WO1999002967A1 - Package and delivery systems for diagnostic devices - Google Patents

Package and delivery systems for diagnostic devices Download PDF

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Publication number
WO1999002967A1
WO1999002967A1 PCT/US1998/013964 US9813964W WO9902967A1 WO 1999002967 A1 WO1999002967 A1 WO 1999002967A1 US 9813964 W US9813964 W US 9813964W WO 9902967 A1 WO9902967 A1 WO 9902967A1
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WO
WIPO (PCT)
Prior art keywords
assay
support means
package
assay means
delivery system
Prior art date
Application number
PCT/US1998/013964
Other languages
French (fr)
Other versions
WO1999002967B1 (en
Inventor
Kendrid D. Corley
Owen L. Johns
Original Assignee
Jonor, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jonor, Inc. filed Critical Jonor, Inc.
Priority to AU83839/98A priority Critical patent/AU8383998A/en
Publication of WO1999002967A1 publication Critical patent/WO1999002967A1/en
Publication of WO1999002967B1 publication Critical patent/WO1999002967B1/en

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L99/00Subject matter not provided for in other groups of this subclass
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B2010/0009Testing for drug or alcohol abuse

Definitions

  • This invention relates, generally, to package and delivery systems for diagnostic devices. More particularly, it relates to a package and delivery system in which the package maintains the integrity of diagnostic reagents until use and facilitates delivery of the diagnostic reagents to a test subject.
  • U.S. Patent Nos . 5,320,217; 4,487,313; and 3,635,567 disclose packaged, moistened therapeutic pads in which the package also functions as an applicator.
  • Multi-part packaged diagnostic device systems such as those disclosed in U.S. Patent Nos .
  • These devices generally include a multi-layer absorbent pad system which is impregnated with one or more chemical reagents which are specific for a particular metabolic analyte in the body fluid. The particular metabolic analyte is then detected by colorimetric detection or other suitable means known in the art .
  • a package and delivery system which includes a support means, an assay means and an articulation means is disclosed.
  • the support means has a first portion, a second portion and a third portion, in which a graspable tab or handle forms the first portion of the support means.
  • the assay means has a first portion and a second portion. The first portion of the assay means is releasably secured in overlying relation upon the second portion of the support means and in underlying relation to the first portion of the support means. The second portion of the assay means is releasably secured in overlying relation upon the second portion of the support means and in underlying relation to the third portion of the support means.
  • the articulation means connects the first and second portions of the assay means .
  • a package and delivery system which includes a support means, an assay means and a separation means is disclosed.
  • the assay means is releasably secured in overlying relation upon the support means and has a first portion and a second portion.
  • the second portion of the assay means is in overlying stackable relation with the first portion of the assay means.
  • the separation means is releasably secured between the first and second port-ions of the assay means .
  • a package and delivery system which includes a support means, an assay means and an articulation means.
  • the support means has a first portion, a second portion and a third portion, in which a gra ⁇ pable tab or handle forms the first portion of the support means.
  • the assay means has a first portion and a second portion. The first portion of the assay means is releasably secured in overlying relation upon the second portion of the support means and in underlying relation to the first and third portions of the support means. The second portion of the assay means is releasably secured in overlying relation upon the second portion of the support means and in underlying relation to the third portion of the support means.
  • the articulation means is located on the third portion of the support means.
  • FIG. 1 is a perspective view of a package and delivery system of the present invention
  • FIG. 2 is a perspective view animation of application of the package and delivery system shown in FIG. 1 ;
  • FIG. 3 a perspective view animation of application of the package and delivery system shown in FIG. 1
  • FIG. 4 a perspective view animation of application of the package and delivery system shown in FIG. 1;
  • FIG. 5 a perspective view animation of application of the package and delivery system shown in FIG. 1;
  • FIG. 6 a perspective view animation of application of the package and delivery system shown in FIG. 1;
  • FIG. 7 a perspective view animation of application of the package and delivery system shown in FIG. 1;
  • FIG. 8 is a perspective view of another embodiment of the package and delivery system of the present invention.
  • FIG. 9 a perspective view animation of application of the package and delivery system shown in FIG. 8;
  • FIG. 10 a perspective view animation of application of the package and delivery system shown in FIG. 8;
  • FIG. 11 a perspective view animation of application of the package and delivery system shown in FIG. 8;
  • FIG. 12 a perspective view animation of application of the package and delivery system shown in FIG. 8;
  • FIG. 13 a perspective view animation of application of the package and delivery system shown in FIG. 8;
  • FIG. 14 is a perspective view of another embodiment of the package and delivery system of the present invention.
  • FIG. 15 is a perspective view of another embodiment of the package and delivery system of the present invention. DETAILED DESCRIPTION OF THE INVENTION
  • FIGS. 1 - 7, FIGS. 8 - 13 and FIG. 15 show the novel package and delivery system of the present invention which is denoted as a whole by reference numeral 10.
  • the package and delivery system 10 has a support means 12 , an assay means 14 and an articulation means 15.
  • Support means 12 functions as a carrier, wrapper and applicator for assay means 14.
