Methods of fabricating physiological sample collection devices

• US 20030212346A1
• Filed: 05/09/2002
• Published: 11/13/2003
• Est. Priority Date: 05/09/2002
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Teodorczyk, Maria, Leong, Koon-Wah, Yuzhakov, Vadim V., McAllister, Devin V., Olson, Lorin, Kiser, Ernest
• Granted Patent: US 7,060,192 B2
• Time in Patent Office: Days
• US Class Current: 600/584
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15184 Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• 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: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Methods of fabricating devices for collecting a sample of physiological and for measuring a characteristic, e.g., an analyte concentration, of the sampled physiological sample. The devices are in the form of a test strip which include a biosensor and at least one skin-piercing element which is a planar extension of a portion of the biosensor. The fabrication methods provide various or forming the test strip and the skin-piercing element.

Claims

1. A method of fabricating at least one test strip device for collecting a sample of physiological fluid and measuring a characteristic thereof, said method comprising:

integrally forming a substrate and at least one microneedle extending planar therefrom; and

forming an opening within said at least one microneedle, wherein said opening occupies a substantial portion of a width, diameter or length dimension of said microneedle.

2. The method according to claim 1 wherein said substrate and said at least one microneedle comprise a metal material.

3. The method according to claim 2 wherein said metal material comprises one or more of the group consisting of aluminum, copper, gold, platinum, palladium, iridium, silver, titanium, tungsten, carbon and stainless steel.

4. The method according to claim 1 wherein said substrate and at least one microneedle comprise an inert material.

5. The method according to claim 2 wherein said substrate and at least one microneedle comprise an inert material.

6. The method according to claim 4 or 5 wherein said inert material comprises one or more of the group consisting of a polymer, silicon, ceramic and glass.

7. The method according to claim 6 wherein said polymer comprises one or more of the group consisting of polyester, polyimide, polycarbonate;

cellophane, fluorinated polymer, ionomer, polyamide, polymethylpentene, polysulfone, polyethylene and its copolymers, polystyrene and its copolymers, polypropylene and its copolymers, polyvinyl chloride and its copolymers, polyvinylidene chloride and its copolymers, and polymer composites reinforced with minerals or nano-particles.

8. The method according to claim 1, further comprising using injection molding techniques.

9. The method according to claim 1, further comprising using photoechemical etching techniques.

10. The method according to claim 1, further comprising using microstamping techniques.

11. The method according to claim 1, further comprising using embossing techniques.

12. The method according to claim 1 wherein said step of forming an opening comprises forming a recess within a surface of said at least one microneedle.

13. The method according to claim 1 further comprising forming a fluid pathway extending from said space-defining configuration to a location within said substrate.

15. The method according to claim 1 comprising using web-based fabrication techniques wherein said substrate and said at least one microneedle are formed from a web of suitable material.

14. The method according to 13 further comprising forming sub-channels extending from said fluid pathway within said biosensor.

16. A method of fabricating a plurality of test strip devices, said method comprising:

providing a first sheet and forming a plurality of skin-piercing elements within said first sheet of material wherein said plurality of skin-piercing elements extend from and are in the same plane as the said first sheet of material, wherein each of said skin-piercing elements comprises an opening occupying a substantial portion of a width, diameter or length dimension of said respective skin-piercing elemnt.

providing a second sheet;

laminating together said first and second sheets; and

cutting said laminated sheets to provide said plurality of test strip devices.

22. The method of claim 16 wherein said first sheet is made from an inert material.

23. The method of claim 22 wherein said microneedles are formed from hot embossing said inert material.

24. The method of claim 16 wherein said second sheet is an inert material.

25. The method of claim 24 further comprising the step of providing a third sheet wherein said second sheet is sandwiched between said first and third sheets during said step of laminating.

26. The method of claim 24 wherein said third sheet is comprised of the same material as said first sheet.

27. The method of claim 24 wherein said second sheet has an adhesive on at least one side.

28. The method of claim 25 wherein said third sheet is porous.

29. The method of claim 26 wherein said third sheet is non-porous.

30. The method of claim 16 wherein a redox reagent system is applied to said first sheet.

31. The method of claim 16 wherein a signal producing system is applied to said first sheet.

17. The method of 16 wherein said first sheet is made of metal material.

18. The method of claim 17 wherein said first sheet is further made of an inert material.

19. The method of claim 17 wherein said skin-piercing elements are photochemically etched into said metal material.

20. The method of claim 17 wherein said skin piercing elements are micro-stamped into said metal material.

21. The method of claim 18 wherein said metal material is deposited on said inert material.