Lancet device with flexible cover

• US 8,647,357 B2
• Filed: 09/16/2011
• Issued: 02/11/2014
• Est. Priority Date: 02/05/2011
• Status: Active Grant

• Current Assignee: POPS! Diabetes Care Inc.
• Original Assignee: Birch Narrows Development Llc
• Inventors: Christensen, Curtis Jerome, Davis, Daniel William, Davis, Erik Daniel
• Primary Examiner(s): Haq, Shafiqul
• Assistant Examiner(s): Hollinden, Gary E
• Application Number:
  US13/234,826
• Publication Number:
  US 20120203083A1
• Time in Patent Office: 879 Days
• Field of Search: None
• US Class Current: 606/181
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/32113 with extendable or retractable guard or blade
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• 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 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15157 Geometry of stocking means or arrangement of piercing elements therein
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence

Abstract

The biological test kit is a device for drawing and, optionally, testing biological samples. The biological test kit is an array of Lancets set in wells in a rigid base. Each lancet well is covered by a protective cover which when deformed permits the lancet to puncture a user or other patient. In one embodiment the biological test kit employs distinct covers for each lancet and in another the covers are formed from sheet material formed into blisters which cover the lancet.

Claims

1. A device comprising:

a) a rigid first layer;

b) one or more lancets secured to the first layer, the one or more lancets and the first layer being stationary relative to one another, said lancets each having a sharp region disposed substantially away from the first layer;

c) one or more second layers disposed in an opposed arrangement relative to the first layer, the first and second layers being arranged to form one or more cavities there-between, each of the one or more second layers forming one or more covers, each cover over one of the lancets; and

d) each of the one or more covers having a first unconstrained configuration in which the lancet sharp region does not protrude past or through the cover and having a second compressed configuration in which the lancet sharp region protrudes through the cover.

2. The device of claim 1 wherein said covers are resilient such that the cover can pass from the unconstrained configuration to the compressed configuration when a compression force is applied and return from the compressed configuration to the unconstrained configuration when said compression force is removed.

3. The device of claim 1 further comprising:

a) at least one chemical test strip for capturing biological samples.

4. The device of claim 3 further comprising a testing apparatus for testing one or more chemical properties of biological samples present on said test strip.

5. A device comprising:

a) a rigid first layer,

b) one or more lancets secured to the first layer, the one or more lancets and the first layer being stationary relative to one another, said lancets each having a sharp region disposed substantially away from the first layer;

c) one or more covers disposed in an opposed arrangement relative to the first layer, each cover covering at least one of said lancets, and said lancet disposed within a well formed in said first layer, said cover disposed to cover said well; and

d) each of the one or more covers having a first unconstrained configuration in which the lancet sharp region does not protrude past or through the cover and having a second compressed configuration in which the lancet sharp region protrudes through the cover.

6. The device of claim 5 wherein said covers are resilient such that the cover can pass from the unconstrained configuration to the compressed configuration when a compression force is applied and return from the compressed configuration to the unconstrained configuration when said compression force is removed.

7. The device of claim 5 further comprising a protective layer covering the one or more covers.

8. The device of claim 5 further comprising:

a) at least one chemical test strip for capturing biological samples.

9. The device of claim 8 further comprising a testing apparatus for testing one or more chemical properties of biological samples present on said test strip.

10. A method of drawing a biological sample comprising:

(a) providing a device that includes;

(i) a rigid first layer,

(ii) a lancet secured to the first layer, said lancet having a sharp region disposed substantially away from the first layer, and

(iii) a second layer disposed in an opposed arrangement relative to the first layer, the first and second layers being arranged to form a cavity therebetween, the second layer forming a cover over the lancet;

(b) pressing the cover toward the first layer with a body part to move the cover from an unconstrained configuration in which the lancet sharp region does not protrude through the cover to a compressed configuration in which the lancet sharp region protrudes through the cover and pierces the body part to produce the biological sample, the first layer and the lancet being stationary relative to one another during pressing.

11. The method of claim 10, further comprising:

(c) collecting the biological sample.

12. The method of claim 11, further comprising:

(d) using a testing apparatus to measure one or more chemical properties of the biological sample.