WO1999002967A1 - Systemes d'emballage et d'apport pour dispositifs diagnostiques - Google Patents

Systemes d'emballage et d'apport pour dispositifs diagnostiques 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
Authority
WO
WIPO (PCT)
Prior art keywords
assay
support means
package
assay means
delivery system
Prior art date
Application number
PCT/US1998/013964
Other languages
English (en)
Other versions
WO1999002967B1 (fr
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/fr
Publication of WO1999002967B1 publication Critical patent/WO1999002967B1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L99/00—Subject matter not provided for in other groups of this subclass
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other 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
    • A61B2010/0009—Testing 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

L'invention concerne un système (10) d'emballage et d'apport pour dispositifs diagnostiques dans lequel l'emballage préserve l'intégrité des réactifs diagnostiques jusqu'à leur utilisation et facilite également l'apport desdits réactifs diagnostiques au sujet d'expérience.
PCT/US1998/013964 1997-07-07 1998-07-06 Systemes d'emballage et d'apport pour dispositifs diagnostiques WO1999002967A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU83839/98A AU8383998A (en) 1997-07-07 1998-07-06 Package and delivery systems for diagnostic devices

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US88884797A 1997-07-07 1997-07-07
US08/888,847 1997-07-07

Publications (2)

Publication Number Publication Date
WO1999002967A1 true WO1999002967A1 (fr) 1999-01-21
WO1999002967B1 WO1999002967B1 (fr) 1999-03-04

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Application Number Title Priority Date Filing Date
PCT/US1998/013964 WO1999002967A1 (fr) 1997-07-07 1998-07-06 Systemes d'emballage et d'apport pour dispositifs diagnostiques

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AU (1) AU8383998A (fr)
WO (1) WO1999002967A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3289977A1 (fr) * 2016-08-30 2018-03-07 Sysmex Corporation Corps de support, ensemble de prélèvement de fluide corporel et procédé de collecte de fluide corporel

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4826759A (en) * 1984-10-04 1989-05-02 Bio-Metric Systems, Inc. Field assay for ligands
US5443080A (en) * 1993-12-22 1995-08-22 Americate Transtech, Inc. Integrated system for biological fluid constituent analysis
US5597532A (en) * 1994-10-20 1997-01-28 Connolly; James Apparatus for determining substances contained in a body fluid

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4826759A (en) * 1984-10-04 1989-05-02 Bio-Metric Systems, Inc. Field assay for ligands
US5443080A (en) * 1993-12-22 1995-08-22 Americate Transtech, Inc. Integrated system for biological fluid constituent analysis
US5597532A (en) * 1994-10-20 1997-01-28 Connolly; James Apparatus for determining substances contained in a body fluid

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3289977A1 (fr) * 2016-08-30 2018-03-07 Sysmex Corporation Corps de support, ensemble de prélèvement de fluide corporel et procédé de collecte de fluide corporel
CN107789012A (zh) * 2016-08-30 2018-03-13 希森美康株式会社 支撑体、体液收集用组合器具和体液收集方法
EP3581107A1 (fr) * 2016-08-30 2019-12-18 Sysmex Corporation Corps de support, ensemble de prélèvement de fluide corporel et procédé de collecte de fluide corporel
US10835214B2 (en) 2016-08-30 2020-11-17 Sysmex Corporation Support body, body fluid collection set, and body fluid collection method
CN107789012B (zh) * 2016-08-30 2021-09-03 希森美康株式会社 支撑体、体液收集用组合器具和体液收集方法

Also Published As

Publication number Publication date
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