Sampling device and sampling method

• US 10,022,081 B2
• Filed: 03/10/2010
• Issued: 07/17/2018
• Est. Priority Date: 03/10/2009
• Status: Active Grant

• Current Assignee: 908 Devices GmbH (908 Devices Inc.)
• Original Assignee: Trace Analytics, GmbH (908 Devices Inc.)
• Inventors: Kunnecke, Wolfgang
• Primary Examiner(s): Towa, Rene
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US13/256,184
• Publication Number:
  US 20120071788A1
• Time in Patent Office: 3,051 Days
• Field of Search: 600573
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14525 using microdialysis
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150366 Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag collection bags as such A61J1/05, A61M1/0209
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus

Abstract

The present invention relates to a sampling device, a sampling system and a method of sampling, and in particular a method of analysis, for application to a living entity.

Claims

1. A sampling device for a sampling access to detect the presence of analyte in a sample, comprising:

a sample chamber taking the form of an internal cavity enclosed within the sampling device, wherein the sample chamber includes a first opening in a first end of the sampling device, said first opening being a sample inlet to receive a sample and a second opening at a second end of the sampling device opposite said first end;

an analyte receiving chamber enclosed within the sampling device and surrounding a portion of the sample chamber;

a separating medium defining an interface between the sample chamber and the analyte receiving chamber, the separating medium adapted to allow the analyte to pass through from the sample chamber into the analyte receiving chamber;

an infeed line passage extending from an infeed line passage opening in the second end of the sampling device to an analyte receiving chamber inlet opening; and

an outfeed line passage extending from an analyte receiving chamber outlet opening to an outfeed line passage opening in the second end of the sampling device,

wherein said sampling device is adapted so that fluid fed into the infeed line passage opening flows into a first end of the analyte receiving chamber, then along the length of the analyte receiving chamber to a second end of the analyte receiving chamber, before flowing into the outfeed line passage and exiting through the outfeed line passage opening.

2. The sampling device of claim 1, wherein a cross-section of the sampling device where the analyte receiving chamber surrounds the sample chamber includes a ring-shaped analyte receiving chamber surrounding a circular sample chamber separated by a ring-shaped separating medium.

3. The sampling device of claim 1, wherein the first end of the analyte receiving chamber is located at the second end of the sampling device and the second end of the analyte receiving chamber is located at the first end of the sampling device.

4. The sampling device of claim 1, wherein at least one of:

the sample chamber takes the form of a passage extending through the sampling device

the sampling device is designed for fitting to a medical sampling access that includes at least one of a hollow needle, a cannula, a catheter, a port, an aspirator, a drain, a reservoir and a connector, and

the sampling device is designed for connection by positive interengagement, a normal force and/or friction to the medical sampling access.

5. The sampling device of claim 1, wherein the sampling device is integrally connected to the sampling access.

6. The sampling device of claim 1, wherein at least one of:

the sampling device is designed to receive the sample that is selected from at least one of blood, blood plasma, lymph, tissue fluid, cerebrospinal fluid, synovial fluid, gastric juice, gall and urine, and

the separating medium is designed to allow the passage of the analyte selected from glucose, lactose, lactate, Na⁺, K⁺, Cl⁻

, H₃O⁺, O₂, CO₂, ammonium, ammonia, methanol, ethanol, formate, acetate, glutamine, glutamate, urea, uric acid, phosphate, antibodies, growth factors, hormones, medications, and narcotics and anesthetics.

7. The sampling device of claim 1, wherein the separating medium is a membrane and the material of the membrane is selected from the group comprising cellulose and derivatives thereof that include at least one of cellulose acetate, PTFE, polycarbonate, polypropylene, polyamides, polyesters, polyethersulfones and polysulfones.

8. The sampling device of claim 1, wherein at least one of:

the inside diameter of the infeed-line passage and/or the outfeed-line passage, at the analyte receiving chamber, is from 0.01 to 2 mm, and

the interface of the separating medium that connects the sample chamber to the analyte receiving chamber is has an area from 0.5 to 350 mm².

9. The sampling device as claimed in claim 1, wherein at least one of:

the inside diameter of the infeed-line passage and/or the outfeed-line passage, at the analyte receiving chamber, is from 0.25 to 0.5 mm, and/or

the interface of the separating medium that connects the sample chamber to the analyte receiving chamber has an area from 1 to 50 mm².

