Precision depth control lancing tip

• US 9,554,741 B2
• Filed: 06/07/2011
• Issued: 01/31/2017
• Est. Priority Date: 12/27/2002
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Roe, Steven N., Wiegel, Chris
• Primary Examiner(s): Eiseman, Adam J
• Assistant Examiner(s): Leedy, Megan
• Application Number:
  US13/154,497
• Publication Number:
  US 20110237979A1
• Time in Patent Office: 2,065 Days
• Field of Search: 600/583, 600/584, 600/573, 600/567, 606/181, 606/182, 500/576
• US Class Current: 1/1
• 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. An integrated sampling device, comprising:

an incision forming member configured to form an incision in tissue, the incision forming member including a lancet and a pry member protruding from the lancet;

a test media configured to analyze body fluid from the incision;

a carrier coupling the incision forming member and the test media together, the carrier including

a tamper evidence link,

living hinges having a first position where the tamper evidence link connects the living hinges together,

the living hinges having expansion members with pry surfaces defining a pry cavity in which the pry member is received, wherein the pry member contacts the pry surfaces when in the pry cavity,

the living hinges having a second position wherein the tamper evidence link is broken,

and

the living hinges are configured to bend from the first position to the second position when the incision forming member is actuated; and

wherein the pry member is configured to break the tamper evidence link by prying the expansion members apart when the incision forming member is moved in a longitudinal direction.

2. The integrated sampling device of claim 1, further comprising:

the carrier having lock arms; and

the incision forming member having a head configured to lock with the lock arms when the incision forming member is armed.

3. The integrated sampling device of claim 2, further comprising:

the incision forming member being configured to be attached to the carrier after sterilization;

the carrier defining a test media cavity in which the test media is received;

the carrier defining a capillary channel inside the test media cavity;

the incision forming member being configured to extend through the capillary channel when forming the incision; and

the carrier having a cross member extending across the capillary channel to prevent removal of the incision forming member from the carrier.

4. The integrated sampling device of claim 3, further comprising:

the incision forming member having a tip configured to form the incision in the tissue; and

a safety cover covering the tip of the incision forming member, wherein the safety cover includes an alignment flange engaging the carrier to hold the safety cover in a stationary position relative to the incision forming member when the incision forming member moves.

5. The integrated sampling device of claim 4, wherein the living hinges include notches that facilitate bending of the living hinges.

6. The integrated sampling device of claim 1, wherein the living hinges include notches that facilitate bending of the living hinges.

7. The integrated sampling device of claim 1, further comprising:

the incision forming member being configured to be attached to the carrier after sterilization;

the carrier defining a test media cavity in which the test media is received;

the carrier defining a capillary channel inside the test media cavity;

the incision forming member being configured to extend through the capillary channel when forming the incision; and

the carrier having a cross member extending across the capillary channel to prevent removal of the incision forming member from the carrier.

8. The integrated sampling device of claim 1, further comprising:

the incision forming member having a tip configured to form the incision in the tissue; and

a safety cover covering the tip of the incision forming member, wherein the safety cover includes an alignment flange engaging the carrier to hold the safety cover in a stationary position relative to the incision forming member when the incision forming member moves.

9. The integrated sampling device of claim 8, wherein the safety cover does not act as a tamper evidence feature.

10. The integrated sampling device of claim 1, wherein:

the incision forming member includes a lancet tip at one end of the lancet and a head at the other end of the lancet; and

the pry member is positioned along the lancet between the lancet tip and the head.

11. The integrated sampling device of claim 10, wherein:

the pry member includes pry surfaces that angled towards the lancet and rounded to make insertion of the incision forming member into the carrier easier; and

the pry surfaces of the expansion members are angled and concavely shaped to coincide with the pry surfaces of the pry member.

12. An integrated sampling device, comprising:

an incision forming member configured to form an incision in tissue;

a test media configured to analyze body fluid from the incision; and

a carrier coupling the incision forming member and the test media together, the carrier including

a tamper evidence link,

living hinges having a first position where the tamper evidence link connects the living hinges together,

the living hinges having a second position wherein the tamper evidence link is broken, and

the living hinges are configured to bend from the first position to the second position when the incision forming member is actuated;

the carrier having lock arms; and

the incision forming member having a head configured to lock with the lock arms when the incision forming member is armed.

13. The integrated sampling device of claim 12, wherein the lock arms define a receptacle in which the head is locked when the incision forming member is armed.

14. The integrated sampling device of claim 12, wherein:

the head includes notches; and

the lock arm arms each include a lock tab constructed to engage a corresponding one of the notches in the head.

15. A system, comprising:

a lancing device;

an integrated sampling device received in the lancing device, wherein the integrated sampling device includes

an incision forming member configured to form an incision in tissue, wherein the incision forming member includes a head where the incision forming member is coupled to the lancing device,

a test media configured to analyze body fluid from the incision,

a carrier coupling the incision forming member and the test media together

one or more living hinges connected to the incision forming member and the test media for retracting the incision forming member relative to the carrier after forming the incision, and

a skin contacting surface where the integrated sampling device contacts the tissue when forming the incision; and

wherein the lancing device includes

a holder holding the integrated sampling device, and

a depth control mechanism including a wheel with a series of steps with graduated thicknesses for controlling the penetration depth of the incision forming member, wherein the wheel is disposed between the carrier and the head of the incision forming member,

wherein the wheel is rotatable to position a selected one of the series of steps between the carrier and the head to control the penetration depth.

