Integrated blood sampling and testing device and method of use thereof

• US 20090112125A1
• Filed: 01/06/2009
• Published: 04/30/2009
• Est. Priority Date: 07/06/2006
• Status: Abandoned Application

• Current Assignee: Rapidx, Ltd.
• Original Assignee: Rapidx, Ltd.
• Inventors: TAMIR, Nili
• Application Number:
  US12/348,973
• Publication Number:
  US 20090112125A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• 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 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• 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 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

The present invention discloses an integrated sampling and testing device for sampling and testing blood from a human finger which comprises clamping means for temporarily clamping a finger below the tip of said finger, a lancet for piercing said finger tip while said finger is held by said clamping means testing means for performing at least one test on blood drawn from said finger, wherein said testing means is aligned with said lancet such that blood drawn from said finger immediately contacts said testing means after being drawn. A method for sampling and testing human blood from a fingertip comprises the steps of: providing an integrated sampling and testing device for sampling and testing blood from a human finger, opening radially-expandable clamping member and inserting a finger therein, closing said radially-expandable clamping member around said finger such that pressure is applied to said finger so as to create a region of increased blood volume and/or pressure at the tip of said finger, piercing said finger using said lancet, ensuring that sufficient blood has been drawn and, subsequently, opening said radially-expandable clamping member so to allow removal of finger, optionally, transferring at least one reagent to said test strip using said reagent transferring means, and waiting and viewing test results.

Claims

1. An integrated sampling and testing device for sampling and testing blood from a human finger, comprising;

a. clamping means for temporarily clamping a finger below the tip of said finger, so as to increase the volume and/or pressure of blood at said finger tip and thereby facilitate drawing of blood from said finger;

b. a lancet for piercing said finger tip while said finger is held by said clamping means, and;

c. testing means for performing at least one test on blood drawn from said finger,

wherein said testing means is aligned with said lancet such that blood drawn from said finger immediately contacts said testing means after being drawn.

2. The integrated sampling and testing device according to claim 1, further comprising reagent transferring means for transferring a predetermined amount of at least one reagent to said testing means after blood has been drawn from said finger.

3. The integrated sampling and testing device according to claim 1, wherein said lancet comprises piercing means, and a lancet housing for housing said piercing means, and wherein said lancet housing further comprises an orifice located at the top portion thereof for allowing said piercing means to temporarily protrude from said housing so as to enable blood sampling.

4. The integrated sampling and testing device according to claim 1, wherein said testing means comprises a test strip.

5. The integrated sampling and testing device according to claim 4, wherein said lancet further includes a capillary sponge for absorbing blood and for conducting blood to said test strip.

6. The integrated sampling and testing device according to claim 4, wherein said test strip includes a housing and a capillary sponge located inside of said housing, and wherein said housing is provided with a blood volume indication window for indicating when sufficient blood has been drawn for the particular test, and a test results window for indicating the results of said test.

7. The integrated sampling and testing device according to claim 4, wherein said lancet housing further comprises a lateral opening positioned directly below said top portion for receiving at least a portion of said test strip, and wherein said test strip has a small orifice therein for allowing said piercing means to pass therethrough at the time of finger piercing, such that blood drawn from the finger tip using said piercing means automatically drips or flows onto said test strip.

8. The integrated sampling and testing device according to claim 1, wherein said clamping means comprises a clip mechanism having a proximal end and a distal end, said proximal comprising a radially-expandable clamping member, and said distal end comprising a handle for actuating said radially-expandable clamping member such that said clamping member can be radially expanded and contracted around said finger for facilitating sampling of blood.

9. The integrated sampling and testing device according to claim 8, wherein said radially-expandable clamping member comprises a flexible tourniquet having a configuration of a ring or a sleeve.

10. An integrated sampling and testing device for sampling and testing blood from a human finger, comprising a lancet for piercing the tip of a finger, and testing means for performing at least one test on blood drawn from said finger, wherein said testing means is aligned with said lancet such that blood drawn from said finger immediately contacts said testing means after being drawn.

11. The integrated sampling and testing device for sampling and testing blood from a human finger according to claim 10, wherein said testing means comprises a test strip.

12. The integrated sampling and testing device according to claim 10, wherein said test strip includes a housing and a capillary sponge located inside of said housing, and wherein said housing is provided with a blood volume indication window for indicating when sufficient blood has been drawn for the particular test, and a test results window for indicating the results of said test.

13. The integrated sampling and testing device according to claim 10, wherein said lancet housing further comprises a lateral opening positioned directly below said top portion for receiving at least a portion of said test strip, and wherein said test strip has an orifice therein for allowing said piercing means to pass therethrough at the time of finger piercing, such that blood drawn from the finger tip using said piercing means automatically drips or flows onto said test strip.

14. A clamping unit for use in combination with a blood sampling device, for increasing the blood volume and/or pressure at the finger tip and thereby facilitating blood sampling, said clamping unit comprising a clip mechanism having a proximal end and a distal end, wherein said proximal end comprises a radially-expandable clamping member adapted for receiving the end of a finger therein, and wherein said distal end comprises a handle for actuating said radially-expandable clamping member, such that when said handle is squeezed/pressed by the user, said clamping member opens to allow insertion of the finger, and when said handle is released, said clamping member closes so as to apply pressure onto the finger, thereby increasing blood volume and/or pressure at the finger tip.

15. The integrated sampling and testing device according to claim 14, wherein said radially-expandable clamping member comprises a flexible tourniquet having a configuration of a ring or a sleeve.

16. A method for sampling and testing human blood from a fingertip, comprising the steps of:

(a) providing an integrated sampling and testing device for sampling and testing blood from a human finger, the device including;

(i) clamping means for temporarily clamping a finger below the tip of said finger, so as to increase the volume and/or pressure of blood at said finger tip and thereby facilitate drawing of blood from said finger, said clamping means comprising a radially-expandable clamping member and a handle for opening and closing said radially-expandable clamping member;

(ii) a lancet for piercing said finger tip while said finger is held by said clamping member;

(iii) a test strip for performing at least one test on blood drawn from said finger, wherein said test strip is aligned with said lancet such that blood drawn from said finger immediately contacts said test strip after being drawn; and

,

(iv) reagent transferring means for transferring a predetermined amount of at least one reagent to said test strip after blood has been drawn from said finger;

(b) opening said radially-expandable clamping member and inserting a finger therein;

(c) closing said radially-expandable clamping member around said finger such that pressure is applied to said finger so as to create a region of increased blood volume and/or pressure at the tip of said finger;

(d) piercing said finger using said lancet;

(e) ensuring that sufficient blood has been drawn and, subsequently, opening said radially-expandable clamping member so to allow removal of finger;

(f) optionally, transferring at least one reagent to said test strip using said reagent transferring means; and

,

(g) waiting and viewing test results.