10. The sampling device as claimed in claim 1, wherein at least one of:

the inside diameter of the infeed-line passage and/or the outfeed-line passage, at the analyte receiving chamber, is from 0.23 to 0.26 mm, and

the interface of the separating medium that connects the sample chamber to the analyte receiving chamber has an area from 2 to 35 mm².

11. The sampling device of claim 5, wherein the sampling access comprises at least one medical sampling access selected from the group consisting of a hollow needle, a cannula, a catheter, a port, an aspirator, a drain, a reservoir, and a connector.

12. A sampling system, comprising

the sampling device of claim 1,

a sensor connection for connecting a sensor for detecting analyte in a transporting medium,

an infeed line, in fluid communication with the infeed-line passage of the sampling device,

an outfeed line, in fluid communication with the outfeed-line passage of the sampling device and with the sensor connection,

a first pump to transport a medium through the outfeed line to the sensor connection.

13. The sampling system of claim 12, further comprising:

a supply of transporting medium and/or

a supply of calibrating medium and/or

a supply of flushing medium,

that are/is in fluid communication, or can be placed in fluid communication, with the infeed line.

14. The sampling system of claim 13, wherein the first pump is arranged between (a) the supply of transporting medium and/or the supply of calibrating medium and/or the supply of flushing medium and (b) the infeed-line passage of the sampling device, to allow medium to be transported from the given supply of medium through the infeed line into the infeed-line passage, and further comprising a control system connected to the first pump, to control the latter in such a way that:

Step a;

transporting medium is present in the analyte receiving chamber for a preselected time and then

Step b;

transporting medium is transported from the analyte receiving chamber into the outfeed-line passage.

15. The sampling system of claim 12, further comprising a control system, connected to the second pump, to control the second pump in such a way that

Step 1:

the sample is drawn by suction into the sample chamber,

Step 2;

the sample that was drawn in is present in the sample chamber for a preselected time and then

Step 3;

the sample that was drawn in is expelled from the sample chamber,

the control system being so arranged that the first pump is controlled in such a way that, in step 2;

Step a);

transporting medium is present in the analyte receiving chamber for a preselected time and then

Step b);

transporting medium is transported from the analyte receiving chamber into the outfeed-line passage.

16. The sampling system of claim 12, further comprising at least one of:

in fluid communication with the sensor connection, a sensor arranged to determine an analyte selected from glucose, lactose, lactate, Na⁺, K⁺, Cl′

, H30⁺, O2, CO2, ammonium, ammonia, methanol, ethanol, formate, acetate, glutamine, glutamate, urea, uric acid, phosphate, antibodies, growth factors, hormones, medications, and narcotics and anesthetics, and

the sampling system being designed to receive the sample selected from blood, blood plasma, lymph, tissue fluid, cerebrospinal fluid, synovial fluid, gastric juice, gall and urine, and

the sampling system further comprising a bypass line for the placing in fluid communication of the supply of transporting medium and/or the supply of calibrating medium and/or the supply of flushing medium with the sensor connection, without the medium passing through the analyte receiving chamber of the sensor device.

17. The sampling system of claim 12, further comprising a sampling line and, connected thereto, a second pump for pumping the sample into the sample chamber.

18. A sampling device to detect the presence of analyte in a sample, comprising

a hollow needle comprising:

a sample chamber taking the form of an internal cavity enclosed within the hollow needle, wherein the sample chamber includes a first opening in a first end of the hollow needle, said first opening being a sample inlet to receive a sample and a second opening at a second end of the sampling device opposite said first end;

an analyte receiving chamber enclosed within the hollow needle and surrounding a portion of the sample chamber;

a separating medium defining an interface between the sample chamber and the analyte receiving chamber, the separating medium adapted to allow the analyte to pass through from the sample chamber into the analyte receiving chamber;

an infeed line passage extending from an infeed line passage opening in the second end of the hollow needle to an analyte receiving chamber inlet opening; and

an outfeed line passage extending from an analyte receiving chamber outlet opening to an outfeed line passage opening in the second end of the hollow needle,

wherein said sampling device is adapted so that fluid fed into the infeed line passage opening flows into a first end of the analyte receiving chamber, then along the length of the analyte receiving chamber to a second end of the analyte receiving chamber, before flowing into the outfeed line passage and exiting through the outfeed line passage opening.