Sampling device and system for collecting a body fluid sample

Patent metadata

Field	Value
Publication number	US-10869625-B2
Application number	US-201715717253-A
Country	US
Kind code	B2
Filing date	Sep 27, 2017
Priority date	Sep 28, 2016
Publication date	Dec 22, 2020
Grant date	Dec 22, 2020

Abstract

This disclosure concerns a sampling device and a system for collecting body fluid, comprising a metal lancing unit having a distal tip suitable for piercing skin and a capillary channel extending between the tip and a proximal section of the lancing unit for collecting body fluid; and further comprising a plastic holding unit affixed to the lancing unit for manipulating the lancing unit in order to form an incision in the skin, wherein the holding unit contains a sorbent adapted for sorption of moisture and/or volatile substances to protect the sampling device from degradation prior to use.

First claim

What is claimed is:

1. A sampling device for collecting a body fluid sample, comprising:
a metal lancing unit having a distal tip configured for piercing skin and a capillary channel extending between the tip and a proximal section of the lancing unit for collecting body fluid;
a plastic holding unit affixed to the lancing unit and configured for manipulating the lancing unit to form an incision in the skin;
a test pad supported between the plastic holding unit and the lancing unit, the test pad contacting the lancing unit; and
the holding unit containing a sorbent adapted for sorption of moisture and/or volatile substances to protect the sampling device from degradation prior to use.

2. The sampling device of claim 1 , wherein the sorbent is selected from the group consisting of carbon black, activated carbon, graphite, desiccant polymers, silica gel, zeolites, ion exchange resins, molecular sieve materials.

3. The sampling device of claim 1 , wherein the sorbent is dispersed in the plastic material of the holding unit or disposed therein or coated thereon.

4. The sampling device of claim 1 , wherein the holding unit is formed from an injection molded component from a molding composition containing the sorbent.

5. The sampling device of claim 1 , wherein the holding unit comprises a plastic structure adapted for releasable engagement of an actuation mechanism.

6. The sampling device of claim 5 , wherein the holding unit has a hole or a recess.

7. The sampling device of claim 1 , wherein the lancing unit comprises an elongate piece of a flat material.

8. The sampling device of claim 7 , wherein the lancing unit is formed from a sheet of stainless steel.

9. The sampling device of claim 1 , wherein the capillary channel comprises a groove or slit which is laterally open to the outside on one side or on two opposite sides.

10. The sampling device of claim 1 , wherein the test paid is adapted for detecting at least one analyte in the body fluid and arranged to receive body fluid via the capillary channel.

11. The sampling device of claim 10 , wherein the test paid is in fluidic connection to the capillary channel.

12. The sampling device of claim 10 , wherein the test pad is retained on a surface area of the holding unit and the surface area confines a measuring window for an optical detection of the analyte.

13. The sampling device of claim 1 , wherein the holding unit is fixedly connected to a proximal part of the lancing unit via form-locked connecting elements.

14. The sampling device of claim 13 , wherein the form-locked connecting elements comprise riveted pins.

15. A sampling system for collecting a sample of a body fluid comprising a sampling device according to claim 1 and further comprising an actuator operable to drive a lancing movement of the lancing unit, wherein the actuator comprises a metallic driving member adapted to engage a plastic structure of the holding unit.

16. The sampling system of claim 15 , wherein the metallic driving member comprises a gripper or hook.

17. The sampling system of claim 15 , wherein the plastic structure has a hole or a recess in the holding unit.

18. The sampling unit of claim 1 , wherein the test pad comprises a test chemistry configured for detecting an analyte in the body fluid sample.

19. A sampling device for collecting a body fluid sample, comprising:
a metal lancing unit having a distal tip configured for piercing skin and a capillary channel extending between the tip and a proximal section of the lancing unit for collecting body fluid;
a one-piece plastic holding unit affixed to the lancing unit and configured for manipulating the lancing unit to form an incision in the skin;
a test pad supported between the plastic holding unit and the lancing unit; and
the holding unit containing a sorbent adapted for sorption of moisture and/or volatile substances to protect the sampling device from degradation prior to use.

Assignees

• Roche Diabetes Care Inc

Inventors

• Leichner Wilhelm

Classifications

• A61B5/150022 Primary

  for capillary blood or interstitial fluid · CPC title

• A61B5/15107

  Piercing being assisted by a triggering mechanism · CPC title

• A61B5/15045

  comprising means for capillary action · CPC title

• A61B5/150519

  Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device · CPC title

• A61B5/15194

  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 title