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Interstitial fluid collection and constituent measurement    
United States Patent5582184   
Link to this pagehttp://www.wikipatents.com/5582184.html
Inventor(s)Erickson; Brian J. (Woodbury, MN); Hilgers; Michael E. (Roseville, MN); Hendrickson; Tracy A. (Minnetonka, MN); Shapland; J. Edward (Shoreview, MN); Solomon; Frank A. (Plymouth, MN); Knudson; Mark B. (Shoreview, MN)
AbstractAn apparatus and method is disclosed for obtaining and measuring constituents in a sample of body fluid. The apparatus includes a member which is sized to penetrate into at least the dermal layer of skin to collect a sample of body fluid located within the dermal layer.
   














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Drawing from US Patent 5582184
Interstitial fluid collection and constituent measurement - US Patent 5582184 Drawing
Interstitial fluid collection and constituent measurement
Inventor     Erickson; Brian J. (Woodbury, MN); Hilgers; Michael E. (Roseville, MN); Hendrickson; Tracy A. (Minnetonka, MN); Shapland; J. Edward (Shoreview, MN); Solomon; Frank A. (Plymouth, MN); Knudson; Mark B. (Shoreview, MN)
Owner/Assignee     Integ Incorporated (Roseville, MN)
Patent assignment
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Publication Date     December 10, 1996
Application Number     08/321,305
PAIR File History     Application Data   Transaction History
Image File Wrapper   Patent Term   Fees
Litigation
Filing Date     October 11, 1994
US Classification     600/576 600/583 600/584 606/181
Int'l Classification     A61B 005/00
Examiner     Hindenburg; Max
Assistant Examiner    
Attorney/Law Firm     Merchant, Gould, Smith, Edill, Welter & Schmidt
Address
Parent Case     CROSS-REFERENCE RELATED APPLICATIONS The present application is a continuation-in-part of U.S. patent application Ser. No. 08/136,304 filed Oct.13, 1993, now abandoned.
Priority Data    
USPTO Field of Search     128/760 128/763 128/770 128/771 604/289 604/290 604/51 604/117 606/181 606/182
Patent Tags     interstitial fluid collection constituent measurement
   
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 Technical Review Submit all comments and votes
 Claims Submit all comments and votes
 


What is claimed is:

1. An apparatus for obtaining a sample of body fluid, said apparatus comprising:

a penetration member with a fluid pathway for fluid to flow at least partially along a length of said member, said member sized to penetrate at least into the dermal layer of skin, said penetration member having a fluid entrance to admit into said fluid pathway a body fluid residing in the dermal layer; and

means for controlling a depth of the penetration of said penetration member so that said fluid entrance penetrates into the dermal layer of skin but not through the dermal layer for a substantially blood free sample of fluid from said layer to flow into said pathway through said entrance.

2. An apparatus according to claim 1 wherein said member includes at least a section composed of a material which is transparent to a light source including infrared light having a wavelength absorbable by glucose.

3. An apparatus according to claim 1 wherein said penetration member is a conduit and said pathway is a passageway within said conduit and wherein said conduit includes a proximal end and a distal end, means for applying a negative pressure to said proximal end of the conduit such that body fluid located adjacent said distal end of the conduit is drawn up into said passageway of the conduit.

4. An apparatus according to claim 1 further including means for compressing the skin adjacent the member such that body fluid located adjacent said penetration member is forced into said entrance and up into said pathway.

5. An apparatus for obtaining a sample of body fluid, said apparatus comprising:

a penetration member having a fluid pathway for fluid to flow at least partially along the length of said member, said member sized to penetrate at least into the dermal layer of a patient's skin for a sample of said fluid to flow along said pathway; and

limit means to limit penetration of said penetration member into and not through said dermal layer.

6. An apparatus according to claim 5 comprising a membrane in close proximity to an end of said penetration member for said sample to flow from said fluid pathway and be deposited on said membrane.

7. An apparatus according to claim 6 wherein said membrane is formed of a microporous material.

8. An apparatus according to claim 7 wherein said membrane is accessible for drying prior to testing of constituents deposited on said membrane.

9. An apparatus according to claim 5 wherein said penetration member is a tubular needle.

10. An apparatus according to claim 9 wherein said needle and limit means cooperate to limit said penetration to be less than 3,000 microns.

11. An apparatus according to claim 10 wherein said neddle is sized to penetration less than a third of a thickness of said dermal layer.

12. An apparatus according to claim 9 wherein said needle is sized for substantially pain-free insertion of said needle into said dermal layer.

13. An apparatus according to claim 12 wherein said needle is smaller than 28 gauge.

14. An apparatus according to claim 9 wherein said needle is sized to collect a substantially blood-free sample of fluid from said dermal layer.

15. An apparatus according to claim 9 comprising a base member, said needle disposed within said base member and having a penetration end protruding beyond a lower surface of said base member and having an opposite end.

16. An apparatus according to claim 9 further comprising means for compressing said skin in a region surrounding said needle upon penetration of said needle into said skin.

17. An apparatus according to claim 15 further comprising a membrane disposed against said opposite end for depositing said sample on said membrane.

18. An apparatus according to claim 15 wherein said needle is selected to have a size smaller than 28 gauge.

19. A method for collecting a sample of body fluid, said method comprising:

selecting a penetrating member having a length sized to partially extend into the dermal layer of skin and having a fluid pathway for fluid to flow at least partially along a length of said member and sizing said member to collect said fluid upon insertion of said member into said skin and without substantial pain upon insertion;

inserting said penetrating member into said skin a depth selected for said penetration member to penetrate into and not through said dermal layer; and

drawing said fluid along said fluid pathway.

20. A method according to claim 19 further comprising compressing skin adjacent said member to urge said fluid along said fluid pathway.
 Description Submit all comments and votes
 


BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an apparatus for testing body fluid constituents. More particularly, the present invention pertains to an apparatus for collecting body fluid for testing.

2. Description of the Art

The prior art has long been seeking procedures for testing and determining the level of blood constituents. Particularly, a great deal of attention has been spent on the development of techniques for measuring blood glucose.

Historically, blood glucose and other bodily analyte measurements were, and remain, invasive. Such measurements are generally made by withdrawing a blood sample and measuring the desired analyte within the blood or plasma. Blood samples can be withdrawn by inserting a needle into a major artery or, more commonly, a vein. A syringe or other device is used to provide any necessary suction and collect the blood sample. Needles used for this sampling technique must be long enough to pass through the skin, subcutaneous tissue, and blood vessel wall. The needle must also have a sufficient diameter to allow timely collection of the blood sample without causing hemolysis of the blood. Minimal diameter to meet these criteria is generally 20 gauge or larger diameter. Such direct vascular blood sampling has several limitations, including pain, hematoma and other bleeding complications, and infection. In addition, due to the vascular damage resulting from the needle puncture, sampling could not be repeated on a routine basis. Finally, it is extremely difficult for patients to perform a direct vascular puncture on themselves.

The other common technique for collecting a blood sample is to cut or lance the skin and the subcutaneous tissue, including the small, underlying blood vessels, to produce a localized bleeding on the body surface. A lancet, knife, or other cutting device is required. The blood on the body surface can then be collected into a small tube or other container. The fingertip is the most frequently used site to collect blood in this method due to the large number of small blood vessels located in the region. One method is shown in U.S. Pat. 4,637,403. This sampling method a