Instruments and system for producing a sample of a body fluid and for analysis thereof

• US 9,186,104 B2
• Filed: 04/29/2013
• Issued: 11/17/2015
• Est. Priority Date: 04/30/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Kraemer, Uwe, Zimmer, Volker, Roedel, Wolfgang, List, Hans, Frey, Stephan-Michael, Hoerauf, Christian, Patel, Paul
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/873,046
• Publication Number:
  US 20130237881A1
• Time in Patent Office: 932 Days
• Field of Search: 600/583, 600/584, 606181-183, 204/403.03, 204/415
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• 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 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• 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
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood

Abstract

Instrument for producing a sample of body liquid for analysis by piercing the skin with a lancing element having a skin piercing tip. The instrument has a housing and a lancing drive for driving a lancing element connected thereto in a puncturing movement. A pressure ring surrounds a skin contact opening and is adapted for pressing against the skin such that the skin bulges into the opening for promoting expression of body fluid. The skin contact opening has an opening area corresponding to a circle with a diameter of at least 3 mm and at most 8 mm, and the instrument comprises a pressing force control device for controlling the pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, to be at least 3 N and at most 8 N.

Claims

1. An instrument for producing a body fluid sample for analysis by piercing skin with a lancing element having a piercing tip, the instrument comprising:

a housing;

a lancing drive within the housing for driving a lancing element connected thereto in a puncturing movement in which the lancing element moves, after triggering the puncturing movement, in a puncture direction until the lancing element reaches a point of maximum displacement and in a reverse direction after the lancing element has reached the point of maximum displacement;

a pressure ring configured to be pressed against the skin such that the skin bulges into a skin contact opening for promoting expression of body fluid, wherein the pressure ring defines an opening area corresponding to a circle with a diameter of at least 3 mm and at most 8 mm; and

a pressing force control device for controlling a pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, wherein the pressing force at the time of triggering is at least 3 N and at most 8 N,

wherein the instrument works without a z-position detection means and without a penetration depth reference element configured for contacting the skin that bulges into the pressure ring.

2. The instrument according to claim 1, wherein the pressure ring defines an opening area corresponding to a circle with a diameter of at most 6 mm.

3. The instrument according to claim 2, wherein the pressure ring defines an opening area corresponding to a circle with a diameter of at most 5 mm.

4. The instrument according to claim 1, wherein the pressing force is at least 4 N and at most 7 N.

5. The instrument according to claim 1, further comprising a holding device for holding an analysis element in the housing such that the body fluid sample produced by piercing the skin can be transported thereto for analysis.

6. The instrument according to claim 1, wherein the instrument comprises a device for automatically triggering the puncturing movement when the pressing force corresponds to a value of at least 3 N;

and

the instrument provides a minimum interaction time period of at most 3 seconds, starting from the triggering of the puncturing movement, for which every user must at least interact with the instrument by a pressing force between the skin and the pressure ring for lancing, expression of sample liquid from the tissue, and collecting an amount of sample liquid for analysis.

7. The instrument according to claim 1, wherein the pressing force at the time of triggering is at least 5 N.

8. An instrument for producing a body fluid sample by piercing skin and for analyzing the body fluid sample, the instrument comprising:

a lancing element having a piercing tip;

a sample collection device for collecting an amount of body fluid sample required for analysis;

a disposable analysis element;

a housing;

a lancing drive within the housing connected to the lancing element and for driving the lancing element connected thereto in a puncturing movement in which the lancing element moves, after triggering the puncturing movement, in a puncture direction until the lancing element reaches a point of maximum displacement and in a reverse direction after the lancing element has reached the point of maximum displacement;

a pressure ring configured to be pressed against the skin such that the skin bulges into a skin contact opening for promoting expression of body fluid;

a holding device for holding the disposable analysis element in the housing such that the body fluid sample is transported thereto from the sample collection device for analysis; and

a pressing force control device that controls a pressing force between the pressure ring and the skin, and a device for automatically triggering the puncturing movement when the pressing force corresponds to a value of at least 3 N, and

wherein the instrument provides a minimum interaction time period of at most 3 seconds, starting from the automatic triggering of the puncturing movement, for which every user must at least interact with the instrument by the pressing force between the skin and the pressure ring of the instrument for lancing, expression of sample liquid from the tissue and collecting an amount of sample liquid for analysis.