  • assay means 14 is releasably secured to support means 12 in such a manner that during application, assay means 14 is delivered to a test subject in a properly mated configuration.
  • Support means 12 has a first portion 18, a second portion 20 and a third portion 22.
  • the first portion 18 of support means 12 forms a graspable tab or handle 24 which facilitates easy removal of assay means 14 from support means 12.
  • Graspable handle 24 also facilitates application of assay means 14 to- the test subject.
  • Support means 12 is preferably a single piece construction and is made of any flexible impervious material . Suitable materials are those that have sufficient strength to support assay means 14 and functions as a carrier, wrapper and applicator for the particular assay means 14 used. In addition, the flexible impervious material may be laminated. Any suitable material is acceptable for use as support means 12, provided, the material releases assay means 14 during application, is impervious to moisture and gases, and provides an inert surface which is compatible with the chemistry of assay means 14.
  • suitable flexible impervious materials useful in the present invention include any commercially available materials such as, but not limited to, polyethylene, polyester, co-polyesters, paper, silicone coated paper, metallic foil, polystyrene, and nylon. It is contemplated that the first portion 18, the second portion 20, and the third portion 22 of support means 12 will have printed thereon instructions for application and use of the diagnostic device of the novel package and delivery system of the present invention.
  • Assay means 14 has a first portion 26 and a second portion 28. Any suitable material is acceptable for use as assay means 14, provided, the material absorbs bodily fluids, stores chemical reagents, and conforms to the test subject's body.
  • the composition of a test matrix useful in assay means 14 is determined by the physio-chemical properties of the chemical system for a specific analyte under test.
  • the composition may be aqueous, solid, cellulose based, viscous, or semi-solid.
  • the composition may be made of materials, including but not limited to gels, powders or any other substance which is capable of holding and immobilizing fluid.
  • the composition may require fixation means such as, but not limited to, covering, insetting, coating, and/or laminating to preposition and hold the test matrix in place during assembly of the novel package and delivery system of the present invention.
  • Each of the first portion 26 and the second portion 28 of assay means 14 may be made from materials such as, but not limited to, open or closed cell foams of polyethylene, polyvinylchloride, polyurethane, silicone, rubber or polytetrafluorethylene .
  • a closed cell polyethylene foam is used for assay means 14.
  • each of the first portion 26 and the second portion 28 of assay means 14 may be impregnated or otherwise provided with one or more chemical reagents which are specific for a particular metabolic analyte or analytes detectable in bodily fluids.
  • first portion 26 and/or the second portion 28 of assay means 14 can be adapted to include wells, reservoirs, reactive membranes or other means suitable for containing wet , dry or gelled chemical reagents.
  • a well or reservoir 32 for receipt of a test matrix is shown in the drawings .
  • Assay means 14 of the novel package and delivery system of the present invention is useful for the detection and/or monitoring of various conditions and disease states, including but not limited to, diabetes, liver disease, acidosis/alkalosis, hypertension, and the nutritional status of the test subject.
  • assay means 14 is adapted for application to the test subject and absorption of metabolic analytes contained in perspiration.
  • assay means 14 is not limited to the detection of any one particular metabolic analyte which may or may not be contained in perspiration.
  • Assay means 14 can be adapted to contain numerous chemical reagents for the detection of various metabolic analytes.
  • assay means 14 can be adapted to detect various metabolic analytes including, but not limited to, carbohydrates, such as, glucose, lactose, galactose, and hydroxybutyric acid; nitrogen moieties, such as, urea, creatine, and uric acid; lipids, such as, cholesterol, triglycerides, low-density lipoprotein (LDL) , and high- density lipoprotein (HDL); enzymes, such as, alanine aminotransferase (ALT) , aspartate aminotransferase (AST) , alkaline phosphatase, creatine phosphokinase (CPK) , and creatine kinase; hormones, such as human chorionic gonadotrophin (HCG) hormone, and luteinizing hormone (LH) ; drugs, such as, theophylline, cocaine, marijuana, barbiturates, and salicylates ; and electrolytes, such as, Na + , K +
  • Assay means 14 is releasably secured to support means 12.
  • the strength of the adhesive bonds between the first portion 26 and the second portion 28 of assay means 14 and the first portion 18, second portion 20 and third portion 22 of support means 12 may be different. These potential differences in adhesive bond strength may or may not require the use of different adhesives to secure the various components to support means 12.
  • One important factor to consider in this regard is that the adhesive which is on the surface of the first portion 26 of assay means 14, which is exposed for application to a test subject upon grasping tab or handle 24 of the first portion 18 of support means 12, typically forms an ' adhesive bond with a skin surface of the test subject which is sufficiently strong to prevent displacement from the skin surface during the remainder of the application process. It will be within the skill in the art to determine if the different adhesive strengths required and the different materials of construction for the various components of the package and delivery system of the present invention necessitate the use of more than one adhesive .
  • pressure sensitive adhesives can be used to releasably secure assay means 14 to support means 12 provided that the adhesive provides sufficient contact and sealing between the parts to prevent transmission of moisture and gases between the releasably secured parts.
  • pressure sensitive rubber based and acrylic based adhesives are useful in the present invention.
  • hot melt pressure sensitive adhesives are used.
