Blood acquisition suspension system

• US 8,684,951 B2
• Filed: 03/16/2011
• Issued: 04/01/2014
• 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): Hoekstra, Jeffrey G
• Assistant Examiner(s): SMITH, FANGEMONIQUE A
• Application Number:
  US13/049,622
• Publication Number:
  US 20110166477A1
• Time in Patent Office: 1,112 Days
• Field of Search: 600/584, 600/583, 600/576, 600/573, 606/181, 606/182
• 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 body fluid sampling device, comprising:

a housing configured to contact tissue;

an integrated lancing-sampling device including a casing and a lancet for lancing an incision in the tissue slidably received in the casing, wherein the casing defines a sampling cavity for drawing body fluid from the incision, wherein the integrated lancing-sampling device is disposed inside the housing, wherein the casing of the integrated lancing-sampling device forms a reference surface upon which penetration depth of the lancet is based when the casing is pressed against the tissue, wherein the casing and the lancet of the lancing-sampling device are configured to be removed from the housing as a single disposable unit; and

a positioner mechanism configured to retract the casing of the integrated lancing-sampling device from contact with the tissue after cutting the incision to a retracted position to promote flow of body fluid from the incision while the housing remains in contact with the tissue, the positioner mechanism being configured to subsequently move the integrated lancing-sampling device from the retracted position to a collection position where the body fluid is collected, wherein the casing of the integrated lancing-sampling device is positioned closer to the tissue at the collection position than at the retracted position.

2. The device of claim 1, further comprising a firing mechanism coupled to the integrated lancing-sampling device for firing the integrated lancing-sampling device.

3. The device of claim 2, further comprising:

wherein the firing mechanism includes a spring configured to fire the lancet; and

means for automatically cocking the spring of the firing mechanism.

4. The device of claim 3, further comprising:

wherein the means for automatically cocking the spring of the firing mechanism includes a motor; and

the firing mechanism including

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,

the spring being 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.

5. The device of claim 4, wherein the motor includes a reversible motor with a drive shaft configured to rotate 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.

6. The device of claim 1, further comprising a depth control mechanism coupled to the integrated lancing-sampling device to adjust the penetration depth of the lancet.

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

8. The device 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.

9. The device of claim 1, wherein the positioner mechanism includes:

a reversible motor with a drive shaft configured to rotate 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, the drive shaft including a drive thread winding in a helical pattern around the drive shaft;

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

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; and

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 drive shaft.

10. A body fluid sampling device, comprising:

an integrated lancing-sampling device including a lancet configured to lance an incision in tissue;

a firing mechanism coupled to the integrated lancing-sampling device, the firing mechanism including a spring configured to fire the lancet;

a cocking mechanism coupled to the spring configured to place the spring in a cocked state, wherein the cocking mechanism includes an electric motor configured to deform the spring for storing potential energy in the spring when in the cocked state;

wherein the integrated lancing-sampling device includes a casing;

wherein the motor is configured to retract the integrated lancing-sampling device from contact with the tissue after cutting the incision and subsequently move the integrated lancing-sampling device to a collection position where the body fluid is collected; and

wherein the casing of the integrated lancing-sampling device is located closer to the tissue at the collection position than when retracted.

11. The device of claim 10, 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.

12. The device of claim 10, wherein the motor includes a reversible motor with a drive shaft configured to rotate 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.

13. A method, comprising:

placing a housing of a body fluid sampling device against tissue;

lancing tissue by firing a lancet of an integrated lancing-sampling device while the housing remains in contact with the tissue, wherein the lancet of the integrated lancing-sampling device is slidably received in a casing, wherein the casing contacts the tissue during said lancing, wherein the casing defines a sampling cavity for drawing body fluid from an incision;

retracting the casing of the integrated lancing-sampling device from contact with the tissue to a retracted position to promote flow of body fluid from the incision after said lancing, wherein the housing remains in contact with the tissue during said retracting;

moving the integrated lancing-sampling device from the retracted position to a collection position after said retracting the casing, wherein the housing remains in contact with the tissue during said moving, wherein the casing of the integrated lancing-sampling device is located closer to the tissue at the collection position than at the retracted position; and

collecting the body fluid by drawing the body fluid from the incision into the sampling cavity of the casing while the housing remains in contact with the tissue.

14. The method of claim 13, further comprising:

wherein the body fluid sampling device includes a reversible motor with a drive shaft, wherein the drive shaft includes a drive thread winding in a helical pattern around the drive shaft;

rotating the drive shaft in a first direction during said retracting; and

rotating the drive shaft in a second direction during said moving the integrated lancing-sampling device.

15. The method of claim 13, further comprising:

wherein the body fluid sampling device 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, and

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 said lancing the tissue includes

cocking the spring by compressing the spring between the drive member and the actuation member with the motor at least until the cocking flange engages the cocking arms to hold the spring in a cocked state, and

releasing the spring by driving one or more arm engagement surfaces of the drive member with the motor to release the cocking flange from the cocking arms.

16. A method, comprising:

cocking a firing mechanism to a cocked state by compressing a spring of the firing mechanism with an electric motor;

firing a lancet with the firing mechanism by releasing the spring from the cocked state;

wherein the lancet is incorporated into an integrated lancing-sampling device in which the lancet is slidably received in a casing of the integrated lancing-sampling device, wherein the casing defines a sampling cavity for drawing body fluid from an incision;

drawing the body fluid from the incision into the sampling cavity of the integrated lancing-sampling device;

further comprising placing a housing of a body fluid sampling device against tissue, wherein the body fluid sampling device includes the firing mechanism;

keeping the housing in contact with the tissue during said firing;

retracting the casing of the integrated lancing-sampling device from contact with the tissue to a retracted position to promote flow of body fluid from the incision after said firing, wherein the housing remains in contact with the tissue during said retracting; and

moving the integrated lancing-sampling device from the retracted position to a collection position after said retracting the casing, wherein the housing remains in contact with the tissue during said moving.

17. The method of claim 16, further comprising:

wherein the firing mechanism includes

a holder in which the lancet 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 said cocking, and

the 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 said cocking includes compressing the spring between the drive member and the actuation member with the motor at least until the cocking flange engages the cocking arms to hold the spring in the cocked state, and

wherein said firing includes releasing the spring by driving one or more arm engagement surfaces of the drive member with the motor to release the cocking flange from the cocking arms.