or mating the cassette portions 147a, 147b together, such as ridges, grooves, flanges, or the like. In the illustrated embodiment recesses 128b are formed to include windows 131, 133, where one window 131 is provided to expose a sample pad of the lateral flow strip 122a and the other window 133 is provided to display a test result or line, which may also include a control line.

In addition, packaging system 110 may also include a conveying surface 134 for collecting scrap that is generated during the packaging process, which may then be collected on a take-up reel for later processing, including for use in forming thermo-formable web 114.

In order to assure that the recesses 128a and 128b are aligned during the packaging process, one or both webs (web 114 and/or 118) may include additional structures, such as tractor holes, which can be added as a punching feature during the thermoforming process and read by a sensor or mechanically engaged for movement of the web (such as a tractor wheel) which provides input to the control system (described below) so that the control system can track and know the location of the web or webs, and their respective recesses, during the feeding and packaging forming process to assist with the alignment process. For example the control system may speed up or slow down one or both the reels feeding the webs to get them synchronized such that their recesses align when enclosing the strips 122a. Alternately, variable tension systems or differential drive systems can be used.

Referring to FIG. 5, in another embodiment, packaging system 210 may use a supply 212 of a pre-formed thermo-formable web 214. Pre-formed thermo-formable web 214 is formed from a planar thermo-formable web which is then thermoformed with a plurality of cavities or recesses before being wound on reel 212a. The reel 212a then feeds the pre-formed thermo-formable web 214 into the packaging process stream, described below. The pre-formed thermo-formable web 214 thus comprises one portion of lateral test flow cassettes or cartridges that are initially connected together in an elongated strip or band as formed from and/or on the thermo-formable web 214.

Referring again to FIG. 5, rather than placing the medical test devices on pre-formed thermo-formable web 214, system 210 is configured to place the medical test devices 222 on a backing web 218 from supply 216. Similar to the previous embodiments, backing web 218 is wound on a reel 216a, such as a powered reel, and, further, as noted in reference to the first embodiment, includes an adhesive layer on the side facing web 214 so that the adhesive can stabilize the strips 222a on the backing web 218 and join the two webs together. The webs are then sealed by the sealing apparatus, as described above. In addition, backing web 218 has a release strip 218a over the adhesive layer, which is removed by a release liner removal apparatus 240, which includes a roller 240a, such as a powered roller, and a guide surface 240b, which is located adjacent reel 216a and removes the release strip as the backing web 218 is fed into the packing process stream and feeds the removed release strip 218a to roller 240a.

After the release strip is removed, backing web 218 is fed under a lateral flow strip assembly 250, which has a supply 252 of a treated substrate 254 that is used to form the lateral flow strip. Lateral flow strip assembly 250 includes a reel 252a, such as a motorized reel, that is wound with the treated substrate 254 and feeds the treated substrate to a cutting apparatus 256, which cuts the substrate 254 into strips to form the lateral flow strips 222a. The lateral flow strips 222a are then deposited by the cutting apparatus 256 on the adhesive side of the backing web 218.

As the backing web 218 flows in the packing process stream, and after lateral flow strips 222a are placed on the backing web 218, reel 212a feeds the pre-formed thermo-formable web 214 onto the backing web 218 over the lateral flow strips 222a to enclose the lateral flow strips 222a between the two webs. Similar to that as described above in reference to system 110, in order to assure alignment of the recesses 228 formed in pre-formed thermo-formable web 214, system 210 may provide structures in known locations on one or both webs, such as track holes or notches, that may be mechanically engaged and sensed by a sensor (e.g. a tractor wheel), which is in communication with the control system. For further details of this alignment method reference is made to the above description.

Similar to the previous embodiments, once the two webs are sealed together and the packages comprising lateral test flow cassettes or cartridges 247 are formed, a cutting apparatus 230 cuts the joined webs between the respective packages to form individual singulated packages 247 or sections of attached packages 247 that may be separated by an end user. Further, as previously noted, a post packaging process of enclosing the respective packages in an outer protective package, such as formed from foil, may also be incorporated into system 210 (also part of the above systems). By sealing the individual packages in foil, the shelf life may be improved.