9. The instrument according to claim 8, wherein the minimum interaction time period is not more than 2 seconds.

10. The instrument according to claim 8, wherein the pressing force control device comprises a spring device arranged such that one end of the spring device acts against the pressure ring and the other end of the spring device acts against the housing.

11. The instrument according to claim 10, wherein the spring device is pre-tensioned such that the force of the spring device acting on the pressure ring varies by not more than 20% within the spring-loaded movement range of the pressure ring.

12. The instrument according to claim 10, wherein the lancet drive is connected with the pressure ring in a defined spatial configuration, such that the distance between the point of maximum displacement of the lancet movement and the pressure ring is independent from the compression status of the spring device and from the axial movement position of the pressure ring.

13. The instrument according to claim 10, further comprising, a pressure ring movement limiting arrangement, by which the maximum displacement of the pressure ring is limited within a spring-loaded movement range of the pressure ring.

14. The instrument according to claim 13, wherein the pressure ring movement limiting arrangement comprises a contact surface in the vicinity of the pressure ring, configured such that when a body part is pressed against the pressure ring and thereby moves the pressure ring, the body part abuts against the contact surface.

15. The instrument according to claim 8, wherein the pressure ring has a mean width of at least 0.5 mm and at most 3.5 mm.

16. The instrument according to claim 8, wherein the device for automatically triggering the puncturing movement triggers the puncturing movement when the pressing force corresponds to a value of at least 5 N.

17. The instrument according to claim 8, wherein the pressure ring defines an opening area corresponding to a circle with a diameter of at least 3 mm.

18. The instrument according to claim 8, wherein the pressure ring defines an opening area corresponding to a circle with a diameter of at most 6 mm.

19. The instrument according to claim 8, wherein the pressure ring defines an opening area corresponding to a circle with a diameter of at most 5 mm.

20. A lancing system for producing a body fluid sample analysis by piercing the skin, the system comprising:

a reusable hand-held-instrument comprising,

a housing;

a lancing drive within the housing connected to a lancing element and for driving a lancing element connected thereto in a puncturing movement in which the lancing element moves, after triggering the puncturing movement, in a puncture direction until the lancing element reaches a point of maximum displacement and in a reverse direction after the lancing element has reached the point of maximum displacement;

a pressure ring configured to be pressed against the skin such that the skin bulges into a skin contact opening for promoting expression of body fluid, wherein the pressure ring defines an opening area corresponding to a circle with a diameter of at least 3 mm and at most 8 mm;

a pressing force control device for controlling a pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, wherein the pressing force is at least 3 N at the time of triggering;

a holding device for holding an analysis element in the housing such that a body fluid sample is transported thereto from the sample collection device for analysis; and

a lancing element interchangeably connected to the drive of the instrument,

wherein the instrument works without a z-position detection means and without a penetration depth reference element configured for contacting the skin that bulges into the pressure ring.

21. The lancing system according to claim 20, wherein the lancing element is a part of an integral lancing and analysis element.

22. The lancing system according to claim 20, wherein the lancing element is a direct sampler having a capillary channel for transporting the body fluid produced by piercing the skin by capillary flow to a sample collection zone thereof.

23. The lancing system according to claim 20, further comprising, a fluid communication device configured such that body fluid sample can be transferred from a sample collection zone of the lancing element to the analysis element for analysis.

24. The lancing system according to claim 20, wherein the hand-held-instrument comprises a device for automatically triggering the puncturing movement when the pressing force corresponds to a value of at least 3 N;

and

the hand-held-instrument provides a minimum interaction time period of at most 3 seconds, starting from the triggering of the puncturing movement, for which every user must at least interact with the hand-held-instrument by a pressing force between the skin and the pressure ring for lancing, expression of sample liquid from the tissue, and collecting an amount of sample liquid for analysis.