  • the first portion 26 of assay means 14 is releasably secured in overlying relation upon the second portion 20 of support means 12 and is releasably secured in underlying relation to the first portion 18 of support means 12.
  • the second portion 28 of assay means 14 is releasably secured in overlying relation upon the second portion 20 of support means 12 and is releasably secured in underlying relation to the third portion 22 of support means 12.
  • the first portion 26 of assay means 14 is releasably secured in overlying relation upon the second portion 20 of support means 12 and is releasably secured in underlying relation to the first portion 18 and third portion 22 of support means 12.
  • the second portion 28 of assay means 14 is releasably secured in overlying relation upon the second portion 20 of support means 12 and is releasably secured in underlying relation to the third portion 22 of support means 12.
  • the first portion 26 of assay means 14 is releasably secured in overlying relation upon support means 12.
  • the first portion 26 and the second portion 28 of assay means 14 are positioned in overlying stackable relation to one another.
  • separation means 30 is releasably secured between the first portion 26 and the second portion 28 of assay means 14. Separation means 30 can completely cover the entire adhesive surface of each of the first portion 26 and the second portion 28 of assay means 14 or it can simply cover the reactive portions of each of the first portion 26 and the second portion 28 of assay means 14.
  • Separation means 30 is preferably a single piece construction and is made of any flexible impervious material.
  • the flexible impervious material may be laminated. Any suitable material is acceptable for use as separation means 30.
  • suitable flexible impervious materials useful in the present invention include any commercially available materials such as, but not limited to, polyethylene, polyester, co- polyesters, paper, silicone coated paper, metallic foil, polystyrene, and nylon.
  • the user removes support means 12 to expose an adhesive surface on the first portion 26 of assay means 14.
  • the first portion 26 of assay means 14 is then applied to a skin surface of the user.
  • separation means 30 is removed by pulling.
  • separation means 30 is a single piece construction which is folded upon itself, by any means known in the art, in such a manner that it is easily releasable from between the first portion 26 and the second portion 28 of assay means 14. Separation means 30 may be removed in whole or in part from the second portion 28 of assay means 14. Removal of separation means 3O will depend on the particular assay means 14 used. Some assay procedures will not need to expose the second portion 28 of assay means 14, in which case the user will merely pull separation means 30 sufficiently so that the first portion 26 and the second portion 28 of assay means 14 are in fluid communication or contact each other. As shown in FIG. 14 a leading edge 34 of separation means 30 may contact the first portion 26 of the assay means 14 and be juxtaposed between support means 12 and the first portion 26 of assay means 14. This configuration facilitates easy removal of the device at the conclusion of the diagnostic test.
  • articulation means 15 connects the first portion 26 of assay means 14 with the second portion 28 of assay means 14.
  • Articulation means 15 may be perforated, creased, folded or otherwise scored to form hinge member 16. Articulation means 15 facilitates delivery and application of a properly mated assay means 14.
  • Articulation means 15 can be made of any suitable flexible material.
  • the flexible articulation material may be laminated. Any suitable material is acceptable for use as articulation means 15, provided, the material is readily foldable .
  • suitable flexible materials useful as articulation means 15, in the present invention include any commercially available materials such as, but not limited to, polyethylene, polyester, co-polyesters, paper, silicone coated papar, metallic foil, polystyrene, and nylon.
  • Articulation means 15 is adhesively secured to the first portion 26 and the second portion 28 of assay means 14.
  • articulation means 15 may be releasably secured to the second portion 20 of support means 12.
  • Any number of readily available pressure sensitive adhesives known in the art can be used to adhesively secure articulation means 15 to the first portion 26 and the second portion 28 of assay means 14 and to releasably secure articulation means 15 to the second portion 20 of support means 12.
  • pressure sensitive rubber based and acrylic based adhesives are useful in the present invention.
  • hot melt pressure sensitive adhesives are used.
  • the strength of the adhesive bond between articulation means 15 and the first portion 26 and the second portion 28 of assay means 14 will be greater than the strength of the adhesive bond between articulation means 15 and the second portion 20 of support means 12 due to the releasable nature of the latter adhesive bond. These differences in adhesive bond strength may or may not require the use of different adhesives to secure articulation means 15 to assay means 14 and support means 12. It will be within the skill in the art to determine if the different materials of construction for the various components of the package and delivery system of the present invention necessitate the use of more than one adhesive.
  • assay means 14 is a single piece construction and the first portion 26 and the second portion 28 of assay means 14 are separated by an integrally formed articulation means 15.
  • the articulation means 15 can be integrally formed by any method of perforation, creasing or scoring known in the art. As shown in FIG. 9, articulation means 15 is integrally formed on the third portion 22 of support means 12. The third portion 22 of support means 12 may be perforated, creased or otherwise scored, by any means known in the art, to produce articulation means 15. Articulation means 15 facilitates delivery and application of a properly mated assay means 14.
  • the novel package and delivery system of the present invention is generally useful for the storage and delivery of diagnostic devices.
  • the application of an assay means according to the present invention is described by referring to the drawings .
  • a properly mated assay means 14 is applied and delivered to the user.
