Method for manufacturing a sterilized lancet integrated biosensor

• US 8,052,926 B2
• Filed: 07/25/2008
• Issued: 11/08/2011
• Est. Priority Date: 12/27/2002
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N., Chan, Frank A., Joseph, Abner David
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): CHORBAJI, MONZER R
• Application Number:
  US12/180,101
• Publication Number:
  US 20090010802A1
• Time in Patent Office: 1,201 Days
• Field of Search: 422/1, 422/22, 422/24, 422/50, 422/410, 422/430, 250/427, 250/432.R, 250/455.11, 250/492.1, 600583-584, 600566-567, 534/25, 534/50, 534/77
• US Class Current: 422/22
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150061 Means for enhancing collection
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/15032 by heating
• CPC Class Codes: A61B 5/150328 by aseptic fluid
• CPC Class Codes: A61B 5/150335 by radiation
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2202/181 Flexible packaging means, e.g. permeable membranes, paper
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: B65B 55/16 by irradiation

Abstract

An integrated disposable includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing at least a portion of a lancet to maintain the sterility of the lancet. The lancet packet and the sterility sheet, in particular, allow the lancet to be sterilized separately from the test strip. The lancet in one form is incorporated into a lancet tape that is sterilized in a continuous, reel-to-reel sterilization process. The lancet tape in one form is sterilized using an electron beam sterilization process. With electron beam sterilization, sterilization is enhanced by irradiating both sides of the tape with electron beams. Sterilization can adversely affect chemical reagents in the test strip. To alleviate this chemistry degradation issue, the lancet packet is attached to the test strip after the lancet is sterilized.

Claims

1. A method of manufacturing a tape of integrated disposables, comprising:

forming guide slots in a web of lancets, wherein the guide slots provide a slot opening at one edge of the web;

attaching a sterility sheet to the web to cover one side of the guide slots;

depositing the lancets in the guide slots;

enclosing the guide slots with the lancets therein by folding the sterility sheet around the edge of the web;

sealing the web of lancets within a sterility sheet;

sterilizing the lancets;

wherein said sterilizing includes exposing the lancets to one or more electron beams directed through the sterility sheet and

joining the web of the lancets with a belt that has a plurality of biosensors after said sterilizing to create the tape of integrated disposables.

2. The method of claim 1, wherein said sealing the web includes sealing between the lancets to form individual lancet packets.

3. The method of claim 2, further comprising:

separating the integrated disposables from the tape after said joining.

4. The method of claim 3, wherein said separating includes cutting the integrated disposables from the tape.

5. The method of claim 1, wherein said sealing includes heat laminating the sterility sheet to the web.

6. The method of claim 1, wherein said sealing includes laser sealing the sterility sheet with the web.

7. The method of claim 1, wherein said exposing includes irradiating opposing sides of the lancets through the sterility sheet.

8. The method of claim 1, wherein said sterilizing the lancets includes exposing the lancets to sterilizing chemicals prior to said sealing the web of the lancets within the sterility sheet.

9. The method of claim 1, wherein said sterilizing includes exposing the lancets to radiation directed through the sterility sheet.

10. The method of claim 1, wherein said sterilizing the lancets occurs after said sealing.

11. The method of claim 1, wherein said joining includes adhering with an adhesive the web of the lancets to the belt of the biosensors.

12. The method of claim 1, wherein said sealing includes:

forming seal lines that are configured to guide the lancets during lancing without the need for a separate guide member.

13. The method of claim 1, wherein said sealing the web includes:

folding the sterility sheet around the web to form a fold line;

creating a seal edge along the fold line;

forming seal lines between the lancets with arched sections along the seal edge; and

cutting along the seal lines to separate the lancets.

14. The method of claim 1, wherein said sealing the web includes:

folding the sterility sheet around the web to form a fold line;

creating a seal edge along the fold line;

forming seal lines between the lancets with notches at the seal edge; and

cutting along the seal lines to separate the lancets.

15. The method of claim 1, wherein said sealing the web includes:

folding the sterility sheet around the web to form a fold line;

creating a seal edge along the fold line;

forming seal lines between the lancets with grid patches at the seal edge; and

cutting along the seal lines to separate the lancets.

