PRECISION DEPTH CONTROL LANCING TIP

• US 20110237979A1
• Filed: 06/07/2011
• Published: 09/29/2011
• Est. Priority Date: 12/27/2002
• 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., Wiegel, Chris
• Granted Patent: US 9,554,741 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 5/150068 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 5/150503 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 5/150549 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 5/1519 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 bodily fluid sampling device is operable to lance with a precise depth and express fluid from both fingertip and alternate sites. In one form, the device is operable to adjust the penetration depth of the lancet into the skin. The bodily fluid sampling device includes a lancet adapted to form an incision in skin. A skin contacting member has an orifice through which the lancet extends when lancing the skin. The orifice has a first opening size that is sized to flatten the skin around the lancet during lancing. The orifice has a second opening size that is larger than the first opening size after the incision is formed to express fluid from the incision.

Claims

1. A device for sampling a bodily fluid from an incision in a user'"'"'s skin, comprising:

an expression member including a first, skin-contacting surface defining a first opening;

a depth-control member including a second, skin-contacting surface defining a second opening smaller than the first opening, the depth-control member being movable between first and second positions relative to the expression member, the depth-control member in the first position being retracted relative to the expression member to be displaced from skin received in the first opening of the expression member, the depth-control member in the second position being positioned relative to the expression member to contact skin received in the first opening of the expression member;

an incision forming member extendable through the second opening of the depth-control member in the second skin-contacting position, wherein the incision forming member and the depth-control member are separate components;

the second skin contacting surface being flat and extending radially inwards towards the second opening, the second skin contacting surface being sized to flatten the skin around the incision forming member;

a retraction mechanism coupled to the depth-control member to retract the depth-control member to the first position during fluid expression by the expression member; and

a lock mechanism configured to lock the depth control member at the first position during fluid expression by the expression member.

2. The device of claim 1, in which the expression member and the depth-control member comprise concentric, annular-shaped skin-contacting surfaces.

3. The device of claim 1 in which the incision forming member includes a lancet configured to extend beyond the second skin-contacting surface of the depth-control member.

4. The device of claim 1, further comprising:

the depth-control opening being sized slightly larger than the tip of the incision forming member;

the first skin-contacting surface being flat, the first skin-contacting surface extending in a radial direction between the expression opening and the depth-control opening when in the second position; and

the first skin-contacting surface is sized to fill the expression opening when in the second position to flatten the skin around the incision forming member.

5. The device of claim 1, in which the retraction mechanism includes a cam arm pivotally coupled to the depth-control member.

6. The device of claim 1, in which the lock mechanism includes a latch engageable with the depth control member.

7. A body fluid sampling device, comprising:

a housing;

an incision forming member being extendable from the housing to form an incision in tissue;

an expression member coupled to the housing, the expression member defining an expression opening configured to express body fluid from the incision;

a depth-control member configured to be received in the expression opening when the incision is formed, the depth-control member being configured to flatten the tissue around the incision forming member when the incision is formed,

a retraction mechanism configured to automatically retract the depth-control member from the expression opening to a retracted position when the expression member is pressed against the tissue; and

a lock mechanism to lock the depth-control member at the retracted position to prevent the depth-control member from smearing the body fluid within the expression opening.

8. The device of claim 7, in which the retraction mechanism includes:

a sleeve slidably received around the housing, and

a cam arm pivotally coupled to the housing, the cam arm engaging the sleeve and the depth-control member to retract the depth-control member from the expression opening when the sleeve slides towards the skin.

9. The device of claim 8, in which the lock mechanism includes:

a latch coupled to the sleeve; and

a lock tab extending from the cam arm that is engageable with the latch.