  • the user grasps with one hand (user not shown) , the device 10 while grasping with the other hand tab or handle 24 of the first portion 18 of support means 12.
  • the user thus pulls the first portion 18 of the support means 12 away from the first portion 26 of assay means 14, exposing an adhesive surface on the first portion 26 of assay means 14.
  • the device 10 is then rotated 180° and the adhesive surface of the first portion of assay means 14 is applied to a skin surface.
  • the second portion 20 of support means 12 is peeled from assay means 14, thus exposing an adhesively coated surface of the first portion 26 of assay means 14 followed by exposure of an adhesively coated surface of the second portion 28 of assay means 14, as shown in FIG. 4 and FIG. 11.
  • the second portion 28 of assay means 14 is rotated about articulation 16 until it contacts the first portion of assay means 14 as shown in FIG. 6 and FIG. 13.
  • the third portion 22 of support means 12 is removed from the second portion 28 of assay means 14, as shown in FIG. 7.
  • part of the third portion 22 of support means 12 is juxtaposed between the first portion 26 of the assay means 14 and the users skin surface which facilitates easy removal of assay means 14 at the completion of the diagnostic test.
  • the package and delivery systems for diagnostic devices of the present invention are made using conventional die cutting tools and technology. It is understood that certain modifications and adjustments of the conventional die cutting tools, which are within the skill in the art, may be required.
  • the conventional die cutting tools For example, after selecting an assay means 14 test matrix which is compatible with polyvinylchloride (PVC) foam, the PVC foam is coated with an adhesive on both sides of the foam. Support means 12 is laminated to one side of the adhesive coated faces while a sacrificial silicone release paper is applied to the other side of the adhesive faces. This laminate is then placed in an unwind station of a die cutting machine. The laminate is then unwound into the machine and the sacrificial liner is removed and rewound.
  • PVC polyvinylchloride
  • each reagent site of assay means 14 are cut through the PVC foam to the wrapper material using conventional partial thickness die cutting tools.
  • a liquid reagent is pumped into one of the wells 32 and a dry reagent containing matrix is placed in a companion well 32 by a conventional vacuum powered pick and place unit.
  • the assay means 14 test matrix may be incorporated or impregnated into the PVC by any method known in the art, which may not require the cutting of well 32.
  • the support means 12 is then folded around the completed assay means 14 as it proceeds through the machine. The final step is to cut each individual diagnostic device off at the end of the die cutting machine.
  • All of the tasks during the manufacturing process may be accomplished by a computer that is programmed to -drive servo motors.
  • the computer maintains the exact location of the various steps of the manufacturing process using conventional feedback devices such as encoders and electric eyes resulting in the production of uniformly formed package and delivery systems for diagnostic devices .

Abstract

A package and delivery system (10) for diagnostic devices in which the package maintains the integrity of diagnostic reagents until use and facilitates delivery of the diagnostic reagents to a test subject is disclosed.

Description

PACKAGE AND DELIVERY SYSTEMS FOR DIAGNOSTIC DEVICES
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates, generally, to package and delivery systems for diagnostic devices. More particularly, it relates to a package and delivery system in which the package maintains the integrity of diagnostic reagents until use and facilitates delivery of the diagnostic reagents to a test subject.
2. Description of the Related Art
Advances in medical diagnostics and treatments have facilitated the development of numerous diagnostic and therapeutic devices for home use by the layperson. These devices must be contained in packages which provide adequate shelf life, protection from external environmental factors during storage and, if necessary, separation of diagnostic and/or therapeutic reagents until use. In addition, the package design of these devices should facilitate proper application and use by the layperson. Numerous approaches have attempted to address the storage and application problems associated with these home use devices .
For example, U.S. Patent Nos . 5,320,217; 4,487,313; and 3,635,567 disclose packaged, moistened therapeutic pads in which the package also functions as an applicator. Multi-part packaged diagnostic device systems, such as those disclosed in U.S. Patent Nos . 5,597,532; 5,445,147; 5,443,080; 5,397,297; 5,203,327; 5,188,966; 5,076,273 4,962,043; 4,960,467; 4,957,108; 4,846,182; 4,837,145, 2,826,759; 4,819,645; 4,732,153; 4,706,676; 4,595,011, 4,444,193; 4,329,999; 3,992,158; 3,901,657 and 3,726,645 are used to collect and analyze constituents of body fluids. Many of these devices are applied to the skin of a test subject after removal of an outer package and one or more additional protective or separative layers, while others of these devices are used to analyze body fluids collected by other means. These devices generally include a multi-layer absorbent pad system which is impregnated with one or more chemical reagents which are specific for a particular metabolic analyte in the body fluid. The particular metabolic analyte is then detected by colorimetric detection or other suitable means known in the art .
However, all of these prior art devices have various shortcomings. For example, the opening sequences of- the packages of many of these devices are confusingly complicated for the average layperson resulting in improper application of the device. In addition, many of these devices have multi-step processes which must be performed in a specified order to obtain accurate test results. These multi-step processes require the removal of intermediate protective sheets from the device and/or the assembly and application of multiple layers in a specified sequence by the test subject to a particular area of his or her body. The assembly of separate components prior to use, oftentimes makes these devices too complicated for the average layperson to apply and use with accuracy. Accordingly, many of these devices are inconvenient to use, are expensive to produce, and due to the abilities of the average layperson are applied with scientifically unacceptable variability which in turn results in inaccurate test results.
