Automatic biological analyte testing meter with integrated lancing device and methods of use

• US 7,572,237 B2
• Filed: 11/04/2003
• Issued: 08/11/2009
• Est. Priority Date: 11/06/2002
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Peterson, Matthew W., Lortz, W. Mark, Sia, Sophia, Kennedy, Daniel F., Tsang, Sammy Cheuksang, Saikley, Charles R., Hamerton-Kelly, Paul R., Vivolo, Joseph A.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US10/701,993
• Publication Number:
  US 20040138588A1
• Time in Patent Office: 2,107 Days
• Field of Search: 600/583, 600/584, 600/573, 600/576, 600/322
• US Class Current: 600/584
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150114 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2205/0266 : Shape memory materials

Abstract

An integrated device is for sampling and testing an analyte. The device generally includes a housing, a lancing device for sampling an analyte, a test strip for substantially capturing at least a portion of the analyte, and a display unit for displaying a result corresponding to the captured portion of the analyte. A method includes performing a single operation to sample an analyte, to capture the sampled analyte, to perform testing on the sampled analyte, and to display a result corresponding to the performed test. A method includes using an integrated sampling and testing device placing the device the device on a test site of a subject, such as a patient, and performing the single operation to obtain a test result. The sampling and testing of analytes may involve testing analytes in blood, such as the blood of a diabetic patient.

Claims

1. A bodily fluid testing device for obtaining and testing a submicroliter bodily fluid sample, comprising:

a housing defining at least a first aperture;

a lancing device including a needle and a lancet drive including a spring, the lancing device operatively coupled to said housing for obtaining a submicroliter bodily fluid sample by advancing the needle through the first aperture in the housing and piercing a skin surface at a bodily fluid sample location and then withdrawing to provide access to the submicroliter bodily fluid sample by a test strip;

a lancet guiding shoulder coupled with the housing;

a lancet guiding collar coupled around the needle within a mechanical tolerance of about 0.05 mm, and the lancet guiding collar having an outer dimension within a mechanical tolerance of about 0.05 mm, and the lancet guiding collar and lancet guiding shoulder having a mutual clearance of no more than approximately 0.13 mm, thereby providing precision control over puncture site location; and

a mount block coupled with a connector that is coupled with a motor within the housing, the mount block configured for coupling the test strip thereto, and the motor configured for moving an edge of the test strip along a non-linear trajectory such that a bodily fluid receiving portion of the edge of the test strip comes to rest at a center of the submicroliter bodily fluid sample without moving the housing relative to the bodily fluid sample location, and

wherein the bodily fluid testing device is configured such that the housing is placed on the bodily fluid sample location, and then after said lancing and withdrawing of the lancing device, the edge of the test strip moves along the non-linear trajectory to the bodily fluid sample contacting location within a mechanical tolerance of about 0.010 inch of said center of said bodily fluid sample in the plane of the skin surface at the bodily fluid sample location.

2. The device of claim 1, wherein the lancing device comprises a cutting edge that is aligned with the test strip, although withdrawn following lancing to provide said bodily fluid sample, when the test strip is received in the housing and moved to said center of said bodily fluid sample.

3. The device of claim 1, wherein the lancing device is operatively coupled to said housing by said spring.

4. The device of claim 1, wherein the lancing device comprises a body having a first axis, and a sharp operatively connected to the body, wherein the sharp has a second axis that is perpendicular to the first axis.

5. The device of claim 1, wherein the lancing device comprises a sharp that has at least two points.

6. The device of claim 1, wherein the lancing device is of a construction sufficient to pierce tissue of a patient.

7. The device of claim 1, wherein the test strip comprises a side-filled test strip to sample a bodily fluid sample that comprises a submicroliter volume.

8. The device of claim 7, wherein the device is configured to sample a submicroliter bodily fluid sample that comprises a diameter of not more than approximately 0.005 inches.

9. The device of claim 1, wherein when the test strip is in the bodily fluid sample-contacting position, a fill channel of the test strip is aligned with the submicroliter bodily fluid sample within 0.005 inches of said center of said bodily fluid sample.

10. The device of claim 9, wherein the device is configured to sample a submicroliter bodily fluid sample that comprises a diameter of not more than approximately 0.005 inches.

11. The device of claim 1, wherein the device is configured for the edge of the test strip to travel along said trajectory including 0.03 inches along the bodily fluid sample location.

12. The device of claim 1, wherein a physiological property that is determined from a captured portion of the bodily fluid sample comprises a glucose level, a carbohydrate level, a hemoglobin level, or a glycated hemoglobin level, or combinations thereof.

13. The device of claim 1, further comprising a controller operatively coupled to the housing for controlling operation of the lancing device.

14. The device of claim 1, further comprising an input unit operatively coupled to the housing for operating the lancing device.

15. The device of claim 1, further comprising a controller operatively coupled to the housing for controlling movement of the test strip when the test strip is received in the housing.

16. The device of claim 1, wherein the trajectory comprises an approach angle of less than 65°

.

17. The device of claim 16, wherein the trajectory comprises an approach angle of not less than approximately 35°

.

18. The device of claim 1, wherein the test strip is configured to sample a submicroliter bodily fluid sample that comprises a volume of ⅓

microliter.

19. The device of claim 18, wherein the device is configured to sample a submicroliter bodily fluid sample that comprises a diameter of not more than approximately 0.005 inches.

20. The device of claim 1, wherein the device is configured to sample a submicroliter bodily fluid sample that comprises a diameter of not more than approximately 0.005 inches.

21. The device of claim 1, wherein the bodily fluid testing device is configured to lance and test without application of a vacuum to the bodily fluid sampling location through the first aperture.

22. The device of claim 1, wherein the lancet guiding collar is concentric with the needle.