Lancet device with flexible cover

• US 9,380,970 B2
• Filed: 01/10/2014
• Issued: 07/05/2016
• Est. Priority Date: 02/05/2011
• Status: Active Grant

• Current Assignee: POPS! Diabetes Care Inc.
• Original Assignee: POPS! Diabetes Care Inc.
• Inventors: Christensen, Curtis Jerome, Davis, Daniel William, Davis, Erik Daniel
• Primary Examiner(s): Crawford, Erik B
• Assistant Examiner(s): Hollinden, Gary E
• Application Number:
  US14/152,668
• Publication Number:
  US 20140163341A1
• Time in Patent Office: 907 Days
• Field of Search: None
• US Class Current: 1/1
• 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 method of producing a wound in a body part of a user comprising the steps of:

(a) the user positioning a device that includes (i) a rigid base, (ii) a stationary lancet secured to the rigid base and having a sharp region disposed substantially away from the rigid base, and (iii) a compressible lancet cover forming a cavity with the rigid base that covers the stationary lancet, the compressible lancet cover having a hole through which the stationary lancet is configured to pass; and

(b) the user compressing the compressible lancet cover with a body part onto the stationary lancet, the stationary lancet remaining stationary relative to the rigid base, until said stationary lancet protrudes through said hole in said compressible lancet cover and pierces said body part without first piercing the compressible lancet cover or anything else, producing a wound in said body part.

2. The method of claim 1 further comprising the step of:

(c) collecting a biological sample from said wounded body part.

3. The method of claim 1 further comprising the step of:

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

4. The method of claim 1, further comprising the steps of:

(c) the user bringing the wounded body part out of contact with the stationary lancet and the compressible lancet cover; and

(d) the user applying a biological sample from the wounded body part to a separate and distinct test apparatus.

5. The method of claim 4, wherein the test apparatus is housed by the rigid base.

6. A device, comprising:

(a) a rigid base;

(b) a first stationary lancet secured to the rigid base and having a sharp region disposed substantially away from the rigid base; and

(c) a first compressible lancet cover with a lancet hole, the first compressible lancet cover forming a first cavity with the rigid base that covers the first stationary lancet and being compressible from an unconstrained configuration in which the first stationary lancet'"'"'s sharp region does not protrude through the lancet hole to a compressed configuration in which the first stationary lancet'"'"'s sharp region protrudes through the lancet hole to the exterior of the first cavity without piercing the first compressible lancet cover or anything else inside the first cavity, wherein the first stationary lancet is stationary relative to the rigid base as the first compressible lancet cover is compressed to the compressed configuration.

7. The device of claim 6, wherein the rigid base includes a lancet region to which the first stationary lancet is secured and a separate test apparatus region that houses a test apparatus.

8. The device of claim 6, wherein the first compressible lancet cover has a convex surface that faces away from the rigid base when the first compressible lancet cover is in the unconstrained configuration.

9. The device of claim 8, wherein, when the first compressible lancet cover is compressed to the compressed configuration, the first stationary lancet protrudes through the lancet hole in the first compressible lancet cover to a prescribed distance.

10. The device of claim 8, wherein the rigid base includes a first well with a first ledge, and the first compressible lancet cover includes a support edge by which the first compressible lancet cover is supported by the first ledge to form the first cavity with the rigid base.

11. The device of claim 10, wherein the support edge of the first compressible lancet cover comprises a plurality of evenly spaced contact points that contact the first ledge.

12. The device of claim 10, wherein the first cavity includes at least one opening in the cavity near where the first compressible lancet cover meets the rigid base.

13. The device of claim 10, wherein the first stationary lancet extends from a closed end of the well, with the first stationary lancet'"'"'s sharp region being disposed substantially away from the closed end of the well, wherein the first stationary lancet'"'"'s sharp region is not farther away from the closed end of the well than is the first ledge.

14. The device of claim 6, wherein the device is without antibiotic or other liquids.

15. The device of claim 6, further comprising:

(d) a second stationary lancet secured to the rigid base and having a sharp region disposed substantially away from the rigid base; and

(e) a second compressible lancet cover with a lancet hole, the second compressible lancet cover forming a second cavity with the rigid base that covers the second stationary lancet and being compressible from an unconstrained configuration in which the second stationary lancet'"'"'s sharp region does not protrude through the lancet hole to a compressed configuration in which the second stationary lancet'"'"'s sharp region protrudes through the lancet hole to the exterior of the second cavity without piercing the second compressible lancet cover or anything else inside the second cavity, wherein the second stationary lancet is stationary relative to the rigid base as the second compressible lancet cover is compressed to the compressed configuration.

16. A method of lancing a body part of a user, comprising:

(a) placing a device on a supporting surface, the device including;

(i) a rigid base,

(ii) a stationary lancet secured to the rigid base and having a sharp region disposed substantially away from the rigid base, and

(iii) a compressible lancet cover with a lancet hole, the compressible lancet cover forming a cavity with the rigid base that covers the stationary lancet; and

(b) pressing the compressible lancet cover with the body part to compress the compressible lancet cover from an unconstrained configuration in which the stationary lancet'"'"'s sharp region does not protrude through the lancet hole to a compressed configuration in which the stationary lancet'"'"'s sharp region protrudes through the lancet hole, thereby piercing the body part without piercing the compressible lancet cover or anything else inside the cavity, wherein the stationary lancet is stationary relative to the rigid base as the compressible lancet cover is pressed to the compressed configuration.

17. The method of claim 16, further comprising:

(c) bringing the body part out of contact with the stationary lancet and the compressible lancet cover; and

(d) applying a biological sample from the body part to a separate and distinct test apparatus.

18. The method of claim 17, wherein the device'"'"'s rigid base includes a lancet region to which the stationary lancet is secured and a separate test apparatus region that houses the test apparatus.

19. The method of claim 18, wherein the device'"'"'s compressible lancet cover has a convex surface that faces away from the rigid base when the compressible lancet cover is in the unconstrained configuration, and wherein, when the compressible lancet cover is compressed to the compressed configuration, the stationary lancet protrudes through the lancet hole in the compressible lancet cover to a prescribed distance.

20. The method of claim 16, wherein the body part is not brought into contact with antibiotic or other liquids.

21. The method of claim 16, wherein (i) the device'"'"'s rigid base includes a well with a ledge, (ii) the compressible lancet cover includes a support edge by which the compressible lancet cover is supported by the ledge to form the cavity with the rigid base, and (iii) the stationary lancet'"'"'s sharp region does not extend past the ledge.

22. The method of claim 21, wherein the support edge of the compressible lancet cover comprises a plurality of evenly spaced contact points that contact the ledge.

23. The method of claim 21, wherein the cavity includes at least one opening in the cavity near where the compressible lancet cover meets the rigid base.