16. The system of claim 15, wherein the integrated sampling device includes a tamper evidence link connected to the living hinges, the tamper evidence link being configured to break when the incision forming member is actuated.

17. The system of claim 15, wherein:

the test media includes an electrochemical test strip;

the living hinges are leaf springs;

the incision forming member having a tip;

the carrier includes a safety cover encapsulating the tip of the incision forming member;

the tip is configured to pierce the safety cover when forming the incision; and

the leaf springs being configured to retract the incision forming member.

18. The system of claim 15, wherein:

the test media is an optical type test media; and

the holder has a window proximal the test media to allow optical analysis of the test media.

19. A method, comprising:

loading an integrated sampling device into a lancing device, wherein the integrated sampling device includes an incision forming member, a test media, and a carrier coupling the incision forming member and the test media together, wherein the carrier includes a tamper evidence link and a pair of living hinges that have a first position where the tamper evidence link connects the living hinges together;

wherein the incision forming member has a pry member;

wherein the living hinges have expansion members with pry surfaces defining a pry cavity in which the pry member is received

wherein the pry member is located in the pry cavity with the pry surfaces contacting the pry member; and

arming the integrated sampling device by prying the expansion members apart with the pry member to break the tamper evidence link as the incision forming member moves in a longitudinal direction so that the living hinges bend from the first position to a second position where the tamper evidence link is broken.

20. The method of claim 19, further comprising:

wherein the carrier has lock arms and the incision forming member has a head; and

wherein said arming includes locking the head of the incision forming member with the lock arms.

21. The method of claim 19, further comprising:

sterilizing the incision forming member separately from the test media; and

installing the incision forming member into the carrier after said sterilizing.

22. The method of claim 21, wherein:

the incision forming member includes a lancet with a lancet tip at one end and a head at an opposite end;

the pry member is positioned along the lancet between the lancet tip and the head;

the pry member includes pry surfaces that are angled towards the lancet and rounded;

the pry surfaces of the expansion members are angled and concavely shaped to coincide with the pry surfaces of the pry member; and

said installing includes inserting the pry member into the pry cavity.

23. A method, comprising:

loading an integrated sampling device into a lancing device, wherein the integrated sampling device includes an incision forming member, a test media, and a carrier coupling the incision forming member and the test media together; and

arming the integrated sampling device, wherein a tamper evidence link is broken during said arming;

wherein the carrier has lock arms and the incision forming member has a head;

wherein said arming includes locking the head of the incision forming member with the lock arms;

wherein the carrier has a cross member extending across a capillary channel; and

preventing removal of the incision forming member from the carrier after said arming by extending the incision forming member in the capillary channel past the cross member.

24. The method of claim 23, wherein:

the head includes notches;

the lock arm arms each include a lock tab; and

said locking the head includes engaging the lock tab of each of the lock arms with a corresponding one of the notches in the head.

25. The method of claim 23, further comprising:

wherein the incision forming member has a pry member;

wherein the carrier includes a pair of living hinges,

wherein the living hinges have expansion members with pry surfaces defining a pry cavity in which the pry member is received; and

wherein said arming includes prying the expansion members apart with the pry member to break the tamper evidence link as the incision forming member moves in a longitudinal direction.

26. The method of claim 23, further comprising:

sterilizing the incision forming member separately from the test media; and

installing the incision forming member into the carrier after said sterilizing.

27. The method of claim 23, further comprising:

piercing the tissue with the incision forming member to form an incision by extending the incision forming member out of the capillary channel;

drawing body fluid from the incision in the tissue into the capillary channel; and

depositing the body fluid in the capillary channel onto to the test media.

28. An integrated sampling device, comprising:

an incision forming member configured to form an incision in tissue, the incision forming member having a pry member;

a test media configured to analyze body fluid from the incision;

a carrier coupling the incision forming member and the test media together, wherein the carrier includes a tamper evidence feature that is configured to indicate use of the integrated sampling device, wherein the tamper evidence feature includes a tamper evidence link that is configured to break when the incision forming member is actuated, the carrier including

living hinges configured to bend when the incision forming member is actuated, wherein the living hinges have pry surfaces defining a pry cavity in which the pry member is received, and

wherein the tamper evidence link connects together the living hinges;

the carrier having lock arms;

the incision forming member having a head configured to lock with the lock arms when the incision forming member is armed;

the incision forming member being configured to be attached to the carrier after sterilization;

the carrier defining a test media cavity in which the test media is received;

the carrier defining a capillary channel inside the test media cavity;

the incision forming member being configured to extend through the capillary channel when forming the incision; and

the carrier having a cross member extending across the capillary channel to prevent removal of the incision forming member from the carrier.

29. The integrated sampling device of claim 28, further comprising:

the incision forming member having a tip configured to form the incision in the tissue; and

a safety cover covering the tip of the incision forming member, wherein the safety cover includes an alignment flange engaging the carrier to hold the safety cover in a stationary position relative to the incision forming member when the incision forming member moves.

30. The integrated sampling device of claim 29, wherein the living hinges include notches that facilitate bending of the living hinges.