Thus, what is needed then is a package and delivery system in which the package maintains the integrity of diagnostic reagents until use and facilitates delivery of the diagnostic reagents to a test subject with a minimum amount of handling by the test subject.
In view of the prior art as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the pertinent art how the needed package and delivery systems for diagnostic devices could be provided.
SUMMARY OF THE INVENTION In accordance with the present invention, a package and delivery system which includes a support means, an assay means and an articulation means is disclosed. The support means has a first portion, a second portion and a third portion, in which a graspable tab or handle forms the first portion of the support means. The assay means has a first portion and a second portion. The first portion of the assay means is releasably secured in overlying relation upon the second portion of the support means and in underlying relation to the first portion of the support means. The second portion of the assay means is releasably secured in overlying relation upon the second portion of the support means and in underlying relation to the third portion of the support means. The articulation means connects the first and second portions of the assay means .
In a further embodiment of the present invention a package and delivery system which includes a support means, an assay means and a separation means is disclosed. The assay means is releasably secured in overlying relation upon the support means and has a first portion and a second portion. The second portion of the assay means is in overlying stackable relation with the first portion of the assay means. The separation means is releasably secured between the first and second port-ions of the assay means .
In yet a further embodiment of the present invention, a package and delivery system which includes a support means, an assay means and an articulation means is disclosed. The support means has a first portion, a second portion and a third portion, in which a graεpable tab or handle forms the first portion of the support means. The assay means has a first portion and a second portion. The first portion of the assay means is releasably secured in overlying relation upon the second portion of the support means and in underlying relation to the first and third portions of the support means. The second portion of the assay means is releasably secured in overlying relation upon the second portion of the support means and in underlying relation to the third portion of the support means. The articulation means is located on the third portion of the support means.
The invention accordingly comprises the features of construction, combination of elements and arrangement of parts that will be exemplified in the description hereinafter set forth, and the scope of the invention will be indicated in the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
For a fuller understanding of the nature of the invention, reference should be made to the following detailed description, taken in connection with the accompanying drawings , in which :
FIG. 1 is a perspective view of a package and delivery system of the present invention;
FIG. 2 is a perspective view animation of application of the package and delivery system shown in FIG. 1 ;
FIG. 3 a perspective view animation of application of the package and delivery system shown in FIG. 1; FIG. 4 a perspective view animation of application of the package and delivery system shown in FIG. 1;
FIG. 5 a perspective view animation of application of the package and delivery system shown in FIG. 1;
FIG. 6 a perspective view animation of application of the package and delivery system shown in FIG. 1;
FIG. 7 a perspective view animation of application of the package and delivery system shown in FIG. 1;
FIG. 8 is a perspective view of another embodiment of the package and delivery system of the present invention;
FIG. 9 a perspective view animation of application of the package and delivery system shown in FIG. 8;
FIG. 10 a perspective view animation of application of the package and delivery system shown in FIG. 8;
FIG. 11 a perspective view animation of application of the package and delivery system shown in FIG. 8;
FIG. 12 a perspective view animation of application of the package and delivery system shown in FIG. 8;
FIG. 13 a perspective view animation of application of the package and delivery system shown in FIG. 8; and
FIG. 14 is a perspective view of another embodiment of the package and delivery system of the present invention.
FIG. 15 is a perspective view of another embodiment of the package and delivery system of the present invention. DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings, in which like numerals refer to like elements thereof, FIGS. 1 - 7, FIGS. 8 - 13 and FIG. 15, show the novel package and delivery system of the present invention which is denoted as a whole by reference numeral 10. The package and delivery system 10 has a support means 12 , an assay means 14 and an articulation means 15.
Support means 12 functions as a carrier, wrapper and applicator for assay means 14. In particular, assay means 14 is releasably secured to support means 12 in such a manner that during application, assay means 14 is delivered to a test subject in a properly mated configuration. Support means 12 has a first portion 18, a second portion 20 and a third portion 22. As shown in the drawings the first portion 18 of support means 12 forms a graspable tab or handle 24 which facilitates easy removal of assay means 14 from support means 12. Graspable handle 24 also facilitates application of assay means 14 to- the test subject.
Support means 12 is preferably a single piece construction and is made of any flexible impervious material . Suitable materials are those that have sufficient strength to support assay means 14 and functions as a carrier, wrapper and applicator for the particular assay means 14 used. In addition, the flexible impervious material may be laminated. Any suitable material is acceptable for use as support means 12, provided, the material releases assay means 14 during application, is impervious to moisture and gases, and provides an inert surface which is compatible with the chemistry of assay means 14.
For example, suitable flexible impervious materials useful in the present invention include any commercially available materials such as, but not limited to, polyethylene, polyester, co-polyesters, paper, silicone coated paper, metallic foil, polystyrene, and nylon. It is contemplated that the first portion 18, the second portion 20, and the third portion 22 of support means 12 will have printed thereon instructions for application and use of the diagnostic device of the novel package and delivery system of the present invention.