Referring to FIG. 5, post packaging processing station apparatus 260 may include a conveying surface (not shown) onto which the individual packages are deposited after they are separated from the two webs. Post packaging processing station 260 includes a foil packaging system or process comprising a first supply 262 of foil 264 that is wound on a reel 262a, such as a motorized wheel, which is fed under a group of packages to form a bottom layer of foil. Similarly, post packaging processing station 260 includes a second supply 266 of foil 268 that is wound on a reel 266a, such as a motorized wheel, and is used to feed foil to a foil printer 270 that may label and/or cut the foil into foil layer sections for feeding onto the top of each respective package. The foil layers are then sealed together using a sealing apparatus 272, which are commercially available, for example, from Thomas Scientific. Once packaged with the outer layer, system 210 then separates the packages into individual packages, again using a cutting apparatus 280, such as a commercially available high speed cutter, which then deposits the individual packages on a take-away conveyor 232. System 210 may additionally include a desiccant material for inclusion with the individual packages. For example, a roll of desiccant material may be provided such as on a reel similar to reels 262a, 266a, with the roll of desiccant material being unwound and provided with the lateral flow cassettes 247. In one such embodiment, the roll of desiccant material may be unwound and applied to the cassettes 247 in advance of cutting apparatus 230 prior to being singulated. Optionally the desiccant material may be laminated to the cassettes 247, such as via an adhesive. Alternatively, the roll of desiccant material may be provided with post packaging processing station 260 after cutting apparatus 230 in advance of printer 270 so as to be sandwiched between the foil layers 264, 268, and may again optionally be laminated to the cassettes 247.

Referring to FIG. 6A, the numeral 310 generally designates another embodiment of a packaging system for packaging medical test devices. Similar to packaging system 210, packaging system 310 includes a supply 312 of a pre-formed thermo-formable web 314 and further includes a second supply 316 of a pre-formed thermo-formable web 318. Pre-formed thermo-formable webs 314, 318 are each formed from a planar thermo-formable web which is thermoformed with a plurality of recesses before being wound on respective reels 312a and 316a (see FIGS. 4 and 8-15 and below for discussion of exemplary webs). It should thus be appreciated that the pre-formed thermo-formable web 314 thus comprises one portion of lateral test flow cassettes or cartridges that are initially connected together in an elongated strip or band as formed from and/or on the thermo-formable web 314 and, likewise, the pre-formed thermo-formable web 318 thus comprises another portion of lateral test flow cassettes or cartridges that are initially connected together in an elongated strip or band as formed from and/or on the thermo-formable web 318. As will be more fully described below, pre-formed thermo-formable web 314 is fed into system 310 and then indexed to receive strips in recesses formed therein and then indexed to be sealed with sections of pre-formed thermo-formable web 318, which facilitates alignment between the respective recesses and other optional structures formed in the webs. Thus, web 314 forms a continuous web, while web 318 is fed onto web 314 in sections.

Similar to the previous embodiments, system 310 includes a strip placement apparatus 320, which is located in packing system 310 to place strips into the recesses in the pre-formed thermo-formable web 314. Reel 316a (under the control of the control system described below) feeds pre-formed thermo-formable web 314 onto a conveyor 332 (FIGS. 6A and 6B) supported on a table 334. Pre-formed thermo-formable web 314 is indexed along conveyor 332 by the control system to a receiving position where it receives strips in a group of recesses formed therein from strip placement apparatus 320 and then is moved to pick and place position along conveyor 322 where it is covered with a section of pre-formed thermo-formable web 318, as more fully described below. A reel 313 of lateral flow test tape 315 feeds the tape 315 into test strip machine 317, where machine 317 singulates the tape 315 into strips 322a by cutting the tape 315 at predetermined lengths. Test strip machine 317 may additionally apply materials to tape 315 and/or strips 322a, such as materials needed for use in conducting a particular test associated with the completed lateral flow cassette 347. Strips 322a are fed from machine 317 via a conveyor 321 from which a pick and place apparatus 320 may select strips 322a for placement into the recesses 328a formed in web 318.

