Integrated lancet and bodily fluid sensor

• US 8,808,321 B2
• Filed: 01/11/2011
• Issued: 08/19/2014
• Est. Priority Date: 09/30/2002
• Status: Expired due to Term

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: DeNuzzio, John D., Keith, Steven, Monahan, Lawrence A., Palmer, Phyllis, Stewart, Bill, Chelak, Todd M., West, Robert E., Allen, William, Karl, Frederick, Griswold, Lee
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US12/929,261
• Publication Number:
  US 20120011705A1
• Time in Patent Office: 1,316 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, 600/583, 600/584, 534/25, 534/50, 534/77, 606181-183, 205/777.5, 204/403.01
• US Class Current: 606/181
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150725 removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• 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 5/1519 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: Y10T 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A lancing device integrated with a sensing strip and method of making and using the same are provided. A lance and analyte sensing strip are combined in a single, preferably disposable, device. In a preferred embodiment, a slot is provided in a support member so the lance can be engaged by a lance driver and driven into the skin producing a bodily fluid sample from a wound. The sensing area of the sensing strip is adjacent to the wound location reducing dexterity requirements for patients.

Claims

1. A method of manufacturing a bodily fluid sample acquisition and testing device, comprising the steps of:

inserting a lance into a primary support member having an elongate slot arranged in an outside surface of said primary support member and extending from a proximal end of the primary support member to a distal end of the primary support member for accessing said lance through said primary support member from outside said primary support member,

sterilizing said primary support member and lance; and

after sterilizing said primary support member and lance, inserting a bodily fluid chemistry sensing strip comprising a sensing area into said primary support member such that said sensing area is adjacent to said lance.

2. The method of claim 1, wherein said sensing area is in electrical contact with two electrodes.

3. The method of claim 1, wherein said sterilization step comprises radiating said primary support member and lance with an electron beam.

4. The method of claim 1, wherein said sterilization step comprises radiating said primary support member and lance with gamma radiation.

5. The method of claim 1, wherein the slot is an open slot oriented in a driving direction of the lance.

6. The method of claim 1, wherein the step of inserting a bodily fluid chemistry sensing strip further comprises inserting the bodily fluid chemistry sensing strip into a secondary slot of the primary support member.