Assay means 14 has a first portion 26 and a second portion 28. Any suitable material is acceptable for use as assay means 14, provided, the material absorbs bodily fluids, stores chemical reagents, and conforms to the test subject's body. The composition of a test matrix useful in assay means 14 is determined by the physio-chemical properties of the chemical system for a specific analyte under test. The composition may be aqueous, solid, cellulose based, viscous, or semi-solid. The composition may be made of materials, including but not limited to gels, powders or any other substance which is capable of holding and immobilizing fluid. The composition may require fixation means such as, but not limited to, covering, insetting, coating, and/or laminating to preposition and hold the test matrix in place during assembly of the novel package and delivery system of the present invention.
Each of the first portion 26 and the second portion 28 of assay means 14 may be made from materials such as, but not limited to, open or closed cell foams of polyethylene, polyvinylchloride, polyurethane, silicone, rubber or polytetrafluorethylene . In a preferred embodiment, of the present invention, a closed cell polyethylene foam is used for assay means 14. In addition, each of the first portion 26 and the second portion 28 of assay means 14 may be impregnated or otherwise provided with one or more chemical reagents which are specific for a particular metabolic analyte or analytes detectable in bodily fluids. It will be understood by those skilled in the art that the first portion 26 and/or the second portion 28 of assay means 14 can be adapted to include wells, reservoirs, reactive membranes or other means suitable for containing wet , dry or gelled chemical reagents. A well or reservoir 32 for receipt of a test matrix is shown in the drawings .
Assay means 14 of the novel package and delivery system of the present invention is useful for the detection and/or monitoring of various conditions and disease states, including but not limited to, diabetes, liver disease, acidosis/alkalosis, hypertension, and the nutritional status of the test subject. In a preferred embodiment of the present invention, assay means 14 is adapted for application to the test subject and absorption of metabolic analytes contained in perspiration. For purposes of the present invention, assay means 14 is not limited to the detection of any one particular metabolic analyte which may or may not be contained in perspiration. Assay means 14 can be adapted to contain numerous chemical reagents for the detection of various metabolic analytes.
For example, assay means 14 can be adapted to detect various metabolic analytes including, but not limited to, carbohydrates, such as, glucose, lactose, galactose, and hydroxybutyric acid; nitrogen moieties, such as, urea, creatine, and uric acid; lipids, such as, cholesterol, triglycerides, low-density lipoprotein (LDL) , and high- density lipoprotein (HDL); enzymes, such as, alanine aminotransferase (ALT) , aspartate aminotransferase (AST) , alkaline phosphatase, creatine phosphokinase (CPK) , and creatine kinase; hormones, such as human chorionic gonadotrophin (HCG) hormone, and luteinizing hormone (LH) ; drugs, such as, theophylline, cocaine, marijuana, barbiturates, and salicylates ; and electrolytes, such as, Na+, K+, Cl~, Li+, and C02.
A variety of immunoassay schemes for visualizing the presence of an analyte of interest, either with or without the aid of scientific instrumentation, are known and need not be detailed here. Any of the chemical species for which affinity chemistry can be or has been developed are appropriate for use in assay means 14 of the present invention. In addition, a variety of diagnostic kits for monitoring an analyte in perspiration have been developed such as those disclosed in U.S. Patent No. 3,552,929 to Fields et al . , U.S. Patent No. 4,706,676 to Peck and U.S. Patent No. 5,445,147 to Schoendorfer et al . which are incorporated herein by reference. From this description it will be understood that the chemical assay portion of any diagnostic test o kit can be modified for incorporation into assay means 14 of the present invention.
Assay means 14 is releasably secured to support means 12. The strength of the adhesive bonds between the first portion 26 and the second portion 28 of assay means 14 and the first portion 18, second portion 20 and third portion 22 of support means 12 may be different. These potential differences in adhesive bond strength may or may not require the use of different adhesives to secure the various components to support means 12. One important factor to consider in this regard is that the adhesive which is on the surface of the first portion 26 of assay means 14, which is exposed for application to a test subject upon grasping tab or handle 24 of the first portion 18 of support means 12, typically forms an' adhesive bond with a skin surface of the test subject which is sufficiently strong to prevent displacement from the skin surface during the remainder of the application process. It will be within the skill in the art to determine if the different adhesive strengths required and the different materials of construction for the various components of the package and delivery system of the present invention necessitate the use of more than one adhesive .
Any number of readily available pressure sensitive adhesives can be used to releasably secure assay means 14 to support means 12 provided that the adhesive provides sufficient contact and sealing between the parts to prevent transmission of moisture and gases between the releasably secured parts. For example, pressure sensitive rubber based and acrylic based adhesives are useful in the present invention. In a preferred embodiment, hot melt pressure sensitive adhesives are used.