In the illustrated embodiment, strip placement apparatus 320 includes a robotic arm 320a that is operable (under the control of a controller 390 of the control system for packaging system 310) to retrieve a strip 322a from a feed of strips 324 and then place a strip in each recess 328a in web 314 of a section of the web 314 when web 314 is indexed to the strip placement location. When in the strip placement location, strip placement apparatus 320 can move arm 320a to fill the recesses 328a of that section of the web 314 with medical device strips 322a. Once the recesses 328a of the section are filled with medical device strips, the web 314 can be advanced to the next indexed location or position (the pick and place position) along conveyor 322 to the pick and place position where a section of web 318 is placed to enclose the strips in that section of web 314, as described below.

As noted above, pre-formed thermo-formable web 318 is fed into system 310 via reel 316a (FIG. 6B). As best seen in FIG. 6B, reel 316a feeds pre-formed thermo-formable web 318 into a guide 334, which then directs web 318 to reels 316b and 316c. Reels 316b and 316c redirect web 318 to another guide 336 adjacent conveyor 332, which is supported on table 334. Pre-formed thermo-formable web 318 is similarly indexed (via the control system) so that a section of the pre-formed thermo-formable web 318 can be aligned with a section of pre-formed thermo-formable web 314 and, thereafter, cut and placed on pre-formed thermo-formable web 314 by a pick and place apparatus 338.

Referring again to FIG. 7, pick and place apparatus 338 includes a plurality of couplers 340 for coupling to a section 318a of web 318 and for moving the section 318a of web 318 onto a corresponding section 314a of web 314 that has been filled with strips 322a (once the section 318a of web 318 has been cut). The section 318a of web 318 may be cut before or after being engaged by pick and place apparatus 338. For example, a suitable cutting apparatus for cutting web 318 may include a cutting apparatus described in U.S. Pat. No. 6,557,446, which is incorporated by reference herein in its entirety.

As best seen in FIG. 7, couplers 340 may be mounted to a plate 342 that is supported for movement between alignment over web 318 and then over web 314 so that the couplers 340 can engage and lift a section 318a of web 318 and then translate it over onto a corresponding section 314a of web 314 and then deposit it on web 314. The recesses 328b of section 318a of web 318 are aligned with the recesses 328a of section 314a of web 314 in clam shell arrangement. Optionally, plate 342 may be mounted to a movable frame that is lifted and lowered by a conventional driver, with plate 342 movably mounted to the movable frame and horizontally translated across the respective webs. A suitable example of a pick and place apparatus that may be used is described and shown in U.S. Pat. No. 6,557,446, which is incorporated by reference herein in its entirety.

In one embodiment, couplers 340 may comprise suction devices 340a, such as suction tubes, or suction cups 340a that are mounted on tubes, and operated by suction lines (not shown). The suctions lines may be coupled to the upper ends of the tubes and controlled by the control system. When suction is delivered to the suction devices 340a, the suction devices 340a engage the section of web 318.

As noted above, cutting of web 318 into the respective sections may be done before or after the suction devices have engaged the section of the web.

To facilitate retention of webs 314 and 318 in the guides 332 and 336, each guide 332 and 336 may include spaced apart opposed lips or flanges 332a and 336a, which help retain the respective webs in the guides and also form a gap therebetween for monitoring the respective webs as described in reference to the sensor described more fully below. Flanges 332a and 336a may terminate over sections of the respective guides to facilitate picking and placing of the sections of web 318 on web 314, as best seen in FIG. 7.

Once the section 318a of web 318 is placed on a corresponding section 314a of web 314 (and over the strips 322a placed in or on web 314), web 318 may be secured thereto, at least temporarily. For example, web 318 may be spot welded or glued or mechanically attached to web 314, for example, using structures (such as pins and sockets) formed on webs 314 and 318. This attachment may be used temporality, as noted, and, thereafter, replaced with sealing, as described below. In the illustrated embodiment of FIG. 7, for example, a peel bar 319 is provided for applying two bands of adhesive at the lateral edges of the web 314 to hold the section 318a of web 318 thereto until they can be securely affixed together, such as via welding.

In the illustrated embodiment, spaced apart opposed lips or flanges 332a of guide 332 may only terminate in the pick and place position along conveyor 332 so that lips or flanges 332a can facilitate retention of web 314 and the section of web 318 along the conveyed path to another section of system 310 where the webs are processed further.

