Process for manufacturing packaged lancets and device for analyzing body fluid

• US 8,234,767 B2
• Filed: 03/18/2010
• Issued: 08/07/2012
• Est. Priority Date: 09/19/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roeper, Josef, Finke, Werner, Harttig, Herbert, Hiller, Bernd, List, Hans
• Primary Examiner(s): COZART, JERMIE E
• Application Number:
  US12/726,534
• Publication Number:
  US 20100222799A1
• Time in Patent Office: 873 Days
• Field of Search: 294/13, 294/14, 294/15, 294/58, 295/251.3, 295/251.4, 295/251.5, 294/18, 436/44, 600/583, 606/181, 534/63
• US Class Current: 29/418
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: B29C 65/16 Laser beams
• CPC Class Codes: B29C 65/1619 Mid infrared radiation [MIR], e.g. by CO or CO2 lasers
• CPC Class Codes: B29C 65/1654 scanning at least one of the parts to be joined
• CPC Class Codes: B29C 65/1674 making use of laser diodes B29C65/167 takes precedence
• CPC Class Codes: B29C 65/48 using adhesives , i.e. using supplementary joining material; solvent bonding
• CPC Class Codes: B29C 65/4815 Hot melt adhesives, e.g. thermoplastic adhesives
• CPC Class Codes: B29C 65/7473 : using radiation, e.g. laser, for simultaneously welding and severing
• CPC Class Codes: B29C 66/1122 : Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/24244 : forming a rectangle
• CPC Class Codes: B29C 66/43 : Joining a relatively small portion of the surface of said articles B29C66/45 takes precedence
• CPC Class Codes: B29C 66/4332 : by folding a sheet over
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/836 : Moving relative to and tangentially to the parts to be joined, e.g. transversely to the displacement of the parts to be joined, e.g. using a X-Y table B29C66/65 takes precedence
• CPC Class Codes: B29K 2023/06 : PE, i.e. polyethylene
• CPC Class Codes: B29K 2023/12 : PP, i.e. polypropylene
• CPC Class Codes: B29K 2023/38 : Polymers of cycloalkenes, e.g. norbornene or cyclopentene
• CPC Class Codes: B29K 2031/04 : Polymers of vinyl acetate, e.g. PVAc, i.e. polyvinyl acetate
• CPC Class Codes: B29K 2033/12 : Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate
• CPC Class Codes: B29K 2067/00 : Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2067/003 : PET, i.e. poylethylene terephthalate
• CPC Class Codes: B29K 2077/00 : Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/753 : Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B65B 11/48 : Enclosing articles, or quantities of material, by folding a wrapper, e.g. a pocketed wrapper, and securing its opposed free margins to enclose contents
• CPC Class Codes: B65B 15/04 : Attaching a series of articles, e.g. small electrical components, to a continuous web ammunition filling F42B
• CPC Class Codes: B65B 51/22 : by friction or ultrasonic or high-frequency electrical means , i.e. by friction or ultrasonic or induction welding
• CPC Class Codes: B65B 55/00 : Preserving, protecting or purifying packages or package contents in association with packaging by packaging under special atmospheric or gaseous conditions B65B31/00; devices for placing protecting sheets, plugs, or wads over contents B65B61/22
• CPC Class Codes: B65B 9/06 : Enclosing successive articles, or quantities of material, in a longitudinally-folded web, or in a web folded into a tube about the articles or quantities of material placed upon it
• CPC Class Codes: Y10T 29/49799 : Providing transitory integral holding or handling portion
• CPC Class Codes: Y10T 29/49885 : with coating before or during assembling
• CPC Class Codes: Y10T 29/49966 : with supplemental joining
• CPC Class Codes: Y10T 29/49968 : Metal fusion joining
• CPC Class Codes: Y10T 29/4997 : At least one part nonmetallic
• CPC Class Codes: Y10T 436/110833 : Utilizing a moving indicator strip or tape

Abstract

Disclosed is a process for manufacturing packaged lancets. The steps of the process include providing a tape comprising a plurality of lancets comprising a lancet tip and a lancet body, enveloping at least the lancet tip with at least one foil, whereby the at least one foil forms a first and a second portion that overlap at least partly, and sealing the at least one foil with a laser beam at least at the edges of the first and second portion of the overlapping foil.

Claims

1. A process for manufacturing packaged lancets, comprising the steps of:

providing a metal sheet comprising a plurality of lancets which are fixed to the metal sheet via at least one predetermined breaking point whereby the lancets comprise a lancet tip and a lancet body;

positioning the metal sheet relatively to a tape comprising at least one foil for enveloping at least the lancet tip;

placing at least one lancet onto the tape and pressing the at least one lancet on the tape so that the at least one breaking point is broken and the lancet is no longer connected with the metal sheet;

and before, simultaneously, or afterwards fixing the lancet on the tape,

removing the metal sheet and enveloping at least the lancet tip with the foil, whereby the foil builds a first and a second portion that overlap at least partly,

and sealing the at least one foil preferably with a laser beam at least at the edges of the first and second portion of the overlapping foil.

2. A process for manufacturing packaged lancets, comprising the steps of:

providing a tape comprising a plurality of lancets comprising a lancet tip and a lancet body,

enveloping at least the lancet tip with at least one foil, whereby the at least one foil builds a first and a second portion that overlap at least partly,

applying a force to the foil in such a way that the foil is pressed onto the lancet by a first component of the force in a first direction and, moreover, by a second component of the force in a second direction perpendicular to the first direction so that the first and second portion of the foil overlaps and at least one portion of the foil is flattened towards the end of the lancet opposite to the lancet tip, and

sealing the at least one foil preferably with a laser beam at least at the edges of the first and second portion of the overlapping foil.

3. The process according to claim 2, whereby one foil covers a first side of the tape and a second foil covers a second side of the tape.

4. The process according to claim 2, whereby a first portion of the foil covers a first side of the tape and a second portion covers a second side of the tape wherein the first and second portion are connected by a third portion which is located in front of the lancet tip.

5. The process of claim 2, wherein the sealing of the foil is established with a laminar laser sealing process.

6. The process of claim 2, wherein the tape is cut by the laser to separate the lancets.

7. The process of claim 6, wherein the sealing of the foil is established by the laser when the tape is cut with the laser.

8. The process according to claim 7, using different energy rates for the sealing and the cutting of the lancets.

9. The process according to claim 2, wherein the tape is constructed of a polymer, preferentially polyester.

10. The process according to claim 2, with the additional step of sterilizing the lancet.

11. The process according to claim 2, wherein the lancet body is attached to a test element.

12. A process according to claim 2, wherein the force is applied by air brusher.

13. The process according to claim 2, wherein the force is applied in a defined angle relatively to the lancet tape.

14. A process according to claim 13 the angle is adjustable preferably as a function of the air pressure.

15. A process of manufacturing a device for analyzing a component in a body fluid, comprising:

providing a lancet with a lancet tip and a lancet body and at least one foil, that envelopes at least the tip of the lancet whereby the at least one foil builds a first and a second portion that overlap each other at least partly, wherein the foil is sealed after enveloping at least a part of the lancet by treating at least the edges built by the two partly overlapping portions of the at least one foil preferably with a laser to keep at least the lancet tip in a hermetic surrounding; and

joining the lancet with a test element comprising a body fluid application field before or after sealing the device.