Blood acquisition suspension system

• US 7,927,291 B2
• Filed: 07/17/2006
• Issued: 04/19/2011
• Est. Priority Date: 12/30/2002
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SMITH, FANGEMONIQUE A
• Application Number:
  US11/457,872
• Publication Number:
  US 20060247554A1
• Time in Patent Office: 1,737 Days
• Field of Search: 600/584, 600/583, 600/300, 600/445, 601/46, 606/182, 606/181
• US Class Current: 600/584
• 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 to 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 kit, comprising:

an integrated lancing-sampling device comprising a lancet to lance an incision in tissue, a test strip to analyze body fluid from the incision, and a casing in which the lancet is slidably received; and

a bodily fluid sampling device including

a housing configured to contact the tissue;

a firing mechanism disposed inside the housing configured to fire the lancet of the integrated lancing-sampling device into the tissue,

a motor operatively coupled to the firing mechanism to temporarily retract the casing of the integrated lancing-sampling device away from the tissue to promote bleeding of the body fluid from the incision after lancing while the housing remains in contact with the tissue and afterwards extend the integrated lancing-sampling device towards the tissue to collect the body fluid from the incision while the housing remains in contact with the tissue;

a holder in which the integrated lancing-sampling device is received; and

an actuation member coupled to the holder, the actuation member being configured to move in a driving direction to press the casing against the tissue so that the lancet slides relative to the casing to extend from the casing for lancing the tissue, the motor being configured to move the actuation member in a retraction direction to temporarily retract the casing of the integrated lancing-sampling device away from the tissue while the housing remains in contact with the tissue.

2. The kit of claim 1, wherein the integrated lancing-sampling device includes a spring to retract the lancet from the incision.

3. The kit of claim 1, wherein the integrated lancing-sampling device includes a reference surface against which the tissue is pressed during lancing to control penetration depth of the lancet.

4. The kit of claim 3, wherein the bodily fluid sampling device includes a penetration depth control mechanism to adjust the penetration depth of the lancet.

13. The kit of claim 1, further comprising:

the bodily fluid sampling device including a housing with a tissue contact portion configured to contact the tissue; and

the tissue contact portion of the housing being configured to remain against the tissue as the casing of the integrated lancing-sampling device retracts away from the tissue and is extended towards the tissue to collect the body fluid from the incision.

14. The kit of claim 1, further comprising:

the motor being an electric motor that includes a drive shaft configured to rotate for retracting and extending the casing of the integrated lancing-sampling device.

5. A kit, comprising:

an integrated lancing-sampling device comprising a lancet to lance an incision in tissue and a test strip to analyze body fluid from the incision; and

a bodily fluid sampling device including

a housing configured to contact the tissue;

a firing mechanism disposed inside the housing configured to fire the lancet of the integrated lancing-sampling device into the tissue,

a motor operatively coupled to the firing mechanism to temporarily retract the integrated lancing-sampling device away from the tissue to promote bleeding of the body fluid from the incision after lancing while the housing remains in contact with the tissue and afterwards extend the integrated lancing-sampling device towards the tissue to collect the body fluid from the incision while the housing remains in contact with the tissue; and

wherein the motor includes a reversible motor with a drive shaft that rotates in a first direction during retraction of the integrated lancing-sampling device and in a second direction during extension of the integrated lancing-sampling device.

15. The kit of claim 5, further comprising:

the bodily fluid sampling device including a housing with a tissue contact portion configured to contact the tissue; and

the integrated lancing-sampling device being separate from the housing for moving relative to the housing.

6. A kit, comprising:

an integrated lancing-sampling device comprising a lancet to lance an incision in tissue and a test strip to analyze body fluid from the incision; and

a bodily fluid sampling device including

a firing mechanism configured to fire the lancet of the integrated lancing-sampling device into the tissue, wherein the firing mechanism includes a firing spring,

a motor operatively coupled to the firing mechanism to temporarily retract the integrated lancing-sampling device away from the tissue to promote bleeding of the body fluid from the incision after lancing and afterwards extend the integrated lancing-sampling device towards the tissue to collect the body fluid from the incision; and

wherein the motor is configured to cock the firing mechanism by compressing the firing spring, the motor including an electric motor with a drive shaft that rotates to compress the firing spring of the firing mechanism.