Referring again to FIG. 6A, once a section 314a of web 314 is filled with strips 322a and then covered with and joined web 318, which together now form a web assembly of lateral test flow cartridges or cassettes 347, the web assembly is conveyed to a second conveyor 344, which may optionally be supported on a second table 346 in the illustrated embodiment but is not required to be separated, where the two webs 314, 318 are now sealed together via a sealing apparatus 372, such as a welding or thermoplastic welding apparatus or machine. After sealing, the web assembly is then conveyed to a cutting apparatus 380 where each lateral flow device is cut and separated for product packing into individual singulated cassettes 347, or groups of cartridges or cassettes 347 are cut and separated for subsequent separating by an end user. In addition to separating cassettes 347, cutting apparatus 380 may also be used to trim lateral edges of the cassettes 347 to remove any apertures formed therein for handling. It should be appreciated that system 310 may additionally include or incorporate a foil packaging system or operation and/or include provision of desiccant material with the cassettes 347. For example, system 310 may incorporate the foil packaging system or process of system 210 and/or incorporate the desiccant providing processing discussed above with regard to system 210. Accordingly, system 310 may include a post packaging processing station in accordance with post processing station 260 as described above.

To facilitate alignment and control over system 310, packing system 310 may include one or more sensors 348 that detect the position or motion of web 314. For example, sensor 348 may be configured as a vision inspection system and be used to detect and/or confirm when all of the strips 322a and/or the last strip 322a has been placed the section 314a of web 314 before moving that section 314a to the pick and place position. As shown in FIG. 7, web 314 and web 318 are each formed to include a plurality of apertures or holes along the lateral edges that may be used for mechanically advancing and/or sensing the position of the respective web 314, 318, where the lateral edges containing the apertures or holes may be subsequently removed during the cutting process for forming the finalized lateral flow cassettes or cartridges 347.

Alternative thermoformed lateral flow cassettes may be constructed in accordance with the present disclosure, including as disclosed with reference to FIGS. 8-15. Referring to FIGS. 8-11, similar to webs 114, 314, web 414 includes recesses 428a that are formed in the thermo-formable web at uniformly spaced intervals or spacing along thermo-formable web 414 and along longitudinal axis 414a of the web that extends in the packaging process stream or feed direction as the thermo-formable web 414 is fed through a packaging system, such as system 310. As best seen in FIG. 9 recesses 428a are sized to at least partially receive medical test device strips therein. As understood from the above description, the preformed thermo-formable web 414 is conveyed in the packaging process stream direction to the strip placement position where the medical test device strips are then placed on the thermo-formable web 414 in the recesses 428a, similar to the previous embodiments. After the medical test devices strips, such as strips 322a, are placed in the recesses, web 414 is then moved and indexed to the next location or position where a section of web 418 is picked and placed over the strips and further then joined with the web 414, as noted above.

Referring to FIG. 9, each recess 428a may include a plurality of lateral ridges 450a that extend transversely across the recess 428a and provide support for the medical device strip in the recess 428a so that the strip is supported above the bottom of the recess 428a. Optionally, some of lateral ridges may be interconnected by longitudinal ridges 452a, 454a that provide additional support for the strip at predetermined portions of the medical device strip, for example in the viewing window, as described below, and where the liquid test sample is deposited on the strip via a deposit window, also described below in reference to FIGS. 12-15.

In addition, as best seen in FIG. 9, similar to the webs described above, each recess 428a of web 414 may be formed with inwardly extending projections 456a at spaced locations along the length the respective recess 428a, which are spaced at a distance equal to or approximately equal to the strip width to help retain the strips in the respective recesses 428a and align them along the central longitudinal axis of the recess 428a.

Referring to FIGS. 12-15, web 418 also includes recesses 428b, 428c. Recesses 428b are located to align with recesses 428a and are provided to form viewing windows so that the strips are viewable. For example, at least a portion of the strips may change to display or indicate a certain test condition—for example, a portion of the strip may change color. The portion of web 418 that forms the windows may be formed by a transparent material, while the rest of web may be formed from an opaque material so that only the portion of the strip that provides the indication of the test condition is visible. Alternately, web 418 may be formed entirely from a transparent material so that the whole strip is visible, with the recess simply drawing the attention of the user to the portion of the strip where the results are displayed or indicated.

Referring again to FIG. 13, each recess 428c includes an opening 428d, such as a central opening, to form a deposit window which allows a test sample to be deposited by a user onto the strip inside the cartridge once in use. In the illustrated embodiment, the additional supports provided by longitudinal ribs 452a and 454a may be aligned with the respective recesses 428b and 428c where additional support to the strip may be advantageous.

