"blood sample collection apparatus and kits"

• US 20130018279A1
• Filed: 09/01/2009
• Published: 01/17/2013
• Est. Priority Date: 09/01/2009
• Status: Abandoned Application

• Current Assignee: Pathway Genomics
• Original Assignee: Pathway Genomics
• Inventors: Plante, James, Becker, David, Nova, Michael, Noaek, Luke
• Application Number:
  US12/584,153
• Publication Number:
  US 20130018279A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14539 for measuring pH
• 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 5/150404 Specific design of proximal end
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/150717 manually removed
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/150984 Microneedles or microblades
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

Blood sample collection apparatus and kits are devised as easy-to-use, reduced pain devices operable by persons not having medical training or other expertise or knowledge. A flexible strip having adhesives on two portions of a first side accommodate therebetween and absorbent pad and substrate with microstructures. The substrate includes microstructures arranged to gently penetrate or pierce skin and cause a small amount of blood to pass to the external surface of a user'"'"'s flesh. An absorbent pad receives and absorbs a blood sample therein. The absorbent pad may additionally support a plurality of chemical agents which further advances mobility of blood in the collection system. These chemical agents may include anticoagulants and blood anticlotting agents to facilitate blood transfer from a donor to the absorbent pad. Additionally, these systems may also include a blood preservative to stabilize blood collected for an extended shipping and transfer period. These blood sample collection systems may further include a numbing agent to improve comfort of use.

Claims

1. ) Blood sample collection apparatus comprising:

a piercing element;

an absorbent pad; and

an adhesive strip,

said piercing element is affixed to said absorbent pad with at least one piercing microstructure extending substantially orthogonally therefrom,

said absorbent pad is affixed to one side of said adhesive strip, the strip having adhesive material on either side of the absorbent pad.

2. ) Blood sample collection apparatus of claim 1, said absorbent pad is comprised of a plurality of layers and said piercing element is integrated therewithin said absorbent pad layers.

3. ) Blood sample collection apparatus of claim 1, said piercing element includes a planar structure formed of a crystalline wafer.

4. ) Blood sample collection apparatus of claim 3, said microstructure is formed in a crystal growing process.

5. ) Blood sample collection apparatus of claim 3, said microstructure is a wafer with a plurality of holes provided therein.

6. ) Blood sample collection apparatus of claim 3, said at least one piercing microstructure is further characterized as either from the group:

lances, barbs, needles, pins, knives, spikes.

7. ) Blood sample collection apparatus of claim 6, said at least one piercing element is further characterized as a hypodermic needle.

8. ) Blood sample collection apparatus of claim 7, said needle is formed integrally with a substrate having a reservoir therein, said reservoir containing a blood thinning or anticoagulant agent.

9. ) Blood sample collection apparatus of claim 6, said at least one piercing element is further characterized as a barb.

10. ) Blood sample collection apparatus of claim 1, said absorbent pad further comprises integrated therewithin at least one chemical agent.

11. ) Blood sample collection apparatus of claim 10, said at least one chemical agent is either from the group including:

numbing agents, blood anticoagulants, blood anticlotting agents, blood thinners, antibacterial agents, perseverant, and blood stabilizers.

12. ) Blood sample collection apparatus of claim 11, said at least one chemical agent includes a plurality of agents where either agent is spatially removed from either other.

13. ) Blood sample collection apparatus of claim 12, further comprises a numbing agent disposed nearest an exposed surface of said absorbent pad.

14. ) Blood sample collection apparatus of claim 1, further comprises a indicator system arranged in opposition to said piercing element, said indicator system is responsive to the presence of a sufficient quantity of blood at the absorbent pad, the indicator system arranged to provide visible indicia when blood is present.

15. ) Blood sample collection apparatus of claim 14, said indicator system is based upon a chemical state change in response to presence of matter of a prescribed pH.

16. ) Blood sample collection apparatus of claim 15, said indicator system includes shaped indicia of a ‘

positive’

or ‘

affirmative’

nature such as a ‘

plus’

sign or ‘

check’

symbol.

17. ) Blood sample collection apparatus of claim 14, said indicator system is comprised of a cover element having a window therein, a medium which changes state in the presence of blood.

18. ) Blood sample collection apparatus of claim 17, said cover element and change medium is disposed on a side of said adhesive strip opposite to the side in which the absorbent pad is affixed, the adhesive strip further having via holes provided therein whereby blood in the absorbent pad may migrate to the change medium.

19. ) Blood sample collection apparatus of claim 1, further comprising a removable protective cover element arranged to be temporarily affixed via the strip adhesive and further to cover and protect the apparatus microstructures.

20. ) Blood sample collection apparatus of claim 19, said cover strips further comprise a ‘

kneebend’

discontinuity to account for and create a cavity between the cover and adhesive in which the microstructures may be accommodated therein.

21. ) Blood sample collection kits comprising:

a durable outer container;

a foam core;

a blood sample collection apparatus;

a sterile envelope; and

a return container,

said durable outer container is suitable for two-way transmission in the mails or private delivery services further having an outer surface suitable for accommodating addressee information which may be changed,

said foam core substantially similar but slightly smaller in shape and size whereby the foam core fits snugly within the outer container, the foam core further having at least two voids or slots formed therein to accommodate said envelope and return container.

22. ) Blood sample collection apparatus of claim 21, said blood sample collection apparatus is a blood sample collection apparatus comprising:

a piercing element;

an absorbent pad; and

an adhesive strip, said piercing element is affixed to said absorbent pad with at least one piercing microstructure extending substantially orthogonally therefrom, said absorbent pad is affixed to one side of said adhesive strip, the strip having adhesive material on either side of the absorbent pad.

23. ) Blood sample collection kits of claim 21, further comprising a preprinted return address label and system use instruction set.