As shown in FIG. 2, the first portion 26 of assay means 14 is releasably secured in overlying relation upon the second portion 20 of support means 12 and is releasably secured in underlying relation to the first portion 18 of support means 12. The second portion 28 of assay means 14 is releasably secured in overlying relation upon the second portion 20 of support means 12 and is releasably secured in underlying relation to the third portion 22 of support means 12. As shown in the embodiment of the present invention depicted in FIG. 9, the first portion 26 of assay means 14 is releasably secured in overlying relation upon the second portion 20 of support means 12 and is releasably secured in underlying relation to the first portion 18 and third portion 22 of support means 12. The second portion 28 of assay means 14 is releasably secured in overlying relation upon the second portion 20 of support means 12 and is releasably secured in underlying relation to the third portion 22 of support means 12.
As shown in the embodiment of the present invention depicted in FIG. 14, the first portion 26 of assay means 14 is releasably secured in overlying relation upon support means 12. The first portion 26 and the second portion 28 of assay means 14 are positioned in overlying stackable relation to one another. During storage and prior to use, separation means 30 is releasably secured between the first portion 26 and the second portion 28 of assay means 14. Separation means 30 can completely cover the entire adhesive surface of each of the first portion 26 and the second portion 28 of assay means 14 or it can simply cover the reactive portions of each of the first portion 26 and the second portion 28 of assay means 14.
Separation means 30 is preferably a single piece construction and is made of any flexible impervious material. In addition, the flexible impervious material may be laminated. Any suitable material is acceptable for use as separation means 30. For example, suitable flexible impervious materials useful in the present invention include any commercially available materials such as, but not limited to, polyethylene, polyester, co- polyesters, paper, silicone coated paper, metallic foil, polystyrene, and nylon.
During application of the device shown in FIG. 14 the user removes support means 12 to expose an adhesive surface on the first portion 26 of assay means 14. The first portion 26 of assay means 14 is then applied to a skin surface of the user. After application, separation means 30 is removed by pulling.
As shown in FIG. 14 separation means 30 is a single piece construction which is folded upon itself, by any means known in the art, in such a manner that it is easily releasable from between the first portion 26 and the second portion 28 of assay means 14. Separation means 30 may be removed in whole or in part from the second portion 28 of assay means 14. Removal of separation means 3O will depend on the particular assay means 14 used. Some assay procedures will not need to expose the second portion 28 of assay means 14, in which case the user will merely pull separation means 30 sufficiently so that the first portion 26 and the second portion 28 of assay means 14 are in fluid communication or contact each other. As shown in FIG. 14 a leading edge 34 of separation means 30 may contact the first portion 26 of the assay means 14 and be juxtaposed between support means 12 and the first portion 26 of assay means 14. This configuration facilitates easy removal of the device at the conclusion of the diagnostic test.
As shown in FIG. 2 articulation means 15 connects the first portion 26 of assay means 14 with the second portion 28 of assay means 14. Articulation means 15 may be perforated, creased, folded or otherwise scored to form hinge member 16. Articulation means 15 facilitates delivery and application of a properly mated assay means 14. Articulation means 15 can be made of any suitable flexible material. In addition, the flexible articulation material may be laminated. Any suitable material is acceptable for use as articulation means 15, provided, the material is readily foldable . For example, suitable flexible materials useful as articulation means 15, in the present invention, include any commercially available materials such as, but not limited to, polyethylene, polyester, co-polyesters, paper, silicone coated papar, metallic foil, polystyrene, and nylon.
Articulation means 15 is adhesively secured to the first portion 26 and the second portion 28 of assay means 14. In addition, articulation means 15 may be releasably secured to the second portion 20 of support means 12. Any number of readily available pressure sensitive adhesives known in the art can be used to adhesively secure articulation means 15 to the first portion 26 and the second portion 28 of assay means 14 and to releasably secure articulation means 15 to the second portion 20 of support means 12. For example, pressure sensitive rubber based and acrylic based adhesives are useful in the present invention. In a preferred embodiment, hot melt pressure sensitive adhesives are used.
The strength of the adhesive bond between articulation means 15 and the first portion 26 and the second portion 28 of assay means 14 will be greater than the strength of the adhesive bond between articulation means 15 and the second portion 20 of support means 12 due to the releasable nature of the latter adhesive bond. These differences in adhesive bond strength may or may not require the use of different adhesives to secure articulation means 15 to assay means 14 and support means 12. It will be within the skill in the art to determine if the different materials of construction for the various components of the package and delivery system of the present invention necessitate the use of more than one adhesive.
In an alternative embodiment of the device of the present invention shown in FIG. 15 assay means 14 is a single piece construction and the first portion 26 and the second portion 28 of assay means 14 are separated by an integrally formed articulation means 15. The articulation means 15 can be integrally formed by any method of perforation, creasing or scoring known in the art. As shown in FIG. 9, articulation means 15 is integrally formed on the third portion 22 of support means 12. The third portion 22 of support means 12 may be perforated, creased or otherwise scored, by any means known in the art, to produce articulation means 15. Articulation means 15 facilitates delivery and application of a properly mated assay means 14.
The novel package and delivery system of the present invention is generally useful for the storage and delivery of diagnostic devices. The application of an assay means according to the present invention is described by referring to the drawings . A properly mated assay means 14 is applied and delivered to the user. In particular, as shown in FIG. 1 and FIG. 8, the user grasps with one hand (user not shown) , the device 10 while grasping with the other hand tab or handle 24 of the first portion 18 of support means 12. As shown in FIG. 2 and FIG. 9, the user thus pulls the first portion 18 of the support means 12 away from the first portion 26 of assay means 14, exposing an adhesive surface on the first portion 26 of assay means 14.
