Blood acquisition suspension system

• US 7,351,212 B2
• Filed: 12/16/2003
• Issued: 04/01/2008
• 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.
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): Apanius; Michael
• Application Number:
  US10/737,660
• Publication Number:
  US 20040127819A1
• Time in Patent Office: 1,568 Days
• Field of Search: 600/576, 600/583, 600/584, 600/573, 606181-183
• 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 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 method, comprising:

placing a housing of a bodily fluid sampling device against a surface of skin, wherein the housing of the bodily fluid sampling device houses an integrated lancet/sampling device that includes a casing that defines a cavity in which a lancet is slidably received and test media disposed along the cavity, wherein the cavity has a cavity opening;

forming an incision in the skin with the integrated lancet/sampling device, wherein said forming the incision includes

controlling penetration depth of the lancet into the skin by pressing with the bodily fluid sampling device the casing at the cavity opening of the integrated lancet/sampling device against the skin to create a reference surface upon which the penetration depth of the lancet is based, and

puncturing the incision in the skin with the lancet by further pressing the integrated lancet/sampling device against the skin to extend the lancet from the cavity opening of the casing into the skin;

retracting the casing at the cavity opening from the skin to a retracted position with the bodily fluid sampling device after said forming the incision to reduce premature closure of the incision, wherein at the retracted position the lancet is removed from the incision and the casing of the integrated lancet/sampling device no longer contacts the skin;

moving the cavity opening of the integrated lancet/sampling device towards the skin with the bodily fluid sampling device to a collection position where the integrated lancet/sampling device is able to collect body fluid from the incision;

collecting the body fluid from the incision with the integrated lancet/sampling device at the collection position by drawing the body fluid from the surface of the skin into the cavity through the cavity opening and onto the test media;

wherein the housing of the bodily fluid sampling remains against the skin during said forming, said retracting, said moving, and said collecting;

wherein the bodily fluid sampling device includes a motor coupled to a firing mechanism;

wherein said forming the incision in the skin includes

cocking the firing mechanism with the motor, and

firing the integrated lancet/sampling device with the firing mechanism; and

wherein said moving the cavity opening includes positioning the integrated lancet/sampling device towards the skin with the motor.

2. The method of claim 1, wherein said moving the integrated lancet/sampling device towards the skin includes reapplying the integrated lancet/sampling device against the skin to contact the casing with the skin.

3. The method of claim 1, wherein said moving the integrated lancet/sampling device towards the skin includes positioning the integrated lancet/sampling device in contact with a drop of the body fluid above the incision.

4. The method of claim 1, further comprising waiting two seconds before said moving the integrated lancet/sampling device towards the skin.

5. The method of claim 1, wherein:

the motor includes a drive gear coupled to the firing mechanism;

said retracting the casing at the cavity opening from the skin includes rotating the drive gear of the motor in a first direction; and

said moving the cavity opening of the integrated lancet/sampling device towards the skin includes rotating the drive gear of the motor in a second direction that is opposite the first direction.

6. The method of claim 1, further comprising analyzing the body fluid with the test media of the integrated lancet/sampling device.

7. A method, comprising:

placing a housing of a bodily fluid sampling device against skin, wherein the skin has a surface, wherein the housing of the bodily fluid sampling device houses an integrated lancet/sampling device that includes a casing that defines a cavity in which a lancet is slidably received and test media disposed along the cavity, wherein the cavity has a cavity opening;

forming an incision at an incision site on the skin with the integrated lancet/sampling device, wherein said forming the incision includes

controlling penetration depth of the lancet into the skin by pressing with the bodily fluid sampling device the casing at the cavity opening of the integrated lancet/sampling device against the skin to create a reference surface upon which the penetration depth of the lancet is based,

puncturing the incision in the skin with the lancet by further pressing the integrated lancet/sampling device against the skin to extend the lancet from the cavity opening of the casing into the skin, and

retracting the lancet back inside the casing;

lifting the casing at the cavity opening off the skin to a retracted position automatically with the bodily fluid sampling device after said forming the incision to reduce premature closure of the incision, wherein at the retracted position the lancet is removed from the incision and the casing of the integrated lancet/sampling device no longer contacts the skin, wherein during said lifting the casing moves relative to the housing away from the skin;

moving the cavity opening of the integrated lancet/sampling device towards the skin with the bodily fluid sampling device to a collection position where the cavity opening of the integrated lancet/sampling device is able to collect body fluid from the incision, wherein during said moving the lancet remains retracted inside the casing;

collecting the body fluid from the incision with the integrated lancet/sampling device at the collection position by drawing the body fluid from the surface of the skin into the cavity through the cavity opening and onto the test media, wherein during said collecting the lancet remains retracted inside the casing; and

wherein the housing of the bodily fluid sampling remains against the skin at the incision site during said forming, said lifting, said moving, and said collecting.

8. The method of claim 7, wherein:

the bodily fluid sampling device includes a motor coupled to a firing mechanism;

said forming the incision in the skin includes

cocking the firing mechanism with the motor, and

firing the integrated lancet/sampling device with the firing mechanism; and

said moving the cavity opening includes positioning the integrated lancet/sampling device towards the skin with the motor.

9. The method of claim 7, wherein said moving the integrated lancet/sampling device towards the skin includes reapplying the integrated lancet/sampling device against the skin to contact the casing with the skin.

10. The method of claim 7, wherein said moving the integrated lancet/sampling device towards the skin includes positioning the integrated lancet/sampling device in contact with a drop of the body fluid above the incision.

11. The method of claim 7, further comprising waiting two seconds before said moving the integrated lancet/sampling device towards the skin.

12. The method of claim 7, wherein:

the motor includes a drive gear coupled to the firing mechanism;

said retracting the casing at the cavity opening from the skin includes rotating the drive gear of the motor in a first direction; and

said moving the cavity opening of the integrated lancet/sampling device towards the skin includes rotating the drive gear of the motor in a second direction that is opposite the first direction.

13. The method of claim 7, further comprising analyzing the body fluid with the test media of the integrated lancet/sampling device.