7. A kit, comprising:

an integrated lancing-sampling device comprising a lancet to lance an incision in tissue and a test strip to analyze body fluid from the incision; and

a bodily fluid sampling device including

a firing mechanism configured to fire the lancet of the integrated lancing-sampling device into the tissue,

a motor operatively coupled to the firing mechanism to temporarily retract the integrated lancing-sampling device away from the tissue to promote bleeding of the body fluid from the incision after lancing and afterwards extend the integrated lancing-sampling device towards the tissue to collect the body fluid from the incision; and

wherein the firing mechanism includes;

a holder in which the integrated lancing-sampling device is received;

a guide rod operatively engaged with the motor, the guide rod including a drive thread winding in a helical pattern around the guide rod;

a drive member engaging the drive thread;

an actuation member coupled to the holder, the actuation member including one or more slide arms slidably attaching the actuation member to the drive member and a cocking flange coupled to the slide arms;

one or more cocking arms engageable with the cocking flange to hold the actuation member in place during cocking;

a spring coupled between the drive member and the actuation member, wherein the spring is configured to be compressed between the drive member and the actuation member as the motor drives the drive member towards the actuation member via the drive thread on the guide rod; and

wherein the drive member includes one or more arm engagement surfaces configured to release the cocking flange from the cocking arms to fire the lancet via the spring.

8. The kit of claim 7, further comprising the integrated lancing-sampling device coupled to the bodily fluid sampling device.

9. The kit of claim 8, wherein:

the integrated lancing-sampling device includes a capillary channel having an opening positioned proximal to a reference surface for collecting the body fluid; and

the motor is configured to position the opening of the capillary channel in contact with a drop of the body fluid on the surface of the tissue during collection of the body fluid.

10. The kit of claim 8, wherein the integrated lancing-sampling device includes a spring coupled to the lancet for retracting the lancet.

11. The kit of claim 7, wherein the bodily fluid sampling device includes a penetration depth adjustment mechanism configured to adjust how far the lancet extends during lancing.

16. The kit of claim 7, further comprising:

the motor including a drive shaft with a drive gear that rotates the guide rod to compress the spring.

17. The kit of claim 16, further comprising:

the bodily fluid sampling device including a housing with a tissue contact portion configured to contact the tissue; and

the integrated lancing-sampling device being separate from the housing for moving relative to the housing.

12. An apparatus, comprising:

a bodily fluid sampling device including

a housing configured to contact the tissue;

a firing mechanism disposed inside the housing configured to fire at tissue an integrated lancing-sampling device that includes a lancet, a test strip, and a reference surface in which the reference surface contacts the tissue to extend the lancet into the tissue to cut an incision,

a positioner mechanism configured to retract the reference surface of the integrated lancing-sampling device from contact with the tissue after cutting the incision while the housing remains in contact with the tissue and subsequently move the integrated lancing-sampling device to a collection position where the body fluid is collected while the housing remains in contact with the tissue; and

wherein the firing mechanism includes;

a motor;

a holder in which the integrated lancing-sampling device is received;

a guide rod operatively engaged with the motor, the guide rod including a drive thread winding in a helical pattern around the guide rod;

a drive member engaging the drive thread;

an actuation member coupled to the holder, the actuation member including one or more slide arms slidably attaching the actuation member to the drive member and a cocking flange coupled to the slide arms;

one or more cocking arms engageable with the cocking flange to hold the actuation member in place during cocking;

a spring coupled between the drive member and the actuation member, wherein the spring is configured to be compressed between the drive member and the actuation member as the motor drives the drive member towards the actuation member via the drive thread on the guide rod; and

wherein the drive member includes one or more arm engagement surfaces configured to release the cocking flange from the cocking arms to fire the lancet via the spring.

18. The apparatus of claim 12, further comprising:

the motor including a drive shaft with a drive gear that rotates the guide rod to compress the spring.

19. The apparatus of claim 12, further comprising:

the bodily fluid sampling device including a housing with a tissue contact portion configured to contact the tissue.