# US 10,869,625 B2 · Sampling device and system for collecting a body fluid sample

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- Number: US 10,869,625 B2
- Document ID: US10869625B2
- Status: Granted
- Kind: B2
- Application number: 15/717,253
- Filed: 2017-09-27
- Published: 2018-03-29
- Granted: 2020-12-22
- Earliest claimed: 2016-09-28
- Assignees: Roche Diabetes Care, Inc.
- Applicants: Roche Diabetes Care, Inc.
- Inventors: Wilhelm Leichner
- Web page: https://patentgrep.com/patent/US10869625B2

## CPC

- A61B 5/157: {Devices} characterised by integrated means for measuring characteristics of blood
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/1477: non-invasive
- A61B 5/150022: {for capillary blood or interstitial fluid}
- A61B 5/150358: {Strips for collecting blood, e.g. absorbent}
- A61B 5/150419: {comprising means for capillary action}
- A61B 5/15045: {comprising means for capillary action}
- A61B 5/150519: {Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device}
- A61B 5/15107: {Piercing being assisted by a triggering mechanism}
- A61B 5/15113: {Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button}
- A61B 5/15144: {comprising driving means, e.g. a spring, for retracting the piercing unit into the housing}
- 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}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## 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.

## Claims

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 5)

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

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 7)

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

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 10)

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

### Claim 12 (depends on 10)

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.

### Claim 13 (depends on 1)

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.

### Claim 14 (depends on 13)

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

### Claim 15 (depends on 1)

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.

### Claim 16 (depends on 15)

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

### Claim 17 (depends on 15)

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

### Claim 18 (depends on 1)

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

### Claim 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.