16. The method of claim 1, wherein said sealing, said sterilizing, and said joining occur in a continuous process.

17. The method of claim 1, wherein said sealing, said sterilizing, and said joining occur in a discontinuous batch process.

18. The method of claim 1, wherein said sealing includes sealing two or more sheets together to form the sterility sheet.

19. The method of claim 1, further comprising:

folding the sterility sheet around the web to form a fold line;

creating a seal edge along the fold line;

forming seal lines between the lancets;

melting the sterility sheet across the seal edge at the seal lines to minimize leakage; and

cutting along the seal lines to separate the lancets.

20. A method of manufacturing a tape of integrated disposables, comprising:

forming guide slots in a web of lancets, wherein the guide slots provide a slot opening at one edge of the web;

attaching a sterility sheet to the web to cover one side of the guide slots;

depositing the lancets in the guide slots;

enclosing the guide slots with the lancet therein by folding the sterility sheet around the edge of the web;

creating the lancet packet tape by sealing a plurality of lancets within the sterility sheet;

wherein said creating the lancet packet tape includes sealing the lancets within the sterility sheet at a pressure higher than typical atmospheric pressure

wherein said creating the lancet packet tape includes forming a seal between each of the lancets to form distinguishable lancet packets;

attaching the lancet packet tape to a biosensor tape that includes a plurality of biosensors; and

sterilizing the lancet packet tape before said attaching the lancet packet tape to the biosensor tape.

21. The method of claim 20, wherein said attaching includes aligning the lancet packets with the biosensors to form distinct integrated disposables as part of an integrated disposable tape.

22. The method of claim 21, further comprising detaching the integrated disposables from the integrated disposable tape.

23. The method of claim 21, further comprising packaging the integrated disposable tape inside a cassette.

24. The method of claim 20, wherein said sterilizing includes irradiating opposing sides of the lancet packet tape with electrons.

25. The method of claim 20, wherein said creating the lancet packet tape includes:

creating guides slots within a guide tape;

depositing the lancets in the guide slots; and

enclosing the guide slots by sealing the sterility sheet to the guide tape.

26. The method of claim 20, wherein said creating the lancet packet tape includes sealing an antiseptic inside the lancet packets.

27. The method of claim 20, wherein said creating the lancet packet tape includes sealing an anticoagulant inside the lancet packets.

28. The method of claim 20, wherein said creating, said attaching, and said sterilizing occur in a continuous process.

29. The method of claim 20, wherein said creating, said attaching, and said sterilizing occur in a discontinuous batch process.

30. The method of claim 20, wherein said creating includes sealing two or more sheets together to form the lancet packet.

31. A method of manufacturing a tape of integrated disposables, comprising:

forming guide slots in a web of lancets, wherein the guide slots provide a slot opening at one edge of the web;

attaching a sterility sheet to the web to cover one side of the guide slots;

depositing the lancets in the guide slots;

enclosing the guide slots with the lancet therein by folding the sterility sheet around the edge of the web to form;

a lancet tape, wherein the lancet tape has opposing first and second sides;

sterilizing the lancet tape with an electron beam sterilization system, wherein said sterilizing includes exposing the lancets to one or more electron beams directed through the sterility sheet wherein said sterilizing the lancet tape includes

irradiating the first side of the lancet tape with one or more first electron beams, and

irradiating the second side of the lancet tape with one or more second electron beams;

sealing the lancet tape within the sterility sheet before said sterilizing; and

attaching a biosensor tape to the lancet tape after said sterilizing to create an integrated disposable tape.

32. The method of claim 31, wherein:

the electron beam sterilization system includes a first emitter that emits the first electron beam and a second emitter that emits the second electron beam;

the first emitter faces the first side of the lancet tape;

the second emitter faces the second side of the lancet tape; and

said sterilizing includes feeding the lancet tape between the first emitter and the second emitter to sterilize the lancet tape in a single pass.

33. The method of claim 31, wherein:

the electron beam sterilization system includes an electron emitter;

said irradiating the first side of the lancet tape includes passing the lancet tape by the emitter with the first side of the lancet tape facing the emitter; and

said irradiating the second side of the lancet tape includes passing the lancet tape by the emitter with the second side of the lancet tape facing the emitter.