Blood acquisition suspension system

• US 20040127819A1
• Filed: 12/16/2003
• Published: 07/01/2004
• Est. Priority Date: 12/30/2002
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N.
• Granted Patent: US 7,351,212 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• 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 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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

Abstract

A body fluid sampling device includes a firing mechanism that is configured to be automatically cocked and fired. In one form, the device includes an electric motor that is operable cock the firing mechanism and fire an integrated lancet/sampling device to form an incision in skin. Subsequent to formation of the incision, the integrated lancet device is temporarily removed from the skin to promote bleeding from the incision. After a specified period of time, the integrated lancet device is then repositioned against the skin in order to collect a fluid sample.

Claims

1. A method, comprising:

forming an incision in skin with a sampling end portion of a body fluid sampling device;

retracting the sampling end portion from the skin to promote flow of body fluid from the incision; and

collecting the body fluid from the incision with the sampling end portion of the body fluid sampling device by extending the sampling end portion toward the skin after said retracting.

2. The method of claim 1, wherein:

the sampling end portion includes an integrated lancing-sampling device that includes a casing that defines a cavity and a lancet slidably received in the cavity;

said forming the incision includes lancing the skin with the lancet by pressing the casing against the skin to expose the lancet; and

said collecting the body fluid includes drawing the body fluid into the cavity via capillary action.

3. The method of claim 2, further comprising:

wherein the integrated lancing-sampling device includes a test strip positioned along the cavity; and

analyzing the body fluid with the test strip.

4. The method of claim 1, further comprising analyzing the body fluid at a test area in the body fluid sampling device.

5. The method of claim 1, wherein:

the sampling device includes a retraction mechanism, the retraction member includes a motor, a drive thread coupled to the motor, a drive member coupled to the drive thread, an actuation member coupled to the drive member, and a spring coupled between the drive member and the actuation member; and

said retracting includes actuating the motor to retract the sampling end portion.

6. The method of claim 1, wherein said retracting includes retracting the sampling end portion for at least two seconds before said collecting.

7. The method of claim 1, further comprising:

wherein the body fluid sampling device includes a lancing mechanism with a motor; and

cocking the lancing mechanism with the motor before said forming the incision.

8. The method of claim 1, wherein said collecting includes pressing the sampling end portion against the skin.

9. The method of claim 1, wherein said collecting includes positioning the sampling end portion above the skin in a non-contacting manner.

10. A body fluid sampling device, comprising:

a lancing device adapted to lance an incision in skin;

a firing mechanism coupled to the lancing device, the firing mechanism having a cocked configuration in which the firing mechanism is cocked for firing the lancing device; and

a motor coupled to the firing mechanism adapted to place the firing mechanism in the cocked configuration.

11. The device of claim 10, wherein:

the firing mechanism includes a spring that is coupled between the motor and the lancing device for firing the lancing device; and

the motor is operable to compress the spring to place the firing mechanism in the cocked configuration.

12. The device of claim 11, further comprising:

wherein the firing mechanism includes an actuation member coupled to the lancing device and the spring;

a drive member coupled to the spring and motor;

wherein the motor is adapted to move the drive member to compress the spring between the actuation member and the drive member.

13. The device of claim 12, further comprising:

one or more cocking arms that engage the actuation member during cocking; and

wherein the drive member has one or more engagement surfaces that are adapted to engage the cocking arms to release the actuation member from the cocking arms for firing the lancing device.

14. The device of claim 13, wherein the engagement surfaces are configured to spread the cocking arms apart to release the actuation member.

15. The device of claim 13, wherein:

the actuation member is slidably coupled to the drive member; and

the actuation member includes a stop tab engageable with the drive member to retract the lancing device from the skin.

16. The device of claim 13, further comprising:

a support structure coupled to the motor;

a guide rod having a drive thread rotatably mounted to the support structure, the drive thread engages the drive member to move the drive member; and

a gear coupled between the motor and the guide rod for transmitting rotational force from the motor to the guide rod.

17. The device of claim 10, wherein the lancing device include an integrated lancing-sampling device that includes a casing defining a lancet cavity, a lancet for lancing the skin slidably received in the lancet cavity and a test means positioned along the lancet cavity to test body fluid drawn into the lancet cavity from the incision.

18. The device of claim 17, further comprising means for temporarily retracting the integrated lancing-sampling device from the skin to promote flow of the body fluid from the incision.

19. The device of claim 10, wherein the motor includes a reversible motor to retract the lancing device from the skin.

20. The device of claim 10, wherein the motor includes an electric motor.

21. A body fluid sampling device, comprising:

an integrated lancing-sampling device including a casing and a lancet for lancing an incision in skin slidably received in the casing, wherein the casing defines a sampling cavity for drawing body fluid from the incision; and

means for retracting and reapplying the integrated lancing-sampling device against the skin to promote flow of body fluid from the incision.

22. The device of claim 21, wherein the means for retracting and reapplying the integrated lancing-sampling device includes a motor operable to retract and reapply the integrated lancing-sampling device against the skin.

23. The device of claim 21, further comprising:

a firing mechanism coupled to the integrated-sampling device for firing the integrated lancing-sampling device; and

means for automatically cocking the firing mechanism.

24. The device of claim 21, further comprising a depth control mechanism coupled to the integrated lancing-sampling device to adjust the penetration depth of the lancet.