As noted above, before the sealing step and after the picking and placing step, each section of web 418 may be joined with web 414 by an adhesive, such as an adhesive layer provided on web 418, tack welds, or a mechanical coupling. Referring to FIGS. 9 and 13, webs 414 and 418 may include mechanical couplers—such in in the form of pins and sockets. In the illustrated embodiment, a pair of sockets 458a are formed in web 414 and a corresponding pair of pins 458b are formed in web 418. Further, in the illustrated embodiment the sockets and pins 458a, 458b are formed by elongated recesses and projections, which are formed in webs 414 and 418, respectively, that frictionally interlock when web 418 is placed and then pressed onto web 414.

For example, after a section web 418 is placed on web 414 (such as shown in FIG. 7), system 310 may index the web assembly downstream from the pick and place location to a pressing location where web 418 is then locally pressed (at the locations of the pins and sockets) onto web 414 by a pressing apparatus. A suitable pressing apparatus may include a rod or shaft that is moved toward web 418 via the control system using a mechanical or pneumatic actuator. Thus, web 418 and web 414 are at least temporarily coupled together before this section of the web assembly is moved to the sealing and cutting apparatus.

After the two webs are sealed together, the individual packages may then be separated by a cutting apparatus 380. The individual packages may then deposited on a take away conveyor (not shown), such a motorized belt conveyor, which optionally transports the individual packages to bins, for example, for further handling.

In order to facilitate alignment of the web and web sections and their respective recesses, similar to the previous embodiments, one or both webs (web 414 and/or 418) may include additional structures, such as tractor or sprocket holes or apertures, which can be added as a punching feature during the thermoforming process and mechanically advanced and read by a sensor (such as a tractor wheel) which provides input to the control system (described below) so that the control system can track and know the precise location of the web or webs, and their respective recesses, during the conveying step to assist with the alignment process. As shown in FIG. 8, such apertures 423 are provided on lateral edges of web 414 and, as shown in FIG. 12, apertures 425 are provided on lateral edges of web 418. For example, the control system may speed up or slow down one or both the reels feeding the webs to get the section of web 418 synchronized with the corresponding section of web 414 such that their recesses align when enclosing the strips.

In the above, embodiment, therefore, web 414 may be a continuous web with the web 418 having sections of the web 418 cut and placed on web 414. The thus joined together webs 414, 418 with their respective recesses form lateral flow test cassettes or cartridges.

All the above systems may be controlled by a control system that uses one or more computers or processors. The control system is in communication with each of the discrete components of the systems 10, 110, 210, 310, for example the reels, rollers, thermoforming apparatus, placing apparatus, pick and place apparatus, sealing apparatuses, cutting apparatuses, take-away conveyors, and the post packaging processing stations, to automate the system and provide a steady or indexed stream, including a high speed steady stream, of packages. Accordingly the method and system described herein provide an improved method of packaging medical test devices using a process that increases through-put and, further, can produce less waste.

Accordingly, the present disclosure describes a method of packaging medical devices and a medical device packing system that uses thermoformable webs, which are either preformed with recesses or formed with recesses during the packing process, and a backing web that encloses medical devices in the recesses to form a package. The backing web may also have recesses formed therein. The medical devices may be sealed between the webs using heat, adhesive, welds, or the like. The recesses of at least one of the webs are carried by the web during the medical device placement and sealing steps to produce a high speed packing process. After sealing the devices between the two webs or web sections, the packages are then separated into individual package, for example, but cutting the joined webs that connect the packages during the initial processing steps.

While several forms of the system and processes have been described herein, it should be understood that any of the processes described in one embodiment can be combined with the other processes or other features in the other embodiments. Further, although described in the context of the webs being supplied on a reel, the webs may be supplied as an array of multiple formed interconnected groups of thermoformed recesses that form the cartridges and are conveyed using conventional conveyors.

	Number	Date	Country
	63657511	Jun 2024	US
	63585713	Sep 2023	US

MEDICAL TEST DEVICE PACKAGE, PACKAGING SYSTEM AND METHOD OF PACKAGING A MEDICAL TEST DEVICE

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