As shown in FIG. 3 and FIG. 10, the device 10 is then rotated 180° and the adhesive surface of the first portion of assay means 14 is applied to a skin surface. Continuing to grasp tab or handle 24 of support means 12, the second portion 20 of support means 12 is peeled from assay means 14, thus exposing an adhesively coated surface of the first portion 26 of assay means 14 followed by exposure of an adhesively coated surface of the second portion 28 of assay means 14, as shown in FIG. 4 and FIG. 11. As shown in FIG. 5 and FIG. 12, the second portion 28 of assay means 14 is rotated about articulation 16 until it contacts the first portion of assay means 14 as shown in FIG. 6 and FIG. 13. The third portion 22 of support means 12 is removed from the second portion 28 of assay means 14, as shown in FIG. 7. As shown in FIG. 13, part of the third portion 22 of support means 12 is juxtaposed between the first portion 26 of the assay means 14 and the users skin surface which facilitates easy removal of assay means 14 at the completion of the diagnostic test.
The package and delivery systems for diagnostic devices of the present invention are made using conventional die cutting tools and technology. It is understood that certain modifications and adjustments of the conventional die cutting tools, which are within the skill in the art, may be required. For example, after selecting an assay means 14 test matrix which is compatible with polyvinylchloride (PVC) foam, the PVC foam is coated with an adhesive on both sides of the foam. Support means 12 is laminated to one side of the adhesive coated faces while a sacrificial silicone release paper is applied to the other side of the adhesive faces. This laminate is then placed in an unwind station of a die cutting machine. The laminate is then unwound into the machine and the sacrificial liner is removed and rewound. While the one adhesive face is exposed, the outer perimeter and well 32 of each reagent site of assay means 14 are cut through the PVC foam to the wrapper material using conventional partial thickness die cutting tools. In the next step of the process, for example, a liquid reagent is pumped into one of the wells 32 and a dry reagent containing matrix is placed in a companion well 32 by a conventional vacuum powered pick and place unit. Alternatively, the assay means 14 test matrix may be incorporated or impregnated into the PVC by any method known in the art, which may not require the cutting of well 32. The support means 12 is then folded around the completed assay means 14 as it proceeds through the machine. The final step is to cut each individual diagnostic device off at the end of the die cutting machine.
All of the tasks during the manufacturing process may be accomplished by a computer that is programmed to -drive servo motors. The computer maintains the exact location of the various steps of the manufacturing process using conventional feedback devices such as encoders and electric eyes resulting in the production of uniformly formed package and delivery systems for diagnostic devices .
It will thus be seen that the objects set forth above, and those made apparent from the foregoing description, are efficiently attained and since certain changes may be made in the foregoing construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing construction or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.
It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.
Now that the invention has been described,

Claims

WHAT IS CLAIMED IS:
1. A package and delivery system comprising: support means, the support means having a first portion, a second portion and a third portion; assay means, the assay means having a first portion and a second portion, the first portion of the assay means releasably secured in overlying relation upon the second portion of the support means and in underlying relation to the first portion of the support means, the second portion of the assay means releasably secured in overlying relation upon the second portion of the support means and in underlying relation to the third portion of the support means; and articulation means connecting the first and second portions of the assay means.
2. A package and delivery system comprising: support means ; assay means releasably secured in overlying relation upon the support means, the assay means having a first portion and a second portion, the first portion and second portion in overlying stackable relation with one another; and separation means releasably secured between the first and second portions of the assay means.
3. A package and delivery system comprising: support means, the support means having a first portion, a second portion and a third portion; assay means, the assay means having a first portion and a second portion, the first portion of the assay means releasably secured in overlying relation upon the second portion of the support means and in underlying relation to the first and third portions of the support means, the second portion of the assay means releasably secured in overlying relation upon the second portion of the support means and in underlying relation to the third portion of the support means; and articulation means located on the third portion of the support means .
PCT/US1998/013964 1997-07-07 1998-07-06 Package and delivery systems for diagnostic devices WO1999002967A1 (en)

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US08/888,847 1997-07-07

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US4826759A (en) * 1984-10-04 1989-05-02 Bio-Metric Systems, Inc. Field assay for ligands
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Publication number Priority date Publication date Assignee Title
EP3289977A1 (en) * 2016-08-30 2018-03-07 Sysmex Corporation Support body, body fluid collection set, and body fluid collection method
CN107789012A (en) * 2016-08-30 2018-03-13 希森美康株式会社 Supporter, humor collecting combined utensil and humor collecting method
EP3581107A1 (en) * 2016-08-30 2019-12-18 Sysmex Corporation Support body, body fluid collection set, and body fluid collection method
US10835214B2 (en) 2016-08-30 2020-11-17 Sysmex Corporation Support body, body fluid collection set, and body fluid collection method
CN107789012B (en) * 2016-08-30 2021-09-03 希森美康株式会社 Support, combined device for collecting body fluid, and body fluid collecting method

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