Precision depth control lancing tip

• US 7,976,477 B2
• Filed: 02/27/2008
• Issued: 07/12/2011
• Est. Priority Date: 12/27/2002
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wiegel, Chris, Roe, Steven N.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SMITH, FANGEMONIQUE A
• Application Number:
  US12/038,302
• Publication Number:
  US 20080147107A1
• Time in Patent Office: 1,231 Days
• Field of Search: 600/583, 600/567, 606/185, 606/182, 606/181
• 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 bodily fluid sampling device, comprising:

an incision forming member adapted to form an incision in skin;

an expression member defining an expression opening configured to express fluid from the incision;

a reference member defining an aperture through which the incision forming member extends when forming the incision, the reference member having a reference surface received in the expression opening during formation of the incision to contact the skin and limit penetration depth of the incision forming member into the skin;

a retraction mechanism coupled to the reference member to retract the reference surface from the expression opening;

a housing connected to the expression member; and

wherein the retraction mechanism includes

a sleeve slidably received around the housing,

a cam arm pivotally coupled to the housing, the cam arm engaging the sleeve and the reference member to retract the reference surface of the reference member from the expression opening when the sleeve slides towards the skin, and

a lock mechanism to lock the reference member in a retracted position in which the reference surface is retracted from the skin.

2. The device of claim 1, wherein the retraction mechanism includes a second cam arm pivotally coupled to the housing, the second cam arm engaging the sleeve and the reference member to retract the reference surface of the reference member from the expression opening when the sleeve slides towards the skin.

3. The device of claim 1, further comprising a spring positioned between the housing and the sleeve to bias the reference surface into the expression opening.

4. The device of claim 3, further comprising a nut coupled to the sleeve and engaging the spring.

5. The device of claim 1, wherein 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.

6. The device of claim 5, wherein the lock mechanism includes a spring biasing the latch to engage the lock tab.

12. The device of claim 1, further comprising:

the reference member being movable between the retracted position and an extended position relative to the expression member, the reference member in the retracted position being retracted relative to the expression member to be displaced from the skin, the reference member in the extended position being positioned relative to the expression member to contact skin; and

wherein the locking mechanism locks with the cam arm when the reference member is in the retracted position.

13. The device of claim 12, further comprising:

the sleeve having a guide slot;

the reference member having a guide boss with a cam pin extending from the guide boss, the guide boss being slidably received in the guide slot;

the cam arm having a reference member engaging slot in which the cam pin is received;

the cam arm having a lock arm portion with a lock tab; and

the lock mechanism having a latch arm pivotally coupled to the housing, the latch arm having a latch notch configured to lock with the lock tab of the cam arm to lock the reference member in the retracted position.

14. The device of claim 13, wherein the cam arm includes

at least two actuation members with a bowed shape to around the sleeve, and

a link portion that joins the actuation members together to give the cam arm a u-shape.

7. A bodily fluid sampling device, comprising:

a skin lancing member adapted to form an incision in skin; and

a skin contacting member having an orifice through which the skin lancing member extends to form the incision, the orifice having a first opening size that is sized to flatten the skin around the skin lancing member while the skin lancing member forms the incision and a second opening size that is larger than the first opening size after the incision is formed to express fluid from the incision, the skin contacting member including

a reference member defining an aperture having the first opening size, the reference member having a reference surface surrounding the first opening, and

an expression member defining an expression opening having the second opening size;

at least a portion of the reference member being positioned in the expression opening during formation of the incision;

a housing connected to the expression member; and

a retraction mechanism to retract the reference member from the expression opening after the incision is formed, the retraction mechanism including

a sleeve slidably received around the housing,

a cam arm pivotally coupled to the housing, the cam arm engaging the sleeve and the reference member to retract the reference surface of the reference member from the expression opening when the sleeve slides towards the skin as the device is pressed against the skin, and

a lock mechanism to lock the reference member in a retracted position where the reference member is retracted from the skin.

8. The device of claim 7, wherein the retraction mechanism includes a second cam arm pivotally coupled to the housing, the second cam arm engaging the sleeve and the reference member.

9. The device of claim 7, further comprising a spring positioned between the housing and the sleeve to bias the reference surface into the expression opening.

10. The device of claim 7, wherein 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.

11. The device of claim 10, wherein the lock mechanism includes a spring biasing the latch to engage the lock tab.

15. The device of claim 8, further comprising:

the reference member being movable between the retracted position and an extended position relative to the expression member, the reference member in the retracted position being retracted relative to the expression member to be displaced from the skin, the reference member in the extended position being positioned relative to the expression member to contact skin; and

wherein the locking mechanism locks with the cam arm when the reference member is in the retracted position.

16. The device of claim 15, further comprising:

the sleeve having a guide slot;

the reference member having a guide boss with a cam pin extending from the guide boss, the guide boss being slidably received in the guide slot;

the cam arm having a reference member engaging slot in which the cam pin is received;

the cam arm having a lock arm portion with a lock tab; and

the lock mechanism having a latch arm pivotally coupled to the housing, the latch arm having a latch notch configured to lock with the lock tab of the cam arm to lock the reference member in the retracted position.

17. The device of claim 16, wherein the cam arm includes

at least two actuation members with a bowed shape to around the sleeve, and

a link portion that joins the actuation members together to give the cam arm a u-shape.